Demystifying the IRB: Human subjects research in academic libraries

Portal

Volumn 10, Issue 3, 2010, Pages 309-321

  Smale, Maura A ^a  

^a NEW YORK CITY COLLEGE OF TECHNOLOGY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77954808512     PISSN: 15312542     EISSN: 15307131     Source Type: Journal    
DOI: 10.1353/pla.0.0114     Document Type: Article

References (43)

1. Margaret Bandy, Joyce Condon, and Ellen Graves, "Participating in Communities of Practice", Medical Reference Services Quarterly 27, 4 (2008):441-9;
2. Katherine Stemmer Frumento and Judith Keating, "The Role of the Hospital Librarian on an Institutional Review Board", Journal of Hospital Librarianship 7, 4 (2007):113-20;
3. Judith G. Robinson and Jessica Lipscomb Gehle, "Medical Research and the Institutional Review Board: The Librarian's Role in Human Subject Testing", Reference Services Review 33, 1 (2005):20-4.
4. Anne Tomlin, "Hospital Librarians and the Johns Hopkins Tragedy", Journal of Hospital Librarianship 2, 4 (2002):89.
5. Robinson and Gehle, 20.
6. Charles B. Wessel, Nancy H. Tannery, and Barbara A. Epstein, "Information-Seeking Behavior and Use of Information Resources by Clinical Research Coordinators", Journal of the Medical Library Association 94, 1 (2006):51.
7. Sally Harvey, "Institutional Review Boards: Another Way for Hospital Librarians to Add Value to their Organization", Journal of Hospital Librarianship 3, 2 (2003):99;
8. Tomlin, 89.
9. Bandy, Condon, and Graves; Frumento and Keating; and Harvey, 99-102.
10. Wessel, Tannery, and Epstein, 52.
11. Robin Levin Penslar and Joan P. Porter, Institutional Review Board Guidebook: Introduction (Washington, DC: United States Department of Health and Human Services), http://www.hhs.gov/ohrp/irb/irb-introduction.htm (accessed March 29, 2010).
12. "The Nuremberg Code" in Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10 (Washington, D. C: U. S. Government Printing Office, 1949), 2:181-2, http://www.hhs.gov/ohrp/ references/nurcode.htm (accessed March 29, 2010).
13. Penslar and Porter.
14. Centers for Disease Control and Prevention, "U. S. Public Health Service Syphilis Study at Tuskegee: Tuskegee Study, 1932-1972", Centers for Disease Control and Prevention, http://www.cdc.gov/tuskegee/(accessed March 29, 2010).
15. Centers for Disease Control and Prevention, "U. S. Public Health Service Syphilis Study at Tuskegee: Research Implications", Centers for Disease Control and Prevention, http://www.cdc.gov/tuskegee/after.htm (accessed March 29, 2010);
16. American Association of University Professors, "Research on Human Subjects: Academic Freedom and the Institutional Review Board", AAUP, http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm (accessed March 29, 2010).
17. Office of the Secretary, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm (accessed April 5, 2010).
18. Penslar and Porter, "Institutional Administration", in Institutional Review Board Guidebook, http://www.hhs.gov/ohrp/irb/irb-chapter1. htm (accessed March 29, 2010).
19. Penslar and Porter, "Institutional Administration. "
20. Code of Federal Regulations, title 45, part 46 (July 14, 2009), http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm (accessed March 29, 2010).
21. "Categories of Research that May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure", Federal Register 63, 60364-60367 (November 1998), http://www.hhs.gov/ohrp/humansubjects/ guidance/expedited98.htm (accessed March 29, 2010).
22. Michele R. Tennant, "The Institutional Review Board and Library Research: Memoirs of a Multi-Site Project" (presentation, annual conference of the Special Libraries Association, Seattle, WA, June 15-18, 2008).
23. CITI: Collaborative Institutional Training Initiative, https://www.citiprogram.org/(accessed March 29, 2010).
24. Zachary M. Schrag, "Macquarie's Innovative Ethics Training", Institutional Review Blog (April 17, 2009), http://www.institutionalreviewblog. com/2009/04/macquariesinnovative-ethics-training.html (accessed March 29, 2010).
25. Patricia A. MacCubbin, "Human Research Protections: The IRB Process and Its Importance", (presentation, program of the Library Association of CUNY Professional Development Committee/Junior Faculty Research Roundtable, New York, NY, February 26, 2009).
26. Rachel Vagts, "Clashing Disciplines: Oral History and the Institutional Review Board", Archival Issues 26, 2 (2002):147.
27. Christopher Shea, "Don't Talk to the Humans: The Crackdown on Social Science Research", Lingua Franca 10, 6 (2000):26-34.
28. Many voices (and in increasing numbers) in the past decade have raised objections that federal regulations, as currently interpreted by many academic IRBs, are too restrictive of social science and humanities research. In the 2006 report Research on Human Subjects: Academic Freedom and the Institutional Review Board, the American Association of University Professors (AAUP) asserted that requests for significant changes to a research protocol, as well as the inability to appeal rejection of a research project by the IRB, constitute a serious infringement on academic freedom. The AAUP suggests a revision to the regulations such that "research whose methodology consists entirely of collecting data by surveys, conducting interviews, or observing behavior in public places be exempt from the requirement of IRB review." The AAUP also recommends that colleges and universities cease their common practice of evaluating all research projects based on the same criteria rather than solely federally funded projects as is required by law. See AAUP, "Research on Human Subjects." Zachary Schrag details the fascinating results of his historical research on the inclusion of social science research under the same IRB regulations and requirements as biomedical research. His examination of archival materials reveals that, while the social sciences were included in discussions of human subjects research from the outset, "application of the regulations to the social sciences... was far less careful than was the development of guidelines for biomedical research" See Zachary M. Schrag, "How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965-1991", The Journal of Policy History 21, 1 (2009):4. Shea suggests that several high-profile research lapses in the late 1990s brought an increase in IRB attention to all research projects involving human subjects, including projects with little to no risk for subjects.
29. See Shea. Adil Shamoo echoes concerns raised by Shea and others and asserts that academic researchers in the humanities and social sciences have abandoned projects because the IRB process is viewed as a hassle and the timelines too lengthy.
30. See Adil E. Shamoo, "Deregulating Low-Risk Research", The Chronicle of Higher Education, August 3, 2007, 16.
31. Vagts, 151;
32. American Anthropological Association, "Code of Ethics of the American Anthropological Association" (February 2009), http://www.aaanet. org/issues/policyadvocacy/upload/AAA-Ethics-Code-2009pdf (accessed March 29, 2010).
33. Michele R. Tennant, a medical librarian at the University of Florida's Health Science Center Libraries, discussed her "negotiation through the IRB process at 18 separate institutions in support of two multi-site studies" in a paper presented at the 2008 conference of the Special Libraries Association. She offers an overview of the complexities of navigating the IRB process when engaged in a research project at medical centers outside of one's home institution. Her paper concludes with valuable suggestions for librarians seeking to perform research that involves multiple locations and IRBs.
34. See Tennant, 1.
35. Nancy Fried Foster and Susan Gibbons, Studying Students: The Undergraduate Research Project at the University of Rochester (Chicago: Association of College and Research Libraries, 2007).
36. A selection of recent projects includes: Randall McClure and Kellian Clink, "How Do You Know That? An Investigation of Student Research Practices in the Digital Age", portal: Libraries and the Academy 9, 1 (2009):115-32;
37. Tracy Gabridge, Millicent Gaskell, and Amy Stout, "Information Seeking Through Students' Eyes: The MIT Photo Diary Study", College & Research Libraries 69, 6 (2008):510-22;
38. Eric Novotny and Ellysa Stern Cahoy, "If We Teach, Do They Learn? The Impact of Instruction on Online Catalog Search Strategies", portal: Libraries and the Academy 6, 2 (2006):155-67;
39. Melissa L. Becher and Janice L. Flug, "Using Student Focus Groups to Inform Library Planning and Marketing", College & Undergraduate Libraries 12, 1/2 (2005):1-18.
40. Doug Suarez, "What Students Do When They Study in the Library", Electronic Journal of Academic and Special Librarianship 8, 3 (2007): http://southernlibrarianship. icaap.org/content/v08n03/suarez-d01.html (accessed March 29, 2010);
41. Foster and Gibbons, 20-9.
42. Rebekah Nathan, My Freshman Year: What a Professor Learned by Becoming a Student. (New York: Penguin, 2005);
43. Tim Clydesdale, The First Year Out: Understanding American Teens After High School. (Chicago: University of Chicago Press, 2007). Nathan's book was written using a pseudonym; just before publication, its author was revealed to be Cathy Small, a professor of anthropology at Northern Arizona University.