Kim asks.
She says first, thanks for the lecture.
Is there space for group education
sessions
prior to the individual informed consent process. For.
Particularly if the length and detail
of the study and the consent form
itself is prohibitive?
If yes, can this group awareness session
be seen
as a recruitment versus education tool
and does it need IRB approval?
There's a lot packed. In there in the work
out there.
I think certainly there are situations,
types of trials, types of populations
in which trials are being done,
where in group education about what the study is about is
critical
and actually very helpful.
And I think it's both education for
the individuals who are part of the group.
But also
sometimes one person will ask a question
and another person wouldn't have thought of.
And so it's a really it's a good way to get people to
engage.
My own view is in most cases,
maybe all, but most cases it then should be followed by an
opportunity
to meet with each individual to decide
whether to,
because sometimes people feel the pressure of the
group.
And that's not what you want.
You want each person to make their own decision.
I do believe, and maybe you know more about this than I do.
I do believe that if there isn't
going to be a group educational session,
that should be part of the materials
that the IRB does review, but I don't know if it's always
required.
Yeah.
I mean, generally the rule is if this thing,
whether it's the consent form or advertise
or perhaps an education module
is something that the investigators
are going to directly engage
the participant with, then I would think that it needs
to be,
but it sort of begs the question of, you know,
some might need
IRB approval, but maybe an introduction
to the types of research that's going on or education
about the intervention, things that are less, you know,
I'm going to after this, I'm going to ask you a question
about your.
Yeah.
And I think that gets to the other part
of that question about recruitment.
Can it be useful for recruitment?
I think the answer is it probably can. Yeah.
But you have to be worried, not worried.
But cognizant of the potential for group pressure.
Yeah.
And I think, you know, back to your comments about that.
So much I think has to do with the people
that get through the door.
So I was working on a project a number of years ago at Penn,
where at the, Alzheimer's Center,
they had sort of open houses
for individuals who had Alzheimer's
and or their partners.
Come learn about the center, learn about research that was
going on.
And I remember thinking like this is a very particular
group of people who are coming.
They they know about it.
They can afford to get themselves here.
They have a partner who can bring them. So,
you know, not to say that's bad, but it does sort of.
Only some people are going to make that.
Hi, Daniel. Thanks. Hi.
Thanks so much for the lecture.
So I was wondering, my question specifically about, voluntary
choice.
So you mentioned, like, we might think that choice is
voluntary.
If there's, like, no deception or no coercion, no undue
influence.
But then you also mentioned things
like pressure from family
or superiors or doctors, and it seems like
that sort of pressure can be,
not deceptive or coercive or undue,
like some sort of,
like guilt tripping or emotional like manipulation.
I'm just wondering how,
like those sorts of things figure into,
like deciding if a choice is voluntary.
Yeah, it's a great question.
I think I mean, maybe I didn't make clear
the the deception,
coercion, undue influence is language
that comes in the regulations.
So there's a way in which some people say,
well, it's it's voluntary
if there's no coercion and undue influence.
But I, I guess personally and some of the studies that
I've
reviewed and talked about,
think pressure matters, right?
If you're feeling and we've had examples of people
across the consult service for example,
who have said,
I don't really want to do this, but my spouse is making me
or my parents expect me to or whatever.
That kind of pressure, I think needs to be
recognized and dealt with.
It's not always okay to feel pressure from other
people
and the person themselves has to be able to say,
well, I feel this pressure from my
I'll give you a great story.
One guy at,
adolescent who said he didn't
want to participate and he was feeling
like his parents were forcing him,
and we talked to him for hours about,
you know, you don't have to do this.
We can find a way to,
get you to say no, and it'll be okay.
And in the end, he said, I'll do it.
And we're like, well, why did you change your mind?
He said, I have to live with them.
And so there is that kind of pressure
that I don't know how to put that into the rubric
of.
Was that been there for a voluntary choice or not?
I think it was, but it was a complicated choice.
Yeah.
So pressure matters.
I guess
like a little more theoretical question on that,
like from a voluntary choice and whether like the presence
of, like better alternative decisions
really matter.
Like, for example, in the case of where he has live with his
parents,
and then he has to live with the decision
to not withdraw the study,
just thinking about like,
real life, like I think that's like
the pressures of everyday life
is important as well.
Like for example, going into, other alternatives
not to have a job which sounds no,
not that great.
So he or she has to have a job.
And how much of that is voluntary?
But at the same time, maybe voluntariness is also
coping with your like life outcomes
and thinking about like while we're given
and then making the choices in that type of context so that
means
I need job to money and to live with my parents.
So I need to also respect like maybe what they want
or in case of other patients like, oh,
this research program is the only way
where I get like new treatments or this is
the only way where I can get money.
So maybe in that sense,
like context really matters for voluntary
like decision making.
I was just wondering if that's like,
I guess
round in the field or is that kind of rotation?
No, I think it's definitely correct
interpretation.
And it raises it.
It exemplifies why I say we need more attention
to
how do we decide if a research decision
is adequately voluntary,
because there are all these influences on
how we make decisions that they just
that's just real.
Even the pressure is an influence
that is not completely ever gone.
But in the case that I just described,
I feel like
this particular individual was feeling pressure.
We addressed it directly,
gave him permission to not participate,
and then he decided, I'm
going to do it anyway because I have to live with
these people.
These are my parents, right?
And so, I think,
there's so many
potential influences on how we make decisions.
What we need to figure out in the context of informed
consent is
what's adequately voluntary, so that we're not finding
somebody who's really feeling pressure
that they cannot resist.
And that doesn't always I think Daniel's question is
right.
It does.
In my view, it doesn't always translate into
coercion.
But there are two types of pressure
that are really,
overbearing.
And people should be able to decide themselves.
Yeah, I agree, like even a case with the boy.
Like, I feel like if you not let him enroll in his
study,
I feel like that would also be a form of,
like, coercion and not respecting his.
Decision so often.
That could be another way of thinking about it.
Yeah. Thank you. Yeah.
And even just sort of this is maybe a,
you know, a
minor example, but, you know, people
put pressure on themselves.
So when we asked people, you know, people really score
high on I definitely know I can leave.
I know no bad things will happen if I do, but they say,
oh, but I'll never leave you.
Like they want to be perceived as a,
you know, a good research subject
and are likely going to do what they need to
in order to be a good research subject.
That's a less like we wouldn't say,
oh gosh, that's too much pressure,
but we don't really know about what those pressures are.
And similarly, people sometimes say things like,
yes, I know that this is my choice.
I know it's my choice.
I know I don't have to do it, but what other choice do I
really have?
You know, and that's an interesting combination of
things.
So yeah, go ahead.
Hi. This is kind of a silly question, but,
no silly question.
No, silly.
So it's a pretty common practice,
like at least in the United States,
in psychology departments, to get a bunch
of undergrads to enroll in studies by,
including that as part of your grade
or giving you extra credit for that.
And, you know, those are usually minimal risk.
Studies that people. Are enrolling in.
But it also seems to directly benefit
the professor
and the department to have more people
enrolling in those studies.
So I'm curious, like what what makes that okay?
In terms of like, yeah, their grades are being
influenced.
They have a professor telling them to do it.
So correct me if I'm wrong, but my understanding is
when a professor has that as a possible way to
get a grade,
there needs to be an alternative for people who don't want to
participate.
Oh, okay.
I might know.
Yeah, I have it is in here in.
So it's required for the course.
Do you have a chance.
Do you have an option not to take the course?
I mean,
I'm trying to figure out I thought that there were. Yet.
To be an option.
When I was in undergrad many years ago.
The expectation was that everybody participate
in a trial.
There was no option.
But my assumption, perhaps naive,
is that that's changed, that the expectation is that,
you know, you're it's recommended
that there's an alternative.
You could write a paper, you could do
something else other than that.
So perhaps we have to look into that again.
Yeah. Yeah.
It's also interesting.
I mean, I, I thought your question
was going to go in a different way
because I mentioned deception.
But there is
in research sometimes psychology research,
a legitimate place for some kinds of deception, but
that's very different than sort of misleading
somebody in, in giving them information about a study.