Measures of Institutional Review Board Quality
| Domain | Measure | Proposed Process or Metric |
|---|---|---|
| Processes | Time 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 | ||
| Compliance | With recordkeeping requirements | |
| With requirements for minutes | ||
| Competencies on roster | ||
| Compliance with the 45 CFR ยง46.111 criteria for approval | ||
| Consent | Inclusion of required elements of consent | |
| Review of the circumstances under which consent is sought | ||
| Error rates | Standards for error attribution | |
| Decision-making quality | Consistency | Consistency with past determinations for similar studies or research contexts |
| Justification for inconsistencies | ||
| Membership and meetings | Alignment of meeting participants and reviewers with context of specific studies being reviewed | |
| Appropriate participation of members and consensus seeking | ||
| Member surveys or interviews | ||
| Consent | Understandability, accessibility, and utility of the consent form to actual participants | |
| Review | Adequacy of minutes to support board decision-making and quality assurance |