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).

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.

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.

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 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.

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

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

This policy describes research for which review by the DUHS Human Research Protection Program (HRPP) is required.  It provides key definitions such as "research", "human subject", "intervention", "interaction", "private information", "identifiable information" and "clinical investigation".  This policy is also where you can find information on the criteria for exemption from IRB review.

This policy describes the key differences between Quality Improvement (QI) activities in health care versus research involving human subjects.  The end of the policy also contains a Quality Improvement vs. Research Checklist, to aid investigators who are trying to determine whether an activity falls in the realm of QI or research involving human subjects.

Planned emergency research is research conducted in emergency settings with participants who cannot provide informed consent because of their life-threatening medical conditions and who do not have an available legally authorized representative. The participant or the participant’s legally authorized representative must be informed about the clinical trial as soon as possible and provide consent if the participant wishes to continue.