Leading experts in the fields of law, science and medicine gathered at HLS May 18 and 19 to discuss the future of human subjects research regulation.
The topic for the conference, sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, was prompted by a July 2011 advance notice of proposed rulemaking from the U.S. Department of Health and Human Services proposing to amend the rule that has governed this research for more than 20 years.
“We felt this might be an opportunity to revisit and actually change things regarding human subjects research,” said HLS Assistant Professor I. Glenn Cohen ’03, co-director of the center. “This is the kind of thing that affects billions of dollars for industry, pharma, hospitals, researchers and universities across the world.”
In announcing a contemplation of the rule change, officials at HHS noted that the research landscape involving human subjects has changed significantly since 1991, when the regulations were last substantially modified. Before then, research involving human subjects was conducted mostly at single sites within academic and medical centers. But, according to the HHS, the subsequent expansion of research into new scientific disciplines and multi-site studies has “highlighted ambiguities in the current rules” and led to questions about whether the current regulatory framework is meeting the needs of both researchers and research subjects.
Greg Koski, former director of HHS’s federal Office for Human Research Protections, the office responsible for regulatory oversight of research funded by the agency, said that he supported a dramatic shift in the regulation of human subjects research and acknowledged that it is highly unusual for a regulatory office to look critically at the system it is charged with overseeing.
HHS is considering a variety of changes to the rules governing regulation of human subjects research, but Koski characterized the proposals as “simply tinkering around the edges of a system that the bioethics community, the investigator community, and virtually every other community see as being somewhat dysfunctional and not achieving the goals for which it was originally intended.”
The current regulatory framework, he said, is largely based on reactions to such tragedies as the Tuskegee syphilis study of 1932 to 1972, in which the U.S. Public Health Service and the Tuskegee Institute conducted a clinical study involving hundreds of poor black men who, despite the advent of penicillin, remained untreated for purposes of studying the disease. Public outrage over Tuskegee and other reported abuses led to the creation of a government commission that drew up a document called the Belmont Report in 1979, which set forth the ethical principles to govern human subjects research and led to the current regulatory structure.
However, Koski said, regulation has been dominated by human-subject protectionism and an ethical-review system that has “devolved to regulatory compliance oversight.” The result, he said, is a system that is “inefficient and burdensome.” His recommendation, he said, was to replace the current system with one modeled after medical training and certification.
He said: “If we were able to develop a paradigm of professionalism in human research, it would likely be every bit as effective, less costly, less burdensome and more efficient than the protectionist, compliance-focused system that we are now seeking to reform. I would argue that reform of our current system is perhaps not the most appropriate or even adequate approach to try to achieve the goals that we seek.”
While some panelists took broad views of the issue, others focused more on specifics. Laura Stark, an assistant professor in the Science in Society Program and the Department of Sociology at Wesleyan University, addressed the functions of Institutional Review Boards, which are mandated by federal regulations to approve, monitor, and review most biomedical and behavioral research involving human subjects, and concluded that reform is necessary.
“It’s commonly assumed that IRBs take regulation and apply it to specific research contexts and to a local population,” she said. “But instead of applying these general regulations to a local context, IRBs apply their own previous decisions to the next protocols that come in. So they’re actually working case to case, rather than from regulations.”
Rosamond Rhodes, a professor of medical education at Mount Sinai School of Medicine in New York City, proposed the creation of a new category of risk, “de minimis risk,” which would apply to research that poses no physical danger to humans and may therefore proceed without obtaining informed consent.
Holly Fernandez Lynch, Petrie-Flom’s executive director, addressed the degree to which labor and employment protections might be applied to research subjects, concluding that subjects generally should not be offered weaker regulatory protections than their counterparts engaged in more traditional work. Were subjects to pursue unionization and collective bargaining, she argued, the Screen Actors Guild might offer the closest model for imitation.
In addition to structural critiques, the conference also addressed the actual impacts that human subjects research may have on specific vulnerable populations.
Osagie K. Obasogie, an associate professor at the University of California’s Hastings College of the Law, spoke of recommendations by the Institute of Medicine to loosen regulatory protections for prisoner research and concluded that they are addressing the issue from the wrong perspective—viewing prisoner vulnerability “solely as a function of what happens in prisons, rather than the commercial forces that can lead researchers to seek prisoners in the first place,” namely because they are “cheap and plentiful.”
Efthimios Parasidis, an assistant professor at Saint Louis University School of Law, spoke about another population that’s been historically vulnerable to use as research subjects: military personnel.
Parasidis pointed out that soldiers have long been used to test the effects of various threats and drugs, ranging from exposure to mustard gas in the 1940s and atomic-weapons explosions in the 1950s to the more recent use of memory-altering drugs to reduce inhibitions to killing, and he said a strong legal framework supports and perpetuates that activity.
For instance, he said, military law mandates that soldiers must follow their commanders’ orders or face the risk of court-martial. And, he said, the Feres doctrine prohibits military personnel from collecting damages from the U.S. government for injuries.
He proposed that the regulations be amended to clearly require informed consent from soldiers before they are used as research subjects, and that the military provide medical monitoring and post-research treatment for soldiers used as research subjects. He also proposed that an exception to the Feres doctrine be provided for violations of research protocols.
As for Cohen’s hope that the conference might help effect change, he’s already taken steps in that direction, sharing conference papers with federal regulators and planning further collaboration between the conference participants.