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 |