NCI CIRB General Updates Erin Odor, IRB Protocol Analyst II Susan - - PowerPoint PPT Presentation
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
Erin Odor, IRB Protocol Analyst II Susan Ebert, Program Director for IRB Operations Office of Responsible Research Practices December 13, 2017
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Session Objectives
boilerplate language
implementation
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language inserted into a CIRB- approved model consent form
Worksheet about Local Context
revised more frequently if needed
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Three ways to access approved boilerplate language
1. Email from ORRP distributed upon approval
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
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Integrating boilerplate language – new CIRB study
Download model consent from CTSU Follow instructions to insert boilerplate language
Upload with initial submission in Buck-IRB
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Integrating boilerplate language – existing study
New boilerplate language approved
Sponsor requires amendment
time of next amendment
Update boilerplate language in ICF
boilerplate language is current
Re-consent if required
approval letter
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No changes may be made to the model consent form beyond approved boilerplate language
Recent examples:
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9 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
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Specific Worksheet
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Receive sponsor docs Prep submission
CSRC boilerplate language
Submit in Buck-IRB
ORRP review
COI/CITI Annual PI Worksheet HSRC review* Privacy Board review*
Authorization to cede Complete Study-Specific Worksheet Approve Study-Specific Worksheet Open study at Ohio State
OSU study team ORRP NCI CIRB * If applicable
Ohio State Institutional Review Process
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Must receive authorization from ORRP before submitting to CIRB
ORRP review
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After a study is opened, who reviews study requests/changes?
Ohio State review
investigators or key personnel
State research locations
HIPAA authorization requests/changes CIRB review only
amendment requests
reports, protocol deviations, & unanticipated problems
notifications Ohio State review first, then CIRB*
investigator
radiation information
* Requires Ohio State authorization to proceed before submitting to CIRB Office of Responsible Research Practices
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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.
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A: No. Sponsors will be responsible for ensuring model consent forms meet the new CoC requirements for NIH-funded studies.
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https://ncicirb.org/institutions/institution-quickguides
http://orrp.osu.edu/irb/osuirbpolicies/nci-central-irb/
Erin’s info: odor.3@osu.edu, 614-688-1332
ncicirbcontact@emmes.com
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Session Take-aways
update with next amendment
before submitting Study-Specific Worksheet
approval letter
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