00:01
The second ethical principle
is going to be beneficience.
00:05
So this is all about having
a favorable risk-benefit ratio.
00:10
So that means that the
potential risks that you envision
that might happen to subjects,
they are minimized
as much as possible.
00:17
The potential benefits
to the individual subjects
are enhanced as
much as possible.
00:22
And that you're really
trying to make sure that
whatever the benefits are,
they might be to the individual,
they might be to
society as a whole,
because you're
increasing knowledge.
00:31
But those potential
benefits are proportionate to
or even outweigh whatever
the risks are involved in
having this person participate
as a research subject.
00:43
The way you figure
out this risk-benefit ratio
is going to be based
on the existing data.
00:48
So previous studies,
previous clinical care,
helps to inform what the
potential benefits might be,
what the potential
harms might be,
how likely it is that
those are going to occur,
and also what the potential
long term consequences might be.
01:02
So if there is a benefit,
how long lasting will it be
if there's a risk
or harm happens,
Is it a permanent harm?
Is it something that might
only be for a short term?
You're going to be informed by
your knowledge of clinical medicine,
prior research,
to know the benefits, the risks,
the likelihood,
and the longer term consequences?
So let's talk a little bit
more about benefits.
01:30
So in general,
a benefit is something that is a value.
01:34
And when we're thinking
about clinical research,
that's generally going
to mean value related to
health or well-being or
the welfare of the individual.
01:43
There may be physical benefits.
01:45
So you know,
medical care, you know,
if you're having an
investigational surgery
or investigational device
or investigational drug,
there may be a
tangible physical medical
benefit in terms of
their participation.
02:01
Some people would also say,
well, there's just
a benefit of being included
in a research study,
that the person will feel like
they are contributing to science,
they're contributing to other
people with the same condition
that might have
some benefits to them.
02:17
There may be these
aspects of hope, you know,
so perhaps standard of
care has not worked for them.
02:24
And they're hoping that this
investigational study is going
to provide some hope for
treatment of their condition.
02:32
Another psychological benefit to
participating in research is altruism.
02:37
So again, feeling like you
are contributing to society,
contributing to other
people with a condition
and it also gives you
a sense of kinship
that you're in this
with other people.
02:49
There may be times
where you might think
about a benefit in
terms of economic.
02:53
So here, you know,
just getting access
to medical care
could be a benefit.
02:59
People might certainly have
availability to clinical care.
03:02
But now,
as a research participant,
there might be a little
bit more closer monitoring
of their condition that
might be seen as a benefit.
03:10
And then in some cases,
we may actually pay research subjects.
03:14
So there may be
monetary benefits.
03:16
When we're thinking
about the benefits
in terms of enrollment
and informed consent,
we generally think of the monetary
benefits as something separate.
03:27
It's something that we're
doing is compensation,
either for the person's time,
for the inconvenience,
for reimbursing them
for the cost associated
with being a
research participants.
03:38
But it is, you know,
one of the benefits to consider.
03:43
Now, let's think about risks.
03:44
So there are a few
concepts to consider
when we're thinking about risks.
03:49
One is that there's always
going to be uncertainty,
you know,
risk is all about probabilities.
03:55
So there's, you know,
you don't know
if a harm is going
to actually happen.
03:58
So some amount of uncertainty,
and some amount of
things that are unanticipated,
you don't know what's going to
happen to the research participant,
there might be unforeseen
risks and you only learn
about those as a result
of doing the research.
04:13
For individuals, there's also
this idea of risk perception.
04:16
So it's always in the
eye of the beholder as to
you know, how risky or
not risky something is.
04:23
So there might be some
general agreement about,
you know, what a risk is or
probabilities of it happening.
04:31
But, you know,
if it's a very serious risk,
people may take that you
perceive that differently,
based on what their
condition is, you know,
if they've got a devastating
medical condition,
maybe they're willing to
take higher risks in order to
have something good
come from the research.
04:50
And the other important
concept when we're
thinking about
risk is relative risk.
04:53
So what is this
being compared to.
04:56
So is it, you know,
what the risks are
that we encounter
in everyday life,
just crossing the street or,
you know,
riding in mass transit, is it...
05:07
you know, what you
experienced just in terms of getting
general clinical care going
to see a physician and,
you know,
getting blood tests taken.
05:16
What is the risk relative
to the everyday experience
of either an individual that's
healthy, or a person that
has a particular condition,
and their usual medical care?
Then when we think about risks,
they're going to be,
you know, physical, psychological,
social, or economic,
just as we were thinking
about for benefits.
05:38
So for the physical risks,
obviously,
there could be bodily injury,
so harm to the body.
05:45
There may also be the
notion of, you know,
if you are wanting
to enroll in a study,
you have to delay
your own treatment
in order to be
enrolled in the study.
05:56
So there might be a lag period,
where you're waiting
for that to happen.
05:59
Whereas if you had
gone with standard of care,
you might have been able
to start your treatment sooner.
06:05
So that might
be a physical risk.
06:08
Psychological risks
could be stress,
you know, just being
a research participant,
the uncertainty of how the
research is going to play out for you
that may lead to
heightened anxiety.
06:21
There may be concerns about
disclosure of medical information.
06:24
So if you're, the researchers
collecting information about you,
obviously need to try to
protect that private information.
06:31
But there might be times
where that gets disclosed.
06:36
So that's a psychological
harm to you.
06:39
There may be kinds of
research where there's
actually deception of
the research participants.
06:43
So you try to, you know,
mask what you're doing
with the underlying
aim of the research.
06:49
Because if you if they
had full knowledge,
like for instance, you know, whether
they're getting a placebo or not,
that might alter, you know,
the results that you get.
06:59
So learning that they
might have been deceived,
as part of the research
could be a risk unto itself.
07:06
In terms of social risks,
there is the inconvenience factor
of just being a research
participant and having to go to,
you know,
study visits and making sure
you're being
monitored correctly.
07:20
There might potentially
be wrongs to personhood.
07:23
So, if information is
being collected about you,
depending on the
kind of research that
might be damaging
to your reputation,
there might be stigmatizing
information learned.
07:33
If that gets disclosed,
that may be a social risk.
07:37
And also, you know,
there may be economic risks.
07:40
So if you're a research participant,
you may not be able to,
you know,
engage in your usual employment,
you may have loss of income,
there may be cost
of transportation to
get to the research.
07:52
There might be issues of
you know, if you're,
you know, research participant
for a particular condition,
and they learn
information about you that
may affect your
insurability in the future.
08:04
So now you've got
a existing condition
that hadn't been
known about before.
08:10
It's only as a result
of the research
that may affect
you economically.
08:16
So anytime we're
thinking about risks,
we have to think about,
you know, what are the ways
that we can prevent that
harm from happening?
And if the harm
actually happens,
if it actually occurs,
how will we address it?
How will we try to mitigate
the effects of that harm?
So we have to put those
two things together, you know,
consideration of the benefits,
consideration of the risks,
and put that as a ratio,
it's going to be a gestalt,
that you know,
a judgment by the researchers
in conversation with
the research participant.
08:50
And they have to decide,
you know, is this worth pursuing?
Sometimes we're going
to have external bodies,
like an institutional review
board that will review these things.
09:00
And they have to say,
is it justifiable to seek
these benefits despite
the risks involved?
Or, you know,
should we just forego
these benefits,
because it's too risky.
09:12
So somebody has to weigh
in on this risk benefit ratio.
09:16
And then for society as a whole,
it has to weigh in of,
you know,
we're hoping for improvements in health
and healthcare and
well-being of individuals.
09:25
When we're trying to seek
those longer term benefits,
knowing that there might
be risks involved, you know,
you know,
how important is for us to,
you know,
seek improvement and knowledge,
seek the development
of new interventions?
Is it worth pursuing the research,
knowing that there
might be risks to actual
individual research participants?