[Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research, December 2011]
The report is a response to President Obama's November 2010 request for "a thorough review of human subjects protection to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government."
At the time of that charge, I warned,
the commission lacks the full range of expertise to review all the federal regulations and international standards that govern human subjects protection. Since the 1960s, committees and commissions composed of medical researchers, psychological researchers, and bioethicists have advised regulators and presidents about human subjects protections without adequately consulting researchers in the social sciences and humanities, who then find themselves subject to rules they were not allowed to shape.
Unfortunately, the report continues this trend.
The Commission claims to have made "attempts to understand the full range of human subjects research conducted or supported by the federal government." (44) But the Commission seems to have been only dimly aware that not all "human subjects research" is medical experimentation.
One passage refers to "Early stage translational research [that] serves to test physiological effects or biological functions of new drugs and medical interventions but is not necessarily designed to benefit subjects " and to "Research in other fields, including housing, social work, and criminology . . ."(19) Ah, yes. The social sciences as Other. A few pages later we get a reference to "Research beyond public health and medicine, in social science and related fields, [that] can involve thousands of research subjects through increasingly accessible survey tools and methodologies that expand experimental rigor." (21) Again with the "experimental rigor."
When the Commission tried to imagine "Non-Clinical Human Subjects Research," it came up with three examples all dealing with health in some way: a HUD study of obesity and diabetes, a DOE study of long-term health impacts from the atomic bombing of Japan, and a DOJ study of the safety of stun guns. (38, Table 2.2).
And several portions of the report suggest that the authors were thinking only about medical research. For example, the report claims that the Common Rule and FDA regulations "extend to most, although not all, research conducted in the United States and nearly all research funded with public monies outside of the country." (32) But these regulations do not cover the vast machinery of marketing surveys conducted every day by private corporations, much less the identifiable private information collected by every supermarket with a loyalty card program. If you understand what human subjects research is under present definitions, you know that the bulk of human subjects research conducted in the United States is not regulated. Nor should it be, if it only involves asking questions of adults.
The consequence of this misunderstanding is a failure to understand that different research enterprises involve different ethical principles. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's Belmont Report ignored warnings that medical ethics were not appropriate for all fields. Today's Commission still wants to shove everyone into the Belmont box:
Medical research that poses risk of physical injury rightly raises more concerns than does routine social survey research, for example. Nonetheless, the same ethical principles govern all of these activities, and serve as enduring guideposts that must not be ignored. (3)
Naturally, if you believe that all ethics is medical ethics, why not make humanities majors study bioethics in college?
Recommendation 7: Expand Ethics Discourse and Education
To ensure the ethical design and conduct of human subjects research, universities, professional societies, licensing bodies, and journals should adopt more effective ways of integrating a lively understanding of personal responsibility into professional research practice. Rigorous courses in bioethics and human subjects research at the undergraduate as well as graduate and professional levels should be developed and expanded to include ongoing engagement and case reviews for investigators at all levels of experience. (22)
Moreover, Recommendation 13 wants the federal government to "require that all federal agencies conducting human subjects research adopt human subjects regulations that are consistent with the ethical requirements of the Common Rule." (102) Unless "human subjects research" is redefined, this could sweep into a flawed system researchers who are sponsored by non-signatory executive agencies, like the National Endowment for the Humanities, and perhaps even legislative agencies like the Library of Congress.
Medical ethics for everyone!
The irony here is that by ignorning ethical complexity, the Commission threatens to diminish rather than enhance "a lively understanding of personal responsibility."
The only really hopeful note in the report is its section on the ANPRM. The Commission "generally supports the objectives of the ANPRM and the goal of better protecting human subjects while reducing burden, delay, and ambiguity for investigators," and it has even learned from the ANPRM that "many social and behavioral scientists have argued that their research is over-regulated in the current system." (97) But no one on the Commission seems to have grasped the ANPRM's message that some research "may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule."