12-18-07 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 NCI Central IRB Process training 12-18-07.ppt

NCI Central IRB Process training 12-18-07.ppt Background What is NCI CIRB? 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 12-18-07.ppt

Submitting to NCI CIRB versus UCSF IRB (CHR) 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 IRB UCSF application, supplements, consent forms Group protocol, sample consent form NCI Central IRB Process training 12-18-07.ppt

How to open a CIRB study at UCSF First: UCSF Investigator and study contact register with CIRB through UCSF HRPP (http://www.research.ucsf.edu/chr/Inst/ContactformNCICIRB.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 12-18-07.ppt

How to open a CIRB study at UCSF (cont’d) 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 12-18-07.ppt

NCI Central IRB Process training 12-18-07.ppt

NCI Central IRB Process training 12-18-07.ppt

How To Open a CIRB study at UCSF (cont’d) Then: 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 12-18-07.ppt

Summary of HRPP ‘facilitated review’ process 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 NCI Central IRB Process training 12-18-07.ppt

How to keep a CIRB study open at UCSF For Modification and Renewal submissions 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 12-18-07.ppt

How To Keep a CIRB study open at UCSF (cont’d) 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). 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) Renewals, in addition to Intent to Rely and UCSF-versions of consent and recruitment docs: 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 12-18-07.ppt

How to keep a CIRB study open at UCSF (cont’d) Notes 1: 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 12-18-07.ppt

How to keep a CIRB study open at UCSF (cont’d) Notes 2: 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 12-18-07.ppt

How to keep a CIRB study open at UCSF (cont’d) 12-18-07 How to keep a CIRB study open at UCSF (cont’d) Post-approval event reporting http://www.research.ucsf.edu/chr/Apply/Post-Approval_Reporting.pdf PI is responsible for keeping up with amendments, expirations, and renewals through CIRB NCI Central IRB Process training 12-18-07.ppt

What’s New with CIRB at UCSF 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 12-18-07.ppt

What’s New - transfer studies 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 12-18-07.ppt

What’s New - Update to Local Context Informed Consent Form 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 12-18-07.ppt

What’s New - Updates to UCSF CIRB Notice of Intent form New section about local recruitment process New section about local informed consent process NCI Central IRB Process training 12-18-07.ppt

NCI Central IRB Process training 12-18-07.ppt Resource Contact Information UCSF CIRB submission general questions: Joanne Mickalian, Assessment Team, HRPP 415-476-1744 Joanne.Mickalian@ucsf.edu UCSF CIRB submission post-approval monitoring questions: Maria Bahn, Quality Improvement Unit, HRPP 415-514-3823 Maria.Bahn@ucsf.edu NCI Central IRB Process training 12-18-07.ppt

NCI Central IRB Process training 12-18-07.ppt

NCI Central IRB Process training 12-18-07.ppt Resource Web Links: UCSF HRPP Information about Participating in CIRB studies: 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 Other Information about CIRB: 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