The world learned last fall of a shocking lapse in medical research ethics. Historian Susan Reverby had uncovered documents showing that in the late 1940s, U.S. and Guatemalan researchers had intentionally infected Guatemalan prisoners, soldiers, and mental patients with syphilis in order to study penicillin's ability to prevent transmission of the disease. The researchers deliberately prevented their subjects from understanding the procedures.
As Professor Reverby's editor for that piece, I am proud of the small role I played in bringing this story to light. As an American, I am proud of the forthright apologies offered by President Obama to the Guatemalan people.
But I am beginning to fear that the president has drawn the wrong lessons from this history. The day before Thanksgiving, he ordered the Presidential Commission for the Study of Bioethical Issues to investigate further the abuses of the 1940s. In the same message, he asked the commission 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." This is an impossible request.
For one thing, the president called upon the Commission “to complete its work within nine months and provide me with a report of its findings and recommendations.” Federal human subjects regulations date back to 1974, and even before that other policies governed federally supported studies. In the half-century since they were first implemented, these policies have created a vast system of oversight, comprising overlapping sets of federal regulations, the continuing work of the Secretary’s Advisory Committee on Human Research Protections, nongovernment actors such as Public Responsibility in Medicine and Research (PRIM&R), and, of course, thousands of institutional review boards around the country.
Such a structure cannot be reviewed in nine months. Consider the work of the Institute of Medicine’s Committee on Assessing the System for Protecting Human Research Participants, which had eleven members, nine expert advisors and liaisons, and a staff of four, all focused on human subjects protections. It took that committee more than 18 months – from October 2000 to May 2002 – to complete its report, Responsible Research: A Systems Approach to Protecting Research Participants. And even then it found itself hampered by “the lack of data regarding the scope and scale of current protection activities.” Nor did the Department of Health and Human Services adopt the committee’s recommendation for continuous collection of data about the national human research protections system.
As bioethicist Christine Grady noted in the September 8, 2010, issue of JAMA, “Protection from unnecessary or excessive risk of harm is an important measure of IRB effectiveness, yet no systematic collection of data on research risks, no system for aggregating risks across studies, and no reliable denominator of annual research participants exist.” The current presidential commission has a broader mandate, fewer resources, less time, and no more systematic data than the Institute of Medicine committee.
Second, 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.
In 2003, the National Research Council’s Panel on Institutional Review Boards, Surveys, and Social Science Research – a spinoff from the Institute of Medicine’s effort – concluded that “any committee or commission established to provide advice to the federal government on human research participant protection policy should represent the full spectrum of disciplines that conduct research involving human participants. In particular, such a body should include members who represent the range of the social, behavioral, and economic sciences.” The current presidential commission – whose members were all appointed for their expertise in medical research, public health research, and bioethics – clearly fails this test.
Third, President Obama also requested “a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study” of the 1940s. Such a study is indeed needed, but it will also take more than nine months and require more resources and expertise than the presidential commission possesses.
For comparison, consider the work done in the 1990s by the Advisory Committee on Human Radiation Experiments, which also studied abuses of federally funded research the 1940s. That committee needed more than a year and a half to complete its work. Though the Guatemala study was much smaller in scope, the impressive work of the radiation committee suggests the value of handing such investigations to a body specifically created for the task, and giving it plenty of time.
Moreover, the reaction to disclosures, in the 1990s, of the abusive radiation studies of the 1940s shows the danger of confusing past research abuses with present concerns. Though the National Bioethics Advisory Commission reported in 2001 that "the current Federal regulations have served to prevent most recurrences of the gross abuses associated with biomedical research in the earlier part of this century," the mere discussion of those abuses produced a panic over human subjects research and an unnecessary expansion of federal restrictions on academic inquiry.
Most dramatically, starting in 1998 the Office for Protection from Research Risks investigated a number of major universities and hospitals and suspended federally-funded research at eight of them. With millions of dollars at stake, universities around the nation hired more administrators to enforce regulatory compliance, swamped researchers with new layers of paperwork and mandatory training, and tried to imagine and prevent every possible risk posed by a given line of inquiry.
I doubt that the president or his advisors knew this history when they prepared the November 24 memo to the presidential commission, and I am sure that their intentions were good. But it is just this combination of good intentions, indifference to ethical differences among scholarly disciplines, and ignorance of the past that has for so long produced ethics regulations unacceptable to many researchers and ineffective in their protection of research participants. The gap between Obama’s request and the resources of his commission makes it hard to imagine a response that will do more good than harm.
Under the circumstances, the presidential commission could best serve the president by giving him not what he asked for, but what he needs. In lieu of “a thorough review of human subjects protection,” it could offer a précis of existing reports on the subject, along with an account of HHS’s failure to adopt their major recommendations. And rather than attempting “a thorough fact-finding investigation” of the Guatemala study, it could use the experience of the Advisory Committee on Human Radiation Experiments to determine what kind of effort would be needed to conduct such an investigation properly, including the enlistment of historians to do the necessary historical research.
President Obama’s memo represents a noble effort to study the past in order to benefit future generations. But attention to history should also caution against a hasty, superficial study of human subjects research, past and present.
Zachary M. Schrag is the author of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Johns Hopkins University Press, 2010).