American
Anthropological Association Response to National Bioethics Advisory Commision
(NBAC) report on Human Research Ethics
(February 2001)
February 16, 2001
Harold Shapiro, M.D.
Chairman
National Bioethics Advisory Commission
6705 Rockledge Drive
Bethesda, MD 20892-7979
Dear Dr. Shapiro:
Thank you for the opportunity to comment on the draft report Ethical and Policy Issues in Research Involving Human Participants. The Consortium of Social Sciences (COSSA) is an advocacy organization for the social and behavioral sciences, supported by more than 105 professional associations, scientific societies, universities, and research institutes.
COSSA believes in promoting sound science with sound ethical practices. Accordingly, most of our professional associations have developed ethical guidelines for researchers to follow in conducting their studies, particularly where human subjects are part of the research design. All of COSSA's member associations embrace the Belmont Report's admonitions of respect for persons, beneficence, and justice.
The Current Human Participant Protection System
COSSA is first and foremost concerned with the disjuncture between principle and practice of the current human participant protection system. Our major dissatisfaction with the human participant system in its current state is the inconsistent performance of Institutional Review Boards (IRBs), particularly with respect to the implementation of the Common Rule as it applies to social and behavioral science research. For example, researchers utilizing secondary data are being asked to seek approval by IRBs to use these data where the information is in anonymous form and where subjects are already protected under earlier protocols.
For the social and behavioral sciences, the current system has the additional problem of fitting our research into a framework that is defined and designed for biomedical/clinical research. As the Commission is certainly aware, IRBs in academic and other research organizations dates back to the mid 1970s when the current federal guidelines were established for the protection of human subjects. While social and behavioral science research was included from the beginning, much of the motivation for such guidelines grew out of concerns regarding informed consent and risks involved in biomedical research. Despite the passage of time, this representation of science continues to dictate the operations of the human participant protection system, the understanding of best ethical practices, and the functioning of IRBs.
COSSA's Concerns with the NBAC Report
There is much that COSSA agrees with in the report, but we are troubled about a number of the issues raised and some of the recommendations. Although we understand that the recommendations in the draft report are designed to provide for a major change in the system, our primary question is whether the new system recommended for adoption by the Commission is the optimal system to protect human research participants without unduly burdening researchers. Consequently, we raise the following seven concerns we have with the report.
First, COSSA supports the creation of an independent office outside of the Department of Health and Human Services (DHHS). We agree that maintaining the office within DHHS signals that the new system remains a biomedical-centered system. Since much of social and behavioral science research is conducted with support from other agencies, such as the National Science Foundation, we believe that an independent office will better serve the needs of all agencies. It is essential, however, that the new entity have an advisory committee that includes a significant amount of members from outside the biomedical sciences. This would allow for sufficient nonbiomedical-centered input into how the new office would operate.
Similarly, if, indeed, the new system will cover all research, the report must explicitly acknowledge that social and behavioral science research does not fit neatly into the biomedical/clinical model. Most of the research conducted by social and behavioral scientists is of minimal risk to participants and therefore, we believe, should come under the expedited review process laid out in the report. Thus, we agree that a new oversight system should focus on risk, not on categories of research. While the concept of administrative review of minimal risk projects is admirable, in practice it is absolutely necessary that the administrative reviewers have appropriate training for the research under review.
Second, given that our main objection with the current system is the role of IRBs, it is essential that their members have appropriate expertise in the research areas that they are reviewing. Individuals who serve on IRBs should not only receive training, education, and certification in ethics, but should have substantive scientific knowledge and methodological skills as well. We believe that some of the recommendations in the report move toward helping to create ethics specialists as IRB members who are not simultaneously expert in both ethics and research. Again, we emphasize that it is essential that IRB members are researchers who have both ethics and research competencies.
Third, COSSA opposes the recommendation that 50 percent of IRB members should be non-scientist, non-institution members. We believe such a ratio detracts from the peer review aspect of research. The more important issue is the competence of IRB members in the methods and topics of the research being reviewed. We support the notion of an increased number of public members. Nevertheless, to have 50 percent or more of the membership to come without expertise in research would prevent a meaningful judge of the ethical practices that are indeed part of the research.
Fourth, while COSSA is cognizant that the report tries hard to incorporate the social and behavioral sciences, there are still instances where the preponderance of the report focuses on the biomedical/clinical model. For instance, in the Overview chapter, the discussion of a longstanding Federal interest in research should also include examples of how research in the social and behavioral sciences has contributed to societal good. Examples are numerous and we would be happy to provide them.
Also in the Overview Chapter, there is a reference to the Behavioral and Cognitive Division at NSF, while omitting the Social and Economic Science Division. Since both divisions conduct research with human participants, they should both be referenced. In fact, the reference should probably be to the Social, Behavioral and Economic Sciences Directorate.
Fifth, COSSA agrees that informed consent should be focused on process, rather than on documentation. There are many instances in social and behavioral science research where obtaining written consent is difficult and would jeopardize the research. We agree that the current system requirements for informed consent do not fit social and behavioral research very well. Thus, we support the notion that the informed consent process should be tailored to suit both the type of research and the interests of the potential participants. We also support flexibility and local discretion over documentation of informed consent.
Further, the report is unclear in outlining when "informed consent" can be waived. For example, the report contains a list of six requirements for waiver of informed consent, all of which must be satisfied before such a waiver may be issued. One of these conditions is that it be possible to inform all research participants of research findings. Certainly, there are circumstances under which such a requirement could be accomplished, but such a task is nearly impossible, for instance, in the analysis of a large collection of completely anonymous records.
Sixth, COSSA agrees wholeheartedly that there should be increased research on ethical issues. There are several programs at the National Science Foundation in the Social, Behavioral and Economic Science Directorate that already supports such research. The Societal Dimensions of Engineering, Science and Technology: Ethics and Value Studies and Research on Science and Technology has a history of supporting ethics research. Similarly, the agency's Law and Social Science Program has long-termed supported research on regulations and systems and their impact, including on the regulation of research. Programs like these can use additional funding.
Seventh, COSSA is equally troubled regarding the proposal to extend the definition of "identifiable" from "readily identifiable" to include any record for which any link to identifying information may exist anywhere. We fear that in many cases researchers will be forced to act as if they are working with truly identifiable data - greatly increasing the cost to ensure nondisclosure (not merely including the cost of regulatory compliance) - when there is no plausible link to identifiers. An example is the analysis of data collected by the Current Population Survey, which is legally protected -- and for which identifying links are typically lost or destroyed after a period of time.
These are among our concerns that suggest that the Commission's report and its recommendations still require essential advice and counsel prior to moving to the next stage of implementation. While COSSA is supportive of the relocation or creation of an independent office outside of HHS, how that office is structured, including the background and composition of those providing the advice, will have the largest effect on how the human participant system is ultimately defined. Social and behavioral science expertise and other forms of expertise beyond the biomedical is essential.
Further, while administrative review seems to offer a useful mechanism to move the research forward while protecting human participants, whether this is done in a meaningful way for social and behavioral science depends on if there is sufficient social and behavioral expertise in framing any new guidance. Accordingly, COSSA respectfully urges the Commission to continue to consult with a wide range of disciplines, including social and behavioral scientists, in its efforts to strengthen protections of human participants in research.
Again, we appreciate the opportunity to comment on the NBAC report, and we offer our assistance in your efforts.
Sincerely,
Howard J. Silver, Ph.D.
Executive Director
American
Anthropological Association Response to National Bioethics Advisory Commision
(NBAC) report on Human Research Ethics
(February 2001)
American
Sociological Association (ASA) Speaks Out on Human Subjects Protection
Issues (February 2001)
The American Political Science Association (APSA) comments
on the draft report, Ethical and Policy Issues in Research Involving Human
Participants