SOCIETY FOR ACADEMIC FREEDOM AND SCHOLARSHIP (SAFS)
1673 Richmond Street #344, London, Ontario, N6G 2N3 email: firstname.lastname@example.org
October 29, 2007
Secretariat on Research Ethics
ProGroup - Continuing Ethics Review
350 Albert Street
Ottawa, Canada K1A 1H5
Re: Continuing Ethics Review (CER) Discussion Paper
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 entitled "Refinements to the Continuing Research Ethics Review (CER) in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS): A Discussion Paper," as per documents posted September 19, 2007, available on-line at <http://www.pre.ethics.gc.ca/english/workgroups/progroup/CER07ConsultInstr.cfm>, as developed by the ProGroup working committee for the Interagency Advisory Panel on Research Ethics (PRE).
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, 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 to the genuine protection of research participants.
We have examined the CER proposal, and offer some comments here, in two sections, first some general points, and then some brief notes on specific aspects.
First at a general level, given the stipulation that the REB is not to do CER (p. 4, line 92), this seems to require an entire new layer of campus personnel (perhaps two, one for the Medical School and one for the rest of campus). This means that there will be further usurpation of resources from the local institution (e.g., lines 387-426). And with two campus committees, just what is the domain of authority for each, how are disagreements between the two bodies to be resolved, and just which does a researcher consult and when? This added layer appears to put the researcher in double jeopardy and to appropriate more scarce resources, to achieve an ill-defined and unmeasured objective.
Second, the proposal is quite vague on key points, such as just what the problem is as perceived by ProGroup, what the review will actually entail, and then how we will know that this added bureaucracy has really accomplished its objective. In fact, no actual measure of effectiveness is identified, though it is claimed that CER will be "more effective" (l. 164, p. 6 and elsewhere).
The lack of specifics in the CER seems curious, and inappropriate. Several times the proposal seems to say that the researcher will be responsible for defining what CER will cover (e.g., l. 87, p. 3). In addition, flexibility is repeatedly mentioned. In theory flexibility may be desirable, but historically flexibility has been locally interpreted as an invitation to uncritically expand the review mandate (what is of late called "creep"). In reality, the requirement to report developments "no matter how small" (lines 303-304, also l. 221) will certainly invite a very heavy-handed CER. Similarly, the proposal continues to mention proportionate review (e.g., l. 99, p. 4 and elsewhere), but locals have historically ignored this, perhaps in part because it also seems to contradict the requirement vis a vis the mandate to consider everything, "no matter how small".
The net result of the lack of specifics is to make the researcher responsible for a poorly defined objective. Just how does this enhance the protection of subjects? That is, if the researcher is competent to devise the methodology and the CER, just why is the CER committee needed (and, by implication, why is the REB or even the TCPS needed)? It isn't clear to us how this researcher-designed process would protect the institution, as it appears to shift the responsibilities of the oversight group(s) to the party being screened? That would seem to open the CER (and REB?) to a potential negligence charge in the even something untoward were to occur.
The third general concern is perhaps the most serious, because CER as described here opens the door to research censorship at a level not before envisioned. This occurs in the form of an open-ended assertion that CER will involve "Periodic review of documents generated by the study" (p. 4, l. 105). (The term "third-party" there is ill-defined, we assume it refers to the CER committee.) Flexibility and open-endedness may be admirable in some circumstances, but given the historical pattern of over-reach by local REBs one can reasonably project that document review will be eventually construed as a mandate for CER, that is, for the CER to review the researcher's manuscript before it goes to a journal.
This is further invited by the notion (lines 174-175) that "quality assurance" is appropriate for the CER. It is correctly noted there that quality assurance goes beyond the mandate of the REB, but we firmly believe that it also is not appropriate for the CER. Quality control is the prerogative of peer review journals, CER at most is about whether the research was conducted as the REB approved. "Quality assurance" by CER should clearly exclude consideration of research outcomes, experimenter conclusions, and manuscript review.
A few brief observations will conclude our commentary.
1. As in past research ethics discussions, the medical theme continues to dominate (e.g., l. 107, p. 4 -- review patient charts, l. 209, clinical trials) -- in spite of line 62, p. 3, which actually omits the reverse conclusion that "what applies to a medical school doesn't apply to a small liberal arts college."
2. In l. 104: just what is the REB if not a "safety monitoring committee"? So we already have this in place?
3. Lines 128-133: Is harmonization with the OHRP the motivation for this CER proposal? Except that OHRP says the REB/IRB should do the CER? Why does this proposal reject that strategy? Why shouldn't the REB be responsible for defending its own reviews?
4. On l. 143, p. 5: Semantic issue: perhaps reverse "participant" and "subject" usage?
5. Line 180, p. 6: Most social science and humanities projects are over before even one year? This does not mean that CER doesn't apply, but it does mean that it would seem to be more appropriate and efficient for the REB to continue with the CER activity, as opposed to bringing on scene an entire new set of players?
6. Lines 314-317: It is good to see "evolving designs" acknowledged, though it does seem to contradict l. 303-304, or grant special status to certain methodologies. It is not clear why benign and methodically beneficial changes are not generally accepted, even in quantitative research.
7. Lines 362-363: Safe storage of data is already required? Actually almost all of Section 4.0 (and others) really just reiterates existing policies? Therefore, what then does CER add? Isn't CER something that has already been in place, perhaps with a name and separate committee?
8. Lines 403-404: We are at a loss as to just how would a researcher enforce this!
9. Line 429: We wish there was some empirical basis for asserting "good practices," as opposed to mere policy musings. The lack of hard evidence has been a long-standing issue in research ethics, and we regret to see that it is not included even in Next Steps.
In conclusion, we continue to have the same general concerns with regard to (1) the lack of a bona fide assessment scheme, and (2) the continued downloading of resource demands in the absence of evidence of benefit.
In other concerns, (3) it is not at all clear what is meant or desired by CER, yet it does seem to put the researcher in a peculiar position of responsibility without authority. This ambiguity can be described as flexibility and open-endedness, but this plan would benefit from a more fully articulated presentation of problem, objective, and assessment. Further, (4) the proposed addition of a layer of local reviewers for CER seems unduly complicated, and not clearly better than simply assigning CER to the portfolio of the local REB. The latter would be less demanding of further resources, and would simplify the chain of authority for the researcher (and the REB).
Finally, as described above, our greatest concern attaches to the prospect that CER will be used to justify local reviews as to which manuscripts can be sent on to professional journals. Censorship may not be what is intended, but the history of research ethics activities has been one to underscore the expectation of "unintended consequences." Combine the authority to review "documents" with the general ambiguity here and one can be sure the local CER will eventually feel entitled to meddle in matters that have more to do with "right thinking" than protecting subjects.
Whatever is done about the vagueness elsewhere, on this point the proposal should explicitly rule out manuscript review, so that the local CER committee will be less able to intrude. Alternatively the proposal could explicitly acknowledge that this censorship option exists in the CER plan, which would be a black cloud over Canadian research. In fact, failure to rule out manuscript review would be the same black cloud.
John Mueller PhD
Sephen Lupker PhD
Members of SAFS Board of Directors