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SO, WELCOME TO THE THIRD 

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SESSION OF ETHICAL AND 

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REGULATORY ASPECTS OF CLINICAL 

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RESEARCH.

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I'M HOLLY, YOU MAY RECOGNIZE ME 

6
00:00:16,450 --> 00:00:18,485
FROM THE FIRST TWO SESSIONS.

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TODAY, I'M GOING TO START WITH 

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00:00:21,221 --> 00:00:23,991
THE RELATIVELY BRIEF LECTURE ON 

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STUDY DESIGN AND THEN DAVE 

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WENDLER FROM OUR DEPARTMENT IS 

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GOING TO JOIN US IN-PERSON AND 

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THEN SEEMA  SHAH IS GOING TO 

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JOIN US BY SOON.

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IF YOU HAVE SELF ENROLLED BUT 

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NOT SELF REGISTERED, PLEASE GO 

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AHEAD AND DO THAT ABOUT A 

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THOUSAND OF YOU HAVE 

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SELF-ENROLLED AND ABOUT 700 

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SELF REGISTERED.

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IF YOU WANT A CERTIFICATE YOU 

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NEED TO TAKE THED EXTRA STEP 

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AND SELF-REGISTER.

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AND FOR QUESTIONS TODAY I 

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CREATED A PLACE IN THE 

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DISCUSSION BOARD, PLEASE PUT 

26
00:01:03,797 --> 00:01:07,167
YOUR QUESTIONS THERE DURING THE 

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 LECTURE AS THAT'S THE EASIEST 

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WAY FOR MIRROR TO FIND THE 

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QUESTIONS.

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DISCLAIMER, GOOD STUDY DESIGN 

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IS KEY TO CONDUCTING ETHICAL 

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RESEARCH.

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THIS IS FROM, DOCUMENT FROM NOW 

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ALMOST QUITE A LONG TIME AGO, 

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BUT REMAINS TRUE.

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RESEARCHERS, US, HAVE A 

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FUNDAMENTAL OBLIGATION TO PLAN, 

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DESIGN AND CONDUCT STUDIES WITH 

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HONESTY, TRUTHFULNESS AND 

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INTEGRITY.

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VALUES HOW RESEARCHERS 

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INTERPRET THEIR WORK.

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SO I'M GOING TO SPEND A LITTLE 

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TIME ON THE FIRST TWO OF THESE 

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00:01:52,045 --> 00:01:52,646
CIRCLED ETHICAL REQUIREMENTS 

46
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TODAY.

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WE ALREADY COVERED INDEPENDENT 

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REVIEW BUT THAT'S SORT OF A KEY 

49
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COME POENT OF THE REVIEW OF THE 

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STUDY DESIGN.

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SO I'M JUST GOING TO GIVE US, 

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SOME BASICS, SO WE'RE REALLY 

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ALL ON THE SAME PAGE.

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SO THERE ARE BASICALLY, TWO 

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TYPES OF RESEARCH AND THIS IS A 

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LITTLE OVER SIMPLIFYING SO 

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YOU'LL SEE WHY I'M MAKING THE 

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DISTINCTIONS, THERE IS BASIC, 

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OBSERVIAL, YOU'RE OBSERVING AND 

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COLLECTING DATA.

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YOU CAN DO THAT RETROSPECTIVELY 

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LOOKING BACK FORWARDS OR 

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LOOKING FORWARD.

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RETROSPECTIVELY, MEANS THAT YOU 

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MAY LOOK AT MEDICAL CHARTS 

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MAYBE FIVE YEARS OF MEDICAL 

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CHARTS.

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EXPERIMENTAL INCLUDES SOME SORT 

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OF INTERVENTION AND ALMOST 

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ALWAYS PERSPECTIVE T WOULD BE 

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HARD TO DO A RETROSPECTIVE 

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TRIAL.

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NOW IN IF THAT VAOERMENT AL 

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DESIGN THERE ARE A COUPLE OF 

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THINGS THAT OFTEN HAPPEN, FIRST 

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THERE IS SOME SORT OF 

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MANIPULATION, CHANGING, 

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ARTIFICIALLY, WE'RE NOT 

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OBSERVING, WE'RE MANIPULATING 

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AT LEAST ONE VARIABLE.

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SOMETIMES THERE IS CONTROL, AND 

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YOU DO THAT IN ORDER TO REDUCE 

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THE LIKELIHOOD THAT EXTERNAL 

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FACTORS WILL INFLUENCE THE 

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00:03:25,105 --> 00:03:27,908
STUDY OUTCOME AND THEN 

86
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RANDOMIZATION TO HOPEFULLY 

87
00:03:28,775 --> 00:03:32,179
ENSURE THAT YOU HAVE AN 

88
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UNBIASED SELECTION AMONG THOSE 

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WHO GET THE INTERVENTION AND 

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THOSE WHO DON'T.

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NOW, THERE IS A SOMETIMES IT'S 

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IMPOSSIBLE TO RANDOMIZE, RIGHT?

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YOU MAY WANT TO COMPARE TO 

94
00:03:46,426 --> 00:03:46,760
INTERVENTIONS.

95
00:03:46,760 --> 00:03:50,630
BUT ONE INTERVENTION REQUIRES A 

96
00:03:50,630 --> 00:03:51,798
INJECTION, THE OTHER REQUIRES A 

97
00:03:51,798 --> 00:03:53,700
PILL.

98
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YOU CAN'T REALLY--I'M SORRY, 

99
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YOU CAN'T REALLY RANDOMIZE IN A 

100
00:03:58,238 --> 00:04:00,073
WAY THAT IS MEANINGFUL TO THE 

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00:04:00,073 --> 00:04:01,441
PERSON BECAUSE THEY'RE GOING TO 

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00:04:01,441 --> 00:04:04,811
KNOW WHICH ONE THEY GET.

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00:04:04,811 --> 00:04:07,247
YOU CAN RANDOMIZE THE 

104
00:04:07,247 --> 00:04:08,748
ASSIGNMENT, BUT YOU CAN'T BLIND 

105
00:04:08,748 --> 00:04:10,517
THE INDIVIDUAL TO WHAT THEY'RE 

106
00:04:10,517 --> 00:04:12,385
GETTING.

107
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AND SO A  QUASI DESIGN IS WHEN 

108
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THERE IS NO RANDOMIZATION.

109
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SO THE FIRST QUESTION WE'RE 

110
00:04:23,330 --> 00:04:25,398
GOING TO ASK ABOUT ANY STUDY IS 

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00:04:25,398 --> 00:04:28,635
WHETHER OR NOT IT HAS SOCIAL 

112
00:04:28,635 --> 00:04:30,670
VALUE, AND DAVE WENDLER WHO IS 

113
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GOING TO FOLLOW ME IS GOING TO 

114
00:04:32,372 --> 00:04:34,674
TALK A BIT ABOUT SOCIAL VALUE.

115
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SO I'M NOT GOING TO SAY MUCH 

116
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ABOUT IT NOW.

117
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BUT FOR THE SAKE OF ARGUMENT, 

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WE'RE GOING TO SAY THAT A 

119
00:04:42,048 --> 00:04:44,918
PROJECT SHOULD NOT GO FORWARD 

120
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UNLESS THERE IS SOCIAL BENEFIT.

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00:04:47,120 --> 00:04:49,389
THAT THERE IS DIRECT BENEFIT TO 

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00:04:49,389 --> 00:04:51,758
PATIENTS OR VALUE TO FUTURE 

123
00:04:51,758 --> 00:04:53,560
PATIENTS OR GAINING KNOWLEDGE 

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00:04:53,560 --> 00:04:55,562
THAT WILL LEAD YOU TO BENEFIT 

125
00:04:55,562 --> 00:04:59,099
FOR FUTURE PATIENTS AND/OR FOR 

126
00:04:59,099 --> 00:05:00,600
INDIVIDUAL PATIENTS.

127
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AND SCIENTIFIC VALIDITY IS A 

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COMPONENT AND A IMPORTANT 

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RESPECT IS THE STUDY DESIGN 

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VALID?

131
00:05:08,008 --> 00:05:10,010
AND EASY WAY TO THINK ABOUT 

132
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THIS CONCEPT IS TO THINK ABOUT 

133
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SAMPLE RISE, RIGHT?

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WHEN YOU'RE DESIGNING YOUR 

135
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STUDY, YOU NEED TO HAVE ENOUGH 

136
00:05:18,618 --> 00:05:20,821
PARTICIPANTS IN ORDER TO ANSWER 

137
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YOUR SCIENTIFIC QUESTION.

138
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IF YOU DON'T HAVE ENOUGH, YOU 

139
00:05:24,024 --> 00:05:26,426
CAN'T ANSWER YOUR QUESTION.

140
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AND YOU HAVE LET'S SAY, YOU, 

141
00:05:28,361 --> 00:05:30,964
YOU EN ROLL 100, YOU REALLY 

142
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NEED 200.

143
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YOU HAVE WASTED THE RESOURCES 

144
00:05:34,534 --> 00:05:37,737
THAT IT TOOK YOU TO DO THAT 

145
00:05:37,737 --> 00:05:39,306
HALF OF THE TRIAL AND YOU'RE 

146
00:05:39,306 --> 00:05:42,409
NOT GOING TO GET AN ANSWER.

147
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SO THAT WOULD BE A BAD STUDY 

148
00:05:44,978 --> 00:05:47,881
DESIGN BECAUSE YOU HAVE THE 

149
00:05:47,881 --> 00:05:50,217
SAMPLE SIZE TOO SMALL OR IT'S 

150
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TOO LARGE, RIGHT.

151
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WILL THES IMAGINE THAT YOU ONLY 

152
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NEED 100 PEOPLE TO EXPOSE TO 

153
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THE INTERVENTION AND CONTROL 

154
00:05:58,024 --> 00:06:00,727
BUT YOU AND, YOU'VE ENROLLED 

155
00:06:00,727 --> 00:06:03,029
200, THAT MEANS YOU'VE EXPOSED 

156
00:06:03,029 --> 00:06:04,731
100 PEOPLE TO MORE RISK THAN 

157
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THEY NEEDED TO BE AND ALSO 

158
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WASTED SOME RESOURCES.

159
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NOW AN IMPORTANT QUESTION ABOUT 

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00:06:16,376 --> 00:06:17,877
SCIENTIFIC VALIDITY, IS THERE 

161
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UNCERTAINTY ABOUT THE POTENTIAL 

162
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BENEFIT OF THE PROPOSED 

163
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INTERVENTION?

164
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IF THERE IS NO UNCERTAINTY, 

165
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THEN WE CANNOT GO FORWARD.

166
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IF WE ALREADY KNOW THE ANSWER, 

167
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WE CANNOT ETHICALLY OR 

168
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SCIENTIFICALLY MOVE FORWARD.

169
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IF YES, IF THERE IS UNCERTAINTY 

170
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THEN A RANDOMIZE CONTROL TRIAL 

171
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MAY BE ACCEPTABLE AND A 

172
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FOLLOW-UP QUESTION WOULD BE IS 

173
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RANDOMIZATION TO A PLACEBO 

174
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ACCEPTABLE.

175
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SO WHEN WE TALK ABOUT A 

176
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RANDOMIZE CONTROL TRIAL, THERE 

177
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IS UNCERTAINITY, RIGHT?

178
00:06:56,983 --> 00:06:59,519
THERE IS AN INDIFFERENCE ABOUT 

179
00:06:59,519 --> 00:07:00,854
COMMUNITY PHYSICIANS ABOUT 

180
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WHICH TREATMENT IS SUPERIOR 

181
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THIS IS REFERRED TO AS  ECO 

182
00:07:10,530 --> 00:07:12,165
POISE, BUT IT MEANS INDIFFERENT 

183
00:07:12,165 --> 00:07:13,300
TO A COMMUNITY OF EXPERTS.

184
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IF YOU'RE DOING A STUDY ABOUT 

185
00:07:15,435 --> 00:07:17,604
DIABETES, IT WOULD BE REALLY 

186
00:07:17,604 --> 00:07:19,239
IMPORTANT FOR THOSE PHYSICIANS 

187
00:07:19,239 --> 00:07:21,374
WHO ARE EXPERTS IN DIABETES OR 

188
00:07:21,374 --> 00:07:23,143
PROVIDING CARE IN DIABETES, 

189
00:07:23,143 --> 00:07:24,477
THERE IS INDIFFERENCE AMONG 

190
00:07:24,477 --> 00:07:27,547
THEM, NOT AMONG ALL CLINICIANS, 

191
00:07:27,547 --> 00:07:28,748
FOR EXAMPLE.

192
00:07:28,748 --> 00:07:30,884
AS I MENTIONED BEFORE, THERE IS 

193
00:07:30,884 --> 00:07:33,186
THIS CONCEPT OF BLINDING, WHERE 

194
00:07:33,186 --> 00:07:36,156
THERE IS YOU MAY WANT BLIND THE 

195
00:07:36,156 --> 00:07:38,258
INDIVIDUALS FROM THEIR 

196
00:07:38,258 --> 00:07:38,558
ASSIGNMENT.

197
00:07:38,558 --> 00:07:41,227
YOU MAY ALSO WANT TO BLIND THE 

198
00:07:41,227 --> 00:07:43,229
INVESTIGATORS SO YOU CAN DO A 

199
00:07:43,229 --> 00:07:45,699
SINGLE BLIND OR A DOUBLE BLIND 

200
00:07:45,699 --> 00:07:48,201
WHERE THE INVESTIGATORS AND THE 

201
00:07:48,201 --> 00:07:51,471
SUBJECTS ARE BLINDED.

202
00:07:51,471 --> 00:07:53,139
SO WHAT ABOUT WHETHER WE CAN 

203
00:07:53,139 --> 00:07:57,577
USE A PLACEBO OR AN ACTIVE 

204
00:07:57,577 --> 00:07:57,811
CONTROL?

205
00:07:57,811 --> 00:08:00,880
SO JUST AS A REMINDER, A 

206
00:08:00,880 --> 00:08:02,649
PLACEBO, RIGHT IS GENERALLY, 

207
00:08:02,649 --> 00:08:05,185
LET'S TAKE THE CLASSIC EXAMPLE 

208
00:08:05,185 --> 00:08:06,853
OF A PILL, IT LOOKS, IT'S A 

209
00:08:06,853 --> 00:08:09,155
PILL THAT LOOKS JUST LIKE THE 

210
00:08:09,155 --> 00:08:11,624
DRUG BUT DOESN'T CONTAIN ANY 

211
00:08:11,624 --> 00:08:12,225
MEDICINE.

212
00:08:12,225 --> 00:08:13,827
AND WE DO THIS, AND IT'S 

213
00:08:13,827 --> 00:08:18,098
IMPORTANT THAT WE SHARE THIS 

214
00:08:18,098 --> 00:08:19,999
WITH POTENTIAL PARTICIPANTS, WE 

215
00:08:19,999 --> 00:08:22,235
DO THIS TO FIND OUT WHETHER THE 

216
00:08:22,235 --> 00:08:25,271
REAL MEDICINE WORKS LIKE WE 

217
00:08:25,271 --> 00:08:26,039
HOPE IT TO.

218
00:08:26,039 --> 00:08:27,374
AND WE NEED TO COMPARE THE 

219
00:08:27,374 --> 00:08:30,110
PEOPLE WHO GET THE MEDICINE TO 

220
00:08:30,110 --> 00:08:31,611
WHOAS WHO DON'T TO SEE IF THE 

221
00:08:31,611 --> 00:08:32,412
MEDICINE WORKS.

222
00:08:32,412 --> 00:08:36,683
SO THE NEXT QUESTION IS WHEN IT 

223
00:08:36,683 --> 00:08:38,084
IS ETHICALLY APPROPRIATE TO 

224
00:08:38,084 --> 00:08:42,689
INCLUDE A PLA TAOEB O?

225
00:08:42,689 --> 00:08:43,556
AND--PLACEBO, AND THE COMMON 

226
00:08:43,556 --> 00:08:45,525
LINE IS WHEN THERE IS NO GOOD 

227
00:08:45,525 --> 00:08:46,760
STANDARD TREATMENT.

228
00:08:46,760 --> 00:08:53,133
SO IMAGINE IT'S 1988, WE KNOW 

229
00:08:53,133 --> 00:08:55,735
THAT H.I.V. CAUSES AIDS BUT WE 

230
00:08:55,735 --> 00:08:57,070
HAVE NO TREATMENT.

231
00:08:57,070 --> 00:09:02,575
SO THE FIRST TRIALS OF AZT, THE 

232
00:09:02,575 --> 00:09:04,677
FIRST ANTI VIRAL WAS TESTED, 

233
00:09:04,677 --> 00:09:06,713
WAS TESTED IN A TRIAL WHERE 

234
00:09:06,713 --> 00:09:09,749
HALF THE PARTICIPANTS GOT A 

235
00:09:09,749 --> 00:09:13,453
PLACEBO, THE OTHER HALF GOT 

236
00:09:13,453 --> 00:09:17,824
ACT, AND THAT WAS ETHICALLY 

237
00:09:17,824 --> 00:09:19,692
ACCEPTABLE BECAUSE THERE WAS NO 

238
00:09:19,692 --> 00:09:22,061
GOOD STANDARD TREATMENT WH. A 

239
00:09:22,061 --> 00:09:24,030
STANDARD TREATMENT EXISTS, 

240
00:09:24,030 --> 00:09:25,665
THERE IS EXPECTATION THAT IT 

241
00:09:25,665 --> 00:09:29,469
THE STUDY WILL BE HAVE AN 

242
00:09:29,469 --> 00:09:31,104
ACTIVE CONTROL, MEANING THAT 

243
00:09:31,104 --> 00:09:33,239
THE OLD MEDICINE IS GOING TO BE 

244
00:09:33,239 --> 00:09:35,542
TESTED AGAINST THE NEW MEDICINE.

245
00:09:35,542 --> 00:09:38,044
THERE ARE A COUPLE OF OTHER 

246
00:09:38,044 --> 00:09:40,480
EXAMPLES THAT WHEN A STANDARD 

247
00:09:40,480 --> 00:09:43,249
TREATMENT EXIST, IT IS 

248
00:09:43,249 --> 00:09:46,386
ETHICALLY ACCEPTABLE TO USE A 

249
00:09:46,386 --> 00:09:46,619
PLACEBO.

250
00:09:46,619 --> 00:09:48,388
SO ONE, IS MAYBE OBVIOUS.

251
00:09:48,388 --> 00:09:53,493
WHEN THE PLACEBOS ARE ADDITIVE, 

252
00:09:53,493 --> 00:09:56,162
SO THERE IS A STANDARD OF CARE, 

253
00:09:56,162 --> 00:09:57,931
IT'S ACCEPTABLE TO THE STANDARD 

254
00:09:57,931 --> 00:10:00,133
OF CARE PLUS THE NEW THING.

255
00:10:00,133 --> 00:10:06,506
AND STANDARD OF CARE, RIGHT?

256
00:10:06,506 --> 00:10:08,141
IT'S MERELY ADDITIVE.

257
00:10:08,141 --> 00:10:10,710
ANOTHER EXAMPLE WHEN THE 

258
00:10:10,710 --> 00:10:11,878
MEDICAL CONDITION AND QUESTION 

259
00:10:11,878 --> 00:10:13,279
IS NOT SERIOUS.

260
00:10:13,279 --> 00:10:17,550
SO LET'S SAY A DRUG COMPANY 

261
00:10:17,550 --> 00:10:22,322
WANTS TO DEVELOP A NEW PAIN 

262
00:10:22,322 --> 00:10:23,456
RELIEVER AND THEY WANT TO EN 

263
00:10:23,456 --> 00:10:26,426
ROLL PEOPLE WHO HAVE HAD A 

264
00:10:26,426 --> 00:10:31,431
HEADACHE FOR A MONTH, WE'RE 

265
00:10:31,431 --> 00:10:33,967
TALKING REGULAR HEADACHE, IT'S 

266
00:10:33,967 --> 00:10:35,768
ACCEPTABLE TO ASK PEOPLE TO NOT 

267
00:10:35,768 --> 00:10:40,340
TAKE A PAIN RELIEVER SO IT 

268
00:10:40,340 --> 00:10:44,043
WOULD BE OKAY TO RANDOMIZE.

269
00:10:44,043 --> 00:10:46,379
AND WHEN BEING AWAY FROM 

270
00:10:46,379 --> 00:10:56,823
MEDICATION WILL NOT CAUSE 

271
00:10:58,525 --> 00:10:59,659
SERIOUS IRREVERSABLE DAMAGE.

272
00:10:59,659 --> 00:11:03,696
YOU HAVE TO BE CAREFUL BECAUSE 

273
00:11:03,696 --> 00:11:05,265
SOME COULD EXPERIENCE HARM.

274
00:11:05,265 --> 00:11:06,499
BUT IF YOU'RE TALKING ABOUT A 

275
00:11:06,499 --> 00:11:08,368
MEDICATION THAT WILL NOT RESULT 

276
00:11:08,368 --> 00:11:11,538
IN THAT, IT MAY BE OKAY TO ASK 

277
00:11:11,538 --> 00:11:12,739
PARTICIPANTS TO STOP TAKING THE 

278
00:11:12,739 --> 00:11:17,577
DRUG THAT THEY'RE TAKING AND BE 

279
00:11:17,577 --> 00:11:21,247
RANDOMIZE WITH A DRUG VERSUS A 

280
00:11:21,247 --> 00:11:24,684
PLACEBO, THIS WILL DEPEND ON 

281
00:11:24,684 --> 00:11:27,554
THE CONTEXT, JUSTIFICATIONS, ET 

282
00:11:27,554 --> 00:11:28,388
CETERA.

283
00:11:28,388 --> 00:11:30,723
OOPS, WRONG DIRECTION.

284
00:11:30,723 --> 00:11:33,493
OH, SO THIS IS ANOTHER 

285
00:11:33,493 --> 00:11:37,797
INTERESTING THING FOR PIECE OF 

286
00:11:37,797 --> 00:11:39,399
PLACEBO.

287
00:11:39,399 --> 00:11:41,467
WHY NOT JUST HAVE A 

288
00:11:41,467 --> 00:11:42,368
NO-INTERVENTION ARM?

289
00:11:42,368 --> 00:11:45,805
SO LET'S SAY YOU'RE TRYING A 

290
00:11:45,805 --> 00:11:47,607
NEW TREATMENT, WHY NOT JUST 

291
00:11:47,607 --> 00:11:50,143
HAVE PEOPLE GET NO INTERVENTION 

292
00:11:50,143 --> 00:11:52,245
AND THE INTERVENTION?

293
00:11:52,245 --> 00:11:53,813
AND MEANING, THAT HALF THE 

294
00:11:53,813 --> 00:11:58,017
PEOPLE WITH GET THE PAIN PATCH, 

295
00:11:58,017 --> 00:11:59,385
THE OTHER HALF WOULDN'T GET THE 

296
00:11:59,385 --> 00:12:01,120
PAIN PATCH.

297
00:12:01,120 --> 00:12:03,056
SO THE CONCERN HERE, IS IF YOU 

298
00:12:03,056 --> 00:12:05,658
JUST GIVE HALF THE PEOPLE THE 

299
00:12:05,658 --> 00:12:07,927
PAIN PATCH AND THE OTHER GROUP, 

300
00:12:07,927 --> 00:12:09,996
NOTHING, WHEN THE OUTCOME CAN 

301
00:12:09,996 --> 00:12:12,932
BE SUBJECTIVE LIKE PAIN OR 

302
00:12:12,932 --> 00:12:13,866
EMOTIONAL OR ENDURANCE OR 

303
00:12:13,866 --> 00:12:15,234
SOMETHING LIKE THAT.

304
00:12:15,234 --> 00:12:18,638
THE INDIVIDUALS WHO GET THE 

305
00:12:18,638 --> 00:12:20,106
PAIN PATCH, MIGHT REPORT 

306
00:12:20,106 --> 00:12:23,543
INFORMATION IN A WAY THAT IS 

307
00:12:23,543 --> 00:12:24,911
BIASED BY THE WAY THAT THEY 

308
00:12:24,911 --> 00:12:28,381
HAVE THE PAIN PATCH OR VICE 

309
00:12:28,381 --> 00:12:30,383
VERSA SO YOU WANT TO HAVE A 

310
00:12:30,383 --> 00:12:33,653
INDIVIDUAL THAT HAS ACTIVE 

311
00:12:33,653 --> 00:12:34,821
INGREDIENT OR A PATCH THAT DOES 

312
00:12:34,821 --> 00:12:37,357
NOT HAVE THE ACTIVE INGREDIENT.

313
00:12:37,357 --> 00:12:39,692
ANOTHER REASON WHY YOU WANT TO 

314
00:12:39,692 --> 00:12:41,828
HAVE SOMETHING IN TERMS OF A 

315
00:12:41,828 --> 00:12:43,429
COMPARISON IS WHEN RISK 

316
00:12:43,429 --> 00:12:46,399
BEHAVIORS MIGHT BE AFFECTED BY 

317
00:12:46,399 --> 00:12:47,634
THINKING ONE RECEIVED THE 

318
00:12:47,634 --> 00:12:48,134
EXPERIMENTAL TREATMENT.

319
00:12:48,134 --> 00:12:50,536
SO WE CAN THINK BACK TO COVID 

320
00:12:50,536 --> 00:12:53,806
FOR EXAMPLE, IF YOU WERE IN A 

321
00:12:53,806 --> 00:12:56,275
TRIAL AND YOU KNEW THAT BECAUSE 

322
00:12:56,275 --> 00:12:58,311
YOU GOT A SHOT, YOU GOT THE 

323
00:12:58,311 --> 00:13:00,313
VACCINE, IF YOU DIDN'T GET THE 

324
00:13:00,313 --> 00:13:03,583
SHOT, YOU DIDN'T GET THE 

325
00:13:03,583 --> 00:13:04,751
VACCINE, ONE POSSIBILITY IS IF 

326
00:13:04,751 --> 00:13:07,053
YOU DIDN'T GET THE SHOT, YOU 

327
00:13:07,053 --> 00:13:10,056
WOULD BE HYPER VIGILANT ABOUT 

328
00:13:10,056 --> 00:13:10,890
AVOIDING COVID.

329
00:13:10,890 --> 00:13:12,725
AND IN COMPARING YOU WITH THOSE 

330
00:13:12,725 --> 00:13:16,462
WHO GOT THE VACCINE, WE WON BE 

331
00:13:16,462 --> 00:13:18,064
ABLE TO TELL THE DIFFERENCE SO 

332
00:13:18,064 --> 00:13:20,299
IT COULD BE IMPORTANT FOR 

333
00:13:20,299 --> 00:13:21,467
EVERYBODY TO GET THE SHOT.

334
00:13:21,467 --> 00:13:23,503
I WANT TO TRANSITION A LITTLE 

335
00:13:23,503 --> 00:13:25,138
AND BRING YOUR ATTENTION TO A 

336
00:13:25,138 --> 00:13:26,906
DOCUMENT THAT YUZ JUST 

337
00:13:26,906 --> 00:13:28,608
PUBLISHED LAST MONTH.

338
00:13:28,608 --> 00:13:34,147
THE WORLD HEALTH ORGANIZATION, 

339
00:13:34,147 --> 00:13:35,748
PUBLISHED GUIDANCE FOR BEST 

340
00:13:35,748 --> 00:13:37,917
PRACTICES FOR CLINICAL TRIALS.

341
00:13:37,917 --> 00:13:39,852
FOR THOSE ACTIVELY ENGAGED IN 

342
00:13:39,852 --> 00:13:40,987
AND INTERESTED IN CLINICAL 

343
00:13:40,987 --> 00:13:43,122
TRIALS, THIS IS A REALLY NICE 

344
00:13:43,122 --> 00:13:44,991
DOCUMENT IN HITTING SOME OF THE 

345
00:13:44,991 --> 00:13:48,428
SORT OF MOST IMPORTANT KEY 

346
00:13:48,428 --> 00:13:50,296
ASPECTS OF THINKING ABOUT 

347
00:13:50,296 --> 00:13:51,597
CLINICAL RESEARCH AND CLINICAL 

348
00:13:51,597 --> 00:13:52,699
TRIALS.

349
00:13:52,699 --> 00:13:56,602
AND INCLUDED THIS LITTLE 

350
00:13:56,602 --> 00:13:57,970
DIAGRAM BECAUSE THEY'RE ALSO 

351
00:13:57,970 --> 00:14:01,641
TALKING ABOUT THE RESEARCH HE  

352
00:14:01,641 --> 00:14:02,842
ECOSYSTEM AND THE IMPORTANT 

353
00:14:02,842 --> 00:14:04,911
PARTS OF THAT SYSTEM THAT 

354
00:14:04,911 --> 00:14:06,546
SUPPORT ALL THE RESEARCH THAT 

355
00:14:06,546 --> 00:14:07,747
IS BEING DONE.

356
00:14:07,747 --> 00:14:09,782
SOY RECOMMEND THAT THOSE OF YOU 

357
00:14:09,782 --> 00:14:11,150
INTERESTED, TAKE A LOOK AT THAT 

358
00:14:11,150 --> 00:14:14,420
AND I JUST PULLED THIS ONE 

359
00:14:14,420 --> 00:14:16,689
PIECE OF THE PUZZLE OUT OF THE 

360
00:14:16,689 --> 00:14:19,258
DOCUMENT, WHERE THEY TALK ABOUT 

361
00:14:19,258 --> 00:14:21,327
THE KEY SCIENTIFIC AND ETHICAL 

362
00:14:21,327 --> 00:14:21,994
CONSIDERATIONS FOR CLINICAL 

363
00:14:21,994 --> 00:14:23,863
TRIALS.

364
00:14:23,863 --> 00:14:27,233
AND YOU WON'T BE SURPRISED BY 

365
00:14:27,233 --> 00:14:29,102
ANY OF THESE PRONOUNCEMENTS 

366
00:14:29,102 --> 00:14:36,275
THAT IT CAN BE DESIGNED, AND 

367
00:14:36,275 --> 00:14:39,412
RESPECTS THE RIGHTS OF 

368
00:14:39,412 --> 00:14:40,146
WELL-BEING PARTICIPANTS AND I 

369
00:14:40,146 --> 00:14:42,615
THINK THESE THREE ARE SORT OF 

370
00:14:42,615 --> 00:14:44,283
NOT NEW BUT I LIKE THAT THEY 

371
00:14:44,283 --> 00:14:46,285
PUT THESE IN THE LIST THAT THE 

372
00:14:46,285 --> 00:14:48,588
RESEARCH NEEDS TO BE 

373
00:14:48,588 --> 00:14:49,689
COLLABORATIVE AND TRANSPARENT, 

374
00:14:49,689 --> 00:14:51,591
BE DESIGNED TO BE FEASIBLE FOR 

375
00:14:51,591 --> 00:14:54,293
THEIR CONTEXT, AND MANAGE TRIAL 

376
00:14:54,293 --> 00:14:56,395
QUALITY EFFECTIVELY AND 

377
00:14:56,395 --> 00:14:56,696
EFFICIENTLY.

378
00:14:56,696 --> 00:15:01,234
SO THE LAST THREE ARE ETHICAL 

379
00:15:01,234 --> 00:15:03,369
BUT ALSO IMPORTANT PRACTICALLY 

380
00:15:03,369 --> 00:15:07,073
IN THINKING ABOUT DESIGN.

381
00:15:07,073 --> 00:15:07,974
AND THEN, ANOTHER ARTICLE THAT 

382
00:15:07,974 --> 00:15:10,743
I JUST WANTED TO BRING YOUR 

383
00:15:10,743 --> 00:15:15,815
ATTENTION TO OR ANOTHER SET OF 

384
00:15:15,815 --> 00:15:16,582
PRINCIPLES, AGAIN THINGS THAT 

385
00:15:16,582 --> 00:15:18,050
YOU WOULD NOT BE SURPRISED TO 

386
00:15:18,050 --> 00:15:20,052
HEAR.

387
00:15:20,052 --> 00:15:24,257
BUT THEY ADD, STUDY FINDINGS 

388
00:15:24,257 --> 00:15:25,792
MUST BE REPORTED PROMPTLY 

389
00:15:25,792 --> 00:15:27,059
DURING AND AFTER THE TRIAL.

390
00:15:27,059 --> 00:15:29,495
AND I WOULD SAY IN THE LAST TEN 

391
00:15:29,495 --> 00:15:31,497
YEARS OR SO, MAYBE EVEN 20, 

392
00:15:31,497 --> 00:15:34,534
THERE IS BEEN MORE EMPHASIS ON 

393
00:15:34,534 --> 00:15:36,536
MAKING SURE THAT STUDY FINDINGS 

394
00:15:36,536 --> 00:15:38,571
GO BACK TO THE STUDY POPULATION 

395
00:15:38,571 --> 00:15:39,071
THAT PARTICIPATED.

396
00:15:39,071 --> 00:15:41,207
SO BACK IN THE DAY, THE 

397
00:15:41,207 --> 00:15:43,042
EXPECTATION WAS YOU DID YOUR 

398
00:15:43,042 --> 00:15:44,577
RESEARCH, DID YOU YOUR CLINICAL 

399
00:15:44,577 --> 00:15:46,412
TRIALS AND THEN YOU PUBLISHED 

400
00:15:46,412 --> 00:15:51,684
IT AND THAT'S IT, YOU CAN VONN 

401
00:15:51,684 --> 00:15:55,188
VAID YOUR FINDINGS TO THE 

402
00:15:55,188 --> 00:15:56,823
SCIENTIFIC COMMUNITY, BUT 

403
00:15:56,823 --> 00:15:58,591
MAYBE, YOU ALSO HAVE AN 

404
00:15:58,591 --> 00:16:00,226
OBLIGATION TO SHARE THOSE 

405
00:16:00,226 --> 00:16:01,527
FINDINGS WITH THOSE WHO 

406
00:16:01,527 --> 00:16:02,595
PARTICIPATED IN THE TRIAL.

407
00:16:02,595 --> 00:16:04,630
AND IT DOESN'T MEAN YOU GIVE 

408
00:16:04,630 --> 00:16:07,166
THEM LIKE HERE ARE YOUR 

409
00:16:07,166 --> 00:16:10,436
FINDINGS, BUT PROVIDE THEM WITH 

410
00:16:10,436 --> 00:16:12,872
THE AGGREGATE FINDINGS, THE 

411
00:16:12,872 --> 00:16:15,641
PRIMARILY FINDINGS IN AND LAY 

412
00:16:15,641 --> 00:16:17,143
LANGUAGE, IN A WAY THAT THEY 

413
00:16:17,143 --> 00:16:17,910
CAN UNDERSTAND.

414
00:16:17,910 --> 00:16:21,514
THAT IT'S IMPORTANT FOR 

415
00:16:21,514 --> 00:16:24,750
INDIVIDUALS TO APPRECIATE THAT 

416
00:16:24,750 --> 00:16:26,152
THEY'RE CONTRIBUTION LEAD TO 

417
00:16:26,152 --> 00:16:28,221
AND OUTCOME AND I WOULD SAY 

418
00:16:28,221 --> 00:16:30,022
THAT'S TRUE, WHETHER IT'S 

419
00:16:30,022 --> 00:16:33,726
POSITIVE OR NEGATIVE.

420
00:16:33,726 --> 00:16:35,761
THAT THEY'RE CONTRIBUTION LEAD 

421
00:16:35,761 --> 00:16:37,830
TO SOMETHING THAT WILL ADVANCE 

422
00:16:37,830 --> 00:16:39,165
SCIENCE AGAIN REGARDLESS OF 

423
00:16:39,165 --> 00:16:40,566
WHETHER IT'S POSITIVE OR 

424
00:16:40,566 --> 00:16:44,637
NEGATIVE IN TERMS OF WHETHER 

425
00:16:44,637 --> 00:16:46,472
THEY ANSWERED, WERE ABLE TO 

426
00:16:46,472 --> 00:16:47,473
ANSWER THE QUESTION THEY SET 

427
00:16:47,473 --> 00:16:48,374
OUT TO.

428
00:16:48,374 --> 00:16:50,843
SO A COME OF MORE COMMENTS 

429
00:16:50,843 --> 00:16:54,313
ABOUT TERMINOLOGY WHEN WE THINK 

430
00:16:54,313 --> 00:16:54,647
ABOUT TRIALS.

431
00:16:54,647 --> 00:16:56,449
AND I'M SURE THAT WE'VE ALL 

432
00:16:56,449 --> 00:16:59,051
MENTIONED THESE IN THE FIRST 

433
00:16:59,051 --> 00:17:01,187
COUPLE OF SESSIONS BUT JUST 

434
00:17:01,187 --> 00:17:02,889
WANT TO CLARIFY.

435
00:17:02,889 --> 00:17:07,326
SO THERE ARE, AGAIN, PROBABLY I 

436
00:17:07,326 --> 00:17:11,631
THINK IT WAS IN THE 1970, THE 

437
00:17:11,631 --> 00:17:14,166
FDA FORMALLY DEFINED TRIALS AS 

438
00:17:14,166 --> 00:17:16,769
PHASE 1, PHASE 2, PHASE 3 AND 

439
00:17:16,769 --> 00:17:19,939
PHASE 4.

440
00:17:19,939 --> 00:17:23,042
AND THIS WAS SORT OF, I KNOW 

441
00:17:23,042 --> 00:17:25,344
DR. LETTER PRESENTED THE EARLY 

442
00:17:25,344 --> 00:17:28,314
HISTORY OF FDA AND HOW THEY 

443
00:17:28,314 --> 00:17:30,349
CAME TO DEVELOP EVEN GUIDELINES 

444
00:17:30,349 --> 00:17:32,885
HOW YOU CAN PREPARE A 

445
00:17:32,885 --> 00:17:35,421
PARTICULAR SOLUTION, HOW IT CAN 

446
00:17:35,421 --> 00:17:36,656
BE LABELED, WHETHER YOU FOUND 

447
00:17:36,656 --> 00:17:37,924
IT TO BE SAFE, WHETHER YOU 

448
00:17:37,924 --> 00:17:40,426
FOUND IT TO BE AFFECTIVE.

449
00:17:40,426 --> 00:17:47,967
IN ALL OF THAT MOMENTUM, THERE 

450
00:17:47,967 --> 00:17:51,804
WAS INTEREST AN INTEREST IN 

451
00:17:51,804 --> 00:17:52,772
PHARMA COMPANIES MOVED FORWARD 

452
00:17:52,772 --> 00:17:54,106
IN THEIR TRIAL DEVELOPMENT, IT 

453
00:17:54,106 --> 00:17:56,409
WAS IMPORTANT FOR THERE TO BE A 

454
00:17:56,409 --> 00:17:57,777
SORT OF EXPECTATION OF HOW 

455
00:17:57,777 --> 00:17:58,811
THINGS MOVE FORWARD.

456
00:17:58,811 --> 00:18:01,714
SO WHEN WE TALK ABOUT PHASE 1 

457
00:18:01,714 --> 00:18:03,482
STUDIES, THOSE ARE THE ONES 

458
00:18:03,482 --> 00:18:06,052
THAT ARE FIRST IN HUMAN, RIGHT.

459
00:18:06,052 --> 00:18:07,553
THERE IS IN MOST CASES, THERE 

460
00:18:07,553 --> 00:18:09,989
IS SOME SORT OF ANIMAL RESEARCH 

461
00:18:09,989 --> 00:18:12,291
AND YOU NOW HAVE R GOING TO SEE 

462
00:18:12,291 --> 00:18:13,859
WHAT HAPPENS WHEN YOU PUT IT 

463
00:18:13,859 --> 00:18:15,494
INTO A HUMAN.

464
00:18:15,494 --> 00:18:16,896
AND GENERALLY, WE'RE GOING TO 

465
00:18:16,896 --> 00:18:19,865
TALK A LITTLE MORE IN DETAIL 

466
00:18:19,865 --> 00:18:21,534
BUT GENERALLY THOSE ARE FOR 

467
00:18:21,534 --> 00:18:21,767
SAFETY.

468
00:18:21,767 --> 00:18:24,270
IS IT OKAY FOR A HUMAN TO 

469
00:18:24,270 --> 00:18:25,938
RECEIVE IT IN A RELATIVELY 

470
00:18:25,938 --> 00:18:28,207
SMALL NUMBER OF PEOPLE.

471
00:18:28,207 --> 00:18:30,977
FROM THOSE 1100 TRIALS ABOUT 70 

472
00:18:30,977 --> 00:18:32,078
GO TO PHASE 2.

473
00:18:32,078 --> 00:18:35,348
ABOUT A THIRD OF THOSE PHASE 3, 

474
00:18:35,348 --> 00:18:37,883
AND 6 OR 7 MAKE IT TO PHASE 4 

475
00:18:37,883 --> 00:18:38,784
OR TO MARKET.

476
00:18:38,784 --> 00:18:40,486
SO AGAIN JUST TO GIVE YOU A 

477
00:18:40,486 --> 00:18:42,221
SENSE OF HOW MUCH RESEARCH 

478
00:18:42,221 --> 00:18:46,125
HAPPENS AT ONE END TO GET 

479
00:18:46,125 --> 00:18:47,426
RELATIVELY FEW AFFECTIVE 

480
00:18:47,426 --> 00:18:50,162
OUTCOMES IN THE END.

481
00:18:50,162 --> 00:18:52,565
AND JUST AGAIN TO GIVE YOU A 

482
00:18:52,565 --> 00:18:55,501
LITTLE CONTEXT, THE NIH 

483
00:18:55,501 --> 00:18:57,336
CLINICAL CENTER IS UNIQUE IN A 

484
00:18:57,336 --> 00:18:59,271
SENSE THAT 95 PERCENT OF THE 

485
00:18:59,271 --> 00:19:01,807
TRIALS CONDUCTED HERE ARE EARLY 

486
00:19:01,807 --> 00:19:03,909
PHASE TRIALS, PHRASE 1 AND 

487
00:19:03,909 --> 00:19:05,511
PHASE 2.

488
00:19:05,511 --> 00:19:09,148
THAT'S NOT THE CASE IN MOST 

489
00:19:09,148 --> 00:19:09,849
ACADEMIC MEDICAL CENTERS.

490
00:19:09,849 --> 00:19:13,085
JUST TO SAY THAT WE ARE AT THE 

491
00:19:13,085 --> 00:19:16,655
SORT OF EXPLORATORY END OF THE 

492
00:19:16,655 --> 00:19:18,557
PIPELINE.

493
00:19:18,557 --> 00:19:20,359
IN 2023, WHICH IS THE MOST 

494
00:19:20,359 --> 00:19:23,396
RESENT DATA THAT I COULD FIND, 

495
00:19:23,396 --> 00:19:25,664
YOU KNOW, ALMOST HALF WERE 

496
00:19:25,664 --> 00:19:28,834
PHASE 2 A LITTLE LESS PHASE 1, 

497
00:19:28,834 --> 00:19:31,137
VERY FEW PHASE 3, PHASE 3 WOULD 

498
00:19:31,137 --> 00:19:33,739
BE A LARGE COMPARATIVE TRIAL.

499
00:19:33,739 --> 00:19:35,474
SO LET'S TALK A LITTLE ABOUT 

500
00:19:35,474 --> 00:19:38,477
EACH ONE AS I SAID, THE PHASE 1 

501
00:19:38,477 --> 00:19:41,414
IS USUALLY A RELATIVELY SMALL 

502
00:19:41,414 --> 00:19:43,916
POPULATION, FIRST IN HUMAN, 

503
00:19:43,916 --> 00:19:48,020
SAFETY, SOMETIMES DOSAGE OR THE 

504
00:19:48,020 --> 00:19:49,455
MAXIMUM TOLERATED DOSE.

505
00:19:49,455 --> 00:19:50,990
MEANING THAT YOU GIVE THE 

506
00:19:50,990 --> 00:19:53,325
INDIVIDUALS IN THE TRIAL 

507
00:19:53,325 --> 00:19:55,127
PERHAPS, LARGER AND LARGER 

508
00:19:55,127 --> 00:19:57,229
DOSES IN ORDER TO FIND THE WAY 

509
00:19:57,229 --> 00:19:59,565
THAT IS TOO MUCH AND BACK OFF 

510
00:19:59,565 --> 00:20:00,132
ONE.

511
00:20:00,132 --> 00:20:03,302
AND YOU USE THAT DOSE TO GO 

512
00:20:03,302 --> 00:20:04,503
INTO PHASE 2.

513
00:20:04,503 --> 00:20:07,907
SO IT'S ONE LOWER THAN THAT 

514
00:20:07,907 --> 00:20:10,776
MAXIMUM ROLL TATED DOSE.

515
00:20:10,776 --> 00:20:12,144
IN PHASE 2, YOU START TO LOOK 

516
00:20:12,144 --> 00:20:19,085
AT THE BIOLOGIC AFFECT.

517
00:20:19,085 --> 00:20:22,154
IN PHASE 1, THEY CAN BE 

518
00:20:22,154 --> 00:20:22,555
RELATIVELY SHORT.

519
00:20:22,555 --> 00:20:23,823
IN PHASE 2, THEY MAY START TO 

520
00:20:23,823 --> 00:20:26,659
GET A LITTLE LONGER IN ORDER TO 

521
00:20:26,659 --> 00:20:30,663
DOCUMENT SOME BIOLOGIC AFFECTS.

522
00:20:30,663 --> 00:20:32,798
SXL PHASE 3, WE'RE NOW GETTING 

523
00:20:32,798 --> 00:20:34,400
LARGER MORE THAN 3000 AS YOU 

524
00:20:34,400 --> 00:20:36,602
CAN RECALL FROM THE COVID 

525
00:20:36,602 --> 00:20:37,970
TRIALS, TENS OF THOUSANDS OF 

526
00:20:37,970 --> 00:20:41,073
PEOPLE IN SOME CASES.

527
00:20:41,073 --> 00:20:42,775
THE INTERVENTION THAT IS GOING 

528
00:20:42,775 --> 00:20:46,345
TO MOVE FORWARD IS BASED ON THE 

529
00:20:46,345 --> 00:20:47,546
RESULTS FROM PHASE 2 AND THIS 

530
00:20:47,546 --> 00:20:49,415
IS WHERE YOU START TO LOOK 

531
00:20:49,415 --> 00:20:51,383
AFFECTIVE AND CONTINUE TO LOOK 

532
00:20:51,383 --> 00:20:54,620
AT SAFETY AND RISK BENEFIT IN 

533
00:20:54,620 --> 00:20:56,322
TERMS OF ADOPTING INTO CLINICAL 

534
00:20:56,322 --> 00:20:57,656
PRACTICE.

535
00:20:57,656 --> 00:21:00,226
PHASE 4 ARE OFTEN REFERRED TO 

536
00:21:00,226 --> 00:21:02,761
AS POST MARKETING TRIALS AND IN 

537
00:21:02,761 --> 00:21:05,397
THOSE, WE'RE LOOKING AT LONG 

538
00:21:05,397 --> 00:21:08,768
TERM SAFETY.

539
00:21:08,768 --> 00:21:09,869
NOT EVERY INTERVENTION GOES 

540
00:21:09,869 --> 00:21:14,907
INTO A POST MARKETING TRIAL.

541
00:21:14,907 --> 00:21:16,775
IN THOSE CASES WHERE THERE IS A 

542
00:21:16,775 --> 00:21:19,278
HIGHER EXPECTATION OF RISK OR 

543
00:21:19,278 --> 00:21:20,412
SERIOUS EVENTS THERE IS AN 

544
00:21:20,412 --> 00:21:22,381
INTEREST IN FOLLOWING THE LONG 

545
00:21:22,381 --> 00:21:23,149
TERM SAFETY.

546
00:21:23,149 --> 00:21:28,621
SO IN TERMS OF OVERSIGHT, WE 

547
00:21:28,621 --> 00:21:31,290
SPEND A LONG LECTURE ON REVIEW 

548
00:21:31,290 --> 00:21:31,524
BOARDS.

549
00:21:31,524 --> 00:21:33,659
THOSE ARE THE LOCAL GROUPS 

550
00:21:33,659 --> 00:21:38,030
AFFILIATED WITH THE INSTITUTION 

551
00:21:38,030 --> 00:21:39,665
THAT THE INVESTIGATOR IS AT AND 

552
00:21:39,665 --> 00:21:41,500
THEY'RE DOING THE INITIAL 

553
00:21:41,500 --> 00:21:43,536
REVIEW OF THE RESEARCH TO SEE 

554
00:21:43,536 --> 00:21:45,538
WHETHER OR NOT IT IS 

555
00:21:45,538 --> 00:21:48,240
APPROPRIATE TO MOVE FORWARD.

556
00:21:48,240 --> 00:21:49,608
ANOTHER THING THAT IS OFTEN IN 

557
00:21:49,608 --> 00:21:51,777
PLACE IS A DATA MONITORING 

558
00:21:51,777 --> 00:21:53,812
COMMITTEE.

559
00:21:53,812 --> 00:21:58,083
SO IN GENERAL, A DATA 

560
00:21:58,083 --> 00:21:58,717
MONITORING COMMITTEE, THEY'RE, 

561
00:21:58,717 --> 00:22:01,620
THERE ARE AT LEAST TWO 

562
00:22:01,620 --> 00:22:02,454
PRIMARILY TYPE.

563
00:22:02,454 --> 00:22:04,924
ONE TYPE OF DATA MONITORING 

564
00:22:04,924 --> 00:22:07,560
COMMITTEE IS ASSIGNED TO A 

565
00:22:07,560 --> 00:22:08,360
PARTICULAR STUDY.

566
00:22:08,360 --> 00:22:15,668
SO AGAIN, LET'S USE COVID AS AN 

567
00:22:15,668 --> 00:22:17,403
EXAMPLE THE COVID TRIALS EACH 

568
00:22:17,403 --> 00:22:19,738
ONE HAD A DATA MONITORING 

569
00:22:19,738 --> 00:22:20,005
COMMITTEE.

570
00:22:20,005 --> 00:22:21,941
THE OTHER TYPE IS DATA 

571
00:22:21,941 --> 00:22:24,210
MONITORING COMMITTEE THAT IS A 

572
00:22:24,210 --> 00:22:26,545
HUB FOR A RANGE OF TRIALS, OR A 

573
00:22:26,545 --> 00:22:30,149
GROUP OF TRIALS OR YOU KNOW, 

574
00:22:30,149 --> 00:22:31,450
THE TRIALS DON'T NECESSARILY 

575
00:22:31,450 --> 00:22:33,352
HAVE TO BE RELATED BUT THEY'RE 

576
00:22:33,352 --> 00:22:36,288
ALL LOOKING AT A PARTICULAR 

577
00:22:36,288 --> 00:22:37,556
CONDITION AND INTERVENTIONS.

578
00:22:37,556 --> 00:22:43,362
FOR EXAMPLE, I SAT ON THE NHIBI 

579
00:22:43,362 --> 00:22:46,098
NATIONAL HEART AND BLOOD 

580
00:22:46,098 --> 00:22:47,967
INSTITUTION PEDIATRIC HEART 

581
00:22:47,967 --> 00:22:49,835
NETWORK, DMC AND WE REVIEWED 

582
00:22:49,835 --> 00:22:53,639
ALL OF THE TRIALS THAT WERE 

583
00:22:53,639 --> 00:22:57,509
CONDUCTED UNDER THAT UMBRELLA.

584
00:22:57,509 --> 00:23:01,280
SO THE GOAL OR THE ROLE OF THE 

585
00:23:01,280 --> 00:23:04,183
DATA MONITORING COMMITTEE, IS 

586
00:23:04,183 --> 00:23:07,353
TO MONITOR THE TRIAL ONCE IT'S 

587
00:23:07,353 --> 00:23:08,320
IN THE FIELD.

588
00:23:08,320 --> 00:23:11,557
IF YOU REMEMBER, THE IRB DOES 

589
00:23:11,557 --> 00:23:14,026
THEIR REVIEWS AND APPROVES OR 

590
00:23:14,026 --> 00:23:15,628
NOT THE PROTOCOL.

591
00:23:15,628 --> 00:23:16,562
THEY GENERALLY DON'T HAVE MUCH 

592
00:23:16,562 --> 00:23:19,565
TO DO WITH THE TRIAL ONCE IT'S 

593
00:23:19,565 --> 00:23:22,034
LAUNCHED.

594
00:23:22,034 --> 00:23:24,536
THE INVESTIGATORS ARE ASKED TO 

595
00:23:24,536 --> 00:23:26,572
PROVIDE ANNUAL REVIEW.

596
00:23:26,572 --> 00:23:28,207
BUT THE IRB IS NOT LOOKING AT 

597
00:23:28,207 --> 00:23:32,344
THE DATA COMING OUT OF THE 

598
00:23:32,344 --> 00:23:34,647
TRIAL EXCEPT FOR ADVERSE EVENTS 

599
00:23:34,647 --> 00:23:36,649
WHICH THEY MAY BE REPORTED TO.

600
00:23:36,649 --> 00:23:38,550
BUT THE DATA MONITORING 

601
00:23:38,550 --> 00:23:40,386
COMMITTEE PICKS UP ONCE THE 

602
00:23:40,386 --> 00:23:42,821
TRIAL STARTS.

603
00:23:42,821 --> 00:23:45,991
AND ONE REALLY IMPORTANT 

604
00:23:45,991 --> 00:23:47,126
COMPONENT OF THAT MOVIN' TO 

605
00:23:47,126 --> 00:23:49,461
GOER IS TO PROTECT SUBJECTS 

606
00:23:49,461 --> 00:23:52,698
FROM PREVIOUSLY ADVERSE EVENTS.

607
00:23:52,698 --> 00:23:55,367
SO, IMAGINE, THERE IS BEEN SOME 

608
00:23:55,367 --> 00:23:57,102
ANIMAL STUDIES, THERE IS BEEN 

609
00:23:57,102 --> 00:24:02,207
SOME PHASE 1, THERE IS BEEN 

610
00:24:02,207 --> 00:24:04,143
SOME PHASE 2 STUDIES, NOT A LOT 

611
00:24:04,143 --> 00:24:05,911
OF TIME THAT'S PASSED SO MAYBE 

612
00:24:05,911 --> 00:24:07,646
THERE IS GOING TO BE AN ADVERSE 

613
00:24:07,646 --> 00:24:09,048
EVENT THAT COMES INTO A YEAR 

614
00:24:09,048 --> 00:24:11,583
INTO THE TRIAL THAT IT WOULD BE 

615
00:24:11,583 --> 00:24:13,085
REALLY IMPORTANT TO MEASURE.

616
00:24:13,085 --> 00:24:15,554
TO FOR EXAMPLE, WITH THE COVID 

617
00:24:15,554 --> 00:24:18,390
VACCINE TRIALS, THERE WAS SOME 

618
00:24:18,390 --> 00:24:20,959
UNLIKELY BUT POTENTIAL ADVERSE 

619
00:24:20,959 --> 00:24:25,531
EVENT THAT THOSE, SO THIS IS 

620
00:24:25,531 --> 00:24:28,767
KNOWN FROM OTHER VACCINE 

621
00:24:28,767 --> 00:24:31,537
PRODUCTS, THAT IF YOU GET THE 

622
00:24:31,537 --> 00:24:35,407
VACCINE, AND ARE THEN EXPOSED 

623
00:24:35,407 --> 00:24:38,143
TO DISEASE, YOU MAY HAVE AN 

624
00:24:38,143 --> 00:24:39,611
EVEN WORSE RESPONSE TO THE 

625
00:24:39,611 --> 00:24:41,814
VIRUS.

626
00:24:41,814 --> 00:24:43,649
AGAIN HIGHLY UNLIKELY, IT WAS 

627
00:24:43,649 --> 00:24:45,484
NOT EXPECTED NOR DID IT HAPPEN 

628
00:24:45,484 --> 00:24:47,152
IN THE COVID VACCINE TRIALS.

629
00:24:47,152 --> 00:24:50,556
BUT ONE OF THE JOBS OF THE 

630
00:24:50,556 --> 00:24:52,157
COMMITTEES WAS TO MONITOR THE 

631
00:24:52,157 --> 00:24:53,459
DATA TO MAKE SURE THAT DID NOT 

632
00:24:53,459 --> 00:24:54,693
HAPPEN.

633
00:24:54,693 --> 00:24:56,395
NOW IF THAT HAPPENS, IT'S THEIR 

634
00:24:56,395 --> 00:24:59,298
JOB TO DECIDE WHETHER OR NOT 

635
00:24:59,298 --> 00:25:01,433
THAT SIGNAL MEANS THAT THE 

636
00:25:01,433 --> 00:25:03,335
STUDY HAS TO STOP.

637
00:25:03,335 --> 00:25:05,304
SO ONE REASON IT MIGHT HAVE TO 

638
00:25:05,304 --> 00:25:09,241
STOP IS BECAUSE THE ADVERSE 

639
00:25:09,241 --> 00:25:12,211
EVENT IS TO SEVERE AND SO 

640
00:25:12,211 --> 00:25:13,445
UNANTICIPATED THAT YOU NEED TO 

641
00:25:13,445 --> 00:25:15,948
STOP THE TRIAL FOR A WHILE AND 

642
00:25:15,948 --> 00:25:18,517
LOOK INTO WHAT HAPPENED, MAYBE 

643
00:25:18,517 --> 00:25:20,486
IT NOTHING TO DO WITH THE 

644
00:25:20,486 --> 00:25:23,689
INTERVENTION THAT THE PERSON 

645
00:25:23,689 --> 00:25:25,057
RECEIVED BUT YOU DON'T WANT TO 

646
00:25:25,057 --> 00:25:26,692
MOVE FORWARD WITH THE TRIAL IF 

647
00:25:26,692 --> 00:25:28,127
THERE IS A POSSIBILITY THAT 

648
00:25:28,127 --> 00:25:29,128
OTHERS WHO ARE RECEIVING THE 

649
00:25:29,128 --> 00:25:30,662
TREATMENT ARE GOING TO HAVE 

650
00:25:30,662 --> 00:25:34,800
THAT SAME ADVERSE EVENT.

651
00:25:34,800 --> 00:25:37,603
SO THEY'RE MONITORING FOR 

652
00:25:37,603 --> 00:25:37,970
ADVERSE EVENTS.

653
00:25:37,970 --> 00:25:39,705
THEY'RE ALSO LOOKING AT HOW IS 

654
00:25:39,705 --> 00:25:41,974
THE TRIAL DOING?

655
00:25:41,974 --> 00:25:43,809
SO AGAIN, LET'S IMAGINE YOU'RE 

656
00:25:43,809 --> 00:25:46,044
DOING YOUR TRIAL AND YOU NEED 

657
00:25:46,044 --> 00:25:48,414
IN ORDER TO ANSWER I COULDN'T 

658
00:25:48,414 --> 00:25:51,350
QUESTION, A SAMPLE OF 200 IN 

659
00:25:51,350 --> 00:25:53,585
ORDER TO FIND OUT WHETHER THE 

660
00:25:53,585 --> 00:25:55,220
NEW TREATMENT IS BETTER THAN 

661
00:25:55,220 --> 00:25:56,555
THE OLD TREATMENT.

662
00:25:56,555 --> 00:25:57,990
AND YOU'RE PLAN TO GO DO THAT 

663
00:25:57,990 --> 00:25:59,391
OVER A YEAR.

664
00:25:59,391 --> 00:26:00,559
THE DATA MONITORING COMMITTEE 

665
00:26:00,559 --> 00:26:03,562
IS ALSO LOOKING AT YOUR 

666
00:26:03,562 --> 00:26:05,998
PROGRESS.

667
00:26:05,998 --> 00:26:08,100
SO IF HALFWAY THROUGH, YOU ONLY 

668
00:26:08,100 --> 00:26:11,737
HAVE 50 PARTICIPANTS AND YOU'RE 

669
00:26:11,737 --> 00:26:14,039
ANTICIPATED ENROLLMENT WAS 100, 

670
00:26:14,039 --> 00:26:16,275
THE DATA COMMITTEE MAY SAY, 

671
00:26:16,275 --> 00:26:18,644
OKAY WHAT'S GOING ON?

672
00:26:18,644 --> 00:26:20,512
WHY AREN'T YOU AT WHERE YOU 

673
00:26:20,512 --> 00:26:22,114
WANT TO BE AND WHAT ARE YOU 

674
00:26:22,114 --> 00:26:23,515
DOING TO ADDRESS THAT?

675
00:26:23,515 --> 00:26:24,650
BECAUSE IT'S IMPORTANT FOR A 

676
00:26:24,650 --> 00:26:26,718
TRIAL TO MOVE FORWARD AND IT'S 

677
00:26:26,718 --> 00:26:29,922
FUNDED FOR A CERTAIN PERIOD, NA 

678
00:26:29,922 --> 00:26:31,557
IS IMPORTANT FOR THE DATA 

679
00:26:31,557 --> 00:26:33,192
MONITORING COMMITTEE TO BE 

680
00:26:33,192 --> 00:26:35,260
AWARE, WHAT HAPPENS IF WE CAN'T 

681
00:26:35,260 --> 00:26:37,963
FULLY EN ROLL THE TRIAL?

682
00:26:37,963 --> 00:26:39,531
SO THEY MIGHT SAY, TELL US WHAT 

683
00:26:39,531 --> 00:26:42,935
YOU'RE DOING TO INCREASE 

684
00:26:42,935 --> 00:26:44,736
ENROLLMENT, SO MAY ADD A NEW 

685
00:26:44,736 --> 00:26:47,072
SITE OR THEY MAY DEVELOP 

686
00:26:47,072 --> 00:26:49,141
RELATIONSHIP WZ LOCAL PROVIDERS 

687
00:26:49,141 --> 00:26:50,776
OR SOMETHING, BUT AGAIN, IT'S 

688
00:26:50,776 --> 00:26:53,979
JUST A WAY TO REMIND THE 

689
00:26:53,979 --> 00:26:56,482
INVESTIGATORS FROM AN 

690
00:26:56,482 --> 00:26:57,483
INDEPENDENT EXTERNAL BODY HOW 

691
00:26:57,483 --> 00:26:58,283
THINGS ARE GOING.

692
00:26:58,283 --> 00:27:00,185
AND I SHOULD HAVE MADE THAT 

693
00:27:00,185 --> 00:27:03,188
MORE CLEAR AT THE BEGINNING.

694
00:27:03,188 --> 00:27:04,089
THE DATA MONITORING COMMITTEE 

695
00:27:04,089 --> 00:27:06,391
IS MADE UP OF INDIVIDUALS WHO 

696
00:27:06,391 --> 00:27:08,193
ARE INDEPENDENT FROM THE STUDY 

697
00:27:08,193 --> 00:27:11,663
GENERALLY INDEPENDENT FROM THE 

698
00:27:11,663 --> 00:27:14,132
PIs LOCAL INSTITUTION.

699
00:27:14,132 --> 00:27:16,001
IF FOR EXAMPLE, LET'S SAY YOU 

700
00:27:16,001 --> 00:27:17,336
HAVE A DATA MONITORING 

701
00:27:17,336 --> 00:27:18,971
COMMITTEE AND YOU ADD A NEW 

702
00:27:18,971 --> 00:27:25,010
SITE AND THAT SITE P.I., WORKS 

703
00:27:25,010 --> 00:27:29,882
WITH THE HEAD OF DMC, THE CHAIR 

704
00:27:29,882 --> 00:27:31,517
MAY HAVE TO RECUSE HER OR 

705
00:27:31,517 --> 00:27:32,518
HIMSELF BUT IT'S INDEPENDENT IN 

706
00:27:32,518 --> 00:27:38,257
THE SENSE THAT THEY DON'T HAVE 

707
00:27:38,257 --> 00:27:44,129
ANY EXPECTATION THAT THEY'RE 

708
00:27:44,129 --> 00:27:48,700
DECISIONS ARE SOMEHOW 

709
00:27:48,700 --> 00:27:51,537
INFLUENCED BY OUTSIDE CONCERNS 

710
00:27:51,537 --> 00:27:54,039
OR BIAS.

711
00:27:54,039 --> 00:27:56,141
SO THE DATA MONITORING 

712
00:27:56,141 --> 00:27:59,144
COMMITTEE ALSO HAS WHAT ARE 

713
00:27:59,144 --> 00:28:01,680
REFERRED TO AS IN THE END, 

714
00:28:01,680 --> 00:28:04,383
STOPPING RULES OR INTERIM 

715
00:28:04,383 --> 00:28:06,818
ANALYSIS, THE LAST.

716
00:28:06,818 --> 00:28:08,954
SO ONE THING THAT YOU WANT TO 

717
00:28:08,954 --> 00:28:12,224
MAKE SURE IS TRUE IS THAT YOU 

718
00:28:12,224 --> 00:28:14,426
ARE NOT EXPOSING SUBJECTS TO 

719
00:28:14,426 --> 00:28:18,096
SOMETHING THAT IS OVERLY RISKY 

720
00:28:18,096 --> 00:28:20,165
OR WITHHOLDING SOMETHING OF 

721
00:28:20,165 --> 00:28:22,501
BENEFIT FROM A GROUP WHO COULD 

722
00:28:22,501 --> 00:28:24,937
BENEFIT.

723
00:28:24,937 --> 00:28:28,640
SOLT, INTERIM ANALYSIS IS THE 

724
00:28:28,640 --> 00:28:30,409
DATA MONITORING COMMITTEE 

725
00:28:30,409 --> 00:28:32,644
RECEIVES DATA THAT IS SOMETIMES 

726
00:28:32,644 --> 00:28:34,513
BLINDED IN THE SENSE THAT IT 

727
00:28:34,513 --> 00:28:35,914
DOESN'T SAY THE NAME OF THE 

728
00:28:35,914 --> 00:28:40,018
DRUG A AND THE NAME OF THE DRUG 

729
00:28:40,018 --> 00:28:46,892
B, IT LITERALLY SAYS DRUG A 

730
00:28:46,892 --> 00:28:47,859
VERSUS B.

731
00:28:47,859 --> 00:28:49,828
IT LOOKS LIKE THE NEW DRUG, 

732
00:28:49,828 --> 00:28:52,564
DRUG B OR SORRY, ONE OF THE 

733
00:28:52,564 --> 00:28:54,499
DRUGS, IS DOING MUCH BERT THAN 

734
00:28:54,499 --> 00:28:56,435
THE OTHER.

735
00:28:56,435 --> 00:28:59,004
AND IN TERMS OF AN INTERIM 

736
00:28:59,004 --> 00:29:01,974
ANALYSIS, IT LOOKS LIKE IT'S 

737
00:29:01,974 --> 00:29:04,276
STATISTICALLY DOING BETTER THAN 

738
00:29:04,276 --> 00:29:06,979
THE A IN THIS CASE.

739
00:29:06,979 --> 00:29:09,047
AND SO, THEY COULD DECIDE 

740
00:29:09,047 --> 00:29:10,682
ACCORDING TO THE INTERIM 

741
00:29:10,682 --> 00:29:12,784
ANALYSIS AND THE STOPPING RULES 

742
00:29:12,784 --> 00:29:16,154
THAT, WE HAVE A STATISTICALLY 

743
00:29:16,154 --> 00:29:17,522
SIGNIFICANT DIFFERENCE AT THIS 

744
00:29:17,522 --> 00:29:19,391
POINT EARLIER THAN WE THOUGHT 

745
00:29:19,391 --> 00:29:21,693
AND WE THINK THE TRIAL SHOULD 

746
00:29:21,693 --> 00:29:25,530
BE STOPPED AND THE INTERVENTION 

747
00:29:25,530 --> 00:29:25,797
UNBLINDED.

748
00:29:25,797 --> 00:29:28,033
NOW WHEN YOU UNBLIND THEM, IT 

749
00:29:28,033 --> 00:29:29,901
COULD BE EITHER THAT PEOPLE 

750
00:29:29,901 --> 00:29:31,937
GETTING THE NEW DRUG ARE BETTER 

751
00:29:31,937 --> 00:29:34,973
OR THE PEOPLE GETTING THE OLD 

752
00:29:34,973 --> 00:29:37,509
DRUG ARE BETTER, YOU DON'T KNOW.

753
00:29:37,509 --> 00:29:38,610
BUT YOU KNOW THAT SOMETHING IS 

754
00:29:38,610 --> 00:29:41,246
GOING ON AND IS THERES 

755
00:29:41,246 --> 00:29:41,913
STATISTICALLY SIGNIFICANT 

756
00:29:41,913 --> 00:29:42,214
DIFFERENCE.

757
00:29:42,214 --> 00:29:44,916
AND SO THAT WOULD BE AN EXAMPLE 

758
00:29:44,916 --> 00:29:47,486
OF SHORTENING A TRIAL BECAUSE 

759
00:29:47,486 --> 00:29:51,623
IT'S DOING EVEN BETTER THAN YOU 

760
00:29:51,623 --> 00:29:52,024
IMAGINED.

761
00:29:52,024 --> 00:29:53,825
AND IN THIS CASE, IT COULD BE 

762
00:29:53,825 --> 00:29:55,260
THAT IT'S THE NEW OR THE OLD 

763
00:29:55,260 --> 00:29:58,230
BUT IT'S A REASON TO STOP 

764
00:29:58,230 --> 00:29:59,364
BECAUSE WITHHOLDING THE 

765
00:29:59,364 --> 00:30:01,099
TREATMENT B PUTS THE 

766
00:30:01,099 --> 00:30:03,802
PARTICIPANTS IN A WORSE OFF 

767
00:30:03,802 --> 00:30:06,204
POSITION AND NOT GIVING THE B 

768
00:30:06,204 --> 00:30:09,174
TO THOSE WHO ARE GETTING A, YOU 

769
00:30:09,174 --> 00:30:11,576
KNOW, THEY SHOULD ALL NOW GET 

770
00:30:11,576 --> 00:30:13,311
THE INTERVENTION.

771
00:30:13,311 --> 00:30:17,382
AND THE OTHER THING TO THINK 

772
00:30:17,382 --> 00:30:19,217
ABOUT IS THAT, BAD THINGS CAN 

773
00:30:19,217 --> 00:30:21,253
HAPPEN AS WELL.

774
00:30:21,253 --> 00:30:25,390
SO STOPPING RULES ARE IN PLACE, 

775
00:30:25,390 --> 00:30:27,426
SOMETIMES STOPPING RULES REFER 

776
00:30:27,426 --> 00:30:30,228
TO LIKE, WE, NO MORE THAN ONE 

777
00:30:30,228 --> 00:30:32,864
DEATH ON THE, SO STOPPING RULES 

778
00:30:32,864 --> 00:30:35,634
ARE LAID OUT IN ADVANCE, THAT 

779
00:30:35,634 --> 00:30:37,069
SAY, IF THIS HAPPENS, WE ARE 

780
00:30:37,069 --> 00:30:40,906
GOING TO STOP THE TRIAL.

781
00:30:40,906 --> 00:30:44,543
AND YOU MAY REOPEN THE TRIAL OR 

782
00:30:44,543 --> 00:30:47,245
STOP AND CLOSE THE TRIAL.

783
00:30:47,245 --> 00:30:51,216
SO THAT'S ALL TO SAY THAT 

784
00:30:51,216 --> 00:30:53,518
ESPECIALLY FOR PHASE 3 TRIALS 

785
00:30:53,518 --> 00:30:55,287
AND SOMETIMES TRIALS THAT ARE 

786
00:30:55,287 --> 00:30:59,024
SORT OF HIGH PROFILE OR THERE 

787
00:30:59,024 --> 00:31:03,095
IS A CONCERN ABOUT SEVERE 

788
00:31:03,095 --> 00:31:04,730
ADVERSE AFFECTS, PHASE 22 

789
00:31:04,730 --> 00:31:08,400
STUDIES HAVE DATA COMMITTEES IN 

790
00:31:08,400 --> 00:31:09,601
ORDER TO MAKE SURE THAT THE 

791
00:31:09,601 --> 00:31:11,436
DATA IS COMING OUT IN A 

792
00:31:11,436 --> 00:31:13,138
REASONABLE TIMELY FASHION AND 

793
00:31:13,138 --> 00:31:14,706
THAT NOTHING ESPECIALLY, BAD OR 

794
00:31:14,706 --> 00:31:16,842
ESPECIALLY GOOD IS HAPPENING IN 

795
00:31:16,842 --> 00:31:20,479
ORDER TO STOP IT AS NEEDED.

796
00:31:20,479 --> 00:31:22,881
SO, WITH THAT, I AM GOING TO 

797
00:31:22,881 --> 00:31:25,317
JUST REMIND YOU THAT GOOD STUDY 

798
00:31:25,317 --> 00:31:27,919
DESIGN IS KEY TO CONDUCT OF AN 

799
00:31:27,919 --> 00:31:28,987
ETHICAL STUDY.

800
00:31:28,987 --> 00:31:33,024
AND WOULD BE HAPPY TO ANSWER 

801
00:31:33,024 --> 00:31:33,291
QUESTIONS.

802
00:31:33,291 --> 00:31:38,997
LET ME SEE IF THERE ARE ANY OUT 

803
00:31:38,997 --> 00:31:40,799
IN THE VIDEO LAND.

804
00:31:40,799 --> 00:31:43,535
LOOKS LIKE JONATHAN HAS A 

805
00:31:43,535 --> 00:31:51,042
QUESTION.

806
00:31:51,042 --> 00:31:52,444
>> HI, THANKS HOLLY.

807
00:31:52,444 --> 00:31:56,381
I HAD A QUESTION ABOUT 

808
00:31:56,381 --> 00:31:58,450
THRESHOLD OF CERTAINTY OR 

809
00:31:58,450 --> 00:31:58,750
UNCERTAINTY.

810
00:31:58,750 --> 00:31:59,217
>> YES.

811
00:31:59,217 --> 00:32:00,552
>> LET'S SAY THAT
SCIENTIST 

812
00:32:00,552 --> 00:32:04,456
JUST WANT TO SEE IF A STUDY IS 

813
00:32:04,456 --> 00:32:05,357
REMRIKABLE.

814
00:32:05,357 --> 00:32:15,667
SEEMS THEY HAVE A 

815
00:32:20,205 --> 00:32:21,072
CERTAIN--REPLICATABLE.

816
00:32:21,072 --> 00:32:22,874
>> IT'S ABOUT THE FIRST
TIME 

817
00:32:22,874 --> 00:32:33,251
YOU'RE DOING A STUDY.

818
00:32:36,354 --> 00:32:39,791
>> IN TERMS OF
REPLICATION, 

819
00:32:39,791 --> 00:32:41,893
REPLICATING IS GOOD, IT'S GOOD 

820
00:32:41,893 --> 00:32:43,094
TO REPLICATE THE FINDING AT 

821
00:32:43,094 --> 00:32:45,130
LEAST IN ONE MORE TRIAL, IT'S 

822
00:32:45,130 --> 00:32:46,464
REALLY THE EXCEPTION TO THE 

823
00:32:46,464 --> 00:32:51,002
RULE THAT ONE TRIAL CHANGES 

824
00:32:51,002 --> 00:32:51,403
CLINICAL PRACTICE.

825
00:32:51,403 --> 00:32:52,604
WE CAN TALK ABOUT MORE EXAMPLES 

826
00:32:52,604 --> 00:32:53,905
OF THAT.

827
00:32:53,905 --> 00:32:56,141
BUT OFTEN, IT'S THE CASE THAT 

828
00:32:56,141 --> 00:32:57,776
THIS GROUP IS DOING A TRIAL AND 

829
00:32:57,776 --> 00:32:59,444
THEY FIND THIS AND ANOTHER 

830
00:32:59,444 --> 00:33:00,712
GROUP IS DOING A TRIAL AND THEY 

831
00:33:00,712 --> 00:33:01,546
FIND THIS.

832
00:33:01,546 --> 00:33:04,482
A GROUP OF PEOPLE LOOK AT THE 

833
00:33:04,482 --> 00:33:08,453
DATA AND SAY WE HAVE ENOUGH NOW 

834
00:33:08,453 --> 00:33:10,655
TO CHANGE CLINICAL PRACTICE.

835
00:33:10,655 --> 00:33:14,593
THERE IS VALUE BUT A DIFFERENT 

836
00:33:14,593 --> 00:33:15,560
EXPECTATION OF UNCERTAINTY ONCE 

837
00:33:15,560 --> 00:33:18,063
YOU'VE DONE THE INITIAL TRIAL.

838
00:33:18,063 --> 00:33:20,131
THE OTHER IMPORTANT THING IS, 

839
00:33:20,131 --> 00:33:22,133
I'M SURE YOU ALL KNOW, NOT 

840
00:33:22,133 --> 00:33:23,535
EVERY STUDY ESPECIALLY THOSE 

841
00:33:23,535 --> 00:33:24,736
WITH NEGATIVE RESULTS APPEAR IN 

842
00:33:24,736 --> 00:33:27,339
THE LITERATURE.

843
00:33:27,339 --> 00:33:29,174
SO IT'S ANOTHER REASON WHY IT'S 

844
00:33:29,174 --> 00:33:31,543
REALLY IMPORTANT TO HAVE 

845
00:33:31,543 --> 00:33:33,144
NEGATIVE RESULTS IN THE 

846
00:33:33,144 --> 00:33:36,348
LITERACY, AND I DON'T MEAN BY 

847
00:33:36,348 --> 00:33:38,617
NEGATIVE BY BAD RESULTS.

848
00:33:38,617 --> 00:33:40,886
WHAT I MEAN, LET'S SAY YOU TEST 

849
00:33:40,886 --> 00:33:42,520
A VERSUS B AND YOU FIND OUT 

850
00:33:42,520 --> 00:33:43,788
THEY'RE NO DIFFERENT.

851
00:33:43,788 --> 00:33:45,957
WELL MABLE THE COMPANY THAT 

852
00:33:45,957 --> 00:33:48,927
SPONSORED YOU IS NOT INTERESTED 

853
00:33:48,927 --> 00:33:50,829
IN MOVING FORWARD.

854
00:33:50,829 --> 00:33:51,663
MAYBE THE JOURNAL DOES NOT 

855
00:33:51,663 --> 00:33:53,732
CARE, YOU DIDN'T FIND ANYTHING, 

856
00:33:53,732 --> 00:33:55,533
YOU JUST FOUND THAT THEY'RE THE 

857
00:33:55,533 --> 00:33:56,268
SAME.

858
00:33:56,268 --> 00:33:59,704
IF THAT DOES NOT GO INTO THE 

859
00:33:59,704 --> 00:34:01,339
LIT RA SEWER, AND SOMEBODY SAYS 

860
00:34:01,339 --> 00:34:04,743
HEY I WANT TO KNOW THIS 

861
00:34:04,743 --> 00:34:07,646
QUESTION THEY LOOK IT UP.

862
00:34:07,646 --> 00:34:08,580
SOMETIME THAT COMMUNITY LEVEL 

863
00:34:08,580 --> 00:34:09,981
OF AGREEMENT HAS TO BE MORE 

864
00:34:09,981 --> 00:34:11,549
THAN JUST LOOKING AT THE 

865
00:34:11,549 --> 00:34:12,717
LITERATURE.

866
00:34:12,717 --> 00:34:16,988
SOMETIMES THERE IS A STATE OF 

867
00:34:16,988 --> 00:34:18,890
-OF-THE-ART, NIH WILL SPONSOR 

868
00:34:18,890 --> 00:34:22,127
THINGS LIKE  STATE-OF-THE-ART 

869
00:34:22,127 --> 00:34:24,095
TREATMENT FOR HELP SITES C SO 

870
00:34:24,095 --> 00:34:26,164
THEY GET THE EXPERTS IN THE 

871
00:34:26,164 --> 00:34:28,233
ROOM AND THEY DEVELOP SOMETHING 

872
00:34:28,233 --> 00:34:30,502
LIKE IS A RESEARCH AGENDA THAT 

873
00:34:30,502 --> 00:34:34,406
HAS TO INFLUENCE HOW THE FIELD 

874
00:34:34,406 --> 00:34:34,739
GOES FORWARD.

875
00:34:34,739 --> 00:34:36,908
THAT'S A MORE COMMUNITY 

876
00:34:36,908 --> 00:34:38,143
ENGAGEMENT OF FINDING WHAT TO 

877
00:34:38,143 --> 00:34:39,277
DO NEXT.

878
00:34:39,277 --> 00:34:42,647
BUT OFTEN IT'S REALIZED ON THE 

879
00:34:42,647 --> 00:34:42,948
LITERATURE.

880
00:34:42,948 --> 00:34:43,748
DANIEL?

881
00:34:43,748 --> 00:34:45,684
>> THIS IS SUPER
INTERESTING.

882
00:34:45,684 --> 00:34:48,787
MY QUESTION IS REGARDING THE 

883
00:34:48,787 --> 00:34:49,754
DATA MONITORING COMMITTEES.

884
00:34:49,754 --> 00:34:51,056
>> YES.

885
00:34:51,056 --> 00:34:56,261
>> SO FOR AN IRB THERE IS 

886
00:34:56,261 --> 00:34:57,929
CLINICIAN SCIENTIST, I'M 

887
00:34:57,929 --> 00:35:01,967
WONDERING FOR LIKE THE 

888
00:35:01,967 --> 00:35:03,368
MONITORING COMMUNITIES ARE 

889
00:35:03,368 --> 00:35:04,536
THOSE JUST COMPRISED OF PEOPLE 

890
00:35:04,536 --> 00:35:06,338
THAT ARE GOING TO BE INTERPRET 

891
00:35:06,338 --> 00:35:12,577
RAW  DATA OR DO THEY HAVE 

892
00:35:12,577 --> 00:35:16,514
SCIENTIST LIKE IF IT'S A TRIAL 

893
00:35:16,514 --> 00:35:18,550
RELATED TO CANCER, IS IT GOING 

894
00:35:18,550 --> 00:35:21,886
TO BE MOSTLY ONCOLOGIST?

895
00:35:21,886 --> 00:35:23,021
>> GREAT QUESTION.

896
00:35:23,021 --> 00:35:24,923
AND I'M SORRY I DIDN'T MENTION 

897
00:35:24,923 --> 00:35:25,857
THIS EARLY, SO THANK YOU SO 

898
00:35:25,857 --> 00:35:28,159
MUCH FOR THE QUESTION.

899
00:35:28,159 --> 00:35:29,961
SOL IN GENERAL, THEY ARE AS I 

900
00:35:29,961 --> 00:35:31,763
SAID EITHER ASSIGNED TO A TRIAL 

901
00:35:31,763 --> 00:35:34,399
OR ASSIGNED TO A SET OF RELATED 

902
00:35:34,399 --> 00:35:36,601
TRIALS.

903
00:35:36,601 --> 00:35:38,837
AND SO THERE WILL ALWAYS BE 

904
00:35:38,837 --> 00:35:40,939
EXPERTS IN THAT FIELD ON THE 

905
00:35:40,939 --> 00:35:42,774
DATA MONITORING COMMITTEE OR 

906
00:35:42,774 --> 00:35:44,709
WHOEVER IS CREATING THE DATA 

907
00:35:44,709 --> 00:35:45,677
MONITORING COMMITTEE, WHETHER 

908
00:35:45,677 --> 00:35:49,247
IT'S THE STIRRING COMMITTEE FOR 

909
00:35:49,247 --> 00:35:57,555
A STUDY OR A UPON  A SPONSOR IS 

910
00:35:57,555 --> 00:35:59,958
SAYING YOU MUST HAVE A DMC.

911
00:35:59,958 --> 00:36:01,726
IN ADDITION TO THAT IN MY 

912
00:36:01,726 --> 00:36:05,196
EXPERIENCE, THERE IS ALWAYS A 

913
00:36:05,196 --> 00:36:06,931
BIO STATUS.

914
00:36:06,931 --> 00:36:10,368
RIGHT, I KNOW ENOUGH BIOSTATS 

915
00:36:10,368 --> 00:36:12,237
TO GET ME TO HERE BUT YOU 

916
00:36:12,237 --> 00:36:13,638
REALLY NEED SOMEBODY WHO KNOWS 

917
00:36:13,638 --> 00:36:17,809
A LOT ABOUT BIOSTATISTICS WITH 

918
00:36:17,809 --> 00:36:21,079
SOME OF THESE STUDIES THAT ARE 

919
00:36:21,079 --> 00:36:21,379
COMPLICATED.

920
00:36:21,379 --> 00:36:24,683
AND IN MY EXPERIENCE THERE IS 

921
00:36:24,683 --> 00:36:26,151
AN EMPHASIS--ON THE TABLE, THAT 

922
00:36:26,151 --> 00:36:28,219
IS NOT EVERY GROUP IS GOING TO 

923
00:36:28,219 --> 00:36:37,328
HAVE CONTENT EXPERTS OF 

924
00:36:37,328 --> 00:36:39,531
BIOSTATUS SND TICIAN BUT A LOT 

925
00:36:39,531 --> 00:36:39,831
OF THEM DO.

926
00:36:39,831 --> 00:36:42,600
THE OTHER THING THAT IS TRUE 

927
00:36:42,600 --> 00:36:44,903
THERE IS USUALLY SOMEBODY WHO 

928
00:36:44,903 --> 00:36:53,445
IS IN THE BODY WHO IS A 

929
00:36:53,445 --> 00:36:55,680
BIOSTATUSSTICIAN AND HER OR HIS 

930
00:36:55,680 --> 00:36:58,249
JOB IS TO PREPARE A REPORT FOR 

931
00:36:58,249 --> 00:36:59,617
THE DATA MONITORING COMMITTEE.

932
00:36:59,617 --> 00:37:00,785
AND PART OF THE COMMITTEE IS 

933
00:37:00,785 --> 00:37:03,354
GOING TO BE CLOSED WHICH MEANS 

934
00:37:03,354 --> 00:37:05,457
ONLY COMMITTEE MEMBERS ARE ON, 

935
00:37:05,457 --> 00:37:07,459
BECAUSE THEY'RE GOING TO BE 

936
00:37:07,459 --> 00:37:10,295
GIVEN DATA THAT IF THE P.I. 

937
00:37:10,295 --> 00:37:14,599
SAW, IT MAY BIAS THEIR CHOICE 

938
00:37:14,599 --> 00:37:14,966
OR PARTICIPANT.

939
00:37:14,966 --> 00:37:19,170
SO THERE IS AN INSIDE MAN OR 

940
00:37:19,170 --> 00:37:21,473
WOMEN WHO IS PREPARING THAT 

941
00:37:21,473 --> 00:37:23,108
DATA AND THEY'RE AN EXPERT IN 

942
00:37:23,108 --> 00:37:27,545
THAT FIELD AND THEY WILL GIVE 

943
00:37:27,545 --> 00:37:28,346
BACK.

944
00:37:28,346 --> 00:37:30,148
IN MY EXPERIENCE, AND I KNOW 

945
00:37:30,148 --> 00:37:32,016
DAVE HAS EXPERIENCE TOO, 

946
00:37:32,016 --> 00:37:33,618
THEY'RE RELATIVELY SMALL, THERE 

947
00:37:33,618 --> 00:37:36,287
ARE THREE OR FOUR CONTENT 

948
00:37:36,287 --> 00:37:36,554
NETWORKS.

949
00:37:36,554 --> 00:37:38,456
IF THERE IS A NETWORK TRIAL, 

950
00:37:38,456 --> 00:37:40,592
THERE MAY BE A COUPLE MORE 

951
00:37:40,592 --> 00:37:42,393
BECAUSE YOU NEED MORE EXPERTISE 

952
00:37:42,393 --> 00:37:46,831
TO COVER THE WATER FRONT, AS IT 

953
00:37:46,831 --> 00:37:49,067
WHERE.

954
00:37:49,067 --> 00:37:52,504
NOT ALL IRB HAS THE SPECIFIC 

955
00:37:52,504 --> 00:37:55,540
EXPERT SEES LIKE DATA 

956
00:37:55,540 --> 00:37:56,407
MONITORING COMMITTEE WOULD.

957
00:37:56,407 --> 00:37:57,275
ANYMORE QUESTIONS?

958
00:37:57,275 --> 00:37:58,810
I'M GOING TO CHECK AGAIN TO SEE 

959
00:37:58,810 --> 00:38:05,216
IF THERE IS ANY OTHER OUT IN 

960
00:38:05,216 --> 00:38:06,050
VIDEOLAND.

961
00:38:06,050 --> 00:38:07,218
OKAY.

962
00:38:07,218 --> 00:38:10,021
WELL AS A REMINDER FOLKS, IF 

963
00:38:10,021 --> 00:38:13,024
YOU DO HAVE QUESTIONS, YOU CAN 

964
00:38:13,024 --> 00:38:15,527
PLACE THEM IN THE DISCUSSION 

965
00:38:15,527 --> 00:38:17,228
BOARD UNDER SESSIONING 3 

966
00:38:17,228 --> 00:38:18,530
QUESTIONS.

967
00:38:18,530 --> 00:38:21,232
OH, THERE ARE QUESTIONS, OH MY 

968
00:38:21,232 --> 00:38:21,432
GOSH.

969
00:38:21,432 --> 00:38:23,434
LET'S SEE IF I CAN ANSWER ONE 

970
00:38:23,434 --> 00:38:25,703
MORE BEFORE WE TRANSITION TO 

971
00:38:25,703 --> 00:38:25,904
DAVE.

972
00:38:25,904 --> 00:38:36,114
OKAY, GREAT.

973
00:38:36,648 --> 00:38:39,584
SO COULD YOU GIVE, I'M GOING TO 

974
00:38:39,584 --> 00:38:41,920
SO MAXINE ASKED CAN YOU GIVE 

975
00:38:41,920 --> 00:38:44,422
EXAMPLE OF MOST RESENT STUDIES 

976
00:38:44,422 --> 00:38:46,491
FAIL IN PHASE 3 OR PHASE 4.

977
00:38:46,491 --> 00:38:49,060
I'M TRYING TO UNDERSTAND WHY SO 

978
00:38:49,060 --> 00:38:50,361
MANY INTERVENTIONS DO WELL 

979
00:38:50,361 --> 00:38:53,832
THROUGH PHASE 2 AND THEN CRASH 

980
00:38:53,832 --> 00:38:54,098
AND BURN.

981
00:38:54,098 --> 00:38:55,466
SO BASICALLY, ONE OF THE 

982
00:38:55,466 --> 00:38:59,270
REASONS WHY IT GOES DOWN FROM, 

983
00:38:59,270 --> 00:39:03,875
YOU KNOW, 100 TO IN PHASE 1 

984
00:39:03,875 --> 00:39:09,581
DOWN TO 70 IN PHASE 2 TO DOWN 

985
00:39:09,581 --> 00:39:12,350
TO 30ISH IN PHASE 3, IT'S TIME.

986
00:39:12,350 --> 00:39:14,018
THEY'RE ABOUT SAFETY AND 

987
00:39:14,018 --> 00:39:17,855
BIOLOGICAL METABOLISM OR 

988
00:39:17,855 --> 00:39:19,691
LOOKING IN A PHASE 2 WHETHER OR 

989
00:39:19,691 --> 00:39:21,259
NOT THE PARTICULAR INTERVENTION 

990
00:39:21,259 --> 00:39:24,462
HAS AN AFFECT IN A PARTICULAR 

991
00:39:24,462 --> 00:39:27,198
TYPE OF TUMOR IN ONCOLOGY FOR 

992
00:39:27,198 --> 00:39:29,901
EXAMPLE, IT'S NOT UNTIL PHASE 2 

993
00:39:29,901 --> 00:39:31,736
TRIAL THAT YOU'RE NOW GIVING ME 

994
00:39:31,736 --> 00:39:33,404
INTERVENTION TO A LARGE GROUP 

995
00:39:33,404 --> 00:39:35,406
OF REGULAR OLD PEOPLE IN THE 

996
00:39:35,406 --> 00:39:39,143
SENSE THAT YOU KNOW, YOU'VE 

997
00:39:39,143 --> 00:39:40,245
ONLY EXPOSED RELATIVELY SMALL 

998
00:39:40,245 --> 00:39:42,981
BUZZ IN THE PHASE 1 AND PHASE 2 

999
00:39:42,981 --> 00:39:43,214
TRIALS.

1000
00:39:43,214 --> 00:39:45,850
SO IT'S IN THE PHASE 3 WHERE 

1001
00:39:45,850 --> 00:39:48,486
YOU'RE DOING THE HEAD TO HEAD 

1002
00:39:48,486 --> 00:39:51,389
TESTING OF COMPOUND A VERSUS 

1003
00:39:51,389 --> 00:39:55,827
COMPOUND B OR PLACEBO VERSUS 

1004
00:39:55,827 --> 00:39:56,728
COMPOUND A.

1005
00:39:56,728 --> 00:39:57,795
AND YOU'RE NOT GOING TO FIND 

1006
00:39:57,795 --> 00:39:59,597
THAT THE NEW COMPOUND IS 

1007
00:39:59,597 --> 00:39:59,897
AFFECTIVE.

1008
00:39:59,897 --> 00:40:01,299
YOU'RE DOING THE TRIAL IN ORDER 

1009
00:40:01,299 --> 00:40:02,934
TO ANSWER THE QUESTION.

1010
00:40:02,934 --> 00:40:04,035
YOU ANSWER THE QUESTION, THE 

1011
00:40:04,035 --> 00:40:07,071
QUESTION IS NO, IT DOESN'T MOVE 

1012
00:40:07,071 --> 00:40:07,472
FORWARD TO MARKET.

1013
00:40:07,472 --> 00:40:10,141
NOW THERE COULD BE SOME OTHER 

1014
00:40:10,141 --> 00:40:12,243
COMMERCIAL MARKET FORCE THAT'S 

1015
00:40:12,243 --> 00:40:13,845
INFLUENCE WHETHER A PARTICULAR 

1016
00:40:13,845 --> 00:40:14,913
INTERVENTION GOES TO PHASE OUT 

1017
00:40:14,913 --> 00:40:15,913
TO MARKET.

1018
00:40:15,913 --> 00:40:17,515
IT COULD BE THAT THE DIFFERENCE 

1019
00:40:17,515 --> 00:40:20,485
IS REALLY SMALL OR NOT LARGE 

1020
00:40:20,485 --> 00:40:23,321
ENOUGH TO SAY, WE SHOULD 

1021
00:40:23,321 --> 00:40:24,555
THEREFORE CHANGE PRACTICE.

1022
00:40:24,555 --> 00:40:28,192
BUT GENERALLY, IT'S BECAUSE THE 

1023
00:40:28,192 --> 00:40:30,728
TRIAL, THE QUESTION IS ANSWERED 

1024
00:40:30,728 --> 00:40:32,597
IS IT MORE AFFECTIVE AND THE 

1025
00:40:32,597 --> 00:40:34,933
ANSWER IS NO.

1026
00:40:34,933 --> 00:40:36,000
BUT, WITH THAT, THANK YOU FOR 

1027
00:40:36,000 --> 00:40:38,303
YOUR QUESTIONS AND I'LL ANSWER 

1028
00:40:38,303 --> 00:40:40,405
THE OTHER TWO HERE ON LINE 

1029
00:40:40,405 --> 00:40:43,107
LATER.

1030
00:40:43,107 --> 00:40:46,744
WITH THAT, I'M GOING TO 

1031
00:40:46,744 --> 00:40:47,779
INTRODUCE DAVE WENDLER.

1032
00:40:47,779 --> 00:40:50,415
DAVE IS ALSO A MEMBER OF OUR 

1033
00:40:50,415 --> 00:40:50,848
DEPARTMENT FACULTY.

1034
00:40:50,848 --> 00:40:55,019
HE CAME TO THE NIH BACK IN 1993 

1035
00:40:55,019 --> 00:41:05,496
AS A POST   DOCTORAL FELLOW.

1036
00:41:06,764 --> 00:41:08,299
DAVE HAS BEEN WITH THE 

1037
00:41:08,299 --> 00:41:10,768
DEPARTMENT SINCE 1993 AND HAS A 

1038
00:41:10,768 --> 00:41:11,736
WIDE RANGE OF INTEREST.

1039
00:41:11,736 --> 00:41:14,339
I'M GOING TO MENTION A COME AS 

1040
00:41:14,339 --> 00:41:22,380
THEIR  RELEVANT TO THE CLASS.

1041
00:41:22,380 --> 00:41:23,481
DECISION-MAKING SURROGATE AND 

1042
00:41:23,481 --> 00:41:26,284
AS RELEVANT TO TODAY, 

1043
00:41:26,284 --> 00:41:28,119
SYSTEMATIC EVALUATION OF RISK 

1044
00:41:28,119 --> 00:41:29,320
AND POTENTIAL BENEFITS SO. 

1045
00:41:29,320 --> 00:41:31,356
DAVE, I'M GOING TO HAND IT ON 

1046
00:41:31,356 --> 00:41:31,589
TO YOU.

1047
00:41:31,589 --> 00:41:41,265
HERE IS YOUR CLICKER.

1048
00:41:41,265 --> 00:41:42,333
UNLESS YOU'RE GOING TO MOVE 

1049
00:41:42,333 --> 00:41:43,234
AROUND.

1050
00:41:43,234 --> 00:41:44,969
>> I WOULD LIKE TO.

1051
00:41:44,969 --> 00:41:46,871
>> I'LL GIVE YOU THIS.

1052
00:41:46,871 --> 00:41:57,348
>> I CANNOT CONTROL
MYSELF.

1053
00:42:02,353 --> 00:42:03,154
>> Reporter:.

1054
00:42:03,154 --> 00:42:03,454
WILL THEDER.

1055
00:42:03,454 --> 00:42:04,789
THANKS.

1056
00:42:04,789 --> 00:42:05,990
DOES THAT SOUND OKAY.

1057
00:42:05,990 --> 00:42:07,692
ARE WE OKAY TO GO?

1058
00:42:07,692 --> 00:42:09,394
GOOD MORNING.

1059
00:42:09,394 --> 00:42:12,930
I'M GOING TO TRY TO DO TWO 

1060
00:42:12,930 --> 00:42:15,700
THINGS DURING THIS TALK, WHICH 

1061
00:42:15,700 --> 00:42:19,237
I HOPE DON'T COME OUT AS 

1062
00:42:19,237 --> 00:42:20,004
CONTRADICTORY.

1063
00:42:20,004 --> 00:42:25,443
SO THE TWO THINGS FIRST ARE TO 

1064
00:42:25,443 --> 00:42:28,513
ARGUE THAT DOING RISK BENEFIT 

1065
00:42:28,513 --> 00:42:30,314
ASSESSMENT IS CENTRAL TO THE 

1066
00:42:30,314 --> 00:42:32,417
ETHICS OF CLINICAL RESEARCH.

1067
00:42:32,417 --> 00:42:35,119
BUT, IT'S NOT DONE VERY OFTEN, 

1068
00:42:35,119 --> 00:42:36,954
IT'S NOT DONE SYSTEMATIC I 

1069
00:42:36,954 --> 00:42:38,423
DON'T THINK IT'S DONE VERY WELL.

1070
00:42:38,423 --> 00:42:39,957
AND SO THE FIRST THING I WANT 

1071
00:42:39,957 --> 00:42:43,895
TO DO IS JUST PRESENT A 

1072
00:42:43,895 --> 00:42:47,131
FRAMEWORK FOR DOING SYSTEMATIC 

1073
00:42:47,131 --> 00:42:48,366
ASSESSMENT OF RESEARCH RISK AND 

1074
00:42:48,366 --> 00:42:49,267
THEN MAKE THE ARGUMENT THAT 

1075
00:42:49,267 --> 00:42:53,304
IT'S IMPORTANT TO DO IT 

1076
00:42:53,304 --> 00:42:53,838
SYSTEMATIC.

1077
00:42:53,838 --> 00:42:57,775
AND THIS IS ANTIDOTAL, BUT I'M 

1078
00:42:57,775 --> 00:42:58,676
CONVINCED NOW, I'VE BEEN DOING 

1079
00:42:58,676 --> 00:43:01,078
THIS FOR 30 YEARS, PEOPLE 

1080
00:43:01,078 --> 00:43:02,780
AREN'T JUST DOING THIS AND 

1081
00:43:02,780 --> 00:43:04,382
THEY'RE NOT DOING IT IN A 

1082
00:43:04,382 --> 00:43:06,250
SYSTEMATIC WAY.

1083
00:43:06,250 --> 00:43:09,787
THAT'S THE FIRST PART.

1084
00:43:09,787 --> 00:43:11,923
SO FOR PEOPLE JUST CARE ABOUT 

1085
00:43:11,923 --> 00:43:14,425
THE BASICS OF THIS, THAT 

1086
00:43:14,425 --> 00:43:15,927
FRAMEWORK IS ENOUGH YOU CANNOT 

1087
00:43:15,927 --> 00:43:17,261
PAY ATTENTION TO THE REST OF 

1088
00:43:17,261 --> 00:43:18,429
THE TALK.

1089
00:43:18,429 --> 00:43:22,033
BUT THE SECOND PART OF THE 

1090
00:43:22,033 --> 00:43:26,337
TALK, IS TO THINK SOME OF THE 

1091
00:43:26,337 --> 00:43:27,238
DIFFERENT CHALLENGES, 

1092
00:43:27,238 --> 00:43:28,840
COMPLEXITIES THAT ARISE WHEN 

1093
00:43:28,840 --> 00:43:31,642
YOU START TO THINK ON HOW TO DO 

1094
00:43:31,642 --> 00:43:32,710
RISK A BENEFITS.

1095
00:43:32,710 --> 00:43:35,012
I THINK THE BASICS ARE PRETTY 

1096
00:43:35,012 --> 00:43:36,481
STRAIGHTFORWARD BUT ALSO A LOT 

1097
00:43:36,481 --> 00:43:38,116
OF REALLY INTERESTING QUESTIONS 

1098
00:43:38,116 --> 00:43:39,550
THAT ARISE ONCE YOU START 

1099
00:43:39,550 --> 00:43:41,586
THINKING ABOUT THESE CAREFULLY.

1100
00:43:41,586 --> 00:43:44,622
AND THESE ARE QUESTIONS A LOT 

1101
00:43:44,622 --> 00:43:49,594
OF HAVE NOT BEEN ADDRESSED.

1102
00:43:49,594 --> 00:43:53,030
SORRY, I'M GOING TO TRY TO NOT 

1103
00:43:53,030 --> 00:43:54,332
BE UNPLEASANT DURING THIS TALK.

1104
00:43:54,332 --> 00:43:56,934
OKAY.

1105
00:43:56,934 --> 00:44:01,072
SO, PEOPLE NOW KNOW THE BELMONT 

1106
00:44:01,072 --> 00:44:02,573
REPORT, BELMONT REPORT IS ONE 

1107
00:44:02,573 --> 00:44:05,209
OF IF NOT THE FOUNDING DOCUMENT 

1108
00:44:05,209 --> 00:44:06,210
OF RESEARCH ETHICS IN THE 

1109
00:44:06,210 --> 00:44:07,712
UNITED STATES.

1110
00:44:07,712 --> 00:44:09,580
AND HERE'S SOME THINGS THAT 

1111
00:44:09,580 --> 00:44:11,415
THEY HAVE TO SAY WITH RESPECT 

1112
00:44:11,415 --> 00:44:13,017
TO RISK BENEFIT ASSESSMENT.

1113
00:44:13,017 --> 00:44:15,319
THEY SAY THINGS LIKE WE SHOULD 

1114
00:44:15,319 --> 00:44:17,688
DO IT AS SYSTEMATIC AS WE CAN, 

1115
00:44:17,688 --> 00:44:19,757
AS CLEARLY AS WE CAN.

1116
00:44:19,757 --> 00:44:22,093
I LIKE THIS LAST ONE, WHICH IS 

1117
00:44:22,093 --> 00:44:23,728
NEVER DONE, IS THAT YOU 

1118
00:44:23,728 --> 00:44:27,899
SHOULDN'T JUST DO IT BASED ON 

1119
00:44:27,899 --> 00:44:31,536
INTUITION, BUT RISK BENEFIT 

1120
00:44:31,536 --> 00:44:32,637
ASSESSMENT THEY'RE EMPIRICAL 

1121
00:44:32,637 --> 00:44:36,340
QUESTIONS, IF I TAKE A A DRUG 

1122
00:44:36,340 --> 00:44:37,642
WHAT ARE THE CHANCES IT'S GOING 

1123
00:44:37,642 --> 00:44:38,342
TO HELP ME?

1124
00:44:38,342 --> 00:44:40,444
WHAT ARE THE CHANCES IT GTS 

1125
00:44:40,444 --> 00:44:41,379
GOING TO HURT ME?

1126
00:44:41,379 --> 00:44:43,281
IN ORDER TO ADDRESS THEM, IT'S 

1127
00:44:43,281 --> 00:44:45,883
VALUABLE TO HAVE AS MUCH AS THE 

1128
00:44:45,883 --> 00:44:49,720
RELEVANT DATA AS YOU CAN.

1129
00:44:49,720 --> 00:44:50,688
BELMONT, EMPHASIZED THAT 50 

1130
00:44:50,688 --> 00:44:52,490
YEARS AGO AND BASICALLY NOBODY 

1131
00:44:52,490 --> 00:44:52,723
DOES IT.

1132
00:44:52,723 --> 00:44:53,925
SO ONE OF THE THINGS THAT WE'VE 

1133
00:44:53,925 --> 00:44:55,793
BEEN TRYING TO ARGUE IS TRYING 

1134
00:44:55,793 --> 00:44:57,361
TO CONVINCE PEOPLE OF THE VALUE 

1135
00:44:57,361 --> 00:44:58,529
AND THE IMPORTANCE OF DOING 

1136
00:44:58,529 --> 00:44:59,196
THAT.

1137
00:44:59,196 --> 00:45:00,965
SO I'M JUST GOING TO GIVE.

1138
00:45:00,965 --> 00:45:04,302
SO WHEN I GIVE TALKS, I USUALLY 

1139
00:45:04,302 --> 00:45:08,472
GIVE TWO TANGENTS BUT WHAT I 

1140
00:45:08,472 --> 00:45:12,376
REALIZE IF I PUT THEM ON THE 

1141
00:45:12,376 --> 00:45:15,646
SLIDES, I'M SNEAKING INTO MORE 

1142
00:45:15,646 --> 00:45:15,880
TANGENT.

1143
00:45:15,880 --> 00:45:17,915
THIS IS A PAPER, YOU CAN SEE WE 

1144
00:45:17,915 --> 00:45:22,920
DID 20 YEARS AGO WHEN SEEMA WAS 

1145
00:45:22,920 --> 00:45:24,922
A POST FELLOW.

1146
00:45:24,922 --> 00:45:28,593
AND THIS WAS A SURVEY OF 

1147
00:45:28,593 --> 00:45:31,529
PERSONS WHO HAD WORKED IN 

1148
00:45:31,529 --> 00:45:34,765
PEDIATRIC RESEARCH, REVIEWED 

1149
00:45:34,765 --> 00:45:36,601
PEDIATRIC STUDIES AND WE GAVE 

1150
00:45:36,601 --> 00:45:41,472
HEM A LIST LIKE A BLOOD DRAW, A 

1151
00:45:41,472 --> 00:45:45,076
ALLERGY SKIN TESTING, BONE 

1152
00:45:45,076 --> 00:45:51,582
MARROW, BY OP  BIOPSY OR AND WE 

1153
00:45:51,582 --> 00:45:54,919
ASKED.

1154
00:45:54,919 --> 00:46:00,157
WHEN YOU HEAR SEEMA'S WALK, 

1155
00:46:00,157 --> 00:46:01,058
YOU'LL HEAR MORE.

1156
00:46:01,058 --> 00:46:09,066
THE FOC PUS ARE TWO THINGS, ONE 

1157
00:46:09,066 --> 00:46:11,636
THAT RB CHAIRS SEEM TO BE VERY 

1158
00:46:11,636 --> 00:46:11,902
CAUTIOUS.

1159
00:46:11,902 --> 00:46:13,371
THAT WAS THE FIRST THING.

1160
00:46:13,371 --> 00:46:22,780
THE SECOND THING WAS THAT THIS 

1161
00:46:22,780 --> 00:46:24,849
WAS DISBURSAL, AND ALMOST A 

1162
00:46:24,849 --> 00:46:26,884
THIRD THOUGHT IT WAS MORE THAN 

1163
00:46:26,884 --> 00:46:28,052
A MINOR INCREASE OVER MINIMUM 

1164
00:46:28,052 --> 00:46:28,986
RISK.

1165
00:46:28,986 --> 00:46:36,294
SO WHY ARE WE GETTING SO MUCH 

1166
00:46:36,294 --> 00:46:36,594
DISBURSEION.

1167
00:46:36,594 --> 00:46:38,329
I THOUGHT IT WAS ESPECIALLY 

1168
00:46:38,329 --> 00:46:39,430
INTERESTING, THESE WERE 

1169
00:46:39,430 --> 00:46:40,197
INTERVIEWED.

1170
00:46:40,197 --> 00:46:45,436
WE CALLED UP 188IRB CHAIR 

1171
00:46:45,436 --> 00:46:47,505
PERSONS AND GAVE THEM A LIST 

1172
00:46:47,505 --> 00:46:50,574
AND TOLD ME, ARE THESE MINOR 

1173
00:46:50,574 --> 00:46:50,841
INCREASE?

1174
00:46:50,841 --> 00:46:55,312
SO YOU MULTIPLY 188 TIMES 8 OR 

1175
00:46:55,312 --> 00:46:56,747
9 WHATEVER THE HECK THAT TURNS 

1176
00:46:56,747 --> 00:47:06,724
OUT TO BE, IT'S ALMOST 15,200 

1177
00:47:06,724 --> 00:47:09,126
AND IN ONE CASE ZERO CASES DID 

1178
00:47:09,126 --> 00:47:10,795
ANY OF THE CHAIRPERSON SAY, I 

1179
00:47:10,795 --> 00:47:14,098
DON'T KNOW.

1180
00:47:14,098 --> 00:47:16,634
AND THAT WAS REALLY STRIKE, 

1181
00:47:16,634 --> 00:47:18,035
BECAUSE A LOT OF THESE THINGS 

1182
00:47:18,035 --> 00:47:19,937
THEY DIDN'T HAVE DATA ON AND 

1183
00:47:19,937 --> 00:47:21,372
THEY SHOULD HAVE SAID, I DON'T 

1184
00:47:21,372 --> 00:47:24,175
KNOW BECAUSE I CANNOT DO WHAT 

1185
00:47:24,175 --> 00:47:25,176
BEAUMONT TELLS ME TO DO.

1186
00:47:25,176 --> 00:47:28,813
I CANNOT DO THIS SYSTEMATIC 

1187
00:47:28,813 --> 00:47:30,881
BECAUSE I DON'T HAVE IT AND I 

1188
00:47:30,881 --> 00:47:31,882
DON'T KNOW IT.

1189
00:47:31,882 --> 00:47:34,452
NOBODY DID THAT, SO WHAT'S 

1190
00:47:34,452 --> 00:47:35,553
GOING ON?

1191
00:47:35,553 --> 00:47:37,188
I THINK WHAT PEOPLE ARE DOING 

1192
00:47:37,188 --> 00:47:39,023
IS AND PART OF THE PROMISE AND 

1193
00:47:39,023 --> 00:47:42,626
THIS IS MY PREVIOUS CAREER WITH 

1194
00:47:42,626 --> 00:47:43,594
SPENCE STUDY BIOLOGY, AND I 

1195
00:47:43,594 --> 00:47:45,863
THINK ONE OF THE THINGS WE DID 

1196
00:47:45,863 --> 00:47:47,732
FROM EVOLUTION IS THAT THE 

1197
00:47:47,732 --> 00:47:49,300
REASON WHY WE'RE HERE RIGHT 

1198
00:47:49,300 --> 00:47:54,038
NOW, IS BECAUSE OUR PREDECESSOR 

1199
00:47:54,038 --> 00:47:55,940
WERE PRETTY GOOD ASSESSORS OF 

1200
00:47:55,940 --> 00:47:58,442
RISK AND THEY MADE THOSE 

1201
00:47:58,442 --> 00:48:01,479
ASSESSMENTS, REALLY REALLY FAST.

1202
00:48:01,479 --> 00:48:06,083
SO YOU IMAGINE, TWO 

1203
00:48:06,083 --> 00:48:06,984
POPULATIONS, THEIR SOUNDS IT 

1204
00:48:06,984 --> 00:48:17,495
COULD BE A SABER TOOTH TIGER, 

1205
00:48:18,596 --> 00:48:19,930
THEY STARTED DISCUSSING, COULD 

1206
00:48:19,930 --> 00:48:26,470
THIS BE A SABER TOOTH TIGER.

1207
00:48:26,470 --> 00:48:28,105
THE OTHER GROUP RAN AWAY.

1208
00:48:28,105 --> 00:48:30,941
GUESS WHO SURVIVED AND 

1209
00:48:30,941 --> 00:48:31,242
REPRODUCED?

1210
00:48:31,242 --> 00:48:34,111
THE SECOND ONE.

1211
00:48:34,111 --> 00:48:35,479
WE INHERENTED THIS RESPONSE 

1212
00:48:35,479 --> 00:48:38,215
WHERE WE MAKE RISK ASSESSMENT 

1213
00:48:38,215 --> 00:48:38,516
REALLY FAST.

1214
00:48:38,516 --> 00:48:40,117
THAT CAN BE VALUABLE IN SOME 

1215
00:48:40,117 --> 00:48:42,853
CASES BUT IN OTHER CASES, IT 

1216
00:48:42,853 --> 00:48:44,955
GIVES US TO STRAY ESPECIALLY IN 

1217
00:48:44,955 --> 00:48:46,390
RESEARCH WHERE WE'RE DEALING 

1218
00:48:46,390 --> 00:48:48,459
WITH UNFAMILIAR THINGS WHERE 

1219
00:48:48,459 --> 00:48:52,329
THE THINGS WE RELY ON.

1220
00:48:52,329 --> 00:48:54,031
THAT'S IRB, JUST GIVE YOU ONE 

1221
00:48:54,031 --> 00:48:55,032
ANOTHER EXAMPLE.

1222
00:48:55,032 --> 00:48:57,168
I STARTED TO DO THIS FOR A LONG 

1223
00:48:57,168 --> 00:48:59,937
TIME SO PEOPLE SOMETIMES CALL 

1224
00:48:59,937 --> 00:49:04,675
ME UP AND ASK CAN YOU TELL HELP 

1225
00:49:04,675 --> 00:49:06,510
US DECIDE IF THAT'S HIGH-RISK 

1226
00:49:06,510 --> 00:49:08,112
OR LOW RISK.

1227
00:49:08,112 --> 00:49:13,150
THESE ARE INVESTIGATORS WHO 

1228
00:49:13,150 --> 00:49:22,993
STUDY METABOLISM, THEY OFTEN DO 

1229
00:49:22,993 --> 00:49:26,397
 GLUCOSE TOLERANCE TEST IS MORE 

1230
00:49:26,397 --> 00:49:27,331
THAN MINIMUM RISK.

1231
00:49:27,331 --> 00:49:29,834
AND YOU HAVE TO HELP US 

1232
00:49:29,834 --> 00:49:31,468
CONVINCE THEM WE'RE BECAUSE 

1233
00:49:31,468 --> 00:49:33,671
CONFIDENT THAT THEY'RE MINIMUM 

1234
00:49:33,671 --> 00:49:33,871
RISK.

1235
00:49:33,871 --> 00:49:41,712
AND I SAID GREAT, SO WHEN YOU 

1236
00:49:41,712 --> 00:49:42,379
DO THESE TESTS.

1237
00:49:42,379 --> 00:49:45,649
YOU KNOW WHAT THE GUY SAID TO 

1238
00:49:45,649 --> 00:49:45,816
ME?

1239
00:49:45,816 --> 00:49:48,419
WHAT ARE YOU TALKING ABOUT WHY 

1240
00:49:48,419 --> 00:49:50,754
WITH WE PRESENT DATA THIS IS A 

1241
00:49:50,754 --> 00:49:52,189
RENOWNED RESEARCHER WHO SPEND 

1242
00:49:52,189 --> 00:49:53,524
HIS CAREER COLLECTING DATA BUT 

1243
00:49:53,524 --> 00:49:56,727
WHEN IT COMES TO ETHICS, HE'S 

1244
00:49:56,727 --> 00:50:00,831
LIKE WHAT DATA GOT TO DO WITH 

1245
00:50:00,831 --> 00:50:02,700
THIS, THEY'RE JUST MINIMUM RISK.

1246
00:50:02,700 --> 00:50:04,235
SO NOBODY IS DOING THIS. AND 

1247
00:50:04,235 --> 00:50:07,605
YOU NOTICE THAT PAPER, 30 YEARS 

1248
00:50:07,605 --> 00:50:10,107
AFTER BELMONT, THIS EXAMPLE 

1249
00:50:10,107 --> 00:50:13,744
ALMOST 45 YEARS AFTER BELMONT, 

1250
00:50:13,744 --> 00:50:15,045
IT'S BEEN A LONG TIME AND 

1251
00:50:15,045 --> 00:50:20,384
PEOPLE ARE STILL NOT DOING IT.

1252
00:50:20,384 --> 00:50:23,587
SO THAT'S THE GROUND AND WHY 

1253
00:50:23,587 --> 00:50:25,756
FRAMEWORK AND THEN I'M GOING TO 

1254
00:50:25,756 --> 00:50:26,991
PRESENT ONE.

1255
00:50:26,991 --> 00:50:29,093
DON'T GET TOO WORKED UP.

1256
00:50:29,093 --> 00:50:31,595
I'M GOING TO TALK ABOUT RISK 

1257
00:50:31,595 --> 00:50:33,964
AND BENEFITS AND THEN PEOPLE 

1258
00:50:33,964 --> 00:50:35,666
GET CONFUSED.

1259
00:50:35,666 --> 00:50:37,101
THESE ARE THE TERMS THAT 

1260
00:50:37,101 --> 00:50:38,035
REGULATION USE.

1261
00:50:38,035 --> 00:50:41,171
AND THEN SAY THEY A RISK IS A 

1262
00:50:41,171 --> 00:50:43,507
CHANCE OF A HARM IF I'M GOING 

1263
00:50:43,507 --> 00:50:45,342
TO STICK A KID WITH A NEEDLE, 

1264
00:50:45,342 --> 00:50:48,078
THAT'S GOING TO RISK.

1265
00:50:48,078 --> 00:50:49,680
--HURT.

1266
00:50:49,680 --> 00:50:51,682
THAT MUST BE A RISK THAT MUST 

1267
00:50:51,682 --> 00:50:53,017
BE SOMETHING ELSE.

1268
00:50:53,017 --> 00:50:57,421
NOW THESE ARE TERMS ABOUT RISKS.

1269
00:50:57,421 --> 00:50:59,089
RISKS APPLY TO A THING THAT 

1270
00:50:59,089 --> 00:51:00,391
WHERE YOU'RE NOT SURE THINGS 

1271
00:51:00,391 --> 00:51:02,326
ARE GOING TO HAPPEN OR WHEN 

1272
00:51:02,326 --> 00:51:04,528
YOU'RE SURE THAT BAD THINGS ARE 

1273
00:51:04,528 --> 00:51:05,696
GOING TO HAPPEN.

1274
00:51:05,696 --> 00:51:08,766
AND BENEFIT IS ALSO POTENTIAL 

1275
00:51:08,766 --> 00:51:09,633
BENEFIT, SPECULATIVE AND 

1276
00:51:09,633 --> 00:51:10,634
CHANCES OF BENEFIT.

1277
00:51:10,634 --> 00:51:14,071
SO THINK ABOUT THESE TERMS VERY 

1278
00:51:14,071 --> 00:51:14,305
BROADLY.

1279
00:51:14,305 --> 00:51:16,140
OKAY, SO HERE'S THE FRAMEWORK 

1280
00:51:16,140 --> 00:51:17,808
THIS YOU'RE GOING TO GO THROUGH 

1281
00:51:17,808 --> 00:51:20,544
AND WE'RE TALKING ABOUT OUR 

1282
00:51:20,544 --> 00:51:23,981
WONDERFUL ALUMNS, THE FIRST 

1283
00:51:23,981 --> 00:51:29,186
AUTHOR WAS POST DOCK FELLOW.

1284
00:51:29,186 --> 00:51:33,557
WHAT I'M GOING TO DO IS 

1285
00:51:33,557 --> 00:51:35,826
BASICALLY GO THROUGH, AND 

1286
00:51:35,826 --> 00:51:37,328
DESCRIBE HOW IT WORKS OR SHOULD 

1287
00:51:37,328 --> 00:51:39,463
WORK AND AS I MENTIONED AT THE 

1288
00:51:39,463 --> 00:51:42,232
TOP I'M ALSO GOING TO GO INTO 

1289
00:51:42,232 --> 00:51:52,543
SOME OF THE MORE COMPLEXITIES.

1290
00:51:52,543 --> 00:51:55,479
OKAY, SO TO START, ONE THING TO 

1291
00:51:55,479 --> 00:51:57,548
NOTICE IS THAT, BASICALLY EVERY 

1292
00:51:57,548 --> 00:52:01,852
CLINICAL TRIAL IS A COMPOSITOR 

1293
00:52:01,852 --> 00:52:03,988
AGGREGATE OF LOTS OF DIFFERENT 

1294
00:52:03,988 --> 00:52:04,855
THINGS.

1295
00:52:04,855 --> 00:52:07,157
YOU BRING PEOPLE IN, YOU 

1296
00:52:07,157 --> 00:52:11,929
MEASURE THEM, WEIGH THEM, YOU 

1297
00:52:11,929 --> 00:52:13,831
TAKE BLOOD DRAWS AND GIVE THEM 

1298
00:52:13,831 --> 00:52:15,299
A DRUG AND SCAN.

1299
00:52:15,299 --> 00:52:17,468
SO THERE IS A LOT OF COMPONENT 

1300
00:52:17,468 --> 00:52:20,004
THAT MAKE UP A GIVEN STUDY.

1301
00:52:20,004 --> 00:52:22,906
SO THE POINT IS, WHY ARE YOU 

1302
00:52:22,906 --> 00:52:25,042
DOING THE RISK ASSESSMENT ON IF 

1303
00:52:25,042 --> 00:52:27,511
THERE IS A LOT OF DIFFERENT 

1304
00:52:27,511 --> 00:52:28,412
COMPONENTS?

1305
00:52:28,412 --> 00:52:29,947
THE ANSWER IS, WHAT YOU SHOULD 

1306
00:52:29,947 --> 00:52:35,819
DO IF YOU DO FIRST, ON THE 

1307
00:52:35,819 --> 00:52:37,421
PERSPECTIVE OF IRB.

1308
00:52:37,421 --> 00:52:39,556
ASSESS EACH ONE OF THOSE AND 

1309
00:52:39,556 --> 00:52:40,491
MAKE SURE THEY'RE ACCEPTABLE 

1310
00:52:40,491 --> 00:52:42,393
AND THEN LOOK AT THE AGGREGATE 

1311
00:52:42,393 --> 00:52:44,228
OR THE STUDY AS A WHOLE.

1312
00:52:44,228 --> 00:52:46,096
SO DO BOTH THE COMPONENT AND 

1313
00:52:46,096 --> 00:52:49,667
STUDY AS A WHOLE.

1314
00:52:49,667 --> 00:52:52,002
NOW, NOT ONLY THE LOSS OF 

1315
00:52:52,002 --> 00:52:53,237
INTERVENTION BUT OFTEN 

1316
00:52:53,237 --> 00:52:54,238
DIFFERENT KINDS OF 

1317
00:52:54,238 --> 00:52:54,938
INTERVENTIONS.

1318
00:52:54,938 --> 00:52:57,474
A LOT OF STUDIES WILL INCLUDE 

1319
00:52:57,474 --> 00:52:58,609
CLINICAL AND RESEARCH 

1320
00:52:58,609 --> 00:53:00,978
INTERVENTION SO THIS IS WHAT IS 

1321
00:53:00,978 --> 00:53:03,947
CALLED ADD ON TRIAL WHERE YOU 

1322
00:53:03,947 --> 00:53:05,115
GIVE EVERYBODY STANDARD OF CARE 

1323
00:53:05,115 --> 00:53:07,351
AND FOR THE ONE ARM YOU ADD 

1324
00:53:07,351 --> 00:53:09,853
SOMETHING ON TOP TO SEE IF THAT 

1325
00:53:09,853 --> 00:53:10,721
IMPROVES STANDARD OF CARE.

1326
00:53:10,721 --> 00:53:17,094
SO FOR THE MOST PART, WHAT IRB, 

1327
00:53:17,094 --> 00:53:18,996
THEY HAVE BE EVALUATE THE 

1328
00:53:18,996 --> 00:53:22,466
RESEARCH NOT THE COMPONENT OF 

1329
00:53:22,466 --> 00:53:23,333
CLINICAL CARE.

1330
00:53:23,333 --> 00:53:26,703
AND THIS A STATEMENT TO TRUKT 

1331
00:53:26,703 --> 00:53:28,105
TO DO THAT FROM THE REGULATIONS.

1332
00:53:28,105 --> 00:53:29,973
THEY SHOULD BE LOOKING AT THE 

1333
00:53:29,973 --> 00:53:31,842
RISKS AND BENEFIT FROM THE 

1334
00:53:31,842 --> 00:53:33,610
RESEARCH AND DISTINGUISHED FROM 

1335
00:53:33,610 --> 00:53:36,880
THINGS THAT THERAPY TO SAOUBT 

1336
00:53:36,880 --> 00:53:38,749
EVEN IF THEY WEREN'T IN THE 

1337
00:53:38,749 --> 00:53:39,016
RESEARCH.

1338
00:53:39,016 --> 00:53:40,284
SO THE THOUGHT HERE IS WHY DO 

1339
00:53:40,284 --> 00:53:41,218
YOU DO THAT?

1340
00:53:41,218 --> 00:53:43,554
THE THOUGHT IS IF IT'S 

1341
00:53:43,554 --> 00:53:44,488
CLINICALLY INDICATED THEN THE 

1342
00:53:44,488 --> 00:53:45,789
PROVIAL OF THAT INTERVENTION IS 

1343
00:53:45,789 --> 00:53:47,257
GOING TO BE ACCEPTABLE, THAT'S 

1344
00:53:47,257 --> 00:53:50,394
WHAT IT MEANS ESSENTIALLY FOR 

1345
00:53:50,394 --> 00:53:51,728
IT TO BE INDICATED.

1346
00:53:51,728 --> 00:53:55,065
SO FOR THE MOST PART, IRB DON'T 

1347
00:53:55,065 --> 00:53:57,367
HAVE TO WORRY.

1348
00:53:57,367 --> 00:54:00,604
THE CAVEAT DURING CAVEATS IF WE 

1349
00:54:00,604 --> 00:54:02,339
GO THROUGH THIS TALK.

1350
00:54:02,339 --> 00:54:06,677
HERE THE WORRY WHAT IRBs NEED 

1351
00:54:06,677 --> 00:54:09,847
TO WORRY THAT THE ADD ON IN THE 

1352
00:54:09,847 --> 00:54:12,382
RIGHT ARM OF THE STUDY THAT MAY 

1353
00:54:12,382 --> 00:54:14,451
INFLUENCE THE STANDARD OF CARE.

1354
00:54:14,451 --> 00:54:19,590
IT MIGHT MAKE IT FOR RISKY.

1355
00:54:19,590 --> 00:54:21,825
SO YOU CAN'T COMPLETELY BRAK IT 

1356
00:54:21,825 --> 00:54:23,227
OFF, THE CLINICAL INTERVENTION, 

1357
00:54:23,227 --> 00:54:24,595
YOU HAVE TO THINK ABOUT IF 

1358
00:54:24,595 --> 00:54:26,230
THERE ARE ANY INTERACTIONS 

1359
00:54:26,230 --> 00:54:29,867
BETWEEN THE RESEARCH AND 

1360
00:54:29,867 --> 00:54:30,367
CLINICAL INTERVENTIONS.

1361
00:54:30,367 --> 00:54:34,872
SO HERE'S THE FRAMEWORK, FIRST 

1362
00:54:34,872 --> 00:54:36,273
STEP IS THAT, REMEMBER YOU'VE 

1363
00:54:36,273 --> 00:54:36,440
GOT.

1364
00:54:36,440 --> 00:54:37,241
THIS IS THE STICK FOR THE 

1365
00:54:37,241 --> 00:54:39,743
DEPARTMENT.

1366
00:54:39,743 --> 00:54:41,512
CLINICAL RESEARCH IS NOT 

1367
00:54:41,512 --> 00:54:45,415
ACCEPTABLE UNLESS IT'S SOCIALLY 

1368
00:54:45,415 --> 00:54:45,682
VALUABLE.

1369
00:54:45,682 --> 00:54:48,218
YOU FIRST MAKE SURE THAT FOR 

1370
00:54:48,218 --> 00:54:49,786
EACH OF THE RESEARCH 

1371
00:54:49,786 --> 00:54:51,822
INTERVENTIONS THAT THERE IS A 

1372
00:54:51,822 --> 00:54:53,857
SOCIAL VALUABLE REASON WHY IS 

1373
00:54:53,857 --> 00:54:55,125
THAT INTERVENTION IN A STUDY?

1374
00:54:55,125 --> 00:55:00,764
SO YOU ASK THE INVESTIGATE 

1375
00:55:00,764 --> 00:55:02,799
--INVESTIGATOR, WHAT ARE YOU 

1376
00:55:02,799 --> 00:55:06,336
GOING TO LEARN FROM THE THIRD 

1377
00:55:06,336 --> 00:55:08,105
MRI THAT YOU COULDN'T LEARN 

1378
00:55:08,105 --> 00:55:09,940
FROM THE SECOND AND YOU WANT A 

1379
00:55:09,940 --> 00:55:11,041
GOOD EXPLANATION FOR THAT.

1380
00:55:11,041 --> 00:55:12,409
ONE OF THE THINGS THAT I'M 

1381
00:55:12,409 --> 00:55:16,213
GOING TO EMPHASIZE IS I SIT ON 

1382
00:55:16,213 --> 00:55:18,815
IRBs WHEN I TALK TO PEOPLE IN 

1383
00:55:18,815 --> 00:55:20,484
THE IRB, I TALK ABOUT HOW 

1384
00:55:20,484 --> 00:55:22,553
IMPORTANT THIS IS IN PRACTICE 

1385
00:55:22,553 --> 00:55:23,954
AND I RAT ABOUT THIS.

1386
00:55:23,954 --> 00:55:28,125
AND WHEN THE IRB SAID, OKAY 

1387
00:55:28,125 --> 00:55:29,993
TELL US WHETHER THE RISKS OR 

1388
00:55:29,993 --> 00:55:31,295
BENEFIT OF THIS STUDY ARE 

1389
00:55:31,295 --> 00:55:33,163
ACCEPTABLE?

1390
00:55:33,163 --> 00:55:36,333
AND MY ANSWER IS ALMOST ALWAYS, 

1391
00:55:36,333 --> 00:55:38,335
I HAVE ABSOLUTELY NO IDEA.

1392
00:55:38,335 --> 00:55:39,970
BECAUSE TO MAKE THESE 

1393
00:55:39,970 --> 00:55:41,104
ASSESSMENT WHETHER OR NOT YOU 

1394
00:55:41,104 --> 00:55:45,475
NEED THE THIRD MRI, WHETHER 

1395
00:55:45,475 --> 00:55:47,377
TESTING THIS NEW TREATMENT FOR 

1396
00:55:47,377 --> 00:55:50,380
LEUKEMIA, BEING ABLE TO MAKE 

1397
00:55:50,380 --> 00:55:51,715
THOSE JUDGMENTS, HAVE YOU TO 

1398
00:55:51,715 --> 00:55:53,116
KNOW A LOT YOU HAVE TO KNOW A 

1399
00:55:53,116 --> 00:55:55,552
LOT OF STUFF THAT I JUST DON'T 

1400
00:55:55,552 --> 00:55:57,487
KNOW FOR INSTANCE LEUKEMIA.

1401
00:55:57,487 --> 00:55:59,356
SO WHENEVER YOU NEED THESE, YOU 

1402
00:55:59,356 --> 00:56:03,260
REALLY NEED PEOPLE WHO HAVE 

1403
00:56:03,260 --> 00:56:05,862
CONTENT EXPERTISE TO MAKE THESE 

1404
00:56:05,862 --> 00:56:06,129
JUDGMENTS.

1405
00:56:06,129 --> 00:56:07,664
YOU CAN RELY ON PHILOSOPHER FOR 

1406
00:56:07,664 --> 00:56:10,367
THE FRAMEWORK BUT YOU CANNOT 

1407
00:56:10,367 --> 00:56:13,870
RELY ON PHILOSOPHER TO DO THE 

1408
00:56:13,870 --> 00:56:14,071
WORK.

1409
00:56:14,071 --> 00:56:15,205
YOU PUT THEM ALTOGETHER AS THE 

1410
00:56:15,205 --> 00:56:18,075
PACKAGE THAT THEY ARE AND YOU 

1411
00:56:18,075 --> 00:56:19,876
EVALUATE THE OVERALL STUDY TO 

1412
00:56:19,876 --> 00:56:24,181
SEE IF IT HAS SOCIAL VALUE.

1413
00:56:24,181 --> 00:56:26,216
TYPICALLY, PEOPLE WILL POINT 

1414
00:56:26,216 --> 00:56:28,752
OUT, YOU HOPE TO GATHER 

1415
00:56:28,752 --> 00:56:30,821
IMPORTANT DATA FROM EVERY TRIAL 

1416
00:56:30,821 --> 00:56:32,556
BUT PRESUMABLY AT LEAST IT'S 

1417
00:56:32,556 --> 00:56:34,625
RARE THAT ANY TRIAL IS GOING TO 

1418
00:56:34,625 --> 00:56:36,994
GIVE YOU DEFINITIVE DATA 

1419
00:56:36,994 --> 00:56:40,664
USUALLY YOU HAVE TO COMPARE 

1420
00:56:40,664 --> 00:56:41,798
DATA FROM OTHER TRIALS AND 

1421
00:56:41,798 --> 00:56:43,567
AGAIN THIS REQUIRES A LOT OF 

1422
00:56:43,567 --> 00:56:44,101
EXPERTISE.

1423
00:56:44,101 --> 00:56:46,603
OKAY, SO LET'S JUST TALK ABOUT 

1424
00:56:46,603 --> 00:56:48,905
SOME OF THE CHALLENGES AT THIS 

1425
00:56:48,905 --> 00:56:49,106
STEP.

1426
00:56:49,106 --> 00:56:50,707
SO ONE OF THE THINGS THAT I 

1427
00:56:50,707 --> 00:56:53,210
THINK IS ALWAYS INTERESTING.

1428
00:56:53,210 --> 00:56:57,547
AND MY EXPERIENCE IN BEING IRBs 

1429
00:56:57,547 --> 00:56:59,883
FOR 20 YEARS, THE ANSWER DIFFER 

1430
00:56:59,883 --> 00:57:01,218
TO THIS QUESTION.

1431
00:57:01,218 --> 00:57:05,622
IMAGINE THAT THE INVESTIGATOR, 

1432
00:57:05,622 --> 00:57:07,057
SUBMITS A PROTOCOL TO YOU.

1433
00:57:07,057 --> 00:57:10,027
THAT'S HOW THE IRBs WOFRJT 

1434
00:57:10,027 --> 00:57:12,195
WHAT'S THE JOB OF THE IRB?

1435
00:57:12,195 --> 00:57:15,232
IS THE JOB JUST TO LOOK AT THAT?

1436
00:57:15,232 --> 00:57:18,335
STUDY THAT GOT SUBMITTED TO 

1437
00:57:18,335 --> 00:57:19,770
THEM AND SEE WHETHER OR NOT 

1438
00:57:19,770 --> 00:57:24,374
THAT STUDY IS ETHICALLY 

1439
00:57:24,374 --> 00:57:25,942
APPROPRIATE OR SHOULD SOMEBODY 

1440
00:57:25,942 --> 00:57:28,178
DO, WELL YOU WANT TO DO X WITH 

1441
00:57:28,178 --> 00:57:30,881
THIS POPULATION BUT HERE'S THE 

1442
00:57:30,881 --> 00:57:32,649
OTHER THING THAT WOULD BE MORE 

1443
00:57:32,649 --> 00:57:33,917
VALUABLE, THAT WOULD BE MORE 

1444
00:57:33,917 --> 00:57:35,752
INTERESTING, THAT WOULD GIVE US 

1445
00:57:35,752 --> 00:57:36,720
MORE VALUABLE DATA?

1446
00:57:36,720 --> 00:57:40,157
IS IT THE JOB OF THE IRB OR 

1447
00:57:40,157 --> 00:57:42,392
SOMEBODY ELSE TO MAKE SHE'S 

1448
00:57:42,392 --> 00:57:43,260
COMPARATIVE JUDGMENT ACROSS 

1449
00:57:43,260 --> 00:57:44,895
STUDIES TO THIS STUDY RATHER 

1450
00:57:44,895 --> 00:57:47,030
THAN THAT STUDY?

1451
00:57:47,030 --> 00:57:49,966
THAT AT LEAST THE IRBs I SAT 

1452
00:57:49,966 --> 00:57:51,535
ON, ALMOST NEVER DO MAYBE THEY 

1453
00:57:51,535 --> 00:57:53,637
SHOULD BE DOING IT OR SOMEBODY 

1454
00:57:53,637 --> 00:57:54,571
SHOULD BE DOING IT.

1455
00:57:54,571 --> 00:57:56,206
AND THE OTHER IS COMPARATIVE 

1456
00:57:56,206 --> 00:57:57,641
WITHIN A TRIAL, WELL YOU JUST 

1457
00:57:57,641 --> 00:58:03,213
DESIGNED IT WITH JUST TWO MRIs 

1458
00:58:03,213 --> 00:58:08,185
BUT IF YOU ADD THIRD MRI, IT 

1459
00:58:08,185 --> 00:58:10,253
WOULD MAKE YOUR TRIAL MORE 

1460
00:58:10,253 --> 00:58:10,520
VALUABLE.

1461
00:58:10,520 --> 00:58:12,556
I THINK THE STUDY PROPOSED IS 

1462
00:58:12,556 --> 00:58:14,624
OKAY, BUT HERE'S A MUCH BETTER 

1463
00:58:14,624 --> 00:58:15,826
STUDY.

1464
00:58:15,826 --> 00:58:17,627
SHOULD YOU SAY THEN TO THE VERG 

1465
00:58:17,627 --> 00:58:18,929
YOU CANNOT DO THIS BECAUSE YOU 

1466
00:58:18,929 --> 00:58:21,331
CANNOT DO THIS BETTER ONE.

1467
00:58:21,331 --> 00:58:23,400
OR DOES IT HAVE TO MEET 

1468
00:58:23,400 --> 00:58:24,000
SUFFICIENT STANDARD.

1469
00:58:24,000 --> 00:58:25,936
AND THE QUESTION AS YOU GO 

1470
00:58:25,936 --> 00:58:27,571
THROUGH ABOUT WHO SHOULD MAKE 

1471
00:58:27,571 --> 00:58:28,038
THE JUDGMENTS.

1472
00:58:28,038 --> 00:58:30,574
WE CAN TALK ABOUT ENHANCEMENTS 

1473
00:58:30,574 --> 00:58:33,110
SO THIS ANNETTE AND I USED TO 

1474
00:58:33,110 --> 00:58:35,045
HAVE THIS DEBATE WHEN WE WROTE 

1475
00:58:35,045 --> 00:58:37,214
THAT PAPER.

1476
00:58:37,214 --> 00:58:38,482
SO TYPICALLY, MOST FOCUS ON 

1477
00:58:38,482 --> 00:58:40,517
DISEASES AND ILLNESSES LIKE 

1478
00:58:40,517 --> 00:58:43,019
CANCERS AND THINGS LIKE THAT.

1479
00:58:43,019 --> 00:58:44,921
BUT WHAT ABOUT TRIALS TO DO 

1480
00:58:44,921 --> 00:58:46,523
WHAT PEOPLE CALL ENHANCEMENTS 

1481
00:58:46,523 --> 00:58:48,825
WHICH IS NOT TO TREAT AN 

1482
00:58:48,825 --> 00:58:50,961
ILLNESS OR DISEASE BUT TO MAKE 

1483
00:58:50,961 --> 00:58:52,963
PEOPLE WHO ARE HEALTHY EVEN 

1484
00:58:52,963 --> 00:58:55,532
BETTER OFF, TO MAKE THEM LIVE 

1485
00:58:55,532 --> 00:58:55,766
LONGER?

1486
00:58:55,766 --> 00:58:58,502
IS THAT IS EQUALLY VALUABLE AS 

1487
00:58:58,502 --> 00:58:59,736
DOING SOMETHING LIKE TREATING 

1488
00:58:59,736 --> 00:59:00,804
CANCER?

1489
00:59:00,804 --> 00:59:02,672
AND AGAIN, SHOULD PEOPLE BE 

1490
00:59:02,672 --> 00:59:04,474
MAKING THOSE ASSESSMENTS AND IF 

1491
00:59:04,474 --> 00:59:07,744
SO WHO SHOULD BE MAKING THEM?

1492
00:59:07,744 --> 00:59:10,213
SO THIS IS JUST SOME 

1493
00:59:10,213 --> 00:59:10,514
SUGGESTIONS.

1494
00:59:10,514 --> 00:59:11,882
I WHAT I GIVE THAT PREVIOUS 

1495
00:59:11,882 --> 00:59:17,687
SLIDE, I GET A LOT OF PUSH BACK 

1496
00:59:17,687 --> 00:59:19,322
FROM IRBs FOLKS, THAT'S WHAT 

1497
00:59:19,322 --> 00:59:20,457
YOU HAVE BEEN DOING.

1498
00:59:20,457 --> 00:59:22,993
SO I TRIED TO COLLECT SOME 

1499
00:59:22,993 --> 00:59:24,594
EVIDENCE TO SUGGEST IN SOME 

1500
00:59:24,594 --> 00:59:26,430
CASES I THINK IRBs SHOULD BE 

1501
00:59:26,430 --> 00:59:29,199
DOING THAT AND THESE ARE CASES, 

1502
00:59:29,199 --> 00:59:31,501
NOW INTERESTINGLY THEY'RE FROM 

1503
00:59:31,501 --> 00:59:32,736
PANDEMICS OR EPIDEMICS SO THE 

1504
00:59:32,736 --> 00:59:37,574
FIRST ONE WAS IN WEST AFRICA 

1505
00:59:37,574 --> 00:59:38,909
DURING EBOLA, WHERE THE PROBLEM 

1506
00:59:38,909 --> 00:59:40,577
WAS THERE IS ONLY SO MANY 

1507
00:59:40,577 --> 00:59:40,844
PATIENTS.

1508
00:59:40,844 --> 00:59:42,446
AND ALL OF A SUDDEN, YOU'VE GOT 

1509
00:59:42,446 --> 00:59:44,948
ALL OF THIS MONEY AND RESOURCES 

1510
00:59:44,948 --> 00:59:49,085
GOING INTO THE AREA TO STUDY 

1511
00:59:49,085 --> 00:59:49,286
EBOLA.

1512
00:59:49,286 --> 00:59:50,821
AND WHAT THESE GUYS POINT WAS, 

1513
00:59:50,821 --> 00:59:54,090
IS THAT THERE IS A LIMITED 

1514
00:59:54,090 --> 00:59:55,325
AMOUNT OF PATIENTS FOR ALL THE 

1515
00:59:55,325 --> 00:59:56,393
STUDIES THAT WE WANT TO DO.

1516
00:59:56,393 --> 00:59:58,495
SO IF WE WANT TO GET THE MOST 

1517
00:59:58,495 --> 00:59:59,563
SOCIAL VALUE OUT OF THIS 

1518
00:59:59,563 --> 01:00:00,931
SITUATION WE'RE GOING TO NEED 

1519
01:00:00,931 --> 01:00:02,933
TO PRIORITIZE WHICH OF THE 

1520
01:00:02,933 --> 01:00:04,401
STUDIES WE ALLOW TO ACCESS 

1521
01:00:04,401 --> 01:00:05,535
THESE PATIENTS AND WHICH ONES 

1522
01:00:05,535 --> 01:00:07,604
WE DON'T AND THEN A SIMILAR 

1523
01:00:07,604 --> 01:00:09,973
THING, THIS IS ARGUMENTS MORE 

1524
01:00:09,973 --> 01:00:11,875
RECENTLY DURING COVID WHERE 

1525
01:00:11,875 --> 01:00:13,944
THERE IS ARGUMENTS EARLY IN THE 

1526
01:00:13,944 --> 01:00:17,080
PANDEMIC, WE WANTED LEARN AS 

1527
01:00:17,080 --> 01:00:20,183
MUCH AS WE COULD ABOUT COULD 

1528
01:00:20,183 --> 01:00:21,985
VID, AT LEAST INITIALLY IN THE 

1529
01:00:21,985 --> 01:00:23,820
LONG RUN THERE WERE LOTS AND 

1530
01:00:23,820 --> 01:00:27,190
LOTS OF PATIENT BUT INITIALLY 

1531
01:00:27,190 --> 01:00:32,195
THERE WEREN'T THAT MANY.

1532
01:00:32,195 --> 01:00:36,366
THESE, THIS GROUP ARGUED THAT 

1533
01:00:36,366 --> 01:00:38,101
WITHIN INSTITUTIONS, SO FOR 

1534
01:00:38,101 --> 01:00:39,669
INSTANCE THE NIH CLINICAL 

1535
01:00:39,669 --> 01:00:43,173
CENTER SHOULD BE PRIORITIZING, 

1536
01:00:43,173 --> 01:00:48,645
JOHN HOPKINS, SO THAT'S 

1537
01:00:48,645 --> 01:00:49,880
POTENTIAL BENEFIT SOCIAL VALUE.

1538
01:00:49,880 --> 01:00:51,515
SO THE NEXT THING TO LOOK AT IS 

1539
01:00:51,515 --> 01:00:52,382
THE RISKS.

1540
01:00:52,382 --> 01:00:54,951
SO THE IDEA IS TO IDENTIFY THE 

1541
01:00:54,951 --> 01:00:58,121
RISK OF  EACH OF THE 

1542
01:00:58,121 --> 01:00:59,089
INDIVIDUALS INTERVENTIONS AND 

1543
01:00:59,089 --> 01:01:01,291
TRY TO REDUCE THEM TO THE 

1544
01:01:01,291 --> 01:01:03,193
EXTENT THAT YOU CAN.

1545
01:01:03,193 --> 01:01:06,596
NOW I'LL COME BACK TO THIS IN A 

1546
01:01:06,596 --> 01:01:06,830
SECOND.

1547
01:01:06,830 --> 01:01:08,565
ONE THING THAT EVERYBODY AGREES 

1548
01:01:08,565 --> 01:01:10,667
IN THIS STEP IS YOU SHOULD LOOK 

1549
01:01:10,667 --> 01:01:13,837
AT ALL THE RISKS THAT I VERY 

1550
01:01:13,837 --> 01:01:14,170
VERY BROADWAY.

1551
01:01:14,170 --> 01:01:16,873
SO OBVIOUSLY THAT MEANS HEALTH 

1552
01:01:16,873 --> 01:01:18,441
RISKS, LIKE IS THIS DRUG GOING 

1553
01:01:18,441 --> 01:01:22,746
TO KNOCK OUT MY KIDNEYS AND I'M 

1554
01:01:22,746 --> 01:01:27,384
GOING TO BE ON DIALYSIS THE 

1555
01:01:27,384 --> 01:01:28,985
REST OF MY LIFE.

1556
01:01:28,985 --> 01:01:31,488
FOR INSTANCE, ECONOMIC RISKS.

1557
01:01:31,488 --> 01:01:35,091
WHAT IF KNOCKING OUT MY KIDNEYS 

1558
01:01:35,091 --> 01:01:38,562
I HAVE A COPAYMENT OF 1,000 AND 

1559
01:01:38,562 --> 01:01:40,564
I'M GOING TO PAY THOUSANDS TO 

1560
01:01:40,564 --> 01:01:44,668
GET THAT KIDNEY PROBLEM FIXED, 

1561
01:01:44,668 --> 01:01:48,104
HOW ABOUT PSYCHOLOGICAL HARMS 

1562
01:01:48,104 --> 01:01:56,846
OF BEING ON DIALYSIS, NOW I'M 

1563
01:01:56,846 --> 01:01:58,882
DIALYSIS AND THERE IS A STIGMA.

1564
01:01:58,882 --> 01:02:01,985
I'M GOING TO TALK ABOUT 

1565
01:02:01,985 --> 01:02:02,419
POTENTIAL BENEFITS.

1566
01:02:02,419 --> 01:02:04,621
IT SEEMS RIGHT, PEOPLE CARE 

1567
01:02:04,621 --> 01:02:06,856
MORE THAN THEIR BODIES, THEY 

1568
01:02:06,856 --> 01:02:08,959
CARE ABOUT THEIR BANK ACCOUNTS, 

1569
01:02:08,959 --> 01:02:10,694
SOME CARE MORE ABOUT THEIR BANK 

1570
01:02:10,694 --> 01:02:12,295
ACCOUNTS THAN THAT ARE BODIES 

1571
01:02:12,295 --> 01:02:14,931
SO WE SHOULD BE WORRIED ABOUT 

1572
01:02:14,931 --> 01:02:15,865
ALL TYPES OF RISKS.

1573
01:02:15,865 --> 01:02:17,667
SO THERE IS A COUPLE OF 

1574
01:02:17,667 --> 01:02:19,769
CHALLENGES WITH THIS, AND THE 

1575
01:02:19,769 --> 01:02:21,738
BASIC IDEA IS WHAT THIS STEP 

1576
01:02:21,738 --> 01:02:23,540
SAYS, IS IN ORDER TO DECIDE 

1577
01:02:23,540 --> 01:02:25,342
WHETHER A STUDY IS ACCEPTABLE 

1578
01:02:25,342 --> 01:02:27,243
BEFORE IT CAN BEGIN, THE IRB 

1579
01:02:27,243 --> 01:02:31,548
HAS TO MAKE SURE THAT THE RISKS 

1580
01:02:31,548 --> 01:02:31,915
ARE ACCEPTABLE.

1581
01:02:31,915 --> 01:02:33,249
OBVIOUSLY CONUNDRUM IS THAT IS 

1582
01:02:33,249 --> 01:02:35,251
THE POINT OF CLINICAL TRIALS, 

1583
01:02:35,251 --> 01:02:37,153
AT LEAST EARLY PHASES TRIALS 

1584
01:02:37,153 --> 01:02:38,555
ARE DESIGNED TO FIGURE OUT WHAT 

1585
01:02:38,555 --> 01:02:40,023
THE RISKS OF A GIVEN 

1586
01:02:40,023 --> 01:02:40,757
INTERVENTION ARE.

1587
01:02:40,757 --> 01:02:43,093
SO THE GOAL OF THE TRIAL IS TO 

1588
01:02:43,093 --> 01:02:45,095
FIND OUT WHAT THE RISKS ARE HOW 

1589
01:02:45,095 --> 01:02:49,032
ARE YOU EVALUATE WHETHER THOSE 

1590
01:02:49,032 --> 01:02:50,200
RISKS ARE ACCEPTABLE.

1591
01:02:50,200 --> 01:02:51,868
IT SEEMS LIKE YOU'VE GOT TO DO 

1592
01:02:51,868 --> 01:02:53,269
THE TRIAL BEFORE YOU DECIDE 

1593
01:02:53,269 --> 01:02:54,404
WHETHER THE TRIAL IS ETHICAL TO 

1594
01:02:54,404 --> 01:02:56,006
DO.

1595
01:02:56,006 --> 01:02:58,141
SO IN THIS, THEY NEED TO BE 

1596
01:02:58,141 --> 01:03:01,344
CREATIVE, THEY NEED TO EXPAND 

1597
01:03:01,344 --> 01:03:02,412
BEYOND THE GIVEN INTERVENTION 

1598
01:03:02,412 --> 01:03:04,147
IF THERE IS NO DATA.

1599
01:03:04,147 --> 01:03:05,482
SOMETIMES THERE IS, SOMETIMES 

1600
01:03:05,482 --> 01:03:06,916
THIS INTERVENTION HAS BEEN USED 

1601
01:03:06,916 --> 01:03:08,718
BEFORE IN OTHER POPULATIONS SEE 

1602
01:03:08,718 --> 01:03:10,987
HOW YOU CAN EXTRAPOLATE TO THIS 

1603
01:03:10,987 --> 01:03:12,656
POPULATION.

1604
01:03:12,656 --> 01:03:13,857
SOMETIMES THIS SPECIFIC DRUG 

1605
01:03:13,857 --> 01:03:15,659
HAS NOT BEEN GIVEN TO THIS 

1606
01:03:15,659 --> 01:03:17,027
POPULATION BUT DRUGS OF THE 

1607
01:03:17,027 --> 01:03:18,428
SAME CLASS HAS BEEN GIVEN AND 

1608
01:03:18,428 --> 01:03:21,131
YOU TRY TO EXTRAPOLATE FROM 

1609
01:03:21,131 --> 01:03:23,566
THAT DATA AND MAYBE THERE IS A 

1610
01:03:23,566 --> 01:03:24,401
MECHANISM.

1611
01:03:24,401 --> 01:03:27,604
SO BASICALLY, THEY'RE TRYING TO 

1612
01:03:27,604 --> 01:03:29,606
MAKE ARGUMENT FOR SIMILAR AND 

1613
01:03:29,606 --> 01:03:31,074
SEEING HOW YOU CAN APPLY THEM 

1614
01:03:31,074 --> 01:03:31,975
TO THIS ONE.

1615
01:03:31,975 --> 01:03:33,777
WITH THE THOUGHT THAT THE 

1616
01:03:33,777 --> 01:03:35,378
FURTHER YOU'RE EXTRAPOLATING, 

1617
01:03:35,378 --> 01:03:37,881
THE GREATER THE UNCERTAINTY AND 

1618
01:03:37,881 --> 01:03:39,516
THEN YOU SHOULD FACTOR INTO THE 

1619
01:03:39,516 --> 01:03:42,252
RISK ASSESSMENT WITH A THOUGHT 

1620
01:03:42,252 --> 01:03:44,354
THAT THE MORE UNCERTAIN YOU ARE 

1621
01:03:44,354 --> 01:03:46,423
THE RISKIER THE INTERVENTION OR 

1622
01:03:46,423 --> 01:03:46,690
STUDY IS.

1623
01:03:46,690 --> 01:03:49,759
SO HERE'S ANOTHER CHALLENGE.

1624
01:03:49,759 --> 01:03:51,327
THE FIRST ONE WAS YOU'VE FWOT 

1625
01:03:51,327 --> 01:03:52,562
TO KNOW SOMETHING ABOUT THE 

1626
01:03:52,562 --> 01:03:53,229
INTERVENTION.

1627
01:03:53,229 --> 01:03:56,166
HERE THE POINT IS, YOU HAVE TO 

1628
01:03:56,166 --> 01:03:57,333
KNOW WHO THE INTERVENTION IS 

1629
01:03:57,333 --> 01:03:59,135
GOING TO BE PUT INTO?

1630
01:03:59,135 --> 01:04:02,772
SO THE RISK OF A CERTAIN DRUG 

1631
01:04:02,772 --> 01:04:03,940
CAN VERY DRAMATICALLY DEPENDING 

1632
01:04:03,940 --> 01:04:05,542
ON WHO IS GOING TO RECEIVE IT 

1633
01:04:05,542 --> 01:04:07,377
BUT YOU DON'T KNOW WHO IS GOING 

1634
01:04:07,377 --> 01:04:10,447
TO RECEIVE IT UNTIL THE TRIAL 

1635
01:04:10,447 --> 01:04:10,680
STARTS.

1636
01:04:10,680 --> 01:04:11,715
SO THE EXAMPLE I HAVE HERE, IS 

1637
01:04:11,715 --> 01:04:14,718
DRUGS THAT ARE CLEARED BY THE 

1638
01:04:14,718 --> 01:04:16,586
KIDNEYS, THEY MAY BE VERY SAFE 

1639
01:04:16,586 --> 01:04:20,957
FOR PEOPLE THAT HAVE GOOD 

1640
01:04:20,957 --> 01:04:21,324
KIDNEY FUNCTION.

1641
01:04:21,324 --> 01:04:23,560
BUT THEY MAY BE VERY DANGEROUS 

1642
01:04:23,560 --> 01:04:27,697
THE DRUG MAY BE BUILDUP IN THE 

1643
01:04:27,697 --> 01:04:29,733
PEOPLE THAT ARE KIDNEY FUNCTION.

1644
01:04:29,733 --> 01:04:32,068
THE OTHER IS TO EXTENT OF RISK 

1645
01:04:32,068 --> 01:04:33,403
AND BENEFITS DEPEND ON WHO EN 

1646
01:04:33,403 --> 01:04:34,704
ROLLS IN THE STUDY.

1647
01:04:34,704 --> 01:04:39,309
SO THE WAY IRBs TRY TO HANDLE 

1648
01:04:39,309 --> 01:04:41,144
THIS IS WITH EXCLUSION AND 

1649
01:04:41,144 --> 01:04:42,545
INCLUSION, YOU TRY TO FIGURE 

1650
01:04:42,545 --> 01:04:44,848
OUT WHO IS GOING TO PHASE 

1651
01:04:44,848 --> 01:04:46,216
EXCESSIVE RISKS AND THEN YOU 

1652
01:04:46,216 --> 01:04:47,217
TRY TO EXCLUDE THEM.

1653
01:04:47,217 --> 01:04:49,352
THE OTHER THING THAT I 

1654
01:04:49,352 --> 01:04:50,053
MENTIONED HERE, IS THE 

1655
01:04:50,053 --> 01:04:51,621
IMPORTANCE, SOMETIMES YOU JUST 

1656
01:04:51,621 --> 01:04:53,022
DON'T KNOW HOW GIVEN DRUG IS 

1657
01:04:53,022 --> 01:04:54,424
GOING TO AFFECT PEOPLE.

1658
01:04:54,424 --> 01:04:55,792
SO THERE IS IMPORTANCE OF 

1659
01:04:55,792 --> 01:04:57,193
MONITORING THE TRIAL AS YOU GO 

1660
01:04:57,193 --> 01:05:00,396
ALONG AND THIS GOES BACK TO 

1661
01:05:00,396 --> 01:05:01,564
HOLLY'S TALK IF YOU START TO 

1662
01:05:01,564 --> 01:05:04,300
MONITORING IN THE THIRD OR 

1663
01:05:04,300 --> 01:05:05,668
FOURTH PARTICIPANT, YOU START 

1664
01:05:05,668 --> 01:05:07,570
TO SEE A TREND OF SIGNIFICANT 

1665
01:05:07,570 --> 01:05:09,906
HARM, YOU NEED TO STOP THE 

1666
01:05:09,906 --> 01:05:12,275
STUDY AND REEVALUATE AND SEE 

1667
01:05:12,275 --> 01:05:15,011
WHETHER OR NOT IT'S OKAY TO 

1668
01:05:15,011 --> 01:05:15,311
KEEP GOING.

1669
01:05:15,311 --> 01:05:17,113
OKAY, SO LET'S GET INTO MORE OF 

1670
01:05:17,113 --> 01:05:18,448
THE WEEDS.

1671
01:05:18,448 --> 01:05:21,417
I ADDED THIS ONE YESTERDAY TO 

1672
01:05:21,417 --> 01:05:23,186
MAKE SURE I REALLY DRIVE YOU 

1673
01:05:23,186 --> 01:05:23,753
GUYS NUTS.

1674
01:05:23,753 --> 01:05:26,923
SO WHEN I TALK ABOUT RISK, I'VE 

1675
01:05:26,923 --> 01:05:28,358
BEEN TALKING ABOUT THE RISKS TO 

1676
01:05:28,358 --> 01:05:30,193
THE INDIVIDUAL WHO ARE IN THE 

1677
01:05:30,193 --> 01:05:30,393
STUDY.

1678
01:05:30,393 --> 01:05:32,996
AND THAT'S THE RISK ASSESSMENT 

1679
01:05:32,996 --> 01:05:35,598
IN CLINICAL RESEARCH IS DONE.

1680
01:05:35,598 --> 01:05:37,634
MORE RECENTLY PEOPLE START 

1681
01:05:37,634 --> 01:05:39,502
TODAY WORRY ABOUT THE RISK THAT 

1682
01:05:39,502 --> 01:05:41,571
ARE CALLED THIRD PARTIES SO. 

1683
01:05:41,571 --> 01:05:44,274
HERE'S AN OBVIOUS EXAMPLE.

1684
01:05:44,274 --> 01:05:45,875
CHALLENGE TRIALS ARE TRIALS 

1685
01:05:45,875 --> 01:05:49,746
WHERE YOU TAKE AN INFECTIOUS 

1686
01:05:49,746 --> 01:05:52,048
AGENT LIKE A VIRUS AND INJECT 

1687
01:05:52,048 --> 01:05:54,117
IT INTO A COUPLE OF RESEARCH 

1688
01:05:54,117 --> 01:05:55,652
PARTICIPANT AND SEE WHAT 

1689
01:05:55,652 --> 01:05:56,019
HAPPENS.

1690
01:05:56,019 --> 01:05:57,821
MAYBE YOU'RE GOING TO TEST 

1691
01:05:57,821 --> 01:05:58,721
DIFFERENT TREATMENT OR THE 

1692
01:05:58,721 --> 01:06:01,724
NATURAL HISTORY OF DISORDER.

1693
01:06:01,724 --> 01:06:03,560
SO OBVIOUSLY INJECTING VIRUSES 

1694
01:06:03,560 --> 01:06:05,328
POSES RISK TO THEM, THAT'S WHAT 

1695
01:06:05,328 --> 01:06:06,863
WE'VE BEEN TALKING ABOUT.

1696
01:06:06,863 --> 01:06:10,600
BUT THE POINT HERE, IS THAT CAN 

1697
01:06:10,600 --> 01:06:13,102
POSE RISK TO OTHER PEOPLE IF 

1698
01:06:13,102 --> 01:06:14,470
YOU'RE IN RESPECTING THE 

1699
01:06:14,470 --> 01:06:15,738
PARTICIPANT AND THE PARTICIPANT 

1700
01:06:15,738 --> 01:06:18,007
WORK WITH THE NURSE SXZ THEY GO 

1701
01:06:18,007 --> 01:06:19,375
ON WEEKEND PASSES, THE 

1702
01:06:19,375 --> 01:06:20,877
PARTICIPANTS GO HOME, THEY 

1703
01:06:20,877 --> 01:06:22,912
COULD TRANSMIT THAT INFECTION 

1704
01:06:22,912 --> 01:06:28,117
TO LOTS OF OTHER PEOPLE.

1705
01:06:28,117 --> 01:06:31,254
SO WHAT DO YOU THINK?

1706
01:06:31,254 --> 01:06:32,722
THAT MEANS, I WILL NOT FORCE 

1707
01:06:32,722 --> 01:06:34,591
PEOPLE TO THINK.

1708
01:06:34,591 --> 01:06:37,727
THAT SEEMS LIKE WE SHOULD TAKE 

1709
01:06:37,727 --> 01:06:39,462
THAT INTO ACCOUNT?

1710
01:06:39,462 --> 01:06:40,930
DON'T YOU AGREE?

1711
01:06:40,930 --> 01:06:44,834
SO YOU SHOULD TAKE THIRD PARTY 

1712
01:06:44,834 --> 01:06:46,569
RISKS INTO ACCOUNT?

1713
01:06:46,569 --> 01:06:48,504
SO THESE ARE SOME REAL EXAMPLES.

1714
01:06:48,504 --> 01:06:51,774
WE DID AN ETHICS GROUNDS ON 

1715
01:06:51,774 --> 01:06:56,079
THIS, ABOUT TEN YEARS AGO.

1716
01:06:56,079 --> 01:06:59,449
WHERE WHERE THERE WAS A 

1717
01:06:59,449 --> 01:07:02,151
PARTICIPANT WHO WAS A PERFECT 

1718
01:07:02,151 --> 01:07:03,786
CANDIDATE FOR THE STUDY AND 

1719
01:07:03,786 --> 01:07:10,493
THEY OFFERED A CHANCE OF 

1720
01:07:10,493 --> 01:07:11,995
PARTICIPANT.

1721
01:07:11,995 --> 01:07:14,697
AND THE PARTICIPANT COULDN'T 

1722
01:07:14,697 --> 01:07:15,531
LEAVE PEOPLE BEHIND.

1723
01:07:15,531 --> 01:07:17,033
SO WITH THE POTENTIAL 

1724
01:07:17,033 --> 01:07:18,668
PARTICIPANT WAS GOING TO DO WAS 

1725
01:07:18,668 --> 01:07:22,639
GOING TO DRIVE FROM THE WEST TO 

1726
01:07:22,639 --> 01:07:23,573
BATHESTA WITH THOSE TWO PEOPLE 

1727
01:07:23,573 --> 01:07:24,607
IN THE CAR.

1728
01:07:24,607 --> 01:07:27,443
AND THE HOME PHYSICIAN WAS 

1729
01:07:27,443 --> 01:07:29,712
REALLY WORRIED THAT THAT DRIVE 

1730
01:07:29,712 --> 01:07:30,947
COULD BE DANGEROUS TO THE OTHER 

1731
01:07:30,947 --> 01:07:32,081
TWO PEOPLE.

1732
01:07:32,081 --> 01:07:34,183
NOT THE PARTICIPANT BUT TO THE 

1733
01:07:34,183 --> 01:07:35,518
OTHER TWO PEOPLE.

1734
01:07:35,518 --> 01:07:37,420
ANOTHER EXAMPLE WE JUST HEARD 

1735
01:07:37,420 --> 01:07:40,189
IN A RESENT ETHIC GROUNDS WAS, 

1736
01:07:40,189 --> 01:07:46,162
PARTICIPANT WHO WAS UNDERGOING 

1737
01:07:46,162 --> 01:07:47,563
PULMONARY TRANSPLANT, THAT 

1738
01:07:47,563 --> 01:07:49,399
REQUIRED THEM TO STAY HERE FOR 

1739
01:07:49,399 --> 01:07:53,036
ABOUT 3 MONTHS T.TURNS OUT THEY 

1740
01:07:53,036 --> 01:07:54,837
HAD KIDS THAT WERE VERY 

1741
01:07:54,837 --> 01:07:56,673
ATTACHED AND PEOPLE WERE 

1742
01:07:56,673 --> 01:07:58,241
WORRIED THAT THE PARTICIPANT 

1743
01:07:58,241 --> 01:08:01,644
BEING AWAY FROM THE THREE KIDS 

1744
01:08:01,644 --> 01:08:02,912
FOR THREE MONTHS WOULD BE 

1745
01:08:02,912 --> 01:08:04,447
TRAUMATIC FOR THE KIDS THAT HAD 

1746
01:08:04,447 --> 01:08:06,616
TO BE WATCHED BY THE 

1747
01:08:06,616 --> 01:08:06,950
GRANDPARENTS.

1748
01:08:06,950 --> 01:08:10,520
IT TURNS OUT IN THAT CASE, THEY 

1749
01:08:10,520 --> 01:08:12,588
DID COME AND PARTICIPATED AND 

1750
01:08:12,588 --> 01:08:14,424
IT WAS REALLY TRAUMATIC FOR THE 

1751
01:08:14,424 --> 01:08:15,558
TWO LITTLE KIDS.

1752
01:08:15,558 --> 01:08:19,762
AND THIS IS A COUPLE OF YEARS 

1753
01:08:19,762 --> 01:08:21,297
LATER EXAMINE THE KIDS ARE 

1754
01:08:21,297 --> 01:08:22,498
STILL EXPERIENCING THE AFFECTS 

1755
01:08:22,498 --> 01:08:24,500
OF IT.

1756
01:08:24,500 --> 01:08:27,971
SO IN THE SECOND POOL, WE SAY 

1757
01:08:27,971 --> 01:08:31,307
OF COURSE YOU SHOULD TAKE 

1758
01:08:31,307 --> 01:08:33,876
ACCOUNT OF THIRD PARTY'S.

1759
01:08:33,876 --> 01:08:35,745
IF YOU HAVE TO DRIVE MORE THAN 

1760
01:08:35,745 --> 01:08:37,513
50 MILES TO GET HERE, YOU CAN'T 

1761
01:08:37,513 --> 01:08:39,616
BE IN OUR TRIAL?

1762
01:08:39,616 --> 01:08:42,385
THEN WE HAVE TO GET ALL OF THIS 

1763
01:08:42,385 --> 01:08:44,420
INFORMATION ABOUT HOW MANY KIDS 

1764
01:08:44,420 --> 01:08:46,522
THEY HAVE AND WHETHER THEY FLY 

1765
01:08:46,522 --> 01:08:47,023
OR DRIVE.

1766
01:08:47,023 --> 01:08:49,625
NOT ONLY IS THAT INTRUSIVE BUT 

1767
01:08:49,625 --> 01:08:51,327
IT BECOMES TO BE TOO MUCH.

1768
01:08:51,327 --> 01:08:53,396
SO I THINK THIS IS A REALLY 

1769
01:08:53,396 --> 01:08:54,864
CHALLENGE BOTH IT SEEMS LIKE 

1770
01:08:54,864 --> 01:08:56,833
SOMETHING WE SHOULD BE DOING ON 

1771
01:08:56,833 --> 01:09:01,137
THE ONE HAND BUT THEN WHEN YOU 

1772
01:09:01,137 --> 01:09:02,038
GENERALIZE THE PRINCIPAL IT 

1773
01:09:02,038 --> 01:09:02,839
SEEMS IMPOSSIBLE TO DO.

1774
01:09:02,839 --> 01:09:05,775
AND I HAVE NO IDEA WHAT THE 

1775
01:09:05,775 --> 01:09:10,279
ANSWER TO THIS PUZZLE IS AND IF 

1776
01:09:10,279 --> 01:09:11,914
ANYBODY KNOWS THIS, I WOULD BE 

1777
01:09:11,914 --> 01:09:13,516
INTERESTED TO HEAR DURING THE 

1778
01:09:13,516 --> 01:09:14,851
QUESTION AND ANSWER.

1779
01:09:14,851 --> 01:09:16,953
OKAY, NOW THE A LITTLE BIT OF 

1780
01:09:16,953 --> 01:09:21,591
IF PHILOSOPHY OF SCIENCE, THAT 

1781
01:09:21,591 --> 01:09:23,026
GETS YOU TO THINK A LITTLE BIT.

1782
01:09:23,026 --> 01:09:25,328
SO WE'VE BEEN TALKING ABOUT 

1783
01:09:25,328 --> 01:09:27,196
RISK AND INTERVENTIONS LIKE 

1784
01:09:27,196 --> 01:09:30,666
GIVING SOMEBODY A DRUG.

1785
01:09:30,666 --> 01:09:32,535
RIGHT YOU INJECT SOMEBODY WITH 

1786
01:09:32,535 --> 01:09:33,369
A DRUG.

1787
01:09:33,369 --> 01:09:34,570
WHAT ARE THE RISK?

1788
01:09:34,570 --> 01:09:35,838
WELL IT'S THE POTENTIAL THAT 

1789
01:09:35,838 --> 01:09:37,840
HARMS ARE GOING TO BE 

1790
01:09:37,840 --> 01:09:39,342
EXPERIENCED AS A RESULT OF THAT.

1791
01:09:39,342 --> 01:09:40,610
THAT SEEMS PRETTY EASY TO 

1792
01:09:40,610 --> 01:09:41,177
IMAGINE.

1793
01:09:41,177 --> 01:09:42,812
WHAT IS IMPORTANT TO NOTICE 

1794
01:09:42,812 --> 01:09:45,181
THOUGH, IN SOME CASES IT 

1795
01:09:45,181 --> 01:09:46,716
DOESN'T MATTER, IT'S IMMATERIAL 

1796
01:09:46,716 --> 01:09:49,752
POLICITY BUT IN SOME CASES IT'S 

1797
01:09:49,752 --> 01:09:51,187
REALLY IMPORTANT THAT WHENEVER 

1798
01:09:51,187 --> 01:09:53,956
WE DO RISK MANAGEMENT 

1799
01:09:53,956 --> 01:09:55,091
ASSESSMENT, WE'RE APPEALING TO 

1800
01:09:55,091 --> 01:09:57,126
SOME BASE LINE OR COMPARISON 

1801
01:09:57,126 --> 01:09:58,795
WHERE WE'RE MAKE THE JUDGMENT.

1802
01:09:58,795 --> 01:10:00,129
SO HERE'S AN EXAMPLE.

1803
01:10:00,129 --> 01:10:01,964
DOES A PHASE 2 OF A TREATMENT 

1804
01:10:01,964 --> 01:10:06,602
THAT HAS BEEN SHOWN SAFE, IT 

1805
01:10:06,602 --> 01:10:08,171
OFFERS A SMALL CHANCE TO THEY 

1806
01:10:08,171 --> 01:10:09,539
HAVE A SERIOUS ILLNESS AND 

1807
01:10:09,539 --> 01:10:11,340
THERE IS A SMALL CHANCE THAT 

1808
01:10:11,340 --> 01:10:18,681
THIS WILL HELP THEM.

1809
01:10:18,681 --> 01:10:21,350
SO IT'S SUPPOSE TO BE A TRICK 

1810
01:10:21,350 --> 01:10:23,686
QUESTION, ANYBODY WANT TO TAKE 

1811
01:10:23,686 --> 01:10:25,955
A SHOT AND ADDRESS THE CLICK OR 

1812
01:10:25,955 --> 01:10:27,023
SHOULD I CLICK TO THE NEXT 

1813
01:10:27,023 --> 01:10:29,592
SLIDE.

1814
01:10:29,592 --> 01:10:31,527
IT DEPENDS, SO IT DEPENDS ON 

1815
01:10:31,527 --> 01:10:32,161
WHAT?

1816
01:10:32,161 --> 01:10:33,529
IT DEPENDS ON WHAT IS GOING TO 

1817
01:10:33,529 --> 01:10:35,398
HAPPEN TO THESE PEOPLE IF THEY 

1818
01:10:35,398 --> 01:10:37,233
DON'T EN ROLL IN MY TRIAL.

1819
01:10:37,233 --> 01:10:39,135
OUTSIDE OF MY TRIAL, THEY WOULD 

1820
01:10:39,135 --> 01:10:41,404
NOT GET ANYTHING THEY WOULD 

1821
01:10:41,404 --> 01:10:44,006
JUST SIT AT HOME AND WATCH TV 

1822
01:10:44,006 --> 01:10:45,641
THEN BEING IN THE TRIAL IS 

1823
01:10:45,641 --> 01:10:46,242
BENEFICIAL FOR THEM BECAUSE 

1824
01:10:46,242 --> 01:10:47,643
THERE IS A SMALL CHANCE OF 

1825
01:10:47,643 --> 01:10:49,946
BENEFIT.

1826
01:10:49,946 --> 01:10:52,648
A SMALL CHANCE OF BENEFIT IS 

1827
01:10:52,648 --> 01:10:54,450
BETTER THAN NO CHANCE.

1828
01:10:54,450 --> 01:10:56,052
SO OVERALL, THE COMPARISON IS 

1829
01:10:56,052 --> 01:10:57,954
POTENTIAL BENEFIT.

1830
01:10:57,954 --> 01:10:59,188
BUT IN CONTRAST, IMAGINE THERE 

1831
01:10:59,188 --> 01:11:00,756
IS A DRUG THAT CURES THIS 

1832
01:11:00,756 --> 01:11:02,859
DISEASE, YOU TAKE IT ONCE AND 

1833
01:11:02,859 --> 01:11:03,793
IT CURES YOU.

1834
01:11:03,793 --> 01:11:07,530
IF THE CHOICE IS BETWEEN TAKE 

1835
01:11:07,530 --> 01:11:09,098
ITING THE DRUG AND BEING ON MY 

1836
01:11:09,098 --> 01:11:13,269
TRIAL, IT LOOKS REALLY RISKY.

1837
01:11:13,269 --> 01:11:19,642
BEING IN MY TRIAL BEN BEING 

1838
01:11:19,642 --> 01:11:29,752
CURED.

1839
01:11:32,255 --> 01:11:34,056
IS THIS, WHAT THE COMPARISON 

1840
01:11:34,056 --> 01:11:37,760
IS, OR WHAT IS AVAILABLE TO 

1841
01:11:37,760 --> 01:11:41,864
PEOPLE OTHERWISE, THERE IS 

1842
01:11:41,864 --> 01:11:42,999
DRAMATICALLY, VARIES DRAUM YOU 

1843
01:11:42,999 --> 01:11:44,767
CANLY IN THE U.S. AND ACROSS 

1844
01:11:44,767 --> 01:11:46,502
THE WORLD.

1845
01:11:46,502 --> 01:11:48,371
SO WHAT THAT MEANS IN THE END 

1846
01:11:48,371 --> 01:11:50,306
IS WHETHER A STUDY IS 

1847
01:11:50,306 --> 01:11:52,875
BENEFICIAL OR RISKY, IS GOING 

1848
01:11:52,875 --> 01:11:54,377
TO DEPEND ON WHERE YOU DO IT.

1849
01:11:54,377 --> 01:11:56,712
IF YOU DO IT IN CERTAIN 

1850
01:11:56,712 --> 01:12:01,551
POPULATIONS, IT MAY BE 

1851
01:12:01,551 --> 01:12:03,653
BENEFICIAL, IT MAY BE RISKY.

1852
01:12:03,653 --> 01:12:07,056
THAT'S CLICK ATED --COMPLICATED 

1853
01:12:07,056 --> 01:12:09,225
AND IT DRIVES PEOPLE NUTS.

1854
01:12:09,225 --> 01:12:10,860
SO IT'S IMPORTANT TO KNOW IF 

1855
01:12:10,860 --> 01:12:12,295
THESE PEOPLE WEREN'T IN OUR 

1856
01:12:12,295 --> 01:12:14,297
TRIAL WHAT WOULD HAPPEN TO THEM 

1857
01:12:14,297 --> 01:12:15,998
INSTEAD AND HOW DOES WHAT WE'RE 

1858
01:12:15,998 --> 01:12:17,834
PROPOSE TO GO DO WITH THEM IN 

1859
01:12:17,834 --> 01:12:19,835
THE TRIAL COMPARED TO WHAT WHAT 

1860
01:12:19,835 --> 01:12:20,970
HAPPEN TO THEM INSTEAD?

1861
01:12:20,970 --> 01:12:24,440
AND THE TRIAL MAY BE RISKY IN 

1862
01:12:24,440 --> 01:12:25,508
SOME PLACES BUT BENEFICIAL IN 

1863
01:12:25,508 --> 01:12:25,975
OTHERS.

1864
01:12:25,975 --> 01:12:28,978
IS THERE GOING TO BE A SESSION, 

1865
01:12:28,978 --> 01:12:30,146
INTERNATIONAL, SO SOMEBODY IS 

1866
01:12:30,146 --> 01:12:31,514
PROBABLY GOING TO TALK ABOUT 

1867
01:12:31,514 --> 01:12:31,714
THIS.

1868
01:12:31,714 --> 01:12:33,916
THIS IS A BIG DEAL ESPECIALLY 

1869
01:12:33,916 --> 01:12:36,185
WHEN YOU TALK ABOUT RESEARCH IN 

1870
01:12:36,185 --> 01:12:37,520
INTERNATIONAL SETTINGS AND THIS 

1871
01:12:37,520 --> 01:12:41,724
THIS WAS A BIG DEAL IN H.I. 

1872
01:12:41,724 --> 01:12:43,593
V.STUDIES ABOUT 30 YEARS AGO 

1873
01:12:43,593 --> 01:12:45,928
THAT TURNED INTO BIG FIGHTS.

1874
01:12:45,928 --> 01:12:48,631
WHICH STILL IS TRUE, NOT AS 

1875
01:12:48,631 --> 01:12:51,100
MUCH AS IT USED TO BE.

1876
01:12:51,100 --> 01:12:53,002
20-30 YEARS AGO IF YOU LIVED IN 

1877
01:12:53,002 --> 01:12:54,003
CERTAIN PLACES, THERE WERE VERY 

1878
01:12:54,003 --> 01:12:56,872
VERY GOOD TREATMENTS FOR H.I.V.

1879
01:12:56,872 --> 01:12:57,773
IN OTHER PARTS OF THE WORLD 

1880
01:12:57,773 --> 01:13:00,243
WHERE THERE WAS A LOT OF 

1881
01:13:00,243 --> 01:13:01,244
H.I.V., THOSE TREATMENTS WERE 

1882
01:13:01,244 --> 01:13:02,345
NOT AVAILABLE.

1883
01:13:02,345 --> 01:13:04,614
SO NOW IMAGINE   YOU HAVE THIS 

1884
01:13:04,614 --> 01:13:05,748
IDEA OF SUPER CHEAP DRUG THAT 

1885
01:13:05,748 --> 01:13:07,850
IS NOT AS GOOD AS THE FANCY 

1886
01:13:07,850 --> 01:13:10,853
ONES YOU CAN GET IN MARYLAND 

1887
01:13:10,853 --> 01:13:12,655
BUT BETTER THAN NOTHING.

1888
01:13:12,655 --> 01:13:17,393
NOW, NOTICE IF YOU RAN THAT 

1889
01:13:17,393 --> 01:13:18,427
TRIAL IN MARYLAND IT'S GOING TO 

1890
01:13:18,427 --> 01:13:20,630
BE LIKE THE EXAMPLE THAT WE 

1891
01:13:20,630 --> 01:13:21,764
GAVE BEFORE WHERE THERE IS A 

1892
01:13:21,764 --> 01:13:23,633
CHANCE OF A CURE BEFORE, BUT 

1893
01:13:23,633 --> 01:13:25,301
LIKE A REALLY GOOD TREATMENT.

1894
01:13:25,301 --> 01:13:29,071
WHERE IT LOOKS LIKE A RISKY AND 

1895
01:13:29,071 --> 01:13:29,705
MAYBE UNETHICAL STUDY.

1896
01:13:29,705 --> 01:13:32,141
BUT IF YOU DO IT IN AFRICA 

1897
01:13:32,141 --> 01:13:35,544
WHERE THEY DON'T HAVE ACCESS TO 

1898
01:13:35,544 --> 01:13:37,280
THOSE TREATMENTS.

1899
01:13:37,280 --> 01:13:38,114
IT LOOKS LIKE THIS IS 

1900
01:13:38,114 --> 01:13:39,148
BENEFICIAL.

1901
01:13:39,148 --> 01:13:40,349
BUT NOW WHAT YOU'RE SAYING IS 

1902
01:13:40,349 --> 01:13:43,552
THAT A TRIAL THAT UNETHICAL TO 

1903
01:13:43,552 --> 01:13:45,721
DO HERE BECAUSE THE RISK IS 

1904
01:13:45,721 --> 01:13:47,823
GOOD TO DO IN AFRICA.

1905
01:13:47,823 --> 01:13:49,959
AND THAT MADE PEOPLE REALLY 

1906
01:13:49,959 --> 01:13:52,862
NERVOUS TO SAY THAT AND SOME 

1907
01:13:52,862 --> 01:13:54,263
PEOPLE THOUGHT THAT THEY MUST 

1908
01:13:54,263 --> 01:13:55,865
BE WRONG SOMEHOW AND WE HAVE TO 

1909
01:13:55,865 --> 01:13:58,100
FIGURE OUT AND THERE WERE SOME 

1910
01:13:58,100 --> 01:13:59,535
HUGE FIGHTS ABOUT THIS.

1911
01:13:59,535 --> 01:14:01,337
THE IMPORTANT POINT IS THE 

1912
01:14:01,337 --> 01:14:02,705
COMPARISON, CAN HAVE REALLY 

1913
01:14:02,705 --> 01:14:04,473
PRACTICAL IMPLICATIONS FOR SOME 

1914
01:14:04,473 --> 01:14:05,074
OF THESE TRIALS.

1915
01:14:05,074 --> 01:14:07,810
OKAY.

1916
01:14:07,810 --> 01:14:10,513
THERE IS END OF PHILOSOPHY FOR 

1917
01:14:10,513 --> 01:14:11,113
A SECOND.

1918
01:14:11,113 --> 01:14:15,451
SO NOW WE'VE IDENTIFIED THE 

1919
01:14:15,451 --> 01:14:16,018
INTERVENTION INTERVENTIONS.

1920
01:14:16,018 --> 01:14:18,321
I JUST DO THIS BECAUSE THIS IS 

1921
01:14:18,321 --> 01:14:20,323
PERSONAL TRAUMA FOR ME, I STILL 

1922
01:14:20,323 --> 01:14:22,458
GET FREAKED OUT BY BLOOD DRAWS 

1923
01:14:22,458 --> 01:14:26,028
I HAD AN INCREDIBLY HARD TIME 

1924
01:14:26,028 --> 01:14:28,931
WHEN I WAS A LITTLE KID, I 

1925
01:14:28,931 --> 01:14:30,066
STILL DO ACTUALLY.

1926
01:14:30,066 --> 01:14:33,969
AND THEN I'VE GOTTEN DOZEN OF 

1927
01:14:33,969 --> 01:14:35,304
BLOOD DRAWS AND THEN A NURSE 

1928
01:14:35,304 --> 01:14:37,173
SAYS TO ME LOOK OUT THE WINDOW.

1929
01:14:37,173 --> 01:14:38,774
AND I LOOKED OUT THE WINDOW AND 

1930
01:14:38,774 --> 01:14:40,609
SHE DID IT AND I SAID ARE YOU 

1931
01:14:40,609 --> 01:14:44,146
GOING TO DO IT AND IT SHE SAYS, 

1932
01:14:44,146 --> 01:14:45,314
WE'RE DONE.

1933
01:14:45,314 --> 01:14:53,923
IT'S NOT THE SENSATION, IT'S  

1934
01:14:53,923 --> 01:14:55,925
SEEING THIS THING GOING INTO 

1935
01:14:55,925 --> 01:14:57,994
YOUR BODY AND IT JUST WENT AWAY.

1936
01:14:57,994 --> 01:15:00,830
WE KNOW PEOPLE WHO KNOW WHAT 

1937
01:15:00,830 --> 01:15:02,665
THEY'RE DOING AND PEOPLE TO BE 

1938
01:15:02,665 --> 01:15:04,533
CREATIVE IN HOW THEY'RE DOING 

1939
01:15:04,533 --> 01:15:05,000
THIS STUFF.

1940
01:15:05,000 --> 01:15:10,206
I KNOW THAT PEOPLE JIGGLING OF 

1941
01:15:10,206 --> 01:15:14,343
THE CHEEK, MY DENTIST, SORRY 

1942
01:15:14,343 --> 01:15:18,280
THESE ARE ANY TANGENTS, IF I'M 

1943
01:15:18,280 --> 01:15:19,615
LATE, I'M SORRY.

1944
01:15:19,615 --> 01:15:21,450
NERVE PATHS SO IF YOU STICK 

1945
01:15:21,450 --> 01:15:22,852
SOMEBODY DOWN HERE, THE REASON 

1946
01:15:22,852 --> 01:15:24,920
WHY IT HITSER, ALL OF THESE 

1947
01:15:24,920 --> 01:15:27,056
NERVE PATHWAY AND YOUR BRAIN 

1948
01:15:27,056 --> 01:15:28,190
DOES SOME COMPLICATED THINGS 

1949
01:15:28,190 --> 01:15:32,762
AND IT SAYS OUCH.

1950
01:15:32,762 --> 01:15:35,965
WELL, THESE PATHWAY COMES 

1951
01:15:35,965 --> 01:15:38,734
TOGETHER AT VARIOUS POINTS.

1952
01:15:38,734 --> 01:15:41,203
THEY CAN'T TRANSMIT MORE THAN 

1953
01:15:41,203 --> 01:15:43,172
ONE SIGNAL.

1954
01:15:43,172 --> 01:15:46,475
AND SOME OF THOSE NERVE 

1955
01:15:46,475 --> 01:15:48,944
PATHWAYS PRIOR SIZE SORT OF 

1956
01:15:48,944 --> 01:15:51,313
DULL POUNDING SENSATIONS OVER 

1957
01:15:51,313 --> 01:15:53,783
SHARP STICKY ONES.

1958
01:15:53,783 --> 01:15:57,653
MY DENTIST USED TO DO, WHEN MY 

1959
01:15:57,653 --> 01:15:59,522
DENTIST WAS STICKING THAT BIG 

1960
01:15:59,522 --> 01:16:01,791
NEEDLE IN MY CHEEK, WHAT YOU DO 

1961
01:16:01,791 --> 01:16:05,861
IS JIGGLE MY CHEEK AND THAT 

1962
01:16:05,861 --> 01:16:07,296
DULL SENSATION WILL GET 

1963
01:16:07,296 --> 01:16:08,864
PRIORITIZED AND I WOULD NOT 

1964
01:16:08,864 --> 01:16:10,733
FEEL THE GETTING STUCK.

1965
01:16:10,733 --> 01:16:12,768
I THINK I WAS 40 BEFORE 

1966
01:16:12,768 --> 01:16:15,104
SOMEBODY DID THAT TO ME, AND I 

1967
01:16:15,104 --> 01:16:17,139
THOUGHT PEOPLE SHOULD BE DOING 

1968
01:16:17,139 --> 01:16:18,307
THIS MORE OFTEN.

1969
01:16:18,307 --> 01:16:20,810
OKAY, SECOND POINT IS SOMETIMES 

1970
01:16:20,810 --> 01:16:24,814
YOU MINUTE EYES RISK IS DO 

1971
01:16:24,814 --> 01:16:27,750
LESS, DO FEWER BLOOD DRAW AND 

1972
01:16:27,750 --> 01:16:31,387
FEWER MRIs BUT IT CAN UNDERMINE 

1973
01:16:31,387 --> 01:16:34,056
THE SOCIAL VALUE WHERE WE HAVE 

1974
01:16:34,056 --> 01:16:35,991
TO BALANCE.

1975
01:16:35,991 --> 01:16:37,460
THE FAIRNESS ISSUE IS ALSO THIS 

1976
01:16:37,460 --> 01:16:40,996
IS ONE THAT WE'VE HAD HUGE 

1977
01:16:40,996 --> 01:16:43,632
DEBATE IN OUR DEPARTMENTS OVER 

1978
01:16:43,632 --> 01:16:46,268
YEARS.

1979
01:16:46,268 --> 01:16:49,071
HERE'S ANOTHER WAYS TO 

1980
01:16:49,071 --> 01:16:51,140
AGGREGATE, EX CLUE ANYBODY WHO 

1981
01:16:51,140 --> 01:16:53,209
FACES REALLY HIGH-RISK FROM IT.

1982
01:16:53,209 --> 01:16:55,978
IF YOU DO THAT, YOU'RE GOING TO 

1983
01:16:55,978 --> 01:16:57,813
MINIMIZE THED AGGREGATE RISK 

1984
01:16:57,813 --> 01:17:00,583
BUT AT THE SAME TIME, THE STUDY 

1985
01:17:00,583 --> 01:17:04,753
HAS A CHANCE FOR BENEFIT.

1986
01:17:04,753 --> 01:17:06,222
AND SOME PEOPLE, ORGANIZE THAT 

1987
01:17:06,222 --> 01:17:06,589
THAT'S UNFAIR.

1988
01:17:06,589 --> 01:17:07,323
OKAY.

1989
01:17:07,323 --> 01:17:10,759
SO HERE'S SOME EXAMPLES.

1990
01:17:10,759 --> 01:17:12,828
EXPERIMENTAL DRUG FOR SERIOUS 

1991
01:17:12,828 --> 01:17:15,130
CONDITIONS WITH VERY FEW 

1992
01:17:15,130 --> 01:17:15,531
AFFECTIVE OPTIONS.

1993
01:17:15,531 --> 01:17:18,534
THIS IS A CONSULT WE HAD A 

1994
01:17:18,534 --> 01:17:20,402
COUPLE OF YEARS AGO.

1995
01:17:20,402 --> 01:17:21,403
SIGNIFICANT BLEEDING THAT 

1996
01:17:21,403 --> 01:17:22,738
REQUIRES TRANSFUSION.

1997
01:17:22,738 --> 01:17:24,139
SO THE INVESTIGATOR COMES TO US 

1998
01:17:24,139 --> 01:17:25,875
AND SAYS, I THINK THIS IS 

1999
01:17:25,875 --> 01:17:28,277
REALLY IMPORTANT TRIAL, THIS IS 

2000
01:17:28,277 --> 01:17:31,647
REALLY IMPORTANT DRUG TO TEST 

2001
01:17:31,647 --> 01:17:33,449
BUT I'M TERRIFIED THAT I'M 

2002
01:17:33,449 --> 01:17:36,385
GOING TO KILL SOME OF MY 

2003
01:17:36,385 --> 01:17:37,520
PARTICIPANT BECAUSE OF BLEEDING.

2004
01:17:37,520 --> 01:17:39,889
AND WHAT I WANT TO DO IS 

2005
01:17:39,889 --> 01:17:41,757
EXCLUDE ANYBODY WHO FACE A 

2006
01:17:41,757 --> 01:17:42,591
HIGH-RISK OF BLEEDING.

2007
01:17:42,591 --> 01:17:44,426
WHO IS THAT?

2008
01:17:44,426 --> 01:17:46,695
PEOPLE WHO BLEEDING DISORDERS, 

2009
01:17:46,695 --> 01:17:57,239
PEOPLE WHO HAVE LOW  PLATELETS 

2010
01:17:59,275 --> 01:18:01,477
FOR WHATEVER REASON.

2011
01:18:01,477 --> 01:18:03,679
AND SOME FOR RELIGIOUS REASONS?

2012
01:18:03,679 --> 01:18:05,247
SO YOU SHOULD EXCLUDE ALL OF 

2013
01:18:05,247 --> 01:18:06,482
THESE PEOPLE.

2014
01:18:06,482 --> 01:18:07,616
IS THAT FAIR?

2015
01:18:07,616 --> 01:18:10,886
THESE ARE THE KIND OF REALLY 

2016
01:18:10,886 --> 01:18:11,820
IMPORTANT DEBATES AND QUESTIONS 

2017
01:18:11,820 --> 01:18:14,323
THAT ARISE WHEN WE START TO 

2018
01:18:14,323 --> 01:18:16,659
THINK ABOUT RISK BENEFIT 

2019
01:18:16,659 --> 01:18:18,694
ASSESSMENT WITH OTHER VALUES 

2020
01:18:18,694 --> 01:18:20,563
LIKE FAIRNESS.

2021
01:18:20,563 --> 01:18:22,831
SO POTENTIAL BENEFITS SO. 

2022
01:18:22,831 --> 01:18:26,101
SOCIAL VALUE, AND NOW RISK AND 

2023
01:18:26,101 --> 01:18:27,603
NOW POTENTIAL BENEFITS OF THE 

2024
01:18:27,603 --> 01:18:28,771
INTERVENTION.

2025
01:18:28,771 --> 01:18:31,640
AND AS WITH RISK, WE LOOK TEPPO 

2026
01:18:31,640 --> 01:18:32,808
TENSION BENEFITS ABOVE AND 

2027
01:18:32,808 --> 01:18:34,176
BEYOND WHAT PEOPLE WOULD GET IF 

2028
01:18:34,176 --> 01:18:36,979
THEY WERE OUTSIDE OF THE TRIAL.

2029
01:18:36,979 --> 01:18:38,881
SO NOW, I WANT TO COME BACK TO 

2030
01:18:38,881 --> 01:18:41,317
THE POINT, I WAS HARPING ON 

2031
01:18:41,317 --> 01:18:43,886
EARLIER REMEMBER WHEN I TALKED 

2032
01:18:43,886 --> 01:18:46,355
ABOUT FINANCIAL RISKS, 

2033
01:18:46,355 --> 01:18:47,690
PSYCHOLOGICAL RISK, STIGMA 

2034
01:18:47,690 --> 01:18:48,390
RISKS.

2035
01:18:48,390 --> 01:18:50,326
AND WE SAID, YOU COUNT ALL OF 

2036
01:18:50,326 --> 01:18:51,493
THEM, IT'S OBVIOUS THAT YOU 

2037
01:18:51,493 --> 01:18:52,795
SHOULD COUNT ALL OF THEM.

2038
01:18:52,795 --> 01:18:55,531
SO HERE'S THE QUESTION, DOES 

2039
01:18:55,531 --> 01:18:58,067
THE POINT APPLY TO POTENTIAL 

2040
01:18:58,067 --> 01:18:59,201
BENEFITS?

2041
01:18:59,201 --> 01:19:02,371
SHOULD YOU INCLUDE NOT JUST THE 

2042
01:19:02,371 --> 01:19:04,206
POTENTIAL BENEFITS OF 

2043
01:19:04,206 --> 01:19:06,108
CLINICALLY GETTING BETTER BUT 

2044
01:19:06,108 --> 01:19:06,976
BENEFITS OF OTHER SORTS OF 

2045
01:19:06,976 --> 01:19:09,511
THINGS THAT CAN HAPPEN TO YOU.

2046
01:19:09,511 --> 01:19:11,547
SO BEFORE WE TALK ABOUT 

2047
01:19:11,547 --> 01:19:12,982
ECONOMIC RISK, IF THERE IS A 

2048
01:19:12,982 --> 01:19:14,783
CHANCE THAT IT'S GOING TO KNOCK 

2049
01:19:14,783 --> 01:19:17,753
OUT MY KIDNEYS AND I'M GOING TO 

2050
01:19:17,753 --> 01:19:20,756
HAVE TO PAY OUT-OF-POCKET.

2051
01:19:20,756 --> 01:19:22,291
THAT'S ECONOMIC STUDY.

2052
01:19:22,291 --> 01:19:25,527
AND IF WE TAKE EVERYBODY 

2053
01:19:25,527 --> 01:19:27,029
PARTICIPATE GETS $500, SHOULD 

2054
01:19:27,029 --> 01:19:29,798
THAT COUNT AS A BENEFIT IF 

2055
01:19:29,798 --> 01:19:32,568
THERE IS ECONOMIC RISKS OVER 

2056
01:19:32,568 --> 01:19:33,702
HERE, AND ECONOMIC BENEFITS 

2057
01:19:33,702 --> 01:19:34,603
OVER THERE.

2058
01:19:34,603 --> 01:19:37,139
AND I WILL JUST SAY THAT ALMOST 

2059
01:19:37,139 --> 01:19:40,309
THE CONSENSUS IN THE 

2060
01:19:40,309 --> 01:19:41,510
LITERATURE, EVERYBODY HAS GOT 

2061
01:19:41,510 --> 01:19:43,646
TO TAKE THOSE INTO 

2062
01:19:43,646 --> 01:19:43,979
CONSIDERATION.

2063
01:19:43,979 --> 01:19:45,848
THE ECONOMIC BENEFIT DON'T, 

2064
01:19:45,848 --> 01:19:47,616
THEY SHOULDN'T CONSIDER THEM AT 

2065
01:19:47,616 --> 01:19:48,117
ALL.

2066
01:19:48,117 --> 01:19:50,986
AND SO OBVIOUSLY, THERE IS THIS 

2067
01:19:50,986 --> 01:19:51,987
QUESTION OF, DOES THAT MAKE 

2068
01:19:51,987 --> 01:19:52,988
SENSE?

2069
01:19:52,988 --> 01:19:54,490
SHOULD WE TREAT THEM 

2070
01:19:54,490 --> 01:19:56,291
DIFFERENTLY AND IF SO WHY 

2071
01:19:56,291 --> 01:19:58,494
SHOULD WE TREAT THEM 

2072
01:19:58,494 --> 01:19:58,794
DIFFERENTLY?

2073
01:19:58,794 --> 01:20:00,262
SO IT'S ONE OF THE OTHER 

2074
01:20:00,262 --> 01:20:01,163
QUESTIONS I'M GOING TO LEAVE US 

2075
01:20:01,163 --> 01:20:01,964
WITH NOW.

2076
01:20:01,964 --> 01:20:06,769
SO ONCE WE IDENTIFY THE RISKS, 

2077
01:20:06,769 --> 01:20:07,703
MINIMIZE THEM, POTENTIAL 

2078
01:20:07,703 --> 01:20:09,638
BENEFITS AND TRY TO MAKE THEM 

2079
01:20:09,638 --> 01:20:12,307
LARGER TO THE EXTENT THAT YOU 

2080
01:20:12,307 --> 01:20:14,843
CAN AND THIS PUTS US BACK IN 

2081
01:20:14,843 --> 01:20:16,378
THE WORRY ABOUT FAIRNESS AGAIN.

2082
01:20:16,378 --> 01:20:23,819
WHEN I WAS IN THE INFECTIOUS 

2083
01:20:23,819 --> 01:20:28,157
DISEASE IRBs THEY WERE JUST 

2084
01:20:28,157 --> 01:20:34,997
TESTED BLOOD INHIBITORS, IT 

2085
01:20:34,997 --> 01:20:37,099
REALLY REVOLUTIONIZED, WHERE 

2086
01:20:37,099 --> 01:20:38,867
H.I.V. WENT FROM A DISEASE THAT 

2087
01:20:38,867 --> 01:20:43,205
KILLED EVERYBODY TO A DISEASE 

2088
01:20:43,205 --> 01:20:44,940
THAT EVERYBODY CAN LIVE WITH.

2089
01:20:44,940 --> 01:20:46,675
AND THE QUESTION WAS WHERE DO 

2090
01:20:46,675 --> 01:20:49,211
WE DO THE TRIALS, DO WE DO IT 

2091
01:20:49,211 --> 01:20:51,513
IN PEOPLE THAT ARE RELATIVELY 

2092
01:20:51,513 --> 01:20:52,314
HEALTHY WITH THE ASSUMPTION 

2093
01:20:52,314 --> 01:20:54,683
THAT THERE WILL BE LESS RISK 

2094
01:20:54,683 --> 01:20:56,518
BECAUSE THEY'RE HEALTHIER AND 

2095
01:20:56,518 --> 01:20:58,320
IN BETTER SHAPE OR DO WE DO IT 

2096
01:20:58,320 --> 01:21:00,689
IN PEOPLE WHO ARE REALLY REALLY 

2097
01:21:00,689 --> 01:21:01,990
SICK WHO PROBABLY FACE GREATER 

2098
01:21:01,990 --> 01:21:05,027
RISK BUT IT IF HELPS THEM, IF 

2099
01:21:05,027 --> 01:21:06,829
IT ACTUALLY WORKS, THEY'RE 

2100
01:21:06,829 --> 01:21:09,465
GOING TO GAIN A LOT MORE.

2101
01:21:09,465 --> 01:21:11,100
SO WE DEBATED THAT AND IT'S 

2102
01:21:11,100 --> 01:21:11,800
INTERESTING, I THINK ABOUT IT 

2103
01:21:11,800 --> 01:21:13,102
NOW.

2104
01:21:13,102 --> 01:21:16,572
I ALWAYS SAY IF IRBs HAVE TO BE 

2105
01:21:16,572 --> 01:21:18,440
ON THE CAUTIOUS SIDE BUT IN 

2106
01:21:18,440 --> 01:21:19,742
THIS CASE, WE ACTUALLY MANDATE 

2107
01:21:19,742 --> 01:21:21,710
THED THAT THE STUDY BE DONE IN 

2108
01:21:21,710 --> 01:21:23,579
PEOPLE WHO WERE SICK.

2109
01:21:23,579 --> 01:21:27,750
SO WE DID PEOPLE WHO HAD LOW 

2110
01:21:27,750 --> 01:21:29,785
COUNTS I THINK UNDER 50.

2111
01:21:29,785 --> 01:21:32,287
SO WE FOCUSED ON THE POTENTIAL 

2112
01:21:32,287 --> 01:21:34,790
BENEFIT RATHER THAN MINIMIZING 

2113
01:21:34,790 --> 01:21:35,624
THE RISK.

2114
01:21:35,624 --> 01:21:37,626
SO NOW WE KNOW WHAT THE RISK, 

2115
01:21:37,626 --> 01:21:39,228
SOCIAL VALUE AND BENEFITS ARE 

2116
01:21:39,228 --> 01:21:41,797
SO WE'RE SUPPOSE TO PUT IT 

2117
01:21:41,797 --> 01:21:43,632
ALTOGETHER AND HERE THE STEP, 

2118
01:21:43,632 --> 01:21:46,068
BASICALLY TO THE POTENTIAL 

2119
01:21:46,068 --> 01:21:47,469
BENEFITS TO THE PARTICIPANT 

2120
01:21:47,469 --> 01:21:49,538
PLUS THE SOCIAL VALUE, PUT 

2121
01:21:49,538 --> 01:21:51,640
THOSE TOGETHER AND TO THOSE 

2122
01:21:51,640 --> 01:21:54,510
JUSTIFY THE RISKS AND THE BURNS 

2123
01:21:54,510 --> 01:21:57,546
AND COSTS OF DOING THE STUDY.

2124
01:21:57,546 --> 01:21:59,782
YOU GOT, YOU HAVE AN ACCEPTABLE 

2125
01:21:59,782 --> 01:22:01,617
STUDY YOU CAN BASICALLY STOP 

2126
01:22:01,617 --> 01:22:03,685
DOING THE RISK BENEFIT 

2127
01:22:03,685 --> 01:22:04,219
ASSESSMENT.

2128
01:22:04,219 --> 01:22:06,488
IF NO, THEN YOU NEED A COUPLE 

2129
01:22:06,488 --> 01:22:08,657
MORE STEPS, THEN I'LL TALK 

2130
01:22:08,657 --> 01:22:10,826
ABOUT SOME ADDITIONAL STEPS.

2131
01:22:10,826 --> 01:22:12,995
THE FIRST THING, SO PEOPLE 

2132
01:22:12,995 --> 01:22:15,464
AGONIZE OVER THIS ALL THE TIME.

2133
01:22:15,464 --> 01:22:17,166
SO THERE IS THIS BIG DEBATE 

2134
01:22:17,166 --> 01:22:21,770
ABOUT THE WAY IN WAY YOU SHOULD 

2135
01:22:21,770 --> 01:22:24,973
TREAT CLINICAL RESEARCH IN THE 

2136
01:22:24,973 --> 01:22:26,375
WAY SAME AS CLINICAL CARE.

2137
01:22:26,375 --> 01:22:28,644
THIS IS A CASE WHERE I THINK 

2138
01:22:28,644 --> 01:22:30,012
PEOPLE GET TOO CONFUSED WHETHER 

2139
01:22:30,012 --> 01:22:32,047
IT COMES TO RESEARCH ETHICS.

2140
01:22:32,047 --> 01:22:36,185
SO WHEN I SAY THIS, THE IRB 

2141
01:22:36,185 --> 01:22:37,119
SHOULD LOOK AT THE BENEFITS 

2142
01:22:37,119 --> 01:22:39,822
WHETHER THEY JUSTIFY THE RISKS.

2143
01:22:39,822 --> 01:22:42,291
THEY'RE LIKE HOW DO YOU DO THAT?

2144
01:22:42,291 --> 01:22:44,359
OUT WEIGH RISK, THAT'S A 

2145
01:22:44,359 --> 01:22:45,894
METAPHOR, WHAT ARE ANY OF THESE 

2146
01:22:45,894 --> 01:22:47,095
THINGS MEAN?

2147
01:22:47,095 --> 01:22:48,997
AND MY RESPONSE TO THAT IS, I 

2148
01:22:48,997 --> 01:22:51,467
KNOW THIS IS HARD, BUT NOTICE 

2149
01:22:51,467 --> 01:22:53,802
THAT'S WHAT DOCTORS AND 

2150
01:22:53,802 --> 01:22:55,170
CLINICIANS DO EVERYDAY.

2151
01:22:55,170 --> 01:22:57,206
THAT'S THE JOB OF CLINICIANS IS 

2152
01:22:57,206 --> 01:22:59,141
TO ASK THEMSELVES FOR THIS 

2153
01:22:59,141 --> 01:23:00,576
PATIENT, TO THE POTENTIAL 

2154
01:23:00,576 --> 01:23:03,078
BENEFITS OF THIS DRUG, OUT 

2155
01:23:03,078 --> 01:23:04,646
WEIGH THE RISK OF THIS IT 

2156
01:23:04,646 --> 01:23:05,247
PATIENT.

2157
01:23:05,247 --> 01:23:06,815
NOW IT'S HARDER TO DO IT IN 

2158
01:23:06,815 --> 01:23:08,217
RESEARCH BECAUSE WE DON'T HAVE 

2159
01:23:08,217 --> 01:23:10,118
AS MUCH DATA BUT AT LEAST I 

2160
01:23:10,118 --> 01:23:11,954
THINK THAT THE APPROACH, THE 

2161
01:23:11,954 --> 01:23:14,389
SORT OF BASIC IDEA IS EXACTLY 

2162
01:23:14,389 --> 01:23:15,224
THE SAME.

2163
01:23:15,224 --> 01:23:17,893
SO I TERMED THIS THE INFORMED 

2164
01:23:17,893 --> 01:23:20,696
CLINICIAN TEST AND WHAT THE IRB 

2165
01:23:20,696 --> 01:23:23,432
SHOULD DO IS PRETEND OR CALL 

2166
01:23:23,432 --> 01:23:23,665
ONE UP.

2167
01:23:23,665 --> 01:23:25,734
AND ACTUALLY ASK THEM, HERE'S 

2168
01:23:25,734 --> 01:23:27,636
THE SITUATION, HERE ARE THE 

2169
01:23:27,636 --> 01:23:28,971
PATIENTS, HERE IS THE DRUG WE 

2170
01:23:28,971 --> 01:23:30,105
WANT TO GIVE THEM.

2171
01:23:30,105 --> 01:23:31,373
HERE'S WHAT WE KNOW ABOUT IT, 

2172
01:23:31,373 --> 01:23:33,909
DO YOU THINK THE POTENTIAL 

2173
01:23:33,909 --> 01:23:35,110
BENEFITS JUSTIFY THE RISK?

2174
01:23:35,110 --> 01:23:37,613
IF THEY SAY YES, IT'S A 

2175
01:23:37,613 --> 01:23:39,081
PROSPECT OF BENEFIT STUDY IF 

2176
01:23:39,081 --> 01:23:41,517
THEY SAY NO, IT'S A WHAT I CALL 

2177
01:23:41,517 --> 01:23:44,953
A NET RISK STUDY.

2178
01:23:44,953 --> 01:23:48,390
A LITTLE BIT MORE PHILOSOPHY 

2179
01:23:48,390 --> 01:23:50,058
HERE IS SO, WHAT I'VE BEEN 

2180
01:23:50,058 --> 01:23:52,995
SAYING IS YOU LOOK AT THE 

2181
01:23:52,995 --> 01:23:54,129
INDIVIDUAL INTERVENTIONS AND 

2182
01:23:54,129 --> 01:23:56,398
THEN THE WHOLE BADGE.

2183
01:23:56,398 --> 01:23:57,799
--PACKAGE.

2184
01:23:57,799 --> 01:24:00,702
WHAT ARE YOU SUPPOSE TO DO?

2185
01:24:00,702 --> 01:24:02,738
WHAT ARE YOU SUPPOSE TO LOOK AT 

2186
01:24:02,738 --> 01:24:05,007
THE INDIVIDUAL INTERVENTIONS 

2187
01:24:05,007 --> 01:24:07,442
AND HERE'S THE BENEFITS.

2188
01:24:07,442 --> 01:24:09,878
DO THE POTENTIAL BENEFITS HAVE 

2189
01:24:09,878 --> 01:24:11,313
TO JUSTIFY THE RISKS?

2190
01:24:11,313 --> 01:24:13,849
SO IMAGINE A STUDY LIKE THIS, 

2191
01:24:13,849 --> 01:24:15,250
IMAGINE A STUDY WHERE I'M GOING 

2192
01:24:15,250 --> 01:24:18,587
TO GIVE PEOPLE A POTENTIAL 

2193
01:24:18,587 --> 01:24:20,756
TREATMENT FOR KIDNEY DISEASE OR 

2194
01:24:20,756 --> 01:24:21,890
LIVER DISEASE, REALLY COULD 

2195
01:24:21,890 --> 01:24:24,559
HELP THEM LOOKS REALLY 

2196
01:24:24,559 --> 01:24:26,261
PROMISING, LOTS OF POTENTIAL 

2197
01:24:26,261 --> 01:24:26,528
BENEFITS.

2198
01:24:26,528 --> 01:24:30,566
BUT IN ORDER TO DO THE STUDY 

2199
01:24:30,566 --> 01:24:35,137
SCIENTIFICALLY, I HAVE TO DO A 

2200
01:24:35,137 --> 01:24:36,571
BIOPSY THAT POSES RISK AND I'M 

2201
01:24:36,571 --> 01:24:38,340
ONLY DOING IT FOR RESEARCH 

2202
01:24:38,340 --> 01:24:38,607
PURPOSES.

2203
01:24:38,607 --> 01:24:43,478
IF YOU LOOK AT THE LIVER BIOPSY 

2204
01:24:43,478 --> 01:24:46,848
OR KIDNEY BIOPSY ON ITS OWN IT 

2205
01:24:46,848 --> 01:24:48,450
LOOKS LIKE NOT BENEFIT 

2206
01:24:48,450 --> 01:24:49,885
INTERVENTION AND AT LEAST IN 

2207
01:24:49,885 --> 01:24:50,619
CHILDREN YOU WOULDN'T BE 

2208
01:24:50,619 --> 01:24:52,354
ALLOWED TO DO IT AND PEOPLE 

2209
01:24:52,354 --> 01:24:53,588
WOULD BE REALLY WORRIED ABOUT 

2210
01:24:53,588 --> 01:24:55,357
DOING IT IN ADULTS.

2211
01:24:55,357 --> 01:24:56,625
IS THAT THE WAY YOU'RE SUPPOSE 

2212
01:24:56,625 --> 01:25:00,128
TO DO IT?

2213
01:25:00,128 --> 01:25:01,496
POTENTIAL BENEFITS HAVE TO 

2214
01:25:01,496 --> 01:25:03,799
JUSTIFY THE RISK OR DO YOU PUT 

2215
01:25:03,799 --> 01:25:04,967
IT TOGETHER AND SAY I KNOW 

2216
01:25:04,967 --> 01:25:07,302
THAT, BUT THE POTENTIAL 

2217
01:25:07,302 --> 01:25:08,670
BENEFITS OF GETTING THE DRUG, 

2218
01:25:08,670 --> 01:25:10,505
THEY JUSTIFY THE RISK OF NOT 

2219
01:25:10,505 --> 01:25:12,607
ONLY THE DRUG BUT ALSO THE RISK 

2220
01:25:12,607 --> 01:25:15,577
OF LIVER OR KIDNEY BIOPSY.

2221
01:25:15,577 --> 01:25:18,413
SO BEING IN THE STUDY IS 

2222
01:25:18,413 --> 01:25:19,514
PROSPECT OF BENEFIT FOR THE 

2223
01:25:19,514 --> 01:25:21,450
PEOPLE WHO ARE GOING TO GET 

2224
01:25:21,450 --> 01:25:22,384
INTO IT.

2225
01:25:22,384 --> 01:25:23,885
THAT'S THE A QUESTION OF YOU 

2226
01:25:23,885 --> 01:25:29,157
HAVE TO LOOK AT EACH ONE 

2227
01:25:29,157 --> 01:25:31,526
INDIVIDUALLY JUSTIFYING THE 

2228
01:25:31,526 --> 01:25:32,427
RISKS OF ANOTHER.

2229
01:25:32,427 --> 01:25:33,395
SO HOPEFULLY THAT'S CLEAR IF 

2230
01:25:33,395 --> 01:25:34,663
IT'S NOT, WE CAN DEFINITELY 

2231
01:25:34,663 --> 01:25:36,932
COME BACK TO IT, I THINK THAT'S 

2232
01:25:36,932 --> 01:25:40,335
A REALLY INTERESTING CHALLENGE.

2233
01:25:40,335 --> 01:25:42,471
HERE'S A PRACTICAL EXAMPLE OF 

2234
01:25:42,471 --> 01:25:45,774
THIS, WE WROTE A PAPER ON THIS.

2235
01:25:45,774 --> 01:25:48,143
IMAGINE A TRIAL IN KIDS, SOME 

2236
01:25:48,143 --> 01:25:50,245
PEOPLE GET THIS POTENTIALLY 

2237
01:25:50,245 --> 01:25:51,380
BENEFICIAL INTERVENTION AND 

2238
01:25:51,380 --> 01:25:53,448
SOME PEOPLE GET A PLACEBO.

2239
01:25:53,448 --> 01:25:55,751
WHAT IS THE RISK BENEFIT 

2240
01:25:55,751 --> 01:25:58,020
ASSESSMENT FOR THE PROFILE OF 

2241
01:25:58,020 --> 01:25:59,521
THAT OVERALL STUDY.

2242
01:25:59,521 --> 01:26:01,490
WHAT SOME PEOPLE WILL SAY IS, 

2243
01:26:01,490 --> 01:26:05,227
WELL, AT THE OUTSET BEFORE 

2244
01:26:05,227 --> 01:26:07,763
AMORIZATION, THERE IS A CHANCE 

2245
01:26:07,763 --> 01:26:10,132
YOU GET THE DRUG AND IF YOU GET 

2246
01:26:10,132 --> 01:26:13,168
THE DRUG, THAT JUSTIFIES BEING 

2247
01:26:13,168 --> 01:26:15,771
RANDOMIZE TO THE PLACEBO.

2248
01:26:15,771 --> 01:26:17,639
WHAT WE ARGUE IS THAT'S A 

2249
01:26:17,639 --> 01:26:20,175
MISTAKE AND YOU NEED TO 

2250
01:26:20,175 --> 01:26:21,410
INDIVIDUALLY LOOK AT THE RISK 

2251
01:26:21,410 --> 01:26:22,911
BENEFIT OF THE TWO ARMS OF THE 

2252
01:26:22,911 --> 01:26:24,613
TRIAL AND THAT MEANS THAT THE 

2253
01:26:24,613 --> 01:26:27,883
RISKS OF THE PLACEBO HAVE TO BE 

2254
01:26:27,883 --> 01:26:30,652
ACCEPTABLE AND YOU CAN'T 

2255
01:26:30,652 --> 01:26:31,820
JUSTIFY THEM BY THE FACT THAT 

2256
01:26:31,820 --> 01:26:33,655
THERE WAS A CHANCE THE PERSON 

2257
01:26:33,655 --> 01:26:36,958
COULD HAVE GOTTEN BUT DIDN'T 

2258
01:26:36,958 --> 01:26:38,126
ACTIVE TREATMENT.

2259
01:26:38,126 --> 01:26:39,995
SO THAT'S JUST ONE SPECIFIC 

2260
01:26:39,995 --> 01:26:41,830
EXAMPLE OF THAT.

2261
01:26:41,830 --> 01:26:43,899
OKAY, SO WE'RE TALKING ABOUT 

2262
01:26:43,899 --> 01:26:45,167
BENEFITS JUSTIFY THE RISK.

2263
01:26:45,167 --> 01:26:47,602
IF YOU DO, YOU HAVE A PROSPECT 

2264
01:26:47,602 --> 01:26:49,004
OF BENEFIT STUDY.

2265
01:26:49,004 --> 01:26:51,973
IF YOU DON'T, HAVE YOU A WHAT I 

2266
01:26:51,973 --> 01:26:54,743
CALL A NET RISK TRIAL.

2267
01:26:54,743 --> 01:26:56,011
SO THE NEXT CHALLENGE IS 

2268
01:26:56,011 --> 01:26:58,080
THINKING ABOUT NET RISK HOW 

2269
01:26:58,080 --> 01:27:00,382
MUCH NET RISK IS ACCEPTABLE.

2270
01:27:00,382 --> 01:27:02,384
SO, WHEN IT COMES TO 

2271
01:27:02,384 --> 01:27:03,919
INDIVIDUALS WHO CAN'T CONSENT 

2272
01:27:03,919 --> 01:27:05,387
LIKE KIDS, THERE ARE SOME 

2273
01:27:05,387 --> 01:27:08,390
PEOPLE WHO THINK IT'S JUST EN 

2274
01:27:08,390 --> 01:27:12,294
ETHICAL, THIS DEBATE HAS BEEN 

2275
01:27:12,294 --> 01:27:13,829
GOING ON FOR YEARS.

2276
01:27:13,829 --> 01:27:17,466
SOME SAY IT'S UNETHICAL TO POSE 

2277
01:27:17,466 --> 01:27:21,536
ANY RISK FOR THE BENEFITS TO 

2278
01:27:21,536 --> 01:27:21,770
PEOPLE.

2279
01:27:21,770 --> 01:27:23,872
WE NEED TO TALK ABOUT THAT IF 

2280
01:27:23,872 --> 01:27:25,040
PEOPLE ARE INTERESTED.

2281
01:27:25,040 --> 01:27:27,075
WHILE LOTS OF PEOPLE HAVE THAT 

2282
01:27:27,075 --> 01:27:29,678
WORRY, IF YOU LOOK AT MOST 

2283
01:27:29,678 --> 01:27:31,646
GUIDELINES, THEY ALLOW SOME 

2284
01:27:31,646 --> 01:27:34,850
RISKS IN KIDS PARTICULARLY AND 

2285
01:27:34,850 --> 01:27:36,551
THTS BUZZ WORD YOU'LL HEAR 

2286
01:27:36,551 --> 01:27:37,886
ABOUT, WHETHER OR NOT THE RISK 

2287
01:27:37,886 --> 01:27:41,656
ARE MINIMUM OR GREATER THAN 

2288
01:27:41,656 --> 01:27:42,524
MINIMAL.

2289
01:27:42,524 --> 01:27:43,792
AND I THINK YOU'LL HEAR ABOUT 

2290
01:27:43,792 --> 01:27:45,227
THIS.

2291
01:27:45,227 --> 01:27:48,196
SO WHAT IS MINIMAL RISK?

2292
01:27:48,196 --> 01:27:51,600
THE STANDARD BASED ON A LOT OF 

2293
01:27:51,600 --> 01:27:52,534
REGULATIONS, WHAT IRBs ARE 

2294
01:27:52,534 --> 01:27:55,604
SUPPOSE TO DO.

2295
01:27:55,604 --> 01:27:56,738
THEY'RE SUPPOSE TO COMPARE THE 

2296
01:27:56,738 --> 01:27:59,608
RISK TO THE RISK ENCOUNTERED IN 

2297
01:27:59,608 --> 01:28:00,642
DAILY LIFE.

2298
01:28:00,642 --> 01:28:05,213
AND IF THE RISK ARE EQUAL TO OR 

2299
01:28:05,213 --> 01:28:09,351
LOWER THAN, COUNTS, IT COUNTS 

2300
01:28:09,351 --> 01:28:11,887
AS A MINIMAL RISK.

2301
01:28:11,887 --> 01:28:13,722
THAT'S THE STANDARD THAT WHEN I 

2302
01:28:13,722 --> 01:28:15,056
WAS STUDY I TALKED ABOUT 

2303
01:28:15,056 --> 01:28:18,560
BEFORE, THAT WE DID WITH SEEMA, 

2304
01:28:18,560 --> 01:28:21,229
THAT'S THE QUESTION WE WERE 

2305
01:28:21,229 --> 01:28:21,530
ASKING THEM.

2306
01:28:21,530 --> 01:28:24,266
IF YOU NOTICE, IF I SAY TO YOU, 

2307
01:28:24,266 --> 01:28:27,402
ALLERGY SKIN TESTING, ALLERGY 

2308
01:28:27,402 --> 01:28:28,870
SKIN TESTING 11-YEAR-OLD, I 

2309
01:28:28,870 --> 01:28:30,639
HOPE ALL OF YOU GUYS WOULD SAY 

2310
01:28:30,639 --> 01:28:32,007
I HAVE NO IDEA.

2311
01:28:32,007 --> 01:28:34,309
YOU HAVE TO TELL ME WHAT THE 

2312
01:28:34,309 --> 01:28:36,545
RISK VALUES OF SKIN TESTING 

2313
01:28:36,545 --> 01:28:38,013
BEFORE I CAN COMPARE THEM AND 

2314
01:28:38,013 --> 01:28:40,749
THAT'S THE THING THAT I WAS 

2315
01:28:40,749 --> 01:28:46,588
POINTING THAT NONE OF THOSE 

2316
01:28:46,588 --> 01:28:47,589
IRBS CHAIRS DID.

2317
01:28:47,589 --> 01:28:50,525
THIS IS A STUDY THAT WE DID 

2318
01:28:50,525 --> 01:28:54,629
WITH WHO IS A PROGRAM AT UCLA 

2319
01:28:54,629 --> 01:28:58,233
WHO WAS A POST-BACK HERE.

2320
01:28:58,233 --> 01:29:02,170
THERE HAVE NOT BEEN DA DA ABOUT 

2321
01:29:02,170 --> 01:29:03,338
WHAT THE PUBLIC THINKS.

2322
01:29:03,338 --> 01:29:07,075
SO WE DID A SURVEY AND WE FOUND 

2323
01:29:07,075 --> 01:29:10,111
IS, REALLY STRONG SUPPORT AMONG 

2324
01:29:10,111 --> 01:29:12,581
THE PUBLIC INCLUDING PARENTS 

2325
01:29:12,581 --> 01:29:18,720
FOR EXPOSING KIDS TO RESEARCH 

2326
01:29:18,720 --> 01:29:21,990
RISKS INCLUDING BONE MARROW 

2327
01:29:21,990 --> 01:29:23,858
BIOPSY WHICH POSES MORE RISKS.

2328
01:29:23,858 --> 01:29:24,926
OKAY, THAT'S KIDS, YOU'RE GOING 

2329
01:29:24,926 --> 01:29:26,428
TO GET MORE OF THAT.

2330
01:29:26,428 --> 01:29:29,564
SO THAT LEAVES THE QUESTION 

2331
01:29:29,564 --> 01:29:31,533
ABOUT WHAT ABOUT COMPETENT 

2332
01:29:31,533 --> 01:29:33,468
ADULTS?

2333
01:29:33,468 --> 01:29:37,405
SHOULD THERE BE LIMITS WHERE 

2334
01:29:37,405 --> 01:29:39,507
RESEARCHERS EXPOSE ADULTS TO 

2335
01:29:39,507 --> 01:29:41,676
RISK FOR THE BENEFITS OF OTHERS?

2336
01:29:41,676 --> 01:29:44,045
AND HOW DO WE DECIDE THAT?

2337
01:29:44,045 --> 01:29:46,915
AND DOES IT DEPEND ON THINGS ON 

2338
01:29:46,915 --> 01:29:48,049
WHETHER THE PARTICIPANTS ARE 

2339
01:29:48,049 --> 01:29:49,951
HEALTHY OR WHETHER THEY'RE SICK.

2340
01:29:49,951 --> 01:29:51,853
PEOPLE DEBATE THAT A LOT.

2341
01:29:51,853 --> 01:29:53,521
HERE IS SOME COMMON ANSWERS 

2342
01:29:53,521 --> 01:29:57,192
THAT RUNS A WHOLE RANGE.

2343
01:29:57,192 --> 01:29:59,527
YOU MAY SAY LOOK, COMPETENT 

2344
01:29:59,527 --> 01:30:01,129
ADULTS GET TO DECIDE WHAT THEY 

2345
01:30:01,129 --> 01:30:03,531
DO WITH THEIR LIVES INCLUDING 

2346
01:30:03,531 --> 01:30:03,932
FACING RISKS.

2347
01:30:03,932 --> 01:30:06,134
SO IF IT'S JUST UP TO THEM.

2348
01:30:06,134 --> 01:30:08,536
OTHER PEOPLE HAVE REALLY STRICT 

2349
01:30:08,536 --> 01:30:11,273
STANDARDS, THEY THINK, NO 

2350
01:30:11,273 --> 01:30:14,042
ACTUALLY AND SOME IRBs DO THIS.

2351
01:30:14,042 --> 01:30:16,378
SHOULD NOT BE MUCH MORE IF ANY 

2352
01:30:16,378 --> 01:30:17,345
GREATER THAN THE RISK THAT 

2353
01:30:17,345 --> 01:30:18,346
WE'RE WILLING TO EXPOSE 

2354
01:30:18,346 --> 01:30:18,847
CHILDREN.

2355
01:30:18,847 --> 01:30:20,448
SOME PEOPLE ARE REALLY STRICT 

2356
01:30:20,448 --> 01:30:23,752
ABOUT THIS AND OTHER PEOPLE 

2357
01:30:23,752 --> 01:30:25,553
HAVE ARGUED, FRANK MILLER USED 

2358
01:30:25,553 --> 01:30:27,255
TO BE IN THIS DEPARTMENT AND HE 

2359
01:30:27,255 --> 01:30:31,593
ARGUED LET'S LOOK AT RESEARCH 

2360
01:30:31,593 --> 01:30:33,895
PARTICIPATION, LET'S LOOK AT 

2361
01:30:33,895 --> 01:30:39,534
WHAT RISKS ARE ACCEPTABLE IN 

2362
01:30:39,534 --> 01:30:40,302
OTHER ALTRUISTIC, IT'S 

2363
01:30:40,302 --> 01:30:42,604
INTERESTING AT THE END OF THIS 

2364
01:30:42,604 --> 01:30:48,009
PAPER, ALTHOUGH THEY SUGGEST 

2365
01:30:48,009 --> 01:30:49,411
THAT'S STANDARD, THEY'RE LIKE 

2366
01:30:49,411 --> 01:30:52,814
WELL MAYBE THAT'S TOO HIGH.

2367
01:30:52,814 --> 01:30:55,183
SOME SUGGEST SIMILAR THINGS BUT 

2368
01:30:55,183 --> 01:30:56,584
IN PUBLIC SERVICE LIKE 

2369
01:30:56,584 --> 01:30:57,419
FIREFIGHTERS AND THOSE ARE 

2370
01:30:57,419 --> 01:31:00,255
GOING TO SET THE LIMITS FOR 

2371
01:31:00,255 --> 01:31:03,525
RESEARCH RISKS WITH COMPETENT 

2372
01:31:03,525 --> 01:31:03,758
ADULTS.

2373
01:31:03,758 --> 01:31:07,896
OKAY, SO JUST A BRIEF SUMMARY, 

2374
01:31:07,896 --> 01:31:10,198
DOING SYSTEMATIC RISK BENEFIT 

2375
01:31:10,198 --> 01:31:12,968
ASSESSMENT IS RIGHT, BELMONT 

2376
01:31:12,968 --> 01:31:13,735
ASSESSMENT WAS RIGHT.

2377
01:31:13,735 --> 01:31:15,537
I DON'T THINK PEOPLE ARE DOING 

2378
01:31:15,537 --> 01:31:16,004
IT RIGHT.

2379
01:31:16,004 --> 01:31:20,108
AND I THINK IF WE DID IT MORE 

2380
01:31:20,108 --> 01:31:21,676
SYSTEMATIC, IT WOULD MAKE THE 

2381
01:31:21,676 --> 01:31:23,078
RESEARCH BETTER AND MORE 

2382
01:31:23,078 --> 01:31:24,412
ETHICAL AND THE SECOND PART 

2383
01:31:24,412 --> 01:31:26,981
WHICH I HOPE DIDN'T GET TOO 

2384
01:31:26,981 --> 01:31:28,783
CONFUSING AND DETRACT FROM 

2385
01:31:28,783 --> 01:31:30,685
UNDERSTANDING THE FRAMEWORK, IS 

2386
01:31:30,685 --> 01:31:32,754
THERE IS REALLY INTERESTING 

2387
01:31:32,754 --> 01:31:35,824
QUESTIONS FOR US FOR ANYBODY 

2388
01:31:35,824 --> 01:31:37,559
INTERESTED IN ETHICS TO FIGURE 

2389
01:31:37,559 --> 01:31:37,726
OUT.

2390
01:31:37,726 --> 01:31:38,560
OKAY.

2391
01:31:38,560 --> 01:31:43,365
SO THANK YOU.

2392
01:31:43,365 --> 01:31:44,532
[APPLAUSE]

2393
01:31:44,532 --> 01:31:46,668
>> DAVE, WE HAVE ABOUT TEN

2394
01:31:46,668 --> 01:31:47,769
MINUTES FOR QUESTIONS.

2395
01:31:47,769 --> 01:31:51,539
IT LOOKS LIKE DANIEL HEADED TO 

2396
01:31:51,539 --> 01:31:51,906
THE MICROPHONE.

2397
01:31:51,906 --> 01:31:54,409
I HAVE TWO QUESTIONS FROM 

2398
01:31:54,409 --> 01:31:54,642
OUTSIDE.

2399
01:31:54,642 --> 01:31:56,644
THIS IS FROM KIM, SHE SAID 

2400
01:31:56,644 --> 01:31:58,713
RAGGEDER THE INFORMED CLINICIAN 

2401
01:31:58,713 --> 01:32:00,115
TESTS, IT'S SLIGHTLY DIFFERENT 

2402
01:32:00,115 --> 01:32:01,483
FOR THE CLINICIAN BECAUSE WE 

2403
01:32:01,483 --> 01:32:03,351
MAKE THE DECISION AT THE 

2404
01:32:03,351 --> 01:32:07,355
INDIVIDUAL LEVEL WHERE AS THE 

2405
01:32:07,355 --> 01:32:08,823
IRB MAKES THE DECISION AT THE 

2406
01:32:08,823 --> 01:32:09,591
POPULATION LEVEL.

2407
01:32:09,591 --> 01:32:12,160
>> YEAH, I THINK THAT'S
RIGHT.

2408
01:32:12,160 --> 01:32:15,030
AND SO THE WAY I THINK ABOUT 

2409
01:32:15,030 --> 01:32:16,765
THE INFORMED CLINICIAN TESTS, 

2410
01:32:16,765 --> 01:32:18,666
WHAT THE INFORMED CLINICIAN HAS 

2411
01:32:18,666 --> 01:32:20,235
TO DO, THEY HAVE TO ASK A 

2412
01:32:20,235 --> 01:32:21,503
QUESTION NOT ABOUT A SPECIFIC 

2413
01:32:21,503 --> 01:32:21,803
INDIVIDUAL.

2414
01:32:21,803 --> 01:32:24,773
THEY HAVE TO AOFK OF THE 

2415
01:32:24,773 --> 01:32:26,408
INDIVIDUAL WHO QUALIFY FOR THIS 

2416
01:32:26,408 --> 01:32:29,811
STUDY GIVEN THE INCLUSION 

2417
01:32:29,811 --> 01:32:31,513
EXCLUSION CRITERIA ARE 

2418
01:32:31,513 --> 01:32:32,180
CURRENTLY WORDED.

2419
01:32:32,180 --> 01:32:34,315
IS IT IN THEIR MEDICAL INTEREST 

2420
01:32:34,315 --> 01:32:36,484
TO BE IN THIS STUDY?

2421
01:32:36,484 --> 01:32:39,454
AND THE CLINICIAN MAY GIVE A 

2422
01:32:39,454 --> 01:32:41,489
COUPLE OF DIFFERENT ANSWERS, 

2423
01:32:41,489 --> 01:32:44,692
THEY MAY YES OR NO AND THEY MAY 

2424
01:32:44,692 --> 01:32:46,528
SAY WELL IT DEPENDS.

2425
01:32:46,528 --> 01:32:48,196
FOR OTHERS IT'S REALLY RISKY.

2426
01:32:48,196 --> 01:32:49,898
AND IF THAT'S THE ANSWER THEY 

2427
01:32:49,898 --> 01:32:52,667
GIVE AND I ASSUME THIS IS KIM'S 

2428
01:32:52,667 --> 01:32:53,334
WORRY, THAT'S IMPORTANT 

2429
01:32:53,334 --> 01:32:55,637
INFORMATION FOR THE IRB MAYBE 

2430
01:32:55,637 --> 01:32:58,440
WHAT THE IRB WANTS TO DO IS GO 

2431
01:32:58,440 --> 01:33:00,742
BACK AND RETHINK THE INCLUSION 

2432
01:33:00,742 --> 01:33:02,610
AND EXCLUSION CRITERIA AND SAY, 

2433
01:33:02,610 --> 01:33:04,446
OKAY, IS THERE A WAY THAT WHAT 

2434
01:33:04,446 --> 01:33:08,349
WE CAN DO IS REJIGGER THEM.

2435
01:33:08,349 --> 01:33:10,185
SO NOW THERE IS THE FAIRNESS 

2436
01:33:10,185 --> 01:33:11,920
FOR THE BACKGROUND, BUT 

2437
01:33:11,920 --> 01:33:12,987
BRAKENING THAT FOR A SECOND, 

2438
01:33:12,987 --> 01:33:16,057
THEY MAY WANT TO THINK ABOUT 

2439
01:33:16,057 --> 01:33:17,525
REDOING THE INCLUSION EXCLUSION.

2440
01:33:17,525 --> 01:33:19,594
I THINK THERE IS SOME CASE 

2441
01:33:19,594 --> 01:33:21,529
WHERE THEY CAN DO THAT IS 

2442
01:33:21,529 --> 01:33:21,863
PRETTY CLEAR.

2443
01:33:21,863 --> 01:33:23,898
IF THEY CANNOT DO IT T I'VE 

2444
01:33:23,898 --> 01:33:28,503
BEEN ON SOME IRBs WHERE WE 

2445
01:33:28,503 --> 01:33:29,637
MANDATED LITERALLY AN 

2446
01:33:29,637 --> 01:33:30,271
INDIVIDUAL, WHICH DOES NOT 

2447
01:33:30,271 --> 01:33:32,474
HAPPEN.

2448
01:33:32,474 --> 01:33:39,113
IT CAN BUT YOU CAN BUILD A 

2449
01:33:39,113 --> 01:33:39,380
PROTOCOL.

2450
01:33:39,380 --> 01:33:40,648
SO RATHER THAN FIDDLING WITH 

2451
01:33:40,648 --> 01:33:42,550
NEM, WHAT WE'RE GOING TO DO IS 

2452
01:33:42,550 --> 01:33:44,085
HAVE AN INDIVIDUAL COMMISSION 

2453
01:33:44,085 --> 01:33:45,987
LOOK AT EACH INDIVIDUAL PERSON 

2454
01:33:45,987 --> 01:33:47,422
AND ASSESS IT FOR THEM.

2455
01:33:47,422 --> 01:33:49,424
THAT'S SOMETHING THAT YOU CAN 

2456
01:33:49,424 --> 01:33:49,591
DO.

2457
01:33:49,591 --> 01:33:50,458
IT'S NOT NECESSARILY SOMETHING 

2458
01:33:50,458 --> 01:33:53,027
THAT YOU CAN DO 5,000 AND A BIG 

2459
01:33:53,027 --> 01:33:53,828
PHASE TRIAL.

2460
01:33:53,828 --> 01:34:01,936
>> BUT EVEN THAT JENNA IS 

2461
01:34:01,936 --> 01:34:04,005
--GENERAL  ASSESSMENT, YES, NO, 

2462
01:34:04,005 --> 01:34:07,876
MAY FEND AND MORE THAN WHAT THE 

2463
01:34:07,876 --> 01:34:08,843
IRB MAY HAVE AT HAND.

2464
01:34:08,843 --> 01:34:09,978
>> ABSOLUTELY.

2465
01:34:09,978 --> 01:34:10,445
>> DANIEL.

2466
01:34:10,445 --> 01:34:12,146
>> THANKS FOR THIS, THIS
IS 

2467
01:34:12,146 --> 01:34:13,214
REALLY INTERESTING.

2468
01:34:13,214 --> 01:34:18,720
MY QUESTION WAS ABOUT THE 

2469
01:34:18,720 --> 01:34:19,721
FALLACY OF THE PACKAGE DEAL.

2470
01:34:19,721 --> 01:34:21,189
>> YEAH.

2471
01:34:21,189 --> 01:34:22,690
>> I WONDER WHETHER YOU
CANNOT 

2472
01:34:22,690 --> 01:34:24,826
JUST NOT APPEAL TO WHETHER OR 

2473
01:34:24,826 --> 01:34:28,730
NOT HIGHLY BENEFICIAL LIKE NET 

2474
01:34:28,730 --> 01:34:30,965
BENEFICIAL INTERVENTION RIGHT 

2475
01:34:30,965 --> 01:34:33,234
SIDE CONTINGENT UPON A HIGHLY 

2476
01:34:33,234 --> 01:34:39,574
RISKY BENEFICIAL LIKE WITH A 

2477
01:34:39,574 --> 01:34:39,841
BIOPSY.

2478
01:34:39,841 --> 01:34:41,743
THROUGH SOMETHING RISKY LIKE 

2479
01:34:41,743 --> 01:34:44,245
THAT, THAT SEEMS RELEVANT 

2480
01:34:44,245 --> 01:34:47,048
VERSUS JUST, YOU KNOW, NOTHING 

2481
01:34:47,048 --> 01:34:49,417
IS CONTINGENT AND HIGHLY RISKY.

2482
01:34:49,417 --> 01:34:51,953
IF THAT'S THE CASE, IT SEEMS 

2483
01:34:51,953 --> 01:34:54,255
LIKE WE CAN JUST JUSTIFY, LIKE 

2484
01:34:54,255 --> 01:34:57,659
IF WE HAVE A REALLY REALLY 

2485
01:34:57,659 --> 01:34:58,493
BENEFICIAL INTERVENTION, IT'S 

2486
01:34:58,493 --> 01:35:02,463
NOT LIKE WE CAN TACK ON A 

2487
01:35:02,463 --> 01:35:03,164
HIGHLY RISK INTERVENTIONS.

2488
01:35:03,164 --> 01:35:06,467
>> GREAT.

2489
01:35:06,467 --> 01:35:09,170
YEAH, DON'T  SIT DOWN YET, LET 

2490
01:35:09,170 --> 01:35:11,906
ME GIVE YOU AN EXAMPLE AND HOPE 

2491
01:35:11,906 --> 01:35:13,808
WHAT YOU THINK.

2492
01:35:13,808 --> 01:35:16,945
SO DANIEL, I GET TO BE 

2493
01:35:16,945 --> 01:35:18,546
PHILOSOPHICAL FOR A SECOND.

2494
01:35:18,546 --> 01:35:19,881
COMPARE TWO DIFFERENT CASES.

2495
01:35:19,881 --> 01:35:23,484
SO WHEN I, WHEN I WHEN I DO 

2496
01:35:23,484 --> 01:35:29,857
THESE WE HAVE THESE DEVASE --WE 

2497
01:35:29,857 --> 01:35:33,294
DON'T THINK IT'S A FALLACY.

2498
01:35:33,294 --> 01:35:35,163
TAKE THE CLINICAL SETTING, 

2499
01:35:35,163 --> 01:35:36,764
THERE ARE A LOTS OF 

2500
01:35:36,764 --> 01:35:37,732
INTERVENTION THAT'S WE GIVE 

2501
01:35:37,732 --> 01:35:39,534
PATIENTS THAT OFFER THEM 

2502
01:35:39,534 --> 01:35:42,036
SPECIFICALLY NO BENEFIT AT ALL 

2503
01:35:42,036 --> 01:35:43,271
AND ARE RISKY.

2504
01:35:43,271 --> 01:35:47,308
AND THE REASON WE GIVE THEM THE 

2505
01:35:47,308 --> 01:35:49,277
INTERVENTION IS THEY SET THEM 

2506
01:35:49,277 --> 01:35:54,649
UP FOR OTHER BENEFITS.

2507
01:35:54,649 --> 01:35:55,883
CENTRAL LINES, RIGHT, SO 

2508
01:35:55,883 --> 01:35:57,919
CENTRAL LINES IS IV GOES 

2509
01:35:57,919 --> 01:36:01,522
STRAIGHT IN TO YOUR BASICALLY 

2510
01:36:01,522 --> 01:36:03,157
SMASHING INTO PEOPLES, I SHOULD 

2511
01:36:03,157 --> 01:36:08,696
NOT SAY SMASHING INTO YOU'RE 

2512
01:36:08,696 --> 01:36:09,430
LOVINGLY INSERTED.

2513
01:36:09,430 --> 01:36:11,633
AND YOU CAN GET RISKY AND HURT 

2514
01:36:11,633 --> 01:36:13,668
AND GET BLEEDING AND IT DOESN'T 

2515
01:36:13,668 --> 01:36:15,536
DO YOU ANY GOOD TO HAVE THIS 

2516
01:36:15,536 --> 01:36:17,438
THING STICK INING YOUR CHEST 

2517
01:36:17,438 --> 01:36:18,039
PER SE.

2518
01:36:18,039 --> 01:36:21,075
THE REASON IS BECAUSE THERE ARE 

2519
01:36:21,075 --> 01:36:23,544
CERTAIN DRUGS THAT'S HOW YOU 

2520
01:36:23,544 --> 01:36:25,380
ADMINISTER THEM.

2521
01:36:25,380 --> 01:36:27,081
THAT PUTS YOU IN POSITION TO 

2522
01:36:27,081 --> 01:36:28,850
GET THE EXPERIMENT, PUT YOU IN 

2523
01:36:28,850 --> 01:36:31,653
POSITION TO GET TREATED.

2524
01:36:31,653 --> 01:36:33,354
SO NOBODY, I NEVER HEARD A 

2525
01:36:33,354 --> 01:36:35,423
CLINICIAN SAY, YOU CANNOT JUST 

2526
01:36:35,423 --> 01:36:37,859
FIGHT RISK OF THE CENTRAL LINE 

2527
01:36:37,859 --> 01:36:39,560
BY POTENTIAL BENEFIT OF ANOTHER 

2528
01:36:39,560 --> 01:36:39,994
INTERVENTION.

2529
01:36:39,994 --> 01:36:42,296
THAT'S A FALLACY OF A PACKAGE 

2530
01:36:42,296 --> 01:36:43,231
DEAL.

2531
01:36:43,231 --> 01:36:44,298
NOBODY SAYS THAT, OF COURSE YOU 

2532
01:36:44,298 --> 01:36:54,542
HAVE TO GET THE CENTRAL LINE.

2533
01:36:54,542 --> 01:36:56,344
OKAY, NOW TAKE A DIFFERENT CASE.

2534
01:36:56,344 --> 01:37:01,416
TAKE THE CASE OF GIVING A DRUG, 

2535
01:37:01,416 --> 01:37:03,518
WHERE THIS EXACT BENEFIT OF THE 

2536
01:37:03,518 --> 01:37:05,553
DRUG WE WERE JUST TALKING ABOUT 

2537
01:37:05,553 --> 01:37:07,555
IN THE CLINICAL CASE, EXACT 

2538
01:37:07,555 --> 01:37:07,855
SAME THING.

2539
01:37:07,855 --> 01:37:09,624
AND IN ORDER TO FIGURE OUT 

2540
01:37:09,624 --> 01:37:11,459
WHETHER OR NOT THIS DRUG WORKS, 

2541
01:37:11,459 --> 01:37:13,094
YOU NEED TO FIGURE OUT WHETHER 

2542
01:37:13,094 --> 01:37:15,096
IT GOES INTO THE TUMOR.

2543
01:37:15,096 --> 01:37:17,131
TO FOUND OUT IF IT GOES INTO 

2544
01:37:17,131 --> 01:37:18,599
TUMOR, YOU NEED TO TAKE A 

2545
01:37:18,599 --> 01:37:20,702
LITTLE BIT OF KIDNEY OR LIVER 

2546
01:37:20,702 --> 01:37:22,637
AND PUT IN THE LAB AND SOMEBODY 

2547
01:37:22,637 --> 01:37:24,138
TELLS YOU WHETHER THE DRUG GOT 

2548
01:37:24,138 --> 01:37:34,415
IN THERE OR NOT?

2549
01:37:39,120 --> 01:37:40,855
THE RISK OF BIOPSY ARE THE 

2550
01:37:40,855 --> 01:37:42,857
EXACTLY THE SAME OF THE CENTRAL 

2551
01:37:42,857 --> 01:37:43,057
LINE.

2552
01:37:43,057 --> 01:37:45,026
WHAT DO YOU THINK ABOUT THAT?

2553
01:37:45,026 --> 01:37:47,562
SO HERE'S WHAT I SAID, ISN'T IT 

2554
01:37:47,562 --> 01:37:47,829
THE SAME.

2555
01:37:47,829 --> 01:37:49,497
THE RISKS ARE THE SAME AND IN 

2556
01:37:49,497 --> 01:37:53,367
ORDER TO GET THE EXPERIMENTAL 

2557
01:37:53,367 --> 01:37:55,570
DRUG, WE NEED TO DO THIS OTHER 

2558
01:37:55,570 --> 01:37:56,304
THING.

2559
01:37:56,304 --> 01:38:00,441
WHAT PEOPLE WHO ARE BY THE 

2560
01:38:00,441 --> 01:38:03,778
FALLACY, SAY NO, YOU COULD GIVE 

2561
01:38:03,778 --> 01:38:14,255
THEM THE, THE EXPERIMENTAL.

2562
01:38:16,724 --> 01:38:17,892
SO THE QUESTION FOR YOU AND WHY 

2563
01:38:17,892 --> 01:38:20,862
I WANT TO YOU STAY THERE, ARE 

2564
01:38:20,862 --> 01:38:22,063
THOSE CASES SIMILAR OR 

2565
01:38:22,063 --> 01:38:22,330
DIFFERENT?

2566
01:38:22,330 --> 01:38:24,832
DO YOU HAVE A SENSOR TOO HARD 

2567
01:38:24,832 --> 01:38:25,099
TO THINK?

2568
01:38:25,099 --> 01:38:27,835
>> I DON'T KNOW.

2569
01:38:27,835 --> 01:38:29,837
IT'S GOOD QUESTION.

2570
01:38:29,837 --> 01:38:31,072
>> THAT'S FAIR.

2571
01:38:31,072 --> 01:38:34,142
>> IF SOMEBODY ELSE DOES.

2572
01:38:34,142 --> 01:38:37,211
>> WE DON'T HAVE TO PURSUE
THAT 

2573
01:38:37,211 --> 01:38:38,579
ONE, THAT IS HARD BUT THAT'S 

2574
01:38:38,579 --> 01:38:42,016
SORT OF A DID LEMMA AND I THINK 

2575
01:38:42,016 --> 01:38:44,719
IRBs RIGHT NOW ARE WORKING ON 

2576
01:38:44,719 --> 01:38:48,856
THE STHAOUMTION IT'S ALWAYS A 

2577
01:38:48,856 --> 01:38:59,233
FALLACY IN A SETTING.

2578
01:39:04,906 --> 01:39:06,674
>> QUOTE UNQUOTE STEP IN
AND 

2579
01:39:06,674 --> 01:39:08,242
RECOMMEND IMPROVEMENT ON A 

2580
01:39:08,242 --> 01:39:08,509
PROTOCOL.

2581
01:39:08,509 --> 01:39:09,811
>> YEAH.

2582
01:39:09,811 --> 01:39:11,979
SO ON THE ONE HAND, YOU MAY 

2583
01:39:11,979 --> 01:39:13,881
THINK WELL PEOPLE ARE PUTTING 

2584
01:39:13,881 --> 01:39:15,983
ALL SORTS OF RESOURCES INTO AND 

2585
01:39:15,983 --> 01:39:18,219
INVESTIGATION IF THERE ISN'T, 

2586
01:39:18,219 --> 01:39:19,654
YOU KNOW, IF THERE IS WAY TO 

2587
01:39:19,654 --> 01:39:22,356
SEE IMPROVE IT AND IF IRB 

2588
01:39:22,356 --> 01:39:24,025
MEMBER SPOTS OR RECOGNIZE THAT, 

2589
01:39:24,025 --> 01:39:26,127
THERE IS POTENTIAL FOR 

2590
01:39:26,127 --> 01:39:36,504
IMPROVEMENT, WHY NOT?

2591
01:39:37,071 --> 01:39:39,173
ON THE OTHER HAND, THERE IS A 

2592
01:39:39,173 --> 01:39:40,641
DIVISION ON LABOR AND THROWING 

2593
01:39:40,641 --> 01:39:43,978
IDEAS FOR IMPROVEMENT IN SOME 

2594
01:39:43,978 --> 01:39:45,713
CASES WITH DRASTICALLY CHANGE 

2595
01:39:45,713 --> 01:39:49,350
FOR INSTANCE, THE RISK BENEFIT 

2596
01:39:49,350 --> 01:39:51,519
FOR PROTOCOL AND THAT MAY DELAY 

2597
01:39:51,519 --> 01:39:52,887
THE REVIEW IN PROCESS.

2598
01:39:52,887 --> 01:39:54,922
WHICH THEN, BRING IN WILL BRING 

2599
01:39:54,922 --> 01:39:58,626
IN THE QUESTION OF, YOU KNOW, 

2600
01:39:58,626 --> 01:40:00,194
RESOURCES, I JUST WANTED TO 

2601
01:40:00,194 --> 01:40:01,329
HEAR MORE ABOUT WHAT YOU 

2602
01:40:01,329 --> 01:40:03,531
THOUGHT ABOUT THIS PARTICULAR?

2603
01:40:03,531 --> 01:40:04,999
>> YEAH, SO CAN I GET YOUR

2604
01:40:04,999 --> 01:40:06,734
ANSWER TO MY QUESTION WHICH IS 

2605
01:40:06,734 --> 01:40:07,535
I DON'T KNOW.

2606
01:40:07,535 --> 01:40:08,970
>> SURE.

2607
01:40:08,970 --> 01:40:12,640
>> SO I THINK, I THINK SO 

2608
01:40:12,640 --> 01:40:14,542
HERE'S WHAT SOME PEOPLE WILL 

2609
01:40:14,542 --> 01:40:17,812
SAY, SOME PEOPLE WILL SAY, IRBs 

2610
01:40:17,812 --> 01:40:19,981
SHOULDN'T BE DOING THAT AT ALL, 

2611
01:40:19,981 --> 01:40:22,516
BECAUSE WHAT THE JOB OF A IRB 

2612
01:40:22,516 --> 01:40:26,187
IS IS TO EVALUATE WHATEVER 

2613
01:40:26,187 --> 01:40:27,655
PROTOCOL GETS PRESENT TODAY 

2614
01:40:27,655 --> 01:40:30,725
THEM?

2615
01:40:30,725 --> 01:40:32,693
AS LONG AS THAT'S ACCEPTABLE, 

2616
01:40:32,693 --> 01:40:35,530
THEY SHOULD NOT BE DOING ANY 

2617
01:40:35,530 --> 01:40:36,864
COMPARISON OR ACROSS DIFFERENT 

2618
01:40:36,864 --> 01:40:38,566
STUDIES THEY CAN DO.

2619
01:40:38,566 --> 01:40:39,467
I THINK THAT'S WRONG.

2620
01:40:39,467 --> 01:40:41,269
I THINK THAT'S JUST A MISTAKE.

2621
01:40:41,269 --> 01:40:43,137
I THINK THERE IS DIFFERENT WAYS 

2622
01:40:43,137 --> 01:40:44,038
TO ARGUE FOR IT.

2623
01:40:44,038 --> 01:40:47,909
ONE WAY IS TO SAY, THAT IT'S 

2624
01:40:47,909 --> 01:40:49,744
KIND OF CONSEQUENCETIAL TO SAY, 

2625
01:40:49,744 --> 01:40:51,178
LOOK WHAT YOU SAID THEY'RE 

2626
01:40:51,178 --> 01:40:53,214
SUPPOSE TO BE DOING, IS WHETHER 

2627
01:40:53,214 --> 01:40:55,283
OR NOT THE THING THAT THEY'RE 

2628
01:40:55,283 --> 01:40:56,183
PROPOSE ISING ETHICAL.

2629
01:40:56,183 --> 01:40:58,653
BUT PART OF MAKING THAT 

2630
01:40:58,653 --> 01:41:00,054
DETERMINATION IS SQUG THE 

2631
01:41:00,054 --> 01:41:01,389
QUESTION ON WHAT THEY CAN DO 

2632
01:41:01,389 --> 01:41:01,656
OTHERWISE.

2633
01:41:01,656 --> 01:41:04,592
AND IF YOU CAN NOT SAY, YOU 

2634
01:41:04,592 --> 01:41:05,893
CANNOT SAY, THAT'S ONE WAY TO 

2635
01:41:05,893 --> 01:41:06,761
ARGUE.

2636
01:41:06,761 --> 01:41:09,130
BUT SOMETHING LIKE THAT IS 

2637
01:41:09,130 --> 01:41:09,330
RIGHT.

2638
01:41:09,330 --> 01:41:10,831
BUT SO THEN THE QUESTION IS, I 

2639
01:41:10,831 --> 01:41:12,767
THINK THE IMPORTANT HARD ONE IS 

2640
01:41:12,767 --> 01:41:14,602
WHAT YOU'RE POINTING TO WHICH I 

2641
01:41:14,602 --> 01:41:16,971
THINK IS A PRACTICAL OF WHO 

2642
01:41:16,971 --> 01:41:17,638
DOES IT.

2643
01:41:17,638 --> 01:41:19,941
I THINK FOR SOME OF THESE 

2644
01:41:19,941 --> 01:41:22,243
THINGS, COMPARE ACROSS STUDIES, 

2645
01:41:22,243 --> 01:41:23,411
IRBs ARE NOT IN A POSITION TO 

2646
01:41:23,411 --> 01:41:24,912
DO THAT.

2647
01:41:24,912 --> 01:41:27,448
SO WE NEED SOMEBODY FURTHER UP 

2648
01:41:27,448 --> 01:41:29,283
STREAM FUNDING AGENCIES, 

2649
01:41:29,283 --> 01:41:30,885
INSTITUTIONS MAKING THOSE 

2650
01:41:30,885 --> 01:41:32,486
DETERMINATION SXZ OPENFULLY 

2651
01:41:32,486 --> 01:41:35,022
IRBs BEING ABLE TO RELY O ON.

2652
01:41:35,022 --> 01:41:37,058
>> THANKS.

2653
01:41:37,058 --> 01:41:38,926
>> ANOTHER SLIGHT
VARIATION ON 

2654
01:41:38,926 --> 01:41:41,762
THAT IS A LOT OF RESEARCH THAT 

2655
01:41:41,762 --> 01:41:43,197
IRBs REVIEW HAVE BEEN REVIEWED 

2656
01:41:43,197 --> 01:41:45,099
BY A GROUP OF SCIENTISTS.

2657
01:41:45,099 --> 01:41:49,737
SO IF IT'S AN NIH GRANT, IT'S 

2658
01:41:49,737 --> 01:41:52,340
GONE THROUGH A PEER REVIEW OF 

2659
01:41:52,340 --> 01:41:57,845
SCIENTIST THAT KNOW THAT FIELD.

2660
01:41:57,845 --> 01:42:01,248
AND HAVE SAID THIS IS A GREAT 

2661
01:42:01,248 --> 01:42:02,483
PROTOCOL, WE THINK IT OUGHT TO 

2662
01:42:02,483 --> 01:42:05,152
BE FUNDED AND BY THE TIME IT 

2663
01:42:05,152 --> 01:42:06,687
GOES THROUGH IRB IT HAS GONE 

2664
01:42:06,687 --> 01:42:07,989
THROUGH THAT PROCESS.

2665
01:42:07,989 --> 01:42:09,757
SO SOME WAY SAY IF THERE IS 

2666
01:42:09,757 --> 01:42:11,459
BEEN A SCIENTIFIC REVIEW, 

2667
01:42:11,459 --> 01:42:21,969
THAT'S A REASON MAYBE TO ONLY 

2668
01:42:22,370 --> 01:42:23,904
STUDY ON IMPORTANT VERSUS AN 

2669
01:42:23,904 --> 01:42:25,806
INVESTIGATOR THAT HE PLAN, SHE 

2670
01:42:25,806 --> 01:42:27,775
PLANS TO FUND WITH 

2671
01:42:27,775 --> 01:42:28,809
DISCRETIONARY FUNDS.

2672
01:42:28,809 --> 01:42:31,278
THAT MAYBE WAS REVIEWED AT THE 

2673
01:42:31,278 --> 01:42:33,614
DEPARTMENT LEVEL, BUT MAYBE NOT 

2674
01:42:33,614 --> 01:42:37,184
REALLY STRICTLY AND NOW IT'S ON 

2675
01:42:37,184 --> 01:42:38,552
THE IRBs DESK.

2676
01:42:38,552 --> 01:42:40,988
I WOULD SAY, YOU KNOW, THAT'S A 

2677
01:42:40,988 --> 01:42:43,724
CASE WHERE THE IRBs REALLY 

2678
01:42:43,724 --> 01:42:45,626
OUGHT TO PAY ATTENTION TO THE 

2679
01:42:45,626 --> 01:42:47,194
STUDY DESIGN AND WHETHER IT'S 

2680
01:42:47,194 --> 01:42:49,797
BEEN WELL DESIGNED, WHETHER IT 

2681
01:42:49,797 --> 01:42:51,432
CAN ACTUALLY ANSWER THE 

2682
01:42:51,432 --> 01:42:52,500
RESEARCH QUESTION BECAUSE NO 

2683
01:42:52,500 --> 01:42:57,772
OTHER GROUP HAS PROVIDED A 

2684
01:42:57,772 --> 01:42:58,939
ROBUST SCIENTIFIC REVIEW.

2685
01:42:58,939 --> 01:43:00,674
DID YOU HAVE A QUESTION, WE 

2686
01:43:00,674 --> 01:43:05,913
HAVE TIME FOR ONE MORE?

2687
01:43:05,913 --> 01:43:07,948
>> FIRST OF ALL THANK YOU
SO 

2688
01:43:07,948 --> 01:43:10,551
MUCH FOR THE TALK IT'S REALLY 

2689
01:43:10,551 --> 01:43:11,919
FASCINATING AND I THINK I'LL 

2690
01:43:11,919 --> 01:43:13,788
TAKE A AWAY A LOT OF QUESTIONS 

2691
01:43:13,788 --> 01:43:14,722
AFTER THIS LECTURE.

2692
01:43:14,722 --> 01:43:16,524
ONE OF THE QUESTIONS I HAD WAS 

2693
01:43:16,524 --> 01:43:18,159
THINKING ABOUT INTERNATIONAL 

2694
01:43:18,159 --> 01:43:19,527
STUDIES AND THE CONCEPT OF 

2695
01:43:19,527 --> 01:43:20,428
FAIRNESS.

2696
01:43:20,428 --> 01:43:23,564
SO LIKE, INTERNATIONAL, THERE 

2697
01:43:23,564 --> 01:43:26,167
IS DIVERSITY OF CULTURE ETHICAL 

2698
01:43:26,167 --> 01:43:27,968
BELIEVES AND SOME MAY VOLVE 

2699
01:43:27,968 --> 01:43:29,470
TAKING ON MORE RISKS OR NET 

2700
01:43:29,470 --> 01:43:31,072
RISKS.

2701
01:43:31,072 --> 01:43:33,374
AS FOR EXAMPLE, I CAN TAKE MORE 

2702
01:43:33,374 --> 01:43:35,643
INDIVIDUAL RISK IF IT BENEFITS 

2703
01:43:35,643 --> 01:43:36,410
SOCIETY.

2704
01:43:36,410 --> 01:43:38,045
FOR EXAMPLE, WHAT IF YOU HAD 

2705
01:43:38,045 --> 01:43:39,880
LIKE A WESTERN CULTURE WHO 

2706
01:43:39,880 --> 01:43:43,284
TAKES ON LESS NET RISKS BECAUSE 

2707
01:43:43,284 --> 01:43:51,659
THEY ARE MORE INDIVIDUALISTIC.

2708
01:43:51,659 --> 01:43:56,297
IS IT OKAY FOR ADULTS TO TAKE 

2709
01:43:56,297 --> 01:43:58,799
ON MORE RISKS IF IT BENEFITS 

2710
01:43:58,799 --> 01:43:59,433
SOCIETY.

2711
01:43:59,433 --> 01:44:00,801
WHAT ARE YOUR THOUGHTS AND DO 

2712
01:44:00,801 --> 01:44:02,369
YOU THINK THAT'S FAIR?

2713
01:44:02,369 --> 01:44:04,271
IT FEELS LIKE WE'RE ALL 

2714
01:44:04,271 --> 01:44:05,506
PARTICIPATING AND THINKING IT'S 

2715
01:44:05,506 --> 01:44:07,041
ETHICAL BUT AT THE SAME TIME IF 

2716
01:44:07,041 --> 01:44:08,742
I IMPART MY WESTERN VIEW, IT 

2717
01:44:08,742 --> 01:44:11,812
DOES NOT ETHICAL FOR ONE GROUP 

2718
01:44:11,812 --> 01:44:14,915
TO TAKE ON MORE RISKS THAN THE 

2719
01:44:14,915 --> 01:44:15,116
OTHER.

2720
01:44:15,116 --> 01:44:15,983
>> I LOVE THAT QUESTION.

2721
01:44:15,983 --> 01:44:18,486
AND I THINK IT'S, I THINK IT 

2722
01:44:18,486 --> 01:44:20,588
APPLIES AS YOU SUGGESTED ACROSS 

2723
01:44:20,588 --> 01:44:23,090
THE BOARD BUT I THINK IT'S 

2724
01:44:23,090 --> 01:44:26,093
ESPECIALLY RELEVANT WHEN YOU 

2725
01:44:26,093 --> 01:44:28,496
THINK ABOUT SOMEBODY LIKE KIDS.

2726
01:44:28,496 --> 01:44:30,297
SO A LOT OF STANDARD FOR 

2727
01:44:30,297 --> 01:44:34,502
MINIMUM RISK ARE BASICALLY AS I 

2728
01:44:34,502 --> 01:44:35,636
SAID, COMPARE THE RISK TO THE 

2729
01:44:35,636 --> 01:44:37,671
RESEARCH TO THE RISK THOUGHT TO 

2730
01:44:37,671 --> 01:44:39,740
BE ACCEPTABLE FOR ORDINARY KIDS 

2731
01:44:39,740 --> 01:44:50,017
IN THAT SOCIETY.

2732
01:44:52,486 --> 01:44:55,656
SO DOES THAT MEAN IF WE'RE IN A 

2733
01:44:55,656 --> 01:44:57,291
SOCIETY THAT WE'RE NOT WILLING 

2734
01:44:57,291 --> 01:44:59,126
TO TAKE RISKS THEN YOU CAN ONLY 

2735
01:44:59,126 --> 01:45:01,695
HAVE A TINY PEDIATRIC RISK BUT 

2736
01:45:01,695 --> 01:45:03,130
IN OTHER COUNTRIES WHERE WE'RE 

2737
01:45:03,130 --> 01:45:04,765
WILLING TO TAKE MORE RISKS, 

2738
01:45:04,765 --> 01:45:09,503
THAT I THINK IS A REALLY GOOD 

2739
01:45:09,503 --> 01:45:09,703
GREAT.

2740
01:45:09,703 --> 01:45:10,905
AND IT RAISES QUESTIONS THAT I 

2741
01:45:10,905 --> 01:45:13,641
THOUGHT ABOUT A FOR A WHILE, 

2742
01:45:13,641 --> 01:45:16,177
WHICH IS THAT IT HAS PRACTICAL 

2743
01:45:16,177 --> 01:45:17,411
IMPLICATIONS, BECAUSE THE 

2744
01:45:17,411 --> 01:45:19,013
REGULATIONS IN CERTAIN 

2745
01:45:19,013 --> 01:45:20,814
COUNTRIES ARE VERY DIFFERENT.

2746
01:45:20,814 --> 01:45:22,883
SO THERE ARE CERTAIN COUNTRIES, 

2747
01:45:22,883 --> 01:45:24,318
I THINK IT'S STILL TRUE.

2748
01:45:24,318 --> 01:45:26,787
BUT A COUPLE OF YEARS AGO, 

2749
01:45:26,787 --> 01:45:28,355
THERE WERE CERTAIN COUNTRIES 

2750
01:45:28,355 --> 01:45:31,392
THAT HAD LAWS THAT SAID, YOU 

2751
01:45:31,392 --> 01:45:32,660
CANNOT EXPOSE A KID TO ANY 

2752
01:45:32,660 --> 01:45:34,862
RESEARCH.

2753
01:45:34,862 --> 01:45:39,066
SO EVEN MINIMAL RISK WAS NOT 

2754
01:45:39,066 --> 01:45:39,300
ALLOWED.

2755
01:45:39,300 --> 01:45:40,501
AND THE PERSON NEXT DOOR 

2756
01:45:40,501 --> 01:45:42,903
ALLOWED THAT.

2757
01:45:42,903 --> 01:45:45,406
DO WE SAY, COUNTRIES GET TO 

2758
01:45:45,406 --> 01:45:46,373
DECIDE.

2759
01:45:46,373 --> 01:45:48,042
NOW HERE'S THE WORRY IMAGINE WE 

2760
01:45:48,042 --> 01:45:49,610
DO ALL THE RESEARCH AND WE 

2761
01:45:49,610 --> 01:45:50,778
LEARN ALL OF THESE THINGS AND 

2762
01:45:50,778 --> 01:45:52,913
THEN THE OTHER COUNTRIES IS 

2763
01:45:52,913 --> 01:45:54,315
LIKE, YEAH, THIS IS GREAT, WE 

2764
01:45:54,315 --> 01:45:56,250
DON'T HAVE TO EXPOSE OUR KIDS 

2765
01:45:56,250 --> 01:45:58,652
TO MY RISK AND WE LEARN ALL OF 

2766
01:45:58,652 --> 01:45:59,787
THIS STUFF OVER HERE.

2767
01:45:59,787 --> 01:46:01,555
THAT DOES NOT SEEM RIGHT?

2768
01:46:01,555 --> 01:46:03,657
WHAT DO YOU DO ABOUT THAT?

2769
01:46:03,657 --> 01:46:04,325
I DON'T KNOW.

2770
01:46:04,325 --> 01:46:06,093
BUT I THINK IT'S A GREAT 

2771
01:46:06,093 --> 01:46:06,360
QUESTION.

2772
01:46:06,360 --> 01:46:09,230
AND I THINK YOU'RE RIGHT, THE 

2773
01:46:09,230 --> 01:46:10,731
PROBLEM ARISES AND WHAT WE DO 

2774
01:46:10,731 --> 01:46:12,333
ABOUT IS HARD AND INTERESTING.

2775
01:46:12,333 --> 01:46:12,866
>> THANK YOU.

2776
01:46:12,866 --> 01:46:15,603
>> THANK YOU.

2777
01:46:15,603 --> 01:46:16,470
>> THANKS, AGAIN DAVE FOR 

2778
01:46:16,470 --> 01:46:17,504
JOINING US.

2779
01:46:17,504 --> 01:46:19,807
WE'RE GOING TO TAKE OUR 

2780
01:46:19,807 --> 01:46:21,041
15-MINUTE BREAK AND THEN WE'RE 

2781
01:46:21,041 --> 01:46:24,411
GOING JOINED ON THE BIG SCREEN 

2782
01:46:24,411 --> 01:46:27,548
BY SEEMA SHAH WHO IS BEAMING IN 

2783
01:46:27,548 --> 01:46:27,648
FROM CHICAGO.

2784
01:46:27,648 --> 01:46:28,682
WELCOME BACK EVERY ONE TO 

2785
01:46:28,682 --> 01:46:32,753
SESSION 3 AND IT'S MY PLEASURE 

2786
01:46:32,753 --> 01:46:38,259
TO INTRODUCE DOCTOR, PROFESSOR 

2787
01:46:38,259 --> 01:46:40,995
SEEMA SHAH SHE A PROFESSOR OF 

2788
01:46:40,995 --> 01:46:50,437
IN PAOED  PEDIATRICS, SHE IS AN 

2789
01:46:50,437 --> 01:46:52,473
EXPERT OF PEDIATRICS AND GLOBAL 

2790
01:46:52,473 --> 01:46:55,209
HEALTH RESEARCH AS WELL AS 

2791
01:46:55,209 --> 01:46:56,610
ETHICAL ISSUES IN DETERMINATION 

2792
01:46:56,610 --> 01:46:58,946
OF DEATH AND THE FUN FACT THAT 

2793
01:46:58,946 --> 01:47:00,314
I MENTIONED EARLIER, AS DAVE 

2794
01:47:00,314 --> 01:47:02,783
WAS A FELLOW HERE, A SEEMA WAS 

2795
01:47:02,783 --> 01:47:05,085
ALSO A FELLOW HERE AND ALSO A 

2796
01:47:05,085 --> 01:47:06,854
MEMBER OF OUR FACULTY.

2797
01:47:06,854 --> 01:47:08,322
SO WITH THAT, I'M GOING TO HAND 

2798
01:47:08,322 --> 01:47:10,424
IT OVER TO SEEMA.

2799
01:47:10,424 --> 01:47:13,227
>> THANKS SO MUCH, HOLLY,
IT'S 

2800
01:47:13,227 --> 01:47:15,763
REALLY A PLEASURE TO BE BACK 

2801
01:47:15,763 --> 01:47:19,099
EVEN IF I'M ONLY BACK VIRTUALLY.

2802
01:47:19,099 --> 01:47:19,767
SORRY I COULDN'T BE THERE IN 

2803
01:47:19,767 --> 01:47:22,136
PERSON.

2804
01:47:22,136 --> 01:47:25,172
AND DAVE WAS A FACULTY MEMBER 

2805
01:47:25,172 --> 01:47:27,741
AND I WAS A ONE OF HIS FELLOW 

2806
01:47:27,741 --> 01:47:30,244
AND LATER HAD THE PLEASURE OF 

2807
01:47:30,244 --> 01:47:32,212
BEING HIS COLLEAGUE AND 

2808
01:47:32,212 --> 01:47:32,546
COLLABORATOR.

2809
01:47:32,546 --> 01:47:33,981
SO SOME OF THE WORK IS SOME OF 

2810
01:47:33,981 --> 01:47:35,382
THE WORK THAT WE DID TOGETHER 

2811
01:47:35,382 --> 01:47:36,750
AND DAVE DID SUBSEQUENTLY.

2812
01:47:36,750 --> 01:47:37,918
SO WHAT I'M GOING TO TALK TO 

2813
01:47:37,918 --> 01:47:40,921
YOU ABOUT TODAY IS ETHICAL 

2814
01:47:40,921 --> 01:47:42,323
INCLUSION OF CHILDREN IN 

2815
01:47:42,323 --> 01:47:45,059
RESEARCH AND THE GOAL IS TO 

2816
01:47:45,059 --> 01:47:47,127
REALLY SHOW YOU HOW WE SHIFTED 

2817
01:47:47,127 --> 01:47:49,663
OVERTIME TO RECOGNIZING THE 

2818
01:47:49,663 --> 01:47:51,231
IMPORTANCE OF RESPONSIBLE 

2819
01:47:51,231 --> 01:47:53,067
INCLUSION OF CHILDREN INSTEAD 

2820
01:47:53,067 --> 01:47:55,469
OF JUST FOCUSING ON THEIR 

2821
01:47:55,469 --> 01:47:55,769
PROTECTION.

2822
01:47:55,769 --> 01:47:57,504
FOCUS ONING IF YOU JUST FOCUS 

2823
01:47:57,504 --> 01:47:59,940
ON PROTECTION, THEN YOU MISS 

2824
01:47:59,940 --> 01:48:01,809
OUT ON MANY POTENTIAL BENEFITS 

2825
01:48:01,809 --> 01:48:04,345
FOR CHILDREN AS A GROUP AND 

2826
01:48:04,345 --> 01:48:06,146
EXPOSE THEM TO RISK IN CLINICAL 

2827
01:48:06,146 --> 01:48:10,250
CARE.

2828
01:48:10,250 --> 01:48:15,255
SO THED BIG MOTIVATION BEHIND 

2829
01:48:15,255 --> 01:48:16,724
PEDIATRIC RESEARCH, WHICH A LOT 

2830
01:48:16,724 --> 01:48:18,992
OF PEOPLE DON'T REALIZE IS THAT 

2831
01:48:18,992 --> 01:48:21,895
THERE IS A GREAT NEED TO FIND 

2832
01:48:21,895 --> 01:48:23,464
INTERVENTION SXZ DOSES THAT 

2833
01:48:23,464 --> 01:48:24,865
WORK FOR CHILDREN GIVEN THAT 

2834
01:48:24,865 --> 01:48:27,167
THEY'RE NOT JUST SMALL ADULT.

2835
01:48:27,167 --> 01:48:30,371
THIS STUDY WAS DONE TO SHOW 

2836
01:48:30,371 --> 01:48:31,905
EVEN ENORMOUS DIFFERENCES 

2837
01:48:31,905 --> 01:48:34,408
BETWEEN ADULTS AND HEAT IN 

2838
01:48:34,408 --> 01:48:41,548
RELATION TO HEAT PERCEPTION.

2839
01:48:41,548 --> 01:48:45,386
KIDS EVEN THAT THEY'RE HEIGHT 

2840
01:48:45,386 --> 01:48:47,321
IS LOWER AND CLOSER TO THE 

2841
01:48:47,321 --> 01:48:47,554
GROUND.

2842
01:48:47,554 --> 01:48:49,857
SO ALL OF THESE THINGS, IN MANY 

2843
01:48:49,857 --> 01:48:51,492
CASES, NOT ALL, SUGGESTS THAT 

2844
01:48:51,492 --> 01:48:54,795
THERE NEEDS TO BE A WAY TO DO 

2845
01:48:54,795 --> 01:48:56,530
RESEARCH ON CHILDREN AND 

2846
01:48:56,530 --> 01:48:56,897
INTERVENTIONS.

2847
01:48:56,897 --> 01:48:59,666
AND THIS QUOTE SUMS IT NICELY, 

2848
01:48:59,666 --> 01:49:01,769
THE VAS MAJORITY OF OF DRUGS 

2849
01:49:01,769 --> 01:49:04,571
WERE NOT DESIGNED OR DEVELOPED 

2850
01:49:04,571 --> 01:49:07,408
FOR PEDIATRIC OR INFANT 

2851
01:49:07,408 --> 01:49:07,708
POPULATIONS.

2852
01:49:07,708 --> 01:49:10,544
WHAT I WOULD LIKE TO TALK ABOUT 

2853
01:49:10,544 --> 01:49:12,646
WHEN TO EN ROLL CHILDREN IN 

2854
01:49:12,646 --> 01:49:14,581
RESEARCH WITH RESPECT TO OTHER 

2855
01:49:14,581 --> 01:49:16,316
TYPES OF RESEARCH, PARTICULARLY 

2856
01:49:16,316 --> 01:49:17,418
RESEARCH IN ADULTS.

2857
01:49:17,418 --> 01:49:19,052
AND THEN WE'LL TALK ABOUT RISK 

2858
01:49:19,052 --> 01:49:21,422
SXZ BENEFITS AND TURN TO 

2859
01:49:21,422 --> 01:49:24,591
DECISION MAKING FOCUSING ON THE 

2860
01:49:24,591 --> 01:49:25,926
CONSENT AND DIS CONSENT.

2861
01:49:25,926 --> 01:49:30,130
SO FIRST WHEN WE WE EN ROLL 

2862
01:49:30,130 --> 01:49:31,231
CHILDREN IN RESEARCH.

2863
01:49:31,231 --> 01:49:32,466
THE FIRST QUESTION IS WHO IS 

2864
01:49:32,466 --> 01:49:33,834
THE CHILD?

2865
01:49:33,834 --> 01:49:36,103
AND THAT VARIES QUITE A BIT 

2866
01:49:36,103 --> 01:49:39,706
FROM PLACE TO PLACE.

2867
01:49:39,706 --> 01:49:40,841
THE TYPICAL DEFINITION IS 

2868
01:49:40,841 --> 01:49:42,709
CHILDREN IT ARE TOO YOUNG TO 

2869
01:49:42,709 --> 01:49:44,645
GIVE THEIR OWN CONSENT.

2870
01:49:44,645 --> 01:49:46,380
AND IN THE UNITED STATES, EVEN 

2871
01:49:46,380 --> 01:49:48,982
IN THE UNITED STATES IT VARIES 

2872
01:49:48,982 --> 01:49:50,384
TWO STATES WHERE YOU DON'T HAVE 

2873
01:49:50,384 --> 01:49:54,721
THE ABILITY TO GIVE CONSENT 

2874
01:49:54,721 --> 01:49:56,390
UNTIL YOU'RE 19, YOU'RE A MINOR 

2875
01:49:56,390 --> 01:49:57,791
UNTIL YOU'RE 19.

2876
01:49:57,791 --> 01:50:00,494
AND AROUND THE WORLD THIS 

2877
01:50:00,494 --> 01:50:01,628
VARIES AS WELL, THERE IS A 

2878
01:50:01,628 --> 01:50:04,031
COUNTRY WHERE YOU NEED TO BE 21.

2879
01:50:04,031 --> 01:50:05,999
AND WE'LL TALK MORE ABOUT 

2880
01:50:05,999 --> 01:50:10,571
CONSENT BUT PROBABLY THE 

2881
01:50:10,571 --> 01:50:11,738
PROBLEM THAT ARISING, BECAUSE 

2882
01:50:11,738 --> 01:50:13,540
CHILDREN CAN'T GIVE THEIR OWN 

2883
01:50:13,540 --> 01:50:18,111
CONSENT AND LACK HUMAN CAPACITY 

2884
01:50:18,111 --> 01:50:19,613
TO GIVE CONSENT, THERE ARE A 

2885
01:50:19,613 --> 01:50:21,181
LOT OF REASONS WHY YOU MAY WANT 

2886
01:50:21,181 --> 01:50:23,851
TO STUDY ADULTS.

2887
01:50:23,851 --> 01:50:32,292
CHILDREN ARE MORE VULNERABLE TO 

2888
01:50:32,292 --> 01:50:36,497
RISKS INSTEAD OF ADULTS.

2889
01:50:36,497 --> 01:50:38,632
BECAUSE CHILDREN MAY HAVE LESS 

2890
01:50:38,632 --> 01:50:42,803
IMMUNITY TO THINGS OR BE MORE 

2891
01:50:42,803 --> 01:50:44,071
FRAGILE IN CERTAIN RESPECTS 

2892
01:50:44,071 --> 01:50:45,539
THAN ADULTS.

2893
01:50:45,539 --> 01:50:46,206
ADDITIONALLY BECAUSE CHILDREN 

2894
01:50:46,206 --> 01:50:48,542
CAN'T GIVE THEIR OWN CONSENT, 

2895
01:50:48,542 --> 01:50:50,511
THEY CANNOT PROTECT THEIR OWN 

2896
01:50:50,511 --> 01:50:51,044
INTEREST.

2897
01:50:51,044 --> 01:50:55,883
AND FINALLY, THERE IS A GREATER 

2898
01:50:55,883 --> 01:50:58,519
POTENTIAL FOR NEGATIVE REACTION 

2899
01:50:58,519 --> 01:51:00,354
IF SOMEBODY GOES WRONG.

2900
01:51:00,354 --> 01:51:02,956
IF YOU'RE RELYING ONLY ON 

2901
01:51:02,956 --> 01:51:06,293
CONSENT OR PERMISSION TO EN 

2902
01:51:06,293 --> 01:51:08,595
ROLL A CHILD IN RESEARCH, YOU 

2903
01:51:08,595 --> 01:51:12,733
MAY NOT BE GETTING THE SAME 

2904
01:51:12,733 --> 01:51:16,169
LEVEL OF MORAL CONSERVATION 

2905
01:51:16,169 --> 01:51:17,404
WHEREFORE THEIR OWN 

2906
01:51:17,404 --> 01:51:18,005
PARTICIPATION.

2907
01:51:18,005 --> 01:51:20,908
HOWEVER, THERE ARE LOTS OF 

2908
01:51:20,908 --> 01:51:22,843
REASONS TONE ROLL CHILDREN 

2909
01:51:22,843 --> 01:51:23,076
SOONER.

2910
01:51:23,076 --> 01:51:26,280
SOMETIMES CHILDREN CAN RECEIVE 

2911
01:51:26,280 --> 01:51:27,548
IMPORTANT BENEFITS DIRECTLY 

2912
01:51:27,548 --> 01:51:29,249
FROM RESEARCHERS, THIS IS OFTEN 

2913
01:51:29,249 --> 01:51:32,152
THE CASE IN LATER STAGE 

2914
01:51:32,152 --> 01:51:33,287
TREATMENT TRIALS PARTICULARLY 

2915
01:51:33,287 --> 01:51:36,089
TRIALS ON RARE CONDITIONS.

2916
01:51:36,089 --> 01:51:37,691
SOME DISEASES ARE CONDITIONS 

2917
01:51:37,691 --> 01:51:40,060
ONLY AFFECT CHILDREN OR AFFECT 

2918
01:51:40,060 --> 01:51:43,196
CHILDREN DIFFERENTLY.

2919
01:51:43,196 --> 01:51:44,998
SO, FOR INSTANCE TUBERCULOSIS 

2920
01:51:44,998 --> 01:51:47,701
IS IN CHILDREN UNDER 10, VERY 

2921
01:51:47,701 --> 01:51:49,436
DIFFERENT FROM ADULT 

2922
01:51:49,436 --> 01:51:50,204
TUBERCULOSIS.

2923
01:51:50,204 --> 01:51:52,539
AND ONCE CHILDREN REACH THE AGE 

2924
01:51:52,539 --> 01:51:54,775
OF 10, AGENTLY SIMILAR 

2925
01:51:54,775 --> 01:51:57,077
CONDITION TO HOW IT'S 

2926
01:51:57,077 --> 01:51:59,613
EXPERIENCED IN ADULTS.

2927
01:51:59,613 --> 01:52:05,085
BUT ALSO THE ISSUE LIKE MALARIA 

2928
01:52:05,085 --> 01:52:06,687
WHICH AFFECTS PEOPLE OF ALL 

2929
01:52:06,687 --> 01:52:13,760
AGES BUT CHILDREN UNDER 5 CAN 

2930
01:52:13,760 --> 01:52:16,296
HAVE MORE SEVERE CONDITIONS.

2931
01:52:16,296 --> 01:52:19,466
FINALLY, THERE IS A IF YOU 

2932
01:52:19,466 --> 01:52:21,501
DELAY, PEDIATRIC TESTING THAT 

2933
01:52:21,501 --> 01:52:27,307
CAN LEAD TO SORT OF DOMINO 

2934
01:52:27,307 --> 01:52:28,976
AFFECT WHERE AVAILABILITY OF 

2935
01:52:28,976 --> 01:52:30,711
THE INTERVENTION IS ALSO 

2936
01:52:30,711 --> 01:52:32,613
DELAYED FOR CHILDREN SO. WHEN 

2937
01:52:32,613 --> 01:52:35,382
YOU TURN TO ETHICAL GUIDANCE TO 

2938
01:52:35,382 --> 01:52:39,219
FIGURE OUT HOW WE BALANCE THESE 

2939
01:52:39,219 --> 01:52:40,754
REASONS, AND RESEARCH, THE 

2940
01:52:40,754 --> 01:52:43,023
WORLD HEALTH ORGANIZATION HAS 

2941
01:52:43,023 --> 01:52:45,993
THE COUNCIL FOR INTERNATIONAL 

2942
01:52:45,993 --> 01:52:49,162
MEDICAL SCIENCE AND YOU'VE 

2943
01:52:49,162 --> 01:52:52,165
HEARD TALK ABOUT THIS GUIDANCE 

2944
01:52:52,165 --> 01:52:55,435
THIS IS REALLY, GUIDANCE IN 

2945
01:52:55,435 --> 01:52:57,237
2016, ADULTS SHOULD BE FIRST IN 

2946
01:52:57,237 --> 01:52:59,272
ALL RESEARCH.

2947
01:52:59,272 --> 01:53:02,676
AND THE DECLARATION, THE 2013 

2948
01:53:02,676 --> 01:53:05,045
VERSION SAID THE PEOPLE WHO 

2949
01:53:05,045 --> 01:53:07,314
CANNOT CONSENT SHOULD NOT BE 

2950
01:53:07,314 --> 01:53:08,448
ENROLLED IN RESEARCH UNLESS 

2951
01:53:08,448 --> 01:53:11,618
THERE IS A PROSPECT OF DIRECT 

2952
01:53:11,618 --> 01:53:13,954
BENEFIT OR RESEARCH IS DESIGNED 

2953
01:53:13,954 --> 01:53:18,258
TO PROMOTE THE GROUP AND 

2954
01:53:18,258 --> 01:53:20,560
INVOLVES MINIMAL RISK OR BURDEN 

2955
01:53:20,560 --> 01:53:22,362
AND CANNOT BE PERFORMED WITH 

2956
01:53:22,362 --> 01:53:25,732
PEOPLE WHO CAN'T CONSENT.

2957
01:53:25,732 --> 01:53:29,469
SO MANY ARE RESTRICTIVE ABOUT 

2958
01:53:29,469 --> 01:53:32,539
WHEN CHILDREN CAN BE ENROLLED 

2959
01:53:32,539 --> 01:53:33,540
IN RESEARCH.

2960
01:53:33,540 --> 01:53:35,642
THERE IS THE MOST SYSTEMATIC 

2961
01:53:35,642 --> 01:53:37,210
APPROACH THAT I FOUND ON THIS 

2962
01:53:37,210 --> 01:53:40,747
WAS AS FAR BACK AS IN 2004.

2963
01:53:40,747 --> 01:53:44,317
SO THIS IS A GROUP EUROPEAN 

2964
01:53:44,317 --> 01:53:46,053
SPECIALIST IN PEDIATRICS WHO 

2965
01:53:46,053 --> 01:53:47,821
CAME TOGETHER AND SAID WHEN 

2966
01:53:47,821 --> 01:53:49,423
SHOULD WE EN ROLL CHILDREN IN 

2967
01:53:49,423 --> 01:53:51,158
RESEARCH.

2968
01:53:51,158 --> 01:53:53,260
OF COURSE PHASES AND RESEARCH 

2969
01:53:53,260 --> 01:53:55,362
WHICH YOU HEARD IN OTHER 

2970
01:53:55,362 --> 01:53:57,931
CLASSES AS WELL, THEY'RE NOT  

2971
01:53:57,931 --> 01:53:59,199
ALWAYS APPLICABLE TO ALL TYPES 

2972
01:53:59,199 --> 01:54:00,300
OF RESEARCH.

2973
01:54:00,300 --> 01:54:02,769
BUT THE WAY THEY THOUGHT ABOUT 

2974
01:54:02,769 --> 01:54:06,406
IT, WAS IF A DISEASE WAS ONLY 

2975
01:54:06,406 --> 01:54:08,475
AFFECTING CHILDREN, THEN YOU 

2976
01:54:08,475 --> 01:54:11,344
NEEDED TO HAVE SAFETY DATA 

2977
01:54:11,344 --> 01:54:13,580
FIRST, BUT YOU CAN GO DIRECTLY 

2978
01:54:13,580 --> 01:54:16,983
TO EN ROLL CHILDREN IN RESEARCH.

2979
01:54:16,983 --> 01:54:18,952
A SECOND CATEGORY, WOULD BE 

2980
01:54:18,952 --> 01:54:20,387
DISEASES TO MAINLY AFFECT 

2981
01:54:20,387 --> 01:54:22,189
CHILDREN OR VERY SERIOUS IN 

2982
01:54:22,189 --> 01:54:23,824
CHILDREN OR WHERE THERE IS NO 

2983
01:54:23,824 --> 01:54:26,793
OR LIMITED TREATMENT AND THERE 

2984
01:54:26,793 --> 01:54:29,396
THERE WAS A NEED FOR SOME DATA 

2985
01:54:29,396 --> 01:54:32,799
AND SOME ADULT ETHICACY DATA 

2986
01:54:32,799 --> 01:54:33,667
BEFORE ENROLLING CHILDREN.

2987
01:54:33,667 --> 01:54:35,569
NOW WHEN YOU TURN TO DISEASES 

2988
01:54:35,569 --> 01:54:36,903
WHERE THERE IS TREATMENT 

2989
01:54:36,903 --> 01:54:38,472
OPTIONS THEN THE IDEA WAS THAT 

2990
01:54:38,472 --> 01:54:40,107
YOU WOULD ACTUALLY GO ALL THE 

2991
01:54:40,107 --> 01:54:42,442
WAY THROUGH, ALL THE RESEARCH 

2992
01:54:42,442 --> 01:54:44,544
ON ADULTS BEFORE TURNING TO 

2993
01:54:44,544 --> 01:54:45,011
CHILDREN.

2994
01:54:45,011 --> 01:54:47,481
AND THIS I THINK IS REALLY AT 

2995
01:54:47,481 --> 01:54:50,083
LEAST ONE OF THE MOST SUSTAINED 

2996
01:54:50,083 --> 01:54:52,152
EFFORTS TO BE MORE SYSTEMATIC 

2997
01:54:52,152 --> 01:54:53,920
ABOUT WHEN TO EN ROLL CHILDREN 

2998
01:54:53,920 --> 01:54:56,490
IN RESEARCH.

2999
01:54:56,490 --> 01:54:57,724
HOWEVER, THESE RECOMMENDATIONS 

3000
01:54:57,724 --> 01:54:59,059
DON'T FOCUS DIRECTLY ON THE 

3001
01:54:59,059 --> 01:55:01,495
RISK AND BENEFITS OF A GIVEN 

3002
01:55:01,495 --> 01:55:02,295
TRIAL.

3003
01:55:02,295 --> 01:55:04,498
THEY SORT OF ASSUME THE RISK 

3004
01:55:04,498 --> 01:55:06,366
AND BENEFITS BASED ON WHETHER 

3005
01:55:06,366 --> 01:55:08,869
THERE ARE TREATMENT OPTIONS AND 

3006
01:55:08,869 --> 01:55:13,473
WHETHER THE DISEASE ONLY AFFECTS

3007
01:55:13,473 --> 01:55:17,344
 CHILDREN OR ADULT.

3008
01:55:17,344 --> 01:55:18,912
THEY ALSO DON'T FOCUS ON THE 

3009
01:55:18,912 --> 01:55:21,214
VALUE AND THEY DON'T FOCUS ON 

3010
01:55:21,214 --> 01:55:23,550
THE DIFFERENCES BETWEEN 

3011
01:55:23,550 --> 01:55:24,084
PREVENTION AND TREATMENT.

3012
01:55:24,084 --> 01:55:28,355
THEY'RE REALLY JUST FOC USED ON 

3013
01:55:28,355 --> 01:55:31,091
TREATMENT AND NOT RESEARCH LIKE 

3014
01:55:31,091 --> 01:55:33,427
VACCINES TO PREVENT CHILDREN 

3015
01:55:33,427 --> 01:55:34,828
FROM BEING INFECTED WITH A 

3016
01:55:34,828 --> 01:55:36,530
PARTICULAR DISEASE.

3017
01:55:36,530 --> 01:55:39,566
SO IT MAY REALLY MAKE MORE 

3018
01:55:39,566 --> 01:55:42,302
SENSE TO FOCUS ON THE RESEARCH 

3019
01:55:42,302 --> 01:55:47,374
GIVEN THE ALTERNATIVES AND GET 

3020
01:55:47,374 --> 01:55:49,910
MORE GRANULAR TO DECIDE WHEN TO 

3021
01:55:49,910 --> 01:55:50,544
EN ROLL CHILDREN.

3022
01:55:50,544 --> 01:55:53,313
SO I THINK THIS IS A HELPFUL 

3023
01:55:53,313 --> 01:55:55,215
PIECE OF GUIDANCE THAT CAN HELP 

3024
01:55:55,215 --> 01:55:56,516
WHEN YOU'RE THINKING ABOUT 

3025
01:55:56,516 --> 01:55:57,050
TREATMENT TRIALS.

3026
01:55:57,050 --> 01:56:00,320
AT LEAST ONE OF THE FIRST 

3027
01:56:00,320 --> 01:56:02,522
APPROACHES TO APPROACH THIS 

3028
01:56:02,522 --> 01:56:03,223
SYSTEMATICALLY.

3029
01:56:03,223 --> 01:56:07,394
THERE IS ALSO A ADDITIONAL 

3030
01:56:07,394 --> 01:56:10,096
PROTECTION THAT PEOPLE TALK 

3031
01:56:10,096 --> 01:56:11,064
ABOUT AGE DECALATION.

3032
01:56:11,064 --> 01:56:13,133
AND THE IDEA IS FIRST YOU HAVE 

3033
01:56:13,133 --> 01:56:15,569
TO DECIDE WHEN YOU EN ROLL 

3034
01:56:15,569 --> 01:56:17,170
CHILDREN IN GENERAL AND THEN 

3035
01:56:17,170 --> 01:56:21,041
HOW YOU PROTECT THEM WHEN YOU 

3036
01:56:21,041 --> 01:56:22,442
START TO ADD CHILDREN.

3037
01:56:22,442 --> 01:56:23,877
AND YOU START WITH OLDER 

3038
01:56:23,877 --> 01:56:25,645
CHILDREN AND THEN WORK YOUR WAY 

3039
01:56:25,645 --> 01:56:27,047
DOWN TO THE YOUNGEST CHILDREN.

3040
01:56:27,047 --> 01:56:29,382
THIS IS BEEN USED IN RESEARCH 

3041
01:56:29,382 --> 01:56:32,085
ON TREATMENTS FOR MALARIA 

3042
01:56:32,085 --> 01:56:38,058
CANCER AND FLU AND VACCINE 

3043
01:56:38,058 --> 01:56:39,192
TRIALS ON ANTHRAX AND A NUMBER 

3044
01:56:39,192 --> 01:56:40,360
OF OTHER CONDITIONS.

3045
01:56:40,360 --> 01:56:43,964
WHAT IS INTERESTING IS THAT IS 

3046
01:56:43,964 --> 01:56:49,469
OFTEN PRESUMED SOB  TO BE A 

3047
01:56:49,469 --> 01:56:53,974
VALUABLE SAFEGUARD AND ETHICS 

3048
01:56:53,974 --> 01:56:55,375
THINKS ABOUT BIOMEDICAL 

3049
01:56:55,375 --> 01:56:57,010
MEASURESES ONE OF THE WAY TO 

3050
01:56:57,010 --> 01:56:58,144
JUSTIFY RESEARCH IN CHILDREN 

3051
01:56:58,144 --> 01:57:00,213
SO. THERE MAY BE SPECIAL CASES 

3052
01:57:00,213 --> 01:57:01,815
WHERE IT'S REALLY IMPORTANT.

3053
01:57:01,815 --> 01:57:02,849
BUT WHAT IS INTERESTING, I 

3054
01:57:02,849 --> 01:57:06,286
THINK IS FOR A LONG TIME PEOPLE 

3055
01:57:06,286 --> 01:57:08,688
SORT OF TREATED DEESCALATION AS 

3056
01:57:08,688 --> 01:57:10,991
IF IT WAS THE APPROACH THAT YOU 

3057
01:57:10,991 --> 01:57:11,825
SHOULD USE WITHOUT QUESTIONING 

3058
01:57:11,825 --> 01:57:12,893
IT.

3059
01:57:12,893 --> 01:57:14,961
AND MORE RECENTLY ESPECIALLY 

3060
01:57:14,961 --> 01:57:17,497
DURING THE COVID PANDEMIC, 

3061
01:57:17,497 --> 01:57:20,967
PEOPLE START TO QUESTION 

3062
01:57:20,967 --> 01:57:22,202
WHETHER DECALATION IS THE BEST 

3063
01:57:22,202 --> 01:57:22,969
IDEA.

3064
01:57:22,969 --> 01:57:26,640
SOL THIS TALKS ABOUT HOW AGE 

3065
01:57:26,640 --> 01:57:29,943
ESCALATION IS USED DURING THE 

3066
01:57:29,943 --> 01:57:31,478
COVID PANDEMIC LEAD TO HARMS 

3067
01:57:31,478 --> 01:57:33,847
AND REALLY DIDN'T ADDRESS THE 

3068
01:57:33,847 --> 01:57:35,382
POTENTIAL BENEFIT FOR CERTAIN 

3069
01:57:35,382 --> 01:57:37,150
GROUPS OF KIDS.

3070
01:57:37,150 --> 01:57:38,585
NOTED THAT ALTHOUGH YOUNG 

3071
01:57:38,585 --> 01:57:42,789
CHILDREN HAD LOWER RISK FROM 

3072
01:57:42,789 --> 01:57:44,858
COVID INFECTION, THERE WERE 

3073
01:57:44,858 --> 01:57:47,093
STILL 650 DEATHS AND OVER 2000 

3074
01:57:47,093 --> 01:57:55,035
CASES OF A MULTI SYSTEMIC 

3075
01:57:55,035 --> 01:58:03,276
INFLAMMATORY SIN DRONE 

3076
01:58:03,276 --> 01:58:07,447
--SYNDROME UNDER THE AGE OF 5.

3077
01:58:07,447 --> 01:58:11,751
AND IN 2021, THE CHILDREN HAD 

3078
01:58:11,751 --> 01:58:15,655
THE LARGEST INCREASE OF 

3079
01:58:15,655 --> 01:58:17,023
HOSPITALIZATIONS AT THE TIME 

3080
01:58:17,023 --> 01:58:18,158
FOR CHILDREN UNDER FIVE.

3081
01:58:18,158 --> 01:58:20,660
SO WHAT THESE AUTHOR CONCLUDE 

3082
01:58:20,660 --> 01:58:24,764
IS WE SHOULD THINK ABOUT 

3083
01:58:24,764 --> 01:58:25,665
DEESCALATION MORE CAREFULLY AND 

3084
01:58:25,665 --> 01:58:27,067
RECOGNIZE THAT IT CAN BE 

3085
01:58:27,067 --> 01:58:28,702
PROBLEMATIC IN A NUMBER OF 

3086
01:58:28,702 --> 01:58:28,902
CASES.

3087
01:58:28,902 --> 01:58:31,705
BUT I THINK THE ONE THAT IS 

3088
01:58:31,705 --> 01:58:33,573
DIFFERENT FROM THE COVID-19 

3089
01:58:33,573 --> 01:58:38,445
EXAMPLE IF YOU HAVE A NARROW 

3090
01:58:38,445 --> 01:58:39,479
CONCEPTION OF BENEFITS FOR 

3091
01:58:39,479 --> 01:58:40,780
CHILDREN TO BE INVOLVED IN 

3092
01:58:40,780 --> 01:58:48,755
RESEARCH, THEN YOU MAY FIND 

3093
01:58:48,755 --> 01:58:50,924
THAT AGE DEESCALATION CAN 

3094
01:58:50,924 --> 01:58:53,360
BENEFIT.

3095
01:58:53,360 --> 01:58:56,096
THERE WERE TWO WAY THAT THIS 

3096
01:58:56,096 --> 01:58:56,396
PLAYED OUT.

3097
01:58:56,396 --> 01:58:57,697
THERE WAS A LACK OF 

3098
01:58:57,697 --> 01:58:58,932
APPRECIATION THAT EVEN YOUNG 

3099
01:58:58,932 --> 01:59:01,468
CHILDREN COULD HAVE SERIOUS 

3100
01:59:01,468 --> 01:59:03,036
RISK FROM COVID INFECTION.

3101
01:59:03,036 --> 01:59:05,338
AND THE SECOND IS THAT THE FACT 

3102
01:59:05,338 --> 01:59:11,011
THAT CHILDREN COULD BECOME 

3103
01:59:11,011 --> 01:59:12,812
INFECTED AND MISS TIME FROM 

3104
01:59:12,812 --> 01:59:14,681
SCHOOL AND NOT BE IN DAYCARE 

3105
01:59:14,681 --> 01:59:17,450
THAT ALL OF THOSE THINGS WERE 

3106
01:59:17,450 --> 01:59:19,085
SIGNIFICANT INDIRECT HARMS THAT 

3107
01:59:19,085 --> 01:59:21,955
COULD APPLY TO CHILDREN.

3108
01:59:21,955 --> 01:59:23,623
IT WAS NOT JUST THE STANDARD 

3109
01:59:23,623 --> 01:59:26,493
WAY THAT WE CALCULATE RISKS.

3110
01:59:26,493 --> 01:59:28,495
AND THOSE THINGS WERE NEGLECTED 

3111
01:59:28,495 --> 01:59:31,965
AS PEOPLE CONSIDERED WHEN TO 

3112
01:59:31,965 --> 01:59:32,866
INVOLVE CHILDREN IN RESEARCH.

3113
01:59:32,866 --> 01:59:37,737
SO I THINK THE LESSON IN 

3114
01:59:37,737 --> 01:59:39,406
COVID-19 IN GENERAL, CHILDREN 

3115
01:59:39,406 --> 01:59:40,273
WERE OFTEN AFTERTHOUGHT IN 

3116
01:59:40,273 --> 01:59:41,674
THESE DECISIONS AND WE NEED TO 

3117
01:59:41,674 --> 01:59:43,743
DO A BETTER JOB OF TRYING TO 

3118
01:59:43,743 --> 01:59:46,212
BENEFIT CHILDREN IN FUTURE 

3119
01:59:46,212 --> 01:59:49,449
PANDEMICS AND TO THINK MORE 

3120
01:59:49,449 --> 01:59:51,251
COMPREHENSIVELY OF ENROLLMENT 

3121
01:59:51,251 --> 01:59:53,553
AND RESEARCH CAN LEAD TO WITH 

3122
01:59:53,553 --> 01:59:54,921
CHILDREN IN THIS GROUP.

3123
01:59:54,921 --> 01:59:56,056
AND WITH MY SEVERAL OF MY 

3124
01:59:56,056 --> 01:59:56,790
COLLEAGUES FROM FORMER 

3125
01:59:56,790 --> 01:59:58,691
COLLEAGUES FROM THE DEPARTMENT 

3126
01:59:58,691 --> 02:00:00,260
OF BIOETHICS, WE WROTE THIS 

3127
02:00:00,260 --> 02:00:03,296
PAPER ON WHEN TO EN ROLL MINORS 

3128
02:00:03,296 --> 02:00:05,031
IN COVID VACCINE TRIALS.

3129
02:00:05,031 --> 02:00:06,433
AS AN ATTEMPT TO LEARN FROM 

3130
02:00:06,433 --> 02:00:11,504
THAT EXPERIENCE.

3131
02:00:11,504 --> 02:00:12,972
OKAY, SO WE TALKED ABOUT THE 

3132
02:00:12,972 --> 02:00:14,040
RISKS AND BENEFITS.

3133
02:00:14,040 --> 02:00:16,209
WHAT DOES THAT MEAN?

3134
02:00:16,209 --> 02:00:18,678
HOW DO WE FOCUS ON RISK AND 

3135
02:00:18,678 --> 02:00:20,547
BENEFITS AND RESEARCH IN 

3136
02:00:20,547 --> 02:00:20,814
CHILDREN?

3137
02:00:20,814 --> 02:00:22,916
SO MOST REGULATIONS INCLUDING 

3138
02:00:22,916 --> 02:00:32,125
THE COUNSEL OF EUROPE, UGANDA,  

3139
02:00:32,125 --> 02:00:33,526
AFRICA AUSTRALIA, THEY ALL 

3140
02:00:33,526 --> 02:00:35,428
PERMIT RESEARCH IN TWO 

3141
02:00:35,428 --> 02:00:35,728
CATEGORIES.

3142
02:00:35,728 --> 02:00:37,730
FIRST, RESEARCH THAT OFFERS A 

3143
02:00:37,730 --> 02:00:39,532
PROSPECT OF DIRECT BENEFIT TO 

3144
02:00:39,532 --> 02:00:42,068
THE CHILD THAT OUT WEIGHS THE 

3145
02:00:42,068 --> 02:00:43,303
RISK ESPECIALLY IN COMPARISON 

3146
02:00:43,303 --> 02:00:44,671
TO THE ALTERNATIVES.

3147
02:00:44,671 --> 02:00:47,640
AND THEN THE SECOND CATEGORY IS 

3148
02:00:47,640 --> 02:00:51,377
RESEARCH THAT POSES MINIMAL 

3149
02:00:51,377 --> 02:00:51,578
RISK.

3150
02:00:51,578 --> 02:00:54,781
SO IT'S NOT SUPPOSE TO BE THE 

3151
02:00:54,781 --> 02:00:57,283
BENEFIT THE CHILD BUT THE RISK 

3152
02:00:57,283 --> 02:01:06,159
IS JUST MINIMAL.

3153
02:01:06,159 --> 02:01:07,527
U.S. REGULATIONS, THERE ARE 

3154
02:01:07,527 --> 02:01:10,330
COUNTRIES THAT ADOPTED OUR 

3155
02:01:10,330 --> 02:01:11,464
REGULATIONS AND CODIFIED THEM 

3156
02:01:11,464 --> 02:01:12,932
INTO THEIR OWN LAWS.

3157
02:01:12,932 --> 02:01:14,467
SO OUR REGULATIONS HAVE FOUR 

3158
02:01:14,467 --> 02:01:16,503
CATEGORIES OF PROTECTION WHICH 

3159
02:01:16,503 --> 02:01:18,571
INCLUDE THE FIRST TWO THAT WE 

3160
02:01:18,571 --> 02:01:19,706
TALKED ABOUT, THAT EXIST AROUND 

3161
02:01:19,706 --> 02:01:21,541
THE WORLD AND TWO OTHERS THAT 

3162
02:01:21,541 --> 02:01:22,675
ARE MUCH LESS COMMON.

3163
02:01:22,675 --> 02:01:26,146
SO YOU CAN DO RESEARCH WITH 

3164
02:01:26,146 --> 02:01:27,747
MINIMAL RISK, RESEARCH THAT 

3165
02:01:27,747 --> 02:01:29,616
OFFERS A DIRECT BENEFIT THAT 

3166
02:01:29,616 --> 02:01:31,417
OUT WEIGHS THE RISK AS PRETTY 

3167
02:01:31,417 --> 02:01:32,552
MUCH ANYWHERE IN THE WORLD.

3168
02:01:32,552 --> 02:01:34,554
AND YOU CAN ALSO DO RESEARCH IN 

3169
02:01:34,554 --> 02:01:36,389
THE UNITED STATES, IF IT'S A 

3170
02:01:36,389 --> 02:01:38,424
APPROVED BY AN INSTITUTION 

3171
02:01:38,424 --> 02:01:43,563
REVIEW BOARD BECAUSE IT POSES A 

3172
02:01:43,563 --> 02:01:46,366
MINOR INCREASE OF MINIMAL RISK 

3173
02:01:46,366 --> 02:01:47,500
AND THAT'S OKAY EVEN IF THERE 

3174
02:01:47,500 --> 02:01:49,202
IS NO DIRECT BENEFIT.

3175
02:01:49,202 --> 02:01:50,537
BUT IN THIS CATEGORY, THE 

3176
02:01:50,537 --> 02:01:52,438
RESEARCHER HAS TO BENEFIT THE 

3177
02:01:52,438 --> 02:01:54,440
GROUP OF PARTICIPANTS FROM 

3178
02:01:54,440 --> 02:01:55,575
WHICH THE PARTICIPANTS ARE 

3179
02:01:55,575 --> 02:01:58,545
COMING FROM AND BENEFIT THEIR 

3180
02:01:58,545 --> 02:01:59,679
CONDITION OR DISORDER.

3181
02:01:59,679 --> 02:02:02,148
AND FINALLY, THERE IS A SORT OF 

3182
02:02:02,148 --> 02:02:05,018
CATCH-ALL CATEGORY WHERE 

3183
02:02:05,018 --> 02:02:06,719
RESEARCH DOESN'T FIT INTO ANY 

3184
02:02:06,719 --> 02:02:08,321
OF THESE CATEGORIES IT CAN BE 

3185
02:02:08,321 --> 02:02:10,156
TAKEN TO A SPECIAL PANEL AND 

3186
02:02:10,156 --> 02:02:12,025
APPROVED BY THAT SPECIAL PANEL 

3187
02:02:12,025 --> 02:02:13,293
WHICH IS APPOINTED BY THE 

3188
02:02:13,293 --> 02:02:15,828
SECRETARY OF HEALTH AND HUMAN 

3189
02:02:15,828 --> 02:02:16,095
SERVICES.

3190
02:02:16,095 --> 02:02:18,464
SO WHEN WE LOOK AT THE 

3191
02:02:18,464 --> 02:02:19,632
REGULATIONS AN IMPORTANT 

3192
02:02:19,632 --> 02:02:21,467
QUESTION IS WHAT DO ALL OF 

3193
02:02:21,467 --> 02:02:23,069
THESE WORDS MEAN?

3194
02:02:23,069 --> 02:02:25,138
AND HOW ARE THEY DEFINED?

3195
02:02:25,138 --> 02:02:26,606
AND DEFINITIONS ARE NOT AS 

3196
02:02:26,606 --> 02:02:29,609
ROBUST.

3197
02:02:29,609 --> 02:02:33,012
SO MINIMAL RISK, I THINK THIS 

3198
02:02:33,012 --> 02:02:35,315
DEFINITION HAS BEEN 

3199
02:02:35,315 --> 02:02:37,450
OPERATIONALIZED BY MANY 

3200
02:02:37,450 --> 02:02:37,717
SCHOLARS.

3201
02:02:37,717 --> 02:02:39,452
SO MINIMAL RISK INVOLVES A RISK 

3202
02:02:39,452 --> 02:02:42,855
OF DAILY LIFE OR ROUTINE OF 

3203
02:02:42,855 --> 02:02:43,690
EXAMINATIONS AND TESTS.

3204
02:02:43,690 --> 02:02:45,458
BUT THERE IS NO DEFINITION FOR 

3205
02:02:45,458 --> 02:02:47,460
WHAT A MINOR INCREASE OVER 

3206
02:02:47,460 --> 02:02:49,395
MINIMAL RISK IS IN THE 

3207
02:02:49,395 --> 02:02:49,829
REGULATIONS.

3208
02:02:49,829 --> 02:02:53,199
AND WE DID A SURVEY OF U.S. 

3209
02:02:53,199 --> 02:02:57,270
CHAIR PERSONS OF INTUITION AL 

3210
02:02:57,270 --> 02:02:58,938
REVIEW BOARDS AS RESEARCH 

3211
02:02:58,938 --> 02:03:00,740
COMMITTEES, MANY YEARS AGO NOW, 

3212
02:03:00,740 --> 02:03:05,812
SO IT'S BACK IN 2004 THAT WE 

3213
02:03:05,812 --> 02:03:08,014
PUBLISHED THIS DATA AND FOUND 

3214
02:03:08,014 --> 02:03:16,656
LIABILITY ON HOW PEOPLE ON IRBs 

3215
02:03:16,656 --> 02:03:17,390
ACCOUNTED SO THEY CAN--ONLY 

3216
02:03:17,390 --> 02:03:20,326
AGREE ON THE EXTREMES BOTH ENDS 

3217
02:03:20,326 --> 02:03:25,598
OF THE SPECTRUM, A 10 WITH CC 

3218
02:03:25,598 --> 02:03:30,003
BLOOD DRAW AND A LUMBAR 

3219
02:03:30,003 --> 02:03:36,809
PUNCTURE IN THAT HEALTHY 

3220
02:03:36,809 --> 02:03:37,110
11-YEAR-OLD.

3221
02:03:37,110 --> 02:03:42,482
IT WAS JUST MINIMAL RISK.

3222
02:03:42,482 --> 02:03:44,784
AND EVERYWHERE ELSE, IT WAS 

3223
02:03:44,784 --> 02:03:46,619
SPLIT AND ACTIVITY AND WE ALSO 

3224
02:03:46,619 --> 02:03:49,689
FOUND THAT ALLERGY SKIN TESTING 

3225
02:03:49,689 --> 02:03:51,357
PEOPLE, DON'T SEEM TO SHOW THIS 

3226
02:03:51,357 --> 02:03:58,998
HERE BUT THERE IS A THIRD IN A 

3227
02:03:58,998 --> 02:03:59,999
EACH CATEGORY.

3228
02:03:59,999 --> 02:04:02,869
SO WHAT I THINK THIS TELLS US 

3229
02:04:02,869 --> 02:04:04,737
IS OFTEN REVIEW COMMITTEE 

3230
02:04:04,737 --> 02:04:07,907
ASSESS RISK BASED ON THEIR 

3231
02:04:07,907 --> 02:04:08,841
INTUITION AND THEIR JUDGMENT 

3232
02:04:08,841 --> 02:04:13,413
AND THIS MAY LEAD TO RISK AND 

3233
02:04:13,413 --> 02:04:15,114
ALSO INCORPORATING BIAS INTO 

3234
02:04:15,114 --> 02:04:17,750
THEIR BIAS.

3235
02:04:17,750 --> 02:04:19,185
AND ESPECIALLY IF YOU HAVE A 

3236
02:04:19,185 --> 02:04:20,753
STUDY BEING DONE IN MULTIPLE 

3237
02:04:20,753 --> 02:04:22,355
SITES AND DIFFERENT SITES HAVE 

3238
02:04:22,355 --> 02:04:24,390
DIVA SESMENTS OF WHAT THE RISK 

3239
02:04:24,390 --> 02:04:25,124
ENTAIL.

3240
02:04:25,124 --> 02:04:26,559
THIS LEADS INTO OTHER ISSUES 

3241
02:04:26,559 --> 02:04:28,127
WHERE THE PERMISSION THAT IS 

3242
02:04:28,127 --> 02:04:32,432
REQUIRED CAN BE DIFFERENT IN 

3243
02:04:32,432 --> 02:04:32,799
DIFFERENT SITES.

3244
02:04:32,799 --> 02:04:34,634
SO IF THE STUDY IS IN THAT 

3245
02:04:34,634 --> 02:04:36,035
THIRD CATEGORY, YOU NEED BOTH 

3246
02:04:36,035 --> 02:04:38,171
PARENTS TO GET THEIR CONSENT.

3247
02:04:38,171 --> 02:04:41,140
AND THAT MAY LEAD TO 

3248
02:04:41,140 --> 02:04:42,675
COMPLICATIONS IN TRYING TO PLAN 

3249
02:04:42,675 --> 02:04:44,010
OUT THE STUDIES.

3250
02:04:44,010 --> 02:04:46,012
SO IT'S BETTER TO USE THE DATA 

3251
02:04:46,012 --> 02:04:48,181
ON RISK OF PROCEDURES AND RISK 

3252
02:04:48,181 --> 02:04:50,616
OF DAILY LIFE AND COMPARE THE 

3253
02:04:50,616 --> 02:04:50,783
TWO.

3254
02:04:50,783 --> 02:04:54,053
AND DAVE AND OTHERS HAVE WORKED 

3255
02:04:54,053 --> 02:04:57,123
ON TRYING TO DO THIS MORE 

3256
02:04:57,123 --> 02:04:58,257
SYSTEMATICALLY AND SHOW HOW IT 

3257
02:04:58,257 --> 02:05:06,899
CAN BE DONE.

3258
02:05:06,899 --> 02:05:11,237
IN MUCH WIDE RANGE OF 

3259
02:05:11,237 --> 02:05:11,537
PROCEDURES.

3260
02:05:11,537 --> 02:05:12,271
OKAY, SO LET'S TURN NOW TO 

3261
02:05:12,271 --> 02:05:17,143
DECISION.

3262
02:05:17,143 --> 02:05:20,847
FIRST WHEN YOU THINK ABOUT 

3263
02:05:20,847 --> 02:05:21,748
PARENTAL CONSENT, IT'S 

3264
02:05:21,748 --> 02:05:22,915
IMPORTANT THAT CHILDREN SHOULD 

3265
02:05:22,915 --> 02:05:24,550
BE ENROLLED ONLY WITH THE PERM 

3266
02:05:24,550 --> 02:05:26,953
PISSING OF THEIR LEGAL GUARDIAN 

3267
02:05:26,953 --> 02:05:28,287
WHICH IS TYPICALLY THEIR PARENT 

3268
02:05:28,287 --> 02:05:32,125
AND IT CAN BE OTHER CAREGIVER.

3269
02:05:32,125 --> 02:05:38,564
AND WHO CAN CONSENT IS LOCAL 

3270
02:05:38,564 --> 02:05:39,399
LAW.

3271
02:05:39,399 --> 02:05:42,368
MOST GUIDELINES AROUND THE 

3272
02:05:42,368 --> 02:05:44,637
WORLD ALLOW WAVING PARENTAL 

3273
02:05:44,637 --> 02:05:47,106
CONSENT AND COMMON EXAMPLE IS 

3274
02:05:47,106 --> 02:05:52,145
GIVEN, THAT SOMETIMES  PARENTAL 

3275
02:05:52,145 --> 02:05:54,247
CONSENT IS NOT A PROTECTION.

3276
02:05:54,247 --> 02:05:57,250
SO WHEN YOU THINK OF A CASE 

3277
02:05:57,250 --> 02:05:58,951
WHERE PARENTS SUSPECTED OF 

3278
02:05:58,951 --> 02:06:00,620
CHILD ABUSE, THERE MAY BE A 

3279
02:06:00,620 --> 02:06:05,324
CONCERNS THAT A  PARENT DOES 

3280
02:06:05,324 --> 02:06:09,729
NOT WANT TO BE PART OF THAT 

3281
02:06:09,729 --> 02:06:11,664
RESEARCH BECAUSE THEY'RE NOT 

3282
02:06:11,664 --> 02:06:12,698
REALLY NOT PROTECTING THEIR 

3283
02:06:12,698 --> 02:06:14,567
CHILDREN IN A WAY THAT THEY 

3284
02:06:14,567 --> 02:06:14,834
SHOULD BE.

3285
02:06:14,834 --> 02:06:18,671
SO THAT MAY BE AN EXAMPLE WHERE 

3286
02:06:18,671 --> 02:06:19,772
WAIVER PARENTAL CONSENT CAN BE 

3287
02:06:19,772 --> 02:06:20,273
JUSTIFY.

3288
02:06:20,273 --> 02:06:22,608
ALSO A NUMBER OF LOCAL AND 

3289
02:06:22,608 --> 02:06:24,444
STATE LOCAL LAWS THAT ALLOW 

3290
02:06:24,444 --> 02:06:26,245
MINORS TO CONSENT FOR 

3291
02:06:26,245 --> 02:06:27,814
THEMSELVES AND THIS CAN BE 

3292
02:06:27,814 --> 02:06:30,316
BASED ON THE STATUS.

3293
02:06:30,316 --> 02:06:32,385
OF THE MINOR FOR INSTANCE IF 

3294
02:06:32,385 --> 02:06:34,887
THAT MINOR IS MARRIED.

3295
02:06:34,887 --> 02:06:36,289
THEY'RE MATURITY IF THEY'RE 

3296
02:06:36,289 --> 02:06:41,327
DETERMINED TO BE A MATURE MINOR.

3297
02:06:41,327 --> 02:06:43,162
OR THEIR CONDITION.

3298
02:06:43,162 --> 02:06:45,531
SO FOR TREATMENT FOR 

3299
02:06:45,531 --> 02:06:46,632
TRANSMITTED INSPECTIONS AND 

3300
02:06:46,632 --> 02:06:50,970
I'LL TALK ABOUT THIS MORE LATER.

3301
02:06:50,970 --> 02:06:53,473
I PROVIDED A MAP HERE WHICH 

3302
02:06:53,473 --> 02:07:01,380
LAYS OUT WHEN MINORS CAN OBTAIN 

3303
02:07:01,380 --> 02:07:01,848
CONTRACEPTIVE SERVICE.

3304
02:07:01,848 --> 02:07:07,186
AND THEY'VE DONE A LOT 

3305
02:07:07,186 --> 02:07:08,287
PROVIDING INFORMATION FOR WHAT 

3306
02:07:08,287 --> 02:07:09,755
THE CURRENT LAW IS, SO IT'S A 

3307
02:07:09,755 --> 02:07:12,592
GOOD RESOURCE TO HAVE IN MIND.

3308
02:07:12,592 --> 02:07:14,494
SO IN THE U.S. REGULATIONS 

3309
02:07:14,494 --> 02:07:17,730
REQUIRE THAT BOTH PARENTS GIVE 

3310
02:07:17,730 --> 02:07:20,299
CONSENT IN RISKY OR NON 

3311
02:07:20,299 --> 02:07:21,367
BENEFICIAL RESEARCH LIKE THE 

3312
02:07:21,367 --> 02:07:22,268
THIRD CATEGORY I WAS JUST 

3313
02:07:22,268 --> 02:07:22,835
TALKING ABOUT.

3314
02:07:22,835 --> 02:07:25,805
A LOT OF EMPHASIS REALLY WANT 

3315
02:07:25,805 --> 02:07:27,974
TO POINT OUT SOMETHING IS IS 

3316
02:07:27,974 --> 02:07:29,642
NOT IN THE REGULAR REGULATIONS 

3317
02:07:29,642 --> 02:07:31,711
BUT SHOULD BE.

3318
02:07:31,711 --> 02:07:33,012
THAT REALLY WHEN WE'RE TALKING 

3319
02:07:33,012 --> 02:07:34,680
ABOUT WHAT PARENTS ARE DOING, 

3320
02:07:34,680 --> 02:07:36,749
THEY'RE GIVING PERMISSION AND 

3321
02:07:36,749 --> 02:07:38,251
THAT'S DIFFERENT THAN GIVING 

3322
02:07:38,251 --> 02:07:38,484
CONSENT.

3323
02:07:38,484 --> 02:07:40,820
SOL IF YOU THINK ABOUT, WHEN A 

3324
02:07:40,820 --> 02:07:43,823
CHILD IS GOING TO SCHOOL, THEY 

3325
02:07:43,823 --> 02:07:45,124
SIGN A PERMISSION NOT A CONSENT 

3326
02:07:45,124 --> 02:07:46,526
FORM.

3327
02:07:46,526 --> 02:07:49,295
AND CONSENT IS WHAT YOU GIVE 

3328
02:07:49,295 --> 02:07:50,596
PERMISSION TO DO SOMETHING TO 

3329
02:07:50,596 --> 02:07:51,797
YOU.

3330
02:07:51,797 --> 02:07:53,165
SO REALLY WHAT PARENTS ARE 

3331
02:07:53,165 --> 02:07:54,634
DOING IS GIVING THEIR 

3332
02:07:54,634 --> 02:07:55,701
PERMISSION FOR THEIR CHILDREN 

3333
02:07:55,701 --> 02:07:58,938
TO BE ENGAGED IN ACTIVITY OR 

3334
02:07:58,938 --> 02:08:00,039
RESEARCH IN THIS CASE.

3335
02:08:00,039 --> 02:08:02,475
AND THE REASON I WOULD LIKE TO 

3336
02:08:02,475 --> 02:08:03,643
MAKE THIS DISTINCTION IS THAT 

3337
02:08:03,643 --> 02:08:06,846
THERE IS A NOTION THAT CONSENT 

3338
02:08:06,846 --> 02:08:13,286
ITSELF IS ONLY, IS MORALLY 

3339
02:08:13,286 --> 02:08:15,187
TRANSFORMATIVE SO IT TURNS IT 

3340
02:08:15,187 --> 02:08:17,490
INTO SOMETHING PERMISSIBLE THAN 

3341
02:08:17,490 --> 02:08:18,291
PERMISSION.

3342
02:08:18,291 --> 02:08:20,092
SO PARENTS HAVE LESS DISCRETION 

3343
02:08:20,092 --> 02:08:21,327
AND AUTHORITY TO CONSENT FOR 

3344
02:08:21,327 --> 02:08:22,695
THEIR CHILDREN TO BE INVOLVED 

3345
02:08:22,695 --> 02:08:25,631
IN A RANGE OF ACTIVITY AND 

3346
02:08:25,631 --> 02:08:26,999
ESPECIALLY BECAUSE PARENTS ARE 

3347
02:08:26,999 --> 02:08:31,938
SUPPOSE TO KEEP THEIR CHILDREN 

3348
02:08:31,938 --> 02:08:34,106
BEST INTEREST, THEY CANNOT GIVE 

3349
02:08:34,106 --> 02:08:37,710
PERMISSION FOR CHILDREN TO BE 

3350
02:08:37,710 --> 02:08:38,844
EXPOSED TO SUBSTANTIAL RISK.

3351
02:08:38,844 --> 02:08:41,380
IN ADDITION TO THIS NOTION, THE 

3352
02:08:41,380 --> 02:08:43,182
PARENTS HAVE TO GIVE PERMISSION 

3353
02:08:43,182 --> 02:08:45,084
AND CONSENT.

3354
02:08:45,084 --> 02:08:47,053
THE REGULATIONS ALSO REQUIRE 

3355
02:08:47,053 --> 02:08:48,721
THAT INSTITUTIONAL REVIEW 

3356
02:08:48,721 --> 02:08:50,523
BOARDS MAKE REVIEWS FOR 

3357
02:08:50,523 --> 02:08:52,558
CHILDREN THAT ARE CAPABLE.

3358
02:08:52,558 --> 02:08:58,030
NOW THEY ONLY DEFINE IN THIS 

3359
02:08:58,030 --> 02:09:00,066
WAY NOT JUST THE OWNER.

3360
02:09:00,066 --> 02:09:02,268
NOW THIS IS NOT THE JUST 

3361
02:09:02,268 --> 02:09:05,137
HOPEFUL DEFINITION BECAUSE IT'S 

3362
02:09:05,137 --> 02:09:06,706
A DEFINING A CONSENT AS WHAT IT 

3363
02:09:06,706 --> 02:09:07,707
IS NOT.

3364
02:09:07,707 --> 02:09:09,308
HOWEVER THE BETTER WAY TO THINK 

3365
02:09:09,308 --> 02:09:12,111
ABOUT IT IS THAT THERE SHOULD 

3366
02:09:12,111 --> 02:09:13,746
BE AGREEMENT BASED ON THE 

3367
02:09:13,746 --> 02:09:15,247
CHILD'S UNDERSTANDING AS MUCH 

3368
02:09:15,247 --> 02:09:17,550
AS SHE IS CAPABLE OF 

3369
02:09:17,550 --> 02:09:19,385
UNDERSTANDING, EVEN IF THAT 

3370
02:09:19,385 --> 02:09:20,553
CHILD CAN'T UNDERSTAND ENOUGH 

3371
02:09:20,553 --> 02:09:22,121
TO GIVE CONSENT.

3372
02:09:22,121 --> 02:09:25,091
IN SOME CASES IT COULD BE 

3373
02:09:25,091 --> 02:09:25,658
SUBMITTED INFORMATION LIKE 

3374
02:09:25,658 --> 02:09:27,593
YOU'LL HAVE TO COME TO THIS 

3375
02:09:27,593 --> 02:09:30,329
RESEARCH SITE THREE TIMES AND 

3376
02:09:30,329 --> 02:09:33,733
THAT IS PRETTY MUCH ALL THAT 

3377
02:09:33,733 --> 02:09:34,667
THE CHILD UNDERSTAND.

3378
02:09:34,667 --> 02:09:37,036
BUT IN OTHER CASES, IT MAY BE 

3379
02:09:37,036 --> 02:09:38,437
MORE SUBSTANTIAL.

3380
02:09:38,437 --> 02:09:40,172
NOW, IT'S IMPORTANT TO 

3381
02:09:40,172 --> 02:09:43,142
RECOGNIZE HOWEVER, THAT THE 

3382
02:09:43,142 --> 02:09:45,144
REASON FOR FIRING CONSENT CAN 

3383
02:09:45,144 --> 02:09:47,747
ALSO SHAPE WHAT IT IS AND ASKED 

3384
02:09:47,747 --> 02:09:48,848
WHAT IT'S BEING ASKED.

3385
02:09:48,848 --> 02:09:51,917
SO WHEN WE INVOLVE CHILDREN IN 

3386
02:09:51,917 --> 02:09:53,419
DECISION-MAKING, IT CAN BE 

3387
02:09:53,419 --> 02:09:54,820
GIVING THEM A SENSE OF CONTROL 

3388
02:09:54,820 --> 02:09:56,589
OVER WHAT IS ABOUT TO HAPPEN TO 

3389
02:09:56,589 --> 02:09:57,423
THEM.

3390
02:09:57,423 --> 02:09:58,557
HAVING, GIVING THEM THE 

3391
02:09:58,557 --> 02:09:59,759
OPPORTUNITY TO PREPARE FOR WHAT 

3392
02:09:59,759 --> 02:10:02,461
THEY ARE GOING TO HAVE TO DO.

3393
02:10:02,461 --> 02:10:03,863
SO CHILD STAY OVERNIGHT IN THE 

3394
02:10:03,863 --> 02:10:04,764
HOSPITAL.

3395
02:10:04,764 --> 02:10:06,432
IT MAY BE IMPORTANT FOR THE 

3396
02:10:06,432 --> 02:10:07,800
CHILD THAT THAT IS COMING UP 

3397
02:10:07,800 --> 02:10:10,403
AND TO BE ABLE TO PACK A BAG 

3398
02:10:10,403 --> 02:10:13,272
AND BRING ALONG THEIR FAVORITE 

3399
02:10:13,272 --> 02:10:14,907
STUFFED ANIMAL.

3400
02:10:14,907 --> 02:10:16,342
IT'S ALSO IMPORTANT TO SHOW 

3401
02:10:16,342 --> 02:10:19,612
RESPECT FOR THEIR GROWING 

3402
02:10:19,612 --> 02:10:20,212
AUTONOMY.

3403
02:10:20,212 --> 02:10:22,348
SO AS A PARENT OF A PRETEEN, I 

3404
02:10:22,348 --> 02:10:24,617
CAN TELL YOU THAT I CANNOT 

3405
02:10:24,617 --> 02:10:27,453
GETAWAY WITH MAKING DECISIONS 

3406
02:10:27,453 --> 02:10:28,854
FOR MY PRETEEN IN THE WAY THAT 

3407
02:10:28,854 --> 02:10:29,922
I USED TO.

3408
02:10:29,922 --> 02:10:32,992
I HAVE TO ENGAGE HER BECAUSE 

3409
02:10:32,992 --> 02:10:34,126
SHE HAS INCREASING CAPACITY IN 

3410
02:10:34,126 --> 02:10:36,462
MAKING DECISIONS AND JUST A 

3411
02:10:36,462 --> 02:10:38,097
CONCERN FOR HER OWN AUTHORITY.

3412
02:10:38,097 --> 02:10:40,700
SHE DOESN'T LIKE TO BE ENGAGED 

3413
02:10:40,700 --> 02:10:43,869
IN THINGS WITHOUT SOME ABILITY 

3414
02:10:43,869 --> 02:10:47,740
TO WEIGH IN.

3415
02:10:47,740 --> 02:10:49,775
SO RESPECTFUL PROCESS THEREFORE 

3416
02:10:49,775 --> 02:10:52,712
WOULD INVOLVE  DIFFERENT STAGES.

3417
02:10:52,712 --> 02:10:54,980
IT CAN BE INFORMING THE CHILD 

3418
02:10:54,980 --> 02:10:57,216
ABOUT INFORMATION, ENGAGING 

3419
02:10:57,216 --> 02:10:58,384
THEM SEEING IF THEY HAVE 

3420
02:10:58,384 --> 02:11:00,386
QUESTIONS AND CONCERNS.

3421
02:11:00,386 --> 02:11:02,722
AND ASKING FOR CONSENT AND 

3422
02:11:02,722 --> 02:11:06,826
FINALLY RESPECTING ANY DISTANT, 

3423
02:11:06,826 --> 02:11:10,229
SO THIS IS DISCOMFORT ANY 

3424
02:11:10,229 --> 02:11:11,831
PROBLEMS THAT THEY'RE HAVING 

3425
02:11:11,831 --> 02:11:13,099
AND ANY OBJECTIONS.

3426
02:11:13,099 --> 02:11:13,899
NOW ALL OF THESE THINGS ARE 

3427
02:11:13,899 --> 02:11:17,369
IMPORTANT TO THE EXTENT THAT A 

3428
02:11:17,369 --> 02:11:19,171
CHILD HAS FULL CAPACITY.

3429
02:11:19,171 --> 02:11:20,806
HOWEVER IF A CHILD HAS LESS 

3430
02:11:20,806 --> 02:11:23,509
CAPACITY IT MAY BE THAT NOT ALL 

3431
02:11:23,509 --> 02:11:25,377
OF THESE THINGS CAN BE DONE.

3432
02:11:25,377 --> 02:11:28,314
SO IF A CHILD CAN'T UNDERSTAND, 

3433
02:11:28,314 --> 02:11:30,149
ASKING THEM TO PARTICIPATE IN 

3434
02:11:30,149 --> 02:11:31,717
RESEARCH IS ESSENTIALLY ASKING 

3435
02:11:31,717 --> 02:11:33,352
THE QUESTION THAT DOES NOT MAKE 

3436
02:11:33,352 --> 02:11:34,620
ANY SENSE TO THEM.

3437
02:11:34,620 --> 02:11:36,789
SO IT MAY BE MORE IMPORTANT FOR 

3438
02:11:36,789 --> 02:11:39,058
YOUNG CHILDREN TO REALLY FOCUS 

3439
02:11:39,058 --> 02:11:41,393
ON INFORMING THEM ABOUT THE 

3440
02:11:41,393 --> 02:11:42,394
RESEARCH ENGAGING THEM SEEING 

3441
02:11:42,394 --> 02:11:44,163
IF THEY HAVE ANY QUESTIONS OR 

3442
02:11:44,163 --> 02:11:45,131
WORRIES.

3443
02:11:45,131 --> 02:11:48,234
AND THEN CHECKING FOR THEIR 

3444
02:11:48,234 --> 02:11:50,069
DISCOMFORT AS STUDIES IS COMING 

3445
02:11:50,069 --> 02:11:51,737
ON TO SEE IF THAT'S AN 

3446
02:11:51,737 --> 02:11:53,939
INCREASING WAY OF RESEARCH.

3447
02:11:53,939 --> 02:11:57,576
WHEN WE THINK ABOUT WHO CAN 

3448
02:11:57,576 --> 02:12:00,646
CONSENT, MOST GUIDELINES DON'T 

3449
02:12:00,646 --> 02:12:00,880
SPECIFY.

3450
02:12:00,880 --> 02:12:03,282
THE U.S. FEDERATIONS ONLY STIPT 

3451
02:12:03,282 --> 02:12:05,651
THAT DETERMINATION OF CONSENT 

3452
02:12:05,651 --> 02:12:07,253
SHOULD BE TAKEN INTO ACCOUNT, 

3453
02:12:07,253 --> 02:12:09,822
THE CAGE MATURITY AND 

3454
02:12:09,822 --> 02:12:10,756
PSYCHOLOGICAL STATE.

3455
02:12:10,756 --> 02:12:13,192
WE DID A STUDY LOOKING AT THIS 

3456
02:12:13,192 --> 02:12:16,362
AND FOUND THAT ANY IRBs USE THE 

3457
02:12:16,362 --> 02:12:18,631
RULE OF 7.

3458
02:12:18,631 --> 02:12:20,466
BUT IT'S INTERESTING BECAUSE 

3459
02:12:20,466 --> 02:12:23,202
THIS RULE IS UNDER THE CHILD 

3460
02:12:23,202 --> 02:12:30,276
UNDER THE AGE OF 7 CAN REALLY 

3461
02:12:30,276 --> 02:12:32,745
GIVE A SENT.

3462
02:12:32,745 --> 02:12:35,114
AND BUT INDIVIDUAL CHILDREN CAN 

3463
02:12:35,114 --> 02:12:38,484
HAVE VERY DIFFERENT CAPACITIES 

3464
02:12:38,484 --> 02:12:39,385
FOR DECISION MAKING.

3465
02:12:39,385 --> 02:12:49,929
SO IF YOU CONSIDER CHRONICLELY 

3466
02:12:57,269 --> 02:13:07,446
ILL CHILDREN.

3467
02:13:09,915 --> 02:13:20,326
AND OTHER CHILDREN WHO HAVE 

3468
02:13:22,828 --> 02:13:23,762
BEEN CHRONICLELY ILL.

3469
02:13:23,762 --> 02:13:26,866
SO IT REALLY IS HOW EVEN ONE 

3470
02:13:26,866 --> 02:13:28,200
FACTOR CAN CUT IN EITHER 

3471
02:13:28,200 --> 02:13:38,077
DIRECTION.

3472
02:13:38,077 --> 02:13:40,813
MOST OF THOSE USE AGE CUT OFF 

3473
02:13:40,813 --> 02:13:43,115
AND MAJORITY USED THE AGE OF 7 

3474
02:13:43,115 --> 02:13:44,550
WHERE CONSENT WAS REQUIRED 

3475
02:13:44,550 --> 02:13:45,885
AFTER THE AGE OF 7 AND THE REST 

3476
02:13:45,885 --> 02:13:49,588
OF THE OTHER HALF OF IRB CHAIRS 

3477
02:13:49,588 --> 02:13:56,795
LEFT IT UP TO THE INVESTIGATOR.

3478
02:13:56,795 --> 02:13:58,697
THIS REALLY RAISES THE QUESTION 

3479
02:13:58,697 --> 02:14:02,368
THE ABILITY TO CONSENT WITH 

3480
02:14:02,368 --> 02:14:04,236
DIFFERENT AGES, SHOULD CHILDREN 

3481
02:14:04,236 --> 02:14:13,212
BE GIVING CONSENT SENT OR.

3482
02:14:13,212 --> 02:14:16,048
THE CHILDREN MAY BECOME LEGALLY 

3483
02:14:16,048 --> 02:14:16,348
TO CONSENT.

3484
02:14:16,348 --> 02:14:18,117
SO THE GUIDANCE I REFERRED TO 

3485
02:14:18,117 --> 02:14:21,320
EARLIER, IF A CHILD BECOMES 

3486
02:14:21,320 --> 02:14:24,089
CAPABLE DURING THE RESEARCH, 

3487
02:14:24,089 --> 02:14:25,691
RESEARCHERS SHOULD OBTAIN THE 

3488
02:14:25,691 --> 02:14:28,127
CONSENT TO CONSIDER 

3489
02:14:28,127 --> 02:14:29,995
PARTICIPATION AT THE TIME.

3490
02:14:29,995 --> 02:14:33,666
AND IF A CHILD SAMPLES ARE HELD 

3491
02:14:33,666 --> 02:14:37,569
IN A DATABASE FOR STORED SAMPLE 

3492
02:14:37,569 --> 02:14:38,470
RESEARCH, OVER THE COURSE OF 

3493
02:14:38,470 --> 02:14:41,907
THE RESEARCH AND IN GENERAL, A 

3494
02:14:41,907 --> 02:14:44,610
LOT OF BE RECONSENTED AT THAT 

3495
02:14:44,610 --> 02:14:45,110
POINT.

3496
02:14:45,110 --> 02:14:46,779
THERE ARE SOME PEOPLE WHO ARE 

3497
02:14:46,779 --> 02:14:50,249
ARGUED TO THE CONTRARY, HAS 

3498
02:14:50,249 --> 02:14:51,083
ARGUED THAT REALLY THERE ARE A 

3499
02:14:51,083 --> 02:14:53,819
LOT OF THINGS THAT PARENTS 

3500
02:14:53,819 --> 02:14:54,720
DECISIONS THE CHILDREN MAKE 

3501
02:14:54,720 --> 02:14:56,388
ABOUT THEIR CHILDREN AND 

3502
02:14:56,388 --> 02:14:57,790
CHILDREN DON'T NECESSARILY GET 

3503
02:14:57,790 --> 02:15:00,059
TO REVISIT ALL OF THEM AT THE 

3504
02:15:00,059 --> 02:15:01,760
AGE OF 18 SO IT'S NOT CLEAR 

3505
02:15:01,760 --> 02:15:03,462
THAT THIS IS ONE OF THOSE CASES 

3506
02:15:03,462 --> 02:15:04,897
WHERE WE SHOULD ALWAYS GO BACK 

3507
02:15:04,897 --> 02:15:06,065
AND ASK CHILDREN FOR THEIR 

3508
02:15:06,065 --> 02:15:08,834
CONSENT.

3509
02:15:08,834 --> 02:15:11,637
AND ADDITIONALLY AS MENTIONED 

3510
02:15:11,637 --> 02:15:22,147
EARLIER, DIFFERENT STATES AND 

3511
02:15:22,681 --> 02:15:25,317
COUNTRIES ALLOW CHILDREN.

3512
02:15:25,317 --> 02:15:27,152
THIS INCLUDES MATURITY.

3513
02:15:27,152 --> 02:15:28,954
SO SOME COUNTIES CAN HAVE 

3514
02:15:28,954 --> 02:15:31,056
DIFFERENT AGES AND THIS CAN 

3515
02:15:31,056 --> 02:15:36,362
VARY BETWEEN THE AGE OF 14 AND 

3516
02:15:36,362 --> 02:15:36,528
21.

3517
02:15:36,528 --> 02:15:39,531
A MINOR WHO IS MINOR AND 

3518
02:15:39,531 --> 02:15:41,800
PREGNANT AND IN THE MILITARY 

3519
02:15:41,800 --> 02:15:44,636
CAN HAVE THE ABILITY TO CONSENT 

3520
02:15:44,636 --> 02:15:46,372
FOR THEMSELVES.

3521
02:15:46,372 --> 02:15:53,012
SOME HAVE STRANGE THAT THEIR 

3522
02:15:53,012 --> 02:15:56,248
CAN HAVE THEIR OWN MEDICAL CARE 

3523
02:15:56,248 --> 02:15:57,583
IF THEY'RE PREGNANT BUT ONCE 

3524
02:15:57,583 --> 02:16:00,986
THE CHILD IS BORN, AND THEY'RE 

3525
02:16:00,986 --> 02:16:04,156
NO LONGER PREGNANT, THEY CAN 

3526
02:16:04,156 --> 02:16:06,525
CONSENT FOR THEIR CHILD BUT NOT 

3527
02:16:06,525 --> 02:16:07,860
FOR THEMSELVES.

3528
02:16:07,860 --> 02:16:13,999
AND SOME IS MATURITY, THAT CAN 

3529
02:16:13,999 --> 02:16:16,769
BE BASED ON EITHER A CLINICIAN 

3530
02:16:16,769 --> 02:16:17,970
EVALUATING THE MINOR AND 

3531
02:16:17,970 --> 02:16:21,607
DECIDED THAT THEY HAVE THIS 

3532
02:16:21,607 --> 02:16:24,143
MATURITY OR BASED ON A COURT 

3533
02:16:24,143 --> 02:16:24,877
PROCESS WHERE COURT DETERMINES 

3534
02:16:24,877 --> 02:16:27,746
THIS.

3535
02:16:27,746 --> 02:16:29,148
AND FINALLY, MANY CASES WHERE 

3536
02:16:29,148 --> 02:16:31,417
CHILDREN CAN CONSENT TO CARE 

3537
02:16:31,417 --> 02:16:33,519
FOR HAVING CERTAIN CONDITIONS.

3538
02:16:33,519 --> 02:16:36,188
FOR INSTANCE, THERE ARE LAWS 

3539
02:16:36,188 --> 02:16:38,791
THAT ARE BASED ON A CONCERN 

3540
02:16:38,791 --> 02:16:39,925
THAT ADOLESCENT FAILED TO 

3541
02:16:39,925 --> 02:16:44,063
RECEIVE THE TREATMENT BECAUSE 

3542
02:16:44,063 --> 02:16:52,571
IT WOULD REVEAL RISKY SEX 

3543
02:16:52,571 --> 02:16:55,140
PRACTICES THAT WOULD INCLUDE 

3544
02:16:55,140 --> 02:16:58,110
GETTING TREATMENT FOR.

3545
02:16:58,110 --> 02:17:01,113
THIS IS NOT ABOUT OH THIS MINOR 

3546
02:17:01,113 --> 02:17:05,684
HAS A GREATER AUTONOMY BUT IF 

3547
02:17:05,684 --> 02:17:09,121
WE LET PARENTAL PERMISSION BE A 

3548
02:17:09,121 --> 02:17:12,491
BARRIER, WE MAY HAVE SEXUAL 

3549
02:17:12,491 --> 02:17:13,459
TRANSMITTED DISEASES GO 

3550
02:17:13,459 --> 02:17:14,359
UNTREATED.

3551
02:17:14,359 --> 02:17:16,428
SO WHEN WE'RE ASKING A QUESTION 

3552
02:17:16,428 --> 02:17:19,832
ABOUT WHETHER CHILDREN CAN GIVE 

3553
02:17:19,832 --> 02:17:21,266
ASSENT OR CONSENT, THERE IS 

3554
02:17:21,266 --> 02:17:22,768
BEEN A STUDIES ON H.I.V. 

3555
02:17:22,768 --> 02:17:23,735
RESEARCH.

3556
02:17:23,735 --> 02:17:26,371
AND THESE STUDIES HAVE SHOWN 

3557
02:17:26,371 --> 02:17:28,741
THAT THERE ARE A LOST REASONS 

3558
02:17:28,741 --> 02:17:30,642
TO QUESTION THE DEFAULT THAT 

3559
02:17:30,642 --> 02:17:32,911
CHILDREN CAN'T GIVE CONSENT 

3560
02:17:32,911 --> 02:17:35,447
UNTIL THEY REACH THAT LEGAL AGE 

3561
02:17:35,447 --> 02:17:37,382
WHERE THEY'RE NOW ABLE TO 

3562
02:17:37,382 --> 02:17:39,418
CONSENT FOR MANY THINGS.

3563
02:17:39,418 --> 02:17:41,920
SO FIRST, ONE CITY INVOLVED 

3564
02:17:41,920 --> 02:17:45,390
USING A CONSENT FORM AND 

3565
02:17:45,390 --> 02:17:47,259
TESTING ADOLESCENTS TO SEE HOW 

3566
02:17:47,259 --> 02:17:48,193
WELL THEY UNDERSTOOD WHAT THEY 

3567
02:17:48,193 --> 02:17:50,028
NEEDED TO KNOW AND OVER THE 

3568
02:17:50,028 --> 02:17:52,164
HALF OF THE ADOLESCENTS 

3569
02:17:52,164 --> 02:17:53,031
ANSWERED ALL THE QUESTIONS 

3570
02:17:53,031 --> 02:17:54,032
CORRECTLY.

3571
02:17:54,032 --> 02:17:55,767
ANOTHER STUDY THAT I 

3572
02:17:55,767 --> 02:17:57,769
PARTICIPATED IN, DID SOMETHING 

3573
02:17:57,769 --> 02:17:59,838
TO TAKE THIS A STEP FURTHER.

3574
02:17:59,838 --> 02:18:04,543
SO WE COMPARED ANALYST TO ADULT 

3575
02:18:04,543 --> 02:18:07,079
AND TESTED THEM AND FOUND NO 

3576
02:18:07,079 --> 02:18:09,481
SIGNIFICANT DIFFERENCE BETWEEN 

3577
02:18:09,481 --> 02:18:13,152
ADULTS AND AGE THE AGE OF 14.

3578
02:18:13,152 --> 02:18:15,854
WE DID FIND A RIL YOUNGER THERE 

3579
02:18:15,854 --> 02:18:18,190
WERE CERTAIN DIFFERENCES IN 

3580
02:18:18,190 --> 02:18:20,659
THEIR COMPREHENSION.

3581
02:18:20,659 --> 02:18:22,094
SO THIS SUGGESTED THAT HAVING A 

3582
02:18:22,094 --> 02:18:23,896
CUT OFF COULD WORK AT LEAST IN 

3583
02:18:23,896 --> 02:18:26,398
THIS CASE ALL THOET TESTS WERE 

3584
02:18:26,398 --> 02:18:30,302
PRETTY SIMPLE SO THEY WERE NOT 

3585
02:18:30,302 --> 02:18:32,838
DELVING DEEP AND UNDERSTANDING.

3586
02:18:32,838 --> 02:18:35,073
FINALLY UNDERSTOOD PLACEBO AND 

3587
02:18:35,073 --> 02:18:37,576
CLINICAL TRIALS BUT DID LESS 

3588
02:18:37,576 --> 02:18:40,145
WELL WITH THINGS LIKE RISK AND 

3589
02:18:40,145 --> 02:18:41,480
RAMIFICATION OR A PARTICULAR 

3590
02:18:41,480 --> 02:18:43,448
RISK THAT OCCURS IN H.I.V. 

3591
02:18:43,448 --> 02:18:46,518
RESEARCH WHERE IF YOU RECEIVE A 

3592
02:18:46,518 --> 02:18:49,488
H.I.V. VACCINE, YOU MAY HAVE 

3593
02:18:49,488 --> 02:18:52,958
FUTURE FALSE POSITIVE UNCERTAIN 

3594
02:18:52,958 --> 02:18:57,262
H.I.V. TESTS HA ARE DONE AND IT 

3595
02:18:57,262 --> 02:18:59,164
LOOKS LIKE, UNLESS A BETTER 

3596
02:18:59,164 --> 02:19:01,333
TEST IS DONE, YOU DON'T KNOW 

3597
02:19:01,333 --> 02:19:03,902
WHETHER OR NOT YOU HAVE H.I.V. 

3598
02:19:03,902 --> 02:19:08,240
SO. THAT IS SOMETHING THAT THEY 

3599
02:19:08,240 --> 02:19:11,210
DIDN'T UNDERSTAND VERY WELL.

3600
02:19:11,210 --> 02:19:17,382
SO WE DID A STAKEHOLDERS ON 

3601
02:19:17,382 --> 02:19:18,350
ADOLESCENT CONSENT TO TRY TO 

3602
02:19:18,350 --> 02:19:19,885
UNDERSTAND HOW DO WE MAKE SENSE 

3603
02:19:19,885 --> 02:19:21,753
OF ALL OF THESE ROLES AND LAWS 

3604
02:19:21,753 --> 02:19:25,691
TO REALLY DO A BETTER JOB OF 

3605
02:19:25,691 --> 02:19:26,558
ADDRESSING ADOLESCENT NEEDS AND 

3606
02:19:26,558 --> 02:19:28,060
RESEARCH.

3607
02:19:28,060 --> 02:19:30,362
REDID SEMI STRUCTURE NEEDS FOR 

3608
02:19:30,362 --> 02:19:32,698
PROPOSED SAMPLING OF 15 

3609
02:19:32,698 --> 02:19:34,766
POLICIES STAKEHOLDERS WHICH 

3610
02:19:34,766 --> 02:19:36,802
INCLUDED LAWYERS AND SCHOOL 

3611
02:19:36,802 --> 02:19:37,536
ADMINISTRATORS AND POLICY 

3612
02:19:37,536 --> 02:19:39,738
MAKERS AND THEN WE CONDUCTED 

3613
02:19:39,738 --> 02:19:41,673
THE ANALYSIS.

3614
02:19:41,673 --> 02:19:43,909
AND WE FOUND THREE THINGS, THE 

3615
02:19:43,909 --> 02:19:47,846
FIRST WAS THAT AGE IS A PROXY 

3616
02:19:47,846 --> 02:19:50,115
FOR DECISION MAKING CAPACITY.

3617
02:19:50,115 --> 02:19:53,919
AND PEOPLE THOUGHT THAT 

3618
02:19:53,919 --> 02:19:56,488
MATURITY AND CONTEXT AND RISK 

3619
02:19:56,488 --> 02:19:57,422
RATIO MATTERED MORE.

3620
02:19:57,422 --> 02:20:00,792
THE SECOND THING IS THAT POLICY 

3621
02:20:00,792 --> 02:20:02,461
COULD EVOLVE, AND THE THIRD IS 

3622
02:20:02,461 --> 02:20:06,064
THAT ADULTS SHOULD BE FOCUSED 

3623
02:20:06,064 --> 02:20:07,966
ON EMPOWERING IN 

3624
02:20:07,966 --> 02:20:09,568
DECISION-MAKING TO MOVE THEM 

3625
02:20:09,568 --> 02:20:11,136
TOWARDS OWNERSHIP OVER THEIR 

3626
02:20:11,136 --> 02:20:13,138
OWN HEALTH OVERTIME.

3627
02:20:13,138 --> 02:20:15,307
SO FOR THE FIRST THING, I WANT 

3628
02:20:15,307 --> 02:20:19,578
TO GIVE YOU A COUPLE OF 

3629
02:20:19,578 --> 02:20:20,045
REPRESENTATIVE QUOTES.

3630
02:20:20,045 --> 02:20:23,882
ONE PERSON POINTED OUT, PEOPLE 

3631
02:20:23,882 --> 02:20:26,418
DON'T MATURE THE SAME WAY.

3632
02:20:26,418 --> 02:20:29,154
AND YOUNGER ADOLESCENT THAT CAN 

3633
02:20:29,154 --> 02:20:30,656
BE QUITE MATURE AND IT JUST 

3634
02:20:30,656 --> 02:20:31,723
DEPENDS.

3635
02:20:31,723 --> 02:20:34,960
THEIR VIEW IS A AGE IN GENERAL 

3636
02:20:34,960 --> 02:20:38,830
IS A CORE PROXY.

3637
02:20:38,830 --> 02:20:41,333
THE SECOND THEME THAT I HAD 

3638
02:20:41,333 --> 02:20:44,169
MENTIONED POLICY SHOULD EVOLVE 

3639
02:20:44,169 --> 02:20:45,971
WITH SOCIETAL VIEWS.

3640
02:20:45,971 --> 02:20:47,839
THIS PERSON, WHO IS IT HELPING 

3641
02:20:47,839 --> 02:20:49,708
IS THE POLICY FOR US TO HELP 

3642
02:20:49,708 --> 02:20:51,710
RIGHT AND RELIGIOUS AND MORAL 

3643
02:20:51,710 --> 02:20:54,579
OR IS IT TO PROTECT FOR WORK 

3644
02:20:54,579 --> 02:20:59,551
FOR OUR ADOLESCENT.

3645
02:20:59,551 --> 02:21:00,719
FOR ME, I THINK THE POLICIES 

3646
02:21:00,719 --> 02:21:03,689
NEED TO CHANGE AND EVEN THE 

3647
02:21:03,689 --> 02:21:08,660
LAWS NEED TO CHANGE TO REFLECT 

3648
02:21:08,660 --> 02:21:09,194
CURRENT SOCIETY.

3649
02:21:09,194 --> 02:21:11,730
AND WITH ACCESS TO SOCIAL 

3650
02:21:11,730 --> 02:21:17,235
MEDIA, THE THINGS THAT 

3651
02:21:17,235 --> 02:21:19,705
ADOLESCENT KNOW HAS REALLY 

3652
02:21:19,705 --> 02:21:21,506
INCREASED, THEY KNOW NOW THAN 

3653
02:21:21,506 --> 02:21:22,708
PREVIOUS GENERAL RAISESING.

3654
02:21:22,708 --> 02:21:24,343
FINALLY WITH THE THIRD THEME, 

3655
02:21:24,343 --> 02:21:26,144
THERE WAS REALLY THE SENSE THAT 

3656
02:21:26,144 --> 02:21:27,980
IT'S IMPORTANT FOR ADULTS TO 

3657
02:21:27,980 --> 02:21:31,917
STILL BE INVOLVED IN DECISIONS 

3658
02:21:31,917 --> 02:21:33,585
IN ADOLESCENTS WHEN THAT'S 

3659
02:21:33,585 --> 02:21:34,386
POSSIBLE AND WHEN THAT'S A 

3660
02:21:34,386 --> 02:21:35,420
PROTECTION.

3661
02:21:35,420 --> 02:21:38,790
BUT IT'S REALLY A SHIFT FROM 

3662
02:21:38,790 --> 02:21:49,167
MAKING DECISIONS IN  

3663
02:21:57,242 --> 02:21:59,010
AUTHORATVIVE.

3664
02:21:59,010 --> 02:22:02,247
FOCUSED ON EAST AFRICAN CONTEXT 

3665
02:22:02,247 --> 02:22:05,684
BUT WHAT WE FOUND.

3666
02:22:05,684 --> 02:22:08,887
BUT FIRST LAWS WITHOUT AGE CUT 

3667
02:22:08,887 --> 02:22:11,923
OFF WHICH IS MATURE MINOR LAWS 

3668
02:22:11,923 --> 02:22:13,959
WHERE A CLINICIAN CAN DETERMINE 

3669
02:22:13,959 --> 02:22:15,727
WHETHER A MINOR HAS THE ABILITY 

3670
02:22:15,727 --> 02:22:17,362
TO MAKE DECISIONS FOR 

3671
02:22:17,362 --> 02:22:18,296
THEMSELVES.

3672
02:22:18,296 --> 02:22:21,733
THAT MAY HELP ADDRESS DIVERSION 

3673
02:22:21,733 --> 02:22:25,904
AND ALLOW CLINICIANS TO REALLY 

3674
02:22:25,904 --> 02:22:28,373
DETERMINE, IF THEY HAVE A LOT 

3675
02:22:28,373 --> 02:22:30,642
MORE MATURITY OR LESS MATURITY 

3676
02:22:30,642 --> 02:22:32,511
BASED ON THEIR AGE.

3677
02:22:32,511 --> 02:22:35,080
ADDITIONALLY, THERE IS A NEED 

3678
02:22:35,080 --> 02:22:36,214
ON CONTINUED RESEARCH IN 

3679
02:22:36,214 --> 02:22:37,449
WORKING TOGETHER TO MAKE 

3680
02:22:37,449 --> 02:22:38,817
DECISIONS.

3681
02:22:38,817 --> 02:22:44,523
SO THIS COULD EVOLVE TRAINING, 

3682
02:22:44,523 --> 02:22:47,059
CARE GIVERS ON HOW TO GUIDE AND 

3683
02:22:47,059 --> 02:22:48,693
FIGURING OUTWEIGHS TO SUPPORT 

3684
02:22:48,693 --> 02:22:51,430
ADO LESS EPT WITH INTERVENTION 

3685
02:22:51,430 --> 02:22:53,365
TO ADDRESS LIMITATIONS.

3686
02:22:53,365 --> 02:22:55,100
THE LATTER RESEARCH SHOWN THAT 

3687
02:22:55,100 --> 02:22:56,968
THEY CAN UNDERSTAND SOME OF THE 

3688
02:22:56,968 --> 02:22:58,370
IMPORTANT CONCEPT.

3689
02:22:58,370 --> 02:23:00,138
BUT THERE MAY BE OTHER 

3690
02:23:00,138 --> 02:23:04,042
LIMITATIONS, WE KNOW THAT THE 

3691
02:23:04,042 --> 02:23:09,581
ADOLESCENT BRAIN IS ONE THAT 

3692
02:23:09,581 --> 02:23:10,482
HAS TROUBLE RESISTING PRESSURE 

3693
02:23:10,482 --> 02:23:13,084
AND MAYBE THERE IS A WAY TO 

3694
02:23:13,084 --> 02:23:16,354
REALLY JUST ADDRESS THOSE 

3695
02:23:16,354 --> 02:23:18,390
DEVELOPMENTAL LIMITATION TO SEE 

3696
02:23:18,390 --> 02:23:20,392
HELP ADOLESCENTS MAKE BETTER 

3697
02:23:20,392 --> 02:23:20,926
DECISIONS BY THEMSELVES.

3698
02:23:20,926 --> 02:23:24,863
SO THIS IS THE PAPER THAT TRIES 

3699
02:23:24,863 --> 02:23:25,897
TO ILLUSTRATES, THE RESEARCH 

3700
02:23:25,897 --> 02:23:31,436
THAT I WAS JUST TALKING ABOUT.

3701
02:23:31,436 --> 02:23:33,705
SO FINALLY DISTANT IS ANOTHER 

3702
02:23:33,705 --> 02:23:36,675
IMPORTANT CONSIDERATION AND 

3703
02:23:36,675 --> 02:23:40,312
MANY GUIDELINES MENTION THAT A 

3704
02:23:40,312 --> 02:23:41,480
CHILD'S DISSENT SHOULD BE NOTED 

3705
02:23:41,480 --> 02:23:45,317
AND A CHILD AND/OR PARENT 

3706
02:23:45,317 --> 02:23:49,020
SHOULD BE ABLE TO WITHDRAWAL AT 

3707
02:23:49,020 --> 02:23:49,287
ANY TIME.

3708
02:23:49,287 --> 02:23:51,923
HOW DO WE KNOW IF A CHILD IS 

3709
02:23:51,923 --> 02:23:53,992
DISSENTING FROM A RESEARCH.

3710
02:23:53,992 --> 02:23:57,696
AGE IS A FACTOR, SO A CRYING 

3711
02:23:57,696 --> 02:24:01,566
CHILD WHO IS THREE MAY JUST BE 

3712
02:24:01,566 --> 02:24:03,869
HAVING A TANTRUM OR HUNGRY AND 

3713
02:24:03,869 --> 02:24:05,737
THAT DOES NOT MEAN THAT THE 

3714
02:24:05,737 --> 02:24:08,006
CHILD IS DISSENT.

3715
02:24:08,006 --> 02:24:10,275
BUT WE SHOULD RESPECT DIS 

3716
02:24:10,275 --> 02:24:13,678
STAINED DISSENT WHO UNDERSTAND 

3717
02:24:13,678 --> 02:24:15,580
WHAT HE OR SHE IS DOING.

3718
02:24:15,580 --> 02:24:23,088
IT MAY BE A CONTRARY TEENAGERS 

3719
02:24:23,088 --> 02:24:25,056
THAT IS SAYING YES TO 

3720
02:24:25,056 --> 02:24:35,267
EVERYTHING.

3721
02:24:35,600 --> 02:24:39,237
IF A CHILD DOESN'T HAVE 

3722
02:24:39,237 --> 02:24:41,740
CAPACITY OR MAKING CONTRARY 

3723
02:24:41,740 --> 02:24:42,707
DECISIONS, REALLY DOESN'T WANT 

3724
02:24:42,707 --> 02:24:44,376
TO DO SOMETHING, WE HAVE TO 

3725
02:24:44,376 --> 02:24:47,746
THINK ABOUT THE PRACTICALITY OF 

3726
02:24:47,746 --> 02:24:49,114
GET THATING CHILD TO 

3727
02:24:49,114 --> 02:24:49,614
PARTICIPATE IN RESEARCH.

3728
02:24:49,614 --> 02:24:52,150
THEY HAVE TO BE  DRAGGED TO THE 

3729
02:24:52,150 --> 02:24:54,719
SITE AND HELD DOWN, THAT'S NOT 

3730
02:24:54,719 --> 02:24:56,988
SOMETHING THAT I THINK IS GOOD 

3731
02:24:56,988 --> 02:24:59,424
FOR EITHER THE RESEARCH STAFF 

3732
02:24:59,424 --> 02:25:00,525
OR THAT CHILD.

3733
02:25:00,525 --> 02:25:02,260
SO THERE MAY BE CASES WHERE 

3734
02:25:02,260 --> 02:25:06,197
EVEN IF THERE IS AN AUTONOMY 

3735
02:25:06,197 --> 02:25:08,567
REASON OR THERE IS NOT A REASON 

3736
02:25:08,567 --> 02:25:11,136
BASED ON THINKING THAT, THE 

3737
02:25:11,136 --> 02:25:13,171
CHILD IS NECESSARILY GOING TO 

3738
02:25:13,171 --> 02:25:16,841
BE HARMED, THAT ACTUAL 

3739
02:25:16,841 --> 02:25:18,343
PRACTICALITY OF IT YOU JUST 

3740
02:25:18,343 --> 02:25:20,745
DON'T EN ROLL THAT CHILD 

3741
02:25:20,745 --> 02:25:22,080
ANYMORE.

3742
02:25:22,080 --> 02:25:23,949
AND DISSENT IS DIFFERENT FROM 

3743
02:25:23,949 --> 02:25:24,816
DISTRESS.

3744
02:25:24,816 --> 02:25:29,187
AND THE IT MAY BE CONTROLLER TO 

3745
02:25:29,187 --> 02:25:33,058
EXPRESS SOMEBODY'S AUTONOMY BUT 

3746
02:25:33,058 --> 02:25:36,928
DISTRESS IS WHEN A CHILD IS 

3747
02:25:36,928 --> 02:25:38,096
EXPERIENCING PSYCHOLOGICAL HARM.

3748
02:25:38,096 --> 02:25:41,499
LIKE IF THERE IS A CHILD WHO IS 

3749
02:25:41,499 --> 02:25:43,335
TERRIFIED OF INJECTIONS AND THE 

3750
02:25:43,335 --> 02:25:46,338
RESEARCH INVOLVES AN INJECTION, 

3751
02:25:46,338 --> 02:25:49,240
THAT MAY INCREASE THE RISK OF 

3752
02:25:49,240 --> 02:25:50,842
RESEARCH PARTICIPATION FOR THAT 

3753
02:25:50,842 --> 02:25:52,677
CHILD BECAUSE OF THE 

3754
02:25:52,677 --> 02:25:53,912
PSYCHOLOGICAL HARM THAT THEY 

3755
02:25:53,912 --> 02:25:55,213
MAY EXPERIENCE.

3756
02:25:55,213 --> 02:25:57,082
THAT MAY BE DIFFERENT OR HIGHER 

3757
02:25:57,082 --> 02:25:59,184
THAN WHAT OTHER CHILDREN 

3758
02:25:59,184 --> 02:25:59,484
EXPERIENCE.

3759
02:25:59,484 --> 02:26:00,585
AND IMPORTANTLY, THERE ARE 

3760
02:26:00,585 --> 02:26:03,622
TIMES WHEN EVEN IN RESEARCH, IT 

3761
02:26:03,622 --> 02:26:08,893
COULD BE ETHICALLY JUSTIFIABLE.

3762
02:26:08,893 --> 02:26:11,429
FOR INSTANCE, IF THE CHILD CAN 

3763
02:26:11,429 --> 02:26:12,631
BENEFIT FROM THE RESEARCH THAT 

3764
02:26:12,631 --> 02:26:14,933
THEY COULD NOT OBTAIN OTHERWISE 

3765
02:26:14,933 --> 02:26:20,071
AND THE HARMS ARE OUT  WEIGHED 

3766
02:26:20,071 --> 02:26:20,939
BY THAT.

3767
02:26:20,939 --> 02:26:22,774
BUT IT'S IMPORTANT TO THINK OF 

3768
02:26:22,774 --> 02:26:24,643
THE LEVEL OF RISK IS THAT IS 

3769
02:26:24,643 --> 02:26:26,611
BEING ADDED TO THE RESEARCH AND 

3770
02:26:26,611 --> 02:26:29,080
DETERMINING WHETHER THE HARMS 

3771
02:26:29,080 --> 02:26:30,382
FROM THAT RESEARCH 

3772
02:26:30,382 --> 02:26:33,184
PARTICIPATION ARE OUT WEIGHED 

3773
02:26:33,184 --> 02:26:35,453
BY THE POTENTIAL RISKS.

3774
02:26:35,453 --> 02:26:44,362
OKAY, SO IN SUM, RESEARCH CHILD 

3775
02:26:44,362 --> 02:26:48,366
ABOUT TREATING CHILDREN AS A 

3776
02:26:48,366 --> 02:26:48,566
GROUP.

3777
02:26:48,566 --> 02:26:49,834
AND MOST ALLOW CHILDREN TO 

3778
02:26:49,834 --> 02:26:52,103
PARTICIPATE IN RESEARCH THAT 

3779
02:26:52,103 --> 02:26:56,007
BENEFITS THEM AND MINIMAL RISK 

3780
02:26:56,007 --> 02:26:58,943
RESEARCH IF THERE IS NO 

3781
02:26:58,943 --> 02:27:00,545
PROSPECT OF BENEFIT.

3782
02:27:00,545 --> 02:27:02,313
I REALLY WANTED TO ENCOURAGE TO 

3783
02:27:02,313 --> 02:27:03,648
YOU RECOGNIZE THAT ALTHOUGH 

3784
02:27:03,648 --> 02:27:06,651
THERE IS LONG BEEN THIS DEFAULT 

3785
02:27:06,651 --> 02:27:07,886
FOR THINKING ABOUT THE 

3786
02:27:07,886 --> 02:27:08,820
PROTECTION OF CHILDREN, THERE 

3787
02:27:08,820 --> 02:27:11,122
ARE MANY CASES WHERE WE NEED TO 

3788
02:27:11,122 --> 02:27:12,991
GIVE CONSIDERATION TO ENROLLING 

3789
02:27:12,991 --> 02:27:16,394
CHILDREN IN RESEARCH EARLIER.

3790
02:27:16,394 --> 02:27:17,796
AND THE COVID-19 PANDEMIC 

3791
02:27:17,796 --> 02:27:22,801
REALLY TAUGHT US THAT SORT OF 

3792
02:27:22,801 --> 02:27:24,002
THINKING REFLECTIVELY AND NOT 

3793
02:27:24,002 --> 02:27:25,337
SPECIFICALLY ABOUT CHILDREN CAN 

3794
02:27:25,337 --> 02:27:26,705
REALLY HURT THEM IN PANDEMIC 

3795
02:27:26,705 --> 02:27:28,473
RESPONSE.

3796
02:27:28,473 --> 02:27:32,143
BUT IN MANY CASES, HOWEVER, TO 

3797
02:27:32,143 --> 02:27:33,778
ENSURE THAT EARLIER INCLUSION 

3798
02:27:33,778 --> 02:27:35,380
OF CHILDREN IS ETHICAL, IT'S 

3799
02:27:35,380 --> 02:27:36,548
IMPORTANT TO ENSURE THAT THERE 

3800
02:27:36,548 --> 02:27:38,216
IS A STRONG EXPECTATION AND 

3801
02:27:38,216 --> 02:27:41,119
THERE IS A RESPECTFUL 

3802
02:27:41,119 --> 02:27:42,721
PERMISSION IN A PROCESS.

3803
02:27:42,721 --> 02:27:46,624
FINALLY, WE REALLY DO NEED BARE 

3804
02:27:46,624 --> 02:27:47,759
GUIDANCE ON WHEN CHILDREN 

3805
02:27:47,759 --> 02:27:49,627
SHOULD DECIDE ON THEIR OWN ON 

3806
02:27:49,627 --> 02:27:51,429
HOW TO PARTICIPATE ON THEIR 

3807
02:27:51,429 --> 02:27:53,131
RESEARCH AND HOW CARE GIVERS 

3808
02:27:53,131 --> 02:27:54,232
CAN MAKE GOOD RESEARCH 

3809
02:27:54,232 --> 02:27:56,735
DECISIONS.

3810
02:27:56,735 --> 02:28:01,172
: AND A LOT STRUGGLE WITH 

3811
02:28:01,172 --> 02:28:07,078
CHILDREN GAIN AUTONOMY AND GO 

3812
02:28:07,078 --> 02:28:08,480
THROUGH ADOLESCENT AND IT 

3813
02:28:08,480 --> 02:28:09,714
DESERVES MORE ATTENTION TO GET 

3814
02:28:09,714 --> 02:28:10,315
THAT RIGHT.

3815
02:28:10,315 --> 02:28:12,016
THANK YOU VERY MUCH, AND I 

3816
02:28:12,016 --> 02:28:13,885
WOULD LOVE TO HEAR FROM YOU AND 

3817
02:28:13,885 --> 02:28:15,253
TURN THE TABLES AND SEE IF YOU 

3818
02:28:15,253 --> 02:28:17,355
HAVE ANY QUESTIONS OR COMMENTS 

3819
02:28:17,355 --> 02:28:19,924
BASED ON YOUR EXPERIENCE.

3820
02:28:19,924 --> 02:28:21,793
>> GREAT, SEEMA, THANK YOU
SO 

3821
02:28:21,793 --> 02:28:24,062
MUCH FOR YOUR LECTURE, I JUST 

3822
02:28:24,062 --> 02:28:26,131
WALKED AWAY FROM MY COMPUTER 

3823
02:28:26,131 --> 02:28:27,465
WHERE THERE MAY BE SOME 

3824
02:28:27,465 --> 02:28:28,433
QUESTIONS.

3825
02:28:28,433 --> 02:28:30,335
WE HAVE A NUMBER OF PEOPLE HERE 

3826
02:28:30,335 --> 02:28:31,970
IN THE AUDIENCE, THEY'RE GOING 

3827
02:28:31,970 --> 02:28:33,838
TO WALK TO THE MICROPHONES IF 

3828
02:28:33,838 --> 02:28:34,973
THEY HAVE A QUESTION.

3829
02:28:34,973 --> 02:28:36,641
AND I'M GOING TO SEE IF THERE 

3830
02:28:36,641 --> 02:28:39,177
ARE QUESTIONS ONLINE.

3831
02:28:39,177 --> 02:28:40,111
BRITNEY AS A QUESTION.

3832
02:28:40,111 --> 02:28:42,647
>> THANKS SO MUCH FOR THIS

3833
02:28:42,647 --> 02:28:44,382
PRESENTATION, I WAS WONDERING 

3834
02:28:44,382 --> 02:28:46,951
IF LAW ABOUT THE AGE OF CONSENT 

3835
02:28:46,951 --> 02:28:49,487
TO RESEARCH ARE CHANGING 

3836
02:28:49,487 --> 02:28:52,056
ALONGSIDE LINES OF AGE CONSENT 

3837
02:28:52,056 --> 02:28:53,458
FOR OTHER THINGS.

3838
02:28:53,458 --> 02:28:55,260
I KNOW VIRGINIA RAISED THEIR 

3839
02:28:55,260 --> 02:28:58,029
MARRIAGE AGE TO 18, THAT 

3840
02:28:58,029 --> 02:29:00,098
AFFECTING RESEARCH OR LEFT UP 

3841
02:29:00,098 --> 02:29:02,000
TO IRBs AND RESEARCHERS TO 

3842
02:29:02,000 --> 02:29:04,068
DECIDE?

3843
02:29:04,068 --> 02:29:05,103
>> YEAH, GREAT QUESTION.

3844
02:29:05,103 --> 02:29:07,672
SO THERE IS THIS INTER PLAY 

3845
02:29:07,672 --> 02:29:12,477
BETWEEN GENERAL LAWS ABOUT WHEN 

3846
02:29:12,477 --> 02:29:14,412
ADOLESCENTS CAN GIVE CONSENT IN 

3847
02:29:14,412 --> 02:29:16,414
RESEARCH WHEN THEY CAN GIVE 

3848
02:29:16,414 --> 02:29:17,182
CONSENT IN RESEARCH.

3849
02:29:17,182 --> 02:29:19,851
SO I THINK AN EXAMPLE YOU GET, 

3850
02:29:19,851 --> 02:29:24,722
BECAUSE A CHILD CAN'T  MARRY 

3851
02:29:24,722 --> 02:29:26,558
UNTIL THEY'RE 18, THAT CHILD 

3852
02:29:26,558 --> 02:29:30,028
COULD NOT MAKE DECISIONS BASED 

3853
02:29:30,028 --> 02:29:32,230
ON THEIR STATUS, IS IT EARLIER?

3854
02:29:32,230 --> 02:29:35,300
SO IT MAY BE BEEN EARLIER AND 

3855
02:29:35,300 --> 02:29:37,302
THEN MADE DECISIONS AND THAT 

3856
02:29:37,302 --> 02:29:39,237
WOULD NO LONGER BE THE CASE.

3857
02:29:39,237 --> 02:29:41,039
BUT THERE ARE A LOT OF OTHER 

3858
02:29:41,039 --> 02:29:44,442
EXAMPLES THAT RAISE QUESTIONS.

3859
02:29:44,442 --> 02:29:46,277
SO FOR, VACCINATIONS SOME 

3860
02:29:46,277 --> 02:29:48,346
STATES ARE TRYING TO LOWER THE 

3861
02:29:48,346 --> 02:29:50,415
AGE AT WHICH, SOME CITIES ARE 

3862
02:29:50,415 --> 02:29:53,151
TRYING TO LOWER THE AGE WHERE 

3863
02:29:53,151 --> 02:29:56,287
THEY CAN GIVE CONSENT GIVING 

3864
02:29:56,287 --> 02:30:04,329
THAT THERE IS ADO LESCENT HAVE 

3865
02:30:04,329 --> 02:30:05,964
STRONG VACCINE USE.

3866
02:30:05,964 --> 02:30:07,098
WE HAD CONSULTS ABOUT THAT, 

3867
02:30:07,098 --> 02:30:12,570
WHERE A CHILD HAD GOTTEN INTO 

3868
02:30:12,570 --> 02:30:15,006
SUMMER CAMP AND HAD TO GET 

3869
02:30:15,006 --> 02:30:15,740
VACCINATIONS.

3870
02:30:15,740 --> 02:30:19,878
AND IT WAS A PRESTIGIOUS CAMP 

3871
02:30:19,878 --> 02:30:23,381
SHE WANTED GET TO HER MOM WAS 

3872
02:30:23,381 --> 02:30:26,284
AGAINST VACCINE AND THEY WANTED 

3873
02:30:26,284 --> 02:30:29,087
TO GET VACCINES WITHOUT HER 

3874
02:30:29,087 --> 02:30:29,954
MOTHER'S CONSENT AND THERE WAS 

3875
02:30:29,954 --> 02:30:31,322
NO WAY.

3876
02:30:31,322 --> 02:30:35,193
SO IT'S UP TO IRBs TO DECIDE IS 

3877
02:30:35,193 --> 02:30:37,262
THE LAW TO CONSENT THE 

3878
02:30:37,262 --> 02:30:38,696
PARTICULAR TREATMENT OR 

3879
02:30:38,696 --> 02:30:40,532
INTERVENTION APPLICABLE TO THIS 

3880
02:30:40,532 --> 02:30:41,633
PARTICULAR RESEARCH STUDY?

3881
02:30:41,633 --> 02:30:44,202
AND THEY SAID THE RESEARCH 

3882
02:30:44,202 --> 02:30:45,637
STUDY INVOLVED THAT SPECIFIC 

3883
02:30:45,637 --> 02:30:48,106
INTERVENTION LIKE GIVING A 

3884
02:30:48,106 --> 02:30:50,608
VACCINE, OR TREATING A CHILD 

3885
02:30:50,608 --> 02:30:52,710
FOR SEXUALLY TRANSMITTED 

3886
02:30:52,710 --> 02:30:55,380
INFECTION, IT CAN MOVE FORWARD 

3887
02:30:55,380 --> 02:30:59,083
AND THERE IS GOOD GUIDANCE NOW 

3888
02:30:59,083 --> 02:31:01,819
FROM THE FDA ON THIS.

3889
02:31:01,819 --> 02:31:05,456
BUT MANY INTERVIEWS ARE STILL 

3890
02:31:05,456 --> 02:31:05,790
RELUCTANT.

3891
02:31:05,790 --> 02:31:08,826
AND PASTER RELUCTANCE IS THAT 

3892
02:31:08,826 --> 02:31:11,062
RESEARCH DOES NOT JUST IN VOLVE 

3893
02:31:11,062 --> 02:31:14,032
INTERVENTION IT'S GOING TO 

3894
02:31:14,032 --> 02:31:15,466
INVOLVE SURVEYS AND BLOOD DRAWS 

3895
02:31:15,466 --> 02:31:17,368
AND OTHER THINGS TO GATHER THE 

3896
02:31:17,368 --> 02:31:20,305
DATA THAT YOU NEED.

3897
02:31:20,305 --> 02:31:21,673
SO THAT'S WHY WHERE IT BECOMES 

3898
02:31:21,673 --> 02:31:24,208
A LITTLE GRAY AND DEFAULT 

3899
02:31:24,208 --> 02:31:25,076
CONSERVATIVE JUDGMENT THAT 

3900
02:31:25,076 --> 02:31:26,311
CHILDREN CANNOT MAKE THESE 

3901
02:31:26,311 --> 02:31:27,645
DECISIONS ON THEIR OWN.

3902
02:31:27,645 --> 02:31:31,482
FINALLY, I WILL SAY IN CERTAIN 

3903
02:31:31,482 --> 02:31:33,251
COUNTRIES WHERE THERE IS A LOT 

3904
02:31:33,251 --> 02:31:35,720
OF RESEARCH GOING ON, STATES 

3905
02:31:35,720 --> 02:31:39,390
HAVE ACTUALLY CREATED LAWS THAT 

3906
02:31:39,390 --> 02:31:40,792
FOCUS ON RESEARCH SPECIFICALLY 

3907
02:31:40,792 --> 02:31:42,493
AND ALLOW CHILDREN UNDER THE 

3908
02:31:42,493 --> 02:31:46,097
AGE OF 18 TO CONSENT TO 

3909
02:31:46,097 --> 02:31:47,432
RESEARCH AND IT'S IMPORTANT IN 

3910
02:31:47,432 --> 02:31:48,833
CASES WHERE CHILDREN MAY BE 

3911
02:31:48,833 --> 02:31:51,235
GOING TO A CLINIC SITE, GETTING 

3912
02:31:51,235 --> 02:31:53,204
TREATMENT FOR H.I.V. AND GOING 

3913
02:31:53,204 --> 02:31:54,872
BY THEMSELVES AND FOR THEM TO 

3914
02:31:54,872 --> 02:31:58,710
EN ROLL IN RESEARCH WITH THEIR 

3915
02:31:58,710 --> 02:31:59,610
PARENTS PERMISSION MAY MAKE IT 

3916
02:31:59,610 --> 02:32:01,913
POSSIBLE FOR THEM TO EN ROLL 

3917
02:32:01,913 --> 02:32:04,615
FROM A PRACTICE PERSPECTIVE.

3918
02:32:04,615 --> 02:32:05,850
GETTING CARE AND SORT OF BEING 

3919
02:32:05,850 --> 02:32:07,151
ABLE TO MAKE THAT DECISION 

3920
02:32:07,151 --> 02:32:09,220
RESEARCH AND THAT IS PERMITTED 

3921
02:32:09,220 --> 02:32:13,024
FOR INSTANCE IN TEN I CAN'T.

3922
02:32:13,024 --> 02:32:17,428
CAN --KENYA.

3923
02:32:17,428 --> 02:32:18,796
GREAT QUESTION, I HOPE TO 

3924
02:32:18,796 --> 02:32:20,198
ELABORATE IF I MISSED THE 

3925
02:32:20,198 --> 02:32:21,366
INTENT OF YOUR QUESTION.

3926
02:32:21,366 --> 02:32:24,402
>> SO I DON'T HAVE ANY NEW

3927
02:32:24,402 --> 02:32:25,870
QUESTIONS FROM THE WEB FOR 

3928
02:32:25,870 --> 02:32:27,338
THOSE OF WHO ARE STILL OUT 

3929
02:32:27,338 --> 02:32:29,974
THERE, YOU CAN GO TO THE 

3930
02:32:29,974 --> 02:32:31,309
DISCUSSION BOARD, THERE IS A 

3931
02:32:31,309 --> 02:32:33,244
PLACE FOR SESSION 3, BUT I HAVE 

3932
02:32:33,244 --> 02:32:34,779
A QUESTION.

3933
02:32:34,779 --> 02:32:38,116
I WANT TODAY FOLLOW-UP ON YOUR 

3934
02:32:38,116 --> 02:32:42,653
LAST SLIDE, ON THE LAST BULLET 

3935
02:32:42,653 --> 02:32:49,260
ABOUT HOW BEST TO THINK ABOUT 

3936
02:32:49,260 --> 02:32:50,862
UNDER WHAT CIRCUMSTANCES OR HOW 

3937
02:32:50,862 --> 02:32:53,898
BEST TO SUPPORT THE ADOLESCENT?

3938
02:32:53,898 --> 02:32:57,602
SO AS YOU WERE TALKING AND YOU 

3939
02:32:57,602 --> 02:33:00,905
KNOW, WE'RE JUST NOW TALKING 

3940
02:33:00,905 --> 02:33:04,208
ABOUT WHEN IS IT OKAY FOR AN 

3941
02:33:04,208 --> 02:33:05,810
ADOLESCENT TO DO THIS ON THEIR 

3942
02:33:05,810 --> 02:33:06,978
OWN.

3943
02:33:06,978 --> 02:33:08,579
AND I'M THINKING ABOUT THE FLIP 

3944
02:33:08,579 --> 02:33:10,415
SIDE, WHEN WOULD IT BE BETTER 

3945
02:33:10,415 --> 02:33:12,283
OR WHEN WOULD BE BEST TO HAVE 

3946
02:33:12,283 --> 02:33:13,418
THE WHOLE FAMILY INVOLVED?

3947
02:33:13,418 --> 02:33:16,821
OR AT LEAST A PARENT INVOLVED 

3948
02:33:16,821 --> 02:33:20,491
TO SUPPORT THE ADOLESCENT IN 

3949
02:33:20,491 --> 02:33:23,227
TAKE MAKING THE DECISION.

3950
02:33:23,227 --> 02:33:26,197
I GUESS TO SAY, IT SEEMS LIKE 

3951
02:33:26,197 --> 02:33:29,600
THERE IS ROOM FOR HAVING 

3952
02:33:29,600 --> 02:33:32,336
RECOMMENDATIONS THAT MAYBE NOT 

3953
02:33:32,336 --> 02:33:35,306
DEFAULT BUT DEFAULT TO THERE IS 

3954
02:33:35,306 --> 02:33:37,141
JUST SOMETHING, THIS IS A 

3955
02:33:37,141 --> 02:33:39,010
DECISION YOU SHOULD BE MAKING 

3956
02:33:39,010 --> 02:33:40,378
WITH YOUR PARENTS.

3957
02:33:40,378 --> 02:33:42,013
NOT THE PARENT PROVIDE 

3958
02:33:42,013 --> 02:33:44,048
PERMISSION EXAMINE WE GET 

3959
02:33:44,048 --> 02:33:47,051
ASSENT FROM YOU BUT THAT'S A 

3960
02:33:47,051 --> 02:33:47,418
JOINT ENDEAVOR.

3961
02:33:47,418 --> 02:33:50,421
AND I DON'T KNOW IF THERE IS 

3962
02:33:50,421 --> 02:33:51,622
ANY RESEARCH ON THAT SPACE OR 

3963
02:33:51,622 --> 02:33:53,357
ANY WORK THAT YOU'RE DOING ON 

3964
02:33:53,357 --> 02:33:54,125
THAT SPACE?

3965
02:33:54,125 --> 02:33:56,761
>> YEAH, THAT'S A GREAT 

3966
02:33:56,761 --> 02:34:00,031
QUESTION.

3967
02:34:00,031 --> 02:34:02,600
SO WE DID ONE STUDY WORD AND IT 

3968
02:34:02,600 --> 02:34:08,473
WAS REALLY INTERESTING BECAUSE, 

3969
02:34:08,473 --> 02:34:10,308
CAREGIVER--SO CLINICIAN REALLY 

3970
02:34:10,308 --> 02:34:13,311
FOCUS AGO NOT IDEA OF JOINT 

3971
02:34:13,311 --> 02:34:14,679
DECISION MAKING AND TRYING TO 

3972
02:34:14,679 --> 02:34:17,215
WORK WITH THE ADOLESCENT 

3973
02:34:17,215 --> 02:34:17,482
TOGETHER.

3974
02:34:17,482 --> 02:34:19,750
THEY REALLY FOCUS ON SORT OF 

3975
02:34:19,750 --> 02:34:21,586
ONE PERSON MAKING THE DECISION.

3976
02:34:21,586 --> 02:34:25,757
SO IT WAS EITHER, ADOLESCENT OR 

3977
02:34:25,757 --> 02:34:28,159
PARENTS MAKE IT BY THEMSELVES 

3978
02:34:28,159 --> 02:34:29,994
AND THEY CHOOSE BOTH OPTIONS IN 

3979
02:34:29,994 --> 02:34:30,795
DIFFERENT CASES.

3980
02:34:30,795 --> 02:34:33,431
SO IT WAS REALLY INTERESTING 

3981
02:34:33,431 --> 02:34:36,367
BECAUSE IN SOME WAYS, I DON'T 

3982
02:34:36,367 --> 02:34:38,002
THINK WHAT REALLY DROVE THIS 

3983
02:34:38,002 --> 02:34:40,738
FINDING AND SOMETHING I WANT TO 

3984
02:34:40,738 --> 02:34:42,140
EXPLORE MORE BUT ALMOST LUKE A 

3985
02:34:42,140 --> 02:34:43,307
LACK OF APPRECIATION FOR THE 

3986
02:34:43,307 --> 02:34:45,209
ABILITY TO RALLY MAKE THESE 

3987
02:34:45,209 --> 02:34:46,277
DECISIONS TOGETHER.

3988
02:34:46,277 --> 02:34:49,046
SXL YOU KNOW, NOW THAT I HAVE 

3989
02:34:49,046 --> 02:34:51,983
TO SAY, I SORT OF UNDERSTAND 

3990
02:34:51,983 --> 02:34:54,752
THAT IT'S IT'S OFTEN A FRAUGHT 

3991
02:34:54,752 --> 02:34:56,587
TIME WHEN YOU'RE TRYING TO MAKE 

3992
02:34:56,587 --> 02:34:58,856
DECISIONS WITH YOUR ADOLESCENTS 

3993
02:34:58,856 --> 02:35:00,925
AND MANY TIMES THEY REJECT THAT 

3994
02:35:00,925 --> 02:35:03,628
AND DON'T WANT TO MAKE THOSE 

3995
02:35:03,628 --> 02:35:07,131
DECISIONS WITH YOU, MY PRETEEN 

3996
02:35:07,131 --> 02:35:09,567
IN MY CASE.

3997
02:35:09,567 --> 02:35:12,203
SOMETIMES IT'S CLEANER TO HAVE 

3998
02:35:12,203 --> 02:35:12,503
THE DECIDER.

3999
02:35:12,503 --> 02:35:16,174
BUT I DON'T THINK IN MOST CASES 

4000
02:35:16,174 --> 02:35:18,476
IS BETTER AS YOU WERE ALLUDING 

4001
02:35:18,476 --> 02:35:18,910
TO.

4002
02:35:18,910 --> 02:35:19,844
>> YEAH.

4003
02:35:19,844 --> 02:35:22,213
>> SO WE DID ANOTHER STUDY

4004
02:35:22,213 --> 02:35:23,714
WHERE WE WERE REALLY TRYING TO 

4005
02:35:23,714 --> 02:35:26,284
USE THE WISDOM OF CROWD SOURCES 

4006
02:35:26,284 --> 02:35:28,820
TO UNDERSTAND WHERE PEOPLE FROM 

4007
02:35:28,820 --> 02:35:30,221
LOW AND MIDDLE INCOME COUNTRIES 

4008
02:35:30,221 --> 02:35:34,458
WHAT IS IT THAT WE SHOULD DO TO 

4009
02:35:34,458 --> 02:35:37,261
TRY AND GET BETTER DECISIONS 

4010
02:35:37,261 --> 02:35:40,698
FOR ADOLESCENTS AND MORE 

4011
02:35:40,698 --> 02:35:41,098
ETHICAL RESEARCH.

4012
02:35:41,098 --> 02:35:43,467
AND ONE OF THE QUESTIONS WE 

4013
02:35:43,467 --> 02:35:46,103
ASKED ABOUT WAS PART WAIVERS, 

4014
02:35:46,103 --> 02:35:47,371
WHAT IF YOU JUST GET THE PARENT 

4015
02:35:47,371 --> 02:35:50,241
OUT OF THE EQUATION.

4016
02:35:50,241 --> 02:35:55,580
AND THAT WAS THE ONE THING MOST 

4017
02:35:55,580 --> 02:35:57,081
PEOPLE OBJECTED TO.

4018
02:35:57,081 --> 02:35:58,783
WE COULD NOT GET WAIVERS 

4019
02:35:58,783 --> 02:36:01,686
BECAUSE POEM HAD THIS INSTINCT 

4020
02:36:01,686 --> 02:36:03,788
THAT FIRST AND IN MANY CASES 

4021
02:36:03,788 --> 02:36:05,122
IT'S IMPORTANT FOR PARENTS TO 

4022
02:36:05,122 --> 02:36:06,991
BE INVOLVED AND THEY ALSO FELT 

4023
02:36:06,991 --> 02:36:10,428
THAT IF PARENTS ARE SORT OF, 

4024
02:36:10,428 --> 02:36:12,897
THEY'RE STUCK THEY HAVE THIS 

4025
02:36:12,897 --> 02:36:14,599
ADOLESCENT AT HOME AND THEIR 

4026
02:36:14,599 --> 02:36:15,533
ADOLESCENT IS GOING TO HAVE TO 

4027
02:36:15,533 --> 02:36:18,269
GO TO THE RESEARCH SITE IF 

4028
02:36:18,269 --> 02:36:21,739
THERE IS A ROIFP AND A PARENT 

4029
02:36:21,739 --> 02:36:23,841
HAS TO DEAL WITH IT, IT DOES 

4030
02:36:23,841 --> 02:36:25,509
NOT MAKE SENSE TO TAKE THE 

4031
02:36:25,509 --> 02:36:27,278
PARENT OUT OF THE EQUATION 

4032
02:36:27,278 --> 02:36:27,878
WHOLELY OUT.

4033
02:36:27,878 --> 02:36:30,047
I THINK THE CHALLENGE, RIGHT IS 

4034
02:36:30,047 --> 02:36:33,884
THERE IS A LOT OF DIFFERENT 

4035
02:36:33,884 --> 02:36:35,353
KIND OF PARENTAL CAN SENT.

4036
02:36:35,353 --> 02:36:37,054
AND WHAT WE NEED TO DO A BETTER 

4037
02:36:37,054 --> 02:36:41,292
JOB I THINK IS FIRST BEING ABLE 

4038
02:36:41,292 --> 02:36:45,329
TO DISTINGUISH WHEN IT'S NOT A 

4039
02:36:45,329 --> 02:36:49,433
GOOD IDEA WHEN TO INVOLVE TO 

4040
02:36:49,433 --> 02:36:51,535
THE PARENT, MAYBE THE PARENT 

4041
02:36:51,535 --> 02:36:54,538
HAS BEEN CHECKED OUT OR THEY 

4042
02:36:54,538 --> 02:36:55,907
WOULD REACT NEGATIVELY AND 

4043
02:36:55,907 --> 02:36:58,376
WAIVER IS THE ONLY OPTION.

4044
02:36:58,376 --> 02:37:01,112
IN OTHER CASES, YOU MAY NEED TO 

4045
02:37:01,112 --> 02:37:03,414
FIGURE OUT HOW CAN THE RESEARCH 

4046
02:37:03,414 --> 02:37:05,917
TEAM ENGAGE THE PARENT OR HELP 

4047
02:37:05,917 --> 02:37:07,084
THE ADOLESCENT AND CHAIR 

4048
02:37:07,084 --> 02:37:08,219
INFORMATION THAT THEY MAY WANT 

4049
02:37:08,219 --> 02:37:10,254
TO SHARE WITH THEIR PARENTS SO 

4050
02:37:10,254 --> 02:37:12,156
THEY CAN WORK TOGETHER AND MAKE 

4051
02:37:12,156 --> 02:37:14,158
THAT DECISIONS AND MAYBE 

4052
02:37:14,158 --> 02:37:15,493
FACILITATE THAT DECISION.

4053
02:37:15,493 --> 02:37:18,763
SO I DO THINK THAT TO ME IS 

4054
02:37:18,763 --> 02:37:19,764
MAYBE IT'S DEPENDS ON WHO IS 

4055
02:37:19,764 --> 02:37:22,133
SHOWING UP TO THE RESEARCH SITE 

4056
02:37:22,133 --> 02:37:25,002
AND IF THE ADOLESCENTS IS THERE 

4057
02:37:25,002 --> 02:37:26,137
BY THEMSELVES AND WORKING WITH 

4058
02:37:26,137 --> 02:37:27,672
THEM TO GET THEIR PARENTS 

4059
02:37:27,672 --> 02:37:29,640
INVOLVED IF THE ADOLESCENT IS 

4060
02:37:29,640 --> 02:37:31,943
THERE WITH THEIR PARENTS AND 

4061
02:37:31,943 --> 02:37:33,411
DOING THIS DELICATE DANCE OF 

4062
02:37:33,411 --> 02:37:34,512
HAVING THAT CONVERSATION.

4063
02:37:34,512 --> 02:37:36,547
BUT WHAT I UNDERSTAND RIGHT NOW 

4064
02:37:36,547 --> 02:37:43,354
IS THAT, IT'S JUST KIND OF NOT 

4065
02:37:43,354 --> 02:37:45,256
A DREDS SYSTEMATIC AND THERE IS 

4066
02:37:45,256 --> 02:37:53,331
NOT A LOT OF WIDE ANS FORERS TO 

4067
02:37:53,331 --> 02:37:53,631
INVESTIGATE.

4068
02:37:53,631 --> 02:37:56,400
WHERE ADOLESCENT MAY BE 

4069
02:37:56,400 --> 02:37:57,435
RELUCTANT TO INVOLVE THEIR 

4070
02:37:57,435 --> 02:37:58,336
PARENTS.

4071
02:37:58,336 --> 02:38:01,405
>> YEAH, YEAH.

4072
02:38:01,405 --> 02:38:04,842
FRAUGHT AND ALSO THEN HARD FOR 

4073
02:38:04,842 --> 02:38:06,744
IRBs RIGHT TO SAY OH THEY SAY 

4074
02:38:06,744 --> 02:38:14,685
THEY'RE GOING TO DO XY AND Z, I 

4075
02:38:14,685 --> 02:38:17,722
GUESS WE HAVE TO TRUST THEM.

4076
02:38:17,722 --> 02:38:19,357
BUT WOULD LIKE THEM FOR MAYBE 

4077
02:38:19,357 --> 02:38:20,758
HAVE SOME SECOND OR THIRD 

4078
02:38:20,758 --> 02:38:21,625
THOUGHTS.

4079
02:38:21,625 --> 02:38:23,661
SO FOR EXAMPLE, YOU MENTIONED 

4080
02:38:23,661 --> 02:38:25,629
THAT SOME STATES WELL IT'S TRUE 

4081
02:38:25,629 --> 02:38:27,765
IN THE STATE OF MARYLAND FOR 

4082
02:38:27,765 --> 02:38:29,333
EXAMPLE, THAT A SOMEBODY WHO IS 

4083
02:38:29,333 --> 02:38:31,669
UNDER THE AGE OF 18 WHO HAS AN 

4084
02:38:31,669 --> 02:38:35,973
S T.D., CAN GO AND SEEK 

4085
02:38:35,973 --> 02:38:37,375
TREATMENT FOR THEMSELVES.

4086
02:38:37,375 --> 02:38:41,512
THEY'RE ALSO ABLE TO PROVIDE 

4087
02:38:41,512 --> 02:38:44,215
PERMISSION TO EN ROLL IN 

4088
02:38:44,215 --> 02:38:44,615
RESEARCH DIRECTLY.

4089
02:38:44,615 --> 02:38:46,017
NOW IF I WAS THE COLIN KISSING 

4090
02:38:46,017 --> 02:38:55,025
OR IF --I WAS THE CLINICIAN, I 

4091
02:38:55,025 --> 02:38:56,827
KNOW THE ADOLESCENTS CAN COME 

4092
02:38:56,827 --> 02:38:59,096
TO YOU BY THEMSELVES BUT IT 

4093
02:38:59,096 --> 02:39:00,698
WOULD BE GREAT IF YOU TALK TO 

4094
02:39:00,698 --> 02:39:02,366
THEM ABOUT WHY THEY DON'T WANT 

4095
02:39:02,366 --> 02:39:03,501
TO ENGAGE THEIR PARENTS AND 

4096
02:39:03,501 --> 02:39:06,337
WHAT THE RISK RIGHT SIDE IN 

4097
02:39:06,337 --> 02:39:08,472
ENGAGING WITH THIS RESEARCH 

4098
02:39:08,472 --> 02:39:09,640
WITHOUT YOUR PARENT'S KNOWLEDGE.

4099
02:39:09,640 --> 02:39:11,642
WE'RE GOING TO DO THE BEST WE 

4100
02:39:11,642 --> 02:39:14,412
CAN TO ENSURE THAT THE 

4101
02:39:14,412 --> 02:39:15,980
INSURANCE COMPANY ISN'T.

4102
02:39:15,980 --> 02:39:19,417
THERE ARE ALL SORTS OF THINGS 

4103
02:39:19,417 --> 02:39:20,918
THAT SHE SHOULD BE CONSIDERING.

4104
02:39:20,918 --> 02:39:22,520
AND IF THEY SAY NO NO NO, THIS 

4105
02:39:22,520 --> 02:39:26,290
IS TOTALLY COOL FOR THEM.

4106
02:39:26,290 --> 02:39:29,060
IT'S EASIER FOR ME TO BE MY BY 

4107
02:39:29,060 --> 02:39:31,595
SELF, JUST ONE MORE QUESTION OR 

4108
02:39:31,595 --> 02:39:32,496
ONE MORE ENGAGEMENT.

4109
02:39:32,496 --> 02:39:33,931
IT FEELS LIKE IT WOULD MAKE 

4110
02:39:33,931 --> 02:39:34,865
SENSE.

4111
02:39:34,865 --> 02:39:36,867
>> I AGREE WITH THAT.

4112
02:39:36,867 --> 02:39:40,838
AND I THINK SOME IS HELPING 

4113
02:39:40,838 --> 02:39:41,138
ADOLESCENTS.

4114
02:39:41,138 --> 02:39:44,542
SO I THINK THE EXAMPLE YOU'RE 

4115
02:39:44,542 --> 02:39:46,610
ALLUDING TO IS THERE CAN BE 

4116
02:39:46,610 --> 02:39:47,845
SOME CASES WHERE TREATMENT, 

4117
02:39:47,845 --> 02:39:49,346
THEY'RE ABLE TO GET 

4118
02:39:49,346 --> 02:39:51,482
CONFIDENTIAL TREATMENT THAT THE 

4119
02:39:51,482 --> 02:39:53,250
EXPERIENCE COMPANY IS BUILD AND 

4120
02:39:53,250 --> 02:39:55,352
THEY SEND A EXPLANATION OF 

4121
02:39:55,352 --> 02:39:56,520
BENEFITS AND PARENTS GETS THAT 

4122
02:39:56,520 --> 02:40:01,258
IN THE MAIL AND SEE THAT THEIR 

4123
02:40:01,258 --> 02:40:02,927
ADOLESCENTS WAS ENGAGED AND 

4124
02:40:02,927 --> 02:40:04,061
GETTING CARE FOR SOMETHING.

4125
02:40:04,061 --> 02:40:06,530
THAT COULD BE ONE WAY TO TALK 

4126
02:40:06,530 --> 02:40:08,866
OUT OF ADOLESCENTS, MAY NOT 

4127
02:40:08,866 --> 02:40:10,968
APPLY TO THE RESEARCH CONTRACT 

4128
02:40:10,968 --> 02:40:13,104
AND INTERVENTIONS ARE NOT.

4129
02:40:13,104 --> 02:40:15,339
BUT STILL I THINK, THE ISSUE 

4130
02:40:15,339 --> 02:40:18,709
MIGHT BE SORT OF FROM AN IRB 

4131
02:40:18,709 --> 02:40:22,279
PER RESPECT PIF HOW DO YOU, HOW 

4132
02:40:22,279 --> 02:40:23,714
CAN RESEARCH DEMONSTRATE THAT 

4133
02:40:23,714 --> 02:40:25,015
THEY GOT THE RIGHT.

4134
02:40:25,015 --> 02:40:25,549
>> YEAH.

4135
02:40:25,549 --> 02:40:28,486
>> FOR TRYING TO ENGAGE
PARENTS.

4136
02:40:28,486 --> 02:40:30,321
AND MAYBE HAVE, YOU KNOW, A 

4137
02:40:30,321 --> 02:40:32,423
SORT OF COMMON SET OF QUESTIONS 

4138
02:40:32,423 --> 02:40:34,425
THEY ASK OR DIFFERENT SOURCES 

4139
02:40:34,425 --> 02:40:37,661
OF GUIDANCE THAT THEY CAN 

4140
02:40:37,661 --> 02:40:38,829
PROVIDE TO ADOLESCENTS TO TRY 

4141
02:40:38,829 --> 02:40:41,132
TO GET THEIR PARENTS TO BE 

4142
02:40:41,132 --> 02:40:41,365
ENGAGED.

4143
02:40:41,365 --> 02:40:45,269
AND THAT MAY BE I THINK, OF 

4144
02:40:45,269 --> 02:40:47,404
THINGS THAT ARE LIKE THIS GRAY 

4145
02:40:47,404 --> 02:40:48,772
AND COMPLICATED ARE HARD TO 

4146
02:40:48,772 --> 02:40:50,374
REGULATE BUT MAYBE ONE WAY TO 

4147
02:40:50,374 --> 02:40:52,443
DO IS JUST REALLY HAVE SOME 

4148
02:40:52,443 --> 02:40:53,177
GREATER DETAIL ABOUT THAT 

4149
02:40:53,177 --> 02:40:54,278
PROCESS.

4150
02:40:54,278 --> 02:40:57,281
>> YEAH, I COMPLETELY
AGREE AND 

4151
02:40:57,281 --> 02:41:00,885
I THINK I COMPLETELY AGREE AS 

4152
02:41:00,885 --> 02:41:03,420
IT RELATES TO CONSENT GENERALLY 

4153
02:41:03,420 --> 02:41:05,789
AND ESPECIALLY IN THIS CONTEXT.

4154
02:41:05,789 --> 02:41:06,891
ALEX HAS A QUESTION.

4155
02:41:06,891 --> 02:41:08,492
>> THANK YOU FOR THIS.

4156
02:41:08,492 --> 02:41:10,828
I WANTED TO ASK ABOUT WHAT YOU 

4157
02:41:10,828 --> 02:41:12,029
THINK SOME GOOD STRATEGIES 

4158
02:41:12,029 --> 02:41:15,499
WOULD BE FOR NOT SYSTEMATICALLY 

4159
02:41:15,499 --> 02:41:16,634
EXCLUDING CHILDREN WHO'S 

4160
02:41:16,634 --> 02:41:18,269
PARENTS ARE MAYBE HARD TO REACH 

4161
02:41:18,269 --> 02:41:20,804
OR HARD TO GET CONSENT FROM.

4162
02:41:20,804 --> 02:41:25,142
IT SEEMS LIKE THERE MAY BE 

4163
02:41:25,142 --> 02:41:27,978
PATTERNS WITH PARENTS THAT ARE 

4164
02:41:27,978 --> 02:41:29,446
HARDER TO ENGAGE.

4165
02:41:29,446 --> 02:41:31,015
WHAT DO YOU THINK ARE SOME GOOD 

4166
02:41:31,015 --> 02:41:32,016
WAYS?

4167
02:41:32,016 --> 02:41:32,983
>> GREAT QUESTION.

4168
02:41:32,983 --> 02:41:35,252
SO WHEN THE STUDY WE DID, 

4169
02:41:35,252 --> 02:41:39,156
LOOKING AT THE STEP HERE FOR 

4170
02:41:39,156 --> 02:41:39,823
ADOLESCENTS IN KENYA.

4171
02:41:39,823 --> 02:41:42,326
ONE OF THE THINGS WE FOUND 

4172
02:41:42,326 --> 02:41:45,329
THERE WERE A LOT OF ADOLESCENTS 

4173
02:41:45,329 --> 02:41:46,997
WERE SHOWING UP FOR CARE AND 

4174
02:41:46,997 --> 02:41:48,632
THEY WERE SHOWING UP BY 

4175
02:41:48,632 --> 02:41:51,001
THEMSELVES AND WITH THOSE 

4176
02:41:51,001 --> 02:41:51,869
ADOLESCENTS, IT WAS 

4177
02:41:51,869 --> 02:41:53,103
EXCEPTIONALLY HARD TO GET THEM 

4178
02:41:53,103 --> 02:41:55,205
TO GET THEIR PARENTS ENGAGED.

4179
02:41:55,205 --> 02:41:57,641
BECAUSE THEIR PARENTS WERE NOT 

4180
02:41:57,641 --> 02:41:58,742
ROUTINELY ENGAGED IN A LOT OF 

4181
02:41:58,742 --> 02:41:59,276
DECISIONS.

4182
02:41:59,276 --> 02:42:04,582
SO WE HAVE APPLIED FOR A WAIVER 

4183
02:42:04,582 --> 02:42:06,417
FROM THE IRB SPECIFICALLY FOR 

4184
02:42:06,417 --> 02:42:13,023
THOSE ADOLESCENTS.

4185
02:42:13,023 --> 02:42:17,261
WHO THOSE WHO SAID THEY 

4186
02:42:17,261 --> 02:42:25,502
COULDN'T GET THEIR PARENT'S 

4187
02:42:25,502 --> 02:42:28,839
PERMISSION.

4188
02:42:28,839 --> 02:42:31,909
WE TRIED TO DO REALLY FOR THE 

4189
02:42:31,909 --> 02:42:33,010
OLDER ADOLESCENTS THAT WERE 

4190
02:42:33,010 --> 02:42:35,346
SHOWING UP FOR THEIR OWN CARE.

4191
02:42:35,346 --> 02:42:36,947
SO I THINK PARENTAL WAIVER IS 

4192
02:42:36,947 --> 02:42:40,351
ONE OF THE BEST TOOLS.

4193
02:42:40,351 --> 02:42:42,286
ANOTHER WAY OF DOING IT, IF 

4194
02:42:42,286 --> 02:42:45,022
THERE IS A WAY TO GET PARENTAL 

4195
02:42:45,022 --> 02:42:46,557
PERMISSION THAT IS ELECTRONIC 

4196
02:42:46,557 --> 02:42:49,860
OR OVER THE PHONE, THAT MAY BE 

4197
02:42:49,860 --> 02:42:51,295
ANOTHER WAY, IF A PARENT IS 

4198
02:42:51,295 --> 02:42:53,330
JUST NOT ABLE TO BE PHYSICALLY 

4199
02:42:53,330 --> 02:42:56,667
PRESENT, THAT THEY CAN STILL BE 

4200
02:42:56,667 --> 02:42:59,103
THERE ENROLLED.

4201
02:42:59,103 --> 02:43:00,037
AND SOMETIMES THAT'S IMPORTANT 

4202
02:43:00,037 --> 02:43:02,106
FROM THE PERSPECTIVE OF 

4203
02:43:02,106 --> 02:43:06,110
WORRYING ABOUT SCUING RESEARCH 

4204
02:43:06,110 --> 02:43:06,443
PARTICIPATION.

4205
02:43:06,443 --> 02:43:12,383
SO THERE IS A GREAT STUDY BY 

4206
02:43:12,383 --> 02:43:13,784
LIEU AND COLLEAGUES WHO DO YOU 

4207
02:43:13,784 --> 02:43:16,220
LEAVE OUT OF THE RESEARCH 

4208
02:43:16,220 --> 02:43:16,453
STUDIES?

4209
02:43:16,453 --> 02:43:20,591
AND THEY FOUND THAT OLDER 

4210
02:43:20,591 --> 02:43:24,528
ADOLESCENT, BLACK ADOLESCENT, 

4211
02:43:24,528 --> 02:43:27,631
ADOLESCENT OF SUBSTANCE USE 

4212
02:43:27,631 --> 02:43:29,333
WERE LESS WELL REPRESENTED IN 

4213
02:43:29,333 --> 02:43:30,868
THE STUDIES.

4214
02:43:30,868 --> 02:43:33,671
SO I THINK IN SOME WAYS, I HOPE 

4215
02:43:33,671 --> 02:43:37,041
THAT GETS TO YOUR QUESTION BUT 

4216
02:43:37,041 --> 02:43:39,310
STRONG REASONS TO GET A WAIVER 

4217
02:43:39,310 --> 02:43:40,477
AND SOMETIMES IT'S IMPORTANT TO 

4218
02:43:40,477 --> 02:43:42,980
GIVE THEM THAT DATA TO SHOW 

4219
02:43:42,980 --> 02:43:44,748
THEM I COULDN'T NEED A WAIVER.

4220
02:43:44,748 --> 02:43:46,016
>> GREAT, THANK YOU.

4221
02:43:46,016 --> 02:43:48,252
>> SURE, THANK YOU.

4222
02:43:48,252 --> 02:43:50,354
>> GREAT, WELL THANK YOU
SO 

4223
02:43:50,354 --> 02:43:52,623
MUCH SEEMA FOR JOINING US.

4224
02:43:52,623 --> 02:43:53,657
IF ADDITIONAL QUESTIONS COME 

4225
02:43:53,657 --> 02:43:56,160
IN, I WILL TRY TO ANSWER THEM 

4226
02:43:56,160 --> 02:43:58,962
OR MIGHT FORWARD THEM TO YOU.

4227
02:43:58,962 --> 02:44:01,432
AND THANKS AGAIN.

4228
02:44:01,432 --> 02:44:02,833
>> OF COURSE, IT'S MY
PLEASURE 

4229
02:44:02,833 --> 02:44:06,036
TO COME AND HOPEFULLY NEXT YEAR 

4230
02:44:06,036 --> 02:44:07,971
I CAN COME IN-PERSON.

4231
02:44:07,971 --> 02:44:09,073
>> THAT WOULD BE GREAT.

4232
02:44:09,073 --> 02:44:09,740
THANK YOU.

4233
02:44:09,740 --> 02:44:10,741
[APPLAUSE]

4234
02:44:10,741 --> 02:44:13,610
>> ALL RIGHT, THANK YOU.

4235
02:44:13,610 --> 02:44:16,180
>> SO NEXT WEEK, WE'RE
GOING TO 

4236
02:44:16,180 --> 02:44:20,017
BE TALKING ABOUT DIVERSITY AND 

4237
02:44:20,017 --> 02:44:23,287
INCLUSION IN CLINICAL TRIALS.

4238
02:44:23,287 --> 02:44:25,055
UKEKO WHO IS ALSO FROM OUR 

4239
02:44:25,055 --> 02:44:26,957
DEPARTMENT WILL JOIN US, YOU'LL 

4240
02:44:26,957 --> 02:44:28,492
HEAR FROM ME AGAIN AND THEN 

4241
02:44:28,492 --> 02:44:32,896
WE'LL HAVE A GUEST, IESHA WHO 

4242
02:44:32,896 --> 02:44:35,365
IS AN EXPERT IN RECRUITMENT AND 

4243
02:44:35,365 --> 02:44:36,300
RETENTION.

4244
02:44:36,300 --> 02:44:37,367
SO THAT'S IT FOR TODAY.

4245
02:44:37,367 --> 02:44:47,544
THANK YOU.