From anonymity to “open doors”: IRB responses to tensions with researchers

BMC Research Notes

Robert Klitzman¹ 

[1] Department of Psychiatry, Columbia University, 1051 Riverside Drive #15, New York, NY, USA

关键词: Communication;    Compliance;    Organizational ethics;    Medical education;    Professionalism;    Ethics education;    Responsible conduct of research;    Research ethics;    IRBs;   

Others  :  1166164
DOI  :  10.1186/1756-0500-5-347

 received in 2011-10-13, accepted in 2012-06-14,  发布年份 2012

【 摘 要 】

Background

Tensions between IRBs and researchers in the US and elsewhere have increased, and may affect whether, how, and to what degree researchers comply with ethical guidelines. Yet whether, how, when, and why IRBs respond to these conflicts have received little systematic attention.

Findings

I contacted 60 US IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. IRBs often try to respond to tensions with researchers and improve relationships in several ways, but range widely in how, when, and to what degree (e.g., in formal and informal structure, content, and tone of interactions). IRBs varied from open and accessible to more distant and anonymous, and in the amount and type of “PR work” and outreach they do. Many boards seek to improve the quantity, quality, and helpfulness of communication with PIs, but differ in how. IRBs range in meetings from open to closed, and may have clinics and newsletters. Memos can vary in helpfulness and tone (e.g., using “charm”). IRBs range considerably, too, in the degrees to which they seek to educate PIs, showing them the underlying ethical principles. But these efforts take time and resources, and IRBs thus vary in degrees of responses to PI complaints.

Conclusions

This study, the first to explore the mechanisms through which IRBs respond to tensions and interactions with PIs, suggests that these committees seek to respond to conflicts with PIs in varying ways – both formal and informal, involving both the form and content of communications. This study has important implications for future practice, research, and policy, suggesting needs for increased attention to not only what IRBs communicate to PIs, but how (i.e., the tone and the nature of interactions). IRBs can potentially improve relationships with PIs in several ways: using more “open doors” rather than anonymity, engaging in outreach (e.g., through clinics), enhancing the tone as well as content of interactions, educating PIs about the underlying ethics, and helping PIs as much and proactively as possible. Increased awareness of these issues can help IRBs and researchers in the US and elsewhere.

【 授权许可】

   
2012 Klitzman; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Gunsalus CK, Bruner EM, Burbules NC, Dash L, Finkin M, Goldberg JP, Greenough WT, Miller GA, Pratt MG, Iriye M, Aronson D: The Illinois White Paper: improving the system for protecting human subjects: counteracting IRB “mission creep. Qual Inq 2007, 13:617-649.
• [2]Greene SM, Geiger AM: A review finds that multicenter studies face substantial challenges but strategies exist to achieve institutional review board approval. J Clin Epidemiol 2006, 59:784-790.
• [3]Heimer CA, Petty J: Bureaucratic ethics: IRBs and the legal regulation of human subjects research. Annu Rev Law Soc Sci 2010, 6:601-626.
• [4]Fleischman AR: Regulating research with human subjects: is the system broken? Trans Am Clin Climatol Assoc 2005, 116:91-102.
• [5]Liberati A: Research ethics committees: can they contribute to the improvement of clinical research in Europe? J Ambul Care Manag 2004, 27:154-165.
• [6]Menikoff J: The paradoxical problem with multiple-IRB review. N Engl J Med 2010, 363:1591-1593.
• [7]Hedgecoe A, Carvalho F, Lobmayer P, Raka F: Research ethics committees in Europe: implementing the directive, respecting diversity. J Med Ethics 2006, 32:483-486.
• [8]Federal Register: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. https://www.federalregister.gov/articles/2011/07/26/2011-18792/human-subjects-research-protections-enhancing-protections-for-research-subjects-and-reducing-burden webcite
• [9]Emanuel EJ, Menikoff J: Reforming the regulations governing research with human subjects. N Engl J Med 2011, 365(12):1145-1150. Epub 2011 Jul 25
• [10]Hamburger P: The new censorship: Institutional Review Boards. Supreme Court Rev 2004, 271-354.
• [11]Whitney SN, Alcser K, Schneider CE, McCullough LB, McGuire AL, Volk RJ: Principal investigator views of the IRB system. Int J Med Sci 2008, 5:68-72.
• [12]Keith-Spiegel P, Koocher GP: The IRB paradox: could the protectors also encourage deceit? Ethics Behav 2005, 15:339-349.
• [13]De Vries R, Anderson MS, Martinson BC: Normal misbehavior: scientists talk about the ethics of research. JERHRE 2006, 1:43-50.
• [14]Klitzman R: Views and experiences of IRBs concerning research integrity. J Law Med Ethics 2011, 39:513-528.
• [15]Klitzman R: “Members of the same club”: challenges and decisions faced by US IRBs in identifying and managing conflicts of interest. PLoS One 2011, 6:e22796.
• [16]Klitzman R: How local IRBs view central IRBs in the US. BMC Med Ethics 2011, 12:13. BioMed Central Full Text
• [17]Klitzman R: US IRBs confronting research in the developing world. Dev World BioethEpub ahead of print
• [18]Klitzman R: The myth of community differences as the cause of variations among IRBs. AJOB Prim Res 2011, 2:24-33.
• [19]Geertz C: Interpretation of cultures: selected essays. Basic Books, New York; 1973.
• [20]Strauss A, Corbin J: Basics of qualitative research – techniques and procedures for developing grounded theory. Sage Publications, Newbury Park; 1990.
• [21]Klitzman R: The ethics police?: IRBs’ views concerning their power. PLoS One 2011, 6(12):e28773.
• [22]Ahmed AH, Nicholson KG: Delays and diversity in the practice of local research ethics committees. J Med Ethics 1996, 22:263-266.
• [23]Kahn JP: Moving from compliance to conscience: why we can and should improve on the ethics of clinical research. Arch Intern Med 2001, 161:925-928.
• [24]Yarborough M, Fryer-Edwards K, Geller G, Sharp RR: Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors. Acad Med 2009, 84:472-477.
• [25]Geller G: Beyond “compliance”: the role of institutional culture in promoting research integrity. Acad Med 2010, 85:1296-1302.