Research Ethics Regulations

April 2005

As Canada's Panel on Research Ethics is reviewing ethical rules and procedures, so in the U.S. there is a major re-examination of ethics regulation. Our neighbour's experience may be instructive.

I am just back from the annual meeting of the Council of Graduate Departments of Psychology (COGDOP) where regulation of research ethics via Institutional Research Boards (IRBs) was a major focus. Many of the developments were viewed by Psychology Chairs with considerable alarm.

Like our REBs, the IRBs also have scholars as members – people who are supposed to understand the problems and pitfalls of research and be somewhat sympathetic to applicants. However, a recent study of the composition of IRBs looked askance at the supposed "conflict of interest" involved in having active researchers judging applications from their peers. They proposed, instead, that IRBs be made up of 50% non-researchers (professors of Philosophy, English and the like) and 50% members of the public. Among other things, COGDOP members noted that the difficulty getting members of the public to IRB meetings would slow the process to a crawl.

Review of ethics proposals is already found to be extremely time-consuming. One Chair said that his program has given up including empirical research in honours theses, because the length of time it takes to review proposals from honours students makes it impossible for them to graduate on time.

Many issues that have come up in the five year history of the Tri-council Policy Statement and its implementation are echoed in the States. Psychology Chairs complained about the application of a bio-medical model to the social sciences. As one Chair said, "we keep having to explain to IRBs that psycho-social research doesn't kill people!"

In the absence of real risk of harm, IRB members tend to cast about for something dangerous in otherwise innocuous proposals. One IRB declared boring research to be unethical. Another IRB, unfamiliar with the subject-matter of a proposal, nevertheless questioned its "internal validity" and ultimately rejected it on the basis that its supposedly poor design would make subjects' participation a waste of time. One IRB was concerned about the suicide question on the Beck Depression Inventory – as issue that has also come up in Canada. The applicant was asked, "Can you guarantee us that someone reading this question will not then go up to the roof and throw himself off?" The researcher could not make any such guarantee, and the IRB required the question be removed – at possible cost to the validity of the test.

There was a time when it was thought that IRBs would proliferate on campuses, with different IRBs attuned to the concerns of different disciplines. But instead there is a tendency to centralize. The University of Illinois, for instance, now has one campus-wide IRB replacing its previous 13. This centralizing tendency arises from budgetary cutbacks and fear of litigation.

As time has gone on, IRBs have become more and more cautious, and increasingly concerned about litigation – although there have been few if any actual lawsuits over adverse incidents from university research. The relationship between IRBs and the research community in some institutions is now openly hostile. It was described various as a "reign of terror" and a "climate of fear." Some Chairs noted that the whole system of research review costs the research community a lot of money, and there is no reason to think that it works. There is virtually no empirical data that would provide feedback on how well ethics regulation is achieving its purpose. In fact, there is some doubt about what that purpose is. As some Chairs pointed out, the purpose is not to protect subjects from harm, it is to protect institutions from legal liability.