This document describes the process by which the Duke University Health System (DUHS) Institutional Review Board (IRB) confirms the qualifications for employees of DUHS to conduct research involving human subjects. Also, this policy provides the definition of "Key Personnel" on a research study.
The Duke University Health System Institutional Review Board (DUHS IRB) may, as needed, request an opinion or clarification from the Office of University Counsel for issues pertaining to research involving human subjects. This policy discusses the process for doing so.
This policy outlines what the IRB requires when a research participant's local physician will be asked to conduct limited, specific, study-directed activities at a site external to Duke. Such activities, limited in scope and approved by the DUHS IRB, might include the planned periodic administration of a study drug, or conducting study-directed follow up evaluations.
The policy describes mandatory State of North Carolina reporting requirements. A physician or other health professional must report certain conditions/circumstances/diseases to State and local agencies whether they are found in the course of non-research clinical care or as part of a research protocol. This policy relates to research-related findings that present themselves during the conduct of a protocol and must be reported outside of the institution.
This policy describes characteristics of the DUHS IRB membership, and processes for voting. Also, the policy provides a definition for quorum in convened IRB meetings.
This policy serves as guidance for the preparation, recording and finalization of minutes for convened meetings of the Duke University Health System Institutional Review Board (DUHS IRB).
This policy describes what the IRB requires when: 1) a DUHS Investigator conducts research external to Duke, 2) a DUHS Investigator is Principal Investigator of a multi-site research project, 3) a DUHS Investigator oversees an operations or coordinating center for multi-site research, 4) a DUHS Investigator oversees a statistical center for multi-site research. The policy also discusses IRB reliance agreements.
The purpose of this policy is to describe the processes by which new IRB members are identified, nominated, trained, and added as members to the IRB and all members are evaluated.
The policy defines non-compliance (serious or continuing) and gives examples. The policy describes how the IRB handles allegations of non-compliance, the process for review, and actions available to the convened IRB.
The policy describes requirements related to the informed consent process in research involving non-English-speaking subjects. The policy discusses translation requirements, and use of the long form consent and short form consent for non-English-speaking subjects.