Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: Nonbiomedical Research
Another option for multicenter trials is to focus on the IRB review step specifically. A research sponsor may pay for review by an IRB, constituted in compliance with FDA regulations for research involving human subjects but not affiliated with any particular research institution and not in control of the investigators, who are accountable instead to the research sponsor. Such organizations are discussed in further detail below.
Nonbiomedical Research
The committee heard about the potential problems of applying an oversight system designed to ensure the ethical conduct of clinical trials in medical research to other research methods. The United States requires review of federally funded research in disciplines outside medicine, but many other countries review only medical research. Although the principles of informed consent and the importance of oversight apply to all research, the principles will be applied in different ways when the risks are social rather than medical and when the goals of research may not be prevention, detection, or treatment of disease. Therefore, the risks and benefits of such projects will be analyzed differently from those of clinical trials, and such projects will require different kinds of expertise and sensitivities to different categories of research participants.
Research in anthropology, sociology, journalism, law, and economics, for example, requires distinct methods. Further, distinct methods and issues apply to the gathering and analysis of data for national statistical databases. Student projects at a college or graduate school or even a high school education research initiative do not map neatly to IRB review mechanisms at an academic medical center. Interviews, surveys, oral histories, and other methods common to the social sciences must be reviewed in light of expertise in relevant fields.
In response to the committee's call for public comments, the committee did not hear pleas to exempt nonmedical research from oversight, but several groups expressed concern that the draft accreditation standards (in this case, the PRIM&R standards) would require elaboration of formal policies and documentation that would be irrelevant for IRBs primarily reviewing social science, behavioral research, anthropology, sociology, oral history, epidemiology, and population studies (Levine, 2001; Overbey, 2001; Shopes, 2001). The committee did hear suggestions to reduce paperwork, to develop criteria sensitive to social and behavioral research, and to expand the categories of research exempt from review when the risks of nonmedical research are inherently low and informed consent can be “presumed” (e.g., by returning a survey form or answering questions in an interview) (Erickson, 2001; Rubin, 2001; Rudder, 2001).
Many of the policy options are relevant to the committee's subsequent report on the overall system of research oversight, but nonmedical research does raise some questions relevant to accreditation specifically. The American Association of University Professors has prepared a white paper on this topic
