Policies

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.

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 their 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”).

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to access publicly available information in order to continue collecting information about subjects who have withdrawn their consent for participation or participants who are lost to follow-up.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 provides the procedures around the IRB's placing a study on hold, suspending a study, or terminating a study.

This policy provides the procedures around using a humanitarian use device, the investigator's and IRB’s responsibilities, and considerations for reporting.