NCI CIRB General Updates Erin Odor, IRB Protocol Analyst II Susan Ebert, Program Director for IRB Operations Office of Responsible Research Practices December 13, 2017
Office of Responsible Research Practices Session Objectives • Define NCI CIRB boilerplate language • Discuss boilerplate implementation • Review CIRB submission procedures • Answer frequently asked questions 2
CIRB Boilerplate language: Definitions & Implementation 3
Office of Responsible Research Practices What is CIRB boilerplate language? • Institution’s standard template language inserted into a CIRB- approved model consent form • Available in English and Spanish versions • Submitted by ORRP via NCI CIRB Annual Institutional Worksheet about Local Context • Reviewed for updates at least annually but can be revised more frequently if needed 4
Office of Responsible Research Practices Finding current boilerplate language Three ways to access approved boilerplate language 1. Email from ORRP distributed upon approval of Annual Institutional Worksheet 2. ORRP NCI Central IRB webpage http://orrp.osu.edu/irb/osuirbpolicies/nci-central-irb/ 3. IRBManager: Approval letter for Annual Institutional Worksheet https://ncicirb.org/institutions/institution-quickguides/irbmanagerbasics/findingapprovalletters 5
Office of Responsible Research Practices Integrating boilerplate language – new CIRB study Download model consent from CTSU Follow instructions to insert boilerplate language - “Insert” vs. “replace” - Highlighted text is instructional & is not boilerplate Upload with initial submission in Buck-IRB 6
Office of Responsible Research Practices Integrating boilerplate language – existing study New boilerplate • ORRP notifies study teams language approved Sponsor requires • Boilerplate language updated at amendment time of next amendment Update boilerplate • Always double check that boilerplate language is current language in ICF Re-consent if • Noted on CIRB required approval letter 7
Office of Responsible Research Practices Remember… No changes may be made to the model consent form beyond approved boilerplate language Recent examples: • Adding local PI/sponsor to first page • Inserting PI contact info into unapproved sections 8
Example of non-boilerplate language addition CIRB-approved Ohio State boilerplate language Neither CIRB-approved Ohio State boilerplate language nor CIRB-approved model consent form language 9
Office of Responsible Research Practices PI contact info changes (model ICF) • Not boilerplate language • Contact info may be updated at any time • Do not upload with revised Study- Specific Worksheet 10
Office of Responsible Research Practices Submission reminders 11
Office of Responsible Research Practices Prep Receive Submit in submission Ohio State Institutional sponsor docs Buck-IRB CSRC boilerplate language Review Process ORRP Complete review Authorization Study-Specific to cede COI/CITI Worksheet Annual PI Worksheet HSRC review* Privacy Board review* Approve Open study at Study-Specific Ohio State Worksheet 12 OSU study team ORRP NCI CIRB * If applicable
Office of Responsible Research Practices Authorization to Cede Must receive authorization from ORRP before submitting to CIRB • Open a new study • PI change • Amendments requiring ORRP review 13
Office of Responsible Research Practices After a study is opened, who reviews study requests/changes? Ohio State review Ohio State review CIRB review only only first, then CIRB* • Add/remove co- • Change of principal • All other investigators or key investigator amendment personnel requests • Changes to • Add/remove Ohio- radiation • Adverse event State research information reports, protocol locations deviations, & unanticipated • Partial waiver of problems HIPAA authorization • Continuing reviews requests/changes • Study closure notifications 14 * Requires Ohio State authorization to proceed before submitting to CIRB
Office of Responsible Research Practices FAQs 15
Office of Responsible Research Practices Q: How do I know when an amendment requires re-consent? A: CIRB’s amendment Outcome Letter (available in CTSU) will note re-consent requirements. Occasionally, a Study Chair may indicate re-consent is required when the amendment is distributed, but CIRB does not require re-consent. The Study Chair’s direction takes precedence. 16
Office of Responsible Research Practices Q: Will Ohio State boilerplate language include Certificate of Confidentiality information? A: No. Sponsors will be responsible for ensuring model consent forms meet the new CoC requirements for NIH-funded studies. 17
Office of Responsible Research Practices Q: Where can I find assistance? • NCI CIRB Quick Guides https://ncicirb.org/institutions/institution-quickguides • ORRP Central IRB page http://orrp.osu.edu/irb/osuirbpolicies/nci-central-irb/ • Contact ORRP directly Erin’s info: odor.3@osu.edu, 614-688-1332 • NCI CIRB Helpdesk ncicirbcontact@emmes.com 18
Office of Responsible Research Practices Session Take-aways • Insert boilerplate language as is • Revised boilerplate language: update with next amendment • Wait for ORRP to send authorization before submitting Study-Specific Worksheet • Amendments: re-consent guidance on CIRB approval letter 19
Office of Responsible Research Practices 20
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