1
00:00:04,071 --> 00:00:06,506
Tell us about this case.

2
00:00:06,506 --> 00:00:09,209
And maybe tell us a little
about the trial.

3
00:00:09,209 --> 00:00:10,377
They're being approached him.

4
00:00:10,377 --> 00:00:11,011
We were all.

5
00:00:11,011 --> 00:00:12,746
Right as it as it says here.

6
00:00:12,746 --> 00:00:14,982
Hopefully everybody can hear me.

7
00:00:14,982 --> 00:00:17,751
B is an adult who presents
with the clinical center.

8
00:00:17,751 --> 00:00:19,086
To participate in.

9
00:00:19,086 --> 00:00:22,589
This means minor increment over
minimal risk,

10
00:00:23,056 --> 00:00:25,893
not for direct benefit dementia
study.

11
00:00:25,893 --> 00:00:29,155
So the day before the study,
the investigator had called this

12
00:00:29,155 --> 00:00:29,529
person

13
00:00:29,529 --> 00:00:31,665
to educate her about the study.

14
00:00:31,665 --> 00:00:33,901
As I was talking about,
to make sure when she comes in

15
00:00:33,901 --> 00:00:36,970
for the capacity assessment,
she has more information.

16
00:00:36,970 --> 00:00:39,062
There's had she's had an
opportunity

17
00:00:39,062 --> 00:00:40,340
to ask him questions.

18
00:00:40,340 --> 00:00:41,441
That sort of thing.

19
00:00:41,441 --> 00:00:43,748
The study does allow for LA
concerned,

20
00:00:43,748 --> 00:00:45,812
and she brings her adult
daughter

21
00:00:45,812 --> 00:00:48,007
in with her, whom she has
already assigned

22
00:00:48,007 --> 00:00:49,783
as her durable power of
attorney.

23
00:00:49,783 --> 00:00:51,818
So that's not an issue at all.

24
00:00:51,818 --> 00:00:53,754
So if she doesn't have capacity,

25
00:00:53,754 --> 00:00:56,390
we can automatically go to the
the adult daughter.

26
00:00:56,390 --> 00:00:58,516
So the study does require us to
come in

27
00:00:58,516 --> 00:01:00,260
and do the capacity assessment.

28
00:01:00,627 --> 00:01:02,935
And at that time, you know, we
determined

29
00:01:02,935 --> 00:01:04,398
she doesn't have capacity

30
00:01:04,398 --> 00:01:06,433
at the time of the assessment,
which then

31
00:01:06,433 --> 00:01:08,468
means, you know, we can go to
surrogate,

32
00:01:08,702 --> 00:01:11,220
but the daughter also then
indicates

33
00:01:11,220 --> 00:01:13,807
that she is eligible to enroll
in a,

34
00:01:14,942 --> 00:01:17,377
MRI study of minimal risk,

35
00:01:17,377 --> 00:01:19,915
or rather minimal risk
longitudinal study

36
00:01:19,915 --> 00:01:21,648
with another NIH institute.

37
00:01:22,182 --> 00:01:25,052
So what are some of the things
that people think about

38
00:01:25,052 --> 00:01:26,762
how we would proceed at this
point

39
00:01:26,762 --> 00:01:28,221
to get her to give one away.

40
00:01:28,522 --> 00:01:32,013
And and don't feel like
you have to run over to the MC

41
00:01:32,013 --> 00:01:32,659
for this.

42
00:01:32,659 --> 00:01:36,964
So imagine this is a situation
that you're faced with.

43
00:01:38,065 --> 00:01:39,833
You know, what do we do?

44
00:01:39,833 --> 00:01:42,669
Should we just go ahead and
enroll her?

45
00:01:42,669 --> 00:01:45,481
One option would be in this
case,

46
00:01:45,481 --> 00:01:48,208
maybe we now go to the daughter

47
00:01:48,208 --> 00:01:51,278
who has durable power of
attorney

48
00:01:51,745 --> 00:01:56,450
and the study allows for an lar
consent.

49
00:01:59,353 --> 00:02:01,688
So tell me, Carol, what is.

50
00:02:01,688 --> 00:02:05,392
So the last bullet here about
that.

51
00:02:05,392 --> 00:02:08,595
She's also eligible
to enroll in another study.

52
00:02:08,595 --> 00:02:11,665
How would that come in
to your considerations?

53
00:02:11,665 --> 00:02:14,285
Well, I think one of the things
that the daughter was concerned

54
00:02:14,285 --> 00:02:14,701
about was

55
00:02:14,701 --> 00:02:18,566
when we discovered
she didn't have capacity at that

56
00:02:18,566 --> 00:02:19,172
moment.

57
00:02:20,640 --> 00:02:21,008
As you

58
00:02:21,008 --> 00:02:24,811
mentioned, the daughter has DPA
and the mother was fine.

59
00:02:24,811 --> 00:02:27,247
The participant was fine
with the daughter,

60
00:02:27,247 --> 00:02:30,217
giving surrogate consent for her
for the intimate study.

61
00:02:30,217 --> 00:02:31,564
However, the daughter was
concerned

62
00:02:31,564 --> 00:02:33,220
about what that meant for the
other study.

63
00:02:33,220 --> 00:02:35,188
Could she participate or not?

64
00:02:35,188 --> 00:02:39,224
And while we don't have any sway
or any decisions to be made or

65
00:02:39,224 --> 00:02:39,993
assessments

66
00:02:39,993 --> 00:02:41,094
for something like that,

67
00:02:41,094 --> 00:02:43,289
one of the things that we always
talk

68
00:02:43,289 --> 00:02:45,365
about is it's a minimal risk
study

69
00:02:45,665 --> 00:02:48,156
that somebody can have capacity
for one

70
00:02:48,156 --> 00:02:50,837
study, but not have capacity for
another.

71
00:02:51,038 --> 00:02:54,238
So it really would be up
to the researchers of that other

72
00:02:54,238 --> 00:02:54,574
study

73
00:02:54,574 --> 00:02:57,392
to make their determination
about whether or not she had

74
00:02:57,392 --> 00:02:57,844
capacity

75
00:02:58,211 --> 00:02:59,713
to give her own consent or not.

76
00:02:59,713 --> 00:03:03,016
Now, of course, the
we would be documenting and,

77
00:03:03,283 --> 00:03:04,970
our researcher would be
documenting

78
00:03:04,970 --> 00:03:06,319
our finding that, you know,

79
00:03:06,319 --> 00:03:08,079
we used a surrogate and that
would be

80
00:03:08,079 --> 00:03:10,123
something that would be
available to them.

81
00:03:10,123 --> 00:03:10,824
They could see that.

82
00:03:10,824 --> 00:03:14,224
But again, it does it shouldn't
have an effect on the other

83
00:03:14,224 --> 00:03:14,628
study.

84
00:03:14,628 --> 00:03:16,296
They need to make their own
determination

85
00:03:16,296 --> 00:03:17,597
because it's a different study.

86
00:03:17,597 --> 00:03:20,133
And she might very well
have capacity for that. Yeah.

87
00:03:20,133 --> 00:03:23,542
So so maybe another way of
saying that

88
00:03:23,542 --> 00:03:25,605
is that the first one,

89
00:03:25,872 --> 00:03:28,875
just to remind
folks, it's a minimal increase

90
00:03:28,875 --> 00:03:29,209
over

91
00:03:29,209 --> 00:03:31,586
minor risk
and no direct benefit to the

92
00:03:31,586 --> 00:03:32,379
participant.

93
00:03:32,946 --> 00:03:35,782
And so I don't mean
to put words in your mouth,

94
00:03:35,782 --> 00:03:38,785
but that's what that study is
riskier.

95
00:03:39,019 --> 00:03:41,822
And the daughter might be
uncomfortable

96
00:03:41,822 --> 00:03:45,511
making a decision
that puts her mother at some

97
00:03:45,511 --> 00:03:45,992
risk,

98
00:03:46,359 --> 00:03:50,397
but maybe more comfortable
with the lower risk.

99
00:03:51,631 --> 00:03:53,633
In the sense that

100
00:03:53,633 --> 00:03:57,070
her burden might be less and,
you know, if something

101
00:03:57,971 --> 00:04:00,974
maybe went wrong. But.

102
00:04:02,142 --> 00:04:04,244
Are you saying that the capacity

103
00:04:04,244 --> 00:04:07,403
might be different because it's
riskier,

104
00:04:07,403 --> 00:04:10,484
or are you saying that the group
who's

105
00:04:10,484 --> 00:04:12,663
assessing in the second study
might have

106
00:04:12,663 --> 00:04:14,788
a different way of assessing
capacity.

107
00:04:14,788 --> 00:04:16,323
I think it can be both okay.

108
00:04:16,323 --> 00:04:19,893
Because the riskier study
that would be ours

109
00:04:20,127 --> 00:04:22,233
does have, like a positron
emission

110
00:04:22,233 --> 00:04:23,497
tomography Pet scan.

111
00:04:23,497 --> 00:04:24,865
They're going to have an
arterial line.

112
00:04:24,865 --> 00:04:26,384
They're going
they can stay on their

113
00:04:26,384 --> 00:04:26,933
medications,

114
00:04:26,933 --> 00:04:29,516
but it's more involved where
again,

115
00:04:29,516 --> 00:04:32,172
there can be yeah, there can can
be

116
00:04:32,172 --> 00:04:34,186
a definitely higher there's
clearly

117
00:04:34,186 --> 00:04:36,143
a higher risk associated with
it.

118
00:04:36,143 --> 00:04:37,911
And it's not for direct benefit.

119
00:04:37,911 --> 00:04:38,612
It's not like

120
00:04:38,612 --> 00:04:40,672
they're going to be giving her
medication

121
00:04:40,672 --> 00:04:42,582
or having a procedure where she
might

122
00:04:42,582 --> 00:04:45,633
her memory might improve
is is strictly for clinical

123
00:04:45,633 --> 00:04:46,219
research.

124
00:04:46,219 --> 00:04:49,222
And I would say a lot of times
what we hear from folks is

125
00:04:49,422 --> 00:04:52,587
they have an understanding
that this isn't going to help

126
00:04:52,587 --> 00:04:52,926
them.

127
00:04:52,926 --> 00:04:55,028
We don't just say not for direct
benefit.

128
00:04:55,028 --> 00:04:57,097
We you know,
they're very good investigators,

129
00:04:57,097 --> 00:04:58,885
very good
about explaining what that

130
00:04:58,885 --> 00:04:59,232
means.

131
00:04:59,232 --> 00:05:00,400
You're helping the future.

132
00:05:00,400 --> 00:05:02,354
And a lot of these folks will
come in

133
00:05:02,354 --> 00:05:04,571
just several in the last couple
of weeks.

134
00:05:05,238 --> 00:05:07,245
You know,
I know this isn't going to help

135
00:05:07,245 --> 00:05:07,440
me,

136
00:05:07,440 --> 00:05:09,186
but my mother had this one
woman,

137
00:05:09,186 --> 00:05:10,243
her brother had it.

138
00:05:10,243 --> 00:05:11,978
They had already both passed
away.

139
00:05:11,978 --> 00:05:13,798
And they were worried about
their children

140
00:05:13,798 --> 00:05:14,881
and their grandchildren.

141
00:05:14,881 --> 00:05:17,217
And so a big part of their
motivation

142
00:05:17,217 --> 00:05:19,853
was that they wanted to be able
to contribute to the future.

143
00:05:19,853 --> 00:05:22,355
And maybe it will help
their family members.

144
00:05:22,355 --> 00:05:25,401
And again, the other,
the minimal risk longitudinal

145
00:05:25,401 --> 00:05:25,759
study

146
00:05:25,959 --> 00:05:28,395
may have nothing to do with
Alzheimer's.

147
00:05:28,395 --> 00:05:30,587
It may have dementia,
it may be something else

148
00:05:30,587 --> 00:05:31,064
entirely.

149
00:05:31,064 --> 00:05:33,553
We didn't know, but it would be
important

150
00:05:33,553 --> 00:05:35,435
then, obviously, for that team

151
00:05:35,435 --> 00:05:37,938
to do their own assessment.
And for the daughter,

152
00:05:37,938 --> 00:05:40,941
she can still weigh in
even if her mother has capacity.

153
00:05:41,408 --> 00:05:43,343
But, it would be a

154
00:05:44,311 --> 00:05:46,224
they would come to their own
decision

155
00:05:46,224 --> 00:05:47,414
separately about that.

156
00:05:47,414 --> 00:05:48,181
Great.

157
00:05:48,181 --> 00:05:52,085
And and it's sometimes right
since, Carol and her group,

158
00:05:52,085 --> 00:05:55,088
I'm just getting the picture
so we can move to the next case.

159
00:05:56,122 --> 00:05:57,757
That, you know,

160
00:05:57,757 --> 00:06:00,860
we might be the folks
who are asked to come in

161
00:06:00,860 --> 00:06:03,030
the Department of Bioethics
might be asked

162
00:06:03,030 --> 00:06:04,631
to come in for the second one.

163
00:06:04,631 --> 00:06:04,931
Right.

164
00:06:04,931 --> 00:06:07,846
And as Carol noted, one
difference

165
00:06:07,846 --> 00:06:10,503
between our approaches is that

166
00:06:11,738 --> 00:06:13,974
for the animated studies

167
00:06:13,974 --> 00:06:16,977
where HSP is written in,

168
00:06:17,244 --> 00:06:21,181
they are tailoring an assessment
specific

169
00:06:21,181 --> 00:06:24,184
to a very specific protocol.

170
00:06:24,718 --> 00:06:27,020
We ask a whole series of
questions

171
00:06:27,020 --> 00:06:29,322
that they're generic in the
sense

172
00:06:29,322 --> 00:06:30,690
that they are.

173
00:06:30,690 --> 00:06:33,727
Tell me about the purpose,
but don't quote me.

174
00:06:33,727 --> 00:06:36,351
Tell me about the purpose of the
study,

175
00:06:36,351 --> 00:06:37,831
or tell me what risks

176
00:06:37,831 --> 00:06:41,234
you might be exposed
to where you're looking for.

177
00:06:41,234 --> 00:06:44,993
You've already prepared to get
particular answers to those

178
00:06:44,993 --> 00:06:45,705
questions.

179
00:06:45,705 --> 00:06:49,525
So it could be that when we do
the assessment for the minimal

180
00:06:49,525 --> 00:06:50,277
risk study,

181
00:06:50,710 --> 00:06:53,713
they do have the capacity to
understand

182
00:06:54,180 --> 00:06:58,084
the, you know, relatively
minimal procedures

183
00:06:58,084 --> 00:07:00,186
that are involved in the MRI
study.

184
00:07:00,186 --> 00:07:02,022
So we're going to go to case
two.

185
00:07:02,022 --> 00:07:04,157
So tell us a little about this
one. Yes.

186
00:07:05,392 --> 00:07:07,130
She has schizophrenia, is
enrolled

187
00:07:07,130 --> 00:07:08,561
in a minimal risk screening

188
00:07:08,561 --> 00:07:12,732
protocol on the inpatient unit
to determine their eligibility

189
00:07:12,732 --> 00:07:16,403
for a more than minimal risk,
not for direct benefit,

190
00:07:16,803 --> 00:07:19,141
double blind, placebo controlled
study

191
00:07:19,141 --> 00:07:21,541
with accompanying Pet and MRI
studies.

192
00:07:22,142 --> 00:07:25,245
The nursing staff at this point,
typically,

193
00:07:25,245 --> 00:07:27,954
with these cases, these folks
come in into this screening

194
00:07:27,954 --> 00:07:28,381
protocol

195
00:07:28,381 --> 00:07:31,534
and they're there for at least
several weeks, sometimes longer,

196
00:07:31,534 --> 00:07:31,885
before

197
00:07:32,118 --> 00:07:35,055
we're doing a capacity
assessment for the,

198
00:07:35,055 --> 00:07:37,503
higher risk study, as in nursing
provides

199
00:07:37,503 --> 00:07:38,458
that education.

200
00:07:38,458 --> 00:07:39,659
About the study.

201
00:07:39,659 --> 00:07:41,933
As I said prior to us coming in
and

202
00:07:41,933 --> 00:07:44,597
assessing them in this
particular study,

203
00:07:44,597 --> 00:07:46,769
either study an LA is not
permitted

204
00:07:46,769 --> 00:07:49,002
to provide consent on their
behalf.

205
00:07:49,002 --> 00:07:52,005
They have to have capacity
in order to part the participant

206
00:07:52,005 --> 00:07:54,939
has to have capacity
in order to participate in the

207
00:07:54,939 --> 00:07:55,342
study.

208
00:07:55,642 --> 00:07:57,920
So at this time, we determined
that

209
00:07:57,920 --> 00:07:59,612
Si did not have capacity.

210
00:07:59,913 --> 00:08:03,285
And also Si had indicated
some reservations about

211
00:08:03,285 --> 00:08:04,317
participating.

212
00:08:04,317 --> 00:08:06,221
And that's not an unusual
scenario

213
00:08:06,221 --> 00:08:07,454
that we have as well.

214
00:08:07,787 --> 00:08:11,424
So what what do people
think our next steps are?

215
00:08:14,761 --> 00:08:18,298
So one option right might just
be okay.

216
00:08:18,631 --> 00:08:20,233
So he doesn't have capacity.

217
00:08:20,233 --> 00:08:23,303
He is therefore not eligible
for this study.

218
00:08:23,670 --> 00:08:26,139
And that's it.

219
00:08:26,139 --> 00:08:27,774
Send him on his way.

220
00:08:27,774 --> 00:08:30,844
Is there any ideas
about an alternative to that.

221
00:08:31,778 --> 00:08:35,391
So what I would say
what we would do is we would,

222
00:08:35,391 --> 00:08:36,349
again, given

223
00:08:36,349 --> 00:08:39,753
that the person has concerns
about participate,

224
00:08:39,753 --> 00:08:40,553
maybe they're

225
00:08:40,553 --> 00:08:42,555
they're not entirely sure
that they want to do

226
00:08:42,555 --> 00:08:44,224
is we have a conversation about
that.

227
00:08:44,224 --> 00:08:45,658
What is that about?

228
00:08:45,658 --> 00:08:47,883
And we talked with the
researchers

229
00:08:47,883 --> 00:08:48,995
to one option is

230
00:08:49,195 --> 00:08:51,793
we would
if the person give them the

231
00:08:51,793 --> 00:08:52,298
choice

232
00:08:52,298 --> 00:08:54,127
because we were always very,
very clear,

233
00:08:54,127 --> 00:08:55,635
especially with this population,

234
00:08:55,835 --> 00:08:58,471
that it's their decision
to participate in the study.

235
00:08:58,471 --> 00:09:01,908
And it's not atypical
that you get really well-meaning

236
00:09:02,475 --> 00:09:04,805
family and friends who they feel
like

237
00:09:04,805 --> 00:09:06,379
they're here at the NIH.

238
00:09:06,379 --> 00:09:07,781
This is the gold standard.

239
00:09:07,781 --> 00:09:10,950
If anybody can help
this, my loved one, you can't.

240
00:09:10,950 --> 00:09:14,283
But we always remind them it's
this person's the participant's

241
00:09:14,283 --> 00:09:14,821
decision.

242
00:09:15,088 --> 00:09:17,757
And we can say there's
there's several options.

243
00:09:17,757 --> 00:09:19,893
You can be discharged.

244
00:09:19,893 --> 00:09:20,593
That's fine.

245
00:09:20,593 --> 00:09:22,818
You can go back home or wherever
that is,

246
00:09:22,818 --> 00:09:25,098
whatever that scenario is if you
want to.

247
00:09:25,432 --> 00:09:28,802
And we can remind them again,
you don't have to do this.

248
00:09:29,069 --> 00:09:32,746
Do you want to, spend
more time learning more about

249
00:09:32,746 --> 00:09:33,540
the study,

250
00:09:33,540 --> 00:09:36,142
and we'll talk about the areas
that they had difficulty with.

251
00:09:36,142 --> 00:09:37,915
We'll talk about it with the
researchers,

252
00:09:37,915 --> 00:09:39,212
because the researchers don't

253
00:09:39,212 --> 00:09:41,748
want to pressure somebody
to stay at that point.

254
00:09:41,748 --> 00:09:45,486
But sometimes at that point,
the person has a clear

255
00:09:45,486 --> 00:09:46,586
understanding,

256
00:09:46,586 --> 00:09:49,178
like, okay, you know,
even though my parents are

257
00:09:49,178 --> 00:09:49,556
saying

258
00:09:49,556 --> 00:09:52,292
and this is somebody
obviously age 18 or older,

259
00:09:52,292 --> 00:09:54,530
and this is not an unusual
scenario

260
00:09:54,530 --> 00:09:56,129
where they say, okay, so

261
00:09:56,129 --> 00:09:57,797
you really mean my parents can't
make me

262
00:09:57,797 --> 00:09:59,299
stay or like, you know, they
can't?

263
00:09:59,299 --> 00:10:01,334
Well, maybe I will stay then.

264
00:10:01,334 --> 00:10:03,485
And I'll say they've been here
for a couple of weeks at this

265
00:10:03,485 --> 00:10:03,736
point.

266
00:10:03,736 --> 00:10:05,007
So they've gotten used to the
unit,

267
00:10:05,007 --> 00:10:06,206
which is really, really helpful.

268
00:10:06,206 --> 00:10:09,476
They've developed a rapport
with the staff, but everybody is

269
00:10:09,476 --> 00:10:12,779
continuous reminding them,
this is your decision about

270
00:10:12,779 --> 00:10:13,513
being here.

271
00:10:13,513 --> 00:10:15,471
And even if you get into the
study,

272
00:10:15,471 --> 00:10:17,317
even if you do go into this more

273
00:10:17,317 --> 00:10:21,698
risky study, higher risk study,
you can still change your your

274
00:10:21,698 --> 00:10:22,122
mind.

275
00:10:22,355 --> 00:10:24,774
And so sometimes what a person
will say,

276
00:10:24,774 --> 00:10:25,258
okay, I

277
00:10:25,258 --> 00:10:27,018
all right, I will stay I know I
can't,

278
00:10:27,018 --> 00:10:28,361
I really can change my mind.

279
00:10:28,361 --> 00:10:30,866
And then we would do more
education and

280
00:10:30,866 --> 00:10:33,500
then we'd reassess and see where
we are.

281
00:10:33,500 --> 00:10:34,100
At that point.

282
00:10:34,100 --> 00:10:35,575
If they still don't have
capacity,

283
00:10:35,575 --> 00:10:36,269
then, you know,

284
00:10:36,269 --> 00:10:37,608
we're talking with the
researchers

285
00:10:37,608 --> 00:10:38,238
and it could be

286
00:10:38,238 --> 00:10:40,738
this person is never going to
have capacity to give their own

287
00:10:40,738 --> 00:10:41,107
consent.

288
00:10:41,107 --> 00:10:42,728
And so they need to start
planning

289
00:10:42,728 --> 00:10:43,443
for discharge.

290
00:10:43,443 --> 00:10:46,846
We've had some people who decide
they want to go back home

291
00:10:46,846 --> 00:10:49,087
and think about this
more and maybe talk with a lot

292
00:10:49,087 --> 00:10:49,482
of times

293
00:10:49,482 --> 00:10:51,101
they're living with family
members,

294
00:10:51,101 --> 00:10:52,118
talk about this more.

295
00:10:52,118 --> 00:10:53,653
And we've had people come back.

296
00:10:53,653 --> 00:10:55,546
I've also had people who had
capacity

297
00:10:55,546 --> 00:10:56,723
and they self-sabotage

298
00:10:56,723 --> 00:10:58,558
because they thought they were
being

299
00:10:58,558 --> 00:11:01,186
made to stay, that their parents
were putting too much pressure

300
00:11:01,186 --> 00:11:01,561
on them,

301
00:11:01,861 --> 00:11:04,002
and then they ultimately went
home,

302
00:11:04,002 --> 00:11:05,532
and then they came back.

303
00:11:05,732 --> 00:11:06,633
And then we've had people.

304
00:11:06,633 --> 00:11:08,034
It's it's typical.

305
00:11:08,034 --> 00:11:10,637
It's not typical
that people don't have capacity.

306
00:11:10,637 --> 00:11:12,605
We've had that a handful of
times

307
00:11:12,605 --> 00:11:14,576
and gave them several
opportunities

308
00:11:14,576 --> 00:11:16,209
and they may stabilize them.

309
00:11:16,209 --> 00:11:18,878
Maybe they make treatment
recommendations, differences,

310
00:11:18,878 --> 00:11:20,613
and then they'll
they'll send them back home

311
00:11:20,613 --> 00:11:23,416
and they won't go through the
the higher risk protocol.

312
00:11:23,416 --> 00:11:25,051
As a general rule,

313
00:11:26,085 --> 00:11:28,187
studies that are

314
00:11:28,187 --> 00:11:30,243
no more than minimal risk or
what

315
00:11:30,243 --> 00:11:32,859
I'll call sort of a natural
history study

316
00:11:32,859 --> 00:11:35,415
so often, folks with rare
disorders

317
00:11:35,415 --> 00:11:37,897
for which there are no
treatments

318
00:11:37,897 --> 00:11:40,513
might enroll in a study here at
the

319
00:11:40,513 --> 00:11:43,503
clinical center and all, quote
unquote.

320
00:11:43,503 --> 00:11:46,472
The team wants to do
is like, collect blood samples,

321
00:11:47,173 --> 00:11:49,576
maybe do some genetic analysis.

322
00:11:49,576 --> 00:11:52,712
So there's very little physical
risk.

323
00:11:52,712 --> 00:11:55,548
So the idea is that in that
case,

324
00:11:55,548 --> 00:11:58,985
it's it's relatively common
for there to be,

325
00:11:59,852 --> 00:12:02,522
an LA designation

326
00:12:02,522 --> 00:12:05,091
when the risk starts to rise.

327
00:12:05,091 --> 00:12:09,696
There are concerns about,
is it okay to enroll someone

328
00:12:09,696 --> 00:12:12,799
who doesn't have capacity in a
trial

329
00:12:12,799 --> 00:12:16,502
that has some risk and no direct
benefit?

330
00:12:18,238 --> 00:12:20,940
It's just a respect for

331
00:12:20,940 --> 00:12:23,890
and the ability of the person
to make a decision on their own

332
00:12:23,890 --> 00:12:24,277
behalf.

333
00:12:24,711 --> 00:12:27,151
And then there's a little sort
of space

334
00:12:27,151 --> 00:12:28,214
in the middle of

335
00:12:28,514 --> 00:12:31,338
there is more than minimal risk,
the potential for direct

336
00:12:31,338 --> 00:12:31,784
benefit.

337
00:12:32,151 --> 00:12:33,920
And that's where there's,

338
00:12:35,755 --> 00:12:38,191
maybe, less common.

339
00:12:38,191 --> 00:12:38,925
Right.

340
00:12:38,925 --> 00:12:41,274
I guess to say sometimes there's
an la,

341
00:12:41,274 --> 00:12:43,863
sometimes, ability, sometimes
there isn't.

342
00:12:43,863 --> 00:12:46,662
That's when it really comes to
the team

343
00:12:46,662 --> 00:12:49,102
and how they want to move
forward

344
00:12:49,102 --> 00:12:52,362
and their considerations
about the intervention or the

345
00:12:52,362 --> 00:12:52,905
disease.

346
00:12:52,905 --> 00:12:53,406
Right.

347
00:12:53,406 --> 00:12:56,042
As Christine and Scott both
mentioned.

348
00:12:56,042 --> 00:12:58,111
Right. Some research.

349
00:12:58,111 --> 00:13:02,068
So let's imagine someone who has
Alzheimer's, who's in a later

350
00:13:02,068 --> 00:13:02,515
stage,

351
00:13:03,616 --> 00:13:06,119
they may not have capacity,

352
00:13:06,119 --> 00:13:08,688
but this study may,

353
00:13:08,688 --> 00:13:11,457
have some direct benefit for
them.

354
00:13:11,457 --> 00:13:14,494
And so we have to enroll people

355
00:13:14,494 --> 00:13:17,664
who have Alzheimer's
in order to find that out.

356
00:13:17,664 --> 00:13:21,777
And so that is a real clear case
where the investigators in

357
00:13:21,777 --> 00:13:22,335
advance

358
00:13:22,335 --> 00:13:24,719
would want to make sure that an
LA

359
00:13:24,719 --> 00:13:27,173
is, allowed to make that
decision.

360
00:13:27,473 --> 00:13:30,276
And also on the heels of that is
important

361
00:13:30,276 --> 00:13:32,211
to remember the concept of a

362
00:13:32,612 --> 00:13:33,212
in the sense.

363
00:13:33,212 --> 00:13:34,380
Yes, as well.

364
00:13:34,380 --> 00:13:37,355
For example,
we had, a woman with Alzheimer's

365
00:13:37,355 --> 00:13:37,884
disease

366
00:13:38,284 --> 00:13:40,353
and her husband had brought her
here.

367
00:13:40,353 --> 00:13:42,422
She clearly did not have
capacity.

368
00:13:42,422 --> 00:13:44,991
She didn't understand
what was going to be done.

369
00:13:44,991 --> 00:13:47,612
Even after we talked with her
about what

370
00:13:47,612 --> 00:13:48,594
the, the tasks

371
00:13:48,594 --> 00:13:50,479
and, the activities were going
to be

372
00:13:50,479 --> 00:13:51,631
as part of the study.

373
00:13:51,931 --> 00:13:54,145
And her husband desperately
wanted her in

374
00:13:54,145 --> 00:13:56,035
this study, was also educating
him

375
00:13:56,035 --> 00:13:58,711
that this was not going
to provide treatment, but he

376
00:13:58,711 --> 00:13:59,072
wanted

377
00:13:59,072 --> 00:14:01,430
it was such a thorough overview
to be able

378
00:14:01,430 --> 00:14:03,676
to identify what was going on
with her.

379
00:14:03,676 --> 00:14:05,655
He was
he was somewhat desperate to get

380
00:14:05,655 --> 00:14:06,112
it done.

381
00:14:06,112 --> 00:14:08,448
And the investigator
we came back from like, well,

382
00:14:08,448 --> 00:14:10,349
if she doesn't have capacity and
we know

383
00:14:10,349 --> 00:14:12,251
this, and they had GPAs and
everything,

384
00:14:12,251 --> 00:14:14,387
but she was very clear
she did not want to be here.

385
00:14:14,387 --> 00:14:16,155
She didn't understand what NIH
was,

386
00:14:16,155 --> 00:14:19,121
but in her mind,
she equated it with medical

387
00:14:19,121 --> 00:14:19,525
care.

388
00:14:19,525 --> 00:14:21,694
And it scared her to terribly.

389
00:14:21,694 --> 00:14:23,365
And we said, you can't enroll
her

390
00:14:23,365 --> 00:14:24,530
because she is clearly

391
00:14:24,530 --> 00:14:26,966
right from the outside saying,
I do not want to be here.

392
00:14:26,966 --> 00:14:28,835
It was very disappointing for
the husband.

393
00:14:28,835 --> 00:14:30,436
And I think what was helpful at
that

394
00:14:30,436 --> 00:14:31,637
point was the investigator

395
00:14:31,637 --> 00:14:34,711
then was working with him
to make sure that he was going

396
00:14:34,711 --> 00:14:35,041
to be

397
00:14:35,041 --> 00:14:37,610
they were going to be referred
on the outside to,

398
00:14:37,610 --> 00:14:40,646
a facility
that could help them a bit more.

399
00:14:40,646 --> 00:14:41,314
At that. Point.