Policies

This policy applies to all research involving human participants that is reviewed by the Duke University Health System (DUHS) Institutional Review Board (IRB). The requirements described in this policy also apply to any study conducted by a Duke investigator that has external IRB oversight.  The purpose of this policy is to define the research-related activities that are permissible under DUHS policies and applicable federal regulations prior to IRB approval, and then also during the period between IRB approval and institutional approval.

This policy defines when the research consent form should be filed within the participant's medical record and when it should not be placed there.

Planned emergency research is research conducted in emergency settings with participants who cannot provide informed consent because of their life-threatening medical conditions and who do not have an available legally authorized representative. The participant or the participant’s legally authorized representative must be informed about the clinical trial as soon as possible and provide consent if the participant wishes to continue.

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".

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.

The policy provides definitions and outlines what conditions must be met before the IRB can approve research involving pregnant women, fetuses, and neonates of uncertain viability.

The policy describes who may serve as Principal Investigator (PI) on studies submitted to the Duke Health IRB.

The policy provides the regulatory definition for a prisoner and outlines additional safeguards and conditions for conducting research involving prisoners.  The policy also discusses what to do if a research subject becomes a prisoner while they are enrolled in a study.

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

This policy describes the key differences between Quality Improvement (QI) activities in health care versus research involving human subjects.  The end of the policy also contains a Quality Improvement vs. Research Checklist, to aid investigators who are trying to determine whether an activity falls in the realm of QI or research involving human subjects.