BACKGROUND: Research has generally examined institutional review boards (IRBs) in isolation, but critical questions arise of how these entities fit into the larger institutional contexts in which they operate and what the implications may be. METHODS: Semi-structured interviews were conducted with leaders of IRBs from among the top 240 institutions receiving funding from the National Institutes of Health. RESULTS: Interviewees felt that institutions may affect IRBs through both broad, indirect features (e.g., size, type of research, and culture of the institution), and more direct, IRB-related factors (e.g., amount of leadership and resource support for the IRB). Interviewees thought that institutional support of IRBs ranged from financial to non-financial, direct and indirect, and that these institutional factors can mold amounts of IRB staff and education, audits, and education of principal investigators (PIs), and tensions IRBs had to address. Respondents felt that these factors can in turn potentially affect IRB reviews of protocols and interactions with principle investigators (PIs). Within the complex systems of an institution, IRBs felt that PIs' experiences and complaints about the IRB to institutional leaders may also shape how the institution related to the IRB. CONCLUSIONS: These data are the first to show how IRBs perceive themselves as working within the contexts of dynamic local institutional relationships and systems that pose challenges and tensions that can potentially affect critical aspects of IRB functioning. The findings have implications for practice, future research, and policy.
BACKGROUND: Research has generally examined institutional review boards (IRBs) in isolation, but critical questions arise of how these entities fit into the larger institutional contexts in which they operate and what the implications may be. METHODS: Semi-structured interviews were conducted with leaders of IRBs from among the top 240 institutions receiving funding from the National Institutes of Health. RESULTS: Interviewees felt that institutions may affect IRBs through both broad, indirect features (e.g., size, type of research, and culture of the institution), and more direct, IRB-related factors (e.g., amount of leadership and resource support for the IRB). Interviewees thought that institutional support of IRBs ranged from financial to non-financial, direct and indirect, and that these institutional factors can mold amounts of IRB staff and education, audits, and education of principal investigators (PIs), and tensions IRBs had to address. Respondents felt that these factors can in turn potentially affect IRB reviews of protocols and interactions with principle investigators (PIs). Within the complex systems of an institution, IRBs felt that PIs' experiences and complaints about the IRB to institutional leaders may also shape how the institution related to the IRB. CONCLUSIONS: These data are the first to show how IRBs perceive themselves as working within the contexts of dynamic local institutional relationships and systems that pose challenges and tensions that can potentially affect critical aspects of IRB functioning. The findings have implications for practice, future research, and policy.
Entities:
Keywords:
academic medical centers; dynamic systems theory; organizational culture; research ethics
Authors: Eric G Campbell; Joel S Weissman; Brian Clarridge; Recai Yucel; Nancyanne Causino; David Blumenthal Journal: Acad Med Date: 2003-08 Impact factor: 6.893
Authors: Jeanne L Speckman; Margaret M Byrne; Jason Gerson; Kenneth Getz; Gary Wangsmo; Carianne T Muse; Jeremy Sugarman Journal: IRB Date: 2007 Mar-Apr