1
00:00:04,238 --> 00:00:05,239
From Kim,

2
00:00:05,239 --> 00:00:08,876
she says regarding the informed
clinician test.

3
00:00:09,209 --> 00:00:11,912
It's slightly different,
though, for the clinician

4
00:00:11,912 --> 00:00:15,649
because we make the decision
at the individual level,

5
00:00:15,649 --> 00:00:17,668
whereas the IRB makes the
decision

6
00:00:17,668 --> 00:00:19,152
at the population level.

7
00:00:19,353 --> 00:00:20,254
Yeah.

8
00:00:20,254 --> 00:00:23,257
Yeah, I think that's right.

9
00:00:24,091 --> 00:00:25,726
And so the way I think about the
informed

10
00:00:25,726 --> 00:00:27,361
clinicians has what the inform
clinician

11
00:00:27,661 --> 00:00:30,425
has to do is they have to ask
the question

12
00:00:30,425 --> 00:00:32,399
not of a specific individual.

13
00:00:32,399 --> 00:00:34,801
What they have to ask is they
have to ask

14
00:00:34,801 --> 00:00:37,771
of the individuals
who qualify for this study.

15
00:00:37,771 --> 00:00:41,569
Given the way the inclusion
exclusion criteria are currently

16
00:00:41,569 --> 00:00:42,075
worded,

17
00:00:43,210 --> 00:00:46,246
is it in their medical interest
to be in the study

18
00:00:46,246 --> 00:00:49,214
and the clinician obviously
might give a couple different

19
00:00:49,214 --> 00:00:49,683
answers.

20
00:00:49,683 --> 00:00:52,050
They might say yes, they might
say no,

21
00:00:52,050 --> 00:00:54,354
or they might say, well, it
depends.

22
00:00:54,354 --> 00:00:56,546
For some subpopulations, this
prospect of

23
00:00:56,546 --> 00:00:58,792
benefit and for others it's
really risky.

24
00:00:59,192 --> 00:01:01,004
And if that's the answer, they
give it,

25
00:01:01,004 --> 00:01:01,561
I said Mrs.

26
00:01:01,561 --> 00:01:02,396
Kim's worried.

27
00:01:02,396 --> 00:01:05,080
That's
really important information for

28
00:01:05,080 --> 00:01:05,699
the IRB.

29
00:01:05,699 --> 00:01:07,889
Then maybe what the IRB wants to
do

30
00:01:07,889 --> 00:01:10,203
is go back and rethink the
inclusion

31
00:01:10,203 --> 00:01:12,697
exclusion criteria and say,
okay,

32
00:01:12,697 --> 00:01:15,342
is there a way that what we can
do

33
00:01:15,342 --> 00:01:17,455
is rejigger them so that we
exclude those

34
00:01:17,455 --> 00:01:19,413
people who face the really high
risk?

35
00:01:19,413 --> 00:01:20,981
Now, of course, there's the
fairness issue

36
00:01:20,981 --> 00:01:22,549
I talked about for the
background,

37
00:01:22,549 --> 00:01:24,117
but bracketing that for a
second,

38
00:01:24,117 --> 00:01:26,354
they might want to think about
redoing

39
00:01:26,354 --> 00:01:28,355
the inclusion exclusion
criteria.

40
00:01:28,655 --> 00:01:30,390
I think there's some case
where they can do that.

41
00:01:30,390 --> 00:01:32,793
It's pretty clear if they can't
do it.

42
00:01:32,793 --> 00:01:35,283
I've actually has been on some
IRBs

43
00:01:35,283 --> 00:01:36,563
where we mandated

44
00:01:36,964 --> 00:01:39,967
and I literally an individual
which doesn't happen.

45
00:01:39,967 --> 00:01:40,801
She's right very often.

46
00:01:40,801 --> 00:01:42,069
But again

47
00:01:42,069 --> 00:01:44,071
where you can build into the
protocol

48
00:01:44,071 --> 00:01:45,628
that we're not sure
if this is going to be

49
00:01:45,628 --> 00:01:46,073
appropriate

50
00:01:46,073 --> 00:01:48,091
for individuals who satisfy the
inclusion

51
00:01:48,091 --> 00:01:49,076
exclusion criteria.

52
00:01:49,443 --> 00:01:51,078
So rather than fiddling with
them,

53
00:01:51,078 --> 00:01:53,146
what we're gonna do is we're
going to have

54
00:01:53,146 --> 00:01:55,102
an individual clinician look at
each

55
00:01:55,102 --> 00:01:57,384
individual person and assess it
for them.

56
00:01:57,384 --> 00:01:58,385
Now that's something you could
do.

57
00:01:58,385 --> 00:02:00,787
A phase one trial
with just rolling ten people.

58
00:02:00,787 --> 00:02:02,188
It's not necessarily
something you could do for

59
00:02:02,188 --> 00:02:02,456
somebody

60
00:02:02,456 --> 00:02:05,058
only 5000 in a big phase three
trial.

61
00:02:05,058 --> 00:02:08,795
But even that general assessment
that you started with.

62
00:02:08,795 --> 00:02:11,798
Right. No. Yes.

63
00:02:12,099 --> 00:02:14,701
And it might depend it's more
than what

64
00:02:14,701 --> 00:02:16,570
the IRB might have at hand.

65
00:02:16,937 --> 00:02:18,805
So that's information that they
could use.

66
00:02:18,805 --> 00:02:20,640
Absolutely. Daniel.

67
00:02:22,109 --> 00:02:22,242
Yeah.

68
00:02:22,242 --> 00:02:22,943
Thanks for that.

69
00:02:22,943 --> 00:02:24,077
It's really interesting.

70
00:02:24,077 --> 00:02:26,380
My question was about the,

71
00:02:26,380 --> 00:02:28,882
the fallacy of the package deal.
Yeah.

72
00:02:28,882 --> 00:02:31,485
So I'm wondering why you can't

73
00:02:31,485 --> 00:02:34,488
just appeal to whether or not,

74
00:02:35,055 --> 00:02:38,058
highly beneficial, like, net
beneficial,

75
00:02:38,492 --> 00:02:40,994
interventions are contingent

76
00:02:40,994 --> 00:02:43,997
upon a highly risky
intervention.

77
00:02:43,997 --> 00:02:45,699
Like with a biopsy.

78
00:02:45,699 --> 00:02:47,802
You know, if there's only if the
only way

79
00:02:47,802 --> 00:02:49,803
you can do some very, like,
beneficial

80
00:02:49,803 --> 00:02:52,183
interventions was through
something risky

81
00:02:52,183 --> 00:02:54,041
like that, that seems relevant.

82
00:02:54,374 --> 00:02:58,078
This is just, you know,
nothing is contingent upon it,

83
00:02:58,078 --> 00:02:59,246
and it's just highly risky.

84
00:02:59,246 --> 00:03:01,548
If that's the case,
it seems like we can just,

85
00:03:01,548 --> 00:03:04,685
you know, justify eliminating it
based on minimizing risk.

86
00:03:04,685 --> 00:03:07,687
Like if you have a really,
really,

87
00:03:07,687 --> 00:03:10,057
beneficial intervention, it's
not like

88
00:03:10,057 --> 00:03:13,193
we can just, like,
tack on a bunch of highly risky.

89
00:03:13,193 --> 00:03:15,495
Yeah. Intervention rates,
you know, acceptable.

90
00:03:15,495 --> 00:03:18,031
Yeah. So I don't I don't see
Daniel.

91
00:03:18,031 --> 00:03:19,758
Let me let me give you let me
give you

92
00:03:19,758 --> 00:03:21,168
an example and see what think.

93
00:03:21,168 --> 00:03:23,703
And I hope this is clear
wrapping.

94
00:03:23,703 --> 00:03:26,232
So. So Daniel this was
I get to be fully topical for a

95
00:03:26,232 --> 00:03:26,606
second.

96
00:03:26,606 --> 00:03:27,841
I hope this is clear as

97
00:03:28,875 --> 00:03:30,610
compare two different cases.

98
00:03:30,610 --> 00:03:33,346
So when I, when I,

99
00:03:33,346 --> 00:03:34,981
when I do this, we have these
debates

100
00:03:34,981 --> 00:03:38,385
of people who are clinicians
in the clinical setting.

101
00:03:38,385 --> 00:03:40,068
We don't see the fallacy of the
package

102
00:03:40,068 --> 00:03:40,887
deal is a fallacy.

103
00:03:40,887 --> 00:03:41,955
That's why it's called the
fallacy.

104
00:03:41,955 --> 00:03:43,799
The poster,
because people think it's a

105
00:03:43,799 --> 00:03:44,224
fallacy.

106
00:03:44,224 --> 00:03:46,726
Take the clinical setting.

107
00:03:46,726 --> 00:03:49,129
There are lots of interventions
that we give patients

108
00:03:49,129 --> 00:03:52,866
that offer them specifically
no benefit at all and are risky.

109
00:03:53,266 --> 00:03:53,900
And the reason

110
00:03:53,900 --> 00:03:55,917
why we give them those
interventions is

111
00:03:55,917 --> 00:03:58,038
they set them up for other
interventions

112
00:03:58,038 --> 00:03:58,939
that are beneficial.

113
00:03:58,939 --> 00:04:02,144
So obvious example consistent
with what you're saying that I'm

114
00:04:02,144 --> 00:04:02,609
assuming

115
00:04:02,609 --> 00:04:05,206
that we mean
by sort of contingent on is

116
00:04:05,206 --> 00:04:06,179
central lines.

117
00:04:06,513 --> 00:04:06,713
Right.

118
00:04:06,713 --> 00:04:09,749
So central lines is I've go
straight in

119
00:04:09,749 --> 00:04:12,298
to you basically smashing into
people's

120
00:04:12,298 --> 00:04:14,454
maybe I should say smash it into

121
00:04:14,688 --> 00:04:18,452
you lovingly and gently inserted
into the chest and then

122
00:04:18,452 --> 00:04:19,326
centralized.

123
00:04:19,326 --> 00:04:20,894
Getting a central line is risky.

124
00:04:20,894 --> 00:04:22,796
You get hurt, you can get
infections,

125
00:04:22,796 --> 00:04:24,698
you can get bleeding, and it
doesn't

126
00:04:24,698 --> 00:04:26,279
do you any good to have this
thing

127
00:04:26,279 --> 00:04:27,768
sticking in your chest, per se.

128
00:04:28,168 --> 00:04:30,023
The reason why we do it
in a clinical setting all the

129
00:04:30,023 --> 00:04:30,303
time is

130
00:04:30,303 --> 00:04:32,889
because there are certain drugs
that that's how you administer

131
00:04:32,889 --> 00:04:33,140
them.

132
00:04:33,140 --> 00:04:35,694
So getting the central line puts
you

133
00:04:35,694 --> 00:04:38,178
in position to get the
experience.

134
00:04:38,178 --> 00:04:40,218
Not sorry,
put you in position to get

135
00:04:40,218 --> 00:04:40,714
treated.

136
00:04:42,482 --> 00:04:44,050
So nobody I've never heard a
clinician

137
00:04:44,050 --> 00:04:46,147
say you can't justify the
benefits

138
00:04:46,147 --> 00:04:48,121
to the rest of the central line

139
00:04:48,121 --> 00:04:51,057
by the potential benefits
of another intervention.

140
00:04:51,057 --> 00:04:52,893
That's a fallacy of a package
deal.

141
00:04:52,893 --> 00:04:54,194
Nobody says that.

142
00:04:54,194 --> 00:04:56,112
They say, of course you have to
give the

143
00:04:56,112 --> 00:04:58,031
central line in to administer
the drug.

144
00:04:58,031 --> 00:05:00,834
That's perfectly fine because.
So that seems acceptable, right?

145
00:05:00,834 --> 00:05:03,438
That's contingent, I assume,
in the way you were talking

146
00:05:03,438 --> 00:05:03,904
about it.

147
00:05:03,904 --> 00:05:04,771
That's acceptable.

148
00:05:04,771 --> 00:05:06,773
Okay. Now I'll take a different
case.

149
00:05:06,773 --> 00:05:10,076
Take the case of giving a drug

150
00:05:11,411 --> 00:05:13,097
where this exact same benefit of
that drug

151
00:05:13,097 --> 00:05:14,181
we were just talking about

152
00:05:14,181 --> 00:05:17,184
in the clinical case,
the exact same thing.

153
00:05:18,485 --> 00:05:20,720
And in order to figure out

154
00:05:20,720 --> 00:05:21,988
whether or not this drug works,

155
00:05:21,988 --> 00:05:24,424
you need to figure out
whether it goes into the tumor

156
00:05:24,424 --> 00:05:26,660
to find out whether or not
the drug goes into the tumor,

157
00:05:26,660 --> 00:05:29,248
you need to do a biopsy
and take a little bit of the

158
00:05:29,248 --> 00:05:29,596
kidney

159
00:05:29,596 --> 00:05:32,132
or the liver or whatever,
and put it in a lab,

160
00:05:32,132 --> 00:05:33,477
and somebody tells you whether
or not

161
00:05:33,477 --> 00:05:34,568
the drug got in there or not.

162
00:05:36,303 --> 00:05:38,087
So imagine that the risk
benefits

163
00:05:38,087 --> 00:05:39,439
exactly the same, right.

164
00:05:39,773 --> 00:05:42,809
So the experimental intervention
offers

165
00:05:42,809 --> 00:05:45,010
the same benefits as that
clinical drug

166
00:05:45,010 --> 00:05:45,912
we were giving.

167
00:05:45,912 --> 00:05:48,682
The risks of the research
biopsy are exactly

168
00:05:48,682 --> 00:05:51,685
the same as the rest of the
central line.

169
00:05:52,018 --> 00:05:53,486
Is that what do you think about
that.

170
00:05:53,486 --> 00:05:54,721
So so here's what I say.

171
00:05:54,721 --> 00:05:57,074
I say look, isn't it the same
the risks

172
00:05:57,074 --> 00:05:59,125
I of course I made them the
same,

173
00:05:59,125 --> 00:06:00,560
but the risks are the same.

174
00:06:00,560 --> 00:06:03,697
And in order to get the
experimental drug,

175
00:06:04,998 --> 00:06:07,968
we need to do this other thing.

176
00:06:07,968 --> 00:06:09,585
What people who worry about the
fallacy,

177
00:06:09,585 --> 00:06:10,637
the package deal says no.

178
00:06:10,637 --> 00:06:12,706
You could give them.

179
00:06:12,706 --> 00:06:15,677
You could give them the the
experiment

180
00:06:15,677 --> 00:06:17,711
without doing the biopsy.

181
00:06:17,711 --> 00:06:20,050
The reason why you're doing
the biopsy is for your research

182
00:06:20,050 --> 00:06:20,447
purposes.

183
00:06:20,447 --> 00:06:23,717
So that's exploiting that
for the purposes of research.

184
00:06:23,717 --> 00:06:25,418
That's the fallacy of the
package deal.

185
00:06:25,418 --> 00:06:28,160
So the question for you and why
I want you to stay there is you

186
00:06:28,160 --> 00:06:28,421
think

187
00:06:28,421 --> 00:06:30,082
ethically are those cases
similar

188
00:06:30,082 --> 00:06:31,591
or are they really different?

189
00:06:31,591 --> 00:06:34,261
Who's right? Do you have a sense
or is too hard to think?

190
00:06:36,963 --> 00:06:37,664
I don't know.

191
00:06:37,664 --> 00:06:39,699
I it's a good question.

192
00:06:39,699 --> 00:06:40,700
I'm not sure I have the answers.

193
00:06:40,700 --> 00:06:41,368
Yeah, yeah.

194
00:06:41,368 --> 00:06:42,502
That's fair. Yeah.

195
00:06:42,502 --> 00:06:44,504
I don't know if someone else
does.

196
00:06:44,504 --> 00:06:44,771
Yeah.

197
00:06:44,771 --> 00:06:46,306
Or we don't have to really
pursue that.

198
00:06:46,306 --> 00:06:47,941
But I think diamond is hard.

199
00:06:47,941 --> 00:06:50,043
But that's that's sort of the
dilemma.

200
00:06:50,043 --> 00:06:51,111
That's the dilemma.

201
00:06:51,111 --> 00:06:54,247
And I think IRBs right now
are working on the assumption

202
00:06:54,514 --> 00:06:57,350
that it's always a fallacy
in the research setting.

203
00:06:57,350 --> 00:06:58,451
And I'm not so convinced.

204
00:06:58,451 --> 00:07:00,087
I think it doesn't seem that
different

205
00:07:00,087 --> 00:07:01,421
in an ethically important way.

206
00:07:01,421 --> 00:07:04,861
But oh, sorry,
I don't have an answer to that

207
00:07:04,861 --> 00:07:05,625
question.

208
00:07:06,159 --> 00:07:08,862
I shan't flesh it out.

209
00:07:08,862 --> 00:07:09,929
I want to ask you about
something.

210
00:07:09,929 --> 00:07:11,807
You said it
much, much earlier as an open

211
00:07:11,807 --> 00:07:12,265
question,

212
00:07:12,265 --> 00:07:15,769
which is whether the IRB members
just would have sometimes,

213
00:07:15,769 --> 00:07:17,627
quote unquote, step in and
recommend

214
00:07:17,627 --> 00:07:19,072
improvements on a protocol.

215
00:07:19,072 --> 00:07:19,406
Yeah.

216
00:07:21,174 --> 00:07:23,376
So on the one hand, you may
think, well,

217
00:07:23,376 --> 00:07:26,390
people are putting all sorts of
resources

218
00:07:26,390 --> 00:07:28,081
into an investigation.

219
00:07:28,081 --> 00:07:31,484
If there isn't, you know,
if there are ways to improve it.

220
00:07:31,484 --> 00:07:33,958
And if the IRB member spots or
recognize

221
00:07:33,958 --> 00:07:36,556
that there's a potential for
improvement,

222
00:07:36,556 --> 00:07:37,457
why not?

223
00:07:37,457 --> 00:07:39,459
Perhaps you may think it's
obligatory.

224
00:07:39,459 --> 00:07:40,293
Right. Yeah.

225
00:07:40,293 --> 00:07:43,263
On the on the other hand,
I also feel like,

226
00:07:44,431 --> 00:07:46,199
there is a question

227
00:07:46,199 --> 00:07:51,404
about the division of labor
and throwing improvements, ideas

228
00:07:51,404 --> 00:07:54,089
for improvements, in case in
some cases

229
00:07:54,089 --> 00:07:55,742
can drastically change.

230
00:07:55,742 --> 00:07:58,511
For instance, the risk
benefit profile for protocol.

231
00:07:58,511 --> 00:08:02,315
And that may delay, the
reviewing

232
00:08:02,315 --> 00:08:05,485
process, which then, you know,
bring in,

233
00:08:05,485 --> 00:08:07,665
will bring in the question of
you

234
00:08:07,665 --> 00:08:08,788
know, resources.

235
00:08:08,788 --> 00:08:09,122
Right.

236
00:08:09,122 --> 00:08:10,748
So I just I just want to hear
more about

237
00:08:10,748 --> 00:08:12,292
what you think about this
particular.

238
00:08:12,525 --> 00:08:13,727
Yeah. So,

239
00:08:15,428 --> 00:08:17,502
so can I give your answer to my
question,

240
00:08:17,502 --> 00:08:18,665
which is I don't know.

241
00:08:18,665 --> 00:08:21,034
Yeah. Sure. Sure. Yeah.

242
00:08:21,034 --> 00:08:23,903
So I think I think

243
00:08:23,903 --> 00:08:26,106
so here's what some people will
say.

244
00:08:26,106 --> 00:08:28,720
Some people will say IRB
shouldn't

245
00:08:28,720 --> 00:08:31,411
be doing that at all, because
what

246
00:08:31,411 --> 00:08:34,581
the job of an IRB is, is to
evaluate

247
00:08:34,581 --> 00:08:38,184
whatever protocol gets presented
to them.

248
00:08:38,618 --> 00:08:41,488
And as long as that's acceptable
they shouldn't be doing

249
00:08:41,488 --> 00:08:44,190
any of these comparisons within
a study.

250
00:08:44,190 --> 00:08:46,028
Different designs of the same
study

251
00:08:46,028 --> 00:08:47,394
or across different size.

252
00:08:47,394 --> 00:08:49,829
They could do.

253
00:08:49,829 --> 00:08:51,297
I think that's wrong.

254
00:08:51,297 --> 00:08:52,932
I think that's just a mistake.

255
00:08:52,932 --> 00:08:54,968
I think there's different ways
to argue for it.

256
00:08:54,968 --> 00:08:57,501
I mean, one way is to say that
and it's

257
00:08:57,501 --> 00:08:59,839
kind of be consequentialist it
away

258
00:08:59,839 --> 00:09:03,476
and to say, look, what you said
they're supposed to be doing is

259
00:09:03,476 --> 00:09:05,177
whether or not the thing that
was proposed

260
00:09:05,177 --> 00:09:06,513
to them is ethically acceptable.

261
00:09:06,713 --> 00:09:08,847
But part of making that
determination

262
00:09:08,847 --> 00:09:10,750
is precisely asking the question

263
00:09:10,950 --> 00:09:12,552
of what they could do otherwise.

264
00:09:12,552 --> 00:09:13,625
And you don't ask what they
could do

265
00:09:13,625 --> 00:09:13,953
otherwise.

266
00:09:13,953 --> 00:09:16,189
You can't say whether or not
this is ethically proper.

267
00:09:16,189 --> 00:09:17,624
That's at least one way to
argue.

268
00:09:17,624 --> 00:09:20,493
But I think something like that
is right.

269
00:09:20,493 --> 00:09:23,599
But so then the question is,
I think the important hard one

270
00:09:23,599 --> 00:09:24,230
is what you

271
00:09:24,230 --> 00:09:26,125
were pointing to, which I think
is it's

272
00:09:26,125 --> 00:09:28,067
just a practical matter of who
does it.

273
00:09:28,535 --> 00:09:30,169
I think for some of these
things,

274
00:09:30,169 --> 00:09:31,704
like comparing across studies,

275
00:09:32,272 --> 00:09:34,741
I just often
aren't in a position to do that.

276
00:09:34,741 --> 00:09:37,252
So I think what we need
is we need somebody further

277
00:09:37,252 --> 00:09:37,744
upstream.

278
00:09:38,077 --> 00:09:41,881
Funding agencies, institutions
making those determinations

279
00:09:41,881 --> 00:09:43,516
and hopefully IRBs being able to
rely on.

280
00:09:44,684 --> 00:09:46,419
Collecting another

281
00:09:46,419 --> 00:09:49,422
slight variation on that is that

282
00:09:50,523 --> 00:09:53,426
a lot of research, that IRB
review

283
00:09:53,426 --> 00:09:56,596
had been reviewed
by a group of scientists.

284
00:09:56,596 --> 00:10:00,867
So if it's an NIH grant
it's gone through a peer review

285
00:10:01,434 --> 00:10:05,071
of hopefully scientists
who know, you know that field

286
00:10:05,371 --> 00:10:08,541
and have said
this is a really great protocol.

287
00:10:08,541 --> 00:10:11,010
We think it ought to be funded.

288
00:10:11,010 --> 00:10:13,278
And by the time it gets to the
IRB,

289
00:10:13,278 --> 00:10:15,482
it has gone through that
process.

290
00:10:15,482 --> 00:10:19,185
And so some might say if there
has been

291
00:10:19,185 --> 00:10:23,957
a robust scientific review,
that's a reason

292
00:10:23,957 --> 00:10:28,027
maybe to only comment on the
study design.

293
00:10:28,027 --> 00:10:31,197
If it's like a real importance
versus

294
00:10:32,298 --> 00:10:36,402
an investigator
proposing a study that he plans,

295
00:10:36,402 --> 00:10:39,948
she plans to fund with
discretionary funds

296
00:10:39,948 --> 00:10:41,975
that maybe was reviewed

297
00:10:41,975 --> 00:10:45,778
at the department level,
but maybe not really strictly.

298
00:10:45,979 --> 00:10:48,481
And now it's on the IRBs desk.

299
00:10:49,983 --> 00:10:52,886
I would say, you know, that's a
case

300
00:10:52,886 --> 00:10:56,741
where the IRB really ought
to pay attention to the study

301
00:10:56,741 --> 00:10:57,223
design

302
00:10:57,423 --> 00:10:59,225
and whether it's been
well-designed,

303
00:10:59,225 --> 00:11:00,426
whether it can actually

304
00:11:00,760 --> 00:11:04,631
answer the research question,
because no other group

305
00:11:04,631 --> 00:11:08,134
has provided a robust scientific
review.

306
00:11:09,002 --> 00:11:09,903
Did you have a question?

307
00:11:09,903 --> 00:11:12,872
We have time for one more.

308
00:11:16,709 --> 00:11:19,379
First, first of all,
thank you so much for the talk.

309
00:11:19,379 --> 00:11:20,613
That was really fascinating.

310
00:11:20,613 --> 00:11:24,034
And I think I'll take away
a lot of questions after this

311
00:11:24,034 --> 00:11:24,584
lecture.

312
00:11:24,984 --> 00:11:27,754
One of the questions I had was,
I guess, thinking

313
00:11:27,754 --> 00:11:31,291
about like international studies
and the concept of fairness.

314
00:11:31,791 --> 00:11:35,982
So like internationally, there's
a diversity of cultural, ethical

315
00:11:35,982 --> 00:11:36,563
beliefs.

316
00:11:36,863 --> 00:11:39,933
And some of them might involve,
for example, taking on

317
00:11:39,933 --> 00:11:43,503
more risk or net risk as like
for example,

318
00:11:43,503 --> 00:11:46,773
I could take a more individual
risk of a benefit society.

319
00:11:47,307 --> 00:11:50,167
And for example,
what if you have like a Western

320
00:11:50,167 --> 00:11:50,643
culture

321
00:11:50,843 --> 00:11:55,014
who takes on less net risk
because they are more aware,

322
00:11:55,014 --> 00:11:57,887
a more individualistic versus a
culture

323
00:11:57,887 --> 00:12:00,687
who believes that it's okay to
enroll

324
00:12:00,687 --> 00:12:02,735
children for the benefit of
society,

325
00:12:02,735 --> 00:12:05,124
or is okay for adults, take on
more risk.

326
00:12:05,325 --> 00:12:07,594
It would benefit society.

327
00:12:07,594 --> 00:12:09,762
Like what are your thoughts on
that?

328
00:12:09,762 --> 00:12:11,698
And do you feel like that's
fair?

329
00:12:12,632 --> 00:12:12,966
Because it

330
00:12:12,966 --> 00:12:15,038
feels like we are all
participating

331
00:12:15,038 --> 00:12:16,636
and thinking it's ethical.

332
00:12:16,836 --> 00:12:18,577
But at the same time, if I
impart

333
00:12:18,577 --> 00:12:20,740
my Western view, it doesn't seem
ethical

334
00:12:20,740 --> 00:12:23,234
for one group
to take on more risk than

335
00:12:23,234 --> 00:12:23,810
another.

336
00:12:24,377 --> 00:12:26,946
Yeah, I love that question.

337
00:12:26,946 --> 00:12:29,132
And I think it's I think it
applies,

338
00:12:29,132 --> 00:12:31,317
as you suggested, across the
board,

339
00:12:31,651 --> 00:12:33,519
but I think it's especially
relevant

340
00:12:33,519 --> 00:12:36,037
this in a practical sense,
when you think about something

341
00:12:36,037 --> 00:12:36,522
like kids.

342
00:12:36,756 --> 00:12:39,292
And so a lot of these standards
for minimal

343
00:12:39,292 --> 00:12:42,295
risk are basically,

344
00:12:42,729 --> 00:12:45,863
as I said, compare
the risks of the research to the

345
00:12:45,863 --> 00:12:46,232
risks

346
00:12:46,232 --> 00:12:48,710
that are thought to be
acceptable

347
00:12:48,710 --> 00:12:51,337
for ordinary kids in that
society.

348
00:12:51,638 --> 00:12:54,871
And your point is right
that, well, the risks that a

349
00:12:54,871 --> 00:12:55,742
given culture

350
00:12:55,742 --> 00:12:57,577
society thinks are acceptable
for kids

351
00:12:57,577 --> 00:12:59,801
might be very different in one
society

352
00:12:59,801 --> 00:13:01,381
or culture to another one.

353
00:13:01,781 --> 00:13:04,917
And so does that mean
if we're in a society where

354
00:13:04,917 --> 00:13:06,808
we're not as willing to take on
risk

355
00:13:06,808 --> 00:13:07,754
for other people,

356
00:13:07,754 --> 00:13:10,878
that then you can only have
a tiny bit of pediatric research

357
00:13:10,878 --> 00:13:11,190
risk.

358
00:13:11,190 --> 00:13:13,292
But in other countries
where we're willing to take

359
00:13:13,292 --> 00:13:15,862
on more risks for others,
you can have more.

360
00:13:15,862 --> 00:13:17,897
That, I think is a really great
question.

361
00:13:17,897 --> 00:13:19,866
And it raises this. I say one
more thing.

362
00:13:19,866 --> 00:13:22,128
It raises question that I've
thought about

363
00:13:22,128 --> 00:13:23,636
for a while, which is that.

364
00:13:25,772 --> 00:13:26,839
It has practical implications

365
00:13:26,839 --> 00:13:28,807
because the regulations in
certain

366
00:13:28,807 --> 00:13:30,543
countries are very different.

367
00:13:30,543 --> 00:13:32,045
So there are certain countries.

368
00:13:32,045 --> 00:13:33,524
Last time I looked at this
couple of years

369
00:13:33,524 --> 00:13:34,580
ago, I think it's still true,

370
00:13:34,580 --> 00:13:37,734
but a couple of years ago
there were certain countries

371
00:13:37,734 --> 00:13:38,551
that had laws

372
00:13:38,551 --> 00:13:41,181
that said you cannot expose a
kid

373
00:13:41,181 --> 00:13:42,855
to any research risk

374
00:13:42,855 --> 00:13:45,679
for the benefit of others,
so an even minimal risk wasn't

375
00:13:45,679 --> 00:13:46,125
allowed.

376
00:13:46,726 --> 00:13:49,729
And the country next door
allowed that.

377
00:13:49,929 --> 00:13:50,997
So okay.

378
00:13:50,997 --> 00:13:54,605
Do we just say, yeah, countries
get to decide what they want to

379
00:13:54,605 --> 00:13:54,834
do?

380
00:13:55,168 --> 00:13:57,103
Now here's the worry.

381
00:13:57,103 --> 00:13:58,960
Imagine then that we do all the
pediatric

382
00:13:58,960 --> 00:14:00,273
research in the one country.

383
00:14:00,273 --> 00:14:01,741
We learn all these things,

384
00:14:01,741 --> 00:14:03,758
and then the other countries
just like,

385
00:14:03,758 --> 00:14:04,844
yeah, this is great.

386
00:14:04,844 --> 00:14:06,612
We don't have to expose our kids
to any risks.

387
00:14:06,612 --> 00:14:08,766
So we learned all this stuff
that these guys are learning

388
00:14:08,766 --> 00:14:09,182
over here.

389
00:14:09,182 --> 00:14:11,350
When they expose their kids to
risk.

390
00:14:11,350 --> 00:14:12,852
That doesn't seem right. Right.

391
00:14:12,852 --> 00:14:14,520
What do you do about that? Yeah.