SOCIETY FOR ACADEMIC FREEDOM AND SCHOLARSHIP (SAFS)
1673 Richmond Street #344, London, Ontario, N6G 2N3 email: safs@safs.ca
November 23, 2007
Sponsors Table Secretariat on Research Ethics
Experts Committee -- Moving Ahead
350 Albert Street
Ottawa, Canada K1A 1H5
secretariat@hrppc-pphrc.ca
(Fax: 613-996-7117)
Re: Moving Ahead Proposal
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 on a draft of "Moving Ahead," as per documents posted August 15, 2007, available on-line at < http://www.hrppc-pphrc.ca/english/movingahead.pdf > and developed by the Experts Committee for the Sponsors' Table for Human Research Participant Protection.
We have in the past expressed concerns about the expansion of research ethics regulations, given the lack of demonstrated effectiveness for such regulations (cf. http://www.safs.ca/issuescases/ethics.html, http://www.safs.ca/interagencymain.html and http://www.safs.ca/issuescases/ncehr.html). As we have noted previously, changes in the research ethics review system have consistently increased the burdens on individual researchers, in the social sciences and humanities (SSH) in particular, and on local university administrations, with no documented benefit in terms of the protection of research participants.
Key Points: A Summary (Click here to see the complete letter)
Skepticism re universal model. The basic assumption of the MA proposal continues to be that a single set of regulations can cover all areas of research scholarship. We are quite convinced that this is simply wrong. In particular, the medical research bias that has been repeatedly criticized is again promoted, both in terms of the substance of the regulations and the personnel. We have been going in a very questionable direction and it appears that the authors of this document are content to go even further in that direction.
Lack of authority. In spite of making the case more than once for the benefits of statutory authorization, the MA proposal repeatedly backs away from seeking legislative authentication. We are not sure that getting such authority would be such a daunting task as is implied in the proposal, and it would seem to have benefits. Greater effort should be directed to realizing this objective, rather than giving up without seriously pursuing it. As it stands, a reader may rightly wonder why it is being avoided (e.g., is there concern on the part of the authors that, in doing so, some of the authority currently claimed by the ethics bureaucracy might be scaled back?).
Self-policing. One raison d' etat for the MA proposal is an existing conflict of interest, but then the proposal ends up proposing a situation involving a different conflict of interest. How can a conflict of interest in the federal agencies be the reason that an über-agency is needed, but then conflict of interest is an acceptable operating plan for the über-agency? We have some sympathy with correcting the existing conflict of interest, but we do not believe that replacing it with another one is any improvement.
Expansion without assessment. There are various claims of improved protection for subjects, improved efficiencies of operations, greater accountability and so forth, but with no assessment scheme. We anticipate that it will be easy to document the added costs of the über-agency, but impossible to verify the claimed improvements. This has been the history of the research ethics enterprise.
Accreditation. Having commented on this in the past, we will only reiterate that accreditation will not prevent research problems arising from human error, nor will it prevent deliberate efforts to circumvent the system. Its costs will certainly exceed its benefits, which may be why there seems so little interest in documenting an assessment scheme for it. However, we expect that this über-agency will eventually come to be, solely for its showcase value. As we have seen time and time again, the appearance of doing something is actually much more important than actually solving any problems.
Proliferation. We have recently commented upon another proposal, the Continuing Ethics Review (CER) document, and we are struck by a parallel in the two documents. The CER proposes an additional committee at the local level, and this MA document proposes as additional committee at the national level. This is precisely the type of expansion that we have been referring to above, coming as it does with no evidence that added committees protect subjects better, but certainly with more local expenses. These expansions are especially worrisome to us given that our concerns focus on research in the social sciences and humanities, where the hazards are minimal and rare. Although there is some expectation in the MA document for federal funding (l. 1469 ff. and 1519 ff.) of the new agency and some recognition of the risks of overloading the volunteer base (p. 62, l. 1474-1483), it is obvious that, if the proposals here are implemented, there will be more hard expenses for local operations that have to come from local budgets (and not just indirect costs as implied, l. 1579-1581).
In short, we are very unsupportive of the proposed "changes" in the MA document. While the current system is far from perfect, these changes certainly don't address the concerns that we continue to have with that system. Neither expansion implements an assessment scheme to document that subject protection has been improved, certainly not one that would satisfy the Auditor General, and in both expansions there are many questions apparent to an outsider. The most obvious results of these two expansions (CER and MA) will be to create more jobs in the "ethics industry" (e.g., l. 1519), complicate the lines of authority, and usurp more local resources, and to do so without first gaining statutory authority.
Sincerely,
John Mueller PhD
Stephen Lupker PhD
Members of SAFS Board of Directors