What I'm going to talk to you about
today is the ethical inclusion of children in research.
And the goal of this talk is really to show you how we've
shifted
over time to recognizing the importance
of responsible
inclusion of children, instead of
just focusing on their protection.
Recognizing that if you just focus on
protection,
then you miss out on many potential
benefits for children as a group
and actually expose them to risks in clinical care.
So the big motivation
behind pediatric research, which I think a lot of people
who haven't spent a lot of time thinking about pediatric
research
don't realize is that there's a great need
to find the interventions
and doses that work for children,
given that they're not just small adults.
This study was done to show even there are these enormous
differences between adults and children
with respect to heat perception.
And this is because of things like the surface
area to body mass ratio and the metabolic rate.
And in different kids or even that there
is lower in they're closer to the ground.
So all of these things, in many cases,
not all,
suggest that there's a need to do specific research
on children for different interventions
and conditions. And
this quote, I think,
really sums it up nicely that the vast
majority of drugs were not designed
or developed for pediatric or infant populations.
So what I'd like to do today is first talk about this
question
of when to enroll children in research
with respect
to other types of research, particularly research in adults.
Then we'll talk about risks and benefits,
and turn to decision making,
focusing on consent and decent.
So first, when we enroll children in
research,
the first question is who is a child?
And legally and culturally, that actually
varies quite a bit from place to place.
The typical definition is that children
or people who are too young
to give their own consent legally,
and in the United States,
this actually even within the United States, this
varies.
So there are two states where,
you don't
have the ability to give general counsel
your 19 year
A minor until you're 19.
And then around the world, this varies as well.
There is at least one country for youth to be 21.
And we'll talk more about consent.
But part of the problem that arises
is that because children
can't give their own consent, at least legally
and often lack lacking the capacity
to give their own consent.
There are lots of reasons you might want
to study adults first in research.
First is that in general, children
are more vulnerable to harm than adults.
It's better not to expose them to unknown
risks.
And this is both because,
there may be certain risks that could compound over the
lifespan,
and also because, children may have less
immunity
to things or be more fragile in certain respects than adults.
Additionally, because children cannot give their own
consent,
they can't protect their own interests
directly.
And then finally, there's a greater potential
for negative attention if something goes
wrong in a pediatric trial.
There's often this concern that if you're
relying really only on parental consent,
for permission to enroll a child in research,
you may not be getting at,
the the same level of moral transformation
that occurs
when somebody consents to research
for their own
participation.
However, there are lots of reasons
to enroll children sooner.
So sometimes children can receive
important benefits directly from research,
especially if there are few alternatives,
and this is often the case in later
stage treatment trials, particularly trials and rare
conditions.
Some diseases or conditions also only affect
children or affect children differently.
So for instance, tuberculosis
is in children under ten very different
from adult tuberculosis.
And once children reach the ten, it's
essentially similar, a similar condition
to how it's experienced in adults.
But there's also the issue of
things like malaria, which is a condition
that affects people of all ages.
But, children under five can have more severe cases.
So there are lots of reasons based on that.
But sometimes you have to study a condition by studying it in
children.
Finally, there's,
if you delay pediatric testing, that can lead to a sort of
domino effect
for ultimately licensure or availability of the test.
Intervention is also delayed for children.
So when you turn to ethical guidance
to figure out how do we balance
these different reasons for and against
enrolling children in research?
The World Health Organization
has the Council for International
Organizations of Medical Sciences,
and you've probably heard of this
talk about this guidance in other,
sessions.
This is really influential guidance,
actually, in 2016 said adults
should be first in research in all cases.
And the Declaration of Helsinki, the 2013 version said
that people who cannot consent, which includes children by
definition,
should not be enrolled in research
unless there's a prospective
direct benefit or the research is designed
to promote the health
of the group, involves minimal risk
or burden, and cannot be performed
with people who can consent.
So, you know, many of the existing guidance
documents
are actually somewhat restrictive
about when children can be enrolled
in research.
There is, I think, the sort of most
systematic
approach that I found on this was from as far back as
2004.
So this was a group, the European specialists in
pediatrics,
who came together to say, when should we enroll children
in research
and think, try to think about it somewhat more systematically
from the perspective of phases and,
of course, phases and research,
which you've probably heard about in other classes as well.
They're not always, applicable to all types of research, but
they the way they thought about it was, is
the disease was only affecting children.
Then you
needed to have preclinical safety data
first,
but you could go directly to enrolling children in
research.
The second category would be diseases
that mainly affect children
or that are very serious in children,
or where there's no or limited treatment.
And there there was a need for some preclinical safety data
and some adult efficacy data before enrolling children.
Now, when you turn to diseases in adults and kids where there
are
treatment options, then the idea was
that you would actually go all the way
through all the research on adults
before turning to children.
And this, I think, is really at least
one of the most sustained efforts
to be more systematic about when to enroll children in
research.
However, these recommendations
don't focus directly on the risks
and benefits of a given trial.
They sort of assume the risks and benefits based on,
whether there are treatment options and
and whether the disease only affects
children or also affects adults.
They also don't focus directly on the importance of the
research
or the social value,
which I think you've also heard about in this
course.
And then they don't focus on the differences between
prevention
and treatment.
They're really just focused on treatment
for an existing condition.
And not on research on things like vaccines to prevent
children
from being infected with a particular disease.
So I think it really may make more sense
to focus on the risk benefit
ratio of research, given the available
alternatives for a particular condition.
And get more granular to decide when to enroll children.
I think this is a helpful piece of,
guidance that can help when you're
thinking about treatment trials and,
at least I think was one of the first
approaches
to approach this systematically.
There's also an additional protection
that people sometimes
talk about, which is called age
de-escalation.
And this is sort of the idea is that first you have to decide
when do enroll children in general,
and then
how do you additionally protect them
when you start to your children.
And the idea is really that in a stepwise
fashion, you start with older children
and then work your way down to the youngest children.
This has been used in research on treatments for malaria,
cancer and flu,
and vaccine trials on anthrax, typhoid, enterovirus
and a number of other conditions.
What's interesting is that this is often
presumed to be a valuable safeguard.
And, the president's commission environment, there's some
thinking
about research and biomedical countermeasures really focused
on
de-escalation is one of the ways to justify research in children.
So there are many special cases where it's really important.
But what's interesting, I think, is that
for a long time, people sort of treated
glaceon as if it was just generally
the approach that you should use
without questioning it. And more recently,
during especially
during the Covid pandemic, people started to question
whether de-escalation was always the best idea.
So this paper really nicely talks
about how,
de-escalation used during the Covid pandemic
led to particular farms and really didn't
address the potential benefits of research
for certain groups of kids.
They noted that although young children had
lower
risks from Covid 19 infection than many other groups,
there were still 651 deaths and over
2000 cases of a multi, a systemic,
inflammatory syndrome in children under the age of
five.
And due to the use of de-escalation,
the vaccines for children under five
were not available during one of the biggest surges
that occurred, the Omicron sort of Omicron surge in
December 2021.
And children had the largest increase
in hospitalizations
and at that time, for children under five specifically.
So what
these authors conclude is that we really should think
about
collection more carefully and recognize
that it can be particularly problematic
in a number of cases.
But I think the one that really is the important to learn
Covid 19 example is that if you have
an unduly narrow conception of the risks
and benefits for children to be involved in research,
then you may find that,
de-escalation
actually prevents children from accessing important
benefits.
I think there are at least two ways
that this played out during Covid.
One was there was,
a lack of appreciation that even young children
could have serious risks from Covid
infection.
And the second is that children,
the fact that children could become infected
within their families and infect their parents and miss time from
school
not being daycare, and all of those things,
were significant
indirect forms that could apply to children
that weren't just the standard ways
that we calculate benefit and risk.
And those things were pretty much
neglected as people considered when to in
children in research.
So I think
the lesson from Covid 19 is that in general, children
were often
an afterthought in these research and policy
decisions,
and we need to do a better job of trying
to benefit children in future pandemics
and to think more comprehensively
about the kinds of benefits that
enrollment and research can lead to for individual
children
and children in this group.
And with several of my colleagues from,
former colleagues from the Department
of Bioethics who wrote this paper on
and went to enroll minors in Covid vaccine
trials,
learning as an attempt to really learn from that
experience.
Okay, so we've talked about the importance
of really focusing on the risks and benefits.
So what does that mean?
How do we focus on risks and benefits in research with
children.
So most regulations including
the Council of Europe Uganda CMS,
as I mentioned earlier,
the legislation in South Africa, Canada,
Australia,
they all permit research that in sort of two categories.
First, research that offers a prospect of direct benefit to
the child
that outweighs the risks, especially
in comparison to the alternatives.
And then the second category is research
that poses minimal risk.
So this is research that's not supposed
to be to benefit the child,
but the amount of risk that it poses
is just minimal.
U.S. federal regulation or
a lot of other regulations around the world.
Except in cases where I think there are countries that have
essentially
just adopted our regulations and,
codified them into their own laws.
So our regulations have four categories
of protection,
which include the first two that we talked about that exist
around the world, and two others that are much less common.
So we can do research into minimal risk
research that offers a prospect of direct
benefit that outweighs the risk as pretty much anywhere in the
world.
And you can also do research in the United States
if it's approved by an institutional review
board,
because it poses a minor increase of mental over minimal
risk.
And that's okay, even if there's no
prospect of direct benefit.
However, in this category, the research has to benefit the,
group of
participants from which the participants
are coming from
and benefit their condition or disorder.
And finally, there's a sort of catchall
category
where if research doesn't fit into any of these categories,
it can be taken to a special panel
and approved by that special panel,
which is appointed by the Secretary
of Health and Human Services.
So when we look
at these regulations, an important
question is what do all these words mean?
How are they defined and their definitions
are not as robust as you might like.
So minimal risk.
I think this definition is,
helpful and has been really operationalized by many
scholars.
So minimal risks
involves the risks of daily life or of routine examinations or
tests.
That's how it's defined in the
regulations.
But there's no definition for what a minor
increase over a minimal risk is in the
regulations.
And we did a survey of us
chairpersons of institutional review
boards or in other countries.
This will be referred to as research ethics
committees.
Many years ago now and this was back in 2004.
And we published these data and found a wide variability on
how,
people on our reviews
interpreted what counted as minimal risk
or greater than minimal risk.
So they could only really agree on the extremes.
Both ends of the spectrum attend CC blood draw and a healthy 11
year old.
Most people said that's minimal risk,
but not even everybody said that.
And a lumbar puncture in that team healthy
11 year old would be considered more of a minimal risk.
People with their 2% who said it.
Was just minimal risk.
And then everywhere else, there was
variability
is pretty much split for memorize and sexual
activity.
And we also found that our just in testing
people were sort of
I don't didn't show this here, but there's about a third of
people
in each category
minimal risk, minor increase over minimal
risk and more than a minor increase over
minimal risk.
So what
I think this tells us is that often review
committees
assess risks based on their intuition
and their judgment,
and this may lead to inaccurate estimations of risk
and also incorporating bias into their judgments.
It also can lead to wide variability,
especially if you have a study
that's being done.
Multiple sites and different sites
have different assessment
of what the risks entail.
This also then leads into other issues
where the permission
that's required, can be different sites.
So if a study is in that third category
of a minor increase
of a minimal risk, you need both parents
to give their consent.
And that may lead to complications
in trying to plan out their studies.
So it's better to use data on the risks of research
procedures and the risks to daily life,
and then compare the two.
And Dave Wendler and others have worked on trying
to
do this more systematically and show how it can be done.
So they've done it for a range of procedures and really sort of
use
that as a proof of concept, that this could be done
for a much wider range of procedures
that IRBs need to review.
Okay, so let's turn now to decision.
First, when you think about parental
consent
and child assent,
it's really important that children should be enrolled
only
with the permission of their legal guardian,
which is typically their parents,
but can be other caregivers.
And who can consent is typically set by local law.
There are many exceptions to parental consent
requirements.
So most guidelines around the world
allow waiving parental consent sometimes.
And the most common example that's given
is that sometimes
parental consent or permission is not a
protection.
So if you think about a case where a child,
where there's research being done on,
parents who are suspected of child abuse,
there may be concerns
that a parent doesn't want to be involved
in that research, partially
because they aren't keeping their kids interests at
heart.
And they
really aren't protecting their children
in the way that they should be.
So that might be an example where waiver
of parental consent can be justified.
There also are a number of state and local laws that allow minors
to consent for themselves.
And these are in three main categories, can be based
on the status
of the minor.
For instance,
if that minors married their maturity,
if they're determined to be a mature minor
with different processes depending on the state or their
condition.
So for,
treatment for sexually transmitted
infections, for instance.
And I'll talk a little bit more about this later.
I've provided a map here of the Guttmacher
Institute, which
lays out when minors can obtain contraceptive services
without a parent's involvement.
And they've done a great job of, in general,
highlighting the
variability across states and providing,
reliable information for what the current law is in various
states.
So it's a good resource to have in mind.
So in the US, regulations require
that both parents give consent in risky
or non beneficial research,
like the third category I was just talking about,
a lot of ethicists however, really
want to point out something which is not in the federal
regulations.
That probably should be that really,
when we're talking about what parents
are doing, they're giving permission
and that's different from giving consent.
So when you think about it, if a child is going to school,
parents sign a permission form.
They don't sign a consent form.
And consent is typically thought to be
when you give consent for somebody
to do something to you.
So really what parents are doing is they're giving their
permission
for their children
to be engaged in some sort of activity
or in research in this case.
And the reason that I think this is really like
to make this distinction is that there's
the notion that consent itself is only
is is more and morally transformative.
So it takes something that could be wrong
and turns it into something that's morally permissible.
Then permission.
So parents have less discretion and less authority,
to consent for their children to be involved in a range of
activities.
And especially, I think,
because parents are supposed to keep
their children's best interests at heart,
they cannot give permission
for children to be exposed to, substantial risk and research.
With it,
in addition to this notion that parents
have to give permission or consent,
the regulations also require that institutional
review
boards make provisions for assent from children who are
capable.
Now, the regulations only define assent in this way.
Affirmative agreement to participate
in research, not just the failure
to how this is not the most helpful
definition
because it's basically defining assent
as what it's not.
However,
I think a better way to think about it
is that
there should be agreement based on the child
understanding as much as she's capable of
understanding,
even if that child cannot understand
enough to give valid consent.
And in some cases it might be really, really
limited
information like, you know, you'll have to come to this
research site,
three times
and that's pretty much all that the child understands.
But in other cases, it may be more substantial.
Now, it's important to recognize,
however, that the reasons
for requiring assent can also shape
what it is that asks is being asked of it.
So when we involve children in decision
making in sort of different directions,
it can be giving them a sense of control
over what's about to happen to them,
having giving them the opportunity
to prepare for what they are
going to have to do.
So if we're trying to stay overnight in the
hospital,
it might be important for the child
to know that that's coming up
and to be able to pack a bag and bring along their favorite
stuffed animal.
It's also important
for to show respect for the growing astronomy.
So over time, children are increasing in
astronomy.
And as a parent of a pre-teen, I can tell you that I can't get
away
with making decisions for my pre-teen
in the way that I used to.
I have to engage her because she wants
she has increasing capacity
to make decisions, and also just a concern
for her own authority.
She doesn't like to be engaged in things
without some, ability to weigh in.
So a respectful assent process, therefore, would involve
different stages that can be informed
in a child's about information.
Engaging them, seeing if they have any questions or
concerns,
asking for their assent, and finally,
respecting any dissent.
So this could involve monitoring discomfort
if they're experiencing any problems
that they're having in the research,
any objections that they know.
All of these things are important
to the extent a child has full capacity.
However, if a child has less capacity,
it may be that not
all of these things need to be done.
So if a child really can't understand
the importance of benefiting others,
asking them to to participate in research
is essentially asking them
a question that doesn't make any sense to
them.
So it may be more important in such case
to for young children to really focus on
informing them about the research,
engaging them and seeing if they have any questions or
worries,
and then checking for their discomfort
as the studies going on,
to see if there's a way in which that's
increasing the risks of the research.
When we
think about who can assent to most guidelines don't specify
this.
The US federal regulations only stipulate
that the determination of assent
should take into account the age, maturity and
psychological state.
We did a study looking at this and found
that many IRBs use the rule of seven.
But it's interesting because I think
this rule is essentially that a child under the age of
seven,
can't really give a child from 7 to 14 can give assent,
and a child from 14 and above is essentially capable of
consent.
But individual children can have very different
capacities
for decision making depending on various
factors.
So if you consider chronically ill children,
one thing that I've seen in our children's
hospital
is that
there are some chronically ill children
who fit in, in and out of the hospital
for many years, and that leads to them
really understanding a lot
about condition, about different procedures
that they might have experienced in the past
that could be used in research in the future. And
really being able to engage and talk a lot
about whether research makes sense
for them.
On the other hand, there are other children
who've been chronically ill
in and out of a hospital, and that's
kind of had an infantilizing effect
for even a child who's above the age of consent
can't actually make that many decisions,
and they're much more
accustomed to their parents helping make those decisions.
So it really is interesting
how even one factor can cut in either
direction.
So when we did the study asking IRBs
about what they did, about half of the IRB
chairs we talked to required investigators
to use a particular method.
And most of those used to age cut off.
The majority use the age of seven,
where assent was required after the age of seven, and the
rest
of the other half of of our vicars
left it up to the investigator.
But this really
raises the question, I think, as we think
about different ones that give children
consent, the ability to consent at different ages for different
reasons.
Should someone be giving assent or consent?
Once children grow, they develop capacity
to reason and understand.
And it's definitely the case that children might even become
legally able to consent during the course of research.
So the guidance I referred to earlier
shown says that if a child
becomes capable of giving independent,
informed consent during the research,
researchers should obtain their consent
to continue participation at that time,
and this might occur instance in children,
if a child samples are held in a database
for storage sample research,
they might become 18 over the course of the research.
And, you know, in general,
a lot of guidance suggests they should be reconsidered at
that point.
There are some people who have argued
to the contrary.
For instance, Ben Bergman, has argued
that really
there are a lot of things that parents decisions
that parents make about their children,
and they don't
children don't necessarily get to revisit
all of them at the age of 18.
So it's not clear in his view that this is one of those cases
where we should always go back and ask children for their
consent.
And additionally, as mentioned earlier,
different states and countries allow minors to legally consent
to treatment or prevention based on different things.
So those can include age, status,
maturity or conditions.
So some places will have different ages.
And as I mentioned, this can vary
quite a bit between the ages of 14 and 21.
Status a miner who's married, who's pregnant, who's,
in the military can have the ability
to consent for themselves.
Some students have these really funny works
so they can have it so that a miner gets to consent
for their own medical care and their child and,
their own medical care when they are pregnant.
But once the child's born and they are no longer pregnant,
then that minor parent gives the consent for their
child,
but can't consent themselves.
There also is this issue of maturity.
So can some states have laws allowing
for mature minors to make decisions
for themselves, and that can be based on
either a clinician
evaluating the minor and deciding that they have this
maturity,
or it can be based on a court process
where court determines this.
And finally, there are many cases
where children can consent
to researching care for having certain conditions.
For instance, there are laws that are based on the concern
that adolescents who fail to receive needed
treatment
because it would reveal sexual risk
behaviors.
For instance,
should be able to get treatment for sexually transmitted
infections
without getting parental permission first.
And this is something that really is
a public health justification.
It's not necessarily about, oh, this minor has greater
autonomy.
But it's that as a public health matter,
if we
let parental permission be a barrier here,
then we would have
sexually transmitted infections that go untreated,
and that might be likely to be transmitted.
When we're asking this
question of whether children can give assent or consent.
There have been several studies now of adolescent participation
in HIV research, and these studies
have shown that there are lots of reasons
to sort of question the default assumption
that children can't give consent until,
they reach that legal age where they are
now able to consent for many things.
So first, one study involved using a simplified assent form
and then testing adolescents to understand, to see how
well they understood, what they needed to know.
And over half of the adolescents answered all the questions
correctly.
Another study, that I participated in
did something to this a step further.
So we compared adolescents to adults
and tested them
on their comprehension for research.
And we found no significant difference
in comprehension of research
between adults and adolescents, each over the age of 14.
We did find that when analysts were a little
younger,
there were certain differences in their comprehension.
So this sort of suggested that having a occur
could work, at least in this case.
Although the tests were pretty simple,
so they weren't really delving deep
into understanding.
Finally, adolescents understood placebo and clinical
trials
pretty well across a range of studies, but
didn't last well with things like risks,
randomization, and a particular risk that occurs in HIV vaccine
research.
For if you receive an HIV vaccine,
you may have
a future false positive, uncertain HIV tests that are
done.
And that false positive may mean that it looks like you
have HIV.
But really, unless a better test is done,
you don't know whether or not you have HIV.
So that type of risk was something
that adolescents didn't necessarily
understand very well.
So we did a study on policy stakeholders on adolescent
consent
to try and understand how do we make sense
of all of these rules and laws,
to really do a better job
of addressing adolescent needs and research.
We did semi-structured interviews
with the purpose of sampling of 15 policy
stakeholders, which included lawyers,
institutional review board members, school
administrators and policy makers.
And then we conducted thematic analysis.
And we found three themes.
The first was that age is a poor proxy
for decision making capacity.
And people think that factors like maternity and context
and the risk and benefit ratio matter more.
The second theme was that policies should evolve
with changing societal views about adolescent autonomy,
and the third is that adults should be focused on empowering
and involving adolescents in decision
making to move them towards ownership
over their own health. Over time.
So for the first theme, I
just want to give you a couple representative quotes for these
themes.
One person pointed out, people don't mature the same way
that there are adults who aren't very mature and
they're,
younger adolescents who can be quite mature.
And it just depends.
So their view is that age in general is a poor proxy for
determining
if somebody has the capacity to make a decision about
research.
The second theme that I had mentioned
is that policy
should evolve with societal views.
And I really liked this quote.
This person said, who is it helping?
Is the policy in place for us to feel
right and religious and moral,
or isn't the policy in place to protect
and to work for our adolescents?
So for me, I just feel the policies need to completely
change.
Even the laws need to change to reflect current society.
And this person also pointed out that
with access to the internet and social
media,
the things that adolescents know and understand really have
evolved.
Their view was adolescents know a lot more
now than adolescents might have known
in previous generations.
Finally, with the third theme,
there was really this sense that it's important
for adults to still be involved in
decisions
about adolescents when that's possible
and when it's a protection.
But that it's really a shift from
making decisions in authoritative way
to fighting adolescents.
So one person's that you guide them,
but ultimately they,
the adolescents, make decision.
So with the study, I think one important
limitation is that it was a qualitative
study, primarily hypothesis generating
and focused on the East African context.
But I think what we found might have broader
implications and really suggest a need for further research.
So first, laws without strict age cutoffs and
greater
flexibility, such as mid term minor laws,
where a clinician can determine whether a minor has
the ability to make decisions for themselves that may help
address
diverse decision making capacities
and allow clinicians to really, determine
that he has a lot more maturity than you
might think or even less maturity than
based on their age.
Additionally, there's a need for continued
research on how to support
caregivers and adolescents in working together to make
decisions.
So this could involve training caregivers
or other adults
and how to guide adolescent decision
making effectively,
and figuring out ways to support adolescents with
interventions
to address their particular developmental limitations.
So a lot of research has shown that adolescents can understand
some of the important concepts, but there may be other
limitations.
We know that the adolescent brain is one
that has trouble resisting peer pressure
and is really susceptible to it,
or tends to focus on short term risks over
long term risks.
And maybe there's a way to really just address those
developmental limitations to help adolescents make better
decisions by themselves.
So this is
a paper that tries to it illustrates,
the research that I was just talking about.
So finally, dissent is another important
consideration.
And many guidelines mention that a child's dissent should
be,
noted and that a child
or their parents have a right to withdraw at any
time.
And this raises a challenge, which is how can we tell
when a child is dissenting from research?
Age is a factor, right?
So a crying child who's three might
just be having a tantrum or upset or hungry.
And that doesn't necessarily mean
that the child is dissenting to research.
But we should respect sustained dissent
by a child who understands
what he or she doing for them is doing,
for the most part, obviously,
there might be very contrary teenagers
who would just say no to everything.
And maybe it's worth figuring out
how to have a conversation with them.
That doesn't automatically get them to know
simply because they want to be
contradictory. But
we also may not
want to force children to undergo research procedures.
So if a child doesn't have capacity
or is making,
contrary decisions, really doesn't
want to do something, we have to think
about the practicality of getting
that child to participate in research.
They have to be dragged to the site,
and they have to be held down to get a research procedure.
And that's not something
that I think isn't good for either
the research staff or that child.
So there may be cases where even if there's not an autonomy
based reason to respect dissent or there's not a reason based
on,
the thinking that the child is necessarily
going to be harmed.
The actual practicality of it's just that you just don't know
that child.
Anything
and decision is different from distrust.
So dissent may reflect things like a desire
for control or to express one's developing
autonomy.
But distress is when a child is experiencing
psychological firm from research persuasion.
So for instance, if you if there's a child
is really terrified of injections,
and the research involves an injection
that may actually increase the risks
of research participation for that child,
because of the psychological harm
that they would be likely to experience
that may be different or higher than what
other children
experience.
Importantly, there are times where, even in
research
could be ethically justifiable to override dissent or distress.
For instance, if a child could obtain benefit
from the research that they couldn't obtain
otherwise,
and the harms of proceeding are outweighed by that sense.
But it's
really important to think about what the level of,
for distress at the level of risk
is that's being added
to the research and determining whether the firms from that
research
participation are outweighed by a potential that.
Okay.
So in some research with children,
fires balancing protection with individuals with the needs,
data about treating children as a group.
And most guidelines strike
this balance by allowing children
to participate in research
that benefits them and minimal research
if there's no prospect of direct,
minimal risk research, if there's no prospect to direct
them.
I really wanted to encourage you
to recognize that although there's long
been this default of thinking
about the protection of children,
there are many cases where we need
to give consideration to enrolling children in
research.
Earlier, and the Covid 19 pandemic
really taught us that lesson.
That sort of thinking reflexively
and not specifically
about children can really hurt them in pandemic
response.
But in many cases, the
however, to ensure that earlier inclusion of children
is ethical, it's important to ensure that there's a strong
and there's a respectful permission
and a process.
Finally, we really do need clear guidance
on
when children should decide on their own
about participating in research
and how caregivers can help support them
and make good research decisions.
And this is something I think a lot of caregivers
struggle
with as children gain increasing autonomy
and become adolescents.
And I think need for sustained attention
to figure out how to get that right.
Thank you very much.