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CAUT Bulletin Archives

January 2001

Health Research Study Shows Ethical Issues Unresolved

Patrick O'Neill

The Governance of Health Research Involving Human Subjects

Michael McDonald et al. Ottawa: Law Commission of Canada, 2000; 365 pp; plastic bound single copy available at no charge from
Health researchers have done much positive work leading to lifesaving and life-extending discoveries. Some have also, on occasion, used methods that offend our ethical sensibilities. We do not need to revisit the Nazi concentration camps for illustrations. We have a number of striking cases in the medical history of North America — brainwashing experiments on schizophrenics, syphilis left untreated in unknowing victims, cancer cells injected into geriatric patients and so on. Little wonder that at the beginning of the 21st century there is increasing interest in having strong ethical standards apply to health research.

In 1998 the Law Commission of Canada commissioned a study of the governance of health research involving humans. Michael McDonald and colleagues have now produced a report for the commission detailing the current status of ethical and legal protections relevant to health research in Canada.

McDonald, the principal investigator, is the author of several chapters. Other authors and their topics include Bernard Dickens on legal issues in biomedical research, Bartha Maria Knoppers on emergencies and the duty to warn, Michael Burgess and Fern Brunger on negotiating collective accountability, Jean Jody on public health research, T. Douglas Kinsella on regulatory status of the Canadian medical profession, Brenda Beagan on ethics review processes, and Marcelo Victor Otero on governance relations in biomedical research.

There is much good information in the report, from reviews of current legal standards to revealing interviews with those involved in the work of local Research Ethics Boards (REBs). The report raises various causes for concern. With regard to REBs, for example, McDonald summarizes the situation this way: REBs tend to focus narrowly on consent forms, they pay too little attention to benefits and harms for research subjects, researchers consider ethics to be a matter of navigating through the REB, and institutions see ethics as little more than the efficient processing of research proposals by a REB.

McDonald remarks that one of the striking conclusions of the study is the discrepancy between ideals expressed in policy and the actual arrangements for accountability and effectiveness of governance in this area. His report calls for the cultivation of a culture of ethics in health research.

The study gives short shrift to the problems associated with funding of research by private industry. Professors Joly and McDonald note that as government funding is trimmed, for-profit corporations play a larger and larger role in funding research. But there is no serious look at situations such as that exemplified by Dr. Nancy Olivieri — situations in which both academic freedom and patient welfare may be at odds with the requirements of a for-profit research sponsor.

From his interviews concerning the functioning of REBs, Otero reports complaints from REB members in Quebec about ready-made consent forms from pharmaceutical companies that actually break the Civil Code of Quebec. Corporatization of research in public institutions deserves more attention in a report such as this.

Because this is a report on health research — which often means medical research — it generally stays clear of the problems that engulfed the creation of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans.

Many of those problems were the result of an attempt to develop a code that would govern not only medical researchers but also psychologists, historians, political scientists, and the like. Thus, protection of research subjects, which is understandably paramount when regulating clinical trials, is an inappropriate standard when applied to the study of political groups or biographies of public figures.

Many of the notions that were controversial in the tri-council process are integrated into this report as received wisdom -- such as McDonald's insistence on the principle of "respect for the dignity and rights of research subjects." (p. v) To the extent that the report is limited to medical and other health research, such ideals are reasonable. But they do not work as well outside the medical context. We would want to respect the dignity of participants in clinical trials in a way that we would not apply to a study of fanatical cults or to the machinations of industrialists.

Despite the health focus of the study, it seems McDonald and his colleagues would like the ideals that guide medical research to apply more generally to any research involving humans. It was this attempt at expansion from health sciences to social sciences that led to controversial debates over the tri-council policy statement — debates in which CAUT and other professional organizations were active and influential participants.

Some of the old ideas sneak back into this report, even though it is ostensibly about health research not about social science. We have, for instance, Professors Burgess and Brunger reinstating the problematic notion that "collectives" affected by research should have a say about the research. For purposes of this report, they use an extended example about genetic testing. But the arguments for the influence of collectives over research are similar to those advanced in the earlier debate over the tri-council policy statement, where the concept was extended to history, sociology, political science and the like.

Once again, we find that the ideal situation is supposed to be one in which a collective may veto research, even if individual members are willing to be subjects. Those individuals, by the way, may not even see themselves as members of the collective, but the researcher is obligated to see them that way.

Will these ideas resurface in a future debate about broader ethical contexts including the social sciences? Without a doubt. While talking about health research, McDonald makes frequent reference to "RIHS" (research involving human subjects) which is clearly much broader than the health research focus of the report to the Law Commission.

Space here limits further reflection on reasons why such expansion of the health research model to social science inquiry is considered by many to be a threat to the legitimate exercise of academic freedom. It is enough to say the battles fought over the original formulation of the tri-council policy statement will have to be re-fought again in its forthcoming revisions.

Patrick O'Neill is the former chair of CAUT's Academic Freedom and Tenure Committee. He is a professor of psychology at Acadia University, whose research focuses on professional ethics.