00:01
One safeguard in the
whole system of clinical
investigation is having
independent review.
00:08
And so, often this is
going to occur at an
institution called an
institutional review board.
00:14
This is a group of
individuals that generally
unaffiliated with
the clinical research,
and they have a
range of expertise.
00:21
There'll be people that
have scientific expertise,
there might be statisticians,
there might be representatives
that have expertise
in ethics or the law.
00:30
And there's also
going to be community
representation,
so offering a lay perspective.
00:35
This board meets,
reviews protocols,
uses their expertise to decide,
is this research worth pursuing?
Is this something that we need
to change the research design,
encourage the
researchers to modify things?
So that the rights and interests of
the research subject are protected.
00:53
The independent review is also
a means to make sure there's
minimization of the impact
of conflicts of interest.
01:00
Some institution will actually
have a separate board
for Conflict of Interest
Committee where they will review
whether there are any personal
interests of the investigator
that need to be managed whether
its financial or other interests.
01:14
The independent review is
also a means to make sure that
there's social accountability
to ensure that the human
subjects that are enrolled
are being treated ethically.
01:23
So it's an independent
party looking in and saying,
we don't want
anybody to be exploited
or taken advantage
of their vulnerabilities.
01:32
This independent review is
a means to accomplish that.
01:36
Generally, when there's
going to be independent review,
they're going to be a few
things that they will do.
01:41
They'll look at the
design of the clinical trial.
01:43
They'll look at the
proposed study population.
01:46
Make sure again,
there's a justice concern that there's
fairness in the selection
of the studies population.
01:53
They'll examine
the risk-benefit ratio.
01:57
And know that,
you know, it is favorable
in terms of more
benefit than risk.
02:02
And whether maybe
the researcher would be,
you know,
forgone because it's too risky.
02:07
They will also look at, you know,
the knowledge to be gained,
and is that part of the benefit
of pursuing the research.
02:14
So we need, you know,
both the clinical investigators
to have responsibility and
take their role seriously.
02:21
And in conducting the research,
we need to make sure
there's active involvement by
the human research participant,
that there has been an
informed consent process,
their understanding of what's
going to happen in the research.
02:34
We might need the this
independent review, in, you know,
different settings,
it'll be accomplished in different ways,
whether it's a committee,
whether it's a
hospital-based or
institution-based.
02:46
But some sort of ethics
review to make sure that
the rights and interests of
participants are protected.
02:52
So clinical investigation
is an important field,
you know,
discovery is wonderful.
02:56
We want to find
cures for diseases.
03:00
We want to advance
medical science.
03:03
We want to understand,
you know, pathophysiology
and what's happening
in the human body
in order to treat
diseases in the future.
03:11
So all of this is great,
and we want people
to be clinical investigators,
clinical researchers.
03:17
They just have to be
aware of their responsibilities
in doing this because
they are involving
other people in the research.
03:24
They have to protect
the rights and interest
of those human
subject participants.