Policies

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 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 document outlines the DUHS IRB procedure for preparing and processing the modifications (“mods”) necessary before a protocol can receive IRB approval.

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.

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.

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.

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 explains the retention of IRB records and other documents.