What's New at CPMC's IRB
Transition from CPMC IRB to Sutter Health IRB
June 30, 2014
As many of you are aware, the Sutter Health Research Governance Council, under the direction of Senior Vice President for Research & Education, Martin Brotman, MD, adopted a plan in December 2012, to implement a consolidated IRB across the Sutter Health system, which is to replace the separate affiliate IRBs.
Beginning July 26, we will be implementing the first phase of the IRB consolidation by initiating submissions to the Sutter Health IRB (or “SHIRB”) and phasing out the IRBs in the West Bay Region (CPMC) and East Bay Region (Alta Bates Summit). This will involve transitioning ongoing studies from the CPMC and Alta Bates Summit IRBs to SHIRB. Later phases (to take place this fall-winter) will involve consolidating the remaining regional IRBs.
The purpose of this memo is to inform CPMC investigators and research staff of some details of this transition and what you will need to know and do as a result of this change. For further information or any questions, please feel free to contact Angela or David (the administrative leaders of SHIRB):
- Angela Belluomini, JD: BelluoA@sutterhealth.org or 415-600-3686
- David Gill, PhD, CIP: GillD@sutterhealth.org or 510-204-1414
1. Who is on the Sutter Health IRB and how many panels are there?
The roster of the Sutter Health IRB is comprised of current members of the IRBs at CPMC, Alta Bates Summit IRB, Sac/Sierra, and PAMF. We hope to add more members in the near future from other Sutter regions.
SHIRB will have the same structure as the CPMC IRB in that it will have two panels, with each panel meeting once a month. Panel #1 will meet the 2nd Thursday of every month; Panel #2 will meet the 4th Thursday of every month. A detailed schedule of meetings and deadlines will be released soon in a separate communication. In addition, SHIRB will utilize the same electronic submission system (IRBNet) as the CPMC IRB—please see below for more details.
Please click here for Sutter Health IRB meeting dates.
2. When is the final date to submit to the CPMC IRB?
July 25 will be the final date to submit any item (new protocol or submission from ongoing protocol) to the CPMC IRB. Full-board items submitted by July 25 will be reviewed at the CPMC IRB meeting on August 12. Expedited items submitted by July 25 will be reviewed within the normal timeframes, with all reviews under the auspices of the CPMC IRB concluded by August 29.
3. What happens on July 26?
Beginning July 26, all items (both new studies and ongoing protocols) will be submitted to the Sutter Health IRB (SHIRB). You will submit all items, as before, using IRBNet. From a user’s point of view (i.e., yours), your experience of submitting via IRBNet should be substantially the same as before, because we are continuing with the same basic IRBNet system. You will be able to log in using your same username and password. All ongoing studies will be automatically “migrated” over into the SHIRB workspace on IRBNet, so that when you log in on July 26, you will be able to find all your studies in the “My Projects” tab as before.
The submission requirements will remain the same. The primary difference is that the IRB submission forms will be revised—some just a little, some more extensively. Starting July 26, you will need to use these forms. As before, you will be able to find all the forms you need in the “Forms and Templates” library. We are available by phone or email to answer any questions you may have when using the new IRB submission forms.
4. When does SHIRB become the IRB of record for my studies?
Starting on July 26, SHIRB will become the IRB of record for all studies previously under the oversight of the CPMC IRB. As noted above, all ongoing studies will be automatically migrated over to the SHIRB workspace on IRBNet.
However, in order to ensure an orderly transition and make sure that all pre-July 26 submissions (and other business) are wrapped up, we will not officially close the CPMC IRB until August 29. Therefore, during this transition period between July 26 and Aug. 29, the CPMC IRB and SHIRB will (technically speaking) have dual oversight over the studies, with the CPMC IRB staying open just to make sure all old business is wrapped up. On August 30, the CPMC IRB will no longer be an operating IRB, and SHIRB will become the sole Sutter IRB of record for studies previously under oversight of the CPMC IRB.
5. What and when do I need to report to my study sponsor regarding this IRB change?
Different sponsors or funders may have different requirements. We suggest you contact your sponsor as soon as possible to find out what their requirements and timelines are for reporting the transition from
CPMC IRB to SHIRB oversight. For FDA-regulated studies, this will include submission of a revised 1572 and perhaps other sponsor-required documents.
6. For ongoing studies, how should I inform subjects of the change in IRB?
- For study participants already enrolled (whether the study is closed to enrollment or not):
Study participants already enrolled in a study should be informed of the change in IRB. You may do this by providing subjects with an IRB-approved information sheet that explains the change and lists the name and contact information for SHIRB. The information sheet does not need to be signed, but it should be documented in the research files that the subject was provided the sheet. This sheet can be provided either at the next in-person study visit or mailed, but in any event should be done by January 1, 2015.
We will provide you with a pre-approved template to use for the information sheet. If this template is used, it does not need to be submitted again for IRB approval. This template will be available on July 26.
- For studies that are enrolling new subjects:
For new enrollees, the informed consent form will need to be revised so that all references to the CPMC IRB are changed to refer to the Sutter Health IRB (e.g., Subject Bill of Rights, “Questions” section, HIPAA authorization). The deadline for submitting these revisions is October 3, 2014. If you need to submit other revisions to the consent form prior to Oct. 3, please take this opportunity to include the change in IRB as well. (Note: For already enrolled subjects, you may either reconsent them using the revised consent form OR use the information sheet described above. You do not need to do both.)
7. Will my study’s expiration date stay the same?
Yes, expiration dates for existing studies will remain the same, and you will continue to receive alerts of upcoming expirations. A schedule of SHIRB meetings, including submission deadlines, will be available in the next few weeks. Please consult this schedule to determine when you should submit a progress report to ensure review prior to the expiration. In the meantime, if you have any additional questions regarding your specific study, please feel free to contact Angela or David.
8. What will be the schedule of fees charged for IRB review?
The schedule of fees for review of new industry-sponsored studies will be the same as currently charged by the CPMC IRB. Further communication regarding the charge policy in general, including the policy as it applies to new non-industry studies, will be forthcoming in the next couple of weeks.
For ongoing studies that are transferred from an affiliate IRB to SHIRB, the following will apply for the remainder of 2014:
- For studies not currently charged IRB fees: No additional fees will be charged for SHIRB review.
- For studies currently charged IRB fees: Previous fee schedule under affiliate IRB will apply.
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