Policies

The policy defines in vitro diagnostic (IVD) device, and describes FDA Guidance stating FDA will exercise enforcement discretion with respect to its current regulations governing the requirement for informed consent when human specimens, not individually identifiable, are used for FDA regulated in vitro diagnostic device investigations.

This policy describes the role and scope of authority of the Institutional Official (IO) for the Duke University Health System (DUHS) Human Research Protection Program (HRPP).

This policy outlines the institutional oversight of human subject research, and the authority, jurisdiction and independence of the DUHS IRB.

The policy describes how the DUHS IRB relies upon and works cooperatively with the Office of Audit, Risk and Compliance (OARC) to investigate complaints, allegations of non-compliance, and allegations of misconduct in human subject research.

This policy provides requirements for conducting or participating in international research. Investigators must be aware of and follow the additional requirements that accompany such research, including those of the country in which the research is being conducted, applicable US regulation, and applicable Duke policy.

The policy describes additional responsibilities belonging to DUHS Investigators who carry the dual roles of Investigator and Sponsor.  If an Investigator in a proposed research project is also the IND/IDE holder and/or is otherwise subject to FDA regulations related to duties as a sponsor/investigator, then additional institutional requirements and responsibilities to FDA apply.

In the course of conducting research with humans, a member of the DUHS research community, such as an investigator, study coordinator, member of the investigator’s key personnel, or a colleague may have concerns or suggestions related to the DUHS human research protection program. These concerns and suggestions are welcomed by the HRPP leaders and staff since they provide a focused opportunity for improvement in the quality of our HRPP.  This policy describes how investigators may bring forth concerns.

The policy explains the absence of a formal IRB stamp on the consent form.  The iRIS-generated footer on the bottom of each page of the consent form serves as the IRB approval stamp or watermark.

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.  This policy also provides the definition of "Key Personnel" on a research study. Furthermore, this policy provides guidance on who should be added as outside key personnel.

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.