Social and Behavioral Sciences Working Group
on Human Research Protections

OVERVIEW

In February 2001, the National Human Research Protections Advisory Committee (NHRPAC) established the first of a number of Working Groups under its aegis. The very first of these groups was in the Social and Behavioral Sciences. This Working Group was co-chaired by Dr. Felice J. Levine, NHRPAC member and then Executive Officer of the American Sociological Association. Since that time, this Working Group has produced important work products, reached out across the social and behavioral science community to gain input and enhanced consideration of human research protection in these sciences, and has designed a day-long course focused on human research ethics.

NHRPAC’s charter expired in August 2002, but with funding from the National Institutes of Health’s Office of Behavioral and Social Sciences Research, the Working Group continued to promote human research ethics in the social and behavioral sciences as an independent, interdisciplinary group of scientists representing research environments, federal agencies, and scientific societies who were dedicated to improving the operations of the human research protection system. Since that time, the Working Group has been housed within the office of the American Educational Research Association (AERA) and is chaired by Dr. Felice Levine in her new capacity as Executive Director of AERA. The Working Group continues to perform substantive work, outreach activities, and education and training, and plans to issue a report on the best practices in the review of social and behavioral sciences research.

ACCOMPLISHMENTS AND REMAINING WORK

Issues of Scientific Substance

Phase I: Immediately following its formation, the Working Group identified a large number of areas and issues in the human research protection system that needed addressing. The Working Group began with those areas that were most pressing or those which cut across multiple fields. The Working Group completed reports for the NHRPAC on: (1) Public Use Data Files, (2) Confidentiality and Research Data Protections, and (3) Third Parties in Research. All three reports were approved by NHRPAC, submitted to the Secretary of the Department of Health and Human Services, and sent to the federal Office of Human Research Protections.

Phase II: As an independent group of social and behavioral scientists, the Working Group continued to examine areas that needed attention in the human research protection system. Reports were initiated in several areas, and two received public comment and were approved for release by the Working Group. These two reports address “Exempt and Expedited Review” and “Risk and Harm,” two areas that are central to the work of Institutional Review Boards and in which there has been some confusion and degree of variability. The reports were shared with the federal agencies, IRBs, and investigators. The Executive Director of the federal Office of Human Research Protections invited the Working Group to work with his Office in translating some of the recommendations for IRB and investigator use. The activities of the Working Group and these reports were discussed at a meeting of the Human Subjects Research Subcommittee, an interagency working group under the Office of Science and Technology Policy.

Phase III: In this final phase, the Working Group intends to complete work on a number of reports that are under review by its subcommittees. These include:

• Informed Consent
• Student Research
• Experimental Research
• Internet Research

Other reports under consideration are:

• Ethnographic and Qualitative Research
• Longitudinal Research
• Observational Research
• Research in Educational Settings

Outreach to Social and Behavioral Science Researchers

Phase I: Since its inception, the Working Group has been engaged in outreach efforts to social and behavioral scientists. Specifically, Working Group members participated in town meetings, roundtable discussions, and symposia at a wide number of professional meetings and specialized conferences. Information about activities of the Working Group and developments within federal agencies involved in human subjects protection were shared with social and behavioral scientists. In addition, information and insights gained from these sessions were used to identify priority issues and to draft papers for consideration by NHRPAC.

The Working Group established a web site to provide information on Working Group activities and other activities related to human research protections in the social and behavioral sciences. Outreach efforts also included Working Group members making presentations and meeting with scientists at the Annual Meetings of the American Sociological Association, American Psychological Association, American Statistical Association, Oral History Association, American Society of Criminology, American Anthropological Association, American Historical Association, Linguistics Society of America, American Association for Public Opinion Research, and the American Psychological Society. Special sessions were also held with department chairs at the Annual Meetings of the American Sociological Association and the American Anthropological Association.

Phase II: Outreach efforts continued when the Working Group was reconstituted as an independent body. In an effort to expose a wider audience to the activities of the Working Group, presentations were made at the annual meeting of Public Responsibility in Medicine and Research and to the trans-NIH Bioethics Committee. Efforts were also made to develop collaborative relationships with government representatives working on the issue, and the Chair of the Working Group was invited to speak to the Human Subjects Research Subcommittee. In addition, the Acting Director of the Office of Human Research Protections spoke to the Working Group and invited input into the work of that office.

A central component of Phase II activities was the completion of a workshop at the Belmont House in Maryland that aimed to improve the operations o f the human research protection system by gaining a better understanding of how IRBs address complex or confusing areas in the review of social and behavioral science protocols. The workshop participants were comprised of a multi-disciplinary group of IRB chairs and members (primarily social and behavioral scientists, but including non-social scientists as well) with substantial experience reviewing social and behavioral science protocols. As a result of this workshop, a compendium of best practices is being developed to share with IRBs and investigators.

To assist in outreach efforts, the Working Group added course presentation materials to the web site. Course materials developed for workshops at the annual meetings of the American Sociological Association, American Psychological Society, Population Association of America, and the American Educational Research Association are available.

Phase III: The Working Group has been aware of the "fault lines" between the Federal Regulations and their application by IRBs in practice. Working Group sessions held at research society meetings brought to light many concerns about problems, but also successful practices in the review of social and behavioral science protocols. In this final phase, the Working Group will complete the preparation of the report on IRB best practices in the review of social and behavioral science protocols. The report will be disseminated widely to IRBs, investigators, federal agencies and other interested parties. The Working Group anticipates working closely with OHRP following publication of the report to assist in developing materials for bridging research and practice.

The Working Group will continue to disseminate its products and collaborate on communication strategies and opportunities with scientific societies and other key organizations like the Association for the Accreditation of Human Research Protection Programs (AAHRPP), National Research Council, and the American Association for the Advancement of Science (AAAS). In addition, outreach efforts will continue to include presentations, report-writing, and dissemination activities.

Education and Training

Phase I: A day-long course was designed on human research protections in the social sciences. The course was held as part of the educational component of the American Sociological Association Annual Meeting. Two volumes of materials were prepared for the course: (1) a notebook with the course syllabus, faculty presentations, and related documents, and (2) a bound book of readings covering the topics and issues in the course and of IRB-approved protocols addressed to different methodologies. Working Group members from academia and government, as well as staff of OHRP, served as faculty for this course.

Phase II: The day-long course model was adapted and offered at the annual meetings of the American Sociological Association (August 2003) and the American Psychological Society (May 2003). A half-day course on human research protections was created and held at the annual meetings of the American Educational Research Association (April 2003) and the Population Association of America (April 2003). Working Group members and leaders in the particular field served as faculty for these courses. Educational materials consisting of faculty presentations, federal regulations, the Belmont Report, and relevant readings were provided to participants.

Phase III: In the coming year, the Working Group is considering the development of additional web-based educational materials for investigators, especially investigators new to service on an IRB.