This policy is meant to serve as guidance for the conduct of convened meetings of the Duke University Health System (DUHS) Institutional Review Board.
This policy discusses the various methods and processes for obtaining and documenting informed consent, including use of the short form consent. The policy also presents a listing of the basic elements of consent, as specified in federal regulations.
The policy describes the IRB's authority to observe or monitor the consent process, and discusses the kinds of research for which such monitoring may be especially appropriate.
As set forth in 45 CFR 46.107(f) and 21 CFR 56.107(f), the IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. This document describes the process for use of a consultant by the DUHS IRB.
When a protocol is approved during initial or continuing review, either with no modifications or with minor modifications to secure approval, the decision includes the period for which IRB approval is to be granted. This approval period must be for one year or less, if the study is subject to FDA regulation, or if the study involves more than minimal risk; and the approval period must be appropriate to the degree of risk (45 CFR 46.109, 21 CFR 56.108 and 21 CFR 56.109). This policy explains this process.
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 discusses several reproductive risk considerations in research: contraception, breastfeeding, fertility, and unintended pregnancy.
This policy describes corrective actions (conflict of interest management plans for Duke faculty and staff) required by the DUSOM Conflict of Interest (COI) Committee or by the Duke Office of Scientific Integrity-Conflict of Interest (DOSI-COI). The policy discusses how the DUHS IRB and DOSI-COI work together to see that corrective actions are implemented as required, in the setting of research involving human subjects.
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.