Do We Need Another Advisory Commission on Human Experimentation?

Abstract

A few months ago Office of Science and Technology Policy (OSTP) published in Federal Register its proposal for establishment of another Bioethics Advisory Commission within Executive Branch ...to consider issues of bioethics arising from research on human biology and behavior, and application of that Central to OSTP's proposal is an inquiry into adequacy of current of rights and welfare of research subjects, [i.e.] informed consent, adequacy and implementation of Federal human subject research guidelines, and concept of 'minimal risk.' We do not need another inquiry, another advisory commission on human experimentation. We need a national commission that has authority, with advice of Congress, to regulate all research involving human subjects. We have had enough advisory bodies: National Commission for Protection of Human Subjects of Biomedical and Behavioral Research (1974-78) and President's Commission for Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1979-83). Both made remarkable contributions and left us a rich legacy of ethical, legal, and policy analysis as well as recommendations for conduct of research. To be sure, as OSTP noted, members of contemplated commission could expand on their work, but I doubt whether they would shed significant new light on the broad overarching principles to govern ethical conduct of (OSTP assigned two other tasks to advisory commission, but was correctly concerned that one of them was itself so broad in scope that it might limit [the commission's] effectiveness. In what follows, I make no judgment about need for advisory commissions in areas unrelated to human experimentation.) The current impetus for establishing another advisory commission is fueled, as its chief supporter Senator Mark Hatfield suggested in a letter to President Clinton, by disclosures of radiation testing on humans during Cold War [that] have raised profound ethical questions for Federal policy makers. Twenty-two years ago, revelations regarding Tuskegee syphilis study, conducted by Public Health Service physicians from 1932 to 1972, led to a similar call for more stringent oversight of human experimentation process which in 1974 culminated in promulgation of federal regulations for protection of human research subjects. The regulations, while an improvement over what we had before, are inadequate. Indeed, in its final report, Tuskegee Syphilis Study Ad Hoc Advisory Panel of Department of Health, Education and Welfare recommended an entirely different approach to regulation of human experimentation. I chaired subcommittee that addressed this charge. Now twenty years later, our recommendations deserve reconsideration. Before describing them, I want to proffer two observations: (1) The federal regulations, promulgated in 1974 at prodding of Senator Edward Kennedy and others, essentially codified criteria for informed consent in conduct of research and, with limited and vague additional instructions, left it to local institutional review boards (IRBs) to review - approve, require modification in, or disapprove - research proposals submitted by their local institutions. Thus, IRBs are forced to make decisions that are compromised by limited time and resources available to them; by their lack of expertise, which prevents them from considering in any depth complex legal, ethical, and societal problems that human experimentation poses; and by pressures of their institutional colleagues to approve their protocols as quickly and unquestioningly as possible. In short, IRBs are left at sea, given a mandate that they could not responsibly carry out without recourse to an overarching body that would structure and guide their work. (2) Already in 1973, it was clear that more was needed than what federal regulations provided. …