From the Viewpoints: Forum on IRBs column of the March 2007 Perspectives
An Annotated Select Bibliography
Linda Shopes, March 2007
I. Regulations, Policies, Guidelines, and Reports
Citro, Constance F., Daniel R. Ilgen, and Cara B. Marrett, eds. Protecting Participants and Facilitating Social and Behavioral Research. Washington, D.C: National Academies Press, 2003.
Available at http://www.nap.edu/books/0309088526/html.
Chapter 3 provides a good history of human subjects regulation, with particular attention to its application to nonscientific research; includes discussion of debates about the propriety of regulating nonbiomedical research going back at least three decades.
COSSA Washington Update
Available at http://www.cossa.org
Newsletter of the Consortium of Social Science Associations; provides excellent regular coverage of current federal issues/debates/actions related to human subjects review; searchable on line.
Division of Contracts, Policy, and Oversight, National Science Foundation. Frequently Asked Questions and Vignettes: Interpreting the Common Rule for the Protection of Human Subjects Behavioral and Social Science Research."
Available at http://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp.
A useful document for understanding and interpreting the Common Rule as it applies to nonbiomedical research.
Giving Voice to the Spectrum. Report of the Social Sciences and Humanities Research Ethics Special Working Committee to the [Canadian] Interagency Advisory Panel of Research Ethics (June 2004). Available at http://www.pre.ethics.gc.ca/english/workgroups/sshwc/reporttopre.cfm.
An effort by Canadian scholars to rethink the applicability of Canadian human subjects regulations to nonbiomedical research.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S. Government Printing Office, 1979.
Available at http://ohsr.od.nih.gov/guidelines/belmont.html . The landmark federal report that defined the fundamental ethical principles to govern research on human subjects.
Oral History Evaluation Guidelines, rev. ed. Carlisle, Pa.: Oral History Association, 2000.
Available at http://www.dickinson.edu/oha/pub_eg.html . The professional standards for oral history, developed by the Oral History Association.
Title 45 (Public Welfare) Code of Federal Regulations, Part 46 (Protection of Human Subjects).
Available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
These are the federal regulations governing research on human subjects, available at the website of the Office of Human Research Protections/US Department of Health & Human Services, which has responsibility for implementing them. OHRP's website includes considerable additional information related to the regulations, their implications, and implementation. Home page is http://www.hhs.gov/ohrp/
II. Commentary and Criticism
Beauchamp, Tom L., Ruth R. Raden, R. Jay Wallace, Jr., and LeRoy Walters. Ethical Issues in Social Science Research. Baltimore: The Johns Hopkins University Press, 1982.
A seminal work in articulating the ethics of social science research within the framework of the Belmont Report.
Begley, Sharon. Review Boards Pose Threat to Tough Work by Social Scientists." Wall Street Journal, November 1, 2002, B1.
Bliss, Alan. Oral History Research." In Institutional Review Board Management and Function, edited by Robert J. Amdur, M.D. and Elizabeth A. Bankert. Sudbury, Mass: Jones and Bartlett Publishers, 2002.
Brainard, Jeffrey. The Wrong Rules for Social Science?" The Chronicle of Higher Education, March 9, 2001, A21. (This and other articles listed in this bibliography from the Chronicle are available at http://chronicle.com for those with a subscription to the periodical.)
Cannella, Gaile S. Regulatory Power: Can a Feminist Poststructuralist Engage in Research Oversight?" Qualitative Inquiry, 10:2 (2004): 235–245.
Center for Advanced Study, University of Illinois. The Illinois White Paper: Improving the System for Protecting Human Subjects—Counteracting IRB ‘Mission Creep'." November 2005. An ambitious effort to refocus human subjects review on research most likely to result in harm and relieve relatively harmless, nonbiomedial or behavioral research from regulatory oversight.
Church, Jonathan T., Linda Shopes, and Margaret A. Blanchard, Should All Disciplines Be Subject to the Common Rule?" Academe 88:3(May-June 2002), 62–69.
Available at http://www.aaup.org/publications/Academe/2002/02mj/02mjftr.htm.
The authors' January 2002 statements before the National Human Research Protections Advisory Commission, raising questions about the appropriateness of IRB review of research in anthropology, history, and journalism.
Gordon, Michael. Historians and Review Boards," Perspectives, 35:6 (September 1997), 35–37. Includes a sample description of an oral history project that can be submitted to an IRB for review.
Gunsalus, C. K. The Nanny State Meets the Inner Lawyer: Over-regulating While Under-Protecting Human Subjects of Research," Ethics and Behavior 14:4 (2004), 369–382.
———. Rethinking Protections for Human Subjects, Chronicle of Higher Education, November 15, 2002, B24.
Hamburger, Philip. The New Censorship: Institutional Review Boards, The Supreme Court Review (2005), 271–354. Argues that federal regulations requiring IRB review of human subjects research violate the First Amendment.
Howard, Jennifer. Oral History Under Review," Chronicle of Higher Education, November 10, 2006, A14 ff.
Human Subject Protection Regulations and Research Outside the Biomedical Sphere, a working conference sponsored by the College of Law, University of Illinois at Champaign-Urbana, April 11–12, 2003;
position papers available at http://www.law.uiuc.edu/conferences/humansubject/papers.asp . Position papers on a variety of topics related to research, harm, risk, and human subjects as they relate to IRB review in nonbiomedical fields; papers generally take a broadly critical view.
Kancelbaum, Barbara. Social Scientists and Institutional Review Boards," Items & Issues [newsletter of the Social Science Research Council] 3: 1-2 (Spring 2002), 1ff.
Katz, Jack. To Participants in the UCLA, May 2002, Fieldwork Conference," May 8, 2002.
Available at http://leroyneiman.sscnet.ucla.edu/katz5_8.htm.
Thoughtful reflections on the asymmetry of federal human subjects regulations and participant-observation research in anthropology; of some relevance to the work of historians.
Milne, Catherine. Overseeing Research: Ethics and the Institutional Review Board," Forum Qualitativ Sozialforschung / Forum: Qualitative Social Research 6:1 (January 2005)
Available at: http://www.qualitative-research.net/fqs-texte/1-05/05-1-41-e.htm.
Nelson, Cary. Can E.T. Phone Home? The Brave New World of University Surveillance," Academe 89:5 (September-October 2003).
Available at http://www.aaup.org/publications/Academe/2003/03so/03sonels.htm.
Oakes, J. Michael. 2002. "Risks and Wrongs in Social Science Research: An Evaluator's Guide to the IRB."Evaluation Review 24 (2002): 443-478.
Protecting Human Beings: Institutional Review Boards and Social Science Research," Academe, 87:3 (May-June 2001), 55–67.
Available at http://www.aaup.org/statements/Redbook/repirb.htm .
A thorough discussion of the difficulties social scientists—including historians—encounter as regulations developed within a biomedical frame of reference are applied to nonbiomedical research; useful as a reference in discussions with local IRBs.
Sieber, John E., Stuart Platter, and Philip Rubin. How (Not) to Regulate Social Behavioral Research," Professional Ethics Report, XV:2 (Spring 2002), 1–3.
Available at http://www.aaas.org/spp/sfrl/per/per29.htm#cover.
Shea, Christopher, Don't Talk to the Humans: The Crackdown on Social Science Research,"Linguafranca, 10:6 (September 2000).
Shopes, Linda, Institutional Review Boards Have a Chilling Effect on Oral History," Perspectives, 38:6 (September 2000), 34–37.
———.Historians and human-subjects research," Recent Science Newsletter, 2:3 (Spring 2001), 6ff.
Speers, Marjorie A., Accreditation Helps Researchers and Subjects Alike," APS [American Psychological Society] Observer 16:5 (May 2003), 9.
Thomson, Judith Jarvis, et al. Report: Research on Human Subjects: Academic Freedom and the Institutional Review Board, Academe 92:5 (Sept. Oct. 2006).
Available at: http://www.aaup.org/AAUP/About/committees/committee+repts/CommA/ResearchonHumanSubjects.htm . Argues that research on autonomous adults whose methodology consists entirely in collecitng data by surveys, conducting interviews, or observing behavior in public places, be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.
Townsend, Robert and Meriam Belli. Oral History and IRBs: Caution Urged as Rule Interpretations Vary Widely, Perspectives, 42:9 (December 2004).
Available at http://www.historians.org/perspectives/issues/2004/0412/0412new4.cfm. A good summary of the current state of affairs at the time of publication regarding IRB review of oral history.
———. with Carl Ashley, Mériam Belli, Richard E. Bond, and Elizabeth Fairhead. Oral History and Review Boards: Little Gain and More Pain, Perspectives, 44:2 (February 2006).
Available at http://www.historians.org/perspectives/issues/2006/0602/index.cfm. Update on IRBs' approach to oral history research, based on a survey of some 240 institutions. The news is not good.
Vagts, Rachel, Clashing Disciplines: Oral History and the Institutional Review Board," Archival Issues 26:2 (2002), 145–152.
Van den Hoonaard, Will C. Is Research Ethics Review a Moral Panic?" Canadian Review of Sociology and Anthropology 38:1 (2001), 19-36.
Canadian colleagues' reflections on the issues of human subjects review in qualitative research.
Updated November 20, 2006
—Linda Shopes first became involved in issues related to IRB review of oral history in 1997 when, as president-elect of the Oral History Association, she and other OHA representatives met with officials of the Office of Protection from Research Risks (the administrative antecedent of the Office of Human Research Protections, which oversees compliance with federal regulations governing research on human subjects), to discuss historians’ concerns. Since then, as a member of the Council of the American Historical Association and as the Council representative to the Association’s Research Division, she has worked to define the AHA’s position on human subjects review of oral history; and, with Donald A. Ritchie representing the Oral History Association, developed the current policy statement discussed in this essay. Linda Shopes also sits as the external member of the Dickinson College Institutional Review Board.