Policies

Current policies related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. View the complete list of policies.The policies are below, and you can search for policies in the following categories:

External Research by Duke Faculty or Staff

Conduct of Research

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.

External Research by Duke Trainees

Conduct of Research

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.

External Use of Duke Data by Former Students & Employees

Conduct of Research

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”).

Finder Organizations & Subjects Lost to Follow-Up or Withdrawn

Conduct of Research

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to access publicly available information in order to continue collecting information about subjects who have withdrawn their consent for participation or participants who are lost to follow-up.

Gadolinium Contrast Agents

Conduct of Research

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.

HIPAA as it Relates to Research

Conduct of Research

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.

HIPAA Exemption

Conduct of Research

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.

Humanitarian Use Devices

Drugs, Devices, & Biologics

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

In Vitro Diagnostic Devices

Drugs, Devices, & Biologics

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.