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.

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.

This policy describes the investigator’s responsibility to explain their plans for compensation of research participants, and the DUHS IRB’s policy for reviewing and approving proposals for such compensation.  The policy also discusses restrictions placed on investigators and key personnel regarding payment to them for conducting the research.

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.

This policy discusses the process for seeking an autopsy authorization from a study participant when an autopsy is proposed as part of a research study.  While pre-death autopsy permission may be obtained during the informed consent process of a research study, the DUHS IRB, in accordance with North Carolina law, requires post-death confirmation of the permission from the research participant’s legally authorized representative.