Background In recent years, tensions between IRBs and principal investigators (PIs) have risen, posing the needs to understand these conflicts, their underlying causes, and possible solutions. Researchers frequently complain about IRBs, but how IRBs perceive and respond to these criticisms is unclear. Methods I conducted in-depth, semi-structured interviews of two hours each with 46 chairs, administrators, and members. I contacted the leadership of 60 IRBs around the country (every fourth one in the list of the top 240 institutions by NIH funding) and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Results Interviewees suggest that IRBs and PIs may view the nature and causes of these conflicts very differently and misunderstand each other, exacerbating tensions. Interviewees often recognized that they were seen by PIs as having power, but many IRBs saw themselves as not having it (e.g., because they are “merely following the regulations,” and their process is “open,” impersonal and unbiased, and they are themselves subject to higher administrative agencies), or as having it, but feeling it is small, and/or justified (e.g., because it is based on overriding goals and “the community values,” and IRBs are trying to help PIs). Questions emerge as to whether IRBs do or should have power, and if so, what kind, how much, and when. Several factors may affect these tensions. Conclusions This study, the first to explore how IRBs perceive and understand conflicts and power relationships with PIs, suggests how IRBs and PIs may differ in viewing their respective roles and relationships, exacerbating tensions. These issues have critical implications for IRBs and PIs—to enhance their awareness and understanding of these conflicts (e.g., that IRBs may have discretionary power) and the underlying causes involved, and for increasing attention to research, practice, and policy concerning these areas of IRB functioning and interactions with PIs.
References
[1]
Burris S (2008) Regulatory innovation in the governance of human subjects research: A cautionary tale and some modest proposals. Regulation Governance 2(1): 65–84.
[2]
Burris S, Moss K (2006) U. S. health researchers review their ethics review boards: A qualitative study. J Empir Res Hum Res Ethics 1(2): 39–58.
[3]
Keith-Spiegel P, Koocher GP, Tabachnick B (2006) What scientists want from their research ethics committees. J Empir Res Hum Res Ethics 1(1): 67–82.
[4]
Koerner AF (2005) Communication scholars' communication and relationship with their IRBs. J Appl Commun Res 33(3): 231–241.
[5]
Gunsalus CK, Bruner EM, Burbules NC, Dash L, Finkin M, et al. (2006) Mission creep in the IRB world. Science 312(5779): 1441.
[6]
Bell J, Whiton J, Connelly S (1998) Final report: Evaluation of NIH implementation of section 491 of the public health service act, mandating a program of protection for research subjects. Arlington, VA: James Bell Associates. 86 p.
[7]
McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, et al. (2003) Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA 290(3): 360–366.
[8]
Dziak K, Anderson R, Sevick MA, Weisman CS, Levine DW, et al. (2005) Variations among institutional review boards in a multisite health services research study. Health Serv Res 40(1): 279–290.
[9]
Greene SM, Geiger AM (2006) A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. J Clin Epidemiol 59: 784–790.
[10]
Fleischman AR (2005) Regulating research with human subjects: Is the system broken? Trans Am Clin Climatol Assoc 116: 91–102.
[11]
Hamburger P (2004) The new censorship: Institutional Review Boards. Supreme Court Rev 271–354.
[12]
Keith-Spiegel P, Koocher GP (2005) The IRB paradox: Could the protectors also encourage deceit? Ethics Behav 15(4): 339–349.
[13]
Menikoff J (2010) The paradoxical problem with multiple-IRB review. New Engl J Med 363: 1591–1593.
[14]
Ahmed AH, Nicholson KG (1996) Delays and diversity in the practice of local research ethics committees. J Med Ethics 22(5): 263–266.
[15]
Department of Health and Human Services (2011) “Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators.” Federal Register 76: 44512–44531.
[16]
Emanuel EJ, Menikoff J (2011) Reforming the regulations governing research with human subjects. New Engl J Med. (10.1056/NEJMsb1106942).
[17]
Klitzman R (2011) Views and experiences of IRBs concerning research integrity. J Law Med Ethics. (in press).
[18]
Klitzman R (2011) “Members of the same club”: Challenges and decisions faced by US IRBs in identifying and managing conflicts of interest. PLoS ONE. (in press).
[19]
Klitzman R (2011) How local IRBs view central IRBs in the US. BMC Med Ethics 12(13).
[20]
Klitzman R (2011) ‘Community’ IRB members: Who are they, what do they do, and do they represent anyone? Acad Med. (in press).
[21]
Klitzman R (2011) US IRBs confronting research in the developing world. Dev World Bioeth. (in press).
[22]
Klitzman R (2011) The myth of community differences as the cause of discrepancies between IRBs. Amer J Bioeth. (in press).
[23]
Geertz C (1973) Interpretation of Cultures: Selected Essays. New York: Basic Books. 470 p.
[24]
Strauss A, Corbin J (1990) Basics of qualitative research: Techniques and procedures for developing grounded theory. Newbury Park: Sage Publications. 336 p.
[25]
Aristotle (Saunders TJ, ed.) (1981) The Politics. New York: Penguin Classics. 512 p.
[26]
Hamilton A, Madison J (2010) The Federalist Papers. (accessed 2011) Available: http://www.foundingfathers.info/federali？stpapers/.
[27]
Smith DA, Visher CA, Davidson LA (1984) Equity and discretionary justice: The influence of race on police arrest decisions. J Crim Law Criminol 75(1): 234–249.
