It offers no guidance. So that takes
me to the Declaration of Helsinki, which I
believe is the most important of the foundational
documents that define medical ethics in the
past hundred years. It was adopted in 1964,
but it hasbeen updated a few times, most recently
in 2013. And in attempts to tie together what
was found in the Declaration of Helsinki with
the basic tenets from the Nuremberg code.
There are five basic pillars that the Declaration
of Helsinki lands upon and these are the five
pillars that we often talk about when we talk
about the pillars of ethics. The first is
principlism, which is all about the respect
for persons. This is a respect for their ability
to make decisions about their own care. You
have to respect vulnerable people as well
under this category, because even vulnerable
people, like children, like perhaps the mentally
incapacitated or the socially or economically
vulnerable, they have the ability and the
right to make decisions for themselves.
Beneficence pops up again and this comes out of Hippocratic
Oath. Beneficence is our attempt to do good.
All medical professionals must always try
to make the world a better place, we try to
do good. On the flipside, we should try not
to do bad, we all have it in us to create
evil, we have to avoid that potential and
that urge. Justice comes up again, justice
is when we treat cases alike and different
cases differently, alike cases alike and different
cases differently. This is a difficult thing
to understand sometimes, but think about a
research project that is offering some sort
of a new therapy to a community, to test out
this new therapy. Why is it being offered
to this community and not that community?
That has to be justified, because if it's
offering an advantage with some kind of beneficence,
why do some people get and others do not.
At the same time, you have to justify why
certain groups are being experimented on and
others are not. We can't be racist, we can't
be sexist, we can't be classist. This is why
justice is so important. We have to act in
the best interest of our subject as well.
Is it in their best interest to be in your
study for example. If it isn't, then you have
to give serious thought to why you're conducting
the study in the first place.
The criticisms of the Declaration of Helsinki
are many. One of them is that it does not
have the force of law, in fact none of these
documents or agreements that I've mentioned
have the force of law. They are guidelines
for helping local regulations to be written,
but they are not laws unto themselves. It
offers no guidance as to how to rank the pillars
again, they are just, "Here are the pillars
beneficence, principalism, non-maleficence"
and so forth, but which is more important
than others, no guidance there. It celebrates
autonomy, now all of the documents and agreements
I've mentioned so far, to some extent are
based upon autonomy, respect for an individual's
right to choose. It can be argued that autonomy
as a sacrosanct value is very much a Western
ideal. It's possible that some non-Western
cultures or populations may not value it as
much. Maybe it's just as important to get
the consent of a family member, a child perhaps,
that you are responsible for, maybe that individual
has as much to say about your care as you. I'm
not saying whether he or she does, I'm just
saying it's a criticism. Also the declaration
assumes that the best expression of autonomy
is informed consent. Maybe there is a better
way to do it, I don't know, but this is one
of the criticisms.
Now let's summarize all the pillars of ethical
research. There are eight of them, even though
there are five the Declaration of Helsinki
identified, one could argue there are eight
or ten or twelve, let's explore these eight.
We've talked about autonomy already. Autonomy
is when we respect an individual's right to
dictate his or her own future. Beneficence
is when we assess that we, the clinician or
the researcher, is trying to do good. Non-maleficence
is when we're trying not to do bad. Justice
again is when we're treating different populations
the same, so we can't be racist, we can't
be sexist and so forth. We try to act in the
best interest of the patient or research subject
and the last three are kind of similar to
each other, so let's go through it together.
There is fidelity, truthfulness and confidentiality.
This has to do with trustworthiness, so by
fidelity, are you being loyal to your patient
or to your subject. For example, your subject
is putting him or herself under your care
and trusting that you will do the best job
you can to give him or her proper care, even
in the context of a research study. You can't
violate that trust that takes us back the trustfulness
again. Trustfulness is the idea that you should
not be lying to your patient or to your subject.
Sometimes we do anyway, think about psychological
studies, where sometimes we will lie to a
subject to get them to think about something
while we test them for something else.
So sometimes it's okay, now generally we try
to avoid any sort of deception. Confidentiality
is when we keep their data and their identities
and their perspectives confidential. We don't
share them unless we have permission from
them to share those ideas, those data points.
Sometimes confidentiality can be related to
anonymity. So the difference is anonymity
is when I don't know, as a researcher, who
the subjects are, confidentiality is when
I do know, but I am not going to share that
information with other people. All the pillars