In her article, "Accreditation helps researchers and sub-jects alike" (Observer, May 2003), Majorie A. Speers, executive director of the Association for the Accreditation of Human Research Protection Programs, Inc., in Washington, DC, tries to make the case for the benefits of accreditation for research ethics boards (IRBs). Some genuine problems are noted in her article, but it is not clear to us just how accreditation would resolve them.
We agree that one important problem with the current IRB system is that the federal guidelines are derived from the medical perspective, and although it is widely acknowledged that this is not appropriate for the social sciences no one seems willing to correct, or even address, the problem - local boards await federal guidance, and federal authorities provide none. One is reminded of the apocryphal mathematics professor who has forgotten how to do a proof, and abruptly ends the lecture exclaiming "The proof is left to the student!"
Left to flounder, some, mostly social science researchers, conclude that social science research fits the minimal risk criterion and warrants expedited review or maybe even needs no review. Others, mostly ethicists and local administrators, decide to ignore the minimal risk and proportionate review possibility and fully review everything. In practice, the latter perspective has trumped the researchers' perspective, even though full-review is not consistent with federal guidelines. And, because the full review for minimal risk procedures provides no added benefit, it is eroding the credibility of the IRB process.
What is puzzling is how accreditation can correct this. Institutions have resorted to the indefensible full-review position on the questionable advice that it protects the institution, not because it protects researchers or participants (e.g., Nature, 2001). That is, the minimal risk and the expedited review options already exist and are known to exist, but they simply are not being honored locally. The machinations of accreditation, such as a collegial, educational site visit (which itself represents considerable local financial and time resources), can have little impact where a conscious decision to ignore these options has been made.
Ultimately any proposed addition to the already burgeoning ethics bureaucracy should have to demonstrate that public safety is improved. However, we have not and do not intend to collect systematic evidence on the effectiveness of the review process, in part or in whole, so the only possible evaluation is to ask whether accreditation would have prevented any of the recent known problems in research. To take three recent examples, one can ask whether an accreditation of the sort described would have prevented: (a) the incident at Johns Hopkins, (b) the brain-theft controversy in the UK, (c) the harassment of a researcher whose results were offensive to some (Tavris, 2002). Of course such counter-conditional questions cannot be answered with certainty, but common sense suggests that incidents like those would not have been prevented by accreditation site visits (or any other IRB actions).
Accreditation seems to be in vogue, in Canada as well as in the USA (SAFS, 2002), but there is neither evidence that it is needed nor more importantly that it would be effective.
The most likely result is that accreditation will continue to download added expense to local institutions without benefiting either researchers or participants. The only tangible benefit from accreditation, we suggest, is to the ever growing bureaucratic industry that promotes it.
University of Calgary
University of Toronto
University of Western Ontario
Nature editorial (2001). "Time to cut regulations that protect only regulators," Nature (November 22, 2001), 414, 379.
Society for Academic Freedom and Scholarship (2002). "SAFS Response to Interagency Advisory Panel on Research Ethics," www.safs.ca/issuescases/pre.html
Tavris, C. (2002). "The High Cost of Skepticism," Skeptical Inquirer, 26(4), 41-44.