This document supplements the DUHS Emergency Preparedness Plan and the Duke University School of Medicine Emergency Preparedness Supplement by addressing considerations specific to human subjects research and IRB oversight.
This policy describes the ongoing training of IRB office staff, chairs, and members, including monthly IRB board training, and evaluation of ongoing training needs
This policy outlines the institutional oversight of human subject research, and the authority, jurisdiction and independence of the DUHS IRB.
This policy describes the circumstances in which the DUHS IRB may choose to serve as a central IRB on a multi-site study, or serve as the IRB-of-Record for an external (non-Duke) site. Additionally the policy outlines the responsibilities of the relying site, and the responsibilities of the Duke study team involved in a multi-site study, when the DUHS IRB is acting as the central IRB for the multi-site study.
Once a study has closed, no further activity can take place. Occasionally, however, there may be a request for study data after a study has closed. Because the Common Rule requires that use of identifiable private information for research occur either with an IRB-approved protocol in place or with an IRB exemption of the research, the DUHS IRB has a mechanism available to allow for the re-opening of a closed study, under limited circumstances.
This policy details and differentiates the alternatives available to members of the Duke community when compensating individuals for participation in a research study. It also details the advantages and disadvantages of each alternative, and provides relevant contact information.
The policy describes who may serve as Principal Investigator (PI) on studies submitted to the Duke Health IRB.
This policy concerns male research subjects’ partners who become pregnant while the male subject is involved in a research study using an investigational drug. The policy details considerations for when a sponsor is asking investigators to collect data on pregnancies that occur in partners of male subjects.
The Duke University Health System (DUHS) Institutional Review Board (IRB) has determined that all females who are of child-bearing potential being considered for participation in a research study, in which there is a possibility of harm to a fetus from the study interventions, must have a negative pregnancy test before undergoing any study-related activities with a potential risk to a fetus. This policy describes Duke requirements for pregnancy testing regimens used in research studies. Additionally, the policy presents a definition for the term "child-bearing potential".
The link below provides information on tissue/specimens that may be excluded from routine submission to surgical pathology: navigate to the DUMC Surgical Pathology website and then scroll down to find "Duke Operative Specimen Exemption".