Authors

Sharona Hoffman

Abstract

Developments in medical research have been occurring at a rapidly increasing rate during the past two decades. Expanding budgets, augmented computer capabilities, and new research tools have all dramatically enhanced research technology. Accompanying the proliferation of medical research are increasing concerns about research risks. This article focuses on placebo-controlled clinical trials. The use of placebos enables clinical investigators to compare results from subjects taking an experimental intervention to results from a group that is receiving an inactive substance, such as a sugar pill, in order to determine the efficacy of the new medication. In recent years, some surgeons have also conducted clinical trials involving sham operations, the equivalent of placebos in the surgical arena. Placebo-controlled trials are of particular concern because of the possible adverse consequences for study participants who could otherwise benefit from receiving active treatment.

Some critics of placebo-controlled clinical trials contend that it is always unethical to deprive patients of available therapy. By contrast, proponents of placebos argue that placebo-controlled studies are cheaper, easier to interpret, and provide more definitive results than other study designs. The use of placebo controls raises profound questions regarding the ethical principle of beneficence, that is, the responsibility of physicians to avoid harming patients and to maximize benefits while minimizing risks for human subjects. Other troubling questions relate to personal autonomy and the ability of individuals to provide meaningful consent to participation in research that might require them to forgo beneficial therapy.

This article analyzes the advantages and disadvantages of placebo controls as well as the many ethical dilemmas associated with their use. It suggests guidelines that elucidate the circumstances in which utilization of placebo controls is appropriate and the factors that militate against their inclusion in studies in particular instances.

Keywords

Clinical research, Institutional Review Board, placebos, FDA, HHS, research regulation, research ethics, autonomy, beneficence

Publication Date

2001

Document Type

Article

Place of Original Publication

Connecticut Law Review

Publication Information

33 Conn. L. Rev. 449 (2001)

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