1
00:00:06,139 --> 00:00:08,242
Kim asks.

2
00:00:08,242 --> 00:00:10,277
She says first, thanks for the
lecture.

3
00:00:10,277 --> 00:00:13,074
Is there space for group
education

4
00:00:13,074 --> 00:00:13,814
sessions

5
00:00:13,814 --> 00:00:17,885
prior to the individual informed
consent process. For.

6
00:00:19,653 --> 00:00:22,890
Particularly if the length and
detail

7
00:00:22,890 --> 00:00:24,659
of the study and the consent
form

8
00:00:24,659 --> 00:00:25,893
itself is prohibitive?

9
00:00:26,193 --> 00:00:29,196
If yes, can this group awareness
session

10
00:00:29,196 --> 00:00:29,796
be seen

11
00:00:29,796 --> 00:00:32,075
as a recruitment versus
education tool

12
00:00:32,075 --> 00:00:33,934
and does it need IRB approval?

13
00:00:33,934 --> 00:00:35,996
There's a lot packed. In there
in the work

14
00:00:35,996 --> 00:00:36,537
out there.

15
00:00:36,537 --> 00:00:40,507
I think certainly there are
situations,

16
00:00:40,507 --> 00:00:42,529
types of trials, types of
populations

17
00:00:42,529 --> 00:00:44,278
in which trials are being done,

18
00:00:44,578 --> 00:00:47,921
where in group education
about what the study is about is

19
00:00:47,921 --> 00:00:48,448
critical

20
00:00:48,448 --> 00:00:50,217
and actually very helpful.

21
00:00:50,217 --> 00:00:52,148
And I think it's both education
for

22
00:00:52,148 --> 00:00:54,521
the individuals who are part of
the group.

23
00:00:54,821 --> 00:00:56,056
But also

24
00:00:56,056 --> 00:00:57,925
sometimes one person will ask a
question

25
00:00:57,925 --> 00:00:59,559
and another person
wouldn't have thought of.

26
00:00:59,559 --> 00:01:02,980
And so it's a really
it's a good way to get people to

27
00:01:02,980 --> 00:01:03,497
engage.

28
00:01:04,631 --> 00:01:06,934
My own view is in most cases,

29
00:01:06,934 --> 00:01:10,334
maybe all, but most cases it
then should be followed by an

30
00:01:10,334 --> 00:01:11,038
opportunity

31
00:01:11,038 --> 00:01:13,295
to meet with each individual to
decide

32
00:01:13,295 --> 00:01:14,007
whether to,

33
00:01:14,007 --> 00:01:16,489
because sometimes
people feel the pressure of the

34
00:01:16,489 --> 00:01:16,843
group.

35
00:01:16,843 --> 00:01:18,745
And that's not what you want.

36
00:01:18,745 --> 00:01:21,748
You want each person
to make their own decision.

37
00:01:22,282 --> 00:01:25,519
I do believe, and maybe you know
more about this than I do.

38
00:01:25,519 --> 00:01:26,887
I do believe that if there isn't

39
00:01:26,887 --> 00:01:28,585
going to be a group educational
session,

40
00:01:28,585 --> 00:01:30,157
that should be part of the
materials

41
00:01:30,157 --> 00:01:33,705
that the IRB does review,
but I don't know if it's always

42
00:01:33,705 --> 00:01:34,328
required.

43
00:01:34,328 --> 00:01:34,695
Yeah.

44
00:01:34,695 --> 00:01:38,899
I mean, generally
the rule is if this thing,

45
00:01:38,899 --> 00:01:41,279
whether it's the consent form or
advertise

46
00:01:41,279 --> 00:01:43,036
or perhaps an education module

47
00:01:43,337 --> 00:01:45,690
is something that the
investigators

48
00:01:45,690 --> 00:01:47,641
are going to directly engage

49
00:01:47,641 --> 00:01:51,333
the participant with,
then I would think that it needs

50
00:01:51,333 --> 00:01:51,812
to be,

51
00:01:52,145 --> 00:01:55,983
but it sort of begs
the question of, you know,

52
00:01:57,017 --> 00:01:58,418
some might need

53
00:01:58,418 --> 00:02:01,421
IRB approval, but maybe an
introduction

54
00:02:01,421 --> 00:02:06,526
to the types of research
that's going on or education

55
00:02:06,526 --> 00:02:10,864
about the intervention, things
that are less, you know,

56
00:02:11,098 --> 00:02:14,395
I'm going to after this, I'm
going to ask you a question

57
00:02:14,395 --> 00:02:15,102
about your.

58
00:02:15,302 --> 00:02:16,536
Yeah.

59
00:02:16,536 --> 00:02:18,098
And I think that gets to the
other part

60
00:02:18,098 --> 00:02:19,539
of that question about
recruitment.

61
00:02:19,539 --> 00:02:21,174
Can it be useful for
recruitment?

62
00:02:21,174 --> 00:02:23,543
I think the answer is it
probably can. Yeah.

63
00:02:23,543 --> 00:02:25,212
But you have to be worried, not
worried.

64
00:02:25,212 --> 00:02:28,482
But cognizant of the potential
for group pressure.

65
00:02:28,849 --> 00:02:29,249
Yeah.

66
00:02:29,249 --> 00:02:34,154
And I think, you know, back
to your comments about that.

67
00:02:34,488 --> 00:02:37,163
So much I think has to do with
the people

68
00:02:37,163 --> 00:02:38,925
that get through the door.

69
00:02:39,493 --> 00:02:42,963
So I was working on a project
a number of years ago at Penn,

70
00:02:42,963 --> 00:02:46,133
where at the, Alzheimer's
Center,

71
00:02:46,500 --> 00:02:49,336
they had sort of open houses

72
00:02:49,336 --> 00:02:51,631
for individuals who had
Alzheimer's

73
00:02:51,631 --> 00:02:53,140
and or their partners.

74
00:02:53,140 --> 00:02:56,213
Come learn about the center,
learn about research that was

75
00:02:56,213 --> 00:02:56,743
going on.

76
00:02:57,177 --> 00:03:01,014
And I remember thinking
like this is a very particular

77
00:03:01,014 --> 00:03:02,582
group of people who are coming.

78
00:03:02,582 --> 00:03:03,984
They they know about it.

79
00:03:03,984 --> 00:03:05,652
They can afford to get
themselves here.

80
00:03:05,652 --> 00:03:07,621
They have a partner
who can bring them. So,

81
00:03:08,989 --> 00:03:11,992
you know, not to say that's bad,
but it does sort of.

82
00:03:12,259 --> 00:03:15,262
Only some people are going to
make that.

83
00:03:15,695 --> 00:03:17,731
Hi, Daniel. Thanks. Hi.

84
00:03:17,731 --> 00:03:19,399
Thanks so much for the lecture.

85
00:03:19,399 --> 00:03:24,207
So I was wondering, my question
specifically about, voluntary

86
00:03:24,207 --> 00:03:24,838
choice.

87
00:03:24,838 --> 00:03:28,320
So you mentioned, like,
we might think that choice is

88
00:03:28,320 --> 00:03:29,042
voluntary.

89
00:03:29,042 --> 00:03:32,629
If there's, like, no deception
or no coercion, no undue

90
00:03:32,629 --> 00:03:33,346
influence.

91
00:03:33,613 --> 00:03:35,693
But then you also mentioned
things

92
00:03:35,693 --> 00:03:37,284
like pressure from family

93
00:03:37,617 --> 00:03:39,875
or superiors or doctors, and it
seems like

94
00:03:39,875 --> 00:03:41,488
that sort of pressure can be,

95
00:03:42,556 --> 00:03:44,826
not deceptive or coercive or
undue,

96
00:03:44,826 --> 00:03:46,059
like some sort of,

97
00:03:46,059 --> 00:03:50,130
like guilt tripping or emotional
like manipulation.

98
00:03:50,363 --> 00:03:51,098
I'm just wondering how,

99
00:03:51,098 --> 00:03:53,371
like those sorts of things
figure into,

100
00:03:53,371 --> 00:03:55,702
like deciding if a choice is
voluntary.

101
00:03:55,702 --> 00:03:57,437
Yeah, it's a great question.

102
00:03:57,437 --> 00:03:59,535
I think I mean, maybe I didn't
make clear

103
00:03:59,535 --> 00:04:00,507
the the deception,

104
00:04:00,507 --> 00:04:02,232
coercion, undue influence is
language

105
00:04:02,232 --> 00:04:03,677
that comes in the regulations.

106
00:04:03,677 --> 00:04:05,944
So there's a way in which some
people say,

107
00:04:05,944 --> 00:04:07,347
well, it's it's voluntary

108
00:04:07,347 --> 00:04:09,583
if there's no coercion
and undue influence.

109
00:04:09,583 --> 00:04:12,942
But I, I guess personally
and some of the studies that

110
00:04:12,942 --> 00:04:13,253
I've

111
00:04:13,854 --> 00:04:15,255
reviewed and talked about,

112
00:04:16,289 --> 00:04:18,191
think pressure matters, right?

113
00:04:18,191 --> 00:04:21,728
If you're feeling
and we've had examples of people

114
00:04:21,728 --> 00:04:23,969
across the consult service for
example,

115
00:04:23,969 --> 00:04:24,831
who have said,

116
00:04:24,831 --> 00:04:28,435
I don't really want to do this,
but my spouse is making me

117
00:04:28,435 --> 00:04:31,438
or my parents expect me to or
whatever.

118
00:04:32,105 --> 00:04:34,014
That kind of pressure, I think
needs to be

119
00:04:34,014 --> 00:04:35,242
recognized and dealt with.

120
00:04:35,242 --> 00:04:38,532
It's not always okay
to feel pressure from other

121
00:04:38,532 --> 00:04:39,012
people

122
00:04:39,346 --> 00:04:43,617
and the person themselves
has to be able to say,

123
00:04:43,950 --> 00:04:45,823
well, I feel this pressure from
my

124
00:04:45,823 --> 00:04:47,420
I'll give you a great story.

125
00:04:47,687 --> 00:04:50,157
One guy at,

126
00:04:50,157 --> 00:04:52,893
adolescent who said he didn't

127
00:04:52,893 --> 00:04:54,751
want to participate and he was
feeling

128
00:04:54,751 --> 00:04:56,463
like his parents were forcing
him,

129
00:04:56,730 --> 00:04:58,415
and we talked to him for hours
about,

130
00:04:58,415 --> 00:05:00,100
you know, you don't have to do
this.

131
00:05:00,567 --> 00:05:01,568
We can find a way to,

132
00:05:04,137 --> 00:05:07,174
get you to say no, and it'll be
okay.

133
00:05:07,541 --> 00:05:10,544
And in the end, he said, I'll do
it.

134
00:05:10,877 --> 00:05:13,146
And we're like, well,
why did you change your mind?

135
00:05:13,146 --> 00:05:15,382
He said, I have to live with
them.

136
00:05:15,382 --> 00:05:17,384
And so there is that kind of
pressure

137
00:05:17,384 --> 00:05:20,376
that I don't know
how to put that into the rubric

138
00:05:20,376 --> 00:05:20,620
of.

139
00:05:20,620 --> 00:05:23,790
Was that been there
for a voluntary choice or not?

140
00:05:24,124 --> 00:05:28,795
I think it was,
but it was a complicated choice.

141
00:05:29,095 --> 00:05:30,063
Yeah.

142
00:05:30,063 --> 00:05:33,066
So pressure matters.

143
00:05:37,237 --> 00:05:38,338
I guess

144
00:05:38,338 --> 00:05:40,974
like a little more
theoretical question on that,

145
00:05:40,974 --> 00:05:45,445
like from a voluntary choice
and whether like the presence

146
00:05:45,445 --> 00:05:47,582
of, like better alternative
decisions

147
00:05:47,582 --> 00:05:48,448
really matter.

148
00:05:48,682 --> 00:05:51,844
Like, for example, in the case
of where he has live with his

149
00:05:51,844 --> 00:05:52,319
parents,

150
00:05:52,552 --> 00:05:54,926
and then he has to live with the
decision

151
00:05:54,926 --> 00:05:56,489
to not withdraw the study,

152
00:05:56,823 --> 00:05:57,657
just thinking about like,

153
00:05:57,657 --> 00:05:59,409
real life, like I think that's
like

154
00:05:59,409 --> 00:06:00,961
the pressures of everyday life

155
00:06:00,961 --> 00:06:02,028
is important as well.

156
00:06:02,028 --> 00:06:05,632
Like for example,
going into, other alternatives

157
00:06:05,632 --> 00:06:07,810
not to have a job which sounds
no,

158
00:06:07,810 --> 00:06:08,835
not that great.

159
00:06:09,069 --> 00:06:10,570
So he or she has to have a job.

160
00:06:10,570 --> 00:06:13,173
And how much of that is
voluntary?

161
00:06:13,173 --> 00:06:16,243
But at the same time,
maybe voluntariness is also

162
00:06:16,910 --> 00:06:19,124
coping with your like life
outcomes

163
00:06:19,124 --> 00:06:21,781
and thinking about like while
we're given

164
00:06:21,781 --> 00:06:25,083
and then making the choices
in that type of context so that

165
00:06:25,083 --> 00:06:25,418
means

166
00:06:25,719 --> 00:06:29,256
I need job to money
and to live with my parents.

167
00:06:29,256 --> 00:06:32,259
So I need to also respect
like maybe what they want

168
00:06:32,592 --> 00:06:34,928
or in case of other patients
like, oh,

169
00:06:34,928 --> 00:06:37,264
this research program is the
only way

170
00:06:37,264 --> 00:06:39,473
where I get like new treatments
or this is

171
00:06:39,473 --> 00:06:41,368
the only way where I can get
money.

172
00:06:41,801 --> 00:06:43,403
So maybe in that sense,

173
00:06:43,403 --> 00:06:45,792
like context really matters for
voluntary

174
00:06:45,792 --> 00:06:47,073
like decision making.

175
00:06:47,407 --> 00:06:49,618
I was just wondering if that's
like,

176
00:06:49,618 --> 00:06:50,110
I guess

177
00:06:50,110 --> 00:06:53,113
round in the field
or is that kind of rotation?

178
00:06:53,113 --> 00:06:54,624
No, I think it's definitely
correct

179
00:06:54,624 --> 00:06:55,315
interpretation.

180
00:06:55,315 --> 00:06:57,350
And it raises it.

181
00:06:57,350 --> 00:07:01,522
It exemplifies
why I say we need more attention

182
00:07:01,522 --> 00:07:01,788
to

183
00:07:02,355 --> 00:07:05,893
how do we decide if a research
decision

184
00:07:05,893 --> 00:07:08,161
is adequately voluntary,

185
00:07:08,728 --> 00:07:11,298
because there are all these
influences on

186
00:07:11,298 --> 00:07:13,300
how we make decisions that they
just

187
00:07:13,300 --> 00:07:14,301
that's just real.

188
00:07:14,701 --> 00:07:16,558
Even the pressure is an
influence

189
00:07:16,558 --> 00:07:18,471
that is not completely ever
gone.

190
00:07:18,838 --> 00:07:21,121
But in the case that I just
described,

191
00:07:21,121 --> 00:07:21,841
I feel like

192
00:07:22,042 --> 00:07:25,679
this particular individual
was feeling pressure.

193
00:07:25,945 --> 00:07:28,682
We addressed it directly,

194
00:07:28,682 --> 00:07:31,264
gave him permission to not
participate,

195
00:07:31,264 --> 00:07:32,919
and then he decided, I'm

196
00:07:32,919 --> 00:07:35,644
going to do it anyway
because I have to live with

197
00:07:35,644 --> 00:07:36,423
these people.

198
00:07:36,623 --> 00:07:38,124
These are my parents, right?

199
00:07:38,124 --> 00:07:40,026
And so, I think,

200
00:07:41,528 --> 00:07:43,963
there's so many

201
00:07:43,963 --> 00:07:47,801
potential influences
on how we make decisions.

202
00:07:48,468 --> 00:07:51,535
What we need to figure out
in the context of informed

203
00:07:51,535 --> 00:07:52,172
consent is

204
00:07:52,172 --> 00:07:55,608
what's adequately voluntary,
so that we're not finding

205
00:07:55,608 --> 00:07:57,641
somebody who's really feeling
pressure

206
00:07:57,641 --> 00:07:58,978
that they cannot resist.

207
00:07:59,612 --> 00:08:02,406
And that doesn't always
I think Daniel's question is

208
00:08:02,406 --> 00:08:02,782
right.

209
00:08:02,782 --> 00:08:03,283
It does.

210
00:08:03,283 --> 00:08:05,730
In my view,
it doesn't always translate into

211
00:08:05,730 --> 00:08:06,286
coercion.

212
00:08:06,753 --> 00:08:08,774
But there are two types of
pressure

213
00:08:08,774 --> 00:08:09,756
that are really,

214
00:08:11,224 --> 00:08:12,659
overbearing.

215
00:08:12,659 --> 00:08:15,395
And people should be able
to decide themselves.

216
00:08:15,395 --> 00:08:18,531
Yeah, I agree,
like even a case with the boy.

217
00:08:18,531 --> 00:08:21,517
Like, I feel like
if you not let him enroll in his

218
00:08:21,517 --> 00:08:21,935
study,

219
00:08:21,935 --> 00:08:24,568
I feel like that would also be a
form of,

220
00:08:24,568 --> 00:08:27,073
like, coercion and not
respecting his.

221
00:08:27,073 --> 00:08:28,041
Decision so often.

222
00:08:28,041 --> 00:08:29,943
That could be another way
of thinking about it.

223
00:08:29,943 --> 00:08:31,111
Yeah. Thank you. Yeah.

224
00:08:32,345 --> 00:08:34,932
And even just sort of this is
maybe a,

225
00:08:34,932 --> 00:08:35,749
you know, a

226
00:08:35,749 --> 00:08:37,888
minor example, but, you know,
people

227
00:08:37,888 --> 00:08:39,552
put pressure on themselves.

228
00:08:39,552 --> 00:08:43,757
So when we asked people,
you know, people really score

229
00:08:43,757 --> 00:08:46,760
high on I definitely know I can
leave.

230
00:08:47,260 --> 00:08:50,196
I know no bad things will happen
if I do, but they say,

231
00:08:50,196 --> 00:08:51,931
oh, but I'll never leave you.

232
00:08:51,931 --> 00:08:53,939
Like they want to be perceived
as a,

233
00:08:53,939 --> 00:08:55,835
you know, a good research
subject

234
00:08:55,835 --> 00:08:57,971
and are likely going to do
what they need to

235
00:08:57,971 --> 00:09:00,473
in order to be a good research
subject.

236
00:09:00,473 --> 00:09:02,292
That's a less like we wouldn't
say,

237
00:09:02,292 --> 00:09:04,110
oh gosh, that's too much
pressure,

238
00:09:04,310 --> 00:09:07,714
but we don't really know
about what those pressures are.

239
00:09:08,248 --> 00:09:11,251
And similarly, people
sometimes say things like,

240
00:09:11,918 --> 00:09:13,820
yes, I know that this is my
choice.

241
00:09:13,820 --> 00:09:14,921
I know it's my choice.

242
00:09:14,921 --> 00:09:18,360
I know I don't have to do it,
but what other choice do I

243
00:09:18,360 --> 00:09:19,159
really have?

244
00:09:19,492 --> 00:09:22,139
You know, and that's
an interesting combination of

245
00:09:22,139 --> 00:09:22,562
things.

246
00:09:22,562 --> 00:09:23,463
So yeah, go ahead.

247
00:09:24,597 --> 00:09:27,102
Hi. This is kind of a silly
question, but,

248
00:09:27,102 --> 00:09:28,234
no silly question.

249
00:09:28,234 --> 00:09:28,635
No, silly.

250
00:09:28,635 --> 00:09:30,885
So it's a pretty common
practice,

251
00:09:30,885 --> 00:09:33,339
like at least in the United
States,

252
00:09:33,339 --> 00:09:35,733
in psychology departments, to
get a bunch

253
00:09:35,733 --> 00:09:38,011
of undergrads to enroll in
studies by,

254
00:09:38,812 --> 00:09:40,441
including that as part of your
grade

255
00:09:40,441 --> 00:09:42,115
or giving you extra credit for
that.

256
00:09:42,115 --> 00:09:43,883
And, you know,
those are usually minimal risk.

257
00:09:43,883 --> 00:09:45,852
Studies that people. Are
enrolling in.

258
00:09:45,852 --> 00:09:48,224
But it also seems to directly
benefit

259
00:09:48,224 --> 00:09:49,122
the professor

260
00:09:49,122 --> 00:09:51,062
and the department to have more
people

261
00:09:51,062 --> 00:09:52,492
enrolling in those studies.

262
00:09:52,492 --> 00:09:55,495
So I'm curious, like what
what makes that okay?

263
00:09:56,996 --> 00:09:59,563
In terms of like, yeah,
their grades are being

264
00:09:59,563 --> 00:10:00,233
influenced.

265
00:10:00,233 --> 00:10:03,236
They have a professor
telling them to do it.

266
00:10:03,503 --> 00:10:06,439
So correct me if I'm wrong,
but my understanding is

267
00:10:06,439 --> 00:10:09,145
when a professor
has that as a possible way to

268
00:10:09,145 --> 00:10:09,909
get a grade,

269
00:10:10,577 --> 00:10:13,657
there needs to be an alternative
for people who don't want to

270
00:10:13,657 --> 00:10:14,314
participate.

271
00:10:14,647 --> 00:10:15,682
Oh, okay.

272
00:10:15,682 --> 00:10:17,650
I might know.

273
00:10:17,650 --> 00:10:19,919
Yeah, I have it is in here in.

274
00:10:19,919 --> 00:10:21,988
So it's required for the course.

275
00:10:21,988 --> 00:10:22,622
Do you have a chance.

276
00:10:22,622 --> 00:10:24,691
Do you have an option
not to take the course?

277
00:10:26,526 --> 00:10:26,893
I mean,

278
00:10:26,893 --> 00:10:30,029
I'm trying to figure out
I thought that there were. Yet.

279
00:10:30,029 --> 00:10:30,763
To be an option.

280
00:10:30,763 --> 00:10:33,900
When I was in undergrad many
years ago.

281
00:10:33,900 --> 00:10:36,970
The expectation
was that everybody participate

282
00:10:36,970 --> 00:10:37,770
in a trial.

283
00:10:37,770 --> 00:10:38,972
There was no option.

284
00:10:38,972 --> 00:10:42,142
But my assumption, perhaps
naive,

285
00:10:42,142 --> 00:10:45,845
is that that's changed,
that the expectation is that,

286
00:10:46,279 --> 00:10:47,931
you know, you're it's
recommended

287
00:10:47,931 --> 00:10:49,382
that there's an alternative.

288
00:10:49,382 --> 00:10:51,189
You could write a paper, you
could do

289
00:10:51,189 --> 00:10:52,752
something else other than that.

290
00:10:52,752 --> 00:10:54,754
So perhaps
we have to look into that again.

291
00:10:54,754 --> 00:10:57,323
Yeah. Yeah.

292
00:10:57,323 --> 00:10:58,224
It's also interesting.

293
00:10:58,224 --> 00:10:59,792
I mean, I, I thought your
question

294
00:10:59,792 --> 00:11:01,084
was going to go in a different
way

295
00:11:01,084 --> 00:11:02,262
because I mentioned deception.

296
00:11:02,262 --> 00:11:04,430
But there is

297
00:11:04,430 --> 00:11:07,333
in research sometimes psychology
research,

298
00:11:07,333 --> 00:11:10,336
a legitimate place
for some kinds of deception, but

299
00:11:10,570 --> 00:11:13,006
that's very different
than sort of misleading

300
00:11:13,006 --> 00:11:16,042
somebody in, in giving them
information about a study.