Inconsistency and Institutional Review Boards

Goldman, Jerry

doi:10.1001/jama.1982.03330020041027

Cited by 68 publications

(36 citation statements)

References 5 publications

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“…Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [8]. Many US [9–15] and international [16–18] studies have found that different research ethics committees reach different conclusions when reviewing the same study.…”

mentioning

confidence: 99%

The Structure and Function of Research Ethics Committees in Africa: A Case Study

Kass¹,

Hyder²,

Ajuwon³

et al. 2007

PLoS Med

105

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mentioning

confidence: 99%

The Structure and Function of Research Ethics Committees in Africa: A Case Study

Kass¹,

Hyder²,

Ajuwon³

et al. 2007

PLoS Med

105

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“…However, the peer review process has come under steady criticism. Empirical studies have raised doubts about the effect of peer review on research quality (e.g., Goldman and Katz 1982;Callahan, Knopp, and Gallagher 2002;Jefferson et al, 2002). Yet, many IRB members indicate that they are willing, even eager (given their workload and specialized expertise) to defer on methodological issues to a funding agency's peer review panel (US Department of Health and Human Services 2002, chap.…”

Section: ''Scientific Benefit''mentioning

confidence: 99%

Balancing Uncertain Risks and Benefits in Human Subjects Research

Barke

2008

Science, Technology, & Human Values

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Composed of scientific and technical experts and lay members, thousands of research ethics committees—Institutional Review Boards (IRBs) in the United States—must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. IRBs handle risk and its uncertainty by adopting a version of the precautionary principle. To assess scientific merit, IRBs use a tacit ``sanguinity principle,'' which treats uncertainty as inevitable, even desirable, in scientific progress. In balancing human subjects risks and scientific benefits, IRBs use uncertainty as a boundary-ordering device that allows the mediation of the science and ethics aspects of their decisions. One effect is the entangling of methodological and ethical review. Some have suggested these should be more clearly separated, but decisions by research ethics committees depend in part on the negotiating space created by incommensurable approaches to uncertainty.

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“…Cleary, 1987;Ferraro et al, 1999) or focuses on descriptive aspects of the IRB including such factors as periodicity of meetings, workload management, and outcomes of reviews (e.g. Gray et al, 1978;Goldman and Katz, 1982;Bell et al, 1998). Barber and colleagues (1973) published what is perhaps the first major study of IRBs, research using questionnaires returned from respondents form more than 300 biomedical IRBs and reporting on their review outcomes.…”

Section: The Irb: Science Ethics Bureaucratizedmentioning

confidence: 99%

“…Indeed, research on IRBs has demonstrated instability in the implementation of rules (Goldman and Katz, 1982), especially as a function of the particular composition of committees (Lane, 2005) and some propensity for subversion of rules (Barber et al, 1973).…”

Section: [It] Is Imperative That the Clarification Of The Roles And mentioning

confidence: 99%

Science ethics as a bureaucratic problem: IRBs, Rules, and Failures of control

Bozeman

Hirsch

2006

Policy Sci

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â€œInstitutionalized science ethicsâ€\x9D refers to the statutory, professional and institution-based ethical standards that guide and constrain scientists' research work. The primary institution responsible for implementing institutionalized science ethics is the Institutional Review Board. We examine the limitations of IRBs and institutionalized science ethics, using bureaucratic theory and, especially, theory related to the development and enactment of rules. We suggest that due to the very character of rules-based systems, improvements in IRB outcomes are unlikely to be achieved through either more or better rules or even by bureaucratic reform. Instead, we suggest that improvements in human subject protection can best be advanced through increased participation. Ours is not a call for more participation by the general public but participation, via â€œParticipant Review Boardsâ€\x9D of persons who are eligible, by the protocols of the research in question, to serve as subjects. This provides a level of legitimacy and face validity that cannot be obtained by IRB affiliates, even by â€œexternal representatives.â€\x9D In making these points, we review a recent science ethics controversy, the KKI/Johns Hopkins lead paint study. In spite of being approved by IRBs, the study resulted in a civil lawsuit that reached the Maryland Court of Appeals. The case illustrates the limits of institutionalized science ethics and the bureaucracies created for their enactment. The case also underscores the complex and equivocal nature of the ethical guidelines established under the National Research Act. Copyright Springer Science+Business Media, Inc. 2005

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Inconsistency and Institutional Review Boards

Cited by 68 publications

References 5 publications

The Structure and Function of Research Ethics Committees in Africa: A Case Study

The Structure and Function of Research Ethics Committees in Africa: A Case Study

Balancing Uncertain Risks and Benefits in Human Subjects Research

Science ethics as a bureaucratic problem: IRBs, Rules, and Failures of control

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