1
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Thanks so much for this
presentation.

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I was wondering if laws
about the age of consent to

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research

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are changing, alongside laws
about age of consent to other

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things.

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So I know

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Virginia and several other
states

8
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recently raised their marriage
age to 18.

9
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Is that affecting research
or is it still kind of left

10
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up to IRBs and researchers to
decide?

11
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Yeah. Great question.

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So there is this interplay
between

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general funds about, when
adolescents

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can get consent and research
and when they can get consent in

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research.

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So I think in the example you
gave,

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because a child can't marry

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until they're 18, that child
couldn't

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independently make decisions

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based on their status in that
state.

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Earlier.

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So it may have been before
that got married earlier

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and then could make decisions
about research

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and that would no longer be the
case.

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But there are lots of other
examples

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that are really interesting that
sort of

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raise questions. So for,

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vaccination, some states
are trying to lower the age at

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which

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and some cities, in fact, are
trying

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to lower the age at which
adolescents

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can get consent to vaccination.

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Recognizing that
there are some adolescents whose

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parents,

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have,
you know, very strong

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anti-vaccine views

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and that maybe something
that children can't do a lot

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about.

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We had concerns about that,
actually,

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where a child had gotten into
the,

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summer camp
and had to get vaccinated to go

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to it.

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It was a really prestigious
summer camp

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that she wanted to go to.

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Her mom was very prominent
and sort of an activist against

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vaccines.

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And, she wanted to get vaccines
without her

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mother's knowledge, consent,
and there was no way to,

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So part of the interplay between
the two is really up to our

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views.

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To decide is the law that's
governing

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consent to a particular type

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of treatment or intervention
applicable

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to this particular research
study.

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And to the extent
the research study primarily

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involves

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that very specific intervention,
like giving a vaccine

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or, treating a child for

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sexually transmitted infection,
it can forward.

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And there is good guidance now

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from the FDA repeat on this.

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But many of these are still
reluctant.

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And part of the reluctance,
I think, comes from the problem

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that research typically doesn't
just involve that intervention.

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Right.

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It's also going to involve maybe
surveys

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or blood draws or other things,

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surrounding provision of the
intervention

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to gather the data.

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So that's where racism comes
a little bit gray

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and where sometimes IRBs default
to that sort of conservative

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judgment

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that children cannot make these
decisions

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on their own.

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Finally, I will say in certain
countries

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where there's a lot of research
going on, for instance, on HIV

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Aids,

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states have actually created
laws

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that focus on research
specifically

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and allow children under the age
of 18

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to consent to research.

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And there's particularly for
certain cases

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where, you know, children

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might be going to a clinic site
getting treatment for HIV

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and going for themselves
and for them to enroll in

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research

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with their parents permission
would just make it possible for

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them

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to involve, from a practical
perspective,

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such as really demonstrating
autonomy,

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getting care and sort of able
to make that decision for

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research.

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And that is permitted,
for instance, in Kenya.

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So great question.

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I hope I answered it, but I
think,

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you know, there's a lot there.

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So I'm happy to elaborate on
something.

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If I missed the entire question.

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But I have a question.

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I wanted to follow up on your
last

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slide on the last bullet

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about how best to think about

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under what circumstances.

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Or how best to support the
adolescent.

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So as you were talking and,

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you know, we're just now talking
about

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when is it okay for an
adolescent

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to do this on their own?

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I'm wondering about the flip
side of,

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you know,

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when would it be better
or when would it be best

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to have the whole family
involved,

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or at least a parent involved,

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to support the adolescent
in making the decision?

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I guess, to say, there's, you
know,

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it seems like there's room

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for having recommendations that

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maybe not default, but

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default to
this is something you should be

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make.

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This is a decision you should be
making

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with your parents, not the
parents.

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Provide permission
and we get assent from you, but

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that it's a joint endeavor.

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And I don't know if you
if there's any, you know,

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research on that space or any
work

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that you're doing on that space.

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Yeah.

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Yeah, that's a great question.

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So we did one study where

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this and it was really
interesting

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because,

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caregivers
so clinicians often really

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focused

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on the idea of joint decision
making and trying to work with

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adolescents

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and their parents together.

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Then the adolescent parents, we
asked.

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Yeah, I've been really focused
on sort of one person making the

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decision.

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So either I listened to make
evaluations

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where the parents make it by
themselves,

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and both adolescents and parents
choose

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both options and different
reasons.

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It was really interesting
because in some ways,

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I don't know what really

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drove this finding, and it's
something

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I really want to explore more.

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But there was almost like a lack
of appreciation

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for the ability
to really make these decisions

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together.

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And, you know, now that I have
I have to say, I sort of

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understand that

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it's often a fraught time
where you're trying to make

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decisions

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with your adolescent, and many
times

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they they reject that

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and don't want to make those
decisions

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with you or your pre-teen, in my
case.

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So, you know, in some ways it's
cleaner

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to just say, here's the decider.

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They make the decision.

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But I don't think in most cases

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it's better for decision making,
as you were alluding to.

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Yeah.

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Yeah.

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And and there's,

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so we did another study where
we're really trying to use the

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wisdom

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of you know, crowdsourcing to
understand

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for people from low

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and middle
income countries, what is it

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that,

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we should do to try and,

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get better decisions for
adolescents

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and more ethical inclusion
of adolescents in research?

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And one of the questions
we asked about was,

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for waivers of.

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So what if you just get the
parents

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out of these things

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that adolescents
make decisions for themselves?

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And that was the one thing
most people objected to.

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We could not get responses on
waivers of parental consent,

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because people, I think, had
this instinct

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that first culturally

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and then this is important
for parents to be involved.

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And then they also felt,
I think, that if parents are

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sort of

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their starter,
they have this adolescent in

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their home,

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their adolescent is going to
have to go

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to the research site.

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If there's a risk
that occurs, parent has to deal

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with it.

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It doesn't make sense
to just take the parent

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out of the patient,
you know, full, fully out,

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I think the challenge, right,

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is there are lots of different
kinds

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of parental analysis.

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Yeah.

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And what we need to do a better
job

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is first, being able to
distinguish

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when it's really not a good idea
to

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involve parents, maybe because
the parents

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just completely checked out.

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Maybe the parent is, a parent
who would react

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really badly
to knowing what their adolescent

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is doing.

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And then in those cases, I think
parental

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waivers, probably the only
option,

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in other cases,
I think we might need to figure

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out

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how can the research team engage
the parent or help the

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adolescent

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engage them and share permission
that

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they might want to share with
the parents

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so that they can work together
to make a good decision,

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and then maybe facilitate that
conversation for the adolescents

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in these.

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So I do think that that to me
is,

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you know,

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maybe it depends on sort of
who's

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showing up to the research site.

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And if the adolescents there by
themselves

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then is working with them
to get their parents

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involved with adolescents there,
with their parents, maybe still

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this

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kind of delicate dance
and having that conversation.

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But you're right.

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What I understand right now
is that it's just kind of,

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not addressed systematically.

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Yeah.

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And there's not a lot of
guidance

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for research teams to figure out
how do they facilitate

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engagement of parents in these
studies,

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when adolescents may be very
reluctant

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00:09:04,711 --> 00:09:06,943
to involve their parents, but
may also on

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some level, want their kids to
be?

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00:09:09,249 --> 00:09:12,285
Yeah, yeah, but fraught

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00:09:12,285 --> 00:09:15,755
and also then hard for IRBs
right.

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To say, oh,
they say they're going to do X,

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Y or Z.

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I guess we're going to need to
trust them

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that x, Y and z

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00:09:23,596 --> 00:09:26,666
is the appropriate way
to engage the family.

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00:09:27,534 --> 00:09:30,537
But I would like them to maybe,
you know,

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have some second or third
thoughts.

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So, for example,
you mentioned that some states

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might.

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Well, it's true in the state of
Maryland,

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for example, that they, someone

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00:09:40,713 --> 00:09:43,683
who's under the age of 18 who
has an STD

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00:09:43,983 --> 00:09:46,419
can go and seek treatment for
themselves.

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They're also able to provide
permission

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00:09:49,449 --> 00:09:51,624
or a center, whatever group

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00:09:51,624 --> 00:09:54,159
to call it, to enroll in
research

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directly.

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Now, if I was the clinician
or if I was the IRB,

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I might say to the clinician,
though

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00:10:00,922 --> 00:10:02,335
they probably wouldn't like it.

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00:10:03,036 --> 00:10:05,105
You know, I know that the
adolescents

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00:10:05,105 --> 00:10:06,840
can come to you by themselves,

263
00:10:07,140 --> 00:10:10,710
but it would be really great
if you talked to them about,

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you know, why they don't want to
engage

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00:10:12,930 --> 00:10:13,880
their parents, what

266
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the risks are in engaging
in this research.

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Without your parent's knowledge,
we're

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going to do the best we can to
make sure

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that the and your insurance
company isn't,

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you know, like it could.

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There are all sorts of things
that they should be considering.

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And if they say no,
no, no, this is totally cool

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with them.

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They know I'm here.

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It's just easier for me
to be here by myself, you know,

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than

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just one more question
or one more engagement.

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00:10:42,408 --> 00:10:45,144
Yeah, it feels like it would
make sense.

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I completely agree with that.

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And I think

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some of it is sort of helping
adolescents

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realize sometimes how hard it is
for.

283
00:10:51,751 --> 00:10:52,552
Right? Yeah.

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So I think the example you're
alluding to is, you know,

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there can be these cases
where an adolescent seeks

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treatment,

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they are able
to get confidential treatment,

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but the insurance companies
build and

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00:11:03,004 --> 00:11:05,031
then they send an explanation of
benefits.

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Home parent gets that in the
mail

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and then sees that their
adolescent

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00:11:09,068 --> 00:11:12,257
was engaged
and, you know, getting care for

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something.

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So that can be one reason or one
way

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to sort of talk to adolescents

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and get them a little bit, for
may not

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00:11:19,787 --> 00:11:21,714
apply fight every the research
context to

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00:11:22,081 --> 00:11:23,416
the interventions are not based
on it,

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but I'm sure it's.

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But still I think the issue
might be sort

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00:11:28,021 --> 00:11:31,090
of from an IRA perspective, how
do,

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00:11:32,592 --> 00:11:35,108
how can researchers demonstrate
that they've got through with

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00:11:35,108 --> 00:11:35,562
the right.

304
00:11:35,562 --> 00:11:38,563
Yes. This is yeah, for trying to
engage

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00:11:38,563 --> 00:11:41,334
parents and maybe have, you
know, a

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00:11:41,334 --> 00:11:45,779
sort of common set of questions
they ask or, different sources

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00:11:45,779 --> 00:11:46,639
of guidance

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00:11:46,639 --> 00:11:48,919
they can provide to adolescents
to try and

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00:11:48,919 --> 00:11:50,710
get their periods to be engaged.

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00:11:50,710 --> 00:11:53,413
Yeah. And that may be a way to,

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that, you know,
I think many things like best

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Fit

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00:11:56,182 --> 00:11:58,497
are that are gray and
complicated or hard

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00:11:58,497 --> 00:12:00,587
to regulate from an IAP
perspective.

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00:12:00,587 --> 00:12:03,328
But maybe one way to do it
is to really just have some

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00:12:03,328 --> 00:12:04,090
greater detail

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00:12:04,090 --> 00:12:05,458
about what that. Process will
be.

318
00:12:05,458 --> 00:12:07,961
Yeah, I completely agree.

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00:12:07,961 --> 00:12:12,162
And I think I completely agree
as a as it relates to consent

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generally,

321
00:12:13,132 --> 00:12:15,963
and maybe especially in this
context,

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00:12:15,963 --> 00:12:17,570
Alex has a question.

323
00:12:18,404 --> 00:12:20,239
Yeah. Thank you for this.

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00:12:20,239 --> 00:12:21,708
I wanted to ask about

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00:12:21,708 --> 00:12:23,727
what do you think some good
strategies

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00:12:23,727 --> 00:12:26,012
would be for not systematically
excluding,

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00:12:27,146 --> 00:12:27,814
children whose

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00:12:27,814 --> 00:12:30,817
parents are maybe hard
to reach or hard to get consent

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00:12:30,817 --> 00:12:31,150
from.

330
00:12:31,150 --> 00:12:33,423
It seems like there might be
some patterns

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00:12:33,423 --> 00:12:35,588
with parents that are harder to
engage.

332
00:12:36,456 --> 00:12:38,107
Well, do you think some good
ways

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00:12:38,107 --> 00:12:39,058
are to not exclude

334
00:12:39,058 --> 00:12:42,061
those children from
participating?

335
00:12:42,495 --> 00:12:44,163
Yeah. Great question.

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00:12:44,163 --> 00:12:47,066
So in the study we did looking
at

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00:12:47,066 --> 00:12:49,755
steps here for adolescents in
Kenya,

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00:12:49,755 --> 00:12:51,771
one of the things we found

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00:12:51,771 --> 00:12:54,671
is that there was, you know,
a bunch of adolescents were

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00:12:54,671 --> 00:12:55,241
showing up

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00:12:55,742 --> 00:12:58,244
for care
and they were showing up by

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00:12:58,244 --> 00:12:59,078
themselves.

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00:12:59,278 --> 00:13:03,483
And with those adolescents,
it was exceptionally hard

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00:13:03,483 --> 00:13:05,852
to get them to get their parents
engaged,

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00:13:05,852 --> 00:13:07,379
because their parents just
weren't

346
00:13:07,379 --> 00:13:08,187
routinely engaged

347
00:13:08,187 --> 00:13:10,757
in a lot of the decisions
that they were making.

348
00:13:10,757 --> 00:13:14,128
So we applied for a waiver
of parental permission from

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00:13:14,128 --> 00:13:14,627
therapy

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00:13:14,627 --> 00:13:16,963
specifically for those
adolescents,

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00:13:16,963 --> 00:13:19,298
where they sort of were showing
up

352
00:13:19,298 --> 00:13:22,035
and they said that they couldn't
get their parental permission.

353
00:13:23,202 --> 00:13:27,240
And it didn't apply across the
board.

354
00:13:27,240 --> 00:13:30,292
And when we did it,
we saw a huge uptake in

355
00:13:30,292 --> 00:13:31,144
adolescents

356
00:13:31,778 --> 00:13:33,513
being able to participate in
research.

357
00:13:33,513 --> 00:13:35,515
And we did use an age cut off.

358
00:13:35,515 --> 00:13:37,503
So we didn't do it for, you
know,

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00:13:37,503 --> 00:13:39,552
adolescents who were 13 or
below.

360
00:13:39,786 --> 00:13:41,220
But we tried to really do it

361
00:13:41,220 --> 00:13:43,121
for the older analysis, more
clearly

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00:13:43,121 --> 00:13:44,757
showing up for their own care.

363
00:13:45,491 --> 00:13:48,494
So I think parental waiver
is one of the best tools.

364
00:13:49,262 --> 00:13:52,365
Another either other possible
ways of doing it another way is,

365
00:13:53,166 --> 00:13:56,269
if there's a way to get parental
permission,

366
00:13:57,003 --> 00:13:59,140
that's electronic or over the
phone,

367
00:13:59,140 --> 00:14:01,040
that that may be another way to

368
00:14:01,274 --> 00:14:04,844
if a parent is just not able
to be physically present,

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00:14:05,611 --> 00:14:08,344
that they could still use it
either, or else will still be

370
00:14:08,344 --> 00:14:08,815
enrolled.

371
00:14:08,815 --> 00:14:10,983
And sometimes I think that's
important.

372
00:14:10,983 --> 00:14:14,916
From the perspective of worrying
about skewing research

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00:14:14,916 --> 00:14:15,988
participation.

374
00:14:16,322 --> 00:14:19,306
So there's a great study
by Lu and colleagues where they

375
00:14:19,306 --> 00:14:19,892
looked at,

376
00:14:19,892 --> 00:14:23,201
you know, when you require
parental permission for

377
00:14:23,201 --> 00:14:23,863
research,

378
00:14:24,230 --> 00:14:27,166
who do you leave
out of the research studies?

379
00:14:27,166 --> 00:14:29,974
And they found that older
adolescents,

380
00:14:29,974 --> 00:14:31,304
lack adolescence.

381
00:14:31,304 --> 00:14:35,641
Adolescents who, self-report
for rates of substance use.

382
00:14:35,942 --> 00:14:38,678
All of those adolescents were
less well

383
00:14:38,678 --> 00:14:41,681
represented in studies
that required permission.

384
00:14:41,948 --> 00:14:43,622
So I think in some ways I don't
think

385
00:14:43,622 --> 00:14:45,251
that's to your question, but
there.

386
00:14:45,251 --> 00:14:46,219
Does have.

387
00:14:46,219 --> 00:14:48,570
Practical ways
and strong reasons to give for

388
00:14:48,570 --> 00:14:48,988
waiver.

389
00:14:48,988 --> 00:14:50,535
And sometimes it's important to
sort of

390
00:14:50,535 --> 00:14:51,090
go to therapy

391
00:14:51,090 --> 00:14:53,002
and give them that data to show
them

392
00:14:53,002 --> 00:14:54,861
why you need a waiver for
certain.

393
00:14:56,529 --> 00:14:56,763
Right.

394
00:14:56,763 --> 00:14:58,865
Thank you. Sure. Thank you.