Initiating the Review: The Principal Investigator (PI) will make application for review and approval of proposed research projects using the IRB's standard forms and including the research protocol and informed consent document. These will be received by the IRB Coordinator and will be given preliminary review by the IRB Chair.
Types of Review: The investigator, the Chair of the IRB, or the IRB itself may request or decide that a project should receive one of the following types of review:
- Exempt from IRB Review. The Chair of the IRB may determine that a project which is of no or very low risk to subjects and which meets Federal criteria for exemption (Appendix) is exempt from review by the IRB. The Chair will announce such exemption at the next IRB meeting.
- Expedited Review. For certain minimal risk projects the IRB Chair (or an experienced IRB member designated by the Chair) may review the project and approve it as "expedited review and approval." If not approved through expedited review, the project will be referred for full Board review. A project may not be disapproved by expedited review. In any case, the Chair will announce the expedited review at the next IRB meeting for assent by the Board. To qualify for expedited review an activity must (1) involve no more than minimal risk and be found on the list published by OHRP contained in the Appendix, or (2) be a minor change in previously approved research during the period of 1 year or less for which approval is authorized by the IRB.
- Full IRB Review. Projects which do not qualify as Exempt or for Expedited Review will be reviewed by the full Board as outlined below in the “Final Consideration by the IRB” section.
- Reciprocal Review. Projects carried out in cooperation with another institution and for which the local PI (or Co-Principal Investigator in instances with dual PIs) is a Cone Health staff member assigned here by the other institution; i.e., the PI (or Co-PI) has dual institutional affiliation (e.g., University of North Carolina Medical School Faculty assigned to the medical teaching programs at Moses Cone), and which project has been approved by the cooperating institution's IRB, may be approved by reciprocal review by the Cone Health IRB Chair. This action will be presented by the Chair at the next IRB meeting for approval by the full IRB. As with Expedited Review, the Chair may determine that the project must have full Board review, but the Chair may not disapprove such a project because such action can only be taken by the full IRB.
Final Consideration by the IRB: The Chair will determine the number of projects that can be reasonably considered at the next meeting (usually four or five full reviews) and the Coordinator will then supply the documents to IRB members prior to the meeting at which discussion is scheduled. The PI of the project will be invited to be present as a consultant for the discussion of a new protocol to provide explanation and answer questions. (If necessary, the PI may send a designee who is equally knowledgeable about the proposed project as a representative to the meeting.)
After open discussion and upon motion and second a vote will be cast on approval of the project; a majority vote of members present in quorum is required for approval. Any IRB member who has an interest or possible conflict of interest in a project must abstain from voting. The vote and any abstention will be recorded in the minutes. In some cases in accordance with certain research organizations' regulations [e.g., Cancer and Leukemia Group B (CALGB)], the PI and associates must be absent for the IRB's final deliberations and vote on approval of a protocol. Such will also be recorded in the minutes.
From time to time when the burden of IRB business is great, the Chair may appoint sub-committees of no less than three members to review projects submitted and then to make recommendation to the full committee. However, in no case will projects be approved without vote of the full IRB.
Types of Action: After the review of a project the IRB may vote to take one of the following actions:
- Approval. The investigator(s) may then begin the project according to plan. The Clerk will complete any forms and provide notification of agencies as required for the project. Documentation will be signed by the Chair.
- Approval contingent upon required changes. The PI will submit the required changes to the protocol to the Chair of the IRB for final documentation of approval.
- Disapproval. The investigator(s) may not initiate the project. The PI may revise the project and resubmit it to the IRB for reconsideration for approval.
- Table consideration of project. The IRB may postpone action pending obtaining further information about the project, or pending alterations to the project recommended by the IRB.
In all cases the minutes of the IRB meeting will record all actions taken, and copies of protocols, documentation of action, and other documents will be kept on file.
Term of Approval: Approval of a project is usually for one year after which time renewal of approval is required if the project is to be continued. Depending on complexity and risk associated with a project, the IRB may require renewal at intervals more frequent than annually. The Coordinator will notify the PI in advance of the time for a renewal request so that progress reports and updates on the project can be supplied to the IRB. Renewal requests will be reviewed and voted on by the full Board. If the renewal request is not submitted by the PI in time for the Board to approve the renewal, the research project must be interrupted as of the expiration date and may not be resumed until approved by the full Board.
Chart Review Approval: Approval of a chart review is usually granted an expedited or exempt approval. If a principal investigator is seeking an approval of a chart review, the Application for Research Requesting an IRB Waiver of Consent and HIPAA Authorization along with other supporting documents, must be completed and submitted to the IRB office. Research for which this form is appropriate generally involves only existing patient records or specimens. If there will be any intervention or interaction (e.g. questionnaires, interviews, randomization), or any direct contact of any kind with the subjects of this research, consent/authorization will need to be obtained, and a full IRB application will be required.