Consent in clinical research

Abstract

The defining goal of clinical research is to generate knowledge that can be used to enhance the therapeutic capacities and decision-making of clinicians and policymakers. Achieving this goal often requires experimenting on or collecting information about human subjects 1 in ways that would, without consent, infringe their rights. Guidelines for human subjects research, such as the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, and the Common Rule Regulations exist because of notorious studies that, among other things, failed to obtain voluntary and informed consent from human subjects. The Nazi doctors forced prisoners into harmful experiments (Claims Conference 2007). The Tuskegee Syphilis Study tricked subjects into accepting a painful non-therapeutic lumbar puncture under the guise of “special free treatment” (Brandt 1978). Had the investigators in these experiments sought voluntary and informed consent, subjects would have refused and avoided serious harm. But protection from unwanted harm is not the only function of consent. In another much-discussed study, patients at the Jewish Chronic Disease Hospital were injected with live cancer cells for a purely scientific purpose, without being told that the injection was not for their benefit and that it contained live cancer cells (Arras 2008). The researchers argued that, since the injection posed no serious risk, the patients did not need to be informed about the contents or purpose of the injection to protect themselves from harm. Nevertheless, by injecting the patients without their informed consent, the researchers had clearly infringed on the patients’ rights to decide what is done to their bodies. The lessons of these early scandals have been learned. The norm of obtaining voluntary and informed consent is now deeply entrenched in clinical research. Yet the topic of consent in clinical research remains a focus of discussion. There are two principal areas of continuing controversy. One centers on the question of when consent to low-risk research is necessary and when it is not. It can be very costly or even infeasible to seek consent for certain types of studies, such as research on biological samples and emergency research. If consent is unnecessary in such studies this would be a boon to science, but there is disagreement about the conditions under which low-risk research may go forward without consent. Another source of controversy derives from a worry that, even when consent is sought from subjects, the consent they provide is often defective. Consent should be adequately informed and voluntary. But empirical research has shown that subjects frequently have deficits in their 26 CONSENT IN CLINICAL RESEARCH