November 28, 2003

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 of research 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 Western Ontario
• Members of SAFS Board of Directors.