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Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation

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Abstract

In response to the system for regulating research with human subjects, researchers have raised two apparently contradictory concerns: that IRBs are excessively inconsistent (often raised by biomedical researchers), and that they are excessively standardizing (often raised by qualitative interview researchers). Why does standardization appear as the dominant theme in qualitative researchers’ experiences with their IRBs? And how do qualitative researchers experience standardization in their IRB encounters? We focus on IRBs role as regulatory bureaucracies, which typically rely heavily on standardized communication and decisions to process information and make large numbers of decisions in a timely manner. We explore the role of standardization in IRB regulation of qualitative research in an analysis of semi-structured interviews with 26 qualitative sociologists from six research universities and three liberal arts colleges in the Northeastern United States. In a regulatory regime oriented toward the norms of experimental research, these frictions resulted partly from a lack of appropriate standardized language and decision-templates, but also from the inherent difficulties of applying standardized decisions to work that is unpredictable, unique, and difficult to routinize.

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Notes

  1. The Rural College and Public University IRBs had password-protected online application systems, and therefore were not included in our comparison.

References

  • Abbott, A. D. (1988). The system of professions: An essay on the division of expert labor. Chicago: University of Chicago Press.

  • American Association of University Professors (2006) Research on human subjects: academic freedom and the institutional review board. Retrieved January 23, 2010 (http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm).

  • American Association of University Professors. (2012). Regulation of research on human subjects: Academic freedom and the institutional review board. Washington: American Association of University Professors.

    Google Scholar 

  • Baron, D. P., & Besanko, D. (1984). Regulation, asymmetric information and auditing. RAND Journal of Economics, 15, 447–470.

    Article  Google Scholar 

  • Bledsoe, C. H., Sherin, B., Galinsky, A. G., Headley, N. M., Heimer, C. A., Kjeldgaard, E., Lindgren, J., Miller, J. D., Roloff, M. E., & Uttal, D. H. (2007). Regulating creativity: research and survival in the IRB iron cage. Northwestern University Law Review, 101(2), 593–641.

    Google Scholar 

  • Bradburd, D. (2006). Fuzzy boundaries and hard rules: unfunded research and the IRB. American Ethnologist, 33(4), 492–498.

  • Cohen, J. (2006). Checking the box (HRPP Blog). Retrieved 1/26, 2016 (http://hrpp.blogspot.com/2006/02/checking-box.html).

  • De Vries, R., DeBruin, D. A., & Goodgame, A. (2004). Ethics review of social, behavioral, and economic research: where should we go from here? Ethics & Behavior, 14(4), 351–368.

    Article  Google Scholar 

  • Dziak, K., Anderson, R., Sevick, M.A., Weisman, C.S., Levine, D.W., & Scholle, S.H. (2005). Variations among institutional review board reviews in a multisite health services research study. Health Services Research, 40(1), 279–290.

  • Fassin, D. (2006). The end of ethnography as collateral damage of ethical regulation? American Ethnologist, 33(4), 522–524.

    Article  Google Scholar 

  • Fitzgerald, M. H. (2004). Punctuated equilibrium, moral panics and the ethics review process. Journal of Academic Ethics, 2, 315–338.

    Article  Google Scholar 

  • Friedson, E. (1994). Professionalism reborn: Theory, prophecy, and policy. Chicago: University of Chicago Press.

    Google Scholar 

  • Galbraith, J. R. (1977). Organization design. Reading, MA: Addison-Wesley.

  • Gunsalus, C.K., Bruner, E.M., Burbules, N.C., Dash, L., Finkin, M., Goldberg, J.P., Greenough, W.T., Miller, G.A., Pratt, M.G., Iriye, M., & Aronson, D. (2007). Improving the system for protecting human subjects: counteracting IRB “Mission Creep”. Qualitative Inquiry, 13(5), 617–649.

  • Hafferty, F.W., & Light, D.W. (1995). Professional dynamics and the changing nature of medical work. Journal of Health and Social Behavior, 35, 132–153.

  • Halpern, S. (2007). Hybrid design, systemic rigidity: institutional dynamics in human research oversight. Regulation and Governance, 2, 85–102.

    Article  Google Scholar 

  • Halpern-Felsher, B. L., Millstein, S. G., Ellen, J. M., Adler, N., Tschann, J., & Biehl, M. (2001). The role of behavioral experience in judging risks. Health Psychology, 20, 120–126.

    Article  Google Scholar 

  • Heimer, C. A., & Petty, J. L. (2010). Bureaucratic ethics: IRBs and the legal regulation of human subjects research. Annual Review of Law and Social Science, 6, 601–626.

    Article  Google Scholar 

  • Hirshon, J.M., Krugman, S.D., Witting, M.D., Furuno, J.P., Limcangco, M.R., Perisse, A.R., & Rasch, E.K. (2002). Variability in institutional review board assessment of minimal-risk research. Academic Emergency Medicine, 9(12), 1417–1420.

  • Irvine, J. (2012). Can’t ask, can’t tell: how institutional review boards keep sex in the closet. Contexts, 11, 28–33.

    Article  Google Scholar 

  • Johnson, T.S. (2008). Qualitative research in question: a narrative of disciplinary power with/in the IRB. (Institutional Review Board) (Personal Account). Qualitative Inquiry, 14(2), 212–232.

  • Katz, J. (2007). Toward a natural history of ethical censorship. Law & Society Review, 41(4), 797–810.

    Article  Google Scholar 

  • Lederman, R. (2006). The perils of working at home: IRB “Mission Creep” as context and content for an ethnography of disciplinary knowledges. American Ethnologist, 33(4), 482–91.

  • Lederman, R. (2007). Educate your IRB: an experiment in cross-disciplinary communication. Anthropology News, 48, 33–34.

    Article  Google Scholar 

  • Leidner, R. (1993). Fast food, fast talk: Service labor and the routinization of everyday life. Berkeley, CA: University of California Press.

  • March, J. G., Simon, H. A., & Guetzkow, H. S. (1993). Organizations (2nd ed.). Cambridge, UK: Blackwell.

  • Michels, R. (1959). Political parties: A sociological study of the oligarchical tendencies of modern democracy. New York, NY: Dover Publications.

  • National Research Council (2014). Proposed revisions to the common rule for the protection of human subjects in the behavioral and social sciences. Washington, D.C.: National Academies Press.

  • O’Connor, M. K., Netting, F. E., & Thomas, M. L. (2008). Grounded theory: managing the challenge for those facing institutional review board oversight. Qualitative Inquiry, 14(1), 28–45.

    Article  Google Scholar 

  • Power, M. (1997). The audit society: Rituals of verification. New York and Oxford: Oxford.

    Google Scholar 

  • Pritchard, I. (2011). How do IRB members make decisions? A review and research agenda. Journal of Empirical Research on Human Research Ethics, 6, 31–46.

    Article  Google Scholar 

  • Sandholtz, K. W. (2012). Making standards stick: a theory of coupled vs. decoupled compliance. Organization Studies, 33, 655–679.

    Article  Google Scholar 

  • Schneider, C. (2015). The censor’s hand: The misregulation of human-subject research. New York: NYU Press.

    Book  Google Scholar 

  • Schrag, Z. M. (2010). Ethical imperialism: Institutional review boards and the social sciences 1965–2009. Baltimore: Johns Hopkins University Press.

    Google Scholar 

  • Scott, J. C. (1998). Seeing like a state: How certain schemes to improve the human condition have failed. New Haven: Yale University Press.

    Google Scholar 

  • Selznick, P. (1949). TVA and the grass roots: A study in the sociology of formal organization. Berkeley: University of California Press.

    Google Scholar 

  • Silverman, H., Hull, S.C., & Sugarman, J. (2001). Variability among institutional review boards’ decisions within the context of a multicenter trial. Critical Care Medicine, 29(2), 235–241.

  • Slovic, P., Fischhoff, B., & Lichtenstein, S. (2001). Facts and fears: Understanding perceived risk. In P. Slovic (Ed.), The perception of risk (pp. 137–153). London and Sterling: Earthscan.

    Google Scholar 

  • Stair, T.O., Reed, C.R., Radeos, M.S., Koski, G., & Camargo, C.A. (2001). Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Academic Emergency Medicine, 8(6), 636–641.

  • Stark, L. J. M. (2006). Morality in science: How research is evaluated in the age of human subjects regulation. Princeton University Press, New Jersey.

  • Stark, L. J. M. (2007). Victims in our own minds? IRBs in myth and practice. (Institutional Review Boards) (Response to Article by Malcolm M. Feeley in this Issue, p. 757). Law & Society Review, 41(4), 777–786.

  • Stark, L. J. M. (2012). Behind closed doors: IRBs and the making of ethical research. Chicago; London: The University of Chicago Press.

    Google Scholar 

  • Stinchcombe, A. L. (1959). Bureaucratic and craft administration of production: a comparative study. Administrative Science Quarterly, 4(2), 168–187.

    Article  Google Scholar 

  • Stinchcombe, A.L. (1990). Information and organizations. University of California Press.

  • Taylor, J., & Patterson, M. (2010). Autonomy and compliance: how qualitative sociologists respond to institutional ethical oversight. Qualitative Sociology, 33, 161–183.

    Article  Google Scholar 

  • Thompson, J. D. (1967). Organizations in action. New York: McGraw Hill.

    Google Scholar 

  • Timmermans, S., & Berg, M. (2003). The gold standard: The challenge of evidence-based medicine and standardization in health care. Philadelphia: Temple University Press.

    Google Scholar 

  • U.S. 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(143), 44512–44531.

    Google Scholar 

  • Waring, J., & Currie, G. (2009). Managing expert knowledge: organizational challenges and managerial futures for the UK medical profession. Organization Studies, 30(7), 755–781.

  • White, R. F. (2007). Institutional review board mission creep: the common rule, social science, and the nanny state. Independent Review, 11(3), 547–564.

  • Yates, J. A. (1989). Control through communication: The rise of system in American management. Baltimore: Johns Hopkins University Press.

    Google Scholar 

Download references

Acknowledgments

Many thanks to Elizabeth Popp Berman, Janice Irvine, Zachary Schrag and Laura Stark for their comments on earlier drafts of this paper. This research benefited from funding from a Boston College Research Expense Grant.

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Correspondence to Sarah Babb.

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Babb, S., Birk, L. & Carfagna, L. Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation. Am Soc 48, 86–102 (2017). https://doi.org/10.1007/s12108-016-9331-z

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