Do we need another advisory commission on human experimentation

A few months ago the Office of Science and Technology Policy (OSTP) published in the Federal Register its proposal for the establishment of another "Bioethics Advisory Commission within the Executive Branch ...to consider issues of bioethics arising from research on human biology and behavior, and the application of that research." Central to OSTP's proposal is an "inquiry" into the adequacy of the current "protection of the rights and welfare of research subjects, [i.e.] informed consent, adequacy and implementation of Federal human subject research guidelines, and the concept of 'minimal risk.'" We do not need another inquiry, another advisory commission on human experimentation. We need a national commission that has the authority, with the advice of Congress, to regulate all research involving human subjects. We have had enough advisory bodies: the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78) and the President's Commission for the 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 the conduct of research. To be sure, as OSTP noted, members of the contemplated commission could "expand on their work," but I doubt whether they would shed significant new light on "the broad overarching principles to govern the ethical conduct of research." (OSTP assigned two other tasks to the 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 the 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 the "disclosures of radiation testing on humans during the Cold War [that] have raised profound ethical questions for Federal policy makers." Twenty-two years ago, the revelations regarding the Tuskegee syphilis study, conducted by Public Health Service physicians from 1932 to 1972, led to a similar call for more stringent oversight of the human experimentation process which in 1974 culminated in the promulgation of the federal regulations for the protection of human research subjects. The regulations, while an improvement over what we had before, are inadequate. Indeed, in its final report, the Tuskegee Syphilis Study Ad Hoc Advisory Panel of the Department of Health, Education and Welfare recommended an entirely different approach to the regulation of human experimentation. I chaired the 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 the prodding of Senator Edward Kennedy and others, essentially codified criteria for informed consent in the 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 the limited time and resources available to them; by their lack of expertise, which prevents them from considering in any depth the complex legal, ethical, and societal problems that human experimentation poses; and by the 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 the federal regulations provided. …