Based on a conference held at McGill Univeristy in 1988.

Failures in research ethics review examinedThe recent tragic death of Ellen Roche1 provides valuable lessons for research ethics review. The reasons for the wrongful administration of hexamethonium stem from researchers failing to act in certain ways, not from deliberate malicious or negligent actions.FIRST FAILING AND FIRST LESSON: PUBLICATION BIASThe first major failing was the failure of researchers who conducted the 1978 San Francisco study of hexamethonium to report similar adverse reactions.The tendency of researchers to fail to publish disappointing results2 or (...) results which are unattractive to them or their sponsors' interests has been well documented.3 It is called publication bias. An important part of publication bias is the failure to report all relevant or potentially relevant results. As this case illustrates, researchers must report or make available all research results, even negative results, and all potentially relevant outcomes of that research. If researchers believe an adverse event is unrelated to the study, they should explain why they believe this rather than omitting the event from their report. Elimination of publication bias is essential to scientific progress, to the protection of participants in research and in maintaining public faith in the integrity of scientists and doctors. Ethics committees and journals should make it clear that all adverse events—related or unrelated—to a project must be acknowledged, evaluated and further details made available to other researchers or the public if requested.SECOND FAILING: FAILURE TO CONDUCT A SYSTEMATIC REVIEWBut there is a more important failing. The most disturbing feature of this case was that literature documenting the pulmonary toxicity of hexamethonium was available before the trial began.In the study protocol submitted to the ethics committee, the researcher cited four reports involving 20 patients given inhaled hexamethonium without adverse event. However, Johns Hopkins investigators found a number of reports between 1953 and 1962, …. (shrink)

I want to sound a warning note and suggest some changes that are needed in the practice of ethical review. It is easy to assume that with a policy as high-minded as the policy of reviewing research on human beings, the only difficulties will be the obstacles put in its way by recalcitrant and unreformed paries: by the special-interest groups affected. But this is not always true of high-minded policies and it is not true, in particular, of the policy of (...) reviewing research. Ethical review is endangering valuable research on human beings and, moreover, it is endangering the very ethic that is needed to govern that research. And this is not anyone's fault, least of all the fault of any special-interest groups. The problem is that the process of ethical review has been driven by an institutional dynamic that is not in anyone's control and this dynamic is now driving us, willy nilly, on to some very stony ground. My argument is developed in four sections. In the next section, section two, I look at a model of policy-making which identifies a reactive, institutional dynamic that lies at the origin of certain policy intitiatives. In the third section I argue that this model fits the appearance and development of the ethical review of human research, showing how the process of review has been motored by a dynamic of step-by-step reaction to chilling tales of abuse. In the fourth section I look at the predictions of the future development of ethical review that the extrapolation of that model yields. And then in the fifth and.. (shrink)