I. REGULATIONS, POLICIES, GUIDELINES, AND REPORTS
II. COMMENTARY AND CRITICISM
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 https://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 non-biomedical research going back at least three decades.
COSSA Washington Update Available at https://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 https://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp.
A useful document for understanding and interpreting the Common Rule as it applies 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 https://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 https://oralhistory.org/network/mw/index.php/Evaluation_Guide
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 https://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 https://www.hhs.gov/ohrp/.
Atkins, E. Taylor, “Oral History and IRBs: An Update from the 2006 HRPP Conference.” Perspectives Online 45:3 (March 2007).
Available at https://www.historians.org/perspectives/issues/2007/0703/index.cfm
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.
Available at https://chronicle.com for those with a subscription to the Chronicle.
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.
Available at https://www.law.uiuc.edu/conferences/whitepaper/
An ambitious effort to refocus human subjects review on research most likely to result in harm and relieve relatively harmless, non-biomedical 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 https://www.aaup.org/AAUP/pubsres/academe/2002/MJ/For+the+Record/FTR2.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.
Available at: https://www.historians.org/perspectives/issues/1997/9709/9709pro.cfm
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, The Chronicle of Higher Education, November 15, 2002, B24.
Available at https://chronicle.com for those with a subscription to the Chronicle.
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.
Haggerty, K. D. “Ethics Creep: Governing Social Science Research in the Name of Ethics.” Qualitative Sociology 27:4 (2004): 391-414.
Howard, Jennifer. “Oral History Under Review.” The Chronicle of Higher Education, November 10, 2006, A14 ff.
Available at https://chronicle.com for those with a Chronicle subscription.
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 https://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.
Institutional Review Blog; maintained by Zachary M. Schrag;
Available at https://institutionalreviewblog.blogspot.com/.
Useful and thoughtful up to date “news and commentary about Institutional Review Board oversight of the humanities and social sciences.”
Kancelbaum, Barbara. “Social Scientists and Institutional Review Boards.” Items & Issues [newsletter of the Social Science Research Council] 3: 1-2 (Spring 2002): 1ff.
Kerr, Robert L. “Unconstitutional Review Board? Considering a First Amendment Challenge to IRB Regulation of Journalistic Research Methods.” Communication Law & Policy 11 (2006): 393-447.
Law and Society Review 41:4 (December 2007): 757-818.
Includes five generally critical articles on IRB review of social science research, including the text of Law and Society Association president Malcolm M. Feeley’s presidential address, three comments, and Feeley’s response. Jack Katz’s article, “Toward a Natural History of Ethical Censorship, is available at https://www.sscnet.ucla.edu/soc/faculty/katz/pubs/Ethical_Censorship_draft.pdf.
Milne, Catherine. “Overseeing Research: Ethics and the Institutional Review Board.” Forum Qualitative Sozialforschung / Forum: Qualitative Social Research 6:1 (January 2005).
Available at: https://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 https://www.aaup.org/AAUP/pubsres/academe/2003/SO/Feat/nels.htm
Oakes, J. Michael. “Risks and Wrongs in Social Science Research: An Evaluator’s Guide to the IRB.” Evaluation Review 24 (2002): 443-478.
Plattner, Stuart. “Human Subjects Protection and Cultural Anthropology.” Anthropological Quarterly 76:2 (Spring 2003):. 287-297.
“Protecting Human Beings: Institutional Review Boards and Social Science Research.” Academe 87:3 (May-June 2001), 55-67.
Available at https://www.aaup.org/AAUP/comm/rep/A/humansubs.htm
A thorough discussion of the difficulties social scientists – including historians – encounter as regulations developed within a biomedical frame of reference are applied to non-biomedical research; useful as a reference in discussions with local IRBs.
Schrag, Zachary M. “Ethical Training for Oral Historians.” Perspectives Online 45:3 (March 2007).
Available at https://www.historians.org/perspectives/issues/2007/0703/index.cfm
———-. “How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965-1991. The Journal of Policy History 21:1 (2009): 1-35.
Available at https://journals.cambridge.org/action/displayIssue?jid=JPH&volumeId=21&seriesId=0&issueId=01
Well researched history of how social science research came to be included within the regulatory embrace of 45 CFR 46.
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 https://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.” AHA Perspectives 38:6 (September 2000): 34-37.
Available at: https://www.historians.org/perspectives/issues/2000/0009/0009vie1.cfm
———-. “Negotiating Institutional Review Boards.” Perspectives Online 45:3 (March 2007).
Available at https://www.historians.org/perspectives/issues/2007/0703/index.cfm
Speers, Marjorie A. “Accreditation Helps Researchers and Subjects Alike.” APS [American Psychological Society] Observer 16:5 (May 2003): 9.
Symposium on Censorship and Institutional Review Boards. Northwestern University Law Review 101:2 (2007).
Available at https://www.law.northwestern.edu/journals/lawreview/issues/101.2.html
Special issue with articles examining IRBs and human subjects review from a legal perspective.
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: https://www.aaup.org/AAUP/comm/rep/A/humansubs.htm
Report issued by AAUP, which argues that “research on autonomous adults whose methodology consists entirely in collecting 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 https://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 https://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.
Prepared by Linda Shopes
Updated May 2009
