Policies

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”).

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to access publicly available information in order to continue collecting information about subjects who have withdrawn their consent for participation or participants who are lost to follow-up.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.

This policy defines the implementation of the Privacy Rule as it applies to clinical research at Duke.  The policy defines the term "protected health information" (PHI) and discusses the eighteen HIPAA identifiers.

The purpose of this policy is to define the procedure for determining if a research activity is subject to or exempt from the Privacy Rule.

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.

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.

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.