Compensating persons injured in human experimentation

Without disparaging the ethical importance of informed consent or of care and supervision in research design, it is possible to assert that ethics requires also that the investigator furnish financial protection to research subjects. Lacking mechanisms for providing this protection, investigators have seldom made such provision in the past, and have left research subjects to rely on the institution's sense of moral obligation or on poorly defined legal rights. Research institutions and research sponsors, especially the federal government and the drug industry that it regulates, could provide for insurance or indemnification through mechanisms yet to be developed. In pursuit of this goal, serious study should begin on the problems of implementing compensation arrangements for all injured research subjects. The Public Health Service and the FDA have not fully discharged their responsibility in the direction of creating conditions under which clinical research can proceed with adequate regard for the subjects' rights.