Transcript NCI Central IRB Process

National Cancer Institute (NCI) Central
Institutional Review Board (CIRB)
Research Studies
UCSF HRPP Submission Process Overview
Tuesday, December 18,
2007
10 am – 11:15 am
Regents Room, Laurel Heights
Campus
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NCI Central IRB Process training
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Background
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What is NCI CIRB?
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Central Institutional Review Board
For use by NCI-sponsored cooperative research
groups
CIRB review replaces review by local IRB (CHR is
UCSF’s IRB)
Local “Facilitated Review” still required
Both IRBs review adverse events
NCI Central IRB Process training
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Submitting to NCI CIRB versus UCSF
IRB (CHR)
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NCI CIRB:
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UCSF IRB
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Documents from CIRB form core of application
UCSF local forms: Notice of Intent to Rely on the
NCI CIRB and
Consent form with UCSF-required additions
UCSF application, supplements, consent forms
Group protocol, sample consent form
NCI Central IRB Process training
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How to open a CIRB study at UCSF
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First:
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UCSF Investigator and study contact register
with CIRB through UCSF HRPP
(http://www.research.ucsf.edu/chr/Inst/Contac
tformNCICIRB.doc)
UCSF investigator notifies UCSF Cancer
Center Protocol Review Committee in
advance of any intentions to rely on the NCI
CIRB
NCI Central IRB Process training
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How to open a CIRB study at UCSF
(cont’d)
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Second:
 If UCSF Radiation Safety and/or Biosafety
Approvals are needed, these approvals must
be in place before local subjects can be
enrolled
 Key Personnel must complete the UCSF
online Human Subjects Protection Training at
https://www.researchonline.ucsf.edu/.
 Download Facilitated Review packet from NCI
CIRB website
NCI Central IRB Process training
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NCI Central IRB Process training
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How To Open a CIRB study at UCSF
(cont’d)
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Then:
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CIRB submission packet – 5 sets:
 “Notice of Intent to Rely” form
 “Local context” consent form
 “Facilitated Review” packet downloaded from
NCI website
NCI Central IRB Process training
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Summary of HRPP ‘facilitated review’
process
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New and Transfer studies
 PI and contact registration with CIRB
 Notice of Intent etc. submission to CHR
 UCSF facilitated review
– Protocol/PI registration with CIRB
– UCSF facilitated review approval letter
Ongoing studies (renewals and modifications)
 Renewed/modified Notice of Intent etc. submission to
CHR
 UCSF facilitated review
– UCSF facilitated review approval letter
NCI Central IRB Process training
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How to keep a CIRB study open at
UCSF
For Modification and Renewal submissions
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Submit “Notice of Intent to Rely” form with either
‘modification’ or ‘renewal’ checked
Submit NCI CIRB Approved consent and
recruitment documents with UCSF-specific
changes incorporated.
NCI Central IRB Process training
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How To Keep a CIRB study open at
UCSF (cont’d)
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Modifications, in addition to Intent to Rely and
UCSF-versions of consent and recruitment docs:
 For CIRB modifications/amendments,
download the current amendment documents
(including the CIRB approval letter for the
amendment).
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For UCSF-only local context change to consent
forms and/or study contacts, prepare a cover letter
describing the changes, and submit along with the
“Notice of Intent to Rely” form, and revised consent
form, with ‘modification’ checked. If a consent form
change is related to an Adverse Event report, also
submit the report for reference.
NCI Central IRB Process training
12-18-07.ppt
How To Keep a CIRB study open at
UCSF (cont’d)
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Renewals, in addition to Intent to Rely and UCSFversions of consent and recruitment docs:
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For CIRB renewals, download the current
continuing review documents (Correspondence
/ CIRB Continuing Review Approval letter,
Protocol , Informed Consent, Support
Documents – e.g. DMC report or study
summary).
NCI Central IRB Process training
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How to keep a CIRB study open at
UCSF (cont’d)
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Notes 1:
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For renewal and modifications including protocol
amendments, submit only the track changes
version of the protocol and consent form (i.e. not
both track change and final copy)
Check the CIRB facilitated review packet to be
sure the most recent CIRB approval letter is
included.
NCI Central IRB Process training
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How to keep a CIRB study open at
UCSF (cont’d)
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Notes 2:
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If a renewal or modification is ‘pending’ with CIRB
at the time the UCSF investigator wishes to join
the study, wait for CIRB approval of the pending
item before submitting the application to the CHR
Work with the CHR staff to register/change
investigators and study contacts on CIRB studies
NCI Central IRB Process training
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How to keep a CIRB study open at
UCSF (cont’d)
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Post-approval event reporting
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http://www.research.ucsf.edu/chr/Apply/PostApproval_Reporting.pdf
PI is responsible for keeping up with
amendments, expirations, and renewals
through CIRB
NCI Central IRB Process training
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What’s New with CIRB at UCSF
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Transfer Studies
Updates to local context information for
consent forms (cost information)
Updates to UCSF CIRB “Notice of Intent”
form
NCI Central IRB Process training
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What’s New - transfer studies
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Existing studies eligible for transfer must have current
CHR approval with no reviews pending (e.g. no
continuing reviews, modifications, local adverse events
or protocol violations under CHR review) at the time of
transfer request submission.
Investigators will be asked to complete a “CHR Study
Close-out Report” for the existing, CHR-approved study
in addition to a new CIRB application packet to CHR
The CHR office will process the closeout report,
conduct a facilitated review of the CIRB application
packet, and if acceptable, register the study with CIRB.
NCI Central IRB Process training
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What’s New - Update to Local Context
Informed Consent Form
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Cost information – template language:
– You and/or your health plan/insurance company will need to pay
for some or all of the costs of treating your cancer in this study.
Some health plans will not pay these costs for taking part in
studies. Check with your health plan/insurance company to find
out what they will pay for. Taking part in this study may or may not
cost you or your insurance company more than the cost of getting
regular cancer treatment. [If applicable, inform the patient of any
tests, procedures or drugs for which there is no charge. Also
clearly state if there are charges resulting from administration of
the test or drug that will be billed to the patient and/or health plan.
For example, “The NCI [or other study sponsor] is supplying [drug]
at no cost to you. However, you or your health plan may need to
pay for costs of the supplies and personnel who give you the
[drug]."] [Include the following sentence if appropriate: If, during
the study, [study drug] becomes approved for use in your cancer,
you and/or your health plan may have to pay for the drug needed
to complete this study.]
NCI Central IRB Process training
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What’s New - Updates to UCSF CIRB
Notice of Intent form
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New section about local recruitment process
New section about local informed consent
process
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Resource Contact Information
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UCSF CIRB submission general questions:
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UCSF CIRB submission post-approval monitoring questions:
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Joanne Mickalian, Assessment Team, HRPP
415-476-1744
[email protected]
Maria Bahn, Quality Improvement Unit, HRPP
415-514-3823
[email protected]
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NCI Central IRB Process training
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Resource Web Links:
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UCSF HRPP Information about Participating in CIRB studies:
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Other Information about CIRB:
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Guidance about CIRB studies
http://www.research.ucsf.edu/chr/Inst/chrInst_NCICIRB.asp
Investigator and Study Coordinator registration form
http://www.research.ucsf.edu/chr/Inst/ContactformNCICIRB.doc
Checklist for making consent form ‘local context changes’
http://www.research.ucsf.edu/chr/Inst/CFChecklistNCI.pdf
UCSF application form for CIRB studies
http://www.research.ucsf.edu/chr/Inst/NoticeRelyCIRB.doc
NCI CIRB website http://www.ncicirb.org/CIRB_Login.asp
Federal Guidance on ‘local context’ issues
http://www.hhs.gov/ohrp/humansubjects/guidance/local.htm
NCI Central IRB Process training
12-18-07.ppt