The policy describes what content can and cannot appear in study advertisements, flyers, and internet postings. The IRB must review the information contained in all advertisements and the mode of their communication.
This document defines the different types of amendments and procedures for IRB review and approval. The policy also discusses when participants must be notified or reconsented, the Investigator's responsibilities, and the IRB's responsibilities.
This policy describes the requirements for a study team member to conduct the consent process in a research study over which the DUHS Institutional Review Board (IRB) serves as the IRB-of-Record. The requirements described in this policy also apply to any study conducted by a Duke investigator that has external IRB oversight.
This document describes how the DUHS IRB assesses the adequacy of a study's data and safety monitoring plan. Also, this policy provides considerations for when a Data Safety Monitoring Board (DSMB) may be required for a study.
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.
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 describes when case reports must be submitted to the IRB for review. If you plan to present or publish a single case report, or a case series of multiple case reports, please read this policy.
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.
The policy describes additional requirements for the review of research involving minors who are Wards of the State. A “Ward” or “Ward of the State” shall mean a minor (under 18 years of age) who is under the legal custody of a state or a subdivision of the State (e.g., a minor placed in foster care in accordance with applicable state law).
This policy describes additional responsibilities assigned to the IRB and to the investigator under DHHS regulations (45 CFR 46 Subpart D) and FDA regulations (21 CFR 50 Subpart D), as applicable. These regulations protect children who are the subjects of 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.
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.