Policies

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.

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.

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.

This policy describes the events that require prompt reporting to the IRB, and sets out timelines for reporting.  The policy offers many examples of problems or events requiring prompt reporting to the IRB.

This policy outlines the limited circumstances under which Duke undergraduate students (work-study, unpaid, or engaged in research for class credit) may conduct the informed consent process, as part of studies submitted to the DUHS IRB.  The policy discusses the training required before undergraduates may conduct the consent process, and the oversight required for these students.

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).