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My name is Carole Squires.

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I am with the NIMH
National Institute of Mental

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Health human subjects protection
unit.

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I'm going to go ahead
and make sure I can get the

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slides going.

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Great.

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As I mentioned, I'm
with NIMH Human Subjects

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Protection Unit,

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also known as HSP.

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We work specifically, under
Doctor

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Maryland Pao.

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She is the office
of the clinical director.

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She is the clinical director of
NIMH.

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She's our direct supervisor.

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There are three of us, myself,

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Katherine Todman,
who is the director of HSPU.

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And Julie Brintnall-Karabelas,
who's here for moral support

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today.

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We are all social workers.

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We are all licensed
professionals here in the DMV

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area.

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As it says here, we are
clinicians

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who are independent of the
researchers.

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And basically being independent
of the research team does allow

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us

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a level of neutrality and
objectivity

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because we are not invested in
whether

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somebody participates in the
study.

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What we want to ensure is that
somebody

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gets all of the information that
they need

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to make an informed decision
to participate in research.

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We are also a part of the team.

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The ability to Consent
assessment team,

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which is a combination of the
bioethics

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department and ourselves.

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We work collaboratively
with them and we work on,

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issues around

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individuals who individuals,
researchers

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get in touch with

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when they have concerns about
somebody's

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ability to give their own
consent.

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Here at the clinical Center,
I'll talk

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about that a bit more in a
moment.

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In addition,
our overall overarching

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functions in HSP,

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as it says here, is
we provide protection and

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advocacy,

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and we focus on what we refer to
as individuals

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who are potentially vulnerable
participants.

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A little bit of background.

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We'll have some case studies
later.

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Well, we'll talk about this a
bit more,

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but the folks that come into our
states,

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we see, children as well as
adults.

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They can have, mood and anxiety
disorders,

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major depression.

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We have a study that looks at
folks

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with schizophrenia, psychotic
disorders.

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We see children that have an
array

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of different, mood disorders as
well.

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But I think one of the things
that we have all come to

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recognize

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is that the term vulnerability
can apply to all of us.

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It doesn't mean that you have to
have

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a behavioral health diagnosis

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in order to be vulnerable.

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One of the examples I use, like
if I were to fall down the

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stairs

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here, ended up in the Ed across
the street.

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People are putting paperwork
in front of my face.

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I'll sign just about anything.

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I may or may not need my husband
to be

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there to help out with this sort
of thing,

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but I think it's important
to just bear in mind that the

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the term vulnerable can be
applied

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to all of us at any potential
given time.

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We assess, develop and implement
protections.

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For example,
some of the the things that we

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do,

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as clinical research advocates
or crawlers, as we call

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ourselves.

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We provide consent monitoring
for all of the new inpatient

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studies.

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That means we're actually
sitting

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there when somebody is,

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the consent is being discussed
with them.

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They're being informed about
what's going

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to be done before they actually
sign it.

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We do participant monitoring,
which means we we go

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see the people who are
inpatients

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and imh studies on a regular
basis.

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At least once a week.

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We attend rounds.
We talk to the clinical staff.

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We have an ongoing relationship
with all of them, to make sure

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that people

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are continuing to be informed
about what

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their they're doing within the
study.

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And do they still want to
participate?

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Then we also help to, assist
in applying the different

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regulations

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and policies like the clinical
center

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policy, NIH policies, federal
policies,

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that sort of thing.

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We also provide education.

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We provide a consent, obtaining
consent

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sort of training.

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It's called elements

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of a successful informed consent
that is mandatory for all NiMH.

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Investigators
are going to be obtaining

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consent,

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but a lot of the clinical center
has embraced it as well.

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Anybody can take it at any time.

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It's only mandatory for New Age.

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Hopefully today.

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Objective wise,

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we are going to be talking about
knowing

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what the consent capacity
process is.

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I'll talk about what we do
within a few.

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Again, more detail about how we
assess

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for capacity consent capacity

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for the different studies
that we have here and also

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identifying

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what contributes to a good
capacity

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assessment in terms of it going
well

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and what the pitfalls can be.

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It can be an anxiety producing,
moment

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sometimes,

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depending on how prepared people
are for.

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And I'll talk a little bit about
that,

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what our experiences are.

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And then we'll also talk about,
things

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to consider

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when you're enrolling
potentially vulnerable

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populations.

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Also, one of the things I want

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to kind of give a shout out to
as well,

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and I mentioned this to Holly
beforehand.

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She says she has uploaded the
link and

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you have access to the
PowerPoint as well.

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We put together, a toolkit
that is very dense,

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very comprehensive and encourage
people

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to take a look at that.

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If somebody on the outside
is thinking about,

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developing research projects
and you are are considering

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enrolling

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people were capacity might be an
issue,

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but even just any individual

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who would be participating,
it talks you through things to

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consider

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about during the consent process
when you are enrolling children.

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All kinds of different things
I think is really, really,

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really good.

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We're very proud of that.

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This is, our new image
consent process flowchart.

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I give a shout out to Catherine
Todman.

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She put this together, and it
really talks

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about, more specifically within.

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And I sure it can be used
for any potential protocol

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when you're thinking about
including

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people who may not have consent
capacity.

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So it takes you, walks
you through the process of

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does the protocol allow what you
do?

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If the protocol doesn't allow
it, then,

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you know, what can you do at
that point?

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So I'm not going to go through
this

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at this point in time.

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But it's there for you.

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Again,
a good reason to take a look at

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the,

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PowerPoint that's uploaded.

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This is then, capacity
assessment

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algorithm, I think is is really
helpful

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as well.

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At the top,
it talks about, you know, the

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before we go

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in to assess somebody's consent
capacity,

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we want to make sure that the
researcher

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is educated, a potential
a participant about the

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protocol.

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That's before we go in.

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It's we always say it's not fair
of us

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to ask questions of a person
about a study

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if they haven't really had an
opportunity

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to talk with the researcher
or somebody from the study team,

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enlightening them, educating
them

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about what the study entails.

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You know, we're interested in
you because

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you have this condition that's
going on.

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These are the tasks or the
procedures

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we're going to ask you to do

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what the potential risks
are of each of those procedures.

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You're going over that
they need to have that prior

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education

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before we can go in
and really properly assess them.

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So then the next category down,
it says

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HSP administers the capacity
assessment.

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What we always do
is we make it a conversation.

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I'll go through the different
domains

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that we use and how we structure
our

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capacity assessment.
The actual tool itself.

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But again, we're interested

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in what people know
and understand about the study.

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And we always encourage clarify

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with people, because we're
asking them

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a lot of questions.

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It's just specifically about the
study,

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what we're determining,

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what we're asking them about.

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We're not concerned about

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whether they live alone in the
community

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or if they can manage their own
finances.

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If they have a job,

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we want to know what their
understanding

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is in this point in time.

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It's kind of a snapshot of what
their understanding is about the

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study.

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So again, I'll talk a little bit
more about the actual questions

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and how we set this up.

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But after we've had time to talk
with them

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and depending on the person,
it can be 10 or 15 minutes.

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It may take a little bit longer
if they have questions

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or they want to talk some more,
that's fine.

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And typically there are two of
us

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that, actually do the
assessment.

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One is the interviewer,
one is the person who's taking

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notes

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and kind of watching and adding
what they need to at the time,

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but they're also,
taking in what the person is

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saying

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typically, then we'll have a few
minutes

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outside of the room

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after we're finished with the
person

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and we can have a discussion,
like,

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do we have concerns about this
person?

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Is there a lot of times
there's not even a question.

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All we can go straight then
into,

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the consent process,

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within I mean, for them we're
providing

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consent monitoring for those
people.

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So what we're looking at
and it talks about the three

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different

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kind of categories that we
we have after we've done the

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assessment,

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is the person able
to give their own consent.

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There's no question.

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Is there a possibility
that the person has a

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are we concerned
that there's a questionable

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ability.

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Maybe they get, you know,

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kind of the overarching
understanding,

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but there may be some specifics
about it.

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So it's a little bit
questionable.

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And we we then are going to take
that

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to the researcher.

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We're going to talk to them
about.

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This is what we found.

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You know, at this point in time
we we do feel like yes, you

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know,

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clinically that these people
get most of it, but they may

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need some,

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some help, some guidance
and some reminders from folks as

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00:09:45,269 --> 00:09:45,618
well.

263
00:09:45,919 --> 00:09:48,376
Or do we find that the person
absolutely

264
00:09:48,376 --> 00:09:49,789
does not have capacity

265
00:09:49,789 --> 00:09:50,990
at this time and again?

266
00:09:50,990 --> 00:09:52,592
Then, as it says here

267
00:09:52,592 --> 00:09:55,545
next the researcher decides
and the different options under

268
00:09:55,545 --> 00:09:56,095
that, then

269
00:09:56,463 --> 00:10:00,033
do they want to spend more time
educating the participant?

270
00:10:00,033 --> 00:10:02,635
It could be that given some more
time,

271
00:10:02,635 --> 00:10:05,277
some more information,
they might actually have

272
00:10:05,277 --> 00:10:05,839
capacity,

273
00:10:06,206 --> 00:10:09,375
to give their own consent,
if the protocol allows it.

274
00:10:10,009 --> 00:10:11,993
At this point, do we want to
pursue,

275
00:10:11,993 --> 00:10:13,646
make sure that it's a legally

276
00:10:13,646 --> 00:10:15,511
authorized representative or a
surrogate

277
00:10:15,511 --> 00:10:17,283
who's giving consent on their
behalf?

278
00:10:17,484 --> 00:10:20,137
Sometimes it's like, yes, they
we feel like, yes, they have

279
00:10:20,137 --> 00:10:20,587
capacity,

280
00:10:20,587 --> 00:10:22,448
but they could benefit from
reminders

281
00:10:22,448 --> 00:10:23,957
and this person helping them,

282
00:10:23,957 --> 00:10:27,627
but they still have the ability
to give their own consent or

283
00:10:27,961 --> 00:10:29,896
they're not going to be enrolled
at all.

284
00:10:29,896 --> 00:10:32,563
So again, that's a conversation
with,

285
00:10:32,563 --> 00:10:33,933
the investigators.

286
00:10:34,501 --> 00:10:36,436
We're talking
amongst ourselves about that.

287
00:10:36,436 --> 00:10:38,671
And we always want to make sure
that,

288
00:10:38,671 --> 00:10:41,508
people are aware,
we want to normalize the process

289
00:10:41,508 --> 00:10:43,666
and make sure that participants
know

290
00:10:43,666 --> 00:10:45,645
that this is a part of the study

291
00:10:45,645 --> 00:10:48,839
in in our cases,
a lot of times it's protocol

292
00:10:48,839 --> 00:10:49,549
mandated.

293
00:10:49,549 --> 00:10:51,186
They have written it into the
protocol

294
00:10:51,186 --> 00:10:52,952
that we're going to be assessing
people.

295
00:10:52,952 --> 00:10:54,587
So we don't want any surprises.

296
00:10:54,587 --> 00:10:56,589
We want people to know
that this is going to happen.

297
00:10:56,589 --> 00:10:59,192
And these are the potential
outcomes.

298
00:10:59,192 --> 00:11:02,629
So this is just some
more information then about,

299
00:11:03,730 --> 00:11:04,264
typically

300
00:11:04,264 --> 00:11:06,358
what happens here at the
clinical center

301
00:11:06,358 --> 00:11:07,300
and specifically,

302
00:11:07,300 --> 00:11:10,014
you know, talking at length
about,

303
00:11:10,014 --> 00:11:11,371
what we do here,

304
00:11:12,639 --> 00:11:14,107
in intimate.

305
00:11:14,107 --> 00:11:17,243
So adult participants
at the clinical center

306
00:11:17,243 --> 00:11:19,216
in order to give their own
consent,

307
00:11:19,216 --> 00:11:20,513
have to have capacity.

308
00:11:20,914 --> 00:11:23,513
So most of the time, most often
what happens in the clinical

309
00:11:23,513 --> 00:11:23,816
center

310
00:11:23,816 --> 00:11:26,819
is that the investigators
who are obtaining consent,

311
00:11:27,220 --> 00:11:28,922
they're using their own clinical
judgment.

312
00:11:28,922 --> 00:11:31,891
They don't necessarily have a
separate,

313
00:11:32,258 --> 00:11:35,230
assessment tool that they use
that has specific questions on

314
00:11:35,230 --> 00:11:35,428
it.

315
00:11:35,428 --> 00:11:37,516
They're using their own clinical
judgment

316
00:11:37,516 --> 00:11:38,331
and acumen and,

317
00:11:38,331 --> 00:11:39,966
you know, that's been approved
by the IRB.

318
00:11:39,966 --> 00:11:41,134
That's fine.

319
00:11:41,134 --> 00:11:44,671
A more formal process
like it says here can include

320
00:11:44,938 --> 00:11:47,707
ourselves, HSP or the A cat
team.

321
00:11:47,707 --> 00:11:51,076
And just as a again, a reminder
we have a

322
00:11:51,076 --> 00:11:54,280
couple of we have an outpatient
study.

323
00:11:54,280 --> 00:11:58,286
We have an inpatient study
where ESP is written into that

324
00:11:58,286 --> 00:11:58,918
protocol

325
00:11:58,918 --> 00:12:03,056
to assess independently assess
someone's consent capacity.

326
00:12:03,356 --> 00:12:05,341
So as it says here, for a
protocol

327
00:12:05,341 --> 00:12:07,093
specific capacity assessment,

328
00:12:07,493 --> 00:12:09,725
you know, it's used
when the protocol requires that

329
00:12:09,725 --> 00:12:10,163
they need

330
00:12:10,163 --> 00:12:13,166
to be formally and independently
assessed.

331
00:12:13,466 --> 00:12:16,636
We create the tool
in advance. What we do is

332
00:12:17,704 --> 00:12:19,839
and again I'll talk about it a
bit more.

333
00:12:19,839 --> 00:12:22,417
We create the questions, we
develop

334
00:12:22,417 --> 00:12:25,511
the expected answers for those
questions,

335
00:12:25,511 --> 00:12:28,027
but we share that with the
investigator,

336
00:12:28,027 --> 00:12:30,416
the Pi of the protocol ahead of
time.

337
00:12:30,416 --> 00:12:31,951
You know, this is what we're
going to ask.

338
00:12:31,951 --> 00:12:34,287
Are these the answers we would
expect?

339
00:12:34,287 --> 00:12:35,855
These are kind of the minimum
requirements.

340
00:12:35,855 --> 00:12:38,291
We're looking at to think about,

341
00:12:38,291 --> 00:12:41,025
so that we can ensure
somebody does have consent

342
00:12:41,025 --> 00:12:41,594
capacity.

343
00:12:41,894 --> 00:12:44,182
And as I said, we also have
expected

344
00:12:44,182 --> 00:12:45,898
responses to the questions

345
00:12:45,898 --> 00:12:46,666
that we developed.

346
00:12:46,666 --> 00:12:50,470
And we also can use prompts,
especially with some folks.

347
00:12:50,470 --> 00:12:51,070
For example,

348
00:12:51,070 --> 00:12:52,888
we have a study that looks at
people

349
00:12:52,888 --> 00:12:54,807
with dementia as an outpatient
study.

350
00:12:55,141 --> 00:12:56,656
And it can be helpful doesn't
mean that

351
00:12:56,656 --> 00:12:57,744
the person doesn't know it,

352
00:12:57,744 --> 00:12:59,646
but they've got short term
memory problems.

353
00:12:59,646 --> 00:13:01,863
And so giving them a prompt
like, well,

354
00:13:01,863 --> 00:13:03,683
are you going to have any scans

355
00:13:04,017 --> 00:13:04,651
of any kind?

356
00:13:04,651 --> 00:13:05,918
And they may not be able to say,

357
00:13:05,918 --> 00:13:07,969
oh, it's going to be a positron
emission

358
00:13:07,969 --> 00:13:10,123
tomography or Pet scan, but they
can say,

359
00:13:10,123 --> 00:13:12,109
I've had these scans where, you
know,

360
00:13:12,109 --> 00:13:13,826
I lay down flat and it's noisy.

361
00:13:13,826 --> 00:13:16,344
Well, they're describing an MRI.
So we know that they do get

362
00:13:16,344 --> 00:13:16,596
that.

363
00:13:16,596 --> 00:13:19,832
So those are the kinds of things
that we feel like it's it's

364
00:13:19,832 --> 00:13:22,399
perfectly acceptable
to talk to them about the

365
00:13:22,399 --> 00:13:23,069
difference.

366
00:13:23,069 --> 00:13:25,316
Then we
they're also generic capacity

367
00:13:25,316 --> 00:13:26,105
assessments.

368
00:13:26,105 --> 00:13:29,442
And as it said,
you know, it's used as a guide

369
00:13:29,442 --> 00:13:31,658
for the unexpected enrollment of
people

370
00:13:31,658 --> 00:13:33,646
who may not have consent
capacity.

371
00:13:33,646 --> 00:13:36,783
And it can, occur in a situation
where,

372
00:13:37,917 --> 00:13:39,844
you know,
the researchers have somebody

373
00:13:39,844 --> 00:13:40,486
who comes in

374
00:13:40,486 --> 00:13:44,152
and this isn't a regular part
of what they see with whatever

375
00:13:44,152 --> 00:13:44,457
the,

376
00:13:45,358 --> 00:13:48,361
the illness or the condition
the person has is not expecting

377
00:13:48,361 --> 00:13:50,521
to see somebody have some
difficulty,

378
00:13:50,521 --> 00:13:52,799
but maybe they want some added
health.

379
00:13:53,499 --> 00:13:55,735
Their own,

380
00:13:55,735 --> 00:13:57,236
assessment, clinical assessment.

381
00:13:57,236 --> 00:13:59,172
They kind of want an outside
opinion.

382
00:13:59,172 --> 00:14:02,017
And so they can contact like the
cat team

383
00:14:02,017 --> 00:14:04,377
and, and the bioethics
department

384
00:14:04,377 --> 00:14:06,864
and one of us may go
or it may be the bioethics

385
00:14:06,864 --> 00:14:07,447
department

386
00:14:07,447 --> 00:14:09,792
that goes,
or it might be us, that sort of

387
00:14:09,792 --> 00:14:10,183
thing.

388
00:14:10,183 --> 00:14:12,151
So it just has more generic
questions.

389
00:14:12,151 --> 00:14:13,820
They're not specific to the
protocol,

390
00:14:13,820 --> 00:14:16,650
but you're looking to make sure
that the person has some

391
00:14:16,650 --> 00:14:17,256
information

392
00:14:17,590 --> 00:14:19,663
about the study itself that, you
know,

393
00:14:19,663 --> 00:14:21,627
lends itself to your
understanding.

394
00:14:21,627 --> 00:14:24,622
Yes. They are,
they have been educated about

395
00:14:24,622 --> 00:14:25,031
this.

396
00:14:25,031 --> 00:14:26,432
And to understand what's going
to happen.

397
00:14:28,768 --> 00:14:31,170
So these are the tools that

398
00:14:31,170 --> 00:14:34,062
in talking about the capacity
assessment

399
00:14:34,062 --> 00:14:36,375
that we use, here with HSP, you

400
00:14:37,243 --> 00:14:40,413
they're clinically derived
and have not been validated.

401
00:14:40,813 --> 00:14:43,249
They do use four different
domains.

402
00:14:43,249 --> 00:14:46,352
And we have approximately 9
to 11 questions.

403
00:14:46,352 --> 00:14:49,622
And they're open ended questions
because we again, we want this

404
00:14:49,622 --> 00:14:52,592
to be more of a conversation
rather than a checklist.

405
00:14:53,159 --> 00:14:55,334
You want to be able to talk to
somebody

406
00:14:55,334 --> 00:14:57,063
because sometimes depending on

407
00:14:57,063 --> 00:14:58,686
whether this is an outpatient
study,

408
00:14:58,686 --> 00:15:00,399
if they're just coming in for
the day

409
00:15:00,399 --> 00:15:02,902
and they're going to be coming
back over

410
00:15:02,902 --> 00:15:04,403
time, you may not have,

411
00:15:04,704 --> 00:15:08,040
they haven't had a lot of time
to have the education piece.

412
00:15:08,341 --> 00:15:10,276
And you want them
they they've gone through

413
00:15:10,276 --> 00:15:12,352
they've driven here with a
family member

414
00:15:12,352 --> 00:15:14,013
perhaps, or maybe on their own.

415
00:15:14,847 --> 00:15:16,549
They've also gone through
admissions.

416
00:15:16,549 --> 00:15:17,750
They're trying to, you know,

417
00:15:17,750 --> 00:15:19,339
make sure that they're in the
right spot

418
00:15:19,339 --> 00:15:20,253
at the right location.

419
00:15:20,253 --> 00:15:22,456
So if there's a little
understandable

420
00:15:22,456 --> 00:15:24,957
anxiety and just kind of getting
settled,

421
00:15:24,957 --> 00:15:26,602
you want to give that person
time

422
00:15:26,602 --> 00:15:28,694
to get settled enough and get
comfortable

423
00:15:28,694 --> 00:15:30,609
enough with you
that you can have that

424
00:15:30,609 --> 00:15:31,264
conversation

425
00:15:31,264 --> 00:15:32,999
and not feel like they're being
quizzed.

426
00:15:34,467 --> 00:15:36,536
Usually we have two evaluators.

427
00:15:36,536 --> 00:15:39,205
We can do it with one person.

428
00:15:39,205 --> 00:15:40,072
It does work.

429
00:15:40,072 --> 00:15:42,749
Well, I think with two,
because then clinically

430
00:15:42,749 --> 00:15:43,376
afterwards

431
00:15:43,376 --> 00:15:45,322
people can can talk with each
other

432
00:15:45,322 --> 00:15:46,212
and share their

433
00:15:46,212 --> 00:15:47,408
their thoughts and their
opinions

434
00:15:47,408 --> 00:15:48,314
about what they've seen.

435
00:15:48,314 --> 00:15:50,550
And make sure that your, your
we're both,

436
00:15:50,550 --> 00:15:52,785
you know, comfortable with
moving ahead.

437
00:15:53,586 --> 00:15:56,524
It consists of, as it mentioned,
tailored questions to each

438
00:15:56,524 --> 00:15:56,923
domain.

439
00:15:56,923 --> 00:15:59,091
And I think this is really,
really helpful.

440
00:15:59,091 --> 00:16:03,696
We developed a shorter version
of the Mcats here,

441
00:16:03,696 --> 00:16:05,231
which is the MacArthur
Competence

442
00:16:05,231 --> 00:16:06,999
Assessment Tool for Clinical
research

443
00:16:06,999 --> 00:16:10,699
that was developed by doctors
Paul Applebaum and Thomas

444
00:16:10,699 --> 00:16:11,237
Grasso.

445
00:16:11,237 --> 00:16:13,272
And they created these four
domains.

446
00:16:13,272 --> 00:16:15,985
It was, in 2001 and was for
individuals

447
00:16:15,985 --> 00:16:17,376
with schizophrenia.

448
00:16:17,376 --> 00:16:19,579
It was many, many more
questions.

449
00:16:19,579 --> 00:16:23,549
And so we tailored it down
to, fewer questions.

450
00:16:23,549 --> 00:16:25,828
But we still use the domain
concept,

451
00:16:25,828 --> 00:16:28,487
which I think is really, really
valuable.

452
00:16:28,988 --> 00:16:30,656
Understanding is the first
domain.

453
00:16:30,656 --> 00:16:32,542
And as it says here, it's
understanding

454
00:16:32,542 --> 00:16:33,993
of the potential participants

455
00:16:34,260 --> 00:16:36,963
personal situations,
study specific procedures.

456
00:16:38,497 --> 00:16:39,532
The questions that

457
00:16:39,532 --> 00:16:42,702
we ask underneath of that domain
typically are like,

458
00:16:42,702 --> 00:16:44,544
what do you have that the
researchers

459
00:16:44,544 --> 00:16:45,938
are interested in studying?

460
00:16:46,205 --> 00:16:49,041
And for example, somebody comes
in, has Alzheimer's disease.

461
00:16:49,041 --> 00:16:51,811
They don't necessarily
have to say Alzheimer's disease.

462
00:16:51,811 --> 00:16:53,983
But if they can convey to you
that they're

463
00:16:53,983 --> 00:16:55,948
having memory difficulties, you
know,

464
00:16:55,948 --> 00:16:57,600
I'm worried about this a lot of
times

465
00:16:57,600 --> 00:16:59,118
they'll say it's in their
family.

466
00:16:59,118 --> 00:17:01,854
So you're asking them questions
about what brings you here

467
00:17:01,854 --> 00:17:04,290
and what are some of the tasks
or the procedures.

468
00:17:04,290 --> 00:17:06,092
What are they going to ask you
to do

469
00:17:06,092 --> 00:17:07,393
as part of the study here

470
00:17:07,593 --> 00:17:10,065
at NIH, as you're going to be
involved

471
00:17:10,065 --> 00:17:11,430
in, then if they get

472
00:17:11,631 --> 00:17:13,183
if that seems clear that they
have

473
00:17:13,183 --> 00:17:15,101
a good understanding of why
they're here,

474
00:17:15,101 --> 00:17:16,977
what they're going to be asked
to do,

475
00:17:16,977 --> 00:17:18,905
then the next domain is
appreciation.

476
00:17:18,905 --> 00:17:21,381
And as it says
here, it's the appreciation of

477
00:17:21,381 --> 00:17:22,041
the effects

478
00:17:22,041 --> 00:17:25,244
of study participation
on the potential participant.

479
00:17:26,012 --> 00:17:28,381
What that kind of translates
to then in questions

480
00:17:28,381 --> 00:17:31,450
is, you know,
what are you going to have to do

481
00:17:32,485 --> 00:17:34,161
in Europe to change a bit in
your life

482
00:17:34,161 --> 00:17:35,087
in order to be here?

483
00:17:35,087 --> 00:17:38,190
For example, we have, a study

484
00:17:38,190 --> 00:17:40,896
on the seventh floor
with people who have psychotic

485
00:17:40,896 --> 00:17:41,427
disorders

486
00:17:41,727 --> 00:17:44,503
and they have to come and stay
for many,

487
00:17:44,503 --> 00:17:46,098
many months at a time.

488
00:17:46,299 --> 00:17:47,366
So what we want to know

489
00:17:47,366 --> 00:17:49,201
is, are you going to have to
come off of you're like,

490
00:17:49,201 --> 00:17:51,871
are you going to come off
of your medications?

491
00:17:51,871 --> 00:17:53,372
Did you have to travel here?

492
00:17:53,372 --> 00:17:55,828
Are you if you're an outpatient,
are you going to be driving

493
00:17:55,828 --> 00:17:56,442
yourself here?

494
00:17:56,442 --> 00:17:57,810
How are you going to get back
and forth?

495
00:17:57,810 --> 00:17:59,145
How is that going to affect your
life?

496
00:17:59,145 --> 00:18:01,248
We even talked to people about
their pets

497
00:18:01,248 --> 00:18:02,581
because that's of course,

498
00:18:02,581 --> 00:18:05,115
a concern for people
that are going to be here for a

499
00:18:05,115 --> 00:18:05,651
long time.

500
00:18:05,651 --> 00:18:07,627
Are they going to have somebody
that can

501
00:18:07,627 --> 00:18:09,455
take care of their animals for
them?

502
00:18:09,655 --> 00:18:11,835
So it's appreciating
what it means to actually be

503
00:18:11,835 --> 00:18:12,058
here

504
00:18:12,058 --> 00:18:15,133
at the clinical center
and how that may impact your

505
00:18:15,133 --> 00:18:15,494
life.

506
00:18:16,028 --> 00:18:17,897
The next domain then, is
reasoning.

507
00:18:17,897 --> 00:18:19,699
And as it says here, it's the
reasoning

508
00:18:19,699 --> 00:18:22,702
of why potential participants
want to be in research.

509
00:18:22,702 --> 00:18:24,570
And one of the things that we
always say,

510
00:18:25,605 --> 00:18:28,183
to people
is we're not the motivation

511
00:18:28,183 --> 00:18:28,741
police.

512
00:18:28,741 --> 00:18:30,443
There are a lot of different
reasons

513
00:18:30,443 --> 00:18:32,395
why people want to come to the
NIH

514
00:18:32,395 --> 00:18:33,946
to participate in a study,

515
00:18:34,146 --> 00:18:36,279
but what we want to make sure
about

516
00:18:36,279 --> 00:18:38,351
is ensuring that people are
using

517
00:18:38,351 --> 00:18:42,421
the information about the study
to make an informed decision.

518
00:18:42,421 --> 00:18:44,832
For example, if it's a study
where there's

519
00:18:44,832 --> 00:18:46,726
no potential for direct benefit,

520
00:18:47,026 --> 00:18:48,918
you know they're not going to be
getting

521
00:18:48,918 --> 00:18:50,763
a medication to treat their
condition,

522
00:18:50,997 --> 00:18:54,407
then you want to ensure
that they're not saying, oh,

523
00:18:54,407 --> 00:18:54,800
yeah,

524
00:18:54,800 --> 00:18:56,469
I'm going to come here
and you're going to cure me.

525
00:18:56,469 --> 00:18:59,572
We want to make sure
that that's not going to happen.

526
00:18:59,572 --> 00:19:02,642
And then the last domain is
choice.

527
00:19:02,642 --> 00:19:03,943
How many?

528
00:19:03,943 --> 00:19:06,112
If you're deciding, yes,
I want to do this.

529
00:19:06,112 --> 00:19:07,079
We're like, that's fine.

530
00:19:07,079 --> 00:19:08,931
But we also want to want you to
know,

531
00:19:08,931 --> 00:19:10,082
we take very seriously

532
00:19:10,082 --> 00:19:11,951
when people don't want to
participate in.

533
00:19:11,951 --> 00:19:15,021
How would you, let the
researchers

534
00:19:15,021 --> 00:19:18,090
know if you changed your mind
about being in the study?

535
00:19:18,090 --> 00:19:19,525
These are the different
hierarchies.

536
00:19:19,525 --> 00:19:21,661
I believe Doctor Kim spoke about
this

537
00:19:21,661 --> 00:19:24,938
a little bit, so I won't
I won't go through that in great

538
00:19:24,938 --> 00:19:25,398
detail.

539
00:19:25,398 --> 00:19:29,001
But, we have legal guardians
that can provide,

540
00:19:29,001 --> 00:19:31,671
you know, individuals
come with a legal guardianship.

541
00:19:31,671 --> 00:19:33,379
That paperwork has to be
reviewed

542
00:19:33,379 --> 00:19:34,673
by the Office of General

543
00:19:34,673 --> 00:19:36,542
Counsel here at the NIH.

544
00:19:36,542 --> 00:19:37,910
I'm a social worker.

545
00:19:37,910 --> 00:19:40,904
The the, researchers,
we need to make sure that

546
00:19:40,904 --> 00:19:41,414
lawyers

547
00:19:41,414 --> 00:19:44,409
are looking at that information
to make sure that it covers

548
00:19:44,409 --> 00:19:44,917
research.

549
00:19:44,917 --> 00:19:48,087
Some people come with outside
durable powers of attorney.

550
00:19:48,087 --> 00:19:50,527
If they don't, they can fill out
an NIH

551
00:19:50,527 --> 00:19:53,092
form 200 here for the advance
directive.

552
00:19:53,292 --> 00:19:55,547
Also, surrogates can be next of
kin

553
00:19:55,547 --> 00:19:57,029
depending on the hirer

554
00:19:57,029 --> 00:19:59,965
or depending on the risk
benefit level of a study.

555
00:20:01,467 --> 00:20:03,269
Being able to,

556
00:20:03,269 --> 00:20:06,405
assign, an NIH advance director

557
00:20:06,405 --> 00:20:09,842
directive, the cat is obligated
to come in

558
00:20:09,842 --> 00:20:12,161
if somebody doesn't have consent
capacity

559
00:20:12,161 --> 00:20:13,179
and they haven't.

560
00:20:13,179 --> 00:20:15,681
And it's a protocol
that allows for surrogate

561
00:20:15,681 --> 00:20:16,182
consent.

562
00:20:16,415 --> 00:20:18,951
But they don't have somebody
that they've named the account

563
00:20:18,951 --> 00:20:21,058
then does need to come in and
assess

564
00:20:21,058 --> 00:20:22,521
to make sure even though

565
00:20:22,955 --> 00:20:25,891
assigning somebody to,

566
00:20:25,891 --> 00:20:28,694
make decisions on your behalf
is kind of a lower, it

567
00:20:28,694 --> 00:20:31,697
definitely is a lower bar
than having consent capacity.

568
00:20:31,931 --> 00:20:34,204
You want to make sure that this
person

569
00:20:34,204 --> 00:20:35,401
is clear about what

570
00:20:35,401 --> 00:20:36,936
this individual is going to do
for them.

571
00:20:36,936 --> 00:20:37,970
You want to make sure

572
00:20:37,970 --> 00:20:39,702
that they're aware that they're
giving

573
00:20:39,702 --> 00:20:41,207
that authority to somebody else.

574
00:20:41,474 --> 00:20:45,160
And so the, the Iccat
team can come in and assess for

575
00:20:45,160 --> 00:20:45,578
that,

576
00:20:47,012 --> 00:20:49,433
the validity of the earlier
talking to

577
00:20:49,433 --> 00:20:50,516
with an earlier.

578
00:20:50,516 --> 00:20:54,141
You want to make sure that those
individuals, you want to confirm

579
00:20:54,141 --> 00:20:54,420
that

580
00:20:54,420 --> 00:20:57,590
they're, this is the person
that the individual wants.

581
00:20:58,891 --> 00:21:02,561
That they're allowed under the,
the different categories that,

582
00:21:03,295 --> 00:21:04,830
they themselves have capacity

583
00:21:04,830 --> 00:21:06,942
to give consent on behalf of
somebody else

584
00:21:06,942 --> 00:21:08,300
to participate in research

585
00:21:08,601 --> 00:21:11,149
and that they're representing
the best wishes of the

586
00:21:11,149 --> 00:21:11,737
individual.

587
00:21:12,338 --> 00:21:14,140
One of the things that we will
ask people

588
00:21:14,140 --> 00:21:17,126
is, are you comfortable
speaking up on behalf of this

589
00:21:17,126 --> 00:21:17,576
person?

590
00:21:17,843 --> 00:21:19,622
You may very well have to say to
the

591
00:21:19,622 --> 00:21:21,647
research team, we can't do this
anymore.

592
00:21:21,647 --> 00:21:23,449
This is too difficult for this
person.

593
00:21:23,449 --> 00:21:25,243
And are you comfortable doing
that,

594
00:21:25,243 --> 00:21:26,986
asking questions on their
behalf.

595
00:21:27,253 --> 00:21:29,452
One of the things that we've
asked

596
00:21:29,452 --> 00:21:31,457
people is, how would you, know

597
00:21:31,457 --> 00:21:33,759
if this individual didn't
want to do something?

598
00:21:33,759 --> 00:21:35,871
And that seems to be a helpful
question

599
00:21:35,871 --> 00:21:36,629
for the team.

600
00:21:36,629 --> 00:21:38,273
You know, are they going to a
lot of times

601
00:21:38,273 --> 00:21:39,565
you'll get an answer right away.

602
00:21:39,565 --> 00:21:40,533
Oh, they'll speak up.

603
00:21:40,533 --> 00:21:42,701
They'll say something
if they don't want to do it.

604
00:21:42,701 --> 00:21:45,672
Some individuals,
may behaviorally dissent,

605
00:21:45,672 --> 00:21:46,639
meaning that,

606
00:21:46,639 --> 00:21:47,640
you know, they might cry

607
00:21:47,640 --> 00:21:49,268
or they might get angry and
stomp off,

608
00:21:49,268 --> 00:21:51,110
but you want to make sure that
this person

609
00:21:51,310 --> 00:21:52,645
is comfortable in this role

610
00:21:52,645 --> 00:21:54,132
and they know what their
obligations

611
00:21:54,132 --> 00:21:55,247
are going to be doing. So,

612
00:21:57,316 --> 00:21:58,817
this is just a bit more
information

613
00:21:58,817 --> 00:22:02,087
about when capacity assessments
go well,

614
00:22:02,988 --> 00:22:05,991
you know, when people know
that it's going to happen,

615
00:22:05,991 --> 00:22:08,382
when the paperwork
has been looked at ahead of

616
00:22:08,382 --> 00:22:08,694
time,

617
00:22:08,694 --> 00:22:10,671
that you make sure that you've
arranged

618
00:22:10,671 --> 00:22:12,598
plenty of time to do the
assessments.

619
00:22:12,598 --> 00:22:15,668
But any and all assessments
before consent is signed,

620
00:22:16,936 --> 00:22:18,963
making sure that the
investigator

621
00:22:18,963 --> 00:22:20,806
finds out how the participant

622
00:22:20,806 --> 00:22:22,513
and the person that they might
name

623
00:22:22,513 --> 00:22:24,610
as their surrogate, how do they
get along?

624
00:22:24,610 --> 00:22:26,011
How do they make decisions?

625
00:22:26,011 --> 00:22:28,681
How have they made decisions in
the past?

626
00:22:28,681 --> 00:22:30,849
That whether the person
is providing assent

627
00:22:30,849 --> 00:22:34,038
or dissent is is very clear
and that you're documenting

628
00:22:34,038 --> 00:22:34,386
what,

629
00:22:35,154 --> 00:22:37,950
what the decisions are
and who that person is going to

630
00:22:37,950 --> 00:22:38,157
be,

631
00:22:38,490 --> 00:22:39,725
these are some of the pitfalls.

632
00:22:39,725 --> 00:22:41,493
It can be very anxiety
provoking.

633
00:22:41,493 --> 00:22:43,976
I mean, our groups, it's less so
simply

634
00:22:43,976 --> 00:22:46,332
because we're written into
protocols

635
00:22:46,332 --> 00:22:48,518
and they know that they have to
schedule

636
00:22:48,518 --> 00:22:49,501
us ahead of time.

637
00:22:49,501 --> 00:22:51,136
And and we know the teams well.

638
00:22:51,136 --> 00:22:53,463
And we've gotten to know the
participant

639
00:22:53,463 --> 00:22:55,207
that we're following as well.

640
00:22:55,474 --> 00:22:56,909
But if somebody doesn't know

641
00:22:56,909 --> 00:22:59,094
if a capacity assessment is
required,

642
00:22:59,094 --> 00:23:01,280
if an LA is allowed for their
study,

643
00:23:01,547 --> 00:23:03,482
they're not talking about it
ahead of time.

644
00:23:03,482 --> 00:23:05,367
It's not normalized in that, you
know,

645
00:23:05,367 --> 00:23:07,152
this is something we do perhaps
for

646
00:23:07,353 --> 00:23:08,120
for everybody.

647
00:23:08,120 --> 00:23:10,497
Depending on the protocol, the
assessment

648
00:23:10,497 --> 00:23:12,758
gets done after the consent is
signed.

649
00:23:13,692 --> 00:23:15,561
Not educating the participant
ahead

650
00:23:15,561 --> 00:23:17,696
of time certainly have had that
happen.

651
00:23:18,063 --> 00:23:22,090
And again, it's not really fair
to ask people questions if they

652
00:23:22,090 --> 00:23:22,601
haven't

653
00:23:22,601 --> 00:23:24,871
had an opportunity to to
understand

654
00:23:24,871 --> 00:23:27,206
more about what the study is
about.

655
00:23:27,873 --> 00:23:30,153
The LA is an identified there's
difficult

656
00:23:30,153 --> 00:23:32,378
or poor communication about what
to do.

657
00:23:32,378 --> 00:23:35,132
People can get very and you
know, anxious

658
00:23:35,132 --> 00:23:37,483
the team as well as a
participant.

659
00:23:38,817 --> 00:23:40,019
These are considerations.

660
00:23:40,019 --> 00:23:41,878
If you're writing a protocol,
you know,

661
00:23:41,878 --> 00:23:43,022
are you going to allow,

662
00:23:43,822 --> 00:23:46,631
people who have legal guardians,
are you going to allow

663
00:23:46,631 --> 00:23:47,192
surrogates

664
00:23:47,459 --> 00:23:49,234
when minors age up out of a
protocol,

665
00:23:49,234 --> 00:23:51,297
are they still allowed to be in
the study?

666
00:23:51,297 --> 00:23:53,933
But maybe they might have
capacity issues

667
00:23:53,933 --> 00:23:56,156
and the additional protections
determining

668
00:23:56,156 --> 00:23:57,903
who administers the assessments.

669
00:23:58,270 --> 00:23:59,672
Policy versus protocol.