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
NCI CIRB Operations Office LPE CIRB EPE CIRB Peds CIRB CPC CIRB
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
Introducing National Cancer Institute s Cancer Prevention and Control Central IRB
Study Chair/ Research Base Cancer Prevention and Control CIRB NCORP: Local and MU Sites
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
Cancer Prevention and Control CIRB: We re filling our seats!
CPC Board Composition Chair 1 Physicians 5 Nurse 2 Pharmacist 1 Statistician 1 Ethicist 1 Patient Advocates 2
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
Study Chair/ Research Base Cancer Prevention and Control CIRB NCORP: Local and MU Sites
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
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!
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
Working on the details
Study Chair/ Research Base Cancer Prevention and Control CIRB NCORP: Local and MU Sites
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)
Enrolling in the NCI CIRB Everyone is in a different place with enrollment Every institution is different Best Tip: Read the instructions
CIRB Operations Office HELPDESK 1-888-657-3711 (M-F, 8-4) ncicirbcontact@emmes.com
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
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
Open your studies Submit Worksheet to CIRB: Receive approval Incorporate CIRBapproved boilerplate consent language Open study: REPEAT
CIRB Website www.ncicirb.org Instructions and forms SOPs Boards Members Schedules FAQs Link to the HelpDesk
Consistent, high-quality expert review Decreased administrative burden for opening/maintaining trials Makes your life a bit easier
We re listening
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
Conducting research with human participants is a privilege granted by willing volunteers