Policies

The policy describes how the IRB confirms and documents the presence of an IND for research involving the use of drugs or biologics (other than the use of a FDA approved, marketed drug/biologic in the course of medical practice). IND exemption criteria are outlined.

This policy explains the retention of IRB records and other documents.

This policy describes how the IRB, CRU, and other HRPP review committees assess the scientific or scholarly validity of a research protocol.

This policy provides definitions for significant risk (SR) device and non-significant risk (NSR) device, and discusses major differences between SR and NSR device studies.  The policy explains IRB responsibilities and Investigator/Sponsor responsibilities in making a risk determination for a device study.

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.

The policy discusses state of North Carolina law terms and principles applicable to human subjects research, including:  legally authorized representative, child, and guardian.

The policy describes requirements related to the informed consent process in research involving participants who speaks a language other than English. The policy discusses translation requirements, documents needed for IRB review, and use of the short and long form consents.

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.

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.

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).