VCOM Institutional Policy and Procedure Manual

5.

DEFINITIONS Keywords as defined by ICH E6

Cooperative Group: Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe which work with NCI to identify important questions in cancer research and to design clinical trials. Groups differ in structure and research focus but share a common purpose---to develop and conduct large-scale trials in multi-institutional settings. Facilitated Review: A unique review process used by local IRBs enrolled in the CIRB Initiative, when they wish to accept the CIRB’s review of a Cooperative Group study. PROCEDURE 1. The IRB Coordinator will complete the NCI CIRB Enrollment Form, signing and submitting two Authorization Agreements. 2. The IRB Coordinator will modify the FederalWide Assurance (FWA) to include the CIRB, which so designates the CIRB to the review of research under this assurance. 3. The IRB Coordinator will provide designated correspondent on behalf of the VCOM IRB, to the CIRB Operations Office. 4. The IRB Coordinator will confirm participation annually in the CIRB Initiative via receipt of email notice from CIRB Enrollment Specialist. 5. The IRB Coordinator will receive PI request for review of a given CIRB approved study. 6. The IRB Coordinator will confirm CIRB approval by downloading the facilitated review packet from the CIRB website which is to include the following: a. CIRB approved application. b. Protocol. c. Informed Consent. d. Serious Adverse Event (SAE) reports. e. Amendments. f. Primary reviewer reviews. g. Outcome letters and other pertinent correspondence. h. Minutes. i. Other documents relevant to a given protocol. 7. The IRB Coordinator will take the facilitated review packet and the PI’s local Informed Consent document(s) to the IRB Chair Person or designated IRB member for review. 8. The IRB Chair Person or designated reviewer will review the documents in consideration of local context issues: a. The informed consent document will be CIRB specific and be in compliance with local and state law, institutional requirements, and VCOM IRB policy. b. Any minor changes/additions to the informed consent document will not alter the meaning of CIRB approved content. If more than minor changes are proposed, facilitated review may not be used but will require full IRB review at the local level. c. The PI will make available local contact phone numbers for study participants, on the informed consent. d. Informed consent translations, used for inclusion of local populations, are true translations. e. The authority of legal guardian(s) as delineated in 45 CFR 46.404 – 46.409 (defining permission of one or both parents) to consent for the legally incompetent or assent for minors is determined by local institutional policy and state law. 6.