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.

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.

The purpose of this policy is to establish the criteria and procedures under which Duke University Health System (DUHS) may rely on an external Institutional Review Board (IRB), for the ethical review and approval of human subjects research.

Special considerations apply to all research involving human subjects supported or conducted by the U.S. Department of Education. These considerations are in addition to those found in 45 CFR 46 Subparts A-D.

Special considerations apply to research involving human subjects supported by a DoD component through a contract, grant, cooperative agreement, or other arrangement.  This policy describes additional requirements for research funded by a DoD component.

The Duke University Health System Institutional Review Board (DUHS IRB) has determined that all females and males of reproductive potential being considered for participation in a research study where a possibility of harm to a fetus exists must practice appropriate contraceptive measures before undergoing any study-related activities that might harm a developing fetus. Appropriate contraceptive measures must be maintained until all known risks to the fetus have ended.

The purpose of this policy is to establish clear institutional standards for compensating individuals who participate in IRB-approved research conducted under the auspices of the Duke University Health System (DUHS) Institutional Review Board (IRB).

The Duke University Health System (DUHS) Institutional Review Board (IRB) interprets responsibility for the costs of treatment for a study-related injury as a risk of study participation, and the potential subject must be fully apprised of this risk before making an informed decision on study participation (45 CFR 46.116(a)(2) and if applicable, 21 CFR 50.25(a)(2)).  The IRB, ORC, and the study team must work together to ensure that the wording in the IRB-approved consent form is consistent with the relevant wording in the fully executed research contract with the sponsor.

The Principal Investigator and/or IRB must determine if it is appropriate to obtain a Certificate of Confidentiality for a study.  The Certificate of Confidentiality is an additional protection for the privacy of subjects and confidentiality of their data in sensitive research.  The policy discusses parameters to consider when deciding whether to obtain a Certificate of Confidentiality.

As a general rule, investigators must not draw more blood from any research subject than is needed to answer the research question, and should design the research to minimize that volume. This policy covers blood drawing limits for protocols reviewed using the expedited procedure, and the convened board procedure.  Also, the policy discusses exceptions to blood drawing limits.