Should the Decisions of Institutional Review Boards Be Consistent?

Friesen, Phoebe; Anm., Yusof; Sheehan, Mark

doi:10.1002/eahr.500022

Cited by 32 publications

(27 citation statements)

References 39 publications

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“…[21][22][23][24][25] It is helpful, in this context, to distinguish procedural and outcome consistency. 26 Understandably, both patients and clinicians find appeal in the idea of outcome consistency: guidance that operated in this way would enable people to know where they stand, in advance of the decision being made. An algorithmic or formula-based decision-making process that sought to crunch the relevant values and facts would likely lie at the heart of guidance of this kind.…”

Section: Procedural Versus Outcome Consistencymentioning

confidence: 99%

Tragic choices in intensive care during the COVID-19 pandemic: on fairness, consistency and community

2020

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Tragic choices arise during the COVID-19 pandemic when the limited resources made available in acute medical settings cannot be accessed by all patients who need them. In these circumstances, healthcare rationing is unavoidable. It is important in any healthcare rationing process that the interests of the community are recognised, and that decision-making upholds these interests through a fair and consistent process of decision-making. Responding to recent calls (1) to safeguard individuals’ legal rights in decision-making in intensive care, and (2) for new authoritative national guidance for decision-making, this paper seeks to clarify what consistency and fairness demand in healthcare rationing during the COVID-19 pandemic, from both a legal and ethical standpoint. The paper begins with a brief review of UK law concerning healthcare resource allocation, considering how community interests and individual rights have been marshalled in judicial deliberation about the use of limited health resources within the National Health Service (NHS). It is then argued that an important distinction needs to be drawn between procedural and outcome consistency, and that a procedurally consistent decision-making process ought to be favoured. Congruent with the position that UK courts have adopted for resource allocation decision-making in the NHS more generally, specific requirements for a procedural framework and substantive triage criteria to be applied within that framework during the COVID-19 pandemic are considered in detail.

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Section: Procedural Versus Outcome Consistencymentioning

confidence: 99%

Tragic choices in intensive care during the COVID-19 pandemic: on fairness, consistency and community

2020

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“…oversight (Silberman and Kahn 2011;Resnik 2014;Friesen et al 2019). However, another explanation, which cannot be ruled out at present, is that inconsistency and variability occur, in part, because IRBs use different standards of evidence for making decisions.…”

Section: A Cmentioning

confidence: 99%

Standards of evidence for institutional review board decision-making

Resnik

2020

Accountability in Research

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A standard of evidence is a rule or norm pertaining to the type or amount of evidence that is required to prove or support a conclusion. Standards of evidence play an important role in institutional review board (IRB) decision-making, but they are not mentioned in the federal research regulations. In this article, I examine IRB standards of evidence from a normative, epistemological perspective and argue that IRBs should rely on empirical evidence for making decisions, but that other sources of evidence, such as intuition, emotion, and rational reflection, can also play an important role in decision-making, because IRB decisions involve an ethical component which is not reducible to science. I also argue that an IRB should approve a study only if it has clear and convincing evidence that the study meets all the approval criteria and other relevant, ethical considerations; and that for studies which expose healthy volunteers to significant risks, an IRB should require that evidence be more than clear and convincing as a condition for approval. Additional empirical research is needed on how IRBs use evidence to make decisions and how standards of evidence influence IRB decision-making at the individual and group level.

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“…10 Such variability can be a cause of concern and wasted resources as sponsors and investigators scramble to meet sometimes conflicting requirements from different IRBs. As noted above, some measure of variability is expected, given both the nature of the ethical problems an IRB must resolve and the reality that the IRB is composed of a small number of individuals with different personal experiences 11 ; it is when this variability is arbitrary that it is unjustified. At a minimum, IRBs should be held to a measure of the consistency of their decisions, with the caveat that variability is actually a sign of good decision-making if it is based on difference of fact and if it is well explained.…”

Section: Measures Of Board Decision Qualitymentioning

confidence: 99%

Institutional Review Board Assessment—Balancing Efficiency and Quality

Rosenfeld

2020

TOJ

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Background: Satisfactory measurements of the quality of institutional review board (IRB) reviews and services continue to be elusive. For evaluative purposes, the review process can be separated into two parts: the administrative functions that support the review board and the review board's decisions. Methods: Administrative performance and board decision-making lend themselves to very different measures of quality. In particular, administrative performance is amenable to measures of process efficiency and correctness, while board decisions require a thoughtful consideration of the meaning of quality in the context of the ethical review of research. Discussion: In the evaluation of administrative process, simple numbers such as mean or median time from submission to determination allow for easy comparison between IRBs, but their use means foregoing the opportunity for nuanced assessment and continuous improvement. The full distribution of measured values would indicate whether the IRB takes longer with complex studies or with certain categories of studies. An analysis of outliers would give the IRB an opportunity to assess particularly problematic areas. While such measures and analyses are not easily standardized or shared, they would be useful within the IRB, and one measure of quality would be whether an IRB had procedures in place for routinely conducting such analyses. In the evaluation of decision quality, at a minimum, IRBs should be held to a measure of the consistency of their decisions. Consistency should be used as an internal quality measure. A potential indicator of quality would be the existence of tools and processes for routinely monitoring the consistency of decisions and requiring clear rationale for inconsistencies. Conclusion: Ongoing quality assessment and continuous improvement in decision-making are likely to require committed resources, but such a commitment will be necessary to provide balance to the impetus to improve efficiency and administrative performance.

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Should the Decisions of Institutional Review Boards Be Consistent?

Cited by 32 publications

References 39 publications

Tragic choices in intensive care during the COVID-19 pandemic: on fairness, consistency and community

Tragic choices in intensive care during the COVID-19 pandemic: on fairness, consistency and community

Standards of evidence for institutional review board decision-making

Institutional Review Board Assessment—Balancing Efficiency and Quality

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