Consent and discontent
Neil S. Wenger, MD; Martin F. Shapiro, MD
CMAJ 1997;157:1691-2
Drs. Wenger and Shapiro are from the Department of Medicine, University of California, Los Angeles, Calif.
© 1997 Canadian Medical Association
s we consider the current status of research ethics and informed consent, it is useful to reflect on the findings recently released in a report of the US Advisory Committee on Human Radiation Experiments. Although the committee found evidence that researchers took issues of consent and voluntariness into consideration as early as the 1940s and '50s, the practice of carrying out experiments without participants' consent was widespread. Much of the experimentation conducted before the current era of human subjects protections (which began in 1974) was guided by the notion that a higher level of consent was required of healthy subjects than of those who were seriously ill. One physicianresearcher interviewed by the committee as part of an oral history project commented with regard to routine medical research in the middle of this century: "All I could say at the end was that these poor people were lying there and we had nothing to offer them and it might have given them some comfort that a lot of people were paying attention to them for this one study. I don't remember ever asking their permission to do it." 
Things have changed. Today, institutional review boards (IRBs) require a higher level of protection for vulnerable subjects than for healthy people. Yet the substantial number of highly publicized cases of scientific misconduct provide evidence of the need for further improvement in the ethical conduct of research. The committee's report suggested that IRBs and government agencies take the lead in guiding more ethical research behaviours.1
Researchers in Scotland evaluated the potential impact of expanding the role of IRBs.2 They randomly selected 12.5% of projects approved by an IRB during the previous year for retrospective review of research practices. Of 30 studies that had begun, 6 had no informed consent forms available for review and 10 had consent forms that were improperly completed. Three of the studies had significantly changed the protocol, one had changed the principal investigator and several had failed to notify the IRB of patients who experienced adverse events. This study suggests that ongoing IRB monitoring of studies in progress is needed in addition to prospective review. Researchers' awareness that such monitoring is occurring may improve their attention to ethical guidelines.
Recent revisions in research codes may also guide investigators. A draft code for research involving humans has been developed jointly in Canada by the Medical Research Council, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. In an era of interdisciplinary research, one of the main objectives of this code is to unify and explicitly state ethical standards, drawing from the best of various disciplines.3 The code outlines IRB procedures and specifies the kinds of research that require IRB review. It also establishes guidelines for reasonable consent procedures across cultures and for minors. Similarly, the specific requirements for conducting research in the US and obtaining consent under certain circumstances had been further clarified. The US Food and Drug Administration revised its regulations to remove the requirement of prior informed consent in the narrow category of experimental treatments provided in an emergency to patients unable to provide consent.4 These new rules recognize that it is difficult in the emergency department to get a comatose patient to sign a consent form before receiving a new drug or experimental therapy.
A much-publicized imbroglio this year highlighted the fact that even when subjects are able to provide consent there is a lack of consensus about what constitutes ethical behaviour in research. The US Centers for Disease Control and Prevention and the National Institutes of Health have funded placebo-controlled trials of zidovudine among pregnant women in developing countries, despite the fact that this medication has previously been shown to substantially diminish the transmission of HIV in a US population. The study was roundly attacked for exposing the controls to a higher rate of transmission of the deadly disease.5 Commentators compared these studies to the infamous Tuskegee Study of Untreated Syphilis. The directors of the funding agencies defended the studies, arguing that the cost of the treatment is well beyond the ability of people in countries such as Malawi to pay and that, therefore, no one is being denied treatment that they otherwise might have received. They also note that informed consent was obtained for participation in the trials. Is it acceptable to conduct trials with untreated controls in a poor country using such a justification? There appears to be a considerable gulf between the advocates and the critics of the HIV studies. Indeed, 2 members of the editorial board of the New England Journal of Medicine resigned in protest over the publication of the critique.6
If the highest ethical standard is to be achieved in the conduct of research, clearly we need to reach a better understanding of what this means. Given the many ways in which deviations can occur and be rationalized, only the most unambiguous policies and guidelines, combined with a strategy for monitoring their implementation, have any hope of being followed.
References
- Advisory Committee on Human Radiation Experiments. Research ethics and the medical profession. JAMA 1996;276:403-9.
- Smith T, Moore EJH, Tunstall-Pedoe H. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms and research records and by interview. BMJ 1997;314:1588-90.
- Baer N. New draft code for research involving humans proved a major challenge. CMAJ 1996;155:442-4.
- Protection of human subjects; Informed consent; Final Rule. 61 Fed Reg 51498 (1996).
- Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997;337:853-6.
- Altman LA. AIDS experts leave journal after studies are criticized. New York Times 1997 Oct 15; Sect A:10.
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