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:
Scientific Validity of a Research Protocol
This policy describes how the IRB, CRU, and other HRPP review committees assess the scientific or scholarly validity of a research protocol.
Specialty Committee Review Forms
The Duke University Health System Institutional Review Board (DUHS IRB) works in coordination with other University Committees and external review resources to protect the safety and welfare of research participants. This policy describes the different specialty committees, and explains the investigator's responsibilities relating to specialty committee reviews.
Subject Problems, Complaints, Concerns and Questions
This policy defines the process by which problems, complaints, concerns, suggestions, or comments from research participants or research personnel are received, reviewed and processed in the Duke University Health System (DUHS) Institutional Review Board (IRB) Office.
Undue Influence Upon the IRB
It is the policy of the DUHS IRB that IRB review activities, and the implementation of DUHS IRB policies and procedures, are to be conducted objectively and without undue influence over deliberations or processes.
Verification of Studies
Investigators are expected to provide the IRB with all relevant information regarding the conduct of the research. In order to ensure that the research is conducted in compliance with all federal and state regulations for the protection of human subjects, the IRB may require verification of information from sources other than the investigator. This policy describes when such independent verification may be needed.
Waiver for a Single Person
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).