Tell us about this case.
And maybe tell us a little about the trial.
They're being approached him.
We were all.
Right as it as it says here.
Hopefully everybody can hear me.
B is an adult who presents with the clinical center.
To participate in.
This means minor increment over minimal risk,
not for direct benefit dementia study.
So the day before the study, the investigator had called this
person
to educate her about the study.
As I was talking about, to make sure when she comes in
for the capacity assessment, she has more information.
There's had she's had an opportunity
to ask him questions.
That sort of thing.
The study does allow for LA concerned,
and she brings her adult daughter
in with her, whom she has already assigned
as her durable power of attorney.
So that's not an issue at all.
So if she doesn't have capacity,
we can automatically go to the the adult daughter.
So the study does require us to come in
and do the capacity assessment.
And at that time, you know, we determined
she doesn't have capacity
at the time of the assessment, which then
means, you know, we can go to surrogate,
but the daughter also then indicates
that she is eligible to enroll in a,
MRI study of minimal risk,
or rather minimal risk longitudinal study
with another NIH institute.
So what are some of the things that people think about
how we would proceed at this point
to get her to give one away.
And and don't feel like you have to run over to the MC
for this.
So imagine this is a situation that you're faced with.
You know, what do we do?
Should we just go ahead and enroll her?
One option would be in this case,
maybe we now go to the daughter
who has durable power of attorney
and the study allows for an lar consent.
So tell me, Carol, what is.
So the last bullet here about that.
She's also eligible to enroll in another study.
How would that come in to your considerations?
Well, I think one of the things that the daughter was concerned
about was
when we discovered she didn't have capacity at that
moment.
As you
mentioned, the daughter has DPA and the mother was fine.
The participant was fine with the daughter,
giving surrogate consent for her for the intimate study.
However, the daughter was concerned
about what that meant for the other study.
Could she participate or not?
And while we don't have any sway or any decisions to be made or
assessments
for something like that,
one of the things that we always talk
about is it's a minimal risk study
that somebody can have capacity for one
study, but not have capacity for another.
So it really would be up to the researchers of that other
study
to make their determination about whether or not she had
capacity
to give her own consent or not.
Now, of course, the we would be documenting and,
our researcher would be documenting
our finding that, you know,
we used a surrogate and that would be
something that would be available to them.
They could see that.
But again, it does it shouldn't have an effect on the other
study.
They need to make their own determination
because it's a different study.
And she might very well have capacity for that. Yeah.
So so maybe another way of saying that
is that the first one,
just to remind folks, it's a minimal increase
over
minor risk and no direct benefit to the
participant.
And so I don't mean to put words in your mouth,
but that's what that study is riskier.
And the daughter might be uncomfortable
making a decision that puts her mother at some
risk,
but maybe more comfortable with the lower risk.
In the sense that
her burden might be less and, you know, if something
maybe went wrong. But.
Are you saying that the capacity
might be different because it's riskier,
or are you saying that the group who's
assessing in the second study might have
a different way of assessing capacity.
I think it can be both okay.
Because the riskier study that would be ours
does have, like a positron emission
tomography Pet scan.
They're going to have an arterial line.
They're going they can stay on their
medications,
but it's more involved where again,
there can be yeah, there can can be
a definitely higher there's clearly
a higher risk associated with it.
And it's not for direct benefit.
It's not like
they're going to be giving her medication
or having a procedure where she might
her memory might improve is is strictly for clinical
research.
And I would say a lot of times what we hear from folks is
they have an understanding that this isn't going to help
them.
We don't just say not for direct benefit.
We you know, they're very good investigators,
very good about explaining what that
means.
You're helping the future.
And a lot of these folks will come in
just several in the last couple of weeks.
You know, I know this isn't going to help
me,
but my mother had this one woman,
her brother had it.
They had already both passed away.
And they were worried about their children
and their grandchildren.
And so a big part of their motivation
was that they wanted to be able to contribute to the future.
And maybe it will help their family members.
And again, the other, the minimal risk longitudinal
study
may have nothing to do with Alzheimer's.
It may have dementia, it may be something else
entirely.
We didn't know, but it would be important
then, obviously, for that team
to do their own assessment. And for the daughter,
she can still weigh in even if her mother has capacity.
But, it would be a
they would come to their own decision
separately about that.
Great.
And and it's sometimes right since, Carol and her group,
I'm just getting the picture so we can move to the next case.
That, you know,
we might be the folks who are asked to come in
the Department of Bioethics might be asked
to come in for the second one.
Right.
And as Carol noted, one difference
between our approaches is that
for the animated studies
where HSP is written in,
they are tailoring an assessment specific
to a very specific protocol.
We ask a whole series of questions
that they're generic in the sense
that they are.
Tell me about the purpose, but don't quote me.
Tell me about the purpose of the study,
or tell me what risks
you might be exposed to where you're looking for.
You've already prepared to get particular answers to those
questions.
So it could be that when we do the assessment for the minimal
risk study,
they do have the capacity to understand
the, you know, relatively minimal procedures
that are involved in the MRI study.
So we're going to go to case two.
So tell us a little about this one. Yes.
She has schizophrenia, is enrolled
in a minimal risk screening
protocol on the inpatient unit to determine their eligibility
for a more than minimal risk, not for direct benefit,
double blind, placebo controlled study
with accompanying Pet and MRI studies.
The nursing staff at this point, typically,
with these cases, these folks come in into this screening
protocol
and they're there for at least several weeks, sometimes longer,
before
we're doing a capacity assessment for the,
higher risk study, as in nursing provides
that education.
About the study.
As I said prior to us coming in and
assessing them in this particular study,
either study an LA is not permitted
to provide consent on their behalf.
They have to have capacity in order to part the participant
has to have capacity in order to participate in the
study.
So at this time, we determined that
Si did not have capacity.
And also Si had indicated some reservations about
participating.
And that's not an unusual scenario
that we have as well.
So what what do people think our next steps are?
So one option right might just be okay.
So he doesn't have capacity.
He is therefore not eligible for this study.
And that's it.
Send him on his way.
Is there any ideas about an alternative to that.
So what I would say what we would do is we would,
again, given
that the person has concerns about participate,
maybe they're
they're not entirely sure that they want to do
is we have a conversation about that.
What is that about?
And we talked with the researchers
to one option is
we would if the person give them the
choice
because we were always very, very clear,
especially with this population,
that it's their decision to participate in the study.
And it's not atypical that you get really well-meaning
family and friends who they feel like
they're here at the NIH.
This is the gold standard.
If anybody can help this, my loved one, you can't.
But we always remind them it's this person's the participant's
decision.
And we can say there's there's several options.
You can be discharged.
That's fine.
You can go back home or wherever that is,
whatever that scenario is if you want to.
And we can remind them again, you don't have to do this.
Do you want to, spend more time learning more about
the study,
and we'll talk about the areas that they had difficulty with.
We'll talk about it with the researchers,
because the researchers don't
want to pressure somebody to stay at that point.
But sometimes at that point, the person has a clear
understanding,
like, okay, you know, even though my parents are
saying
and this is somebody obviously age 18 or older,
and this is not an unusual scenario
where they say, okay, so
you really mean my parents can't make me
stay or like, you know, they can't?
Well, maybe I will stay then.
And I'll say they've been here for a couple of weeks at this
point.
So they've gotten used to the unit,
which is really, really helpful.
They've developed a rapport with the staff, but everybody is
continuous reminding them, this is your decision about
being here.
And even if you get into the study,
even if you do go into this more
risky study, higher risk study, you can still change your your
mind.
And so sometimes what a person will say,
okay, I
all right, I will stay I know I can't,
I really can change my mind.
And then we would do more education and
then we'd reassess and see where we are.
At that point.
If they still don't have capacity,
then, you know,
we're talking with the researchers
and it could be
this person is never going to have capacity to give their own
consent.
And so they need to start planning
for discharge.
We've had some people who decide they want to go back home
and think about this more and maybe talk with a lot
of times
they're living with family members,
talk about this more.
And we've had people come back.
I've also had people who had capacity
and they self-sabotage
because they thought they were being
made to stay, that their parents were putting too much pressure
on them,
and then they ultimately went home,
and then they came back.
And then we've had people.
It's it's typical.
It's not typical that people don't have capacity.
We've had that a handful of times
and gave them several opportunities
and they may stabilize them.
Maybe they make treatment recommendations, differences,
and then they'll they'll send them back home
and they won't go through the the higher risk protocol.
As a general rule,
studies that are
no more than minimal risk or what
I'll call sort of a natural history study
so often, folks with rare disorders
for which there are no treatments
might enroll in a study here at the
clinical center and all, quote unquote.
The team wants to do is like, collect blood samples,
maybe do some genetic analysis.
So there's very little physical risk.
So the idea is that in that case,
it's it's relatively common for there to be,
an LA designation
when the risk starts to rise.
There are concerns about, is it okay to enroll someone
who doesn't have capacity in a trial
that has some risk and no direct benefit?
It's just a respect for
and the ability of the person to make a decision on their own
behalf.
And then there's a little sort of space
in the middle of
there is more than minimal risk, the potential for direct
benefit.
And that's where there's,
maybe, less common.
Right.
I guess to say sometimes there's an la,
sometimes, ability, sometimes there isn't.
That's when it really comes to the team
and how they want to move forward
and their considerations about the intervention or the
disease.
Right.
As Christine and Scott both mentioned.
Right. Some research.
So let's imagine someone who has Alzheimer's, who's in a later
stage,
they may not have capacity,
but this study may,
have some direct benefit for them.
And so we have to enroll people
who have Alzheimer's in order to find that out.
And so that is a real clear case where the investigators in
advance
would want to make sure that an LA
is, allowed to make that decision.
And also on the heels of that is important
to remember the concept of a
in the sense.
Yes, as well.
For example, we had, a woman with Alzheimer's
disease
and her husband had brought her here.
She clearly did not have capacity.
She didn't understand what was going to be done.
Even after we talked with her about what
the, the tasks
and, the activities were going to be
as part of the study.
And her husband desperately wanted her in
this study, was also educating him
that this was not going to provide treatment, but he
wanted
it was such a thorough overview to be able
to identify what was going on with her.
He was he was somewhat desperate to get
it done.
And the investigator we came back from like, well,
if she doesn't have capacity and we know
this, and they had GPAs and everything,
but she was very clear she did not want to be here.
She didn't understand what NIH was,
but in her mind, she equated it with medical
care.
And it scared her to terribly.
And we said, you can't enroll her
because she is clearly
right from the outside saying, I do not want to be here.
It was very disappointing for the husband.
And I think what was helpful at that
point was the investigator
then was working with him to make sure that he was going
to be
they were going to be referred on the outside to,
a facility that could help them a bit more.
At that. Point.