ANOTHER SAFS RESPONSE TO INTERAGENCY ADVISORY PANEL ON
RESEARCH ETHICS (PRE)
November 28,
2003 Dear
Committee Members: We are a
national organization dedicated to academic freedom and scholarship
(http://www.safs.ca).We are writingin responseto a call
for comment, as
per http://pre.ethics.gc.ca/english/publicparticipation/callforcomments/cons
ultationmemo.cfm. Our mandate is somewhat different from most of those
addressed on your cover memo, for example, they are all involved in
administering the TCPS [Tri Council Policy Statement] whereas we are
not, but we think our perspective does address a missing element in the
proposed plan. As we
understand it, PRE has initiated this "call for comments on a proposal
for a TCPS Implementation Feedback Framework (TIFF)," to gain
information on how the TCPS is implemented by Research Ethics Boards
(REB) in Agency-funded institutions. We are pleased to
see this effort, in principle, but we are also disappointed with the
absence of some specific assessments that could and should be made with
regard to the implementation of the TCPS. We have
consistently expressed our serious concerns about the continued
expansion of regulations and bureaucracy surrounding the implementation
of the TCPS. By all appearances, TIFF will further compound the
bureaucracy.We find any increased
bureaucracy troublesome given the lack of demonstrated effectiveness of
the TCPS as it already exists. Changes in the research ethics review
system in the past decade have greatly increased the burdens on
individual researchers and on local university administrations and
budgets.However, as we have noted in
other consultations, there has been no documented benefit
from all these
regulations,
and very likely no actual benefit, in terms of the genuine
protection ofresearch participants.
We salute
PRE's "evidence-based approach," but we request that it also be
extended to this particular aspect of REBs as well. It is
now clear that scholarship has been constrained by the TCPS
regulations. Unfortunately, it is also clear that there has been little
concern for the apparent ineffectiveness of the constraints.This cost-benefit problem is especially
apparent in the Social Sciences and Humanities (SSH), where, among
other things, local REBs struggle to enact variants of regulations
specifically tailored for medical research and practice (e.g., the
concept of "Good Clinical Practices" currently under discussion).We have provided more detailed comments on
these to the PRE Social Sciences And Humanities Research Ethics Special
Working Committee (http://www.safs.ca/issuescases/ethics.html), and will not
repeat those here, focusing instead on the proposed TIFF. The
TIFF, as it is described (document by the PRE Task Group on
Implementation, dated Summer, 2003), seems directed to what might be
described as the "activity level" of REBs.That
is, TIFF as proposed yields a policy-oriented analysis that provides a
description of what REBs do, while saying nothing about the actual
effectiveness of the review process.Once
again, however, it is this latter component, and this component alone,
that can justify constraints on scholarship, and the further usurpation
of local resources in the generation of annual TIFF reports and visits.The research community's acceptance of the
TCPS would surely be enhanced
if there were actual evidence of
effectiveness for the constraints.Furthermore,
public trust would certainly be increased if the regulations were
clearly shown to produce actual benefits to the public (as opposed to
merely providing a raison d'etre for the regulators).In fact, it is hard to think of a constituency that would not be
happy to have actual evidence of improved public safety. The TCPS
is supposed to "advance the protection of human participants." It is
now time to provide evidence-based assessment of improvements in this
regard.Annuals reports that detail the
number of REBs and the number of projects reviewed, for example, may or
may not be of value, but in no sense do they demonstrate that
experimental participants are the least bit safer as a result of the
sacrifices to the freedom of inquiry that present regulations require. Let us
also note that, with regard to the evidence to be collected by TIFF, it
is of concern that all of the annual report measures mentioned are to
be provided by the REB and institution, with no input from the scholars.In the absence of such input it is hard to see
how the envisaged "learning loops" between REBs, researchers, and
others can possibly develop.We also find
it difficult to understand how this approach is consistent with the
claim that this process "aims at engaging a process based on
collaboration, consultation, partnering and mutual respect of roles and
responsibilities." Finally,
although TIFF aspires to apply to "all disciplines," whenever examples
are mentioned in the TIFF proposal they continue to come from applied
medical research, typically "clinical trials." The presumptions that
the TCPS should continue to "grow" (i.e., expand) and that all research
is efficiently covered by one set of regulations (i.e., medical
research), require thought and critical analysis that probably extend
beyond what the TIFF, as described, can achieve.Nonetheless,
with some further thought here at the outset, TIFF might at least begin
to provide some actual evidence on just which of the specific
regulations do (or do not) improve public safety. This is an
opportunity that should not be missed. Sincerely, John
Mueller,PhD, University of Calgary Steve
Lupker, PhD, University of
WesternOntario Members
of SAFS Board of Directors.
Newsletter, January 2004 -Text