The Executive Officer’s Column
Sociologists and IRBs
Sadly, to some, the combination of sociologists and Institutional Review Boards (IRBs) are fighting words and to others, an oxymoron. To the National Research Council’s (NRC) Panel on Institutional Review Boards, Surveys and Social Science, chaired by sociologist Cora B. Marrett, however, they are a “challenge...how best to encourage IRBs to use the flexibility in the [federal] regulations appropriately for different types of research methods, topics, and study populations.”
The prepublication report of this panel (Protecting Participants and Facilitating Social and Behavioral Sciences Research, 2003; see www.nap.edu) is a thoughtful, useful, and hopeful document, emphasizing the benefits to behavioral and social scientists of cross-fertilizing knowledge and practice among social scientists, biomedical researchers, and IRB members. Focusing on the problems of typical research that sociologists and other social scientists do (rather than high-risk research), the report presses for IRBs to use the flexibilities in review procedures already available in the federal regulations. This flexibility exists with regard to securing informed consent and maintaining data/subject confidentiality in minimal risk studies in order to facilitate social science research as well as protect its subjects.
The report offers recommendations for what OHRP (the federal Office for Human Research Protections) should do to encourage IRBs not to “over interpret” the regulations at a time when universities and other research institutions tend to react defensively to high-profile stories in the press. These recommendations are not lifeless; they will feed into and support on-going movement in this area. ASA, for example, has been working diligently with others to provide OHRP with working papers on topics vital to social science research so it can provide informed guidance documents to IRBs and researchers. The National Science Foundation and OBSSR (the Office of Behavioral and Social Science Research at the National Institutes of Health) are also focused on the development of such guidance at the federal level.
Expedited Review, Approved Protocols
But more is needed. The NRC report also makes recommendations to IRBs about the need to increase efficiency by making greater use of procedures in social science research such as expedited review and approved research protocols that “allow researchers flexibility to make specific decisions during the course of their research without the need to seek further review.” Helping IRBs learn to do this better is one goal of the Social and Behavioral Sciences Working Group on Human Research Protections (see www.aera.net/humansubjects/). This group is chaired by Felice J. Levine, former ASA Executive Officer, and includes ASA members Christine Bachrach, Virginia Cain, Robert Hauser, Karen Hegtvedt, and myself. The group is holding an IRB Best Practices Workshop in July to develop a guide and resource tools for IRBs, researchers, and regulators.
Still more is needed. The end user researcher needs to get engaged in improving human subjects review processes. There are personal strategies for this (e.g., becoming more familiar with the processes and their flexibilities by participating in the human subjects protection training at the ASA Annual Meeting in Atlanta). There are also departmental strategies (e.g., encouraging curriculum development for all sociology courses that includes training about research ethics and regulation; developing procedures for instructor- and department-level review of course-based research that involves human participants but falls short of needing IRB review).
And there are university-wide strategies that can be used to leverage improvements in the efficiency of the human subjects review process that are vital to the social sciences. For example, universities can seek formal accreditation of their policies, procedures, and IRBs. The Association for the Accreditation of Human Research Protection Programs (AAHRPP), for example, uses a voluntary, peer-driven, educational model in human research protections review, recognizing that IRBs cannot be the sole vehicle for ensuring consistent research protections and that all in the university research community share a stake in the safety of human subjects and an interest in facilitating research. (See article on AAHRPP on p. 3 of this issue of Footnotes.)
AAHRPP leads a widely respected, nation-wide, voluntary accreditation program that engages individual researchers from all disciplines, departments, schools, and IRBs in a serious self-examination of an institution’s entire review process. Led by psychologist and epidemiologist Marjorie Speers, AAHRPP was launched by the Consortium of Social Science Associations (COSSA) and seven other member societies in 2001. Behavioral and social scientists sit on its board and participate in the site visit phase of the accreditation process. In helping to found AAHRPP, COSSA, of which ASA is a founding member, insisted on an accreditation mechanism deliberately sensitive to and knowledgeable about social science research. The accreditation process also had to encompass clinical research—in order to ensure it was attractive to large universities with medical schools—and the accreditation approach had to be educational and collegial.
As Speers points out, “The behavior of IRBs is driven by...federal regulations...written from a clinical perspective...[and by] suspensions of major research programs between 1991 and 2001...[that have made IRBs and their institutions] adverse to risk.” The potential strength of this accreditation process for social science research lies in AAHRPP’s assistance and guidance in helping a university engage in an inclusive and exhaustive self-review of its existing processes from the bottom up—from end user to the IRB to the Office of General Counsel.
AAHRPP is beginning to develop experience doing what the NRC report calls for—”cross-fertilization” at the operational level—by engaging social scientists and the clinical sciences in an in-depth examination of an institution’s human subjects review processes. Speers believes, with some early AAHRPP experience as support, that this type of accreditation process will encourage development of more streamlined and appropriate mechanisms in universities that reflect a level of protection commensurate with the level and nature of the risks involved. If successful, formal accreditation may reduce the tendency of universities and IRBs toward “hyper compliance.” This is hopeful news for social scientists.
Sally T. Hillsman, Executive Officer