HUMAN SUBJECTS' PROTECTION DRAWS ATTENTION OF MANY ACTORS |
Howard J. Silver, Executive Director
Angela L. Sharpe, Associate Director for Government Affairs
Consortium of Social Science Associations (COSSA)
The death of a University of Pennsylvania student in a gene therapy trial last year has led to heightened focus on the system to protection human participants in research. Multiple activities both inside and outside government are occurring that are scrutinizing the way how the government oversees the system, how university Institutional Review Boards operate, where the social and behavioral sciences fit into a system designed for biomedical and clinical research, and ultimately how to better protect people who participate in research.
The system is governed by regulations under a Common Rule which has been adopted by 17 government agencies. The Common Rule lays out procedures for Institutional Review Boards, what kinds of research are exempt from their purview, and what kinds of research should receive expedited review since there is minimal risk to participants. The difficulty has arisen, in that, as Felice Levine of the American Sociological Association pointed out in recent testimony, there "are growing fault lines in the system that protects human participants," and "a gap has developed between law and policy, 'on the books' and 'in action.'"
To examine all this, the Department of Health and Human Services has created the Office of Human Research Protection (OHRP) in the Office of the Secretary. This new entity replaces the Office of Protection from Research Risk housed at the National Institutes of Health. The new OHRP is headed by Greg Koski, an M.D., Ph.D. from Massachusetts. Koski speaking at the COSSA Annual Meeting called for a "simpler, more uniform, more efficient, and more effective system" that would "put the interests of the research participant squarely in the middle and have everyone share responsibility for the conduct of the research." This would include certification of researchers and accreditation of IRBs.
(Information about the Office of Human Research Protection is available at http://ohrp.osophs.dhhs.gov )
Another player in these activities is the National Bioethics Advisory Commission (NBAC), which was established in 1995 and has issued five reports making recommendations regarding human subjects protections. Princeton University President Harold Shapiro chairs the panel. NBAC's released its latest draft report in December and is accepting comments until February 17, 2001 (see www.bioethics.gov).
The report cites the major challenges facing the current oversight system: inconsistent interpretation and implementation of regulations at the federal level; incomplete protection of vulnerable groups; difficulty in amending the Common Rule and its non-adaptability to emerging ethical issues of scientific developments; limited scope, existing regulations apply only to Federally sponsored research; weaknesses in the mechanisms enforcing the regulations; emphasis on procedural requirements over ethical principles; failure to adequately address ethical issues for different types of research; burden imposed by IRBs by excessive paperwork; the challenge of multi-site research for IRBs; and the lack of adequate training or preparation by individuals and institutions that conduct and review research.
The report suggests three broad changes: 1) a general shift of requirements away from procedure and toward education; 2) a more strategic use of IRB review; and 3) a more strategic use of monitoring, including accreditation. The recommendations will increase the responsibilities of investigators, IRBs, and institutions. In addition, the report calls for a National Office of Human Research Oversight, that would be an independent agency, housed outside the current Departmental structure.
The Department of Health and Human Services' National Human Research Protection Advisory Committee (NHRPAC), met for the first time in late December. The panel, chaired by Mary Faith Marshall, Professor of Medicine and Bioethics Officer at Kansas State University Medical Center, spent considerable time examining the social and behavioral sciences and how they fit into the system. The Committee heard Felice Levine raise questions about the structure of IRBs, in terms of their composition and expertise, and the application of standards of research drawn from a clinical or biomedical perspective to the social sciences. The Committee concluded that further attention to the non-biomedical aspects of the human protection problem were necessary. They sought answers to such questions as how many social scientists are members of IRBs? How many social science protocols are considered by IRBs? How many social science protocols are rejected because of potential psychological or emotional risk to the subjects? How should risk be defined for these sciences?
Another panel examining this issue has been appointed by the Institute of Medicine (IOM) of the National Academies. The IOM Committee is chaired by Daniel Federman, M.D., Dean for Alumni Relations and Clinical Teaching at Harvard Medical School. Among its members is Roderick J.A. Little, Ph.D., Professor and Chair of the Department of Biostatistics at the University of Michigan's School of Public Health. This committee's mandate is to "Assess the System for Protecting Human Research Subjects." It will issue three reports. The first, due by April 1, 2001, will look at accreditation standards for IRBs. The other two will scrutinize the overall structure and functioning of human subject protection activities, including, but not restricted to, IRBs, and provide criteria for evaluating the performance of human subject protection activities.
On January 22, 2001 the IOM Committee had a public forum where it heard witnesses comment on draft accreditation standards devised by Public Responsibility in Medicine and Research (PRIM&R), a group that has been in the business of educating IRB members and others about the human subject protection system. A number of witnesses, including some from federal agencies, suggested that IOM was putting the cart before the horse by producing accreditation standards prior to an overall assessment of the system. COSSA, with Levine as its witness, called attention to how the proposed standards created problems for the social and behavioral sciences. In particular, she pointed out that there have been problems where researchers utilizing secondary data are being asked to seek approval by IRBs to use these data, although the information is anonymous and the subjects are already protected under earlier protocols. Thus, she declared that the "accreditation standards should clarify what the scope of the human protection system is and is not." The analysis, Levine remarked, of public-use data where information is maintained in anonymous form and without personal identifiers "is research about people, but not on people."
(Information about the IOM panel and the proposed standards is available at www.iom.edu/hrrp)
Finally, with accreditation on the horizon, the Association of American Medical Colleges (AAMC) has taken the lead in organizing the Association for the Accreditation of Human Research Protection Programs, Inc. This would be a non-profit entity, outside the government, that would become an accreditation body to monitor and evaluate human protection programs at major educational institutions. Possibly joining AAMC in this endeavor are the Association of American Universities, the Federation of American Societies of Experimental Biology, the National Association of State Universities and Land Grant Colleges, the National Health Council, Public Responsibility in Medicine and Research, the Pharmaceutical Research Association, and COSSA.
All of this activity will continue into the immediate future. Congress expects to convene hearings on the NBAC report and some of its recommendations will require legislation. The IOM accreditation standards, if the schedule holds, will appear in a few months. The NHRPAC will meet again in April. Heightened scrutiny of the activities of IRBs, investigators and institutions will persist.