Thanks so much for this presentation.
I was wondering if laws about the age of consent to
research
are changing, alongside laws about age of consent to other
things.
So I know
Virginia and several other states
recently raised their marriage age to 18.
Is that affecting research or is it still kind of left
up to IRBs and researchers to decide?
Yeah. Great question.
So there is this interplay between
general funds about, when adolescents
can get consent and research and when they can get consent in
research.
So I think in the example you gave,
because a child can't marry
until they're 18, that child couldn't
independently make decisions
based on their status in that state.
Earlier.
So it may have been before that got married earlier
and then could make decisions about research
and that would no longer be the case.
But there are lots of other examples
that are really interesting that sort of
raise questions. So for,
vaccination, some states are trying to lower the age at
which
and some cities, in fact, are trying
to lower the age at which adolescents
can get consent to vaccination.
Recognizing that there are some adolescents whose
parents,
have, you know, very strong
anti-vaccine views
and that maybe something that children can't do a lot
about.
We had concerns about that, actually,
where a child had gotten into the,
summer camp and had to get vaccinated to go
to it.
It was a really prestigious summer camp
that she wanted to go to.
Her mom was very prominent and sort of an activist against
vaccines.
And, she wanted to get vaccines without her
mother's knowledge, consent, and there was no way to,
So part of the interplay between the two is really up to our
views.
To decide is the law that's governing
consent to a particular type
of treatment or intervention applicable
to this particular research study.
And to the extent the research study primarily
involves
that very specific intervention, like giving a vaccine
or, treating a child for
sexually transmitted infection, it can forward.
And there is good guidance now
from the FDA repeat on this.
But many of these are still reluctant.
And part of the reluctance, I think, comes from the problem
that research typically doesn't just involve that intervention.
Right.
It's also going to involve maybe surveys
or blood draws or other things,
surrounding provision of the intervention
to gather the data.
So that's where racism comes a little bit gray
and where sometimes IRBs default to that sort of conservative
judgment
that children cannot make these decisions
on their own.
Finally, I will say in certain countries
where there's a lot of research going on, for instance, on HIV
Aids,
states have actually created laws
that focus on research specifically
and allow children under the age of 18
to consent to research.
And there's particularly for certain cases
where, you know, children
might be going to a clinic site getting treatment for HIV
and going for themselves and for them to enroll in
research
with their parents permission would just make it possible for
them
to involve, from a practical perspective,
such as really demonstrating autonomy,
getting care and sort of able to make that decision for
research.
And that is permitted, for instance, in Kenya.
So great question.
I hope I answered it, but I think,
you know, there's a lot there.
So I'm happy to elaborate on something.
If I missed the entire question.
But I have a question.
I wanted to follow up on your last
slide on the last bullet
about how best to think about
under what circumstances.
Or how best to support the adolescent.
So as you were talking and,
you know, we're just now talking about
when is it okay for an adolescent
to do this on their own?
I'm wondering about the flip side of,
you know,
when would it be better or when would it be best
to have the whole family involved,
or at least a parent involved,
to support the adolescent in making the decision?
I guess, to say, there's, you know,
it seems like there's room
for having recommendations that
maybe not default, but
default to this is something you should be
make.
This is a decision you should be making
with your parents, not the parents.
Provide permission and we get assent from you, but
that it's a joint endeavor.
And I don't know if you if there's any, you know,
research on that space or any work
that you're doing on that space.
Yeah.
Yeah, that's a great question.
So we did one study where
this and it was really interesting
because,
caregivers so clinicians often really
focused
on the idea of joint decision making and trying to work with
adolescents
and their parents together.
Then the adolescent parents, we asked.
Yeah, I've been really focused on sort of one person making the
decision.
So either I listened to make evaluations
where the parents make it by themselves,
and both adolescents and parents choose
both options and different reasons.
It was really interesting because in some ways,
I don't know what really
drove this finding, and it's something
I really want to explore more.
But there was almost like a lack of appreciation
for the ability to really make these decisions
together.
And, you know, now that I have I have to say, I sort of
understand that
it's often a fraught time where you're trying to make
decisions
with your adolescent, and many times
they they reject that
and don't want to make those decisions
with you or your pre-teen, in my case.
So, you know, in some ways it's cleaner
to just say, here's the decider.
They make the decision.
But I don't think in most cases
it's better for decision making, as you were alluding to.
Yeah.
And and there's,
so we did another study where we're really trying to use the
wisdom
of you know, crowdsourcing to understand
for people from low
and middle income countries, what is it
that,
we should do to try and,
get better decisions for adolescents
and more ethical inclusion of adolescents in research?
And one of the questions we asked about was,
for waivers of.
So what if you just get the parents
out of these things
that adolescents make decisions for themselves?
And that was the one thing most people objected to.
We could not get responses on waivers of parental consent,
because people, I think, had this instinct
that first culturally
and then this is important for parents to be involved.
And then they also felt, I think, that if parents are
sort of
their starter, they have this adolescent in
their home,
their adolescent is going to have to go
to the research site.
If there's a risk that occurs, parent has to deal
with it.
It doesn't make sense to just take the parent
out of the patient, you know, full, fully out,
I think the challenge, right,
is there are lots of different kinds
of parental analysis.
Yeah.
And what we need to do a better job
is first, being able to distinguish
when it's really not a good idea to
involve parents, maybe because the parents
just completely checked out.
Maybe the parent is, a parent who would react
really badly to knowing what their adolescent
is doing.
And then in those cases, I think parental
waivers, probably the only option,
in other cases, I think we might need to figure
out
how can the research team engage the parent or help the
adolescent
engage them and share permission that
they might want to share with the parents
so that they can work together to make a good decision,
and then maybe facilitate that conversation for the adolescents
in these.
So I do think that that to me is,
you know,
maybe it depends on sort of who's
showing up to the research site.
And if the adolescents there by themselves
then is working with them to get their parents
involved with adolescents there, with their parents, maybe still
this
kind of delicate dance and having that conversation.
But you're right.
What I understand right now is that it's just kind of,
not addressed systematically.
Yeah.
And there's not a lot of guidance
for research teams to figure out how do they facilitate
engagement of parents in these studies,
when adolescents may be very reluctant
to involve their parents, but may also on
some level, want their kids to be?
Yeah, yeah, but fraught
and also then hard for IRBs right.
To say, oh, they say they're going to do X,
Y or Z.
I guess we're going to need to trust them
that x, Y and z
is the appropriate way to engage the family.
But I would like them to maybe, you know,
have some second or third thoughts.
So, for example, you mentioned that some states
might.
Well, it's true in the state of Maryland,
for example, that they, someone
who's under the age of 18 who has an STD
can go and seek treatment for themselves.
They're also able to provide permission
or a center, whatever group
to call it, to enroll in research
directly.
Now, if I was the clinician or if I was the IRB,
I might say to the clinician, though
they probably wouldn't like it.
You know, I know that the adolescents
can come to you by themselves,
but it would be really great if you talked to them about,
you know, why they don't want to engage
their parents, what
the risks are in engaging in this research.
Without your parent's knowledge, we're
going to do the best we can to make sure
that the and your insurance company isn't,
you know, like it could.
There are all sorts of things that they should be considering.
And if they say no, no, no, this is totally cool
with them.
They know I'm here.
It's just easier for me to be here by myself, you know,
than
just one more question or one more engagement.
Yeah, it feels like it would make sense.
I completely agree with that.
And I think
some of it is sort of helping adolescents
realize sometimes how hard it is for.
Right? Yeah.
So I think the example you're alluding to is, you know,
there can be these cases where an adolescent seeks
treatment,
they are able to get confidential treatment,
but the insurance companies build and
then they send an explanation of benefits.
Home parent gets that in the mail
and then sees that their adolescent
was engaged and, you know, getting care for
something.
So that can be one reason or one way
to sort of talk to adolescents
and get them a little bit, for may not
apply fight every the research context to
the interventions are not based on it,
but I'm sure it's.
But still I think the issue might be sort
of from an IRA perspective, how do,
how can researchers demonstrate that they've got through with
the right.
Yes. This is yeah, for trying to engage
parents and maybe have, you know, a
sort of common set of questions they ask or, different sources
of guidance
they can provide to adolescents to try and
get their periods to be engaged.
Yeah. And that may be a way to,
that, you know, I think many things like best
Fit
are that are gray and complicated or hard
to regulate from an IAP perspective.
But maybe one way to do it is to really just have some
greater detail
about what that. Process will be.
Yeah, I completely agree.
And I think I completely agree as a as it relates to consent
generally,
and maybe especially in this context,
Alex has a question.
Yeah. Thank you for this.
I wanted to ask about
what do you think some good strategies
would be for not systematically excluding,
children whose
parents are maybe hard to reach or hard to get consent
from.
It seems like there might be some patterns
with parents that are harder to engage.
Well, do you think some good ways
are to not exclude
those children from participating?
Yeah. Great question.
So in the study we did looking at
steps here for adolescents in Kenya,
one of the things we found
is that there was, you know, a bunch of adolescents were
showing up
for care and they were showing up by
themselves.
And with those adolescents, it was exceptionally hard
to get them to get their parents engaged,
because their parents just weren't
routinely engaged
in a lot of the decisions that they were making.
So we applied for a waiver of parental permission from
therapy
specifically for those adolescents,
where they sort of were showing up
and they said that they couldn't get their parental permission.
And it didn't apply across the board.
And when we did it, we saw a huge uptake in
adolescents
being able to participate in research.
And we did use an age cut off.
So we didn't do it for, you know,
adolescents who were 13 or below.
But we tried to really do it
for the older analysis, more clearly
showing up for their own care.
So I think parental waiver is one of the best tools.
Another either other possible ways of doing it another way is,
if there's a way to get parental permission,
that's electronic or over the phone,
that that may be another way to
if a parent is just not able to be physically present,
that they could still use it either, or else will still be
enrolled.
And sometimes I think that's important.
From the perspective of worrying about skewing research
participation.
So there's a great study by Lu and colleagues where they
looked at,
you know, when you require parental permission for
research,
who do you leave out of the research studies?
And they found that older adolescents,
lack adolescence.
Adolescents who, self-report for rates of substance use.
All of those adolescents were less well
represented in studies that required permission.
So I think in some ways I don't think
that's to your question, but there.
Does have.
Practical ways and strong reasons to give for
waiver.
And sometimes it's important to sort of
go to therapy
and give them that data to show them
why you need a waiver for certain.
Right.
Thank you. Sure. Thank you.