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By Penni Mitchell
(HALIFAX) New Canadian guidelines created to ensure that publicly funded health research is strongly rooted in ethics may not be so ethical after all. According to a group of 11 women researchers who provided input into the guidelines, last minute changes were made to the document that watered down or deleted many sections designed to empower women and other disadvantaged groups.
A tri-council working group set up by Canada's three main research funding bodies-the Medical Research Council, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council-was established in 1994 to gather input on the broad topic of ethics in research involving humans. After going through several stages of revisions, a Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans, dated January 1998, is now on the verge of being adopted by all three funding bodies.
Francoise Baylis, a professor of Bioethics and a member of the Feminist Health Care Ethics Research Network, says that if the January 1998 version of the Policy Statement is adopted, "the interests of women and other systematically disadvantaged groups in Canada will not be adequately protected."
The Feminist Ethics Network is a multidisciplinary group of researchers from faculties of philosophy, women's studies, history, sociology, anthropology, epidemiology, medicine, public health and law. The Feminist Ethics Network, sponsored by the Social Sciences and Humanities Research Council, recommended clauses to address ways that women and other disadvantaged groups could be afforded greater equality in how research is conducted, and in setting the research agenda. Many of the Feminist Ethics Network's recommendations were included in an earlier so-called 'final version circulated in July 1997, however many of the relevant clauses on equality and diversity were significantly amended when the January 1998 Policy Statement was circulated for approval.
The exclusion of women as subjects in medical research is a long-standing debate. The popular illustrative example is the study of all male subjects which recommended Aspirin as an effective preventive in reducing heart attacks for the general population, even though no data were collected to indicate whether the results were applicable to women. (As it turned out, the results were not applicable to women.) Traditionally, medical researchers have excluded women of childbearing age from medical studies unless they were on contraception because their hormonal cycles were considered to be "a confounding influence" and because damage to fetuses could occur if research subjects became pregnant.
The Feminist Ethics Network argued that inequality in treatment and research is unethical and that the automatic exclusion designed to protect fetuses unnecessarily omits a large segment of the female population from research - notably women who are not heterosexual or are not sexually active or are not fertile.
Both the July 1997 version and the January 1998 Policy Statement acknowledge that the inclusion of women in research "is essential if men and women are equally to benefit from research." It is noted that "research data on drug dosages, device effects, treatments, cultural norms, moral development, and social behaviour obtained from male-only studies likely will not be generalizable to women." In other words, the Policy Statement appears to recognize that it is medically dangerous to exclude women from research. As well, both versions of the research guidelines state that "no woman should be automatically excluded from relevant research." However, this inclusion requirement is qualified by the clause "depending on the themes and objectives of the research" in the January 1998 version. It explains that this clause means that including women is "relevant to some, but not all research." Jocelyn Downie, Director of the Health Law Institute at Dalhousie and a Feminist Ethics Network member, calls this an 'escape clause' that allows the agencies to appear to have taken a strong stand on the inclusion of women, but allows researchers to avoid meaningful inclusion.
The fight for more inclusive research guidelines may not be over. The Feminist Ethics Network has sent a summary of its objections to a variety of players in the policy-making process in a continuing effort to ensure that women's interests are protected and promoted.
Further Information
At press time, the July 1997 version of the code was still posted on the web site of the Medical Research Council at: http://wwwmrc.hc-sg.ca/ethics/code or phone (613)941-2672.
The Feminist Ethics Network summary is available through the CWHN, and on its website: http://www.cwhn.ca or phone (204) 942-5500. For further information on The Feminist Ethics Network recommendations, contact Francoise Baylis at the Office of Bioethics Education and Research, Dalhousie University (902) 494-3801 or e-mail francoise.baylis@dal.ca ; or Jocelyn Downie at Health Law Institute, Dalhouse University (902) 494-6881 or e-mail jocelyn.downie@dal.ca ;or Susan Sherwin, Philosophy Dept. Dalhousie University (902) 494-3393 or e-mail susan.sherwin@dal.ca .