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REASONS FOR COMPENSATION

Reasons for compensating injured research subjects tend to fall into three categories: economic, ethical, and political.

Economic Reasons

The economic reason derives from the concept of risk-spreading and the economic theory that the costs of injury should be borne by the person who can best and most efficiently afford them.1 When injuries occur, there are only two choices: (1) to leave the losses where they lie—with the injured person; or (2) to shift the financial losses to another person—the person who caused the injury, if any, or society as a whole. In most instances, economic theory would favor shifting the losses to a research sponsor or institution2 because these ordinarily have greater resources than an individual research subject and they can recoup the losses by means of increased prices or other revenue-generating mechanisms. However, given the rarity of research injuries, it is possible that the administrative costs could exceed the efficiency gains of loss shifting.

In practice, economic theory rarely controls policy choices concerning the allocation of losses. Rather, social conceptions of moral rights and duties influence who should bear the financial consequences of different types of injury. This brings us to the second reason for compensating research subjects—ethical principles.

Ethical Reasons

Since the 1960s, individual commentators,3and national commissions have agreed that the ethical principles of justice and virtue support, if not require, compensating research subjects who are harmed as a result of participating in research. The ad hoc panel created by the federal government's Department of Health, Education, and Welfare (HEW) to review the Tuskegee Syphilis Study recommended a no-fault compensation system in 1973.4 The HEW Task Force on the Compensation of Injured Research Subjects recommended compensating injured subjects of research conducted or supported by the Public Health Service in 1977.5 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created in 1974, generally endorsed the Task Force's recommendations, but, without studying the issue, recommended only that subjects be told whether or not compensation was available.6

In 1982, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research found that compensation is appropriate and desirable, but, given the small number of serious injuries arising



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