The incident at Virginia Commonwealth University as reported here is sobering: a 450 percent increase in IRB administrative personnel (2 to 9), a 250 percent increase in lRB membership (20 to 50), and a 1,875 percent increase in the budget (from $40,000 to $750,000) [July/August 2002 Observer]. Academic program budgets do not realize such stunning growth, and because IRB expenses continue to be downloaded to the local institution, some legitimate academic expenses no doubt had to be diverted to cover these increases for the IRB industry.
Such reallocation of scarce funds begs for accountability, an argument two of us recently ventured in the Observer (October 2001). One must hope there is in place a good program evaluation scheme to assure that the anticipated benefits are realized, basic pre-post assessments. However, as we await those data, we can ask the hindsight question: Would the incident that provoked this have been prevented by the revised arrangement? Frankly it is not clear just what the problem was, given that as reported no subjects were harmed, no confidences breached, no evidence the third party was identifiable, and so forth. Therefore, it is hard to see how public safety could be improved here, much less why additional expenditures were required.
However, apart from the issue of accountability, the VCU incident seems to raise a glaring ethical issue that seems to have escaped IRB attention. As we read it, the incident derived from person A opening person B’s mail. Tampering with the mail is a federal crime. The father’s complaint stemmed from the equivalent of an illegal search, or at the least the search was less than completely “ethical.” Why is this not a consideration, or is it a consideration for bona fide courts rather than lRBs?
We can only speculate, but had the father taken this to a real court, as opposed to an ethics agency, would it have been thrown out on grounds of an illegal search, or perhaps just dismissed as frivolous? One suspects that whatever a true court decided would not require a 20-fold increase in budget.
This case seems to illustrate, among other things, continued disdain for accountability in the IRB process. There is no systematic assessment of what works and what doesn’t, not even a clear conception of what the goal of such reviews has become. Of course, one must be cautious when dealing with a synopsis, but unless there is something serious not reported here, it appears to be a continued waste of time and money, as well as being somewhat selective or even cavalier in some matters of ethics.
University of Calgary
University of Toronto
University of Western Ontario