Special considerations apply to all research involving human subjects supported or conducted by the U.S. Department of Education. These considerations are in addition to those found in 45 CFR 46 Subparts A-D.
This policy describes broader recruitment methods allowable for research protocols, and the IRB’s role in reviewing and considering the appropriateness of the recruitment methods in regard to the target population and the research objectives.
It is the policy of the Duke University Health System IRB (DUHS IRB) that qualified human subject research be reviewed using the expedited procedure in accordance with federal regulations. An expedited procedure refers to review of research involving human subjects by the IRB Chair, Vice Chair or qualified IRB member designee in accordance with 45 CFR 46.110 and 21 CFR 56.110. This policy defines this expedited process.
This policy defines an active research study and outlines the notification procedures for IRB expiration. The policy also discusses lapses in IRB approval.
Duke University Health System (DUHS) may rely on an external IRB, meaning the IRB of another institution or organization, or an independent (commercial) IRB, for review and approval of human research if such reliance benefits DUHS, its investigators, and/or its research participants. Examples of when such reliance may be considered include: research in which DUHS as an institution has a conflicting interest; multi-site research in which DUHS employees are involved in minimal risk study activities only; Phase II, III or IV multi-site, industry-initiated, industry-sponsored research; and federally sponsored research for which a federally sponsored central IRB is duly constituted, or for federally sponsored research requiring the use of a central IRB. This policy outlines requirements for Duke investigators when using an external IRB as the IRB-of-record for a study.
When a Duke faculty member or staff member, whether on sabbatical or not, proposes to do human subject research at a site other than within DUHS, but in connection with his or her Duke responsibilities, the conduct of the research must meet all applicable federal regulations governing the protection of human research subjects and this policy.
When a Duke trainee proposes to do human subject research at a site other than within DUHS, the conduct of the research must meet all federal regulations that govern the protection of human research subjects. This policy applies to Duke students, residents and fellows who do research involving human subjects while away from DUHS as a part of their training program. It also applies to DUSOM faculty members not on sabbatical or leave who do such research while away from DUHS.
The purpose of this policy is to define the conditions under which former Duke faculty/employees, former Duke students, or external personnel conducting research at Duke, whether through appropriate written agreements or in fulfillment of academic requirements, may continue to have access to research data/samples generated or obtained by these individuals during their tenure at Duke (collectively, “Materials”). These Materials are owned solely by Duke University and may not be taken or accessed by these individuals without completion of the applicable requirements described in this policy and approval provided by the Department Chair, Division Chief, CRU Director, or their authorized designee. All appropriate transfer agreements must be finalized before transfer of the Materials. The needs of current and potential research at Duke must always be considered before Materials are removed from Duke.
This policy, developed in coordination with the Duke University Health System Office of Counsel, addresses the use of private, “finder” organizations to access publicly available information in order to continue collecting information about subjects who have withdrawn their consent for participation or subjects who are lost to follow-up.
A rare but serious adverse reaction has been observed in patients who received gadolinium (Gd) based contrast agents during MRI examinations, a reaction called nephrogenic systemic fibrosis (NSF). Patients with kidney disease are at increased risk of developing NSF. NSF may cause skin thickening, joint pain and/or swelling. In rare cases NSF can lead to lung and heart problems and cause death. Because of this potentially serious risk to some research participants, the Duke University Health System Institutional Review Board (DUHS IRB) requires additional safeguards when the use of gadolinium based contrast agents in research is planned.