Task Force Focuses on Research Regulation Impact
by Sangy Panicker, Director, Research Ethics Office

The Task Force on Research Regulation (TFoRR) held its first meeting November 14-15, 2003. The Task Force discussed the current state of affairs in the human research regulation arena and its impact on psychological science. Over the last five years, human research has been subjected to heightened scrutiny by legislators and regulators. A variety of changes have been recommended for stricter oversight and enforcement of regulations pertaining to research with human participants. Although many of these recommended changes stem from lapses in the conduct of biomedical research, they will have a direct impact on behavioral research. Some of the issues include increased accountability for regulations that have always been on the books, but have not been strictly enforced, revamping of the traditional institutional review board (IRB) system, accreditation of human research protection programs, and mandatory education in research ethics for all research personnel.

As a result of this increased scrutiny, some IRBs have become more stringent in their application of relevant regulations. In turn, anecdotal evidence suggests that many psychological researchers are experiencing trouble dealing with their IRB, such as extended delays in getting their research approved, or IRBs requiring changes made to research protocols that the investigators deem unreasonable or unnecessary. There also seems to be some indication that most IRBs are better equipped to review biomedical research than behavioral research protocols. Thus, the Task Force decided on a multi-focus approach to dealing with the issue. A summary of the plan follows:

Long term goal – Intensify advocacy efforts at the legislative and regulatory levels to influence pending legislative proposals and any ensuing regulations. Lobby for more behavioral science representation at the federal agency level and on national advisory panels.

Intermediate goal – Gain a more systematic understanding of the impact that changes in the regulatory landscape have had on research in psychology and the behavioral sciences.

Immediate goals – Produce and disseminate educational resources to two distinct target groups:

* Investigators (Faculty and students) – a comprehensive Web-based, dynamic, step-by-step resource that would enable researchers to navigate the IRB process. Include information that researchers need to know, such as relevant regulations, thorny design issues and possible solutions or alternatives, data-sharing requirements, and confidentiality issues.

* IRBs (Administrators and members) – Conduct workshops and seminars in collaboration with organizations such as Public Responsibility in Medicine and Research (PRIM&R) to educate IRBs about issues relevant to effectively reviewing behavioral research such as risk assessment, and consent issues. Also, conduct a needs assessment survey of IRBs to find out topic areas in the review of behavioral research (e.g., deception, sexual behaviors, illegal activities, and third party risks) that they find most challenging and subsequently develop appropriate educational resources for broad dissemination. Finally, assess the extent to which IRBs routinely incorporate sufficient expertise to handle the range of protocols contributed by behavioral scientists.

Members of the Task Force are: Michael Fendrich, University of Illinois at Chicago (Chair); David Barlow, Boston University; Andrew Baum, University of Pittsburgh; Celia Fisher, Fordham University; Daniel Ilgen, Michigan State University; Jacquelyn James, Harvard University; Louis Penner, Wayne State University.

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