Freedom to be altruistic: allowing for risk/knowledge ratios in decisions concerning multiple sclerosis research

In their thoughtful criticism of the conclusion by a joint panel of the Canadian Institutes of Health Research and the Multiple Sclerosis (MS) Society of Canada concerning Dr. Paolo Zamboni’s “liberation procedure” for chronic cerebrospinal venous insufficiency (CCSVI), Dr. Andreas Laupacis and Dr. Arthur Slutsky missed an important public policy point: there is an additional, little-developed freedom involved in patient autonomy in Canadian law, which is the other face of the coin of informed consent. Note that I speak of a coin of freedom, not of right. If there is a right, someone is under a duty, and there is no duty on anyone to conduct studies of the liberation procedure. The court would reject a claim for an order against researchers or institutions that such a study be done. The correlative of a freedom—the classic example is the freedom to walk in a public park—is that no one has the right to object. The legal philosophers call this a “no-right” to distinguish it from a duty. In the case we are considering, no researcher has the legal right to omit obtaining informed consent when signing up subjects (indeed, this side of the coin is now treated as a duty of disclosure when the researcher is embarked on a study and is recruiting subjects); similarly, for the obverse of the freedom coin in question, for patients satisfying the requirements for enrolment in a study of the liberation procedure, no researcher has the right to refuse those who choose to participate, as argued below. Laupacis and Slutsky summarized the panel’s decision as follows: “the evidence linking CCSVI and MS was so unconvincing that it would be inappropriate at this time to perform a clinical trial examining the benefits and risks of endovascular treatment as a therapy for MS.” Risk/benefit is an incomplete ratio: also relevant is risk/knowledge. Health Canada advises researchers developing informed consent documents not to mention that a research ethics committee has approved the research because “approval means only that the Committee considers the risks to fall within a scale of risks which a reasonable participant may be invited to accept, and that the risk-to-benefit (or risk-to-knowledge) ratio of the study appears favourable.” [Emphasis added.] Where is the fair-minded risk-to-knowledge analysis in the panel’s deliberations or its conclusion? A patient has a right to determine what shall be done to his or her body, as well as what shall not be done to it. The freedom I claim is implied in an extract of the decision by Justice Sydney Robins in an Ontario Court of Appeal case, Fleming v Reid, quoted in a publication of the Canadian Medical Protective Association. There, Justice Robins said: