Subject Comprehension, Standards of Information Disclosure and Potential Liability in Research

Beginning of article

I. Introduction

The history of modern research ethics can be traced to the ten articles of the Nuremberg Code, a response to the atrocities that Nazi physicians had perpetrated upon their hapless victims in so-called "medical experiments." Informed consent to research was the first and most prominent of those ten articles. In spite of this attempt to regulate human subjects research, however, some twenty years later Dr. Henry K. Beecher published a critical survey of twenty-two research projects conducted in the United States in the years subsequent to Nuremberg. (1) Beecher observed that in the vast majority of cases research subjects were never adequately apprised of the nature of the research conducted upon them. He reiterated the need for informed consent as a necessary component of morally acceptable research on human subjects. At the same time, however, he acknowledged that in practice it is often difficult to obtain adequately informed consent. Hence Beecher insisted on a second component in order for patients to be s afeguarded in the research process, namely "intelligent, informed, conscientious, compassionate, responsible investigators." (2)

There can be no doubt that the conduct of ethical research rests ultimately in the hands of persons of integrity. Yet Beecher's own investigations indicated that we would be foolish to assume this high standard is always or usually attained. In the years subsequent to Beecher's article a consensus has emerged that independent review of proposed research on human subjects is essential. This is the position set forth in the World Medical Association's Declaration of Helsinki, (3) and it serves as the historical basis of the contemporary Research Ethics Board (REB). Prior review by a duly constituted committee has become the ethical sine qua non of modem human subjects research.

Despite the widespread implementation of REB review, however, difficulties persist with regard to the matter of ensuring informed consent on the part of prospective research subjects. (4) The 1980 Supreme Court decision in Reibl v. Hughes (5) established the Canadian standard for informed consent to therapeutic treatment. However, the leading Canadian case for consent in the context of research and experimentation was established some 15 years earlier in Halushka v. University of Saskatchewan et al. (6) In Halushka Justice Hall argued that the duty owed by researchers toward prospective subjects is greater than that owed by medical practitioners to their patients. (7) A stricter standard of disclosure in the research context is now generally accepted in law. (8) To quote one authority on the subject, it is "the most exacting duty possible, requiring 'full and frank disclosure' of all risks, no matter how remote or how rare." (9)

Canadian legal (10) and ethical (11) commentators continue to cite Halushka as the leading case on informed consent to research. This is understandable in that it is one of the few cases of this nature that has made its way through the courts. (12) It is also the case that established that the standard for consent to research is stricter than that applied to therapy. However, it can be argued that Halushka in fact invoked a weaker standard of informed consent than that which was later applied in Reibi v. Hughes. Since so much commentary on consent to research continues to invoke Halushka, it is necessary to examine what this judgment did in fact establish, how it is related to the later judgment in Reibl, and to consider the combined implications of these and subsequent cases for consent to research.

This paper considers what can be learned from Halushka v. University of Saskatchewan, Reibl v. Hughes and subsequent decisions (13) with regard to consent to participate in clinical trials. In particular it is argued that the standard of information disclosure utilized currently in many clinical trials fails to meet the strict standard set in Reibl v. Hughes. Researchers who proceed on an inadequate standard of information disclosure and comprehension may fail in both their legal and moral obligations to ensure that prospective research subjects are given an opportunity to provide valid consent. The paper concludes with some suggestions as to how the role of the REB should be redefined with regard to the informed consent process.

II. Halushka v. University of Saskatchewan and Reibl v. Hughes: A Comparative Review

Halushka v. University of Saskatchewan et al. is a case of non-therapeutic, experimental research. Inasmuch as it is one of the few cases of this type in North America that has produced a legal judgement, it has set the standard.

The case arose in 1961 when Walter Halushka, a student at the University of Saskatchewan, volunteered to participate in a clinical trial to test a new drug. Although Mr. Halushka signed a consent form that authorized the procedure, the physician researchers failed to inform him that the drug was a new anaesthetic about which they had little knowledge and with which they had no prior experience. They did not inform him he might be exposed to certain unknown risks. Instead they assured Mr. Halushka there was nothing to worry about. Furthermore, while he was informed that the test would require that a catheter be inserted into a vein in his arm, it was not explained that this catheter would be pushed up the vein and through his heart as the experiment proceeded. In fact, when the catheter was advanced through the heart chambers and the anaesthetic was administered, Mr. Halushka suffered a complete cardiac arrest. It took approximately one minute and thirty seconds to open his chest and separate his ribs so that manual heart massage could be performed. Although the physician researchers were able to resuscitate Mr. Halushka, he suffered some brain damage with a resulting diminution of mental ability.

Justice Hall makes several significant points in ruling on this case. First, he acknowledges that ordinarily both medical therapy and medical research require prior informed consent from patients/subjects. Second, he notes that the differences between the therapeutic situation and the research situation may permit a different standard of informed consent in each context. This is because of therapeutic privilege, the legal doctrine that permits physicians to withhold information from patients or their proxies if they reasonably believe it would not be in the patient's best interests to receive it, or if they believe such information could interfere with the patient's treatment or cure. (14) In such cases physicians may have to "balance the probable effect of lack of treatment against the risk involved in treatment itself." (15) Hence in some situations it may be permissible to proceed with treatment without prior fully informed consent. Although the emerging consensus is that …