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00:00:07,246 --> 00:00:09,849
EVERYONE TO THE ETHICAL AND 

2
00:00:09,849 --> 00:00:14,520
REGULATORY ASPECTS OF CLINICAL 

3
00:00:14,520 --> 00:00:16,722
RESEARCH 2024 AND THIRD TIME 

4
00:00:16,722 --> 00:00:20,426
THAT DEPARTMENT OF BIOETHICS HAS

5
00:00:20,426 --> 00:00:21,560
OFFERED THIS COURSE. 

6
00:00:21,560 --> 00:00:24,030
I'M HOLLY TAYLOR AND FACULTY IN 

7
00:00:24,030 --> 00:00:26,198
THE DEPARTMENT OF BIOETHICS AND 

8
00:00:26,198 --> 00:00:28,334
WILL BE YOUR COURSE DIRECTOR. 

9
00:00:28,334 --> 00:00:30,102
YOU WILL SEE ME MULTIPLE TIMES 

10
00:00:30,102 --> 00:00:32,605
AND WE ALSO HAVE OTHER FACULTY 

11
00:00:32,605 --> 00:00:34,874
FROM THE DEPARTMENT AND GUEST 

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FACULTY THAT WILL JOIN US EITHER

13
00:00:36,442 --> 00:00:38,310
IN PERSON OR VIRTUALLY 

14
00:00:38,310 --> 00:00:40,913
THROUGHOUT THE TERM. 

15
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I AM GOING TO GIVE YOU ALL A 

16
00:00:43,382 --> 00:00:45,084
RELATIVELY QUICK INTRODUCTION TO

17
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THE COURSE WITH A FOCUS ON SOME 

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00:00:48,187 --> 00:00:51,690
LOGISTICS OF USING CANVAS, WHICH

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00:00:51,690 --> 00:00:56,562
IS THE WEB-BASED PROGRAM WE ARE 

20
00:00:56,562 --> 00:00:58,297
USING TO RUN THE COURSE. 

21
00:00:58,297 --> 00:01:00,933
IF YOU COULD PUT MY SLIDES UP ON

22
00:01:00,933 --> 00:01:03,235
THE SCREEN. 

23
00:01:03,235 --> 00:01:13,512
SO THIS IS ME. 

24
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QUICK DISCLAIMER AND REMINDER WE

25
00:01:17,149 --> 00:01:19,351
ARE SPEAKING ON BEHALF OF 

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OURSELVES AND NOT TAKING AN 

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OFFICIAL POSITION AS IT RELATES 

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TO NIEHS DHH OR US GOVERNMENT 

29
00:01:28,260 --> 00:01:30,529
AND I WON'T READ ALL OF THE 

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OBJECTIVES. 

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THESE ARE IN THE SYLLABUS YOU 

32
00:01:32,431 --> 00:01:33,933
CAN REFER TO. 

33
00:01:33,933 --> 00:01:35,201
THERE IS OBJECTIVES FOR THE 

34
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COURSE AS WELL AS FOR EACH 

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00:01:37,036 --> 00:01:37,403
SESSION. 

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00:01:37,403 --> 00:01:39,105
I HAVE JUST HIGHLIGHTED A COUPLE

37
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OF THINGS HERE; RIGHT?  

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DR. GRADY WILL INTRODUCE A 

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00:01:44,810 --> 00:01:46,345
FRAMEWORK THIS MORNING THAT WILL

40
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BE A BASIS FOR THE COURSE AND 

41
00:01:48,848 --> 00:01:50,783
LOOKING MORE CLOSELY AT SOME OF 

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00:01:50,783 --> 00:01:54,820
THE KEY PRINCIPLES IN THE 

43
00:01:54,820 --> 00:01:55,421
FRAMEW

44
00:01:55,421 --> 00:01:55,721
FRAMEWORK. 

45
00:01:55,721 --> 00:01:57,456
WE WILL TALK ABOUT CODES AND 

46
00:01:57,456 --> 00:01:58,624
REGULATIONS AND I SHOULD SAY 

47
00:01:58,624 --> 00:02:01,760
THAT WE ARE IN THE US AND AT NIH

48
00:02:01,760 --> 00:02:03,963
AND MOST OF WHAT WE WILL TALK 

49
00:02:03,963 --> 00:02:05,664
ABOUT IS US CENTRIC. 

50
00:02:05,664 --> 00:02:08,834
I AM HOPING THAT MUCH OF THIS IS

51
00:02:08,834 --> 00:02:11,570
RELEVANT TO THOSE NOT IN THE US 

52
00:02:11,570 --> 00:02:14,974
AND FEEL FREE TO ASK QUESTIONS 

53
00:02:14,974 --> 00:02:16,408
ABOUT THINGS AND I CAN MAYBE 

54
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REFER YOU TO RESOURCES IF IT IS 

55
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NOT SOMETHING I KNOW BECAUSE I'M

56
00:02:22,748 --> 00:02:24,450
GENERALLY DOMESTICALLY FOCUSED. 

57
00:02:24,450 --> 00:02:27,686
WE WILL TALK ABOUT IRBS AND 

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INFORMED CONSENT AND RISKS AND 

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BENEFITS AND FAIR SUBJECT 

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SELECTION AND WILL HAVE A DAY ON

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GENETICS RESEARCH AND WILL HAVE 

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A PANEL THIS YEAR OF INDIVIDUALS

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WHO HAVE PARTICIPATED IN 

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CLINICAL RESEARCH HERE AT 

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CLINICAL CENTER THAT I'M REALLY 

66
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EXCITED ABOUT AND WILL END THE 

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TERM WITH A PANEL OR THREE 

68
00:02:52,912 --> 00:02:54,914
DIFFERENT LECTURES ON 

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INTERNATIONAL COLLABORATIVE 

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RESEARCH. 

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00:02:57,449 --> 00:02:59,018
HERE IS THE OVERVIEW. 

72
00:02:59,018 --> 00:03:00,419
THIS IS ALSO IN THE SYLLABUS 

73
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JUST TO GIVE YOU A SNAPSHOT. 

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00:03:02,555 --> 00:03:05,691
THESE ARE TOPICS WE WILL COVER. 

75
00:03:05,691 --> 00:03:07,760
AS YOU KNOW, WE MEET EVERY 

76
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WEDNESDAY MORNING AT 8:30. 

77
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THIS IS A WAY FOR YOU TO CHECK 

78
00:03:12,531 --> 00:03:15,968
IN ON WHAT WILL HAPPEN EACH DAY.

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00:03:15,968 --> 00:03:18,637
ON THE SYLLABUS, YOU WILL FIND 

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00:03:18,637 --> 00:03:20,406
ADDITIONAL INFORMATION AND 

81
00:03:20,406 --> 00:03:23,209
REMINDER THAT WE LIVESTREAM 

82
00:03:23,209 --> 00:03:26,745
BETWEEN 8:30 AND 11:30 A.M. US 

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EASTERN. 

84
00:03:27,446 --> 00:03:29,415
THIS IS NOT RELEVANT TO THOSE 

85
00:03:29,415 --> 00:03:31,083
THAT ARE NOT LISTENING. 

86
00:03:31,083 --> 00:03:32,451
IF YOU HAVE TO MISS A SESSION 

87
00:03:32,451 --> 00:03:35,321
FOR EXAMPLE OR HAVE A SCHEDULING

88
00:03:35,321 --> 00:03:37,089
CONFLICT THROUGHOUT THE TERM, 

89
00:03:37,089 --> 00:03:38,424
THE COURSE -- MY RECORDING OF 

90
00:03:38,424 --> 00:03:40,292
THIS AND ALL OF THE LECTURES 

91
00:03:40,292 --> 00:03:42,962
TODAY WILL BE POSTED ON THE 

92
00:03:42,962 --> 00:03:45,197
CANVAS SITE AND ON THE PAST 

93
00:03:45,197 --> 00:03:47,433
EVENTS FOR THE NIH VIDEO CAST 

94
00:03:47,433 --> 00:03:49,868
WHERE YOU ARE ALL LINKED IN NOW 

95
00:03:49,868 --> 00:03:52,004
ABOUT 48 HOURS LATER. 

96
00:03:52,004 --> 00:03:53,939
SO SOON AS THOSE ARE AVAILABLE, 

97
00:03:53,939 --> 00:03:55,307
I WILL POST THEM. 

98
00:03:55,307 --> 00:03:57,443
YOU CAN REVIEW THEM THEN. 

99
00:03:57,443 --> 00:03:59,578
AND IT MIGHT BE A SHORTER TIME 

100
00:03:59,578 --> 00:04:01,513
OR A LITTLE LONGER TIME. 

101
00:04:01,513 --> 00:04:04,383
THAT IS GENERALLY WHEN OUR GREAT

102
00:04:04,383 --> 00:04:07,686
AV CREW IS ABLE TO GET THE 

103
00:04:07,686 --> 00:04:08,921
MATERIAL TO ME. 

104
00:04:08,921 --> 00:04:10,689
ALL OF YOU -- NOT EVERYONE BUT 

105
00:04:10,689 --> 00:04:13,259
MOST THAT ARE LISTENING HAVE 

106
00:04:13,259 --> 00:04:14,260
ENROLLED IN THE COURSE. 

107
00:04:14,260 --> 00:04:17,162
THAT MEANS YOU HAVE ACCESS TO 

108
00:04:17,162 --> 00:04:17,396
CANVAS. 

109
00:04:17,396 --> 00:04:19,331
FOR ANYONE JUST LISTENING TO 

110
00:04:19,331 --> 00:04:20,833
THE LIVESTREAM AND YOU WANT TO 

111
00:04:20,833 --> 00:04:22,568
HAVE ACCESS TO COURSE MATERIALS,

112
00:04:22,568 --> 00:04:25,337
WHAT YOU WILL NEED TO DO IS 

113
00:04:25,337 --> 00:04:28,207
ENROLL IN CANVAS. 

114
00:04:28,207 --> 00:04:29,942
AND THAT INFORMATION IS 

115
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AVAILABLE. 

116
00:04:30,242 --> 00:04:32,077
I WILL -- LET'S SEE. 

117
00:04:32,077 --> 00:04:33,178
WE WILL MAKE SURE THAT 

118
00:04:33,178 --> 00:04:35,147
INFORMATION -- IT IS AVAILABLE 

119
00:04:35,147 --> 00:04:37,916
ON THE DEPARTMENT OF BIOETHICS 

120
00:04:37,916 --> 00:04:38,183
WEBSITE. 

121
00:04:38,183 --> 00:04:42,121
IF YOU GOOGLE NIH DEPARTMENT OF 

122
00:04:42,121 --> 00:04:43,989
BIOETHICS AND GO TO COURSES, YOU

123
00:04:43,989 --> 00:04:46,091
WILL FIND INFORMATION YOU NEED 

124
00:04:46,091 --> 00:04:47,226
TO SELF-ENROLL. 

125
00:04:47,226 --> 00:04:50,729
IF YOU WANT A CERTIFICATE OF 

126
00:04:50,729 --> 00:04:53,232
COMPLETION, YOU NEED TO ALSO 

127
00:04:53,232 --> 00:04:53,599
SELF-REGISTER. 

128
00:04:53,599 --> 00:04:56,001
THERE IS A SURVEY QUIZ ON CANVAS

129
00:04:56,001 --> 00:04:56,902
YOU NEED TO COMPLETE. 

130
00:04:56,902 --> 00:05:00,439
MANY OF YOU HAVE DONE THAT 

131
00:05:00,439 --> 00:05:00,839
ALREADY. 

132
00:05:00,839 --> 00:05:01,740
THANK YOU VERY MUCH. 

133
00:05:01,740 --> 00:05:04,243
IN ORDER TO GET A CERTIFICATE --

134
00:05:04,243 --> 00:05:06,912
A GENERAL CERTIFICATE, YOU NEED 

135
00:05:06,912 --> 00:05:08,113
TO COMPLETE THREE SESSION 

136
00:05:08,113 --> 00:05:11,050
QUIZZES THAT ARE ALL IN CANVAS 

137
00:05:11,050 --> 00:05:12,785
AT THE END OF EACH MODULE. 

138
00:05:12,785 --> 00:05:14,720
I THINK I HAVE AN EXAMPLE OF 

139
00:05:14,720 --> 00:05:16,422
THAT IN A SECOND. 

140
00:05:16,422 --> 00:05:18,857
FOR THOSE GETTING THE GENERAL 

141
00:05:18,857 --> 00:05:19,525
CERTIFICATE, YOU NEED TO 

142
00:05:19,525 --> 00:05:21,126
COMPLETE THREE OF THE QUIZZES. 

143
00:05:21,126 --> 00:05:23,162
IF YOU ARE COMPLETING THE COURSE

144
00:05:23,162 --> 00:05:26,265
TOWARDS THE NIH CORE CURRICULUM 

145
00:05:26,265 --> 00:05:29,234
ON CLINICAL RESEARCH, YOU NEED 

146
00:05:29,234 --> 00:05:30,703
TO COMPLETE AT LEAST SIX OF 

147
00:05:30,703 --> 00:05:32,705
THOSE AND YOU MIGHT AS WELL DO 

148
00:05:32,705 --> 00:05:34,773
ALL 7. 

149
00:05:34,773 --> 00:05:36,975
SO IN ADDITION TO THE QUIZ AND 

150
00:05:36,975 --> 00:05:41,714
THAT IS, AGAIN, IN CANVAS, ALEX,

151
00:05:41,714 --> 00:05:44,249
WHO IS MY ASSISTANT THIS TERM IS

152
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GOING TO SECOND YOU A SESSION 

153
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EVALUATION THAT IS TO GIVE US 

154
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FEEDBACK ABOUT WHETHER WE ARE 

155
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SHARING, MEETING THE GOALS AND 

156
00:05:53,826 --> 00:05:54,793
OBJECTIVES AND GETTING 

157
00:05:54,793 --> 00:05:57,529
INFORMATION TO YOU IN A CLEAR 

158
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WAY. 

159
00:05:57,796 --> 00:06:01,166
SO YOU WILL RECEIVE THAT BY 

160
00:06:01,166 --> 00:06:01,734
E-MAIL. 

161
00:06:01,734 --> 00:06:04,436
PLEASE SEND, YOU KNOW, RETURN 

162
00:06:04,436 --> 00:06:04,803
THAT. 

163
00:06:04,803 --> 00:06:06,472
SO THESE WILL COME TO YOU BY 

164
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E-MAIL AND QUIZZES FOR THE 

165
00:06:08,307 --> 00:06:09,541
SESSIONS WILL NOT. 

166
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WILL YOU HAVE TO GO IN AND 

167
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COMPLETE THOSE. 

168
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NOW, LAST WEEK, I SENT OUT THE 

169
00:06:16,548 --> 00:06:19,485
PRECOURSE ASSESSMENT. 

170
00:06:19,485 --> 00:06:23,222
THANK YOU TO THE 300 + OF YOU 

171
00:06:23,222 --> 00:06:25,023
WHO COMPLETED THAT ASSIGNMENT. 

172
00:06:25,023 --> 00:06:26,158
IT IS NOW CLOSED. 

173
00:06:26,158 --> 00:06:28,093
I WANTED TO GET YOUR KNOWLEDGE 

174
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BEFORE THE COURSE BEGINS. 

175
00:06:29,228 --> 00:06:31,630
IF YOU DIDN'T HAVE A CHANCE TO 

176
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COMPLETE IT, NOT A PROBLEM.  YOU

177
00:06:33,832 --> 00:06:36,435
-- IT IS CLOSED. 

178
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YOU CAN'T. 

179
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WILL YOU HAVE ANOTHER CHANCE AT 

180
00:06:38,170 --> 00:06:39,872
THE END OF THE COURSE. 

181
00:06:39,872 --> 00:06:42,040
I WILL SEND OUT BY E-MAIL A POST

182
00:06:42,040 --> 00:06:44,042
COURSE ASSESSMENT. 

183
00:06:44,042 --> 00:06:47,246
FEEL FREE TO SEND THAT BACK. 

184
00:06:47,246 --> 00:06:49,281
THAT IS -- THIS GOES TO EVERYONE

185
00:06:49,281 --> 00:06:52,418
WHO IS SELF-ENROLLED. 

186
00:06:52,418 --> 00:06:54,286
SO NOT JUST THOSE THAT HAVE 

187
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REGISTERED. 

188
00:06:54,753 --> 00:06:57,289
I WOULD LOVE TO HEAR FROM ALL OF

189
00:06:57,289 --> 00:06:57,689
YOU. 

190
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SO HOPEFULLY EVERYONE IS NOW 

191
00:07:00,426 --> 00:07:01,827
FAMILIAR WITH THIS WEBSITE. 

192
00:07:01,827 --> 00:07:05,731
THIS IS WHAT THE CANVAS HUB 

193
00:07:05,731 --> 00:07:08,767
LOOKS LIKE FROM YOUR 

194
00:07:08,767 --> 00:07:09,101
PERSPECTIVE. 

195
00:07:09,101 --> 00:07:11,270
IF YOU SELF-ENROLLED, IT SHOULD 

196
00:07:11,270 --> 00:07:13,939
HAVE TAKEN YOU RIGHT TO THIS 

197
00:07:13,939 --> 00:07:14,173
PLACE. 

198
00:07:14,173 --> 00:07:16,241
FOR SOME REASON IF YOU ARE 

199
00:07:16,241 --> 00:07:18,210
ENROLLED IN MULTIPLE CANVAS 

200
00:07:18,210 --> 00:07:19,511
COURSES, YOU MIGHT HAVE TO FIND 

201
00:07:19,511 --> 00:07:20,779
IT ON YOUR HOMEPAGE. 

202
00:07:20,779 --> 00:07:24,450
I WANTED TO HIGHLIGHT THE 

203
00:07:24,450 --> 00:07:25,083
SELF-REGISTRATION SURVEY. 

204
00:07:25,083 --> 00:07:28,320
IT IS AT THE TOP OF THE KEY 

205
00:07:28,320 --> 00:07:29,254
DOCUMENT SECTION. 

206
00:07:29,254 --> 00:07:31,223
YOU CAN CLICK RIGHT THERE OR 

207
00:07:31,223 --> 00:07:34,493
CLICK JUST TO THE RIGHT WHERE 

208
00:07:34,493 --> 00:07:37,229
THE BLUE HIGHLIGHTED VERSION OF 

209
00:07:37,229 --> 00:07:38,497
THE QUIZ IS. 

210
00:07:38,497 --> 00:07:41,433
AGAIN, THIS IS -- OOPS.  SORRY 

211
00:07:41,433 --> 00:07:43,702
THIS IS INSIDE OF CANVAS. 

212
00:07:43,702 --> 00:07:45,003
PLEASE COMPLETE THAT IF YOU 

213
00:07:45,003 --> 00:07:46,638
WOULD LIKE TO GET A CERTIFICATE 

214
00:07:46,638 --> 00:07:47,172
OF COMPLETION. 

215
00:07:47,172 --> 00:07:49,441
THERE IS THE BUTTON TO PUSH WHEN

216
00:07:49,441 --> 00:07:50,976
YOU GET THERE. 

217
00:07:50,976 --> 00:07:52,811
NOW, I JUST WANT TO SCROLL DOWN 

218
00:07:52,811 --> 00:07:54,746
A LITTLE AND SHARE A LITTLE MORE

219
00:07:54,746 --> 00:07:56,782
ABOUT WHAT IS ON THIS PAGE. 

220
00:07:56,782 --> 00:07:59,384
IF YOU SCROLL DOWN FROM THE KEY 

221
00:07:59,384 --> 00:08:00,986
DOCUMENTS, YOU WILL GET TO 

222
00:08:00,986 --> 00:08:04,423
SESSION 1 WHICH IS WHERE WE ARE 

223
00:08:04,423 --> 00:08:05,057
TODAY. 

224
00:08:05,057 --> 00:08:07,025
THE FIRST LINK ON EVERY MODULE 

225
00:08:07,025 --> 00:08:09,294
IS THE LINK TO THE VIDEOCAST. 

226
00:08:09,294 --> 00:08:12,898
SO IF YOU FORGET OR YOU HAVE NOT

227
00:08:12,898 --> 00:08:14,566
CLICKED IT IN YOUR WEB BROWSER 

228
00:08:14,566 --> 00:08:17,069
AS A PLACE TO RETURN TO, YOU CAN

229
00:08:17,069 --> 00:08:20,405
ALWAYS GO TO THE FIRST LINK IN 

230
00:08:20,405 --> 00:08:23,242
THE SESSION. 

231
00:08:23,242 --> 00:08:25,010
IN ADDITION, THERE IS A SESSION 

232
00:08:25,010 --> 00:08:26,845
SUMMARY FOR EACH DAY. 

233
00:08:26,845 --> 00:08:29,248
YOU CAN OPEN THAT.  AGAIN, 

234
00:08:29,248 --> 00:08:30,949
ORIENT YOURSELF WHAT WILL 

235
00:08:30,949 --> 00:08:33,418
HAPPEN.  OBJECTIVES AND SCHEDULE

236
00:08:33,418 --> 00:08:35,254
AND YOU WILL SEE THERE, THERE IS

237
00:08:35,254 --> 00:08:37,155
A LISTING OF THE READINGS. 

238
00:08:37,155 --> 00:08:39,658
THE READINGS ARE FOR YOU. 

239
00:08:39,658 --> 00:08:42,094
YOU ARE WELCOME TO REVIEW THEM. 

240
00:08:42,094 --> 00:08:43,962
YOU CAN LOOK AT THEM AFTER THE 

241
00:08:43,962 --> 00:08:46,465
CLASS HAS ENDED AND SOME MAY BE 

242
00:08:46,465 --> 00:08:48,267
RESOURCES FOR YOU MOVING ON. 

243
00:08:48,267 --> 00:08:51,003
BUT ALL OF THE READINGS ARE 

244
00:08:51,003 --> 00:08:53,906
LINKED IN THE MODULE. 

245
00:08:53,906 --> 00:08:55,908
SO, FOR TODAY, FOR EXAMPLE, HERE

246
00:08:55,908 --> 00:08:57,409
ARE THE READINGS. 

247
00:08:57,409 --> 00:08:59,244
YOU SHOULD BE ABLE TO CLICK ON 

248
00:08:59,244 --> 00:09:00,946
EACH ONE OF THOSE. 

249
00:09:00,946 --> 00:09:03,949
THEY SHOULD COME UP. 

250
00:09:03,949 --> 00:09:05,484
I CHECKED THEM ALL YESTERDAY. 

251
00:09:05,484 --> 00:09:06,485
THEY WERE WORKING. 

252
00:09:06,485 --> 00:09:09,388
THAT IS WHERE YOU GET ACCESS TO 

253
00:09:09,388 --> 00:09:10,322
YOUR READINGS. 

254
00:09:10,322 --> 00:09:14,526
AND THEN THE SESSION QUIZZES ARE

255
00:09:14,526 --> 00:09:18,096
ALWAYS AT THE VERY BOTTOM OF THE

256
00:09:18,096 --> 00:09:18,497
MODULE. 

257
00:09:18,497 --> 00:09:20,432
AFTER TODAY'S LECTURE, I WILL --

258
00:09:20,432 --> 00:09:24,136
YOU WILL BE ABLE TO GO TO THAT 

259
00:09:24,136 --> 00:09:26,939
QUIZ AT 11:30 AND COMPLETE IT.  

260
00:09:26,939 --> 00:09:30,943
YOU DON'T HAVE TO DO IT UNTIL 

261
00:09:30,943 --> 00:09:31,209
11:30. 

262
00:09:31,209 --> 00:09:33,412
IT WILL OPEN AFTER THE COURSE 

263
00:09:33,412 --> 00:09:35,247
ENDS BUT IS ALWAYS AT THE END OF

264
00:09:35,247 --> 00:09:37,015
THE MODULE. 

265
00:09:37,015 --> 00:09:40,018
ONE OR TWO MORE THINGS FOR 

266
00:09:40,018 --> 00:09:40,419
TODAY. 

267
00:09:40,419 --> 00:09:43,155
SO AS WE HAVE -- I GUESS THERE 

268
00:09:43,155 --> 00:09:46,825
IS ABOUT 20 OF US HERE IN THE 

269
00:09:46,825 --> 00:09:48,360
AMPHITHEATRE, WHICH IS TOTALLY 

270
00:09:48,360 --> 00:09:49,995
AWESOME AND WILL MENTION THAT 

271
00:09:49,995 --> 00:09:52,431
ANYBODY ELSE ON THE NIH CAMPUS 

272
00:09:52,431 --> 00:09:55,000
AND WANTS TO JOIN US IN PERSON, 

273
00:09:55,000 --> 00:09:56,768
BY ALL MEANS, COME. 

274
00:09:56,768 --> 00:09:58,770
IT MEANS, A, IT IS LOVELY TO 

275
00:09:58,770 --> 00:10:01,373
HAVE PEOPLE IN THE AUDIENCE. 

276
00:10:01,373 --> 00:10:03,141
B, YOU GUYS ALWAYS GET FIRST 

277
00:10:03,141 --> 00:10:04,076
DIBS ON QUESTIONS. 

278
00:10:04,076 --> 00:10:07,112
IF YOU HAVE QUESTIONS IN THE AM 

279
00:10:07,112 --> 00:10:08,981
FEE THEATRE, THERE ARE TWO MICS 

280
00:10:08,981 --> 00:10:11,249
AND AV FOLKS WOULD LIKE YOU TO 

281
00:10:11,249 --> 00:10:12,417
GO USE THOSE SO EVERYONE CAN 

282
00:10:12,417 --> 00:10:13,385
HEAR THE QUESTION. 

283
00:10:13,385 --> 00:10:16,421
IF YOU ARE VIEWING ON VIDEOCAST 

284
00:10:16,421 --> 00:10:18,223
AND WANT TO ASK A QUESTION, CAN 

285
00:10:18,223 --> 00:10:19,825
YOU DO ONE OF TWO THINGS. 

286
00:10:19,825 --> 00:10:22,294
IF YOU ARE SELF-ENROLLED IN 

287
00:10:22,294 --> 00:10:24,529
CANVAS, YOU CAN GO TO THE PAGE 

288
00:10:24,529 --> 00:10:26,331
THAT I HAVE -- THE PLACE THAT I 

289
00:10:26,331 --> 00:10:28,867
HAVE CREATED ON THE DISCUSSIONS 

290
00:10:28,867 --> 00:10:32,037
BOARD THAT IS CALLED SESSION 1 

291
00:10:32,037 --> 00:10:32,337
QUESTIONS. 

292
00:10:32,337 --> 00:10:34,606
AND YOU CAN GO THERE AND ASK 

293
00:10:34,606 --> 00:10:35,641
YOUR QUESTION. 

294
00:10:35,641 --> 00:10:37,609
IF WE DON'T GET TO YOUR QUESTION

295
00:10:37,609 --> 00:10:40,812
DURING CLASS, I WILL ANSWER YOUR

296
00:10:40,812 --> 00:10:41,880
QUESTIONS ON THAT DISCUSSION 

297
00:10:41,880 --> 00:10:42,481
BOARD. 

298
00:10:42,481 --> 00:10:44,683
IF YOU ARE NOT IN CANVAS BUT 

299
00:10:44,683 --> 00:10:46,985
WANT TO ASK A QUESTION, YOU CAN 

300
00:10:46,985 --> 00:10:50,255
SEND THOSE QUESTIONS TO THIS 

301
00:10:50,255 --> 00:10:52,624
E-MAIL.  ALEX WILL GET THEM. 

302
00:10:52,624 --> 00:10:55,460
LE FORWARD THEM TO ME DURING 

303
00:10:55,460 --> 00:10:58,930
CLASS AND/OR WE WILL POST THEM 

304
00:10:58,930 --> 00:11:00,432
IN THE DISCUSSION SESSION.  

305
00:11:00,432 --> 00:11:03,635
I WILL ANSWER THEM THERE.  

306
00:11:03,635 --> 00:11:05,837
SO A COUPLE MORE THINGS ABOUT 

307
00:11:05,837 --> 00:11:07,406
THE SESSION QUIZZES. 

308
00:11:07,406 --> 00:11:11,777
IF YOU DON'T WANT A CERTIFICATE,

309
00:11:11,777 --> 00:11:13,412
DON'T BOTHER WITH THE QUIZZES. 

310
00:11:13,412 --> 00:11:16,682
IF YOU WANT A CERTIFICATE OF 

311
00:11:16,682 --> 00:11:17,349
COMPLETION, YOU HAVE TO TAKE AT 

312
00:11:17,349 --> 00:11:19,084
LEAST THREE OF THE 7. 

313
00:11:19,084 --> 00:11:22,754
IF NIH EMPLOYEE PURSUING THE 

314
00:11:22,754 --> 00:11:25,057
CORE CURRICULUM, YOU HAVE TO DO 

315
00:11:25,057 --> 00:11:25,724
AT LEAST 6. 

316
00:11:25,724 --> 00:11:28,226
THE SCORE DOESN'T MATTER. 

317
00:11:28,226 --> 00:11:30,696
PLEASE DON'T E-MAIL ME TO SAY, 

318
00:11:30,696 --> 00:11:33,231
OH, GOSH.  I GOT THEM ALL WRONG.

319
00:11:33,231 --> 00:11:34,566
CAN I TAKE IT AGAIN?  

320
00:11:34,566 --> 00:11:37,769
THE ANSWER WILL BE NO. 

321
00:11:37,769 --> 00:11:39,538
THE SCORE DOESN'T MATTER. 

322
00:11:39,538 --> 00:11:41,640
AND, AGAIN, THE QUIZZES, AS I 

323
00:11:41,640 --> 00:11:45,944
SAID, ALL OF THE QUIZZES ARE 

324
00:11:45,944 --> 00:11:46,945
AVAILABLE AFTER CLASS. 

325
00:11:46,945 --> 00:11:50,082
YOU WILL SEE HERE THAT THREE OF 

326
00:11:50,082 --> 00:11:52,050
-- FOUR OF THEM ARE GREEN THAT 

327
00:11:52,050 --> 00:11:53,351
MEANS THEY ARE AVAILABLE. 

328
00:11:53,351 --> 00:11:55,153
WHEN YOU OPEN IT UP, YOU WILL 

329
00:11:55,153 --> 00:11:57,189
SEE SOME ARE GREEN AND SOME 

330
00:11:57,189 --> 00:11:57,589
AREN'T. 

331
00:11:57,589 --> 00:11:59,624
THE SESSION QUIZ IS OPEN AFTER 

332
00:11:59,624 --> 00:12:00,325
CLASS. 

333
00:12:00,325 --> 00:12:03,361
SO THESE WILL BE GREEN WHEN YOU 

334
00:12:03,361 --> 00:12:05,363
GO THERE TO COMPLETE SESSION 4 

335
00:12:05,363 --> 00:12:06,965
QUIZ, FOR EXAMPLE. 

336
00:12:06,965 --> 00:12:08,633
I NEED TO UPDATE THAT.  IT WILL 

337
00:12:08,633 --> 00:12:11,036
BE AVAILABLE FOR YOU THEN. 

338
00:12:11,036 --> 00:12:13,071
IF YOU GO TO THAT PAGE, YOU 

339
00:12:13,071 --> 00:12:15,140
WON'T SEE THEM ALL JUST YET. 

340
00:12:15,140 --> 00:12:17,109
THAT IS IT FOR ME. 

341
00:12:17,109 --> 00:12:20,445
SO ON TO THE CONTENT OF THE 

342
00:12:20,445 --> 00:12:20,679
COURSE. 

343
00:12:20,679 --> 00:12:24,449
WE ARE GOING TO HAVE DR. 

344
00:12:24,449 --> 00:12:26,485
CHRISTINE GRADY GIVE US AN 

345
00:12:26,485 --> 00:12:28,420
INTRODUCTION TO THE FRAMEWORK 

346
00:12:28,420 --> 00:12:30,288
FOR ETHICAL CONDUCT OF RESEARCH,

347
00:12:30,288 --> 00:12:32,858
WHICH I SAID WILL BE SORT OF THE

348
00:12:32,858 --> 00:12:33,658
BACKBONE OF YOUR COURSE. 

349
00:12:33,658 --> 00:12:35,260
THERE SAY READING ABOUT THE 

350
00:12:35,260 --> 00:12:37,329
FRAMEWORK AS WELL THAT I WOULD 

351
00:12:37,329 --> 00:12:38,597
HIGHLY RECOMMEND THAT YOU READ. 

352
00:12:38,597 --> 00:12:41,633
IT WILL JUST GIVE YOU A GOOD 

353
00:12:41,633 --> 00:12:45,370
BASE FOR WHAT IS COMING IN THE 

354
00:12:45,370 --> 00:12:52,410
REST OF THE COURSE. 

355
00:12:52,410 --> 00:12:54,379
DR. GRADY -- AND IS CHIEF OF THE

356
00:12:54,379 --> 00:12:59,818
DEPARTMENT OF BIOETHICS. 

357
00:12:59,818 --> 00:13:04,322
FOR ALL DEPARTMENT OF ETHICS 

358
00:13:04,322 --> 00:13:05,690
BIOETHICS FACULTY I INCLUDED A 

359
00:13:05,690 --> 00:13:07,793
LINK YOU CAN USE TO GET 

360
00:13:07,793 --> 00:13:09,795
ADDITIONAL INFORMATION. 

361
00:13:09,795 --> 00:13:11,496
DR. GRADY HAS A LOT OF 

362
00:13:11,496 --> 00:13:13,865
EXPERIENCE AND WILL NOTE SHE IS 

363
00:13:13,865 --> 00:13:15,267
A NATIONAL LEADER AND SCHOLAR 

364
00:13:15,267 --> 00:13:19,704
WHO SERVED FROM 2010 TO 2017 AS 

365
00:13:19,704 --> 00:13:22,174
A COMMISSIONER FOR PRESIDENT'S 

366
00:13:22,174 --> 00:13:23,241
COMMISSION ON STUDY OF B

367
00:13:23,241 --> 00:13:26,578
BIOETHICAL ISSUES AND WIDE RANGE

368
00:13:26,578 --> 00:13:28,046
OF INTERESTS IN CLINICAL R- HE 

369
00:13:28,046 --> 00:13:30,782
SEARCH AND NURSING ETHICS AND IS

370
00:13:30,782 --> 00:13:32,818
WORKING RECENTLY ON MORAL 

371
00:13:32,818 --> 00:13:34,119
CHALLENGES NURSES FACE WHEN 

372
00:13:34,119 --> 00:13:35,086
DELIVERING CARE. 

373
00:13:35,086 --> 00:13:37,722
I WILL NOTE THAT SHE CURRENTLY 

374
00:13:37,722 --> 00:13:40,425
CO-CHAIRS THE NIH-WIDE NEURO 

375
00:13:40,425 --> 00:13:42,861
ETHICS WORKING GROUP OF THE NIH 

376
00:13:42,861 --> 00:13:44,429
BRAIN INITIATIVE THAT IS BRAIN 

377
00:13:44,429 --> 00:13:46,164
RESEARCH THROUGH ADVANCINO 

378
00:13:46,164 --> 00:13:48,433
VATTIVE NEUROTECHNOLOGIES THAT 

379
00:13:48,433 --> 00:13:50,502
IS NIH-WIDE EFFORT. 

380
00:13:50,502 --> 00:13:54,372
SHE CO-CHAIRS ONE OF THE NEURO 

381
00:13:54,372 --> 00:13:54,873
ETHICS WORKING GROUPS. 

382
00:13:54,873 --> 00:14:00,178
WITH THAT, I WILL HAND IT OFF TO

383
00:14:00,178 --> 00:14:06,084
DR. GRADY. 

384
00:14:06,084 --> 00:14:08,119
>> THANK YOU, HOLLY. 

385
00:14:08,119 --> 00:14:10,055
GOOD MORNING, EVERYONE IN THE 

386
00:14:10,055 --> 00:14:13,925
ROOM AND EVERYWHERE ELSE YOU ARE

387
00:14:13,925 --> 00:14:14,593
WATCHING FROM. 

388
00:14:14,593 --> 00:14:16,428
AS HOLLY MENTIONED, I WILL TALK 

389
00:14:16,428 --> 00:14:18,697
ABOUT A FRAMEWORK FOR ETHICAL 

390
00:14:18,697 --> 00:14:21,066
CONDUCT OF CLINICAL RESEARCH. 

391
00:14:21,066 --> 00:14:22,567
HOLLY ELUDED TO THIS IS A 

392
00:14:22,567 --> 00:14:23,935
FRAMEWORK THAT THE COURSE IS 

393
00:14:23,935 --> 00:14:25,103
SORT OF BUILT ON. 

394
00:14:25,103 --> 00:14:27,072
YOU -- THE THINGS I WILL TALK 

395
00:14:27,072 --> 00:14:30,308
ABOUT IN THE NEXT 40 MINUTES YOU

396
00:14:30,308 --> 00:14:31,643
WILL HEAR OVER AND OVER AGAIN 

397
00:14:31,643 --> 00:14:33,345
THROUGHOUT THE REST OF THE 

398
00:14:33,345 --> 00:14:33,578
COURSE. 

399
00:14:33,578 --> 00:14:35,280
I WILL MAKE REFERENCES TO THOSE.

400
00:14:35,280 --> 00:14:37,382
BEFORE I START, I WANT TO THANK 

401
00:14:37,382 --> 00:14:39,684
HOLLY FOR DOING A GREAT JOB 

402
00:14:39,684 --> 00:14:42,287
ORGANIZING THIS COURSE AND ALEX.

403
00:14:42,287 --> 00:14:43,388
THANK YOU BOTH. 

404
00:14:43,388 --> 00:14:46,024
THERE IS MY DISCLAIMER.  I HAVE 

405
00:14:46,024 --> 00:14:46,825
NO CONFLICTS OF INTEREST. 

406
00:14:46,825 --> 00:14:48,693
I THINK WHEN WE THINK ABOUT 

407
00:14:48,693 --> 00:14:51,229
ETHICS OF CLINICAL RESEARCH, 

408
00:14:51,229 --> 00:14:53,265
THERE ARE SEVERAL BIG PICTURE 

409
00:14:53,265 --> 00:14:55,200
QUESTIONS WE SHOULD ASK 

410
00:14:55,200 --> 00:14:55,567
OURSELVES. 

411
00:14:55,567 --> 00:14:57,335
ONE IS, FIRST, BEFORE I ASK ANY 

412
00:14:57,335 --> 00:14:59,271
OF THEM, I WANT TO MAKE SURE WE 

413
00:14:59,271 --> 00:15:00,872
UNDERSTAND WHAT WE ARE TALKING 

414
00:15:00,872 --> 00:15:02,107
ABOUT WHEN TALKING ABOUT 

415
00:15:02,107 --> 00:15:03,742
CLINICAL RESEARCH AND THERE IS 

416
00:15:03,742 --> 00:15:05,243
LOTS OF KINDS OF RESEARCH WE 

417
00:15:05,243 --> 00:15:06,978
MIGHT BE INTERESTED IN THE 

418
00:15:06,978 --> 00:15:09,314
ETHICS OF AND CLINICAL RESEARCH 

419
00:15:09,314 --> 00:15:12,417
BEING RESEARCH ABOUT THE HEALTH 

420
00:15:12,417 --> 00:15:13,585
OF HUMANS. 

421
00:15:13,585 --> 00:15:15,754
AND IT IS EITHER RESEARCH TO -- 

422
00:15:15,754 --> 00:15:16,955
TO UNDERSTAND BETTER THE HEALTH 

423
00:15:16,955 --> 00:15:19,724
OF HUMANS OR ILLNESS IN HUMANS 

424
00:15:19,724 --> 00:15:22,661
OR TO INTERVENE IN PREVENTION IN

425
00:15:22,661 --> 00:15:24,462
DIAGNOSING OR TREATING. 

426
00:15:24,462 --> 00:15:26,531
THAT IS DOMAIN OF RESEARCH WE 

427
00:15:26,531 --> 00:15:28,934
ARE TALKING ABOUT AND PRECLUDES 

428
00:15:28,934 --> 00:15:32,337
FOR EXAMPLE BASIC RESEARCH, 

429
00:15:32,337 --> 00:15:34,172
PRECLINICAL RESEARCH AND 

430
00:15:34,172 --> 00:15:36,174
RESEARCH WITH NON-HUMAN ANIMALS 

431
00:15:36,174 --> 00:15:38,443
AND ALL KINDS OF RESEARCH NOT 

432
00:15:38,443 --> 00:15:40,111
RELATED TO HUMAN HEALTH. 

433
00:15:40,111 --> 00:15:41,246
THREE IMPORTANT QUESTIONS. 

434
00:15:41,246 --> 00:15:43,882
WHAT IS THE VALUE AND WHY DO WE 

435
00:15:43,882 --> 00:15:45,917
DO RESEARCH AT ALL IS ONE 

436
00:15:45,917 --> 00:15:46,818
QUESTION TO ASK. 

437
00:15:46,818 --> 00:15:48,853
SECOND SUBSET OF THAT IS IF WE 

438
00:15:48,853 --> 00:15:51,289
DO RESEARCH AT ALL TO TRY TO 

439
00:15:51,289 --> 00:15:52,791
UNDERSTAND HUMANS, WHY DO WE 

440
00:15:52,791 --> 00:15:55,760
HAVE TO INCLUDE HUMANS IN IT AND

441
00:15:55,760 --> 00:15:57,028
INVOLVE HUMANS AND EXPERIMENT ON

442
00:15:57,028 --> 00:15:57,829
HUMANS?  

443
00:15:57,829 --> 00:16:00,365
IF ANSWER TO BOTH OF THOSE IS IT

444
00:16:00,365 --> 00:16:01,700
IS IMPORTANT AND WE NEED TO 

445
00:16:01,700 --> 00:16:04,769
INVOLVE HUMANS, HOW SHOULD WE DO

446
00:16:04,769 --> 00:16:08,139
IT IN THE MOST ETHICAL MANNER.  

447
00:16:08,139 --> 00:16:09,741
I WILL TRY TO COVER THESE 

448
00:16:09,741 --> 00:16:11,810
BRIEFLY AND WITH RESPECT TO THE 

449
00:16:11,810 --> 00:16:13,511
VALUE, THIS IS JUST ONE EXAMPLE.

450
00:16:13,511 --> 00:16:16,014
THIS IS THE NIH WEBSITE THAT 

451
00:16:16,014 --> 00:16:18,283
TALKS ABOUT IMPACT OF NIH 

452
00:16:18,283 --> 00:16:19,417
RESEARCH. 

453
00:16:19,417 --> 00:16:21,586
NIH IS ONE FUNDER OF RESEARCH 

454
00:16:21,586 --> 00:16:23,688
AND HAPPENS TO BE PROBABLY THE 

455
00:16:23,688 --> 00:16:25,123
LARGEST PUBLIC FUNDER OF 

456
00:16:25,123 --> 00:16:27,625
RESEARCH IN THE WORLD AND IS ONE

457
00:16:27,625 --> 00:16:27,892
FUNDER. 

458
00:16:27,892 --> 00:16:31,296
YOU CAN SEE ON THE LEFT-HAND 

459
00:16:31,296 --> 00:16:35,200
SIDE HERE THAT IT TALKS ABOUT 

460
00:16:35,200 --> 00:16:37,969
IMPROVING HEALTH, 

461
00:16:37,969 --> 00:16:38,903
REVOLUTIONIZING SCIENCE AND 

462
00:16:38,903 --> 00:16:41,339
SERVING SOCIETY AND VALUE OF 

463
00:16:41,339 --> 00:16:42,874
RESEARCH IS TO UNDERSTAND AND 

464
00:16:42,874 --> 00:16:44,409
IMPROVE HEALTH FOR SURE AND WHAT

465
00:16:44,409 --> 00:16:46,144
WE WILL TALK ABOUT MOSTLY. 

466
00:16:46,144 --> 00:16:48,146
THERE IS A COUPLE OTHER THINGS. 

467
00:16:48,146 --> 00:16:50,715
WE LEARN TO DO SCIENCE BETTER 

468
00:16:50,715 --> 00:16:52,117
AND LEARN NEW TECHNIQUES THAT 

469
00:16:52,117 --> 00:16:54,919
WILL IN THE FUTURE HELP IMPROVE 

470
00:16:54,919 --> 00:16:55,286
HEALTH. 

471
00:16:55,286 --> 00:16:57,322
THERE IS A WAY IN WHICH RESEARCH

472
00:16:57,322 --> 00:17:00,058
ACTUALLY HAS A HUGE IMPACT ON 

473
00:17:00,058 --> 00:17:01,593
OTHER ASPECTS OF SOCIETY. 

474
00:17:01,593 --> 00:17:04,162
FOR EXAMPLE, IF YOU GO TO THE 

475
00:17:04,162 --> 00:17:06,064
WEBSITE ON SERVING SOCIETY, IT 

476
00:17:06,064 --> 00:17:07,999
WILL TALK ABOUT ECONOMIC VALUE 

477
00:17:07,999 --> 00:17:10,201
OF DOING RESEARCH THAT IS A BOOM

478
00:17:10,201 --> 00:17:14,672
TO THE ECONOMY AND RAISES -- IT 

479
00:17:14,672 --> 00:17:17,642
PLACES WHERE RESEARCH IS FUNDED,

480
00:17:17,642 --> 00:17:19,944
ECONOMY IS IMPROVED AND BY 

481
00:17:19,944 --> 00:17:22,047
HELPING PEOPLE BE HEALTHIER, WE 

482
00:17:22,047 --> 00:17:23,081
IMPROVE THE ECONOMY BECAUSE 

483
00:17:23,081 --> 00:17:23,982
PEOPLE CAN WORK. 

484
00:17:23,982 --> 00:17:26,151
THERE IS LOTS OF WAYS IN WHICH 

485
00:17:26,151 --> 00:17:28,153
RESEARCH ITSELF IS VALUABLE. 

486
00:17:28,153 --> 00:17:31,656
THIS IS JUST, YOU KNOW, NIH. 

487
00:17:31,656 --> 00:17:33,491
EVERYWHERE ELSE THAT FUNDS 

488
00:17:33,491 --> 00:17:35,260
RESEARCH OR DOES RESEARCH HAS 

489
00:17:35,260 --> 00:17:38,463
THE SAME KIND OF GOALS. 

490
00:17:38,463 --> 00:17:41,166
SO WHAT ABOUT INCLUDING HUMANS? 

491
00:17:41,166 --> 00:17:44,402
SO, ONE THING THAT IS PROBABLY 

492
00:17:44,402 --> 00:17:46,571
TRUE IS THAT THE KINDS OF 

493
00:17:46,571 --> 00:17:49,741
RESULTS THAT WE GET FROM DOING 

494
00:17:49,741 --> 00:17:50,775
CLINICAL RESEARCH HAVE 

495
00:17:50,775 --> 00:17:53,078
COMPELLING SOCIETAL HEALTH 

496
00:17:53,078 --> 00:17:53,478
BENEFITS. 

497
00:17:53,478 --> 00:17:56,014
THEY ARE NEW THERAPIES, 

498
00:17:56,014 --> 00:17:59,250
DIAGNOSTIC AND PREVENTIVE 

499
00:17:59,250 --> 00:18:00,218
STRATEGIES.  IMPROVEMENT AND 

500
00:18:00,218 --> 00:18:02,120
QUALITY OF LIFE, ET CETERA. 

501
00:18:02,120 --> 00:18:05,023
ALL OF US CAN PROBABLY RECOGNIZE

502
00:18:05,023 --> 00:18:06,324
EXAMPLES OF PEOPLE WHO HAVE 

503
00:18:06,324 --> 00:18:08,093
SURVIVED FROM A DEVASTATING 

504
00:18:08,093 --> 00:18:10,662
DISEASE OR NOT GOT A DEVASTATING

505
00:18:10,662 --> 00:18:12,330
DISEASE BECAUSE OF RESEARCH 

506
00:18:12,330 --> 00:18:13,264
DISCOVERIES. 

507
00:18:13,264 --> 00:18:16,434
FOR EXAMPLE, TREATMENTS FOR HIV 

508
00:18:16,434 --> 00:18:18,736
HAVE CHANGED TRAJECTORY OF HIV 

509
00:18:18,736 --> 00:18:21,539
FROM A RAPIDLY FATAL DISEASE TO 

510
00:18:21,539 --> 00:18:23,508
PRETTY PEOPLE LIVING A NORMAL 

511
00:18:23,508 --> 00:18:25,510
LIFE WITH CHRONIC CONTROLLED 

512
00:18:25,510 --> 00:18:28,413
DISEASE AND TREATMENTS FOR 

513
00:18:28,413 --> 00:18:29,547
CHILDHOOD LEUKEMIA HAVE CHANGED 

514
00:18:29,547 --> 00:18:34,452
FROM RAPID DECLINE IN DEATH TO 

515
00:18:34,452 --> 00:18:37,555
90 PLUS PERCENT SURVIVAL AND 

516
00:18:37,555 --> 00:18:39,224
LIPID LOWERING DRUGS, CONSTANTLY

517
00:18:39,224 --> 00:18:43,461
-- MANY, MANY PEOPLE ARE ON 

518
00:18:43,461 --> 00:18:46,197
LIPID LOWERING DRUGS THAT HAS 

519
00:18:46,197 --> 00:18:48,433
IMPROVED MORBIDITY AND MORTALITY

520
00:18:48,433 --> 00:18:50,001
FROM CARDIOVASCULAR DISEASE AND 

521
00:18:50,001 --> 00:18:53,571
VACCINES FOR MEASLES OR POLIO OR

522
00:18:53,571 --> 00:18:55,840
HPV OR COVID AND SO MANY OTHERS.

523
00:18:55,840 --> 00:18:58,376
YOU CAN SORT OF THINK ABOUT THE 

524
00:18:58,376 --> 00:18:59,811
KINDS OF THINGS THAT HAVE BEEN 

525
00:18:59,811 --> 00:19:01,646
SHOWN TO WORK THROUGH CLINICAL 

526
00:19:01,646 --> 00:19:03,515
RESEARCH THAT HAVE MADE A MAJOR 

527
00:19:03,515 --> 00:19:06,050
IMPACT ON THE HEALTH OF SOCIETY 

528
00:19:06,050 --> 00:19:08,419
AND OF PEOPLE AND SAVING LIVES 

529
00:19:08,419 --> 00:19:11,256
AND IMPROVING THE QUALITY OF 

530
00:19:11,256 --> 00:19:11,856
HEALTH. 

531
00:19:11,856 --> 00:19:13,658
ALSO, AND THIS IS SORT OF THE 

532
00:19:13,658 --> 00:19:14,926
SAME IDEA. 

533
00:19:14,926 --> 00:19:17,061
IT IS SORT OF A MORE MICRO 

534
00:19:17,061 --> 00:19:17,295
LEVEL. 

535
00:19:17,295 --> 00:19:20,064
WHEN YOU GO TO A PHYSICIAN'S 

536
00:19:20,064 --> 00:19:22,000
OFFICE TO GET TREATED FOR 

537
00:19:22,000 --> 00:19:23,735
SOMETHING, YOU HOPE THAT THE 

538
00:19:23,735 --> 00:19:26,671
PHYSICIAN HAS SOME EVIDENCE UPON

539
00:19:26,671 --> 00:19:27,305
WHICH TO MAKE A SUGGESTION ABOUT

540
00:19:27,305 --> 00:19:29,307
WHAT YOU HAVE AND WHAT TO DO 

541
00:19:29,307 --> 00:19:30,708
ABOUT IT. 

542
00:19:30,708 --> 00:19:32,877
THOSE KINDS -- THAT EVIDENCE, 

543
00:19:32,877 --> 00:19:35,013
AGAIN, COMES FROM CLINICAL 

544
00:19:35,013 --> 00:19:36,414
RESEARCH AND MOST OF THE KINDS 

545
00:19:36,414 --> 00:19:39,083
OF THINGS WE DO WHEN WE GO TO A 

546
00:19:39,083 --> 00:19:40,752
DOCTOR'S OFFICE IS BASED ON 

547
00:19:40,752 --> 00:19:42,253
RESEARCH THAT HAD BEEN DONE IN 

548
00:19:42,253 --> 00:19:44,889
THE PAST. 

549
00:19:44,889 --> 00:19:47,258
THERE IS ALSO A PRETTY CLEAR 

550
00:19:47,258 --> 00:19:48,426
UNDERSTANDING THAT HUMAN 

551
00:19:48,426 --> 00:19:50,228
PARTICIPATION IS NECESSARY IN 

552
00:19:50,228 --> 00:19:53,498
ORDER TO GAIN ACCURATE AND 

553
00:19:53,498 --> 00:19:57,235
RELEVANT DATA FOR HUMANS. 

554
00:19:57,235 --> 00:19:59,270
WE DO -- THE NORMAL TRAJECTORY 

555
00:19:59,270 --> 00:20:03,208
OF RESEARCH IS BASIC IN VIVO -- 

556
00:20:03,208 --> 00:20:07,145
I MEAN IN VITRO, SORRY THAN 

557
00:20:07,145 --> 00:20:09,514
PRECLINICAL IN NON-HUMAN ANIMALS

558
00:20:09,514 --> 00:20:12,283
AND MOST NON-HUMAN ANIMALS ARE 

559
00:20:12,283 --> 00:20:14,452
NOT PERFECT FOR HUMANS AND 

560
00:20:14,452 --> 00:20:16,454
TESTING THINGS FOR HUMANS AND 

561
00:20:16,454 --> 00:20:19,357
UNDERSTANDING THINGS FOR HUMANS 

562
00:20:19,357 --> 00:20:20,858
IN RESEARCH IS IMPORTANT TO 

563
00:20:20,858 --> 00:20:22,360
UNDERSTAND HOW HUMANS WORK AND 

564
00:20:22,360 --> 00:20:23,962
WHAT WORKS IN HUMANS AND REASON 

565
00:20:23,962 --> 00:20:25,830
WHY WE DO IT. 

566
00:20:25,830 --> 00:20:27,899
WHY IS IT CHALLENGING THEN?  

567
00:20:27,899 --> 00:20:30,068
RESEARCH IS GOOD AND HUMANS 

568
00:20:30,068 --> 00:20:31,803
NECESSARY AND WHAT IS THE 

569
00:20:31,803 --> 00:20:33,104
PROBLEM; RIGHT?  

570
00:20:33,104 --> 00:20:34,906
PROBLEM IS PRIMARY GOAL OF DOING

571
00:20:34,906 --> 00:20:36,407
RESEARCH IS TO GENERATE 

572
00:20:36,407 --> 00:20:38,209
KNOWLEDGE AND GENERATE USEFUL 

573
00:20:38,209 --> 00:20:39,644
KNOWLEDGE ABOUT HUMAN HEALTH AND

574
00:20:39,644 --> 00:20:41,246
ILLNESS AND NO THE TO BENEFIT 

575
00:20:41,246 --> 00:20:43,014
PEOPLE THAT ARE PART OF THE 

576
00:20:43,014 --> 00:20:44,282
STUDY AND DOESN'T MEAN THAT 

577
00:20:44,282 --> 00:20:46,417
PEOPLE IN STUDIES DON'T BENEFIT.

578
00:20:46,417 --> 00:20:47,252
THEY OFTEN DO. 

579
00:20:47,252 --> 00:20:50,722
THAT IS NOT THE GOAL. 

580
00:20:50,722 --> 00:20:51,923
THEY OFTEN DON'T BENEFIT. 

581
00:20:51,923 --> 00:20:55,093
WE ARE REALLY ASKING A SMALL 

582
00:20:55,093 --> 00:20:57,929
NUMBER OF PEOPLE TO ACCEPT RISK 

583
00:20:57,929 --> 00:20:59,264
AND BURDEN IN ORDER TO ANSWER 

584
00:20:59,264 --> 00:21:00,565
IMPORTANT QUESTIONS THAT MIGHT 

585
00:21:00,565 --> 00:21:04,202
BE BENEFICIAL TO OTHERS. 

586
00:21:04,202 --> 00:21:06,170
THEREFORE THE PEOPLE WHO ARE 

587
00:21:06,170 --> 00:21:08,072
BEING ENROLLED IN RESEARCH AND 

588
00:21:08,072 --> 00:21:09,274
WHO ARE PARTICIPATING IN 

589
00:21:09,274 --> 00:21:11,809
RESEARCH ARE MEANS TO DEVELOPING

590
00:21:11,809 --> 00:21:14,879
USEFUL KNOWLEDGE AND THEREFORE 

591
00:21:14,879 --> 00:21:18,616
AT RISK OF BEING EXPLOITED. 

592
00:21:18,616 --> 00:21:20,918
THERE IS LOTS OF PUBLIC SORT OF 

593
00:21:20,918 --> 00:21:22,420
FEELING ABOUT THIS ISSUE AND IF 

594
00:21:22,420 --> 00:21:25,757
YOU TALK TO PEOPLE WHO DON'T 

595
00:21:25,757 --> 00:21:28,426
KNOW MUCH ABOUT RESEARCH YOU 

596
00:21:28,426 --> 00:21:33,464
CAN'T DO MUCH RESEARCH ON HUMANS

597
00:21:33,464 --> 00:21:36,000
AND MAKING HUMANS INTO GUINEA 

598
00:21:36,000 --> 00:21:38,036
PIGS AND MUCH RESEARCH ON GOALS 

599
00:21:38,036 --> 00:21:39,504
OF RESEARCH AND HOW RESEARCH IS 

600
00:21:39,504 --> 00:21:41,973
DONE AND IS LOTS OF FEELINGS 

601
00:21:41,973 --> 00:21:45,076
ABOUT NOT USING PEOPLE AS HUMAN 

602
00:21:45,076 --> 00:21:47,245
GUINEA PIGS AND ETHICS OF 

603
00:21:47,245 --> 00:21:51,015
CLINICAL RESEARCH IF WHAT I SAID

604
00:21:51,015 --> 00:21:52,850
MADE SENSE SO FAR HAS TWO REALLY

605
00:21:52,850 --> 00:21:55,620
IMPORTANT PARTS OR GOALS TO IT. 

606
00:21:55,620 --> 00:21:58,289
ONE, WE WANT TO PROMOTE 

607
00:21:58,289 --> 00:21:59,657
RESPONSIBLE AND YOUTHFUL 

608
00:21:59,657 --> 00:22:01,292
RESEARCH THAT WILL BENEFIT 

609
00:22:01,292 --> 00:22:05,263
SOCIETY AND FUTURE PATIENTS THAT

610
00:22:05,263 --> 00:22:07,365
IS ETHICAL DOING GOOD CLINICAL 

611
00:22:07,365 --> 00:22:10,034
R- HE SEARCH AND SAME TIME WANT 

612
00:22:10,034 --> 00:22:11,936
TO MINIMIZE ANY HARM AND 

613
00:22:11,936 --> 00:22:13,538
POSSIBILITY OF EXPLOITATION BY 

614
00:22:13,538 --> 00:22:16,074
PROTECTING RIGHTS AND WELFARE OF

615
00:22:16,074 --> 00:22:17,942
THE PARTICIPANTS AND PROTECTING 

616
00:22:17,942 --> 00:22:19,210
AND RESPECTING. 

617
00:22:19,210 --> 00:22:22,013
BOTH OF THOSE ARE IMPORTANT. 

618
00:22:22,013 --> 00:22:22,947
SOMETIMES THEY COME INTO 

619
00:22:22,947 --> 00:22:25,049
TENSION, BY THE WAY. 

620
00:22:25,049 --> 00:22:27,652
ETHICAL REQUIREMENTS WE WILL 

621
00:22:27,652 --> 00:22:29,253
LEARN ABOUT OR YOU WILL LEARN 

622
00:22:29,253 --> 00:22:31,155
ABOUT IN THIS COURSE AND SOME 

623
00:22:31,155 --> 00:22:33,825
MIGHT KNOW ABOUT ALREADY HOW TO 

624
00:22:33,825 --> 00:22:35,693
PROVIDE GUIDANCE TO ALLOW THIS 

625
00:22:35,693 --> 00:22:38,363
TO HA P AND EDGE KALILY CONDUCT 

626
00:22:38,363 --> 00:22:39,864
RESEARCH TO PROMOTE RESPONSIBLE 

627
00:22:39,864 --> 00:22:43,034
RESEARCH SEEKING PROGRESS 

628
00:22:43,034 --> 00:22:44,068
MINIMIZING EXPLOITATION AND HARM

629
00:22:44,068 --> 00:22:46,337
OR POSSIBILITY OF ENSURING 

630
00:22:46,337 --> 00:22:47,638
RIGHTS OF WELFARE AND 

631
00:22:47,638 --> 00:22:49,674
PARTICIPANTS ARE RESPECTED 

632
00:22:49,674 --> 00:22:51,442
HELPING TO MAINTAIN TRUST OF THE

633
00:22:51,442 --> 00:22:53,144
PUBLIC IN THE RESEARCH 

634
00:22:53,144 --> 00:22:53,711
ENTERPRISE THAT ARE ALL 

635
00:22:53,711 --> 00:22:55,279
IMPORTANT PIECES OF IT. 

636
00:22:55,279 --> 00:22:57,348
HOW DO WE -- HOW DO WE CONDUCT 

637
00:22:57,348 --> 00:22:58,950
RESEARCH EDGE KALILY?  

638
00:22:58,950 --> 00:23:03,454
HOW DO WE DO THAT AND PROMOTE 

639
00:23:03,454 --> 00:23:04,889
RESEARCH PROTECTING RIGHTS AND 

640
00:23:04,889 --> 00:23:06,891
WELFARE MAINTAINING PUBLIC 

641
00:23:06,891 --> 00:23:07,125
TRUST. 

642
00:23:07,125 --> 00:23:09,827
WE LEARNED OVER THE COURSE OF 

643
00:23:09,827 --> 00:23:11,396
HISTORY THROUGH MANY HISTORICAL 

644
00:23:11,396 --> 00:23:12,330
LESSONS THINGS THAT ARE 

645
00:23:12,330 --> 00:23:14,098
IMPORTANT IN TERMS HOW TO 

646
00:23:14,098 --> 00:23:16,768
CONDUCT RESEARCH AND WE CAN GO 

647
00:23:16,768 --> 00:23:18,035
THROUGH ETHICAL REASONS. 

648
00:23:18,035 --> 00:23:20,805
I WILL DO A LITTLE OF EACH AND 

649
00:23:20,805 --> 00:23:24,075
WON'T SPEND MUCH TIME ON 

650
00:23:24,075 --> 00:23:24,342
HISTORY. 

651
00:23:24,342 --> 00:23:26,377
LATER SUSAN LEDDERER WILL SPEAK 

652
00:23:26,377 --> 00:23:29,881
TO YOU.  SHE IS A HISTORIAN THAT

653
00:23:29,881 --> 00:23:32,917
HAS DONE A HUGE AMOUNT OF WORK 

654
00:23:32,917 --> 00:23:35,853
ON HISTORY OF ETHICS AND 

655
00:23:35,853 --> 00:23:37,722
RESEARCH AND WILL LET HER GIVE 

656
00:23:37,722 --> 00:23:40,057
SPECIFIC EXAMPLES. 

657
00:23:40,057 --> 00:23:46,264
SHE IS A WONDERFUL RESOUCHER AS 

658
00:23:46,264 --> 00:23:50,435
WELL.  YEARS AGO [INDISCERNIBLE]

659
00:23:50,435 --> 00:23:52,970
WHICH TRIED TO DIVIDE THE ETHICS

660
00:23:52,970 --> 00:23:55,506
OF CLINICAL RESEARCH 

661
00:23:55,506 --> 00:23:56,707
HISTORICALLY INTO DIFFERENT 

662
00:23:56,707 --> 00:23:57,442
ERAS. 

663
00:23:57,442 --> 00:23:59,277
BRIEFLY, TO GIVE YOU A SENSE OF 

664
00:23:59,277 --> 00:24:01,479
HOW THIS WENT, YOU KNOW, FOR A 

665
00:24:01,479 --> 00:24:03,214
LONG TIME, HUNDREDS OF YEARS, 

666
00:24:03,214 --> 00:24:05,650
THERE WERE NO RULES OR 

667
00:24:05,650 --> 00:24:07,151
GUIDELINES AND THERE WERE NO 

668
00:24:07,151 --> 00:24:08,820
LIMITS ON WHAT PEOPLE COULD DO. 

669
00:24:08,820 --> 00:24:11,989
IN FACT, THERE WASN'T MUCH MONEY

670
00:24:11,989 --> 00:24:14,058
OR THERE WEREN'T MANY RESOURCES 

671
00:24:14,058 --> 00:24:16,394
FOR CLINICAL RESEARCH EITHER. 

672
00:24:16,394 --> 00:24:17,895
RESEARCH WAS OFTEN DONE BY 

673
00:24:17,895 --> 00:24:20,565
INDIVIDUAL SCIENTISTS OR 

674
00:24:20,565 --> 00:24:22,400
CLINICIANS WHO HAD SOME EXTRA 

675
00:24:22,400 --> 00:24:23,267
TIME OR MONEY. 

676
00:24:23,267 --> 00:24:26,370
BUT MOSTLY WITH THE MOTIVE OF 

677
00:24:26,370 --> 00:24:27,839
TRYING TO BENEFIT INDIVIDUALS 

678
00:24:27,839 --> 00:24:31,542
THAT THEY WERE RESPONSIBLE FOR. 

679
00:24:31,542 --> 00:24:33,611
AND BECAUSE THERE WERE SO FEW 

680
00:24:33,611 --> 00:24:34,946
GUIDELINES, THERE WAS LOTS OF --

681
00:24:34,946 --> 00:24:37,615
YOU KNOW, SOMETIMES THE 

682
00:24:37,615 --> 00:24:39,817
EXPERIMENTS WERE WORSE THAN NO 

683
00:24:39,817 --> 00:24:40,117
EXPERIMENT. 

684
00:24:40,117 --> 00:24:42,653
THERE WAS A LOT OF NEGATIVE 

685
00:24:42,653 --> 00:24:45,590
OUTCOMES RATHER THAN ONLY 

686
00:24:45,590 --> 00:24:46,757
POSITIVE. 

687
00:24:46,757 --> 00:24:48,059
THAT -- WHEN THERE WAS MORE 

688
00:24:48,059 --> 00:24:49,861
MONEY AND RESOURCES AND 

689
00:24:49,861 --> 00:24:51,629
ATTENTION TO RESEARCH, EXCUSE 

690
00:24:51,629 --> 00:24:53,831
ME, AND VALUE OF RESEARCH, WE 

691
00:24:53,831 --> 00:24:56,200
WENT INTO WHAT PEOPLE HAVE IN 

692
00:24:56,200 --> 00:24:58,736
RETROSPECT CALLED A VERIUTE 

693
00:24:58,736 --> 00:24:59,837
ILLTARIAN ERA. 

694
00:24:59,837 --> 00:25:02,640
PEOPLE THAT WERE MARGINALIZED 

695
00:25:02,640 --> 00:25:04,709
AND CAPTIVE AND UNIMPORTANT TO 

696
00:25:04,709 --> 00:25:08,246
SOCIETY WERE ASKED TO 

697
00:25:08,246 --> 00:25:09,981
PARTICIPATE IN RESEARCH THAT WAS

698
00:25:09,981 --> 00:25:12,116
SEEN AS GOOD FOR COMMON GOOD AND

699
00:25:12,116 --> 00:25:13,284
GOOD FOR THE MAJORITY. 

700
00:25:13,284 --> 00:25:16,053
YOU WILL HEAR ABOUT SOME OF THE 

701
00:25:16,053 --> 00:25:18,256
EXAMPLES FROM SUSAN LATER IN 

702
00:25:18,256 --> 00:25:21,058
PROBABLY YOU KNOW SOME OF THEM 

703
00:25:21,058 --> 00:25:23,261
ANYWAY IN HISTORY AND LED TO AN 

704
00:25:23,261 --> 00:25:24,996
ERA OF SCRUTINY AND SOME 

705
00:25:24,996 --> 00:25:27,765
EXPOSURE OF THOSE KINDS OF 

706
00:25:27,765 --> 00:25:30,501
EXPERIMENTS DONE WITH PRISONERS 

707
00:25:30,501 --> 00:25:32,236
AND ORPHANS AND OTHER VERY 

708
00:25:32,236 --> 00:25:34,939
VULNERABLE PEOPLE AND PEOPLE -- 

709
00:25:34,939 --> 00:25:36,173
THE SCIENTIFIC AND LAY COMMUNITY

710
00:25:36,173 --> 00:25:38,175
STARTED TO SAY WHAT ARE WE 

711
00:25:38,175 --> 00:25:38,409
DOING?  

712
00:25:38,409 --> 00:25:40,111
WHAT IS HAPPENING WITH RESEARCH 

713
00:25:40,111 --> 00:25:42,446
AND WAS INTENSE SCRUTINY DRIVEN 

714
00:25:42,446 --> 00:25:46,183
BY A COUPLE OF VERY PUBLIC 

715
00:25:46,183 --> 00:25:46,584
CASES. 

716
00:25:46,584 --> 00:25:47,985
THAT LED TO QUESTIONS ABOUT WHAT

717
00:25:47,985 --> 00:25:51,289
THE LIMITS AND SCOPE OF CLINICAL

718
00:25:51,289 --> 00:25:52,590
RESEARCH OUGHT TO BE. 

719
00:25:52,590 --> 00:25:55,192
FROM THAT SCRUTINY, THERE WERE 

720
00:25:55,192 --> 00:25:58,563
DERIVED A NUMBER OF RULES AND 

721
00:25:58,563 --> 00:26:00,464
REGULATIONS THAT EMPHASIZED AND 

722
00:26:00,464 --> 00:26:02,800
FOCUSED ON PROTECTION OF THE 

723
00:26:02,800 --> 00:26:04,402
PARTICIPANTS AND PROTECTION OF 

724
00:26:04,402 --> 00:26:06,337
HUMAN PARTICIPANTS IN RESEARCH. 

725
00:26:06,337 --> 00:26:08,272
YOU WILL SEE AND MAYBE YOU KNOW 

726
00:26:08,272 --> 00:26:10,541
LOTS OF RULES AND REGULATIONS 

727
00:26:10,541 --> 00:26:12,410
HAVE THAT AS THEIR PRIMARY 

728
00:26:12,410 --> 00:26:12,877
FOCUS. 

729
00:26:12,877 --> 00:26:15,212
I WOULD SAY IN THE LAST NOW 

730
00:26:15,212 --> 00:26:17,448
ALMOST 30 YEARS, I GUESS, THERE 

731
00:26:17,448 --> 00:26:20,418
HAS BEEN A LITTLE BIT OF A 

732
00:26:20,418 --> 00:26:23,187
PENDULUM SWING IN THE SENSE THAT

733
00:26:23,187 --> 00:26:25,222
CLINICAL RESEARCH IS RECOGNIZED 

734
00:26:25,222 --> 00:26:27,692
AS A BENEFIT.  THAT A BENEFIT 

735
00:26:27,692 --> 00:26:29,260
SOMETIMES TO PEOPLE WHO WANT TO 

736
00:26:29,260 --> 00:26:30,861
BE IN CLINICAL TRIALS BECAUSE IT

737
00:26:30,861 --> 00:26:33,965
IS A WAY FOR THEM TO ACCESS 

738
00:26:33,965 --> 00:26:36,400
EXPERIMENTAL DRUGS THEY COULDN'T

739
00:26:36,400 --> 00:26:37,735
GET ELSEWHERE, EXCUSE ME. 

740
00:26:37,735 --> 00:26:40,404
ALSO, TO BENEFIT FOR POPULATIONS

741
00:26:40,404 --> 00:26:43,407
AND HAS BEEN FOR EXAMPLE 

742
00:26:43,407 --> 00:26:44,809
RECOGNITION THAT CHILDREN HAVE 

743
00:26:44,809 --> 00:26:46,477
BEEN WHAT SOME PEOPLE CALL 

744
00:26:46,477 --> 00:26:48,412
THERAPEUTIC ORPHANS AND HAS BEEN

745
00:26:48,412 --> 00:26:50,481
INSUFFICIENT AMOUNT OF RESEARCH 

746
00:26:50,481 --> 00:26:53,084
TO GENERATE EVIDENCE ON HOW TO 

747
00:26:53,084 --> 00:26:54,318
TREAT CHILDREN APPROPRIATELY. 

748
00:26:54,318 --> 00:26:55,753
THEREFORE INCLUDING THEM IN 

749
00:26:55,753 --> 00:26:57,588
RESEARCH IS A BENEFIT. 

750
00:26:57,588 --> 00:26:59,156
THEN WE LEARN HOW TO TREAT 

751
00:26:59,156 --> 00:27:00,157
CHILDREN. 

752
00:27:00,157 --> 00:27:02,526
THAT HAS BEEN A VERY INSIGHT 

753
00:27:02,526 --> 00:27:04,562
THAT HAPPENED OVER THE LAST 30 

754
00:27:04,562 --> 00:27:07,832
OR SO YEARS. 

755
00:27:07,832 --> 00:27:10,868
DURING THIS TIME, AND CURRENTLY,

756
00:27:10,868 --> 00:27:12,803
THERE ARE -- THERE WERE DERIVED 

757
00:27:12,803 --> 00:27:16,407
A NUMBER OF CODES AND GUIDELINES

758
00:27:16,407 --> 00:27:18,542
AND REGULATIONS THAT GUIDE 

759
00:27:18,542 --> 00:27:18,976
CLINICAL RESEARCH. 

760
00:27:18,976 --> 00:27:20,511
SOME OF THESE YOU PROBABLY HAVE 

761
00:27:20,511 --> 00:27:21,312
HEARD ABOUT. 

762
00:27:21,312 --> 00:27:22,146
EXCUSE ME. 

763
00:27:22,146 --> 00:27:26,283
I WILL MENTION A FEW OF THEM 

764
00:27:26,283 --> 00:27:28,786
JUST BRIEFLY.  NUR EMBERG CODE 

765
00:27:28,786 --> 00:27:32,323
WAS CODE WRITTEN AT END OF WWII 

766
00:27:32,323 --> 00:27:35,292
TRIAL OF NAZI DOCTORS DOING 

767
00:27:35,292 --> 00:27:37,628
NUMBER OF EXPERIMENTS ON NAZI 

768
00:27:37,628 --> 00:27:40,231
PERFECTIZENERS OF WWII. 

769
00:27:40,231 --> 00:27:43,467
DECLARATION OF HELSINKI FOLLOWED

770
00:27:43,467 --> 00:27:46,103
15 YEARS LATER ALMOST BY WORLD 

771
00:27:46,103 --> 00:27:48,406
MEDICAL ASSOCIATION AND BEGAN TO

772
00:27:48,406 --> 00:27:51,409
REALIZE THAT ALTHOUGH THE 

773
00:27:51,409 --> 00:27:53,310
TENANTS OF THE NUR EMBERG CODE 

774
00:27:53,310 --> 00:27:54,745
WERE IMPORTANT THEY DIDN'T APPLY

775
00:27:54,745 --> 00:27:57,314
SO OBVIOUSLY TO RESEARCH DONE BY

776
00:27:57,314 --> 00:28:07,858
DOCTORS WITH PATIENTS TO TRY TO 

777
00:28:14,298 --> 00:28:14,632
IMPROVE PATIENTS. 

778
00:28:14,632 --> 00:28:17,301
THAT DECLARATION HAS BEEN 

779
00:28:17,301 --> 00:28:19,970
REVISED MULTIPLE TIMES AND MOST 

780
00:28:19,970 --> 00:28:22,540
RECENT PUBLISHED VERSION IS 

781
00:28:22,540 --> 00:28:22,740
2013. 

782
00:28:22,740 --> 00:28:24,975
THEY ARE IN THE PROCESS OF 

783
00:28:24,975 --> 00:28:27,011
REVISING IT AT THIS MOMENT AND 

784
00:28:27,011 --> 00:28:29,547
HAS BEEN A NUMBER OF MEETINGS 

785
00:28:29,547 --> 00:28:31,882
AROUND THE WORLD TO 

786
00:28:31,882 --> 00:28:33,484
CONSULTANCIES TO TRY TO GET THAT

787
00:28:33,484 --> 00:28:34,185
REVISED AGAIN. 

788
00:28:34,185 --> 00:28:37,822
WE WILL SEE A NEW DECLARATION OF

789
00:28:37,822 --> 00:28:40,324
HELSINKI, I'M ASSUMING, THIS 

790
00:28:40,324 --> 00:28:40,524
YEAR. 

791
00:28:40,524 --> 00:28:41,792
BELMONT REPORT WAS A REPORT FROM

792
00:28:41,792 --> 00:28:44,161
THE NATIONAL -- THE UNITED 

793
00:28:44,161 --> 00:28:46,030
STATES NATIONAL COMMISSION FOR 

794
00:28:46,030 --> 00:28:50,134
THE PROTECTION OF PARTICIPANTS 

795
00:28:50,134 --> 00:28:52,002
OF BIOMEDICAL AND BEHAVIORAL 

796
00:28:52,002 --> 00:28:53,738
RESEARCH THAT WAS A COMMISSION 

797
00:28:53,738 --> 00:28:56,941
PUT INTO PLACE AFTER THE 

798
00:28:56,941 --> 00:29:04,048
EXPOSURE OF THE TUSKEGEE PUBLIC 

799
00:29:04,048 --> 00:29:07,918
HEALTH SERVE CIVILUS STUDIES. 

800
00:29:07,918 --> 00:29:11,622
BELMONT REPORT IS NOT A SET OF 

801
00:29:11,622 --> 00:29:15,493
RULES BUT EXPLICATION FOR 

802
00:29:15,493 --> 00:29:18,929
UNDERLYING RULES OF ETHICS AND 

803
00:29:18,929 --> 00:29:20,397
DOCUMENT THAT IS SHORT AND EASY 

804
00:29:20,397 --> 00:29:25,436
TO READ AND BASIS ON WHICH OUR 

805
00:29:25,436 --> 00:29:35,913
REGULATIONS HAVE BEEN MADE. 

806
00:29:38,916 --> 00:29:40,117
CIOMS PROVIDES INTERNATIONAL 

807
00:29:40,117 --> 00:29:42,520
GUIDELINES AND THOSE GUIDELINES 

808
00:29:42,520 --> 00:29:43,687
ORIGINALLY TOOK THE GOAL THAT 

809
00:29:43,687 --> 00:29:47,191
THEY TOOK WAS TO TAKE THE 

810
00:29:47,191 --> 00:29:48,826
PRINCIPLES ENUNCIATED IN 

811
00:29:48,826 --> 00:29:50,861
DECLARATION OF HELSINKI APPLYING

812
00:29:50,861 --> 00:29:53,297
THEM SPECIFICALLY TO KINDS OF 

813
00:29:53,297 --> 00:29:56,333
RESEARCH SPONSORED BY RESEARCH 

814
00:29:56,333 --> 00:29:59,236
RICH COUNTRY KUN DUCTED IN 

815
00:29:59,236 --> 00:30:01,338
RESOURCE POORER COUNTRY. 

816
00:30:01,338 --> 00:30:01,639
EXCUSE ME. 

817
00:30:01,639 --> 00:30:03,440
THEY ARE ONE THING THAT I REALLY

818
00:30:03,440 --> 00:30:06,644
LIKE ABOUT CIOMS GUIDELINES IS 

819
00:30:06,644 --> 00:30:09,079
NOT ONLY DO THEY HAVE TENANTS 

820
00:30:09,079 --> 00:30:11,282
THAT ALL THESE OTHERS DO TOO BUT

821
00:30:11,282 --> 00:30:13,417
THEY EXPLAIN THEM AND HAVE MANY 

822
00:30:13,417 --> 00:30:14,852
PARAGRAPHS OF EXPLANATION AND 

823
00:30:14,852 --> 00:30:16,153
WHY THEY THINK THIS IS IMPORTANT

824
00:30:16,153 --> 00:30:17,888
HOW YOU WOULD ACTUALLY IMPLEMENT

825
00:30:17,888 --> 00:30:19,657
IT AND IS A USEFUL DOCUMENT TO 

826
00:30:19,657 --> 00:30:22,092
LOOK AT FOR MORE THAN JUST 

827
00:30:22,092 --> 00:30:24,895
INTERNATIONAL RESEARCH. 

828
00:30:24,895 --> 00:30:26,864
ICHGCP IS INTERNATIONAL 

829
00:30:26,864 --> 00:30:28,432
CONFERENCE ON HARMONIZATION AND 

830
00:30:28,432 --> 00:30:30,301
GOOD CLINICAL PRACTICE 

831
00:30:30,301 --> 00:30:32,203
GUIDELINES INTERNATIONAL 

832
00:30:32,203 --> 00:30:34,205
CONFERENCE ON HARMONIZATION WAS 

833
00:30:34,205 --> 00:30:37,741
A GROUP THAT GOT TOGETHER IN THE

834
00:30:37,741 --> 00:30:39,510
1990YS TO SAY WE ARE DOING 

835
00:30:39,510 --> 00:30:40,711
CLINICAL RESEARCH AROUND THE 

836
00:30:40,711 --> 00:30:42,279
WORLD AND WHEN DOING RESEARCH IN

837
00:30:42,279 --> 00:30:44,348
THE UNITED STATES AND WANT TO 

838
00:30:44,348 --> 00:30:46,417
ADOPT FINDINGS IN THE EUROPEAN 

839
00:30:46,417 --> 00:30:48,419
UNION, IT HAS TO GO THROUGH THE 

840
00:30:48,419 --> 00:30:50,454
WHOLE PROCESS ALL OVER AGAIN. 

841
00:30:50,454 --> 00:30:53,290
THERE WAS AN EFFORT TO HARM 

842
00:30:53,290 --> 00:30:54,892
YNIZE REGULATIONS SO RESEARCH 

843
00:30:54,892 --> 00:30:56,026
DONE IN ONE JURISDICTION COULD 

844
00:30:56,026 --> 00:30:58,829
BE ACCEPTED BY ANOTHER 

845
00:30:58,829 --> 00:31:02,833
JURISDICTION BY THE REGULATORY 

846
00:31:02,833 --> 00:31:03,500
AUTHORITIES. 

847
00:31:03,500 --> 00:31:05,302
ICH DOCUMENTS HAS MULTIPLE, 

848
00:31:05,302 --> 00:31:07,371
MULTIPLE VOLUMES ABOUT MULTIPLE 

849
00:31:07,371 --> 00:31:10,407
THINGS RELATED HOW TO DO 

850
00:31:10,407 --> 00:31:11,308
CLINICAL RESEARCH AND ONE 

851
00:31:11,308 --> 00:31:12,743
IMPORTANT GUIDANCE FROM HOW TO 

852
00:31:12,743 --> 00:31:14,678
DO RESEARCH EDGE KALILY IS THE 

853
00:31:14,678 --> 00:31:17,948
GOOD CLINICAL PRACTICE 

854
00:31:17,948 --> 00:31:19,617
GUIDELINES AND THAT HAS BECOME 

855
00:31:19,617 --> 00:31:22,286
IN MANY JURISDICTIONS AROUND THE

856
00:31:22,286 --> 00:31:24,288
WORLD THE GUIDING REGULATORY 

857
00:31:24,288 --> 00:31:26,857
FRAMEWORK FOR HOW RESEARCH IS 

858
00:31:26,857 --> 00:31:28,025
DONE IN THAT JURISDICTION. 

859
00:31:28,025 --> 00:31:30,527
SO IN ADDITION TO CODES AND 

860
00:31:30,527 --> 00:31:32,496
GUIDELINES WE HAVE REGULATIONS. 

861
00:31:32,496 --> 00:31:35,299
IN THE UNITED STATES, WE HAVE 

862
00:31:35,299 --> 00:31:38,602
THE COMMON RULE, WHICH IS A SET 

863
00:31:38,602 --> 00:31:41,338
OF REGULATIONS ABOUT HOW TO 

864
00:31:41,338 --> 00:31:44,041
PROTECT PARTICIPANTS IN RESEARCH

865
00:31:44,041 --> 00:31:47,645
THAT IS ADOPTED AND HAS BEEN 

866
00:31:47,645 --> 00:31:50,481
ADOPTED BY 17US FEDERAL 

867
00:31:50,481 --> 00:31:51,048
AGENCIES. 

868
00:31:51,048 --> 00:31:52,616
ONE OF WHICH IS THE DEPARTMENT 

869
00:31:52,616 --> 00:31:54,952
OF HEALTH AND HUMAN SERVICES AND

870
00:31:54,952 --> 00:31:57,221
DEPARTMENT OF HEALTH AND HUMAN 

871
00:31:57,221 --> 00:31:58,322
SERVICES WHICH IS THE AGENCY 

872
00:31:58,322 --> 00:32:00,357
THAT NIH BELONGS TO. 

873
00:32:00,357 --> 00:32:04,228
IT USES THE COMMON RULE THAT IS 

874
00:32:04,228 --> 00:32:08,399
FOUND AT US45 CODE OF FEDERAL 

875
00:32:08,399 --> 00:32:08,766
REGULATIONS.46. 

876
00:32:08,766 --> 00:32:10,434
YOU KNOW, YOU MIGHT SAY WHO 

877
00:32:10,434 --> 00:32:11,702
CARES ABOUT THAT. 

878
00:32:11,702 --> 00:32:13,737
YOU WILL FIND AROUND HERE FOR 

879
00:32:13,737 --> 00:32:17,308
EXAMPLE, PEOPLE SAY WHAT IS 

880
00:32:17,308 --> 00:32:18,309
45CFR46 SAY?  

881
00:32:18,309 --> 00:32:20,411
YOU HAVE TO KNOW WHAT IT MEANS. 

882
00:32:20,411 --> 00:32:22,313
THAT IS THE COMMON RULE. 

883
00:32:22,313 --> 00:32:24,415
INTERESTINGLY, THE FDA, FOOD AND

884
00:32:24,415 --> 00:32:26,050
DRUG ADMINISTRATION HAS THEIR 

885
00:32:26,050 --> 00:32:27,885
OWN SET OF REGULATIONS THAT ARE 

886
00:32:27,885 --> 00:32:29,453
NOT -- THEY DON'T -- THEY DON'T 

887
00:32:29,453 --> 00:32:31,088
FALL UNDER THE COMMON RULE AND 

888
00:32:31,088 --> 00:32:34,558
HAVE A SET OF REGULATIONS -- 

889
00:32:34,558 --> 00:32:36,026
SEVERAL SETS OF REGULATIONS 

890
00:32:36,026 --> 00:32:38,529
RELEVANT TO ETHICS OF DOING 

891
00:32:38,529 --> 00:32:40,397
RESEARCH AND MOST RELEVANT ARE 

892
00:32:40,397 --> 00:32:43,000
PROBABLY ONES FOUND AT 24CFR50 

893
00:32:43,000 --> 00:32:43,867
AND 56. 

894
00:32:43,867 --> 00:32:45,869
THEY ARE VERY SIMILAR TO WHAT 

895
00:32:45,869 --> 00:32:52,409
YOU SEE IN 45CFR46 AND NOT 

896
00:32:52,409 --> 00:32:53,277
IDENTICAL AND IMPORTANT TO THINK

897
00:32:53,277 --> 00:32:55,512
ABOUT DIFFERENCES THERE AND IF 

898
00:32:55,512 --> 00:32:57,414
SOMEBODY IS DEVELOPING A PRODUCT

899
00:32:57,414 --> 00:32:59,283
THAT WILL ULTIMATELY WANT TO 

900
00:32:59,283 --> 00:33:01,418
APPLY FOR FDA APPROVAL, THEY 

901
00:33:01,418 --> 00:33:06,857
HAVE TO FOLLOW FD REGS. 

902
00:33:06,857 --> 00:33:09,093
IN ADDITION TO REGULATIONS THAT 

903
00:33:09,093 --> 00:33:11,762
GOVERN AGENCIES, THERE ARE OFTEN

904
00:33:11,762 --> 00:33:13,464
OR MAYBE USUALLY INSTITUTIONAL 

905
00:33:13,464 --> 00:33:15,165
POLICIES THAT PEOPLE HAVE TO 

906
00:33:15,165 --> 00:33:17,468
ADHERE TO. 

907
00:33:17,468 --> 00:33:20,237
NIH, FOR EXAMPLE, HAS A NUMBER 

908
00:33:20,237 --> 00:33:21,939
OF POLICIES ABOUT WHO TO INCLUDE

909
00:33:21,939 --> 00:33:23,340
AND HOW RESEARCH OUGHT TO BE 

910
00:33:23,340 --> 00:33:25,376
DONE EDGE KALILY THAT ARE 

911
00:33:25,376 --> 00:33:27,077
RELEVANT TO RESEARCH FUNDED BY 

912
00:33:27,077 --> 00:33:30,481
OR DONE WITHIN THE NIH. 

913
00:33:30,481 --> 00:33:32,449
AND HOLLY MENTIONED EARLIER THAT

914
00:33:32,449 --> 00:33:35,386
MOST OF OUR FOCUS IS DOMESTIC. 

915
00:33:35,386 --> 00:33:37,421
MANY RESEARCH PROJECTS IN THESE 

916
00:33:37,421 --> 00:33:40,424
-- IN THIS DAY ARE DONE ACROSS 

917
00:33:40,424 --> 00:33:40,924
BORDERS. 

918
00:33:40,924 --> 00:33:43,127
THERE ARE LAWS AND REGULATIONS 

919
00:33:43,127 --> 00:33:45,696
IN MANY, MANY OTHER 

920
00:33:45,696 --> 00:33:46,697
JURISDICTIONS THAT ARE ALSO 

921
00:33:46,697 --> 00:33:47,197
RELEVANT. 

922
00:33:47,197 --> 00:33:48,966
IF SOMEBODY IS DOING RESEARCH 

923
00:33:48,966 --> 00:33:51,568
FUNDED BY NIH, IT DOESN'T MATTER

924
00:33:51,568 --> 00:33:53,303
WHERE IT IS BEING DONE THEY HAVE

925
00:33:53,303 --> 00:33:55,739
TO FOLLOW STILL NIH RULES AND 

926
00:33:55,739 --> 00:33:58,042
MAY ALSO HAVE TO FOLLOW LAWS AND

927
00:33:58,042 --> 00:33:59,343
REGULATIONS OF JURISDICTION IN 

928
00:33:59,343 --> 00:34:02,212
WHICH THEY ARE CONDUCTING 

929
00:34:02,212 --> 00:34:02,479
RESEARCH. 

930
00:34:02,479 --> 00:34:04,181
SO LOTS OF DETAILS. 

931
00:34:04,181 --> 00:34:06,817
I WENT OVER THAT PRETTY FAST. 

932
00:34:06,817 --> 00:34:10,120
I WANT TO FOCUS A MOMENT ON WHAT

933
00:34:10,120 --> 00:34:11,188
THE BELMONT REPORT DOES INCLUDE.

934
00:34:11,188 --> 00:34:13,290
I THINK I MENTIONED IT IS NOT A 

935
00:34:13,290 --> 00:34:15,259
CODE IN THE SAME WAY AS THE 

936
00:34:15,259 --> 00:34:17,294
OTHERS BUT HAS ETHICAL 

937
00:34:17,294 --> 00:34:20,397
PRINCIPLES UNDERLYING CONDUCT OF

938
00:34:20,397 --> 00:34:21,498
RESEARCH AND EXPLICATES THEM AND

939
00:34:21,498 --> 00:34:23,300
WHAT THEY ARE AND HOW THEY APPLY

940
00:34:23,300 --> 00:34:26,070
AND RESPECT FOR PERSONS APPLYING

941
00:34:26,070 --> 00:34:30,607
TO PROCESS OF INFORMED CONSENT 

942
00:34:30,607 --> 00:34:34,211
AND BENEFICENCE -- AND JUSTICE 

943
00:34:34,211 --> 00:34:35,846
TO PROCESS OF SELECTING 

944
00:34:35,846 --> 00:34:36,513
PARTICIPANTS FAIRLY AND WILL 

945
00:34:36,513 --> 00:34:38,348
HEAR ABOUT ALL THOSE MORE AND 

946
00:34:38,348 --> 00:34:39,416
OTHER THING AND IMPORTANT THING 

947
00:34:39,416 --> 00:34:41,285
I THINK THAT THE BELMONT REPORT 

948
00:34:41,285 --> 00:34:44,421
DOES AND VERY FEW OF THE OTHER 

949
00:34:44,421 --> 00:34:47,024
DOCUMENTS DO IS DESCRIBE THE 

950
00:34:47,024 --> 00:34:47,925
DISTINCTION AND BOUNDARIES 

951
00:34:47,925 --> 00:34:51,061
BETWEEN CLINICAL PRACTICE AND 

952
00:34:51,061 --> 00:34:52,396
CLINICAL RESEARCH. 

953
00:34:52,396 --> 00:34:53,530
AND INTERESTINGLY, WHEN YOU 

954
00:34:53,530 --> 00:34:56,400
THINK ABOUT THE KINDS OF ETHICAL

955
00:34:56,400 --> 00:34:58,602
ISSUES OR TENSIONS THAT COME UP 

956
00:34:58,602 --> 00:35:02,239
IN A CLINICAL RE-ENVIRONMENT, 

957
00:35:02,239 --> 00:35:05,309
THEY OFTEN ARE BECAUSE OF 

958
00:35:05,309 --> 00:35:11,281
TENSION OR CONFUSION ABOUT THESE

959
00:35:11,281 --> 00:35:13,217
BOUNDARIES AND WANT TO SPEND A 

960
00:35:13,217 --> 00:35:14,852
MINUTE TALKING ABOUT WHAT I MEAN

961
00:35:14,852 --> 00:35:15,519
BY THAT. 

962
00:35:15,519 --> 00:35:16,820
DIFFERENCE BETWEEN CLINICAL 

963
00:35:16,820 --> 00:35:18,622
RESEARCH AND PRACTICE IS 

964
00:35:18,622 --> 00:35:18,922
MULTIFOLD. 

965
00:35:18,922 --> 00:35:20,157
FIRST OF ALL, THERE ARE 

966
00:35:20,157 --> 00:35:23,594
DIFFERENT GOALS THAT I MENTIONED

967
00:35:23,594 --> 00:35:28,398
THAT GOAL OF RESEARCH IS 

968
00:35:28,398 --> 00:35:30,167
ANSWERING GENERALIZABLE 

969
00:35:30,167 --> 00:35:30,734
QUESTIONS AND GOAL OF 

970
00:35:30,734 --> 00:35:32,002
[INDISCERNIBLE] IS HELPING 

971
00:35:32,002 --> 00:35:34,605
PEOPLE IN FRONT OF YOU BASED ON 

972
00:35:34,605 --> 00:35:37,541
EVIDENCE THAT SOMEBODY COLLECTED

973
00:35:37,541 --> 00:35:37,908
BEFORE. 

974
00:35:37,908 --> 00:35:40,410
WE ALSO USE DIFFERENT METHODS 

975
00:35:40,410 --> 00:35:41,945
AND IN RESEARCH YOU MIGHT BE 

976
00:35:41,945 --> 00:35:46,049
AWARE AND HEAR MORE ABOUT AND WE

977
00:35:46,049 --> 00:35:49,153
RANDOMIZE PEOPLE TO GET THIS OR 

978
00:35:49,153 --> 00:35:50,454
THAT DRUG AND BLIND THEM MEANING

979
00:35:50,454 --> 00:35:51,922
THEY ARE NOT ALLOWED TO KNOW 

980
00:35:51,922 --> 00:35:54,925
WHAT THEY ARE GETTING AND 

981
00:35:54,925 --> 00:35:55,959
INVESTIGATOR DOESN'T KNOW WHAT 

982
00:35:55,959 --> 00:35:57,861
THEY ARE GETTING EITHER THAT IS 

983
00:35:57,861 --> 00:36:00,597
A DOUBLE BLIND AND OFFER AS 

984
00:36:00,597 --> 00:36:02,366
PLACEBOS ONE PART OF A CONTROL 

985
00:36:02,366 --> 00:36:05,302
GROUP THAT IS COMMON IN RESEARCH

986
00:36:05,302 --> 00:36:07,604
AND DO DOSE ESCALATION IN TRIALS

987
00:36:07,604 --> 00:36:09,439
AND THESE THREE PEOPLE WILL GET 

988
00:36:09,439 --> 00:36:11,275
THIS DOSE AND NEXT THREE PEOPLE 

989
00:36:11,275 --> 00:36:13,110
A HIGHER DOSE AND IS A NUMBER OF

990
00:36:13,110 --> 00:36:15,312
REALLY IMPORTANT METHODOLOGIES 

991
00:36:15,312 --> 00:36:19,850
IN RESEARCH THAT ARE CRITICAL TO

992
00:36:19,850 --> 00:36:23,020
GETTING GOOD UNBIASED DATA YOU 

993
00:36:23,020 --> 00:36:25,088
WOULD FIND ANNAGE MA IN CLINICAL

994
00:36:25,088 --> 00:36:27,257
PRACTICE AND GOING TO DOCTOR'S 

995
00:36:27,257 --> 00:36:30,294
OFFICE WITH A SORE THROAT AND 

996
00:36:30,294 --> 00:36:32,062
DOCTOR SAID I WILL GIVE YOU A 

997
00:36:32,062 --> 00:36:33,797
DRUG BUT I WON'T TELL YOU WHAT 

998
00:36:33,797 --> 00:36:35,832
IT IS I DON'T KNOW WHAT IT IS 

999
00:36:35,832 --> 00:36:38,001
YOU WOULD BE LIKE I THINK I NEED

1000
00:36:38,001 --> 00:36:40,404
A NEW DOCTOR AND THERE IS A 

1001
00:36:40,404 --> 00:36:42,005
REALLY INTERESTING DICHOTOMY 

1002
00:36:42,005 --> 00:36:43,740
BETWEEN METHODS COMMON TO EACH 

1003
00:36:43,740 --> 00:36:46,510
OF THOSE DOMAINS. 

1004
00:36:46,510 --> 00:36:48,345
THERE IS ALSO DIFFERENT 

1005
00:36:48,345 --> 00:36:49,713
JUSTIFICATIONS FOR RISK. 

1006
00:36:49,713 --> 00:36:51,615
IN CLINICAL PRACTICE, CERTAINLY 

1007
00:36:51,615 --> 00:36:53,550
PEOPLE ABSORB AND ACCEPT 

1008
00:36:53,550 --> 00:36:54,518
WHATEVER RISK. 

1009
00:36:54,518 --> 00:36:55,953
THERE IS RISKS WITH 

1010
00:36:55,953 --> 00:36:59,289
INTERVENTIONS OF ALL KINDS AND 

1011
00:36:59,289 --> 00:37:01,925
THOSE RISKS ARE JUSTIFIED 

1012
00:37:01,925 --> 00:37:04,428
BECAUSE THEY -- THEY BENEFIT 

1013
00:37:04,428 --> 00:37:07,197
THAT IS PRESUMED TO BE HAPPENING

1014
00:37:07,197 --> 00:37:09,833
BY GIVING THIS INTERVENTION 

1015
00:37:09,833 --> 00:37:10,701
OUTWEIGHS THE RISK. 

1016
00:37:10,701 --> 00:37:12,903
SO THE RISK IS WORTH IT FOR THAT

1017
00:37:12,903 --> 00:37:13,203
INDIVIDUAL. 

1018
00:37:13,203 --> 00:37:15,038
IN RESEARCH, WE ASK PEOPLE 

1019
00:37:15,038 --> 00:37:17,040
SOMETIMES TO DO THINGS FOR WHICH

1020
00:37:17,040 --> 00:37:19,610
THERE ARE NO BENEFITS THEN. 

1021
00:37:19,610 --> 00:37:21,612
WE MAY ASK THEM, FOR EXAMPLE, TO

1022
00:37:21,612 --> 00:37:25,549
HAVE AN EXTRA BIOPSY OR EXTRA 

1023
00:37:25,549 --> 00:37:27,384
BLOOD DRAW OR X-RAY AND TAKE A 

1024
00:37:27,384 --> 00:37:32,256
DRUG TO GET A PHARMACOKINETIC 

1025
00:37:32,256 --> 00:37:33,457
READING ON IT. 

1026
00:37:33,457 --> 00:37:35,759
THOSE ARE THINGS DONE FOR MONTH 

1027
00:37:35,759 --> 00:37:37,694
BENEFIT TO INDIVIDUALS AND THEY 

1028
00:37:37,694 --> 00:37:42,032
ACCEPT RISKS FOR INTEREST OF 

1029
00:37:42,032 --> 00:37:42,499
SCIENCE. 

1030
00:37:42,499 --> 00:37:44,401
THERE ARE DIFFERENT LEVELS OF 

1031
00:37:44,401 --> 00:37:45,202
UNCERTAINTY AND NOT EVERYTHING 

1032
00:37:45,202 --> 00:37:47,337
IN CLINICAL PRACTICE IS CERTAIN 

1033
00:37:47,337 --> 00:37:48,238
FOR SURE. 

1034
00:37:48,238 --> 00:37:49,840
PEOPLE WE OFTEN HAVE TO SAY HERE

1035
00:37:49,840 --> 00:37:52,409
IS WHAT WE KNOW OR DON'T KNOW 

1036
00:37:52,409 --> 00:37:54,378
AND WHAT WE WILL TRY AND FOR 

1037
00:37:54,378 --> 00:37:56,747
MOST PART IN CLINICAL PRACTICE 

1038
00:37:56,747 --> 00:37:59,983
WHAT IS DONE IS BASED ON PRIOR 

1039
00:37:59,983 --> 00:38:02,252
EVIDENCE OR PRIOR EXPERIENCE OR 

1040
00:38:02,252 --> 00:38:03,687
STANDARDS IN THE COMMUNITY AND 

1041
00:38:03,687 --> 00:38:07,424
IN RESEARCH, STARTING POINT IS 

1042
00:38:07,424 --> 00:38:10,127
UNCERTAINTY AND IN OTHER WORDS 

1043
00:38:10,127 --> 00:38:12,162
WE WOULDN'T DO A CLINICAL TRIAL 

1044
00:38:12,162 --> 00:38:15,332
AND WE ARE TESTING A VERSUS B 

1045
00:38:15,332 --> 00:38:16,867
AND KNOW A IS BETTER WHY WOULD 

1046
00:38:16,867 --> 00:38:18,702
WE DO THE TRIAL?  

1047
00:38:18,702 --> 00:38:19,870
STARTING POINT IS WE DON'T KNOW 

1048
00:38:19,870 --> 00:38:24,107
WHICH IS BETTER, SAFER, OR MORE 

1049
00:38:24,107 --> 00:38:25,108
EFFECTIVE OR WHATEVER. 

1050
00:38:25,108 --> 00:38:28,078
THAT IS THE STARTING POINT AND 

1051
00:38:28,078 --> 00:38:31,882
DIFFERENCES IN GOALS METHODS 

1052
00:38:31,882 --> 00:38:32,449
JUSTIFICATION FOR RISK AND 

1053
00:38:32,449 --> 00:38:33,684
LEVELS UNCERTAINTY WE HAVE 

1054
00:38:33,684 --> 00:38:35,752
DIFFERENT OBLIGATIONS OF 

1055
00:38:35,752 --> 00:38:36,987
PLAYERS, IF YOU WILL. 

1056
00:38:36,987 --> 00:38:40,424
CLINICIANS HAVE OBLIGATION TO 

1057
00:38:40,424 --> 00:38:41,992
COMPETENTLY OFFER CARE AND 

1058
00:38:41,992 --> 00:38:44,594
TREATMENT IN THEIR PATIENT'S 

1059
00:38:44,594 --> 00:38:46,330
BEST INTEREST AND IS THEIR 

1060
00:38:46,330 --> 00:38:47,698
OBLIGATION. 

1061
00:38:47,698 --> 00:38:49,833
RESEARCHERS HAVE OBLIGATION TO 

1062
00:38:49,833 --> 00:38:51,068
CONFIDENTLY CONDUCT RESEARCH 

1063
00:38:51,068 --> 00:38:53,303
WHILE REINSPECTING RIGHTS AND 

1064
00:38:53,303 --> 00:38:55,005
WELFARE OF THEIR PARTICIPANTS 

1065
00:38:55,005 --> 00:38:56,340
AND VERY DIFFERENT OBLIGATIONS 

1066
00:38:56,340 --> 00:38:56,640
AS WELL. 

1067
00:38:56,640 --> 00:38:59,309
NOW YOU GET TO THIS POINT IN MY 

1068
00:38:59,309 --> 00:39:02,312
TALK.  YOU WILL SAY, WHOA.  THAT

1069
00:39:02,312 --> 00:39:04,147
IS A LOT OF STUFF AND DOESN'T 

1070
00:39:04,147 --> 00:39:04,748
MAKE ANY SENSE. 

1071
00:39:04,748 --> 00:39:07,517
I THINK OFTEN TIMES FOR 

1072
00:39:07,517 --> 00:39:08,418
INVESTIGATORS AND PEOPLE 

1073
00:39:08,418 --> 00:39:09,753
INVOLVED IN RESEARCH AND PEOPLE 

1074
00:39:09,753 --> 00:39:13,023
THAT ARE ON IRBS ARE LIKE, OKAY.

1075
00:39:13,023 --> 00:39:14,725
SO HOW DO WE KNOW?  

1076
00:39:14,725 --> 00:39:16,960
HOW DO WE REALLY KNOW WHAT TO 

1077
00:39:16,960 --> 00:39:17,294
DO?  

1078
00:39:17,294 --> 00:39:19,796
DO WE FOLLOW THE COMMON RULE OR 

1079
00:39:19,796 --> 00:39:22,733
FOLLOW THE DECLARATION OF 

1080
00:39:22,733 --> 00:39:25,402
HELSINKI OR HAVE TO KNOW BOTH OR

1081
00:39:25,402 --> 00:39:27,437
WHAT IF THEY CONFLICT AND HOW DO

1082
00:39:27,437 --> 00:39:29,740
WE FIGURE OUT WHAT TO DO?  

1083
00:39:29,740 --> 00:39:31,775
THERE IS LOTS UNFORTUNATE 

1084
00:39:31,775 --> 00:39:32,075
CONFUSION. 

1085
00:39:32,075 --> 00:39:33,910
TO ADD TO THAT, A LOT OF THE 

1086
00:39:33,910 --> 00:39:35,379
GUIDANCE THAT I HAVE MENTIONED 

1087
00:39:35,379 --> 00:39:37,381
AND RULES AND REGULATIONS AND 

1088
00:39:37,381 --> 00:39:39,683
CODES OF ETHICS WERE DEVELOPED 

1089
00:39:39,683 --> 00:39:41,451
IN RESPONSE TO A PARTICULAR 

1090
00:39:41,451 --> 00:39:44,154
HISTORICAL EVENT. 

1091
00:39:44,154 --> 00:39:46,857
SO AS I MENTIONED, NUREMBERG WAS

1092
00:39:46,857 --> 00:39:50,193
A RESPONSE TO NAZI GERMANY AND 

1093
00:39:50,193 --> 00:39:52,329
HELSINKI RESPONSE TO NUREMBERG 

1094
00:39:52,329 --> 00:39:54,698
CODE AND BELMONT RESPONSE TO 

1095
00:39:54,698 --> 00:39:55,999
TUSKEGEE AMONG OTHER THINGS AND 

1096
00:39:55,999 --> 00:39:57,968
EACH OF THEM SORT OF CAME ABOUT 

1097
00:39:57,968 --> 00:39:58,802
HISTORICALLY BECAUSE OF 

1098
00:39:58,802 --> 00:40:01,505
SOMETHING THAT HAD HAPPENED AND 

1099
00:40:01,505 --> 00:40:04,508
THEREFORE THEIR MAIN FOLK -- 

1100
00:40:04,508 --> 00:40:06,743
FOCUS IS OFTEN IN RESPONSE TO 

1101
00:40:06,743 --> 00:40:10,814
THAT HISTORICAL EVENT. 

1102
00:40:10,814 --> 00:40:14,418
THE END RESULT IS THAT DIFFERENT

1103
00:40:14,418 --> 00:40:17,053
REGULATIONS AND GUIDANCE COMES 

1104
00:40:17,053 --> 00:40:20,123
SOMETIMES INTO CONFLICT AND HAVE

1105
00:40:20,123 --> 00:40:21,158
DIFFERENT INTERPRETATIONS OR 

1106
00:40:21,158 --> 00:40:24,428
EMPHASIZE DIFFERENT THINGS AND 

1107
00:40:24,428 --> 00:40:26,496
UNDERSTANDING THEM IS DIVERGENCE

1108
00:40:26,496 --> 00:40:27,664
AND MENTIONED ALREADY THAT 

1109
00:40:27,664 --> 00:40:29,266
DIFFERENT REGULATIONS MIGHT 

1110
00:40:29,266 --> 00:40:32,402
APPLY AND FOR EXAMPLE IF 

1111
00:40:32,402 --> 00:40:33,970
NIH-FUNDED INVESTIGATOR, YOU ARE

1112
00:40:33,970 --> 00:40:38,108
-- YOU HAVE TO FOLLOW COMMON 

1113
00:40:38,108 --> 00:40:38,308
RULE. 

1114
00:40:38,308 --> 00:40:40,911
IF NIH INVESTIGATOR DEVELOPING A

1115
00:40:40,911 --> 00:40:42,879
PRODUCT YOU WANT TO ULTIMATELY 

1116
00:40:42,879 --> 00:40:46,983
GET APPROVED BY FDA YOU HAVE TO 

1117
00:40:46,983 --> 00:40:49,453
FOLLOW FDA REGULATIONS 

1118
00:40:49,453 --> 00:40:50,954
INVESTIGATOR FOLLOWING COMMON 

1119
00:40:50,954 --> 00:40:54,624
RULE OF FDA REGULATIONS AND WANT

1120
00:40:54,624 --> 00:40:55,358
PAPER PUBLISHED IN JOURNAL YOU 

1121
00:40:55,358 --> 00:41:00,430
HAVE TO FOLLOW DECLARATION OF 

1122
00:41:00,430 --> 00:41:01,331
SIN CAN I. 

1123
00:41:01,331 --> 00:41:02,966
YOU HAVE TO KNOW WHAT IT IS AND 

1124
00:41:02,966 --> 00:41:04,367
ALL THESE ARE IMPORTANT TO KNOW 

1125
00:41:04,367 --> 00:41:11,107
ABOUT AND NOW I WILL TAKE YOU TO

1126
00:41:11,107 --> 00:41:12,876
A DIFFERENT PLACE AND THINK THAT

1127
00:41:12,876 --> 00:41:14,945
RECOGNIZING NUMBER OF DIFFERENT 

1128
00:41:14,945 --> 00:41:16,813
GUIDANCES REGULATIONS AND 

1129
00:41:16,813 --> 00:41:19,115
CONFUSION THEY MIGHT GENERATE 

1130
00:41:19,115 --> 00:41:21,685
LED US 20-SOME ODD YEARS AGO TO 

1131
00:41:21,685 --> 00:41:24,921
DEVELOP WHAT WE CALL SYSTEMATIC 

1132
00:41:24,921 --> 00:41:27,524
COHERENT UNIVERSALLY APPLICABLE 

1133
00:41:27,524 --> 00:41:29,292
FRAMEWORK THAT IS FRAMEWORK YOU 

1134
00:41:29,292 --> 00:41:32,162
WILL LEARN ABOUT AND HEAR ABOUT 

1135
00:41:32,162 --> 00:41:34,598
REPEATEDLY THROUGHOUT THE COURSE

1136
00:41:34,598 --> 00:41:36,299
AND FRAMEWORK HAS EIGHT 

1137
00:41:36,299 --> 00:41:39,569
PRINCIPLES SEE WHAT THEY ARE 

1138
00:41:39,569 --> 00:41:40,871
COLLABORATIVE PARTNERSHIP AND 

1139
00:41:40,871 --> 00:41:42,272
FAIR SUBJECT OR PARTICIPANT 

1140
00:41:42,272 --> 00:41:45,141
SELECTION FAVORABLE RISK BENEFIT

1141
00:41:45,141 --> 00:41:46,142
INDEPENDENT REVIEW INFORMED 

1142
00:41:46,142 --> 00:41:47,644
CONCEPT AND R--EE INSPECT FOR 

1143
00:41:47,644 --> 00:41:49,513
ENROLLED SUBJECTS. 

1144
00:41:49,513 --> 00:41:51,615
I WILL BRIEFLY SAY WHAT EACH OF 

1145
00:41:51,615 --> 00:41:53,683
THEM MEAN AND WHY WE THINK IT IS

1146
00:41:53,683 --> 00:41:55,819
IMPORTANT AND SOME CHALLENGES 

1147
00:41:55,819 --> 00:41:57,287
WITH IT. 

1148
00:41:57,287 --> 00:41:58,722
COLLABORATIVE PARTNERSHIP, 

1149
00:41:58,722 --> 00:41:59,723
BASICALLY IF THE GOAL OF 

1150
00:41:59,723 --> 00:42:01,892
RESEARCH IS TO TRY TO IMPROVE 

1151
00:42:01,892 --> 00:42:03,827
HEALTH WE HAVE TO REALIZE IT 

1152
00:42:03,827 --> 00:42:05,729
SHOULD BE A PARTNERSHIP WITH THE

1153
00:42:05,729 --> 00:42:09,332
RELEVANT PARTNERS AND THOSE, FOR

1154
00:42:09,332 --> 00:42:11,768
EXAMPLE, WHO ARE RESPONSIBLE FOR

1155
00:42:11,768 --> 00:42:13,503
PLANNING CONDUCTING AND 

1156
00:42:13,503 --> 00:42:15,705
OVERSEEING RESEARCH INTEGRATING 

1157
00:42:15,705 --> 00:42:17,307
RESULTS OF RESEARCH INTO A 

1158
00:42:17,307 --> 00:42:19,543
HEALTH SYSTEM AND CONTRIBUTION 

1159
00:42:19,543 --> 00:42:21,811
OF VARIOUS PARTNERS INVOLVED AND

1160
00:42:21,811 --> 00:42:23,013
COLLABORATION WITH EXISTING 

1161
00:42:23,013 --> 00:42:25,448
SYSTEMS OF HEALTH THAT MEANS 

1162
00:42:25,448 --> 00:42:27,017
COLLABORATING WITH POLICY MAKERS

1163
00:42:27,017 --> 00:42:30,020
AND HEALTH SYSTEMS AND COMMUNITY

1164
00:42:30,020 --> 00:42:31,821
ADVISORY BOARDS OR COMMUNITIES 

1165
00:42:31,821 --> 00:42:34,457
AND PATIENT ADVOCATES AND 

1166
00:42:34,457 --> 00:42:36,927
ADVOCATES FOR RESEARCH FUNDING 

1167
00:42:36,927 --> 00:42:39,062
AND COLLABORATING INVESTIGATORS 

1168
00:42:39,062 --> 00:42:40,864
PRACTICING CLINICIANS, 

1169
00:42:40,864 --> 00:42:42,465
PARTICIPANTS, THE LIST COULD GO 

1170
00:42:42,465 --> 00:42:44,234
ON AND THINKING ABOUT WHO ARE 

1171
00:42:44,234 --> 00:42:48,004
IMPORTANT PARTNERS IN ANY 

1172
00:42:48,004 --> 00:42:50,874
RESEARCH ENDEAVOR SO RESEARCH IS

1173
00:42:50,874 --> 00:42:51,942
RESPONSIVE TO WHAT PARTNERS NEED

1174
00:42:51,942 --> 00:42:54,811
AND RESPECTS CONTRIBUTIONS OF 

1175
00:42:54,811 --> 00:42:55,011
EACH. 

1176
00:42:55,011 --> 00:42:57,213
THERE IS LOTS OF EXAMPLES OF 

1177
00:42:57,213 --> 00:42:59,082
COLLABORATIVE PARTNERSHIP AND 

1178
00:42:59,082 --> 00:42:59,983
SOME PROBABLY MORE EFFECTIVE 

1179
00:42:59,983 --> 00:43:02,752
THAN OTHERS AND MANY STUDIES 

1180
00:43:02,752 --> 00:43:04,588
HAVE COMMUNITY ADVISORY BOARDS 

1181
00:43:04,588 --> 00:43:09,059
AND ARE MANY ADVOCACY GROUPS AND

1182
00:43:09,059 --> 00:43:11,528
LIKE RARE -- ADVOCACY FOR RARE 

1183
00:43:11,528 --> 00:43:15,165
DISEASES AND FRIENDS OF CANCER 

1184
00:43:15,165 --> 00:43:16,633
AND CLINICAL HAS PATIENT 

1185
00:43:16,633 --> 00:43:18,335
ADVISORY GROUP AND DIFFERENT 

1186
00:43:18,335 --> 00:43:19,869
EXAMPLES OF COLLABORATION THAT 

1187
00:43:19,869 --> 00:43:21,871
MAKES SENSE AND COLLABORATION IS

1188
00:43:21,871 --> 00:43:22,706
ALSO COMPLEX. 

1189
00:43:22,706 --> 00:43:27,210
IF YOU GO, FOR EXAMPLE, TO A 

1190
00:43:27,210 --> 00:43:29,012
RECENT ISSUE OF THE NEW ENGLAND 

1191
00:43:29,012 --> 00:43:31,748
JOURNAL AND LOOK AT RANDOMIZED 

1192
00:43:31,748 --> 00:43:33,516
TRIALS THAT MIGHT BE REPORTED IN

1193
00:43:33,516 --> 00:43:36,820
THERE YOU WILL SOMETIMES SEE A 

1194
00:43:36,820 --> 00:43:43,893
STUDY THAT HAS 40 AUTHORS DONE 

1195
00:43:43,893 --> 00:43:48,264
IN 83 COUNTRIES WITH 6 HUNDRED 

1196
00:43:48,264 --> 00:43:51,368
SITES AND 10 THOUSAND PEOPLE. 

1197
00:43:51,368 --> 00:43:54,638
THAT IN ONE WAY THEY ARE ALL 

1198
00:43:54,638 --> 00:43:56,006
COLLABORATORS THAT IS A COMPLEX 

1199
00:43:56,006 --> 00:43:57,707
MESS OF PEOPLE TO FIGURE OUT HOW

1200
00:43:57,707 --> 00:43:59,609
TO COLLABORATE WITH AND IS 

1201
00:43:59,609 --> 00:44:01,444
CHALLENGING AND CHALLENGES ARE 

1202
00:44:01,444 --> 00:44:03,780
IDENTIFYING WHO PARTNERS ARE AND

1203
00:44:03,780 --> 00:44:06,182
WHO RIGHT PARTNERS ARE AND HOW 

1204
00:44:06,182 --> 00:44:07,250
TO ENGAGE THEM. 

1205
00:44:07,250 --> 00:44:08,885
THERE IS INFORMATION AND LOTS OF

1206
00:44:08,885 --> 00:44:11,187
LITERATURE NOW ON PATIENT 

1207
00:44:11,187 --> 00:44:15,258
ENGAGEMENT PUBLIC ENGAGEMENT AND

1208
00:44:15,258 --> 00:44:15,892
COMMUNITY-BASE ENGAGEMENT AND 

1209
00:44:15,892 --> 00:44:17,327
IMPORTANT CONCEPTS REALLY BUT 

1210
00:44:17,327 --> 00:44:19,462
ALL OVER THE MAP IN TERMS WHAT 

1211
00:44:19,462 --> 00:44:27,604
THAT MODE ENGAGEMENT LOOKS LIKE.

1212
00:44:27,604 --> 00:44:30,573
SECOND VALUABLE PRINCIPLE WE 

1213
00:44:30,573 --> 00:44:34,644
TALK ABOUT IN WORLD AS SOCIAL 

1214
00:44:34,644 --> 00:44:36,813
VALUE AND THIS BASICALLY WHAT IT

1215
00:44:36,813 --> 00:44:39,149
IS, IS THE QUESTION HAS TO BE 

1216
00:44:39,149 --> 00:44:41,351
WORTH ASKING AND WILL WE LEARN 

1217
00:44:41,351 --> 00:44:42,786
SOMETHING USEFUL TO SOMEBODY AND

1218
00:44:42,786 --> 00:44:44,387
GOAL IS TO FIND USEFUL 

1219
00:44:44,387 --> 00:44:48,158
INFORMATION TO UNDERSTAND OR 

1220
00:44:48,158 --> 00:44:48,992
IMPROVE HUCHL AN HEALTH QUESTION

1221
00:44:48,992 --> 00:44:51,661
WE ARE ASKING IN THIS STUDY OR 

1222
00:44:51,661 --> 00:44:53,329
PROGRAM OF RESEARCH GOING TO DO 

1223
00:44:53,329 --> 00:44:54,597
THAT?  

1224
00:44:54,597 --> 00:44:56,399
SHOULD ANSWER VALUABLE 

1225
00:44:56,399 --> 00:44:59,569
QUESTION, ONE THAT CAN OR WILL 

1226
00:44:59,569 --> 00:45:00,837
GENERATE NEW KNOWLEDGE OR 

1227
00:45:00,837 --> 00:45:02,539
UNDERSTANDING ABOUT HUMAN HEALTH

1228
00:45:02,539 --> 00:45:04,407
OR ILLNESS THAT COULD BE 

1229
00:45:04,407 --> 00:45:06,710
SOCIALLY VALUABLE, CLINICALLY 

1230
00:45:06,710 --> 00:45:09,746
VALUABLE OR SCIENTIFICALLY 

1231
00:45:09,746 --> 00:45:10,013
VALUABLE. 

1232
00:45:10,013 --> 00:45:11,948
WE OFTEN ASK, YOU KNOW, THEN 

1233
00:45:11,948 --> 00:45:14,250
WHAT IS THE VALUE OF ANSWERING A

1234
00:45:14,250 --> 00:45:14,884
SPECIFIC QUESTION?  

1235
00:45:14,884 --> 00:45:18,321
NOT ALWAYS SO EASY TO JUDGE BUT 

1236
00:45:18,321 --> 00:45:19,389
THINKING CAREFULLY ABOUT WHAT WE

1237
00:45:19,389 --> 00:45:21,524
WILL LEARN AND HOW USEFUL IT 

1238
00:45:21,524 --> 00:45:22,959
WILL BE AND HOW WILL WE KNOW IF 

1239
00:45:22,959 --> 00:45:25,662
IT IS USEFUL AND TO WHOM WILL 

1240
00:45:25,662 --> 00:45:27,530
KNOWLEDGE BE USEFUL?  

1241
00:45:27,530 --> 00:45:29,332
IS IT TO PARTICIPANTS IN THE 

1242
00:45:29,332 --> 00:45:30,467
STUDY?  

1243
00:45:30,467 --> 00:45:31,634
SOMETIMES IT IS. 

1244
00:45:31,634 --> 00:45:33,136
SOMETIMES IS IT TO COMMUNITY 

1245
00:45:33,136 --> 00:45:35,338
WHICH THEY LIVE OR PEOPLE TO 

1246
00:45:35,338 --> 00:45:36,406
SIMILAR CONDITIONS OR FUTURE 

1247
00:45:36,406 --> 00:45:38,508
PEOPLE OR SOCIETY IN GENERAL OR 

1248
00:45:38,508 --> 00:45:39,909
SCIENCE AND SPONSORS AND COULD 

1249
00:45:39,909 --> 00:45:40,977
BE LOTS OF ANSWERS TO THE 

1250
00:45:40,977 --> 00:45:42,612
QUESTION AND TRYING TO FIGURE 

1251
00:45:42,612 --> 00:45:47,317
OUT WHAT VALUE IS OF A SPECIFIC 

1252
00:45:47,317 --> 00:45:47,550
STUDY. 

1253
00:45:47,550 --> 00:45:50,019
THERE IS ROOM FOR MORE WORK ON 

1254
00:45:50,019 --> 00:45:51,788
THIS TOPIC. 

1255
00:45:51,788 --> 00:45:55,859
THERE IS A, I THINK A VERY 

1256
00:45:55,859 --> 00:45:58,094
IMPORTANT ISSUE OF BIOEDGE INGS 

1257
00:45:58,094 --> 00:45:59,963
OF EIGHT YEARS AGO TRYING TO ASK

1258
00:45:59,963 --> 00:46:01,464
THE QUESTION ABOUT, YOU KNOW, 

1259
00:46:01,464 --> 00:46:03,399
WHAT IS REALLY SOCIAL VALUE AND 

1260
00:46:03,399 --> 00:46:05,068
HOW DO WE UNDERSTAND IT?  

1261
00:46:05,068 --> 00:46:06,369
A NUMBER OF IMPORTANT QUESTIONS 

1262
00:46:06,369 --> 00:46:09,472
AND PAPERS IN THAT VOLUME. 

1263
00:46:09,472 --> 00:46:12,041
THIS IS ONE FROM PEOPLE IN OUR 

1264
00:46:12,041 --> 00:46:14,210
GROUP WHO WERE DEFENDING SOCIAL 

1265
00:46:14,210 --> 00:46:15,078
VALUE REQUIREMENT. 

1266
00:46:15,078 --> 00:46:17,080
ANOTHER FROM A PERSON IN OUR 

1267
00:46:17,080 --> 00:46:18,481
GROUP WHO WAS QUESTIONING SOCIAL

1268
00:46:18,481 --> 00:46:19,816
VALUE REQUIREMENT AND THINKING 

1269
00:46:19,816 --> 00:46:22,719
ABOUT THE LIMITS OF IT. 

1270
00:46:22,719 --> 00:46:24,988
PEOPLE HAVE BUILT ON THIS. 

1271
00:46:24,988 --> 00:46:27,423
THERE WAS A VERY USEFUL PAPER IN

1272
00:46:27,423 --> 00:46:30,293
THE HASTINGS CENTER IN 2018 BY 

1273
00:46:30,293 --> 00:46:32,395
DANY WHO TALKED ABOUT, YOU KNOW,

1274
00:46:32,395 --> 00:46:35,265
HOW TO THINK ABOUT SOCIAL VALUE 

1275
00:46:35,265 --> 00:46:37,400
IN A DIFFERENT WAY. 

1276
00:46:37,400 --> 00:46:38,802
THERE HAVE BEEN PEOPLE LIKE ONE 

1277
00:46:38,802 --> 00:46:43,373
OF MY FELLOWS.  I WROTE A PAPER 

1278
00:46:43,373 --> 00:46:45,542
OR CHAPTER FOR A BOOK RECENTLY 

1279
00:46:45,542 --> 00:46:47,010
TRYING TO SELECT CASES AND 

1280
00:46:47,010 --> 00:46:49,612
EXEMPLIFY WHAT VALUE MEANS IN 

1281
00:46:49,612 --> 00:46:50,947
SPECIFIC CASES AND PICKED HIGH 

1282
00:46:50,947 --> 00:46:53,349
VALUE CASES AND LOW VALUE CASES 

1283
00:46:53,349 --> 00:46:55,018
AS AN EXPLORATION. 

1284
00:46:55,018 --> 00:46:57,220
SO THAT IS A LOT MORE TO BE DONE

1285
00:46:57,220 --> 00:46:58,988
ABOUT WHAT SOCIAL VALUE IS. 

1286
00:46:58,988 --> 00:47:01,958
YOU WILL HEAR IT THROUGHOUT THIS

1287
00:47:01,958 --> 00:47:02,559
COURSE. 

1288
00:47:02,559 --> 00:47:04,761
THIRD IS VALID SCIENTIFIC 

1289
00:47:04,761 --> 00:47:05,094
METHODOLOGY. 

1290
00:47:05,094 --> 00:47:06,896
YOU HAVE PARTNERS IN PLACE AND 

1291
00:47:06,896 --> 00:47:09,933
QUESTION THAT IS WORTH ASKING. 

1292
00:47:09,933 --> 00:47:12,135
NEXT REAL IMPORTANT ETHICAL 

1293
00:47:12,135 --> 00:47:13,837
REQUIREMENT IS SETTING UP THE 

1294
00:47:13,837 --> 00:47:17,440
STUDY SO THAT IT IS VALID AND 

1295
00:47:17,440 --> 00:47:19,776
YOU GET RELIABLE, 

1296
00:47:19,776 --> 00:47:20,443
UNDERSTANDABLE, INFORMATION THAT

1297
00:47:20,443 --> 00:47:22,712
YOU CAN MAKE SENSE OUT OF AND 

1298
00:47:22,712 --> 00:47:24,347
YOU CAN ANSWER THE QUESTION. 

1299
00:47:24,347 --> 00:47:26,816
THAT DOESN'T MEAN IT HAS TO BE A

1300
00:47:26,816 --> 00:47:27,283
POSITIVE TRIAL. 

1301
00:47:27,283 --> 00:47:29,085
IT JUST MEANS YOU HAVE TO BE 

1302
00:47:29,085 --> 00:47:32,188
ABLE TO KNOW WHAT THE ANSWER TO 

1303
00:47:32,188 --> 00:47:33,957
THE QUESTION IS.  EXCUSE ME.  

1304
00:47:33,957 --> 00:47:35,091
WHEN YOU ARE DONE. 

1305
00:47:35,091 --> 00:47:37,060
THAT INCLUDES A BUNCH OF THINGS 

1306
00:47:37,060 --> 00:47:39,896
LIKE HOW TO DESIGN THE TRIAL AND

1307
00:47:39,896 --> 00:47:41,397
WHAT METHODS WILL BE THAT YOU 

1308
00:47:41,397 --> 00:47:42,932
WILL USE AND WHAT STATISTICS 

1309
00:47:42,932 --> 00:47:45,335
WILL YOU BE USING AND WHAT 

1310
00:47:45,335 --> 00:47:48,404
STATISTICAL POWER. 

1311
00:47:48,404 --> 00:47:52,642
THE GOAL BEING VALID, RELIABLE, 

1312
00:47:52,642 --> 00:47:54,644
GENERALIZABLE, AND INTERPRETABLE

1313
00:47:54,644 --> 00:47:55,044
DATA. 

1314
00:47:55,044 --> 00:47:57,513
THERE IS ALSO AN IMPORTANT PART 

1315
00:47:57,513 --> 00:48:01,284
OF VALID SCIENTIFIC METHODOLOGY 

1316
00:48:01,284 --> 00:48:02,919
THAT IS FEASIBILITY. 

1317
00:48:02,919 --> 00:48:05,622
SOME QUESTIONS CAN'T BE ANSWERED

1318
00:48:05,622 --> 00:48:06,990
BECAUSE YOU CAN'T DESIGN THE 

1319
00:48:06,990 --> 00:48:08,892
STUDY IN A WAY THAT WILL EVER 

1320
00:48:08,892 --> 00:48:10,326
COME UP WITH AN ANSWER. 

1321
00:48:10,326 --> 00:48:12,028
MAKING SURE THAT WHAT YOU ARE 

1322
00:48:12,028 --> 00:48:14,130
ASKING AND HOW YOU ARE DESIGNING

1323
00:48:14,130 --> 00:48:17,367
IT IS FEASIBLE IS AN IMPORTANT 

1324
00:48:17,367 --> 00:48:20,403
PART OF JUSTIFYING ASKING PEOPLE

1325
00:48:20,403 --> 00:48:22,438
TO PARTICIPATE. 

1326
00:48:22,438 --> 00:48:24,073
SOMETIMES WHEN WE TALK ABOUT 

1327
00:48:24,073 --> 00:48:27,076
SCIENTIFIC METHODOLOGY AS AN 

1328
00:48:27,076 --> 00:48:28,244
ETHICAL REQUIREMENT PEOPLE SAY 

1329
00:48:28,244 --> 00:48:29,846
THAT IS SCIENCE NOT ETHICS. 

1330
00:48:29,846 --> 00:48:32,048
MY SLIDE HERE IS TO TELL YOU YOU

1331
00:48:32,048 --> 00:48:33,116
CAN'T PULL THEM APART. 

1332
00:48:33,116 --> 00:48:36,686
THEY ARE TOTALLY INTEGRATED AND 

1333
00:48:36,686 --> 00:48:39,122
ONLY TO MAKE SOMETHING ETHICALLY

1334
00:48:39,122 --> 00:48:41,824
OKAY HAS TO BE SCIENTIFICALLY 

1335
00:48:41,824 --> 00:48:44,394
RIGOROUS AND SOMETHING THAT IS 

1336
00:48:44,394 --> 00:48:45,194
SCIENTIFICALLY RIGOROUS SHOULD 

1337
00:48:45,194 --> 00:48:46,763
BE ETHICAL AS WELL AND IS A 

1338
00:48:46,763 --> 00:48:47,730
NUMBER OF DIFFERENT 

1339
00:48:47,730 --> 00:48:49,465
CONSIDERATIONS IN THINKING ABOUT

1340
00:48:49,465 --> 00:48:52,035
SCIENTIFIC VALIDITY. 

1341
00:48:52,035 --> 00:48:54,437
THESE ARE JUST SOME EXAMPLES. 

1342
00:48:54,437 --> 00:48:57,106
CHOOSING THE ENDPOINTS, YOU 

1343
00:48:57,106 --> 00:49:00,410
KNOW, HOW DO YOU MEASURE A -- 

1344
00:49:00,410 --> 00:49:04,247
THE EFFECT OF AN ANTIVIRAL OR 

1345
00:49:04,247 --> 00:49:04,514
VACCINE?  

1346
00:49:04,514 --> 00:49:09,152
IS IT ANTIBODIES, INFECTION OR 

1347
00:49:09,152 --> 00:49:10,753
DISEASE AND MATTERS IN NUMBER OF

1348
00:49:10,753 --> 00:49:12,388
PEOPLE YOU NEED AND UNCERTAINTY 

1349
00:49:12,388 --> 00:49:14,791
AT END OF THE STUDY, ET CETERA. 

1350
00:49:14,791 --> 00:49:17,827
WHEN DO YOU USE RANDOMIZED 

1351
00:49:17,827 --> 00:49:19,662
DOUBLE BLIND PLACEBO CONTROLLED 

1352
00:49:19,662 --> 00:49:22,865
TRIAL AND MAKING TRIALS 

1353
00:49:22,865 --> 00:49:24,400
NONINFERIORITY OR SUPERIORITY 

1354
00:49:24,400 --> 00:49:27,003
AND USING QUANTITATIVE OR 

1355
00:49:27,003 --> 00:49:28,838
QUALITATIVE METHOD AND MEASURING

1356
00:49:28,838 --> 00:49:30,740
OUTCOME AND WHAT IS MEASURE OF 

1357
00:49:30,740 --> 00:49:32,241
OUTCOME TO BUILD INTO A STUDY 

1358
00:49:32,241 --> 00:49:34,310
AND HOW DO YOU FOLLOW PEOPLE AND

1359
00:49:34,310 --> 00:49:36,012
WHAT POWER DO YOU NEED AND 

1360
00:49:36,012 --> 00:49:38,214
SAMPLE SIZES AND WHAT METHODS OR

1361
00:49:38,214 --> 00:49:40,249
STATISTICAL METHODS DO YOU NEED,

1362
00:49:40,249 --> 00:49:40,817
ET CETERA. 

1363
00:49:40,817 --> 00:49:42,852
THOSE ARE INTERESTING AND 

1364
00:49:42,852 --> 00:49:43,953
IMPORTANT QUESTIONS THAT HAS 

1365
00:49:43,953 --> 00:49:45,621
BEEN CARTOONS OWE TLUT AND 

1366
00:49:45,621 --> 00:49:48,825
CONTROL GROUP AND OUT OF CONTROL

1367
00:49:48,825 --> 00:49:51,294
GROUP AND PLACEBO MEMBER WHO 

1368
00:49:51,294 --> 00:49:53,262
DIED AND MEMBER PLACEBO GROUP 

1369
00:49:53,262 --> 00:49:55,965
AND THIS ONE I THINK IS REALLY 

1370
00:49:55,965 --> 00:49:56,399
FUN. 

1371
00:49:56,399 --> 00:49:59,435
YOU KNOW, THE -- THE POSSIBLE 

1372
00:49:59,435 --> 00:50:04,374
WOES OF STATISTICS THAT CAN BE 

1373
00:50:04,374 --> 00:50:04,640
MISUSED. 

1374
00:50:04,640 --> 00:50:05,575
ALL THAT IS IMPORTANT. 

1375
00:50:05,575 --> 00:50:08,011
THERE IS ALSO REALLY INTERESTING

1376
00:50:08,011 --> 00:50:09,345
CHALLENGES RIGHT NOW THAT WE ARE

1377
00:50:09,345 --> 00:50:12,315
SORT OF LEARNING MORE ABOUT. 

1378
00:50:12,315 --> 00:50:13,883
DECENTRALIZED TRIALS AND 

1379
00:50:13,883 --> 00:50:16,119
PRAGMATIC TRIALS AND PLATFORM 

1380
00:50:16,119 --> 00:50:18,654
TRIALS AND SECONDARY ANALYSIS OF

1381
00:50:18,654 --> 00:50:20,890
DATA OR SPECIMENS THAT ALL OF 

1382
00:50:20,890 --> 00:50:23,393
WHICH HAVE METHODS THAT ARE 

1383
00:50:23,393 --> 00:50:25,328
DIFFERENT FROM SORT OF STANDARD 

1384
00:50:25,328 --> 00:50:28,431
ONE IN-PERSON RANDOMIZED CONTROL

1385
00:50:28,431 --> 00:50:28,698
TRIAL. 

1386
00:50:28,698 --> 00:50:30,133
BUT REQUIRES VERY CAREFUL 

1387
00:50:30,133 --> 00:50:31,768
THOUGHT ABOUT HOW TO SET IT UP 

1388
00:50:31,768 --> 00:50:34,337
SO IT IS RIGOROUS AND VALID AND 

1389
00:50:34,337 --> 00:50:37,373
YOU WILL GET INTERPRETABLE DATA 

1390
00:50:37,373 --> 00:50:38,041
AND FEASIBLE. 

1391
00:50:38,041 --> 00:50:39,409
YOU WILL HEAR ABOUT SOME OF 

1392
00:50:39,409 --> 00:50:39,909
THESE. 

1393
00:50:39,909 --> 00:50:42,445
I DON'T HAVE TIME TO GO OVER 

1394
00:50:42,445 --> 00:50:44,047
THEM TODAY. 

1395
00:50:44,047 --> 00:50:46,349
FAIR SUBJECT SELECTION OR 

1396
00:50:46,349 --> 00:50:47,483
PARTICIPATANT SELECTION IS 

1397
00:50:47,483 --> 00:50:49,152
BASICALLY WHAT IT SOUNDS LIKE 

1398
00:50:49,152 --> 00:50:53,089
AND MAIN ISSUE IS THAT THE 

1399
00:50:53,089 --> 00:50:55,224
SCIENTIFIC OBJECTIVES SHOULD 

1400
00:50:55,224 --> 00:50:57,527
GUIDE INCLUSION CRIT EAR YA AND 

1401
00:50:57,527 --> 00:50:59,328
RECRUITMENT STRATEGIES AND 

1402
00:50:59,328 --> 00:50:59,629
SELECTION. 

1403
00:50:59,629 --> 00:51:01,564
THIS IS BASED -- YOU KNOW, SOME 

1404
00:51:01,564 --> 00:51:03,766
OF THIS IS IN THE BELMONT REPORT

1405
00:51:03,766 --> 00:51:05,501
BASED ON A RESPONSE TO PREVIOUS 

1406
00:51:05,501 --> 00:51:08,037
KINDS OF RESEARCH THAT WERE DONE

1407
00:51:08,037 --> 00:51:10,306
WHERE PRIVILEGE OR EASY 

1408
00:51:10,306 --> 00:51:11,307
AVAILABILITY OR VULNERABILITY 

1409
00:51:11,307 --> 00:51:16,412
WERE USED AS CRATE EAR YA FOR 

1410
00:51:16,412 --> 00:51:18,081
SELECT PARTICIPANTS THAT ARE ALL

1411
00:51:18,081 --> 00:51:21,918
WRONG CRITERIA. 

1412
00:51:21,918 --> 00:51:24,387
THERE IS A DAVE THAT YOU WILL 

1413
00:51:24,387 --> 00:51:26,722
HEAR FROM THE COURSE TALKS ABOUT

1414
00:51:26,722 --> 00:51:29,092
FLIPPING IT ON ITS SIDE SAYING 

1415
00:51:29,092 --> 00:51:30,893
BEST WAY TO THINK ABOUT FAIR 

1416
00:51:30,893 --> 00:51:33,596
PARTICIPANT SELECTION IS TO SAY 

1417
00:51:33,596 --> 00:51:35,932
THERE IS NO EXCLUSION. 

1418
00:51:35,932 --> 00:51:38,101
EVERYBODY IS ELIGIBLE WITHOUT 

1419
00:51:38,101 --> 00:51:38,634
JUSTIFICATION. 

1420
00:51:38,634 --> 00:51:40,503
SO THEN YOU MIGHT SAY, WHAT ARE 

1421
00:51:40,503 --> 00:51:41,704
JUSTIFICATIONS THAT SOMETIMES 

1422
00:51:41,704 --> 00:51:44,273
COULD BE USED TO EXCLUDE PEOPLE?

1423
00:51:44,273 --> 00:51:46,509
SOMETIMES THEY ARE 

1424
00:51:46,509 --> 00:51:48,177
SCIENTIFICALLY INAPPROPRIATE AND

1425
00:51:48,177 --> 00:51:49,278
CAN'T STUDY TREATMENT IN PEOPLE 

1426
00:51:49,278 --> 00:51:50,880
WITH BREAST CANCER THAT DON'T 

1427
00:51:50,880 --> 00:51:52,415
HAVE BREAST CANCER. 

1428
00:51:52,415 --> 00:51:54,650
FOR EXAMPLE SOMETIMES IT IS RISK

1429
00:51:54,650 --> 00:51:56,986
AND CONTENTIOUS AND IMPORTANT 

1430
00:51:56,986 --> 00:51:58,454
AND RISK IS HIGH FOR CERTAIN 

1431
00:51:58,454 --> 00:52:00,256
GROUP OF PEOPLE IT IS MAYBE 

1432
00:52:00,256 --> 00:52:02,024
APPROPRIATE AND JUSTIFIABLE TO 

1433
00:52:02,024 --> 00:52:05,128
EXCLUDE THEM AND EVEN MORE 

1434
00:52:05,128 --> 00:52:06,295
CONTROVERSY ABOUT VULNERABILITY 

1435
00:52:06,295 --> 00:52:08,331
AND SOME PEOPLE SAY YOU SHOULD 

1436
00:52:08,331 --> 00:52:09,799
EXCLUDE PEOPLE THAT ARE 

1437
00:52:09,799 --> 00:52:11,000
VULNERABLE AND WILL TALK ABOUT 

1438
00:52:11,000 --> 00:52:14,270
IT IN A MINUTE.  IT IS 

1439
00:52:14,270 --> 00:52:14,971
CONTENTIOUS. 

1440
00:52:14,971 --> 00:52:17,440
IT IS PART OF FAIR PARTICIPANT 

1441
00:52:17,440 --> 00:52:18,407
SELECTION THAT HAS US THINK 

1442
00:52:18,407 --> 00:52:20,843
ABOUT HOW TO FAIRLY DISTRIBUTE 

1443
00:52:20,843 --> 00:52:22,645
HARMS AND BENEFITS OF RESEARCH 

1444
00:52:22,645 --> 00:52:25,414
AND IN OTHER WORDS DON'T ALWAYS 

1445
00:52:25,414 --> 00:52:28,484
PICK SAME PEOPLE OVER AND OVER 

1446
00:52:28,484 --> 00:52:29,785
AGAIN THAT THEN ACCEPT ALL OF 

1447
00:52:29,785 --> 00:52:31,787
THE RISKS WITHOUT GETTING 

1448
00:52:31,787 --> 00:52:33,856
BENEFITS OR SELECT A GROUP THAT 

1449
00:52:33,856 --> 00:52:35,558
WILL ALWAYS TAKE RISKS WHEN 

1450
00:52:35,558 --> 00:52:37,260
BENEFITS GO TO SOMEBODY ELSE. 

1451
00:52:37,260 --> 00:52:39,328
THOSE KINDS OF CONSIDERATIONS 

1452
00:52:39,328 --> 00:52:43,032
ARE IMPORTANT AT THE FRONTEND IN

1453
00:52:43,032 --> 00:52:43,533
SELECTING PARTICIPANTS. 

1454
00:52:43,533 --> 00:52:46,068
AND I MENTIONED THIS EARLIER. 

1455
00:52:46,068 --> 00:52:47,436
THERE IS A REALLY INTERESTING 

1456
00:52:47,436 --> 00:52:49,705
SWITCH THAT HAS HAPPENED OVER 

1457
00:52:49,705 --> 00:52:52,074
TIME WHERE BOTH OF THESE END UP 

1458
00:52:52,074 --> 00:52:53,176
BEING IMPORTANT. 

1459
00:52:53,176 --> 00:52:55,845
THEY ARE REALLY HISTORICALLY 

1460
00:52:55,845 --> 00:52:57,480
SITUATED IN DIFFERENT WAYS AND 

1461
00:52:57,480 --> 00:52:59,749
RESEARCH WAS SEEN FOR A LONG 

1462
00:52:59,749 --> 00:53:02,418
TIME AS A BURDEN. 

1463
00:53:02,418 --> 00:53:03,286
PARTICIPANTS NEED PROTECTION 

1464
00:53:03,286 --> 00:53:05,254
FROM THAT BURDEN OR FROM THE 

1465
00:53:05,254 --> 00:53:05,555
RISK. 

1466
00:53:05,555 --> 00:53:07,890
AS I MENTIONED EARLIER IF SEEN 

1467
00:53:07,890 --> 00:53:09,825
AS A BENEFIT, PEOPLE NEED ACCESS

1468
00:53:09,825 --> 00:53:11,561
TO RESEARCH. 

1469
00:53:11,561 --> 00:53:14,463
BOTH OF THESE ARE STILL TRUE. 

1470
00:53:14,463 --> 00:53:17,433
THE PENDULUM SWINGS BACK AND 

1471
00:53:17,433 --> 00:53:18,968
FORTH A LITTLE BIT BETWEEN THE 

1472
00:53:18,968 --> 00:53:21,971
TWO AND MENTIONED PROTECTING 

1473
00:53:21,971 --> 00:53:23,573
VULNERABLE GROUPS AND PROTECTION

1474
00:53:23,573 --> 00:53:25,141
ABOUT WHAT VULNERABILITY MEANS 

1475
00:53:25,141 --> 00:53:26,776
ACTUALLY IN THE CONTEXT OF 

1476
00:53:26,776 --> 00:53:28,844
RESEARCH AND IF WE PROTECT 

1477
00:53:28,844 --> 00:53:30,313
PEOPLE TOO MUCH WE KEEP THEM OUT

1478
00:53:30,313 --> 00:53:32,782
OF -- PREVENT THEM FROM GETTING 

1479
00:53:32,782 --> 00:53:34,750
BENEFITS OF RESEARCH AND I'M NOT

1480
00:53:34,750 --> 00:53:37,653
SURE IF THERE IS ANOTHER SESSION

1481
00:53:37,653 --> 00:53:40,389
ON VULNERABILITY AT ALL?  

1482
00:53:40,389 --> 00:53:45,094
>> NOT SPECIFICALLY. 

1483
00:53:45,094 --> 00:53:47,563
>> CHILDREN, OKAY.  THERE
IS 

1484
00:53:47,563 --> 00:53:48,931
REALLY CHALLENGES TO SELECTING 

1485
00:53:48,931 --> 00:53:50,433
APPROPRIATE PARTICIPANTS FOR A 

1486
00:53:50,433 --> 00:53:52,368
STUDY AND FOR EXAMPLE THIS IS 

1487
00:53:52,368 --> 00:53:55,671
ONE THAT COMES UP ALL THE TIME. 

1488
00:53:55,671 --> 00:53:58,841
IS IT PREFERABLE TO TOUCH AN 

1489
00:53:58,841 --> 00:54:00,409
EARLY PARTICULARLY RISKY THERAPY

1490
00:54:00,409 --> 00:54:02,612
IN HEALTHY AFFECTED ADULTS THAT 

1491
00:54:02,612 --> 00:54:04,981
CAN GIVE THEIR OWN CONSENT OR IN

1492
00:54:04,981 --> 00:54:07,416
SEVERELY ILL INFANTS OTHERWISE 

1493
00:54:07,416 --> 00:54:10,553
LIKELY TO DIE AS INFANTS IF THEY

1494
00:54:10,553 --> 00:54:12,321
DON'T GET SOMETHING SMA WORKS 

1495
00:54:12,321 --> 00:54:14,457
AND REAL DILEMMA HAPPENED IN 

1496
00:54:14,457 --> 00:54:16,659
STUDIES AND ANOTHER EXAMPLE OF 

1497
00:54:16,659 --> 00:54:19,028
CHALLENGE IS WHEN YOU ENROLL 

1498
00:54:19,028 --> 00:54:20,263
PREGNANT PEOPLE IN RESEARCH AND 

1499
00:54:20,263 --> 00:54:22,431
ANOTHER TOPIC THAT COULD TAKE A 

1500
00:54:22,431 --> 00:54:24,433
WHOLE LECTURE AND SOMETIMES 

1501
00:54:24,433 --> 00:54:25,101
DOES. 

1502
00:54:25,101 --> 00:54:27,203
NEXT ELEMENT IS FAVORABLE RISK 

1503
00:54:27,203 --> 00:54:28,070
BENEFIT. 

1504
00:54:28,070 --> 00:54:31,307
THE QUESTIONS REALLY ASK ARE 

1505
00:54:31,307 --> 00:54:34,176
RISKS TO SUBJECTS NECESSARY AND 

1506
00:54:34,176 --> 00:54:35,578
MINIMIZED TO EXTENT POSSIBLE AND

1507
00:54:35,578 --> 00:54:37,280
IS A JUDGMENT THAT ALL OF US 

1508
00:54:37,280 --> 00:54:39,515
HAVE TO MAKE AS INVESTIGATORS 

1509
00:54:39,515 --> 00:54:42,585
RESEARCH TEAMS IRB MEMBERS AND 

1510
00:54:42,585 --> 00:54:44,420
PARTICIPANTS AND ARE RISKS 

1511
00:54:44,420 --> 00:54:46,355
JUSTIFIED BY EITHER BENEFIT TO 

1512
00:54:46,355 --> 00:54:47,990
THE INDIVIDUAL OR SOCIAL VALUE 

1513
00:54:47,990 --> 00:54:49,225
OF THE STUDY?  

1514
00:54:49,225 --> 00:54:53,362
THAT IS A -- YOU KNOW, IN 

1515
00:54:53,362 --> 00:54:54,964
COMMENSURATE SOME PEOPLE SAY 

1516
00:54:54,964 --> 00:54:57,667
EVALUATION BUT IMPORTANT ONE TO 

1517
00:54:57,667 --> 00:54:58,434
MAKE. 

1518
00:54:58,434 --> 00:55:01,637
MANY ARGUE FOR THE NEED ALSO TO 

1519
00:55:01,637 --> 00:55:03,939
ENHANCE BENEFITS. 

1520
00:55:03,939 --> 00:55:05,174
IMPORTANTLY, AS BELMONT REPORT 

1521
00:55:05,174 --> 00:55:07,310
POINTS OUT AND MENTIONED ALREADY

1522
00:55:07,310 --> 00:55:09,845
A COUPLE OF TIMES SOMETIMES 

1523
00:55:09,845 --> 00:55:11,147
INTERESTS OTHER THAN THOSE OF 

1524
00:55:11,147 --> 00:55:13,516
THE SUBJECTS AND IN OTHER WORDS 

1525
00:55:13,516 --> 00:55:14,717
PARTICIPANTS OF STUDY CAN 

1526
00:55:14,717 --> 00:55:19,188
JUSTIFY RISKS AS LONG AS RIGHTS 

1527
00:55:19,188 --> 00:55:20,790
OF PARTICIPANTS HAVE BEEN 

1528
00:55:20,790 --> 00:55:21,257
PROTECTED. 

1529
00:55:21,257 --> 00:55:23,059
LOTS OF CHALLENGES. 

1530
00:55:23,059 --> 00:55:24,694
ONE, HOW DO YOU IDENTIFY WHICH 

1531
00:55:24,694 --> 00:55:27,530
RISKS AN PD BENEFITS COUNT AND 

1532
00:55:27,530 --> 00:55:30,266
HAS BEEN LOTS OF INTERESTING 

1533
00:55:30,266 --> 00:55:33,502
DEBATE ABOUT IN SOME GUIDANCE IT

1534
00:55:33,502 --> 00:55:34,737
SAYS WE SHOULD CONSIDER 

1535
00:55:34,737 --> 00:55:36,839
PHYSICAL, PSYCHOSOCIAL AND 

1536
00:55:36,839 --> 00:55:39,408
ECONOMIC AND LEGAL RISKS AND WE 

1537
00:55:39,408 --> 00:55:41,744
DON'T CONSIDER PHYSICAL, 

1538
00:55:41,744 --> 00:55:43,746
PSYCHOSOCIAL, ECONOMIC AND LEGAL

1539
00:55:43,746 --> 00:55:45,748
BENEFITS AND HOW DO WE DEAL WITH

1540
00:55:45,748 --> 00:55:48,384
THAT AND MINIMIZE RISK SNZ. 

1541
00:55:48,384 --> 00:55:50,653
YOU WILL HEAR FROM SOME OTHERS 

1542
00:55:50,653 --> 00:55:52,888
THAT IN -- IN PROTECTING CERTAIN

1543
00:55:52,888 --> 00:55:55,358
GROUPS OF PEOPLE, ONE STRATEGY 

1544
00:55:55,358 --> 00:55:57,660
THAT WE USE IS BY REGULATION. 

1545
00:55:57,660 --> 00:55:59,261
WE LIMIT AMOUNT OF RISKS THAT 

1546
00:55:59,261 --> 00:56:01,764
PEOPLE CAN BE EXPOSED TO AND 

1547
00:56:01,764 --> 00:56:03,132
HAPPENS WITH CHILDREN WITH 

1548
00:56:03,132 --> 00:56:05,067
PREGNANT PERSONS AND WITH 

1549
00:56:05,067 --> 00:56:07,203
PRISONERS AND THERE IS A HUGE 

1550
00:56:07,203 --> 00:56:08,904
DEBATE ABOUT DIRECT VERSUS 

1551
00:56:08,904 --> 00:56:11,607
INDIRECT BENEFITS. 

1552
00:56:11,607 --> 00:56:15,344
DIRECT BENEFITS AS THE KIND OF 

1553
00:56:15,344 --> 00:56:16,078
BENEFIT JUSTIFYING CERTAIN 

1554
00:56:16,078 --> 00:56:18,414
AMOUNT OF RISKS AND INDIRECT 

1555
00:56:18,414 --> 00:56:20,883
BENEFITS MONEY OR ACCESS TO GOOD

1556
00:56:20,883 --> 00:56:22,518
CLINICIANS OR ACCESS TO OTHER 

1557
00:56:22,518 --> 00:56:25,187
KINDS OF CARE MAY NOT BE KINDS 

1558
00:56:25,187 --> 00:56:26,889
OF BENEFIT YOU WANT TO JUSTIFY A

1559
00:56:26,889 --> 00:56:30,626
RISK BASED ON AND THEY STILL 

1560
00:56:30,626 --> 00:56:33,229
HAPPEN IN RESEARCH. 

1561
00:56:33,229 --> 00:56:35,965
DETERMINING THAT LEVEL IS A 

1562
00:56:35,965 --> 00:56:36,265
CHALLENGE. 

1563
00:56:36,265 --> 00:56:36,732
TWO MORE. 

1564
00:56:36,732 --> 00:56:39,268
THREE MORE, I GUESS. 

1565
00:56:39,268 --> 00:56:41,103
INDEPENDENT REVIEW IS ENSURING 

1566
00:56:41,103 --> 00:56:42,238
REGULATORY AND ETHICAL 

1567
00:56:42,238 --> 00:56:43,773
REQUIREMENTS HAVE BEEN FULFILLED

1568
00:56:43,773 --> 00:56:46,409
AND IS A PROCESS THAT CHECKS 

1569
00:56:46,409 --> 00:56:48,511
INVESTIGATOR BIASES AND 

1570
00:56:48,511 --> 00:56:50,346
CONFLICTS AND ENSURES PUBLIC 

1571
00:56:50,346 --> 00:56:51,914
THAT RESEARCH IS NOT EXPLOITING 

1572
00:56:51,914 --> 00:56:54,150
INDIVIDUALS OR GROUPS AND YOU 

1573
00:56:54,150 --> 00:56:56,185
WILL LEARN MORE ABOUT IRBS LATER

1574
00:56:56,185 --> 00:56:57,119
TODAY. 

1575
00:56:57,119 --> 00:56:59,622
I WANTED TO PUT UP REGULATORY 

1576
00:56:59,622 --> 00:57:03,826
CRITERIA BOTH IN 45CFR AND 

1577
00:57:03,826 --> 00:57:04,160
21CFR56. 

1578
00:57:04,160 --> 00:57:06,162
YOU CAN SEE THAT THEY MIMIC A 

1579
00:57:06,162 --> 00:57:08,664
LOT OF WHAT I ALREADY SAID. 

1580
00:57:08,664 --> 00:57:10,633
RISKS ARE MINIMIZED AND 

1581
00:57:10,633 --> 00:57:12,835
JUSTIFIED BY ANTICIPATED 

1582
00:57:12,835 --> 00:57:15,504
BENEFITS EVEN IF AREN'T ANY TO 

1583
00:57:15,504 --> 00:57:17,006
PARTICIPANTS AND FAIR SUBJECT 

1584
00:57:17,006 --> 00:57:19,975
SELECTION AND THEN INFORMED 

1585
00:57:19,975 --> 00:57:21,710
CONSENT IS ADEQUATE. 

1586
00:57:21,710 --> 00:57:27,049
OUR NEXT I FORGOT ABOUT THIS. 

1587
00:57:27,049 --> 00:57:28,684
TWO REGULATORY BODIES TO KNOW 

1588
00:57:28,684 --> 00:57:31,020
ABOUT OFFICE OF HUMAN RESEARCH 

1589
00:57:31,020 --> 00:57:32,354
PROTECTIONS THAT IS THE 

1590
00:57:32,354 --> 00:57:34,990
DEPARTMENT OF HEALTH AND HUMAN 

1591
00:57:34,990 --> 00:57:36,926
SERVICES OFFICE THAT OVERSEES 

1592
00:57:36,926 --> 00:57:39,595
RESEARCH FUNDED BY HHS AND WE 

1593
00:57:39,595 --> 00:57:41,931
HAVE AN INTRAMURAL OFFICE OF 

1594
00:57:41,931 --> 00:57:45,267
HUMAN SUBJECTS RESEARCH 

1595
00:57:45,267 --> 00:57:46,669
PROTECTION THAT IS THE 

1596
00:57:46,669 --> 00:57:50,606
FEDERALWIDE ASSURANCE HOLDER FOR

1597
00:57:50,606 --> 00:57:52,374
THE INTRAMURAL PROGRAM. 

1598
00:57:52,374 --> 00:57:53,642
I WILL SKIP THAT. 

1599
00:57:53,642 --> 00:57:56,145
NEXT ONE IS INFORMED CONSENT. 

1600
00:57:56,145 --> 00:57:58,848
THIS IS BASICALLY A PROCESS THAT

1601
00:57:58,848 --> 00:58:00,382
ENSURES INDIVIDUALS HAVE AN 

1602
00:58:00,382 --> 00:58:01,450
OPPORTUNITY TO DECIDE WHETHER 

1603
00:58:01,450 --> 00:58:03,719
THEY WANT TO PARTICIPATE OR 

1604
00:58:03,719 --> 00:58:04,920
CONTINUE TO PARTICIPATE AND 

1605
00:58:04,920 --> 00:58:06,789
WHETHER IT IS COMPATIBLE WITH 

1606
00:58:06,789 --> 00:58:08,390
THEIR GOALS AND INTERESTS AND 

1607
00:58:08,390 --> 00:58:10,025
VALUES AND MANY PEOPLE WHEN WE 

1608
00:58:10,025 --> 00:58:11,660
FIRST PUT OUT THIS FRAMEWORK 

1609
00:58:11,660 --> 00:58:13,362
SAID, YOU KNOW, WHAT MAKES 

1610
00:58:13,362 --> 00:58:15,998
CLINICAL R- HE SEARCH ETHICAL?  

1611
00:58:15,998 --> 00:58:17,533
EVERYBODY SAYS INFORMED CONCEPT 

1612
00:58:17,533 --> 00:58:20,302
THAT YOU CAN SEE IS 7TH ON LIST 

1613
00:58:20,302 --> 00:58:22,037
OF 8 PRINCIPLES AND POINT BEING 

1614
00:58:22,037 --> 00:58:25,307
THAT YOU DON'T ASK PEOPLE TO 

1615
00:58:25,307 --> 00:58:26,275
PARTICIPATE UNTIL ALL OF THE 

1616
00:58:26,275 --> 00:58:28,010
OTHER THINGS ARE SATISFIED. 

1617
00:58:28,010 --> 00:58:30,880
YOU HAVE TO HAVE A GOOD QUESTION

1618
00:58:30,880 --> 00:58:33,649
OR VALID SCIENCE AND SCIENTIFIC 

1619
00:58:33,649 --> 00:58:34,683
METHODOLOGY AND MAKE SURE YOU 

1620
00:58:34,683 --> 00:58:36,385
UNDERSTAND RISKS AND BENEFITS 

1621
00:58:36,385 --> 00:58:39,555
HAVING AN INDEPENDENT REVIEW 

1622
00:58:39,555 --> 00:58:40,556
BEFORE INVITE PEOPLE TO 

1623
00:58:40,556 --> 00:58:41,090
PARTICIPATE. 

1624
00:58:41,090 --> 00:58:43,125
INFORMED CONSENT HAS LOTS OF 

1625
00:58:43,125 --> 00:58:45,794
PIECES AND I'M COMING NEXT WEEK 

1626
00:58:45,794 --> 00:58:47,630
TO SPEAK TO YOU IN MORE DEPTH 

1627
00:58:47,630 --> 00:58:49,532
ABOUT IT AND WILL SKIP IT FOR 

1628
00:58:49,532 --> 00:58:51,100
NOW AND LOTS OF INTERESTING 

1629
00:58:51,100 --> 00:58:53,669
CHALLENGES NOW IN TERMS OF 

1630
00:58:53,669 --> 00:58:58,040
INFORMED CONCEPT AND FOCUSING ON

1631
00:58:58,040 --> 00:58:58,607
LONGSTANDING PROBLEMS AND 

1632
00:58:58,607 --> 00:59:00,543
QUANTITY OF INFORMED CONSENT AND

1633
00:59:00,543 --> 00:59:03,045
HOW TO ASSESS CAPACITY CONCEPT 

1634
00:59:03,045 --> 00:59:05,648
AND LOTS OF CHANGES ALSO IN HOW 

1635
00:59:05,648 --> 00:59:07,750
WE OBTAIN INFORMED CONCEPT NOW 

1636
00:59:07,750 --> 00:59:10,219
AND SOME IS BASED ON CHANGES IN 

1637
00:59:10,219 --> 00:59:12,354
RESEARCH METHODS. 

1638
00:59:12,354 --> 00:59:13,956
THE EIGHTH OF THE PRINCIPLES IS 

1639
00:59:13,956 --> 00:59:17,426
WHAT IS CALLED RESPECT FOR 

1640
00:59:17,426 --> 00:59:18,494
ENROLLED PARTICIPANTS THAT IS 

1641
00:59:18,494 --> 00:59:19,895
PROBABLY ANOTHER ONE THAT NEEDS 

1642
00:59:19,895 --> 00:59:21,630
A LOT OF ATTENTION AND WHAT I 

1643
00:59:21,630 --> 00:59:22,898
MEAN BY IT. 

1644
00:59:22,898 --> 00:59:25,134
EARLY ON WHEN WE DEVELOPED THE 

1645
00:59:25,134 --> 00:59:26,435
FRAMEWORK, THERE WAS AN IDEA AS 

1646
00:59:26,435 --> 00:59:28,938
I MENTIONED THAT PEOPLE SAY WHAT

1647
00:59:28,938 --> 00:59:30,205
MAKES CLINICAL RESEARCH ETHICAL 

1648
00:59:30,205 --> 00:59:35,210
AND GET IRB TO REVIEW IT AND GET

1649
00:59:35,210 --> 00:59:36,512
PERSON'S INFORMED CONSENT AND 

1650
00:59:36,512 --> 00:59:38,480
ETHICS IS DONE AND ETHICS MAKES 

1651
00:59:38,480 --> 00:59:39,648
NO SENSE AT ALL BEGINNING OF 

1652
00:59:39,648 --> 00:59:41,150
TRIAL YOU ARE BEGINNING TO 

1653
00:59:41,150 --> 00:59:43,152
ENGAGE WITH PEOPLE THAT ARE IN 

1654
00:59:43,152 --> 00:59:44,453
THE STUDY AND YOU HAVE 

1655
00:59:44,453 --> 00:59:46,288
RESPONSIBILITIES AND ETHICAL 

1656
00:59:46,288 --> 00:59:47,656
RESPONSIBILITIES TO THOSE PEOPLE

1657
00:59:47,656 --> 00:59:50,292
AND YOU HAVE ETHICAL 

1658
00:59:50,292 --> 00:59:51,794
RESPONSIBILITIES TO THE -- YOU 

1659
00:59:51,794 --> 00:59:55,130
KNOW, THE WORLD IN TERMS OF 

1660
00:59:55,130 --> 00:59:56,165
REPORTING YOUR DATA AND SCIENCE.

1661
00:59:56,165 --> 00:59:58,100
THERE IS A LOT THAT HAPPENS 

1662
00:59:58,100 --> 01:00:00,402
AFTER INFORMED CONCEPT IS 

1663
01:00:00,402 --> 01:00:02,037
OBTAINED THAT IS A PARTIAL LIST 

1664
01:00:02,037 --> 01:00:04,373
AND IT IS PROTECTING 

1665
01:00:04,373 --> 01:00:06,342
CONFIDENTIALITY AND MONITORING 

1666
01:00:06,342 --> 01:00:08,377
WELFARE AND RIGHT TO WITHDRAW 

1667
01:00:08,377 --> 01:00:10,312
AND PROVIDING INFORMATION, ET 

1668
01:00:10,312 --> 01:00:10,679
CETERA. 

1669
01:00:10,679 --> 01:00:12,181
AND THERE ARE SOME INTERESTING 

1670
01:00:12,181 --> 01:00:13,816
CHALLENGES THAT WE DON'T DO A 

1671
01:00:13,816 --> 01:00:15,985
GOOD JOB OF PROVIDING RESULTS OR

1672
01:00:15,985 --> 01:00:17,653
INFORMATION TO PARTICIPANTS OR 

1673
01:00:17,653 --> 01:00:20,422
COMMUNITIES AFTER STUDIES ARE 

1674
01:00:20,422 --> 01:00:21,023
DONE. 

1675
01:00:21,023 --> 01:00:23,392
SO THIS IS OUR FRAMEWORK AND 

1676
01:00:23,392 --> 01:00:26,428
SYSTEMATIC AND SEQUENTIAL AND WE

1677
01:00:26,428 --> 01:00:27,363
ARGUE NECESSARY. 

1678
01:00:27,363 --> 01:00:29,665
SOMETIMES THERE ARE WAIVERS OF 

1679
01:00:29,665 --> 01:00:31,066
CERTAIN PROCEDURAL REQUIREMENTS 

1680
01:00:31,066 --> 01:00:33,702
THAT ARE UNIVERSAL AND IT HAS TO

1681
01:00:33,702 --> 01:00:36,405
BE ADAPTED TO THE CONTEXT. 

1682
01:00:36,405 --> 01:00:37,773
IT DOES REQUIRE BALANCING 

1683
01:00:37,773 --> 01:00:39,141
SPECIFICATION AND JUDGMENT THAT 

1684
01:00:39,141 --> 01:00:41,210
YOU WILL HEAR ABOUT THAT THRU 

1685
01:00:41,210 --> 01:00:42,044
OUT THE COURSE. 

1686
01:00:42,044 --> 01:00:44,346
WE NEED PEOPLE THAT ARE INFORMED

1687
01:00:44,346 --> 01:00:45,581
INVESTIGATORS AND IRB MEMBERS 

1688
01:00:45,581 --> 01:00:46,915
AND OTHERS INTERESTED IN 

1689
01:00:46,915 --> 01:00:48,384
RESEARCH TO BE ABLE TO 

1690
01:00:48,384 --> 01:00:49,418
UNDERSTAND WHAT PRINCIPLES ARE 

1691
01:00:49,418 --> 01:00:53,489
AND HOW TO APPLY THEM. 

1692
01:00:53,489 --> 01:00:55,324
THAT IS THAT. 

1693
01:00:55,324 --> 01:00:57,993
I JUST AM NOT EVEN ONE MINUTE 

1694
01:00:57,993 --> 01:00:58,427
OVER.  ALMOST. 

1695
01:00:58,427 --> 01:01:01,230
>> PERFECTLY TIMED. 

1696
01:01:01,230 --> 01:01:04,166
FIRST, DEEP APOLOGIES TO THOSE 

1697
01:01:04,166 --> 01:01:07,036
OUT THERE LINKING TO THE VIDEO 

1698
01:01:07,036 --> 01:01:09,271
CAST.  WE HAD A PROBLEM WITH IT 

1699
01:01:09,271 --> 01:01:10,439
EARLIER ON. 

1700
01:01:10,439 --> 01:01:11,674
WE ARE NOW LIVE. 

1701
01:01:11,674 --> 01:01:13,409
WILL YOU HAVE ACCESS TO THE 

1702
01:01:13,409 --> 01:01:15,744
RECORDING OF THE FIRST PART OF 

1703
01:01:15,744 --> 01:01:17,913
THE -- MY SESSION IN THE FIRST 

1704
01:01:17,913 --> 01:01:19,815
PART OF CHRISTINE'S SESSION WHEN

1705
01:01:19,815 --> 01:01:21,183
WE POST IT ONLINE. 

1706
01:01:21,183 --> 01:01:25,454
AND FOR THOSE OF YOU WHO ARE OUT

1707
01:01:25,454 --> 01:01:29,625
IN VIDEOCAST LAND, IF YOU HAVE 

1708
01:01:29,625 --> 01:01:31,593
QUESTIONS FOR CHRISTINE OR SUSAN

1709
01:01:31,593 --> 01:01:33,796
OR ME LATER, THERE IS A 

1710
01:01:33,796 --> 01:01:36,098
DISCUSSION BOARD THAT IS CALLED 

1711
01:01:36,098 --> 01:01:38,467
SESSION 1 QUESTIONS. 

1712
01:01:38,467 --> 01:01:42,805
FEEL FREE TO POST QUESTIONS 

1713
01:01:42,805 --> 01:01:43,138
THERE.  

1714
01:01:43,138 --> 01:01:45,140
SO WE HAVE LOTS OF PEOPLE IN THE

1715
01:01:45,140 --> 01:01:45,941
ROOM. 

1716
01:01:45,941 --> 01:01:47,242
I'M HOPING SOME OF YOU HAVE SOME

1717
01:01:47,242 --> 01:01:47,676
QUESTIONS. 

1718
01:01:47,676 --> 01:01:51,613
IF YOU DO HAVE A QUESTION, 

1719
01:01:51,613 --> 01:01:53,415
THERE ARE TWO MICS HERE. 

1720
01:01:53,415 --> 01:01:56,018
FEEL FREE TO GO TO EITHER ONE, 

1721
01:01:56,018 --> 01:01:59,722
AV FOLKS WOULD LIKE TO HAVE YOU 

1722
01:01:59,722 --> 01:02:01,056
RECORD IT. 

1723
01:02:01,056 --> 01:02:04,927
IT LOOKS LIKE YOU HAVE A 

1724
01:02:04,927 --> 01:02:06,495
QUESTION. 

1725
01:02:06,495 --> 01:02:06,895
>> GOOD. 

1726
01:02:06,895 --> 01:02:11,166
>> I WAS HOPING YOU COULD
GIVE 

1727
01:02:11,166 --> 01:02:13,402
ME EXAMPLES OF A SOCIAL VALUE 

1728
01:02:13,402 --> 01:02:15,437
CLINICAL AND SCIENTIFIC VALUE 

1729
01:02:15,437 --> 01:02:17,539
ARE FAIRLY EASY TO UNDERSTAND 

1730
01:02:17,539 --> 01:02:18,540
AND VISUALIZE EVEN AND NOT 

1731
01:02:18,540 --> 01:02:21,910
EXACTLY SURE HOW TO INTERPRET 

1732
01:02:21,910 --> 01:02:22,678
SOCIAL VALUE. 

1733
01:02:22,678 --> 01:02:24,480
>> SOCIAL VALUE, TWO WAYS
TO 

1734
01:02:24,480 --> 01:02:25,848
ANSWER YOUR QUESTION AND ONE IS 

1735
01:02:25,848 --> 01:02:27,683
THAT IS RUBRIC UNDER WHICH WE 

1736
01:02:27,683 --> 01:02:31,086
PUT ALL OF THAT.  THERE IS SOME 

1737
01:02:31,086 --> 01:02:34,289
OF THAT. 

1738
01:02:34,289 --> 01:02:37,426
VALUABLE USEFUL CLINICALLY AND 

1739
01:02:37,426 --> 01:02:37,860
SCIENTIFICALLY. 

1740
01:02:37,860 --> 01:02:39,461
THERE COULD BE I HAVE TO THINK 

1741
01:02:39,461 --> 01:02:43,098
OF AN EXPERIMENT OF STUDY THAT 

1742
01:02:43,098 --> 01:02:47,469
HAD I DON'T KNOW.  MAYBE CASH 

1743
01:02:47,469 --> 01:02:49,404
TRANSFERS FOR CERTAIN VACCINE 

1744
01:02:49,404 --> 01:02:50,773
UPTAKE OR SOMETHING LIKE THAT. 

1745
01:02:50,773 --> 01:02:53,175
THAT IS HEALTH RELATED AND HAS 

1746
01:02:53,175 --> 01:02:56,078
SOCIAL VALUE AS WELL AS PERHAPS 

1747
01:02:56,078 --> 01:02:57,746
INDIVIDUAL VALUE FOR 

1748
01:02:57,746 --> 01:02:59,515
PARTICIPANTS OR PEOPLE WHO -- IF

1749
01:02:59,515 --> 01:03:01,884
WE PROVE IT WORKS AND COMES TO 

1750
01:03:01,884 --> 01:03:02,317
MIND. 

1751
01:03:02,317 --> 01:03:02,718
>> YEAH. 

1752
01:03:02,718 --> 01:03:05,788
>> THERE ARE OTHER
EXAMPLES.  

1753
01:03:05,788 --> 01:03:08,023
I'M BLINKING WHAT THEY MIGHT BE 

1754
01:03:08,023 --> 01:03:09,291
AND IMPORTANT THING IS PEOPLE 

1755
01:03:09,291 --> 01:03:11,760
THINK OF SOCIAL VALUE HAVING 

1756
01:03:11,760 --> 01:03:13,395
CLINICAL RELEVANCE AND MY OWN 

1757
01:03:13,395 --> 01:03:15,464
VIEW IS THAT IS TOO NARROW. 

1758
01:03:15,464 --> 01:03:17,232
IF YOU THINK ABOUT FOR EXAMPLE 

1759
01:03:17,232 --> 01:03:20,702
EARLY PHASE STUDIES AND EARLY 

1760
01:03:20,702 --> 01:03:22,871
PHASE EXPERIMENTS, MAYBE THEY 

1761
01:03:22,871 --> 01:03:24,573
WILL HAVE CLINICAL VALUE DOWN 

1762
01:03:24,573 --> 01:03:26,275
THE ROAD AND WHAT THEY AT THE 

1763
01:03:26,275 --> 01:03:28,277
TIME HAVE IS SCIENTIFIC VALUE 

1764
01:03:28,277 --> 01:03:29,978
AND WE ARE LEARNING WHAT THIS 

1765
01:03:29,978 --> 01:03:31,713
THING DOES AND HOW THIS THING OR

1766
01:03:31,713 --> 01:03:34,082
HOW SAFE IT IS AND WE CAN GO AND

1767
01:03:34,082 --> 01:03:37,186
TEST IT FOR CLINICAL VALUE. 

1768
01:03:37,186 --> 01:03:39,087
>> GREAT.  YOU WANT
INTRODUCE 

1769
01:03:39,087 --> 01:03:39,388
YOURSELF?  

1770
01:03:39,388 --> 01:03:43,258
>> SURE.  I'M CHARLENE AND

1771
01:03:43,258 --> 01:03:45,294
POSTBACK ERTA AND GREAT 

1772
01:03:45,294 --> 01:03:46,895
INTRODUCTION DR. GRADY AND THANK

1773
01:03:46,895 --> 01:03:47,496
SO YOU MUCH. 

1774
01:03:47,496 --> 01:03:51,233
I HAD A SIMILAR QUESTION ABOUT 

1775
01:03:51,233 --> 01:03:52,501
THE JUSTIFICATIONS FOR RESEARCH 

1776
01:03:52,501 --> 01:03:54,670
AND WHILE I CAN UNDERSTAND 

1777
01:03:54,670 --> 01:03:57,840
REASONS WHY WE WANT SOCIAL VALUE

1778
01:03:57,840 --> 01:03:59,474
OR VALUE IN SOME SENSE FOR ANY 

1779
01:03:59,474 --> 01:04:01,109
FORM OF RESEARCH AND I GUESS 

1780
01:04:01,109 --> 01:04:03,312
ALSO WONDERING ABOUT ARGUMENTS 

1781
01:04:03,312 --> 01:04:04,947
AGAINST IT AND WHAT TYPE OF 

1782
01:04:04,947 --> 01:04:06,748
ARGUMENTS THEY LOOK LIKE AND IS 

1783
01:04:06,748 --> 01:04:09,184
IT JUST INABILITY TO MEASURE 

1784
01:04:09,184 --> 01:04:10,886
VALUE OR IS THERE SOMETHING 

1785
01:04:10,886 --> 01:04:11,286
ELSE?  

1786
01:04:11,286 --> 01:04:14,923
IS THERE ANY CASES THAT I COULD 

1787
01:04:14,923 --> 01:04:16,758
THINK OF WHERE AT CONCEPTION 

1788
01:04:16,758 --> 01:04:18,727
RESEARCH MIGHT NOT HAVE VALUE OR

1789
01:04:18,727 --> 01:04:20,996
PROJECTED VALUE AND ENDED UP 

1790
01:04:20,996 --> 01:04:24,233
BEING VERY VALUABLE DOWN THE 

1791
01:04:24,233 --> 01:04:24,466
LINE?  

1792
01:04:24,466 --> 01:04:25,500
>> GREAT QUESTION. 

1793
01:04:25,500 --> 01:04:29,538
WHERE THIS IDEA CAME FROM IS A 

1794
01:04:29,538 --> 01:04:32,407
SCHOLAR WHO WROTE IN THE 1980S 

1795
01:04:32,407 --> 01:04:35,277
AND NAMED BENJAMIN FRIEDMAN AND 

1796
01:04:35,277 --> 01:04:37,646
HE WROTE A PAPER ONE TIME CALLED

1797
01:04:37,646 --> 01:04:39,348
SOCIAL VALUE. 

1798
01:04:39,348 --> 01:04:41,250
BASICALLY HE DESCRIBED IN THE 

1799
01:04:41,250 --> 01:04:43,452
PAPER THAT HE HAD WHAT HE CALLED

1800
01:04:43,452 --> 01:04:47,222
A NIGHTMARE WALKING DOWN THE 

1801
01:04:47,222 --> 01:04:48,724
HALL AND NIGHTMARE AND FRIEND 

1802
01:04:48,724 --> 01:04:50,893
CAME UP TO HIM AND SAID I 

1803
01:04:50,893 --> 01:04:53,128
SUCCESSFULLY TRANSPLANTED AN 

1804
01:04:53,128 --> 01:04:55,964
APPENDIX AND IN THE ARTICLE BEN 

1805
01:04:55,964 --> 01:04:58,400
GEE SAYS AND SCRATCHED HEAD AND 

1806
01:04:58,400 --> 01:05:01,503
SAID IS THAT ETHICAL AND FRIEND 

1807
01:05:01,503 --> 01:05:04,072
SAID I GOT THE GUY'S INFORMED 

1808
01:05:04,072 --> 01:05:06,909
CONSENT AND QUESTION WAS WHAT IS

1809
01:05:06,909 --> 01:05:08,377
YOUTHFULNESS OF UNDERSTANDING 

1810
01:05:08,377 --> 01:05:10,479
TRANSPLANTATION OF APPENDIX?  IS

1811
01:05:10,479 --> 01:05:12,180
THERE ANYTHING WE CAN LEARN FROM

1812
01:05:12,180 --> 01:05:14,816
THAT OR REASON TRANSPLANTING 

1813
01:05:14,816 --> 01:05:16,385
APPENDIX WOULD OR COULD BE A 

1814
01:05:16,385 --> 01:05:18,220
GOOD THING AND USING IT 

1815
01:05:18,220 --> 01:05:20,389
CLINICALLY OR SCIENTIFICALLY OR 

1816
01:05:20,389 --> 01:05:20,689
SOCIALLY?  

1817
01:05:20,689 --> 01:05:23,525
WHAT IS THE POINT?  

1818
01:05:23,525 --> 01:05:24,927
SO THAT IS A EXAMPLE. 

1819
01:05:24,927 --> 01:05:27,262
I THINK AT THE SAME TIME YOU 

1820
01:05:27,262 --> 01:05:28,196
MIGHT IMAGINE THAT AT A 

1821
01:05:28,196 --> 01:05:29,331
DIFFERENT POINT IN TIME AND 

1822
01:05:29,331 --> 01:05:31,266
DON'T KNOW THAT -- I CAN'T COME 

1823
01:05:31,266 --> 01:05:33,769
UP WITH A SCIENTIFIC EXPLANATION

1824
01:05:33,769 --> 01:05:36,405
BUT MAYBE THERE IS A SCIENTIFIC 

1825
01:05:36,405 --> 01:05:38,040
REASON TO TRANSPLANT AN 

1826
01:05:38,040 --> 01:05:38,874
APPENDIX, FOR EXAMPLE. 

1827
01:05:38,874 --> 01:05:41,243
IF THERE IS, WE COULD LEARN 

1828
01:05:41,243 --> 01:05:44,379
SOMETHING VALUABLE THAT MIGHT 

1829
01:05:44,379 --> 01:05:47,215
HELP TO UNDERSTAND OR PROMOTE 

1830
01:05:47,215 --> 01:05:50,185
HUMAN HEALTH AND MAYBE IT WOULD 

1831
01:05:50,185 --> 01:05:51,820
BECOME SOCIALLY VALUABLE AND 

1832
01:05:51,820 --> 01:05:52,788
QUESTION TO START WITH IS WHAT 

1833
01:05:52,788 --> 01:05:54,523
IS THE REASON OR WHAT IS THE SO 

1834
01:05:54,523 --> 01:05:57,292
WHAT OF DOING THIS STUDY?  

1835
01:05:57,292 --> 01:05:59,261
WHAT WILL WE -- WHY ARE WE DOING

1836
01:05:59,261 --> 01:06:00,829
IT AND WHAT WILL WE LEARN FROM 

1837
01:06:00,829 --> 01:06:01,997
IT?  

1838
01:06:01,997 --> 01:06:03,098
THAT IS THE MOTIVATION BEHIND 

1839
01:06:03,098 --> 01:06:05,334
SOCIAL VALUE AND THERE ARE 

1840
01:06:05,334 --> 01:06:06,601
EXAMPLES OF STUDIES THAT HAVE 

1841
01:06:06,601 --> 01:06:09,371
BEEN DONE AND PEOPLE SAY WHY DID

1842
01:06:09,371 --> 01:06:11,239
ANYONE EVER DO THAT?  

1843
01:06:11,239 --> 01:06:13,508
WE DIDN'T -- YOU KNOW, WHAT IS 

1844
01:06:13,508 --> 01:06:15,610
USEFULNESS OF THAT QUESTION?  

1845
01:06:15,610 --> 01:06:16,745
THERE HAVE BEEN CERTAINLY 

1846
01:06:16,745 --> 01:06:19,848
STUDIES THAT HAVE COME OUT MORE 

1847
01:06:19,848 --> 01:06:21,416
POSITIVELY VALUABLE THAN WERE 

1848
01:06:21,416 --> 01:06:22,351
PREDICTED AT THE TIME. 

1849
01:06:22,351 --> 01:06:26,188
DOES THAT ANSWER YOUR QUESTION? 

1850
01:06:26,188 --> 01:06:29,524
SORT OF?  

1851
01:06:29,524 --> 01:06:30,659
>> GO AHEAD. 

1852
01:06:30,659 --> 01:06:32,060
>> I'M JONATHAN. 

1853
01:06:32,060 --> 01:06:32,594
>> I KNOW. 

1854
01:06:32,594 --> 01:06:34,596
>> GOOD TO SEE YOU AGAIN. 

1855
01:06:34,596 --> 01:06:37,466
I WAS WONDERING IF YOU COULD 

1856
01:06:37,466 --> 01:06:39,401
TALK A LITTLE ABOUT THE 

1857
01:06:39,401 --> 01:06:41,136
METHODOLOGIES THAT WERE USED IN 

1858
01:06:41,136 --> 01:06:44,806
LIKE THE BELMONT REPORT OR THE 

1859
01:06:44,806 --> 01:06:47,075
HELSINKI OR WHAT WAS IT?  

1860
01:06:47,075 --> 01:06:51,079
HELSINKI -- DECLARATION OF 

1861
01:06:51,079 --> 01:06:53,849
HELSINKI WAS IT AN 

1862
01:06:53,849 --> 01:06:56,151
INTERDISCIPLINARY BACKGROUND AND

1863
01:06:56,151 --> 01:06:58,120
PEOPLE BRINGING THESE THINGS 

1864
01:06:58,120 --> 01:07:00,055
SETTLING THEM OR WHAT DO THEY DO

1865
01:07:00,055 --> 01:07:00,322
EXACTLY. 

1866
01:07:00,322 --> 01:07:01,623
>> GREAT QUESTION AND WHAT
I 

1867
01:07:01,623 --> 01:07:04,159
KNOW AND PROBABLY NOT ANYTHING 

1868
01:07:04,159 --> 01:07:06,261
AND BELMONT REPORT WRITTEN BY 

1869
01:07:06,261 --> 01:07:07,262
NATIONAL COMMISSION THAT IS ONE 

1870
01:07:07,262 --> 01:07:09,031
OF THE FIRST IN THE UNITED 

1871
01:07:09,031 --> 01:07:11,867
STATES THAT FOCUSED ON ETHICS AT

1872
01:07:11,867 --> 01:07:14,202
ALL AND WAS CERTAINLY FOCUSED ON

1873
01:07:14,202 --> 01:07:18,573
PROTECTION OF HUMAN SUBJECTS. 

1874
01:07:18,573 --> 01:07:20,375
STAFF WROTE THE BELMONT REPORT. 

1875
01:07:20,375 --> 01:07:22,844
WITH DOCUMENTS, I -- YOU CAN 

1876
01:07:22,844 --> 01:07:26,048
FIND THEM, HISTORICAL VERSIONS 

1877
01:07:26,048 --> 01:07:27,349
OF THEM. 

1878
01:07:27,349 --> 01:07:30,619
BOB LEVINE WAS AN EDGE CYST OR 

1879
01:07:30,619 --> 01:07:31,787
PHYSICIAN EDGE SIFT AT YALE 

1880
01:07:31,787 --> 01:07:34,056
DOING WORK IN ESTABLISHMENT OF 

1881
01:07:34,056 --> 01:07:36,658
ETHICS IN CLINICAL RESEARCH AND 

1882
01:07:36,658 --> 01:07:38,860
HE WROTE BACKGROUND PAPER GIVEN 

1883
01:07:38,860 --> 01:07:42,264
TO THE STAFF THAT STAFF INCLUDED

1884
01:07:42,264 --> 01:07:45,567
PEOPLE LIKE TOM BEACHUM 

1885
01:07:45,567 --> 01:07:47,669
PHILOSOPHER AT GEORGETOWN AND 

1886
01:07:47,669 --> 01:07:51,440
FAMOUS FOR FOUR PRINCIPLES 

1887
01:07:51,440 --> 01:07:53,575
GEORGETOWN MANTRA OF BIOETHICS 

1888
01:07:53,575 --> 01:07:56,378
AND HOPEFULLY I DON'T SAY THINGS

1889
01:07:56,378 --> 01:07:59,114
THAT YOU DON'T KNOW WHAT I'M 

1890
01:07:59,114 --> 01:07:59,881
TALKING ABOUT. 

1891
01:07:59,881 --> 01:08:01,550
PEOPLE ASKED TO SUPPLY THEM AND 

1892
01:08:01,550 --> 01:08:03,351
EXPERTISE OF THE PEOPLE IN THE 

1893
01:08:03,351 --> 01:08:05,387
ROOM AND STAFF AND THEN IT HAD 

1894
01:08:05,387 --> 01:08:07,489
TO BE APPROVED BY THE COMMISSION

1895
01:08:07,489 --> 01:08:10,525
AND THERE -- THAT SORT OF 

1896
01:08:10,525 --> 01:08:11,893
MULTI-DISCIPLINARY EFFORT THERE 

1897
01:08:11,893 --> 01:08:14,763
AND DECLARATION OF HELSINKI IS 

1898
01:08:14,763 --> 01:08:15,063
DIFFERENT. 

1899
01:08:15,063 --> 01:08:17,499
IN EACH OF THE DOMESTIC MEDICAL 

1900
01:08:17,499 --> 01:08:19,835
ASSOCIATIONS WE HAVE AMERICAN 

1901
01:08:19,835 --> 01:08:21,269
MEDICAL ASSOCIATION AND 

1902
01:08:21,269 --> 01:08:23,538
ASSOCIATIONS LIKE THAT IN MANY 

1903
01:08:23,538 --> 01:08:24,639
COUNTRIES IN THE WORLD AND 

1904
01:08:24,639 --> 01:08:26,842
MEDICAL WORLD ASSOCIATION IS 

1905
01:08:26,842 --> 01:08:28,176
COLLABORATION OF ALL OF THOSE 

1906
01:08:28,176 --> 01:08:29,478
AND MOST PEOPLE THAT WOULD BE 

1907
01:08:29,478 --> 01:08:31,880
AROUND THE TABLE DECIDING ARE 

1908
01:08:31,880 --> 01:08:33,582
PHYSICIANS THAT RUN THEIR 

1909
01:08:33,582 --> 01:08:34,883
MEDICAL ASSOCIATION IN THEIR 

1910
01:08:34,883 --> 01:08:38,553
COUNTRY AND AT LEAST IN THE LAST

1911
01:08:38,553 --> 01:08:40,222
SEVERAL ITERATIONS OF 

1912
01:08:40,222 --> 01:08:43,225
DECLARATION OF HELSINKI HAD 

1913
01:08:43,225 --> 01:08:44,226
CONSULTANCIES I MENTIONED THEY 

1914
01:08:44,226 --> 01:08:46,361
HAD NOW AND BRING IN PEOPLE AND 

1915
01:08:46,361 --> 01:08:47,729
INVITE PEOPLE TO COME AND GIVE 

1916
01:08:47,729 --> 01:08:49,764
THEM, YOU KNOW, TALKS AND 

1917
01:08:49,764 --> 01:08:51,133
INFORMATION AND BACKGROUND 

1918
01:08:51,133 --> 01:08:53,268
MATERIALS ABOUT SPECIFIC ISSUES 

1919
01:08:53,268 --> 01:08:56,371
AND YOU DELIBERATE ABOUT THOSE. 

1920
01:08:56,371 --> 01:08:58,907
>> QUICK SIDEBAR, THE 

1921
01:08:58,907 --> 01:09:00,442
TRANSCRIPTS OF EVERYTHING THAT 

1922
01:09:00,442 --> 01:09:02,978
THE NATIONAL COMMISSION DID ARE 

1923
01:09:02,978 --> 01:09:04,946
IN A ROOM AT GEORGETOWN AND I 

1924
01:09:04,946 --> 01:09:06,448
VISITED IT MANY YEARS AGO. 

1925
01:09:06,448 --> 01:09:07,082
>> YEAH. 

1926
01:09:07,082 --> 01:09:10,519
>> YOU HAVE TO BE
MONITORED. 

1927
01:09:10,519 --> 01:09:13,488
FACULTY -- A MEMBER OF THE 

1928
01:09:13,488 --> 01:09:14,990
LIBRARY STAFF HAD TO SIT THERE 

1929
01:09:14,990 --> 01:09:17,058
WITH ME TO MAKE SURE I DIDN'T 

1930
01:09:17,058 --> 01:09:17,826
RUN OFF WITH ANYTHING. 

1931
01:09:17,826 --> 01:09:21,596
IF YOU ARE INTERESTED IN, 

1932
01:09:21,596 --> 01:09:24,399
JONATHAN, THERE IS A PLETHORA OF

1933
01:09:24,399 --> 01:09:27,335
PAPER TO REVIEW AND WHOLE SET 

1934
01:09:27,335 --> 01:09:30,672
FOR THOSE INTERESTED FOR EACH 

1935
01:09:30,672 --> 01:09:33,441
REPORT THAT THE COMMISSION WROTE

1936
01:09:33,441 --> 01:09:34,676
INCLUDING BELMONT REPORT AND ONE

1937
01:09:34,676 --> 01:09:37,646
ON IRBS AND PSYCHOSURGERY AND 

1938
01:09:37,646 --> 01:09:41,483
ARE BOUND COPIES OF REPORTS THAT

1939
01:09:41,483 --> 01:09:44,119
THEN -- BELMONT REPORT AND THESE

1940
01:09:44,119 --> 01:09:47,789
THAT LED TO ADDITIONAL AND ONES 

1941
01:09:47,789 --> 01:09:50,158
ON KIDS AND ADDITIONAL 

1942
01:09:50,158 --> 01:09:51,760
REGULATIONS ON OUR SHELF IN THE 

1943
01:09:51,760 --> 01:09:52,027
LIBRARY. 

1944
01:09:52,027 --> 01:09:53,795
>> WE HAVE LOTS IN THE 

1945
01:09:53,795 --> 01:09:54,095
DEPARTMENT. 

1946
01:09:54,095 --> 01:09:58,900
>> IF NOT THERE IN NIH
LIBRARY. 

1947
01:09:58,900 --> 01:10:02,737
THANK YOU, AGAIN CHRISTINE. 

1948
01:10:02,737 --> 01:10:03,505
>> GO AHEAD. 

1949
01:10:03,505 --> 01:10:05,807
>> WE ARE IN A HIGHLY
REGULATORY

1950
01:10:05,807 --> 01:10:08,143
STATE FOR RESEARCH NOW. 

1951
01:10:08,143 --> 01:10:10,979
WE DO SCIENTIFIC REVIEW 

1952
01:10:10,979 --> 01:10:12,447
COMMITTEES BEFORE WE GET THEM 

1953
01:10:12,447 --> 01:10:16,084
AND SUBMIT TO THE IRB AND SINCE 

1954
01:10:16,084 --> 01:10:20,388
COMMON RULINCEPTION 20 YEARS AGO

1955
01:10:20,388 --> 01:10:25,527
AND THESE OTHER WONDERFUL CODES 

1956
01:10:25,527 --> 01:10:27,028
AND REGULATORY PROCEDURES WE 

1957
01:10:27,028 --> 01:10:28,396
HAVE NOW IS THERE SOME WAY THEY 

1958
01:10:28,396 --> 01:10:32,367
ARE TRACKING IF THE IMPACT LIKE 

1959
01:10:32,367 --> 01:10:33,668
ARE WE -- 

1960
01:10:33,668 --> 01:10:34,369
>> YEAH. 

1961
01:10:34,369 --> 01:10:36,338
>> WE ARE DOING BETTER
RESEARCH 

1962
01:10:36,338 --> 01:10:39,674
I KNOW AND NOW YOU READ ABOUT AI

1963
01:10:39,674 --> 01:10:41,943
BEING USED AND PEOPLE PUBLISHING

1964
01:10:41,943 --> 01:10:43,845
FALSE DATA AND IS THERE 

1965
01:10:43,845 --> 01:10:45,380
REGULATORY OR SOME PLACE WE CAN 

1966
01:10:45,380 --> 01:10:47,182
GO SEE HOW WE ARE DOING?  

1967
01:10:47,182 --> 01:10:49,517
WE ARE I THINK DOING WELL BUT 

1968
01:10:49,517 --> 01:10:51,653
DON'T KNOW AND WILL WE COVER 

1969
01:10:51,653 --> 01:10:54,856
THAT IN THE COURSE OR. 

1970
01:10:54,856 --> 01:10:56,391
>> GREAT QUESTION.  

1971
01:10:56,391 --> 01:10:58,660
SAD ANSWER IS THERE IS NO 

1972
01:10:58,660 --> 01:10:59,961
COMPREHENSIVE SUMMARY HOW WE 

1973
01:10:59,961 --> 01:11:00,996
HAVE BEEN DOING. 

1974
01:11:00,996 --> 01:11:01,429
>> RIGHT. 

1975
01:11:01,429 --> 01:11:03,164
>> THERE ARE PIECES OF
EVIDENCE 

1976
01:11:03,164 --> 01:11:04,666
ABOUT HOW WE HAVE BEEN DOING. 

1977
01:11:04,666 --> 01:11:06,735
>> I THINK SO. 

1978
01:11:06,735 --> 01:11:07,302
>> YEAH. 

1979
01:11:07,302 --> 01:11:09,504
>> I THINK MAYBE HOLLY
WILL TALK

1980
01:11:09,504 --> 01:11:11,006
ABOUT IT WITH SPECIFIC REFERENCE

1981
01:11:11,006 --> 01:11:13,208
TO HOW IRBS ARE DOING. 

1982
01:11:13,208 --> 01:11:13,742
>> YEAH. 

1983
01:11:13,742 --> 01:11:15,310
>> YEAH.  SO EXACTLY. 

1984
01:11:15,310 --> 01:11:17,412
THERE ARE -- YOU KNOW, INFORMED 

1985
01:11:17,412 --> 01:11:19,581
CONCEPT IS A GOOD EXAMPLE HOW WE

1986
01:11:19,581 --> 01:11:21,549
HAVE NOT MADE A LOT OF PROGRESS 

1987
01:11:21,549 --> 01:11:23,985
AND WE HAVE DONE LOTS OF 

1988
01:11:23,985 --> 01:11:26,187
EMPIRICAL WORK TO IMPROVE 

1989
01:11:26,187 --> 01:11:29,958
PROCESS AND SHORTENED FORMS, ET 

1990
01:11:29,958 --> 01:11:30,358
CETERA. 

1991
01:11:30,358 --> 01:11:32,394
FORMS ARE STILL LONG. 

1992
01:11:32,394 --> 01:11:34,562
THERE ARE SPACES AMONG MANY 

1993
01:11:34,562 --> 01:11:35,964
TOPICS DISCUSSED THAT THERE IS A

1994
01:11:35,964 --> 01:11:37,399
BIT OF EVIDENCE THAT THINGS HAVE

1995
01:11:37,399 --> 01:11:39,267
GOTTEN BETTER AND WE WILL TALK 

1996
01:11:39,267 --> 01:11:41,469
ABOUT A COUPLE OF THOSE DURING 

1997
01:11:41,469 --> 01:11:41,770
THE COURSE. 

1998
01:11:41,770 --> 01:11:42,737
>> YEAH. 

1999
01:11:42,737 --> 01:11:44,205
>> THANK YOU VERY MUCH.  

2000
01:11:44,205 --> 01:11:45,040
>> THANK YOU. 

2001
01:11:45,040 --> 01:11:47,275
>> IF FOLKS HAVE QUESTIONS
THAT 

2002
01:11:47,275 --> 01:11:49,044
COME TO YOU AFTERWARDS, FEEL 

2003
01:11:49,044 --> 01:11:51,246
FREE TO GO TO THE DISCUSSION 

2004
01:11:51,246 --> 01:11:53,982
BOARD IN CANVAS AND WRITE THEM 

2005
01:11:53,982 --> 01:11:55,517
DOWN.  

2006
01:11:55,517 --> 01:11:58,186
I WILL ANSWER THOSE AT -- YOU 

2007
01:11:58,186 --> 01:12:02,724
KNOW, I WILL BE ANSWERING THEM, 

2008
01:12:02,724 --> 01:12:04,092
PERIOD. 

2009
01:12:04,092 --> 01:12:06,895
GREAT.  

2010
01:12:06,895 --> 01:12:08,663
ANOTHER THING I DIDN'T MENTION 

2011
01:12:08,663 --> 01:12:10,332
WHEN WE STARTED IS WE ALWAYS 

2012
01:12:10,332 --> 01:12:13,501
HAVE A 15 MINUTE BREAK AFTER DR.

2013
01:12:13,501 --> 01:12:15,403
LEDDERER'S LECTURE WE WILL HAVE 

2014
01:12:15,403 --> 01:12:18,039
A 15 MINUTE BREAK AND THOSE 

2015
01:12:18,039 --> 01:12:20,542
WATCHING BY VIDEO, GRAB A CUP OF

2016
01:12:20,542 --> 01:12:22,310
COFFEE AND THOSE THAT ARE HERE 

2017
01:12:22,310 --> 01:12:22,944
DO THE SAME. 

2018
01:12:22,944 --> 01:12:25,914
WITHOUT FURTHER ADO, I WILL 

2019
01:12:25,914 --> 01:12:28,383
INTRODUCE OUR FIRST GUEST 

2020
01:12:28,383 --> 01:12:30,585
LECTURER, SUSAN LEDERER IS 

2021
01:12:30,585 --> 01:12:33,121
RONALD L NUMBERS PROFESSOR OF 

2022
01:12:33,121 --> 01:12:37,759
MEDICAL HISTORY AND BIOETHICS 

2023
01:12:37,759 --> 01:12:38,793
UNIVERSITY OF WISCONSIN SCHOOL 

2024
01:12:38,793 --> 01:12:40,362
OF MEDICINE AND PUBLIC HEALTH 

2025
01:12:40,362 --> 01:12:44,399
AND HISTORIAN OF 19TH AND 20TH 

2026
01:12:44,399 --> 01:12:46,434
CENTURY AMERICAN MEDICINE IN 

2027
01:12:46,434 --> 01:12:48,870
PUBLIC HEAL MG AND PUBLISHED A 

2028
01:12:48,870 --> 01:12:51,606
BOOK THAT MADE ME THE PERSON I 

2029
01:12:51,606 --> 01:12:53,208
AM AND SPEND MOST MOST OF MY 

2030
01:12:53,208 --> 01:13:00,148
TIME DOG RESEARCHICS ETHICS. 

2031
01:13:00,148 --> 01:13:02,951
I READ HER BOOK BEFORE THE 

2032
01:13:02,951 --> 01:13:05,353
SECOND WORLD WAR AND FEEL FREE 

2033
01:13:05,353 --> 01:13:06,921
IF YOU WANT CITATIONS FOR THAT 

2034
01:13:06,921 --> 01:13:10,291
AND WITHOUT FURTHER ADO, I WILL 

2035
01:13:10,291 --> 01:13:12,160
HAND IT TO DR. LEDERER. 

2036
01:13:12,160 --> 01:13:15,096
>> THANK YOU.  CAN YOU
HEAR ME? 

2037
01:13:15,096 --> 01:13:19,334
>> WE CAN.  WE CAN'T SEE
YOU GET

2038
01:13:19,334 --> 01:13:21,703
BUT DEFINITELY HEAR YOU.  FEEL 

2039
01:13:21,703 --> 01:13:22,670
FREE TO START. 

2040
01:13:22,670 --> 01:13:24,839
>> OKAY.  YOU WILL PUT MY
SLIDES

2041
01:13:24,839 --> 01:13:25,140
UP?  

2042
01:13:25,140 --> 01:13:28,443
>> YES.  I WILL MOVE YOUR
SLIDES

2043
01:13:28,443 --> 01:13:29,077
FORWARD. 

2044
01:13:29,077 --> 01:13:29,711
LET ME KNOW WHEN. 

2045
01:13:29,711 --> 01:13:31,579
>> ALL RIGHT.  COULD YOU
SHOW 

2046
01:13:31,579 --> 01:13:32,147
THE NEXT SLIDE. 

2047
01:13:32,147 --> 01:13:35,784
>> YUP.  I'M ON YOUR
DISCLOSURE.

2048
01:13:35,784 --> 01:13:39,387
>> MY DISCLOSURE SLIDE. 

2049
01:13:39,387 --> 01:13:41,523
THEN THE NEXT SLIDE. 

2050
01:13:41,523 --> 01:13:44,392
OKAY.  WHAT I WILL TALK ABOUT 

2051
01:13:44,392 --> 01:13:48,096
THIS MORNING IS WHAT I WILL CALL

2052
01:13:48,096 --> 01:13:50,165
A SCANDALISHLY SHORT HISTORY OF 

2053
01:13:50,165 --> 01:13:52,300
RESEARCH ETHICS AND SO MUCH MORE

2054
01:13:52,300 --> 01:13:53,735
I COULD SAY AND HOPEFULLY WHAT I

2055
01:13:53,735 --> 01:13:55,437
SPEAK TO YOU ABOUT THIS MORNING 

2056
01:13:55,437 --> 01:13:58,807
WILL GIVE YOU SOME APPRECIATION 

2057
01:13:58,807 --> 01:14:01,042
OF THE ROLE OF THE PAST IN 

2058
01:14:01,042 --> 01:14:04,112
SHAPING RULES FOR RESEARCH THAT 

2059
01:14:04,112 --> 01:14:06,080
GOVERNED USE OF HUMAN SUBJECTS 

2060
01:14:06,080 --> 01:14:08,817
IN RESEARCH, YOU KNOW, FOR 

2061
01:14:08,817 --> 01:14:13,154
DECADES AND DR. GRADY SO 

2062
01:14:13,154 --> 01:14:15,156
ELOQUENTLY DESCRIBED, REQUIRE 

2063
01:14:15,156 --> 01:14:16,458
VIGILANCE BECAUSE RESEARCH 

2064
01:14:16,458 --> 01:14:18,593
CHANGES AND SOCIETY CHANGES AND 

2065
01:14:18,593 --> 01:14:20,428
IT IS IMPORTANT TO KEEP FACT 

2066
01:14:20,428 --> 01:14:24,032
THAT THESE ARE CHANGEABLE IN 

2067
01:14:24,032 --> 01:14:24,833
MIND. 

2068
01:14:24,833 --> 01:14:27,035
SO WHAT I WANT TO FOCUS ON TODAY

2069
01:14:27,035 --> 01:14:28,369
IS WHY WE HAVE PARTICULAR KINDS 

2070
01:14:28,369 --> 01:14:31,306
OF RULES WE HAD AND THE ROLE OF 

2071
01:14:31,306 --> 01:14:33,341
SCANDALS AND TRAGEDIES AND 

2072
01:14:33,341 --> 01:14:37,345
REVELATIONS OF ABUSES. 

2073
01:14:37,345 --> 01:14:39,247
SHAPED THE PARTICULAR 

2074
01:14:39,247 --> 01:14:39,581
REGULATIONS. 

2075
01:14:39,581 --> 01:14:40,849
AND I WANT TO ALSO MAKE A 

2076
01:14:40,849 --> 01:14:43,485
BROADER HISTTO R KALELE POINT 

2077
01:14:43,485 --> 01:14:46,754
THAT US POLICY -- HEALTH POLICY 

2078
01:14:46,754 --> 01:14:48,389
IN GENERAL OVER THE COURSE OF 

2079
01:14:48,389 --> 01:14:52,694
THE 20TH CENTURY WAS ALSO 

2080
01:14:52,694 --> 01:14:55,430
RESPONSIVE TO SCANDAL AND 

2081
01:14:55,430 --> 01:14:57,098
TRAGEDY AND WILL GO THROUGH VERY

2082
01:14:57,098 --> 01:14:59,167
BRIEFLY A SERIES OF -- OF 

2083
01:14:59,167 --> 01:15:01,302
EXAMPLES TO HELP PUT THIS IN 

2084
01:15:01,302 --> 01:15:01,970
MIND. 

2085
01:15:01,970 --> 01:15:03,004
THE NEXT SLIDE.  

2086
01:15:03,004 --> 01:15:05,507
SOME OF YOU MAY KNOW THAT THE 

2087
01:15:05,507 --> 01:15:07,075
FIRST FOOD AND DRUG REGULATION 

2088
01:15:07,075 --> 01:15:10,311
OCCURRED IN 1906 AND WERE 

2089
01:15:10,311 --> 01:15:12,380
CONCERNS ABOUT THE SAFETY OF 

2090
01:15:12,380 --> 01:15:16,885
PATENT MEDICINES, FOR EXAMPLE. 

2091
01:15:16,885 --> 01:15:21,489
LACK OF SAFETY AND SEE COCAINE 

2092
01:15:21,489 --> 01:15:24,359
TOOTH DROPS AND IT ACTUALLY 

2093
01:15:24,359 --> 01:15:26,494
CONTAINS COCAINE IN SMALL DOSES 

2094
01:15:26,494 --> 01:15:28,396
AND REALLY WAS NEXT SLIDE, THE 

2095
01:15:28,396 --> 01:15:30,598
CONCERN OVER THE SAFETY OF THE 

2096
01:15:30,598 --> 01:15:35,537
FOOD SUPPLY AND SOME MIGHT HAVE 

2097
01:15:35,537 --> 01:15:38,940
READ UPTON SINCLAIR'S -- THE 

2098
01:15:38,940 --> 01:15:41,476
JUNGLE AND AS HE FAMOUSLY SAID 

2099
01:15:41,476 --> 01:15:44,379
HE AIMED FOR THE NATION'S HEART 

2100
01:15:44,379 --> 01:15:46,714
AND REACHED THE STOMACH THAT 

2101
01:15:46,714 --> 01:15:50,752
PUSHED US CONGRESS IN 1906 AND 

2102
01:15:50,752 --> 01:15:53,087
NEXT SLIDE TO PASS THE FOOD AND 

2103
01:15:53,087 --> 01:15:55,857
DRUG ACT IN 1906 WHICH WAS THE 

2104
01:15:55,857 --> 01:15:58,560
FIRST SORT OF REGULATORY VENTURE

2105
01:15:58,560 --> 01:16:01,396
TO ENSURE THE SAFETY OF FOOD AND

2106
01:16:01,396 --> 01:16:05,233
DRUGS USED BY AMERICAN CONSUMERS

2107
01:16:05,233 --> 01:16:10,538
AND NEXT SLIDE. 

2108
01:16:10,538 --> 01:16:12,140
MAJOR REVISION OF FOOD AND DRUG 

2109
01:16:12,140 --> 01:16:17,579
ACT OCCURRED IN 1938 FOLLOWING 

2110
01:16:17,579 --> 01:16:19,547
TERRIBLE TRAGEDY IN WHICH A 

2111
01:16:19,547 --> 01:16:22,584
CHEMIST USED AS A SOLVENT FOR 

2112
01:16:22,584 --> 01:16:26,054
NEW DRUGS DIE ETHYLENE GLYCOL 

2113
01:16:26,054 --> 01:16:27,889
USED IN ANTIFREEZE USED IN 

2114
01:16:27,889 --> 01:16:31,893
DEATHS OF MORE THAN 1 HUNDRED 

2115
01:16:31,893 --> 01:16:32,360
CHILDREN 

2116
01:16:32,360 --> 01:16:36,130
NEXT SLIDE. 

2117
01:16:36,130 --> 01:16:38,399
I'M SORRY. 

2118
01:16:38,399 --> 01:16:40,401
OKAY.  AGAIN, LED TO TRAGIC 

2119
01:16:40,401 --> 01:16:42,070
DEATHS AND THERE WAS NOTHING 

2120
01:16:42,070 --> 01:16:44,105
THAT THE FOOD AND DRUG 

2121
01:16:44,105 --> 01:16:46,574
ADMINISTRATION COULD ACTUALLY DO

2122
01:16:46,574 --> 01:16:48,476
TO PULL DRUGS OFF THE MARKET. 

2123
01:16:48,476 --> 01:16:49,277
NEXT SLIDE. 

2124
01:16:49,277 --> 01:16:51,279
THERE WERE ALSO CONCERNS ABOUT 

2125
01:16:51,279 --> 01:16:54,015
THE SAFETY OF COSMETICS AND MAS 

2126
01:16:54,015 --> 01:16:56,217
CARE AH THAT WOULD BLIND WOMEN 

2127
01:16:56,217 --> 01:16:57,619
AND REDUCING DRUGS THAT WOULD 

2128
01:16:57,619 --> 01:16:59,420
MAKE YOU LOSE WEIGHT AND ALSO 

2129
01:16:59,420 --> 01:17:00,054
KILL YOU. 

2130
01:17:00,054 --> 01:17:00,888
NEXT SLIDE. 

2131
01:17:00,888 --> 01:17:04,392
IT LED TO THE FIRST SORT OF 

2132
01:17:04,392 --> 01:17:07,895
MAJOR REVISIONS OF THE FOOD AND 

2133
01:17:07,895 --> 01:17:12,600
DRUG AND COSMETIC ACT FOR THE 

2134
01:17:12,600 --> 01:17:15,837
FIRST TIME. 

2135
01:17:15,837 --> 01:17:19,040
FOR THE FIRST TIME.  

2136
01:17:19,040 --> 01:17:20,475
THAT DRUGS AND COSMETICS 

2137
01:17:20,475 --> 01:17:23,077
ACTUALLY HAD TO BE TESTED FOR 

2138
01:17:23,077 --> 01:17:24,312
TOXICITY BEFORE MARKETING AND 

2139
01:17:24,312 --> 01:17:26,180
HAD TO BE DIRECTIONS ON THE 

2140
01:17:26,180 --> 01:17:28,383
PACKAGE AND THAT SOME DRUGS WERE

2141
01:17:28,383 --> 01:17:30,585
TOO DANGEROUS TO BE DISPENSED 

2142
01:17:30,585 --> 01:17:35,156
JUST OVER THE COUNTER AND HAD TO

2143
01:17:35,156 --> 01:17:38,660
BE DISPENSED BY PRESCRIPTION 

2144
01:17:38,660 --> 01:17:39,093
ON

2145
01:17:39,093 --> 01:17:39,293
ONLY. 

2146
01:17:39,293 --> 01:17:43,431
NEXT SLIDE IN 1960S, REVELATION 

2147
01:17:43,431 --> 01:17:45,400
OF PLETHORA OF CHILDREN BORN 

2148
01:17:45,400 --> 01:17:48,369
WITH UNUSUAL BIRTH DEFECTS 

2149
01:17:48,369 --> 01:17:51,472
EVENTUALLY CONNECTED TO PRENATAL

2150
01:17:51,472 --> 01:17:53,574
USE OF THAL IDOMIDE NEXT SLIDE 

2151
01:17:53,574 --> 01:17:57,278
LEADING TO AMENDMENTS OF FOOD 

2152
01:17:57,278 --> 01:17:59,580
AND DRUG ACT IN [INDISCERNIBLE] 

2153
01:17:59,580 --> 01:18:01,482
HARRIS AMENDMENTS FDA FOR FIRST 

2154
01:18:01,482 --> 01:18:03,518
TIME COULD DEMAND SCIENTIFIC 

2155
01:18:03,518 --> 01:18:06,087
DATA TO DETERMINE THAT THE DRUG 

2156
01:18:06,087 --> 01:18:07,021
WORKED. 

2157
01:18:07,021 --> 01:18:07,555
NEXT SLIDE. 

2158
01:18:07,555 --> 01:18:10,625
IN A VERY DIFFERENT REALM, 

2159
01:18:10,625 --> 01:18:15,596
TALKING ABOUT THE REGULATION OF 

2160
01:18:15,596 --> 01:18:16,397
ANIMAL EXPERIMENTATION, FOR 

2161
01:18:16,397 --> 01:18:19,434
SOMETHING -- SORRY. 

2162
01:18:19,434 --> 01:18:20,868
NEXT SLIDE. 

2163
01:18:20,868 --> 01:18:25,139
OKAY.  IN A VERY DIFFERENT 

2164
01:18:25,139 --> 01:18:28,476
REALM, FOR SOMETHING LIKE SEVEN 

2165
01:18:28,476 --> 01:18:31,245
DECADES, CONGRESS HAD BEEN 

2166
01:18:31,245 --> 01:18:32,380
REVISITING POTENTIAL LEGISLATION

2167
01:18:32,380 --> 01:18:34,482
TO PROTECT ANIMALS USED IN 

2168
01:18:34,482 --> 01:18:37,385
RESEARCH AND AFTER THIS PHOTO 

2169
01:18:37,385 --> 01:18:39,487
ESSAY THAT APPEARED IN LIFE 

2170
01:18:39,487 --> 01:18:47,328
MAGAZINE IN 1966, NEXT SLIDE. 

2171
01:18:47,328 --> 01:18:48,229
CONGRESS RECEIVED MORE MAIL 

2172
01:18:48,229 --> 01:18:51,733
ABOUT THIS, YOU KNOW, THEFT OF 

2173
01:18:51,733 --> 01:18:53,334
DOGS AND ORGANIZED PET THEFT AND

2174
01:18:53,334 --> 01:18:54,702
TREATMENT OF ANIMALS BEFORE 

2175
01:18:54,702 --> 01:18:57,004
GETTING TO THE LABORATORY AND 

2176
01:18:57,004 --> 01:19:00,241
CONGRESS GOT MORE MAIL THAN THEY

2177
01:19:00,241 --> 01:19:04,979
DID ABOUT THE VIETNAM WAR AND 

2178
01:19:04,979 --> 01:19:07,181
PASSED ANIMAL WELFARE ACT AND 

2179
01:19:07,181 --> 01:19:08,549
LIKE NATIONAL RESEARCH ACT HAS 

2180
01:19:08,549 --> 01:19:12,220
BEEN AMENDED OVER YEARS AS 

2181
01:19:12,220 --> 01:19:14,722
ANIMAL EXPERIMENTATION ITSELF 

2182
01:19:14,722 --> 01:19:19,260
ALSO CHANGED AND NEXT SLIDE THE 

2183
01:19:19,260 --> 01:19:20,328
NATIONAL RESEARCH ACT THAT WE 

2184
01:19:20,328 --> 01:19:22,964
WILL TALK ABOUT TODAY THAT WAS 

2185
01:19:22,964 --> 01:19:24,232
SHAPED BY REVELATIONS 

2186
01:19:24,232 --> 01:19:26,834
PARTICULARLY IN 1960S OF ABUSES 

2187
01:19:26,834 --> 01:19:31,906
OF HUMAN SUBJECTS IN AMERICAN 

2188
01:19:31,906 --> 01:19:33,741
MEDICAL RESEARCH. 

2189
01:19:33,741 --> 01:19:36,277
NEXT SLIDE. 

2190
01:19:36,277 --> 01:19:41,849
EVEN BEFORE THE TUSKEGEE 

2191
01:19:41,849 --> 01:19:43,684
SYPHILIS STUDY TIPPING POINT FOR

2192
01:19:43,684 --> 01:19:45,787
CONGRESS TO PASS THERE WERE NAZI

2193
01:19:45,787 --> 01:19:47,922
MEDICAL EXPERIMENTS AND 

2194
01:19:47,922 --> 01:19:49,657
EXPERIMENTATION IN THE UNITED 

2195
01:19:49,657 --> 01:19:49,891
STATES. 

2196
01:19:49,891 --> 01:19:53,461
BOTH OF THE HISTORY OF HUMAN 

2197
01:19:53,461 --> 01:19:55,196
EXPERIMENTATION AROUND HISTORY 

2198
01:19:55,196 --> 01:20:00,268
OF CONTROVERSY AND CONCERN ABOUT

2199
01:20:00,268 --> 01:20:02,804
MORAL PROBLEMS RAISED BY HUMAN 

2200
01:20:02,804 --> 01:20:04,372
EXPERIMENTATION ARE OLDER AND 

2201
01:20:04,372 --> 01:20:06,274
WILL GIVE A BRIEF EXAMPLE. 

2202
01:20:06,274 --> 01:20:09,010
NEXT SLIDE. 

2203
01:20:09,010 --> 01:20:12,880
AS EARLY AS -- OKAY.  NEXT 

2204
01:20:12,880 --> 01:20:14,882
SLIDE. 

2205
01:20:14,882 --> 01:20:16,918
IN 19 HUNDRED, UNITED STATES 

2206
01:20:16,918 --> 01:20:22,690
CONGRESS ACTUALLY ENTERTAINED OR

2207
01:20:22,690 --> 01:20:25,059
LEGISLATION THAT WOULD HAVE A 

2208
01:20:25,059 --> 01:20:29,831
SENATE BILL OF 3424 REGULARING 

2209
01:20:29,831 --> 01:20:31,799
HUMAN EXPERIMENTATION IN 

2210
01:20:31,799 --> 01:20:32,600
DISTRICT OF COLUMBIA AND 19 

2211
01:20:32,600 --> 01:20:37,538
HUNDRED WOULD HAVE REQUIRED 

2212
01:20:37,538 --> 01:20:38,439
INVESTIGATORS TO DISCLOSE IN 

2213
01:20:38,439 --> 01:20:41,475
ADVANCE PURPOSE AND PROCEDURES 

2214
01:20:41,475 --> 01:20:43,244
OF NONTHERAPEUTIC EXPERIMENTS 

2215
01:20:43,244 --> 01:20:44,745
INVOLVING HUMAN BEINGS AND NEXT 

2216
01:20:44,745 --> 01:20:44,979
SLIDE. 

2217
01:20:44,979 --> 01:20:49,584
IT ALSO CALLED FOR AN EXPLICIT 

2218
01:20:49,584 --> 01:20:51,953
BAN ON USING PEOPLE IN STUDIES 

2219
01:20:51,953 --> 01:20:56,357
AND PEOPLE DEEMED UNABLE TO -- 

2220
01:20:56,357 --> 01:20:59,360
UNABLE TO CONSENT TO 

2221
01:20:59,360 --> 01:20:59,861
PARTICIPATION. 

2222
01:20:59,861 --> 01:21:01,329
THIS INCLUDED CHILDREN UNDER THE

2223
01:21:01,329 --> 01:21:03,831
AGE OF 21 AND INFANTS AND 

2224
01:21:03,831 --> 01:21:06,067
PREGNANT WOMEN WHO WERE DEEMED 

2225
01:21:06,067 --> 01:21:08,236
UNABLE TO EXERCISE SORT OF ADULT

2226
01:21:08,236 --> 01:21:11,706
DECISION MAKING CAPACITY. 

2227
01:21:11,706 --> 01:21:13,808
THAT IS ANOTHER STORY. 

2228
01:21:13,808 --> 01:21:16,377
SO THESE BILLS DID NOT PASS. 

2229
01:21:16,377 --> 01:21:19,146
BUT IT IS -- IT EXHIBITS A 

2230
01:21:19,146 --> 01:21:20,381
CONCERN THAT PEOPLE HAD ABOUT 

2231
01:21:20,381 --> 01:21:22,250
DIRECTION IN WHICH MEDICAL 

2232
01:21:22,250 --> 01:21:23,017
RESEARCH WAS DEVELOPING AND 

2233
01:21:23,017 --> 01:21:26,821
DON'T WANT TO GIVE YOU IDEA THAT

2234
01:21:26,821 --> 01:21:27,255
RESPONSIBLE MEDICAL 

2235
01:21:27,255 --> 01:21:29,223
EXPERIMENTATION WAS IN FACT NOT 

2236
01:21:29,223 --> 01:21:30,625
OCCURRING AT THIS TIME. 

2237
01:21:30,625 --> 01:21:32,360
ONE OF THE BEST EXAMPLES OF THIS

2238
01:21:32,360 --> 01:21:34,128
IS THE NEXT SLIDE. 

2239
01:21:34,128 --> 01:21:36,030
IT IS THE EXPERIMENTS CONDUCTED 

2240
01:21:36,030 --> 01:21:40,001
UNDER THEOS PISSES OF THE U.S. 

2241
01:21:40,001 --> 01:21:41,669
ARMY AND YELLOW FEVER BOARD 

2242
01:21:41,669 --> 01:21:43,905
EXPERIMENTS IN CUBA IN 19 

2243
01:21:43,905 --> 01:21:46,540
HUNDRED AND 1901 AND SOME MAY 

2244
01:21:46,540 --> 01:21:50,278
KNOW NAME OF WALTER REED WHO LED

2245
01:21:50,278 --> 01:21:51,379
A COMMISSION. 

2246
01:21:51,379 --> 01:21:54,148
THEY WERE INTERESTED IN 

2247
01:21:54,148 --> 01:21:55,583
ESTABLISHING HOW YELLOW FEVER 

2248
01:21:55,583 --> 01:21:58,819
SPREAD AND WAS A REAL THREAT IN 

2249
01:21:58,819 --> 01:22:01,088
THE SOUTHERN UNITED STATES AND 

2250
01:22:01,088 --> 01:22:01,822
CENTRAL AMERICA AND SOUTH 

2251
01:22:01,822 --> 01:22:06,360
AMERICA IN THIS TIME PERIOD. 

2252
01:22:06,360 --> 01:22:08,229
THEY WERE DETERMINED TO 

2253
01:22:08,229 --> 01:22:09,864
ESTABLISH THE VECTOR OF YELLOW 

2254
01:22:09,864 --> 01:22:11,332
FEVER THAT THEY EVENTUALLY DID 

2255
01:22:11,332 --> 01:22:15,636
AND FOR THAT RESEARCH HAD TO 

2256
01:22:15,636 --> 01:22:18,372
EXPOSE HUMAN BEINGS TO 

2257
01:22:18,372 --> 01:22:19,507
CONSIDERABLE RISK AND NEXT 

2258
01:22:19,507 --> 01:22:20,107
SLIDE. 

2259
01:22:20,107 --> 01:22:21,809
THEY NEEDED -- THEY NEEDED 

2260
01:22:21,809 --> 01:22:23,110
PEOPLE THAT WERE NEW TO THE 

2261
01:22:23,110 --> 01:22:24,845
ISLAND AND MANY OF THE PEOPLE 

2262
01:22:24,845 --> 01:22:28,382
WERE NEWLY ARRIVED SPANISH 

2263
01:22:28,382 --> 01:22:30,051
PEOPLE AND THEY NEEDED NAÏVE 

2264
01:22:30,051 --> 01:22:32,386
SUBJECTS TO SEE IF THEY COULD 

2265
01:22:32,386 --> 01:22:34,922
SPREAD DISEASE THROUGH VARIOUS 

2266
01:22:34,922 --> 01:22:38,459
MEANS INCLUDING MOSQUITOS AND 

2267
01:22:38,459 --> 01:22:39,360
REINTRODUCED A WRITTEN 

2268
01:22:39,360 --> 01:22:41,495
PERMISSION FORM AVAILABLE IN 

2269
01:22:41,495 --> 01:22:43,364
ENGLISH AND SPANISH AND IT, YOU 

2270
01:22:43,364 --> 01:22:45,967
KNOW, IT DID NOT OR WOULDN'T 

2271
01:22:45,967 --> 01:22:48,102
MEET STANDARDS OF INFORMED 

2272
01:22:48,102 --> 01:22:50,304
CONSENT AND WAS EXTRAORDINARY OF

2273
01:22:50,304 --> 01:22:52,373
ITS TIME WARNING DANGER TO LIFE 

2274
01:22:52,373 --> 01:22:54,375
AND EXPERIMENTS AND EFFECTIVE 

2275
01:22:54,375 --> 01:22:57,044
CLOTHING AND MOSQUITOS AND 

2276
01:22:57,044 --> 01:23:00,014
PROMISED GOOD MEDICAL CARE AND 

2277
01:23:00,014 --> 01:23:00,848
IDENTIFIED CONSIDERABLE 

2278
01:23:00,848 --> 01:23:02,049
COMPENSATION MEN WOULD RECEIVE 

2279
01:23:02,049 --> 01:23:03,718
IF THEY SIGNED AND WERE SELECTED

2280
01:23:03,718 --> 01:23:06,253
FOR THE STUDY. 

2281
01:23:06,253 --> 01:23:08,990
NEXT SLIDE. 

2282
01:23:08,990 --> 01:23:10,391
SUBJECTS WHO WERE SELECTED 

2283
01:23:10,391 --> 01:23:14,328
RECEIVED 1 HUNDRED DOLLARS IN 

2284
01:23:14,328 --> 01:23:15,296
AMERICAN GOLD A CONSIDERABLE SUM

2285
01:23:15,296 --> 01:23:17,498
AT THE TIME AND PROMISED TO GIVE

2286
01:23:17,498 --> 01:23:19,934
2 HUNDRED DOLLARS TO SURVIVING 

2287
01:23:19,934 --> 01:23:25,306
FAMILY IF DEATH OCCURS AND 

2288
01:23:25,306 --> 01:23:27,408
FRANKFORTNATELY NO PARTICIPANTS 

2289
01:23:27,408 --> 01:23:30,478
IN STUDY DIED AND INVESTIGATORS 

2290
01:23:30,478 --> 01:23:37,151
SUCK COUPLED TO YELLOW FEVER 

2291
01:23:37,151 --> 01:23:39,920
DURING THE COURSE OF THE STUDY 

2292
01:23:39,920 --> 01:23:41,455
AND NEXT SLIDE AND BEGINNING 

2293
01:23:41,455 --> 01:23:45,659
WITH SHIFT TO WWII REPRESENTING 

2294
01:23:45,659 --> 01:23:47,728
AN IMPORTANT MOMENT IN HISTORY 

2295
01:23:47,728 --> 01:23:48,796
OF RESEARCH IN THE UNITED STATES

2296
01:23:48,796 --> 01:23:53,200
AND IN ETHICS AND 1941 PRESIDENT

2297
01:23:53,200 --> 01:23:55,002
ROOSEVELT'S OFFICE FOR 

2298
01:23:55,002 --> 01:23:56,504
SCIENTIFIC RESEARCH WAS 

2299
01:23:56,504 --> 01:23:59,807
ESTABLISHED AND IMPORTANTLY FOR 

2300
01:23:59,807 --> 01:24:03,177
MEDICAL RESEARCH WAS ADVENT OF 

2301
01:24:03,177 --> 01:24:04,111
UNPRECEDENTED FEDERAL FUNDING 

2302
01:24:04,111 --> 01:24:05,813
FOR MEDICAL RESEARCH THAT WAS 

2303
01:24:05,813 --> 01:24:11,619
RELATED TO THE WAR EFFORT THAT 

2304
01:24:11,619 --> 01:24:12,920
SOMETHING SMA WOULD CONTINUE 

2305
01:24:12,920 --> 01:24:14,789
AFTER THE WAR AND IMPORTANT 

2306
01:24:14,789 --> 01:24:16,290
MOMENT IN THE GROWING 

2307
01:24:16,290 --> 01:24:17,058
RECOGNITION IN IMPORTANCE OF 

2308
01:24:17,058 --> 01:24:20,194
MEDICAL RESEARCH NOT ONLY TO US 

2309
01:24:20,194 --> 01:24:24,065
SOCIETY AND TO OUR PLACE IN THE 

2310
01:24:24,065 --> 01:24:26,867
WORLD AS WELL. 

2311
01:24:26,867 --> 01:24:27,968
NEXT SLIDE. 

2312
01:24:27,968 --> 01:24:31,238
NOW, I ALSO MENTIONED IF YOU 

2313
01:24:31,238 --> 01:24:35,810
WILL NAZI MEDICAL 

2314
01:24:35,810 --> 01:24:38,079
EXPERIMENTATION AND AGAIN AS IN 

2315
01:24:38,079 --> 01:24:39,647
THE UNITED STATES HIGH RANKING 

2316
01:24:39,647 --> 01:24:42,450
NAZI OFFICIALS BELIEVED THAT 

2317
01:24:42,450 --> 01:24:44,051
MEDICAL RESEARCH WOULD HELP 

2318
01:24:44,051 --> 01:24:46,754
GERMANY WIN THE WAR AND 

2319
01:24:46,754 --> 01:24:48,389
UNDERTOOK AMBITIOUS AND 

2320
01:24:48,389 --> 01:24:52,326
FRIGHTENING PROGRAM OF RESEARCH 

2321
01:24:52,326 --> 01:24:58,599
TO ADVANCE MEDICAL INTERESTS AND

2322
01:24:58,599 --> 01:25:00,401
SOME MIGHT BE FAMILIAR YOU TO. 

2323
01:25:00,401 --> 01:25:02,703
IT IS USEFUL TO BRIEFLY REVISIT 

2324
01:25:02,703 --> 01:25:04,538
THEM AND IF YOU COULD GO TO THE 

2325
01:25:04,538 --> 01:25:06,440
NEXT SLIDE AND AMONG FIRST THAT 

2326
01:25:06,440 --> 01:25:12,379
WERE UNDERTAKEN WERE THOSE AT 

2327
01:25:12,379 --> 01:25:17,651
DACA CONCENTRATION CAMP EFFECTS 

2328
01:25:17,651 --> 01:25:20,154
OF EMERSION OF FREEZING WATER 

2329
01:25:20,154 --> 01:25:22,523
AND ENDED WITH DEATH OF THE 

2330
01:25:22,523 --> 01:25:23,891
PARTICIPANT SORT OF HOW LONG IT 

2331
01:25:23,891 --> 01:25:26,560
WOULD TAKE TO DIE IF IN FREEZING

2332
01:25:26,560 --> 01:25:28,329
WATER AND WOULD EQUIPMENT FOR 

2333
01:25:28,329 --> 01:25:29,763
EXAMPLE HELP YOU TO SURVIVE 

2334
01:25:29,763 --> 01:25:31,532
LONGER SO YOU MIGHT BE RESCUED 

2335
01:25:31,532 --> 01:25:33,667
AND SO FORTH. 

2336
01:25:33,667 --> 01:25:35,169
NEXT SLIDE. 

2337
01:25:35,169 --> 01:25:39,673
ALSO AT DACAU CONCENTRATION CAMP

2338
01:25:39,673 --> 01:25:41,675
AND STUDIES AND ECHLTHS OF HIGH 

2339
01:25:41,675 --> 01:25:44,612
ALTITUDE AND LOW OXYGEN 

2340
01:25:44,612 --> 01:25:45,212
CONCENTRATION AND IT WAS 

2341
01:25:45,212 --> 01:25:48,349
IMPORTANT BECAUSE THEY WANTED TO

2342
01:25:48,349 --> 01:25:50,117
STUDY POST MORTEM CHANGES IN THE

2343
01:25:50,117 --> 01:25:50,417
BRAIN. 

2344
01:25:50,417 --> 01:25:51,185
NEXT SLIDE. 

2345
01:25:51,185 --> 01:25:53,554
AS IN THE UNITED STATES, NAZIS 

2346
01:25:53,554 --> 01:25:56,257
WERE INTERESTED IN SEA WATER 

2347
01:25:56,257 --> 01:25:58,926
STUDIES AND HOW TO QUICKLY 

2348
01:25:58,926 --> 01:26:01,662
DESALINATE SEE WATER TO PROMOTE 

2349
01:26:01,662 --> 01:26:03,931
SURVIVAL AT SEA SO FLYERS FOR 

2350
01:26:03,931 --> 01:26:07,234
EXAMPLE COULD BE RESCUED OR NAVY

2351
01:26:07,234 --> 01:26:09,570
PERSONNEL AND YOU SEE HERE A 

2352
01:26:09,570 --> 01:26:12,373
VICTIM OFA VICTIM OF NAZI 

2353
01:26:12,373 --> 01:26:14,275
MEDICAL EXPERIMENTS INVOLVING 

2354
01:26:14,275 --> 01:26:15,910
AMONG OTHER THINGS, YOU KNOW, 

2355
01:26:15,910 --> 01:26:17,444
GIVING PEOPLE TO SEE HOW LONG 

2356
01:26:17,444 --> 01:26:19,146
YOU WOULD SURVIVE WITH 

2357
01:26:19,146 --> 01:26:20,814
ABSOLUTELY NO WATER AND FORCING 

2358
01:26:20,814 --> 01:26:23,350
SEA WATER ON PEOPLE AND GIVING 

2359
01:26:23,350 --> 01:26:26,153
SEA WATER FLAVORED WITH TOMATO 

2360
01:26:26,153 --> 01:26:27,821
EXTRACT AND INVOLVING GREAT 

2361
01:26:27,821 --> 01:26:30,524
SUFFERING IF NOT DEATH TO THE 

2362
01:26:30,524 --> 01:26:32,893
PARTICIPANTS AND NEXT SLIDE. 

2363
01:26:32,893 --> 01:26:36,997
SO THE STUDY OF BIRDS AND WOUNDS

2364
01:26:36,997 --> 01:26:38,732
WAS ALSO OF GREAT INTEREST IN 

2365
01:26:38,732 --> 01:26:40,367
THE UNITED STATES AND STANDARD 

2366
01:26:40,367 --> 01:26:42,570
BURDEN AND WOUND DEVELOPED ON 

2367
01:26:42,570 --> 01:26:45,539
ANIMAL SUBJECTS CHIEF PIGS AND 

2368
01:26:45,539 --> 01:26:48,008
DOGS AND POLISH WOMEN AT 

2369
01:26:48,008 --> 01:26:49,677
CONCENTRATION CAMP AND 

2370
01:26:49,677 --> 01:26:52,213
DELIBERATELY INFECT OR CUT OPEN 

2371
01:26:52,213 --> 01:26:54,982
TO CREATE A WOUND AND INFECTED 

2372
01:26:54,982 --> 01:26:57,751
WITH BACTERIA DIRT SLIVERS OF 

2373
01:26:57,751 --> 01:26:59,353
GLASS TO STUDY NATURAL HISTORY 

2374
01:26:59,353 --> 01:27:03,357
OF THE WOUND AND VARIOUS WAYS TO

2375
01:27:03,357 --> 01:27:06,527
PROMOTE HEALING. 

2376
01:27:06,527 --> 01:27:10,331
NEXT SLIDE. 

2377
01:27:10,331 --> 01:27:11,198
OKAY.  

2378
01:27:11,198 --> 01:27:14,034
AFTER THE WAR, AFTER THE TRIALS 

2379
01:27:14,034 --> 01:27:18,105
OF THE MAJOR NAZI WAR CRIMINALS,

2380
01:27:18,105 --> 01:27:20,374
U.S. MILITARY TRIBUNAL TOOK ON 

2381
01:27:20,374 --> 01:27:22,109
VARIOUS GROUPS AND FIRST 

2382
01:27:22,109 --> 01:27:25,012
PROSECUTION OF VARIOUS GROUPS 

2383
01:27:25,012 --> 01:27:27,348
FOR WAR CRIMES. 

2384
01:27:27,348 --> 01:27:29,917
FIRST GROUP WAS NAZI DOCTORS 

2385
01:27:29,917 --> 01:27:34,755
AND IN 1946, TRIAL OF THE UNITED

2386
01:27:34,755 --> 01:27:39,059
STATES VERSUS KARL BRANT ET AL 

2387
01:27:39,059 --> 01:27:41,128
BEGAN AND NEXT SLIDE, ACTION 

2388
01:27:41,128 --> 01:27:43,631
BROUGHT AGAINST 23 HIGH-RANKING 

2389
01:27:43,631 --> 01:27:46,834
NAZI MEDICAL PERSONNEL AND 22 

2390
01:27:46,834 --> 01:27:49,536
MEN AND ONE WOMAN AND WOMAN 

2391
01:27:49,536 --> 01:27:50,537
DOCTOR PRESIDING OVER SOME BURN 

2392
01:27:50,537 --> 01:27:53,641
AND WOUND STUDIES AT ROBIN'S 

2393
01:27:53,641 --> 01:27:53,907
BROOK. 

2394
01:27:53,907 --> 01:27:55,442
THERE IS MUCH THAT COULD BE SAID

2395
01:27:55,442 --> 01:27:58,712
AND ENTIRE BOOKS WRITTEN ABOUT 

2396
01:27:58,712 --> 01:28:00,381
NAZI DOCTORS TRIAL AND WHAT I 

2397
01:28:00,381 --> 01:28:03,384
WILL SAY HERE IS NEXT SLIDE. 

2398
01:28:03,384 --> 01:28:06,954
THAT WHAT AMONG ISSUES FOR 

2399
01:28:06,954 --> 01:28:09,256
TRIBUNAL WAS HOW TO JUDGE THESE.

2400
01:28:09,256 --> 01:28:11,125
WERE THESE NORMAL MEDICAL 

2401
01:28:11,125 --> 01:28:13,694
RESEARCH OR WERE THERE RULES 

2402
01:28:13,694 --> 01:28:15,929
ABOUT RESEARCH AND HOW TO ASSESS

2403
01:28:15,929 --> 01:28:19,900
GUILT OR INNOCENCE OF THE NAZI 

2404
01:28:19,900 --> 01:28:21,135
DOCTORS ON TRIAL. 

2405
01:28:21,135 --> 01:28:24,805
AND IN SO DOING, THEY ACTUALLY 

2406
01:28:24,805 --> 01:28:27,041
FORMULATED A LIST OF PRINCIPLES 

2407
01:28:27,041 --> 01:28:31,512
THAT CONSTITUTED PERMISSIBLE OR 

2408
01:28:31,512 --> 01:28:32,546
ACCEPTABLE HUMAN 

2409
01:28:32,546 --> 01:28:32,946
EXPERIMENTATION. 

2410
01:28:32,946 --> 01:28:33,480
NEXT SLIDE. 

2411
01:28:33,480 --> 01:28:36,083
I WILL SAY THAT THERE WAS SOME 

2412
01:28:36,083 --> 01:28:37,718
SQUIRMING ON THE PART OF SOME OF

2413
01:28:37,718 --> 01:28:39,887
THE AMERICAN DOCTORS THAT WERE 

2414
01:28:39,887 --> 01:28:42,923
CALLED IN TO ADVISE ABOUT THE 

2415
01:28:42,923 --> 01:28:44,191
TRIAL. 

2416
01:28:44,191 --> 01:28:45,726
THE DEFENSE ATTORNEYS 

2417
01:28:45,726 --> 01:28:47,528
REPRESENTING KARL BRANT, FOR 

2418
01:28:47,528 --> 01:28:49,029
EXAMPLE, SORT OF MADE A 

2419
01:28:49,029 --> 01:28:50,864
COMPARISON AND WHAT IS DIFFERENT

2420
01:28:50,864 --> 01:28:53,500
WITH NAZI CONCENTRATION CAMP 

2421
01:28:53,500 --> 01:28:54,501
EXPERIMENTS INVOLVING PRISONERS 

2422
01:28:54,501 --> 01:28:57,104
AND KINDS OF EXPERIMENTS BEING 

2423
01:28:57,104 --> 01:28:58,939
CONDUCTED IN AMERICAN PRISONS AT

2424
01:28:58,939 --> 01:29:00,574
THE SAME TIME AND EXPERIMENTS 

2425
01:29:00,574 --> 01:29:02,843
THAT INVOLVED DELIBERATE 

2426
01:29:02,843 --> 01:29:05,679
INFECTION WITH DISEASE AND 

2427
01:29:05,679 --> 01:29:07,214
EXPERIMENTS IN WHICH SOMETIMES 

2428
01:29:07,214 --> 01:29:09,650
PRISONERS IN FACT DIED. 

2429
01:29:09,650 --> 01:29:09,983
NEXT SLIDE. 

2430
01:29:09,983 --> 01:29:15,255
ONE OF THE THINGS THAT WAS 

2431
01:29:15,255 --> 01:29:16,256
ACTUALLY BROUGHT INTO EVIDENCE 

2432
01:29:16,256 --> 01:29:18,792
BY NAZI OR GERMAN DEFENSE 

2433
01:29:18,792 --> 01:29:22,062
ATTORNEY WAS AN ISSUE OF LIFE 

2434
01:29:22,062 --> 01:29:24,765
MAGAZINE FROM JUNE 4TH 1945 

2435
01:29:24,765 --> 01:29:28,135
FEATURING MALARIA RESEARCH AT 

2436
01:29:28,135 --> 01:29:32,339
STATEVILLE PRISON IN ILLINOIS 

2437
01:29:32,339 --> 01:29:35,476
WHERE SOME 40 OR 50 INMATES 

2438
01:29:35,476 --> 01:29:36,643
ACTUALLY UNDERWENT INFECTION 

2439
01:29:36,643 --> 01:29:42,516
WITH LOADED MOSQUITOS IN ORDER 

2440
01:29:42,516 --> 01:29:44,685
TO STUDY MALARIA AND ITS 

2441
01:29:44,685 --> 01:29:46,053
TREATMENT AND NEXT SLIDE. 

2442
01:29:46,053 --> 01:29:49,223
AS I ALREADY MENTIONED, WHEN 

2443
01:29:49,223 --> 01:29:51,125
THEY DELIVERED THEIR VERDICT IN 

2444
01:29:51,125 --> 01:29:54,061
NAZI DOCTOR'S TRIAL, THEY -- 

2445
01:29:54,061 --> 01:29:55,796
JUDGES WITH ADVICE OF SEVERAL 

2446
01:29:55,796 --> 01:29:58,399
PHYSICIANS PUT TOGETHER A SET OF

2447
01:29:58,399 --> 01:30:00,901
10 PRINCIPLES, CALLED 

2448
01:30:00,901 --> 01:30:03,003
PERMISSIBLE MEDICAL EXPERIMENTS 

2449
01:30:03,003 --> 01:30:07,875
WE HAVE COME TO KNOW AND 

2450
01:30:07,875 --> 01:30:09,843
UNIVERSALLY IS CALLED NUREMBERG 

2451
01:30:09,843 --> 01:30:12,212
CODE AND SEE IT ON YOUR READINGS

2452
01:30:12,212 --> 01:30:16,350
AND DISCUSSIONS USUALLY ABOUT 

2453
01:30:16,350 --> 01:30:18,519
NUREMBERG CODE FIRST PRINCIPLE 

2454
01:30:18,519 --> 01:30:20,754
GETS ATTENTION AND DESERVEDLY SO

2455
01:30:20,754 --> 01:30:23,690
AND SETS EXTRAORDINARILY HIGH 

2456
01:30:23,690 --> 01:30:25,759
STANDARD THAT VOLUNTARY CONSENT 

2457
01:30:25,759 --> 01:30:31,131
OF HUMAN SUBJECT IS ABSOLUTELY 

2458
01:30:31,131 --> 01:30:31,732
ESSENT

2459
01:30:31,732 --> 01:30:32,032
ESSENTIAL. 

2460
01:30:32,032 --> 01:30:33,233
IT DOESN'T PERMIT PROXY CONSENT 

2461
01:30:33,233 --> 01:30:36,370
AND FOR EXAMPLE CHILDREN ARE NOT

2462
01:30:36,370 --> 01:30:39,406
LEGITIMATE SUBJECTS ACCORDING TO

2463
01:30:39,406 --> 01:30:40,641
NUREMBERG CODE AND EXCLUDES 

2464
01:30:40,641 --> 01:30:42,209
OFTEN PEOPLE IN INSTITUTIONS AND

2465
01:30:42,209 --> 01:30:47,080
SO FORTH DEPENDING ON ONE'S 

2466
01:30:47,080 --> 01:30:47,448
INTERPRETATION. 

2467
01:30:47,448 --> 01:30:48,081
NEXT SLIDE. 

2468
01:30:48,081 --> 01:30:49,983
THERE WERE, OF COURSE, OTHERS. 

2469
01:30:49,983 --> 01:30:51,885
I WON'T GO THROUGH THEM. 

2470
01:30:51,885 --> 01:30:54,388
JUST SOME THAT WERE SEEN AS 

2471
01:30:54,388 --> 01:30:55,923
EXTREMELY IMPORTANT TO AMERICAN 

2472
01:30:55,923 --> 01:30:57,958
PHYSICIANS WHO WANTED TO DEFEND 

2473
01:30:57,958 --> 01:30:59,326
MEDICAL RESEARCH AND THAT 

2474
01:30:59,326 --> 01:31:01,195
RESEARCH HAD TO BE BASED ON 

2475
01:31:01,195 --> 01:31:04,031
PRIOR ANIMAL STUDIES AND IT WAS 

2476
01:31:04,031 --> 01:31:07,100
INTENDED AT OUTSET TO AVOID 

2477
01:31:07,100 --> 01:31:08,469
UNNECESSARY SUFFERING AND 

2478
01:31:08,469 --> 01:31:11,004
SHOULDN'T HAVE DEATH AS ENDPOINT

2479
01:31:11,004 --> 01:31:13,407
STUDIES AND RISK SHOULDN'T 

2480
01:31:13,407 --> 01:31:15,609
EXCEED BENEFIT AND 

2481
01:31:15,609 --> 01:31:19,346
SCIENTIFICALLY ONLY QUALIFIED 

2482
01:31:19,346 --> 01:31:21,148
PERSONNEL WERE TO CONDUCT 

2483
01:31:21,148 --> 01:31:23,083
STUDIES AND NEXT IN CASE YOU ARE

2484
01:31:23,083 --> 01:31:25,319
INTERESTED I WILL TELL THAW 7 OF

2485
01:31:25,319 --> 01:31:28,288
THE NAZI DOCTORS WERE ACQUITTED 

2486
01:31:28,288 --> 01:31:30,491
ON INSUFFICIENT EVIDENCE AND 

2487
01:31:30,491 --> 01:31:33,694
SEVEN RECEIVED DEATH SENTENCES 9

2488
01:31:33,694 --> 01:31:34,928
RECEIVING PRISON SENTENCES 

2489
01:31:34,928 --> 01:31:37,898
RANGING FROM 10 YEARS TO LIFE 

2490
01:31:37,898 --> 01:31:40,367
IMPRISONMENT AND SURPRISING TO 

2491
01:31:40,367 --> 01:31:42,503
ME THAT ALMOST ALL NINE WHO 

2492
01:31:42,503 --> 01:31:45,839
RECEIVE PRISON SENTENCES HAD 

2493
01:31:45,839 --> 01:31:48,375
SENTENCES SERIOUSLY COMMUTED TO 

2494
01:31:48,375 --> 01:31:52,246
ONE YEAR OR ONLY A FEW YEARS AND

2495
01:31:52,246 --> 01:31:56,350
BACK IN MEDICAL PRACTICE IN FACT

2496
01:31:56,350 --> 01:32:02,656
IN GERMANY. 

2497
01:32:02,656 --> 01:32:06,159
KARL BRANT WAS AMONG THOSE 

2498
01:32:06,159 --> 01:32:07,628
SENTENCED TO DEATH AND OFFERED 

2499
01:32:07,628 --> 01:32:11,298
HIS BODY TO EXPERIMENTATION TO 

2500
01:32:11,298 --> 01:32:12,966
THE U.S. ARMY THAT REJECTED HIS 

2501
01:32:12,966 --> 01:32:17,671
OFFER AND HE WAS HANGED AT 

2502
01:32:17,671 --> 01:32:20,173
LUNZBERG PRISON AND NEXT SLIDE 

2503
01:32:20,173 --> 01:32:21,909
THERE IS DEBATE AMONG COLLEAGUES

2504
01:32:21,909 --> 01:32:24,144
AND RESEARCH IN HISTORY OF 

2505
01:32:24,144 --> 01:32:26,680
ETHICS AND RESEARCH IN 1950S AND

2506
01:32:26,680 --> 01:32:30,017
60S AND 70S IN THE UNITED STATES

2507
01:32:30,017 --> 01:32:32,085
ABOUT WHAT NUREMBERG CODE 

2508
01:32:32,085 --> 01:32:34,388
ACTUALLY MEANT TO MEDICAL 

2509
01:32:34,388 --> 01:32:35,722
RESEARCHERS AND ARE ARGUMENTS 

2510
01:32:35,722 --> 01:32:41,895
SORT OF ON BOTH SIDES. 

2511
01:32:41,895 --> 01:32:43,463
SOME HAVE MADE CLAIM THAT 

2512
01:32:43,463 --> 01:32:47,434
MEDICAL RESEARCHERS DIDN'T KNOW 

2513
01:32:47,434 --> 01:32:49,169
NUREMBERG CODE EXISTED AND I 

2514
01:32:49,169 --> 01:32:52,306
DON'T SUPPORT THIS AND 1953 FOR 

2515
01:32:52,306 --> 01:32:54,508
EXAMPLE JOURNAL OF SCIENCE AND 

2516
01:32:54,508 --> 01:32:58,111
SCIENTIFIC JOURNAL WITH LARGEST 

2517
01:32:58,111 --> 01:32:58,946
CIRCULATION PUBLISHED CODE IN 

2518
01:32:58,946 --> 01:33:01,648
BIG ARTICLE AND RESULTS OF 

2519
01:33:01,648 --> 01:33:02,282
SYMPOSIUM DISCUSSING THIS AND 

2520
01:33:02,282 --> 01:33:04,484
SEEMS TO ME THAT IS REACHING A 

2521
01:33:04,484 --> 01:33:06,053
BROAD AUDIENCE. 

2522
01:33:06,053 --> 01:33:09,056
AND I WILL ALSO SAY THAT IN 

2523
01:33:09,056 --> 01:33:12,526
1953, THE SECRETARY OF DEFENSE, 

2524
01:33:12,526 --> 01:33:14,528
CHARLIE WILSON, ACTUALLY SIGNED 

2525
01:33:14,528 --> 01:33:16,663
A MEMORANDUM REQUIRING THE CODE 

2526
01:33:16,663 --> 01:33:18,966
FOR ALL RESEARCH CONDUCTED BY 

2527
01:33:18,966 --> 01:33:22,135
THE US ARMED FORCES. 

2528
01:33:22,135 --> 01:33:23,837
AND CURIOUSLY AND PERHAPS 

2529
01:33:23,837 --> 01:33:25,672
IRONICALLY, THE DOCUMENT WAS 

2530
01:33:25,672 --> 01:33:27,874
ALSO CLASSIFIED AS TOP SECRET 

2531
01:33:27,874 --> 01:33:32,412
AND SEEMS TO BE SOMETHING OF AN 

2532
01:33:32,412 --> 01:33:34,147
IMPLEMENTATION FAILURE. 

2533
01:33:34,147 --> 01:33:36,116
NONETHELESS, IT CAME TO THE 

2534
01:33:36,116 --> 01:33:39,252
ATTENTION OF MANY PEOPLE. 

2535
01:33:39,252 --> 01:33:40,354
NEXT SLIDE. 

2536
01:33:40,354 --> 01:33:43,423
ON THE OTHER HAPPENED, A NUMBER 

2537
01:33:43,423 --> 01:33:46,526
OF, YOU KNOW, COMMENTATORS HAVE 

2538
01:33:46,526 --> 01:33:49,029
ARGUED THAT MOST AMERICAN 

2539
01:33:49,029 --> 01:33:51,632
RESEARCHERS DISMISS THE 

2540
01:33:51,632 --> 01:33:53,834
NUREMBERG CODE AS SOMETHING THAT

2541
01:33:53,834 --> 01:33:56,870
GERMANS AND BARR BARIAN NAZIS 

2542
01:33:56,870 --> 01:33:58,672
WOULD NEED AND AMERICAN 

2543
01:33:58,672 --> 01:34:00,374
RESEARCHERS DIDN'T NEED. 

2544
01:34:00,374 --> 01:34:02,376
THEY WERE CAREFUL AND CONCERNED 

2545
01:34:02,376 --> 01:34:04,645
ABOUT BOTH THE SAFETY AND 

2546
01:34:04,645 --> 01:34:07,648
WELFARE OF THEIR SUBJECTS. 

2547
01:34:07,648 --> 01:34:08,181
NEXT SLIDE. 

2548
01:34:08,181 --> 01:34:12,986
I THIS I  -- I THINK IT IS 

2549
01:34:12,986 --> 01:34:14,788
IMPORTANT TO KEEP IN MIND THOUGH

2550
01:34:14,788 --> 01:34:17,891
IF YOU WERE TO ASK IF AMERICAN 

2551
01:34:17,891 --> 01:34:22,462
RESEARCHERS INVESTIGATORS MET 

2552
01:34:22,462 --> 01:34:24,698
NUREMBERG CODE AND REQUIREMENTS 

2553
01:34:24,698 --> 01:34:26,667
AND RESEARCH GOING ON DURING AND

2554
01:34:26,667 --> 01:34:29,069
AFTER THE WAR ABSOLUTELY NOT.  

2555
01:34:29,069 --> 01:34:32,139
IT SET AN EXTRAORDINARILY HIGH 

2556
01:34:32,139 --> 01:34:32,406
STANDARD. 

2557
01:34:32,406 --> 01:34:34,508
NEXT SLIDE.  I WANT TO SORT OF 

2558
01:34:34,508 --> 01:34:38,011
MAKE THE POINT HERE IN 1950S 

2559
01:34:38,011 --> 01:34:40,213
THERE WAS TREMENDOUS SOCIAL 

2560
01:34:40,213 --> 01:34:42,749
SUPPORT FOR MEDICAL RESEARCH 

2561
01:34:42,749 --> 01:34:44,418
ENTERPRISE AND GREAT ADMIRATION 

2562
01:34:44,418 --> 01:34:46,420
FOR MEDICAL RESEARCHERS 

2563
01:34:46,420 --> 01:34:49,222
THEMSELVES AND IN PART IT IS 

2564
01:34:49,222 --> 01:34:50,824
BECAUSE MEDICAL RESEARCH AT THIS

2565
01:34:50,824 --> 01:34:53,527
TIME WAS ASSOCIATED WITH 

2566
01:34:53,527 --> 01:34:55,529
VOLUNTEERS AND IT WAS A 

2567
01:34:55,529 --> 01:34:55,929
VOLUNTARY ACTION. 

2568
01:34:55,929 --> 01:34:59,466
THERE WAS ACTUALLY A SOCIETY 

2569
01:34:59,466 --> 01:35:02,202
CREATED FOR BOTH THESE HUMAN 

2570
01:35:02,202 --> 01:35:04,604
GUINEA PIGS IN WHICH THEY WERE 

2571
01:35:04,604 --> 01:35:07,074
HONORED FOR WILLINGNESS TO RISK 

2572
01:35:07,074 --> 01:35:09,009
WELFARE AND LIVES TO ADVANCE 

2573
01:35:09,009 --> 01:35:09,409
MEDICAL RESEARCH. 

2574
01:35:09,409 --> 01:35:12,279
THERE WAS ALSO A LONG TRADITION 

2575
01:35:12,279 --> 01:35:14,181
OF SELF-EXPERIMENTATION THAT 

2576
01:35:14,181 --> 01:35:16,116
MANY PEOPLE IN THE PUBLIC AND I 

2577
01:35:16,116 --> 01:35:18,452
THINK SOME RESEARCHERS SAW IT AS

2578
01:35:18,452 --> 01:35:21,488
KIND OF THE GOLD STANDARD AND IF

2579
01:35:21,488 --> 01:35:23,290
INVESTIGATOR WILLING TO RISK HIS

2580
01:35:23,290 --> 01:35:26,193
OR HER OWN BODY, IT -- THEN, YOU

2581
01:35:26,193 --> 01:35:27,928
KNOW, THAT WAS A TEST HOW MUCH 

2582
01:35:27,928 --> 01:35:30,530
THEY WERE INVESTED IN IT AND 

2583
01:35:30,530 --> 01:35:32,332
TODAY, OF COURSE, 

2584
01:35:32,332 --> 01:35:32,933
SELF-EXPERIMENTATION IS NOT 

2585
01:35:32,933 --> 01:35:34,634
RECOMMENDED AND I'M SURE YOU 

2586
01:35:34,634 --> 01:35:37,104
WILL HEAR MORE ABOUT THAT IN THE

2587
01:35:37,104 --> 01:35:38,071
REST OF THE COURSE. 

2588
01:35:38,071 --> 01:35:41,174
I ALSO WILL SAY THAT 1950S, 

2589
01:35:41,174 --> 01:35:43,477
THERE HAD BEEN SO MANY GREAT 

2590
01:35:43,477 --> 01:35:47,147
ADVANCES IN MEDICINE ASSOCIATED 

2591
01:35:47,147 --> 01:35:49,683
WITH WAR TIME EXPERIENCE AND 

2592
01:35:49,683 --> 01:35:52,119
PRIMARILY WITH THINGS LIKE 

2593
01:35:52,119 --> 01:35:53,787
ANTIBIOTICS AND IMPORTANCE OF 

2594
01:35:53,787 --> 01:35:55,088
BLOOD TRANSFUSION AND PEOPLE 

2595
01:35:55,088 --> 01:35:58,325
WERE CONFIDENT THAT ONLY GREAT 

2596
01:35:58,325 --> 01:36:00,360
THINGS WERE ALSO TO COME. 

2597
01:36:00,360 --> 01:36:04,030
IN PART IT IS IMPORTANT TO KEEP 

2598
01:36:04,030 --> 01:36:05,932
IN MIND THE SOCIAL RESPONSE TO 

2599
01:36:05,932 --> 01:36:07,501
RESEARCH AND RESEARCH TRAGEDY 

2600
01:36:07,501 --> 01:36:09,402
THAT WAS VERY DIFFERENT THAN IT 

2601
01:36:09,402 --> 01:36:11,605
WOULD BE ONLY A DECADE LATER AND

2602
01:36:11,605 --> 01:36:13,440
I HAVE ALWAYS BEEN SURPRISED 

2603
01:36:13,440 --> 01:36:14,908
WHEN I FOUND THIS ARTICLE THAT 

2604
01:36:14,908 --> 01:36:18,745
IS FOR THE NEW YORK TIMES AS YOU

2605
01:36:18,745 --> 01:36:21,615
CAN SEE IT IS REPORTING DEATH IN

2606
01:36:21,615 --> 01:36:24,017
RESEARCH OF 18 YEAR OLD FRESHMAN

2607
01:36:24,017 --> 01:36:26,052
AT SEATTLE UNIVERSITY THAT WAS 

2608
01:36:26,052 --> 01:36:28,955
-- HE HAD VOLUNTEERED TO TAKE 

2609
01:36:28,955 --> 01:36:33,693
PART IN A BLOOD SUBSTITUTE STUDY

2610
01:36:33,693 --> 01:36:34,327
AND DIED. 

2611
01:36:34,327 --> 01:36:35,695
HIS FATHER WAS ASKED BY 

2612
01:36:35,695 --> 01:36:39,099
REPORTERS WAS HE GOING TO SUE 

2613
01:36:39,099 --> 01:36:41,401
UNIVERSITY OR SUE AUTHORITIES?  

2614
01:36:41,401 --> 01:36:43,537
HIS FATHER SAID, OF COURSE NOT. 

2615
01:36:43,537 --> 01:36:45,906
THIS WAS A PROJECT THAT WAS 

2616
01:36:45,906 --> 01:36:47,174
INTENDED TO ADVANCE MEDICAL 

2617
01:36:47,174 --> 01:36:49,609
KNOWLEDGE AND HE WAS GOING TO 

2618
01:36:49,609 --> 01:36:54,648
TREASURE HIS SON'S, YOU KNOW, 

2619
01:36:54,648 --> 01:36:56,349
HEROIC PARTICIPATION IN SUCH A 

2620
01:36:56,349 --> 01:36:58,451
STUDY AND IMAGINE IT COULD BE A 

2621
01:36:58,451 --> 01:37:00,353
VERY DIFFERENT RESPONSE TODAY IF

2622
01:37:00,353 --> 01:37:04,357
A FRESHMAN DIED IN A RESEARCH 

2623
01:37:04,357 --> 01:37:04,624
PROJECT. 

2624
01:37:04,624 --> 01:37:05,892
NEXT SLIDE. 

2625
01:37:05,892 --> 01:37:07,427
THAT MAY ALSO EXPLAIN 

2626
01:37:07,427 --> 01:37:09,563
WILLINGNESS TO HAVE LARGE 

2627
01:37:09,563 --> 01:37:10,897
NUMBERS OF CHILDREN PARTICIPATE 

2628
01:37:10,897 --> 01:37:13,400
IN TRIALS OF THE NEW POLIO 

2629
01:37:13,400 --> 01:37:14,668
VACCINE IN 1954. 

2630
01:37:14,668 --> 01:37:18,538
I WILL REMIND YOU THAT POLIO 

2631
01:37:18,538 --> 01:37:22,542
REVERSED THE USUAL TREND OF 

2632
01:37:22,542 --> 01:37:24,945
INFECTIOUS DISEASE DEATH IN 19TH

2633
01:37:24,945 --> 01:37:28,882
AND 20TH CENTURY AND EPIDEMIC 

2634
01:37:28,882 --> 01:37:29,816
POLIO GOT WORSE TERRIFIED 

2635
01:37:29,816 --> 01:37:32,352
AMERICAN PARENTS AND CHILDREN 

2636
01:37:32,352 --> 01:37:35,822
AND 1952 WAS WORST POLIO 

2637
01:37:35,822 --> 01:37:38,992
EPIDEMIC ON RECORD AND TWO YEARS

2638
01:37:38,992 --> 01:37:41,094
LATER JONAS SAL K DEVELOPED WITH

2639
01:37:41,094 --> 01:37:44,364
FUNDING FROM NATIONAL FOUNDATION

2640
01:37:44,364 --> 01:37:48,168
FOR INFITILE PARALYSIS AND A 

2641
01:37:48,168 --> 01:37:49,870
VACCINE AND 2000 AMERICAN 

2642
01:37:49,870 --> 01:37:51,371
CHILDREN PARTICIPATED IN TRIALS 

2643
01:37:51,371 --> 01:37:53,673
OF THE VACCINE AND YOU SEE A 

2644
01:37:53,673 --> 01:37:57,611
PICTURE OF THOSE POLIO PIONEERS.

2645
01:37:57,611 --> 01:37:58,178
NEXT SLIDE. 

2646
01:37:58,178 --> 01:38:00,380
HERE YOU SEE IT IS NOT AN 

2647
01:38:00,380 --> 01:38:01,548
INFORMED CONSENT FORM. 

2648
01:38:01,548 --> 01:38:04,317
IT IS ACTUALLY A PARENTAL 

2649
01:38:04,317 --> 01:38:06,519
REQUEST FORM FOR A CHILD TO 

2650
01:38:06,519 --> 01:38:10,257
PARTICIPATE IN THIS 

2651
01:38:10,257 --> 01:38:11,258
POLIOMYELITIS VACCINATION FIELD 

2652
01:38:11,258 --> 01:38:12,292
TRIAL. 

2653
01:38:12,292 --> 01:38:16,229
IT REPRESENTS A SORT OF EARLY 

2654
01:38:16,229 --> 01:38:18,531
ATTEMPT TO AT LEAST IN SOME WAYS

2655
01:38:18,531 --> 01:38:21,801
NOT AS ADVANCED IN WALTER REED'S

2656
01:38:21,801 --> 01:38:23,837
EARLY 19 HUNDRED BUT EARLY 

2657
01:38:23,837 --> 01:38:25,272
ATTEMPT TO INFORM AT LEAST THE 

2658
01:38:25,272 --> 01:38:27,307
PARENT OF THE CHILD AND 

2659
01:38:27,307 --> 01:38:29,276
CONDITIONS OF PARTICIPATION AND 

2660
01:38:29,276 --> 01:38:32,312
RISKS INVOLVED AND OR THE PARENT

2661
01:38:32,312 --> 01:38:34,547
TO AUTHORIZE THEIR 

2662
01:38:34,547 --> 01:38:34,915
PARTICIPATION. 

2663
01:38:34,915 --> 01:38:38,318
OF COURSE IT LED TO SUCCESSFUL 

2664
01:38:38,318 --> 01:38:39,986
DEMONSTRATION OF AN EFFECTIVE 

2665
01:38:39,986 --> 01:38:46,192
AND MOSTLY SAFE VACCINE THAT -- 

2666
01:38:46,192 --> 01:38:47,527
THAT WAS RESPONSIBLE FOR THE 

2667
01:38:47,527 --> 01:38:48,962
ERADICATION OF POLIO IN THE 

2668
01:38:48,962 --> 01:38:49,863
UNITED STATES. 

2669
01:38:49,863 --> 01:38:51,364
AGAIN, SORT OF SOON THE WORLD 

2670
01:38:51,364 --> 01:38:55,035
AND AT LEAST THAT IS THE HOPE. 

2671
01:38:55,035 --> 01:38:56,102
NEXT ONE. 

2672
01:38:56,102 --> 01:38:59,205
NOW, FOR THE MEDICAL RESEARCH 

2673
01:38:59,205 --> 01:39:00,440
COMMUNITY, WHO ARE NOT UNAWARE 

2674
01:39:00,440 --> 01:39:04,344
OF SOME OF THE MORAL PROBLEMS OF

2675
01:39:04,344 --> 01:39:06,680
MEDICAL EXPERIMENTATION IN THIS 

2676
01:39:06,680 --> 01:39:07,480
PERIOD. 

2677
01:39:07,480 --> 01:39:10,850
THEY WERE CONCERNED THAT THE 

2678
01:39:10,850 --> 01:39:12,552
NUREMBERG CODE REPRESENTED 2 -- 

2679
01:39:12,552 --> 01:39:18,558
IT WAS UNWORKABLE GUIDE FOR 

2680
01:39:18,558 --> 01:39:20,927
THEIR MEDICAL RESEARCH AND WOULD

2681
01:39:20,927 --> 01:39:23,463
NOT ALLOW EXPERIMENTS ON 

2682
01:39:23,463 --> 01:39:25,332
CHILDREN OR ALLOW EXPERIMENTS ON

2683
01:39:25,332 --> 01:39:27,434
PEOPLE THAT ARE INSTITUTIONIZED 

2684
01:39:27,434 --> 01:39:31,304
AND DYING AND MENTALLY ILL. 

2685
01:39:31,304 --> 01:39:33,506
THERE ARE EFFORTS I'M MOST 

2686
01:39:33,506 --> 01:39:36,343
FAMILIAR WITH EFFORTS OF WORLD 

2687
01:39:36,343 --> 01:39:38,244
MEDICAL ASSOCIATION THAT DR. 

2688
01:39:38,244 --> 01:39:39,779
GRADY ALREADY REFERRED TO AND 10

2689
01:39:39,779 --> 01:39:43,984
YEAR EFFORT FROM 1954 TO 1964 TO

2690
01:39:43,984 --> 01:39:46,486
CREATE A WORKABLE CODE OF ETHICS

2691
01:39:46,486 --> 01:39:48,021
THAT, AGAIN, IS THE CHALLENGE 

2692
01:39:48,021 --> 01:39:51,324
THAT IS A PERENNIAL ONE AND HOW 

2693
01:39:51,324 --> 01:39:53,426
YOU PROTECT HUMAN SUBJECTS AND 

2694
01:39:53,426 --> 01:39:55,195
AT SAME TIME ENABLE MEDICAL R- 

2695
01:39:55,195 --> 01:39:58,698
HE SEARCH TO ADVANCE FROM WHICH 

2696
01:39:58,698 --> 01:40:00,367
PRESUMABLY ALL WOULD BENEFIT. 

2697
01:40:00,367 --> 01:40:03,536
SO IT WAS LARGELY THE COMMITTEE 

2698
01:40:03,536 --> 01:40:08,341
ON ETHICS OF THE WMA AND ITS 

2699
01:40:08,341 --> 01:40:11,478
AMERICAN REPRESENTATIVES AND 

2700
01:40:11,478 --> 01:40:12,545
FRENCH REPRESENTATIVES AND 

2701
01:40:12,545 --> 01:40:14,014
BRITISH REPRESENTATIVES WHO 

2702
01:40:14,014 --> 01:40:17,050
STRUGGLED OVER WHAT WOULD BE AN 

2703
01:40:17,050 --> 01:40:18,118
EFFECTIVE SET OF RECOMMENDATIONS

2704
01:40:18,118 --> 01:40:22,088
FOR CLINICAL RESEARCHERS. 

2705
01:40:22,088 --> 01:40:23,256
NEXT SLIDE. 

2706
01:40:23,256 --> 01:40:25,025
WELL THIS CULMINATED AND YOU 

2707
01:40:25,025 --> 01:40:29,262
HEARD IN THE 1964 DECLARATION OF

2708
01:40:29,262 --> 01:40:31,398
HELSINKI IN WHICH POSITIONS FROM

2709
01:40:31,398 --> 01:40:34,067
ALL OVER THE WORLD UNANIMOUSLY 

2710
01:40:34,067 --> 01:40:36,302
RECOMMENDED A NOT A CODE OF 

2711
01:40:36,302 --> 01:40:39,172
ETHICS BUT RECOMMENDATIONS THAT 

2712
01:40:39,172 --> 01:40:45,645
WERE GUIDING CLINICAL RESEARCH. 

2713
01:40:45,645 --> 01:40:47,147
NEXT SLIDE. 

2714
01:40:47,147 --> 01:40:49,616
THIS REFERS TO ORIGINAL 

2715
01:40:49,616 --> 01:40:53,620
DECLARATION OF HELSINKI IN 1964.

2716
01:40:53,620 --> 01:40:56,322
YOU KNOW IT UNDERGONE 

2717
01:40:56,322 --> 01:40:57,424
SIGNIFICANT REVISIONS AND 

2718
01:40:57,424 --> 01:40:59,559
PERHAPS IS ONE UNDER HAPPENING 

2719
01:40:59,559 --> 01:41:01,728
EVEN AS WE SPEAK AND WHAT 

2720
01:41:01,728 --> 01:41:02,629
PERHAPS IS MOST IMPORTANT 

2721
01:41:02,629 --> 01:41:04,097
DIFFERENCE FOR RESEARCHERS FROM 

2722
01:41:04,097 --> 01:41:07,400
THE EARLY NUREMBERG CODE IS IT 

2723
01:41:07,400 --> 01:41:13,606
PERMITTED PROXY CONSENT.  

2724
01:41:13,606 --> 01:41:16,342
IT -- SO, FOR EXAMPLE, CHILDREN 

2725
01:41:16,342 --> 01:41:18,445
COULD PARTICIPATE IN CHILDS IN A

2726
01:41:18,445 --> 01:41:23,016
NUMBER OF NEW VACCINES COMING 

2727
01:41:23,016 --> 01:41:25,285
ONLINE THAT PRISONER POPULATIONS

2728
01:41:25,285 --> 01:41:27,921
COULD PARTICIPATE IN TRIALS OF 

2729
01:41:27,921 --> 01:41:28,354
NEW DRUGS. 

2730
01:41:28,354 --> 01:41:29,956
THERE IS AN EXPLOSION IN THE 

2731
01:41:29,956 --> 01:41:31,758
NUMBER OF DRUGS THAT BECOME 

2732
01:41:31,758 --> 01:41:35,161
AVAILABLE IN THE 1950S, 60S AND 

2733
01:41:35,161 --> 01:41:37,797
70S AND WILL REMIND YOU PRISONER

2734
01:41:37,797 --> 01:41:38,898
EXPERIMENTATION WAS NOT 

2735
01:41:38,898 --> 01:41:42,068
PERMITTED IN COUNTRIES LIKE THE 

2736
01:41:42,068 --> 01:41:42,335
UK. 

2737
01:41:42,335 --> 01:41:44,471
AND FRANCE AND IN THE UNITED 

2738
01:41:44,471 --> 01:41:46,573
STATES EVERY MAJOR 

2739
01:41:46,573 --> 01:41:48,908
PHARMACEUTICAL COMPANY HAD A 

2740
01:41:48,908 --> 01:41:51,611
MAJOR PRISON WARD FACILITY FOR 

2741
01:41:51,611 --> 01:41:55,882
TESTING NEW DRUGS AND OTHER 

2742
01:41:55,882 --> 01:41:56,249
INTERVENTIONS. 

2743
01:41:56,249 --> 01:41:56,850
NEXT SLIDE. 

2744
01:41:56,850 --> 01:41:59,652
THIS IS JUST TO SHOW SORT OF, 

2745
01:41:59,652 --> 01:42:03,890
AGAIN, SORT OF RESEARCH AND 

2746
01:42:03,890 --> 01:42:04,891
RESEARCH ETHICS. 

2747
01:42:04,891 --> 01:42:07,427
ARE, YOU KNOW, ARE NOT STAGNANT 

2748
01:42:07,427 --> 01:42:08,928
AND CHANGE OVER TIME AND BOTH 

2749
01:42:08,928 --> 01:42:10,697
WAY THAT RESEARCH IS CONDUCTED 

2750
01:42:10,697 --> 01:42:12,365
AND HOW IT IS UNDERSTOOD AND 

2751
01:42:12,365 --> 01:42:16,369
CONTEXT IN WHICH IT IS BEING 

2752
01:42:16,369 --> 01:42:19,172
EXPERIENCED AS WELL AS SORT OF 

2753
01:42:19,172 --> 01:42:21,841
CHALLENGES AND ETHICAL 

2754
01:42:21,841 --> 01:42:23,943
CHALLENGES THAT CON FRONT US. 

2755
01:42:23,943 --> 01:42:25,011
NEXT SLIDE. 

2756
01:42:25,011 --> 01:42:27,347
SO THAT IS BEING DONE ON THE 

2757
01:42:27,347 --> 01:42:29,115
INTERNATIONAL LEVEL. 

2758
01:42:29,115 --> 01:42:30,950
BACK IN THE UNITED STATES, I -- 

2759
01:42:30,950 --> 01:42:35,355
I WANT TO RETURN NOW TO THE -- 

2760
01:42:35,355 --> 01:42:37,223
TO THE UNITED STATES AND ITS 

2761
01:42:37,223 --> 01:42:39,626
RESPONSE TO SCANDAL AND TRAGEDY 

2762
01:42:39,626 --> 01:42:42,128
AND WHAT WILL PRECIPITATE 

2763
01:42:42,128 --> 01:42:45,331
NATIONAL RESEARCH ACT IN 1974. 

2764
01:42:45,331 --> 01:42:46,499
NEXT SLIDE. 

2765
01:42:46,499 --> 01:42:48,168
WELL, AS I HAVE ALREADY 

2766
01:42:48,168 --> 01:42:51,571
INDICATED BY 1960S, THERE IS NO 

2767
01:42:51,571 --> 01:42:53,873
LONGER SORT OF FAITH IN MEDICAL 

2768
01:42:53,873 --> 01:42:56,276
RESEARCH ENTERPRISE AND IS A 

2769
01:42:56,276 --> 01:42:57,911
TIME OF CHALLENGE TO ALL 

2770
01:42:57,911 --> 01:43:01,281
INSTITUTIONS AND PHYSICIANS ARE 

2771
01:43:01,281 --> 01:43:03,383
NO EXCEPTION AND TWO THINGS 

2772
01:43:03,383 --> 01:43:06,819
LARGELY ARE RESPONSIBLE FOR 

2773
01:43:06,819 --> 01:43:09,923
PROPELLING CONGRESS TO ACT IS 

2774
01:43:09,923 --> 01:43:13,860
ONE IS RELEASE OF HENRY BEECHERS

2775
01:43:13,860 --> 01:43:16,362
BOMB SHELL ARTICLE IN NEW 

2776
01:43:16,362 --> 01:43:18,565
ENGLAND JOURNAL OF MEDICINE AND 

2777
01:43:18,565 --> 01:43:20,466
WHAT REPRESENTS TIPPING POINT 

2778
01:43:20,466 --> 01:43:24,537
REVELATION IN 1972 OF 4 YEAR 

2779
01:43:24,537 --> 01:43:35,148
STUDY OF UN -- CIVIL US -- HE WA

2780
01:43:36,416 --> 01:43:40,153
PROFESSOR OF A- NTHESIA RESEARCH

2781
01:43:40,153 --> 01:43:41,287
HARVARD MEDICAL SCHOOL AND WOULD

2782
01:43:41,287 --> 01:43:44,791
GO ON IN OTHER ARENAS AS 

2783
01:43:44,791 --> 01:43:46,960
CONVENER AS HARVARD AD HOC 

2784
01:43:46,960 --> 01:43:48,294
COMMITTEE ON BRAIN DEATH AND 

2785
01:43:48,294 --> 01:43:51,097
NEXT SLIDE IN 1966 HE PUBLISHED 

2786
01:43:51,097 --> 01:43:52,398
THIS ARTICLE THAT I ENCOURAGE 

2787
01:43:52,398 --> 01:43:58,438
YOU TO READ AND IS VERY SHORT 

2788
01:43:58,438 --> 01:44:02,242
THIS ARTICLE ETHICS IN CLINICAL 

2789
01:44:02,242 --> 01:44:03,543
RESEARCH NEXT SLIDE, PLEASE 

2790
01:44:03,543 --> 01:44:05,278
DISCUSSES WITHOUT NAMING NAMES 

2791
01:44:05,278 --> 01:44:08,348
OR NAMING JOURNALS TALKED ABOUT 

2792
01:44:08,348 --> 01:44:11,050
22 EXAMPLES WHAT HE CALLED 

2793
01:44:11,050 --> 01:44:12,218
QUESTIONABLE RESEARCH PRACTICES 

2794
01:44:12,218 --> 01:44:13,353
THAT WERE QUESTIONABLE IN THAT 

2795
01:44:13,353 --> 01:44:16,356
THEY WERE IN SO FAR AS THEY WERE

2796
01:44:16,356 --> 01:44:17,290
BEING CONDUCTED WITHOUT CONCERN 

2797
01:44:17,290 --> 01:44:19,692
FOR SAFETY AND WELFARE OF 

2798
01:44:19,692 --> 01:44:21,928
PARTICIPANTS AND OVERRIDING 

2799
01:44:21,928 --> 01:44:23,930
POINT THAT BEECHER WANTED TO 

2800
01:44:23,930 --> 01:44:27,166
COMMUNICATE WAS THIS WASN'T SORT

2801
01:44:27,166 --> 01:44:30,169
OF FROM FRINGE OR RESEARCHERS 

2802
01:44:30,169 --> 01:44:35,441
BUT PEOPLE AT VERY  HEART OF THE

2803
01:44:35,441 --> 01:44:37,377
MEDICAL RESEARCH AT INPRIZES IN 

2804
01:44:37,377 --> 01:44:42,682
US MAJOR RESEARCHERS AND MAJOR 

2805
01:44:42,682 --> 01:44:43,249
INSTITUTIONS. 

2806
01:44:43,249 --> 01:44:46,719
ANOTHER POINT THAT BEECHER 

2807
01:44:46,719 --> 01:44:50,156
WANTED TO MAKE IS IT INVOLVED 

2808
01:44:50,156 --> 01:44:54,560
POPULATIONS THAT WOULD MEET MOST

2809
01:44:54,560 --> 01:44:56,062
PEOPLES DEFINITIONS OF 

2810
01:44:56,062 --> 01:44:59,766
VULNERABLE AND WHO WERE SUBLTS 

2811
01:44:59,766 --> 01:45:02,201
MENTALLY EFFECTIVE CHILDREN TERM

2812
01:45:02,201 --> 01:45:04,537
USED AT TIME AND JUVENILE 

2813
01:45:04,537 --> 01:45:08,441
DELINQUENTS ELDERLY SEENILE AND 

2814
01:45:08,441 --> 01:45:12,345
DEMENTED SOLDIERS IN ARMED 

2815
01:45:12,345 --> 01:45:15,381
FORCES CHARITY PATIENTS GROUP WE

2816
01:45:15,381 --> 01:45:17,183
DON'T OFTEN SEE ALCOHOLICS 

2817
01:45:17,183 --> 01:45:18,551
CHILDREN AND NEWBORNS AND 

2818
01:45:18,551 --> 01:45:24,557
PATIENT AS THE N ICHLT HIH CLIN 

2819
01:45:24,557 --> 01:45:27,727
CENTER AND 2 OF 22 EXAMPLES 

2820
01:45:27,727 --> 01:45:29,529
WOULD HAVE BEEN WELL-KNOWN TO 

2821
01:45:29,529 --> 01:45:33,533
READERS OF NEW YORK TIMES AND 

2822
01:45:33,533 --> 01:45:34,567
MAJOR NEWSPAPERS IN UNITED 

2823
01:45:34,567 --> 01:45:37,370
STATES AND IN 2016 WASN'T 

2824
01:45:37,370 --> 01:45:42,141
IDENTIFIED AS STUDIES OF 

2825
01:45:42,141 --> 01:45:43,843
HEPATITIS WILL OE BROOK STATE 

2826
01:45:43,843 --> 01:45:47,080
SCHOOL BUT NONETHELESS INVOLVED 

2827
01:45:47,080 --> 01:45:49,349
THEM.  WILL OE BROOK LARGE 

2828
01:45:49,349 --> 01:45:52,251
UNDERFUNDED INSTITUTION ON 

2829
01:45:52,251 --> 01:45:55,488
STATEN ISLAND INTENDED FOR 

2830
01:45:55,488 --> 01:45:58,091
MENTALLY EFFECTED CHILDREN AND 

2831
01:45:58,091 --> 01:46:04,364
TERRIBLE PLACE BY ALL -- BY ALL 

2832
01:46:04,364 --> 01:46:07,867
OBSERVERS AT INSTITUTION 

2833
01:46:07,867 --> 01:46:10,269
HEPATITIS WAS RIEF AND 

2834
01:46:10,269 --> 01:46:12,171
PEDIATRICIAN AT NYU PROPOSE 

2835
01:46:12,171 --> 01:46:14,407
TODAY USE NEWLY ADMITTED 

2836
01:46:14,407 --> 01:46:17,710
CHILDREN WITH PARENT'S CONSENT 

2837
01:46:17,710 --> 01:46:19,579
AND GIVE THEM HEPATITIS AND 

2838
01:46:19,579 --> 01:46:23,349
STUDY THEM IN SPECIAL WARD AT 

2839
01:46:23,349 --> 01:46:28,020
WILLOW BROOK TO UNDERSTAND 

2840
01:46:28,020 --> 01:46:38,564
NATURAL HISTORY OF HEPATITIS A. 

2841
01:46:39,766 --> 01:46:42,368
IDEA THAT TESTERS ARE USING 

2842
01:46:42,368 --> 01:46:44,337
VULNERABLE CHILDREN GIVING THEM 

2843
01:46:44,337 --> 01:46:54,881
DISEASE THAT DISTURBED MANY IDEA

2844
01:46:55,381 --> 01:46:59,819
IS WORKING TOWARDS EFFECTIVE 

2845
01:46:59,819 --> 01:47:01,921
VACCINE AND WORK TOWARDS SPREAD 

2846
01:47:01,921 --> 01:47:04,690
OF DISEASE AND THROUGHOUT CAREER

2847
01:47:04,690 --> 01:47:07,293
DEPENDED STUDIES AND MENTIONED 

2848
01:47:07,293 --> 01:47:08,795
PARENTAL CONSENT THAT IN SOME 

2849
01:47:08,795 --> 01:47:12,365
WAYS WAS SORT OF YOU KNOW HE WAS

2850
01:47:12,365 --> 01:47:16,335
IN VANGUARD. 

2851
01:47:16,335 --> 01:47:18,171
CRITICS EMPHASIZED GROUP CONSENT

2852
01:47:18,171 --> 01:47:19,672
BRINGING PARENTS TOGETHER AND 

2853
01:47:19,672 --> 01:47:22,442
TELLING ABOUT STUDY HAVING THEM 

2854
01:47:22,442 --> 01:47:24,177
SIGN A BRIEF FORM AND MANY 

2855
01:47:24,177 --> 01:47:27,947
PEOPLE HAVE FOUND THAT 

2856
01:47:27,947 --> 01:47:28,347
PROBLEMATIC. 

2857
01:47:28,347 --> 01:47:31,851
ALSO ISSUES ABOUT WITHHOLDING 

2858
01:47:31,851 --> 01:47:34,654
GAMMA GLOBULIN FROM INFECTED 

2859
01:47:34,654 --> 01:47:38,024
CHILDREN AND ESTABLISHING HAVING

2860
01:47:38,024 --> 01:47:38,991
A BENEFICIAL EFFECT. 

2861
01:47:38,991 --> 01:47:40,726
NEXT SLIDE. 

2862
01:47:40,726 --> 01:47:42,028
OTHER ONE THAT IS OR WOULD HAVE 

2863
01:47:42,028 --> 01:47:44,397
BEEN KNOWN TO READERS OF NEW 

2864
01:47:44,397 --> 01:47:47,834
YORK TIMES AND OTHER PAPER WAS 

2865
01:47:47,834 --> 01:47:50,736
EXPERIMENTS CONDUCTED AT JEWISH 

2866
01:47:50,736 --> 01:47:51,637
CONIC DISEASE HOSPITAL AND WHICH

2867
01:47:51,637 --> 01:47:54,273
THEY WERE INTERESTED IN STUDYING

2868
01:47:54,273 --> 01:47:56,843
WHAT LIVE CANCER CELLS DO IN 

2869
01:47:56,843 --> 01:48:00,346
BODIES OF ELDERLY PATIENTS 

2870
01:48:00,346 --> 01:48:02,782
FUNDED BY US PUBLIC HEALTH 

2871
01:48:02,782 --> 01:48:05,585
SERVICE AND AMERICAN CANCER 

2872
01:48:05,585 --> 01:48:07,420
SOCIETY AND DIDN'T GET CONSENT 

2873
01:48:07,420 --> 01:48:10,823
OF ELDER WILL I PEOPLE AND 

2874
01:48:10,823 --> 01:48:13,793
IDENTIFIED AT SEEN I'LL AND 

2875
01:48:13,793 --> 01:48:16,195
DEMENTED AND REASON BEING DIDN'T

2876
01:48:16,195 --> 01:48:18,264
WISH TO STIR UP UNNECESSARY ANG 

2877
01:48:18,264 --> 01:48:23,903
XI IT'S RTIES IN PATIENTS THAT 

2878
01:48:23,903 --> 01:48:25,872
HAD PHOBIAS OF CANCER AND 

2879
01:48:25,872 --> 01:48:27,139
CHESTER WAS PRINCIPLE 

2880
01:48:27,139 --> 01:48:30,543
INVESTIGATOR AT MEMORIAL SLOAN 

2881
01:48:30,543 --> 01:48:36,015
KETTERING AND DIDN'T DO HIS CASE

2882
01:48:36,015 --> 01:48:40,353
ANY FAVOR WHEN GAVE AN INTERVIEW

2883
01:48:40,353 --> 01:48:44,857
TO SCIENCE IN MAGAZINE OF AAAS 

2884
01:48:44,857 --> 01:48:47,894
AND REPORTER ASKED HIM WOULD HE 

2885
01:48:47,894 --> 01:48:49,595
EXPERIMENT ON HIMSELF WITH 

2886
01:48:49,595 --> 01:48:54,300
INJECTIONS OF LIVE CANCER CELLS?

2887
01:48:54,300 --> 01:48:59,705
I WON'T READ LIVE QUOTE AND HE 

2888
01:48:59,705 --> 01:49:00,339
SAID I WOULDN'T HAVE HESITATED 

2889
01:49:00,339 --> 01:49:02,475
IF SERVING A USEFUL PURPOSE AND 

2890
01:49:02,475 --> 01:49:04,343
GOES ON I DIDN'T REGARD 

2891
01:49:04,343 --> 01:49:06,379
EXPERIMENT AS DANGEROUS AND LAST

2892
01:49:06,379 --> 01:49:07,380
SENTENCE I WILL CALL YOUR 

2893
01:49:07,380 --> 01:49:09,582
ATTENTION TO AND FACING IT THERE

2894
01:49:09,582 --> 01:49:12,351
ARE RELATIVELY FEW SKILLED 

2895
01:49:12,351 --> 01:49:15,021
CANCER RESEARCHERS AND SEEMED 

2896
01:49:15,021 --> 01:49:17,256
STUPID TO TAKE THE LITTLE RISK 

2897
01:49:17,256 --> 01:49:20,359
AND DIDN'T WIN HIM FRIENDS AND 

2898
01:49:20,359 --> 01:49:20,760
ADMIRERS. 

2899
01:49:20,760 --> 01:49:21,894
NEXT SLIDE. 

2900
01:49:21,894 --> 01:49:25,731
AGAIN, PERHAPS THE SINGULAR AND 

2901
01:49:25,731 --> 01:49:27,433
MOST IMPORTANT MOMENT THAT WAS 

2902
01:49:27,433 --> 01:49:30,169
CAPPING MORE THAN A DECADE OF 

2903
01:49:30,169 --> 01:49:32,572
DISCUSSIONS ABOUT LEGISLATION TO

2904
01:49:32,572 --> 01:49:37,310
PROTECT HUMAN SUBJECTS WAS 

2905
01:49:37,310 --> 01:49:41,781
REVELATION OF TUSKEGEE CIVILIS 

2906
01:49:41,781 --> 01:49:52,191
STUDY JULY 25TH, 1972. 

2907
01:49:56,996 --> 01:49:59,565
STUDY BEGAN IN 1972 AND INTENDED

2908
01:49:59,565 --> 01:50:02,602
TO BE 6 MONTH STUDY AND WAS 

2909
01:50:02,602 --> 01:50:05,905
ENDED BY DEPARTMENT OF HEALTH 

2910
01:50:05,905 --> 01:50:07,773
AND EDUCATION WELFARE IN 1972 

2911
01:50:07,773 --> 01:50:12,078
AND SEEN BY PUBLIC HEALTH 

2912
01:50:12,078 --> 01:50:15,314
SERVICE SURGEON GENERAL THOMAS 

2913
01:50:15,314 --> 01:50:18,851
PERRIN AFTER 1936 TO 1948 AND 

2914
01:50:18,851 --> 01:50:22,121
PERRIN WAS A CRUSADER AGAINST 

2915
01:50:22,121 --> 01:50:25,224
SYPHILIS AND OTHER SEXUALLY 

2916
01:50:25,224 --> 01:50:28,027
TRANSMITTED DISEASES AND INTEND 

2917
01:50:28,027 --> 01:50:30,062
ON VANQUISHING THESE DISEASES 

2918
01:50:30,062 --> 01:50:32,298
FROM THE UNITED STATES AND SORT 

2919
01:50:32,298 --> 01:50:35,968
OF OPENLY DISCUSSING THE SORT OF

2920
01:50:35,968 --> 01:50:39,905
TOLL THAT THIS DISEASE EXERTED. 

2921
01:50:39,905 --> 01:50:41,741
NEXT SLIDE. 

2922
01:50:41,741 --> 01:50:44,343
SO IT TURNS OUT THAT THEY DID IT

2923
01:50:44,343 --> 01:50:48,347
-- A STUDY, SIX COUNTIES OF 

2924
01:50:48,347 --> 01:50:50,282
INCIDENTS OF SYPHILIS AND FOUND 

2925
01:50:50,282 --> 01:50:52,818
THAT THEY HAD AN EXTRAORDINARILY

2926
01:50:52,818 --> 01:50:54,453
HIGH INCIDENCE. 

2927
01:50:54,453 --> 01:50:57,490
IT WAS SELECTED BECAUSE THERE 

2928
01:50:57,490 --> 01:51:02,028
WAS A VETERAN'S HOSPITAL FOR 

2929
01:51:02,028 --> 01:51:04,430
AFRICAN AMERICAN SERVICEMAN IN 

2930
01:51:04,430 --> 01:51:06,298
TUSKEGEE AND INITIAL 6 MONTH 

2931
01:51:06,298 --> 01:51:10,336
STUDY AND FROM THE START IT 

2932
01:51:10,336 --> 01:51:12,204
INVOLVED DECEPTION OF 

2933
01:51:12,204 --> 01:51:14,240
PARTICIPANTS AND RAIFEN WHO 

2934
01:51:14,240 --> 01:51:17,009
PLAYED AN IMPORTANT ROLE IN THE 

2935
01:51:17,009 --> 01:51:18,010
STUDY WROTE LETTERS TO MEN 

2936
01:51:18,010 --> 01:51:20,613
OFFERING WHAT HE CALLED LAST 

2937
01:51:20,613 --> 01:51:21,981
CHANCE FOR SPECIAL FREE 

2938
01:51:21,981 --> 01:51:23,449
TREATMENT FOR THEIR BAD BLOOD 

2939
01:51:23,449 --> 01:51:26,719
AND TURNS OUT WHAT HE WAS 

2940
01:51:26,719 --> 01:51:37,263
OFFERING WAS LUMBAR PUNCTURE A 

2941
01:51:37,830 --> 01:51:38,431
COMPLETELY DIAGNOSTIC PROCEDURE 

2942
01:51:38,431 --> 01:51:40,166
AND NOTHING CURATIVE ABOUT IT. 

2943
01:51:40,166 --> 01:51:42,535
MEN FOUND IT VERY PAINFUL. 

2944
01:51:42,535 --> 01:51:44,236
ACTUALLY, ONE THING I THINK IS 

2945
01:51:44,236 --> 01:51:45,438
INTERESTING AND SUGGESTS THAT 

2946
01:51:45,438 --> 01:51:47,740
THERE IS EVEN SOME LIMITED 

2947
01:51:47,740 --> 01:51:49,809
AGENCY ON PART OF PARTICIPANTS 

2948
01:51:49,809 --> 01:51:52,578
IS THAT THEY -- IT WAS DONE ONE 

2949
01:51:52,578 --> 01:51:54,547
TIME ONLY BECAUSE RESEARCHERS 

2950
01:51:54,547 --> 01:51:57,016
REALIZED IF THEY WANTED TO DO 

2951
01:51:57,016 --> 01:52:00,286
MORE SPINAL PUNCTURES IN FUTURE 

2952
01:52:00,286 --> 01:52:03,089
RESEARCH POPULATION WOULD 

2953
01:52:03,089 --> 01:52:06,125
COMPLETELY ABSENT ITSELF FROM 

2954
01:52:06,125 --> 01:52:07,026
FURTHER PARTICIPATION. 

2955
01:52:07,026 --> 01:52:08,327
N SLIDE. 

2956
01:52:08,327 --> 01:52:11,263
IN SOME -- AT SOMETIMES TUSKEGEE

2957
01:52:11,263 --> 01:52:13,032
WAS TALKED ABOUT STUDY OF NATURE

2958
01:52:13,032 --> 01:52:15,000
AND WERE MEN WHO WERE VERY POOR 

2959
01:52:15,000 --> 01:52:16,235
AND DIDN'T HAVE MEDICAL CARE AND

2960
01:52:16,235 --> 01:52:20,339
WEREN'T GOING TO SEE A DOCTOR OR

2961
01:52:20,339 --> 01:52:22,475
GET TREATMENT. 

2962
01:52:22,475 --> 01:52:24,343
PUBLIC HEALTH SERVICE TOOK STEPS

2963
01:52:24,343 --> 01:52:25,811
TO ENSURE THEY WOULDN'T GET 

2964
01:52:25,811 --> 01:52:28,180
TREATMENT WHEN 254 OF MEN WERE 

2965
01:52:28,180 --> 01:52:30,583
CALLED UP FOR MILITARY SERVICE 

2966
01:52:30,583 --> 01:52:33,652
IN WORLD WAR II AND PUBLIC 

2967
01:52:33,652 --> 01:52:35,621
HEALTH SERVICE INTERVENED WITH 

2968
01:52:35,621 --> 01:52:37,389
DRAFT BOARD SAYING DON'T TAKE 

2969
01:52:37,389 --> 01:52:39,058
THESE MEN. 

2970
01:52:39,058 --> 01:52:41,093
WE -- THEY ARE IN OUR STUDY AND 

2971
01:52:41,093 --> 01:52:43,996
WE WANT TO FOLLOW UNTREATED 

2972
01:52:43,996 --> 01:52:45,698
SYPHILIS IF THEY HAD BEEN 

2973
01:52:45,698 --> 01:52:47,800
INDUCTED IF INTO THE ARMY OR 

2974
01:52:47,800 --> 01:52:51,337
HADN'T BEEN AND ONCE IDENTIFIED 

2975
01:52:51,337 --> 01:52:53,172
AS CIVILITYIC WOULD HAVE 

2976
01:52:53,172 --> 01:52:53,906
RECEIVED FREE TREATMENT FOR 

2977
01:52:53,906 --> 01:52:56,175
THEIR DISEASE FROM THE ARMY. 

2978
01:52:56,175 --> 01:52:58,244
NEXT SLIDE. 

2979
01:52:58,244 --> 01:53:02,148
CRUCIAL TO THE SUCCESS OF THE 

2980
01:53:02,148 --> 01:53:04,350
SOCIETY OF STUDY WAS NURSE 

2981
01:53:04,350 --> 01:53:06,519
RIVERS A TRAINED NURSE 

2982
01:53:06,519 --> 01:53:09,221
GRADUATING FROM TUSKEGEE 

2983
01:53:09,221 --> 01:53:12,358
UNIVERSITY CRUCIAL IN BRIDGING 

2984
01:53:12,358 --> 01:53:15,294
LARGE CULTURAL GAP BETWEEN 

2985
01:53:15,294 --> 01:53:16,896
UNLETTERED FARMERS AND PUBLIC 

2986
01:53:16,896 --> 01:53:19,565
HEALTH SERVICE RESEARCHERS WHO 

2987
01:53:19,565 --> 01:53:22,201
CAME AT IRREGULAR INTERVALS OVER

2988
01:53:22,201 --> 01:53:25,004
THE 40 YEARS. 

2989
01:53:25,004 --> 01:53:26,438
NEXT SLIDE. 

2990
01:53:26,438 --> 01:53:28,107
NURSE RIVERS FOR EXAMPLE GIVEN 

2991
01:53:28,107 --> 01:53:32,011
JOB OF OBTAINING PERMISSION FOR 

2992
01:53:32,011 --> 01:53:32,711
POST MORTEM PARTICIPATION AND 

2993
01:53:32,711 --> 01:53:34,013
INTERESTING TO ME THAT ONE THING

2994
01:53:34,013 --> 01:53:36,182
THEY ASKED THEM FOR WAS 

2995
01:53:36,182 --> 01:53:40,186
PERMISSION FOR AUTOPSY AND THEIR

2996
01:53:40,186 --> 01:53:40,452
FAMILIES. 

2997
01:53:40,452 --> 01:53:43,656
AND HER JOB BECAME EASIER WHEN 

2998
01:53:43,656 --> 01:53:46,325
MILL BECK FUND OFFERED BURIAL 

2999
01:53:46,325 --> 01:53:48,527
STIPEND $50 LATER RAISED TO 1 

3000
01:53:48,527 --> 01:53:50,896
HUNDRED DOLLARS AND REPORTED IN 

3001
01:53:50,896 --> 01:53:53,899
PUBLIC HEALTH REPORTS IN 1953 

3002
01:53:53,899 --> 01:53:57,102
ARTICLE HAD ONE REFUSAL IN 140 

3003
01:53:57,102 --> 01:53:57,870
REQUESTS. 

3004
01:53:57,870 --> 01:53:58,237
NEXT SLIDE. 

3005
01:53:58,237 --> 01:54:00,139
SO THE STUDY WAS NOT A SECRET 

3006
01:54:00,139 --> 01:54:03,309
AND WERE 13 PUBLICATIONS BETWEEN

3007
01:54:03,309 --> 01:54:05,644
1936 AND 1970 TO YOU ARE IN OPEN

3008
01:54:05,644 --> 01:54:09,181
MEDICAL LITERATURE AND IN 1954 

3009
01:54:09,181 --> 01:54:11,984
AFTER THINGS LIKE THE 

3010
01:54:11,984 --> 01:54:13,719
PUBLICATION IN SCIENCE AT 

3011
01:54:13,719 --> 01:54:14,954
NUREMBERG CODE THAT FOR FIRST 

3012
01:54:14,954 --> 01:54:17,990
TIME IN STUDY THEN WERE 

3013
01:54:17,990 --> 01:54:20,125
IDENTIFIED AS QUOTE VOLUNTEERS 

3014
01:54:20,125 --> 01:54:21,727
WITH SOCIAL INVENTIVES.

3015
01:54:21,727 --> 01:54:24,930
NEXT SLIDE IN AN EFFORT TO 

3016
01:54:24,930 --> 01:54:26,365
PROMOTE KIND OF THE KNOWLEDGE 

3017
01:54:26,365 --> 01:54:28,334
THAT THEY WERE IN A MEDICAL 

3018
01:54:28,334 --> 01:54:33,205
RESEARCH STUDY IN 1957, THE 

3019
01:54:33,205 --> 01:54:36,141
PUBLIC HEALTH SERVICE REWARDED 

3020
01:54:36,141 --> 01:54:39,345
MEN WITH A CERTIFICATE SIGNED BY

3021
01:54:39,345 --> 01:54:40,246
THE SURGEON GENERAL. 

3022
01:54:40,246 --> 01:54:42,314
EACH MAN IN THE STUDY RECEIVED A

3023
01:54:42,314 --> 01:54:44,583
DOLLAR FOR EVERY YEAR THEY HAD 

3024
01:54:44,583 --> 01:54:48,354
PARTICIPATED AND RECEIVED $25 

3025
01:54:48,354 --> 01:54:52,892
AND THIS CERTIFICATE THAT SAYS 

3026
01:54:52,892 --> 01:54:54,260
ACTIVE PARTICIPATION IN THE 

3027
01:54:54,260 --> 01:54:56,161
TUESDAY KEITHEE MEDICAL RESEARCH

3028
01:54:56,161 --> 01:54:57,963
STUDY THAT DIDN'T TRANSLATE 

3029
01:54:57,963 --> 01:54:59,331
NECESSARILY TO MEN WHO STILL MAY

3030
01:54:59,331 --> 01:55:01,667
NOT HAVE KNOWN THAT THEY WERE 

3031
01:55:01,667 --> 01:55:04,270
ACTIVELY PARTICIPATING IN 

3032
01:55:04,270 --> 01:55:06,505
MEDICAL RESEARCH. 

3033
01:55:06,505 --> 01:55:07,106
>> SUSAN. 

3034
01:55:07,106 --> 01:55:07,773
>> YES. 

3035
01:55:07,773 --> 01:55:08,774
>> WE ARE AT TIME. 

3036
01:55:08,774 --> 01:55:10,409
>> ALREADY.  OKAY.  

3037
01:55:10,409 --> 01:55:13,145
>> MAYBE YOU CAN FINISH UP
WITH 

3038
01:55:13,145 --> 01:55:15,814
TUS KEITHEE AND FOLKS INTERESTED

3039
01:55:15,814 --> 01:55:17,716
CAN LOOK AT GAUT MALA STUDY. 

3040
01:55:17,716 --> 01:55:21,220
>> I'M VERY SORRY AND
VIRTUALLY 

3041
01:55:21,220 --> 01:55:24,223
DONE WITH TUSKEGEE AND GOING TO 

3042
01:55:24,223 --> 01:55:26,358
SAY BLUE RIBBON PANEL BUT STUDY 

3043
01:55:26,358 --> 01:55:27,593
COULD I HAVE NEXT SLIDE UP. 

3044
01:55:27,593 --> 01:55:32,731
>> THAT IS UP 19691. 

3045
01:55:32,731 --> 01:55:35,534
>> NEXT SLIDE, PLEASE. 

3046
01:55:35,534 --> 01:55:38,137
1972 THAT STUDY IS REVEALED AND 

3047
01:55:38,137 --> 01:55:39,872
NEXT SLIDE. 

3048
01:55:39,872 --> 01:55:43,943
1974 THERE ARE HEARINGS AND 

3049
01:55:43,943 --> 01:55:47,546
PRESIDING BY SENATOR TED KENNEDY

3050
01:55:47,546 --> 01:55:49,214
AMONG OTHERS AND CREATION OF 

3051
01:55:49,214 --> 01:55:51,350
NATIONAL COMMISSION TO STUDY 

3052
01:55:51,350 --> 01:55:55,487
MORAL ISSUES POSED BY HUMAN 

3053
01:55:55,487 --> 01:55:58,624
EXPERIMENT

3054
01:55:58,624 --> 01:55:59,024
EXPERIMENTATION. 

3055
01:55:59,024 --> 01:56:00,359
THIS IS ORGANIZATION THAT 

3056
01:56:00,359 --> 01:56:01,827
SPONSORS PUBLICATION OF BELMONT 

3057
01:56:01,827 --> 01:56:03,929
REPORT THAT YOU HEARD SO MUCH 

3058
01:56:03,929 --> 01:56:04,663
ABOUT. 

3059
01:56:04,663 --> 01:56:06,632
OKAY.  WELL, I -- I'M SORRY. 

3060
01:56:06,632 --> 01:56:09,768
I THOUGHT I STILL HAD MORE TIME.

3061
01:56:09,768 --> 01:56:10,803
>> THAT SOW KAY. 

3062
01:56:10,803 --> 01:56:13,072
>> I APOLOGIZE FOR GOING
OVER 

3063
01:56:13,072 --> 01:56:13,272
TIME. 

3064
01:56:13,272 --> 01:56:14,807
>> IT IS QUITE ALL RIGHT. 

3065
01:56:14,807 --> 01:56:18,077
AND ONE OF THE THINGS I WILL SAY

3066
01:56:18,077 --> 01:56:20,379
IS THAT I CERTAINLY HOPE I 

3067
01:56:20,379 --> 01:56:23,215
WETTED YOUR APPETITE FOR AN 

3068
01:56:23,215 --> 01:56:26,585
INTEREST IN THE HISTORY OF HUMAN

3069
01:56:26,585 --> 01:56:30,155
EXPERIMENTATION AND IF YOU HAVE 

3070
01:56:30,155 --> 01:56:31,557
QUESTIONS OR YOU WOULD LIKE 

3071
01:56:31,557 --> 01:56:33,993
RECOMMENDATIONS FOR READING 

3072
01:56:33,993 --> 01:56:35,227
ABOUT THIS INTERESTING AND 

3073
01:56:35,227 --> 01:56:38,630
COMPELLING HISTORY, I WELCOME 

3074
01:56:38,630 --> 01:56:40,933
YOU, E-MAIL FROM YOU IF THAT 

3075
01:56:40,933 --> 01:56:42,801
WOULD BE DESIRABLE. 

3076
01:56:42,801 --> 01:56:43,335
>> TERRIFIC. 

3077
01:56:43,335 --> 01:56:46,205
>> THANK YOU SO MUCH,
SUSAN. 

3078
01:56:46,205 --> 01:56:48,007
ROUND OF APPLAUSE FROM MOST THAT

3079
01:56:48,007 --> 01:56:50,342
ARE HERE AND WE NOW GET TO SEE 

3080
01:56:50,342 --> 01:56:51,477
YOU, WHICH IS LOVELY. 

3081
01:56:51,477 --> 01:56:52,144
>> OKAY. 

3082
01:56:52,144 --> 01:56:54,980
>> WE HAVE FOLKS HERE IN
THE 

3083
01:56:54,980 --> 01:56:56,215
AUDITORIUM WHO MAY HAVE 

3084
01:56:56,215 --> 01:56:57,950
QUESTIONS AND I'M GOING TO SEND 

3085
01:56:57,950 --> 01:57:01,920
THEM TO THE MICS. 

3086
01:57:01,920 --> 01:57:02,421
>> OKAY.  

3087
01:57:02,421 --> 01:57:04,356
>> I WILL CHECK THE
DISCUSSION 

3088
01:57:04,356 --> 01:57:06,158
BOARD TO SEE IF WE HAVE 

3089
01:57:06,158 --> 01:57:08,160
QUESTIONS FROM THOSE WHO ARE 

3090
01:57:08,160 --> 01:57:08,460
LOGGING IN. 

3091
01:57:08,460 --> 01:57:10,829
WE HAVE BRIT ANY WITH A 

3092
01:57:10,829 --> 01:57:11,530
QUESTION. 

3093
01:57:11,530 --> 01:57:12,398
A HISTTO RIAN. 

3094
01:57:12,398 --> 01:57:16,001
>> I'M BRITTNEY AND
HISTORIAN IN

3095
01:57:16,001 --> 01:57:16,835
BIOETHICS, BRAND NEW. 

3096
01:57:16,835 --> 01:57:17,770
>> YES. 

3097
01:57:17,770 --> 01:57:21,840
>> I WAS WONDERING ABOUT 

3098
01:57:21,840 --> 01:57:23,809
IMPLICATIONS OF TUSKEGEE BEYOND 

3099
01:57:23,809 --> 01:57:25,244
PARTICIPANTS IF NOT INFORMED OF 

3100
01:57:25,244 --> 01:57:26,912
THEIR SYPHILIS STATUS AND PEOPLE

3101
01:57:26,912 --> 01:57:29,415
WHOM THEY WERE HAVING RELATIONS 

3102
01:57:29,415 --> 01:57:31,316
MIGHT HAVE ALSO BEEN EFFECTED BY

3103
01:57:31,316 --> 01:57:32,684
THEIR LACK OF TREATMENT AND WHAT

3104
01:57:32,684 --> 01:57:34,753
KIND OF CONSIDERATIONS WERE PUT 

3105
01:57:34,753 --> 01:57:36,388
IN PLACE FOR THOSE PEOPLE WHO 

3106
01:57:36,388 --> 01:57:38,791
WEREN'T ENROLLED IN THE STUDY. 

3107
01:57:38,791 --> 01:57:41,627
>> WELL, THAT IS A VERY 

3108
01:57:41,627 --> 01:57:44,363
INTERESTING AND IMPORTANT 

3109
01:57:44,363 --> 01:57:46,065
QUESTION. 

3110
01:57:46,065 --> 01:57:50,169
THE ASSUMPTION OF THE 

3111
01:57:50,169 --> 01:57:52,171
INVESTIGATORS WAS THAT -- THESE 

3112
01:57:52,171 --> 01:57:54,173
WERE PEOPLE WHOSE CIVILITYIC 

3113
01:57:54,173 --> 01:57:56,341
INFECTION AND MEN IN THE STUDY 

3114
01:57:56,341 --> 01:57:58,477
AND CIVILITYIC INFECTION WAS AT 

3115
01:57:58,477 --> 01:58:00,646
LEAST OF FIVE YEARS AND THEY 

3116
01:58:00,646 --> 01:58:04,349
WERE BELIEVED TO HAVE -- BE NO 

3117
01:58:04,349 --> 01:58:05,250
LONGER INFECTIOUS. 

3118
01:58:05,250 --> 01:58:08,620
THE WHOLE -- THE WHOLE 

3119
01:58:08,620 --> 01:58:10,622
UNDERSTANDING OF HOW AND WHY AND

3120
01:58:10,622 --> 01:58:12,391
UNDER WHAT CIRCUMSTANCES YOU 

3121
01:58:12,391 --> 01:58:15,861
COULD GET SUPER INFECTED OR 

3122
01:58:15,861 --> 01:58:18,697
REINFECTED IS MURKY AND NOT 

3123
01:58:18,697 --> 01:58:19,731
DISCUSSED AND DON'T BELIEVE 

3124
01:58:19,731 --> 01:58:21,800
THERE WAS ANY -- THERE WERE ANY 

3125
01:58:21,800 --> 01:58:27,072
PLANS, YOU KNOW, TO PROTECT, YOU

3126
01:58:27,072 --> 01:58:28,307
KNOW, PARTNERS AND CHILDREN. 

3127
01:58:28,307 --> 01:58:30,008
CERTAINLY AS WE KNOW, I MEAN, 

3128
01:58:30,008 --> 01:58:31,844
WHAT IS HAPPENING TODAY, THERE 

3129
01:58:31,844 --> 01:58:36,348
HAS BEEN TREMENDOUS INCREASE IN 

3130
01:58:36,348 --> 01:58:38,484
CONGENITAL SYPHILIS FOR EXAMPLE 

3131
01:58:38,484 --> 01:58:39,718
AS THE DISEASE HAS BECOME SORT 

3132
01:58:39,718 --> 01:58:42,287
OF -- HAS BECOME MORE 

3133
01:58:42,287 --> 01:58:42,821
WIDESPREAD. 

3134
01:58:42,821 --> 01:58:44,356
IT IS AN EXCELLENT QUESTION. 

3135
01:58:44,356 --> 01:58:46,325
IT DOES NOT SEEM TO BE SOMETHING

3136
01:58:46,325 --> 01:58:48,727
THAT WAS ON THE AGENDA AND OF 

3137
01:58:48,727 --> 01:58:51,530
THE PUBLIC HEALTH SERVICE AND 

3138
01:58:51,530 --> 01:58:52,431
FRANKLY I DON'T SEE MUCH 

3139
01:58:52,431 --> 01:58:54,366
DISCUSSION ABOUT IT, YOU KNOW, 

3140
01:58:54,366 --> 01:58:56,668
IN THE 1970S. 

3141
01:58:56,668 --> 01:59:00,973
>> THANK YOU.  I'M
WONDERING AND

3142
01:59:00,973 --> 01:59:02,841
DON'T SEE ANYONE RUNNING TO THE 

3143
01:59:02,841 --> 01:59:04,576
MICROPHONE AND WOULD LOVE TO 

3144
01:59:04,576 --> 01:59:06,011
GIVE YOU AN OPPORTUNITY TO TELL 

3145
01:59:06,011 --> 01:59:10,048
US ABOUT THE -- AT LEAST THE 

3146
01:59:10,048 --> 01:59:13,418
LEGACY OF THE TUSKEGEE STUDY 

3147
01:59:13,418 --> 01:59:15,654
THROUGH THE CLINTON 

3148
01:59:15,654 --> 01:59:16,021
ADMINISTRATION. 

3149
01:59:16,021 --> 01:59:18,557
>> SURE.  WHAT I WAS GOING
TO 

3150
01:59:18,557 --> 01:59:22,628
SAY IS THAT SO IN -- IN A STUDY 

3151
01:59:22,628 --> 01:59:25,130
FORMALLY ENDS, IN 1973, IT DOES 

3152
01:59:25,130 --> 01:59:29,168
HAVE THIS IMPACT ON THE -- YOU 

3153
01:59:29,168 --> 01:59:32,905
KNOW, ON NATIONAL RESEARCH ACT. 

3154
01:59:32,905 --> 01:59:36,775
I THINK THAT THERE REMAIN, YOU 

3155
01:59:36,775 --> 01:59:40,012
KNOW, DIFFERENT AUDIENCES FOR 

3156
01:59:40,012 --> 01:59:42,548
TUSKEGEE SYPHILIS STUDY AND IN 

3157
01:59:42,548 --> 01:59:43,882
AFRICAN AMERICAN COMMUNITY I 

3158
01:59:43,882 --> 01:59:45,450
THINK THERE WAS MUCH GREATER 

3159
01:59:45,450 --> 01:59:48,086
SORT OF KNOWLEDGE ABOUT THE 

3160
01:59:48,086 --> 01:59:50,355
STUDY AND AT LEAST -- AT LEAST 

3161
01:59:50,355 --> 01:59:52,724
IN SOME CASES A BELIEF THAT THE 

3162
01:59:52,724 --> 01:59:55,327
MEN IN THE STUDY WERE ACTUALLY 

3163
01:59:55,327 --> 01:59:57,696
INFECTED THAT I THINK IS NOT THE

3164
01:59:57,696 --> 01:59:59,364
CASE BUT NEVERTHELESS, I THINK 

3165
01:59:59,364 --> 02:00:00,799
THERE ARE GOOD REASONS TO 

3166
02:00:00,799 --> 02:00:01,967
BELIEVE THAT THERE WERE. 

3167
02:00:01,967 --> 02:00:05,337
I THIS I IT CAME AS -- WHAT SORT

3168
02:00:05,337 --> 02:00:07,306
OF THE WHITE MEDICAL 

3169
02:00:07,306 --> 02:00:08,240
ESTABLISHMENT THAT CAME AS A 

3170
02:00:08,240 --> 02:00:12,711
HUGE SHOCK WAS IN 1992, SORT OF 

3171
02:00:12,711 --> 02:00:15,214
IN THE MIDST OF, YOU KNOW, THE 

3172
02:00:15,214 --> 02:00:19,084
AIDS EPIDEMIC AND WAS 

3173
02:00:19,084 --> 02:00:19,418
RECOGNITION. 

3174
02:00:19,418 --> 02:00:21,453
I REMEMBER CLEARLY PUBLICATION 

3175
02:00:21,453 --> 02:00:23,088
OF EDITORIAL IN NEW YORK TIMES 

3176
02:00:23,088 --> 02:00:26,491
THAT WAS ASTOUNDED THAT 

3177
02:00:26,491 --> 02:00:28,327
AFRICAN-AMERICANS MIGHT BE 

3178
02:00:28,327 --> 02:00:31,697
RELUCTANT TO PARTICIPATE IN 

3179
02:00:31,697 --> 02:00:33,465
RESEARCH INVOLVING HIV AND THEY 

3180
02:00:33,465 --> 02:00:35,701
MIGHT BE RELUCTANT TO TAKE A 

3181
02:00:35,701 --> 02:00:37,936
VACCINE THAT WAS DEVELOPED BY 

3182
02:00:37,936 --> 02:00:38,670
THE FEDERAL GOVERNMENT. 

3183
02:00:38,670 --> 02:00:40,939
AGAIN, THAT IS PART OF THE -- I 

3184
02:00:40,939 --> 02:00:44,042
WOULD SAY LONGSTANDING LEGACY AT

3185
02:00:44,042 --> 02:00:46,411
LEAST IN SOME ELEMENTS OF THE 

3186
02:00:46,411 --> 02:00:48,747
AFRICAN AMERICAN COMMUNITY AND 

3187
02:00:48,747 --> 02:00:52,651
DISTRUST OF THE ROLE OF THE 

3188
02:00:52,651 --> 02:00:55,887
FEDERAL GOVERNMENT AND THINK ONE

3189
02:00:55,887 --> 02:00:58,590
THING THAT I FOUND INTERESTING 

3190
02:00:58,590 --> 02:01:02,094
IS THAT I DISCOVERED IN 1994 

3191
02:01:02,094 --> 02:01:05,631
THAT THERE HAD BEEN NO APOLOGY 

3192
02:01:05,631 --> 02:01:09,268
OR WAS A FINANCIAL SETTLEMENT 

3193
02:01:09,268 --> 02:01:12,170
OUT OF COURT THAT THE GOVERNMENT

3194
02:01:12,170 --> 02:01:14,806
ENTERED INTO THAT AWARDED MEN IN

3195
02:01:14,806 --> 02:01:18,443
STUDY OR FAMILY'S $32,000 AND 

3196
02:01:18,443 --> 02:01:21,213
LIFELONG MEDICAL CARE IF THEY 

3197
02:01:21,213 --> 02:01:23,315
WANTED IT. 

3198
02:01:23,315 --> 02:01:26,385
YOU KNOW, BURIAL STIPEND. 

3199
02:01:26,385 --> 02:01:28,687
BUT THERE HAD BEEN NO 

3200
02:01:28,687 --> 02:01:29,321
PRESIDENTIAL APOLOGY. 

3201
02:01:29,321 --> 02:01:33,225
I THINK THAT IT WAS IN THE WAKE 

3202
02:01:33,225 --> 02:01:36,295
OF THE PRESIDENT -- PRESIDENT 

3203
02:01:36,295 --> 02:01:37,229
CLINTON'S APOLOGY TO THOSE 

3204
02:01:37,229 --> 02:01:39,731
AMERICANS WHOSE LIVES HAD BEEN 

3205
02:01:39,731 --> 02:01:41,633
DARKENED BY THE SHADOW OF THE 

3206
02:01:41,633 --> 02:01:45,737
ATOM AND MAINLY HUMAN RADIATION 

3207
02:01:45,737 --> 02:01:48,140
EXPERIMENTS AND REVELATION OF 

3208
02:01:48,140 --> 02:01:50,208
LARGE SCALE EXPOSURE OF 

3209
02:01:50,208 --> 02:01:52,878
AMERICANS TO IONIZING RADIATION 

3210
02:01:52,878 --> 02:01:55,247
IN THE COLD WAR AND PRESIDENT 

3211
02:01:55,247 --> 02:01:57,249
CLINTON OFFERED APOLOGIES AND 

3212
02:01:57,249 --> 02:01:59,384
YEAR LATER INVITED MEN FROM 

3213
02:01:59,384 --> 02:02:01,386
STUDY OR SURVIVORS TO THE WHITE 

3214
02:02:01,386 --> 02:02:04,323
HOUSE FOR A FEDERAL APOLOGY. 

3215
02:02:04,323 --> 02:02:06,792
THIS CAME WITH THE ESTABLISHMENT

3216
02:02:06,792 --> 02:02:12,331
OF A BIOETHICS INSTITUTE AT 

3217
02:02:12,331 --> 02:02:15,934
TUSKEGEE UNIVERSITY AND FUNDS TO

3218
02:02:15,934 --> 02:02:18,303
EXPLORE SORT OF LONGSTANDING 

3219
02:02:18,303 --> 02:02:20,339
RACIAL DISPARITIES IN HUMAN 

3220
02:02:20,339 --> 02:02:23,608
EXPERIMENTATION IN BOTH RISKS 

3221
02:02:23,608 --> 02:02:29,815
AND BENEFITS. 

3222
02:02:29,815 --> 02:02:34,252
>> AT TIME ARE 3 OR 4 MEN
THAT 

3223
02:02:34,252 --> 02:02:37,723
REMAINED ALIVE AT SESSION WITH 

3224
02:02:37,723 --> 02:02:39,858
PRESIDENT CLINTON AND THINK LAST

3225
02:02:39,858 --> 02:02:41,793
SURVIVING MAN PASSED A NUMBER OF

3226
02:02:41,793 --> 02:02:42,260
YEARS AGO. 

3227
02:02:42,260 --> 02:02:44,329
>> YES.  THAT IS RIGHT.  I
THINK

3228
02:02:44,329 --> 02:02:48,333
TODAY -- THERE IS -- IF PEOPLE 

3229
02:02:48,333 --> 02:02:50,369
ARE INTERESTED I CAN RECOMMEND 

3230
02:02:50,369 --> 02:02:52,337
TWO VIDEO INTERVIEWS OR PROGRAMS

3231
02:02:52,337 --> 02:02:54,940
THAT I THINK ARE VERY REVEALING 

3232
02:02:54,940 --> 02:02:57,209
THAT HAVE BENEFIT OF YOU GET TO 

3233
02:02:57,209 --> 02:03:01,947
SEE SOME OF THE INVESTIGATARS OR

3234
02:03:01,947 --> 02:03:03,448
ONE INVESTIGATOR THAT WAS STILL 

3235
02:03:03,448 --> 02:03:05,450
SURVIVING AND SOME MEN IN THE 

3236
02:03:05,450 --> 02:03:08,286
STUDY THAT GIVES YOU A MUCH MORE

3237
02:03:08,286 --> 02:03:09,421
APPRECIATION FOR WHAT THEY 

3238
02:03:09,421 --> 02:03:10,956
EXPERIENCED OVER THE COURSE OF 

3239
02:03:10,956 --> 02:03:13,058
THE FOUR YEARS AND SUBSEQUENT AS

3240
02:03:13,058 --> 02:03:13,258
WELL. 

3241
02:03:13,258 --> 02:03:15,227
>> THAT WOULD BE GREAT AND
WE 

3242
02:03:15,227 --> 02:03:17,329
COULD POST THAT FOR EVERYONE TO 

3243
02:03:17,329 --> 02:03:19,131
TAKE A LOOK.  

3244
02:03:19,131 --> 02:03:21,299
WELL, THANK YOU VERY MUCH, 

3245
02:03:21,299 --> 02:03:21,967
SUSAN. 

3246
02:03:21,967 --> 02:03:23,668
WE VERY MUCH APPRECIATE YOUR 

3247
02:03:23,668 --> 02:03:25,070
VISITING US TODAY. 

3248
02:03:25,070 --> 02:03:26,071
AND THANK YOU AGAIN. 

3249
02:03:26,071 --> 02:03:30,375
>> ALL RIGHT.  THANK YOU,
HOLLY.

3250
02:03:30,375 --> 02:03:31,743
>> BYE, BYE. 

3251
02:03:31,743 --> 02:03:36,381
>> SO AS I SAID, WE WILL
TAKE A 

3252
02:03:36,381 --> 02:03:41,753
15 MINUTE BREAK AT THIS POINT. 

3253
02:03:41,753 --> 02:03:44,322
PLEASE BE BACK IN 15 MINUTES 

3254
02:03:44,322 --> 02:03:46,391
WHICH WILL BE ABOUT 10:50. 

3255
02:03:46,391 --> 02:03:49,956
YOU WILL HEAR FROM ME ABOUT
IRBS. 

3256
02:04:46,698 --> 02:04:48,533
>> AT LEAST TWO REALLY
IMPORTANT

3257
02:04:48,533 --> 02:04:50,101
PILLARS IN PROTECTION OF 

3258
02:04:50,101 --> 02:04:51,636
SUBJECTS OF HUMAN RESEARCH AND 

3259
02:04:51,636 --> 02:04:53,371
ONE IS THE INSTITUTIONAL REVIEW 

3260
02:04:53,371 --> 02:04:55,273
BOARD THAT WE WILL TALK ABOUT 

3261
02:04:55,273 --> 02:04:58,209
AND SECOND IS INFORMED CONSENT. 

3262
02:04:58,209 --> 02:05:02,213
THE INSTITUTIONAL REVIEW BOARD'S

3263
02:05:02,213 --> 02:05:09,354
RESPONSIBILITY IS MAKING SURE 

3264
02:05:09,354 --> 02:05:13,124
THAT WHAT THEY REVIEW IS 

3265
02:05:13,124 --> 02:05:14,626
RESPECTING PARTICIPANTS AND IN 

3266
02:05:14,626 --> 02:05:16,394
WAY THAT IS APPROPRIATE, ET 

3267
02:05:16,394 --> 02:05:16,628
CETERA. 

3268
02:05:16,628 --> 02:05:20,131
ONE CAN ASSUME OR SYSTEM IS SET 

3269
02:05:20,131 --> 02:05:27,605
UP SO ONE CAN ASSUME THAT IF 

3270
02:05:27,605 --> 02:05:29,007
REVIEW BOARD APPROVED RESEARCH 

3271
02:05:29,007 --> 02:05:30,975
IT IS CONSIDERED SAFE FOR AN 

3272
02:05:30,975 --> 02:05:33,044
INDIVIDUAL TO PROVIDE INFORMED 

3273
02:05:33,044 --> 02:05:33,678
CONSENT THEN. 

3274
02:05:33,678 --> 02:05:36,247
IF WE DIDN'T HAVE INSTITUTIONAL 

3275
02:05:36,247 --> 02:05:40,018
REVIEW BOARDS, INVESTIGATORS 

3276
02:05:40,018 --> 02:05:42,186
COULD GO DIRECTLY TO INDIVIDUALS

3277
02:05:42,186 --> 02:05:43,788
ASKING THEM TO BE IN THEIR 

3278
02:05:43,788 --> 02:05:45,757
RESEARCH AND SAW EXAMPLES HOW 

3279
02:05:45,757 --> 02:05:49,827
THAT COULD GO WRONG AND REMINDER

3280
02:05:49,827 --> 02:05:57,235
WHEN WE TALK ABOUT HOW SYSTEM 

3281
02:05:57,235 --> 02:05:58,136
PROTECTS SUBJECTS WE CAN TALK 

3282
02:05:58,136 --> 02:05:59,771
ABOUT THE REVIEW AND WHOLE DAY 

3283
02:05:59,771 --> 02:06:02,073
ON INFORMED CONSENT AND DR. 

3284
02:06:02,073 --> 02:06:04,042
GRADY WILL BE BACK AND DR. SCOTT

3285
02:06:04,042 --> 02:06:06,477
KIM ON FACULTY WILL BE BACK AND 

3286
02:06:06,477 --> 02:06:08,146
SOMEONE FROM NATIONAL INSTITUTE 

3287
02:06:08,146 --> 02:06:09,847
OF MENTAL HEALTH TALKING ABOUT 

3288
02:06:09,847 --> 02:06:12,250
HOW THEY ASSESS CAPACITY HERE AT

3289
02:06:12,250 --> 02:06:22,627
THE CLINICAL CENTER.  

3290
02:06:22,827 --> 02:06:24,495
HERE ARE KEY POINTS I WANT YOU 

3291
02:06:24,495 --> 02:06:26,397
TO GET AND FIRST IRBS ARE 

3292
02:06:26,397 --> 02:06:28,633
RESPONSIBLE FOR REVIEW AND 

3293
02:06:28,633 --> 02:06:30,435
OVERSIGHT OF ALL HUMAN SUBJECT 

3294
02:06:30,435 --> 02:06:34,205
RESEARCH CONDUCTED IN THE UNITED

3295
02:06:34,205 --> 02:06:40,778
STATES AT AN ACADEMIC MEDICAL 

3296
02:06:40,778 --> 02:06:42,313
CENTER THAT HAS SOUGHT AND 

3297
02:06:42,313 --> 02:06:45,016
GAINED FEDERAL WIDE ASSURANCE 

3298
02:06:45,016 --> 02:06:46,951
FROM OFFICE OF HUMANWIDE 

3299
02:06:46,951 --> 02:06:50,922
PROTECTIONS THAT IS HHS LEVEL 

3300
02:06:50,922 --> 02:06:55,093
OFFICE TO REVIEW ALL RESEARCH 

3301
02:06:55,093 --> 02:06:56,561
THAT HAPPENS AT THEIR 

3302
02:06:56,561 --> 02:06:57,595
INSTITUTIONS AND WILL TALK MORE 

3303
02:06:57,595 --> 02:06:58,830
ABOUT THAT. 

3304
02:06:58,830 --> 02:07:00,798
I WANTED TO MAKE JUST THE POINT 

3305
02:07:00,798 --> 02:07:06,204
THAT OUTSIDE OF THE UNITED 

3306
02:07:06,204 --> 02:07:10,475
STATES, THESE BODIES ARE ETHICAL

3307
02:07:10,475 --> 02:07:14,679
REVIEW BOARDS RESEARCH ETHICS 

3308
02:07:14,679 --> 02:07:17,148
COMMITTEES AND INDEPENDENT 

3309
02:07:17,148 --> 02:07:17,982
ETHICS COMMITTEES, ET CETERA.  

3310
02:07:17,982 --> 02:07:20,118
THOSE THAT ARE IN PLACES LIKE 

3311
02:07:20,118 --> 02:07:21,986
THE UNITED STATES, A LOT OF WHAT

3312
02:07:21,986 --> 02:07:24,255
I WILL COVER IS SIMILAR TO WHAT 

3313
02:07:24,255 --> 02:07:28,159
BOARDS DO IN OTHER COUNTRIES. 

3314
02:07:28,159 --> 02:07:34,198
TODAY, MOST COUNTRIES THAT 

3315
02:07:34,198 --> 02:07:36,667
ACTIVELY ENGAGE IN HUMAN SUBJECT

3316
02:07:36,667 --> 02:07:39,670
RESEARCH HAVE REVIEW AND 

3317
02:07:39,670 --> 02:07:40,772
OVERSIGHT MECHANISMS TO PROTECT 

3318
02:07:40,772 --> 02:07:44,509
CITIZENS OF THEIR COUNTRY OR 

3319
02:07:44,509 --> 02:07:47,512
REGION. 

3320
02:07:47,512 --> 02:07:49,914
AND IN THE UNITED STATES, IRBS 

3321
02:07:49,914 --> 02:07:53,718
ARE GUIDED IN REVIEW BY TWO 

3322
02:07:53,718 --> 02:07:55,286
FEDERAL REGULATIONS DR. GRADY 

3323
02:07:55,286 --> 02:07:58,489
MENTIONED AFRND ONE THAT COVERS 

3324
02:07:58,489 --> 02:08:04,295
ALL OF HHS. 

3325
02:08:04,295 --> 02:08:11,102
KEY COMPONENT OF THAT APPLIES TO

3326
02:08:11,102 --> 02:08:14,038
COMMON RULES AND APPLIES TO 17 

3327
02:08:14,038 --> 02:08:17,208
OTHER FEDERAL DEPARTMENTS AND 

3328
02:08:17,208 --> 02:08:19,977
DEPARTMENT OF ENERGY AND 

3329
02:08:19,977 --> 02:08:23,714
DEPARTMENT OF HOUSING AND URBAN 

3330
02:08:23,714 --> 02:08:24,615
DEVELOPMENT, ET CETERA. 

3331
02:08:24,615 --> 02:08:26,717
SO THE KEY FEDERAL REGULATIONS 

3332
02:08:26,717 --> 02:08:28,286
IN THE UNITED STATES ARE HHS 

3333
02:08:28,286 --> 02:08:30,988
ONES AND WHEN COMING TO REVIEW 

3334
02:08:30,988 --> 02:08:33,257
AND APPROVAL OF DRUGS, FDA KICKS

3335
02:08:33,257 --> 02:08:35,326
IN AS WELL AND THEY ARE VERY 

3336
02:08:35,326 --> 02:08:37,895
SIMILAR AND IRBS IN THE UNITED 

3337
02:08:37,895 --> 02:08:40,331
STATES ARE LOCAL MEANING THAT 

3338
02:08:40,331 --> 02:08:41,833
EVERY ACADEMIC MEDICAL INSTITUTE

3339
02:08:41,833 --> 02:08:44,235
THAT IS KWON DUCTING HUMAN 

3340
02:08:44,235 --> 02:08:47,405
SUBJECT RESEARCH HAS A LOCAL IRB

3341
02:08:47,405 --> 02:08:50,208
OR MULTIPLE IRBS AND USED TO 

3342
02:08:50,208 --> 02:08:52,543
WORK AT JOHN'S HOPKINS SITTING 

3343
02:08:52,543 --> 02:08:55,646
ON MEDICAL SCHOOL IRB AND THERE 

3344
02:08:55,646 --> 02:08:58,816
WERE 7IRBS TO REVIEW AND APPROVE

3345
02:08:58,816 --> 02:09:00,785
ALL RESEARCH HAPPENING AT 

3346
02:09:00,785 --> 02:09:08,092
INSTITUTION AND WERE ALL LOCAL 

3347
02:09:08,092 --> 02:09:10,194
IN SENSE WE NEEDED 7 TO KEEP UP 

3348
02:09:10,194 --> 02:09:11,896
WITH RESEARCH THAT WAS GOING ON 

3349
02:09:11,896 --> 02:09:13,664
AND GROUPS CAN DEVELOP POLICY 

3350
02:09:13,664 --> 02:09:16,267
AND PRACTICE BASED ON FEDERAL 

3351
02:09:16,267 --> 02:09:17,702
REGULATIONS AND CAN BE MORE 

3352
02:09:17,702 --> 02:09:20,171
STRICT AND FEDERAL REGULATIONS 

3353
02:09:20,171 --> 02:09:24,141
ARE BASELINE AND OUTSIDE OF THE 

3354
02:09:24,141 --> 02:09:28,112
U SC

3355
02:09:28,412 --> 02:09:29,747
USIRBS ARE LOCAL AND SOMETIMES 

3356
02:09:29,747 --> 02:09:31,782
REGIONAL AND IN UK IS DONE BY 

3357
02:09:31,782 --> 02:09:33,017
REGIONS AND IN OTHER COUNTRIES 

3358
02:09:33,017 --> 02:09:37,021
THERE IS A NATIONAL IRB AND 

3359
02:09:37,021 --> 02:09:39,123
UGANDA, FOR EXAMPLE, THERE ARE 

3360
02:09:39,123 --> 02:09:40,725
BOTH LOCAL COMMITTEES ATTACHED 

3361
02:09:40,725 --> 02:09:43,728
TO ACADEMIC INSTITUTIONS AND A 

3362
02:09:43,728 --> 02:09:45,196
NATIONAL IRB. 

3363
02:09:45,196 --> 02:09:46,731
ALL TO SAY FOR THOSE OUT THERE 

3364
02:09:46,731 --> 02:09:48,733
THAT ARE NOT IN THE US, YOU 

3365
02:09:48,733 --> 02:09:50,701
MIGHT WANT TO FIND OUT HOW THE 

3366
02:09:50,701 --> 02:09:56,674
SYSTEM WORKS IN YOUR SETTING. 

3367
02:09:56,674 --> 02:09:58,442
ONE THING I WANTED TO SAY IS IF 

3368
02:09:58,442 --> 02:10:01,846
YOU ARE DOING RESEARCH AND HAVE 

3369
02:10:01,846 --> 02:10:04,048
A QUESTION AND YOU DON'T KNOW IF

3370
02:10:04,048 --> 02:10:06,017
IT NEEDS TO BE -- RESEARCH NEEDS

3371
02:10:06,017 --> 02:10:07,885
TO BE SUBMIT TODAY IRB OR 

3372
02:10:07,885 --> 02:10:09,954
THINKING ABOUT RESEARCH YOU ARE 

3373
02:10:09,954 --> 02:10:11,188
PLANNING, ASK THEM. 

3374
02:10:11,188 --> 02:10:14,825
THEY ARE THERE TO HELP 

3375
02:10:14,825 --> 02:10:15,893
INVESTIGATORS NAVIGATE THEIR 

3376
02:10:15,893 --> 02:10:17,795
RESEARCH AND MAKE SURE THAT IT 

3377
02:10:17,795 --> 02:10:20,031
MEETS ETHICAL STANDARDS AND WHEN

3378
02:10:20,031 --> 02:10:22,166
IN DOUBT, GO AND FIND THAT 

3379
02:10:22,166 --> 02:10:25,169
INSTITUTION WHETHER IT IS LOCAL,

3380
02:10:25,169 --> 02:10:28,806
REGIONAL, NATIONAL AND ASK THEM 

3381
02:10:28,806 --> 02:10:37,615
QUESTIONS THIS IS REITERATION OF

3382
02:10:37,615 --> 02:10:39,083
INDEPENDENT REVIEW ETHICAL 

3383
02:10:39,083 --> 02:10:43,387
REQUIREMENT AND IRB IS MEANT TO 

3384
02:10:43,387 --> 02:10:46,424
REVIEW RESEARCH AND MEANT TO BE 

3385
02:10:46,424 --> 02:10:48,092
REVIEWED BY INDIVIDUALS NO THE 

3386
02:10:48,092 --> 02:10:50,661
CONDUCTING RESEARCH AND GOAL IS 

3387
02:10:50,661 --> 02:10:53,197
TO ASSURE SOME PUBLIC OR SOCIAL 

3388
02:10:53,197 --> 02:10:53,798
ACCOUNTABILITY; RIGHT?  

3389
02:10:53,798 --> 02:10:56,434
IF YOU ARE THINKING ABOUT 

3390
02:10:56,434 --> 02:10:57,668
ENROLLING IN RESEARCH YOU MIGHT 

3391
02:10:57,668 --> 02:11:03,240
HAVE NO IDEA WHAT AN IRB IS. 

3392
02:11:03,240 --> 02:11:05,142
IF YOU DID IT WOULD GIVE YOU A 

3393
02:11:05,142 --> 02:11:07,144
SENSE THAT A LEARNED BODY 

3394
02:11:07,144 --> 02:11:08,813
REVIEWED RESEARCH AND CONSIDERED

3395
02:11:08,813 --> 02:11:12,216
IT SAFE AND IRB IS ALSO THERE TO

3396
02:11:12,216 --> 02:11:14,785
MINIMIZE IMPACT OF POTENTIAL 

3397
02:11:14,785 --> 02:11:17,888
RESEARCHER CONFLICT OF INTEREST.

3398
02:11:17,888 --> 02:11:19,357
AND THIS IS JUST A GREAT QUOTE 

3399
02:11:19,357 --> 02:11:21,692
THAT I REALLY USE EVERY TIME 

3400
02:11:21,692 --> 02:11:24,695
THAT I TALK ABOUT IRBS FROM 

3401
02:11:24,695 --> 02:11:29,200
EDGAR AND ROTHMAN BACK IN 1995 

3402
02:11:29,200 --> 02:11:31,736
AND UNQUESTIONABLY, THEIR VERY 

3403
02:11:31,736 --> 02:11:34,205
EXISTENCE TEMPERED INEVITABLE 

3404
02:11:34,205 --> 02:11:36,173
PROPENSITY OF RESEARCHERS TO 

3405
02:11:36,173 --> 02:11:39,377
PURSUE INVESTIGATIONS WITHOUT 

3406
02:11:39,377 --> 02:11:40,244
DISPASSIONATELY OUTWEIGHING 

3407
02:11:40,244 --> 02:11:42,213
RISKS AND ASKING OTHERS TO 

3408
02:11:42,213 --> 02:11:43,848
ASSUME AND FULLY INFORM SUBJECTS

3409
02:11:43,848 --> 02:11:45,583
OF THEM AND ANOTHER WAY TO SAY 

3410
02:11:45,583 --> 02:11:49,754
THIS IS THAT JUST THAT IRBS 

3411
02:11:49,754 --> 02:11:51,622
EXIST HOPEFULLY IN THEIR MIND 

3412
02:11:51,622 --> 02:11:53,758
AND REMIND INVESTIGATORS THAT 

3413
02:11:53,758 --> 02:11:56,927
THEY HAVE TO THINK ABOUT 

3414
02:11:56,927 --> 02:11:58,295
SUBJECTS AND THEIR RESEARCH AND 

3415
02:11:58,295 --> 02:12:01,132
THERE IS A BODY THAT WILL 

3416
02:12:01,132 --> 02:12:01,966
REVIEW. 

3417
02:12:01,966 --> 02:12:04,468
ON ONE HAND, INVESTIGATORS MIGHT

3418
02:12:04,468 --> 02:12:07,271
THINK, OH, MY GOSH; RIGHT?  

3419
02:12:07,271 --> 02:12:10,241
THIS MIGHT BE A CURE AND THEY 

3420
02:12:10,241 --> 02:12:11,742
MIGHT OVERESTIMATE POTENTIAL 

3421
02:12:11,742 --> 02:12:14,178
BENEFIT AND WHY YOU HAVE THE 

3422
02:12:14,178 --> 02:12:15,379
INSTITUTIONAL REVIEW BOARD TO 

3423
02:12:15,379 --> 02:12:18,182
ADDRESS THAT SORT OF INHERENT 

3424
02:12:18,182 --> 02:12:19,817
PERSONAL CONFLICT; RIGHT?  

3425
02:12:19,817 --> 02:12:22,553
IF I'M DOG A RESEARCH PROJECT, I

3426
02:12:22,553 --> 02:12:29,727
COURSE I THINK IT WILL WORK. 

3427
02:12:29,727 --> 02:12:32,196
WE DO RESEARCH TO FIND OUT IF IT

3428
02:12:32,196 --> 02:12:33,597
WOULD WORK AND IF WE KNEW IT 

3429
02:12:33,597 --> 02:12:35,433
WORKED WE WOULDN'T HAVE TO DO 

3430
02:12:35,433 --> 02:12:38,669
RESEARCH AND IRB IS SAYING 

3431
02:12:38,669 --> 02:12:40,638
PLANNING AND SOUND AND PROTECTS 

3432
02:12:40,638 --> 02:12:42,907
SUBJECTS AND IS A BIT OF A GARD 

3433
02:12:42,907 --> 02:12:45,176
RAIL FOR INVESTIGATORS COMING TO

3434
02:12:45,176 --> 02:12:47,311
CONFLICT OF INTEREST. 

3435
02:12:47,311 --> 02:12:50,681
I WILL TOUCH ON A NUMBER OF KEY 

3436
02:12:50,681 --> 02:12:52,450
COMPONENTS WHAT IRBS DO AND 

3437
02:12:52,450 --> 02:12:57,655
HAPPY TO ANSWER QUESTIONS AND 

3438
02:12:57,655 --> 02:13:00,257
WILL ALWAYS BE THE CASE, WE HAVE

3439
02:13:00,257 --> 02:13:02,993
PUT READINGS ON CANVAS FOR THOSE

3440
02:13:02,993 --> 02:13:05,463
THAT WANT TO LEARN MORE ABOUT 

3441
02:13:05,463 --> 02:13:07,164
IRBS AND ARE ARTICLES ABOUT IRBS

3442
02:13:07,164 --> 02:13:09,266
IF YOU HAVE QUESTIONS ABOUT THEM

3443
02:13:09,266 --> 02:13:10,701
CAN YOU ASK THEM TODAY OR ASK 

3444
02:13:10,701 --> 02:13:12,536
THEM AS WE MOVE FORWARD IN THE 

3445
02:13:12,536 --> 02:13:12,937
CLASS. 

3446
02:13:12,937 --> 02:13:14,538
WHAT IS THEIR ROLE?  

3447
02:13:14,538 --> 02:13:17,908
AS I SAID, THEIR ROLE IS TO 

3448
02:13:17,908 --> 02:13:20,444
REVIEW AND OVERSEE ALL OF THE 

3449
02:13:20,444 --> 02:13:22,613
HUMAN SUBJECT RESEARCH THAT IS 

3450
02:13:22,613 --> 02:13:24,582
HAPPENING AT AN INDIVIDUAL 

3451
02:13:24,582 --> 02:13:25,216
INSTITUTION. 

3452
02:13:25,216 --> 02:13:27,351
IN THE UNITED STATES, IRB, WHEN 

3453
02:13:27,351 --> 02:13:29,386
I SAY INSTITUTIONAL REVIEW 

3454
02:13:29,386 --> 02:13:33,224
BOARD, I'M REFERRING TO THE 

3455
02:13:33,224 --> 02:13:34,191
GROUP OF INDIVIDUALS WHO ARE 

3456
02:13:34,191 --> 02:13:36,293
BROUGHT TOGETHER TO REVIEW A 

3457
02:13:36,293 --> 02:13:39,396
PARTICULAR PROTOCOL OR PROTOCOLS

3458
02:13:39,396 --> 02:13:40,631
AND DECIDE WHETHER OR NOT THEY 

3459
02:13:40,631 --> 02:13:48,639
OUGHT TO BE APPROVED OR NOT 

3460
02:13:48,639 --> 02:13:50,841
OFTEN IN THE UNITED STATES IRBS 

3461
02:13:50,841 --> 02:13:52,643
ARE ONE COMPONENT OF WHAT IS 

3462
02:13:52,643 --> 02:13:54,311
REFERRED TO AS HUMAN PROTECTION 

3463
02:13:54,311 --> 02:13:56,013
RESEARCH PROGRAM AND SOME 

3464
02:13:56,013 --> 02:13:57,948
INSTITUTIONS HAVE IRBS BUT THERE

3465
02:13:57,948 --> 02:14:00,050
HAS TO BE AN ADMINISTRATIVE 

3466
02:14:00,050 --> 02:14:01,485
INFRASTRUCTURE FOR THAT IRB TO 

3467
02:14:01,485 --> 02:14:04,388
BE SUPPORTED AND I MAY REFER TO 

3468
02:14:04,388 --> 02:14:07,158
TODAY AND MOVING FORWARD THE 

3469
02:14:07,158 --> 02:14:08,859
HUMAN RESEARCH PROTECTION 

3470
02:14:08,859 --> 02:14:11,328
PROGRAM TO CONVEY THE SORT OF 

3471
02:14:11,328 --> 02:14:13,130
ADMINISTRATIVE BODY THAT IS IN 

3472
02:14:13,130 --> 02:14:14,498
CHARGE AND IN THE UNITED STATES 

3473
02:14:14,498 --> 02:14:16,300
ACCORDING TO FEDERAL 

3474
02:14:16,300 --> 02:14:23,340
REGULATIONS, IRBS MUST HAVE AT 

3475
02:14:23,340 --> 02:14:27,411
LEAST FIVE MEMBERS. 

3476
02:14:27,411 --> 02:14:29,213
THERE ARE REQUIREMENTS FOR FIVE 

3477
02:14:29,213 --> 02:14:30,881
MEMBERS AND ONE HAS TO BE 

3478
02:14:30,881 --> 02:14:32,316
AFFILIATED WITH THE INSTITUTION 

3479
02:14:32,316 --> 02:14:34,718
AND ONE HAS TO BE A 

3480
02:14:34,718 --> 02:14:35,052
NONSCIENTIST. 

3481
02:14:35,052 --> 02:14:36,754
WHEN I'M NOT TEACHING, I DO LOTS

3482
02:14:36,754 --> 02:14:39,823
OF EMPIRICAL RESEARCH ABOUT 

3483
02:14:39,823 --> 02:14:46,197
RESEARCH ETHICS AND WORKED ON A 

3484
02:14:46,197 --> 02:14:51,302
STUDY A COUPLE YEARS AGO WHERE 

3485
02:14:51,302 --> 02:14:54,104
IRBS HAVE ONE PERSON THAT IS 

3486
02:14:54,104 --> 02:14:55,339
UNAFFILIATED AND ONE 

3487
02:14:55,339 --> 02:14:56,874
NONSCIENTIST AND MEANS THERE IS 

3488
02:14:56,874 --> 02:14:58,876
ONE PERSON WHO IS NOT A 

3489
02:14:58,876 --> 02:15:00,644
PHYSICIAN OR PHD TRAINED 

3490
02:15:00,644 --> 02:15:02,313
SCIENTIST AND THAT IS HARD.  

3491
02:15:02,313 --> 02:15:04,548
OOPS.  SORRY TO BE THE ONLY 

3492
02:15:04,548 --> 02:15:06,150
PERSON NOT A SCIENTIST IN THE 

3493
02:15:06,150 --> 02:15:06,550
ROOM. 

3494
02:15:06,550 --> 02:15:09,053
SOME COUNTRIES LIKE NEWSDAEL 

3495
02:15:09,053 --> 02:15:10,721
YOIND FOR EXAMPLE HAVE VERY 

3496
02:15:10,721 --> 02:15:12,823
DIFFERENT APPROACHES AND THEIR 

3497
02:15:12,823 --> 02:15:14,358
EQUIVALENT INSTITUTIONAL REVIEW 

3498
02:15:14,358 --> 02:15:16,227
BOARD HAS TO HAVE ONE MORE 

3499
02:15:16,227 --> 02:15:18,596
MEMBER OF THE COMMUNITY THAN 

3500
02:15:18,596 --> 02:15:19,964
THERE ARE SCIENTISTS. 

3501
02:15:19,964 --> 02:15:23,534
IF FOUR SCIENTISTS THEY HAVE TO 

3502
02:15:23,534 --> 02:15:26,537
HAVE FIVE COMMUNITY MEMBERS. 

3503
02:15:26,537 --> 02:15:27,738
THANK YOU DIFFERENT COUNTRIES 

3504
02:15:27,738 --> 02:15:30,174
SET UP SYSTEMS IN DIFFERENT WAYS

3505
02:15:30,174 --> 02:15:31,809
TO MAKE SURE THAT VOICE IS SORT 

3506
02:15:31,809 --> 02:15:34,178
OF AT THE TABLE AND ARE A NUMBER

3507
02:15:34,178 --> 02:15:35,779
OF CHALLENGES IN SORT OF 

3508
02:15:35,779 --> 02:15:37,314
ESSENTIAL TO AN INSTITUTIONAL 

3509
02:15:37,314 --> 02:15:38,549
REVIEW BOARD. 

3510
02:15:38,549 --> 02:15:45,055
ONE IS THE INDIVIDUAL. 

3511
02:15:45,055 --> 02:15:46,357
WE CAN QUICKLY DEAL WITH THAT 

3512
02:15:46,357 --> 02:15:50,127
WITH IRBS.  I HAPPEN TO BE ON 

3513
02:15:50,127 --> 02:15:52,363
IRB BOARD AT CLINICAL CENTER AND

3514
02:15:52,363 --> 02:15:53,964
SUBMITTING RESEARCH TO THE IRB, 

3515
02:15:53,964 --> 02:15:56,634
I CAN'T BE ON IRB WHEN RESEARCH 

3516
02:15:56,634 --> 02:15:58,302
IS REVIEWED; RIGHT?  

3517
02:15:58,302 --> 02:16:00,170
THAT IS A CLEAR WAY TO REMOVE 

3518
02:16:00,170 --> 02:16:01,205
CONFLICT OF INTEREST I WOULD 

3519
02:16:01,205 --> 02:16:02,640
HAVE IF I WAS SITTING IN THE 

3520
02:16:02,640 --> 02:16:04,341
ROOM AND I WOULD SAY OF COURSE 

3521
02:16:04,341 --> 02:16:09,446
IT IS AWESOME AND NEEDS TO BE 

3522
02:16:09,446 --> 02:16:09,713
APPROVED. 

3523
02:16:09,713 --> 02:16:11,715
LET'S SAY MY SUPERVISOR AND DR. 

3524
02:16:11,715 --> 02:16:14,251
GRADY IS MY SUPERVISOR AND I'M 

3525
02:16:14,251 --> 02:16:17,621
WORKING WITH CHRISTINE ON A 

3526
02:16:17,621 --> 02:16:19,490
PROJECT AND HER PROJECT COMES TO

3527
02:16:19,490 --> 02:16:22,192
ME AT IRB AND WILL RAISE MY HAND

3528
02:16:22,192 --> 02:16:25,496
AND EVERYBODY THIS IS MY BOSS 

3529
02:16:25,496 --> 02:16:27,965
WHO HAS A SUPERVISORY ROLE OVER 

3530
02:16:27,965 --> 02:16:29,466
ME AND DON'T FEEL I'M BEST 

3531
02:16:29,466 --> 02:16:31,235
PERSON TO REVIEW AND CAN 

3532
02:16:31,235 --> 02:16:33,170
SELF-RECUSE MYSELF FROM THE 

3533
02:16:33,170 --> 02:16:34,305
DELIBERATIONS. 

3534
02:16:34,305 --> 02:16:39,243
NOW, OUTSIDE OF THE NIH, ALMOST 

3535
02:16:39,243 --> 02:16:41,912
ALL RESEARCH CONDUCTED AT 

3536
02:16:41,912 --> 02:16:43,580
ACADEMIC MEDICAL CENTERS IS 

3537
02:16:43,580 --> 02:16:46,216
FUNDED BY NATIONAL INSTITUTES OF

3538
02:16:46,216 --> 02:16:46,617
HEALTH. 

3539
02:16:46,617 --> 02:16:50,154
IMAGINE YOU ARE AN IRB MEMBER 

3540
02:16:50,154 --> 02:16:52,790
AT, WE WILL USE JOHN'S HOPKINS 

3541
02:16:52,790 --> 02:16:56,060
AS AN EXAMPLE. 

3542
02:16:56,060 --> 02:17:00,331
WHAT HAPPENS IS IF YOUR GRAND TO

3543
02:17:00,331 --> 02:17:05,002
THE NIH IS FUNDED IT IS REVIEWED

3544
02:17:05,002 --> 02:17:06,904
BY INSTITUTIONAL REVIEW BOARD AT

3545
02:17:06,904 --> 02:17:08,772
YOUR INSTITUTION BEFORE IT COULD

3546
02:17:08,772 --> 02:17:09,773
BE IMPLEMENTED. 

3547
02:17:09,773 --> 02:17:14,211
IF THE IRB IS THE SORT OF ONLY 

3548
02:17:14,211 --> 02:17:17,915
THING BETWEEN THE RESEARCH 

3549
02:17:17,915 --> 02:17:20,084
GETTING DONE AND THE -- YOU 

3550
02:17:20,084 --> 02:17:23,020
KNOW, GETTING THE FUNDING, THEN 

3551
02:17:23,020 --> 02:17:25,289
IRB ITSELF HAS A CONFLICT OF 

3552
02:17:25,289 --> 02:17:26,457
INTEREST; RIGHT?  

3553
02:17:26,457 --> 02:17:29,126
IF THE IRB DOESN'T APPROVE IT, 

3554
02:17:29,126 --> 02:17:30,794
THE INSTITUTION DOESN'T GET THE 

3555
02:17:30,794 --> 02:17:31,028
MONEY. 

3556
02:17:31,028 --> 02:17:33,030
THAT IS NO THE TO SAY THAT 

3557
02:17:33,030 --> 02:17:38,202
THEREFORE ALL IRBS ARE 

3558
02:17:38,202 --> 02:17:40,571
ESSENTIALLY CONFLICTED AND CAN'T

3559
02:17:40,571 --> 02:17:42,005
DO THEIR JOB. 

3560
02:17:42,005 --> 02:17:43,374
UNFORTUNATELY IT DOESN'T MEAN 

3561
02:17:43,374 --> 02:17:43,574
THAT. 

3562
02:17:43,574 --> 02:17:45,676
I MAKE THAT POINT BECAUSE THERE 

3563
02:17:45,676 --> 02:17:47,111
ARE CONFLICTS OF INTERESTS AND 

3564
02:17:47,111 --> 02:17:48,812
TENSIONS WHEN WE TALK ABOUT 

3565
02:17:48,812 --> 02:17:50,848
ETHICS AND TALK ABOUT THE 

3566
02:17:50,848 --> 02:17:54,184
INFRASTRUCTURE DEVELOPED TO SORT

3567
02:17:54,184 --> 02:17:59,323
OF OVER VIEW AND OVERSEE ETHICS 

3568
02:17:59,323 --> 02:18:02,192
IN ANY -- YOU KNOW, ANY SORT OF 

3569
02:18:02,192 --> 02:18:05,162
SYSTEM SETUPS AND INSTITUTIONAL 

3570
02:18:05,162 --> 02:18:09,333
REVIEW BOARDS AND INFORMED 

3571
02:18:09,333 --> 02:18:11,468
CONSENT AND QUICK DIGRESSION TO 

3572
02:18:11,468 --> 02:18:13,337
INFORMED CONSENT AND I'M 

3573
02:18:13,337 --> 02:18:14,104
INVESTIGATOR AND SOMEONE YOU 

3574
02:18:14,104 --> 02:18:16,473
WANT TO ENROLL IN YOUR STUDY AND

3575
02:18:16,473 --> 02:18:18,008
MIGHT HAVE INCENTIVE TO NOT TELL

3576
02:18:18,008 --> 02:18:20,210
YOU ABOUT REALLY PROBLEMATIC 

3577
02:18:20,210 --> 02:18:21,979
RISK EVEN THOUGH IN THE FORM AND

3578
02:18:21,979 --> 02:18:24,248
WON'T POINT IT OUT.  I WANT YOU 

3579
02:18:24,248 --> 02:18:26,183
TO REALLY ENROLL AND ONLY TO SAY

3580
02:18:26,183 --> 02:18:29,186
THIS WILL BE A THEME AS WE MOVE 

3581
02:18:29,186 --> 02:18:31,021
FORWARD THAT THERE WILL BE 

3582
02:18:31,021 --> 02:18:33,056
CHALLENGED EVEN WHEN WE SET UP 

3583
02:18:33,056 --> 02:18:35,259
SYSTEMS TO HOPEFULLY MAKE THE 

3584
02:18:35,259 --> 02:18:35,592
SYSTEM WORK. 

3585
02:18:35,592 --> 02:18:39,163
GROUP DYNAMICS IS ANOTHER ISSUE 

3586
02:18:39,163 --> 02:18:40,764
THAT RELATES TO IRBS. 

3587
02:18:40,764 --> 02:18:43,033
SO I HAVE SERVED ON MANY IRBS 

3588
02:18:43,033 --> 02:18:47,137
OVER THE MANY YEARS OF MY 

3589
02:18:47,137 --> 02:18:47,971
CAREER. 

3590
02:18:47,971 --> 02:18:50,174
AND THEY ARE BODIES THAT 

3591
02:18:50,174 --> 02:18:53,277
SOMETIMES HAVE BEEN TOGETHER FOR

3592
02:18:53,277 --> 02:19:01,618
T10 OR 15 MORE YEARS AND SOME 

3593
02:19:01,618 --> 02:19:03,520
IRBS DON'T HAVE ANY TERM LIMITS.

3594
02:19:03,520 --> 02:19:06,457
YOU CAN ENCOUNTER OBSERVER DRIFT

3595
02:19:06,457 --> 02:19:08,826
OR SORT OF EVERYONE SEES TO THIS

3596
02:19:08,826 --> 02:19:10,694
PERSON WHEN IT COMES TO THAT OR 

3597
02:19:10,694 --> 02:19:16,533
CHAIR HAS A LOT OF SAY OR SWAY. 

3598
02:19:16,533 --> 02:19:18,769
THERE ARE THINGS ANY GROUP THAT 

3599
02:19:18,769 --> 02:19:20,304
IS TOGETHER A LONG TIME MIGHT 

3600
02:19:20,304 --> 02:19:22,372
ENCOUNTER AND BECAUSE OF THAT 

3601
02:19:22,372 --> 02:19:24,441
IRBS DO SET TERM LIMITS. 

3602
02:19:24,441 --> 02:19:27,611
WHEN AT SCHOOL OF PUBLIC HEALTH 

3603
02:19:27,611 --> 02:19:29,012
AT HOPKINS, YOU COULD SERVE FOR 

3604
02:19:29,012 --> 02:19:31,215
THREE YEARS AND ROTATE OFF AND 

3605
02:19:31,215 --> 02:19:33,784
GROUP WAS -- ALWAYS HAD SOME 

3606
02:19:33,784 --> 02:19:35,185
CARRYOVER AND NOT EVERYBODY'S 

3607
02:19:35,185 --> 02:19:36,720
TERM LIMIT ENDED AT THE SAME 

3608
02:19:36,720 --> 02:19:40,123
TIME AND WAS A WAY TO SORT OF 

3609
02:19:40,123 --> 02:19:42,759
ADDRESS BOTH MEETING THE 

3610
02:19:42,759 --> 02:19:45,629
EXPERTISE AND AVOIDING GRUPP 

3611
02:19:45,629 --> 02:19:46,864
THINK SORT OF ATTITUDES. 

3612
02:19:46,864 --> 02:19:51,635
WHY DO WE NEED THIS IRB?  I 

3613
02:19:51,635 --> 02:20:02,045
ELUDED TO THIS ALREADY. 

3614
02:20:08,252 --> 02:20:10,854
WHEN AN ACADEMIC MEDICAL CENTER 

3615
02:20:10,854 --> 02:20:13,290
SETS UP FEDERAL RIDE ASSURANCE 

3616
02:20:13,290 --> 02:20:14,124
WITH FEDERAL GOVERNMENT THEY SAY

3617
02:20:14,124 --> 02:20:16,093
IN DOCUMENTATION THAT I WILL 

3618
02:20:16,093 --> 02:20:19,830
REVIEW ALL RESEARCH AT MY 

3619
02:20:19,830 --> 02:20:20,664
INSTITUTION REGARDLESS OF THE 

3620
02:20:20,664 --> 02:20:26,169
SOURCE OF FUNDING AND MEANS THAT

3621
02:20:26,169 --> 02:20:29,072
AN ACADEMIC MEDICAL CENTER ALL 

3622
02:20:29,072 --> 02:20:31,341
RESEARCH WHETHER NIH OR GATES 

3623
02:20:31,341 --> 02:20:33,544
FUNDED OR SELF-FUNDED 

3624
02:20:33,544 --> 02:20:34,711
DISCRETIONARY FUND FUNDED, ET 

3625
02:20:34,711 --> 02:20:36,847
CETERA, IT IS ALL REVIEWED. 

3626
02:20:36,847 --> 02:20:38,916
YOU CAN'T ESCAPE, QUOTE ON 

3627
02:20:38,916 --> 02:20:41,919
QUOTE, THE REVIEW BY GETTING 

3628
02:20:41,919 --> 02:20:43,387
FUNDING FROM A SOURCE OTHER THAN

3629
02:20:43,387 --> 02:20:45,589
THE NATIONAL INSTITUTES OF 

3630
02:20:45,589 --> 02:20:48,992
HEALTH WHEN IN THE US AND FDA 

3631
02:20:48,992 --> 02:20:51,995
REQUIRES IRB REVIEW ALSO. 

3632
02:20:51,995 --> 02:20:53,430
PHARMACEUTICAL COMPANIES HOPING 

3633
02:20:53,430 --> 02:20:57,000
TO SEND A PACKAGE OF MATERIALS 

3634
02:20:57,000 --> 02:20:59,036
FOR MARKETING DRUG IN THE 

3635
02:20:59,036 --> 02:21:02,773
FUTURE, FDA WILL SAY DID YOU 

3636
02:21:02,773 --> 02:21:06,710
HAVE AN IRB REVIEW CLINICAL 

3637
02:21:06,710 --> 02:21:09,846
PROTOCALS AND NEED TO SAY OF 

3638
02:21:09,846 --> 02:21:12,049
COURSE I DID AND FEDERALWIDE 

3639
02:21:12,049 --> 02:21:13,917
ASSURANCE I MENTIONED AND 

3640
02:21:13,917 --> 02:21:16,987
REITERATES IDEA THAT YOU AGREE 

3641
02:21:16,987 --> 02:21:21,058
TO REVIEW ALL -- YOU REVIEW ALL 

3642
02:21:21,058 --> 02:21:21,992
RESEARCH REGARDLESS OF FUNDING 

3643
02:21:21,992 --> 02:21:26,863
AND TWO OTHER THINGS ABOUT THIS 

3644
02:21:26,863 --> 02:21:30,334
FWA AND ONE IS INSTITUTIONS 

3645
02:21:30,334 --> 02:21:33,270
OUTSIDE OF THE UNITED STATES CAN

3646
02:21:33,270 --> 02:21:40,577
REQUEST A FEDERALWIDE ASSURANCE 

3647
02:21:40,577 --> 02:21:42,946
THAT IS WEIRD AND HAPPENS AND 

3648
02:21:42,946 --> 02:21:44,481
YOU HAVE TO NOTE WHICH 

3649
02:21:44,481 --> 02:21:46,183
REGULATIONS OR ETHICAL CODE YOU 

3650
02:21:46,183 --> 02:21:48,151
WILL FOLLOW AND IN UNITED STATES

3651
02:21:48,151 --> 02:21:49,820
IT IS ALMOST ALWAYS THE BELMONT 

3652
02:21:49,820 --> 02:21:51,888
REPORT AND IN INTERNATIONAL 

3653
02:21:51,888 --> 02:21:53,457
ORGANIZATIONS, OFTEN THEY WILL 

3654
02:21:53,457 --> 02:21:57,494
SAY THE DECLARATION OF HELSINKI.

3655
02:21:57,494 --> 02:21:58,762
THEY DON'T HAVE THE BELMONT 

3656
02:21:58,762 --> 02:22:01,365
REPORT THAT IS US CENTRIC AND 

3657
02:22:01,365 --> 02:22:04,801
DECLARATION OF HELSINKI IS MEANT

3658
02:22:04,801 --> 02:22:06,436
TO BE INTERNATIONAL SET WHAT 

3659
02:22:06,436 --> 02:22:09,139
STANDARD YOU ARE USING AS YOUR 

3660
02:22:09,139 --> 02:22:10,807
BASELINE AND IN TERMS OF 

3661
02:22:10,807 --> 02:22:12,209
RESPONSIBILITIES DR. GRADY 

3662
02:22:12,209 --> 02:22:14,177
MENTIONED THEM QUICKLY AND THESE

3663
02:22:14,177 --> 02:22:16,113
ARE REVIEW CRITERIA IN THE 

3664
02:22:16,113 --> 02:22:19,683
FEDERAL REGULATIONS AND I WANT 

3665
02:22:19,683 --> 02:22:22,019
YOU TO NOTICE THAT THIS IS 

3666
02:22:22,019 --> 02:22:24,254
VERBATIM. 

3667
02:22:24,254 --> 02:22:25,288
OKAY?  

3668
02:22:25,288 --> 02:22:30,160
THIS IS ALL DIRECTION THAT IRB 

3669
02:22:30,160 --> 02:22:32,996
GETS AND RISK MINIMIZED AND 

3670
02:22:32,996 --> 02:22:36,533
REASONABLE WHEN COMPARED WITH 

3671
02:22:36,533 --> 02:22:40,237
BENEFIT AND IS LOTS OF 

3672
02:22:40,237 --> 02:22:41,371
DISCRETION AND RESPONSIBILITY ON

3673
02:22:41,371 --> 02:22:46,176
BEHALF OF IRB TO FIGURE OUT WHAT

3674
02:22:46,176 --> 02:22:49,212
ARE RISKS AND MINIMIZED AND 

3675
02:22:49,212 --> 02:22:51,615
REASONABLE AND WHAT ARE BENEFITS

3676
02:22:51,615 --> 02:22:53,417
AND REGULATIONS JUST DON'T GIVE 

3677
02:22:53,417 --> 02:22:55,085
IRBS A LOT OF HELP WHICH MEANS 

3678
02:22:55,085 --> 02:23:00,090
THAT MOST IRBS DEVELOP POLICIES 

3679
02:23:00,090 --> 02:23:03,393
FOR THEIR INVESTIGATORS AND IRB 

3680
02:23:03,393 --> 02:23:06,329
MEMBERS TO FOLLOW AND ARE 

3681
02:23:06,329 --> 02:23:09,433
ADDITIONAL REVIEW CRITERIA AND 

3682
02:23:09,433 --> 02:23:12,402
MOST IRBS WILL MAKE SURE THEY 

3683
02:23:12,402 --> 02:23:14,571
TICK A BOX RELATED TO EACH OF 

3684
02:23:14,571 --> 02:23:16,006
THESE THINGS THAT WE CHECKED AND

3685
02:23:16,006 --> 02:23:19,509
MADE SURE THAT EACH OF THESE 

3686
02:23:19,509 --> 02:23:23,113
THINGS IS TRUE CHECKING BEAU.   

3687
02:23:23,113 --> 02:23:26,183
THAT SAFETY AND MONITORING 

3688
02:23:26,183 --> 02:23:28,919
PROVISIONS ARE IN PLACE IS NOT 

3689
02:23:28,919 --> 02:23:31,621
LOOKING AT PROVISIONS AND YOU 

3690
02:23:31,621 --> 02:23:33,190
ARE IN FACT SURE THEY ARE 

3691
02:23:33,190 --> 02:23:36,293
ADEQUATE FOR MONITORING SAFETY 

3692
02:23:36,293 --> 02:23:46,737
AND THERE IS ADDITIONAL. 

3693
02:23:53,777 --> 02:23:59,683
IF A PROJECT IS FUNDED BY NIH 

3694
02:23:59,683 --> 02:24:01,818
IRB NEEDS TO MAKE SURE IT IS 

3695
02:24:01,818 --> 02:24:05,222
COMPLIANT WITH GUIDELINES AND 

3696
02:24:05,222 --> 02:24:08,425
STATES HAVE PARTICULAR LAWS FOR 

3697
02:24:08,425 --> 02:24:10,727
IRBS AND IN MARY LOIRND WE NEED 

3698
02:24:10,727 --> 02:24:15,365
TO KNOW WHAT STATE LAWS ARE AND 

3699
02:24:15,365 --> 02:24:16,233
CHRISTINE MENTIONED PULLED 

3700
02:24:16,233 --> 02:24:17,434
TOGETHER FOR NATIONAL RESEARCH 

3701
02:24:17,434 --> 02:24:20,670
ACT AND THEY PUT OUT A LOT OF 

3702
02:24:20,670 --> 02:24:21,571
RECOMMENDATIONS AND ALL 

3703
02:24:21,571 --> 02:24:24,274
SUBSEQUENT NATIONAL COMMISSIONS 

3704
02:24:24,274 --> 02:24:26,877
HAVE BIG CREATED BIG REPORTS AND

3705
02:24:26,877 --> 02:24:28,979
MANY ON SHELF IN MY OFFICE THAT 

3706
02:24:28,979 --> 02:24:30,347
ADD ADDITIONAL RECOMMENDATIONS. 

3707
02:24:30,347 --> 02:24:36,286
SO IT IS UP TO THE IRB TO DECIDE

3708
02:24:36,286 --> 02:24:37,954
WILL WE FOLLOW THOSE 

3709
02:24:37,954 --> 02:24:39,222
RECOMMENDATIONS AND USE THEM TO 

3710
02:24:39,222 --> 02:24:41,324
DRAFT OUR LOCAL POLICY AND 

3711
02:24:41,324 --> 02:24:43,727
PLENTY TO INCORPORATE. 

3712
02:24:43,727 --> 02:24:47,731
NOW, WHAT IRBS NEED TO DO IS 

3713
02:24:47,731 --> 02:24:48,298
REVIEW RESEARCH. 

3714
02:24:48,298 --> 02:24:51,668
THIS IS HOW RESEARCH IS DEFINED 

3715
02:24:51,668 --> 02:24:54,070
IN REGULATIONS AND SYSTEMATIC 

3716
02:24:54,070 --> 02:24:55,272
INVESTIGATION INCLUDING RESEARCH

3717
02:24:55,272 --> 02:24:56,940
DEVELOPMENT, TESTING, AND 

3718
02:24:56,940 --> 02:24:58,809
EVALUATION AND DESIGNED TO 

3719
02:24:58,809 --> 02:25:00,777
CONTRIBUTE TO GENERALIZABLE 

3720
02:25:00,777 --> 02:25:03,313
KNOWLEDGE AND SHOULD REMIND YOU 

3721
02:25:03,313 --> 02:25:04,848
OF SCIENTISTIC VALIDITY AND SO 

3722
02:25:04,848 --> 02:25:07,584
THE IDEA HERE IS THAT IF YOU ARE

3723
02:25:07,584 --> 02:25:09,452
DOING THIS, YOU HAVE TO GO TO 

3724
02:25:09,452 --> 02:25:11,488
THE IRB. 

3725
02:25:11,488 --> 02:25:14,191
NOW, THIS CREATES SOME CONCERNS.

3726
02:25:14,191 --> 02:25:18,028
SO I DO A LOT OF QUALITATIVE 

3727
02:25:18,028 --> 02:25:18,295
RESEARCH. 

3728
02:25:18,295 --> 02:25:20,564
MY INTENT IS NOT TO CONTRIBUTE 

3729
02:25:20,564 --> 02:25:23,300
TO GENERALIZABLE KNOWLEDGE AND 

3730
02:25:23,300 --> 02:25:25,836
I'M EXPLORING PHENOMENON TO 

3731
02:25:25,836 --> 02:25:28,538
IDENTIFY THEMES AND PATTERNS 

3732
02:25:28,538 --> 02:25:30,140
THAT MIGHT BE TRANSFERABLE TO 

3733
02:25:30,140 --> 02:25:32,375
ANOTHER SETTING AND AM I DOING 

3734
02:25:32,375 --> 02:25:33,476
RESEARCH?  

3735
02:25:33,476 --> 02:25:33,777
ABSOLUTELY. 

3736
02:25:33,777 --> 02:25:36,146
THIS IS WHAT IS WRITTEN IN THE 

3737
02:25:36,146 --> 02:25:38,181
CODE AND IRBS NEED TO THINK 

3738
02:25:38,181 --> 02:25:39,616
ABOUT WHAT DOES THAT REALLY MEAN

3739
02:25:39,616 --> 02:25:41,117
FOR MY INSTITUTION?  

3740
02:25:41,117 --> 02:25:42,886
IF PEOPLE LIKE HOLLY, I DON'T 

3741
02:25:42,886 --> 02:25:44,621
WANT HER RESEARCH NOT TO BE 

3742
02:25:44,621 --> 02:25:46,189
REVIEWED AND WE HAVE TO MAKE 

3743
02:25:46,189 --> 02:25:48,291
SURE EVERYONE KNOWS WE ARE 

3744
02:25:48,291 --> 02:25:50,193
REVIEWING QUALITATIVE WORK AS 

3745
02:25:50,193 --> 02:25:51,127
WELL. 

3746
02:25:51,127 --> 02:25:52,529
THESE ARE POTENTIAL CATEGORIES 

3747
02:25:52,529 --> 02:25:55,065
THAT IRB WILL APPLY TO YOUR 

3748
02:25:55,065 --> 02:25:57,567
RESEARCH AND ONE, THEY CAN SAY 

3749
02:25:57,567 --> 02:26:01,571
IT IS NOT HUMAN SUBJECT RESEARCH

3750
02:26:01,571 --> 02:26:03,173
AND THEREFORE NOT REQUIRED TO 

3751
02:26:03,173 --> 02:26:05,275
FOLLOW ALL RULES AND REGULATIONS

3752
02:26:05,275 --> 02:26:07,210
AND SOME RESEARCH IS EXEMPT FROM

3753
02:26:07,210 --> 02:26:08,144
IRB REVIEW. 

3754
02:26:08,144 --> 02:26:09,946
YOU STILL HAVE TO SUBMIT YOUR 

3755
02:26:09,946 --> 02:26:13,516
RESEARCH TO THE IRB FOR THEM TO 

3756
02:26:13,516 --> 02:26:14,684
DETERMINE IT IS EXEMPT. 

3757
02:26:14,684 --> 02:26:18,288
ONE THING THAT ALL OF THE 

3758
02:26:18,288 --> 02:26:21,992
CATEGORIES HAVE IN COMMON IS IT 

3759
02:26:21,992 --> 02:26:24,694
IS NO MORE THAN MINIMAL RISK AND

3760
02:26:24,694 --> 02:26:27,364
MEETS THE CRITERIA AND ONE MOST 

3761
02:26:27,364 --> 02:26:29,332
RELEVANT TO ME AND MY COLLEAGUES

3762
02:26:29,332 --> 02:26:31,501
HERE AT DEPARTMENT OF BIOETHICS 

3763
02:26:31,501 --> 02:26:33,937
IS IT IS DATA COLLECTED WITHOUT 

3764
02:26:33,937 --> 02:26:35,272
IDENTIFIERS AND IF I DID A 

3765
02:26:35,272 --> 02:26:37,774
SURVEY OF ALL OF YOU ABOUT WHAT 

3766
02:26:37,774 --> 02:26:39,376
YOU ATE FOR BREAKFAST THIS 

3767
02:26:39,376 --> 02:26:40,810
MORNING AND SOCIAL VALUE QUITE 

3768
02:26:40,810 --> 02:26:41,044
LOW. 

3769
02:26:41,044 --> 02:26:43,313
I WOULD SAY WE WILL DO THIS. 

3770
02:26:43,313 --> 02:26:44,681
I WON'T COLLECT YOUR NAMES BUT 

3771
02:26:44,681 --> 02:26:46,950
WANT YOU TO ANSWER THE 

3772
02:26:46,950 --> 02:26:47,350
QUESTIONS. 

3773
02:26:47,350 --> 02:26:48,718
THAT WOULD QUALIFY AS EXEMPT 

3774
02:26:48,718 --> 02:26:50,387
FROM IRB REVIEW. 

3775
02:26:50,387 --> 02:26:52,088
THOUGH THEY SHOULDN'T APPROVE IT

3776
02:26:52,088 --> 02:26:54,090
BECAUSE THERE IS NO SOCIAL 

3777
02:26:54,090 --> 02:26:54,324
VALUE. 

3778
02:26:54,324 --> 02:26:57,127
THE NEXT CATEGORY IS EXPEDITED 

3779
02:26:57,127 --> 02:26:59,129
REVIEW AND EXPEDITED IN THIS 

3780
02:26:59,129 --> 02:27:00,463
CASE DOESN'T MEAN FASTER. 

3781
02:27:00,463 --> 02:27:03,066
IT MEANS THAT THE RESEARCH THAT 

3782
02:27:03,066 --> 02:27:05,602
YOU ARE SUBMITTING IS NO MORE 

3783
02:27:05,602 --> 02:27:06,603
THAN MINIMAL RISK. 

3784
02:27:06,603 --> 02:27:09,873
IT CAN BE REVIEWED BY A 

3785
02:27:09,873 --> 02:27:11,541
CHAIRPERSON OR EXPERIENCED 

3786
02:27:11,541 --> 02:27:13,543
REVIEWER AND TECHNICALLY COULD 

3787
02:27:13,543 --> 02:27:15,946
BE FASTER AND IS NOT ALWAYS 

3788
02:27:15,946 --> 02:27:16,379
FASTER. 

3789
02:27:16,379 --> 02:27:17,814
THE FINAL AND SORT OF MOST 

3790
02:27:17,814 --> 02:27:20,016
IMPORTANT CATEGORY IS -- WHEN IT

3791
02:27:20,016 --> 02:27:22,185
COMES TO ICHT RB IS RESEARCH 

3792
02:27:22,185 --> 02:27:24,321
THAT HAS MORE THAN MINIMAL RISK 

3793
02:27:24,321 --> 02:27:27,223
AND IF RESEARCH HAS MORE THAN 

3794
02:27:27,223 --> 02:27:29,626
MINIMAL RISK THAT IS PHYSICAL OR

3795
02:27:29,626 --> 02:27:30,527
PSYCHOLOGICAL, ET CETERA, IT HAS

3796
02:27:30,527 --> 02:27:34,431
TO BE REVIEWED BY A FULL 

3797
02:27:34,431 --> 02:27:34,864
COMMITTEE. 

3798
02:27:34,864 --> 02:27:37,467
AND THAT INITIAL PROTOCOL THAT 

3799
02:27:37,467 --> 02:27:41,104
YOU SUBMIT GOES THROUGH FIRST AN

3800
02:27:41,104 --> 02:27:43,139
INITIAL ADMINISTRATIVE REVIEW 

3801
02:27:43,139 --> 02:27:44,708
AND THIS LITTLE DIAGRAM HERE IS 

3802
02:27:44,708 --> 02:27:50,180
TO HIGHLIGHT THAT THE IRB IS 

3803
02:27:50,180 --> 02:27:53,049
SEPARATE FROM THE ADMINISTRATIVE

3804
02:27:53,049 --> 02:27:54,951
STAFF STAFFING HUMAN RESEARCH 

3805
02:27:54,951 --> 02:27:56,987
PROGRAM AND ARE REVIEWING 

3806
02:27:56,987 --> 02:27:58,321
RESEARCH PLAN AND ANYTHING THAT 

3807
02:27:58,321 --> 02:28:02,192
THE POTENTIAL SUBJECT WILL SEE 

3808
02:28:02,192 --> 02:28:05,762
THAT INCLUDES CONSENT AND 

3809
02:28:05,762 --> 02:28:07,731
ADVERTISEMENTS AND THEY 

3810
02:28:07,731 --> 02:28:09,366
COORDINATE ALSO OTHER ANCILLARY 

3811
02:28:09,366 --> 02:28:12,068
REVIEWS AND IF REVIEW OF 

3812
02:28:12,068 --> 02:28:14,070
PHARMACEUTICALS OR REVIEW OF 

3813
02:28:14,070 --> 02:28:15,939
RADIATION OR OF CONFLICT OF 

3814
02:28:15,939 --> 02:28:17,307
INTEREST, THIS GROUP IS 

3815
02:28:17,307 --> 02:28:18,341
COORDINATING THAT REVIEW THAT 

3816
02:28:18,341 --> 02:28:22,012
WILL BE RELEVANT IN A SECOND. 

3817
02:28:22,012 --> 02:28:24,748
RESEARCH GOES TO THE IRB AND 

3818
02:28:24,748 --> 02:28:27,183
THEY DELIBERATE.  AGAIN, THAT IS

3819
02:28:27,183 --> 02:28:29,185
THIS GREW OF EXPERTS AND THERE 

3820
02:28:29,185 --> 02:28:30,754
ARE AT LEAST FIVE OF THEM AND 

3821
02:28:30,754 --> 02:28:36,192
THEY CAN DO A COUPLE THINGS AND 

3822
02:28:36,192 --> 02:28:37,761
APPROVE WITH STIPULATIONS AND 

3823
02:28:37,761 --> 02:28:39,295
DEFER OR DISAPPROVE. 

3824
02:28:39,295 --> 02:28:43,633
IN MY EXPERIENCE, IRBS ALMOST 

3825
02:28:43,633 --> 02:28:45,168
NEVER DISAPPROVE. 

3826
02:28:45,168 --> 02:28:47,637
PART OF THAT IS BECAUSE 

3827
02:28:47,637 --> 02:28:48,671
INVESTIGATORS THESE DAYS KNOW 

3828
02:28:48,671 --> 02:28:50,907
THAT THEIR RESEARCH HAS TO SORT 

3829
02:28:50,907 --> 02:28:52,876
OF BE AT A PARTICULAR STANDARD 

3830
02:28:52,876 --> 02:28:56,312
IN ORDER TO EVEN BE CONSIDERED. 

3831
02:28:56,312 --> 02:28:59,082
SOME RESEARCH IS DEFERRED WHEN 

3832
02:28:59,082 --> 02:29:02,819
THERE IS SORT OF A BIG PROBLEM 

3833
02:29:02,819 --> 02:29:05,188
ON ITS WAY TO APPROVAL AND THEY 

3834
02:29:05,188 --> 02:29:07,490
FORGOT TO TALK ABOUT HOW THEY 

3835
02:29:07,490 --> 02:29:09,059
ARE RECRUITING THEIR SUBJECTS OR

3836
02:29:09,059 --> 02:29:10,493
FORGOT TO INCLUDE INFORMATION 

3837
02:29:10,493 --> 02:29:12,729
ABOUT RISKS THAT THEY WILL 

3838
02:29:12,729 --> 02:29:14,864
EXPOSE SUBJECTS TO.  

3839
02:29:14,864 --> 02:29:17,834
APPROVE WITH STIPULATIONS MIGHT 

3840
02:29:17,834 --> 02:29:18,935
BE SOMETHING AS STRAIGHT FORWARD

3841
02:29:18,935 --> 02:29:21,638
AS YOU ARE APPROVED AND YOU HAVE

3842
02:29:21,638 --> 02:29:23,873
TO EXCEPT REVISIONS WE MADE TO 

3843
02:29:23,873 --> 02:29:26,176
YOUR CONSENT FORM AND STRAIGHT 

3844
02:29:26,176 --> 02:29:30,180
UP APPROVAL IS ALSO VERY SELDOM 

3845
02:29:30,180 --> 02:29:40,356
THE CASE. 

3846
02:29:35,991 --> 02:29:38,794
WHEN I WAS AT SCHOOL OF PUBLIC 

3847
02:29:38,794 --> 02:29:41,897
HEALTH AT JOHN'S HOPKINS YOU ARE

3848
02:29:41,897 --> 02:29:43,232
ALL TOO YOUNG TO PROBABLY 

3849
02:29:43,232 --> 02:29:45,401
REMEMBER THIS BUT SCHOOL OF 

3850
02:29:45,401 --> 02:29:47,570
MEDICINE AT JOHN'S HOPKINS WAS 

3851
02:29:47,570 --> 02:29:50,806
CLOSED AND IRB SHUT DOWN AFTER A

3852
02:29:50,806 --> 02:29:52,675
HEALTHY VOLUNTEER DIED IN AN 

3853
02:29:52,675 --> 02:29:54,944
ASTHMA STUDY AND ONE OF THE 

3854
02:29:54,944 --> 02:29:56,946
THINGS THEY SAID OH, HRP WHO 

3855
02:29:56,946 --> 02:29:59,081
CLOSED IT DOWN SAID IS YOU HAVE 

3856
02:29:59,081 --> 02:30:01,083
TO REREVIEW ALL OF THE RESEARCH 

3857
02:30:01,083 --> 02:30:03,386
ARE YOU CONDUCTING AND THOUSANDS

3858
02:30:03,386 --> 02:30:06,555
OF PROTOCOLS AND SUBSET OF THOSE

3859
02:30:06,555 --> 02:30:10,659
WERE BEING CONDUCTED BY SCHOOL 

3860
02:30:10,659 --> 02:30:12,328
OF PUBLIC HEALTH FACULTY AND I 

3861
02:30:12,328 --> 02:30:14,697
WAS ON THE GROUP THAT HAD TO -- 

3862
02:30:14,697 --> 02:30:18,067
THAT GOT TO REVIEW ALL THAT 

3863
02:30:18,067 --> 02:30:19,201
RESEARCH AND THERE WERE MORE 

3864
02:30:19,201 --> 02:30:21,837
THAN 50 PROTOCOLS AND WE 

3865
02:30:21,837 --> 02:30:23,305
APPROVED ONE WITHOUT 

3866
02:30:23,305 --> 02:30:24,573
STIPULATIONS AND ALL OTHERS HAD 

3867
02:30:24,573 --> 02:30:26,509
SOME SORT OF STIPULATION WE 

3868
02:30:26,509 --> 02:30:28,944
WANTED CHANGED AND ALL TO SAY 

3869
02:30:28,944 --> 02:30:30,946
THAT MOST RESEARCH IS GOING TO 

3870
02:30:30,946 --> 02:30:32,415
BE APPROVED WITH STIPULATIONS 

3871
02:30:32,415 --> 02:30:34,116
AND THERE WILL BE SOMETHING THAT

3872
02:30:34,116 --> 02:30:36,852
THE IRB WILL WANT YOU TO DO. 

3873
02:30:36,852 --> 02:30:39,989
THE OTHER THINGS THAT IRBS DO IS

3874
02:30:39,989 --> 02:30:42,458
THEY ARE IN CHARGE OF CONTINUING

3875
02:30:42,458 --> 02:30:43,092
REVIEW. 

3876
02:30:43,092 --> 02:30:45,394
SO, FOR THOSE PROTOCOLS REVIEWED

3877
02:30:45,394 --> 02:30:47,930
BY A FULL COMMITTEE, 

3878
02:30:47,930 --> 02:30:48,597
INVESTIGATORS HAVE TO COME BACK 

3879
02:30:48,597 --> 02:30:51,467
TO THE IRB AND GIVE AN UPDATE. 

3880
02:30:51,467 --> 02:30:54,770
IF YOU CHANGE YOUR STUDY AND THE

3881
02:30:54,770 --> 02:30:56,939
GENERAL RULE IS IF YOU WILL 

3882
02:30:56,939 --> 02:30:59,742
CHANGE THE RISK BENEFIT 

3883
02:30:59,742 --> 02:31:01,076
ASSESSMENT FOR THE SUBJECTS, 

3884
02:31:01,076 --> 02:31:03,512
THEN YOU HAVE TO AMEND YOUR 

3885
02:31:03,512 --> 02:31:03,746
STUDY. 

3886
02:31:03,746 --> 02:31:06,382
FOR EXAMPLE, IF YOU ARE DOING --

3887
02:31:06,382 --> 02:31:09,852
IMAGINE YOU ARE DOING A STUDY 

3888
02:31:09,852 --> 02:31:11,987
WHERE YOU HAVE -- YOUR PLAN IS 

3889
02:31:11,987 --> 02:31:16,492
TO TAKE ONE BIOPSY FROM A COLON.

3890
02:31:16,492 --> 02:31:19,395
DURING A CLINICALLY INDICATED 

3891
02:31:19,395 --> 02:31:22,031
COLONOSCOPY AND YOU REALIZE THAT

3892
02:31:22,031 --> 02:31:23,999
IS NOT ENOUGH AND YOU NEED A 

3893
02:31:23,999 --> 02:31:25,100
SECOND SAMPLE. 

3894
02:31:25,100 --> 02:31:27,036
THAT WOULD CLEARLY SHIFT THE 

3895
02:31:27,036 --> 02:31:29,972
RISK BENEFIT BALANCE FOR THE 

3896
02:31:29,972 --> 02:31:30,372
PARTICIPANTS. 

3897
02:31:30,372 --> 02:31:32,775
YOU WOULD HAVE TO AMEND YOUR 

3898
02:31:32,775 --> 02:31:33,042
STUDY. 

3899
02:31:33,042 --> 02:31:34,743
AND SEND THAT TO THE IRB AND 

3900
02:31:34,743 --> 02:31:37,112
THEY HAVE TO APPROVE IT BEFORE 

3901
02:31:37,112 --> 02:31:42,785
YOU COULD ACTUALLY EXPOSE ANYONE

3902
02:31:42,785 --> 02:31:44,720
TO THAT SECOND BIOPSY. 

3903
02:31:44,720 --> 02:31:47,690
I WANT TO SEND A MINUTE, 2 OR 3 

3904
02:31:47,690 --> 02:31:49,558
MINUTES ON A PRESENT POLICY 

3905
02:31:49,558 --> 02:31:50,326
ISSUE. 

3906
02:31:50,326 --> 02:31:52,561
A NUMBER OF YEARS AGO BOTH THE 

3907
02:31:52,561 --> 02:31:58,534
NIH AND HHS PUT IN POLICY THAT 

3908
02:31:58,534 --> 02:32:01,670
SAID IF YOU ARE CONDUCTING 

3909
02:32:01,670 --> 02:32:02,271
MULTISIELT RESEARCH IN THE 

3910
02:32:02,271 --> 02:32:03,706
UNITED STATES YOU NEED OR CAN OR

3911
02:32:03,706 --> 02:32:08,577
NEED TO IDENTIFY A SINGLE IRB OF

3912
02:32:08,577 --> 02:32:09,478
RECORD. 

3913
02:32:09,478 --> 02:32:11,981
BACK TO MY LITTLE DIAGRAM HERE, 

3914
02:32:11,981 --> 02:32:14,683
BEFORE THE SINGLE IRB POLICY, IF

3915
02:32:14,683 --> 02:32:17,853
YOU ARE CONDUCTING A MULTICENTER

3916
02:32:17,853 --> 02:32:19,989
TRIAL AND HERE I HAVE FIVE SITES

3917
02:32:19,989 --> 02:32:21,724
AND COORDINATING CENTER.  THIS 

3918
02:32:21,724 --> 02:32:24,760
IS SORT OF, YOU KNOW, THIS IS 

3919
02:32:24,760 --> 02:32:27,997
LIKE MANY TRIALS.  IT IS LIKE AN

3920
02:32:27,997 --> 02:32:28,998
AVERAGE ONCOLOGY TRIAL OR 

3921
02:32:28,998 --> 02:32:31,100
SOMETHING AND YOU HAVE A 

3922
02:32:31,100 --> 02:32:34,103
COORDINATING CENTER AND FIVE 

3923
02:32:34,103 --> 02:32:35,638
SITES RECREWING CANCER PATIENTS 

3924
02:32:35,638 --> 02:32:37,106
INTO THE STUDY AND MEANT THAT 

3925
02:32:37,106 --> 02:32:39,975
YOU WOULD HAVE ONE IRB REVIEW BY

3926
02:32:39,975 --> 02:32:42,878
THE COORDINATING CENTER AND FIVE

3927
02:32:42,878 --> 02:32:44,813
IRB REVIEWS THAT EACH OF THE 

3928
02:32:44,813 --> 02:32:46,682
SITES WOULD DO ON AND IT ADDED 

3929
02:32:46,682 --> 02:32:48,050
UP TO 6. 

3930
02:32:48,050 --> 02:32:50,252
INVESTIGATORS DID NOT LIKE THIS 

3931
02:32:50,252 --> 02:32:50,886
AT ALL. 

3932
02:32:50,886 --> 02:32:53,689
IT CREATED DELAYS THAT MEANT 

3933
02:32:53,689 --> 02:32:55,157
THAT THEY COULDN'T DO THEIR 

3934
02:32:55,157 --> 02:32:57,993
RESEARCH AND IDENTIFY THE MOST 

3935
02:32:57,993 --> 02:33:01,063
APPROPRIATE EFFECTIVE 

3936
02:33:01,063 --> 02:33:01,597
INTERVENTION, ET CETERA. 

3937
02:33:01,597 --> 02:33:07,002
SO IN RESPONSE, NIH AND HHS 

3938
02:33:07,002 --> 02:33:08,671
DECIDED THAT THEY WOULD REQUIRE 

3939
02:33:08,671 --> 02:33:11,240
THAT THERE BE A SINGLE IRB OF 

3940
02:33:11,240 --> 02:33:11,473
RECORD. 

3941
02:33:11,473 --> 02:33:13,442
NOW WHAT THIS MEANS IS THE 

3942
02:33:13,442 --> 02:33:16,345
COORDINATING CENTER OR IRB OR 

3943
02:33:16,345 --> 02:33:19,515
INSTITUTION DESIGNATED CONDUCTS 

3944
02:33:19,515 --> 02:33:22,418
ONE IRB REVIEW AND FIVE 

3945
02:33:22,418 --> 02:33:24,453
INDIVIDUAL SITES SAY TO THAT IRB

3946
02:33:24,453 --> 02:33:27,289
THAT WE WILL DO WHATEVER YOU 

3947
02:33:27,289 --> 02:33:27,856
SAY. 

3948
02:33:27,856 --> 02:33:30,359
YOUR APPROVAL WILL BE OUR 

3949
02:33:30,359 --> 02:33:30,626
APPROVAL. 

3950
02:33:30,626 --> 02:33:32,194
NOW, ONE CHALLENGE WITH THAT, 

3951
02:33:32,194 --> 02:33:34,897
THAT I TRIED TO CONVEY WITH 

3952
02:33:34,897 --> 02:33:36,899
LITTLE LINES IS THAT, THAT 

3953
02:33:36,899 --> 02:33:38,834
DOESN'T RELIEVE THAT LOCAL 

3954
02:33:38,834 --> 02:33:40,269
INSTITUTIONS FROM DOING ALL OF 

3955
02:33:40,269 --> 02:33:42,204
THE OTHER REVIEWS AND CONFLICT 

3956
02:33:42,204 --> 02:33:46,408
OF INTEREST AND RADIATION AND 

3957
02:33:46,408 --> 02:33:46,775
PHARMACEUTICAL. 

3958
02:33:46,775 --> 02:33:48,877
SO THE POLICY HAS BEEN IN PLACE 

3959
02:33:48,877 --> 02:33:50,546
FOR A NUMBER OF YEARS NOW AND 

3960
02:33:50,546 --> 02:33:52,781
ARE EVALUATIONS THAT ARE 

3961
02:33:52,781 --> 02:33:54,950
UNDERWAY AND OUTCOMES ARE 

3962
02:33:54,950 --> 02:33:56,151
UNCLEAR WHETHER IT IN FACT MAKES

3963
02:33:56,151 --> 02:33:59,121
THE SYSTEM MORE EFFICIENT. 

3964
02:33:59,121 --> 02:34:02,124
AND THERE HAS BEEN A LOT OF WORK

3965
02:34:02,124 --> 02:34:03,592
IN DEVELOPING THINGS LIKE THE 

3966
02:34:03,592 --> 02:34:08,497
SMART IRB WHICH IS A WAY THAT 

3967
02:34:08,497 --> 02:34:09,798
INDIVIDUAL INSTITUTIONS CAN 

3968
02:34:09,798 --> 02:34:11,400
LEARN ABOUT HOW TO BEST 

3969
02:34:11,400 --> 02:34:15,471
COORDINATE WITH OTHER SITES. 

3970
02:34:15,471 --> 02:34:17,573
SO, WE WILL SEE WHERE IT GOES 

3971
02:34:17,573 --> 02:34:19,975
AND THAT IS A CURRENT ISSUE IN 

3972
02:34:19,975 --> 02:34:21,610
IRB POLICY. 

3973
02:34:21,610 --> 02:34:23,979
HERE IS MY SUMMARY SLIDE. 

3974
02:34:23,979 --> 02:34:25,948
WHEN IN DOUBT ABOUT YOUR 

3975
02:34:25,948 --> 02:34:28,984
RESEARCH, ASK YOUR LOCAL 

3976
02:34:28,984 --> 02:34:30,152
COMMITTEE.  THEY ARE THE BEST 

3977
02:34:30,152 --> 02:34:31,954
SITUATED TO ANSWER ANY OF YOUR 

3978
02:34:31,954 --> 02:34:32,721
QUESTIONS. 

3979
02:34:32,721 --> 02:34:34,156
SO THAT IS IT FOR ME. 

3980
02:34:34,156 --> 02:34:36,925
I AM NOW GOING TO TAKE QUESTIONS

3981
02:34:36,925 --> 02:34:38,494
FOR THE NEXT 20 MINUTES WHICH 

3982
02:34:38,494 --> 02:34:39,995
MEANS I WILL GO OVER THERE AND 

3983
02:34:39,995 --> 02:34:42,264
GET MY COMPUTER TO SEE IF ANYONE

3984
02:34:42,264 --> 02:34:44,800
OUT IN VIDEO LAND IS ASKING A 

3985
02:34:44,800 --> 02:34:45,401
QUESTION. 

3986
02:34:45,401 --> 02:34:48,804
FEEL FREE FOR THOSE HERE TO GO 

3987
02:34:48,804 --> 02:34:51,974
TO THE MICROPHONES AND ASK 

3988
02:34:51,974 --> 02:34:52,708
QUESTIONS. 

3989
02:34:52,708 --> 02:34:54,543
GREAT.  JONATHAN, GO AHEAD. 

3990
02:34:54,543 --> 02:34:57,379
>> HI.  THANKS, HOLLY, FOR

3991
02:34:57,379 --> 02:34:57,680
EVERYTHING. 

3992
02:34:57,680 --> 02:34:59,715
I WAS WONDERING IF THERE HAS 

3993
02:34:59,715 --> 02:35:02,317
BEEN ANY TALK OF USING AI 

3994
02:35:02,317 --> 02:35:05,688
SOMEHOW IN IRBS ESPECIALLY TO 

3995
02:35:05,688 --> 02:35:07,089
MAYBE EXPEDITE THINGS OR I DON'T

3996
02:35:07,089 --> 02:35:09,391
KNOW IF THERE IS ANYTHING THAT 

3997
02:35:09,391 --> 02:35:10,392
AI COULD DO BUT. 

3998
02:35:10,392 --> 02:35:11,960
>> SHORT ANSWER IS YES. 

3999
02:35:11,960 --> 02:35:14,463
THERE IS A LOT OF CHATTER FOR 

4000
02:35:14,463 --> 02:35:18,934
LACK OF A BETTER WORD AND OF 

4001
02:35:18,934 --> 02:35:21,403
USING AI TO DO A VARIETY OF 

4002
02:35:21,403 --> 02:35:23,305
THINGS AND HEARD THE TAIL END OF

4003
02:35:23,305 --> 02:35:26,442
A TALK THE OTHER DAY. 

4004
02:35:26,442 --> 02:35:27,976
YOU WILL LEARN NEXT WEEK THAT 

4005
02:35:27,976 --> 02:35:31,980
THERE IS A NEW REQUIREMENT AS IT

4006
02:35:31,980 --> 02:35:33,982
RELATES TO INFORMED CONSENT FORM

4007
02:35:33,982 --> 02:35:37,386
THAT AT THE VERY TOP OF THE FORM

4008
02:35:37,386 --> 02:35:39,621
THERE IS KEY INFORMATION THAT IS

4009
02:35:39,621 --> 02:35:40,389
THE MOST IMPORTANT INFORMATION 

4010
02:35:40,389 --> 02:35:43,926
THAT THE POTENTIAL PARTICIPANT 

4011
02:35:43,926 --> 02:35:44,460
SHOULD KNOW. 

4012
02:35:44,460 --> 02:35:47,229
AND SO A GROUP AT THE UNIVERSITY

4013
02:35:47,229 --> 02:35:49,465
OF MICHIGAN HAS BASICALLY 

4014
02:35:49,465 --> 02:35:52,668
CREATED A WAY WITH QUERIES TO 

4015
02:35:52,668 --> 02:35:55,571
CHATGPT 4 OR 5 OR 6 TO SAY, HERE

4016
02:35:55,571 --> 02:35:58,574
IS THE CONCEPT FORM. 

4017
02:35:58,574 --> 02:36:01,076
PLEASE PULL OUT THE KEY 

4018
02:36:01,076 --> 02:36:03,979
INFORMATION AND PUT IT IN A 

4019
02:36:03,979 --> 02:36:06,782
READABLE, YOU KNOW, EIGHTH GRADE

4020
02:36:06,782 --> 02:36:08,917
LANGUAGE AND THEY BETA TESTED 

4021
02:36:08,917 --> 02:36:10,486
THAT FOR A WHILE AND HAVEN'T 

4022
02:36:10,486 --> 02:36:14,923
ADOPTED IT AS A SERVICE FOR ALL 

4023
02:36:14,923 --> 02:36:17,126
INVESTIGA

4024
02:36:17,126 --> 02:36:17,493
INVESTIGATORS. 

4025
02:36:17,493 --> 02:36:19,828
THAT IS ONE WAY INVESTIGATORS 

4026
02:36:19,828 --> 02:36:22,965
ARE USING IT TO SUPPLY WITH 

4027
02:36:22,965 --> 02:36:24,767
REGULATIONS AND HAS BEEN CHATTER

4028
02:36:24,767 --> 02:36:27,636
ABOUT COULD YOU USE AI TO DO 

4029
02:36:27,636 --> 02:36:30,439
THAT ADMINISTRATIVE REVIEW, FOR 

4030
02:36:30,439 --> 02:36:30,706
EXAMPLE. 

4031
02:36:30,706 --> 02:36:32,808
THIS IS THE PROTOCOL AND MAKE 

4032
02:36:32,808 --> 02:36:34,643
SURE IT HAS ALL 7 COMPONENTS AND

4033
02:36:34,643 --> 02:36:36,011
THAT THERE IS SOMETHING THAT 

4034
02:36:36,011 --> 02:36:37,079
MAKES SENSE BELOW. 

4035
02:36:37,079 --> 02:36:40,415
THERE IS A LOT OF IDEAS AND IS 

4036
02:36:40,415 --> 02:36:42,251
NOT YET ANY CHATTER ABOUT 

4037
02:36:42,251 --> 02:36:45,954
REPLACING THE IRB WITH AI BUT 

4038
02:36:45,954 --> 02:36:47,456
WHO KNOWS. 

4039
02:36:47,456 --> 02:36:49,625
>> HI, DANIELLE. 

4040
02:36:49,625 --> 02:36:51,894
>> HI.  THIS IS SUPER 

4041
02:36:51,894 --> 02:36:52,227
INTERESTING. 

4042
02:36:52,227 --> 02:36:55,798
MY QUESTION IS ABOUT YOU 

4043
02:36:55,798 --> 02:36:58,400
MENTIONED THAT IRBS VARY IN 

4044
02:36:58,400 --> 02:37:01,103
TERMS OF PRACTICE AND POLICY 

4045
02:37:01,103 --> 02:37:03,672
BESIDES BEING BEHOLDENED TO 

4046
02:37:03,672 --> 02:37:05,440
FEDERAL REGULATIONS AND CURIOUS 

4047
02:37:05,440 --> 02:37:07,476
HOW MUCH THEY VARY FROM 

4048
02:37:07,476 --> 02:37:08,477
INSTITUTION TO INSTITUTION. 

4049
02:37:08,477 --> 02:37:09,111
>> YEAH. 

4050
02:37:09,111 --> 02:37:10,746
>> DO THEY LOOK VASTLY
DIFFERENT

4051
02:37:10,746 --> 02:37:13,448
OR GENERALLY PRETTY SIMILAR?  

4052
02:37:13,448 --> 02:37:14,416
>> GREAT QUESTION. 

4053
02:37:14,416 --> 02:37:16,652
SHORT ANSWER IS IT IS A BIT OF A

4054
02:37:16,652 --> 02:37:18,353
BELL CURVE; RIGHT?  

4055
02:37:18,353 --> 02:37:21,023
A REALLY GOOD EXAMPLE IS WHEN 

4056
02:37:21,023 --> 02:37:23,992
YOU ARE DOING PEDIATRIC 

4057
02:37:23,992 --> 02:37:28,564
RESEARCH, THE IRB MUST 

4058
02:37:28,564 --> 02:37:30,532
CATEGORIZE RESEARCH AS NO MORE 

4059
02:37:30,532 --> 02:37:33,502
THAN MINIMAL RISK OR MORE THAN 

4060
02:37:33,502 --> 02:37:36,705
MINIMAL RISK WITH A PROSPECT OF 

4061
02:37:36,705 --> 02:37:38,207
DIRECT BENEFIT AND MORE THAN 

4062
02:37:38,207 --> 02:37:40,008
MINIMAL RISK AND POTENTIAL 

4063
02:37:40,008 --> 02:37:41,510
BENEFIT TO THE GROUP OF CHILDREN

4064
02:37:41,510 --> 02:37:43,645
THAT ARE REPRESENTED BY THE 

4065
02:37:43,645 --> 02:37:46,048
POPULATION THAT YOU ARE 

4066
02:37:46,048 --> 02:37:46,348
ENROLLING. 

4067
02:37:46,348 --> 02:37:47,883
SO THAT DEFINITION OF MINIMAL 

4068
02:37:47,883 --> 02:37:50,252
RISK IS REALLY IMPORTANT AS IT 

4069
02:37:50,252 --> 02:37:52,688
RELATES TO WHAT CATEGORY OF 

4070
02:37:52,688 --> 02:37:54,323
RESEARCH IT IS.  

4071
02:37:54,323 --> 02:37:56,458
IF THERE IS A LOT -- IF THERE IS

4072
02:37:56,458 --> 02:37:58,360
A LOT OF RISK, THERE HAS TO BE 

4073
02:37:58,360 --> 02:37:59,995
DIRECT BENEFIT. 

4074
02:37:59,995 --> 02:38:01,964
IN THE THIRD CATEGORY, YOU KNOW,

4075
02:38:01,964 --> 02:38:04,233
YOU HAVE TO BE ABLE TO SAY, 

4076
02:38:04,233 --> 02:38:06,602
WELL, WHAT -- HOW MUCH RISK IS 

4077
02:38:06,602 --> 02:38:11,840
TOO MUCH TO EXPOSE, ET CETERA?  

4078
02:38:11,840 --> 02:38:18,347
SO SIMA SHAW A FELL FOE IN 

4079
02:38:18,347 --> 02:38:21,016
DEPARTMENT OF BIOMEDICAL ETHICS 

4080
02:38:21,016 --> 02:38:23,318
ASKED IRBS FOR PEDIATRIC 

4081
02:38:23,318 --> 02:38:25,354
RESEARCH HOW DO YOU DEFINE 

4082
02:38:25,354 --> 02:38:26,955
MINIMAL RISK?  

4083
02:38:26,955 --> 02:38:29,625
THIS IS A LIST OF POTENTIAL 

4084
02:38:29,625 --> 02:38:31,293
THINGS AND WHICH WOULD YOU CALL 

4085
02:38:31,293 --> 02:38:34,630
MINIMAL RISK OR NOT?  

4086
02:38:34,630 --> 02:38:37,132
BLOOD DRAW UP TO A LUMBAR 

4087
02:38:37,132 --> 02:38:39,635
PUNCTURE OR TAKE AN AMOUNT OF 

4088
02:38:39,635 --> 02:38:41,336
BLOOD; RIGHT?  

4089
02:38:41,336 --> 02:38:43,105
SHE SORT OF SAID. 

4090
02:38:43,105 --> 02:38:44,840
BOTTOM LINE THERE WAS LOTS OF 

4091
02:38:44,840 --> 02:38:46,341
VARIATION AND IT WAS A BELL 

4092
02:38:46,341 --> 02:38:48,010
CURVE AND SOME IRBS WOULD SAY 

4093
02:38:48,010 --> 02:38:51,780
NONE OF THAT IS MINIMAL RISK AND

4094
02:38:51,780 --> 02:38:53,882
A SIMPLE BLOOD DRAW WHERE AT 

4095
02:38:53,882 --> 02:38:55,851
OTHER END LUMBAR PUNCTURE, NO.  

4096
02:38:55,851 --> 02:38:56,485
NOT AGAIN. 

4097
02:38:56,485 --> 02:38:58,020
THAT IS A LITTLE EXTREME. 

4098
02:38:58,020 --> 02:39:01,123
BUT YOU GET THE IDEA. 

4099
02:39:01,123 --> 02:39:03,158
SO, IT IS WITHIN A BELL CURVE. 

4100
02:39:03,158 --> 02:39:05,894
WE AS ETHICS TYPES MIGHT WORRY 

4101
02:39:05,894 --> 02:39:07,896
ABOUT EITHER END; RIGHT?  

4102
02:39:07,896 --> 02:39:10,465
WE MIGHT WORRY ABOUT EXPOSING 

4103
02:39:10,465 --> 02:39:12,534
KIDS TO TOO MUCH RISK OR MIGHT 

4104
02:39:12,534 --> 02:39:14,436
WORRY ABOUT VALUABLE RESEARCH 

4105
02:39:14,436 --> 02:39:15,704
THAT IS NOT HAPPENING BECAUSE 

4106
02:39:15,704 --> 02:39:16,638
THEY ARE SO STRICT. 

4107
02:39:16,638 --> 02:39:19,574
THAT IS GENERALLY TRUE. 

4108
02:39:19,574 --> 02:39:23,478
WHEN YOU LOOK AT THE LITERATURE 

4109
02:39:23,478 --> 02:39:25,113
ABOUT IT IS NOT VERY WIDE BUT 

4110
02:39:25,113 --> 02:39:29,217
THERE IS LITERATURE ABOUT HOW 

4111
02:39:29,217 --> 02:39:36,858
IRBS HAVE SOME SAID EXEMPT AND 

4112
02:39:36,858 --> 02:39:38,860
OTHERS SAID IT WAS EXPEDITED AND

4113
02:39:38,860 --> 02:39:40,996
BELL CURVE AND LITTLE ON EITHER 

4114
02:39:40,996 --> 02:39:41,196
END. 

4115
02:39:41,196 --> 02:39:41,697
GO AHEAD. 

4116
02:39:41,697 --> 02:39:46,068
>> HI.  I HAVE A QUESTION
ABOUT 

4117
02:39:46,068 --> 02:39:48,904
QUALITY CONTROL. 

4118
02:39:48,904 --> 02:39:51,974
>> I IMAGINE A NUMBER OF
LOCAL 

4119
02:39:51,974 --> 02:39:53,642
IRBS AND A BUNCH OF DIFFERENT 

4120
02:39:53,642 --> 02:39:55,143
PEOPLE SITTING ON COMMITTEES AND

4121
02:39:55,143 --> 02:39:57,913
PROCEDURE FOR IRBS TO SIT AND 

4122
02:39:57,913 --> 02:39:59,614
STEP BACK AND LOOK AT ALL CASES 

4123
02:39:59,614 --> 02:40:01,817
THAT THEY HAVE, YOU KNOW, 

4124
02:40:01,817 --> 02:40:03,752
PRESIDING OVER AND LOOKED AT IN 

4125
02:40:03,752 --> 02:40:05,554
THE PAST A NUMBER OF MONTHS. 

4126
02:40:05,554 --> 02:40:06,088
>> YEAH. 

4127
02:40:06,088 --> 02:40:07,756
>> AND MAKE DETERMINATION
ABOUT 

4128
02:40:07,756 --> 02:40:09,358
WHETHER THEIR DECISIONS HAVE 

4129
02:40:09,358 --> 02:40:10,692
BEEN GENERALLY CONSISTENT?  

4130
02:40:10,692 --> 02:40:11,393
>> YES. 

4131
02:40:11,393 --> 02:40:13,695
THIS IS A TOPIC THAT IS VERY 

4132
02:40:13,695 --> 02:40:15,397
CLOSE TO MY HEART AND SPEND A 

4133
02:40:15,397 --> 02:40:17,032
LOT OF TIME THESE DAYS THINKING 

4134
02:40:17,032 --> 02:40:18,967
ABOUT HOW WE CAN EVALUATE 

4135
02:40:18,967 --> 02:40:23,505
QUALITY OF IRB REVIEW AND 

4136
02:40:23,505 --> 02:40:23,805
OVERSIGHT. 

4137
02:40:23,805 --> 02:40:26,575
SHORT ANSWER IS THERE ARE SOME 

4138
02:40:26,575 --> 02:40:29,077
TOOLS THAT ARE INADEQUATE, I 

4139
02:40:29,077 --> 02:40:29,745
WOULD SAY. 

4140
02:40:29,745 --> 02:40:33,882
THAT AN IRB COULD STEP BACK AND 

4141
02:40:33,882 --> 02:40:37,986
REVIEW OR LOOK AT. 

4142
02:40:37,986 --> 02:40:40,856
HOW DID WE DEDECIDE TO LOOK AT 

4143
02:40:40,856 --> 02:40:42,057
PEDIATRIC RESEARCH AND SEE HOW 

4144
02:40:42,057 --> 02:40:44,359
WE DECIDED WHETHER OR NOT WE 

4145
02:40:44,359 --> 02:40:47,896
SAID ALWAYS THAT A BLOOD DRAW 

4146
02:40:47,896 --> 02:40:48,830
WAS MINIMAL RISK.  

4147
02:40:48,830 --> 02:40:51,299
ONE COULD DO THAT AND IRBS ARE 

4148
02:40:51,299 --> 02:40:53,869
BUSY AND DON'T HAVE ENOUGH STAFF

4149
02:40:53,869 --> 02:40:55,771
OR FUNDING AND FOR SOME IS A BIT

4150
02:40:55,771 --> 02:41:00,042
OF A LUXURY TO TAKE THAT STEP 

4151
02:41:00,042 --> 02:41:00,575
BACK. 

4152
02:41:00,575 --> 02:41:03,912
THERE ARE -- THERE IS A WUM OF 

4153
02:41:03,912 --> 02:41:06,415
WAYS IN WHICH INSTITUTIONS 

4154
02:41:06,415 --> 02:41:07,616
IMPROVE LIKELIHOOD THAT PEOPLE 

4155
02:41:07,616 --> 02:41:09,151
AROUND THE TABLE ARE WELL 

4156
02:41:09,151 --> 02:41:10,652
SITUATED AND THEY ARE ALL 

4157
02:41:10,652 --> 02:41:13,121
TRAINED IN A PARTICULAR WAY AND 

4158
02:41:13,121 --> 02:41:15,223
THEY HAVE IN-SERVICE TRAINING 

4159
02:41:15,223 --> 02:41:18,393
AND I'M SURE IF A CHAIR HAD A 

4160
02:41:18,393 --> 02:41:20,796
CONCERN YOU ARE ON IRB AND FELL 

4161
02:41:20,796 --> 02:41:22,431
ASLEEP AND NEVER BROUGHT IN 

4162
02:41:22,431 --> 02:41:23,999
REVIEWS IN AND THEY PROBABLY HAD

4163
02:41:23,999 --> 02:41:26,234
A CHAT WITH YOU ASKING YOU -- AT

4164
02:41:26,234 --> 02:41:27,903
THE EXTREMES; RIGHT?  

4165
02:41:27,903 --> 02:41:30,172
THERE ARE WAYS THAT SORT OF 

4166
02:41:30,172 --> 02:41:33,375
LOCAL QUALITY COULD BE 

4167
02:41:33,375 --> 02:41:35,243
MAINTAINED AND ARE WAYS YOU 

4168
02:41:35,243 --> 02:41:38,246
COULD STEP BACK AND SOME 

4169
02:41:38,246 --> 02:41:39,948
INSTITUTIONS DO AD HOC AUDITS 

4170
02:41:39,948 --> 02:41:41,550
NOT FOR CAUSE; RIGHT?  

4171
02:41:41,550 --> 02:41:44,286
WE ARE NOT WORRIED ABOUT A 

4172
02:41:44,286 --> 02:41:46,088
PARTICULAR PERSON'S PROTOCOL AND

4173
02:41:46,088 --> 02:41:47,556
YOU CAN'T REVIEW EVERYTHING AND 

4174
02:41:47,556 --> 02:41:50,826
SAY I WILL RANDOMLY SELECT 10 

4175
02:41:50,826 --> 02:41:52,627
PROJECTS TAKING A DEEP DIVE AND 

4176
02:41:52,627 --> 02:41:54,196
AUDITS CAN INFORM, WOW.  

4177
02:41:54,196 --> 02:41:55,997
EVERYBODY IS FORGETTING TO DO X 

4178
02:41:55,997 --> 02:41:58,366
AND WE HAVE TO REORIENT 

4179
02:41:58,366 --> 02:42:00,268
INVESTIGATORS AND IRBS TO MAKE 

4180
02:42:00,268 --> 02:42:01,837
SURE THIS IS PRESENT. 

4181
02:42:01,837 --> 02:42:04,873
>> GO AHEAD. 

4182
02:42:04,873 --> 02:42:07,242
>> HI.  

4183
02:42:07,242 --> 02:42:07,642
SALLY. 

4184
02:42:07,642 --> 02:42:09,611
>> HI.  MORE PRACTICAL
QUESTION 

4185
02:42:09,611 --> 02:42:10,879
ON SOMETHING YOU PUT UP. 

4186
02:42:10,879 --> 02:42:11,446
>> YUP. 

4187
02:42:11,446 --> 02:42:13,215
>> ABOUT IRBS AND 

4188
02:42:13,215 --> 02:42:14,149
RESPONSIBILITIES AND YOU WROTE 

4189
02:42:14,149 --> 02:42:17,018
THAT IRBS HAVE TO DO CONTINUING 

4190
02:42:17,018 --> 02:42:17,285
REVIEWS. 

4191
02:42:17,285 --> 02:42:17,719
>> YES. 

4192
02:42:17,719 --> 02:42:21,957
>> ON STUDIES THAT RECEIVE
FULL 

4193
02:42:21,957 --> 02:42:22,424
COMMITTEE REVIEW. 

4194
02:42:22,424 --> 02:42:25,093
>> YEAH.  EXPEDITED
REVIEWS THAT

4195
02:42:25,093 --> 02:42:26,128
ARE MINIMAL RISK. 

4196
02:42:26,128 --> 02:42:27,796
>> YEAH. 

4197
02:42:27,796 --> 02:42:29,798
>> ARE YOU SAYING -- THIS
IS 

4198
02:42:29,798 --> 02:42:32,000
GOOD IF YOU ARE, THAT THEY DON'T

4199
02:42:32,000 --> 02:42:38,340
NEED CONTINUING INTERVIEW AND 

4200
02:42:38,340 --> 02:42:39,374
KNOW GO TO LOCAL. 

4201
02:42:39,374 --> 02:42:41,643
>> GREAT QUESTION.  ONE
THING 

4202
02:42:41,643 --> 02:42:43,545
NONE OF US MENTIONED TODAY IS 

4203
02:42:43,545 --> 02:42:46,214
COMMON RULE IS REVISED IN 2018 

4204
02:42:46,214 --> 02:42:47,983
AND AFTER A VERY LONG PROTRACTED

4205
02:42:47,983 --> 02:42:50,085
PROCESS AND ONE OF THE THINGS 

4206
02:42:50,085 --> 02:42:53,655
THAT IS DIFFERENT FROM BEFORE 

4207
02:42:53,655 --> 02:42:55,690
2018 IS THAT ONLY FULL COMMITTEE

4208
02:42:55,690 --> 02:42:58,426
REVIEWED PROTOCOLS ARE REQUIRED 

4209
02:42:58,426 --> 02:43:01,496
TO PROVIDE AN ANNUAL REVIEW. 

4210
02:43:01,496 --> 02:43:01,997
>> AH. 

4211
02:43:01,997 --> 02:43:04,032
>> IF EXPEDITED YOU DON'T
HAVE 

4212
02:43:04,032 --> 02:43:04,833
TO. 

4213
02:43:04,833 --> 02:43:08,403
NOW, SOME IRBS COULD SAY WE WANT

4214
02:43:08,403 --> 02:43:10,305
TO DO MORE THAN WHAT THE 

4215
02:43:10,305 --> 02:43:12,908
REGULATIONS REQUIRE AND WE WANT 

4216
02:43:12,908 --> 02:43:14,843
TO REVIEW ALL EXPEDITED 

4217
02:43:14,843 --> 02:43:15,143
RESEARCH. 

4218
02:43:15,143 --> 02:43:16,745
THERE ARE NO LONGER REQUIRED BY 

4219
02:43:16,745 --> 02:43:19,114
FEDERAL REGULATIONS TO DO THAT. 

4220
02:43:19,114 --> 02:43:19,981
>> GOTCHA. 

4221
02:43:19,981 --> 02:43:22,184
>> WHEN THEY APPROVE,
WHICHEVER 

4222
02:43:22,184 --> 02:43:23,885
IRB YOU ARE IN, WHEN THEY 

4223
02:43:23,885 --> 02:43:25,353
APPROVE OF YOUR STUDY, THEY WILL

4224
02:43:25,353 --> 02:43:26,188
TELL YOU. 

4225
02:43:26,188 --> 02:43:26,688
>> EXACTLY. 

4226
02:43:26,688 --> 02:43:28,190
>> WE WANT TO CONTINUE
REVIEW 

4227
02:43:28,190 --> 02:43:29,591
EVERY YEAR AND WANT TO KNOW WHAT

4228
02:43:29,591 --> 02:43:30,692
IS GOING ON. 

4229
02:43:30,692 --> 02:43:31,960
>> EXACTLY.  EXACTLY.  

4230
02:43:31,960 --> 02:43:32,260
SOMETIMES. 

4231
02:43:32,260 --> 02:43:34,963
>> IT IS NOT REQUIRED?  

4232
02:43:34,963 --> 02:43:35,897
>> NOT REQUIRED. 

4233
02:43:35,897 --> 02:43:38,033
SOME IRBS WILL DO A SHORTER 

4234
02:43:38,033 --> 02:43:39,968
PERIOD AND HERE AT THE CLINICAL 

4235
02:43:39,968 --> 02:43:42,204
CENTER AND WILL MENTION THIS IN 

4236
02:43:42,204 --> 02:43:43,471
ANOTHER LECTURE. 

4237
02:43:43,471 --> 02:43:44,806
THE VAST MAJORITY OF RESEARCH 

4238
02:43:44,806 --> 02:43:49,077
THAT HAPPENS HERE IS PHASE 1 

4239
02:43:49,077 --> 02:43:50,645
RESEARCH.  VERY EARLY AND FIRST 

4240
02:43:50,645 --> 02:43:51,613
IN HUMAN TRIALS. 

4241
02:43:51,613 --> 02:43:53,648
WHEN THAT TYPE OF TRIAL IS GOING

4242
02:43:53,648 --> 02:43:55,784
ON THE IRB MIGHT SAY YOU KNOW 

4243
02:43:55,784 --> 02:43:56,017
WHAT?  

4244
02:43:56,017 --> 02:43:58,086
WE ARE WORRIED ABOUT THAT AND 

4245
02:43:58,086 --> 02:43:59,955
WANT TO REALLY HAVE CLOSE -- WE 

4246
02:43:59,955 --> 02:44:01,389
WANT TO BE VERY CAREFUL ABOUT 

4247
02:44:01,389 --> 02:44:02,824
THE RISKS THAT PEOPLE ARE 

4248
02:44:02,824 --> 02:44:04,559
EXPOSED TO AND WANT TO MAKE SURE

4249
02:44:04,559 --> 02:44:05,760
THAT EVERYTHING IS MOVING 

4250
02:44:05,760 --> 02:44:08,230
FORWARD AND WE WANT TO REVIEW 

4251
02:44:08,230 --> 02:44:11,499
YOU IN SIX MONTHS AND IRB ALWAYS

4252
02:44:11,499 --> 02:44:14,736
HAS THE OPTION TO ASK FOR 

4253
02:44:14,736 --> 02:44:15,503
SOMETHING EARLIER IF THEY WANT 

4254
02:44:15,503 --> 02:44:15,837
TO. 

4255
02:44:15,837 --> 02:44:16,738
>> THANK YOU VERY MUCH. 

4256
02:44:16,738 --> 02:44:19,307
>> GREAT.  THAT IS THE END
OF 

4257
02:44:19,307 --> 02:44:20,942
OUR SESSION FOR TODAY.  THANK 

4258
02:44:20,942 --> 02:44:23,678
YOU ALL.  SORRY, AGAIN, FOR THE 

4259
02:44:23,678 --> 02:44:25,447
GLITCH IN THE VIDEO FOR ALL OF 

4260
02:44:25,447 --> 02:44:27,449
YOU OUT THERE IN VIDEO LAND. 

4261
02:44:27,449 --> 02:44:29,718
WE WILL BE BACK HERE NEXT 

4262
02:44:29,718 --> 02:44:31,152
WEDNESDAY, SAME TIME AND SAME 

4263
02:44:31,152 --> 02:44:33,455
LINK AND WE ARE FINGERS CROSSED 

4264
02:44:33,455 --> 02:44:34,889
IT WILL WORK. 

4265
02:44:34,889 --> 02:44:36,891
FEEL FREE TO SEND ME ANY 

4266
02:44:36,891 --> 02:44:38,260
QUESTIONS AND PUT THEM ON THE 

4267
02:44:38,260 --> 02:44:39,961
DISCUSSION BOARD.  I WILL TRY TO

4268
02:44:39,961 --> 02:44:50,105
ANSWER