September 2003
September 25, 2003
Social Sciences And Humanities
Research Ethics
Special Working Committee
Interagency Advisory Panel
on Research Ethics
(PRE)
SSHWC@pre.ethics.gc.ca
Dear Committee Members:
We are a national organization
dedicated to academic freedom and scholarship (http://www.safs.ca).
We are writing in response to a call for comment, as per http://www.pre.ethics.gc.ca/english/publicparticipation/commentondocuments.cfm.
As we understand it, PRE’s
Social Sciences and Humanities Research Ethics Special Working Committee
(SSHWC) is presently engaged in a “consultation on evolving the Tri-Council
Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)
to better meet the needs of Canada’s Social Sciences and Humanities (SSH)
Communities.”
We are pleased to see this
discussion, because we have had concerns about the continued expansion
of ethics regulations, especially given the lack of demonstrated effectiveness
for such regulations. In our judgment, changes in the research ethics review
system, in the past decade in particular, have greatly increased the burdens
on individual researchers in the SSH and on local university administrations,
with no documented benefit, and very likely no actual benefit, to the genuine
protection of research participants. This cost-benefit problem is especially
apparent in the SSH, and thus we feel modifications of the TCPS are very
much in order, at least in the SSH. We will summarize some issues that
we believe need to be addressed.
1. The medical
model is being misapplied.
As we see it, many if not
most of the problems were due to the attempt to create a single set of
guidelines for all three granting agencies. This may have some veneer of
efficiency in the eyes of bureaucrats, but in practice it has not worked.
For one thing, what this blending has done is to allow the discussion of
research safety to be completely dominated by what is a very limited biomedical
model, the “clinical trials” paradigm.
This clinical-trials domination
is directly observed in many ways, for example, the preoccupation in the
TCPS and other documents with the benefits for the pharmaceutical industry.
A further problem, and a more serious one perhaps, is that this clinical-trials
mindset also indirectly shapes ethics reviews in SSH when, in fact, SSH
research does not follow that format. That is:
2. The criterion for
important research has been redefined.
Due to the acceptance of
the assumption that the biomedical model provides a good prototype, all
research areas have become implicitly burdened with the notion that the
only good research is that which provides improved (medical) “treatment”
(and the sooner the better). This concentration on desirable outcomes or
“benefits” undermines the primary issue, subject safety, by giving prominence
to agendas that make decisions about what is “socially desirable” research.
That is, this clinical treatment emphasis shifts the role of research from
decoding nature to producing positive outcomes, and it is a powerful mechanism
by which inquiry in the SSH is being inappropriately constrained.
“Social desirability” is
an ideological matter. It has nothing to do with public safety.
Extrapolated uncritically to SSH, this concept is now undermining the epistemological
integrity of research efforts in SSH. REBs have become involved in trying
to evaluate research outcomes, which they should not be doing, nor should
they be trying to direct research efforts to “desirable” areas. These epistemological
matters are of no consequence to the subject’s experience in the experimental
setting. There is no justification for assessing SSH proposals on the basis
of positive outcomes, and this confusion, derived from the clinical-trials
mindset, provides a serious constraint on inquiry in SSH research.
A second reason that the
criteria in the review process have shifted to therapeutic benefits and
“social desirability” appears to be that there is no evidence that SSH
research has ever been an issue in terms of public safety (i.e., there
is no actual evidence that these reviews are really needed in the first
place re safety). The strategy of justifying ethics reviews routinely starts
with the recitation of historical problem cases involving medical research,
such as Nuremberg, Willowbrook, Tuskegee, and so forth. These sad events
are used to create a “moral panic” to not let such unfortunate things occur
again by instituting ever more regulations. In fact, however, in spite
of the rhetoric from the bioethicists, nothing about the present REBs would
have prevented the past problems even in medical research. That is, the
perpetrators of such atrocities would have ignored the review formality,
so there is no justification to reference them as a defense for present
REB practices, certainly not in SSH research. It is intellectually dishonest,
and unethical, to claim otherwise.
As a result, the general
ideological agenda of social control now drives the review process for
SSH proposals, rather than the issue of safety. That is, the SSH ethics
reviews are not only indirectly driven by applied biomedical research values,
that is, short-term therapeutic benefits repackaged as social engineering,
but directly driven by the intrusion of professional ethicists to define
the counterpart of “worthwhile” research in the SSH. This subterfuge of
replacing the safety criterion with ideology has occurred uncritically,
and there is certainly no evidence that the subject’s research experience
is improved by it.
With the ideology of “social
desirability” as the REB’s agenda, the behavioral difference between an
REB and a censorship board disappears. Good intentions are not relevant,
as censors always claim to be improving things. Public safety, no more
and no less, must be reasserted as the focus of REB activity.
This muddle may have occurred
as local REBs struggled to implement federal regulations, but the federal
agencies could easily be characterized as having given passive consent
by not intervening. Federal agencies need to explicitly reassert what REBs
are to examine (safety), and not examine (ideology), and further assure
that locals REBs do not feel justified to indulge in censorship of substance
or methodology. The criteria for importance in SSH research
must be allowed to once again be quality in epistemological theory testing
and theory building.
3. Utopia has become
a goal, even though a perfect world is not achievable.
The expectation of “zero
risk” has replaced the notion of “everyday risk” in ethics reviews. The
question was never to be “could something go wrong,” but whether the likelihood
of adverse consequences would exceed normal life, everyday risk.
Ironically, the distinction
between these two notions, zero vs. everyday risk, is actually still quite
clear in medical research where the concept of “side-effects” is well accepted
by researchers, subjects, and review boards. Yet REBs in SSH now turn back
proposals in pursuit of the fiction of “zero risk;” that is, REBs seem
to require that absolutely no psychological discomfort could possibly occur.
Of course, when directly confronted with such a silly notion, REB reviewers
of SSH proposals may deny using this zero-risk value system, nonetheless
people are viewed as far less robust psychologically than physically, judging
by the trivial concerns that are often directed back to the SSH researcher.
Some of the reason for this
likely follows from the nebulous nature of the “problem” that the SSH ethics
review is now trying to solve, whereby hypothetical and unlikely incidents
now are the only ones reviewers can identify. The task demands during the
review meetings are such that if the reviewers do not object to something
they fear that they will be construed as incompetent, so they grasp at
something, no matter how inconsequential it is on the everyday-risk scale.
The world does contain everyday
risk, everyday deception, and everyday ethics. There is no justification
for the pursuit of perfection to have ever become a mandate, and allowing
it to continue as the goal constitutes a serious, unrealistic, and unnecessary
constraint on freedom of inquiry. With respect to this issue, it is not
just a matter of rescuing SSH from the medical model but also a matter
of re-establishing reality contact within REBs in the SSH. Ethics committees
and reviewers need to be explicitly redirected to the “everyday risk” criterion,
and how it differs from zero risk. They need to understand that finding
no meaningful problem is likely the modal condition in a SSH research proposal,
and not a sign of laziness or incompetence. They must also be encouraged
to honor the concepts of exempt research, expedited research, proportionate
review, waiver of consent, and waiver of documentation of consent.
4. There is no
objective evidence for the effectiveness of, nor need for, REBs.
Is the world a safer place
now that SSH researchers have to get ethics approval for everything they
do? Answering this question requires (a) knowing what the reviews are trying
to achieve (the problem definition), (b) knowing what the baseline (pre-regulation)
level of the problem was, and (c) monitoring the change. This is simple
pre-post assessment logic, and yet somehow the ethics industry has grown
continuously for three decades with no one ever being concerned to document
the effectiveness of any of the many new regulations that have been enacted!
Further, as noted in points 2 and 3 above, the problem has been so redefined
and obfuscated in the SSH reviews that now we do not really know what is
actually considered “wrong” nor what the goal looks like. “Respect, beneficence,
and justice” are commendable aspirations, but if self-defined by an ethics
reviewer, unmonitored and undocumented, then they become an open-ended
license for at least manipulating the research agenda by irrelevant ideological
dictates, and quite possibly explicit censorship.
On campus we try to measure
performance through annual reports, course evaluations, all sorts of things.
It is, therefore, quite remarkable that REBs apparently are exempt, self-policing
bodies. It is an extreme of irony that for a service directed toward research
there are no data (research) on the effectiveness of any aspect of the
enterprise! Review committees may think that requesting a cosmetic change
in the consent form, for example, justifies the enterprise, but the only
meaningful measure of value is the subject’s experience, and we just do
not have any data on what regulations have produced benefits, if any, there.
In fact, the failure to document
both the necessity and effectiveness of REBs is irresponsible and unethical
in itself. The present plan for running REBs would not survive submission
to a peer-review journal (and certainly not to an REB!). We now have three
decades of accumulated constraints on freedom of inquiry and freedom of
association in SSH research, all of it without any evidence that any of
these regulations has changed the subject’s research experience for the
better. Taxpayers deserve better, we all do. The lack of concern with data
on the cost-benefits of the ethics enterprise no doubt contributes to the
feeling of alienation from the process among researchers compared to regulators.
That is, researchers reasonably ask: “Why are we doing this if there is
no evidence that it improves anything?”
5. The researcher
has become a nuisance.
Given the lack of evidence
on effectiveness of REB actions, researchers understandably have been inclined
to opt out of the process in a number of ways. However, the fact is that
there are very few mechanisms for meaningful input from researchers even
if or when they want to participate. The communications and regulations
involving research ethics have not only come from the medical area to the
rest of us in SSH, but communications and review mechanisms now operate
on the presumption that the researcher is unethical and must prove innocence.
Not only do researchers not feel interested, the sentiment that their involvement
is not wanted, and even that the researcher is the problem, is quite clear.
As sad as that is, there is every reason to believe that the relationship
will deteriorate even further in the future.
Problems with this perspective
have been revealed in recent ugly incidents whereby research ethics issues
have been used to harass researchers, for example:
In these witch-hunts there was
considerable loss for the researchers, and yet apparently there were no
consequences for the universities for behaving this way. The full extent
of this type of harassment is unclear. There are other cases that appear
to involve similar harassment, but it is difficult to be sure given the
secrecy that surrounds these complaints –apparently in the interest of
protecting the institutions rather than the researcher (Nature, 2001).
However, one must realize that most of these stories involved senior scholars
who could go public given some protection by tenure, whereas it is reasonable
to believe that such incidents involving junior scholars, and students,
are both more numerous and far less visible because they are unable to
go public. Further, because of their inexperience, junior faculty and students
lack a meaningful perspective on what constitutes a reasonable, collegial
question from an ethics committee, versus inappropriate censorship.
Given the lack of consequences
to the institutions for such abusive treatment of researchers, there is
no reason to expect such malicious witch-hunts to diminish in number or
severity in the future. To the extent that (a) we continue to permit the
fuzzy goal state (ethics and social engineering instead of safety) and
(b) fail to document effectiveness, it seems likely that in the future
there will be more such incidents rather than fewer. The most parsimonious
and most accurate description of these activities is “censorship.”
6. The existence
of REBs themselves sets up many double standards.
Why is it that academics
must be so restricted in terms of human interaction, compared to others?
An anthropologist wanting to conduct interviews in Central America spent
two years getting clearance, whereas CBC newsreader Peter Mansbridge could
be there in 24 hours or less. Just imagine how long reporting about the
war in Iraq would have been delayed if an academic had wanted to be embedded
with the military rather than Geraldo and Christiane Amanpour. Journalists
can study hand-washing behavior in airports, without clearance and without
consent forms. Are we less ethical than journalists? Why can a telemarketer
simply ring up and ask “Would you mind answering a few questions?” whereas
an academic would require an 8-page legalistic consent form, signed and
witnessed? It is not just a restriction of freedom of speech, but restricted
freedom of association for academics, with, once again, no evidence that
the subject’s experience is affected in any way. Would it really be an
unreasonable attribution here to say that some people (and some REBs) just
need to control other people’s behavior, which is censorship in most dictionaries,
not safety.
7. The future of
academic research.
As it becomes increasingly
difficult to do SSH research from an academic platform, with more and more
regulations of undocumented validity, it seems reasonable to expect a faculty
selection process to occur. Ironically, the tactic of being obliged to
deal with minor and apparently meaningless demands is a key part of the
process whereby prison guards establish authority over prisoners, such
as in Zimbardo’s infamous prison experiment.
Some faculty may capitulate and carry on,
but it would not be surprising that many senior faculty may move their
efforts re scholarship to consulting activity, books, or other venues that
avoid confronting unwarranted constraints on their intellectual inquiries.
There are also more subtle
selection processes. For example, in the case of graduate students,
it’s not enough just to meet local REB criteria. We are aware of instances,
where the external examiner on a PhD thesis piously objected that “This
would not have been approved by my REB,” even though it had been approved
by the student’s local REB. So, on the basis of the examiner’s mere assertion
(as opposed to a formal review by the second REB), the students have had
to redo their thesis. The lengthy processing time for ethics proposals
itself has added months in many cases to the normal time to complete a
degree, even for innocuous research that takes less time to execute than
the review delay, and now this added trap lies in wait for the student
at the last moment.
Do such experiences encourage
students to consider continuing a career in academic research? Not likely.
Blend in observations of their faculty mentors being treated à la
Loftus, plus the constraints of speech codes and related manifestations
of political correctness in coursework, and it becomes fairly easy to see
a selection process at work in defining the nature of future academic researchers.
Specifically, subject matter expertise will become less important, and
instead a critical trait for academic survival will be deference. Research
activities will be restricted to conventional “safe” and popular questions,
using non-controversial methods that fit within the proscribed limits of
right-thinking ethicists. Policy bureaucrats will have prevailed.
As the meek inherit the universities,
where will break-through research get done? Where will controversial thinking
occur? But, most importantly, where is the evidence that the subject’s
research experience is improved by any of these constraints on inquiry
on campus?
We realize that this is a
strong commentary. However, the constraints on inquiry have been great,
ill-conceived, and yet, as far as anyone can document, unnecessary as far
as the participant’s experience is concerned. Correcting this will require
more than simple tweaking, and it must start with the honest admission
that this 30-year “experiment” has produced null results at considerable
cost to many disciplines and researchers.
We hope these thoughts are
helpful to your committee. If we can provide further input, or clarify
any of the points here, please let us know. We look forward to following
the progress of your committee’s work, because it is important that change
occur.
Sincerely,
John Mueller, University
of Calgary
Steve Lupker , University
of Western Ontario
John and Steve are members
of SAFS Board of Directors.
Gillis, C. (2000).
Professor again in hot water over findings. National Post, November
18, 2000.
Lougheed, T. (2003) A question
of ethics. University Affairs, June/July 2003, 10-13.
Nature, editorial
(2001). Time to cut regulations that protect only regulators. Nature,
2001, 414, 379.
Tavris, C. (2002). The high
cost of skepticism. Skeptical Inquirer, 26, 14(4), 41-44.
http://www.csicop.org/si/2002-07/high-cost.html
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