Magazine article Issues in Science and Technology

Research Ethics from the Inside: Institutional Review Boards Are Responsible for Protecting the Rights of Human Research Subjects. How Do They Really Work?

Magazine article Issues in Science and Technology

Research Ethics from the Inside: Institutional Review Boards Are Responsible for Protecting the Rights of Human Research Subjects. How Do They Really Work?

Article excerpt

The Constant Gardener, a suspenseful 2001 novel by John Le Carre (later made into a popular film), centers around a pharmaceutical company that, to beat the competition to market, rushed a tuberculosis drug through clinical trials despite knowing it would harm the poor, desperate African research subjects, and even turned to murder to protect its secrets and profits. As le Carre made clear in an afterward to the book, his tale should not test the reader's credulity: "By comparison with the reality, my story [is] as tame as a holiday postcard."

But I have a different and more hopeful story to tell, based on my experience leading a private-sector research ethics board. The roots of this story lie in the protracted international effort to develop principles and guidelines that protect human research subjects from unethical treatment. This effort formally began in the aftermath of World War II with the Nuremberg Code of 1947, created by the International Law Commission of the United Nations to codify the principles of voluntary and informed consent by research subjects. Research ethics principles were further developed by the World Health Organization (WHO) in the Declaration of Helsinki of 1964, and by the United States in the congressionally mandated Belmont Report of 1979, which outlined the ethical principles underlying biomedical and behavioral research that in turn informed the human subjects regulations adopted in 1981 by the National Institutes of Health (NIH) and the Food and Drug Administration. In 1991, NIH codified the Federal Policy for the Protection of Human Subjects in what came to be called the Common Rule, as other federal agencies joined in as signatories. And in 1993, the WHO released the International Ethical Guidelines for Biomedical Research Involving Human Subjects.

In another key action, the United States adopted the National Research Act of 1974, which called for organizations conducting research to establish committees called Institutional Review Boards (IRBs). Their purpose would be to ensure that human subjects are made fully aware of the risks and benefits of their participation in research, in terms they can understand, so they can give informed consent. Participation must offer the prospect of a genuine benefit, even if in the distant future or to society at large. Payment for participation does not constitute a benefit, and being paid handsomely cannot be construed as compensation for accepting excessive risk.

Under the federal Common Rule, human subjects must be informed that after agreeing to participate in research, they can back out at any time, with no questions asked or pressure to stay. Descriptions of procedures must be provided at the educational level of research subjects. If subjects report or display "adverse events"--such as illness plausibly resulting from research exposures or self-destructive behavior after completing an intrusive questionnaire--the researchers conducting the study must report the events to the IRB. In turn, the IRB may demand that the research protocol be revised, that future adverse events be monitored and reported to the IRB on a specified schedule, or that the research be suspended or terminated entirely. For multiyear projects, researchers are typically expected to report their experiences to the IRB annually, to obtain approvals to protocol changes before they are implemented, and to explain how protocol revisions will monitor for recurrences of adverse events while minimizing, if not eliminating, them.

Inventing research ethics

In the early 1990s it remained to be seen how the Common Rule would shake out. Would implementation focus largely on NIH? Would IRB reviews be restricted largely to biomedical and behavioral research? I was the newest officer in a management consulting firm whose modest $20 million in revenues came mostly from conducting health-related survey and evaluation research under contract to federal agencies, with training, technical assistance, and educational product development representing smaller lines of work. …

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