IRB Reviewer Checklists | Duke Health Institutional Review Board

Adults Unable to Consent: Checklist for Research Involving Adults Unable to Consent

Checklist for Research Involving Adults Unable to Consent

Checklist on Adequate Provisions for Soliciting the Permission of Parents or Guardians and Checklist on Adequate Provisions for Soliciting the Assent of Children (for IRB Reviewer)

Checklist on Adequate Provisions for Soliciting the Permission of Parents or Guardians and Checklist on Adequate Provisions for Soliciting the Assent of Children

Children: Checklist for Review of Research Involving Children

DoD Supported Research Checklist

Checklist for research funded by the Department of Defense (DoD)

Expedited Review Checklist

Humanitarian Use Device Checklist

Checklist for Use of a Humanitarian Use Device

IDE Checklist

The IDE Checklist should be used to determine if an IDE is needed.

The IVD Regulatory Assessment Guide should be used to help determine when an In Vitro Diagnostic Device is subject to 21 CFR 812, the FDA's IDE regulations.

IND Checklist

Checklist to determine if an IND is needed.

Neonates: Checklist for Research Involving Neonates of UnCertain Viability, Placenta, Dead Fetus, or Fetal Material

Pregnant Women: Checklist for Research Involving Pregnant Women or Fetuses

Prisoners: Checklist for Research Involving Prisoners