Policies

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.

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 describes the conflict of interest (COI) rules for DUHS IRB members and consultants.

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.

This document provides the procedures for IRB continuing review of a research study as well as possible IRB actions upon review.

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.