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of ethical practice rely upon informed consent.
It's a phrase that pops up all the time, and in
fact even people who aren't in the medical
profession have heard the term informed consent,
you hear it on TV shows all the time, or in
courtrooms. Informed consent requires communicating
with subjects or patients and a full appreciation
of the potential risks and benefits of the
therapy or the intervention that we're measuring.
We have to avoid coercion and we have to respect
the final decisions of the subject or patient.
Have you given any thought to what informed
consent really means, hope you have. Informed
consent is one of the key pillars of ethics.
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It's exercising autonomy such that permission
is given by the subject for a medical procedure.
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It doesn't have to be a medical procedure,
but sometimes it is and it is based upon a
clear appreciation and understanding of the
facts, the implications, the risks, the consequences
of the procedure. Do you see how this gets
complicated quite fast, can you see where
some of the challenges to informed consent
might manifest? For example, consent can be
expressed, but not internally given. Someone
can say yes I agree to undergo this procedure,
but they don't really want to, why might this
happen, can you imagine some scenarios, may
be someone is being pressured by a family
member, maybe they want to make the doctor
happy, we see that quite often in power imbalances
between subject and clinician. Sometimes the
understanding that is required to properly
give informed consent is not there. This often
happens when the subject is poorly educated
or there is a language barrier, or again a
power barrier. Someone can say, "Oh yes, I
agree to this", but they don't fully understand
what they're getting into. It's your, our
responsibility as researchers and clinicians,
to make sure that the individual that we're
dealing with has as much as a full appreciation
of the facts as we can ascertain. In most
research formal circumstances, we acquire
informed consent in a written document of
some kind, the written document often legally
trumps any oral consent. So sometimes someone
can say later on, "I didn't consent to that",
but in writing they did. That is unfortunate,
because we're saying the legalities trump
the right of an individual. This is the world
we live in. Now some of the elements of valid
informed consent to consider are disclosure.
You have to disclose the risks if you know
them and the risks include physical risks
and psychological risks, sometimes social
risks. Capacity, have you assessed whether
or not the individual you're dealing with
has the capacity intellectually to understand
the risk that you are expressing. It isn't
always an intellectual barrier, it could be
a linguistic barrier or a cultural barrier,
you have to use language that he or she is
capable of understanding. And voluntariness,
autonomy must be exercised absent of coercion.
Coercion manifests in many subtle ways, it
is not simply, do this experiment or else,
it could be trying to appeal to approval,
"If you do this experiment I'll be very happy",
that sort of thing. So even something as soft
as that can be considered to be a kind of
manipulation, we have to avoid that if we
can.
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Let's change gears now and talk about one
of the most important new regulations in US
law, HIPAA. HIPAA stands for the Health Insurance
Portability and Accountability Act, and it
came out in 1996. It talks about the management
of electronic health records, and now we're
into the whole new, brave new world of data
management, electronic data. This has introduced
a whole host of new ethical challenges to
medical researchers. So HIPAA mandates that
additional consent measures have to be built
into all research projects that involve electronic
health records, which ones do, pretty much
all new research projects to some extent involve
some idea or some capacity or some extent
of electronic records, whether it's looking
through records, whether it's adding to those
records. So written authorization is required
under HIPAA from individual before their
personal health information can be used for
research purposes. Now if someone has already
died, and you're doing the research posthumously,
you don't require their authorization.
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Now let us talk about Research Ethics Boards.
The Research Ethics Board is the group of