Operations and Procedures
The IRB shall meet regularly, usually once a month, to review research proposals within its responsibilities and jurisdiction as stated above. The time and place will be determined by the IRB, and the Coordinator will notify the members at least ten days in advance of the next meeting and will supply copies of materials for review and discussion.
Quorum: A quorum of one more than half of the rostered IRB members, including one member whose concerns are primarily non-scientific, is required for each formal IRB action, such as approval of new research projects and renewal of ongoing projects. The minutes of the meeting will always indicate whether a quorum is present, and the minutes will reflect any change in attendance of members during the course of the meeting that would affect quorum.
The minutes of the meetings will include all the information stipulated in 45 CFR 46.115 (a)(2). The minutes will document, among other things:
- Members present and members absent.
- Approval (or correction if necessary) of the minutes of the previous meeting
- Separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB.
- The vote on all IRB actions. To document the continued existence of a quorum, each vote will be recorded in this format; e.g.: Total = 8; for = 7; opposed = 0; abstained = 1.
- The date of expiration of approval on each approved new or renewed protocol.
- The reporting to the Board of expedited review and approval of projects, safety and adverse event reports, addenda and other changes to approved protocols, and other items not requiring full Board discussion and approval.
The Coordinator to the IRB will record and sign the minutes; the Chair of the IRB will approve and sign the minutes, which will then be distributed to the Board members for review and final approval at the next IRB meeting.
Informed Consent: The documentation of understandable information provided to a prospective subject about a research project and of the consent of such subject to participate in the research is essential. The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117. A written consent document that embodies the basic elements of the informed consent, as listed on the CH IRB template, must be adhered to. The informed consent is an element of a project that will be most carefully reviewed by the committee to protect the rights of human subjects. Other essential elements for informed consent are listed in the Appendix along with a standard form approved by The Cone Health IRB, which is also supplied to each PI requesting application forms for a project. OHRP’s document “Tips on Informed Consent” (3/16/93) and “Informed Consent Checklist” (9/30/98) is included in the Appendix. Cone Health IRB will remain in conformity with this guidance.
Before a project is submitted to the IRB for review and approval, a “peer review” must take place to consider the project for its scientific merit, research design and methodology, and applicability to local practice.
For projects originating locally, a group of peers of the Principal Investigator and associate investigators will assemble to review the project and provide feedback about the study. The Office of Research Support does exist and can meet as needed to assist in the development and revision of protocols.
The form provided in the Principal Investigator’s application packet must be completed to indicate appropriate peer review.
The fact that peer review is required prior to IRB submission does not preclude the IRB from evaluating the scientific merit, research design and methodology of the project as it may deem appropriate in its review process.
In the case of multicenter and cooperative research projects with other institutions and research organizations (e.g., national oncology and cardiology studies) which have received scientific review and approval by the National Institutes of Health (NIH), the National Cancer Institute (NCI), or the Food and Drug Administration (FDA); or, in the case of academically based peer review groups (e.g., UNC-Chapel Hill School of Medicine; UNCG School of Nursing) a statement must be provided naming the reviewing agency and the date of the review.
Administrative Advance Approval of Proposed Research: If the research is to be carried out in a unit or division of the Health System, the Unit Manager must be informed in advance in order to determine any potential effect on the Unit’s resources of funds, time or personnel. A form for the Unit Manager’s signature to indicate notification and approval is included in the Application Packet to be used when this situation applies.
Cone Health IRB will assume ultimate responsibility for all Research involving Cone Health Employees and Patients.
Revised March 2013