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For the self regulation of research practices.
There seems to be widespread consensus
on several matters these days.
First, that the current regulatory climate
encourages a highly conservative approach
on the part of [IRB's] in applying
the Belmont principles.
Second, that there is a strong tendency
on the part of [IRB's] to interpret those principles
in a manor most befitting high risk
biomedical clinical research.
Third, that many [IRB's] often do not seem to display
considered judgement of how different kinds
of research procedures demand different ways
of making sense of things like
risk and benefit and vulnerability.
In other words the system appears
to have a very difficult time understanding
how matters of informed consent, confidentiality,
anonymity, risk benefit and harm for different
kinds of research differ depending on the kind
of research practices.
These things are differentually understood
depending on whether we are engaged in research
practices devoted primarily to the study
of the body and mind through touching, drugging
and cutting.
Or were primarily interesting in studying
the words and actions of people that requires
watching them and talking to them.
The second episode is a stark reminder that
the ethics of research whether in the social,
behavioral or biomedical sciences is not
simply a matter of the protection of human subjects.
But about what constitutes socially responsible science.
This was in the two presentations
I was in this morning this was a clear theme.
What is it mean to do research
that promotes the social good.
For me at that conference it was a dream
come true and a nightmare.
It was a dream come true because it was such
*** territory for exploring the local and global,
social, political, economic and moral
implications of what is being discovered
in the industry as it moved from molecular
antibodies to protein based drugs to regenerative medicine.
It was a nightmare because the science
was so clear that the science that was being
developed in those areas is progressing
so rapidily that it was out pacing our ability
as psychologist and political scientist
and ethicist to simultaneously conceptualize
and analyze these ethical and political
issues involved in that science.
For example a few of those complex issues are these:
Are current systems governance of health care
arrangements adecuate to regulate
emergent biomedical technologies.
Is the expenditure of monies on these biomedical
technologies and drug therapies justified.
In other words would the money be better spent
on preventative health care programs.
Are emerging technologies actually likely
to close the current considerable gap
in racial disparities in the health care system.
What are the social consequences of medical care
as we move from to personalized direct
individualized patient medicine
as a result of target therapies.
If you doubt that this is going to happen it will happen
you will have medicine tailored just for you.
The third episode, the three epsiode reveils
the kind of difficulties that are involved
in careful ethical analysis in an actual case of research.
Does video taping those children in the study
in Cypress incur more than customary risk
and exposure to harm.
If her observational studies primarily concerned
with identifying the patterns or types
of chilren's actions rather than the behavior
of any single child.
Then how do we assess the risk of participation
to any single individual in the study.
What expectations norms and values
informed research practices in the particular
circumstances of research in Cypress.
What types and levels of risks
are entailed in having conversations with children
about their ways of interacting with their peers.
Is this one of those cases of research most likely
to have serious consequences
and hence should it be subject
to the most thorough kind of ethical review.
How can I be sure as a research supervisor
that the researcher who is in Cypress
will be conducting herself in ethically
and scientifically responsible ways in the field
as that study actually unfold.
We actually worked out a way to do that.
In recent years many particularly humanistically
inclined as well as qualitatively trained researchers.
But, also researchers in the field of community
development as well as community based
interventions and so on.
Have been rendering extremely harsh
criticism of [IRB's] at their insitutions
based on a variety of cases of actual outrages
[IRB's] practice this should be familiar to many of you.
And many of these criticisms claim that the review
boards oversight is more legalistic
then ethically instructive and seemingly ignorant
careful consideration of the kind of research
that's being actually proposed.
Several critics have gone so far as to denounce
the relavence of the entire process
of prospective ethical review
for the kind of research that they do.
As a case base researcher I would certainly
admit that cases call our attention to problems.
The critical issue always though
is identifying the kinds of problems that are actually
brought into view by the case.
Are for example are we talking about cases
unwanted ethical surveilance
as some of my colleagues call it.
Over zealous is it a case of over zealous review?
Is it a case of an over worked review board?
Is it a case of a review board
being more concerned about legal action
than ethical guidance?
Is it a case of lack of understanding of specific
research practices?
Is it a case of inappropriate understandings
of risk and harm?
In other words just because something
is going wrong we need to do a much more
careful analysis of what is this a case of.
Anyone who have done qualitative research
realizes that kind of question can not go unanswered.
More over in making inference from cases
we know that the principle of charity
demands from us that we treat those
charged with conducting [IRB] reviews
as acting with intelligence, sincerity
and good faith until we are convinced by evidence
and argument to the contrary.
From the many cases of difficulties
that non-biomedical researchers have had
with garnering [IRB] approval for their research.
I would argue we learn some simple, profound
and often unsettling truths.
In other words what did these cases teach us.
Some of these truths are the following:
That institutional mechanism that we have
established to do good often become pathological over time.
That well intentioned people
makes mistakes in judgement
that in the face in pressures to protect an institution
appeals to common sense or often given less weight
then appeals to procedures.
That exercising, defending and explaining
practical ethical judgements is much harder to do
than exercising, defending and explaining
that one follow the rules.
That the question of what constitutes a research
which seems to be a never ending debate
inside an [IRB].
Is a rubust and never ending debate within the university
and that an [IRB] can not decide
the question of what is research
within any greater clarity and certainty
than we normally mustard in all the other
conversations we have about that
inside a university.
An interlocking set of problems
surrounds the self regulation of research
within our universities
and these problems include the definition of research.
The confusion of legal compliance
with sound ethical review.
The problem of insuring ethical behavior in advance
of what actually transpires in a given study.
Review board work load another problem
and defining and understanding the ethical
demands and risks of varies metodologies
is still yet another problem.
Addressing these problems
within our academic communities is in it's self
an ethical obligation of our being a member
of these communities.
It is part of our academic duty
as Donald Kennedy once said.
Efforts to deal with these problems affectively
are often however frustrated by several unhelpful
kinds of responses that I want to talk about.
Here are the unhelpful kinds of responses:
Get the [IRB] off my back it's unnecessary surveilance.
This is a common response and it ignores the fact
that some kind of prospective review
of ethics of research is and will always likely be
a fact of academic life.
The question of how best
to do such a prospective review is an open question.
But, whether such a review should be done is not.
Review and surveillance are not synonymous terms.
We routinely engage in