1
00:00:05,053 --> 00:00:07,522
GOOD MORNING AND WELCOME TO 

2
00:00:07,522 --> 00:00:10,892
THE 2023 ETHICAL AND REGULATORY 

3
00:00:10,892 --> 00:00:11,927
ASPECTS RESEARCH.

4
00:00:11,927 --> 00:00:15,430
I THINK IT'S THE 25th YEAR WE'VE

5
00:00:15,430 --> 00:00:16,898
OFFERED THE COURSE AND HAPPY TO 

6
00:00:16,898 --> 00:00:26,475
BE HERE WITHOUT A MASK TODAY.

7
00:00:26,475 --> 00:00:29,778
I'M GOING TO FIRST INTRODUCE 

8
00:00:29,778 --> 00:00:31,747
MYSELF AND GO THROUGH 

9
00:00:31,747 --> 00:00:34,383
INTRODUCTORY REMARKS AND MOVE ON

10
00:00:34,383 --> 00:00:34,916
TO CONTENT.

11
00:00:34,916 --> 00:00:38,220
YOU'LL SEE THIS FROM A NUMBER OF

12
00:00:38,220 --> 00:00:38,387
US.

13
00:00:38,387 --> 00:00:39,921
I AM SPEAKING FOR MYSELF.

14
00:00:39,921 --> 00:00:43,392
I'M NOT EXPRESSING THE VIEWS OF 

15
00:00:43,392 --> 00:00:49,197
NIH, HHS OR THE U.S. GOVERNMENT.

16
00:00:49,197 --> 00:00:52,267
SO THESE ARE THE COURSE 

17
00:00:52,267 --> 00:00:52,567
OBJECTIVES.

18
00:00:52,567 --> 00:00:53,769
I'M NOT GOING READ THROUGH THEM.

19
00:00:53,769 --> 00:00:56,004
THEY'RE ON THE SYLLABUS AND IN 

20
00:00:56,004 --> 00:00:59,141
THE DOCUMENTS ON CANVAS WHICH 

21
00:00:59,141 --> 00:01:01,109
I'LL SAY A LITTLE MORE ABOUT BUT

22
00:01:01,109 --> 00:01:02,711
THE BOTTOM LINE IS WE WANT TO 

23
00:01:02,711 --> 00:01:06,448
GIVE YOU BOTH SUBSTANCE, 

24
00:01:06,448 --> 00:01:08,083
KNOWLEDGE AND SOME SKILLS TO 

25
00:01:08,083 --> 00:01:10,652
APPLY WHAT YOU LEARNED HERE TO 

26
00:01:10,652 --> 00:01:14,756
YOUR WORK, YOUR RESEARCH, 

27
00:01:14,756 --> 00:01:16,458
WHATEVER IT IS THAT YOU PLAN TO 

28
00:01:16,458 --> 00:01:21,797
USE THIS INFORMATION FOR.

29
00:01:21,797 --> 00:01:22,931
SO HERE'S A QUICK OVERVIEW OF 

30
00:01:22,931 --> 00:01:23,665
THE COURSE.

31
00:01:23,665 --> 00:01:27,135
TODAY'S THE FIRST OF SEVEN WEEKS

32
00:01:27,135 --> 00:01:30,272
AND WE'RE GOING TO DO SOME 

33
00:01:30,272 --> 00:01:32,841
BASICS TODAY THEN NEXT WEEK 

34
00:01:32,841 --> 00:01:34,943
WE'RE GOING TO TRANSITION TO 

35
00:01:34,943 --> 00:01:35,777
ISSUES AROUND INFORMED CONSENT 

36
00:01:35,777 --> 00:01:38,380
FOLLOWED BY STUDY DESIGN, A DAY 

37
00:01:38,380 --> 00:01:42,417
DEDICATED TO GENETICS WITH SOME 

38
00:01:42,417 --> 00:01:46,154
OF THE UNIQUE ASPECTS OF GENETIC

39
00:01:46,154 --> 00:01:47,088
RESEARCH AND HAVE EQUITY AND 

40
00:01:47,088 --> 00:01:48,223
SUBJECT SELECTION AND HAVE AN 

41
00:01:48,223 --> 00:01:51,827
INTERNATIONAL DAY AND THEN THE 

42
00:01:51,827 --> 00:01:55,630
LAST DAY IS ETHICS IN NOVEL 

43
00:01:55,630 --> 00:01:55,964
TECHNOLOGIES.

44
00:01:55,964 --> 00:01:58,066
I'LL ALSO NOTE THE MAJORITY OF 

45
00:01:58,066 --> 00:02:03,605
THE FACULTY WILL BE FROM THE NIH

46
00:02:03,605 --> 00:02:05,740
DEPARTMENT HERE OF BIOETHICS AND

47
00:02:05,740 --> 00:02:08,543
THE CLINICAL CENTER REALIZING I 

48
00:02:08,543 --> 00:02:11,446
FORGOT TO INTRODUCE MYSELF.

49
00:02:11,446 --> 00:02:13,849
I'M HOLLY TAYLOR ON THE FACULTY 

50
00:02:13,849 --> 00:02:15,884
IN THE DEPARTMENT AND I'LL BE 

51
00:02:15,884 --> 00:02:17,986
THE EMCEE FOR THE WHOLE COURSE 

52
00:02:17,986 --> 00:02:20,288
SO YOU'LL SEE A LOT OF ME BOTH 

53
00:02:20,288 --> 00:02:24,593
INTRODUCING FOLKS AND GIVING A 

54
00:02:24,593 --> 00:02:26,828
NUMBER OF LECTURES.

55
00:02:26,828 --> 00:02:28,296
A COUPLE ADMINISTRATIVE DETAILS,

56
00:02:28,296 --> 00:02:30,432
IF YOU'RE VIEWING US THROUGH THE

57
00:02:30,432 --> 00:02:33,134
LIVE VIDEO STREAM BUT HAVEN'T 

58
00:02:33,134 --> 00:02:35,937
YET REGISTERED OR ENROLLED AND 

59
00:02:35,937 --> 00:02:38,807
REGISTERED IN THE COURSE AND 

60
00:02:38,807 --> 00:02:43,512
YOU'D LIKE TO, THERE'S -- YOU 

61
00:02:43,512 --> 00:02:45,080
CAN SELF-ENROLL.

62
00:02:45,080 --> 00:02:46,848
WE'VE SENT OUT INFORMATION ON 

63
00:02:46,848 --> 00:02:48,016
HOW TO DO THAT.

64
00:02:48,016 --> 00:02:50,185
WE'LL DO THAT AGAIN AFTER 

65
00:02:50,185 --> 00:02:54,155
TODAY'S SESSION.

66
00:02:54,155 --> 00:03:02,163
IF YOU SELF-ENROLL YOU'LL HAVE 

67
00:03:02,163 --> 00:03:03,164
ACCESS TO ALL THE MATERIALS AND 

68
00:03:03,164 --> 00:03:05,467
IF YOU WANT ACCESS TO ALL THE 

69
00:03:05,467 --> 00:03:07,769
LECTURES THAT'S THE PLACE TO GO.

70
00:03:07,769 --> 00:03:09,671
THERE'S A SELF-REGISTRATION FORM

71
00:03:09,671 --> 00:03:11,139
AND WE NEED TO YOU COMPLETE THAT

72
00:03:11,139 --> 00:03:15,644
IF YOU WANT TO GET A CERTIFICATE

73
00:03:15,644 --> 00:03:18,346
OF COMPLETION.

74
00:03:18,346 --> 00:03:20,482
THE WAY WE KEEP TRACK OF WHETHER

75
00:03:20,482 --> 00:03:22,117
YOU PARTICIPATED OR VIEWED A 

76
00:03:22,117 --> 00:03:23,818
LECTURE LIVE OR A RECORDING IS 

77
00:03:23,818 --> 00:03:29,157
WE ASK YOU TO COMPLETE A SESSION

78
00:03:29,157 --> 00:03:32,160
QUIZ THAT IS ON CANVAS AND ONE 

79
00:03:32,160 --> 00:03:33,895
OTHER REASONS TO GO TO THE 

80
00:03:33,895 --> 00:03:42,671
CERTIFICATE.

81
00:03:42,671 --> 00:03:44,039
THERE'S GOING TO BE A WORD OF 

82
00:03:44,039 --> 00:03:46,474
THE DAY AND TWO QUESTIONS YOU'LL

83
00:03:46,474 --> 00:03:47,976
NEED TO COMPLETE.

84
00:03:47,976 --> 00:03:51,079
THE WORD FOR TODAY IS BELMONT.

85
00:03:51,079 --> 00:03:51,913
YOU'LL LEARN A LITTLE BIT MORE 

86
00:03:51,913 --> 00:03:55,684
ABOUT WHAT BELMONT IS, THE 

87
00:03:55,684 --> 00:03:57,218
BELMONT REPORT AND EACH DAY 

88
00:03:57,218 --> 00:03:58,853
WE'LL GIVE YOU A WORD OF THE DAY

89
00:03:58,853 --> 00:04:01,957
AND WE'LL TRY TO WORK IT IN A 

90
00:04:01,957 --> 00:04:03,525
COUPLE TIMES BUT DON'T PANIC 

91
00:04:03,525 --> 00:04:05,126
ABOUT THE WORD OF THE DAY.

92
00:04:05,126 --> 00:04:14,169
THESE QUIZZES AREN'T RATED.

93
00:04:14,169 --> 00:04:18,039
IT'S REALLY JUST TO LET US KNOW 

94
00:04:18,039 --> 00:04:20,842
YOU'RE OUT THERE AND VIEWING.

95
00:04:20,842 --> 00:04:23,311
AND THERE'S A SESSION TO LET US 

96
00:04:23,311 --> 00:04:25,213
KNOW WHETHER WE MET THE 

97
00:04:25,213 --> 00:04:27,048
OBJECTIVES WE MET FOR OURSELVES 

98
00:04:27,048 --> 00:04:30,485
FOR EACH OF THE SESSIONS AND 

99
00:04:30,485 --> 00:04:34,489
CONNOR WHO IS HERE IN LIPSETT 

100
00:04:34,489 --> 00:04:36,591
WILL SEND THAT TO YOU.

101
00:04:36,591 --> 00:04:38,126
IT'S A QUICK EVALUATION TO GIVE 

102
00:04:38,126 --> 00:04:48,603
US FEEDBACK ON OUR LECTURES.

103
00:04:49,437 --> 00:04:51,072
I'VE SENT AN ASSESSMENT TO 

104
00:04:51,072 --> 00:04:52,607
EVERYONE WHO ENROLLED IN THE 

105
00:04:52,607 --> 00:04:52,841
COURSE.

106
00:04:52,841 --> 00:04:55,343
I'LL RESEND THAT TODAY.

107
00:04:55,343 --> 00:05:01,850
THERE'S ABOUT 850 OF YOU THINK 

108
00:05:01,850 --> 00:05:03,251
PRE SELF-REGISTERED IN THE 

109
00:05:03,251 --> 00:05:05,887
COURSE AND IF ALL OF YOU COULD 

110
00:05:05,887 --> 00:05:08,223
TAKE IT THAT'D BE GREAT.

111
00:05:08,223 --> 00:05:11,726
ABOUT 250 HAVE TAKEN IT SO FAR 

112
00:05:11,726 --> 00:05:16,464
EVEN THOUGH YOU LISTEN TO 

113
00:05:16,464 --> 00:05:17,599
TODAY'S LECTURE I'LL LEAVE IT 

114
00:05:17,599 --> 00:05:18,933
OPEN TO SEE IF WE GET ADDITIONAL

115
00:05:18,933 --> 00:05:23,004
RESPONSES.

116
00:05:23,004 --> 00:05:25,507
I'M JUST GOING TO WALK THROUGH 

117
00:05:25,507 --> 00:05:27,842
WHAT THE CANVAS HUB WILL LOOK 

118
00:05:27,842 --> 00:05:28,743
LIKE FOR YOU.

119
00:05:28,743 --> 00:05:31,713
SO WHEN YOU LOG INTO THE COURSE 

120
00:05:31,713 --> 00:05:33,314
WEBSITE, THIS IS WHAT YOU'LL 

121
00:05:33,314 --> 00:05:33,682
SEE.

122
00:05:33,682 --> 00:05:38,153
THERE'S KEY DOCUMENTS AT THE 

123
00:05:38,153 --> 00:05:38,453
TOP.

124
00:05:38,453 --> 00:05:39,521
THE SELF-REGISTRATION FORM IS 

125
00:05:39,521 --> 00:05:42,157
LINKED AT THE TOP.

126
00:05:42,157 --> 00:05:45,660
THERE'S COURSE BASICS.

127
00:05:45,660 --> 00:05:48,163
THE SYLLABUS WHICH IS ACTUALLY 

128
00:05:48,163 --> 00:05:49,064
NOW I TOOK IT IT'S FINAL AND 

129
00:05:49,064 --> 00:05:51,132
POSTED THERE.

130
00:05:51,132 --> 00:05:56,104
AND A COUPLE OF OTHER KEY 

131
00:05:56,104 --> 00:06:01,576
DOCUMENTS INCLUDING MY BIO AS 

132
00:06:01,576 --> 00:06:02,811
WELL AS WITH THE FACULTY YOU'LL 

133
00:06:02,811 --> 00:06:04,179
HEAR FROM.

134
00:06:04,179 --> 00:06:05,947
THERE'S A LINK TO THE 

135
00:06:05,947 --> 00:06:06,581
SELF-REGISTRATION TO THE RIGHT 

136
00:06:06,581 --> 00:06:07,449
OF THE SCREEN.

137
00:06:07,449 --> 00:06:09,017
YOU CAN CLICK THERE OR THERE TO 

138
00:06:09,017 --> 00:06:15,123
SELF-REGISTER.

139
00:06:15,123 --> 00:06:17,792
THIS IS WHAT YOU'LL SEE AND 

140
00:06:17,792 --> 00:06:19,661
THEY'LL GET INFORMATION FROM YOU

141
00:06:19,661 --> 00:06:21,429
HOW YOU'D LIKE TO SEE YOUR NAME 

142
00:06:21,429 --> 00:06:23,264
ON THE CERTIFICATE AND THINGS 

143
00:06:23,264 --> 00:06:23,965
LIKE THAT.

144
00:06:23,965 --> 00:06:26,534
THE OTHER THING I WANT TO POINT 

145
00:06:26,534 --> 00:06:28,903
OUT IS FOR EACH SESSION THERE'S 

146
00:06:28,903 --> 00:06:32,373
ON THE CANVAS HUB IT'S CALLED A 

147
00:06:32,373 --> 00:06:32,607
MODULE.

148
00:06:32,607 --> 00:06:34,576
THIS IS SESSION 1.

149
00:06:34,576 --> 00:06:35,910
THAT CIRCLE IS SUPPOSED TO BE ON

150
00:06:35,910 --> 00:06:36,778
THE TOP DOCUMENT THERE BUT 

151
00:06:36,778 --> 00:06:40,648
THERE'S A SUMMARY OF EACH 

152
00:06:40,648 --> 00:06:44,018
SESSION THERE, LINKS TO THE 

153
00:06:44,018 --> 00:06:44,385
TEXTBOOKS.

154
00:06:44,385 --> 00:06:45,820
THERE'S ALSO INFORMATION THERE, 

155
00:06:45,820 --> 00:06:47,956
THE POWER POINT SLIDES FOR ALL 

156
00:06:47,956 --> 00:06:49,691
THE PRESENTATIONS ARE POSTED AT 

157
00:06:49,691 --> 00:06:51,993
8:00 A.M. ON THE DAY OF CLASS.

158
00:06:51,993 --> 00:06:55,997
IF YOU OPEN THIS UP TODAY, THOSE

159
00:06:55,997 --> 00:06:58,433
ARE THE FIRST THINGS YOU'LL SEE 

160
00:06:58,433 --> 00:07:01,069
THE POWER POINTS FOR EACH OF THE

161
00:07:01,069 --> 00:07:01,402
PRESENTATIONS.

162
00:07:01,402 --> 00:07:03,438
THIS IS WHAT OUR SESSION LOOKS 

163
00:07:03,438 --> 00:07:03,638
LIKE.

164
00:07:03,638 --> 00:07:07,142
EACH THE SESSION SUMMARIES LOOKS

165
00:07:07,142 --> 00:07:07,342
LIKE.

166
00:07:07,342 --> 00:07:08,910
THERE'S THE OBJECTIVES FOR THAT 

167
00:07:08,910 --> 00:07:09,944
SESSION, A SCHEDULE AND THE 

168
00:07:09,944 --> 00:07:12,447
READINGS AND AS I MENTIONED THE 

169
00:07:12,447 --> 00:07:17,652
POWER POINTS WILL BE POSTED.

170
00:07:17,652 --> 00:07:18,787
THEY'RE POSTED NOW.

171
00:07:18,787 --> 00:07:22,657
IF YOU WANT TO ACCESS THOSE 

172
00:07:22,657 --> 00:07:23,258
FOLLOW ALONG.

173
00:07:23,258 --> 00:07:26,494
THERE'S ACCESS TO THE READINGS 

174
00:07:26,494 --> 00:07:31,900
AND  YOU CAN CLICK ON THEM AND 

175
00:07:31,900 --> 00:07:34,636
IT WILL TAKE YOU ONLINE AND AS 

176
00:07:34,636 --> 00:07:36,971
OF TODAY THERE ARE ABOUT 10 OF 

177
00:07:36,971 --> 00:07:38,606
US PHYSICALLY HERE IN LIPSETT.

178
00:07:38,606 --> 00:07:42,076
FOR THOSE OF US ON CAMPUS AT THE

179
00:07:42,076 --> 00:07:44,813
NIH, FEEL FREE NEXT WEEK TO COME

180
00:07:44,813 --> 00:07:47,348
AND BE HERE IN PERSON OR JUST 

181
00:07:47,348 --> 00:07:50,018
DROP IN SESSION 4, SESSION 3, 

182
00:07:50,018 --> 00:07:50,985
WHATEVER, THAT'D BE GREAT.

183
00:07:50,985 --> 00:07:53,321
SO IF YOU'RE HERE YOU GET 

184
00:07:53,321 --> 00:07:55,857
PRIORITY IN TERMS OF ASKING 

185
00:07:55,857 --> 00:07:57,458
QUESTIONS SO THAT'S ONE THING 

186
00:07:57,458 --> 00:07:59,961
THAT IS IN FAVOR OF COMING.

187
00:07:59,961 --> 00:08:02,263
BUT BECAUSE THE VAST MAJORITY OF

188
00:08:02,263 --> 00:08:03,665
YOU ARE ONLINE, WE HAVE A COUPLE

189
00:08:03,665 --> 00:08:07,135
OF WAYS FOR YOU TO GET QUESTIONS

190
00:08:07,135 --> 00:08:13,174
TO ME AND TO CONNOR AFTER EACH 

191
00:08:13,174 --> 00:08:15,543
SESSION SO AFTER EACH LECTURE 

192
00:08:15,543 --> 00:08:16,811
THERE'S TIME SET ASIDE FOR 

193
00:08:16,811 --> 00:08:17,178
DISCUSSION.

194
00:08:17,178 --> 00:08:18,780
ONE WAY TO POSE A QUESTION IS TO

195
00:08:18,780 --> 00:08:21,482
GO TO THE DISCUSSION BOARD IN 

196
00:08:21,482 --> 00:08:25,453
CANVAS AND THERE'S A PLACE THAT 

197
00:08:25,453 --> 00:08:27,255
POSE QUESTIONS FOR SESSION 1 

198
00:08:27,255 --> 00:08:27,856
HERE.

199
00:08:27,856 --> 00:08:28,990
POSE YOUR QUESTION THERE.

200
00:08:28,990 --> 00:08:31,359
I'LL HAVE IT AT MY LAPTOP.

201
00:08:31,359 --> 00:08:39,133
YOU CAN ALSO SEND AN E-MAIL TO 

202
00:08:39,133 --> 00:08:43,805
MISS  -- THIS E-MAIL AND CONNOR 

203
00:08:43,805 --> 00:08:45,006
WILL GET IT TO US.

204
00:08:45,006 --> 00:08:46,941
SO IF WE DON'T HAVE A CHANCE TO 

205
00:08:46,941 --> 00:08:50,912
ANSWER THOSE QUESTIONS IN REAL 

206
00:08:50,912 --> 00:08:53,281
TIME, IF YOU SEND IT BY E-MAIL I

207
00:08:53,281 --> 00:08:54,315
POST IT FOR YOU IN THE 

208
00:08:54,315 --> 00:08:55,516
DISCUSSION BOARD AND ANSWER THE 

209
00:08:55,516 --> 00:08:56,451
QUESTIONS THERE.

210
00:08:56,451 --> 00:08:59,287
IF I CAN'T ANSWER IT AND IT'S 

211
00:08:59,287 --> 00:09:00,421
SOMETHING THAT SOMEONE ELSE 

212
00:09:00,421 --> 00:09:02,123
COVERED, I'LL REACH OUT TO THEM 

213
00:09:02,123 --> 00:09:03,124
AND ASK THEM TO ANSWER THE 

214
00:09:03,124 --> 00:09:08,296
QUESTION.

215
00:09:08,296 --> 00:09:10,465
SO I MENTIONED THE SESSION 

216
00:09:10,465 --> 00:09:10,932
QUIZZES.

217
00:09:10,932 --> 00:09:12,233
IMPORTANT THING TO KEEP IN MIND 

218
00:09:12,233 --> 00:09:14,869
IF YOU WANT TO CERTIFICATE OF 

219
00:09:14,869 --> 00:09:16,170
COMPLETION, YOU HAVE TO COMPLETE

220
00:09:16,170 --> 00:09:17,872
THREE OF THE SEVEN QUIZZES.

221
00:09:17,872 --> 00:09:19,707
YOU CAN COMPLETE ALL OF THEM IF 

222
00:09:19,707 --> 00:09:20,975
YOU WANT BUT YOU HAVE TO 

223
00:09:20,975 --> 00:09:26,748
COMPLETE AT LEAST THREE.

224
00:09:26,748 --> 00:09:27,916
IF YOU'RE AN NIH EMPLOYEE AND 

225
00:09:27,916 --> 00:09:30,752
CONTRACTOR AND WANT TO APPLY 

226
00:09:30,752 --> 00:09:32,854
THIS COURSE TOWARD THE CORE 

227
00:09:32,854 --> 00:09:35,023
CURRICULUM CREDIT AND A NURSE 

228
00:09:35,023 --> 00:09:38,092
AND WANT CEU CREDITS I KNOW 

229
00:09:38,092 --> 00:09:39,460
THERE'S ABOUT 50 FROM THE NIH 

230
00:09:39,460 --> 00:09:40,929
AND ANOTHER 25 WHO IDENTIFIED 

231
00:09:40,929 --> 00:09:44,132
YOU'RE INTERESTED IN GETTING THE

232
00:09:44,132 --> 00:09:45,333
CERTIFICATE AS A NURSE OR NIH 

233
00:09:45,333 --> 00:09:46,935
EMPLOYEE, YOU HAVE TO TAKE AT 

234
00:09:46,935 --> 00:09:47,902
LEAST SIX OR SEVEN OF THOSE 

235
00:09:47,902 --> 00:09:52,707
QUIZZES.

236
00:09:52,707 --> 00:09:54,809
AGAIN, SCORES DON'T MATTER.

237
00:09:54,809 --> 00:09:57,745
I'M SAYING THIS BECAUSE I OFTEN 

238
00:09:57,745 --> 00:10:00,815
GET E-MAILS AFTER CLASS, PLEASE,

239
00:10:00,815 --> 00:10:03,151
PLEASE HOLLY TELL ME THE WORD OF

240
00:10:03,151 --> 00:10:03,851
THE DAY.

241
00:10:03,851 --> 00:10:05,420
TODAY IT'S BELMONT AND IF YOU 

242
00:10:05,420 --> 00:10:07,121
DON'T HEAR IT, IT'S OKAY.

243
00:10:07,121 --> 00:10:10,458
YOU CAN GUESS.

244
00:10:10,458 --> 00:10:14,228
FINAL THING IS THIS IS WHERE THE

245
00:10:14,228 --> 00:10:15,496
QUIZZES ARE.

246
00:10:15,496 --> 00:10:17,865
THEY'RE UNDER THE TAB CALLED 

247
00:10:17,865 --> 00:10:20,668
QUIZ AND EACH SESSION OPENS AT 

248
00:10:20,668 --> 00:10:21,970
11:30 SO RIGHT AFTER CLASS YOU 

249
00:10:21,970 --> 00:10:28,643
CAN GO RIGHT TO THE SESSION QUIZ

250
00:10:28,643 --> 00:10:30,278
AND COMPLETE IT.

251
00:10:30,278 --> 00:10:32,947
THE QUIZZES ARE ALSO LINKED ON 

252
00:10:32,947 --> 00:10:37,685
THE MODULE PAGE GOING TO SESSION

253
00:10:37,685 --> 00:10:39,654
1 YOU'LL SCROLL TO THE BOTTOM 

254
00:10:39,654 --> 00:10:43,124
AND SEE THE LINK TO THE QUIZ.

255
00:10:43,124 --> 00:10:44,559
PLEASE SEND ME ADMINISTRATIVE 

256
00:10:44,559 --> 00:10:46,127
QUESTIONS YOU HAVE AND THERE'S A

257
00:10:46,127 --> 00:10:48,196
LINK TO A DOCUMENT THAT SAYS 

258
00:10:48,196 --> 00:10:48,930
COURSE BASICS.

259
00:10:48,930 --> 00:10:52,066
SO IF YOU HAVE A QUESTION ABOUT 

260
00:10:52,066 --> 00:10:54,369
SOME OF THE STUFF YOU'VE COVERED

261
00:10:54,369 --> 00:10:56,437
THAT'S A PLACE -- I'VE COVERED 

262
00:10:56,437 --> 00:10:59,974
THAT'S A PLACE TO GO BUT I'M 

263
00:10:59,974 --> 00:11:02,043
HAPPY TO ANSWER QUESTIONS.

264
00:11:02,043 --> 00:11:03,644
WE'LL GO TO CONTENT FOR SESSION 

265
00:11:03,644 --> 00:11:04,078
1.

266
00:11:04,078 --> 00:11:06,681
WE'LL START THE DAY WITH A 

267
00:11:06,681 --> 00:11:06,948
FRAMEWORK.

268
00:11:06,948 --> 00:11:09,584
THEN WE'LL HAVE A GUEST LECTURER

269
00:11:09,584 --> 00:11:13,721
WHO IS GOING TO COME IN ON ZOOM 

270
00:11:13,721 --> 00:11:15,857
AND YOU'LL SEE ME AGAIN TALKING 

271
00:11:15,857 --> 00:11:16,991
ABOUT INSTITUTIONAL REVIEW 

272
00:11:16,991 --> 00:11:17,291
BOARDS.

273
00:11:17,291 --> 00:11:19,694
IT'S MY GREAT PLEASURE TO 

274
00:11:19,694 --> 00:11:22,563
INTRODUCE DR. CHRISTINE GRADY 

275
00:11:22,563 --> 00:11:24,232
THE CHIEF OF OUR DEPARTMENT HERE

276
00:11:24,232 --> 00:11:26,000
OF BIOETHICS.

277
00:11:26,000 --> 00:11:27,969
SHE'S A NURSE BY TRAINING ALSO 

278
00:11:27,969 --> 00:11:33,474
HAS A Ph.D. IN PHILOSOPHY, DOES 

279
00:11:33,474 --> 00:11:37,745
A TON OF EMPIRICAL AND 

280
00:11:37,745 --> 00:11:38,713
CONCEPTUAL WORK AROUND INFORMED 

281
00:11:38,713 --> 00:11:40,448
CONSENT, STUDY DESIGN, RESEARCH 

282
00:11:40,448 --> 00:11:43,718
ETHICS AND RECENTLY WORK AROUND 

283
00:11:43,718 --> 00:11:45,720
MORAL DISTRESS THAT HEALTH CARE 

284
00:11:45,720 --> 00:11:47,121
PROVIDERS EXPERIENCE ESPECIALLY 

285
00:11:47,121 --> 00:11:47,588
POST COVID.

286
00:11:47,588 --> 00:11:50,024
SHE'S BEEN WITH THE DEPARTMENT 

287
00:11:50,024 --> 00:11:52,627
FOR A VERY LONG TIME.

288
00:11:52,627 --> 00:11:54,729
SHE TAUGHT THIS COURSE FOR THE 

289
00:11:54,729 --> 00:11:57,098
FIRST 20 PLUS YEARS AND IT'S MY 

290
00:11:57,098 --> 00:11:59,700
GREAT PLEASURE TO HAND IT OVER 

291
00:11:59,700 --> 00:12:02,103
TO HER FOR THE FRAMEWORK WE'RE 

292
00:12:02,103 --> 00:12:03,137
GOING TO USE YOU'LL HEAR ABOUT 

293
00:12:03,137 --> 00:12:10,178
THROUGHOUT THE COURSE.

294
00:12:10,178 --> 00:12:11,779
>> THANK YOU, HOLLY.

295
00:12:11,779 --> 00:12:12,380
YES, I'VE BEEN AROUND A LONG 

296
00:12:12,380 --> 00:12:15,716
TIME.

297
00:12:15,716 --> 00:12:17,819
THIS COURSE I'VE BEEN DOING MANY

298
00:12:17,819 --> 00:12:18,019
YEARS.

299
00:12:18,019 --> 00:12:21,389
I HAVE THE PLEASURE -- FIRST, 

300
00:12:21,389 --> 00:12:22,490
GOOD MORNING TO EVERYBODY HERE.

301
00:12:22,490 --> 00:12:24,258
IT'S NICE TO SEE FACES HERE AND 

302
00:12:24,258 --> 00:12:26,627
EVERYONE ONLINE.

303
00:12:26,627 --> 00:12:27,528
GOOD MORNING TO YOU, TOO.

304
00:12:27,528 --> 00:12:28,729
I'LL SET UP THE FRAMEWORK FOR 

305
00:12:28,729 --> 00:12:31,132
THE ETHICAL CONDUCT OF RESEARCH 

306
00:12:31,132 --> 00:12:33,000
AND THAT'S WHAT I'M GOING TO DO.

307
00:12:33,000 --> 00:12:35,736
I HAVE THE SAME DISCLAIMER AS 

308
00:12:35,736 --> 00:12:39,140
WELL AS I HAVE NO CONFLICTS TO 

309
00:12:39,140 --> 00:12:39,841
DECLARE.

310
00:12:39,841 --> 00:12:41,542
I WANT TO START BY PROPOSING THE

311
00:12:41,542 --> 00:12:43,277
TWO QUESTIONS WE NEED TO ASK 

312
00:12:43,277 --> 00:12:45,746
FROM AN ETHICAL PERSPECTIVE 

313
00:12:45,746 --> 00:12:47,515
ABOUT CLINICAL RESEARCH ARE 

314
00:12:47,515 --> 00:12:53,721
SHOULD WE DO IT, NUMBER ONE AND 

315
00:12:53,721 --> 00:12:55,690
IF SO, HOW SHOULD WE DO IT.

316
00:12:55,690 --> 00:12:59,127
I SHOULD START BY SAYING WHAT IS

317
00:12:59,127 --> 00:13:04,799
CLINICAL RESEARCH.

318
00:13:04,799 --> 00:13:05,500
CLINICAL RESEARCH IS RESEARCH 

319
00:13:05,500 --> 00:13:08,803
WITH HUMANS MOST OF THE TIME AND

320
00:13:08,803 --> 00:13:10,171
CERTAINLY IN OUR WORLD RELATED 

321
00:13:10,171 --> 00:13:10,438
TO HEALTH.

322
00:13:10,438 --> 00:13:12,807
BUT NOT ALWAYS.

323
00:13:12,807 --> 00:13:17,345
SO SHOULD WE DO IT?

324
00:13:17,345 --> 00:13:19,347
WELL, ONE THING IS CLINICAL 

325
00:13:19,347 --> 00:13:20,848
RESEARCH HAS RESULTED IN 

326
00:13:20,848 --> 00:13:22,817
COMPELLING SOCIETAL HEALTH 

327
00:13:22,817 --> 00:13:23,117
BENEFITS.

328
00:13:23,117 --> 00:13:25,453
CERTAINLY THINGS LIKE NEW 

329
00:13:25,453 --> 00:13:26,721
THERAPIES, DIAGNOSTIC AND 

330
00:13:26,721 --> 00:13:27,922
PREVENTIVE STRATEGIES, IMPROVING

331
00:13:27,922 --> 00:13:30,758
THE QUALITY OF LIFE AND 

332
00:13:30,758 --> 00:13:32,493
UNDERSTANDING THE PATH OF 

333
00:13:32,493 --> 00:13:32,894
DISEASE.

334
00:13:32,894 --> 00:13:33,594
THERE'S A LOT OF GOOD EXAMPLES 

335
00:13:33,594 --> 00:13:36,264
WE CAN TALK ABOUT.

336
00:13:36,264 --> 00:13:39,133
ONE RECENT ONE, COVID VACCINES.

337
00:13:39,133 --> 00:13:40,468
CLINICAL RESEARCH, DEVELOPED, 

338
00:13:40,468 --> 00:13:42,003
FOUND HOW TO MAKE THE VACCINES, 

339
00:13:42,003 --> 00:13:43,704
DEVELOP THE VACCINES AND THEN 

340
00:13:43,704 --> 00:13:46,440
THE VACCINES SAVED MANY PEOPLE'S

341
00:13:46,440 --> 00:13:46,674
LIVES.

342
00:13:46,674 --> 00:13:49,343
HIV THERAPIES.

343
00:13:49,343 --> 00:13:51,646
I STARTED MY CLINICAL WORK MANY 

344
00:13:51,646 --> 00:13:54,549
YEARS AGO IN HIV WHEN IT WAS A 

345
00:13:54,549 --> 00:13:57,718
UNIFORMLY FATAL DISEASE AND NOW 

346
00:13:57,718 --> 00:13:59,353
IT'S A CHRONIC DISEASE THAT 

347
00:13:59,353 --> 00:14:00,788
THANKS TO THE RESEARCH THAT 

348
00:14:00,788 --> 00:14:04,192
DEVELOPED THERAPIES PEOPLE LIVE 

349
00:14:04,192 --> 00:14:06,761
PRETTY NORMAL LIFE SPAN AND HAVE

350
00:14:06,761 --> 00:14:14,335
A GOOD QUALITY OF LIFE.

351
00:14:14,335 --> 00:14:16,837
STATINS ARE ANOTHER EXAMPLE THEY

352
00:14:16,837 --> 00:14:19,040
REDUCE TRIGLYCERIDES AND 

353
00:14:19,040 --> 00:14:20,241
CHOLESTEROL IN THE BLOOD AND 

354
00:14:20,241 --> 00:14:23,978
HAVE HELPED MANY PEOPLE AVOID 

355
00:14:23,978 --> 00:14:25,112
HEART DISEASE.

356
00:14:25,112 --> 00:14:27,882
THERE ARE OTHER VERY DRAMATIC 

357
00:14:27,882 --> 00:14:29,584
ONES.

358
00:14:29,584 --> 00:14:34,722
IN THIS BUILDING THERE'S CHEMO 

359
00:14:34,722 --> 00:14:37,325
THERAPY FOR CHILDHOOD LEUKEMIA 

360
00:14:37,325 --> 00:14:42,163
WHICH USED TO BE FATAL AND NOW 

361
00:14:42,163 --> 00:14:43,931
HAS A 90% SURVIVAL RATE.

362
00:14:43,931 --> 00:14:46,567
GET THE SENSE OF THE BENEFITS OF

363
00:14:46,567 --> 00:14:48,102
DOING RESEARCH FOR SOCIETY FOR 

364
00:14:48,102 --> 00:14:49,870
THE HEALTH OF INDIVIDUALS IS 

365
00:14:49,870 --> 00:14:50,972
PRETTY GREAT.

366
00:14:50,972 --> 00:14:54,075
THE SECOND BULLET HERE IS ABOUT 

367
00:14:54,075 --> 00:14:59,146
CLINICAL RESEARCH PROVIDES 

368
00:14:59,146 --> 00:14:59,413
EVIDENCE.

369
00:14:59,413 --> 00:15:00,915
PROVIDES AN EVIDENCE BASE FOR 

370
00:15:00,915 --> 00:15:01,215
CLINICIANS.

371
00:15:01,215 --> 00:15:03,784
WHEN YOU GO TO THE DOCTOR FOR 

372
00:15:03,784 --> 00:15:05,486
WHATEVER YOU GO TO THE DOCTOR 

373
00:15:05,486 --> 00:15:08,289
FOR YOU WANT THE DOCTOR TO HAVE 

374
00:15:08,289 --> 00:15:10,358
SOME EVIDENCE FOR HOW TO 

375
00:15:10,358 --> 00:15:13,127
DIAGNOSE YOU OR TREAT YOU.

376
00:15:13,127 --> 00:15:17,198
THAT EVIDENCE SHOULD COME OR 

377
00:15:17,198 --> 00:15:17,932
OFTEN DOES COME FROM CLINICAL 

378
00:15:17,932 --> 00:15:21,636
RESEARCH.

379
00:15:21,636 --> 00:15:22,637
I THINK IT'S ALSO INTERESTING TO

380
00:15:22,637 --> 00:15:24,438
THINK ABOUT THE OTHER IMPACTS OF

381
00:15:24,438 --> 00:15:24,972
RESEARCH.

382
00:15:24,972 --> 00:15:28,175
THIS IS FROM FROM THE NIH WEB 

383
00:15:28,175 --> 00:15:28,376
PAGE.

384
00:15:28,376 --> 00:15:30,044
IT DOES INCLUDE MORE THAN 

385
00:15:30,044 --> 00:15:31,379
CLINICAL RESEARCH BECAUSE NIH IS

386
00:15:31,379 --> 00:15:32,680
ABOUT MORE THAN CLINICAL 

387
00:15:32,680 --> 00:15:32,947
RESEARCH.

388
00:15:32,947 --> 00:15:36,150
YOU CAN SEE ON THE LEFT-HAND 

389
00:15:36,150 --> 00:15:37,585
SIDE OF THE SCREEN THERE 

390
00:15:37,585 --> 00:15:40,955
IMPROVING HEALTH IN THE WAYS I 

391
00:15:40,955 --> 00:15:42,156
JUST DESCRIBED REVOLUTIONIZING 

392
00:15:42,156 --> 00:15:44,759
SCIENCE AND SERVING SOCIETY.

393
00:15:44,759 --> 00:15:47,094
I WANT TO SPEND A SECOND ON THE 

394
00:15:47,094 --> 00:15:49,063
SERVING SOCIETY PART.

395
00:15:49,063 --> 00:15:50,097
RESEARCH HAS THESE OTHER 

396
00:15:50,097 --> 00:15:51,399
OUTCOMES THAT ARE ACTUALLY 

397
00:15:51,399 --> 00:15:53,668
PRETTY BENEFICIAL.

398
00:15:53,668 --> 00:15:55,269
SOME ARE ECONOMIC.

399
00:15:55,269 --> 00:15:56,570
THERE'S DATA ON THE DIRECT 

400
00:15:56,570 --> 00:15:58,339
ECONOMIC CONTRIBUTIONS OF 

401
00:15:58,339 --> 00:15:59,540
MEDICAL RESEARCH.

402
00:15:59,540 --> 00:16:01,942
SOME OF IT IS SPURRING ECONOMIC 

403
00:16:01,942 --> 00:16:04,011
GROWTH, GIVING JOBS, CREATING 

404
00:16:04,011 --> 00:16:06,814
INDUSTRIES, THINGS LIKE THAT.

405
00:16:06,814 --> 00:16:08,749
AND THEN THERE ARE SOCIETAL 

406
00:16:08,749 --> 00:16:10,518
BENEFITS OF IMPROVED HEALTH AND 

407
00:16:10,518 --> 00:16:13,454
OF IMPROVED RESEARCH.

408
00:16:13,454 --> 00:16:14,555
PRODUCTIVITY OR UNDERSTANDING 

409
00:16:14,555 --> 00:16:18,359
HOW DIETARY GUIDELINES SHOULD BE

410
00:16:18,359 --> 00:16:18,592
FORMED.

411
00:16:18,592 --> 00:16:19,860
THOSE ARE THE KINDS OF THINGS 

412
00:16:19,860 --> 00:16:21,429
AND IF YOU'RE INTERESTED YOU CAN

413
00:16:21,429 --> 00:16:22,229
GO TO THE WEBSITE.

414
00:16:22,229 --> 00:16:25,966
IF I'VE CONVINCED YOU, RESEARCH 

415
00:16:25,966 --> 00:16:28,235
IS A GOOD THING.

416
00:16:28,235 --> 00:16:32,006
THE QUESTION THEN IS, WHY IS IT 

417
00:16:32,006 --> 00:16:34,008
PROBLEMATIC ETHICALLY?

418
00:16:34,008 --> 00:16:34,842
IT'S PROBLEMATIC ESSENTIALLY FOR

419
00:16:34,842 --> 00:16:35,576
THIS REASON.

420
00:16:35,576 --> 00:16:37,511
THE PRIMARY GOAL OF CLINICAL 

421
00:16:37,511 --> 00:16:40,314
RESEARCH IS TO GENERATE USEFUL 

422
00:16:40,314 --> 00:16:40,815
KNOWLEDGE.

423
00:16:40,815 --> 00:16:41,982
USEFUL KNOWLEDGE ABOUT HUMAN 

424
00:16:41,982 --> 00:16:44,118
HEALTH AND ILLNESS BUT NOT TO 

425
00:16:44,118 --> 00:16:47,321
BENEFIT THE PARTICIPANTS IN THEY

426
00:16:47,321 --> 00:16:49,824
OR NOT NECESSARILY TO BENEFIT 

427
00:16:49,824 --> 00:16:51,926
THE PARTICIPANTS IN STUDIES 

428
00:16:51,926 --> 00:16:55,796
THOUGH SOMETIMES THEY DO BENEFIT

429
00:16:55,796 --> 00:16:57,031
DIRECTLY.

430
00:16:57,031 --> 00:16:58,232
IF THAT'S RIGHT AND THE WAY 

431
00:16:58,232 --> 00:17:00,468
RESEARCH IS SET UP, THEN WE'RE 

432
00:17:00,468 --> 00:17:02,236
BASICALLY ASKING A SMALL NUMBER 

433
00:17:02,236 --> 00:17:04,305
OF PEOPLE TO ACCEPT A CERTAIN 

434
00:17:04,305 --> 00:17:07,808
AMOUNT OF RISK AND BURDEN AND 

435
00:17:07,808 --> 00:17:08,709
INCONVENIENCE IN ORDER TO LEARN 

436
00:17:08,709 --> 00:17:15,116
HOW TO BENEFIT OTHERS.

437
00:17:15,116 --> 00:17:17,985
THEREFORE THERE'S MEANS TO 

438
00:17:17,985 --> 00:17:20,121
DEVELOPING USEFUL KNOWLEDGE AND 

439
00:17:20,121 --> 00:17:25,960
THE RISK OF BEING EXPLORATIVE 

440
00:17:25,960 --> 00:17:28,796
AND THIS IS COMMON WISDOM.

441
00:17:28,796 --> 00:17:29,964
PEOPLE THINK OF CLINICAL 

442
00:17:29,964 --> 00:17:36,670
RESEARCH AS USING PEOPLE AS 

443
00:17:36,670 --> 00:17:38,205
GUINEA PIGS AND THERE'S 

444
00:17:38,205 --> 00:17:38,839
MISUNDERSTANDING HOW RESEARCH 

445
00:17:38,839 --> 00:17:42,576
GETS DONE AND HOW PEOPLE ARE 

446
00:17:42,576 --> 00:17:44,912
ENGAGED IN RESEARCH NOT 

447
00:17:44,912 --> 00:17:46,914
NECESSARILY AS HUMAN GUINEA 

448
00:17:46,914 --> 00:17:47,114
PIGS.

449
00:17:47,114 --> 00:17:50,651
IT LEADS US TO THE DEMAND FOR 

450
00:17:50,651 --> 00:17:52,019
THE ETHICS IN CLINICAL RESEARCH 

451
00:17:52,019 --> 00:17:55,122
TO HAVE AT LEAST TWO PRONGS.

452
00:17:55,122 --> 00:17:59,126
THE ETHIC OF CLINICAL RESEARCH 

453
00:17:59,126 --> 00:18:00,694
PROMOTES RESPONSIBLE AND USEFUL 

454
00:18:00,694 --> 00:18:02,363
RESEARCH THAT HAS THE 

455
00:18:02,363 --> 00:18:03,964
POSSIBILITY OF BENEFITING 

456
00:18:03,964 --> 00:18:07,401
SOCIETY WHILE WE'RE PROTECTING 

457
00:18:07,401 --> 00:18:09,570
MINIMIZING HARM TO MINIMIZING 

458
00:18:09,570 --> 00:18:10,805
THE POSSIBILITY OF EXPLOITATION 

459
00:18:10,805 --> 00:18:13,274
AND PROTECTING THE RIGHTS AND 

460
00:18:13,274 --> 00:18:16,177
WELFARE OF THE PARTICIPANTS THAT

461
00:18:16,177 --> 00:18:18,078
WE'RE ENGAGED IN CLINICAL 

462
00:18:18,078 --> 00:18:18,345
RESEARCH.

463
00:18:18,345 --> 00:18:21,015
THE ETHICS OF CLINICAL RESEARCH 

464
00:18:21,015 --> 00:18:21,549
REALLY HAS BOTH OF THESE 

465
00:18:21,549 --> 00:18:25,653
DEMANDS.

466
00:18:25,653 --> 00:18:27,021
THERE ARE A NUMBER OUT THERE OF 

467
00:18:27,021 --> 00:18:29,957
ETHICAL REQUIREMENTS AND 

468
00:18:29,957 --> 00:18:31,692
GUIDANCE IN THE LITERATURE AND 

469
00:18:31,692 --> 00:18:31,992
REGULATIONS.

470
00:18:31,992 --> 00:18:33,027
THERE ARE CODES OF ETHICS AND 

471
00:18:33,027 --> 00:18:35,129
THING LIKE THAT.

472
00:18:35,129 --> 00:18:36,764
BASICALLY THESE ALL TRY TO DO 

473
00:18:36,764 --> 00:18:37,364
THOSE TWO THINGS.

474
00:18:37,364 --> 00:18:39,667
THEY PROMOTE THE RESPONSIBLE 

475
00:18:39,667 --> 00:18:41,435
CONDUCT OF RESEARCH WHILE 

476
00:18:41,435 --> 00:18:43,871
SEEKING PROGRESS IN 

477
00:18:43,871 --> 00:18:47,341
UNDERSTANDING AND INTERVENING 

478
00:18:47,341 --> 00:18:48,375
HEALTH AND MINIMIZING 

479
00:18:48,375 --> 00:18:51,145
EXPLOITATION OF THE INDIVIDUALS 

480
00:18:51,145 --> 00:18:54,381
ENGAGED AND MAKE SURE THEIR 

481
00:18:54,381 --> 00:18:58,185
RIGHTS AND WELFARE ARE RESPECTED

482
00:18:58,185 --> 00:18:59,186
WHILE CONTRIBUTING TO KNOWLEDGE 

483
00:18:59,186 --> 00:19:00,421
AND MAINTAIN PUBLIC TRUST IN THE

484
00:19:00,421 --> 00:19:03,491
ENTERPRISE OF RESEARCH.

485
00:19:03,491 --> 00:19:08,696
SO HOW DO WE THINK ABOUT HOW TO 

486
00:19:08,696 --> 00:19:10,531
DO A CLINICAL RESEARCH TO 

487
00:19:10,531 --> 00:19:11,899
PROMOTE USEFUL KNOWLEDGE AND 

488
00:19:11,899 --> 00:19:14,935
PROTECT HUMAN SUBJECTS?

489
00:19:14,935 --> 00:19:17,972
AND I THINK THERE'S TWO MAIN 

490
00:19:17,972 --> 00:19:21,008
AVENUES OF LEARNING THAT WE HAVE

491
00:19:21,008 --> 00:19:21,175
HAD.

492
00:19:21,175 --> 00:19:25,546
ONE IS THROUGH HISTORICAL 

493
00:19:25,546 --> 00:19:27,147
LESSONS AND SUSAN LETTER IS 

494
00:19:27,147 --> 00:19:28,916
COMING AFTER ME AND TALKING 

495
00:19:28,916 --> 00:19:30,684
ABOUT SPECIFIC CASES IN THE 

496
00:19:30,684 --> 00:19:32,887
HISTORY OF HOW WE HAVE THOUGHT 

497
00:19:32,887 --> 00:19:34,421
ABOUT ETHICS AND CLINICAL 

498
00:19:34,421 --> 00:19:34,688
RESEARCH.

499
00:19:34,688 --> 00:19:36,824
I'M GOING TO FOCUS MOSTLY ON THE

500
00:19:36,824 --> 00:19:37,725
ETHICAL REASONS.

501
00:19:37,725 --> 00:19:41,962
HOW DO WE THINK ABOUT IT 

502
00:19:41,962 --> 00:19:42,229
ETHICALLY.

503
00:19:42,229 --> 00:19:44,331
I'LL START WITH ONE SLIDE ON 

504
00:19:44,331 --> 00:19:46,467
HISTORY BECAUSE SUSAN'S GOING TO

505
00:19:46,467 --> 00:19:48,569
TALK ABOUT SPECIFIC CASES BUT I 

506
00:19:48,569 --> 00:19:50,170
THINK IF YOU LOOK OVER THE 

507
00:19:50,170 --> 00:19:52,806
TRAJECTORY OF TIME, THERE HAVE 

508
00:19:52,806 --> 00:19:54,775
BEEN ERAS OF DIFFERENCE IN TERMS

509
00:19:54,775 --> 00:19:57,545
OF HOW WE THOUGHT ABOUT ETHICS 

510
00:19:57,545 --> 00:19:58,579
OF CLINICAL RESEARCH.

511
00:19:58,579 --> 00:20:02,650
THERE WAS A LONG PERIOD OF TIME 

512
00:20:02,650 --> 00:20:05,052
WHERE THE ETHICS OF RESEARCH WAS

513
00:20:05,052 --> 00:20:06,487
TOTALLY DEPENDENT ON THE 

514
00:20:06,487 --> 00:20:07,888
INDIVIDUALS DOING IT AND THEIR 

515
00:20:07,888 --> 00:20:14,762
PEER PRESSURE TO DO IT RIGHT.

516
00:20:14,762 --> 00:20:19,133
THEN THERE WAS AN ADMITTEDLY NOW

517
00:20:19,133 --> 00:20:20,734
UTILITARIAN PERIOD OF RESEARCH 

518
00:20:20,734 --> 00:20:22,336
WRITTEN ABOUT IN THAT WAY WHEN 

519
00:20:22,336 --> 00:20:24,939
THE IDEA WAS WE COULD ASK 

520
00:20:24,939 --> 00:20:29,977
PEOPLE, EVEN VULNERABLE AND 

521
00:20:29,977 --> 00:20:30,778
MARGINALIZED PEOPLE TO HELP 

522
00:20:30,778 --> 00:20:32,079
TREATMENT AND UNDERSTANDING OF 

523
00:20:32,079 --> 00:20:33,948
HEALTH FOR OTHERS, SOCIETY.

524
00:20:33,948 --> 00:20:35,316
REALLY USING PEOPLE FOR THE 

525
00:20:35,316 --> 00:20:36,517
BENEFIT OF OTHERS IN A VERY 

526
00:20:36,517 --> 00:20:40,120
DIRECT WAY.

527
00:20:40,120 --> 00:20:41,956
THAT LED TO A LOT OF SCRUTINY 

528
00:20:41,956 --> 00:20:43,357
ABOUT WHY ARE WE DOING THIS AND 

529
00:20:43,357 --> 00:20:46,327
WHAT IS THE SCOPE WE SHOULD BE 

530
00:20:46,327 --> 00:20:46,527
DOING?

531
00:20:46,527 --> 00:20:48,495
SHOULD WE BE ALLOWING THAT KIND 

532
00:20:48,495 --> 00:20:49,597
OF RESEARCH?

533
00:20:49,597 --> 00:20:51,131
SHOULD THERE BE RULES OR LIMITS 

534
00:20:51,131 --> 00:20:53,300
ON WHAT WE CAN DO TO PEOPLE TO 

535
00:20:53,300 --> 00:20:54,568
ANSWER QUESTIONS THAT MAY BE 

536
00:20:54,568 --> 00:20:56,203
USEFUL FOR OTHERS.

537
00:20:56,203 --> 00:20:58,706
THAT LED TO AN ERA OF RULES AND 

538
00:20:58,706 --> 00:20:59,006
REGULATIONS.

539
00:20:59,006 --> 00:21:00,908
THERE'S LOTS OF REGULATIONS PUT 

540
00:21:00,908 --> 00:21:01,875
INTO AFFECT.

541
00:21:01,875 --> 00:21:06,647
MANY OF WHICH WE STILL OPERATE 

542
00:21:06,647 --> 00:21:06,847
UNDER.

543
00:21:06,847 --> 00:21:10,084
AND THE ENTERPRISE OF CLINICAL 

544
00:21:10,084 --> 00:21:11,919
RESEARCH BECAME VERY WELL 

545
00:21:11,919 --> 00:21:16,457
REGULATED AND IS WELL REGULATED.

546
00:21:16,457 --> 00:21:20,761
I'D SAY SUBSEQUENT TO THAT THERE

547
00:21:20,761 --> 00:21:24,365
WAS A PENDULUM SWING TO 

548
00:21:24,365 --> 00:21:26,433
RECOGNIZING RESEARCH IS AN 

549
00:21:26,433 --> 00:21:27,735
IMPORTANT BENEFIT AND SOMETIMES 

550
00:21:27,735 --> 00:21:33,107
THE RULES AND REGULATIONS LIMIT 

551
00:21:33,107 --> 00:21:35,409
IT TOO MUCH AND DIMINISH THE 

552
00:21:35,409 --> 00:21:36,710
LIMITS OF DOING THE RESEARCH.

553
00:21:36,710 --> 00:21:37,978
THIS IS BENEFITS RECOGNIZED ON 

554
00:21:37,978 --> 00:21:39,446
THE PART OF INDIVIDUALS WHO 

555
00:21:39,446 --> 00:21:41,115
WANTED TO BE PART OF RESEARCH 

556
00:21:41,115 --> 00:21:43,517
BECAUSE THEY FELT THEY COULD GET

557
00:21:43,517 --> 00:21:45,052
BENEFIT FROM BEING A PART OF 

558
00:21:45,052 --> 00:21:47,354
RESEARCH AND ALSO FROM GROUPS 

559
00:21:47,354 --> 00:21:49,757
WHO SAID HOW ARE WE GOING TO 

560
00:21:49,757 --> 00:21:53,093
KNOW HOW TO TREAT CHILDREN 

561
00:21:53,093 --> 00:21:55,629
UNLESS WE INCLUDE CHILDREN IN 

562
00:21:55,629 --> 00:21:56,730
RESEARCH AND FOCUSSED ON 

563
00:21:56,730 --> 00:21:56,997
CHILDREN.

564
00:21:56,997 --> 00:21:58,532
THAT'S THE KIND OF BENEFIT 

565
00:21:58,532 --> 00:22:03,704
THAT'S BEEN RECOGNIZED.

566
00:22:03,704 --> 00:22:04,672
THROUGHOUT THESE DIFFERENT ERAS 

567
00:22:04,672 --> 00:22:06,206
OF HISTORY THERE'S BEEN A NUMBER

568
00:22:06,206 --> 00:22:07,708
OF CODES AND REGULATIONS THAT 

569
00:22:07,708 --> 00:22:09,209
HAVE BEEN DEVELOPED.

570
00:22:09,209 --> 00:22:11,445
I'M GOING TO SAY NOT MUCH ABOUT 

571
00:22:11,445 --> 00:22:13,580
ANY OF THESE BUT MAKE SURE THAT 

572
00:22:13,580 --> 00:22:14,782
YOU KNOW THEY'RE OUT THERE.

573
00:22:14,782 --> 00:22:18,285
SOME OF THEM YOU'VE PROBABLY 

574
00:22:18,285 --> 00:22:23,724
HEARD ABOUT BEFORE LIKE THE 

575
00:22:23,724 --> 00:22:26,393
NUREMBERG CODE THE OUTCOME OF 

576
00:22:26,393 --> 00:22:30,731
THE NAZI DOCTOR'S TRIAL AND IT'S

577
00:22:30,731 --> 00:22:32,866
A USEFUL DOCUMENT AND HAS A LOT 

578
00:22:32,866 --> 00:22:34,935
OF FORCE STILL BUT DOESN'T HAVE 

579
00:22:34,935 --> 00:22:35,869
ANY AUTHORITY REALLY YET HAS 

580
00:22:35,869 --> 00:22:38,405
GOOD TENETS TO IT.

581
00:22:38,405 --> 00:22:42,376
THE FIRST ONE IS ABOUT VOLUNTARY

582
00:22:42,376 --> 00:22:44,411
CONSENT AND THAT HAS BEEN THE 

583
00:22:44,411 --> 00:22:45,946
SOURCE OF A LOT OF FOCUS ON THE 

584
00:22:45,946 --> 00:22:47,948
NEED FOR CONSENT IN RESEARCH.

585
00:22:47,948 --> 00:22:52,386
THE DECLARATION OF HELSINKI WAS 

586
00:22:52,386 --> 00:22:53,987
WRITTEN BY THE WORLD MEDICAL 

587
00:22:53,987 --> 00:22:55,355
ASSOCIATION WHICH IS AN 

588
00:22:55,355 --> 00:22:57,157
ASSOCIATION OF ALL OF THE 

589
00:22:57,157 --> 00:22:58,192
AMERICAN MEDICAL ASSOCIATIONS 

590
00:22:58,192 --> 00:23:00,928
AROUND THE WORLD FROM THE 

591
00:23:00,928 --> 00:23:02,896
DIFFERENT COUNTRIES.

592
00:23:02,896 --> 00:23:05,966
THEY WROTE IT ACTUALLY IN THE 

593
00:23:05,966 --> 00:23:08,469
'60s INITIALLY BECAUSE OF THE 

594
00:23:08,469 --> 00:23:11,972
REACTION TO THE CODE WAS WELL, 

595
00:23:11,972 --> 00:23:14,041
THAT'S FOR PRISONERS.

596
00:23:14,041 --> 00:23:17,911
WE WANTED A CODE FOR DOCTORS 

597
00:23:17,911 --> 00:23:19,480
TREATING AND ENROLLING PATIENTS 

598
00:23:19,480 --> 00:23:21,148
IN RESEARCH.

599
00:23:21,148 --> 00:23:23,584
THEY WROTE THAT DECLARATION 

600
00:23:23,584 --> 00:23:25,619
INITIALLY IN 1964.

601
00:23:25,619 --> 00:23:26,854
IT'S BEEN REVISED AT LEAST SIX 

602
00:23:26,854 --> 00:23:29,957
OR SEVEN TIMES, RECENTLY IN 

603
00:23:29,957 --> 00:23:30,657
2013.

604
00:23:30,657 --> 00:23:32,292
MY UNDERSTANDING IS THAT IT'S 

605
00:23:32,292 --> 00:23:37,097
CURRENTLY BEING REVISED AGAIN.

606
00:23:37,097 --> 00:23:38,398
DECLARATION OF HELSINKI DOES 

607
00:23:38,398 --> 00:23:39,500
HAVE A LOT OF FORCE AROUND THE 

608
00:23:39,500 --> 00:23:42,202
WORLD AND HAS BEEN THE SOURCE OF

609
00:23:42,202 --> 00:23:42,669
A LOT OF CONTROVERSY.

610
00:23:42,669 --> 00:23:46,340
SOME OF THE TENETS OF THE 

611
00:23:46,340 --> 00:23:47,107
DECLARATION HAVE BEEN DEBATED 

612
00:23:47,107 --> 00:23:49,176
QUITE HEAVILY OVER THE YEARS AND

613
00:23:49,176 --> 00:23:51,411
I CAN TALK ABOUT THAT LATER IF 

614
00:23:51,411 --> 00:23:52,880
PEOPLE ARE INTERESTED.

615
00:23:52,880 --> 00:23:55,649
THE BELMONT REPORT, HOLLY 

616
00:23:55,649 --> 00:23:58,352
MENTIONED THE BELMONT REPORT 

617
00:23:58,352 --> 00:23:59,586
CAME OUT OF THE FIRST COMMISSION

618
00:23:59,586 --> 00:24:00,254
IN THE UNITED STATES CALLED THE 

619
00:24:00,254 --> 00:24:01,555
NATIONAL COMMISSION FOR THE 

620
00:24:01,555 --> 00:24:04,258
PROTECTION OF HUMAN SUBJECTS OF 

621
00:24:04,258 --> 00:24:05,959
BIO MEDICAL AND BEHAVIORAL 

622
00:24:05,959 --> 00:24:07,728
RESEARCH A SHORT.

623
00:24:07,728 --> 00:24:09,129
USUALLY REFERRED TO AS THE 

624
00:24:09,129 --> 00:24:09,997
NATIONAL COMMISSION.

625
00:24:09,997 --> 00:24:13,066
AND THEY WROTE THE BELMONT 

626
00:24:13,066 --> 00:24:14,935
REPORT SAYING SOMETHING ABOUT IN

627
00:24:14,935 --> 00:24:17,805
A MINUTE BECAUSE IT'S UNIQUE OR 

628
00:24:17,805 --> 00:24:18,438
DISTINCT IN SOME RESPECTS FROM 

629
00:24:18,438 --> 00:24:22,009
THE OTHERS.

630
00:24:22,009 --> 00:24:26,480
THE CIOMS/WHO INTERNATIONAL 

631
00:24:26,480 --> 00:24:28,916
GUIDELINES WERE WRITTEN 

632
00:24:28,916 --> 00:24:39,126
INITIALLY IN 1993 IT'S FOR 

633
00:24:39,126 --> 00:24:41,962
COUNCIL OF INTERNATIONAL 

634
00:24:41,962 --> 00:24:44,665
ORGANIZATION AND IT'S WHEN 

635
00:24:44,665 --> 00:24:47,634
THERE'S A COUNTRY DOING RESEARCH

636
00:24:47,634 --> 00:24:49,136
COLLABORATIVELY OR NOT WITH A 

637
00:24:49,136 --> 00:24:52,072
HOST COUNTRY WITH LESS 

638
00:24:52,072 --> 00:24:52,339
RESOURCES.

639
00:24:52,339 --> 00:24:56,910
SO THE CIOMS INITIALLY THE 

640
00:24:56,910 --> 00:24:59,079
INTERNATIONAL GUIDELINES TOOK 

641
00:24:59,079 --> 00:25:00,914
THE PRINCIPLES IN THE 

642
00:25:00,914 --> 00:25:02,749
DECLARATION OF HELSINKI AND 

643
00:25:02,749 --> 00:25:04,785
TRIED TO ELABORATE ON THEM FOR 

644
00:25:04,785 --> 00:25:06,653
THE CONTEXT OF INTERNATIONAL 

645
00:25:06,653 --> 00:25:07,354
COLLABORATIVE RESEARCH.

646
00:25:07,354 --> 00:25:08,622
THEY'VE ALSO BEEN REVISED 

647
00:25:08,622 --> 00:25:10,290
SEVERAL TIMES.

648
00:25:10,290 --> 00:25:11,825
RECENTLY IN 2016.

649
00:25:11,825 --> 00:25:15,062
ONE OF THE NICE THINGS FROM MY 

650
00:25:15,062 --> 00:25:16,396
PERSPECTIVE THESE GUIDELINES NOT

651
00:25:16,396 --> 00:25:21,335
ONLY ARE THERE TENETS BUT 

652
00:25:21,335 --> 00:25:22,603
THERE'S EXPLANATIONS OF WHY THEY

653
00:25:22,603 --> 00:25:25,839
THINK IT'S AN IMPORTANT TENET.

654
00:25:25,839 --> 00:25:29,977
THEIR REASONING BEHIND THEIR 

655
00:25:29,977 --> 00:25:34,882
PRINCIPLES ARE IN THE DOCUMENT.

656
00:25:34,882 --> 00:25:37,017
THEN I KRIF H/GCP THE 

657
00:25:37,017 --> 00:25:39,186
INTERNATIONAL CONFERENCE ON 

658
00:25:39,186 --> 00:25:39,519
HARMONIZATION.

659
00:25:39,519 --> 00:25:43,523
GOOD CLINICAL PRACTICE 

660
00:25:43,523 --> 00:25:46,393
GUIDELINES -- ICH/GCP.

661
00:25:46,393 --> 00:25:48,862
THIS IS FROM RECOGNITION THAT 

662
00:25:48,862 --> 00:25:49,730
OFTEN TIMES RESEARCH IS BEING 

663
00:25:49,730 --> 00:25:52,065
DONE IN ONE PART OF THE WORLD 

664
00:25:52,065 --> 00:25:53,634
AND THE RESULT ARE TO BE ADOPTED

665
00:25:53,634 --> 00:25:54,668
IN ANOTHER PART OF THE WORLD.

666
00:25:54,668 --> 00:25:57,004
THERE'S REGULATORY AGENCIES IN 

667
00:25:57,004 --> 00:25:58,538
EVERY COUNTRY.

668
00:25:58,538 --> 00:25:59,706
TO AVOID HAVING TO REPEAT 

669
00:25:59,706 --> 00:26:00,941
RESEARCH IN EVERY COUNTRY THAT'S

670
00:26:00,941 --> 00:26:03,577
GOING TO TRY TO REGULATE IT A 

671
00:26:03,577 --> 00:26:08,248
NUMBER OF COUNTRIES GOT TOGETHER

672
00:26:08,248 --> 00:26:11,952
I THINK INITIALLY IN THE 1990s 

673
00:26:11,952 --> 00:26:16,490
AND PUT TOGETHER THE ICH/GCP 

674
00:26:16,490 --> 00:26:17,958
SAYING IF COUNTRIES FOLLOWED 

675
00:26:17,958 --> 00:26:20,594
THOSE GUIDELINE THE REGULATORY 

676
00:26:20,594 --> 00:26:22,529
AUTHORITIES WOULD ACCEPT THE 

677
00:26:22,529 --> 00:26:23,664
DATA THAT CAME FROM THE RESEARCH

678
00:26:23,664 --> 00:26:25,365
DONE IN THAT WAY.

679
00:26:25,365 --> 00:26:30,904
AND ICH/GCP ADOPTS THE ETHICAL 

680
00:26:30,904 --> 00:26:33,006
GUIDANCE THAT CAME FROM THE 

681
00:26:33,006 --> 00:26:33,840
DECLARATION OF HELSINKI.

682
00:26:33,840 --> 00:26:35,542
THOSE ARE DIFFERENT FROM THE 

683
00:26:35,542 --> 00:26:36,209
REGULATIONS.

684
00:26:36,209 --> 00:26:39,947
AND THESE ARE SELECTIVE 

685
00:26:39,947 --> 00:26:40,247
REGULATIONS.

686
00:26:40,247 --> 00:26:42,449
IN THE UNITED STATES, THE COMMON

687
00:26:42,449 --> 00:26:45,852
RULE IS THE REGULATIONS THAT 

688
00:26:45,852 --> 00:26:48,055
GOVERN THE ETHICS OF RESEARCH 

689
00:26:48,055 --> 00:26:50,891
WITH HUMANS THAT'S FUNDED BY THE

690
00:26:50,891 --> 00:26:51,525
FEDERAL GOVERNMENT.

691
00:26:51,525 --> 00:26:53,794
SO ALL OF YOU WHO ARE LISTEN WHO

692
00:26:53,794 --> 00:26:59,633
HAVE ANYTHING TO DO WITH NIH OR 

693
00:26:59,633 --> 00:27:00,434
RECEIVE NIH OR FEDERAL 

694
00:27:00,434 --> 00:27:01,401
GOVERNMENT GOVERNMENT FROM THE 

695
00:27:01,401 --> 00:27:03,136
UNITED STATES YOU HAVE TO FOLLOW

696
00:27:03,136 --> 00:27:04,871
A COMMON RULE WHEN YOU DO 

697
00:27:04,871 --> 00:27:06,106
RESEARCH WITH HUMANS.

698
00:27:06,106 --> 00:27:08,308
FDA HAS A SEPARATE SET OF 

699
00:27:08,308 --> 00:27:10,377
REGULATIONS AND THE REGULATIONS 

700
00:27:10,377 --> 00:27:11,945
ARE ACTUALLY QUITE SIMILAR TO 

701
00:27:11,945 --> 00:27:15,115
THE COMMON RULE BUT NOT 

702
00:27:15,115 --> 00:27:15,916
IDENTICAL.

703
00:27:15,916 --> 00:27:17,985
AND FDA HAS A DIFFERENT MISSION 

704
00:27:17,985 --> 00:27:23,123
IN WHICH THE MISSION IS TO 

705
00:27:23,123 --> 00:27:25,225
PROTECT THE AMERICAN PUBLIC SO 

706
00:27:25,225 --> 00:27:27,160
THEY'RE CONCERNED WITH HOW DATA 

707
00:27:27,160 --> 00:27:28,562
ARE COLLECTED AND WHETHER 

708
00:27:28,562 --> 00:27:29,896
PRODUCTS THAT ARE TESTED SHOW 

709
00:27:29,896 --> 00:27:34,601
SAFETY AND EFFICACY.

710
00:27:34,601 --> 00:27:37,237
MOST INSTITUTIONS INCLUDING THE 

711
00:27:37,237 --> 00:27:39,006
NIH HAS FURTHER POLICY AND GID 

712
00:27:39,006 --> 00:27:41,074
LINES WHICH GUIDE CLINICAL 

713
00:27:41,074 --> 00:27:41,508
RESEARCH.

714
00:27:41,508 --> 00:27:43,543
THEN IF YOU'RE DOING 

715
00:27:43,543 --> 00:27:44,311
COLLABORATIVE RESEARCH AROUND 

716
00:27:44,311 --> 00:27:47,814
THE WORLD, MANY JURISDICTIONS 

717
00:27:47,814 --> 00:27:49,483
HAVE SIMILAR LAWS AND 

718
00:27:49,483 --> 00:27:51,251
REGULATIONS SPECIFIC TO THE 

719
00:27:51,251 --> 00:27:52,319
JURISDICTION.

720
00:27:52,319 --> 00:27:53,987
SO THERE'S A LOT OF MOVING PARTS

721
00:27:53,987 --> 00:27:54,187
HERE.

722
00:27:54,187 --> 00:27:55,622
A LOT OF THINGS THAT NEED TO BE 

723
00:27:55,622 --> 00:27:56,323
PAID ATTENTION TO WHEN 

724
00:27:56,323 --> 00:27:58,959
SOMEBODY'S DOING RESEARCH.

725
00:27:58,959 --> 00:28:00,160
I WANT TO SAY ONE ADDITIONAL 

726
00:28:00,160 --> 00:28:03,463
THING ABOUT THE BELMONT REPORT 

727
00:28:03,463 --> 00:28:06,933
AND I DIDN'T EVEN KNOW BUT IT'S 

728
00:28:06,933 --> 00:28:08,568
AN IMPORTANT DOCUMENT BECAUSE IT

729
00:28:08,568 --> 00:28:10,737
BEGIN BY TRYING TO EXPLICATE THE

730
00:28:10,737 --> 00:28:11,938
ETHICAL PRINCIPLES THAT UNDER 

731
00:28:11,938 --> 00:28:19,179
LIE  -- UNDERLIE THE CONDUCT AND

732
00:28:19,179 --> 00:28:21,882
RESPECT FOR PERSONS, BENEFICENCE

733
00:28:21,882 --> 00:28:24,184
AND RESPECT FOR PERSONS APPLIED 

734
00:28:24,184 --> 00:28:25,485
TO PROCESS OF INFORMED CONSENT 

735
00:28:25,485 --> 00:28:27,854
AND BENEFICENCE APPLIED TO HOW 

736
00:28:27,854 --> 00:28:31,725
WE ASSESS RISKS AND BENEFITS AND

737
00:28:31,725 --> 00:28:34,327
JUSTICE TO HOW WE SELECT 

738
00:28:34,327 --> 00:28:36,263
PARTICIPANTS IN STUDIES AND 

739
00:28:36,263 --> 00:28:37,764
ASSURE SOME DISTRIBUTION OF THE 

740
00:28:37,764 --> 00:28:39,833
BENEFITS AND BURDENS OF 

741
00:28:39,833 --> 00:28:40,100
RESEARCH.

742
00:28:40,100 --> 00:28:41,368
IT'S A VERY USEFUL DOCUMENT.

743
00:28:41,368 --> 00:28:43,537
IT'S A RELATIVELY SHORT 

744
00:28:43,537 --> 00:28:43,804
DOCUMENT.

745
00:28:43,804 --> 00:28:45,338
EASY TO READ AND USEFUL FOR 

746
00:28:45,338 --> 00:28:46,640
THINKING ABOUT THE KINDS OF 

747
00:28:46,640 --> 00:28:51,411
CHALLENGES WE FACE IN RESEARCH 

748
00:28:51,411 --> 00:28:57,384
THOUGH IT'S 50 YEARS OLD.

749
00:28:57,384 --> 00:28:58,118
AND ANOTHER THING THAT'S 

750
00:28:58,118 --> 00:28:59,152
INTERESTING AND IMPORTANT IS 

751
00:28:59,152 --> 00:29:02,255
SPELL OUT THE BOUNDARIES BETWEEN

752
00:29:02,255 --> 00:29:03,690
CLINICAL PRACTICE AND CLINICAL 

753
00:29:03,690 --> 00:29:03,957
RESEARCH.

754
00:29:03,957 --> 00:29:05,125
HOW THEY'RE DIFFERENT.

755
00:29:05,125 --> 00:29:05,859
I'M SAIL A LITTLE BIT MORE ABOUT

756
00:29:05,859 --> 00:29:15,936
THAT IN A MINUTE.

757
00:29:15,936 --> 00:29:17,037
THE DIFFERENCE BETWEEN RESEARCH 

758
00:29:17,037 --> 00:29:18,738
AND CLINICAL PRACTICE I THINK IS

759
00:29:18,738 --> 00:29:19,840
IMPORTANT FOR THINKING ABOUT THE

760
00:29:19,840 --> 00:29:22,175
ETHICAL TENSIONS THAT WE 

761
00:29:22,175 --> 00:29:24,344
SOMETIMES FACE WHEN WE'RE DOING 

762
00:29:24,344 --> 00:29:24,644
RESEARCH.

763
00:29:24,644 --> 00:29:25,846
HERE'S SOME OF THE DIFFERENCES.

764
00:29:25,846 --> 00:29:27,681
THEY HAVE DIFFERENT GOALS.

765
00:29:27,681 --> 00:29:28,782
I ALREADY MENTIONED THE FACT 

766
00:29:28,782 --> 00:29:30,750
THAT RESEARCH, THE GOAL OF 

767
00:29:30,750 --> 00:29:32,319
RESEARCH IS TO GENERATE USEFUL 

768
00:29:32,319 --> 00:29:38,024
KNOWLEDGE THAT WILL HELP US 

769
00:29:38,024 --> 00:29:41,261
BETTER UNDERSTAND HEALTH AND 

770
00:29:41,261 --> 00:29:42,395
DISEASE AND HOW TO BETTER 

771
00:29:42,395 --> 00:29:43,763
DIAGNOSE AND TREAT IT.

772
00:29:43,763 --> 00:29:44,564
CLINICAL PRACTICE ON THE OTHER 

773
00:29:44,564 --> 00:29:48,201
HAND, THE GOAL IS TO BENEFIT THE

774
00:29:48,201 --> 00:29:50,070
PERSON OR PEOPLE FOR WHOM YOU'RE

775
00:29:50,070 --> 00:29:52,005
INTERACTING WITH.

776
00:29:52,005 --> 00:29:53,940
YOU USE THE EVIDENCE THAT'S BEEN

777
00:29:53,940 --> 00:29:54,774
GENERATED BY RESEARCH HOPEFULLY 

778
00:29:54,774 --> 00:29:56,276
IN THE PAST TO SAY WHAT'S THE 

779
00:29:56,276 --> 00:29:57,677
BEST THING I CAN DO TO PROMOTE 

780
00:29:57,677 --> 00:29:59,312
THE WELFARE OF THIS PERSON OR 

781
00:29:59,312 --> 00:30:02,382
THIS GROUP IN FRONT OF ME.

782
00:30:02,382 --> 00:30:04,951
SO THE GOALS ARE VERY DIFFERENT 

783
00:30:04,951 --> 00:30:06,086
BETWEEN RESEARCH AND PRACTICE.

784
00:30:06,086 --> 00:30:07,354
THERE'S ALSO DIFFERENT METHODS.

785
00:30:07,354 --> 00:30:09,556
IN CLINICAL RESEARCH IT'S NOT 

786
00:30:09,556 --> 00:30:13,860
UNCOMMON FOR US TO RANDOMIZE 

787
00:30:13,860 --> 00:30:14,094
PEOPLE.

788
00:30:14,094 --> 00:30:16,663
DRUG A OR DRUG B OR USE A 

789
00:30:16,663 --> 00:30:17,931
PLACEBO SAYING WE'LL GIVE YOU 

790
00:30:17,931 --> 00:30:20,867
DRUG A BUT YOU'RE GOING TO GET A

791
00:30:20,867 --> 00:30:23,904
SUGAR PILL OR USE DOSE 

792
00:30:23,904 --> 00:30:24,204
ESCALATION.

793
00:30:24,204 --> 00:30:25,739
THE LOWEST DOSE AND INCREASE 

794
00:30:25,739 --> 00:30:27,908
WITH COHORTS OF PEOPLE.

795
00:30:27,908 --> 00:30:30,977
OR TO BLIND THE ASSIGNMENT OF 

796
00:30:30,977 --> 00:30:32,145
TREATMENT, IN OTHER WORDS, YOU 

797
00:30:32,145 --> 00:30:35,182
GET DRUG A AND DRUG B BUT YOU'RE

798
00:30:35,182 --> 00:30:36,016
NOT GOING TO KNOW WHICH ONE 

799
00:30:36,016 --> 00:30:37,384
YOU'RE GETTING AND I'M NOT GOING

800
00:30:37,384 --> 00:30:37,851
TO KNOW EITHER AS THE 

801
00:30:37,851 --> 00:30:40,887
INVESTIGATOR.

802
00:30:40,887 --> 00:30:42,956
THOSE METHODS ARE IMPORTANT TO 

803
00:30:42,956 --> 00:30:44,991
INCREASE THE RIGOR AND 

804
00:30:44,991 --> 00:30:45,825
RELIABILITY OF RESEARCH AND 

805
00:30:45,825 --> 00:30:47,027
RESEARCH RESULTS.

806
00:30:47,027 --> 00:30:48,929
BUT THEY'RE NOT METHODS YOU 

807
00:30:48,929 --> 00:30:51,097
WOULD SEE IN CLINICAL PRACTICE.

808
00:30:51,097 --> 00:30:52,666
IF YOU WENT TO YOUR DOCTOR AND 

809
00:30:52,666 --> 00:30:53,934
THEY SAID TO YOU, I'M GOING TO 

810
00:30:53,934 --> 00:30:56,836
GIVE YOU A PILL FOR YOUR STREP 

811
00:30:56,836 --> 00:30:58,538
THROAT BUT I'M NOT GOING TO KNOW

812
00:30:58,538 --> 00:30:59,973
WHAT IT IS AND NEITHER ARE YOU, 

813
00:30:59,973 --> 00:31:02,442
YOU'LL SAY LIKE, WHAT?

814
00:31:02,442 --> 00:31:03,977
WHY AM I HERE?

815
00:31:03,977 --> 00:31:07,247
I'M NOT COMING TO THIS DOCTOR 

816
00:31:07,247 --> 00:31:07,714
ANYMORE.

817
00:31:07,714 --> 00:31:09,115
THERE'S ALSO DIFFERENT 

818
00:31:09,115 --> 00:31:11,785
JUSTIFICATION FOR RISK.

819
00:31:11,785 --> 00:31:14,187
CERTAINLY IN PRACTICE SETTING 

820
00:31:14,187 --> 00:31:16,456
INTERVENTIONS WE USE FOR 

821
00:31:16,456 --> 00:31:17,224
DIAGNOSTIC PREVENTION AND 

822
00:31:17,224 --> 00:31:18,391
TREATMENT PURPOSES ALL HIGH 

823
00:31:18,391 --> 00:31:21,194
RISKS BUT THE RISKS ARE 

824
00:31:21,194 --> 00:31:22,229
JUSTIFIED BECAUSE THE 

825
00:31:22,229 --> 00:31:23,163
INTERVENTION IS THOUGHT TO BE 

826
00:31:23,163 --> 00:31:24,464
BENEFICIAL FOR THIS PERSON AT 

827
00:31:24,464 --> 00:31:25,198
THIS TIME.

828
00:31:25,198 --> 00:31:27,133
THAT'S WHY WE DO IT.

829
00:31:27,133 --> 00:31:28,969
IN RESEARCH WE SOMETIMES ASK 

830
00:31:28,969 --> 00:31:30,804
PEOPLE TO ACCEPT RISK FOR THINGS

831
00:31:30,804 --> 00:31:33,473
NOT FOR THEM AT ALL.

832
00:31:33,473 --> 00:31:36,276
WE'LL ASK FOR AN EXTRA BLOOD 

833
00:31:36,276 --> 00:31:40,347
DRAW OR A BIOPSY OR IMAGING OR 

834
00:31:40,347 --> 00:31:41,881
SOME KIND OF TEST SOLELY DONE 

835
00:31:41,881 --> 00:31:47,654
FOR THE PURPOSES OF RESEARCH AND

836
00:31:47,654 --> 00:31:50,323
HAS NO IMPLICATIONS FOR THE 

837
00:31:50,323 --> 00:31:51,124
WELFARE OF THE INDIVIDUAL BEING 

838
00:31:51,124 --> 00:31:52,292
ASKED TO DO IT.

839
00:31:52,292 --> 00:31:53,860
OF COURSE THERE'S DIFFERENT 

840
00:31:53,860 --> 00:31:56,396
LEVELS OF UNCERTAINTY.

841
00:31:56,396 --> 00:31:58,865
IN CLINICAL PRACTICE, WE HOPE 

842
00:31:58,865 --> 00:32:01,468
PEOPLE USE EVIDENCE THAT EXISTS 

843
00:32:01,468 --> 00:32:03,803
AND EXPERIENCE TO SAY YOU HAVE 

844
00:32:03,803 --> 00:32:05,405
THIS DISEASE, THIS IS HOW IT 

845
00:32:05,405 --> 00:32:07,741
SHOULD BE TREATED BECAUSE I KNOW

846
00:32:07,741 --> 00:32:08,975
THE EVIDENCE, I'VE DONE THIS 

847
00:32:08,975 --> 00:32:09,209
BEFORE.

848
00:32:09,209 --> 00:32:11,211
THIS IS WHAT THE GUIDELINES SAY.

849
00:32:11,211 --> 00:32:14,648
IN RESEARCH WE START WITH 

850
00:32:14,648 --> 00:32:14,948
UNCERTAINTY.

851
00:32:14,948 --> 00:32:15,949
THE ONLY REASON TO DO RESEARCH 

852
00:32:15,949 --> 00:32:17,417
IS BECAUSE WE DON'T KNOW THE 

853
00:32:17,417 --> 00:32:19,753
ANSWER TO THOSE QUESTIONS.

854
00:32:19,753 --> 00:32:23,356
IN ORDER TO TRY TO REDUCE 

855
00:32:23,356 --> 00:32:23,957
UNCERTAINTY OR UNDRESS 

856
00:32:23,957 --> 00:32:30,463
UNCERTAINTY WE DO RESEARCH.

857
00:32:30,463 --> 00:32:33,800
RESEARCHERS HAVE DIFFERENT 

858
00:32:33,800 --> 00:32:35,101
OBLIGATIONS.

859
00:32:35,101 --> 00:32:36,503
CLINICIANS HAVE AN OBLIGATION TO

860
00:32:36,503 --> 00:32:38,104
OFFER CARE AND TREATMENT IN 

861
00:32:38,104 --> 00:32:39,339
THEIR PATIENT'S BEST INTEREST 

862
00:32:39,339 --> 00:32:42,142
AND RESEARCHERS HAVE AN 

863
00:32:42,142 --> 00:32:43,910
OBLIGATION TO CONFIDENTLY 

864
00:32:43,910 --> 00:32:44,444
CONDUCT RESEARCH WHILE 

865
00:32:44,444 --> 00:32:45,712
RESPECTING AND PROTECTING THE 

866
00:32:45,712 --> 00:32:48,014
RIGHTS AND WELFARE OF THEIR 

867
00:32:48,014 --> 00:32:51,851
SUBJECTS OR PARTICIPANTS.

868
00:32:51,851 --> 00:32:55,121
SO HERE'S WHERE I LAND AT THIS 

869
00:32:55,121 --> 00:32:55,322
POINT.

870
00:32:55,322 --> 00:32:58,258
I'VE GIVEN YOU SIX CODES OF 

871
00:32:58,258 --> 00:33:00,593
ETHICS, SIX REGULATIONS, LOTS OF

872
00:33:00,593 --> 00:33:02,796
HISTORY, LOTS OF DETAILS AND I 

873
00:33:02,796 --> 00:33:04,364
THINK WHAT ENDS UP HAPPENING AT 

874
00:33:04,364 --> 00:33:07,067
SOME POINT FOR MANY PEOPLE WHO 

875
00:33:07,067 --> 00:33:08,835
ARE EITHER DOING RESEARCH, 

876
00:33:08,835 --> 00:33:10,737
CONDUCTING RESEARCH AS 

877
00:33:10,737 --> 00:33:13,239
RESEARCHERS, REVIEWING RESEARCH 

878
00:33:13,239 --> 00:33:15,842
AS IRB MEMBERS OR INTERESTED 

879
00:33:15,842 --> 00:33:17,310
OTHERS INTERESTED IN THE ETHICS 

880
00:33:17,310 --> 00:33:18,712
RESEARCH THEY'RE LIKE OKAY, HOW 

881
00:33:18,712 --> 00:33:20,947
DO I KNOW IT'S THE MOST 

882
00:33:20,947 --> 00:33:21,715
IMPORTANT THING?

883
00:33:21,715 --> 00:33:23,650
HOW DO I PUT ALL THIS TOGETHER.

884
00:33:23,650 --> 00:33:24,517
THE INTERESTING THING ABOUT THE 

885
00:33:24,517 --> 00:33:27,120
CODES AND REGULATIONS IS THEY'RE

886
00:33:27,120 --> 00:33:29,189
NOT ALL THE SAME.

887
00:33:29,189 --> 00:33:32,659
MANY OF THEM WERE DEVELOPED IN 

888
00:33:32,659 --> 00:33:33,993
RESPONSE TO SPECIFIC HISTORICAL 

889
00:33:33,993 --> 00:33:34,427
EVENT.

890
00:33:34,427 --> 00:33:39,899
SO AS A MENTIONED, THE NUREMBERG

891
00:33:39,899 --> 00:33:41,634
CODE CAME FROM WORLD WAR II IN 

892
00:33:41,634 --> 00:33:44,137
THE NAZI DOCTOR TRIAL AND THE 

893
00:33:44,137 --> 00:33:49,476
BELMONT REPORT CAME AFTER THE 

894
00:33:49,476 --> 00:33:52,011
EXPOSITION OF THE RESEARCH DONE 

895
00:33:52,011 --> 00:33:53,546
IN THE TUSKEGEE STUDY YOU'LL 

896
00:33:53,546 --> 00:33:54,848
HEAR ABOUT LATER.

897
00:33:54,848 --> 00:33:56,983
THE GUIDANCE THAT DOES EXIST WAS

898
00:33:56,983 --> 00:34:00,820
IN RESPONSE TO SPECIFIC 

899
00:34:00,820 --> 00:34:02,122
HISTORICAL EVENTS AND THEREFORE 

900
00:34:02,122 --> 00:34:05,892
EMPHASIZES OR RESPONDS TO THINGS

901
00:34:05,892 --> 00:34:07,560
THAT HAPPENED HISTORICALLY.

902
00:34:07,560 --> 00:34:08,795
THEREFORE THEY'RE NOT IDENTICAL.

903
00:34:08,795 --> 00:34:12,699
THEY HAVE DIFFERENT REQUIREMENTS

904
00:34:12,699 --> 00:34:19,739
AND DIFFERENT EMPHASISES.

905
00:34:19,739 --> 00:34:24,244
 -- EMPHASIS AND YOU CAN READ 

906
00:34:24,244 --> 00:34:28,314
ONE IN THE DECLARATION OF 

907
00:34:28,314 --> 00:34:33,686
HELSINKI THAT DOESN'T MATCH WHAT

908
00:34:33,686 --> 00:34:35,054
YOU READ IN THE ICHP.

909
00:34:35,054 --> 00:34:37,724
AND WE THOUGHT THERE WAS A NEED 

910
00:34:37,724 --> 00:34:41,995
FOR A SYSTEMATIC COHERENT 

911
00:34:41,995 --> 00:34:42,796
UNIVERSALLY APPLICABLE FRAMEWORK

912
00:34:42,796 --> 00:34:45,965
FOR THINKING OF THE ETHICS OF 

913
00:34:45,965 --> 00:34:47,100
CLINICAL RESEARCH AND THAT'S THE

914
00:34:47,100 --> 00:34:49,002
FRAMEWORK I'LL INTRODUCE YOU TO.

915
00:34:49,002 --> 00:34:51,604
AS HOLLY SAID THIS WILL COME UP 

916
00:34:51,604 --> 00:34:53,907
OVER AND OVER AGAIN THROUGHOUT 

917
00:34:53,907 --> 00:34:55,575
THE COURSE BECAUSE PEOPLE USE IT

918
00:34:55,575 --> 00:34:58,745
TO DIVE INTO SPECIFIC AREAS.

919
00:34:58,745 --> 00:35:00,346
I'LL DO A VERY BROAD OVERVIEW.

920
00:35:00,346 --> 00:35:03,082
THE FRAMEWORK HAS EIGHT 

921
00:35:03,082 --> 00:35:03,383
PRINCIPLES.

922
00:35:03,383 --> 00:35:05,518
COLLABORATIVE PARTNERSHIP, 

923
00:35:05,518 --> 00:35:08,254
VALUABLE SCIENTIFIC QUESTION, 

924
00:35:08,254 --> 00:35:10,523
VALID METHODOLOGY, FAIR SUBJECT 

925
00:35:10,523 --> 00:35:16,129
SELECTION, FAVORABLE INDEPENDENT

926
00:35:16,129 --> 00:35:18,097
REVIEW AND INFORMED CONSENT AND 

927
00:35:18,097 --> 00:35:21,468
WHAT IS COLLABORATIVE 

928
00:35:21,468 --> 00:35:21,901
PARTNERSHIP?

929
00:35:21,901 --> 00:35:24,070
IF YOU THINK OF THE GOAL OF 

930
00:35:24,070 --> 00:35:26,673
CLINICAL RESEARCH AS DEVELOPING 

931
00:35:26,673 --> 00:35:29,342
USEFUL KNOWLEDGE, THE YOUTHFUL 

932
00:35:29,342 --> 00:35:31,110
KNOWLEDGE IS ONLY YOUTHFUL IF 

933
00:35:31,110 --> 00:35:32,312
IT'S PERCEIVED AS YOUTHFUL BY 

934
00:35:32,312 --> 00:35:33,613
LOTS OF OTHER PEOPLE NOT JUST 

935
00:35:33,613 --> 00:35:37,550
THE RESEARCHER THEMSELVES.

936
00:35:37,550 --> 00:35:39,786
SO IN THAT REGARD, ETHICAL 

937
00:35:39,786 --> 00:35:40,987
RESEARCH SHOULD BE A 

938
00:35:40,987 --> 00:35:42,455
COLLABORATIVE PARTNERSHIP WITH 

939
00:35:42,455 --> 00:35:44,724
THE RELEVANT PARTNERS AND THAT 

940
00:35:44,724 --> 00:35:45,959
COULD BE COLLABORATION IN THE 

941
00:35:45,959 --> 00:35:47,227
PLANNING, IN THE CONDUCTING, IN 

942
00:35:47,227 --> 00:35:50,563
THE OVERSEEING OF RESEARCH AND 

943
00:35:50,563 --> 00:35:52,732
ALSO COLLABORATION IN 

944
00:35:52,732 --> 00:35:55,134
INTEGRATING ANY RESEARCH RESULTS

945
00:35:55,134 --> 00:35:57,470
INTO A HEALTH SYSTEM OTHERWISE 

946
00:35:57,470 --> 00:35:59,706
THEY WOULD BE USEFUL.

947
00:35:59,706 --> 00:36:01,541
IT ALSO CALLS FOR RESPECT FOR 

948
00:36:01,541 --> 00:36:03,576
THE CONTRIBUTIONS OF THE VARIOUS

949
00:36:03,576 --> 00:36:04,210
PARTNERS.

950
00:36:04,210 --> 00:36:09,315
AND COLLABORATION WITH THE 

951
00:36:09,315 --> 00:36:10,049
EXISTING SYSTEMS OF HEALTH 

952
00:36:10,049 --> 00:36:12,018
USEFUL INFORMATION CAN BE 

953
00:36:12,018 --> 00:36:12,952
INTEGRATED.

954
00:36:12,952 --> 00:36:14,187
PARTNERSHIPS COULD BE WITH A 

955
00:36:14,187 --> 00:36:15,121
BUNCH OF PEOPLE AND IT DEPENDS 

956
00:36:15,121 --> 00:36:16,489
ON THE RESEARCH, THE PURPOSE OF 

957
00:36:16,489 --> 00:36:21,528
THE RESEARCH, THE SETTING FOR 

958
00:36:21,528 --> 00:36:25,131
THE RESEARCH AND MANY OTHER 

959
00:36:25,131 --> 00:36:26,900
FACTORS BUT YOU MIGHT IMAGINE 

960
00:36:26,900 --> 00:36:29,502
COLLABORATIVE PARTNERS WITH 

961
00:36:29,502 --> 00:36:30,403
PATIENT ADVOCATES AND ADVOCATES 

962
00:36:30,403 --> 00:36:32,772
FOR FUNDING, INVESTIGATORS, 

963
00:36:32,772 --> 00:36:34,807
ESPECIALLY COLLABORATING 

964
00:36:34,807 --> 00:36:35,708
INVESTIGATORS, CLINICIANS, 

965
00:36:35,708 --> 00:36:40,880
PARTICIPANTS AND THERE COULD BE 

966
00:36:40,880 --> 00:36:45,151
OTHERS AND YOU MAY HEAR OF SOME 

967
00:36:45,151 --> 00:36:47,654
OF THEM AND COMMUNITY ADVISORY 

968
00:36:47,654 --> 00:36:50,223
BOARDS, COALITION OF PATIENTS 

969
00:36:50,223 --> 00:36:53,593
THAT WORK TOGETHER AS ADVOCACY 

970
00:36:53,593 --> 00:36:57,430
GROUPS AND THERE ARE ADVISORY 

971
00:36:57,430 --> 00:36:59,065
GROUPS FOR THIS TOP RIGHT CORNER

972
00:36:59,065 --> 00:37:01,267
IS A GROUP AT THE NIH THAT 

973
00:37:01,267 --> 00:37:02,435
ADVISES THE NIH ON PRIORITY 

974
00:37:02,435 --> 00:37:02,669
SETTING.

975
00:37:02,669 --> 00:37:05,138
YOU COULD SEE AT THE BOTTOM, IN 

976
00:37:05,138 --> 00:37:08,541
MANY COUNTRIES AROUND THE WORLD 

977
00:37:08,541 --> 00:37:10,610
THERE ARE WAYS TO ENGAGE 

978
00:37:10,610 --> 00:37:11,244
COMMUNITIES IN DISCUSSIONS ABOUT

979
00:37:11,244 --> 00:37:13,146
WHAT RESEARCH SHOULD BE DONE AND

980
00:37:13,146 --> 00:37:14,948
HOW RESEARCH SHOULD BE DONE IN A

981
00:37:14,948 --> 00:37:15,381
PARTICULAR CASE.

982
00:37:15,381 --> 00:37:18,151
SO THERE ARE LOTS OF EXAMPLES OF

983
00:37:18,151 --> 00:37:19,118
THIS.

984
00:37:19,118 --> 00:37:21,220
THERE'S ALSO INTERESTING 

985
00:37:21,220 --> 00:37:21,521
CHALLENGES.

986
00:37:21,521 --> 00:37:23,356
ONE IS HOW DO YOU IDENTIFY WHO 

987
00:37:23,356 --> 00:37:25,725
THE PARTNERS OUGHT TO BE IN THE 

988
00:37:25,725 --> 00:37:26,359
PARTICULAR CASE?

989
00:37:26,359 --> 00:37:28,995
AND I THINK THAT'S A REALLY 

990
00:37:28,995 --> 00:37:29,629
INTERESTING CHALLENGE BECAUSE 

991
00:37:29,629 --> 00:37:34,334
YOU SAW THAT LIST I GAVE BUT 

992
00:37:34,334 --> 00:37:36,269
THAT LIST WAS NOT ALL INCLUSIVE.

993
00:37:36,269 --> 00:37:37,937
THERE MIGHT BE OTHERS.

994
00:37:37,937 --> 00:37:40,807
IN SOME CASES, THE PARTNERS 

995
00:37:40,807 --> 00:37:42,308
OUGHT TO BE ONE GROUP WITHOUT SO

996
00:37:42,308 --> 00:37:43,710
MANY OF THE OTHERS BUT FIGURING 

997
00:37:43,710 --> 00:37:46,379
OUT WHO THE RIGHT PARTNERS ARE.

998
00:37:46,379 --> 00:37:47,947
THEN THERE'S REALLY INTERESTING 

999
00:37:47,947 --> 00:37:50,583
DEEP QUESTIONS, UNRESOLVED 

1000
00:37:50,583 --> 00:37:53,620
QUESTIONS ABOUT THE METHODS OF 

1001
00:37:53,620 --> 00:37:53,987
ENGAGEMENT.

1002
00:37:53,987 --> 00:37:55,221
ONE COULD IMAGINE, FOR EXAMPLE, 

1003
00:37:55,221 --> 00:37:57,890
YOU HAVE A VERY ACTIVE COMMUNITY

1004
00:37:57,890 --> 00:38:00,159
ADVISORY BOARD AND THAT'S A 

1005
00:38:00,159 --> 00:38:01,160
PARTNERSHIP THAT COULD INFLUENCE

1006
00:38:01,160 --> 00:38:02,695
THE RESEARCH AND COULD BE REALLY

1007
00:38:02,695 --> 00:38:04,197
A VERY IMPORTANT PART OF HOW YOU

1008
00:38:04,197 --> 00:38:07,166
DECIDE TO DO RESEARCH.

1009
00:38:07,166 --> 00:38:09,802
BUT THE PARTICIPANTS IN THE 

1010
00:38:09,802 --> 00:38:11,304
STUDY DON'T FEEL LIKE THEY'RE 

1011
00:38:11,304 --> 00:38:12,805
ENGAGED AT ALL OR YOU ENGAGE 

1012
00:38:12,805 --> 00:38:15,408
PEOPLE IN REVIEWING A CONSENT 

1013
00:38:15,408 --> 00:38:17,143
FORM BUT DON'T IS THIS A STUDY 

1014
00:38:17,143 --> 00:38:19,145
THAT SHOULD BE DONE HERE OR IS 

1015
00:38:19,145 --> 00:38:20,747
THERE A DIFFERENT WAY WE SHOULD 

1016
00:38:20,747 --> 00:38:22,248
BE DOING IT?

1017
00:38:22,248 --> 00:38:24,350
I PULLED RANDOMLY AN ARTICLE 

1018
00:38:24,350 --> 00:38:25,084
FROM THE NEW ENGLAND JOURNAL 

1019
00:38:25,084 --> 00:38:27,120
FROM THIS WEEK JUST TO GIVE YOU 

1020
00:38:27,120 --> 00:38:33,426
A FLAVOR OF THE COMPLEXITY OF SO

1021
00:38:33,426 --> 00:38:35,995
MUCH RESEARCH AND THIS ISN'T 

1022
00:38:35,995 --> 00:38:38,798
EVEN THE MOST COMPLEX BUT THAT 

1023
00:38:38,798 --> 00:38:42,001
THE 292 INFANTS AT 39 CENTERS IN

1024
00:38:42,001 --> 00:38:43,569
EUROPE ACROSS MULTIPLE COUNTRIES

1025
00:38:43,569 --> 00:38:46,873
AND YOU CAN SEE THE NUMBER OF 

1026
00:38:46,873 --> 00:38:47,640
COLLABORATING INVESTIGATORS WHO 

1027
00:38:47,640 --> 00:38:51,110
ARE AUTHORS ON THE PAPER AND THE

1028
00:38:51,110 --> 00:38:52,712
LAST SENTENCE OF THAT AUTHORSHIP

1029
00:38:52,712 --> 00:38:54,914
IS FOR THE PREDICT STUDY GROUP.

1030
00:38:54,914 --> 00:38:56,115
SO THERE'S A LARGER GROUP 

1031
00:38:56,115 --> 00:38:57,316
INVOLVED IN THIS.

1032
00:38:57,316 --> 00:39:01,788
THINKING ABOUT THE PARTNERSHIPS 

1033
00:39:01,788 --> 00:39:04,691
HERE WITH THE COLLABORATORS IS A

1034
00:39:04,691 --> 00:39:05,391
COMPLICATED THING BUT IMPORTANT 

1035
00:39:05,391 --> 00:39:10,063
FOR THE SUCCESS OF RESEARCH.

1036
00:39:10,063 --> 00:39:11,831
THE SECOND PRINCIPLE IN THE 

1037
00:39:11,831 --> 00:39:14,300
FRAMEWORK IS THE VALUABLE 

1038
00:39:14,300 --> 00:39:15,101
SCIENTIFIC QUESTION.

1039
00:39:15,101 --> 00:39:17,937
THIS BASICALLY MEANS IF RESEARCH

1040
00:39:17,937 --> 00:39:19,872
IS THE GOAL IS TO GENERATE 

1041
00:39:19,872 --> 00:39:21,641
USEFUL KNOWLEDGE THEN THE 

1042
00:39:21,641 --> 00:39:25,211
QUESTION IS BEING ASKED IN ANY 

1043
00:39:25,211 --> 00:39:26,679
PARTICULAR CASE HAS TO BE ONE 

1044
00:39:26,679 --> 00:39:27,814
THAT WILL GENERATE USEFUL 

1045
00:39:27,814 --> 00:39:28,581
KNOWLEDGE.

1046
00:39:28,581 --> 00:39:29,816
THERE HAS TO BE A QUESTION WORTH

1047
00:39:29,816 --> 00:39:30,183
ASKING.

1048
00:39:30,183 --> 00:39:32,285
ONE THAT WILL GENERATE NEW 

1049
00:39:32,285 --> 00:39:33,686
KNOWLEDGE OR UNDERSTANDING ABOUT

1050
00:39:33,686 --> 00:39:36,489
HUMAN HEALTH OR ILLNESS THAT'S 

1051
00:39:36,489 --> 00:39:38,858
SOCIALLY, CLINICALLY OR 

1052
00:39:38,858 --> 00:39:39,358
SCIENTIFICALLY USEFUL.

1053
00:39:39,358 --> 00:39:42,795
THIS IS A REALLY IMPORTANT 

1054
00:39:42,795 --> 00:39:43,963
PRINCIPLE IN DISTINGUISHING THE 

1055
00:39:43,963 --> 00:39:46,232
DIFFERENCE BETWEEN CLINICAL 

1056
00:39:46,232 --> 00:39:46,733
RESEARCH AND PRACTICE.

1057
00:39:46,733 --> 00:39:48,267
IN CLINICAL PRACTICE WE DON'T 

1058
00:39:48,267 --> 00:39:49,936
CARE ABOUT THIS.

1059
00:39:49,936 --> 00:39:51,104
CLINICAL RESEARCH IT'S NOT ONE 

1060
00:39:51,104 --> 00:39:52,004
OF THE FIRST THINGS WE SHOULD 

1061
00:39:52,004 --> 00:39:53,306
CARE ABOUT.

1062
00:39:53,306 --> 00:39:56,642
HOW WILL THE RESEARCH ADD VALUE?

1063
00:39:56,642 --> 00:40:00,113
THERE ARE LOTS OF INTERESTING 

1064
00:40:00,113 --> 00:40:01,314
CHALLENGES ABOUT THIS AS WELL.

1065
00:40:01,314 --> 00:40:02,949
ONE IS HOW DO WE FIGURE OUT THE 

1066
00:40:02,949 --> 00:40:04,550
VALUE OF ANSWERING THE RESEARCH 

1067
00:40:04,550 --> 00:40:07,053
QUESTION AND HYPOTHESIZE WHAT 

1068
00:40:07,053 --> 00:40:08,788
WE'LL LEARN AND HOW USEFUL 

1069
00:40:08,788 --> 00:40:10,590
LEARNING IT WILL BE AND IN WHAT 

1070
00:40:10,590 --> 00:40:11,491
WAY IT WILL BE USEFUL BUT 

1071
00:40:11,491 --> 00:40:13,726
THERE'S QUESTIONS ABOUT HOW THAT

1072
00:40:13,726 --> 00:40:15,728
VALUE WILL BE JUDGED ESPECIALLY 

1073
00:40:15,728 --> 00:40:18,898
AT THE FRONT END AND TO WHOM THE

1074
00:40:18,898 --> 00:40:19,632
KNOWLEDGE WILL BE VALUABLE.

1075
00:40:19,632 --> 00:40:22,902
IT COULD BE A NUMBER OF 

1076
00:40:22,902 --> 00:40:25,471
DIFFERENT GROUPS BUT THERE ARE 

1077
00:40:25,471 --> 00:40:29,175
SOME DEBATES ABOUT LOCAL SOCIAL 

1078
00:40:29,175 --> 00:40:30,176
VALUE VERSUS LARGER SOCIAL VALUE

1079
00:40:30,176 --> 00:40:33,146
AND THINGS LIKE THAT.

1080
00:40:33,146 --> 00:40:37,950
THERE'S BEEN A LOT OF REALLY 

1081
00:40:37,950 --> 00:40:39,118
INTERESTING BIOETHICS LITERATURE

1082
00:40:39,118 --> 00:40:41,988
ON THIS QUESTION ON SOCIAL VALUE

1083
00:40:41,988 --> 00:40:44,123
IN THE LESS THAN 10 YEARS.

1084
00:40:44,123 --> 00:40:46,759
THIS WAS A WHOLE ISSUE OF THE 

1085
00:40:46,759 --> 00:40:48,861
JOURNAL BIOETHICS DEDICATED TO 

1086
00:40:48,861 --> 00:40:53,566
SOCIAL VALUE WITH DEBATES ABOUT 

1087
00:40:53,566 --> 00:40:55,101
IF IT'S REALLY IMPORTANT HOW DO 

1088
00:40:55,101 --> 00:40:57,170
WE UNDERSTAND WHAT IT IS.

1089
00:40:57,170 --> 00:40:58,671
PEOPLE ARGUING WHETHER DIFFERENT

1090
00:40:58,671 --> 00:41:00,006
KINDS OF RESEARCH NEED TO HAVE 

1091
00:41:00,006 --> 00:41:02,208
SOCIAL VALUE AND OTHERS DON'T.

1092
00:41:02,208 --> 00:41:05,845
LOTS OF DEBATES ABOUT THAT.

1093
00:41:05,845 --> 00:41:08,614
AND I GOT TO PUT A CHAPTER 

1094
00:41:08,614 --> 00:41:10,516
TOGETHER WITH ONE OF MY FELLOWS 

1095
00:41:10,516 --> 00:41:11,751
A COUPLE YEARS AGO WHERE WE 

1096
00:41:11,751 --> 00:41:13,619
TRIED TO LOOK BACK AND SAY, 

1097
00:41:13,619 --> 00:41:14,420
LET'S LOOK THROUGH THE 

1098
00:41:14,420 --> 00:41:17,190
LITERATURE AND THINK OF CASES 

1099
00:41:17,190 --> 00:41:21,761
THAT REALLY WERE EXEMPLARS OF 

1100
00:41:21,761 --> 00:41:24,897
HIGH SOCIAL VALUE AND LOW SOCIAL

1101
00:41:24,897 --> 00:41:28,234
VALUE AND TRY TO SORT THIS OUT.

1102
00:41:28,234 --> 00:41:29,335
IT WAS AN INTERESTING EXERCISE.

1103
00:41:29,335 --> 00:41:31,070
I THINK YOU MIGHT ENJOY READING 

1104
00:41:31,070 --> 00:41:33,940
IT IF YOU'RE INTERESTED IN THE 

1105
00:41:33,940 --> 00:41:34,140
TOPIC.

1106
00:41:34,140 --> 00:41:36,309
I WILL SAY WE GOT PUSHBACK FOR 

1107
00:41:36,309 --> 00:41:36,976
THE FOLLOWING REASON BECAUSE 

1108
00:41:36,976 --> 00:41:38,511
THEY WERE CASES OF RESEARCH 

1109
00:41:38,511 --> 00:41:41,013
ALREADY DONE AND SO JUDGING 

1110
00:41:41,013 --> 00:41:43,950
SOCIAL VALUE POST RESEARCH IS 

1111
00:41:43,950 --> 00:41:44,951
DIFFERENT THAN JUDGING IT AT THE

1112
00:41:44,951 --> 00:41:48,187
FRONT END.

1113
00:41:48,187 --> 00:41:50,857
THE THIRD PRINCIPLE IN THE 

1114
00:41:50,857 --> 00:41:53,459
FRAMEWORK IS VALID SCIENTIFIC 

1115
00:41:53,459 --> 00:41:53,759
METHODOLOGY.

1116
00:41:53,759 --> 00:41:54,994
THIS BASICALLY SAYS YOU'VE GOT 

1117
00:41:54,994 --> 00:41:57,997
YOUR PARTNERS, YOU GOT A 

1118
00:41:57,997 --> 00:41:59,098
QUESTION WORTH ADDRESSING, NOW 

1119
00:41:59,098 --> 00:42:00,633
YOU'VE GOT A STRUCTURE THE STUDY

1120
00:42:00,633 --> 00:42:01,567
SO YOU GET AN ANSWER YOU CAN 

1121
00:42:01,567 --> 00:42:04,537
INTERPRET AND USE.

1122
00:42:04,537 --> 00:42:09,108
AND SO IT SHOULD BE DESIGNED IN 

1123
00:42:09,108 --> 00:42:17,450
A METHODOLOGICALLY MANNER TO BE 

1124
00:42:17,450 --> 00:42:17,717
FEASIBLE.

1125
00:42:17,717 --> 00:42:19,285
THIS COVERS A LOT OF TERRITORY.

1126
00:42:19,285 --> 00:42:20,853
ONE OF THE THINGS SOME PEOPLE 

1127
00:42:20,853 --> 00:42:22,755
HAVE SAID OVER MANY YEARS ABOUT 

1128
00:42:22,755 --> 00:42:26,359
THIS PRINCIPLE IN THE ETHICAL 

1129
00:42:26,359 --> 00:42:28,694
FRAMEWORK IS WHY DO WE CARE 

1130
00:42:28,694 --> 00:42:29,362
ABOUT SCIENCE.

1131
00:42:29,362 --> 00:42:33,966
IT'S NOT ETHICS, IT'S SCIENCE.

1132
00:42:33,966 --> 00:42:36,636
BUT SCIENCE AND ETHICS ARE 

1133
00:42:36,636 --> 00:42:40,539
INEXTRICABLY COMBINED.

1134
00:42:40,539 --> 00:42:42,275
SO ALL THESE, EVERY SCIENTIFIC 

1135
00:42:42,275 --> 00:42:44,477
DECISION YOU MAKE IN DESIGNING A

1136
00:42:44,477 --> 00:42:46,979
TRIAL OR DECIDING HOW TO CONDUCT

1137
00:42:46,979 --> 00:42:50,950
A TRIAL HAS ETHICAL IMPLICATIONS

1138
00:42:50,950 --> 00:42:52,418
AND ETHICAL SCIENCE.

1139
00:42:52,418 --> 00:42:53,719
WHAT ARE SOME THINGS PEOPLE MAY 

1140
00:42:53,719 --> 00:42:57,690
BE DEBATING IN TERMS OF 

1141
00:42:57,690 --> 00:42:59,358
SCIENTIFIC VALIDITY?

1142
00:42:59,358 --> 00:43:01,627
WHAT END POINTS DO YOU WANT IN A

1143
00:43:01,627 --> 00:43:02,461
GIVEN STUDY.

1144
00:43:02,461 --> 00:43:04,897
WHAT KIND OF DESIGN FOR A DOUBLE

1145
00:43:04,897 --> 00:43:08,301
BLIND CONTROL OR A 

1146
00:43:08,301 --> 00:43:09,335
NON-INFERIORITY OR SUPERIORITY 

1147
00:43:09,335 --> 00:43:12,371
DESIGN OR TO BE QUALITATIVE OR 

1148
00:43:12,371 --> 00:43:14,407
QUANTITATIVE DESIGN?

1149
00:43:14,407 --> 00:43:17,376
CHOICES OF PROCEDURE, CHOICES OF

1150
00:43:17,376 --> 00:43:20,546
STATISTICAL METHODS OR 

1151
00:43:20,546 --> 00:43:21,080
ANALYTICAL METHODS AND 

1152
00:43:21,080 --> 00:43:22,048
IMPORTANTLY FEASIBILITY.

1153
00:43:22,048 --> 00:43:24,617
IF A STUDY DESIGN IN A WAY THAT 

1154
00:43:24,617 --> 00:43:25,918
IS IMPOSSIBLE TO DO, IN OTHER 

1155
00:43:25,918 --> 00:43:27,720
WORDS, YOU CAN'T MEASURE WHAT 

1156
00:43:27,720 --> 00:43:29,555
YOU'RE HOPING TO MEASURE OR YOU 

1157
00:43:29,555 --> 00:43:31,657
COULDN'T BE ABLE TO GET PEOPLE 

1158
00:43:31,657 --> 00:43:33,192
TO -- THERE AREN'T PEOPLE TO 

1159
00:43:33,192 --> 00:43:34,460
ENROLL OR YOU WOULDN'T BE ABLE 

1160
00:43:34,460 --> 00:43:36,595
IT GET THEM TO ENROLL, IT'S NOT 

1161
00:43:36,595 --> 00:43:37,897
AN ETHICAL STUDY BECAUSE YOU 

1162
00:43:37,897 --> 00:43:40,700
CAN'T FINISH IT.

1163
00:43:40,700 --> 00:43:42,401
YOU SHOULDN'T START IT IF YOU 

1164
00:43:42,401 --> 00:43:44,270
KNOW YOU CAN'T FINISH IT.

1165
00:43:44,270 --> 00:43:46,605
THERE'S LOTS OF WAYS TO THINK 

1166
00:43:46,605 --> 00:43:47,540
ABOUT THIS CONCERN ABOUT AND 

1167
00:43:47,540 --> 00:43:49,175
WAYS PEOPLE THINK ABOUT THE 

1168
00:43:49,175 --> 00:43:51,444
ETHICS OF SCIENTIFIC VALIDITY 

1169
00:43:51,444 --> 00:43:52,745
AND STUDY DESIGN.

1170
00:43:52,745 --> 00:43:56,148
MOST I'LL REPRESENT IN CARTOONS.

1171
00:43:56,148 --> 00:43:57,817
YOU HAVE A CONTROL AND OUT OF 

1172
00:43:57,817 --> 00:43:58,317
CONTROL GROUP.

1173
00:43:58,317 --> 00:44:03,422
WE HAVE CARTOONS THAT SAY I DIED

1174
00:44:03,422 --> 00:44:06,892
AS A MEMBER OF THE PLACEBO GROUP

1175
00:44:06,892 --> 00:44:07,860
AND WE HAVE INTERESTING 

1176
00:44:07,860 --> 00:44:09,228
STATISTICS AND HOW THEY CAN BE 

1177
00:44:09,228 --> 00:44:11,230
USED TO MAKE YOUR OWN 

1178
00:44:11,230 --> 00:44:13,332
CONCLUSIONS OR TO MAKE WRONG 

1179
00:44:13,332 --> 00:44:13,799
CONCLUSION.

1180
00:44:13,799 --> 00:44:18,637
THERE'S LOTS OF INTERESTING 

1181
00:44:18,637 --> 00:44:20,139
EXAMPLES OF SCIENTIFIC VALIDITY 

1182
00:44:20,139 --> 00:44:21,640
QUESTIONS TO BE ADDRESSED.

1183
00:44:21,640 --> 00:44:24,443
THERE'S NEWER STUDY DESIGNS 

1184
00:44:24,443 --> 00:44:25,578
WHICH STILL NEEDS ATTENTION FROM

1185
00:44:25,578 --> 00:44:33,386
THE PERSPECTIVE OF ETHICS.

1186
00:44:33,386 --> 00:44:34,920
DECENTRALIZED TRIALS EXPLODED 

1187
00:44:34,920 --> 00:44:35,688
DURING THE PANDEMIC.

1188
00:44:35,688 --> 00:44:37,323
THE BASIC IDEA IS PEOPLE 

1189
00:44:37,323 --> 00:44:42,595
PARTICIPATE FROM HOME OR FROM 

1190
00:44:42,595 --> 00:44:46,532
THEIR OWN CLINICAL PRACTICE AND 

1191
00:44:46,532 --> 00:44:49,902
ALL THE INTERACTIONS ARE REMOTE.

1192
00:44:49,902 --> 00:44:51,370
IN OTHER WORDS, CONSENT IS 

1193
00:44:51,370 --> 00:44:55,074
ELECTRONIC AND INTERACTION 

1194
00:44:55,074 --> 00:44:56,876
EITHER THROUGH TELEMEDICINE OR 

1195
00:44:56,876 --> 00:44:57,510
FOR SOMEBODY ELSE VISITING THE 

1196
00:44:57,510 --> 00:45:02,114
HOME.

1197
00:45:02,114 --> 00:45:04,483
DATA IS COLLECTED AND SENT 

1198
00:45:04,483 --> 00:45:04,950
DIGITALLY.

1199
00:45:04,950 --> 00:45:06,018
IT'S AN INTERESTING MODEL THAT'S

1200
00:45:06,018 --> 00:45:07,086
BEING USED.

1201
00:45:07,086 --> 00:45:08,754
A LOT OF PEOPLE WORRY ABOUT 

1202
00:45:08,754 --> 00:45:14,827
THINGS LIKE RELIABILITY OF DATA.

1203
00:45:14,827 --> 00:45:16,862
ISOLATION OF PARTICIPANTS.

1204
00:45:16,862 --> 00:45:18,064
THERE'S INTERESTING ISSUES 

1205
00:45:18,064 --> 00:45:19,932
RAISED BUT IT NEEDS MORE 

1206
00:45:19,932 --> 00:45:21,634
ATTENTION FROM AN ETHICAL 

1207
00:45:21,634 --> 00:45:23,102
PERSPECTIVE.

1208
00:45:23,102 --> 00:45:25,438
PRAGMATIC TRIALS HAVE GOTTEN A 

1209
00:45:25,438 --> 00:45:26,806
FAIR AMOUNT OF ATTENTION IN THE 

1210
00:45:26,806 --> 00:45:28,274
LAST EIGHT OR 10 YEARS.

1211
00:45:28,274 --> 00:45:30,709
IT'S THE KIND OF TRIAL THAT'S 

1212
00:45:30,709 --> 00:45:36,048
DONE NOT COMPLETELY UNCERTAIN 

1213
00:45:36,048 --> 00:45:37,983
ABOUT A NEW INTERVENTION BUT 

1214
00:45:37,983 --> 00:45:39,618
MORE LIKE TWO DRUGS FOR 

1215
00:45:39,618 --> 00:45:40,853
HYPERTENSION AND THEY BOTH SEEM 

1216
00:45:40,853 --> 00:45:41,754
TO WORK.

1217
00:45:41,754 --> 00:45:43,255
SOME PEOPLE THINK ONE'S BETTER 

1218
00:45:43,255 --> 00:45:45,624
THAN THE OTHER AND ONE HAS MORE 

1219
00:45:45,624 --> 00:45:49,628
SIDE EFFECTS SO THEY SET UP 

1220
00:45:49,628 --> 00:45:51,130
HEAD-TO-HEAD TRIALS.

1221
00:45:51,130 --> 00:45:54,667
THERE'S RIGOROUS DEBATES HOW 

1222
00:45:54,667 --> 00:45:56,569
CONSENT OUGHT TO BE OBTAINED AND

1223
00:45:56,569 --> 00:45:57,870
OTHER THINGS ABOUT PRAGMATIC 

1224
00:45:57,870 --> 00:45:58,104
TRIALS.

1225
00:45:58,104 --> 00:45:59,238
PEOPLE IN OUR DEPARTMENT ARE 

1226
00:45:59,238 --> 00:46:00,272
WORKING ON THAT.

1227
00:46:00,272 --> 00:46:02,241
PLATFORM TRIALS, AGAIN, 

1228
00:46:02,241 --> 00:46:04,743
SOMETHING RELATIVELY NEW 

1229
00:46:04,743 --> 00:46:07,113
EXPLODED DURING COVID.

1230
00:46:07,113 --> 00:46:09,248
THE IDEA BEING THAT YOU HAVE A 

1231
00:46:09,248 --> 00:46:13,719
TRIAL WHERE YOU CAN HAVE ONE 

1232
00:46:13,719 --> 00:46:16,422
CONTROL GROUP AND ROTATE IN AND 

1233
00:46:16,422 --> 00:46:17,523
OUT OF THE EXPERIMENTAL 

1234
00:46:17,523 --> 00:46:20,126
INTERVENTION SO YOU DON'T HAVE 

1235
00:46:20,126 --> 00:46:23,762
TO COMPLETELY GET A NEW CONTROL 

1236
00:46:23,762 --> 00:46:24,563
OVER TIME.

1237
00:46:24,563 --> 00:46:27,533
IN THEORY IT'S A GREAT MODEL.

1238
00:46:27,533 --> 00:46:28,834
IN PRACTICE IT'S A LITTLE MORE 

1239
00:46:28,834 --> 00:46:30,035
COMPLICATED THAN IT SOUNDS.

1240
00:46:30,035 --> 00:46:34,106
THERE'S INTERESTING THINGS TO 

1241
00:46:34,106 --> 00:46:34,974
THINK ABOUT.

1242
00:46:34,974 --> 00:46:37,143
THEN FOR NOW AT LEAST 10 YEARS 

1243
00:46:37,143 --> 00:46:38,277
WE'VE BEEN ARGUING ABOUT HOW DO 

1244
00:46:38,277 --> 00:46:45,885
WE THINK WITH THE ETHICS OF 

1245
00:46:45,885 --> 00:46:47,386
RESEARCH DONE WITH STORE SAMPLES

1246
00:46:47,386 --> 00:46:48,654
AND BIO SPECIMENS.

1247
00:46:48,654 --> 00:46:51,357
HOW THEY'RE OBTAINED TO BEGIN 

1248
00:46:51,357 --> 00:46:52,591
WITH, HOW THEY'RE STORED, WHO 

1249
00:46:52,591 --> 00:46:53,893
GETS TO USE THEM AND WHAT 

1250
00:46:53,893 --> 00:46:59,498
PERMISSION YOU NEED TO USE THEM.

1251
00:46:59,498 --> 00:47:01,233
ETCETERA.

1252
00:47:01,233 --> 00:47:03,502
THE NEXT PRINCIPLE IS FAIR 

1253
00:47:03,502 --> 00:47:04,970
SUBJECT SELECTION.

1254
00:47:04,970 --> 00:47:07,106
COLLABORATIVE PARTNERSHIP, 

1255
00:47:07,106 --> 00:47:08,841
SOCIAL VALUE, SCIENTIFIC 

1256
00:47:08,841 --> 00:47:10,276
METHODOLOGY AND THIS IS THE 

1257
00:47:10,276 --> 00:47:10,643
FOURTH.

1258
00:47:10,643 --> 00:47:13,245
ONCE YOU'VE GOT A DESIGN AND 

1259
00:47:13,245 --> 00:47:16,315
PROCESS BY WHICH YOU THINK YOU 

1260
00:47:16,315 --> 00:47:18,784
WANT TO RUN THE STUDY, THERE 

1261
00:47:18,784 --> 00:47:20,619
NEEDS TO BE SOME DECISIONS ABOUT

1262
00:47:20,619 --> 00:47:22,688
WHO GETS ENROLLED AND WHO GETS 

1263
00:47:22,688 --> 00:47:24,623
INVITED TO PARTICIPATE.

1264
00:47:24,623 --> 00:47:27,126
AND OF COURSE THE SCIENTIFIC 

1265
00:47:27,126 --> 00:47:29,261
OBJECTIONS SHOULD GUIDE 

1266
00:47:29,261 --> 00:47:29,895
INCLUSION CRITERIA.

1267
00:47:29,895 --> 00:47:34,433
AND RECRUITMENT STRATEGIES AND 

1268
00:47:34,433 --> 00:47:36,702
SELECTION AND THE BELMONT FOR 

1269
00:47:36,702 --> 00:47:38,103
EXAMPLE TALKS ABOUT PARTICIPANTS

1270
00:47:38,103 --> 00:47:39,972
SHOULD BE SELECTED BASED ON 

1271
00:47:39,972 --> 00:47:42,575
SCIENCE NOT PRIVILEGE OR EASY 

1272
00:47:42,575 --> 00:47:44,510
AVAILABILITY OR VULNERABILITY.

1273
00:47:44,510 --> 00:47:49,582
AND THOSE ARE THINGS THAT 

1274
00:47:49,582 --> 00:47:51,317
HISTORICALLY HAVE HAPPENED.

1275
00:47:51,317 --> 00:47:53,385
ONE OF THE WAYS TO THINK ABOUT 

1276
00:47:53,385 --> 00:47:55,120
FAIR SUBJECT SELECTION IS 

1277
00:47:55,120 --> 00:47:57,022
FLIPPING IT ON ITS HEAD, SO TO 

1278
00:47:57,022 --> 00:48:00,025
SPEAK AND SAY EVERYBODY SHOULD 

1279
00:48:00,025 --> 00:48:00,559
BE ELIGIBLE.

1280
00:48:00,559 --> 00:48:02,194
EVERYBODY SHOULD BE INCLUDED 

1281
00:48:02,194 --> 00:48:02,728
UNLESS THERE'S REASONS TO 

1282
00:48:02,728 --> 00:48:07,700
EXCLUDE THEM.

1283
00:48:07,700 --> 00:48:10,202
THE TWO REASONS PEOPLE PULLED 

1284
00:48:10,202 --> 00:48:14,039
OUT TO SAY -- WELL, THREE, TWO 

1285
00:48:14,039 --> 00:48:16,508
AND A HALF I'LL SAY WHY.

1286
00:48:16,508 --> 00:48:18,911
REASONS TO EXCLUDE SOMEBODY 

1287
00:48:18,911 --> 00:48:20,512
SCIENTIFICALLY TOTALLY 

1288
00:48:20,512 --> 00:48:20,846
INAPPROPRIATE.

1289
00:48:20,846 --> 00:48:22,648
IF YOU'RE STUDYING A TREATMENT 

1290
00:48:22,648 --> 00:48:24,250
FOR BREAST CANCER YOU NEED 

1291
00:48:24,250 --> 00:48:27,119
PEOPLE WHO HAVE BREAST CANCER TO

1292
00:48:27,119 --> 00:48:32,157
BE IN THE STUDY.

1293
00:48:32,157 --> 00:48:34,326
THERE MAY BE RISK-RELATED 

1294
00:48:34,326 --> 00:48:35,394
REASONS FOR EXCLUSION.

1295
00:48:35,394 --> 00:48:38,264
MAYBE IN THE SAME STUDY THE 

1296
00:48:38,264 --> 00:48:43,102
INTERVENTION IS ALREADY KNOWN TO

1297
00:48:43,102 --> 00:48:45,170
HAVE SERIOUS RENAL TOXICITY.

1298
00:48:45,170 --> 00:48:46,171
YOU MAY EXCLUDE PEOPLE WHO HAVE 

1299
00:48:46,171 --> 00:48:49,742
POORER KIDNEY FUNCTION.

1300
00:48:49,742 --> 00:48:53,345
THE THIRD OR THE HALF 

1301
00:48:53,345 --> 00:48:54,246
JUSTIFICATION THAT SOMETIMES 

1302
00:48:54,246 --> 00:48:57,316
PEOPLE USE IS VULNERABLE.

1303
00:48:57,316 --> 00:48:59,118
AND VULNERABLE IS A COMPLICATED 

1304
00:48:59,118 --> 00:49:02,921
TOPIC AND YOU CAN HAVE A WHOLE 

1305
00:49:02,921 --> 00:49:05,224
SESSION ON IT IN A COUPLE WEEKS 

1306
00:49:05,224 --> 00:49:06,392
SO I WON'T SPEND TOO MUCH TIME 

1307
00:49:06,392 --> 00:49:10,729
BUT THERE ARE PEOPLE WHO SAY IF 

1308
00:49:10,729 --> 00:49:11,764
VULNERABLE YOU SHOULD BE 

1309
00:49:11,764 --> 00:49:14,833
EXCLUDED FROM CERTAIN KINDS OF 

1310
00:49:14,833 --> 00:49:16,502
AND OTHERS SAY YOU SHOULD FIND 

1311
00:49:16,502 --> 00:49:18,270
PEOPLE WHO ARE VULNERABLE.

1312
00:49:18,270 --> 00:49:19,305
IT DEPENDS ON WHY YOU'RE 

1313
00:49:19,305 --> 00:49:22,908
VULNERABLE.

1314
00:49:22,908 --> 00:49:24,310
THERE'S A RECOGNIZED NEED TO 

1315
00:49:24,310 --> 00:49:27,613
MAKE SURE THAT NOT JUST HOW 

1316
00:49:27,613 --> 00:49:29,815
INDIVIDUALS ARE ASKED OR INVITED

1317
00:49:29,815 --> 00:49:31,417
OR SELECTED TO BE INVITED TO 

1318
00:49:31,417 --> 00:49:34,386
PARTICIPATE IN A STUDY BUT ALSO 

1319
00:49:34,386 --> 00:49:36,021
HOW WE THINK WITH THE GROUPS.

1320
00:49:36,021 --> 00:49:38,457
HOW DO WE FAIRLY DISTRIBUTE THE 

1321
00:49:38,457 --> 00:49:40,059
POSSIBLE HARMS OF DOING RESEARCH

1322
00:49:40,059 --> 00:49:41,694
AND THE POSSIBLE BENEFITS.

1323
00:49:41,694 --> 00:49:44,330
SO YOU WOULDN'T WANT TO GO TO 

1324
00:49:44,330 --> 00:49:46,131
THE SAME ENCLAVE OF PEOPLE WHO 

1325
00:49:46,131 --> 00:49:48,534
ARE ALREADY BURDENED BY DISEASE 

1326
00:49:48,534 --> 00:49:51,103
OR POVERTY AND ASK THEM TO 

1327
00:49:51,103 --> 00:49:52,204
CONTINUALLY BE PARTICIPANTS IN 

1328
00:49:52,204 --> 00:49:53,706
RESEARCH ESPECIALLY IF THEY'RE 

1329
00:49:53,706 --> 00:49:56,709
NOT GETTING ALL THE BENEFITS OR 

1330
00:49:56,709 --> 00:49:58,677
BENEFITS NEVER GO TO THEM.

1331
00:49:58,677 --> 00:50:02,748
THINKING ABOUT THE DISTRIBUTION 

1332
00:50:02,748 --> 00:50:04,883
AN IMPORTANT PART OF FAIR 

1333
00:50:04,883 --> 00:50:06,752
SUBJECT SELECTION.

1334
00:50:06,752 --> 00:50:07,753
THIS IS AN INTERESTING CHALLENGE

1335
00:50:07,753 --> 00:50:10,089
WHEN WE ARE THINKING ABOUT FAIR 

1336
00:50:10,089 --> 00:50:12,658
SUBJECT SELECTION AND THAT IS 

1337
00:50:12,658 --> 00:50:14,360
THAT FOR A LONG TIME AND SOME OF

1338
00:50:14,360 --> 00:50:17,596
THE GUIDANCE THAT EXISTS 

1339
00:50:17,596 --> 00:50:18,630
SUGGESTS PARTICIPATING RESEARCH 

1340
00:50:18,630 --> 00:50:21,900
IS A BURDEN AND PEOPLE NEED 

1341
00:50:21,900 --> 00:50:22,201
PROTECTION.

1342
00:50:22,201 --> 00:50:23,702
BUT THERE'S ALSO THIS 

1343
00:50:23,702 --> 00:50:25,904
RECOGNITION AND SOME GUIDANCE 

1344
00:50:25,904 --> 00:50:27,573
RECOGNIZES IT CLEARLY THAT 

1345
00:50:27,573 --> 00:50:30,042
RESEARCH IS A BENEFIT AND 

1346
00:50:30,042 --> 00:50:31,677
PARTICIPANTS NEED ACCESS.

1347
00:50:31,677 --> 00:50:32,244
THERE'S A LITTLE BIT OF A 

1348
00:50:32,244 --> 00:50:33,679
TENSION BETWEEN THE TWO AND 

1349
00:50:33,679 --> 00:50:35,147
THERE'S BEEN A SWING BACK AND 

1350
00:50:35,147 --> 00:50:36,048
FORTH BETWEEN THE TWO AND ONE 

1351
00:50:36,048 --> 00:50:40,652
THAT COMES UP QUITE A BIT.

1352
00:50:40,652 --> 00:50:42,020
THERE ARE ALSO SOME REALLY 

1353
00:50:42,020 --> 00:50:43,088
INTERESTING CHALLENGES.

1354
00:50:43,088 --> 00:50:45,824
I MENTIONED PROTECTING THE 

1355
00:50:45,824 --> 00:50:46,759
VULNERABLE GROUPS YOU'LL HEAR 

1356
00:50:46,759 --> 00:50:47,326
MORE ABOUT.

1357
00:50:47,326 --> 00:50:52,865
I WANT TO PUT TWO QUESTIONS TO 

1358
00:50:52,865 --> 00:50:53,899
THINK ABOUT.

1359
00:50:53,899 --> 00:50:56,301
ONE IS THINKING ABOUT WHO THE 

1360
00:50:56,301 --> 00:50:57,136
APPROPRIATE PARTICIPANTS ARE AND

1361
00:50:57,136 --> 00:50:59,371
IT HAPPENS ALL THE TIME.

1362
00:50:59,371 --> 00:51:01,840
FOR EXAMPLE IN THE STUDY TESTING

1363
00:51:01,840 --> 00:51:04,309
AN EARLY POTENTIALLY RISKY 

1364
00:51:04,309 --> 00:51:07,946
THERAPY IN A GENETIC DISORDER, 

1365
00:51:07,946 --> 00:51:10,282
IS IT BETTER TO ENROLL OR TO 

1366
00:51:10,282 --> 00:51:12,584
INVITE FIRST HEALTHY AFFECTED 

1367
00:51:12,584 --> 00:51:14,720
ADULTS WHO CAN CONSENT BUT HAVE 

1368
00:51:14,720 --> 00:51:15,320
MILD DISEASE?

1369
00:51:15,320 --> 00:51:18,023
THAT'S WHY THEY LIVE TO THE AGE 

1370
00:51:18,023 --> 00:51:20,692
THEY ARE OR TO TEST IT IN 

1371
00:51:20,692 --> 00:51:23,095
SEVERELY ILL INFANTS WHO ARE 

1372
00:51:23,095 --> 00:51:24,930
OTHERWISE NOT GOING TO MAKE IT 

1373
00:51:24,930 --> 00:51:30,002
PAST INFANCY?

1374
00:51:30,002 --> 00:51:32,104
THAT'S A REAL LIVE QUESTION 

1375
00:51:32,104 --> 00:51:33,338
THAT'S BEEN DEBATE AND DECIDED 

1376
00:51:33,338 --> 00:51:34,606
IN DIFFERENT WAYS IN DIFFERENT 

1377
00:51:34,606 --> 00:51:35,107
CASES.

1378
00:51:35,107 --> 00:51:36,041
ANOTHER ONE I'M PARTICULARLY 

1379
00:51:36,041 --> 00:51:37,409
INTERESTED IN AND HAVE BEEN WORK

1380
00:51:37,409 --> 00:51:40,779
ON A LITTLE BIT OVER THE YEARS 

1381
00:51:40,779 --> 00:51:41,947
IS ABOUT ENROLLING PREGNANT 

1382
00:51:41,947 --> 00:51:47,119
PERSONS IN RESEARCH.

1383
00:51:47,119 --> 00:51:54,226
AGAIN, IT'S THIS SORT OF WE 

1384
00:51:54,226 --> 00:51:55,060
RECOGNIZE THERE'S NOT A LOT OF 

1385
00:51:55,060 --> 00:51:57,896
DATA FOR HOW TO TREAT SOMEONE 

1386
00:51:57,896 --> 00:51:59,965
WHO IS PREGNANT ON THE OTHER 

1387
00:51:59,965 --> 00:52:02,034
HAND ENROLLING SOMEONE WHO IS 

1388
00:52:02,034 --> 00:52:03,435
PREGNANT INTO RESEARCH HAS LOTS 

1389
00:52:03,435 --> 00:52:10,375
OF ETHICAL COMPLEXITIES AND 

1390
00:52:10,375 --> 00:52:12,010
THINKING ABOUT THE CRITERIA IS A

1391
00:52:12,010 --> 00:52:12,711
CHALLENGING THING.

1392
00:52:12,711 --> 00:52:15,047
THE NEXT IS FAVORABLE RISK 

1393
00:52:15,047 --> 00:52:15,280
BENEFIT.

1394
00:52:15,280 --> 00:52:17,616
THOUGH WE'VE DECIDED THIS STUDY 

1395
00:52:17,616 --> 00:52:21,053
HAS VALUE AND IT'S SET UP IN A 

1396
00:52:21,053 --> 00:52:23,088
WAY THAT CAN GET INTERPRETABLE 

1397
00:52:23,088 --> 00:52:25,891
DATA THAT IS USEFUL AND WE MADE 

1398
00:52:25,891 --> 00:52:28,160
CONSCIOUS DELIBERATE DECISIONS 

1399
00:52:28,160 --> 00:52:32,764
WHO TO INVITE TO PARTICIPATE NOW

1400
00:52:32,764 --> 00:52:33,999
YOU THINK OF THE RISK AND 

1401
00:52:33,999 --> 00:52:34,833
BENEFITS TO THE INDIVIDUALS IN 

1402
00:52:34,833 --> 00:52:35,534
THE STUDY.

1403
00:52:35,534 --> 00:52:39,204
IS THERE A WAY TO MINIMIZE EVEN 

1404
00:52:39,204 --> 00:52:42,074
MORE OR MINIMIZE OVER ALL THE 

1405
00:52:42,074 --> 00:52:46,745
RISKS THAT AN INDIVIDUAL 

1406
00:52:46,745 --> 00:52:49,748
PARTICIPANT IS EXPOSED TO?

1407
00:52:49,748 --> 00:52:50,516
ARE THEY JUSTIFIED BY POTENTIAL 

1408
00:52:50,516 --> 00:52:52,050
BENEFIT TO THEM OR THE 

1409
00:52:52,050 --> 00:52:53,418
IMPORTANCE OF THE SOCIAL VALUE 

1410
00:52:53,418 --> 00:52:55,087
TO SOCIETY?

1411
00:52:55,087 --> 00:52:57,456
AND THEN A SEPARATE 

1412
00:52:57,456 --> 00:52:58,123
CONSIDERATION THAT PEOPLE TALK 

1413
00:52:58,123 --> 00:53:01,693
ABOUT ARE THE BENEFIT OR CAN THE

1414
00:53:01,693 --> 00:53:08,734
BENEFITS BE FURTHER ENHANCED?

1415
00:53:08,734 --> 00:53:09,902
YOU'LL HAVE A WHOLE SESSION ON 

1416
00:53:09,902 --> 00:53:12,070
RISK AND BENEFIT.

1417
00:53:12,070 --> 00:53:15,941
THE BELMONT REPORT SAYS AND MOST

1418
00:53:15,941 --> 00:53:17,843
SAY IT'S CORRECT AND INTEREST ON

1419
00:53:17,843 --> 00:53:19,745
THOSE OTHER THAN THE SUBJECT MAY

1420
00:53:19,745 --> 00:53:20,979
BE SUFFICIENT BY THEMSELVES.

1421
00:53:20,979 --> 00:53:23,315
THIS MEANS YOU CAN ENROLL 

1422
00:53:23,315 --> 00:53:24,082
SOMEBODY IN RESEARCH WHEN 

1423
00:53:24,082 --> 00:53:27,085
THERE'S NO BENEFITS AT ALL TO 

1424
00:53:27,085 --> 00:53:28,687
THAT INDIVIDUAL AS LONG AS THE 

1425
00:53:28,687 --> 00:53:30,355
SUBJECT'S RIGHTS HAVE BEEN 

1426
00:53:30,355 --> 00:53:31,356
PROTECTED AND I WOULD ADD AS 

1427
00:53:31,356 --> 00:53:37,129
LONG AS THE STUDY HAS SOCIAL 

1428
00:53:37,129 --> 00:53:37,829
VALUE.

1429
00:53:37,829 --> 00:53:38,497
THERE ARE SOME REALLY 

1430
00:53:38,497 --> 00:53:40,098
INTERESTING CHALLENGES HERE AS 

1431
00:53:40,098 --> 00:53:40,332
WELL.

1432
00:53:40,332 --> 00:53:42,467
IDENTIFYING WHICH RISKS AND 

1433
00:53:42,467 --> 00:53:45,571
BENEFITS COUNT AND I THINK DAVE 

1434
00:53:45,571 --> 00:53:48,006
WENDLER IS GIVING THAT LECTURE 

1435
00:53:48,006 --> 00:53:51,109
AND DOES A GREAT JOB OF 

1436
00:53:51,109 --> 00:53:53,078
CHALLENGING SHOULD THIS BE A 

1437
00:53:53,078 --> 00:53:53,312
RISK.

1438
00:53:53,312 --> 00:53:54,379
THERE'S A CHALLENGE IN TERMS OF 

1439
00:53:54,379 --> 00:54:01,820
HOW TO MINIMIZE THE RISKS.

1440
00:54:01,820 --> 00:54:04,456
PEOPLE SAY CAN YOU GET ENOUGH 

1441
00:54:04,456 --> 00:54:07,259
DATA FROM THE MRIs TO GIVE YOU 

1442
00:54:07,259 --> 00:54:09,595
THE INFORMATION YOU NEED?

1443
00:54:09,595 --> 00:54:12,497
THERE ARE REGULATIONS THAT LIMIT

1444
00:54:12,497 --> 00:54:17,903
RISKS FOR CERTAIN POPULATIONS SO

1445
00:54:17,903 --> 00:54:19,338
REGULATIONS THAT GUIDE RESEARCH 

1446
00:54:19,338 --> 00:54:20,906
WITH CHILDREN LIMIT RISK TO 

1447
00:54:20,906 --> 00:54:22,040
CHILDREN IN RESEARCH AN THERE'S 

1448
00:54:22,040 --> 00:54:23,375
CATEGORIES OF LIMITS.

1449
00:54:23,375 --> 00:54:25,310
THERE'S LIMITS ON RISK WITH 

1450
00:54:25,310 --> 00:54:26,612
PREGNANT PERSONS.

1451
00:54:26,612 --> 00:54:29,615
THERE'S LIMITS ON RISK WITH 

1452
00:54:29,615 --> 00:54:29,915
PRISONERS.

1453
00:54:29,915 --> 00:54:30,816
THOSE ARE THE ADDITIONAL 

1454
00:54:30,816 --> 00:54:31,450
REGULATIONS IN ADDITION TO THE 

1455
00:54:31,450 --> 00:54:34,252
COMMON RULE.

1456
00:54:34,252 --> 00:54:36,521
THERE'S A LOT OF INTERESTING 

1457
00:54:36,521 --> 00:54:37,723
DEBATES ABOUT DIRECT VERSUS 

1458
00:54:37,723 --> 00:54:38,857
INDIRECT BENEFITS.

1459
00:54:38,857 --> 00:54:40,659
SOME PEOPLE SAY THE ONLY KIND OF

1460
00:54:40,659 --> 00:54:43,862
BENEFIT THAT SHOULD BE THOUGHT 

1461
00:54:43,862 --> 00:54:45,430
OF WITH RESPECT TO AN INDIVIDUAL

1462
00:54:45,430 --> 00:54:48,600
PARTICIPANT ARE THE DIRECT BEN 

1463
00:54:48,600 --> 00:54:51,036
FITS OF THE POTENTIAL DIRECT 

1464
00:54:51,036 --> 00:54:53,538
BENEFITS FROM THE INTERVENTION 

1465
00:54:53,538 --> 00:54:55,440
ITSELF AND NOT THE BENEFITS 

1466
00:54:55,440 --> 00:54:59,111
PEOPLE SOMETIMES DESIRE LIKE 

1467
00:54:59,111 --> 00:55:01,546
PAYMENT OR ACCESS TO GOOD 

1468
00:55:01,546 --> 00:55:03,115
CLINICIAN OR ACCESS TO 

1469
00:55:03,115 --> 00:55:04,383
TREATMENTS THEY OTHERWISE 

1470
00:55:04,383 --> 00:55:05,517
COULDN'T GET AND THINGS LIKE 

1471
00:55:05,517 --> 00:55:08,787
THAT AND THERE'S CHALLENGES IN 

1472
00:55:08,787 --> 00:55:12,658
TERMS OF HOW DO WE DETERMINE AND

1473
00:55:12,658 --> 00:55:14,059
PEOPLE DISAGREE ABOUT THE LEVEL 

1474
00:55:14,059 --> 00:55:15,093
OF RISK.

1475
00:55:15,093 --> 00:55:17,029
IS THIS MINIMAL RISK OR GREATER 

1476
00:55:17,029 --> 00:55:18,930
THAN MINIMAL RISK AND PEOPLE 

1477
00:55:18,930 --> 00:55:20,732
DISAGREE ABOUT PROSPECT AND 

1478
00:55:20,732 --> 00:55:22,467
BENEFIT, WHAT IT IS AND HOW YOU 

1479
00:55:22,467 --> 00:55:23,702
KNOW IT AND YOU'LL HEAR MORE 

1480
00:55:23,702 --> 00:55:24,269
ABOUT THESE THINGS IN THIS 

1481
00:55:24,269 --> 00:55:27,639
COURSE THE TWO MORE OR THREE 

1482
00:55:27,639 --> 00:55:32,744
MORE INDEPENDENT REVIEW EXISTS 

1483
00:55:32,744 --> 00:55:34,012
TO ENSURE THE REGULATORY AND 

1484
00:55:34,012 --> 00:55:36,081
ETHICAL REQUIREMENTS HAVE BEEN 

1485
00:55:36,081 --> 00:55:38,817
FULFILLED AND TO CHECK CONFLICTS

1486
00:55:38,817 --> 00:55:40,318
AND ASSURE THE PUBLIC THE 

1487
00:55:40,318 --> 00:55:42,554
RESEARCH IS NOT EXPLOITIVE AND 

1488
00:55:42,554 --> 00:55:45,424
THIS IS DONE IN THE UNITED 

1489
00:55:45,424 --> 00:55:47,726
STATES BY INDEPENDENT 

1490
00:55:47,726 --> 00:55:50,696
INSTITUTIONAL REVIEW BOARDS 

1491
00:55:50,696 --> 00:55:50,929
AROUND.

1492
00:55:50,929 --> 00:55:52,564
AROUND THE WORLD THEY'RE OFTEN 

1493
00:55:52,564 --> 00:55:53,899
CALLED RESEARCH ETHICS 

1494
00:55:53,899 --> 00:55:55,434
COMMITTEES BUT THEY'RE REVIEW 

1495
00:55:55,434 --> 00:55:58,303
BODIES OF PEERS USUALLY AND 

1496
00:55:58,303 --> 00:55:59,104
NON-AFFILIATED PEOPLE WHO MAKE 

1497
00:55:59,104 --> 00:56:01,206
SURE THESE THINGS ARE TRUE AND 

1498
00:56:01,206 --> 00:56:04,376
THE CRITERIA IN THE COMMON RULE 

1499
00:56:04,376 --> 00:56:12,050
AND IN THE FDA REGS FOR WHAT 

1500
00:56:12,050 --> 00:56:13,819
IRBs SHOULD LOOK AT IN DECIDING 

1501
00:56:13,819 --> 00:56:15,420
WHETHER TO APPROVE THE STUDY ARE

1502
00:56:15,420 --> 00:56:16,288
REFLECTIVE OF THE THINGS I 

1503
00:56:16,288 --> 00:56:17,422
TALKED ABOUT.

1504
00:56:17,422 --> 00:56:21,927
ME RISKS ARE MINIMIZED, 

1505
00:56:21,927 --> 00:56:22,861
JUSTIFIED BY ANTICIPATED 

1506
00:56:22,861 --> 00:56:24,696
BENEFITS OR SOCIAL VALUE AND 

1507
00:56:24,696 --> 00:56:26,865
FAIR SUBJECT SELECTION AND THE 

1508
00:56:26,865 --> 00:56:27,466
NEXT THING I'LL TALK ABOUT IS 

1509
00:56:27,466 --> 00:56:35,707
INFORMED CONSENT.

1510
00:56:35,707 --> 00:56:39,111
THERE'S A LOT OF INTERESTING 

1511
00:56:39,111 --> 00:56:42,180
CHALLENGES WITH IRB'S.

1512
00:56:42,180 --> 00:56:43,014
INFORMED CONSENT.

1513
00:56:43,014 --> 00:56:46,184
THIS IS NOW THE SEVENTH OR THE 

1514
00:56:46,184 --> 00:56:47,352
EIGHTH AND INTERESTINGLY WHEN WE

1515
00:56:47,352 --> 00:56:52,257
FIRST STARTED WORKING ON THIS 

1516
00:56:52,257 --> 00:56:54,392
FRAMEWORK WE HAD TALKED TO LOTS 

1517
00:56:54,392 --> 00:56:58,530
OF PEOPLE WHAT MAKES RESEARCH 

1518
00:56:58,530 --> 00:56:59,097
ETHICAL?

1519
00:56:59,097 --> 00:57:00,365
THEY'D SAY, OH, INFORMED CONSENT

1520
00:57:00,365 --> 00:57:03,101
AND THERE WAS A PROLIFIC AND 

1521
00:57:03,101 --> 00:57:09,641
WONDERFUL WRITER 30 YEARS AGO, 

1522
00:57:09,641 --> 00:57:14,079
BENJAMIN FREEDMAN WHO WROTE AN 

1523
00:57:14,079 --> 00:57:15,380
ARTICLE THAT SAID HE RAN INTO A 

1524
00:57:15,380 --> 00:57:18,049
COLLEAGUE THAT WAS EXCITED AND I

1525
00:57:18,049 --> 00:57:19,151
JUST TRANSPLANTED MY FIRST 

1526
00:57:19,151 --> 00:57:29,694
APPENDIX AND HE SAID HE GOT THE 

1527
00:57:32,264 --> 00:57:33,598
INFORMED CONSENT.

1528
00:57:33,598 --> 00:57:34,733
AND USED THAT TO DESCRIBE 

1529
00:57:34,733 --> 00:57:36,268
INFORMED CONSENT IS NOT THE WAY 

1530
00:57:36,268 --> 00:57:37,536
TO MAKE RESEARCH ETHICAL.

1531
00:57:37,536 --> 00:57:38,804
THERE'S A BUNCH OF STUFF THAT 

1532
00:57:38,804 --> 00:57:41,373
NEEDS TO HAPPEN FIRST AND HE 

1533
00:57:41,373 --> 00:57:46,044
PROPOSES THE IDEA OF SOCIAL 

1534
00:57:46,044 --> 00:57:46,244
VALUE.

1535
00:57:46,244 --> 00:57:49,181
THIS IS BASED ON RESPECT FOR 

1536
00:57:49,181 --> 00:57:49,714
PERSONS.

1537
00:57:49,714 --> 00:57:51,650
THE RESPECT FOR THE CAPACITY AND

1538
00:57:51,650 --> 00:57:54,653
WRITE PEOPLE HAVE TO DECIDE 

1539
00:57:54,653 --> 00:57:56,922
WHETHER THEY WANT TO PARTICIPATE

1540
00:57:56,922 --> 00:57:58,757
IN RESEARCH OR CONTINUE TO 

1541
00:57:58,757 --> 00:58:00,559
PARTICIPATE AND WHETHER IT'S 

1542
00:58:00,559 --> 00:58:03,094
COMPATIBLE WITH THEIR GOALS AND 

1543
00:58:03,094 --> 00:58:03,595
INTERESTS.

1544
00:58:03,595 --> 00:58:05,363
WE'LL TALK ABOUT THIS NEXT WEEK.

1545
00:58:05,363 --> 00:58:06,631
THERE'S DIFFERENT PARTS TO 

1546
00:58:06,631 --> 00:58:07,098
INFORMED CONSENT.

1547
00:58:07,098 --> 00:58:09,134
I WON'T GO INTO THEM NOW.

1548
00:58:09,134 --> 00:58:11,303
THERE ARE ALSO A LOT OF 

1549
00:58:11,303 --> 00:58:11,603
CHALLENGES.

1550
00:58:11,603 --> 00:58:12,771
THE QUALITY OF INFORMED CONSENT 

1551
00:58:12,771 --> 00:58:14,039
HAS BEEN SHOWN OVER AND OVER 

1552
00:58:14,039 --> 00:58:17,909
AGAIN TO BE MODEST BUT AS WE 

1553
00:58:17,909 --> 00:58:23,515
HOPED IT SHOULD BE, THERE'S LOTS

1554
00:58:23,515 --> 00:58:26,218
OF WAYS FOR THE CONSENT GOES.

1555
00:58:26,218 --> 00:58:27,552
THE CAPACITY TO CONSENT SAY 

1556
00:58:27,552 --> 00:58:29,521
CHALLENGE AND I THINK SCOTT WILL

1557
00:58:29,521 --> 00:58:31,089
TALK ABOUT THAT NEXT WEEK.

1558
00:58:31,089 --> 00:58:32,858
THERE'S MANY APPROACH TO 

1559
00:58:32,858 --> 00:58:33,725
INFORMED CONSENT.

1560
00:58:33,725 --> 00:58:35,927
I MENTIONED ELECTRONIC CONSENT.

1561
00:58:35,927 --> 00:58:39,097
THAT'S HAPPENED IN THE LAST 10 

1562
00:58:39,097 --> 00:58:40,632
YEARS OR LESS.

1563
00:58:40,632 --> 00:58:51,176
LOTS OF NEW WAYS TO GET CONSENT.

1564
00:58:55,146 --> 00:58:56,414
AND HUGE DEBATES ABOUT THE 

1565
00:58:56,414 --> 00:58:59,017
APPROPRIATE CONSENT METHOD FOR 

1566
00:58:59,017 --> 00:59:02,587
USING BIO SAYS MENS COLLECTED A 

1567
00:59:02,587 --> 00:59:05,156
LONG TIME AGO.

1568
00:59:05,156 --> 00:59:07,092
LAST BUT NOT LEAST IN THE 

1569
00:59:07,092 --> 00:59:09,494
FRAMEWORK IS RESPECT FOR 

1570
00:59:09,494 --> 00:59:10,395
ENROLLED PARTICIPANTS.

1571
00:59:10,395 --> 00:59:12,731
THIS ONE I THINK DOES NEED MORE 

1572
00:59:12,731 --> 00:59:14,399
ATTENTION AND I WOULD SAY WHEN 

1573
00:59:14,399 --> 00:59:16,468
WE WERE FIRST DEVELOPING THE 

1574
00:59:16,468 --> 00:59:17,969
FRAMEWORK, WHEN WE REALLY DELVED

1575
00:59:17,969 --> 00:59:19,804
INTO THE OTHER GUIDANCE THAT 

1576
00:59:19,804 --> 00:59:21,506
EXISTED, THE CODES AND 

1577
00:59:21,506 --> 00:59:23,108
REGULATIONS AND LITERATURE, 

1578
00:59:23,108 --> 00:59:24,709
THERE WAS THIS SORT OF IDEA IF 

1579
00:59:24,709 --> 00:59:25,777
YOU WERE DOING ETHICAL RESEARCH 

1580
00:59:25,777 --> 00:59:28,113
YOU HAD TO COME UP WITH A GOOD 

1581
00:59:28,113 --> 00:59:30,048
IDEA AND HAD TO HAVE IT REVIEWED

1582
00:59:30,048 --> 00:59:32,784
FROM THE IRB AND HAVE TO HAVE IT

1583
00:59:32,784 --> 00:59:33,952
APPROVED AND ETHICS WERE DONE 

1584
00:59:33,952 --> 00:59:36,054
AND THAT DIDN'T MAKE SENSE TO ME

1585
00:59:36,054 --> 00:59:36,988
AT ALL.

1586
00:59:36,988 --> 00:59:39,324
IN SOME RESPECTS YOU'RE JUST 

1587
00:59:39,324 --> 00:59:40,091
BEGINNING.

1588
00:59:40,091 --> 00:59:42,060
YOU'RE BEGINNING OF A 

1589
00:59:42,060 --> 00:59:43,094
RELATIONSHIP AND THE PARTNERSHIP

1590
00:59:43,094 --> 00:59:44,729
WITH THE PEOPLE IN THE STUDY AND

1591
00:59:44,729 --> 00:59:47,098
ALSO THE PEOPLE WHO YOU OWE THE 

1592
00:59:47,098 --> 00:59:50,001
RESULTS TO.

1593
00:59:50,001 --> 00:59:50,969
ETHICAL RESEARCH REQUIRES 

1594
00:59:50,969 --> 00:59:54,039
CONTINUED RESPECT FOR THE RIGHTS

1595
00:59:54,039 --> 00:59:57,142
AND WELFARE OF PARTICIPANTS OF 

1596
00:59:57,142 --> 00:59:59,110
THE RESEARCH AND INCLUDES 

1597
00:59:59,110 --> 01:00:00,712
PROTECTING CONFIDENTIALITY, 

1598
01:00:00,712 --> 01:00:01,813
MONITORING THEIR WELFARE, 

1599
01:00:01,813 --> 01:00:04,182
RECOGNIZING THEY HAVE A RIGHT TO

1600
01:00:04,182 --> 01:00:06,051
WITHDRAW WITHOUT REASON IF THEY 

1601
01:00:06,051 --> 01:00:06,251
WANT.

1602
01:00:06,251 --> 01:00:07,252
PROVIDING NEW INFORMATION WHICH 

1603
01:00:07,252 --> 01:00:11,156
IS A CHALLENGING THING AND 

1604
01:00:11,156 --> 01:00:13,558
INCLUDING INFORMING THEM OF 

1605
01:00:13,558 --> 01:00:14,359
FINDING AND PLANNING FOR WHAT 

1606
01:00:14,359 --> 01:00:24,869
HAPPENS AFTER THE TRIAL ENDS.

1607
01:00:26,504 --> 01:00:28,640
AND SURPRISINGLY WE'RE BAD ADDS 

1608
01:00:28,640 --> 01:00:31,743
A COMMUNITY IN GIVING 

1609
01:00:31,743 --> 01:00:33,044
INFORMATION BACK TO PARTICIPANTS

1610
01:00:33,044 --> 01:00:35,113
AFTER THE STUDIES ARE OVER.

1611
01:00:35,113 --> 01:00:38,083
THEY DON'T ALWAYS KNOW WHAT 

1612
01:00:38,083 --> 01:00:38,350
HAPPENED.

1613
01:00:38,350 --> 01:00:40,852
SOME PEOPLE DON'T KNOW AND YOU 

1614
01:00:40,852 --> 01:00:42,554
CAN ASK THEM LATER WHETHER THEY 

1615
01:00:42,554 --> 01:00:43,922
GOT PLACEBO OR NOT AND DON'T 

1616
01:00:43,922 --> 01:00:45,357
KNOW THE RESULTS OF THE TRIAL 

1617
01:00:45,357 --> 01:00:45,590
EITHER.

1618
01:00:45,590 --> 01:00:48,326
THERE'S A HUGE EFFORT TO TRY TO 

1619
01:00:48,326 --> 01:00:49,561
THINK ABOUT WHAT ARE THE 

1620
01:00:49,561 --> 01:00:51,629
OBLIGATIONS AND WHAT ARE 

1621
01:00:51,629 --> 01:00:52,697
MECHANISMS FOR POST TRIAL ACCESS

1622
01:00:52,697 --> 01:00:57,569
TO INTERVENTIONS THAT PEOPLE ARE

1623
01:00:57,569 --> 01:00:58,370
BENEFIT FROM.

1624
01:00:58,370 --> 01:01:02,040
LAST SLIDE, THE FRAMEWORK IS 

1625
01:01:02,040 --> 01:01:03,108
SYSTEMIC AND SEQUENTIAL.

1626
01:01:03,108 --> 01:01:06,044
YOU START AT THE PARTNERSHIP AND

1627
01:01:06,044 --> 01:01:07,112
GO TO WHAT HAPPENS AFTER THE 

1628
01:01:07,112 --> 01:01:14,119
STUDY.

1629
01:01:14,119 --> 01:01:15,754
EACH ONE IS NECESSARY THOUGH THE

1630
01:01:15,754 --> 01:01:19,491
PROCEDURAL REQUIREMENTS CAN BE 

1631
01:01:19,491 --> 01:01:23,061
WAVED UNDER CERTAIN 

1632
01:01:23,061 --> 01:01:25,397
CIRCUMSTANCES AND THEY'RE 

1633
01:01:25,397 --> 01:01:25,830
UNIVERSAL.

1634
01:01:25,830 --> 01:01:27,866
IN OTHER WORDS, ALL THOSE APPLY 

1635
01:01:27,866 --> 01:01:29,868
IN EVERY SETTING AT EVERY TIME 

1636
01:01:29,868 --> 01:01:32,303
AND YET THEY NEED TO BE ADAPTED.

1637
01:01:32,303 --> 01:01:34,205
SO HOW YOU THINK ABOUT RISKS AND

1638
01:01:34,205 --> 01:01:35,707
BENEFITS IN ONE CONTEXT MAY BE 

1639
01:01:35,707 --> 01:01:36,841
VERY DIFFERENT THAN HOW YOU 

1640
01:01:36,841 --> 01:01:38,510
THINK ABOUT IT IN ANOTHER 

1641
01:01:38,510 --> 01:01:38,743
CONTEXT.

1642
01:01:38,743 --> 01:01:40,045
THAT'S APPROPRIATE BUT YOU STILL

1643
01:01:40,045 --> 01:01:41,346
HAVE TO THINK ABOUT RISKS AND 

1644
01:01:41,346 --> 01:01:42,647
BENEFITS AND HOW TO MINIMIZE 

1645
01:01:42,647 --> 01:01:45,617
THEM AND ENHANCE THE BENEFITS.

1646
01:01:45,617 --> 01:01:46,985
THEY REQUIRE BALANCING 

1647
01:01:46,985 --> 01:01:48,019
SPECIFICATION AND JUDGMENT.

1648
01:01:48,019 --> 01:01:49,888
THAT'S WHY COURSES LIKE THIS 

1649
01:01:49,888 --> 01:01:52,190
HOPEFULLY HELP PEOPLE TO BEGIN 

1650
01:01:52,190 --> 01:01:53,691
TO GRAPPLE WITH HOW TO MAKE 

1651
01:01:53,691 --> 01:01:56,161
THOSE KINDS OF JUDGMENTS AND HOW

1652
01:01:56,161 --> 01:01:57,495
TO THINK ABOUT HOW THE DIFFERENT

1653
01:01:57,495 --> 01:01:58,096
CONSIDERATIONS ARE AND HOW TO 

1654
01:01:58,096 --> 01:02:03,101
MAKE DECISIONS ABOUT THAT.

1655
01:02:03,101 --> 01:02:07,839
THAT'S THE END.

1656
01:02:07,839 --> 01:02:09,974
>> THANK YOU SO MUCH,
CHRISTINE.

1657
01:02:09,974 --> 01:02:12,043
SO WE NOW HAVE TEN MINUTES FOR 

1658
01:02:12,043 --> 01:02:15,080
QUESTION

1659
01:02:15,080 --> 01:02:15,580
QUESTIONS.

1660
01:02:15,580 --> 01:02:18,183
THOSE IN THE ROOM YOU'LL SEE TWO

1661
01:02:18,183 --> 01:02:18,750
MICROPHONES.

1662
01:02:18,750 --> 01:02:21,086
QUICK, LINE UP WITH YOUR 

1663
01:02:21,086 --> 01:02:21,352
QUESTIONS.

1664
01:02:21,352 --> 01:02:22,821
IF THOSE OUT IN VIDEO LAND WOULD

1665
01:02:22,821 --> 01:02:24,556
LIKE TO ASK A QUESTION, YOU CAN 

1666
01:02:24,556 --> 01:02:26,091
POST IT ON THE DISCUSSION BOARD 

1667
01:02:26,091 --> 01:02:30,228
IN CANVAS.

1668
01:02:30,228 --> 01:02:31,996
IT SAYS POSE QUESTIONS HERE.

1669
01:02:31,996 --> 01:02:36,234
YOU CAN ALSO SEND AN E-MAIL TO 

1670
01:02:36,234 --> 01:02:39,637
BIOETHICS -- INQUIRIES AT MAIL 

1671
01:02:39,637 --> 01:02:44,909
AT NIH.gov.

1672
01:02:44,909 --> 01:02:47,112
I DON'T YET HAVE QUESTIONS FROM 

1673
01:02:47,112 --> 01:02:57,322
VIDEO LAND.

1674
01:03:01,693 --> 01:03:03,094
TAKE IT AWAY.

1675
01:03:03,094 --> 01:03:06,898
>> 

1676
01:03:06,898 --> 01:03:08,633
>> YOU WILL HEAR A LOT
ABOUT 

1677
01:03:08,633 --> 01:03:11,002
EACH OF THE KEY PRINCIPLES THAT 

1678
01:03:11,002 --> 01:03:15,140
WERE PRESENTED AS PRISTINE 

1679
01:03:15,140 --> 01:03:20,145
MENTIONED NEXT WEEK WE'RE DOING 

1680
01:03:20,145 --> 01:03:26,951
INFORMED CONSENT.

1681
01:03:26,951 --> 01:03:28,119
THIS IS THE SORT OF WELCOME TO 

1682
01:03:28,119 --> 01:03:28,653
THE CLASS.

1683
01:03:28,653 --> 01:03:29,654
THESE ARE THE TOPICS WE'RE GOING

1684
01:03:29,654 --> 01:03:34,192
TO COVER.

1685
01:03:34,192 --> 01:03:35,293
>> WE COULD CHAT FOR SEVEN

1686
01:03:35,293 --> 01:03:40,798
MINUTES.

1687
01:03:40,798 --> 01:03:43,334
>> I THINK THE FRAMEWORK
COULD 

1688
01:03:43,334 --> 01:03:45,270
BE CHALLENGED ON A NUMBER OF 

1689
01:03:45,270 --> 01:03:45,703
FRONTS.

1690
01:03:45,703 --> 01:03:47,438
WE STARTED WITH THE DISCLAIMER.

1691
01:03:47,438 --> 01:03:49,207
THIS IS OUR REASON AND NOBODY 

1692
01:03:49,207 --> 01:03:52,744
ELSE'S AND WE PUBLISHED MULTIPLE

1693
01:03:52,744 --> 01:03:54,445
TIMES AND MULTIPLE WAYS AND 

1694
01:03:54,445 --> 01:03:59,350
PEOPLE USED IT IN MULTIPLE WAYS.

1695
01:03:59,350 --> 01:04:02,353
THE FACT THAT SOME NATIONAL 

1696
01:04:02,353 --> 01:04:03,555
REGULATIONS ADOPTED THE 

1697
01:04:03,555 --> 01:04:05,323
FRAMEWORK AS THE WAY TO THINK 

1698
01:04:05,323 --> 01:04:07,659
ABOUT HOW TO REVIEW A STUDY AND 

1699
01:04:07,659 --> 01:04:08,660
THINK ABOUT WHAT WHETHER A STUDY

1700
01:04:08,660 --> 01:04:11,129
IS ETHICAL.

1701
01:04:11,129 --> 01:04:14,165
MAKES ME THINK IT'S USEFUL AND 

1702
01:04:14,165 --> 01:04:15,033
IT WAS USEFUL PRODUCT TO PUT OUT

1703
01:04:15,033 --> 01:04:17,669
IN THE WORLD.

1704
01:04:17,669 --> 01:04:18,469
AS I MENTIONED THERE ARE 

1705
01:04:18,469 --> 01:04:19,704
CHALLENGES TO EACH OF THOSE.

1706
01:04:19,704 --> 01:04:24,042
THERE ARE CHALLENGES TO HOW TO 

1707
01:04:24,042 --> 01:04:28,146
DECIDE AND THERE'S ROOM FOR MORE

1708
01:04:28,146 --> 01:04:32,684
RESEARCH ON EACH OR EVERY ONE OF

1709
01:04:32,684 --> 01:04:34,686
THOSE.

1710
01:04:34,686 --> 01:04:40,992
>> PLEASE USE THE MIC WE
HAVE 

1711
01:04:40,992 --> 01:04:50,268
PEOPLE WHO HAVE IT HARD TO HEAR.

1712
01:04:50,268 --> 01:04:57,675
FEEL FREE TO SEND IN QUESTIONS.

1713
01:04:57,675 --> 01:05:00,478
WE USUALLY HAVE A CHATTY GROUP.

1714
01:05:00,478 --> 01:05:03,081
MAYBE PEOPLE ARE SLEEPING IN 

1715
01:05:03,081 --> 01:05:03,848
TODAY.

1716
01:05:03,848 --> 01:05:08,586
>> THE FIRST QUESTION IS
KIND OF

1717
01:05:08,586 --> 01:05:09,087
SIMPLE.

1718
01:05:09,087 --> 01:05:10,755
THE RATING HAD SEVEN ETHICAL 

1719
01:05:10,755 --> 01:05:13,591
PRINCIPLES AND YOU ADDED THE 

1720
01:05:13,591 --> 01:05:15,293
FIRST ONE AND I'M WONDERING 

1721
01:05:15,293 --> 01:05:17,895
WHETHER THE FIRST ONE WAS 

1722
01:05:17,895 --> 01:05:20,331
DEBATED OR HOW THAT PROCESS 

1723
01:05:20,331 --> 01:05:20,531
WENT.

1724
01:05:20,531 --> 01:05:25,370
>> GREAT QUESTION.

1725
01:05:25,370 --> 01:05:29,040
WHEN WE FIRST STARTED REVIEWING 

1726
01:05:29,040 --> 01:05:30,775
THE DOCUMENTATION THAT EXISTS IN

1727
01:05:30,775 --> 01:05:32,277
CODE AND LITERATURE AND WHAT WE 

1728
01:05:32,277 --> 01:05:32,510
NEEDED.

1729
01:05:32,510 --> 01:05:34,279
WE HAD SEVEN AND STARTED WITH 

1730
01:05:34,279 --> 01:05:36,047
SOCIAL VALUE AS THE FIRST AND 

1731
01:05:36,047 --> 01:05:37,448
MOST IMPORTANT AND THEN WE TOOK 

1732
01:05:37,448 --> 01:05:38,850
IT ON THE ROAD.

1733
01:05:38,850 --> 01:05:40,251
WE TOOK THE FRAMEWORK AND WENT 

1734
01:05:40,251 --> 01:05:42,487
TO DIFFERENT GROUPS BOTH IN THE 

1735
01:05:42,487 --> 01:05:43,121
UNITED STATES AND ALL AROUND THE

1736
01:05:43,121 --> 01:05:48,359
WORLD.

1737
01:05:48,359 --> 01:05:48,993
AND INTERNATIONAL COLLEAGUES 

1738
01:05:48,993 --> 01:05:50,895
THOUGHT WE NEEDED SOMETHING 

1739
01:05:50,895 --> 01:05:53,431
ABOUT COLLABORATION AND THAT'S 

1740
01:05:53,431 --> 01:05:55,667
THE FIRST STARTING POINT BEFORE 

1741
01:05:55,667 --> 01:06:03,107
YOU EVEN GET TO THE RESEARCH 

1742
01:06:03,107 --> 01:06:07,578
QUESTION.

1743
01:06:07,578 --> 01:06:11,449
>> YOU HAD A SLIDE ABOUT
THE 

1744
01:06:11,449 --> 01:06:13,051
STANDARDS FOR MEDICAL CARE AND 

1745
01:06:13,051 --> 01:06:17,388
MEDICAL RESEARCH.

1746
01:06:17,388 --> 01:06:20,425
I'M WONDERING ABOUT THE TENSION 

1747
01:06:20,425 --> 01:06:21,959
WHEN CLINICAL RESEARCH IS THE 

1748
01:06:21,959 --> 01:06:23,961
LAST RESORT FOR A PATIENT AND 

1749
01:06:23,961 --> 01:06:25,229
WHETHER WE PRIORITIZE STANDINGS 

1750
01:06:25,229 --> 01:06:31,102
OF MEDICAL CARE IN THOSE 

1751
01:06:31,102 --> 01:06:34,305
SITUATIONS OR WHETHER OR NOT ONE

1752
01:06:34,305 --> 01:06:35,406
GOES TO THE OTHER.

1753
01:06:35,406 --> 01:06:42,180
>> I'LL EXPAND IT A LITTLE
BIT.

1754
01:06:42,180 --> 01:06:43,081
THERE ARE CLEARLY TENSIONS 

1755
01:06:43,081 --> 01:06:44,148
BETWEEN RESEARCH AND MEDICAL 

1756
01:06:44,148 --> 01:06:46,951
CARE IN RESEARCH SETTINGS FOR 

1757
01:06:46,951 --> 01:06:48,152
SEVERAL REASONS.

1758
01:06:48,152 --> 01:06:50,988
ONE IS BECAUSE MANY PEOPLE WHO 

1759
01:06:50,988 --> 01:06:51,589
ARE CONDUCTING RESEARCH ARE 

1760
01:06:51,589 --> 01:06:55,893
TRAINED AS CLINICIANS.

1761
01:06:55,893 --> 01:06:58,196
THEY FEEL THE PULL TO DO WHAT'S 

1762
01:06:58,196 --> 01:07:03,468
BEST FOR THEIR PATIENT WHILE 

1763
01:07:03,468 --> 01:07:04,836
THEY'RE ALSO IN THE BUSINESS OF 

1764
01:07:04,836 --> 01:07:06,537
DOING WHAT'S RIGHT BY THE STUDY.

1765
01:07:06,537 --> 01:07:08,639
SOMETIMES STUDIES ARE STRICT IN 

1766
01:07:08,639 --> 01:07:12,210
TERMS OF WHAT YOU CAN AN CANNOT 

1767
01:07:12,210 --> 01:07:12,443
DO.

1768
01:07:12,443 --> 01:07:14,011
IN OTHER WORDS, WITH RESPECT TO 

1769
01:07:14,011 --> 01:07:19,183
THINGS LIKE CHANGING DOSE OR 

1770
01:07:19,183 --> 01:07:22,320
CHANGING DRUGS OR ADDING OR 

1771
01:07:22,320 --> 01:07:26,891
SUBTRACTING THINGS.

1772
01:07:26,891 --> 01:07:29,360
YOUR QUESTION THOUGH IS 

1773
01:07:29,360 --> 01:07:31,362
IMPORTANT IN TERMS OF WHEN YOU 

1774
01:07:31,362 --> 01:07:32,864
THINK OF PEOPLE WITH SERIOUS 

1775
01:07:32,864 --> 01:07:39,003
ILLNESSES WHO OFTEN TIMES HAVE 

1776
01:07:39,003 --> 01:07:40,171
EXHAUSTED AVAILABLE STANDARD 

1777
01:07:40,171 --> 01:07:43,074
CLINICAL OPTIONS FOR THEMSELVES,

1778
01:07:43,074 --> 01:07:45,877
HOW DO WE CONVENIENCE THAT 

1779
01:07:45,877 --> 01:07:46,677
TENSION BETWEEN WHAT THE STUDY 

1780
01:07:46,677 --> 01:07:47,445
IS ASKING AND WHAT THE PERSON 

1781
01:07:47,445 --> 01:07:53,484
NEEDS.

1782
01:07:53,484 --> 01:07:59,457
THERE'S EXAMPLES OF GOOD AND BAD

1783
01:07:59,457 --> 01:08:01,526
OUTCOMES BUT CLINICAL 

1784
01:08:01,526 --> 01:08:02,460
INVESTIGATORS HAVE ATTENTIVE TO 

1785
01:08:02,460 --> 01:08:04,729
THE NEEDS OF THEIR PARTICIPANTS,

1786
01:08:04,729 --> 01:08:06,397
THEIR PATIENTS.

1787
01:08:06,397 --> 01:08:07,832
SO IF SOMEBODY IS NOT DOING WELL

1788
01:08:07,832 --> 01:08:10,101
ON A STUDY DRUG OR HAS 

1789
01:08:10,101 --> 01:08:11,202
ADDITIONAL PROBLEM THAT NEEDS TO

1790
01:08:11,202 --> 01:08:15,840
BE ADDRESSED, THE STUDY WOULD 

1791
01:08:15,840 --> 01:08:18,242
PRECLUDE THE STUDY FOR THEIR 

1792
01:08:18,242 --> 01:08:22,246
MODIFICATION TO THE STUDY.

1793
01:08:22,246 --> 01:08:23,080
>> WE HAVE ONE MORE
QUESTION 

1794
01:08:23,080 --> 01:08:29,153
FROM KELLY.

1795
01:08:29,153 --> 01:08:33,024
>> CAN YOU CLARIFY MORE OF
THE 

1796
01:08:33,024 --> 01:08:34,091
DIFFERENCE BETWEEN DIRECT AND 

1797
01:08:34,091 --> 01:08:34,725
INDIRECT WHEN YOU DO RISK 

1798
01:08:34,725 --> 01:08:41,466
BENEFIT RATIO.

1799
01:08:41,466 --> 01:08:44,569
IT'S A HUGE DEBATE AND UNDER 

1800
01:08:44,569 --> 01:08:45,303
ANALYZED DEBATE.

1801
01:08:45,303 --> 01:08:48,606
I GAVE A TALK ON IT A FEW MONTHS

1802
01:08:48,606 --> 01:08:50,441
AGO AND THE DIFFERENCE BETWEEN 

1803
01:08:50,441 --> 01:08:51,976
DIRECT AND INDIRECT AND I'LL TRY

1804
01:08:51,976 --> 01:08:54,312
TO DO IT IN ONE SENTENCE.

1805
01:08:54,312 --> 01:09:00,751
BASICALLY THE IDEA IS THAT WHEN 

1806
01:09:00,751 --> 01:09:03,588
YOU'RE ASSESSING THE PROSPECT OF

1807
01:09:03,588 --> 01:09:07,458
BENEFIT TO THE INDIVIDUAL IN A 

1808
01:09:07,458 --> 01:09:08,926
STUDY IN ORDER TO DECIDE WHETHER

1809
01:09:08,926 --> 01:09:12,597
OR NOT THE RISK OF THE STUDY ARE

1810
01:09:12,597 --> 01:09:13,998
JUSTIFIED, MANY PEOPLE ARGUE THE

1811
01:09:13,998 --> 01:09:15,466
ONLY BENEFIT YOU SHOULD BE 

1812
01:09:15,466 --> 01:09:18,503
MAKING THE COMPARISON WITH IS 

1813
01:09:18,503 --> 01:09:20,404
THE DIRECT POTENTIAL BUT DIRECT 

1814
01:09:20,404 --> 01:09:21,038
BENEFIT OF THE INTERVENTION AND 

1815
01:09:21,038 --> 01:09:28,946
TESTING.

1816
01:09:28,946 --> 01:09:31,682
THERE'S LOTS OF OTHER BENEFITS 

1817
01:09:31,682 --> 01:09:32,517
DESCRIBED FROM PARTICIPATING 

1818
01:09:32,517 --> 01:09:32,783
RESEARCH.

1819
01:09:32,783 --> 01:09:35,953
ONE IS CONTRIBUTING TO THE GOOD.

1820
01:09:35,953 --> 01:09:37,989
PEOPLE LIKE TO DO THAT AND TALK 

1821
01:09:37,989 --> 01:09:43,394
ABOUT THAT.

1822
01:09:43,394 --> 01:09:45,563
SOME IS KINSHIP BENEFITS BECAUSE

1823
01:09:45,563 --> 01:09:48,266
THEIR BEST FRIEND OR RELATIVE 

1824
01:09:48,266 --> 01:09:49,800
HAD SOMETHING OR THEY'RE PASSING

1825
01:09:49,800 --> 01:09:52,003
IT ON TO THEIR CHILDREN.

1826
01:09:52,003 --> 01:09:58,075
SOMETIMES IT'S I HAVE ACCESS TO 

1827
01:09:58,075 --> 01:09:59,911
DR. TAYLOR AT THE NIH AND I WANT

1828
01:09:59,911 --> 01:10:01,746
TO GO TO THAT PERSON AND THAT'S 

1829
01:10:01,746 --> 01:10:03,180
A BENEFIT TO ME EVEN IF I DON'T 

1830
01:10:03,180 --> 01:10:04,248
GET DIRECT BENEFIT FROM THE 

1831
01:10:04,248 --> 01:10:09,020
INTERVENTION.

1832
01:10:09,020 --> 01:10:11,289
THE DIFFERENCE REALLY IS WHAT IS

1833
01:10:11,289 --> 01:10:14,358
PERCEIVED TO BE A BENEFIT BY A 

1834
01:10:14,358 --> 01:10:15,526
NUMBER OF PEOPLE AND WHAT'S 

1835
01:10:15,526 --> 01:10:20,698
ALLOWABLE FOR MAKING THE 

1836
01:10:20,698 --> 01:10:26,637
ASSESSMENT OF WHETHER THE RISKS 

1837
01:10:26,637 --> 01:10:27,104
ARE JUSTIFIED.

1838
01:10:27,104 --> 01:10:29,941
>> WE'LL NEED TO GO TO OUR
NEXT 

1839
01:10:29,941 --> 01:10:30,174
SPEAKER.

1840
01:10:30,174 --> 01:10:35,112
I CAN ADDRESS YOUR QUESTION 

1841
01:10:35,112 --> 01:10:36,480
AFTER THE SESSION.

1842
01:10:36,480 --> 01:10:41,652
THANK YOU THOUGH FOR THE 

1843
01:10:41,652 --> 01:10:45,489
QUESTIONS IN THE ROOM AND I DID 

1844
01:10:45,489 --> 01:10:47,091
SEE PEOPLE THAT SENT IN QUESTION

1845
01:10:47,091 --> 01:10:48,726
AND ANSWER THEM IN NON-REAL TIME

1846
01:10:48,726 --> 01:10:52,530
AND FOR THOSE WHO ARE HAVING 

1847
01:10:52,530 --> 01:10:54,098
TROUBLE FINDING WHERE TO POSE 

1848
01:10:54,098 --> 01:10:55,633
QUESTIONS, I HAVE A PLACE -- I 

1849
01:10:55,633 --> 01:10:57,568
WILL HAVE A PLACE EACH DAY ON 

1850
01:10:57,568 --> 01:10:59,270
THE DISCUSSION BOARD WHERE YOU 

1851
01:10:59,270 --> 01:11:05,009
CAN ASK QUESTIONS AND YOU DIDN'T

1852
01:11:05,009 --> 01:11:08,713
HAVE A CHANCE TO VIEW THE FIRST 

1853
01:11:08,713 --> 01:11:11,349
PART YOU CAN GO TO THE POWER 

1854
01:11:11,349 --> 01:11:12,650
POINT AND THERE'S INSTRUCTIONS 

1855
01:11:12,650 --> 01:11:14,218
HOW TO DO IT.

1856
01:11:14,218 --> 01:11:16,787
SO WITHOUT ANY MORE DELAY, IT IS

1857
01:11:16,787 --> 01:11:20,124
MY GRATE PLEASURE TO INTER -- 

1858
01:11:20,124 --> 01:11:21,492
GREAT PLEASURE TO INTRODUCE OUR 

1859
01:11:21,492 --> 01:11:22,893
NEXT SPEAKER TO TALK TO US ABOUT

1860
01:11:22,893 --> 01:11:24,595
THE HISTORY OF RESEARCH ETHICS.

1861
01:11:24,595 --> 01:11:25,997
THERE'S NO BETTER PERSON TO DO 

1862
01:11:25,997 --> 01:11:29,834
IT THAN SUSAN LEADERER.

1863
01:11:29,834 --> 01:11:33,504
SHE'S THE RONALD L. NUMBERS 

1864
01:11:33,504 --> 01:11:34,438
PROFESSOR AT THE UNIVERSITY OF 

1865
01:11:34,438 --> 01:11:37,742
WISCONSIN SCHOOL OF MEDICINE.

1866
01:11:37,742 --> 01:11:40,344
SHE SPENT TIME AT BOTH YALE AND 

1867
01:11:40,344 --> 01:11:42,947
PENN STATE.

1868
01:11:42,947 --> 01:11:45,850
SHE'S THE AUTHOR OF ONE OF THE 

1869
01:11:45,850 --> 01:11:48,486
KEY BOOKS IN THE HISTORY OF 

1870
01:11:48,486 --> 01:11:49,754
HUMAN EXPERIMENTATION CALLED 

1871
01:11:49,754 --> 01:11:53,791
SUBJECTED TO SCIENCE, HUMAN 

1872
01:11:53,791 --> 01:11:56,327
EXPERIMENTATION IN AMERICA 

1873
01:11:56,327 --> 01:11:58,162
BEFORE THE SECOND WORLD WAR.

1874
01:11:58,162 --> 01:12:00,197
I HAVE A COPY ON MYSELF I'M 

1875
01:12:00,197 --> 01:12:03,968
HAPPY TO LET YOU BORROW IT AND 

1876
01:12:03,968 --> 01:12:14,845
WORKING ON A BOOK ON COREPOREAL 

1877
01:12:19,150 --> 01:12:19,717
PHILANTHROPY.

1878
01:12:19,717 --> 01:12:22,586
>> I HOPE EVERYONE CAN
HEAR ME.

1879
01:12:22,586 --> 01:12:23,220
>> WE CAN.

1880
01:12:23,220 --> 01:12:25,056
>> PERFECT.

1881
01:12:25,056 --> 01:12:30,027
HAPPY TO BE WITH YOU VIRTUALLY 

1882
01:12:30,027 --> 01:12:36,033
FROM BEAUTIFUL, WISCONSIN AND 

1883
01:12:36,033 --> 01:12:37,802
I'M GOING TO TALK TO YOU ABOUT 

1884
01:12:37,802 --> 01:12:43,774
HOW WE GOT TO THIS PLACE IN 

1885
01:12:43,774 --> 01:12:46,711
TERMS OF UNDERSTANDING THE 

1886
01:12:46,711 --> 01:12:47,611
ETHICS OF CLINICAL 

1887
01:12:47,611 --> 01:12:48,879
EXPERIMENTATION AND WHY DO WE 

1888
01:12:48,879 --> 01:12:53,451
HAVE THE RULES FOR RESEARCH NOW 

1889
01:12:53,451 --> 01:12:55,386
AND PREVIOUSLY AND SUGGEST TO 

1890
01:12:55,386 --> 01:12:58,089
YOU IN A RAPID FASHION THAT A 

1891
01:12:58,089 --> 01:13:02,359
LOT OF U.S. HEALTH POLICY IN THE

1892
01:13:02,359 --> 01:13:03,894
20th CENTURY OCCURRED AS A 

1893
01:13:03,894 --> 01:13:07,098
RESPONSE TO SCANDAL AND TRAGEDY.

1894
01:13:07,098 --> 01:13:09,734
SOME MAY BE AWARE IN THE EARLY 

1895
01:13:09,734 --> 01:13:15,106
20th CENTURY THERE WAS 

1896
01:13:15,106 --> 01:13:21,045
CONSIDERABLE CONCERN OVER DRUGS 

1897
01:13:21,045 --> 01:13:24,982
AND THERE WERE CONCERNS OF THE 

1898
01:13:24,982 --> 01:13:30,121
SAFETY OF THE FOOD AND MEAT 

1899
01:13:30,121 --> 01:13:30,554
SUPPLY.

1900
01:13:30,554 --> 01:13:37,128
SOME MAY REMEMBER THERE WAS A 

1901
01:13:37,128 --> 01:13:38,095
QUESTION OF THE SAFETY OF THE 

1902
01:13:38,095 --> 01:13:42,500
FOOD SUPPLY RESULTED IN THE 

1903
01:13:42,500 --> 01:13:43,134
FIRST FEDERAL REGULATION IN THIS

1904
01:13:43,134 --> 01:13:53,277
REGARD.

1905
01:13:54,545 --> 01:13:58,382
THERE WAS AN ELIXIR TRAGEDY THAT

1906
01:13:58,382 --> 01:14:02,119
LED GREATER REGULATION IN THE 

1907
01:14:02,119 --> 01:14:09,593
FOOD DRUG AND COMETIC ACT.

1908
01:14:09,593 --> 01:14:11,328
THE THERE WAS A DRUG AND TRYING 

1909
01:14:11,328 --> 01:14:16,867
TO MAKE IT MORE PALATABLE TO 

1910
01:14:16,867 --> 01:14:17,501
CHILDREN AND 107 PEOPLE DIED AS 

1911
01:14:17,501 --> 01:14:27,812
A RESULT OF THIS.

1912
01:14:30,748 --> 01:14:32,983
AND THERE WERE CONCERNS ABOUT 

1913
01:14:32,983 --> 01:14:36,720
COSMETIC AND DIETARY DRUGS THAT 

1914
01:14:36,720 --> 01:14:39,156
BLINDED PEOPLE OR MASCARA, FOR 

1915
01:14:39,156 --> 01:14:41,158
EXAMPLE, THAT CAUSED WOMEN TO 

1916
01:14:41,158 --> 01:14:42,059
LOSE THEIR EYESIGHT.

1917
01:14:42,059 --> 01:14:44,728
CONGRESS PASSED A MAJOR REVISION

1918
01:14:44,728 --> 01:14:49,667
OF FOOD DRUG AND COSMETICS IN 

1919
01:14:49,667 --> 01:14:49,867
1938.

1920
01:14:49,867 --> 01:14:53,337
THERE WERE MAJOR CHANGES IN THE 

1921
01:14:53,337 --> 01:14:58,509
LAW THAT CALLED FOR REGULATION 

1922
01:14:58,509 --> 01:15:03,013
AND TEST OF SAFETY BEFORE DRUGS 

1923
01:15:03,013 --> 01:15:06,050
COULD BE RELEASED TO THE MARKET.

1924
01:15:06,050 --> 01:15:11,155
IN THE 1960s, I'M SURE YOU'RE 

1925
01:15:11,155 --> 01:15:18,495
AWARE OF THE SULFANALMIDE AND 

1926
01:15:18,495 --> 01:15:20,030
THERE WAS USE OF THE DRUG BEFORE

1927
01:15:20,030 --> 01:15:28,505
IT WAS RELEASED IN EUROPE AND 

1928
01:15:28,505 --> 01:15:29,940
LED TO AN AMOUNT THE WORK OF 

1929
01:15:29,940 --> 01:15:31,141
FRANCIS KELSEY IN THE FDA WAS 

1930
01:15:31,141 --> 01:15:34,879
CRITICAL TO THIS AND FOR THE 

1931
01:15:34,879 --> 01:15:35,713
FIRST TIME FDA COULD DEMAND 

1932
01:15:35,713 --> 01:15:37,248
SCIENTIFIC DATA TO ENSURE DRUGS 

1933
01:15:37,248 --> 01:15:37,748
WERE NOT ONLY SAFE BUT 

1934
01:15:37,748 --> 01:15:47,925
EFFECTIVE.

1935
01:15:55,132 --> 01:15:57,968
AND THERE WAS REGULATION OF 

1936
01:15:57,968 --> 01:15:59,770
ANIMAL WELFARE FOR LABORATORY 

1937
01:15:59,770 --> 01:15:59,937
USE.

1938
01:15:59,937 --> 01:16:01,939
FOR OVER 60 YEARS, CONGRESS 

1939
01:16:01,939 --> 01:16:02,806
CONSIDERED SUCH LEGISLATION AND 

1940
01:16:02,806 --> 01:16:05,309
THE TIPPING POINT CAME IN 

1941
01:16:05,309 --> 01:16:08,812
FEBRUARY OF 1966 WHEN A PHOTO 

1942
01:16:08,812 --> 01:16:12,683
ESSAY IN LIFE MAGAZINE 

1943
01:16:12,683 --> 01:16:14,318
DEMONSTRATED THE DIRE CONDITIONS

1944
01:16:14,318 --> 01:16:15,986
IN WHICH ANIMALS WERE KEPT IN 

1945
01:16:15,986 --> 01:16:19,990
THE CONDITIONS BEFORE THE 

1946
01:16:19,990 --> 01:16:21,592
LABORATORY AND THE FIRST 

1947
01:16:21,592 --> 01:16:27,064
INVESTIGATION WAS THE ANIMAL 

1948
01:16:27,064 --> 01:16:33,637
FEDERAL WELFARE ACT AND IN 1974 

1949
01:16:33,637 --> 01:16:34,905
THE FIRST FEDERAL LEGISLATION 

1950
01:16:34,905 --> 01:16:37,775
THE NATIONAL RESEARCH ACT WAS 

1951
01:16:37,775 --> 01:16:41,912
PASSED IN 1974 AFTER THE 

1952
01:16:41,912 --> 01:16:45,049
REVELATION OF THE TUSKEGEE 

1953
01:16:45,049 --> 01:16:49,119
SYPHILIS STUDY WHICH I'M SURE 

1954
01:16:49,119 --> 01:16:50,721
MANY ARE FAMILIAR.

1955
01:16:50,721 --> 01:16:53,190
IT'S MY OPPORTUNITY TO SORT OF 

1956
01:16:53,190 --> 01:16:57,761
SAY EVEN BEFORE THE TUSKEGEE 

1957
01:16:57,761 --> 01:16:58,963
SYPHILIS STUDY WAS PUBLIC THERE 

1958
01:16:58,963 --> 01:17:01,298
WERE NAZI EXPERIMENTS.

1959
01:17:01,298 --> 01:17:03,033
THE USE OF HUMAN SUBJECTS IN 

1960
01:17:03,033 --> 01:17:04,335
RESEARCH AND THE CONCERN ABOUT 

1961
01:17:04,335 --> 01:17:06,570
THE ETHICAL USE OF HUMAN 

1962
01:17:06,570 --> 01:17:16,981
SUBJECTS WAS MUCH OLDER.

1963
01:17:22,820 --> 01:17:24,054
IN 1900 THE UNITED STATES 

1964
01:17:24,054 --> 01:17:27,291
CONGRESS ACTUALLY CONSIDERED A 

1965
01:17:27,291 --> 01:17:29,326
BILL A LAW THAT WOULD HAVE 

1966
01:17:29,326 --> 01:17:30,394
REQUIRED INVESTIGATORS TO 

1967
01:17:30,394 --> 01:17:31,762
DISCLOSE IN ADVANCE THE PURPOSE 

1968
01:17:31,762 --> 01:17:35,699
AND PROCEDURES OF ANY 

1969
01:17:35,699 --> 01:17:39,003
NON-THERAPEUTIC EXPERIMENT 

1970
01:17:39,003 --> 01:17:39,636
INVOLVING HUMAN BEINGS AND IN 

1971
01:17:39,636 --> 01:17:41,205
THE LEGISLATION WHICH WAS NOT 

1972
01:17:41,205 --> 01:17:46,377
ADOPTED, HOWEVER, THEY WERE 

1973
01:17:46,377 --> 01:17:47,745
PARTICULARLY INTERESTED IN 

1974
01:17:47,745 --> 01:17:50,881
BANNING EXPERIMENTS THAT WOULD 

1975
01:17:50,881 --> 01:17:52,583
HAVE INVOLVED PEOPLE DEEMED 

1976
01:17:52,583 --> 01:17:57,321
UNABLE TO CONSENT BANNING 

1977
01:17:57,321 --> 01:18:01,025
INFANTS AND PEOPLE UNDER 21 AND 

1978
01:18:01,025 --> 01:18:03,494
PREGNANT WOMAN DEEMED INCAPABLE 

1979
01:18:03,494 --> 01:18:05,462
OF MAKING INFORMED DECISIONS AT 

1980
01:18:05,462 --> 01:18:09,433
THAT TIME.

1981
01:18:09,433 --> 01:18:10,968
THERE WERE IN FACT EXPERIMENTERS

1982
01:18:10,968 --> 01:18:13,637
WHO WERE CONCERNED ABOUT THEIR 

1983
01:18:13,637 --> 01:18:15,005
OWN RESPONSIBILITIES AS 

1984
01:18:15,005 --> 01:18:17,274
RESEARCHERS AND FOR THE WELFARE 

1985
01:18:17,274 --> 01:18:20,144
OF THEIR SUBJECTS.

1986
01:18:20,144 --> 01:18:23,714
I WOULD POINT TO THE U.S. ARMY 

1987
01:18:23,714 --> 01:18:29,319
YELLOW FEVER BOARD IN CUBA.

1988
01:18:29,319 --> 01:18:33,791
THIS WAS AFTER THE  TAKING OVER 

1989
01:18:33,791 --> 01:18:36,293
THE ISLAND AND YELLOW FEVER WAS 

1990
01:18:36,293 --> 01:18:38,228
A TERRIBLE PLAGUE ON ISLANDERS 

1991
01:18:38,228 --> 01:18:43,467
AND GREAT CONCERN IN 

1992
01:18:43,467 --> 01:18:49,139
UNDERSTANDING HOW TO DO 

1993
01:18:49,139 --> 01:18:52,109
EXPERIMENTS AND THEY TRIED TO 

1994
01:18:52,109 --> 01:18:52,876
TRANSMIT YELLOW FEVER BETWEEN 

1995
01:18:52,876 --> 01:18:54,078
PEOPLE AND WERE CONCERNED ABOUT 

1996
01:18:54,078 --> 01:18:58,615
THE WELFARE OF THEIR SUBJECTS 

1997
01:18:58,615 --> 01:19:01,285
AND RESPONSIBILITIES AND THERE 

1998
01:19:01,285 --> 01:19:02,619
WERE WRITTEN PERMISSION FORMS --

1999
01:19:02,619 --> 01:19:04,955
I KNOW YOU CAN'T READ THAT BUT 

2000
01:19:04,955 --> 01:19:07,224
ONE THING I WAS INTERESTED IN IS

2001
01:19:07,224 --> 01:19:09,993
THEY WERE AVAILABLE IN BOTH 

2002
01:19:09,993 --> 01:19:12,062
ENGLISH AND SPANISH FOR NEWLY 

2003
01:19:12,062 --> 01:19:12,863
ARRIVED IMMIGRANT AND THE 

2004
01:19:12,863 --> 01:19:14,731
DOCUMENT WARNED OF DANGER TO 

2005
01:19:14,731 --> 01:19:16,633
LIFE BY PARTICIPATING IN THE 

2006
01:19:16,633 --> 01:19:17,568
EXPERIMENTS.

2007
01:19:17,568 --> 01:19:19,503
PROMISED GOOD MEDICAL CARE IN 

2008
01:19:19,503 --> 01:19:20,871
THE ARMY HOSPITAL AND ALSO 

2009
01:19:20,871 --> 01:19:30,447
DISCUSSED COMPENSATION.

2010
01:19:30,447 --> 01:19:32,816
AND THERE WERE $200 IF DEATH 

2011
01:19:32,816 --> 01:19:34,284
OCCURRED AND THANKFULLY IN THIS 

2012
01:19:34,284 --> 01:19:42,059
SET OF STUDIES, NO ONE DIED AS A

2013
01:19:42,059 --> 01:19:42,960
RESULT.

2014
01:19:42,960 --> 01:19:45,095
AGAIN, THERE WAS A ROBUST 

2015
01:19:45,095 --> 01:19:47,197
HISTORY I'LL JUMP FOR REASONS OF

2016
01:19:47,197 --> 01:19:51,101
TIME TO WORLD WAR II WHICH WAS 

2017
01:19:51,101 --> 01:19:55,072
AN EXTRAORDINARILY IMPORTANT 

2018
01:19:55,072 --> 01:19:59,977
TRANSITION MOMENT AND THERE'S 

2019
01:19:59,977 --> 01:20:01,111
UNPRECEDENTED FEDERAL FUNDING 

2020
01:20:01,111 --> 01:20:03,313
RELATED TO THE WAR EFFORT FOR 

2021
01:20:03,313 --> 01:20:05,182
THE F.D.R. OFFICE FOR SCIENTIFIC

2022
01:20:05,182 --> 01:20:06,683
RESEARCH AND DEVELOPMENT.

2023
01:20:06,683 --> 01:20:11,155
THIS WAS A WATERSHED MOMENT.

2024
01:20:11,155 --> 01:20:15,792
FUNDING NEW RESEARCHERS FOR 

2025
01:20:15,792 --> 01:20:21,798
EXAMPLE, THEY WERE INTERESTED IN

2026
01:20:21,798 --> 01:20:24,101
THE AFFECTS OF COLD WATER, HIGH 

2027
01:20:24,101 --> 01:20:27,171
ALTITUDE AND DESALINIZATION 

2028
01:20:27,171 --> 01:20:30,774
STUDIES FOR PILOTS AND THE 

2029
01:20:30,774 --> 01:20:35,512
SEARCH FOR UNIVERSAL BLOOD 

2030
01:20:35,512 --> 01:20:38,749
SUBSTITUTE AND MALARIA, 

2031
01:20:38,749 --> 01:20:40,584
GONORRHEA AND HEPATITIS.

2032
01:20:40,584 --> 01:20:42,819
TO REMIND YOU THE KINDS OF 

2033
01:20:42,819 --> 01:20:43,053
STUDIES.

2034
01:20:43,053 --> 01:20:53,297
THIS WAS DONE IN GALVESTON BAY 

2035
01:20:53,297 --> 01:20:54,998
AND THEY WERE KEPT ALIVE LONG 

2036
01:20:54,998 --> 01:20:59,069
ENOUGH AND RESCUES TO DESALINATE

2037
01:20:59,069 --> 01:21:00,604
WATER.

2038
01:21:00,604 --> 01:21:02,372
MALARIA RESEARCH IN U.S. PRISONS

2039
01:21:02,372 --> 01:21:09,980
WHERE PRISONERS VOLUNTEERED TO 

2040
01:21:09,980 --> 01:21:11,648
INFECTED WITH LOADED MOSQUITOS 

2041
01:21:11,648 --> 01:21:13,417
SO THEY CAN STUDY THE BEST WAY 

2042
01:21:13,417 --> 01:21:15,085
TO AVERT IT AND THE SEARCH FOR A

2043
01:21:15,085 --> 01:21:25,095
VACCINE TO PREVENT IT.

2044
01:21:25,095 --> 01:21:28,198
THERE WERE SIMILAR MILITARY 

2045
01:21:28,198 --> 01:21:32,569
MEDICAL RESEARCH AGENDA THAT THE

2046
01:21:32,569 --> 01:21:33,003
NAZIS HAD.

2047
01:21:33,003 --> 01:21:36,607
THEY'RE FIGHTING IN SIMILAR 

2048
01:21:36,607 --> 01:21:40,544
FIELDS AND YET WE KNOW THE NAZI 

2049
01:21:40,544 --> 01:21:44,114
RESEARCHERS CARRIED OUT THEIR 

2050
01:21:44,114 --> 01:21:50,420
EXPERIMENTS TO MUCH GREATER MORE

2051
01:21:50,420 --> 01:21:53,624
BRUTAL EXTENT OFTEN RESULTING IN

2052
01:21:53,624 --> 01:21:55,025
DEATH IN THE CONCENTRATION CAMP 

2053
01:21:55,025 --> 01:21:55,759
STUDIES.

2054
01:21:55,759 --> 01:21:58,095
SOME MAY BE FAMILIAR THE FIRST 

2055
01:21:58,095 --> 01:22:00,998
EXPERIMENTS UNDERTAKEN ON BEHALF

2056
01:22:00,998 --> 01:22:01,965
OF THE GERMAN AIR FORCE WERE 

2057
01:22:01,965 --> 01:22:05,502
HELD IN A CONCENTRATION CAMP AND

2058
01:22:05,502 --> 01:22:07,971
THEY WERE THRUST INTO COLD WATER

2059
01:22:07,971 --> 01:22:12,075
UNTIL THEY DIED IN AN EFFORT TO 

2060
01:22:12,075 --> 01:22:14,611
STUDY HOW LONG SOMEONE COULD 

2061
01:22:14,611 --> 01:22:14,845
SURVIVE.

2062
01:22:14,845 --> 01:22:16,947
THEY WERE INTERESTED IN 

2063
01:22:16,947 --> 01:22:19,049
DEVELOPING VESTS THAT WOULD KEEP

2064
01:22:19,049 --> 01:22:20,484
PEOPLE ALIVE LONGER SO THEY 

2065
01:22:20,484 --> 01:22:22,252
COULD BE RESCUED.

2066
01:22:22,252 --> 01:22:23,453
THEY WERE INTERESTED IN STUDYING

2067
01:22:23,453 --> 01:22:26,823
EFFECTS OF THE BEST WAY TO 

2068
01:22:26,823 --> 01:22:29,526
REWARM PEOPLE WHO HAD BEEN IN 

2069
01:22:29,526 --> 01:22:30,093
FREEZING WATER FOR LENGTHY 

2070
01:22:30,093 --> 01:22:40,370
PERIOD OF TIME.

2071
01:22:45,842 --> 01:22:49,212
AND IN THE STUDIES DEATH WAS AN 

2072
01:22:49,212 --> 01:22:49,446
INPUT.

2073
01:22:49,446 --> 01:22:52,182
THEY WANTED TO HAVE THE ABILITY 

2074
01:22:52,182 --> 01:22:54,484
TO STUDY POSTMORTEM CHANGES IN 

2075
01:22:54,484 --> 01:22:55,752
THE BRAIN DUE TO CHANGES IN 

2076
01:22:55,752 --> 01:23:06,129
OXYGEN CONCENTRATION.

2077
01:23:08,732 --> 01:23:09,766
THEY WERE INTERESTED IN SEEING 

2078
01:23:09,766 --> 01:23:12,202
HOW LONG PEOPLE COULD SURVIVE IF

2079
01:23:12,202 --> 01:23:14,438
THEY DRANK SEA WATER, IF THEY 

2080
01:23:14,438 --> 01:23:16,707
WERE ABLE TO DESALINATE THE 

2081
01:23:16,707 --> 01:23:19,276
WATER.

2082
01:23:19,276 --> 01:23:21,411
IN THIS CASE THEY USED INMATE IN

2083
01:23:21,411 --> 01:23:25,215
STUDIES TO MAKE THE SEA WATER 

2084
01:23:25,215 --> 01:23:29,086
POTABLE AND JUST A LITTLE BIT 

2085
01:23:29,086 --> 01:23:32,789
THIS COMES FROM TESTIMONY ABOUT 

2086
01:23:32,789 --> 01:23:35,659
THE SEA WATER EXPERIMENTS IN 

2087
01:23:35,659 --> 01:23:43,400
WHICH GERMAN, CZECH AND POLISH 

2088
01:23:43,400 --> 01:23:44,835
WERE RECRUITED FOR WHAT WAS 

2089
01:23:44,835 --> 01:23:49,940
DESCRIBED AS A CLEAN-UP WORK 

2090
01:23:49,940 --> 01:23:50,173
DETAIL.

2091
01:23:50,173 --> 01:23:52,209
IN THE INTEREST OF BETTER 

2092
01:23:52,209 --> 01:23:57,581
RATIONS AND BETTER WORKING 

2093
01:23:57,581 --> 01:24:03,320
CONDITIONS, THEY AGREED TO GO 

2094
01:24:03,320 --> 01:24:06,056
AND THEY FOUND OUT THEY WERE 

2095
01:24:06,056 --> 01:24:07,758
SPLIT INTO FIVE DIFFERENT GROUPS

2096
01:24:07,758 --> 01:24:10,894
AND SOME WERE GIVEN NO WATER AT 

2097
01:24:10,894 --> 01:24:18,034
ALL TO SEE HOW LONG THEY WOULD 

2098
01:24:18,034 --> 01:24:28,345
SURVIVE AND DIESEL NA-- 

2099
01:24:28,345 --> 01:24:31,715
DESALINATED SEA WATER AND 

2100
01:24:31,715 --> 01:24:32,449
ANOTHER EXPERIMENT WITH THE SEA 

2101
01:24:32,449 --> 01:24:36,586
WATER AND WE KNOW FROM TESTIMONY

2102
01:24:36,586 --> 01:24:41,324
OF PEOPLE LIKE HIM WHEN THE 

2103
01:24:41,324 --> 01:24:43,093
INMATES WERE UNABLE TO COMPLY 

2104
01:24:43,093 --> 01:24:45,262
WITH THE BRUTAL EXPERIMENTAL 

2105
01:24:45,262 --> 01:24:47,431
REGIMENT THEY WERE FORCED AND 

2106
01:24:47,431 --> 01:24:49,833
HELD DOWN AND PHYSICALLY GIVEN 

2107
01:24:49,833 --> 01:24:51,501
THE SALT WATER FOR EXAMPLE AND 

2108
01:24:51,501 --> 01:24:58,208
THAT THEY ALSO UNDERWENT WITHOUT

2109
01:24:58,208 --> 01:24:59,709
ANESTHESIA SUCH AS LIVER 

2110
01:24:59,709 --> 01:25:02,212
PUNCTURES AND SPINAL PUNCTURES 

2111
01:25:02,212 --> 01:25:12,722
SO THEY COULD STUDY SALINATE.

2112
01:25:30,140 --> 01:25:34,644
AND HERE POLISH WOMEN WERE 

2113
01:25:34,644 --> 01:25:36,880
REFERRED TO EBB ET GIRLS BECAUSE

2114
01:25:36,880 --> 01:25:39,082
OF THEIR EXPERIMENTAL STATUS AND

2115
01:25:39,082 --> 01:25:40,684
THE RESEARCHERS CREATED WOUNDS 

2116
01:25:40,684 --> 01:25:44,354
IN AN EFFORT TO CREATE THE 

2117
01:25:44,354 --> 01:25:47,090
STANDARDIZED WOUND WITH 

2118
01:25:47,090 --> 01:25:48,091
INCISIONS, INFECTED THEM WITH 

2119
01:25:48,091 --> 01:25:54,064
BACTERIA, DIRT AND SLIVERS GLASS

2120
01:25:54,064 --> 01:25:56,666
IT STUDY THE BEST WAY TO TREAT 

2121
01:25:56,666 --> 01:25:57,601
STANDARDIZED WOUNDS.

2122
01:25:57,601 --> 01:25:58,802
IN THE UNITED STATES THERE WAS 

2123
01:25:58,802 --> 01:26:01,638
ALSO INTEREST IN CREATING A 

2124
01:26:01,638 --> 01:26:02,539
STANDARDIZED WOUND BUT THIS WAS 

2125
01:26:02,539 --> 01:26:08,979
DONE ON ANIMAL SUBJECTS BOTH 

2126
01:26:08,979 --> 01:26:14,918
DOGS AND PIGS WERE USED TO LOOK 

2127
01:26:14,918 --> 01:26:18,154
AT THE EFFICACY OF PENICILLIN 

2128
01:26:18,154 --> 01:26:24,594
INTRODUCED IN 1941 IN THE U.S.

2129
01:26:24,594 --> 01:26:26,229
YOU'RE PERHAPS ALL FAMILIAR 

2130
01:26:26,229 --> 01:26:28,064
AFTER WORLD WAR II THERE WERE A 

2131
01:26:28,064 --> 01:26:32,335
SERIES OF TRIALS OF HIGH-RANKING

2132
01:26:32,335 --> 01:26:36,072
NAZIS AND IN 1946 A 

2133
01:26:36,072 --> 01:26:39,009
U.S. MILITARY TRIBUNAL TRIED 23 

2134
01:26:39,009 --> 01:26:40,377
HIGH-RANKING NAZI MEDICAL 

2135
01:26:40,377 --> 01:26:44,981
PERSONNEL FOR THEIR CRIMES 

2136
01:26:44,981 --> 01:26:49,819
AGAINST HUMANITY IN A COURT IN 

2137
01:26:49,819 --> 01:26:50,520
NUREMBERG.

2138
01:26:50,520 --> 01:26:53,557
IT'S CALLED THE NUREMBERG 

2139
01:26:53,557 --> 01:26:57,661
DOCTORS TRIAL OR THE UNITED 

2140
01:26:57,661 --> 01:27:01,698
STATES AGAINST KARL BRANDT ET 

2141
01:27:01,698 --> 01:27:07,904
AL. AND HE WAS HITLER'S PERSONAL

2142
01:27:07,904 --> 01:27:11,041
PHYSICIAN AND OTHER HIGH RANKING

2143
01:27:11,041 --> 01:27:15,645
DOCTORS INCLUDING ONE FEMALE 

2144
01:27:15,645 --> 01:27:22,252
PHYSICIAN WHO PROV PRESIDED OVE 

2145
01:27:22,252 --> 01:27:24,888
CARE OF INMATE AT ONE 

2146
01:27:24,888 --> 01:27:26,189
CONCENTRATION CAMP.

2147
01:27:26,189 --> 01:27:27,157
WHAT STANDARDS SHOULD BE USED TO

2148
01:27:27,157 --> 01:27:37,567
JUDGE THESE EXPERIMENTS?

2149
01:27:38,001 --> 01:27:39,002
WERE THERE INTERNATIONAL 

2150
01:27:39,002 --> 01:27:46,509
STANDARDS?

2151
01:27:46,509 --> 01:27:48,111
AND THERE WERE FINDINGS WHAT WAS

2152
01:27:48,111 --> 01:27:49,312
ETHICAL TO DO BUT LITTLE IN THE 

2153
01:27:49,312 --> 01:27:51,081
WAY OF FORMAL LAW AND 

2154
01:27:51,081 --> 01:27:59,022
REGULATION.

2155
01:27:59,022 --> 01:28:02,859
THE DEFENSE ATTORNEYS THAT 

2156
01:28:02,859 --> 01:28:03,960
REPRESENTED KARL BRANDT SAID 

2157
01:28:03,960 --> 01:28:06,262
THERE WAS LITTLE DIFFERENCE FROM

2158
01:28:06,262 --> 01:28:08,031
THE GERMAN PRACTICE USING 

2159
01:28:08,031 --> 01:28:10,500
CONCENTRATION CAMP INMATES 

2160
01:28:10,500 --> 01:28:12,569
BECAUSE IN THE UNITED STATES 

2161
01:28:12,569 --> 01:28:14,704
RESEARCHERS WERE USING PRISONERS

2162
01:28:14,704 --> 01:28:16,640
DURING WARTIME.

2163
01:28:16,640 --> 01:28:17,674
PRISONERS PARTICIPATED IN A 

2164
01:28:17,674 --> 01:28:21,311
SERIES OF STUDIES INVOLVING 

2165
01:28:21,311 --> 01:28:23,580
MALARIA, SEXUALLY TRANSMITTED 

2166
01:28:23,580 --> 01:28:30,720
DISEASES AND OTHER THINGS.

2167
01:28:30,720 --> 01:28:33,523
OF THE TRIAL OF THE NAZI DOCTORS

2168
01:28:33,523 --> 01:28:36,059
THE DEFENSE ATTORNEYS USED AS 

2169
01:28:36,059 --> 01:28:38,261
EVIDENCE THE ISSUE OF LIFE 

2170
01:28:38,261 --> 01:28:43,066
MAGAZINE FROM 1945 THAT SHOWED A

2171
01:28:43,066 --> 01:28:46,136
PRISON WARD IN ILLINOIS THAT 

2172
01:28:46,136 --> 01:28:51,174
INVOLVED DELIBERATELY INFECTING 

2173
01:28:51,174 --> 01:28:56,379
PRISONERS WITH VERY SERIOUS 

2174
01:28:56,379 --> 01:28:58,982
STRAINS OF MALARIA BUT AGAIN 

2175
01:28:58,982 --> 01:29:00,684
THOUGH THEY BOTH USED PRISONERS 

2176
01:29:00,684 --> 01:29:01,317
THEY USED THEM UNDER DIFFERENT 

2177
01:29:01,317 --> 01:29:11,528
CONDITIONS.

2178
01:29:15,832 --> 01:29:24,074
AND THERE'S JUDGES THAT HAD NO 

2179
01:29:24,074 --> 01:29:25,075
MEDICAL TRAINING AND HE 

2180
01:29:25,075 --> 01:29:27,410
INFLUENCED -- THERE WERE OTHERS 

2181
01:29:27,410 --> 01:29:29,579
BUT HE INFLUENCED THE CREATION 

2182
01:29:29,579 --> 01:29:33,116
OF A DOCUMENT THE JUDGES CALLED 

2183
01:29:33,116 --> 01:29:34,084
PERMISSIBLE MEDICAL EXPERIMENTS 

2184
01:29:34,084 --> 01:29:39,055
WHICH HAS COME TO BE KNOWN AS 

2185
01:29:39,055 --> 01:29:48,364
THE NUREMBERG CODE.

2186
01:29:48,364 --> 01:29:51,067
IT'S CONDITIONS HOW IT WAS 

2187
01:29:51,067 --> 01:29:52,669
PERMISSIBLE, ETHICAL TO USE 

2188
01:29:52,669 --> 01:29:54,237
HUMAN SUBJECTS IN RESEARCH.

2189
01:29:54,237 --> 01:29:56,005
IT'S MOST OFTEN CITED AND I HOPE

2190
01:29:56,005 --> 01:29:58,708
YOU GET TO READ THE NUREMBERG 

2191
01:29:58,708 --> 01:29:59,075
CODE.

2192
01:29:59,075 --> 01:30:00,944
IT'S THE FIRST PRINCIPLE THE 

2193
01:30:00,944 --> 01:30:03,213
VOLUNTARY CONCEPT OF THE HUMAN 

2194
01:30:03,213 --> 01:30:06,049
SUBJECT IS ABSOLUTELY ESSENTIAL.

2195
01:30:06,049 --> 01:30:11,621
IT GOES IN A LENGTHY PERIOD ON 

2196
01:30:11,621 --> 01:30:13,990
TO DOCUMENT THE CONDITIONS UNDER

2197
01:30:13,990 --> 01:30:19,195
WHICH AN INDIVIDUAL CAN GIVE 

2198
01:30:19,195 --> 01:30:24,367
CONCEPT.

2199
01:30:24,367 --> 01:30:26,536
IT REQUIRES PRIOR ANIMAL 

2200
01:30:26,536 --> 01:30:27,070
EXPERIMENTATION.

2201
01:30:27,070 --> 01:30:29,873
THE GOAL IS TO AVOID ALL 

2202
01:30:29,873 --> 01:30:30,974
UNNECESSARY SUFFERING AND 

2203
01:30:30,974 --> 01:30:33,042
THERE'S NO REASON TO THINK DEATH

2204
01:30:33,042 --> 01:30:35,078
WILL RESULT AND RISK SHOULD NOT 

2205
01:30:35,078 --> 01:30:36,112
EXCEED BENEFIT AND RESEARCH 

2206
01:30:36,112 --> 01:30:38,548
SHOULD ONLY BE CONDUCTED BY 

2207
01:30:38,548 --> 01:30:40,950
SCIENTIFICALLY QUALIFIED 

2208
01:30:40,950 --> 01:30:42,685
PERSONNEL NOT BY SOLDIERS OR BY 

2209
01:30:42,685 --> 01:30:43,386
LAY PEOPLE WITHOUT ANY TRAINING 

2210
01:30:43,386 --> 01:30:51,561
WHATSOEVER.

2211
01:30:51,561 --> 01:30:53,963
SEVEN WERE ACQUITTED AND SEVEN 

2212
01:30:53,963 --> 01:30:55,899
RECEIVED DEATH SENTENCES AND 

2213
01:30:55,899 --> 01:31:03,106
NINE GOT 10 YEARS TO LIFE 

2214
01:31:03,106 --> 01:31:04,340
IMPRISONMENT.

2215
01:31:04,340 --> 01:31:10,280
THE OTHERS HAD THEIR SENTENCES 

2216
01:31:10,280 --> 01:31:20,423
REDUCED.

2217
01:31:24,160 --> 01:31:26,963
WHAT DID THE NUREMBERG CODE MEAN

2218
01:31:26,963 --> 01:31:31,568
TO MEDICAL RESEARCHERS?

2219
01:31:31,568 --> 01:31:33,803
ON THE ONE HAND THERE'S A GOOD 

2220
01:31:33,803 --> 01:31:34,938
ARGUMENT AMERICAN RESEARCHERS 

2221
01:31:34,938 --> 01:31:38,641
WERE AWARE OF IT.

2222
01:31:38,641 --> 01:31:40,777
THE JOURNAL OF SCIENCE PUBLISHED

2223
01:31:40,777 --> 01:31:43,313
A CODE AND A SYMPOSIUM FOR THE 

2224
01:31:43,313 --> 01:31:43,913
WAY AMERICAN MEDICAL RESEARCH 

2225
01:31:43,913 --> 01:31:47,817
WORKED.

2226
01:31:47,817 --> 01:31:52,622
WE KNOW THE SECRETARY OF DEFENSE

2227
01:31:52,622 --> 01:31:53,790
REQUIRED OR SIGNED INTO MILITARY

2228
01:31:53,790 --> 01:31:56,359
REGULATION THAT IT WAS TO BE 

2229
01:31:56,359 --> 01:31:58,294
USED FOR RESEARCH AT THE ARMED 

2230
01:31:58,294 --> 01:31:58,528
FORCES.

2231
01:31:58,528 --> 01:31:59,596
AT THE SAME TIME IT WAS 

2232
01:31:59,596 --> 01:32:06,336
CLASSIFIED AS TOP SECRET.

2233
01:32:06,336 --> 01:32:10,640
SOME INVESTIGATORS WHO WANTED 

2234
01:32:10,640 --> 01:32:12,809
ACCESS TO THIS INFORMATION WERE 

2235
01:32:12,809 --> 01:32:15,111
THWARTED AT THE FACT OF THAT 

2236
01:32:15,111 --> 01:32:25,388
CLASSIFICATION.

2237
01:32:25,922 --> 01:32:27,190
AND IN AMERICAN MEDICAL RESEARCH

2238
01:32:27,190 --> 01:32:28,825
THE RESEARCHERS WERE ALREADY 

2239
01:32:28,825 --> 01:32:30,093
VERY CAREFUL ABOUT THE SAFETY 

2240
01:32:30,093 --> 01:32:36,866
AND WELFARE OF THEIR SUBJECTS.

2241
01:32:36,866 --> 01:32:39,102
SO PUT BOLDLY WHAT WOULD THEY 

2242
01:32:39,102 --> 01:32:41,237
HAVE IN THEIR OVERCOAT?

2243
01:32:41,237 --> 01:32:41,638
NOT AT THAT TIME.

2244
01:32:41,638 --> 01:32:44,040
AND I JUST WANT TO REMIND YOU IN

2245
01:32:44,040 --> 01:32:46,276
THE 1950s, AMERICAN MEDICAL 

2246
01:32:46,276 --> 01:32:51,314
RESEARCH WAS ASSOCIATED WITH 

2247
01:32:51,314 --> 01:32:51,614
VOLUNTEERS.

2248
01:32:51,614 --> 01:32:55,084
A LONG TRADITION OF 

2249
01:32:55,084 --> 01:32:56,786
EXPERIMENTATION AND THERE WERE 

2250
01:32:56,786 --> 01:32:57,787
TREMENDOUS ADVANCES DURING THE 

2251
01:32:57,787 --> 01:33:03,092
SECOND WORLD WAR IN MEDICINE 

2252
01:33:03,092 --> 01:33:05,828
THAT THEY HOPED FOR GREAT 

2253
01:33:05,828 --> 01:33:11,034
ADVANCES IN MEDICINE AS A RESULT

2254
01:33:11,034 --> 01:33:13,036
OF ONGOING EXPERIMENTATION SOME 

2255
01:33:13,036 --> 01:33:15,238
MAY BE FAMILIAR WITH THE POLIO 

2256
01:33:15,238 --> 01:33:20,443
EPIDEMIC RANGE WAS 1952 AND ONE 

2257
01:33:20,443 --> 01:33:22,745
OF THE GREAT ADVANCES BY THE 

2258
01:33:22,745 --> 01:33:27,817
GROUP AT THE UNIVERSITY OF 

2259
01:33:27,817 --> 01:33:31,087
PITTSBURGH WAS A TEST INVOLVING 

2260
01:33:31,087 --> 01:33:33,723
1.8 AMERICAN CHILDREN AGES 6 AND

2261
01:33:33,723 --> 01:33:40,663
7 OF THE POLIO VACCINE AND ALSO 

2262
01:33:40,663 --> 01:33:42,365
PARENTS HAD TO REQUEST THEY'RE 

2263
01:33:42,365 --> 01:33:46,336
CHILD PARTICIPATE IN THE STUDY 

2264
01:33:46,336 --> 01:33:50,640
AND ACTUALLY SIGN A FORM -- NOT 

2265
01:33:50,640 --> 01:33:52,642
INFORMED CONSENT BUT SIGNED A 

2266
01:33:52,642 --> 01:33:53,910
PARENTAL REQUEST FORM KNOWING 

2267
01:33:53,910 --> 01:33:56,846
THAT THEIR CHILDREN WOULD EITHER

2268
01:33:56,846 --> 01:33:57,480
RECEIVE A VACCINE OR A PLACEBO 

2269
01:33:57,480 --> 01:34:02,952
VACCINE.

2270
01:34:02,952 --> 01:34:05,088
LET ME MAKE THE POINT MOST 

2271
01:34:05,088 --> 01:34:07,090
PERSON RESEARCHERS REGARD THE 

2272
01:34:07,090 --> 01:34:09,659
NUREMBERG CODE AS UNWORKABLE AND

2273
01:34:09,659 --> 01:34:14,697
SET THE BAR TOO HIGH FOR PEOPLE 

2274
01:34:14,697 --> 01:34:17,266
WHO COULD PARTICIPATE IN 

2275
01:34:17,266 --> 01:34:17,667
CLINICAL RESEARCH.

2276
01:34:17,667 --> 01:34:20,069
IT WOULDN'T ALLOW EXPERIMENTS ON

2277
01:34:20,069 --> 01:34:21,838
CHILDREN WHICH WERE AN IMPORTANT

2278
01:34:21,838 --> 01:34:23,673
POPULATION FOR DISCOVERING 

2279
01:34:23,673 --> 01:34:24,073
VACCINES.

2280
01:34:24,073 --> 01:34:29,012
IT WOULD NOT ALLOW EXPERIMENT ON

2281
01:34:29,012 --> 01:34:30,079
OTHER POPULATIONS DEEMED -- WHO 

2282
01:34:30,079 --> 01:34:30,646
WOULD BENEFIT FROM SUCH 

2283
01:34:30,646 --> 01:34:33,116
EXPERIMENTATION.

2284
01:34:33,116 --> 01:34:35,051
AND THERE WAS A GREAT EFFORT TO 

2285
01:34:35,051 --> 01:34:38,521
DEVELOP A MUCH MORE WORKABLE 

2286
01:34:38,521 --> 01:34:39,989
CODE ONE THAT WOULD PROTECT 

2287
01:34:39,989 --> 01:34:46,429
SUBJECTS AND ALLOW RESEARCH TO 

2288
01:34:46,429 --> 01:34:46,696
CONTINUE.

2289
01:34:46,696 --> 01:34:57,240
THIS IS THE 1964 DECLARATION OF 

2290
01:34:58,374 --> 01:35:02,045
HELSINKI DIRECTING DOCTORS AND 

2291
01:35:02,045 --> 01:35:03,746
IT CONTINUES TO BE USED TODAY 

2292
01:35:03,746 --> 01:35:06,249
AND TO BE REFERRED TO IN A 

2293
01:35:06,249 --> 01:35:07,550
NUMBER OF NATIONS AS GUIDING 

2294
01:35:07,550 --> 01:35:15,958
PRINCIPLES FOR RESEARCH.

2295
01:35:15,958 --> 01:35:18,094
I WILL SAY AGAIN THIS WAS DEEMED

2296
01:35:18,094 --> 01:35:20,396
BY RESEARCHERS AS MUCH MORE 

2297
01:35:20,396 --> 01:35:23,199
AMENABLE TO IMPROVING OR 

2298
01:35:23,199 --> 01:35:28,738
ADVANCING BIO MEDICAL KNOWLEDGE.

2299
01:35:28,738 --> 01:35:31,674
THIS SLIDE REMINDS YOU THAT THE 

2300
01:35:31,674 --> 01:35:34,510
REGULATION AND EXPECTATIONS OF 

2301
01:35:34,510 --> 01:35:36,579
CLINICAL RESEARCH CHANGE 

2302
01:35:36,579 --> 01:35:39,048
OVERTIME AND THIS EFFORTS BY THE

2303
01:35:39,048 --> 01:35:41,284
WORLD MEDICAL ASSOCIATION TO 

2304
01:35:41,284 --> 01:35:42,018
CREATE SORT OF THE BEST 

2305
01:35:42,018 --> 01:35:52,428
PRACTICES GOING FORWARD.

2306
01:35:54,864 --> 01:35:58,367
LET ME RETURN TO MY ONGOING 

2307
01:35:58,367 --> 01:35:59,368
RESPONSE TO TRAGEDY IN HUMAN 

2308
01:35:59,368 --> 01:36:09,011
EXPERIMENTATION.

2309
01:36:09,011 --> 01:36:12,748
NO LONGER FAITH IN MEDICAL 

2310
01:36:12,748 --> 01:36:18,321
RESEARCHERS AND IN 1966 I'LL 

2311
01:36:18,321 --> 01:36:26,429
REFER TO IS THE DISCUSSION AND 

2312
01:36:26,429 --> 01:36:28,097
CHALLENGES IN HUMAN 

2313
01:36:28,097 --> 01:36:28,865
EXPERIMENTATION AND TAPPED BY 

2314
01:36:28,865 --> 01:36:33,069
THE ABOWS OF HUMAN SUBJECTS 

2315
01:36:33,069 --> 01:36:34,370
ESPECIALLY IN THE TUSKEGEE 

2316
01:36:34,370 --> 01:36:36,038
SYPHILIS STUDY.

2317
01:36:36,038 --> 01:36:41,677
SO HENRY BEACHER WAS A PROFESSOR

2318
01:36:41,677 --> 01:36:47,116
OF ANESTHESIA RESEARCH AT 

2319
01:36:47,116 --> 01:36:52,989
HARVARD MEDICAL SCHOOL AND 

2320
01:36:52,989 --> 01:36:56,359
CONVENE THE HARVARD COMMITTEE 

2321
01:36:56,359 --> 01:36:59,095
FOR TRANSPLANTATION AND OTHER 

2322
01:36:59,095 --> 01:36:59,328
ASPECTS.

2323
01:36:59,328 --> 01:37:02,865
IN 1966 HE PUBLISHED AN ARTICLE 

2324
01:37:02,865 --> 01:37:04,033
IN THE NEW ENGLAND JOURNAL OF 

2325
01:37:04,033 --> 01:37:05,134
MEDICINE IF YOU HAVE THE TIME I 

2326
01:37:05,134 --> 01:37:06,369
ENCOURAGE YOU TO READ IT.

2327
01:37:06,369 --> 01:37:14,477
IT'S A VERY SHORT ARTICLE BUT 

2328
01:37:14,477 --> 01:37:16,946
HAD FAR REACHING AFFECTS AND 

2329
01:37:16,946 --> 01:37:21,350
DESCRIBED THE TREMENDOUS GROWTH 

2330
01:37:21,350 --> 01:37:30,092
OF THE HUMAN CLINICAL RESEARCH 

2331
01:37:30,092 --> 01:37:31,394
AND QUESTIONED RESEARCH OF 

2332
01:37:31,394 --> 01:37:32,295
QUESTIONABLE RESEARCH PRACTICES 

2333
01:37:32,295 --> 01:37:33,729
AND OUTLINED 22 EXAMPLES.

2334
01:37:33,729 --> 01:37:40,102
THE POINT IS THIS WASN'T A 

2335
01:37:40,102 --> 01:37:45,875
FRINGE PROBLEM OR SOMEBODY IN 

2336
01:37:45,875 --> 01:37:51,380
THEIR GARAGE BUT FROM MAINSTREAM

2337
01:37:51,380 --> 01:37:54,850
RESEARCHERS AND FUNDERS OF 

2338
01:37:54,850 --> 01:37:55,585
BIOMEDICAL RESEARCH.

2339
01:37:55,585 --> 01:37:58,821
HE MADE REFERENCE TO 22 

2340
01:37:58,821 --> 01:38:00,022
PUBLISHED ARTICLES AND FIVE FROM

2341
01:38:00,022 --> 01:38:02,358
THE NEW ENGLAND JOURNAL OF 

2342
01:38:02,358 --> 01:38:04,827
MEDICINE, FIVE FROM THE JOURNAL 

2343
01:38:04,827 --> 01:38:06,829
OF CLINICAL INVESTIGATION AND 

2344
01:38:06,829 --> 01:38:15,905
JAMA CIRCULATION AND SO FORTH.

2345
01:38:15,905 --> 01:38:19,075
HE WAS CONCERNED ABOUT YOUNG ERS

2346
01:38:19,075 --> 01:38:20,843
BECAUSE OF THE ONCE PRECEDENTED 

2347
01:38:20,843 --> 01:38:26,182
ATTENTION TO MEDICAL RESEARCH IN

2348
01:38:26,182 --> 01:38:35,491
THE 1940s THAT HAD AN UN  -- 

2349
01:38:35,491 --> 01:38:36,792
INFLUX AND TALK ABOUT 

2350
01:38:36,792 --> 01:38:37,393
RESPONSIBILITY FOR THE 

2351
01:38:37,393 --> 01:38:39,528
PROTECTION AND WELFARE OF THEIR 

2352
01:38:39,528 --> 01:38:49,639
PATIENTS AND HUMAN SUBJECTS.

2353
01:38:49,639 --> 01:38:51,307
I WANTED TO POINT OUT THE PEOPLE

2354
01:38:51,307 --> 01:38:53,109
BEACHER WAS CONCERNED WITH AND 

2355
01:38:53,109 --> 01:38:55,211
THE LANGUAGE IS IN QUOTATION 

2356
01:38:55,211 --> 01:38:56,979
BECAUSE IT'S THE LANGUAGE OF THE

2357
01:38:56,979 --> 01:38:58,814
DAY IN THE 1960s AND THE 

2358
01:38:58,814 --> 01:39:01,350
EXPERIMENTS HE IDENTIFIED AS 

2359
01:39:01,350 --> 01:39:03,019
PARTICULARLY QUESTIONABLE 

2360
01:39:03,019 --> 01:39:06,989
INVOLVED SO-CALLED MENTALLY 

2361
01:39:06,989 --> 01:39:11,761
DEFECTIVE CHILDREN AND THE 

2362
01:39:11,761 --> 01:39:14,497
ELDERLY AND SENILE AND CHARITY 

2363
01:39:14,497 --> 01:39:21,237
PATIENTS, THE TERMINALLY ILL, 

2364
01:39:21,237 --> 01:39:27,243
ALCOHOLICS AND CHILDREN OF THE 

2365
01:39:27,243 --> 01:39:29,312
NEWLY OPENED NIH CLINICAL 

2366
01:39:29,312 --> 01:39:30,880
CENTERS AND TWO WELL KNOWN 

2367
01:39:30,880 --> 01:39:36,552
EXAMPLES CONSIDERED ABUSES AS 

2368
01:39:36,552 --> 01:39:47,096
SCANDALS IN THE 1960s ONE WAS 

2369
01:39:47,096 --> 01:39:49,165
THE WILLOWBROCK INSTITUTION IN 

2370
01:39:49,165 --> 01:39:50,800
STATEN ISLAND FOR CHILDREN AT A 

2371
01:39:50,800 --> 01:39:55,771
TIME WHEN VIRTUALLY ALL PARENTS 

2372
01:39:55,771 --> 01:39:58,240
WERE INFORMED THEY SHOULD 

2373
01:39:58,240 --> 01:40:00,443
INSTITUTIONALIZE SUCH CHILDREN.

2374
01:40:00,443 --> 01:40:01,410
HEPATITIS WAS RIFE AT THE 

2375
01:40:01,410 --> 01:40:01,944
INSTITUTION AND THE 

2376
01:40:01,944 --> 01:40:06,082
INVESTIGATORS WANTED TO STUDY 

2377
01:40:06,082 --> 01:40:10,353
HOW TO PREVENT AND TREAT THIS 

2378
01:40:10,353 --> 01:40:12,688
DISEASE AND SO NEWLY ADMITTED 

2379
01:40:12,688 --> 01:40:13,589
CHILDREN WHOSE PARENTS GAVE 

2380
01:40:13,589 --> 01:40:21,263
CONSENT AT THIS TIME THEY WERE 

2381
01:40:21,263 --> 01:40:24,700
GIVEN MILK SHAKES WITH LIVE 

2382
01:40:24,700 --> 01:40:26,102
HEPATITIS AND THEN PLACED IN THE

2383
01:40:26,102 --> 01:40:31,107
MEDICAL WARD FOR THE PHYSICIANS 

2384
01:40:31,107 --> 01:40:32,007
AND THEIR EXPERIENCE WITH THE 

2385
01:40:32,007 --> 01:40:42,284
DISEASE STUDIED.

2386
01:40:43,486 --> 01:40:46,055
AND THEY CONTINUED TO DEFEND THE

2387
01:40:46,055 --> 01:40:47,022
STUDIES.

2388
01:40:47,022 --> 01:40:52,194
HE WAS A PIONEER IN HAVING IN 

2389
01:40:52,194 --> 01:40:54,663
ENLISTING PARENTS IN THEIR 

2390
01:40:54,663 --> 01:40:56,732
RESEARCH BY INFORMING THEM WHAT 

2391
01:40:56,732 --> 01:41:00,035
WOULD HAPPEN AND THE CARE THEY 

2392
01:41:00,035 --> 01:41:02,104
WOULD RECEIVE IF THEIR CHILDREN 

2393
01:41:02,104 --> 01:41:05,174
INDEED FELL ILL BUT THERE 

2394
01:41:05,174 --> 01:41:06,041
CONTINUED TO BE ISSUES ABOUT 

2395
01:41:06,041 --> 01:41:08,144
COERCION AND WAS THE ONLY WAY TO

2396
01:41:08,144 --> 01:41:09,678
GET YOUR CHILD IN THE 

2397
01:41:09,678 --> 01:41:16,819
INSTITUTION AND ALSO ABOUT STUDY

2398
01:41:16,819 --> 01:41:17,920
DESIGN.

2399
01:41:17,920 --> 01:41:20,423
THE OTHER NOTORIOUS EXAMPLE FROM

2400
01:41:20,423 --> 01:41:23,893
THE 1960s AND IDENTIFIED WAS OF 

2401
01:41:23,893 --> 01:41:26,395
THE JEWISH DISEASE HOSPITAL CASE

2402
01:41:26,395 --> 01:41:30,099
AND AGAIN NOTE THE FUNDERS, THE 

2403
01:41:30,099 --> 01:41:32,735
PUBLIC HEALTH SERVICE AND THE 

2404
01:41:32,735 --> 01:41:34,203
AMERICAN CANCER SOCIETY INVOLVED

2405
01:41:34,203 --> 01:41:37,373
IN THE MOVEMENT OF CANCER AND 

2406
01:41:37,373 --> 01:41:40,843
BODIES AND INVOLVED INJECTING 

2407
01:41:40,843 --> 01:41:46,715
LIVE CANCER CELLS INTO ELDERLY 

2408
01:41:46,715 --> 01:41:50,352
PATIENTS WITHOUT THEIR KNOWLEDGE

2409
01:41:50,352 --> 01:41:52,655
AND EXPLAINED THEY DID NOT SEEK 

2410
01:41:52,655 --> 01:41:56,192
TO EXPLAIN THE NATURE OF THE IN 

2411
01:41:56,192 --> 01:42:03,933
SECTIONS TO THESE ELDERLY IN 

2412
01:42:03,933 --> 01:42:10,272
SOME CASES DEMENTED PATIENTS AND

2413
01:42:10,272 --> 01:42:11,807
I'LL POINT OUT THE LEAD 

2414
01:42:11,807 --> 01:42:14,577
INVESTIGATOR WHO WAS ON THE 

2415
01:42:14,577 --> 01:42:20,983
STAFF OF KETTERING, GAVE A KIND 

2416
01:42:20,983 --> 01:42:23,519
OF DISASTROUS INTERVIEW WITH 

2417
01:42:23,519 --> 01:42:28,457
SCIENCE MAGAZINE IN 1964 WHEN HE

2418
01:42:28,457 --> 01:42:30,726
WAS ASKED WHY HE DEVIATED FROM 

2419
01:42:30,726 --> 01:42:35,998
THE TRADITION OF USING HIS OWN 

2420
01:42:35,998 --> 01:42:41,704
BODY BEFORE EXPERIMENTING ON 

2421
01:42:41,704 --> 01:42:48,110
OTHERS AND HE SAID LET'S FACE IT

2422
01:42:48,110 --> 01:42:50,713
THERE'S RELATIVELY FEW CANCER 

2423
01:42:50,713 --> 01:42:53,082
RESEARCHERS AND SEEMS STUPID TO 

2424
01:42:53,082 --> 01:42:54,083
TAKE A LITTLE RISK.

2425
01:42:54,083 --> 01:42:56,452
THIS DID NOT END WELL FOR HIM 

2426
01:42:56,452 --> 01:42:59,088
AND HE HAD HIS LICENSE SUSPENDED

2427
01:42:59,088 --> 01:43:02,591
FOR A SHORT TIME.

2428
01:43:02,591 --> 01:43:07,696
IT WAS THE REVELATION OF THE 

2429
01:43:07,696 --> 01:43:11,033
TUSKEGEE STUDY MORE THAN ANY 

2430
01:43:11,033 --> 01:43:14,837
OTHER SINGLE STUDY OR EXAMPLES 

2431
01:43:14,837 --> 01:43:17,439
THAT COMPELLED CONGRESS TO ADOPT

2432
01:43:17,439 --> 01:43:19,842
THE FIRST FEDERAL LEGISLATION 

2433
01:43:19,842 --> 01:43:22,177
SEEKING TO PROTECT THE HUMAN 

2434
01:43:22,177 --> 01:43:32,721
SUBJECTS OF BIOMEDICAL RESEARCH.

2435
01:43:33,656 --> 01:43:39,228
THE STUDY INVOLVED A POPULATION 

2436
01:43:39,228 --> 01:43:42,031
OF AFRICAN AMERICAN MEN IN RURAL

2437
01:43:42,031 --> 01:43:44,366
ALABAMA WHERE THE INCIDENCE OF 

2438
01:43:44,366 --> 01:43:45,734
SYPHILIS WAS EXTRAORDINARILY 

2439
01:43:45,734 --> 01:43:46,035
HIGH.

2440
01:43:46,035 --> 01:43:48,103
IT WAS PART OF AN EFFORT AT THE 

2441
01:43:48,103 --> 01:43:49,905
PUBLIC HEALTH SERVICE TO IMPROVE

2442
01:43:49,905 --> 01:43:54,076
OR TO TAKE UP THE STUDY OF SEX 

2443
01:43:54,076 --> 01:43:59,214
HI  -- SEXUALLY TRANSMITTED 

2444
01:43:59,214 --> 01:44:00,282
DISEASES.

2445
01:44:00,282 --> 01:44:05,788
THE SURGEON GENERAL PUBLISHED AN

2446
01:44:05,788 --> 01:44:07,957
INFLUENTIAL BOOK IN 1937, SHADOW

2447
01:44:07,957 --> 01:44:11,126
ON THE LAND AND OVERSAW MUCH OF 

2448
01:44:11,126 --> 01:44:13,028
THE STUDY THROUGH 1948 WHEN HE 

2449
01:44:13,028 --> 01:44:18,467
STEPPED DOWN BUT THIS COMES FROM

2450
01:44:18,467 --> 01:44:19,935
HIS BOOK SHOWING THAT IN ALABAMA

2451
01:44:19,935 --> 01:44:22,171
WHERE THE TUSKEGEE STUDY BEGAN 

2452
01:44:22,171 --> 01:44:24,440
HAD A 35% OF THE AFRICAN 

2453
01:44:24,440 --> 01:44:27,109
AMERICAN POPULATION WAS 

2454
01:44:27,109 --> 01:44:27,943
REPORTEDLY INFECTED WITH 

2455
01:44:27,943 --> 01:44:31,013
SYPHILIS SO IT WAS A PUBLIC 

2456
01:44:31,013 --> 01:44:32,414
HEALTH EMERGENCY OF HIGH ORDER 

2457
01:44:32,414 --> 01:44:35,017
AND ONE THEIR REASONS WHY THEY 

2458
01:44:35,017 --> 01:44:36,518
SELECTED THAT GROUP OF 

2459
01:44:36,518 --> 01:44:37,820
INDIVIDUALS FOR WHAT WAS 

2460
01:44:37,820 --> 01:44:47,096
INITIALLY A SHORT-TERM STUDIO.

2461
01:44:47,096 --> 01:44:56,238
THE STUDY DEVOVLEKED TO UNTIL 

2462
01:44:56,238 --> 01:44:58,307
PEOPLE DIED OF SYPHILIS OVER THE

2463
01:44:58,307 --> 01:45:02,578
COURSE THEIR NEXT 40 YEARS.

2464
01:45:02,578 --> 01:45:04,813
THEY WERE SENT AND AS THE STUDY 

2465
01:45:04,813 --> 01:45:05,814
MOVED FROM TREATMENT WHAT WAS 

2466
01:45:05,814 --> 01:45:09,018
GOING TO BE A TREATMENT STUDY TO

2467
01:45:09,018 --> 01:45:11,720
A STUDY IN NATURE AND AMONG 

2468
01:45:11,720 --> 01:45:13,989
THOSE WHO SOME OF THE INITIAL 

2469
01:45:13,989 --> 01:45:18,894
TESTING ON THE POPULATION SO 

2470
01:45:18,894 --> 01:45:21,463
THEY COULD FOLLOW THE PROGRESS 

2471
01:45:21,463 --> 01:45:23,265
IN THE BODY OF UNTREATED 

2472
01:45:23,265 --> 01:45:26,101
SYPHILIS AND DID THIS BY 

2473
01:45:26,101 --> 01:45:27,870
DECEIVING THE MEN WHO WOULD BE 

2474
01:45:27,870 --> 01:45:31,640
STUDY PARTICIPANTS WITH A LAST 

2475
01:45:31,640 --> 01:45:32,541
CHANCE FOR SPECIAL TREATMENT FOR

2476
01:45:32,541 --> 01:45:33,642
THEIR BAD BLOOD.

2477
01:45:33,642 --> 01:45:35,911
AMONG THE LAST SPECIAL FREE 

2478
01:45:35,911 --> 01:45:38,747
TREATMENTS WAS LUMBAR PUNCTURE 

2479
01:45:38,747 --> 01:45:42,017
WHICH WAS AN ENTIRELY DIAGNOSTIC

2480
01:45:42,017 --> 01:45:43,152
PROCEDURE AND ONE IN WHICH THE 

2481
01:45:43,152 --> 01:45:47,156
MEN SUFFERED GREATLY AND REFUSED

2482
01:45:47,156 --> 01:45:48,557
IN SUBSEQUENT YEARS TO EVER 

2483
01:45:48,557 --> 01:45:59,101
UNDER GO SPINAL PUNCTURE AGAIN.

2484
01:46:00,969 --> 01:46:06,041
WHAT THE PUBLIC HEALTH SERVICE 

2485
01:46:06,041 --> 01:46:13,982
DID WAS TO REFUSE THE DRAFT 

2486
01:46:13,982 --> 01:46:18,320
BOARD OF MEGAN COUNTY TO CALL UP

2487
01:46:18,320 --> 01:46:21,356
MEN IN STUDY BECAUSE THEY WERE 

2488
01:46:21,356 --> 01:46:24,526
DRAFTED AND IF THEY HAD BEEN 

2489
01:46:24,526 --> 01:46:25,494
DRAFTED THEIR SYPHILIS WOULD 

2490
01:46:25,494 --> 01:46:30,099
HAVE BEEN TREATED BY THE ARMY.

2491
01:46:30,099 --> 01:46:33,335
THE STUDY INVOLVED AN AFRICAN 

2492
01:46:33,335 --> 01:46:35,104
AMERICAN NURSE TAXED WITH 

2493
01:46:35,104 --> 01:46:37,539
GETTING PERMISSION FROM THE MEN 

2494
01:46:37,539 --> 01:46:40,676
FOR THE POSTMORTEM AFTER THEIR 

2495
01:46:40,676 --> 01:46:40,909
DEATHS.

2496
01:46:40,909 --> 01:46:46,448
SHE FOUND IT EASIER TO DO IN A 

2497
01:46:46,448 --> 01:46:50,586
BURIAL STIPEND WAS PROVIDED AND 

2498
01:46:50,586 --> 01:46:53,989
PUBLISHED AN ARTICLE IN 1953 

2499
01:46:53,989 --> 01:46:54,590
DESCRIBING ONE REFUSAL IN 140 

2500
01:46:54,590 --> 01:47:04,266
REQUESTS.

2501
01:47:04,266 --> 01:47:04,800
1954 LITERATURE MEN ARE 

2502
01:47:04,800 --> 01:47:06,602
CONSIDERED SOCIAL VOLUNTEERS 

2503
01:47:06,602 --> 01:47:09,071
WITH BURIAL INSURANCE.

2504
01:47:09,071 --> 01:47:16,779
IN 1957 THERE'S AN EFFORT BY 

2505
01:47:16,779 --> 01:47:21,550
INVESTIGATORS TO GIVE MEN A 

2506
01:47:21,550 --> 01:47:23,819
CERTIFICATE SIGNED BY THE 

2507
01:47:23,819 --> 01:47:25,754
SURGEON GENERAL AND A DOLLAR FOR

2508
01:47:25,754 --> 01:47:28,157
EACH YEAR THEY SERVED IN THE 

2509
01:47:28,157 --> 01:47:30,092
STUDY, SO $25.

2510
01:47:30,092 --> 01:47:34,329
THERE WAS A BLUE RIBBON PANEL TO

2511
01:47:34,329 --> 01:47:39,501
ALONG WHETHER IT SHOULD 

2512
01:47:39,501 --> 01:47:48,844
CONDITION SHOULD BE CONTINUED 

2513
01:47:48,844 --> 01:47:51,079
AND THE MEN OFFERED TREATMENT 

2514
01:47:51,079 --> 01:47:55,417
BUT THE STUDY CONTINUED UNTIL 

2515
01:47:55,417 --> 01:47:57,119
1972 WHEN IT WENT OUT OVER THE 

2516
01:47:57,119 --> 01:48:03,725
WIRE SERVICE AND CREATED PUBLIC 

2517
01:48:03,725 --> 01:48:04,259
FUROR.

2518
01:48:04,259 --> 01:48:05,727
THE LEGISLATION WAS PASSED IN 

2519
01:48:05,727 --> 01:48:09,331
1974 AND CONTINUES TO THIS DAY 

2520
01:48:09,331 --> 01:48:12,501
THOUGH IT HAS BEEN AMENDED.

2521
01:48:12,501 --> 01:48:16,038
CREATED A NATION CONVENTION TO 

2522
01:48:16,038 --> 01:48:18,106
STUDY THE MORAL ISSUES OPPOSED 

2523
01:48:18,106 --> 01:48:21,176
BY HUMAN EXPERIMENTATION AND 

2524
01:48:21,176 --> 01:48:23,111
FEDERAL REGULATIONS FOR IRBs AND

2525
01:48:23,111 --> 01:48:25,714
WRITTEN INFORMED CONSENT.

2526
01:48:25,714 --> 01:48:30,252
I WILL SAY THAT THERE REMAINED 

2527
01:48:30,252 --> 01:48:37,426
PERSISTENT STORIES ABOUT THE 

2528
01:48:37,426 --> 01:48:39,261
TUSKEGEE SYPHILIS STORY AND THE 

2529
01:48:39,261 --> 01:48:40,629
GOVERNMENT INVESTIGATORS 

2530
01:48:40,629 --> 01:48:45,434
DELIBERATELY INFECTED THE MEN.

2531
01:48:45,434 --> 01:48:46,702
THERE'S NO EVIDENCE WHATSOEVER 

2532
01:48:46,702 --> 01:48:51,106
THAT THE INVESTIGATORS SOUGHT TO

2533
01:48:51,106 --> 01:48:53,208
CHOOSE MEN WHO WERE ABLE TO DATE

2534
01:48:53,208 --> 01:48:53,809
THEIR INFECTION FOR AT LEAST 

2535
01:48:53,809 --> 01:49:01,316
FIVE YEARS.

2536
01:49:01,316 --> 01:49:02,951
HOWEVER, CONCERNS ABOUT THE 

2537
01:49:02,951 --> 01:49:03,585
TREATMENT PARTICULARLY OF 

2538
01:49:03,585 --> 01:49:06,088
MINORITY PARTICIPANTS IN 

2539
01:49:06,088 --> 01:49:08,891
RESEARCH.

2540
01:49:08,891 --> 01:49:13,061
IN FACT IN THE EARLY DAYS OF 

2541
01:49:13,061 --> 01:49:15,697
AIDS RESEARCH, MANY MAINSTREAM 

2542
01:49:15,697 --> 01:49:19,334
OBSERVERS WERE ASTONISHED TO 

2543
01:49:19,334 --> 01:49:22,537
LEARN AS THE EDITORIAL IN THE 

2544
01:49:22,537 --> 01:49:26,275
NEW YORK TIMES FROM 1992 

2545
01:49:26,275 --> 01:49:27,242
SUGGESTS THAT AFRICAN AMERICANS 

2546
01:49:27,242 --> 01:49:30,078
MAY BE SUSPICION OF A GOVERNMENT

2547
01:49:30,078 --> 01:49:33,448
EFFORT OR EVEN VACCINE TO TREAT 

2548
01:49:33,448 --> 01:49:37,486
HIV BECAUSE OF THE PRIOR 

2549
01:49:37,486 --> 01:49:38,854
EXPERIENCE AND WHAT WAS DONE IN 

2550
01:49:38,854 --> 01:49:40,989
THE TUSKEGEE STUDY.

2551
01:49:40,989 --> 01:49:42,491
I PUT THE SLIDE IN BRIEFLY TO 

2552
01:49:42,491 --> 01:49:48,096
CALL YOUR ATTENTION TO THE FACT 

2553
01:49:48,096 --> 01:49:50,999
THAT OVER THE YEARS THERE'S BEEN

2554
01:49:50,999 --> 01:49:54,236
OTHER SIGNIFICANT REVELATIONS.

2555
01:49:54,236 --> 01:49:57,739
ONE WAS IN 1994 AND 1995 WHEN 

2556
01:49:57,739 --> 01:50:08,283
THE FACT THAT THE HUMAN -- THE 

2557
01:50:08,850 --> 01:50:11,153
FEDERAL GOVERNMENT HAD STUDIES 

2558
01:50:11,153 --> 01:50:13,622
WITH IONIZING RADIATION IN THE 

2559
01:50:13,622 --> 01:50:15,257
UNITED STATES AND A COMMISSION 

2560
01:50:15,257 --> 01:50:17,159
WAS CREATED.

2561
01:50:17,159 --> 01:50:20,462
THERE WAS A PRESIDENTIAL APOLOGY

2562
01:50:20,462 --> 01:50:21,463
FOR THOSE INDIVIDUALS WHOSE 

2563
01:50:21,463 --> 01:50:23,498
LIVES HAD BEEN DARKENED BY THE 

2564
01:50:23,498 --> 01:50:25,901
SHADOW OF THE ATOM AND THE FACT 

2565
01:50:25,901 --> 01:50:26,835
THE FEDERAL GOVERNMENT FUNDED 

2566
01:50:26,835 --> 01:50:29,538
RESEARCH INVOLVING THEIR BODIES 

2567
01:50:29,538 --> 01:50:30,472
OFTEN WITHOUT THEIR CONSENT OR 

2568
01:50:30,472 --> 01:50:36,812
KNOWLEDGE.

2569
01:50:36,812 --> 01:50:39,948
THAT LED TO THE RECOGNITION THAT

2570
01:50:39,948 --> 01:50:44,419
THERE HAD BEEN NO APOLOGY TO THE

2571
01:50:44,419 --> 01:50:46,989
PARTICIPANTS THEIR TUSKEGEE 

2572
01:50:46,989 --> 01:50:51,193
STUDY AND IN 1957 THE WHITE 

2573
01:50:51,193 --> 01:51:01,737
HOUSE FORMALLY A -- 1997 WHITE 

2574
01:51:03,171 --> 01:51:07,509
HOUSE OFFICIALLY APOLOGIZED WITH

2575
01:51:07,509 --> 01:51:10,178
THE PRESIDENT, VICE PRESIDENT 

2576
01:51:10,178 --> 01:51:11,346
AND SURGEON GENERAL.

2577
01:51:11,346 --> 01:51:17,652
AGAIN THE REVELATION OF SCANDAL 

2578
01:51:17,652 --> 01:51:21,289
AND TRAGEDY CONTINUED.

2579
01:51:21,289 --> 01:51:22,324
THE PUBLIC HEALTH SERVICE 

2580
01:51:22,324 --> 01:51:24,960
TRAVELED TO GUATEMALA IN 1946 

2581
01:51:24,960 --> 01:51:29,698
AND 1948 AND INFECTED THOUSANDS 

2582
01:51:29,698 --> 01:51:38,640
OF GAUATEMGUATEMALANS AND THEY 

2583
01:51:38,640 --> 01:51:39,674
APOLOGIZED FOR THE AMERICANS' 

2584
01:51:39,674 --> 01:51:40,509
CONDUCT HERE.

2585
01:51:40,509 --> 01:51:45,981
THIS IS A STUDY IN WHICH THE 

2586
01:51:45,981 --> 01:51:48,083
PUBLIC HEALTH SERVICE 

2587
01:51:48,083 --> 01:51:50,419
INVESTIGATORS FUNDED BY NIH USED

2588
01:51:50,419 --> 01:51:52,154
SEX WORKERS IN AN EFFORT TO 

2589
01:51:52,154 --> 01:52:02,697
TRANSMIT SYPHILIS AND GONORRHEA 

2590
01:52:06,668 --> 01:52:09,504
GUATEMALAN SOLDIERS AND THEY 

2591
01:52:09,504 --> 01:52:13,608
INFECTED THE INMATE OF MENTAL 

2592
01:52:13,608 --> 01:52:15,577
HOSPITALS WITH SYPHILIS, 

2593
01:52:15,577 --> 01:52:19,548
GONORRHEA AND OTHER STDs IN SOME

2594
01:52:19,548 --> 01:52:22,217
CASES WITH PUNCTURE AND INFECTED

2595
01:52:22,217 --> 01:52:23,819
1500 PRISONERS.

2596
01:52:23,819 --> 01:52:25,187
NOW, ONE IMPORTANT DIFFERENCE 

2597
01:52:25,187 --> 01:52:28,824
HERE IN THIS STUDY IS BY 1946 

2598
01:52:28,824 --> 01:52:31,093
THERE WAS PENICILLIN AND FROM 

2599
01:52:31,093 --> 01:52:34,096
THE REFERENCE WE KNOW SOME OO% 

2600
01:52:34,096 --> 01:52:35,130
OF THOSE INDIVIDUALS RECEIVED 

2601
01:52:35,130 --> 01:52:43,205
PENICILLIN AS A TREATMENT.

2602
01:52:43,205 --> 01:52:48,743
THE GUATEMALAN STUDIES WERE 

2603
01:52:48,743 --> 01:52:54,082
NEVER REVEALED AND THERE WAS 

2604
01:52:54,082 --> 01:52:54,683
CORRESPONDENCE THAT BECAME 

2605
01:52:54,683 --> 01:52:56,017
AVAILABLE BETWEEN THE 

2606
01:52:56,017 --> 01:52:57,919
RESEARCHERS AND THIS PARTICULAR 

2607
01:52:57,919 --> 01:53:00,856
QUOTE HAS OFTEN BEEN CITED, WE 

2608
01:53:00,856 --> 01:53:02,090
COULDN'T DO SUCH AN EXPERIMENT 

2609
01:53:02,090 --> 01:53:04,926
IN OUR OWN COUNTRY.

2610
01:53:04,926 --> 01:53:15,403
THAT'S THOMAS HERON IN 1948.

2611
01:53:16,805 --> 01:53:19,107
AND IF YOU HAVE INTEREST CONSULT

2612
01:53:19,107 --> 01:53:21,143
THE PRESIDENTIAL COMMISSION 

2613
01:53:21,143 --> 01:53:26,014
STUDY REPORT, ETHICALLY 

2614
01:53:26,014 --> 01:53:28,116
IMPOSSIBLE FROM SEPTEMBER 2011.

2615
01:53:28,116 --> 01:53:32,888
THIS IS THE HISTORY IN A QUICK 

2616
01:53:32,888 --> 01:53:33,822
SNAPSHOT AND I THINK THE 

2617
01:53:33,822 --> 01:53:35,724
CHALLENGE IS CLEAR AND WE ALL 

2618
01:53:35,724 --> 01:53:37,425
FACE IT AS A SOCIETY AND 

2619
01:53:37,425 --> 01:53:39,995
RESEARCHERS HOW BEST TO PROTECT 

2620
01:53:39,995 --> 01:53:40,896
HUMAN SUBJECTS AND TO 

2621
01:53:40,896 --> 01:53:41,530
SIMULTANEOUSLY ADVANCE MEDICAL 

2622
01:53:41,530 --> 01:53:42,097
KNOWLEDGE.

2623
01:53:42,097 --> 01:53:52,340
SO THANK YOU.

2624
01:54:00,148 --> 01:54:04,419
I KNOW I'VE GONE LONG.

2625
01:54:04,419 --> 01:54:04,586
>> 

2626
01:54:04,586 --> 01:54:12,827
[OFF-MIC]

2627
01:54:12,827 --> 01:54:14,729
>> I ASSUMED YOU WERE
MAKING 

2628
01:54:14,729 --> 01:54:16,531
THAT UP.

2629
01:54:16,531 --> 01:54:20,468
WE ALSO HAVE FOLKS OUT IN VIDEO 

2630
01:54:20,468 --> 01:54:23,004
LAND WHO ARE ABLE TO ASK 

2631
01:54:23,004 --> 01:54:25,040
QUESTIONS ON THE DISCUSSION 

2632
01:54:25,040 --> 01:54:28,410
BOARD AND ALSO SEND US E-MAILS 

2633
01:54:28,410 --> 01:54:32,881
AND FOR A REMINDER, WE HAVE A 

2634
01:54:32,881 --> 01:54:36,251
TEN-MINUTE BREAK SORRY, A 

2635
01:54:36,251 --> 01:54:37,652
15-MINUTE BREAK AFTER SUSAN'S 

2636
01:54:37,652 --> 01:54:42,757
AVAILABLE FOR QUESTIONS.

2637
01:54:42,757 --> 01:54:48,096
SO I HAVE IN THE PAST BROUGHT 

2638
01:54:48,096 --> 01:54:50,265
CANDY TO ENTICE PEOPLE TO ASK 

2639
01:54:50,265 --> 01:54:50,532
QUESTIONS.

2640
01:54:50,532 --> 01:55:01,042
I MIGHT HAVE TO DO THAT AGAIN.

2641
01:55:12,153 --> 01:55:16,758
AND GIVEN THE LESSONS, WE DO 

2642
01:55:16,758 --> 01:55:20,128
HAVE SOME EXAMPLES OF STUDIES 

2643
01:55:20,128 --> 01:55:22,330
THAT HAVE GONE AWRY AS RECENTLY 

2644
01:55:22,330 --> 01:55:26,768
AS JUST A COUPLE OF YEARS AGO.

2645
01:55:26,768 --> 01:55:29,237
IN TERMS OF EXPOSING HUMANS TO 

2646
01:55:29,237 --> 01:55:31,539
RISKS THAT YOU AND I THINK THEY 

2647
01:55:31,539 --> 01:55:34,876
SHOULDN'T BE EXPOSED TO.

2648
01:55:34,876 --> 01:55:37,612
AND I'M WONDERING ANY THOUGHTS 

2649
01:55:37,612 --> 01:55:39,347
YOU MIGHT HAVE ON IS THIS JUST 

2650
01:55:39,347 --> 01:55:43,084
ALWAYS GOING TO HAPPEN?

2651
01:55:43,084 --> 01:55:44,486
WE'VE LEARNED SO MUCH FROM 

2652
01:55:44,486 --> 01:55:47,989
HISTORY BUT WE WILL CONTINUE TO 

2653
01:55:47,989 --> 01:55:49,524
LEARN FROM CONTEMPORARY HISTORY 

2654
01:55:49,524 --> 01:55:53,528
BECAUSE IT'S LIKELY TO CONTINUE 

2655
01:55:53,528 --> 01:55:53,762
ON.

2656
01:55:53,762 --> 01:55:55,230
WE'RE ALL HUMANS I GUESS AS PART

2657
01:55:55,230 --> 01:56:04,139
OF THE CHALLENGE HERE.

2658
01:56:04,139 --> 01:56:06,074
>> THAT'S AN IMPORTANT
QUESTION 

2659
01:56:06,074 --> 01:56:07,075
AND ONE THING THAT'S SURPRISED 

2660
01:56:07,075 --> 01:56:13,148
ME AS AN OBSERVER OF HOW THEY GO

2661
01:56:13,148 --> 01:56:23,692
ON IS THAT IT'S MY UNDERSTANDING

2662
01:56:32,133 --> 01:56:34,636
IF AN INVESTIGATOR CONDUCTS 

2663
01:56:34,636 --> 01:56:36,938
PRIVATE RESEARCH IT MAY NOT BE 

2664
01:56:36,938 --> 01:56:39,741
COVERED BY THESE FEDERAL 

2665
01:56:39,741 --> 01:56:40,041
REGULATIONS.

2666
01:56:40,041 --> 01:56:41,309
IS THAT YOUR UNDERSTANDING AS 

2667
01:56:41,309 --> 01:56:45,914
WELL, HOLLY?

2668
01:56:45,914 --> 01:56:46,514
>> YEAH.

2669
01:56:46,514 --> 01:56:48,850
IN GENERAL IF YOU ARE CONDUCTING

2670
01:56:48,850 --> 01:56:50,952
RESEARCH AT AN INSTITUTION THAT 

2671
01:56:50,952 --> 01:56:53,521
RECEIVES FEDERAL MONEY LIKE MOST

2672
01:56:53,521 --> 01:56:55,123
ACADEMIC MEDICAL CENTERS, OR 

2673
01:56:55,123 --> 01:56:57,459
YOU'RE IN THE PRIVATE SECTOR 

2674
01:56:57,459 --> 01:56:58,760
PURSUING RESEARCH THAT YOU HOPE 

2675
01:56:58,760 --> 01:57:03,565
TO BE SUBMITTING TO THE FDA FOR 

2676
01:57:03,565 --> 01:57:04,733
MARKETING APPROVAL YOU'RE 

2677
01:57:04,733 --> 01:57:08,737
REQUIRED TO HAVE IRB REVIEW.

2678
01:57:08,737 --> 01:57:10,905
BUT THAT DOESN'T MEAN 

2679
01:57:10,905 --> 01:57:12,107
NECESSARILY THAT ALL RESEARCH IS

2680
01:57:12,107 --> 01:57:14,609
THEREFORE REVIEWED BY SOME SORT 

2681
01:57:14,609 --> 01:57:17,112
OF INSTITUTIONAL REVIEW BOARD OR

2682
01:57:17,112 --> 01:57:18,079
RESEARCH ETHICS COMMITTEE.

2683
01:57:18,079 --> 01:57:20,248
WE WERE ACTUALLY JUST HAVING A 

2684
01:57:20,248 --> 01:57:21,683
CONVERSATION THE OTHER DAY AFTER

2685
01:57:21,683 --> 01:57:25,086
A PRESENTATION THAT I MADE HERE 

2686
01:57:25,086 --> 01:57:26,221
IN THE DEPARTMENT ABOUT THE 

2687
01:57:26,221 --> 01:57:32,427
FOLLOWING COULD BE TRUE.

2688
01:57:32,427 --> 01:57:33,695
FOR EXAMPLE, IF I'M A PRIVATE 

2689
01:57:33,695 --> 01:57:34,462
PHARMACEUTICAL COMPANY AND 

2690
01:57:34,462 --> 01:57:37,098
INTERESTED IN DEVELOPING A NEW 

2691
01:57:37,098 --> 01:57:40,235
DRUG, I KNOW I HAVE TO SUBMIT 

2692
01:57:40,235 --> 01:57:42,737
RESEARCH THAT I WILL INCLUDE IN 

2693
01:57:42,737 --> 01:57:45,673
MY MARKETING APPLICATION TO BE 

2694
01:57:45,673 --> 01:57:47,876
REVIEWED BY AN IRB.

2695
01:57:47,876 --> 01:57:50,211
BUT MAYBE I DO A COUPLE OF 

2696
01:57:50,211 --> 01:57:52,647
STUDIES BEFORE JUST TO MAKE SURE

2697
01:57:52,647 --> 01:57:55,950
I'M ON THE RIGHT TRACK AND THEN 

2698
01:57:55,950 --> 01:57:58,286
I SUBMIT THE SIX FOLLOW-UP 

2699
01:57:58,286 --> 01:58:01,956
STUDIES TO THE FDA FOR APPROVAL.

2700
01:58:01,956 --> 01:58:08,129
SO I DON'T THINK IT HAPPENS VERY

2701
01:58:08,129 --> 01:58:10,165
OFTEN BECAUSE I THINK AND I 

2702
01:58:10,165 --> 01:58:11,266
DON'T KNOW IF THE PHARMACEUTICAL

2703
01:58:11,266 --> 01:58:12,634
COMPANY WAS CAUGHT DOING SUCH A 

2704
01:58:12,634 --> 01:58:15,069
THING OR GOING TO A LOW AND 

2705
01:58:15,069 --> 01:58:16,538
MIDDLE INCOME COUNTRY AND DOING 

2706
01:58:16,538 --> 01:58:18,573
THE RESEARCH FIRST AND THEN 

2707
01:58:18,573 --> 01:58:20,542
DOING IT IN THE UNITED STATES IT

2708
01:58:20,542 --> 01:58:22,110
PURSUE MARKETING APPROVAL I 

2709
01:58:22,110 --> 01:58:23,111
THINK WE WOULD FIND OUT ABOUT IT

2710
01:58:23,111 --> 01:58:33,455
BUT IT IS POSSIBLE.

2711
01:58:33,788 --> 01:58:35,690
BUT THAT'S A SPACE IN WHICH 

2712
01:58:35,690 --> 01:58:38,293
THERE COULD IN VIOLATIONS OF THE

2713
01:58:38,293 --> 01:58:41,262
FEDERAL REGULATIONS BECAUSE THEY

2714
01:58:41,262 --> 01:58:42,096
DON'T THINK THEY HAVE TO FOLLOW 

2715
01:58:42,096 --> 01:58:46,468
IT.

2716
01:58:46,468 --> 01:58:49,270
>> I KNOW I WAS STRUCK BY 

2717
01:58:49,270 --> 01:58:51,439
STUDIES THAT BECAME OR CAME TO 

2718
01:58:51,439 --> 01:58:56,878
PUBLIC NOTICE INVOLVING AN 

2719
01:58:56,878 --> 01:59:00,915
OFFSHORE HERPES VACCINE TRIAL 

2720
01:59:00,915 --> 01:59:02,083
BUT BEFORE THEY MOVED OFFSHORE 

2721
01:59:02,083 --> 01:59:04,953
THEY WERE CONDUCTING STUDIES AT 

2722
01:59:04,953 --> 01:59:06,955
A UNIVERSITY AT ILLINOIS THAT 

2723
01:59:06,955 --> 01:59:08,156
INVOLVED HAVING THE RESEARCH 

2724
01:59:08,156 --> 01:59:08,690
PARTICIPANTS GOING TO THE 

2725
01:59:08,690 --> 01:59:14,195
HOLIDAY INN.

2726
01:59:14,195 --> 01:59:19,934
IT STRIKES ME AND THE FACT THAT 

2727
01:59:19,934 --> 01:59:23,171
IF THIS RECEIVED IT DIDN'T COME 

2728
01:59:23,171 --> 01:59:24,639
TO PEOPLE'S ATTENTION AT THE 

2729
01:59:24,639 --> 01:59:25,807
TIME I FIND BAFFLING.

2730
01:59:25,807 --> 01:59:27,575
>> I HAVE A COUPLE
QUESTIONS 

2731
01:59:27,575 --> 01:59:31,079
FROM THOSE OUT IN VIDEO LAND AND

2732
01:59:31,079 --> 01:59:33,548
HERE'S AN INTERESTING ONE.

2733
01:59:33,548 --> 01:59:35,817
ONE THAT I'M SURE YOU THOUGHT 

2734
01:59:35,817 --> 01:59:38,386
ABOUT GIVEN THAT WE TALKED ABOUT

2735
01:59:38,386 --> 01:59:40,488
THESE EXPERIMENTS THAT IN 

2736
01:59:40,488 --> 01:59:43,091
RETROSPECT WERE UNETHICAL EITHER

2737
01:59:43,091 --> 01:59:45,326
IN THEIR PLANNING, EXECUTION, 

2738
01:59:45,326 --> 01:59:45,627
ETCETERA.

2739
01:59:45,627 --> 01:59:46,995
WHAT DO WE DO WITH THE 

2740
01:59:46,995 --> 01:59:49,297
INFORMATION THAT WE GAINED FROM 

2741
01:59:49,297 --> 01:59:52,100
THOSE RESEARCH PROJECTS?

2742
01:59:52,100 --> 01:59:53,735
SO THE UNETHICAL EXPERIMENTS 

2743
01:59:53,735 --> 01:59:56,971
THAT HAPPENED DURING THE NAZI 

2744
01:59:56,971 --> 01:59:59,073
ERA OR RESULTS FROM THE SYPHILIS

2745
01:59:59,073 --> 02:00:01,476
TRIAL OR FROM THE JEWISH CHRONIC

2746
02:00:01,476 --> 02:00:02,277
DISEASE HOSPITAL TRIAL?

2747
02:00:02,277 --> 02:00:07,515
WHAT DO WE AS THE RESEARCH 

2748
02:00:07,515 --> 02:00:10,118
COMMUNITY SHOULD WE USE THE 

2749
02:00:10,118 --> 02:00:11,185
INFORMATION?

2750
02:00:11,185 --> 02:00:13,388
>> THAT'S CERTAINLY
SOMETHING I 

2751
02:00:13,388 --> 02:00:14,722
THOUGHT ABOUT AND SURE SOMETHING

2752
02:00:14,722 --> 02:00:19,827
YOU THOUGHT ABOUT AS WELL.

2753
02:00:19,827 --> 02:00:27,101
I THINK THERE'S THREE POSITIONS.

2754
02:00:27,101 --> 02:00:29,270
ONE IS YOU USE THE INFORMATION 

2755
02:00:29,270 --> 02:00:34,642
OR YOU USE THE INFORMATION BUT 

2756
02:00:34,642 --> 02:00:38,146
CALL ATTENTION TO EXTRAORDINARY 

2757
02:00:38,146 --> 02:00:39,314
TRAGIC OR SCANDALOUS CONDITIONS 

2758
02:00:39,314 --> 02:00:40,181
IN WHICH IT OCCURRED.

2759
02:00:40,181 --> 02:00:44,819
I FIRST ENCOUNTERED THE DEBATE 

2760
02:00:44,819 --> 02:00:49,190
WHEN I ATTENDED BACK IF THE '90s

2761
02:00:49,190 --> 02:00:50,658
A CONFERENCE ON NAZI MEDICAL 

2762
02:00:50,658 --> 02:00:50,959
EXPERIMENT.

2763
02:00:50,959 --> 02:00:55,530
I WAS VERY MOVED WHEN A WOMAN 

2764
02:00:55,530 --> 02:00:58,967
WHO HAD BEEN IN A STUDY MADE THE

2765
02:00:58,967 --> 02:01:01,636
CASE POWERFULLY NONE OF THAT 

2766
02:01:01,636 --> 02:01:04,372
INFORMATION SHOULD BE USED GIVEN

2767
02:01:04,372 --> 02:01:05,506
HOW IT WAS -- AND THAT STAYS 

2768
02:01:05,506 --> 02:01:09,711
WITH ME TO THIS DAY.

2769
02:01:09,711 --> 02:01:11,679
I'VE ALSO HEARD OTHER 

2770
02:01:11,679 --> 02:01:17,218
CONCENTRATION CAMP INMATE MAKE 

2771
02:01:17,218 --> 02:01:22,590
THE ARGUMENT IF WE CAN GET 

2772
02:01:22,590 --> 02:01:33,134
REDEPARTMENTIVE  -- REDEMPTIVE 

2773
02:01:35,470 --> 02:01:37,772
VALUE AND WE SHOULD LOOK AT HOW 

2774
02:01:37,772 --> 02:01:39,107
AND WHAT WAY INFORMATION GETS 

2775
02:01:39,107 --> 02:01:49,350
INCORPORATED.

2776
02:01:56,824 --> 02:02:01,429
AND IT INVOLVED EXPLOITATION AND

2777
02:02:01,429 --> 02:02:03,564
THE PROGRESS OF FUTURE PATIENTS 

2778
02:02:03,564 --> 02:02:14,108
WE'RE USING IT MINDFUL OF THAT 

2779
02:02:19,080 --> 02:02:20,281
THERE'S PRESSURE TO MAKE SURE 

2780
02:02:20,281 --> 02:02:21,582
THESE THINGS DON'T GET IN THE 

2781
02:02:21,582 --> 02:02:26,621
LITERATURE BUT GET A BROADER 

2782
02:02:26,621 --> 02:02:26,821
VIEW.

2783
02:02:26,821 --> 02:02:29,090
THAT'S WHY IT'S SO INTERESTING 

2784
02:02:29,090 --> 02:02:32,026
IN THE CASE OF THE GUATAMALAN 

2785
02:02:32,026 --> 02:02:32,593
STUDIES THEY DECIDED NOT TO 

2786
02:02:32,593 --> 02:02:42,103
PUBLISH.

2787
02:02:42,103 --> 02:02:48,943
THAT'S A LONG ANSWER.

2788
02:02:48,943 --> 02:02:50,712
>> GREAT ANSWER AND I'LL
POST A 

2789
02:02:50,712 --> 02:02:54,115
LINK IN CANVAS THERE'S AN 

2790
02:02:54,115 --> 02:02:55,783
ARTICLE EDITED FROM MANY YEARS 

2791
02:02:55,783 --> 02:02:56,617
AGO THAT SHARES THE PERSPECTIVES

2792
02:02:56,617 --> 02:03:07,095
YOU SHARED AND TO HEAR FROM 

2793
02:03:07,962 --> 02:03:10,631
SOMEONE IN AN EXPERIMENT AND 

2794
02:03:10,631 --> 02:03:12,100
RESPECT AND TAKE IN THEIR VIEWS 

2795
02:03:12,100 --> 02:03:15,269
ON HOW THE INFORMATION SHOULD BE

2796
02:03:15,269 --> 02:03:16,237
USED AND THERE ARE DIFFERENT 

2797
02:03:16,237 --> 02:03:19,340
STORIES AND IT'S A REALLY GREAT 

2798
02:03:19,340 --> 02:03:21,042
BOOK.

2799
02:03:21,042 --> 02:03:23,077
I'LL POST THAT.

2800
02:03:23,077 --> 02:03:29,383
ONE AND ALSO I'LL HIGHLIGHT THAT

2801
02:03:29,383 --> 02:03:39,093
YOU MENTION ED THE DECLARATION F

2802
02:03:39,093 --> 02:03:48,102
HEL -- HELSINKI THEY NEED TO 

2803
02:03:48,102 --> 02:03:58,579
MAKE SURE THEY'RE REVIEWED.

2804
02:04:05,286 --> 02:04:06,554
ANY JOURNAL WILL REQUIRE DUKE A 

2805
02:04:06,554 --> 02:04:07,388
LOT OF INSTITUTIONAL REVIEW 

2806
02:04:07,388 --> 02:04:14,529
BOARD APPROVAL.

2807
02:04:14,529 --> 02:04:15,963
THANK YOU FOR JOINING US FROM 

2808
02:04:15,963 --> 02:04:16,864
WISCONSIN AND HAVE A LOVELY REST

2809
02:04:16,864 --> 02:04:23,070
OF YOUR DAY.

2810
02:04:23,070 --> 02:04:27,642
>> THANK YOU SO MUCH.

2811
02:04:27,642 --> 02:04:29,610
THANK YOU.

2812
02:04:29,610 --> 02:04:29,911
>> OKAY.

2813
02:04:29,911 --> 02:04:35,850
WORD OF THE DAY, BELMONT.

2814
02:04:35,850 --> 02:04:38,786
WE HAVE NOW REACHED THE BREAK.

2815
02:04:38,786 --> 02:04:41,222
WE'LL DO THIS EVERY DAY WE HAVE 

2816
02:04:41,222 --> 02:04:41,422
CLASS.

2817
02:04:41,422 --> 02:04:46,227
WE'LL HAVE A 15-MINUTE BREAK.

2818
02:04:46,227 --> 02:04:47,395
PLEASE REJOIN THE LINK AT 10:50 

2819
02:04:47,395 --> 02:04:55,736
OR MOVE IT ON IN THE BACKGROUND 

2820
02:04:55,736 --> 02:04:57,839
I'M GOING TO FINISH WITH 

2821
02:04:57,839 --> 02:04:58,439
INSTITUTIONAL REVIEW BOARDS.

2822
02:04:58,439 --> 02:05:04,764
FEEL FREE TO BREAK.

2823
02:05:06,866 --> 02:05:08,067
JUST TO REMIND YOU THE WORD OF 

2824
02:05:08,067 --> 02:05:09,702
THE DAY IS BELMONT.

2825
02:05:09,702 --> 02:05:11,871
AND YOU GET TO HAVE ME AS YOUR 

2826
02:05:11,871 --> 02:05:13,973
LAST SPEAKER AND I'M GOING TO 

2827
02:05:13,973 --> 02:05:16,042
TALK A BIT ABOUT INSTITUTIONAL 

2828
02:05:16,042 --> 02:05:16,776
REVIEW BOARDS.

2829
02:05:16,776 --> 02:05:19,612
DR. GRADY INTRODUCED THE TOPIC.

2830
02:05:19,612 --> 02:05:23,549
IT'S ONE OF THE KEY BENCHMARKS 

2831
02:05:23,549 --> 02:05:25,118
INDEPENDENT REVIEW AND I AM 

2832
02:05:25,118 --> 02:05:26,452
GOING TO APOLOGIZE IN ADVANCE 

2833
02:05:26,452 --> 02:05:32,125
AND SAY I HAVE A VERY DOMESTIC 

2834
02:05:32,125 --> 02:05:34,560
PERSPECTIVE ON THE TOPIC.

2835
02:05:34,560 --> 02:05:35,962
THAT SAID I'M GUESSING EVERY 

2836
02:05:35,962 --> 02:05:36,829
INSTITUTION THAT THOSE OF YOU 

2837
02:05:36,829 --> 02:05:39,332
OUT THERE ARE AFFILIATED WITH 

2838
02:05:39,332 --> 02:05:41,200
HAVE SOMETHING LIKE AN 

2839
02:05:41,200 --> 02:05:43,603
INSTITUTIONAL REVIEW BOARD OR 

2840
02:05:43,603 --> 02:05:46,439
RESEARCH ETHICS COMMITTEE WHERE 

2841
02:05:46,439 --> 02:05:47,473
SOMEONE PROPOSING RESEARCH HAS 

2842
02:05:47,473 --> 02:05:49,742
TO GO TO WITH THEIR PROPOSAL AND

2843
02:05:49,742 --> 02:05:53,613
IT IS REVIEWED AND APPROVED BY 

2844
02:05:53,613 --> 02:05:56,315
THEM BEFORE IT CAN BE PUT INTO A

2845
02:05:56,315 --> 02:05:57,350
HUMAN SUBJECT.

2846
02:05:57,350 --> 02:05:59,619
SOMETIMES THAT'S A NATIONAL 

2847
02:05:59,619 --> 02:06:02,054
BOARD OR A REGIONAL BOARD OR 

2848
02:06:02,054 --> 02:06:04,524
SIMILAR TO THE MODEL WE HAVE 

2849
02:06:04,524 --> 02:06:05,291
HERE IN THE U.S.

2850
02:06:05,291 --> 02:06:07,260
A BOARD THAT IS AFFILIATED WITH 

2851
02:06:07,260 --> 02:06:11,697
THE ACADEMIC MEDICAL INSTITUTE 

2852
02:06:11,697 --> 02:06:14,700
OR UNIVERSITY THAT THE 

2853
02:06:14,700 --> 02:06:15,635
INVESTIGATOR IS PLANNING TO DO 

2854
02:06:15,635 --> 02:06:22,375
THEIR RESEARCH AT.

2855
02:06:22,375 --> 02:06:24,343
WITH THAT, HERE'S MY DISCLAIMER 

2856
02:06:24,343 --> 02:06:31,584
AGAIN IN CASE YOU  FORGOT.

2857
02:06:31,584 --> 02:06:34,587
I'M ONLY SPEAKING FOR MYSELF.

2858
02:06:34,587 --> 02:06:37,123
THERE'S AT LEAST TWO PILLARS OF 

2859
02:06:37,123 --> 02:06:38,491
PROTECTION IN HUMAN SUBJECTS.

2860
02:06:38,491 --> 02:06:39,892
THE INSTITUTIONAL REVIEW BOARD 

2861
02:06:39,892 --> 02:06:50,269
AND INFORMED CONSENT.

2862
02:07:02,114 --> 02:07:02,982
IT'S OFFERED THROUGH A 

2863
02:07:02,982 --> 02:07:04,150
PARTICIPANT THROUGH THE PROCESS 

2864
02:07:04,150 --> 02:07:05,218
OF AN INFORMED CONSENT.

2865
02:07:05,218 --> 02:07:08,221
THE FIRST LAYER IS THE 

2866
02:07:08,221 --> 02:07:10,490
INSTITUTIONAL REVIEW BOARD AND 

2867
02:07:10,490 --> 02:07:11,591
THE SECOND IS INFORMED CONSENT.

2868
02:07:11,591 --> 02:07:14,560
AS CHRISTINE NOTED, YOU CAN'T DO

2869
02:07:14,560 --> 02:07:15,995
IT JUST BECAUSE YOU GOT CONCEPT 

2870
02:07:15,995 --> 02:07:16,929
FROM THE INDIVIDUAL.

2871
02:07:16,929 --> 02:07:20,800
YOU HAVE TO SEND IT TO AN 

2872
02:07:20,800 --> 02:07:22,969
INDEPENDENT GROUP TO EVALUATE 

2873
02:07:22,969 --> 02:07:24,203
AND WE'LL TALK A LITTLE BIT 

2874
02:07:24,203 --> 02:07:25,505
ABOUT WHY THAT'S THE CASE AND 

2875
02:07:25,505 --> 02:07:31,611
WE'LL HAVE A WHOLE DAY ON 

2876
02:07:31,611 --> 02:07:39,018
INFORMED CONSENT NEXT WEEK.

2877
02:07:39,018 --> 02:07:41,320
SO KEY POINTS IF YOU NAP FROM 

2878
02:07:41,320 --> 02:07:43,456
THIS POINT ON TO THE END HERE'S 

2879
02:07:43,456 --> 02:07:44,957
THE KEY POINTS.

2880
02:07:44,957 --> 02:07:46,893
IRBs ARE RESPONSIBLE FOR THE 

2881
02:07:46,893 --> 02:07:48,494
REVIEW AND OVERSIGHT OF HUMAN 

2882
02:07:48,494 --> 02:07:50,530
SUBJECT RESEARCH.

2883
02:07:50,530 --> 02:07:51,998
HERE IN THE UNITED STATES AND 

2884
02:07:51,998 --> 02:07:53,933
AGAIN WHERE YOU ARE OUT THERE 

2885
02:07:53,933 --> 02:07:57,503
YOU LIKELY HAVE SOME SORT OF 

2886
02:07:57,503 --> 02:07:59,839
NATIONAL OR REGIONAL REGULATION.

2887
02:07:59,839 --> 02:08:02,675
IRBs ARE GUIDED IN THEIR REVIEW 

2888
02:08:02,675 --> 02:08:05,778
BY FEDERAL REGULATIONS.

2889
02:08:05,778 --> 02:08:08,447
THE 45CFR CALLED THE COMMON 

2890
02:08:08,447 --> 02:08:08,981
RULE.

2891
02:08:08,981 --> 02:08:11,617
IT'S COMMON TO MOST FEDERAL 

2892
02:08:11,617 --> 02:08:11,884
AGENCIES.

2893
02:08:11,884 --> 02:08:13,219
ODDLY ONE EXCEPTION TO THAT RULE

2894
02:08:13,219 --> 02:08:14,687
IS THE FOOD AND DRUG 

2895
02:08:14,687 --> 02:08:17,456
ADMINISTRATION WOULD HAVE THEIR 

2896
02:08:17,456 --> 02:08:19,792
OWN CODE OF FEDERAL REGULATIONS 

2897
02:08:19,792 --> 02:08:21,527
RELATED TO IRBs BUT THEY ARE 

2898
02:08:21,527 --> 02:08:25,231
VERY SIMILAR IF NOT IDENTICAL AS

2899
02:08:25,231 --> 02:08:26,365
IT RELATES TO WHAT'S REQUIRED OF

2900
02:08:26,365 --> 02:08:27,800
IRBs.

2901
02:08:27,800 --> 02:08:32,138
IRBs ARE LOCAL AND THEY DEVELOP 

2902
02:08:32,138 --> 02:08:34,507
THEIR OWN POLICY AND PRACTICE 

2903
02:08:34,507 --> 02:08:38,477
AND THINK OF THE IRB AS YOUR 

2904
02:08:38,477 --> 02:08:39,579
FRIEND NOT NEARLY AN 

2905
02:08:39,579 --> 02:08:41,280
ADMINISTRATIVE BARRIER.

2906
02:08:41,280 --> 02:08:42,982
IF YOU HAVE A QUESTION ABOUT 

2907
02:08:42,982 --> 02:08:45,451
WHETHER YOU'RE DOING RESEARCH, 

2908
02:08:45,451 --> 02:08:48,588
WHETHER YOUR RESEARCH EXPOSES 

2909
02:08:48,588 --> 02:08:53,492
INDIVIDUALS TO MORE THAN MINIMAL

2910
02:08:53,492 --> 02:08:53,793
RISK.

2911
02:08:53,793 --> 02:08:54,827
ASK SOMEBODY IN THE IRB.

2912
02:08:54,827 --> 02:08:56,028
THAT'S WHY THEY'RE THERE AND THE

2913
02:08:56,028 --> 02:08:59,432
EXPERTISE THEY HAVE.

2914
02:08:59,432 --> 02:09:02,401
A REMINDER FROM THE ARTICLE AND 

2915
02:09:02,401 --> 02:09:05,304
THE BENCHMARKS DR. GRADY 

2916
02:09:05,304 --> 02:09:07,640
REVIEWED, THE REASON WE DO THIS,

2917
02:09:07,640 --> 02:09:09,642
THE REASON WE HAVE THIS 

2918
02:09:09,642 --> 02:09:10,743
INDEPENDENT REVIEW AND WE'LL 

2919
02:09:10,743 --> 02:09:14,146
TALK WHETHER A LOCAL 

2920
02:09:14,146 --> 02:09:16,482
INSTITUTIONAL REVIEW BOARD IS 

2921
02:09:16,482 --> 02:09:19,619
REALLY INDEPENDENT.

2922
02:09:19,619 --> 02:09:26,058
THE IDEA IS THAT THE ROLE 

2923
02:09:26,058 --> 02:09:27,560
THERE'S SOCIAL ACCOUNTABILITY 

2924
02:09:27,560 --> 02:09:29,695
AND TRUST US WE'RE REVIEWING 

2925
02:09:29,695 --> 02:09:32,665
THIS BEFORE IT GOES INTO A HUMAN

2926
02:09:32,665 --> 02:09:35,534
SUBJECT AND TO MINIMIZE THE 

2927
02:09:35,534 --> 02:09:37,770
IMPACT OF A POTENTIAL 

2928
02:09:37,770 --> 02:09:38,738
RESEARCHER'S INHERENT CONFLICT 

2929
02:09:38,738 --> 02:09:46,812
OF INTEREST IN THEIR OWN WORK.

2930
02:09:46,812 --> 02:09:48,114
INTERESTINGLY I'M VERY 

2931
02:09:48,114 --> 02:09:53,586
INTERESTED IN IRBs AS THE TOPIC 

2932
02:09:53,586 --> 02:09:56,989
OF RESEARCH AND I HAVE QUESTIONS

2933
02:09:56,989 --> 02:10:01,227
IN TERMS OF THE WORK THAT I DO 

2934
02:10:01,227 --> 02:10:06,332
BUT MANY YEARS AGO NOW IT WAS 

2935
02:10:06,332 --> 02:10:09,635
NOTED UNQUESTIONABLY THERE'S THE

2936
02:10:09,635 --> 02:10:11,404
EXISTENCE OF IRB HAS TEMPERED 

2937
02:10:11,404 --> 02:10:16,175
THE PROPENSITY OF RESEARCHERS TO

2938
02:10:16,175 --> 02:10:19,612
PURSUE INVESTIGATIONS WITHOUT 

2939
02:10:19,612 --> 02:10:20,546
DISPASSIONATELY WEIGHING THE 

2940
02:10:20,546 --> 02:10:22,214
RISK THEY'RE ASKING OTHER TO 

2941
02:10:22,214 --> 02:10:26,419
ASSUME OR FULLY INFORMING 

2942
02:10:26,419 --> 02:10:27,119
SUBJECTS.

2943
02:10:27,119 --> 02:10:30,456
THE MERE EXISTENCE SAY BIT OF A 

2944
02:10:30,456 --> 02:10:32,158
DETERRENT FOR ROGUE 

2945
02:10:32,158 --> 02:10:33,025
INVESTIGATORS TO EVEN ANTICIPATE

2946
02:10:33,025 --> 02:10:37,196
OR COME UP WITH A PROJECT THAT 

2947
02:10:37,196 --> 02:10:42,735
MIGHT PUT HUMAN SUBJECTS AT A 

2948
02:10:42,735 --> 02:10:44,870
HIGHER RISK AND IF THEY DID 

2949
02:10:44,870 --> 02:10:46,138
PROPOSE SOMETHING LIKE THAT PART

2950
02:10:46,138 --> 02:10:49,675
OF THE IRB IS TO ASSUME THE RISK

2951
02:10:49,675 --> 02:10:51,410
AND BENEFITS ARE APPROPRIATELY 

2952
02:10:51,410 --> 02:10:52,678
BALANCED.

2953
02:10:52,678 --> 02:10:55,614
SO HERE'S THE SORT OF ESSENTIAL 

2954
02:10:55,614 --> 02:10:56,549
CONFLICT OF INTEREST.

2955
02:10:56,549 --> 02:11:01,353
YOU'RE AN INVESTIGATOR, YOU 

2956
02:11:01,353 --> 02:11:03,289
THINK HOLY COW THIS MAY BE A 

2957
02:11:03,289 --> 02:11:05,091
CURE FOR CONDITION A, B OR C.

2958
02:11:05,091 --> 02:11:06,926
BY DEFINITION OF BEING A HUMAN 

2959
02:11:06,926 --> 02:11:08,761
YOU'LL HAVE A LOT OF FAITH IN 

2960
02:11:08,761 --> 02:11:12,064
YOUR OWN THINKING ABOUT IT AND 

2961
02:11:12,064 --> 02:11:13,933
JUSTIFICATION FOR DOING THE 

2962
02:11:13,933 --> 02:11:14,433
RESEARCH.

2963
02:11:14,433 --> 02:11:17,570
SO THE IRB THERE IS TO HELP 

2964
02:11:17,570 --> 02:11:20,206
TEMPER THAT CONFLICT OF 

2965
02:11:20,206 --> 02:11:20,473
INTEREST.

2966
02:11:20,473 --> 02:11:22,842
THE EXCITE YOU SHOULD BE EXCITED

2967
02:11:22,842 --> 02:11:24,810
ABOUT YOUR RESEARCH BUT THE IRBs

2968
02:11:24,810 --> 02:11:26,445
ROLE IS TO PERHAPS TEMPER SOME 

2969
02:11:26,445 --> 02:11:30,049
OF THAT EXCITE MANY.

2970
02:11:30,049 --> 02:11:30,549
-- EXCITEMENT.

2971
02:11:30,549 --> 02:11:32,017
THE IRB SAYS THIS LOOKS LIKE 

2972
02:11:32,017 --> 02:11:32,651
EXCITING WORK.

2973
02:11:32,651 --> 02:11:35,421
LET'S MAKE SURE THE PLAN IS 

2974
02:11:35,421 --> 02:11:36,689
SCIENTIFICALLY SOUND AND 

2975
02:11:36,689 --> 02:11:38,457
APPROPRIATELY PROTECTS THE 

2976
02:11:38,457 --> 02:11:38,691
SUBJECT.

2977
02:11:38,691 --> 02:11:40,025
ESSENTIALLY THAT'S WHAT THE JOB 

2978
02:11:40,025 --> 02:11:41,260
OF THE IRB IS.

2979
02:11:41,260 --> 02:11:42,294
I'M GOING TO TALK A LITTLE BIT 

2980
02:11:42,294 --> 02:11:44,330
ABOUT THE ROLE, THE SCOPE AND 

2981
02:11:44,330 --> 02:11:47,533
RESPONSIBILITIES AND THE REVIEW 

2982
02:11:47,533 --> 02:11:49,902
ITSELF AND WE WILL HAVE AGAIN 01

2983
02:11:49,902 --> 02:11:54,874
MINUTES FOR DISCUSSION.

2984
02:11:54,874 --> 02:11:56,342
AS A SAID, THEIR JOB, THE JOB OF

2985
02:11:56,342 --> 02:11:58,277
THIS BODY OF INDIVIDUALS IS THE 

2986
02:11:58,277 --> 02:11:59,478
REVIEW AND OVERSIGHT OF HUMAN 

2987
02:11:59,478 --> 02:12:05,351
SUBJECT RESEARCH.

2988
02:12:05,351 --> 02:12:07,086
HERE IN THE UNITED STATES AT 

2989
02:12:07,086 --> 02:12:08,287
YOUR AVERAGE MEDICAL CENTER TRUE

2990
02:12:08,287 --> 02:12:11,624
AT THE NIH AS WELL, THE IRB, 

2991
02:12:11,624 --> 02:12:18,430
THAT COMMITTEE THAT REVIEWS IS 

2992
02:12:18,430 --> 02:12:20,699
ONE COMPONENT REFERRED TO AS THE

2993
02:12:20,699 --> 02:12:23,435
HUMAN PROTECTION PROGRAM OR SOME

2994
02:12:23,435 --> 02:12:23,669
VARIANT.

2995
02:12:23,669 --> 02:12:26,705
THERE'S AN INFRASTRUCTURE 

2996
02:12:26,705 --> 02:12:27,873
REVIEWING WHAT YOU SUBMIT BEFORE

2997
02:12:27,873 --> 02:12:29,642
IT ACTUALLY GETS TO THE IRB TO 

2998
02:12:29,642 --> 02:12:33,512
MAKE SURE THAT ALL THE 

2999
02:12:33,512 --> 02:12:34,079
APPROPRIATE ADMINISTRATIVE 

3000
02:12:34,079 --> 02:12:36,315
COMPONENTS ARE IN PLACE.

3001
02:12:36,315 --> 02:12:37,950
FOR EXAMPLE, WAS THERE 

3002
02:12:37,950 --> 02:12:39,652
SCIENTIFIC REVIEW?

3003
02:12:39,652 --> 02:12:42,054
IF THERE WAS, PLEASE POST THAT 

3004
02:12:42,054 --> 02:12:42,788
IN YOUR APPLICATION.

3005
02:12:42,788 --> 02:12:47,326
WAS IT REVIEWED BY THE BIO 

3006
02:12:47,326 --> 02:12:47,793
SAFETY COMMITTEE?

3007
02:12:47,793 --> 02:12:49,662
DID YOU INCLUDE YOUR CONSENT 

3008
02:12:49,662 --> 02:12:50,696
FORM?

3009
02:12:50,696 --> 02:12:51,430
ETCETERA, ETCETERA.

3010
02:12:51,430 --> 02:12:52,698
SOME THINGS NEED TO BE PART OF 

3011
02:12:52,698 --> 02:12:55,835
THE PROPOSAL BEFORE IT GETS TO 

3012
02:12:55,835 --> 02:13:00,206
THE IRB THE GROUP NEEDS TO MAKE 

3013
02:13:00,206 --> 02:13:00,639
SURE.

3014
02:13:00,639 --> 02:13:04,376
THIS IS THE REGULATIONS -- OOPS,

3015
02:13:04,376 --> 02:13:08,714
IRBs NEED A MINIMUM OF FIVE 

3016
02:13:08,714 --> 02:13:13,752
MEMBERS AND AMONG THOSE MEMBERS 

3017
02:13:13,752 --> 02:13:15,988
ONE NEEDS TO BE UNAFFILIATED 

3018
02:13:15,988 --> 02:13:17,256
WITH THE INSTITUTION AND ONE 

3019
02:13:17,256 --> 02:13:24,363
NEEDS TO BE A NON SCIENTIST.

3020
02:13:24,363 --> 02:13:27,633
SOMETIMES IRBs HAS ONE PERSON 

3021
02:13:27,633 --> 02:13:28,500
WHO MEETS BOTH.

3022
02:13:28,500 --> 02:13:30,603
BY DEFINITION THEY'RE OFTEN IN 

3023
02:13:30,603 --> 02:13:31,036
THE MINORITY.

3024
02:13:31,036 --> 02:13:36,275
THEY'RE OFTEN LARGER THAN FIVE 

3025
02:13:36,275 --> 02:13:42,314
A

3026
02:13:42,314 --> 02:13:43,649
AND CHALLENGING IN BEING A ROOM 

3027
02:13:43,649 --> 02:13:47,419
OF SCIENTISTS BUT A KEY ROLE.

3028
02:13:47,419 --> 02:13:49,021
ACROSS THE GLOBE AS THE 

3029
02:13:49,021 --> 02:13:51,957
DIFFERENT VERSIONS.

3030
02:13:51,957 --> 02:13:55,060
IN NEW ZEALAND MY FAVORITE IRB 

3031
02:13:55,060 --> 02:13:57,663
MEMBERSHIP RULE IS THERE ALWAYS 

3032
02:13:57,663 --> 02:14:00,866
HAS TO BE ONE MORE NON-SCIENTIST

3033
02:14:00,866 --> 02:14:01,267
THAN SCIENTIST.

3034
02:14:01,267 --> 02:14:02,268
IT MEANS THEY HAVE A BIG PLACE 

3035
02:14:02,268 --> 02:14:07,339
AT THE TABLE AND I THINK THERE 

3036
02:14:07,339 --> 02:14:12,211
SHOULD BE MORE REGULAR OLD 

3037
02:14:12,211 --> 02:14:13,846
VOICES AT THE TABLE.

3038
02:14:13,846 --> 02:14:15,514
REGULATIONS DON'T REQUIRE THAT.

3039
02:14:15,514 --> 02:14:17,750
I SAY THEY SHOULD BE CLINICAL.

3040
02:14:17,750 --> 02:14:19,919
WE HAVE AN INTERESTING SETUP OF 

3041
02:14:19,919 --> 02:14:22,488
ONE ENORMOUS GROUP OF PEOPLE WHO

3042
02:14:22,488 --> 02:14:25,124
SERVE ON THE IRBs.

3043
02:14:25,124 --> 02:14:26,625
THE IRB MEETS FOUR OR FIVE TIMES

3044
02:14:26,625 --> 02:14:33,499
A WEEK AND AT LEAST FIVE PEOPLE 

3045
02:14:33,499 --> 02:14:38,570
ARE SLOTTED INTO THOSE MEETINGS 

3046
02:14:38,570 --> 02:14:44,777
AND AS THE LOCAL AND IT CAN VAR 

3047
02:14:44,777 --> 02:14:46,245
VARY IN THE REVIEW.

3048
02:14:46,245 --> 02:14:47,980
AS LONG AS THE VARIABILITY IS 

3049
02:14:47,980 --> 02:14:52,017
NOT EXPOSING PEOPLE TO TOO MUCH 

3050
02:14:52,017 --> 02:14:57,389
RISK OR APPROVING POORLY 

3051
02:14:57,389 --> 02:15:02,461
REVIEWED RESEARCH, WE'RE HOPING 

3052
02:15:02,461 --> 02:15:04,263
WE'RE SOMEWHERE IN THE MIDDLE 

3053
02:15:04,263 --> 02:15:04,797
AND IRBs CONSIDER THINGS 

3054
02:15:04,797 --> 02:15:07,800
DIFFERENTLY.

3055
02:15:07,800 --> 02:15:10,069
SOME OF THE CHALLENGES.

3056
02:15:10,069 --> 02:15:12,905
ONE I MENTIONED THERE'S A 

3057
02:15:12,905 --> 02:15:14,707
CONFLICT OF INTEREST.

3058
02:15:14,707 --> 02:15:17,309
SO THINK ABOUT THE FOLLOWING.

3059
02:15:17,309 --> 02:15:19,478
LET'S SAY WE'RE AT BIG 

3060
02:15:19,478 --> 02:15:22,881
UNIVERSITY A AND THE IRB IS MADE

3061
02:15:22,881 --> 02:15:26,819
UP OF FACULTY MEMBERS FROM BIG 

3062
02:15:26,819 --> 02:15:28,954
UNIVERSITY A AND INCLUDES AT 

3063
02:15:28,954 --> 02:15:30,389
LEAST ONE PERSON NOT FROM 

3064
02:15:30,389 --> 02:15:31,357
UNIVERSITY A.

3065
02:15:31,357 --> 02:15:33,592
UNIVERSITY A RELIES IN PART FOR 

3066
02:15:33,592 --> 02:15:35,995
THEIR BUDGETING ON THE GRANT 

3067
02:15:35,995 --> 02:15:36,562
DOLLARS THAT COME INTO THAT 

3068
02:15:36,562 --> 02:15:39,498
INSTITUTION.

3069
02:15:39,498 --> 02:15:42,534
SO THOSE PEOPLE AROUND THE TABLE

3070
02:15:42,534 --> 02:15:44,303
KNOW THAT THE RESEARCH THEY'RE 

3071
02:15:44,303 --> 02:15:48,674
REVIEWING HAS LIKELY ALREADY 

3072
02:15:48,674 --> 02:15:50,042
BEEN FUNDED IF THEY DON'T 

3073
02:15:50,042 --> 02:15:50,843
APPROVE IT THE DOLLARS DON'T 

3074
02:15:50,843 --> 02:15:56,648
COME TO THE INSTITUTION.

3075
02:15:56,648 --> 02:15:57,850
I THINK THAT'S A POTENTIAL 

3076
02:15:57,850 --> 02:15:59,018
CONFLICT OF INTEREST AND IT 

3077
02:15:59,018 --> 02:16:00,452
DOESN'T MEAN IT'S DOING A BAD 

3078
02:16:00,452 --> 02:16:01,820
JOB BUT WE NEED TO ACKNOWLEDGE 

3079
02:16:01,820 --> 02:16:07,459
THAT THAT MIGHT BE THE CASE AND 

3080
02:16:07,459 --> 02:16:09,028
THAT INSTITUTIONS HAVE HIGH 

3081
02:16:09,028 --> 02:16:10,829
STAKES WHEN THINKING ABOUT HOW 

3082
02:16:10,829 --> 02:16:11,797
ALL THESE PIECES OF THEIR 

3083
02:16:11,797 --> 02:16:13,966
INSTITUTION FIT TOGETHER.

3084
02:16:13,966 --> 02:16:15,801
YOU CAN ALSO HAVE AN INDIVIDUAL 

3085
02:16:15,801 --> 02:16:16,935
CONFLICT OF INTEREST.

3086
02:16:16,935 --> 02:16:19,638
SO IF I'M SITTING ON THE IRB AND

3087
02:16:19,638 --> 02:16:22,641
A CO-INVESTIGATOR OF MINE ON 

3088
02:16:22,641 --> 02:16:25,144
ANOTHER PROJECT SUBMITS AS 

3089
02:16:25,144 --> 02:16:26,311
PRINCIPLE INVESTIGATOR A PROJECT

3090
02:16:26,311 --> 02:16:28,113
THEY WANT TO HAVE REVIEWED BY 

3091
02:16:28,113 --> 02:16:30,849
THE IRB, I MIGHT HAVE TO SAY, 

3092
02:16:30,849 --> 02:16:35,154
I'VE GOT TO STEP OUT BECAUSE I 

3093
02:16:35,154 --> 02:16:36,288
HAVE A VERY CLEAR PROFESSIONAL 

3094
02:16:36,288 --> 02:16:37,489
RELATIONSHIP WITH THIS PERSON.

3095
02:16:37,489 --> 02:16:39,992
I'M PRETTY SURE IT'S NOT GOING 

3096
02:16:39,992 --> 02:16:42,327
TO INFLUENCE MY DECISION OR MY 

3097
02:16:42,327 --> 02:16:43,262
DISCUSSION HERE BUT JUST TO BE 

3098
02:16:43,262 --> 02:16:45,364
ON THE SAFE SIDE I'M GOING TO 

3099
02:16:45,364 --> 02:16:46,632
STEP OUT.

3100
02:16:46,632 --> 02:16:48,400
OTHER CHALLENGES ARE BASICALLY 

3101
02:16:48,400 --> 02:16:50,836
THE CULTURE OF IRBs.

3102
02:16:50,836 --> 02:16:54,673
SOME IRBs HAVE BEEN TOGETHER FOR

3103
02:16:54,673 --> 02:17:00,212
10 YEARS, 15 YEARS.

3104
02:17:00,212 --> 02:17:04,283
THEY MIGHT START TO HAVE GROUP 

3105
02:17:04,283 --> 02:17:07,653
THINK AND IF THERE'S A STRONG 

3106
02:17:07,653 --> 02:17:10,589
CHAIR THE GROUP MY START TO CEDE

3107
02:17:10,589 --> 02:17:11,590
TO THE CHAIR'S DECISION.

3108
02:17:11,590 --> 02:17:13,892
IT'S IMPORTANT TO THINK WITH THE

3109
02:17:13,892 --> 02:17:16,795
FACT THAT THERE ARE SOME 

3110
02:17:16,795 --> 02:17:18,297
CHALLENGES IN HAVING AN 

3111
02:17:18,297 --> 02:17:23,936
INDEPENDENT REVIEW.

3112
02:17:23,936 --> 02:17:27,739
BUT AS THE FIRST QUOTE SAID ONE 

3113
02:17:27,739 --> 02:17:30,175
MIGHT ARGUE MERELY HAVING THE 

3114
02:17:30,175 --> 02:17:32,244
GROUP IS AT LEAST HELPING ENSURE

3115
02:17:32,244 --> 02:17:33,912
MOST RESEARCH THAT'S CONDUCTED 

3116
02:17:33,912 --> 02:17:34,480
PROTECTS THE HUMAN SUBJECTS 

3117
02:17:34,480 --> 02:17:41,086
INVOLVED.

3118
02:17:41,086 --> 02:17:42,788
I MENTIONED IN RESPONSE TO THE 

3119
02:17:42,788 --> 02:17:43,956
EARLIER QUESTIONS WHY DO YOU 

3120
02:17:43,956 --> 02:17:48,427
NEED AN IRB AT YOUR INSTITUTION?

3121
02:17:48,427 --> 02:17:51,630
THE REGULATION SAYS IF YOU ARE 

3122
02:17:51,630 --> 02:17:53,465
RECEIVING FEDERAL FUNDS MOST 

3123
02:17:53,465 --> 02:17:55,334
PLACES DO THESE DAYS, YOU HAVE 

3124
02:17:55,334 --> 02:17:59,638
TO REVIEW NOT ONLY THE RESEARCH 

3125
02:17:59,638 --> 02:18:05,777
THAT'S FEDERALLY FUNDED BUT SO 

3126
02:18:05,777 --> 02:18:07,980
IF I'M AT AN INSTITUTION, MY 

3127
02:18:07,980 --> 02:18:10,616
PROJECT IS FUNDED BY THE GATES 

3128
02:18:10,616 --> 02:18:11,550
FOUNDATION, NOT BY THE FEDERAL 

3129
02:18:11,550 --> 02:18:13,852
GOVERNMENT BECAUSE I'M 

3130
02:18:13,852 --> 02:18:16,488
AFFILIATED WITH AN ACADEMIC 

3131
02:18:16,488 --> 02:18:17,556
MEDICAL CENTER RECEIVING FEDERAL

3132
02:18:17,556 --> 02:18:19,625
FUNDS I'M HELD TO THE SAME 

3133
02:18:19,625 --> 02:18:19,892
STANDARD.

3134
02:18:19,892 --> 02:18:20,559
I HAVE TO SUBMIT MY PROTOCOL FOR

3135
02:18:20,559 --> 02:18:26,098
REVIEW.

3136
02:18:26,098 --> 02:18:27,633
THOUGH GATES IS ALSO GOING TO 

3137
02:18:27,633 --> 02:18:30,335
REQUIRE THAT REVIEW.

3138
02:18:30,335 --> 02:18:32,738
MOST LARGE NONPROFITS SAY OF 

3139
02:18:32,738 --> 02:18:35,607
COURSE YOU'LL GET A REVIEW AND 

3140
02:18:35,607 --> 02:18:38,010
OVERSIGHT ONCE THE MONEY IS 

3141
02:18:38,010 --> 02:18:38,377
ALLOCATED.

3142
02:18:38,377 --> 02:18:41,113
AS I MENTIONED THE ALSO REQUIRES

3143
02:18:41,113 --> 02:18:43,115
IRB REVIEW.

3144
02:18:43,115 --> 02:18:44,750
ANY PHARMACEUTICAL COMPANY 

3145
02:18:44,750 --> 02:18:45,517
PRIVATE ACTOR WILL MAKE SURE 

3146
02:18:45,517 --> 02:18:47,853
THEIR RESEARCH IS REVIEWED WITH 

3147
02:18:47,853 --> 02:18:51,089
THE CAVEAT I MENTIONED EARLIER.

3148
02:18:51,089 --> 02:18:53,759
AS MENTIONED, THE WAY IN WHICH 

3149
02:18:53,759 --> 02:18:54,426
THE FEDERAL GOVERNMENT SET UP 

3150
02:18:54,426 --> 02:18:55,494
SOME REQUIREMENTS.

3151
02:18:55,494 --> 02:18:58,597
THE WAY THEY DO THAT IS THROUGH 

3152
02:18:58,597 --> 02:19:01,300
A FEDERAL WIDE ASSURANCE.

3153
02:19:01,300 --> 02:19:04,903
EACH IRB, EACH LOCAL IRB HAS TO 

3154
02:19:04,903 --> 02:19:05,904
LITERALLY ASSURE THE FEDERAL 

3155
02:19:05,904 --> 02:19:10,709
GOVERNMENT THAT THEY ARE GOING 

3156
02:19:10,709 --> 02:19:14,746
TO REVIEW ALL RESEARCH ACCORDING

3157
02:19:14,746 --> 02:19:19,318
TO CFR4546 ALSO POSTED IN CANVAS

3158
02:19:19,318 --> 02:19:21,887
IF YOU'D LIKE TO REVIEW IT AND 

3159
02:19:21,887 --> 02:19:23,622
THEY'LL REVIEW IT REGARDLESS OF 

3160
02:19:23,622 --> 02:19:25,691
FUNDING MECHANISM AND FOLLOW THE

3161
02:19:25,691 --> 02:19:28,293
PRINCIPLES OF BELMONT AND FOLLOW

3162
02:19:28,293 --> 02:19:31,230
INTERNATIONALLY RECOGNIZED 

3163
02:19:31,230 --> 02:19:31,496
STANDARD.

3164
02:19:31,496 --> 02:19:33,198
FOR EXAMPLE IF IT'S A 

3165
02:19:33,198 --> 02:19:34,933
NON-U.S. IRB WHO CAN ALSO 

3166
02:19:34,933 --> 02:19:37,436
REGISTER FOR A FEDERAL WIDE 

3167
02:19:37,436 --> 02:19:38,804
ASSURANCE WITH THE 

3168
02:19:38,804 --> 02:19:42,241
U.S. GOVERNMENT THEY'LL FOLLOW 

3169
02:19:42,241 --> 02:19:49,881
THE DECLARATION OF  HELSINKI AND

3170
02:19:49,881 --> 02:19:51,283
A WELL REGARDED SET OF 

3171
02:19:51,283 --> 02:19:51,817
REGULATIONS APPLIED MORE 

3172
02:19:51,817 --> 02:19:59,358
INTERNATIONALLY.

3173
02:19:59,358 --> 02:20:02,394
I'M SURE I HAVE WILL SECTIONS 

3174
02:20:02,394 --> 02:20:03,295
ASSIGNED FOR READING SO YOU'LL 

3175
02:20:03,295 --> 02:20:06,498
SEE THE CIOMS AGAIN.

3176
02:20:06,498 --> 02:20:08,734
CHRISTINE MENTIONED A SUBSET OF 

3177
02:20:08,734 --> 02:20:11,637
THE RESPONSIBILITIES IRBs HAVE.

3178
02:20:11,637 --> 02:20:13,872
MINIMIZING RISKS, MAKING SURE 

3179
02:20:13,872 --> 02:20:14,773
THEY'RE REMEMBER WHEN COMPARED 

3180
02:20:14,773 --> 02:20:22,681
TO BENEFIT, ETCETERA.

3181
02:20:22,681 --> 02:20:25,917
LITERALLY THIS IS ALL THE 

3182
02:20:25,917 --> 02:20:27,619
FEDERAL REGULATIONS SAY ABOUT 

3183
02:20:27,619 --> 02:20:29,454
THE REVIEW HENCE SOME LOCAL 

3184
02:20:29,454 --> 02:20:29,755
VARIABILITY.

3185
02:20:29,755 --> 02:20:31,623
THE BASIC GUIDELINES ARE THERE 

3186
02:20:31,623 --> 02:20:34,626
BUT IRBs INTERPRET THEM SLIGHTLY

3187
02:20:34,626 --> 02:20:35,160
DIFFERENTLY.

3188
02:20:35,160 --> 02:20:35,861
THERE'S A LOT OF ADDITIONAL 

3189
02:20:35,861 --> 02:20:38,497
CRITERIA THAT THE IRB MAY ALSO 

3190
02:20:38,497 --> 02:20:40,599
BE APPLYING.

3191
02:20:40,599 --> 02:20:41,800
LOCAL INSTITUTION POLICY.

3192
02:20:41,800 --> 02:20:42,801
THERE'S NIH GUIDELINES LIKE 

3193
02:20:42,801 --> 02:20:46,271
WE'LL TALK ABOUT THIS LATER IN 

3194
02:20:46,271 --> 02:20:47,639
THE CLASS.

3195
02:20:47,639 --> 02:20:48,974
INVESTIGATORS ARE HELD TO MAKE 

3196
02:20:48,974 --> 02:20:51,576
SURE WOMEN AND MEMBERS OF 

3197
02:20:51,576 --> 02:20:53,378
MINORITY POPULATIONS CHILDREN, 

3198
02:20:53,378 --> 02:20:56,782
AND OLDER ADULTS ARE INCLUDED IN

3199
02:20:56,782 --> 02:20:58,483
RESEARCH AND SO THE IRB OUGHT TO

3200
02:20:58,483 --> 02:21:01,520
BE THINKING ABOUT THAT WHEN 

3201
02:21:01,520 --> 02:21:02,921
REVIEWING THE RECRUITMENT PLAN 

3202
02:21:02,921 --> 02:21:04,022
FOR THE PROJECT.

3203
02:21:04,022 --> 02:21:06,325
FDA, REGULATION, STATE LAWS, 

3204
02:21:06,325 --> 02:21:08,760
NATIONAL COMMISSION 

3205
02:21:08,760 --> 02:21:09,394
RECOMMENDATIONS.

3206
02:21:09,394 --> 02:21:14,766
SO, AGAIN THE REGULATIONS GIVE 

3207
02:21:14,766 --> 02:21:17,502
THEM A VERY SPARSE OUTLINE AND 

3208
02:21:17,502 --> 02:21:19,738
THE IRBs THEN FILL THAT IN WITH 

3209
02:21:19,738 --> 02:21:22,240
ALL SORTS OF OTHER RESOURCES.

3210
02:21:22,240 --> 02:21:24,209
IRB'S REVIEW RESEARCH AND 

3211
02:21:24,209 --> 02:21:26,111
ACCORDING TO THE FEDERAL 

3212
02:21:26,111 --> 02:21:28,480
REGULATIONS, RESEARCH IS A 

3213
02:21:28,480 --> 02:21:29,214
SYSTEMATIC INVESTIGATION 

3214
02:21:29,214 --> 02:21:31,683
INCLUDING RESEARCH DEVELOPMENT 

3215
02:21:31,683 --> 02:21:33,518
TESTING AND EVALUATION DESIGNED 

3216
02:21:33,518 --> 02:21:36,021
TO CONTRIBUTE TO GENERALIZABLE 

3217
02:21:36,021 --> 02:21:36,288
KNOWLEDGE.

3218
02:21:36,288 --> 02:21:38,790
A QUICK SIDE NOTE AS SOMEONE WHO

3219
02:21:38,790 --> 02:21:40,859
DOESN'T DO QUALITATIVE RESEARCH 

3220
02:21:40,859 --> 02:21:42,127
IT DOESN'T MEAN WHEN I DO 

3221
02:21:42,127 --> 02:21:45,163
RESEARCH THAT I KNOW IS NOT 

3222
02:21:45,163 --> 02:21:46,231
GOING TO CONTRIBUTE TO 

3223
02:21:46,231 --> 02:21:46,898
GENERALIZABLE KNOWLEDGE I'M 

3224
02:21:46,898 --> 02:21:49,034
HOPING THAT THE KNOWLEDGE I 

3225
02:21:49,034 --> 02:21:51,403
GENERATE WILL BE TRANSFERRABLE 

3226
02:21:51,403 --> 02:21:54,106
TO OTHER SETTINGS SO OVER TIME 

3227
02:21:54,106 --> 02:21:59,211
REMEMBERING THESE WERE FIRST 

3228
02:21:59,211 --> 02:22:01,413
INTRODUCED BACK IN 1980, THEY 

3229
02:22:01,413 --> 02:22:04,750
HAVE NOT CHANGED MUCH SINCE.

3230
02:22:04,750 --> 02:22:06,651
THE WORLD OF RESEARCH HAS 

3231
02:22:06,651 --> 02:22:09,955
CHANGED QUITE A BIT IN THE 

3232
02:22:09,955 --> 02:22:10,789
INTERIM.

3233
02:22:10,789 --> 02:22:13,325
THERE'S SOME READING BETWEEN THE

3234
02:22:13,325 --> 02:22:15,460
LINES OR APPLYING BEYOND THE 

3235
02:22:15,460 --> 02:22:20,399
LETTER OF THE LAW AS IT WERE.

3236
02:22:20,399 --> 02:22:23,268
AND THERE'S IRBs IN CHARGE OF 

3237
02:22:23,268 --> 02:22:25,470
TELLING YOU WHETHER OR NOT 

3238
02:22:25,470 --> 02:22:26,138
YOU'RE RESEARCH FITS INTO ONE OF

3239
02:22:26,138 --> 02:22:30,409
THE CATEGORIES.

3240
02:22:30,409 --> 02:22:31,810
THERE'S SOME REASON THE IRB ONCE

3241
02:22:31,810 --> 02:22:34,146
YOU SUBMIT THE PROPOSAL SAY THIS

3242
02:22:34,146 --> 02:22:36,515
IS NOT HUMAN SUBJECT RESEARCH.

3243
02:22:36,515 --> 02:22:38,917
SO FOR EXAMPLE IF YOU WERE GOING

3244
02:22:38,917 --> 02:22:41,520
TO BE DOING LET'S SAY I'M GOING 

3245
02:22:41,520 --> 02:22:45,724
TO BE DOING AN AMOUSE SURVEY OF 

3246
02:22:45,724 --> 02:22:46,825
WHATEVER EVERYBODY ORDERED AT 

3247
02:22:46,825 --> 02:22:49,961
THE -- ANONYMOUS ORDER OF WHAT 

3248
02:22:49,961 --> 02:22:51,563
EVERYBODY ORDERED AT THE COFFEE 

3249
02:22:51,563 --> 02:22:52,431
BAR TODAY.

3250
02:22:52,431 --> 02:22:54,566
THAT'S NOT REALLY HUMAN SUBJECT 

3251
02:22:54,566 --> 02:22:54,833
RESEARCH.

3252
02:22:54,833 --> 02:22:56,935
I'M JUST ASKING SOME QUESTIONS 

3253
02:22:56,935 --> 02:23:01,807
ABOUT HOW MAYBE I WANT TO RUN MY

3254
02:23:01,807 --> 02:23:03,942
COFFEE HOUSE.

3255
02:23:03,942 --> 02:23:06,578
IF I SUBMITTED A PROPOSAL TO THE

3256
02:23:06,578 --> 02:23:09,014
IRB THEY'D SAY, HOLLY, YOU KNOW 

3257
02:23:09,014 --> 02:23:10,615
THAT'S NOT HUMAN SUBJECT 

3258
02:23:10,615 --> 02:23:11,650
RESEARCH.

3259
02:23:11,650 --> 02:23:15,454
ANOTHER CATEGORY THAT THERE ARE 

3260
02:23:15,454 --> 02:23:16,855
EIGHT CRITERIA FOR ARE EXEMPT 

3261
02:23:16,855 --> 02:23:18,590
FROM IRB REVIEW THOUGH THE 

3262
02:23:18,590 --> 02:23:20,759
EXEMPT IS A LITTLE TRICKY.

3263
02:23:20,759 --> 02:23:23,595
SO IF YOUR PROJECT MEETS ONE OF 

3264
02:23:23,595 --> 02:23:24,963
THE EIGHT CRITERIA AND THERE'S 

3265
02:23:24,963 --> 02:23:27,566
NO MORE THAN MINIMAL RISK, 

3266
02:23:27,566 --> 02:23:29,201
YOU'RE RESEARCH IS EXEMPT FROM 

3267
02:23:29,201 --> 02:23:31,636
IRB REVIEW BUT YOU STILL HAVE TO

3268
02:23:31,636 --> 02:23:33,538
SUBMIT A PROPOSAL FOR WHAT 

3269
02:23:33,538 --> 02:23:37,209
YOU'RE PLANNING TO DO SO THE IRB

3270
02:23:37,209 --> 02:23:40,779
CAN DETERMINE THAT IT'S EXEMPT.

3271
02:23:40,779 --> 02:23:42,214
SO WE AS INVESTIGATORS CAN'T 

3272
02:23:42,214 --> 02:23:43,648
MAKE THAT DECISION.

3273
02:23:43,648 --> 02:23:44,549
WE HAVE TO LET THE IRB MAKE THAT

3274
02:23:44,549 --> 02:23:49,054
DECISION.

3275
02:23:49,054 --> 02:23:51,890
TWO OTHER CATEGORIES, EXPEDITED 

3276
02:23:51,890 --> 02:23:53,358
AND FULL COMMITTEE REVIEW.

3277
02:23:53,358 --> 02:23:56,628
SO EXPEDITED RESEARCH IS 

3278
02:23:56,628 --> 02:23:59,231
RESEARCH THAT'S NOT EXEMPT WHEN 

3279
02:23:59,231 --> 02:24:01,533
THERE IS NO MORE THAN MINIMAL 

3280
02:24:01,533 --> 02:24:03,368
RISK AND IT DOESN'T HAVE TO GO 

3281
02:24:03,368 --> 02:24:04,603
TO THE FULL COMMITTEE.

3282
02:24:04,603 --> 02:24:07,272
IT CAN BE REVIEWED BY A 

3283
02:24:07,272 --> 02:24:07,873
CHAIRPERSON OR AN EXPERIENCED 

3284
02:24:07,873 --> 02:24:11,042
REVIEWER.

3285
02:24:11,042 --> 02:24:14,779
YOU MIGHT THINK EXPEDITED MEANS 

3286
02:24:14,779 --> 02:24:15,013
QUICKER.

3287
02:24:15,013 --> 02:24:16,214
DOESN'T ALWAYS MEAN THAT.

3288
02:24:16,214 --> 02:24:21,653
IT DOES MEAN THAT THE PROCESS IS

3289
02:24:21,653 --> 02:24:23,788
BRIEFER PERHAPS BUT IT DOESN'T 

3290
02:24:23,788 --> 02:24:25,156
ALWAYS MEAN FASTER.

3291
02:24:25,156 --> 02:24:28,627
THE FINAL CATEGORY IS FULL 

3292
02:24:28,627 --> 02:24:31,096
COMMITTEE REVIEW.

3293
02:24:31,096 --> 02:24:34,266
SO IT IS GOING TO BE MORE THAN 

3294
02:24:34,266 --> 02:24:35,166
MINIMAL RISK.

3295
02:24:35,166 --> 02:24:36,535
ANY RESEARCH THAT EXPOSES A 

3296
02:24:36,535 --> 02:24:38,837
HUMAN SUBJECT TO MORE THAN 

3297
02:24:38,837 --> 02:24:41,239
MINIMAL RISK HAS TO BE REVIEWED 

3298
02:24:41,239 --> 02:24:42,340
BY A FULL COMMITTEE.

3299
02:24:42,340 --> 02:24:45,210
THERE'S EXCEPTIONS TO THIS.

3300
02:24:45,210 --> 02:24:47,379
I'LL GIVE A QUICK EXAMPLE.

3301
02:24:47,379 --> 02:24:52,984
I DID RESEARCH WITH A FELLOW 

3302
02:24:52,984 --> 02:24:55,620
LAST YEAR WHERE WE DID AN 

3303
02:24:55,620 --> 02:24:57,556
ANONYMOUS SURVEY OF PARTICIPANTS

3304
02:24:57,556 --> 02:24:58,890
ABOUT THEIR EXPERIENCE WITH 

3305
02:24:58,890 --> 02:25:06,898
COVID VACCINATION.

3306
02:25:06,898 --> 02:25:08,033
WOULD BE EXEMPT IF OUR SUBJECTS 

3307
02:25:08,033 --> 02:25:11,803
WERE ADULTS BUT THEY WERE UNDER 

3308
02:25:11,803 --> 02:25:13,605
18 THEREFORE CHIRP IN THE EYES 

3309
02:25:13,605 --> 02:25:14,606
OF THE REGULATION.

3310
02:25:14,606 --> 02:25:16,775
NO MORE THAN MINIMAL RISK BUT WE

3311
02:25:16,775 --> 02:25:22,347
HAD TO SUBMIT THAT FOR EXPEDITED

3312
02:25:22,347 --> 02:25:22,747
REVIEW.

3313
02:25:22,747 --> 02:25:23,381
THERE'S LITTLE EXCEPTION AND IF 

3314
02:25:23,381 --> 02:25:27,319
YOU HAVE A QUESTION, ASK YOUR 

3315
02:25:27,319 --> 02:25:30,455
REVIEW COMMITTEE ALWAYS IN MY 

3316
02:25:30,455 --> 02:25:33,091
OPINION BETTER TO UNDERSTAND 

3317
02:25:33,091 --> 02:25:35,093
WHAT THE EXPECTATION IS SO 

3318
02:25:35,093 --> 02:25:36,194
YOU'RE NOT DISAPPOINTED WHEN 

3319
02:25:36,194 --> 02:25:38,530
THEY SAY, HOLLY YOU SAID THIS IS

3320
02:25:38,530 --> 02:25:38,763
EXEMPT.

3321
02:25:38,763 --> 02:25:39,464
IT'S NOT.

3322
02:25:39,464 --> 02:25:41,232
YOU HAVE TO SUBMIT A FULL 

3323
02:25:41,232 --> 02:25:46,137
PROPOSAL BECAUSE IT'S EXPEDITED,

3324
02:25:46,137 --> 02:25:46,404
ETCETERA.

3325
02:25:46,404 --> 02:25:48,039
A LITTLE ABOUT THE REVIEW 

3326
02:25:48,039 --> 02:25:48,273
PROCESS.

3327
02:25:48,273 --> 02:25:49,140
THERE'S THE INITIAL 

3328
02:25:49,140 --> 02:25:51,543
ADMINISTRATIVE REVIEW OF THE 

3329
02:25:51,543 --> 02:25:54,245
RESEARCH PLAN, CONSENT 

3330
02:25:54,245 --> 02:25:55,814
DOCUMENTS.

3331
02:25:55,814 --> 02:26:06,358
IF YOU'RE GOING TO ADVERTISE THE

3332
02:26:07,626 --> 02:26:09,561
NEEDS TO REVIEW IT.

3333
02:26:09,561 --> 02:26:11,596
I HAVE THIS DIAGRAM BECAUSE I'M 

3334
02:26:11,596 --> 02:26:13,698
GOING TO SHOW YOU IT AGAIN.

3335
02:26:13,698 --> 02:26:17,168
IF YOU THINK ABOUT THAT HUMAN 

3336
02:26:17,168 --> 02:26:17,769
RESEARCH PROTECTION PROGRAM 

3337
02:26:17,769 --> 02:26:20,772
THERE'S AN OFFICE IN CHARGE OF 

3338
02:26:20,772 --> 02:26:22,507
ADMINISTRATIVE REVIEW, 

3339
02:26:22,507 --> 02:26:25,343
COORDINATING ANCILLARY REVIEWS 

3340
02:26:25,343 --> 02:26:26,544
THE RESEARCH IS ALSO GOING 

3341
02:26:26,544 --> 02:26:28,146
THROUGH AND THEN THE GREEN BOX 

3342
02:26:28,146 --> 02:26:30,782
IS TO REPRESENT THE IRB.

3343
02:26:30,782 --> 02:26:31,650
THAT'S THE HUMAN SUBJECTS 

3344
02:26:31,650 --> 02:26:40,425
REVIEW.

3345
02:26:40,425 --> 02:26:42,127
WHEN THE IRB GETS TOGETHER THERE

3346
02:26:42,127 --> 02:26:43,928
SHOULD BE SOME DELIBERATION 

3347
02:26:43,928 --> 02:26:45,463
ABOUT THE PROJECT.

3348
02:26:45,463 --> 02:26:47,198
THERE'S GOING TO BE A 

3349
02:26:47,198 --> 02:26:50,368
PRESENTATION VIA PRIMARY OR 

3350
02:26:50,368 --> 02:26:52,303
SECONDARY REVIEWER.

3351
02:26:52,303 --> 02:26:52,937
HOPEFULLY THERE'S DISCUSSION 

3352
02:26:52,937 --> 02:26:54,539
ABOUT KEY ETHICAL CONCERNS AND 

3353
02:26:54,539 --> 02:26:56,775
THEN THERE'S A DECISION.

3354
02:26:56,775 --> 02:26:59,644
APPROVAL, APPROVAL WITH SOME 

3355
02:26:59,644 --> 02:27:02,347
SORT OF STIPULATION OR 

3356
02:27:02,347 --> 02:27:02,781
CONDITION.

3357
02:27:02,781 --> 02:27:05,316
IF THERE'S A COUPLE BIG THINGS 

3358
02:27:05,316 --> 02:27:07,686
PROBLEMATIC IT MIGHT BE DEFERRED

3359
02:27:07,686 --> 02:27:10,221
OR DISAPPROVED.

3360
02:27:10,221 --> 02:27:13,625
AND DISAPPROVAL IS VERY RARE IN 

3361
02:27:13,625 --> 02:27:15,994
MY EXPERIENCE OF VIEWING MANY 

3362
02:27:15,994 --> 02:27:18,329
MANY PROPOSALS.

3363
02:27:18,329 --> 02:27:19,597
STIPULATION IS THE MOST COMMON 

3364
02:27:19,597 --> 02:27:26,037
THING AN IRB IS GOING TO DO.

3365
02:27:26,037 --> 02:27:30,241
THEY MIGHT APPROVE IT AS IS BUT 

3366
02:27:30,241 --> 02:27:31,743
IN MY EXPERIENCE THAT'S ALSO 

3367
02:27:31,743 --> 02:27:37,682
RELATIVELY RARE.

3368
02:27:37,682 --> 02:27:39,984
SO AFTER THAT INITIAL REVIEW, 

3369
02:27:39,984 --> 02:27:42,420
THE IRB IS ALSO RESPONSIBLE FOR 

3370
02:27:42,420 --> 02:27:44,389
CONTINUING REVIEW OF PROPOSALS 

3371
02:27:44,389 --> 02:27:45,557
THAT WENT TO THE FULL COMMITTEE 

3372
02:27:45,557 --> 02:27:48,293
FOR REVIEW.

3373
02:27:48,293 --> 02:27:51,196
SO NOT THE EXPEDITED, NOT THE 

3374
02:27:51,196 --> 02:27:52,464
EXEMPT BUT ALL THAT RESEARCH 

3375
02:27:52,464 --> 02:27:55,800
THAT WAS REVIEWED INITIALLY IF 

3376
02:27:55,800 --> 02:27:59,037
IT'S CONTINUING, IT'S NOT JUST A

3377
02:27:59,037 --> 02:28:04,509
ONE AND DONE AS IT WERE, YOU'RE 

3378
02:28:04,509 --> 02:28:06,377
REQUIRED TO GIVE AT LEAST AN 

3379
02:28:06,377 --> 02:28:08,012
ANNUAL UPDATE TO THE IRB.

3380
02:28:08,012 --> 02:28:11,616
THE IRB HAS THE WHEREWITHAL TO 

3381
02:28:11,616 --> 02:28:12,650
ASK YOU TO COME BACK MORE 

3382
02:28:12,650 --> 02:28:12,951
FREQUENTLY.

3383
02:28:12,951 --> 02:28:15,420
THEY CAN SAY, YOU KNOW WHAT, 

3384
02:28:15,420 --> 02:28:17,188
THIS IS FIRST IN HUMAN.

3385
02:28:17,188 --> 02:28:17,789
REALLY INTERESTING NOVEL 

3386
02:28:17,789 --> 02:28:18,056
TREATMENT.

3387
02:28:18,056 --> 02:28:19,924
WE WANT TO SEE THIS AFTER SIX 

3388
02:28:19,924 --> 02:28:21,960
MONTHS BECAUSE WE JUST WANT TO 

3389
02:28:21,960 --> 02:28:24,963
SEE HOW IT'S GOING AND HOW THE 

3390
02:28:24,963 --> 02:28:25,864
RESEARCH IS ACCRUING PATIENTS, 

3391
02:28:25,864 --> 02:28:27,432
ETCETERA.

3392
02:28:27,432 --> 02:28:29,400
YOU ALSO NEED TO GO BACK TO THE 

3393
02:28:29,400 --> 02:28:31,136
IRB IF YOU HAVE AN AMENDMENT.

3394
02:28:31,136 --> 02:28:35,240
MAYBE YOU WANT TO ADD A NEW 

3395
02:28:35,240 --> 02:28:38,143
ADVERTISEMENT OR YOU WANT TO 

3396
02:28:38,143 --> 02:28:38,943
EXPAND YOUR POPULATION BECAUSE 

3397
02:28:38,943 --> 02:28:41,379
IT'S PRETTY CLEAR YOU'RE NOT 

3398
02:28:41,379 --> 02:28:43,648
GOING TO BE ABLE TO MEET THE 

3399
02:28:43,648 --> 02:28:45,383
NUMBER THAT YOU HAD BECAUSE A 

3400
02:28:45,383 --> 02:28:48,219
LOT OF PEOPLE ARE DROPPING OUT.

3401
02:28:48,219 --> 02:28:50,388
ANYTHING LIKE THAT EVEN IF 

3402
02:28:50,388 --> 02:28:54,292
SOMEONE ON YOUR TEAM IS A 

3403
02:28:54,292 --> 02:28:54,959
LEADING INSTITUTION YOU HAVE TO 

3404
02:28:54,959 --> 02:28:56,795
AMEND YOUR PROTOCOL AND 

3405
02:28:56,795 --> 02:28:58,763
IMPORTANTLY YOU NEED TO REPORT 

3406
02:28:58,763 --> 02:29:02,367
TO THE IRB ANY ADVERSE EVENTS 

3407
02:29:02,367 --> 02:29:02,934
THAT OCCURRED.

3408
02:29:02,934 --> 02:29:05,937
THOSE ARE -- UNLESS THEY ARE 

3409
02:29:05,937 --> 02:29:08,273
SEVERE ADVERSE EVENTS WHERE YOU 

3410
02:29:08,273 --> 02:29:09,841
HAVE TO REPORT THEM RIGHT AWAY 

3411
02:29:09,841 --> 02:29:10,875
YOU REPORT THOSE TO THE IRB ON 

3412
02:29:10,875 --> 02:29:15,013
AN ANNUAL BASIS.

3413
02:29:15,013 --> 02:29:16,447
I'M GOING TO BRIEFLY TALK ABOUT 

3414
02:29:16,447 --> 02:29:19,751
THE SINGLE IRB OF RECORD POLICY 

3415
02:29:19,751 --> 02:29:26,791
HERE IN THE UNITED STATES.

3416
02:29:26,791 --> 02:29:34,499
OVER TEENS IN THE 2000s THERE 

3417
02:29:34,499 --> 02:29:37,502
WAS FEEDBACK REQUESTED, NEW 

3418
02:29:37,502 --> 02:29:42,707
DRAFTS, ETCETERA, THAT RESULTED 

3419
02:29:42,707 --> 02:29:49,180
IN TWO POLICIES ABOUT IS THE USE

3420
02:29:49,180 --> 02:29:52,150
OF AN IRB FOR SINGLE SITE 

3421
02:29:52,150 --> 02:29:52,784
RESEARCH.

3422
02:29:52,784 --> 02:29:55,787
ALL RESEARCH FUND THE NIH IF 

3423
02:29:55,787 --> 02:29:58,089
IT'S MULTISITE IT HAS TO BE 

3424
02:29:58,089 --> 02:30:00,725
REVIEWED BY A SINGLE IRB AND A 

3425
02:30:00,725 --> 02:30:02,026
COUPLE YEARS LATER WAS ADOPTED 

3426
02:30:02,026 --> 02:30:07,365
INTO THE REVISION OF THE COMMON 

3427
02:30:07,365 --> 02:30:07,765
RULE.

3428
02:30:07,765 --> 02:30:13,771
SO NOW ANY RESEARCH FUND 

3429
02:30:13,771 --> 02:30:17,242
RESEARCH AND HUMAN SERVICES 

3430
02:30:17,242 --> 02:30:20,778
INCLUDING THE NIH HAS TO DO A 

3431
02:30:20,778 --> 02:30:22,113
SINGLE IRB WHEN DOING MULTI-SITE

3432
02:30:22,113 --> 02:30:23,715
RESEARCH.

3433
02:30:23,715 --> 02:30:26,784
I'M BRINGING BACK MY DIAGRAM.

3434
02:30:26,784 --> 02:30:31,956
IF YOU WERE DOING A RESEARCH 

3435
02:30:31,956 --> 02:30:33,791
PROJECT WHERE YOU HAD MULTIPLE 

3436
02:30:33,791 --> 02:30:38,096
CENTERS AND IMAGINE AN ONCOLOGY 

3437
02:30:38,096 --> 02:30:39,697
TRIAL WITH 39 DIFFERENT SITES.

3438
02:30:39,697 --> 02:30:42,567
BEFORE THIS POLICY YOU HAD THE 

3439
02:30:42,567 --> 02:30:48,172
OPTION OF USING A SINGLE IRB BUT

3440
02:30:48,172 --> 02:30:52,543
IT WAS NOT COMMON.

3441
02:30:52,543 --> 02:31:01,753
EVERY SITE PLANNING TO APPROVE 

3442
02:31:01,753 --> 02:31:07,525
TO APPROVE PATIENTS AND AND FIVE

3443
02:31:07,525 --> 02:31:09,227
IRBs WOULD REVIEW THE SITE AND 

3444
02:31:09,227 --> 02:31:12,797
IF THERE'S A COORDINATING CENTER

3445
02:31:12,797 --> 02:31:14,232
THERE WOULD ALSO BE A REVIEW 

3446
02:31:14,232 --> 02:31:17,035
THERE AND GET A TOTAL OF SIX IRB

3447
02:31:17,035 --> 02:31:17,268
REVIEWS.

3448
02:31:17,268 --> 02:31:20,104
NOT SURPRISINGLY, THIS WAS 

3449
02:31:20,104 --> 02:31:21,272
FRUSTRATING TO INVESTIGATORS, 

3450
02:31:21,272 --> 02:31:24,475
LOTS OF EMPIRICAL EVIDENCE THAT 

3451
02:31:24,475 --> 02:31:29,514
MULTIPLE REVIEWS MEANT LOTS OF 

3452
02:31:29,514 --> 02:31:32,317
TIME A QUICK IRB CAN GET IT DONE

3453
02:31:32,317 --> 02:31:33,451
IN JANUARY AND THEN ONE IN MAY 

3454
02:31:33,451 --> 02:31:41,459
AND JULY AND AUGUST.

3455
02:31:41,459 --> 02:31:43,294
IF YOU WANT TO FACILITATE THE 

3456
02:31:43,294 --> 02:31:44,162
CONDUCT OF HIGH QUALITY RESEARCH

3457
02:31:44,162 --> 02:31:49,934
THAT WAS A GRAY AREA.

3458
02:31:49,934 --> 02:31:52,337
 THIS IS WHAT HAPPENS AFTER THE 

3459
02:31:52,337 --> 02:31:52,570
POLICY.

3460
02:31:52,570 --> 02:31:53,871
I MOVED THE LITTLE GREEN BOX TO 

3461
02:31:53,871 --> 02:31:55,473
THE COORDINATING CENTER.

3462
02:31:55,473 --> 02:32:00,545
THE COORDINATING CENTER MIGHT BE

3463
02:32:00,545 --> 02:32:04,382
ONE OF THE ACADEMIC MEDICAL 

3464
02:32:04,382 --> 02:32:04,615
CENTERS.

3465
02:32:04,615 --> 02:32:06,651
ONE CAN SELF-DESIGNATE AS THE 

3466
02:32:06,651 --> 02:32:08,152
SINGLE IRB OF REPORT OR THE 

3467
02:32:08,152 --> 02:32:10,321
GROUP COULD DECIDE TO GO TO A 

3468
02:32:10,321 --> 02:32:13,958
COMMERCIAL IRB OF WHICH THERE 

3469
02:32:13,958 --> 02:32:15,593
ARE A COUPLE IN THE UNITED 

3470
02:32:15,593 --> 02:32:21,566
STATES THESE DAYS.

3471
02:32:21,566 --> 02:32:23,001
THERE'S ONE SINGLE IRB REVIEW 

3472
02:32:23,001 --> 02:32:25,169
AND IT GOES OUT TO THE OTHER 

3473
02:32:25,169 --> 02:32:25,970
FIVE SITES AND THAT'S THE REVIEW

3474
02:32:25,970 --> 02:32:34,946
OF RECORD.

3475
02:32:34,946 --> 02:32:36,881
BUT IT DOESN'T MEAN THEY'RE NOT 

3476
02:32:36,881 --> 02:32:39,484
RESPONSIBLE FOR THE ANCILLARY 

3477
02:32:39,484 --> 02:32:39,917
REVIEWS.

3478
02:32:39,917 --> 02:32:43,488
DID IT GO THROUGH THE BIO SAFETY

3479
02:32:43,488 --> 02:32:43,755
COMMITTEE?

3480
02:32:43,755 --> 02:32:46,190
DID IT GO THROUGH THE GROUP 

3481
02:32:46,190 --> 02:32:50,795
REVIEWING THE PHARMACEUTICAL AND

3482
02:32:50,795 --> 02:32:52,130
TREATMENT GROUP?

3483
02:32:52,130 --> 02:32:53,598
WHAT IS THE RELATIONSHIP WITH 

3484
02:32:53,598 --> 02:32:55,266
GRANTS AND CONTRACTS.

3485
02:32:55,266 --> 02:32:58,703
WHILE THE GOAL WAS TO FACILITATE

3486
02:32:58,703 --> 02:33:00,805
THE REVIEW AND APPROVAL, THERE'S

3487
02:33:00,805 --> 02:33:02,573
STILL A LOT GOING ON AT THAT 

3488
02:33:02,573 --> 02:33:06,144
LOCAL SITE THAT NEEDS TO HAPPEN 

3489
02:33:06,144 --> 02:33:11,449
AND THE POLICY HAS BEEN IN PLACE

3490
02:33:11,449 --> 02:33:15,753
NOW JUST A COUPLE YEARS.

3491
02:33:15,753 --> 02:33:17,722
THERE'S ONGOING EMPIRICAL 

3492
02:33:17,722 --> 02:33:19,390
RESEARCH AND PROBABLY WON'T BE 

3493
02:33:19,390 --> 02:33:21,459
CLEAR FOR A NUMBER OF YEARS 

3494
02:33:21,459 --> 02:33:22,693
WHETHER THE POLICY HAS HAD THE 

3495
02:33:22,693 --> 02:33:24,395
EFFECT OF STREAMLINING THE 

3496
02:33:24,395 --> 02:33:29,500
REVIEW AND APPROVAL OF RESEARCH.

3497
02:33:29,500 --> 02:33:31,536
THE GOAL WAS CLEARLY TO EXPEDITE

3498
02:33:31,536 --> 02:33:34,405
THAT REVIEW BECAUSE THE MULTIPLE

3499
02:33:34,405 --> 02:33:35,440
REVIEWS WERE SLOWING THINGS 

3500
02:33:35,440 --> 02:33:35,640
DOWN.

3501
02:33:35,640 --> 02:33:40,878
TO BE DETERMINED.

3502
02:33:40,878 --> 02:33:41,946
A QUICK SIDE NOTE.

3503
02:33:41,946 --> 02:33:44,315
I'LL SAY I'M A BIG PROPONENT OF 

3504
02:33:44,315 --> 02:33:47,618
WHAT I'LL CALL EMPIRICALLY 

3505
02:33:47,618 --> 02:33:51,355
INFORMED POLICY.

3506
02:33:51,355 --> 02:33:56,494
PRIOR TO THE SINGLE IRB RECORD 

3507
02:33:56,494 --> 02:33:57,962
POLICY THERE WAS NO EMPIRICAL 

3508
02:33:57,962 --> 02:34:00,965
EVIDENCE THIS SYSTEM WOULD BE 

3509
02:34:00,965 --> 02:34:02,366
MORE EFFICIENT THAN THE 

3510
02:34:02,366 --> 02:34:03,601
TRADITIONAL SYSTEM.

3511
02:34:03,601 --> 02:34:05,670
IF YOU HAD ASKED ME I MIGHT HAVE

3512
02:34:05,670 --> 02:34:10,074
FUNDED SOME SORT OF 

3513
02:34:10,074 --> 02:34:10,842
DEMONSTRATION PROJECTS TO 

3514
02:34:10,842 --> 02:34:13,144
DETERMINE HOW THIS WAS ALL GOING

3515
02:34:13,144 --> 02:34:14,979
TO WORK OUT BEFORE IT BECAME A 

3516
02:34:14,979 --> 02:34:15,546
NATIONAL POLICY.

3517
02:34:15,546 --> 02:34:21,619
BECAUSE IRBs ARE LOCAL, YOU CAN 

3518
02:34:21,619 --> 02:34:26,691
IMAGINE THAT THERE'S A LOT OF 

3519
02:34:26,691 --> 02:34:28,392
HETEROGENEITY BUT I'M NOT THE 

3520
02:34:28,392 --> 02:34:29,293
BENEVOLENT DICTATOR SO THEY 

3521
02:34:29,293 --> 02:34:39,537
DIDN'T ASK ME.

3522
02:34:42,773 --> 02:34:44,408
IRBs HAVE REGULATIONS TO FOLLOW 

3523
02:34:44,408 --> 02:34:50,481
AND THEY'RE LOCAL AND IF YOU 

3524
02:34:50,481 --> 02:34:55,219
EVER HAVE A QUESTION THEY'RE THE

3525
02:34:55,219 --> 02:34:56,621
PEOPLE TO ASK AND NOW WE HAVE 10

3526
02:34:56,621 --> 02:34:57,488
MINUTES FOR QUESTIONS AND I LOVE

3527
02:34:57,488 --> 02:35:07,832
TO ANSWER QUESTIONS.

3528
02:35:18,342 --> 02:35:20,111
>> I WANTED TO ASK ABOUT
THIS 

3529
02:35:20,111 --> 02:35:22,480
LOCAL AND AUTONOMOUS COMPONENT.

3530
02:35:22,480 --> 02:35:27,485
SO I WAS HOPING YOU COULD TELL 

3531
02:35:27,485 --> 02:35:28,419
US A LITTLE BIT MORE ABOUT WHY 

3532
02:35:28,419 --> 02:35:30,555
THEY'RE SET UP THIS WAY AND 

3533
02:35:30,555 --> 02:35:32,790
WHETHER OR NOT YOU THINK IT'S A 

3534
02:35:32,790 --> 02:35:34,325
GOOD IDEA FOR THEM TO BE SET UP 

3535
02:35:34,325 --> 02:35:43,634
THIS WAY GIVEN THERE'S OTHERWISE

3536
02:35:43,634 --> 02:35:45,236
A LOT OF FEDERAL REGULATION OR 

3537
02:35:45,236 --> 02:35:46,237
INTERNATIONAL AGREEMENT HOW THEY

3538
02:35:46,237 --> 02:35:47,605
OUGHT TO BE SET UP.

3539
02:35:47,605 --> 02:35:48,639
>> GREAT QUESTION.

3540
02:35:48,639 --> 02:35:50,308
INTERESTINGLY ENOUGH IF YOU LOOK

3541
02:35:50,308 --> 02:35:52,743
BACK AT THE ORIGINAL POLICY THAT

3542
02:35:52,743 --> 02:35:56,781
WAS PLANNED TO BE IMPLEMENTED --

3543
02:35:56,781 --> 02:35:59,884
SO ANOTHER QUICK REVIEW AND TIME

3544
02:35:59,884 --> 02:36:00,585
LINE.

3545
02:36:00,585 --> 02:36:02,987
WE HAD TUSKEGEE SYPHILIS STUDY 

3546
02:36:02,987 --> 02:36:05,389
AND THE NATIONAL COMMISSION IN 

3547
02:36:05,389 --> 02:36:08,693
1974, BELMONT REPORT IN 1978.

3548
02:36:08,693 --> 02:36:14,765
AFTER 1978 THE BELMONT REPORT 

3549
02:36:14,765 --> 02:36:16,434
WAS BASICALLY TRANSFORMED INTO A

3550
02:36:16,434 --> 02:36:19,870
SET OF REGULATIONS WE HAVE 

3551
02:36:19,870 --> 02:36:20,271
TODAY.

3552
02:36:20,271 --> 02:36:21,105
ONE OF THE THINGS THAT WERE IN 

3553
02:36:21,105 --> 02:36:23,608
THE FIRST SET OF REGULATIONS -- 

3554
02:36:23,608 --> 02:36:27,612
THIS WAS IN THE LATE '70s SAID 

3555
02:36:27,612 --> 02:36:28,913
ISHAK DEMOCRATIC MEDICAL 

3556
02:36:28,913 --> 02:36:32,216
INSTITUTIONS HAVE A CHOICE.

3557
02:36:32,216 --> 02:36:35,186
THEY CAN EITHER SET UP THEIR OWN

3558
02:36:35,186 --> 02:36:36,587
LIKAL IRB ACCORDING TO THE 

3559
02:36:36,587 --> 02:36:40,157
FEDERAL REGULATIONS AND LET US 

3560
02:36:40,157 --> 02:36:40,791
KNOW, THE FEDERAL GOVERNMENT 

3561
02:36:40,791 --> 02:36:41,826
GOVERNMENT THAT'S WHAT THEY'RE 

3562
02:36:41,826 --> 02:36:44,128
DOING OR SEND ALL THEIR RESEARCH

3563
02:36:44,128 --> 02:36:44,695
TO A FEDERAL GOVERNMENT FOR 

3564
02:36:44,695 --> 02:36:50,401
REVIEW.

3565
02:36:50,401 --> 02:36:55,206
IT MIGHT HAVE BEEN FEASIBLE IN 

3566
02:36:55,206 --> 02:36:55,573
1979.

3567
02:36:55,573 --> 02:36:59,310
CLEARLY NOT FEASIBLE TO MANY AND

3568
02:36:59,310 --> 02:37:05,283
IT MEANT THAT IN ORDER FOR THE 

3569
02:37:05,283 --> 02:37:11,222
RESEARCH TO BE REVIEWED 

3570
02:37:11,222 --> 02:37:12,290
SYSTEMATICALLY IT HAD TO BE SENT

3571
02:37:12,290 --> 02:37:13,524
DOWN TO THE LOCAL INSTITUTION.

3572
02:37:13,524 --> 02:37:15,860
IT COULD HAVE BEEN AT THAT POINT

3573
02:37:15,860 --> 02:37:18,429
THEY SAID, INTERESTING, YOU 

3574
02:37:18,429 --> 02:37:20,264
KNOW, THERE'S CONFLICTS OF 

3575
02:37:20,264 --> 02:37:22,933
INTEREST THAT MAY BE EMBEDDED IN

3576
02:37:22,933 --> 02:37:23,734
AN INSTITUTIONAL REVIEW BOARD 

3577
02:37:23,734 --> 02:37:25,036
THAT'S LOCAL.

3578
02:37:25,036 --> 02:37:31,642
MAYBE WE CAN HAVE REGIONAL IRBs 

3579
02:37:31,642 --> 02:37:42,186
OR ONE THEY ALL USE THAT ADHERES

3580
02:37:43,487 --> 02:37:44,088
TO THE FEDERAL GOVERNMENT'S 

3581
02:37:44,088 --> 02:37:47,625
REGULATIONS BUT WE END YOU HAD 

3582
02:37:47,625 --> 02:37:48,959
UP WHERE WE ARE TODAY WHERE EACH

3583
02:37:48,959 --> 02:37:49,760
INSTITUTION IS LOCAL AND ADOPTS 

3584
02:37:49,760 --> 02:37:56,767
THEIR OWN APPROACH.

3585
02:37:56,767 --> 02:37:58,669
THEY HAVE MUCH MORE IN COMMON 

3586
02:37:58,669 --> 02:38:01,439
THAN THEY DON'T HAVE IN COMMON.

3587
02:38:01,439 --> 02:38:07,378
AS I MENTIONED, THERE'S 

3588
02:38:07,378 --> 02:38:07,945
EMPIRICAL EVIDENCE IN THE 

3589
02:38:07,945 --> 02:38:10,981
LITERATURE THAT OUR GUEST 

3590
02:38:10,981 --> 02:38:13,150
LECTURER IN A COUPLE DAYS ON THE

3591
02:38:13,150 --> 02:38:13,884
INCLUSION OF CHILDREN IN 

3592
02:38:13,884 --> 02:38:16,787
RESEARCH WHILE SHE WAS A FELLOW 

3593
02:38:16,787 --> 02:38:19,490
HERE OR ON FACULTY SHE SENT OUT 

3594
02:38:19,490 --> 02:38:23,594
A SURVEY TO IRB CHAIRS AND SAID 

3595
02:38:23,594 --> 02:38:26,063
HERE'S RAY LIST OF A BUNCH OF 

3596
02:38:26,063 --> 02:38:28,532
PROCEDURES THAT MIGHT BE 

3597
02:38:28,532 --> 02:38:29,166
PROPOSED IN A PROJECT INCLUDING 

3598
02:38:29,166 --> 02:38:33,204
CHILDREN.

3599
02:38:33,204 --> 02:38:38,776
BLOOD DRAW, FISCAL, LUMBAR 

3600
02:38:38,776 --> 02:38:43,781
PUNCTURE, SKIN BIOPSY, 

3601
02:38:43,781 --> 02:38:45,015
GASTROINTESTINAL BIOPSY.

3602
02:38:45,015 --> 02:38:48,085
YOU, IRB CHAIR TELL US HOW YOUR 

3603
02:38:48,085 --> 02:38:50,654
IRB WOULD DESIGNATE ANY OF THESE

3604
02:38:50,654 --> 02:38:53,357
AS MINIMAL RISK OR MORE THAN 

3605
02:38:53,357 --> 02:38:54,325
MINIMAL RISK.

3606
02:38:54,325 --> 02:38:57,194
YOU CAN GUESS WHERE THE OUTCOME 

3607
02:38:57,194 --> 02:38:57,795
IS.

3608
02:38:57,795 --> 02:38:59,630
THERE WAS VARIABILITY.

3609
02:38:59,630 --> 02:39:01,098
SO WHILE EVERYBODY SAID A BLOOD 

3610
02:39:01,098 --> 02:39:05,169
DRAW WAS NO MORE THAN MINIMAL 

3611
02:39:05,169 --> 02:39:07,738
RISK SOME SAID A LUMBAR PUNCTURE

3612
02:39:07,738 --> 02:39:11,609
WAS NO MORE THAN MINIMAL RISK.

3613
02:39:11,609 --> 02:39:14,278
THE HETEROGENEITY MATTERS IF WE,

3614
02:39:14,278 --> 02:39:15,579
WHO ARE INTERESTED IN WHO IS 

3615
02:39:15,579 --> 02:39:18,516
BEING EXPOSED TO RESEARCH, THAT 

3616
02:39:18,516 --> 02:39:20,751
IT AIRS ON THE SIDE OF EXPOSING 

3617
02:39:20,751 --> 02:39:22,153
HUMAN SUBJECTS TO MORE RISK THAN

3618
02:39:22,153 --> 02:39:23,821
THEY WOULD BE EXPOSED TO 

3619
02:39:23,821 --> 02:39:27,625
OTHERWISE.

3620
02:39:27,625 --> 02:39:32,997
AND AS FAR AS I KNOW THERE'S NO 

3621
02:39:32,997 --> 02:39:36,200
EVIDENCE CLEAR EVIDENCE THAT 

3622
02:39:36,200 --> 02:39:43,474
THAT HETEROGENEITY LEADS TO 

3623
02:39:43,474 --> 02:39:46,210
UNACCEPTABLE HARMS AND ONE THING

3624
02:39:46,210 --> 02:39:50,147
THE SINGLE IRB REVIEW MIGHT 

3625
02:39:50,147 --> 02:39:53,484
REMEDY IS THAT IF THE SINGLE IRB

3626
02:39:53,484 --> 02:39:57,121
SAYS OH, GOSH, LUMBAR PUNCTURES 

3627
02:39:57,121 --> 02:39:59,356
ARE MORE THAN MINIMAL RISK AND 

3628
02:39:59,356 --> 02:40:00,858
THERE'S GENERAL AGREEMENT THE 

3629
02:40:00,858 --> 02:40:01,859
CENTERS THEY'RE BEHOLDEN TOO 

3630
02:40:01,859 --> 02:40:02,760
HAVE TO FOLLOW THE SAME 

3631
02:40:02,760 --> 02:40:08,766
GUIDELINE.

3632
02:40:08,766 --> 02:40:17,241
SO SOME WOULD ARGUE IRBs ARE 

3633
02:40:17,241 --> 02:40:19,610
CONSERVATIVE AND TOO CAREFUL AND

3634
02:40:19,610 --> 02:40:21,745
AN ADMINISTRATIVE BARRIER AND 

3635
02:40:21,745 --> 02:40:24,114
IMAGINE THE ADVANCES WE WOULD 

3636
02:40:24,114 --> 02:40:25,583
MAKE IF THEY WEREN'T SO STRICT 

3637
02:40:25,583 --> 02:40:26,684
ABOUT PROTECTING HUMAN SUBJECTS 

3638
02:40:26,684 --> 02:40:36,861
FROM RISK.

3639
02:40:38,829 --> 02:40:41,131
THERE'S VALUE IN KNOWLEDGE AND 

3640
02:40:41,131 --> 02:40:42,566
CURING DISEASE AND MAKING 

3641
02:40:42,566 --> 02:40:44,768
SCIENTIFIC ADVANCES BUT YOU HAVE

3642
02:40:44,768 --> 02:40:46,971
THIS PRESSURE TO MINIMIZE THE 

3643
02:40:46,971 --> 02:40:49,874
POTENTIAL RISKS WHICH IS A GOOD 

3644
02:40:49,874 --> 02:40:50,140
THING.

3645
02:40:50,140 --> 02:40:51,575
AND BECAUSE WE TALKED ABOUT THE 

3646
02:40:51,575 --> 02:40:55,746
FACT THAT ALL THESE PLACE LOCAL,

3647
02:40:55,746 --> 02:40:59,583
YOU CAN IMAGINE WHY A LOCAL 

3648
02:40:59,583 --> 02:41:02,319
INSTITUTION MIGHT BE MORE 

3649
02:41:02,319 --> 02:41:03,621
CONSERVATIVE IN ERRING ON THE 

3650
02:41:03,621 --> 02:41:07,157
SIDE OF NOT PUSHING THE 

3651
02:41:07,157 --> 02:41:07,424
ENVELOPE.

3652
02:41:07,424 --> 02:41:09,159
THERE'S A HISTORY IN THE REVIEW 

3653
02:41:09,159 --> 02:41:11,395
OF HUMAN SUBJECT RESEARCH WHERE 

3654
02:41:11,395 --> 02:41:13,430
A NUMBER OF INSTITUTIONS WERE 

3655
02:41:13,430 --> 02:41:17,601
CLOSED DOWN FOR A VARIETY OF 

3656
02:41:17,601 --> 02:41:19,003
REASONS ACADEMIC MEDICAL 

3657
02:41:19,003 --> 02:41:19,703
CENTERS, DUKE, JOHNS HOPKINS, 

3658
02:41:19,703 --> 02:41:24,808
ETCETERA.

3659
02:41:24,808 --> 02:41:26,143
THAT'S A RISK THEY REALLY WANT 

3660
02:41:26,143 --> 02:41:28,746
TO AVOID.

3661
02:41:28,746 --> 02:41:29,947
THERE'S A LOT OF DIFFERENT 

3662
02:41:29,947 --> 02:41:35,619
PIECES OF THE PUZZLE THAT NEED 

3663
02:41:35,619 --> 02:41:39,523
TO BE PUT TOGETHER.

3664
02:41:39,523 --> 02:41:41,959
IT MAY BE TRUE IF WE EXPOSED 

3665
02:41:41,959 --> 02:41:43,627
HUMANS TO MORE RISK WE'D MAKE 

3666
02:41:43,627 --> 02:41:53,904
FASTER PROGRESS.

3667
02:41:59,677 --> 02:42:02,947
SOME OF YOU LEARNED IN THE NIH 

3668
02:42:02,947 --> 02:42:04,582
ORIENTATION THE VAST MAJORITY OF

3669
02:42:04,582 --> 02:42:05,883
RESEARCH OR ONE BIG CHUNK OF 

3670
02:42:05,883 --> 02:42:07,284
RESEARCH THAT HAPPENS HERE AT 

3671
02:42:07,284 --> 02:42:11,221
THE CLINICAL CENTER IS PHASE 1 

3672
02:42:11,221 --> 02:42:11,488
RESEARCH.

3673
02:42:11,488 --> 02:42:13,591
IT'S THE OPPOSITE IN THE WORLD 

3674
02:42:13,591 --> 02:42:16,660
THE AT ACADEMIC MEDICAL CENTER 

3675
02:42:16,660 --> 02:42:18,862
AND DO LESS PHASE 1 RESEARCH AND

3676
02:42:18,862 --> 02:42:24,401
MORE PHASE 2 AND PHASE 3 

3677
02:42:24,401 --> 02:42:24,802
RESEARCH.

3678
02:42:24,802 --> 02:42:32,676
SO THERE ARE REASONS WHY 

3679
02:42:32,676 --> 02:42:34,278
CALCULUS IS COMPLICATED AN 

3680
02:42:34,278 --> 02:42:36,146
PLACES LIKE THE CLINICAL CENTER 

3681
02:42:36,146 --> 02:42:40,017
CAN SORT OF AFFORD PUSHING THE 

3682
02:42:40,017 --> 02:42:42,920
ENVELOPE IN A WAY AN ACADEMIC 

3683
02:42:42,920 --> 02:42:43,754
MEDICAL INSTITUTE AND CENTER MAY

3684
02:42:43,754 --> 02:42:47,625
NOT BE WILLING TO.

3685
02:42:47,625 --> 02:42:49,460
THAT'S THE BALANCE WE HAVE IN 

3686
02:42:49,460 --> 02:42:49,827
MAKING PROGRESS.

3687
02:42:49,827 --> 02:43:00,004
CAROLINE.

3688
02:43:07,778 --> 02:43:11,649
>> I'M WONDERING HOW YOU
DEFINE 

3689
02:43:11,649 --> 02:43:14,084
IRB COMMITTEES BEING 

3690
02:43:14,084 --> 02:43:16,487
CONSERVATIVE BECAUSE THEY SEEM 

3691
02:43:16,487 --> 02:43:18,288
TO APPROVE THE VAST MAJORITY OF 

3692
02:43:18,288 --> 02:43:27,297
APPLICATIONS.

3693
02:43:27,297 --> 02:43:31,635
THE VAST MAJORITY OF RESEARCH AN

3694
02:43:31,635 --> 02:43:34,772
IRB REVIEWS IS EVENTUALLY 

3695
02:43:34,772 --> 02:43:35,572
APPRESSED.

3696
02:43:35,572 --> 02:43:36,507
THERE'S A CONDITION THE 

3697
02:43:36,507 --> 02:43:38,776
INVESTIGATOR HAS TO FIX.

3698
02:43:38,776 --> 02:43:43,881
WHAT I MEAN BY CONSERVATIVE IS 

3699
02:43:43,881 --> 02:43:46,950
THAT IF THEY REVIEW A PROTOCOL 

3700
02:43:46,950 --> 02:43:49,853
WHERE THERE'S CONCERN ABOUT 

3701
02:43:49,853 --> 02:43:52,189
RISKS, THEY MAY FOCUS ON HOW THE

3702
02:43:52,189 --> 02:43:53,791
INVESTIGATOR OUGHT TO MINIMIZE 

3703
02:43:53,791 --> 02:43:59,063
THOSE RISKS AND PUSH THE 

3704
02:43:59,063 --> 02:44:00,531
INVESTIGATOR TO DROP PARTICULAR 

3705
02:44:00,531 --> 02:44:05,903
ASPECTS OF THE PROTOCOL TO MAKE 

3706
02:44:05,903 --> 02:44:09,273
SURE THEY ARE PROTECTING 

3707
02:44:09,273 --> 02:44:10,441
SUBJECTS FROM THE MOST EXTREME 

3708
02:44:10,441 --> 02:44:20,417
RISK THEY MAY BE EXPOSED TO.

3709
02:44:20,417 --> 02:44:22,619
AND INVESTIGATORS KNOW THIS AND 

3710
02:44:22,619 --> 02:44:26,924
KNOW IRBs WILL NOT BE OPEN TO 

3711
02:44:26,924 --> 02:44:27,891
APPROVING RESEARCH THAT MIGHT 

3712
02:44:27,891 --> 02:44:29,593
PUSH THE ENVELOPE IN A 

3713
02:44:29,593 --> 02:44:31,161
PARTICULAR WAY.

3714
02:44:31,161 --> 02:44:32,730
SO IT KIND OF FEEDS ON ITSELF.

3715
02:44:32,730 --> 02:44:38,769
WHAT I MEAN BY CONSERVATIVE IS 

3716
02:44:38,769 --> 02:44:41,905
BEING VERY CAREFUL IN MAKING 

3717
02:44:41,905 --> 02:44:43,207
SURE THE POTENTIAL DIRECT 

3718
02:44:43,207 --> 02:44:44,842
BENEFITS TO THE SUBJECTS, THE 

3719
02:44:44,842 --> 02:44:46,510
BENEFIT TO FUTURE PATIENTS.

3720
02:44:46,510 --> 02:44:48,445
THE BENEFITS OF THE LARGER 

3721
02:44:48,445 --> 02:44:52,583
POPULATION IS IN BALANCE WITH 

3722
02:44:52,583 --> 02:44:54,084
THE POTENTIAL RISK THEY'RE 

3723
02:44:54,084 --> 02:44:58,956
EXPOSING THE SUBJECTS TO.

3724
02:44:58,956 --> 02:44:59,757
GREAT, IT'S 11:30.

3725
02:44:59,757 --> 02:45:02,760
THANK YOU FOR ATTENDING IN 

3726
02:45:02,760 --> 02:45:05,629
PERSON FOR THOSE WHO MADE THE 

3727
02:45:05,629 --> 02:45:05,863
TREK.

3728
02:45:05,863 --> 02:45:07,664
WE'LL NOT MEET HERE NEXT WEEK.

3729
02:45:07,664 --> 02:45:09,199
WE'LL MEET IN BUILDING 31.

3730
02:45:09,199 --> 02:45:10,601
I'M GOING SHARE DIRECTIONS WITH 

3731
02:45:10,601 --> 02:45:12,770
OUR FELLOWS.

3732
02:45:12,770 --> 02:45:16,173
I'M HAPPY TO SHARE THEM WITH YOU

3733
02:45:16,173 --> 02:45:16,607
AS WELL.

3734
02:45:16,607 --> 02:45:18,208
COME UP AND PUT YOUR E-MAIL 

3735
02:45:18,208 --> 02:45:20,244
ADDRESS OR SEND ME AN E-MAIL AND

3736
02:45:20,244 --> 02:45:23,280
I'LL SEND THEM BACK TO YOU.

3737
02:45:23,280 --> 02:45:31,622
MY E-MAIL IS STRAIGHTFORWARD, 

3738
02:45:31,622 --> 02:45:32,523
HOLLY.TAYLOR2@NIH.gov.

3739
02:45:32,523 --> 02:45:36,393
YOU CAN REACH OUT TO THE 

3740
02:45:36,393 --> 02:45:37,694
BIOETHICS INQUIRY AND IT WILL GO

3741
02:45:37,694 --> 02:45:38,862
TO CONNOR AND WE'LL MAKE SURE 

3742
02:45:38,862 --> 02:45:39,630
YOU GET DIRECTIONS.

3743
02:45:39,630 --> 02:45:49,807
THANK YOU.