Article Figures & Data
Tables
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 §46.111 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
In this issue
Jump to section
Cited By...
- No citing articles found.