Thalidomide, Lenalidomide, or Their Analogs

Conduct of Research

The Duke University Health System Institutional Review Board (DUHS IRB) adopted this policy for the review of research that involves the administration of thalidomide, lenalidomide, or analogs thereof, to human subjects.

Reliance by External Sites on the DUHS IRB

Conduct of Research

This policy describes the circumstances in which the DUHS IRB may choose to serve as a central IRB on a multi-site study, or serve as the IRB-of-Record for an external (non-Duke) site.  Additionally the policy outlines the responsibilities of the relying site, and the responsibilities of the Duke study team involved in a multi-site study, when the DUHS IRB is acting as the central IRB for the multi-site study.

Re-opening a Closed Study

Conduct of Research

Once a study has closed, no further activity can take place. Occasionally, however, there may be a request for study data after a study has closed. Because the Common Rule requires that use of identifiable private information for research occur either with an IRB-approved protocol in place or with an IRB exemption of the research, the DUHS IRB has a mechanism available to allow for the re-opening of a closed study, under limited circumstances.

Processing Payments to Participants

Conduct of Research

This policy details and differentiates the alternatives available to members of the Duke community when compensating individuals for participation in a research study. It also details the advantages and disadvantages of each alternative, and provides relevant contact information.

Policy on the Duke Financial Services Web Site

Pregnant Partners of Research Subjects

Conduct of Research

This policy concerns male research subjects’ partners who become pregnant while the male subject is involved in a research study using an investigational drug.  The policy details considerations for when a sponsor is asking investigators to collect data on pregnancies that occur in partners of male subjects.

Pregnancy Testing

Conduct of Research

The Duke University Health System (DUHS) Institutional Review Board (IRB) has determined that all females who are of child-bearing potential being considered for participation in a research study, in which there is a possibility of harm to a fetus from the study interventions, must have a negative pregnancy test before undergoing any study-related activities with a potential risk to a fetus.  This policy describes Duke requirements for pregnancy testing regimens used in research studies.  Additionally, the policy presents a definition for the term "child-bearing potential".

Pathology Tissue/Specimen Exclusions

Conduct of Research

The link below provides information on tissue/specimens that may be excluded from routine submission to surgical pathology: navigate to the DUMC Surgical Pathology website and then scroll down to find "Duke Operative Specimen Exemption".

Multiple Site Research

Conduct of Research

This policy describes what the IRB requires when: 1) a DUHS Investigator conducts research external to Duke, 2) a DUHS Investigator is Principal Investigator of a multi-site research project, 3) a DUHS Investigator oversees an operations or coordinating center for multi-site research, 4) a DUHS Investigator oversees a statistical center for multi-site research.  The policy also discusses IRB reliance agreements.

Local Physician Participation

Conduct of Research

This policy outlines what the IRB requires when a research participant's local physician will be asked to conduct limited, specific, study-directed activities at a site external to Duke.  Such activities, limited in scope and approved by the DUHS IRB, might include the planned periodic administration of a study drug, or conducting study-directed follow up evaluations.