Academic journal article The Hastings Center Report

Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research

Academic journal article The Hastings Center Report

Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research

Article excerpt

Federal policies on human subjects research have performed a near-about face. In the 1970s, policies were motivated chiefly by a belief that subjects needed protection from the harms and risks of research. Now the driving concern is that patients, and the populations they represent, need access to the benefits of research.

Justice has long been one of the central principles in the ethical conduct of research on human subjects. But its application, as reflected in federal policies pertaining to human subjects research, has undergone a remarkable shift over a relatively short span of time. Understanding this shift is important not only for interpreting claims about justice in human subjects research, but also for assessing the status and adequacy of policies for protecting subjects.

In the 1970s, these policies emphasized the protection of human subjects from the risks of harm in research, and justice was seen as part of this protection. Since the early 1990s, however, justice as applied in research ethics has emphasized the need to ensure access to the potential benefits that research has to offer. That such a dramatic shift could occur so quickly is extraordinary, especially in light of the understanding, coalescing over the same period, that subjects have an inadequate understanding of the research in which they are participating and are inadequately protected by existing practices and policies. The tension between these developments offers an important lesson for research protection as the context of human subject research becomes more complex. Our goal here is to attempt to understand how the pendulum has swung from protection to access, where in its arc we are, and where we should be.

Justice in the Belmont Era: Protection from Exploitation

The development of human subject protection policy in the United States was driven by a history of exploitation of subjects, most notably by research on "vulnerable" subject populations that came to light between the mid-1960s and the early 1970s. The landmark examples were the Willowbrook State School hepatitis vaccine research on institutionalized children; the Jewish Chronic Disease Hospital cancer research, involving the injection of cancer cells into elderly nursing home residents; and the so-called Tuskegee Syphilis Study, which had been under way for decades but was exposed to an appalled nation in 1972.[1] Those examples contributed to a sense that human subjects research in the United States permitted scandalous practices--inadequate attempts to inform subjects about research and obtain their consent, exploitive recruitment strategies, the use of vulnerable subject populations, and a willingness to expose subjects to significant risk without any potential for direct medical benefit. Further, there was a sense that the risks and benefits of research were split apart--the risks were borne by subjects, the benefits accrued to others.

Thus the early history of U.S. research ethics policy focused on the risks rather than the benefits of research, and on preventing subjects from being exposed to unacceptable or exploitive levels of risk, particularly without the prospect of offsetting direct medical benefits. The Belmont Report, issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978, identified justice as requiring the fair distribution of the burdens and benefits of research in subject selection and recruitment; in practice, however, justice was interpreted as requiring the prevention of any further exploitation of vulnerable groups.[2] The emphasis was realized through the promulgation of research policies that staked much on protection and that singled out particular groups--namely, prisoners, children, and pregnant women and fetuses--for additional protections.

Prisoners were deemed vulnerable because of the nature of their living environment. Adequate informed consent, it was believed, was not possible when subjects lived in a setting that constrained the autonomy on which the concept of informed consent is based. …

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