00:01
The third principle to
consider when we're
thinking about clinical
research is justice.
00:06
So there are two ways that
justice is going to be considered,
both in terms of how we
select research subjects,
and also what we
do with the results
of research once
it's been conducted.
00:18
So let me talk to you a
little bit about, you know,
fairness in the selection
of a research subject.
00:23
So the main goal, you know,
the main thing that should drive
how we decide who
a research subject is
the scientific goals of the
research, you know,
how will it best answer
the research question?
We have a hypothesis,
who is the population
that's best going to answer
that hypothetical question.
00:45
We should not rely on, you know,
we can choose people
that are vulnerable,
or people that are privileged,
or other social
factors to decide who
the research participants
are going to be.
00:56
It really should be
the scientific goals
that drive recruitment
and enrollment.
01:01
And then subject
selection really should
depend on the inclusion
and exclusion criteria,
you know,
so the parameters that we've set
for who should be a
research participant,
what's our research population,
define that clearly.
01:15
And then use recruitment
strategies to try to
get those that
population into the study.
01:21
Those are the potential
groups that we should
be targeting for
enrollment rather than
just going to one
segment of the society.
01:32
Because of historic examples,
it's important to
consider vulnerability.
01:37
You know, people when
they have a medical condition,
especially are
vulnerable in some way.
01:42
But when we're thinking
about clinical research,
there are other vulnerabilities
we need to consider
of whether or not to have
them be research participants.
01:51
The three I'd like to focus on
are consent-based vulnerability,
harm-based vulnerability
and wrong-based vulnerability.
02:00
So in consent-based
vulnerability,
these are individuals
where there's concern that
they will be incapable of
protecting their own interest,
especially in regard to the
informed consent process.
02:13
So we may have
individuals that either lack
decision-making capacity or have
fluctuating decision-making capacity,
or, you know,
we're concerned that they're
going to lose
capacity in the future.
02:27
So for example, you know,
a person that might have
fluctuating capacity would
be person with bipolar disorder.
02:35
When they're in the
midst of their mania
or the depths of
their depression,
they may lack judgment
about making sound decisions.
02:43
Once they're stable
with their mental illness,
they might be able to have
capacity to make decisions,
but to do mental health
research on individuals
with bipolar disorder can be
tricky because you need to know,
do they have the capacity
to be doing the informed
consent process and agreeing
to be a research participant?
For prospective,
you know, vulnerability,
we might think of a patient
with Alzheimer's disease.
03:07
So in the early
stages of dementia,
they might be able to
make their own decisions.
03:12
But as the dementia progresses,
they lose their
cognitive abilities.
03:16
They may not be able to give
voluntary informed
consent on their own.
03:20
They need somebody
to speak for them.
03:22
Are we going to enroll them
as a research participant,
especially for questions
about Alzheimer's disease
or about treating the
dementia have to make those
considerations for
consent-based vulnerability.
03:35
And then they're going to
be individuals where they
never have capacity or
they've completely lost capacity.
03:42
In those cases, should they
even be research participants.
03:47
There might be particular
conditions where it's going to be
helpful to learn information
about that condition.
03:53
But again,
they will need somebody to speak
on their behalf a
proxy decision maker
to say this is in
their best interest.
04:00
A second kind of vulnerability
is harm-based vulnerability.
04:03
So here,
we're concerned that because
of the person's
personal situation,
they're going to be
susceptible to additional
harm if they are a
research participants.
04:13
So one example might be that
they have other comorbidities,
they have other
medical conditions.
04:18
They're entering the study,
you know, for diabetes,
but they also
have heart disease.
04:23
Now, as a research participant,
they have additional harms
that affect their diabetes,
that may be a vulnerability that
the researcher
needs to consider.
04:34
Or, you know, there might
be psychosocial features
of the person's
personal situation
that puts them at risk
for additional harm.
04:41
So they enter into
a clinical research
study on a surgical
intervention.
04:48
They don't have insurance,
that's their personal situation,
they have a
complication from their
participation in this
surgical research.
04:56
But they now have no means
of paying for the additional
medical care that came
as a result of the research
that makes them vulnerable,
more susceptible to additional harm.
05:07
The third kind
of vulnerability
is going to be
wrong-based vulnerability.
05:11
So here, there's concerns
that the person will not be able
to protect their rights
as a decision maker.
05:17
So the issue here would be
whether there's going to be
exploitation or infringement
of that person's rights
based on their
personal situation,
perhaps, you know, they're poor,
and they're entering research,
in order to get medical care.
05:33
But really,
that's going to be exploitative of
their situation to be
a research participant.
05:39
All of these kinds of vulnerability
needs to be considered
as a clinical researcher
when you're debating
whether or not to enroll
certain populations.
05:50
Also said that justice is about,
you know,
what do we do with the results
once we've conducted
the research,
so there needs to be a fairness
in the application
of those results.
05:59
So a general caveat is,
you know, the results of
the research should
be generalizable to the
populations who will
eventually use that
intervention if it
does prove effective.
06:09
What that means is,
who you select as your study group,
the study population should
include all those people
that might potentially use
this intervention in the future.
06:19
So you wouldn't want to,
you know, restrict women
from being research participants,
if you know, in the future
that women might,
you know, take advantage
of this intervention
if it proves effective.
06:30
You know, historically,
that was the case,
women were denied access
to being research participants.
06:36
So we need to have a broad
based population in our study group,
knowing if they're going to
get the intervention in the future,
we need to have answers of
how it works in that population.
06:48
The other caveat, you know,
when we're thinking about
justice is groups
recruited to bear the risks
and the burdens of
research should also be
in a position once
the research is done,
to share in the benefits if that
intervention proves effective.
07:03
So the stark example here
is resource poor countries,
they might have populations that
are used as research participants.
07:12
But if they don't have the
resources after the fact,
if it proves successful,
they won't have the means of
actually paying
for that intervention.
07:21
That's in a way
exploiting that population.
07:24
So we need to make sure
that there are processes
and systems in
place to make sure
they can get the benefits
of research if they've been
exposed to the burdens
and the risks of the research.