NCI s Cancer Prevention and Control Institutional Review Board
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1 National Cancer Institute U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health NCI s Cancer Prevention and Control Institutional Review Board Wake Forest NCORP Research Based Annual Meeting Linda Parreco, RN, MS October 17, 2014
2 NCI CIRB Operations Office LPE CIRB EPE CIRB Peds CIRB CPC CIRB
3 History of NCI CIRB Initiative 1997 NCI Clinical Trial Program Review Group: eliminate duplicative IRB reviews of multisite trials 1999 NCI Facilitated Review model Central IRB 2001 Phase 3 Adult Treatment Trials Board launched 2004 Pediatric Phase 2-3 cancer treatment & cancer control Board launched 2013 Adult Early Phase Emphasis Board Independent Model AAHRPP Accreditation Legacy CCOP Participation
4 Introducing National Cancer Institute s Cancer Prevention and Control Central IRB
5 Study Chair/ Research Base Cancer Prevention and Control CIRB NCORP: Local and MU Sites
6 1 st Perspective Operations & Boards Government staff and roles CIRB Operations Office 9/1/14: Contract to EMMES Corporation Support all CIRB Operations Boards: staff and manage Institutions: enrollment and support IT infrastructure, website, HelpDesk AAHRPP accreditation support
7 Cancer Prevention and Control CIRB: We re filling our seats!
8 CPC Board Composition Chair 1 Physicians 5 Nurse 2 Pharmacist 1 Statistician 1 Ethicist 1 Patient Advocates 2
9 WHEN? January, 2015 Tell me more! Full board convenes monthly via web-enhanced conference call WHAT? DCP Studies: cancer prevention and control NCORP Early Phase Prevention Consortia Initial review of new protocols; amendments, CR CCDR: future discussions regarding feasibility Legacy CCOP studies continue with local IRBs
10 Study Chair/ Research Base Cancer Prevention and Control CIRB NCORP: Local and MU Sites
11 2 nd Perspective: Study Chair and Research Base Research Base scientific review process: No Change DCP review process: No Change CIRB: reviews approval on hold version submitted by Study Chair/RB Final approval by DCP Distribution
12 2 nd Perspective: Study Chair and Research Base Submission deadlines: 2 weeks before scheduled CIRB meeting Dates are posted on the CIRB website TIP: pay attention to the dates!
13 2 nd Perspective: Study Chair and Research Base CIRB Operations Office: Schedules review; assigns reviewers Notifies SC/RB of date and time for review May send questions to SC before review Joins SC/RB/DCP in review meeting
14
15 Working on the details
16 Study Chair/ Research Base Cancer Prevention and Control CIRB NCORP: Local and MU Sites
17 3 rd Perspective: NCORP Local and MU Sites Enroll in the CIRB Open CIRB-approved studies Cancer treatment (NCTCN) Pediatric treatment and cancer control (COG) Cancer prevention and control (DCP)
18 Enrolling in the NCI CIRB Everyone is in a different place with enrollment Every institution is different Best Tip: Read the instructions
19 CIRB Operations Office HELPDESK (M-F, 8-4)
20 Tricky Terminology NCORP Grantee/Primary Institution Component Sub-Component If the grant-funded arrangement and the CIRB arrangement are the same, it is merely a coincidence Laura Covington CIRB Signatory Institution Component Affiliate
21 NCORP Enrollment Stats Total NCORP Orgs: 806 # Enrolled 543 (67%) # Not Enrolled 263 # In Process 84 (10%) # Not Started 179 (23%) Enrolled In Process Not Started
22 Open your studies Submit Worksheet to CIRB: Receive approval Incorporate CIRBapproved boilerplate consent language Open study: REPEAT
23 CIRB Website Instructions and forms SOPs Boards Members Schedules FAQs Link to the HelpDesk
24 Consistent, high-quality expert review Decreased administrative burden for opening/maintaining trials Makes your life a bit easier
25 We re listening
26 Many hands make light work NCI CIRB Initiative Jeff Abrams, Meg Mooney Sharon Hampp, Jaci Goldberg DCP Leadership & Operations Groups Lori Minasian Worta McCaskill-Stevens Leslie Ford Eva Szabo Amanda Brown Troy Budd Gary Della Zanna Marge Good Brandy Heckman- Stoddard Karl Krueger Lisa Rooney Anne Ryan Judy Smith Anne Tompkins Cynthia Whitman Margaret Wojtowicz
27 Conducting research with human participants is a privilege granted by willing volunteers
28
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