Policies

Current policies related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. View the complete list of policies.The policies are below, and you can search for policies in the following categories:

Waiver for a Single Person

Review by the IRB

This policy details the process for an investigator's request for a waiver of selected inclusion/exclusion criteria for a single person (request to enroll an ineligible person).

Waivers or Alteration of Consent & HIPAA Authorization

Consent

This policy defines when the IRB can approve a waiver of informed consent and HIPAA authorization.  The policy also outlines the requirements for a waiver of documentation of consent, thus waiving the requirement for the investigator to obtain a signed and dated consent form for some or all participants.