Use of Checklists
While members are not required to fill out these checklists, they should be familiar with the information in these checklists and be referred to when reviewing studies. These checklists will assist in the review IRB process to help assure that the federal and local requirements for IRB review and approval are met.
Individual researchers may also wish to review these checklists so that they understand what the requirements are for IRB approval.
List of Checklists
The following is a list of checklists available for the IRB members to use as tools for the IRB reviews. These may be used both for individual member preparation of the review as well as at the convened meetings. Laminates of all but the staff screening checklists listed below will be available at the convened IRB meetings.
- Criteria Required by Federal Regulations for IRB Approval of a Human Research Study
- Criteria Required by Federal Regulation to Approve Informed Consent
- Checklist – Criteria for IRB Approval of Research
- UCLA IRB Committee Actions (Review Outcomes)
- Summary Table on Subpart D, 45 CFR 46 and 21 CFR 50: Additional DHHS Protections for Children Involved as Subjects in Research; Additional Safeguards for Children in Clinical Investigations (FDA)
- Summary Table of Subpart B, 45 CFR 46: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- Right to Try Reviewer Checklist
- Non-compliance Checklist
- Post-Approval Reports Checklist: Chair/Designee Review
- Post-Approval Reports Checklist: Board Review