For Board Reviewers
INSPIR II
Templates Available:
- IRB Reviewers’ Template for New Applications. [Word]
- IRB Reviewers’ Template for Amendments. [Word]
- IRB Reviewers’ Template for Renewals/Continuing Reviews. [Word]
Board Education:
- IRB Board Member Introduction to INSPIR. [PDF]
- Session #1– IRB Review Criterion #1 [45 CFR 46.111(a)(1)] – minimizing risks. [PDF]
- Session #2– IRB Review Criterion #2 [45 CFR 46.111(a)(2)] – risk/benefit relationship. [PDF]
- Session #3– IRB Review Criterion #3 [45 CFR 46.111(a)(3)] – equitable subject selection. [PDF]
- Session #4– IRB Review Criterion #4 [45 CFR 46.111(a)(4)] – informed consent process. [PDF]
- Session #5– IRB Review Criterion #5 [45 CFR 46.111(a)(5)] – informed consent documentation. [PDF]
- Session #6– Waiver of Consent and Waiver of Documentation of Consent. [PDF]
- Session #7– Criteria For Approval: 45 CFR 46.111, 21 CFR 56.111. [PDF]
- Session #8– Criteria For Approval: 45 CFR 46.111, 25 CFR 56.111. [PDF]