In December, the Presidential Commission for the Study of Bioethical Issues released a 200-page report, Moral Science: Protecting Participants in Human Subjects in Research. Continuing a decades-old tradition, the report treats medical experimentation as the model for all research with human beings, ignoring the rights and responsibilities of researchers in other fields. By doing so, it goes against the progress made this summer by federal regulators, who for the first time in decades acknowledged the dangers of overregulation and a one-size-fits-all ethics.
The new 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 that:
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 wrote that it made "attempts to understand the full range of human subjects research conducted or supported by the federal government." (page 44) But it seems to have been only dimly aware that not all human subjects research is medical experimentation. For example, in one of the few references to nonmedical research, the report states, "Research beyond public health and medicine, in social science and related fields, can involve thousands of research subjects through increasingly accessible survey tools and methodologies that expand experimental rigor." (page 21) But what about research in those fields that is not experimental, or even quantitatively rigorous?
A table on nonclinical human subjects research contained three examples, all dealing with health in some way: a study of obesity and diabetes, another of long-term health impacts from the atomic bombing of Japan, and a third concerning of the safety of stun guns. (page38). Several other parts of the report suggest that the authors were thinking only about medical research. For example, the report states 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." (page 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.
Had the commission understood what human subjects research is under present definitions, it would know that the bulk of human subjects research conducted in the U.S. is not regulated. Nor should it be, if it only involves asking questions of adults.
It is not surprising that the report struggles to understand social science research, for its authors appear to have devoted little attention to the question. In the report's 240 footnotes, I found only one (footnote 23) referring to a source that concerns the ethics of social science research. And even that is to a 2003 report, which itself did a poor job exploring the ethical debates among scholars.
One consequence of this inattention is a failure to understand that different research enterprises involve different ethical principles. The advance notice of proposed rulemaking (ANPRM), released in July by the Department of Health and Human Services and the Office of Science and Technology Policy, asks if some research (such as classics, history, languages, literature, and journalism) "may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule." But the presidential commission has ignored this possibility
Instead, Moral Science asserts that today's human subjects rules "reflect widely accepted principles of ethics," principles that are left unnamed in that passage but presumably are the familiar Belmont trinity: respect for persons, beneficence, and justice. It goes on to say: "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." (page 3) In effect, the report is claiming that the Belmont principles are widely accepted by researchers in all activities now governed by federal regulations.
The report offers no evidence for these claims, and it ignores evidence to the contrary. At the Belmont conference itself in 1976, legal scholar Charles Fried and sociologist Albert Reiss argued that freedom of inquiry was as important as any other principle, and that beneficence in particular might not make sense for scholars engaged in uncovering wrongdoing. Historian Linda Shopes reiterated this position in 2002, telling the National Human Research Protections Advisory Committee that "Constraints on critical inquiry violate the principle firmly held by historians that public knowledge of the past serves the public good, however painful, difficult, or even incriminating that knowledge may be to specific individuals or communities."
Last year, the American Anthropological Association released a draft ethics code that recognizes "differing ethical frameworks of collaborators representing other disciplines or areas of practice." But rather than investigate the decades of ethical debates among social scientists, Moral Science seeks to shove everyone into the Belmont box.
The dangers of the narrow approach taken by Moral Science can be seen in its recommendations. Recommendation 7 calls for "Rigorous courses in bioethics and human subjects research at the undergraduate as well as graduate and professional levels . . ." Lest it seem far-fetched to imagine that this could lead to researchers in the social sciences and humanities sitting through mandatory bioethics courses irrelevant to their pursuits, consider the testimony to the commission by Ronald Bayer, the cochair of the Center for the History and Ethics of Public Health at Columbia University. Bayer described existing standardized training as "mortifyingly stupid, and stupefying." The commission's proposals would only aggravate such inappropriate training.
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." (page 102) Unless human subjects research is redefined, this could mean extending regulations to agencies that have not adopted the Common Rule, like the National Endowment for the Humanities and the Library of Congress. This would impose inappropriate rules on countless researchers who have thus far avoided them. The commission claims to promote "regulatory parsimony," but it recommends regulatory extravagance.
Moral Science does contain some hopeful notes. 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." Better still, it notes that "scientific discoveries and advancements depend on the intellectual freedom of researchers coupled with the responsibility of individuals and institutions to use their creative potential in morally responsible ways. Regulatory oversight must be limited to that which is truly necessary to ensure justice, fairness, security, and safety while pursuing the public good." (pages 96-97) Such nods to freedom are all too rare in writings about research ethics.
On the whole, however, Moral Science pays scant attention to the social sciences yet feels comfortable making recommendations that could affect all research. In releasing this report, the presidential commission has shown the same ethical arrogance as its predecessors.
Zachary M. Schrag, an associate professor in the Department of History and Art History at George Mason University, is the author of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Johns Hopkins University Press, 2010).