The Myth of Community Differences as the Cause of Variations Among IRBs

Klitzman, Robert

doi:10.1080/21507716.2011.601284

Cited by 33 publications

(40 citation statements)

References 27 publications

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“…26,27,28,29 Many interviewees also discussed issues concerning the quality of science – e.g., how IRBs view the quality of science across a wide range of protocols, what standards they use, how they ensure and balance the quality of science against other goals, and view their role in these regards. It was felt that the attitudes and dilemmas of IRB personnel as expressed in these interviews could provide directions for future systematic research in this domain.…”

Section: Introductionmentioning

confidence: 99%

How good does the science have to be in proposals submitted to Institutional Review Boards? An Interview Study of Institutional Review Board personnel

Klitzman

2013

Clinical Trials

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Background IRBs have been increasingly criticized for how they review protocols, but how IRBs perceive, and make decisions about, the quality of the science of protocols has not been examined. Purpose To explore how and when IRBs view and make decisions about the quality of the science of studies they review. Methods I contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed IRB chairs, co-chairs, administrators and a director from 34 (response rate=55%), and an additional 7 members. Results Interviewees faced several ambiguities and questions concerning the quality of the science of protocols. IRBs are often not sure how, and to what extent to evaluate the science of protocols; whether the science should be “good enough” (and if so, what that means) vs. as good as possible. Federal regulations state that IRBs should ensure that risks are minimized, and commensurate with benefits. Thus, at times IRBs feel that changing the science is ethically necessary. But IRBs also then struggle with whether to adopt a higher threshold; 1) that social, and thus scientific benefits be maximized; and 2) that scientific efforts and resources should not be wasted. Committees face dilemmas – e.g., if a “perfect” study is not feasible. For protocols already approved elsewhere (e.g., by the National Institutes of Health [NIH]), IRB's vary in how much they feel they can request alterations; and sometimes make changes nonetheless. Larger institutional contexts and biases can shape these issues, and IRBs differ in how much they are “pro-research”, and have sufficient expertise. IRBs at times also approve studies despite reservations about the science. Limitations This study includes interviews with IRBs, but not observations of IRB meetings. Conclusions IRBs often face ambiguities and conflicting goals in assessing scientific quality. Many IRBs try to improve the science beyond what the regulations mandate. These data have important implications for improving practice, education, research, and policy.

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Section: Introductionmentioning

confidence: 99%

How good does the science have to be in proposals submitted to Institutional Review Boards? An Interview Study of Institutional Review Board personnel

Klitzman

2013

Clinical Trials

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“…Recent empirical research has examined several dimensions of IRBs governing clinical research. Studies have sought to characterize the composition of IRBs (Schuppli and Fraser 2007), differences in IRB process (Larson et al 2006), the nature and cause of outcome differentials (Abbott and Grady 2011;Klitzman 2011), how IRBs interact with their broader institutional settings (Klitzman 2013c), the extent to which IRBs successfully apply the Common Rule federal regulations for ethical research (Lidz et al 2012a), as well as how IRB members perceive and address a variety of different issues that arise during prospective review (Klitzman 2012b(Klitzman , 2013a(Klitzman , 2013b. Such research helps to highlight where oversight processes may break down or have room for improvement.…”

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confidence: 99%

Barriers to Effective Deliberation in Clinical Research Oversight

Wenner

2015

HEC Forum

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“…In these interviews, issues concerning coercion and undue influence frequently arose. Interviewees’ perceptions of RI were related to how they saw and addressed conflicts of interest,17 central IRBs,18 relationships with researchers19 and the so-called ‘community’ members,20 variations between IRBs21 and research in the developing world 22. Interviewees also discussed how they saw and approached issues related to coercion and undue influence.…”

Section: Introductionmentioning

confidence: 99%

How IRBs view and make decisions about coercion and undue influence: Table 1

Klitzman

2012

J Med Ethics

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Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with defining of ‘coercion’ and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. Conclusions These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research.

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The Myth of Community Differences as the Cause of Variations Among IRBs

Cited by 33 publications

References 27 publications

How good does the science have to be in proposals submitted to Institutional Review Boards? An Interview Study of Institutional Review Board personnel

How good does the science have to be in proposals submitted to Institutional Review Boards? An Interview Study of Institutional Review Board personnel

Barriers to Effective Deliberation in Clinical Research Oversight

How IRBs view and make decisions about coercion and undue influence: Table 1

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