IRB Researcher's Checklist

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.

• Criteria required by FDA for IRB Approval of Human Research study
• Criteria required by Federal Regulation to Approve Informed Consent
• Criteria for IRB Approval of Research (nonmedical) - checklist
• Requirements for IRB Review and Approval for Biomedical research – checklist
• LU IRB Committee Actions (Review Outcomes)
• Categories of Research that May be Reviewed through an Expedited Review Procedure, 45 CFR 46.110
• 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 Investigation (FDA)
• Summary Table of Subpart B, 45 CFR 46: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research