Measures of Institutional Review Board Quality

DomainMeasureProposed Process or Metric
ProcessesTime to event (eg, review, final determination, approval of final consent version)Standard definition for all event triggers
Ongoing review of outliers
Ongoing review of metric distributions
Complexity score
ComplianceWith recordkeeping requirements
With requirements for minutes
Competencies on roster
Compliance with the 45 CFR ยง46.111 criteria for approval
ConsentInclusion of required elements of consent
Review of the circumstances under which consent is sought
Error ratesStandards for error attribution
Decision-making qualityConsistencyConsistency with past determinations for similar studies or research contexts
Justification for inconsistencies
Membership and meetingsAlignment of meeting participants and reviewers with context of specific studies being reviewed
Appropriate participation of members and consensus seeking
Member surveys or interviews
ConsentUnderstandability, accessibility, and utility of the consent form to actual participants
ReviewAdequacy of minutes to support board decision-making and quality assurance