My name is Carole Squires.
I am with the NIMH National Institute of Mental
Health human subjects protection unit.
I'm going to go ahead and make sure I can get the
slides going.
Great.
As I mentioned, I'm with NIMH Human Subjects
Protection Unit,
also known as HSP.
We work specifically, under Doctor
Maryland Pao.
She is the office of the clinical director.
She is the clinical director of NIMH.
She's our direct supervisor.
There are three of us, myself,
Katherine Todman, who is the director of HSPU.
And Julie Brintnall-Karabelas, who's here for moral support
today.
We are all social workers.
We are all licensed professionals here in the DMV
area.
As it says here, we are clinicians
who are independent of the researchers.
And basically being independent of the research team does allow
us
a level of neutrality and objectivity
because we are not invested in whether
somebody participates in the study.
What we want to ensure is that somebody
gets all of the information that they need
to make an informed decision to participate in research.
We are also a part of the team.
The ability to Consent assessment team,
which is a combination of the bioethics
department and ourselves.
We work collaboratively with them and we work on,
issues around
individuals who individuals, researchers
get in touch with
when they have concerns about somebody's
ability to give their own consent.
Here at the clinical Center, I'll talk
about that a bit more in a moment.
In addition, our overall overarching
functions in HSP,
as it says here, is we provide protection and
advocacy,
and we focus on what we refer to as individuals
who are potentially vulnerable participants.
A little bit of background.
We'll have some case studies later.
Well, we'll talk about this a bit more,
but the folks that come into our states,
we see, children as well as adults.
They can have, mood and anxiety disorders,
major depression.
We have a study that looks at folks
with schizophrenia, psychotic disorders.
We see children that have an array
of different, mood disorders as well.
But I think one of the things that we have all come to
recognize
is that the term vulnerability can apply to all of us.
It doesn't mean that you have to have
a behavioral health diagnosis
in order to be vulnerable.
One of the examples I use, like if I were to fall down the
stairs
here, ended up in the Ed across the street.
People are putting paperwork in front of my face.
I'll sign just about anything.
I may or may not need my husband to be
there to help out with this sort of thing,
but I think it's important to just bear in mind that the
the term vulnerable can be applied
to all of us at any potential given time.
We assess, develop and implement protections.
For example, some of the the things that we
do,
as clinical research advocates or crawlers, as we call
ourselves.
We provide consent monitoring for all of the new inpatient
studies.
That means we're actually sitting
there when somebody is,
the consent is being discussed with them.
They're being informed about what's going
to be done before they actually sign it.
We do participant monitoring, which means we we go
see the people who are inpatients
and imh studies on a regular basis.
At least once a week.
We attend rounds. We talk to the clinical staff.
We have an ongoing relationship with all of them, to make sure
that people
are continuing to be informed about what
their they're doing within the study.
And do they still want to participate?
Then we also help to, assist in applying the different
regulations
and policies like the clinical center
policy, NIH policies, federal policies,
that sort of thing.
We also provide education.
We provide a consent, obtaining consent
sort of training.
It's called elements
of a successful informed consent that is mandatory for all NiMH.
Investigators are going to be obtaining
consent,
but a lot of the clinical center has embraced it as well.
Anybody can take it at any time.
It's only mandatory for New Age.
Hopefully today.
Objective wise,
we are going to be talking about knowing
what the consent capacity process is.
I'll talk about what we do within a few.
Again, more detail about how we assess
for capacity consent capacity
for the different studies that we have here and also
identifying
what contributes to a good capacity
assessment in terms of it going well
and what the pitfalls can be.
It can be an anxiety producing, moment
sometimes,
depending on how prepared people are for.
And I'll talk a little bit about that,
what our experiences are.
And then we'll also talk about, things
to consider
when you're enrolling potentially vulnerable
populations.
Also, one of the things I want
to kind of give a shout out to as well,
and I mentioned this to Holly beforehand.
She says she has uploaded the link and
you have access to the PowerPoint as well.
We put together, a toolkit that is very dense,
very comprehensive and encourage people
to take a look at that.
If somebody on the outside is thinking about,
developing research projects and you are are considering
enrolling
people were capacity might be an issue,
but even just any individual
who would be participating, it talks you through things to
consider
about during the consent process when you are enrolling children.
All kinds of different things I think is really, really,
really good.
We're very proud of that.
This is, our new image consent process flowchart.
I give a shout out to Catherine Todman.
She put this together, and it really talks
about, more specifically within.
And I sure it can be used for any potential protocol
when you're thinking about including
people who may not have consent capacity.
So it takes you, walks you through the process of
does the protocol allow what you do?
If the protocol doesn't allow it, then,
you know, what can you do at that point?
So I'm not going to go through this
at this point in time.
But it's there for you.
Again, a good reason to take a look at
the,
PowerPoint that's uploaded.
This is then, capacity assessment
algorithm, I think is is really helpful
as well.
At the top, it talks about, you know, the
before we go
in to assess somebody's consent capacity,
we want to make sure that the researcher
is educated, a potential a participant about the
protocol.
That's before we go in.
It's we always say it's not fair of us
to ask questions of a person about a study
if they haven't really had an opportunity
to talk with the researcher or somebody from the study team,
enlightening them, educating them
about what the study entails.
You know, we're interested in you because
you have this condition that's going on.
These are the tasks or the procedures
we're going to ask you to do
what the potential risks are of each of those procedures.
You're going over that they need to have that prior
education
before we can go in and really properly assess them.
So then the next category down, it says
HSP administers the capacity assessment.
What we always do is we make it a conversation.
I'll go through the different domains
that we use and how we structure our
capacity assessment. The actual tool itself.
But again, we're interested
in what people know and understand about the study.
And we always encourage clarify
with people, because we're asking them
a lot of questions.
It's just specifically about the study,
what we're determining,
what we're asking them about.
We're not concerned about
whether they live alone in the community
or if they can manage their own finances.
If they have a job,
we want to know what their understanding
is in this point in time.
It's kind of a snapshot of what their understanding is about the
study.
So again, I'll talk a little bit more about the actual questions
and how we set this up.
But after we've had time to talk with them
and depending on the person, it can be 10 or 15 minutes.
It may take a little bit longer if they have questions
or they want to talk some more, that's fine.
And typically there are two of us
that, actually do the assessment.
One is the interviewer, one is the person who's taking
notes
and kind of watching and adding what they need to at the time,
but they're also, taking in what the person is
saying
typically, then we'll have a few minutes
outside of the room
after we're finished with the person
and we can have a discussion, like,
do we have concerns about this person?
Is there a lot of times there's not even a question.
All we can go straight then into,
the consent process,
within I mean, for them we're providing
consent monitoring for those people.
So what we're looking at and it talks about the three
different
kind of categories that we we have after we've done the
assessment,
is the person able to give their own consent.
There's no question.
Is there a possibility that the person has a
are we concerned that there's a questionable
ability.
Maybe they get, you know,
kind of the overarching understanding,
but there may be some specifics about it.
So it's a little bit questionable.
And we we then are going to take that
to the researcher.
We're going to talk to them about.
This is what we found.
You know, at this point in time we we do feel like yes, you
know,
clinically that these people get most of it, but they may
need some,
some help, some guidance and some reminders from folks as
well.
Or do we find that the person absolutely
does not have capacity
at this time and again?
Then, as it says here
next the researcher decides and the different options under
that, then
do they want to spend more time educating the participant?
It could be that given some more time,
some more information, they might actually have
capacity,
to give their own consent, if the protocol allows it.
At this point, do we want to pursue,
make sure that it's a legally
authorized representative or a surrogate
who's giving consent on their behalf?
Sometimes it's like, yes, they we feel like, yes, they have
capacity,
but they could benefit from reminders
and this person helping them,
but they still have the ability to give their own consent or
they're not going to be enrolled at all.
So again, that's a conversation with,
the investigators.
We're talking amongst ourselves about that.
And we always want to make sure that,
people are aware, we want to normalize the process
and make sure that participants know
that this is a part of the study
in in our cases, a lot of times it's protocol
mandated.
They have written it into the protocol
that we're going to be assessing people.
So we don't want any surprises.
We want people to know that this is going to happen.
And these are the potential outcomes.
So this is just some more information then about,
typically
what happens here at the clinical center
and specifically,
you know, talking at length about,
what we do here,
in intimate.
So adult participants at the clinical center
in order to give their own consent,
have to have capacity.
So most of the time, most often what happens in the clinical
center
is that the investigators who are obtaining consent,
they're using their own clinical judgment.
They don't necessarily have a separate,
assessment tool that they use that has specific questions on
it.
They're using their own clinical judgment
and acumen and,
you know, that's been approved by the IRB.
That's fine.
A more formal process like it says here can include
ourselves, HSP or the A cat team.
And just as a again, a reminder we have a
couple of we have an outpatient study.
We have an inpatient study where ESP is written into that
protocol
to assess independently assess someone's consent capacity.
So as it says here, for a protocol
specific capacity assessment,
you know, it's used when the protocol requires that
they need
to be formally and independently assessed.
We create the tool in advance. What we do is
and again I'll talk about it a bit more.
We create the questions, we develop
the expected answers for those questions,
but we share that with the investigator,
the Pi of the protocol ahead of time.
You know, this is what we're going to ask.
Are these the answers we would expect?
These are kind of the minimum requirements.
We're looking at to think about,
so that we can ensure somebody does have consent
capacity.
And as I said, we also have expected
responses to the questions
that we developed.
And we also can use prompts, especially with some folks.
For example,
we have a study that looks at people
with dementia as an outpatient study.
And it can be helpful doesn't mean that
the person doesn't know it,
but they've got short term memory problems.
And so giving them a prompt like, well,
are you going to have any scans
of any kind?
And they may not be able to say,
oh, it's going to be a positron emission
tomography or Pet scan, but they can say,
I've had these scans where, you know,
I lay down flat and it's noisy.
Well, they're describing an MRI. So we know that they do get
that.
So those are the kinds of things that we feel like it's it's
perfectly acceptable to talk to them about the
difference.
Then we they're also generic capacity
assessments.
And as it said, you know, it's used as a guide
for the unexpected enrollment of people
who may not have consent capacity.
And it can, occur in a situation where,
you know, the researchers have somebody
who comes in
and this isn't a regular part of what they see with whatever
the,
the illness or the condition the person has is not expecting
to see somebody have some difficulty,
but maybe they want some added health.
Their own,
assessment, clinical assessment.
They kind of want an outside opinion.
And so they can contact like the cat team
and, and the bioethics department
and one of us may go or it may be the bioethics
department
that goes, or it might be us, that sort of
thing.
So it just has more generic questions.
They're not specific to the protocol,
but you're looking to make sure that the person has some
information
about the study itself that, you know,
lends itself to your understanding.
Yes. They are, they have been educated about
this.
And to understand what's going to happen.
So these are the tools that
in talking about the capacity assessment
that we use, here with HSP, you
they're clinically derived and have not been validated.
They do use four different domains.
And we have approximately 9 to 11 questions.
And they're open ended questions because we again, we want this
to be more of a conversation rather than a checklist.
You want to be able to talk to somebody
because sometimes depending on
whether this is an outpatient study,
if they're just coming in for the day
and they're going to be coming back over
time, you may not have,
they haven't had a lot of time to have the education piece.
And you want them they they've gone through
they've driven here with a family member
perhaps, or maybe on their own.
They've also gone through admissions.
They're trying to, you know,
make sure that they're in the right spot
at the right location.
So if there's a little understandable
anxiety and just kind of getting settled,
you want to give that person time
to get settled enough and get comfortable
enough with you that you can have that
conversation
and not feel like they're being quizzed.
Usually we have two evaluators.
We can do it with one person.
It does work.
Well, I think with two, because then clinically
afterwards
people can can talk with each other
and share their
their thoughts and their opinions
about what they've seen.
And make sure that your, your we're both,
you know, comfortable with moving ahead.
It consists of, as it mentioned, tailored questions to each
domain.
And I think this is really, really helpful.
We developed a shorter version of the Mcats here,
which is the MacArthur Competence
Assessment Tool for Clinical research
that was developed by doctors Paul Applebaum and Thomas
Grasso.
And they created these four domains.
It was, in 2001 and was for individuals
with schizophrenia.
It was many, many more questions.
And so we tailored it down to, fewer questions.
But we still use the domain concept,
which I think is really, really valuable.
Understanding is the first domain.
And as it says here, it's understanding
of the potential participants
personal situations, study specific procedures.
The questions that
we ask underneath of that domain typically are like,
what do you have that the researchers
are interested in studying?
And for example, somebody comes in, has Alzheimer's disease.
They don't necessarily have to say Alzheimer's disease.
But if they can convey to you that they're
having memory difficulties, you know,
I'm worried about this a lot of times
they'll say it's in their family.
So you're asking them questions about what brings you here
and what are some of the tasks or the procedures.
What are they going to ask you to do
as part of the study here
at NIH, as you're going to be involved
in, then if they get
if that seems clear that they have
a good understanding of why they're here,
what they're going to be asked to do,
then the next domain is appreciation.
And as it says here, it's the appreciation of
the effects
of study participation on the potential participant.
What that kind of translates to then in questions
is, you know, what are you going to have to do
in Europe to change a bit in your life
in order to be here?
For example, we have, a study
on the seventh floor with people who have psychotic
disorders
and they have to come and stay for many,
many months at a time.
So what we want to know
is, are you going to have to come off of you're like,
are you going to come off of your medications?
Did you have to travel here?
Are you if you're an outpatient, are you going to be driving
yourself here?
How are you going to get back and forth?
How is that going to affect your life?
We even talked to people about their pets
because that's of course,
a concern for people that are going to be here for a
long time.
Are they going to have somebody that can
take care of their animals for them?
So it's appreciating what it means to actually be
here
at the clinical center and how that may impact your
life.
The next domain then, is reasoning.
And as it says here, it's the reasoning
of why potential participants want to be in research.
And one of the things that we always say,
to people is we're not the motivation
police.
There are a lot of different reasons
why people want to come to the NIH
to participate in a study,
but what we want to make sure about
is ensuring that people are using
the information about the study to make an informed decision.
For example, if it's a study where there's
no potential for direct benefit,
you know they're not going to be getting
a medication to treat their condition,
then you want to ensure that they're not saying, oh,
yeah,
I'm going to come here and you're going to cure me.
We want to make sure that that's not going to happen.
And then the last domain is choice.
How many?
If you're deciding, yes, I want to do this.
We're like, that's fine.
But we also want to want you to know,
we take very seriously
when people don't want to participate in.
How would you, let the researchers
know if you changed your mind about being in the study?
These are the different hierarchies.
I believe Doctor Kim spoke about this
a little bit, so I won't I won't go through that in great
detail.
But, we have legal guardians that can provide,
you know, individuals come with a legal guardianship.
That paperwork has to be reviewed
by the Office of General
Counsel here at the NIH.
I'm a social worker.
The the, researchers, we need to make sure that
lawyers
are looking at that information to make sure that it covers
research.
Some people come with outside durable powers of attorney.
If they don't, they can fill out an NIH
form 200 here for the advance directive.
Also, surrogates can be next of kin
depending on the hirer
or depending on the risk benefit level of a study.
Being able to,
assign, an NIH advance director
directive, the cat is obligated to come in
if somebody doesn't have consent capacity
and they haven't.
And it's a protocol that allows for surrogate
consent.
But they don't have somebody that they've named the account
then does need to come in and assess
to make sure even though
assigning somebody to,
make decisions on your behalf is kind of a lower, it
definitely is a lower bar than having consent capacity.
You want to make sure that this person
is clear about what
this individual is going to do for them.
You want to make sure
that they're aware that they're giving
that authority to somebody else.
And so the, the Iccat team can come in and assess for
that,
the validity of the earlier talking to
with an earlier.
You want to make sure that those individuals, you want to confirm
that
they're, this is the person that the individual wants.
That they're allowed under the, the different categories that,
they themselves have capacity
to give consent on behalf of somebody else
to participate in research
and that they're representing the best wishes of the
individual.
One of the things that we will ask people
is, are you comfortable speaking up on behalf of this
person?
You may very well have to say to the
research team, we can't do this anymore.
This is too difficult for this person.
And are you comfortable doing that,
asking questions on their behalf.
One of the things that we've asked
people is, how would you, know
if this individual didn't want to do something?
And that seems to be a helpful question
for the team.
You know, are they going to a lot of times
you'll get an answer right away.
Oh, they'll speak up.
They'll say something if they don't want to do it.
Some individuals, may behaviorally dissent,
meaning that,
you know, they might cry
or they might get angry and stomp off,
but you want to make sure that this person
is comfortable in this role
and they know what their obligations
are going to be doing. So,
this is just a bit more information
about when capacity assessments go well,
you know, when people know that it's going to happen,
when the paperwork has been looked at ahead of
time,
that you make sure that you've arranged
plenty of time to do the assessments.
But any and all assessments before consent is signed,
making sure that the investigator
finds out how the participant
and the person that they might name
as their surrogate, how do they get along?
How do they make decisions?
How have they made decisions in the past?
That whether the person is providing assent
or dissent is is very clear and that you're documenting
what,
what the decisions are and who that person is going to
be,
these are some of the pitfalls.
It can be very anxiety provoking.
I mean, our groups, it's less so simply
because we're written into protocols
and they know that they have to schedule
us ahead of time.
And and we know the teams well.
And we've gotten to know the participant
that we're following as well.
But if somebody doesn't know
if a capacity assessment is required,
if an LA is allowed for their study,
they're not talking about it ahead of time.
It's not normalized in that, you know,
this is something we do perhaps for
for everybody.
Depending on the protocol, the assessment
gets done after the consent is signed.
Not educating the participant ahead
of time certainly have had that happen.
And again, it's not really fair to ask people questions if they
haven't
had an opportunity to to understand
more about what the study is about.
The LA is an identified there's difficult
or poor communication about what to do.
People can get very and you know, anxious
the team as well as a participant.
These are considerations.
If you're writing a protocol, you know,
are you going to allow,
people who have legal guardians, are you going to allow
surrogates
when minors age up out of a protocol,
are they still allowed to be in the study?
But maybe they might have capacity issues
and the additional protections determining
who administers the assessments.
Policy versus protocol.