COTTAGE HEALTH SYSTEM POLICY

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SUBJECT:

Research Conducted in Collaboration with the NCI CIRB Initiative

Cooperative Research

 

DEPT: IRB POLICY #: 8012.25

 

GOAL:  

To establish written guidelines regarding Cottage Health System Institutional Review Board's functions related to the review of local research conducted in agreement with the National Cancer Institute's Central IRB program.

 

POLICY:  

The Cottage Health System Institutional Review Board has formally established a collaborative effort with the Cancer Center of Santa Barbara and the National Cancer Institute Central IRB regarding the ongoing review and oversight of cooperative group oncology studies for both pediatrics and adults.

 

PROCEDURE:

In agreement with the Cancer Center of Santa Barbara (CCSB) and the National Cancer Institute's Central IRB (NCI CIRB) program, Cottage Health System IRB (CHS IRB) has accepted the terms outlined by the NCI CIRB in order to facilitate local review of pediatric and adult cooperative group-affiliated oncology research.

 

Approval Process

The NCI CIRB conducts formal reviews and approves pediatric and adult oncology research.  Only Phase II and III research is currently eligible.  Once a study has been approved by the NCI CIRB, the protocol and all other study-related documents are posted to their website.

 

The designated CCSB study coordinator will download and print all relevant information, including a copy of the minutes from the meeting at which the particular study was reviewed.  The application is then submitted to the CHS IRB.

 

As per the NCI CIRB definition of functions, the CHS IRB review is conducted by expedited review by the IRB Chair or another IRB member specifically appointed by the Chair.  The IRB Chair reviews the packet to ensure that the CIRB has met the standards set forth in 45 CFR 46 and to determine if there are additional local human subjects concerns, which must be addressed if the protocol is to open at CCSB.  A full board review is not required at the local level.

 

  • If the IRB Chair accepts the CIRB review, the CIRB becomes the IRB of record for that study and performs all required reviews of the protocol, including amendments, serious adverse events, and continuing reviews.
  • If the CHS IRB chooses not to accept the CIRB review, it may still choose to conduct its own review and retain full responsibility for the study, thus allowing the investigator to open the study in the standard way per the CHS IRB's IRB Review of Research policy (see policy 8012.06).
  • If the IRB accepts the CIRB review, but has questions or modifications, these requests are returned to the investigator, similar to procedures used for other IRB-reviewed studies.  The study coordinator submits these suggestions to the NCI CIRB for review and approval.  Once the changes have been made and approved by the CIRB, the CHS IRB provides local approval of the study.

Continuation and Oversight of the Study

The NCI CIRB sends a monthly email to participating sites listing changes that have occurred in active CIRB studies (i.e. amendments, continuing reviews, etc.).  The study coordinator will review the NCI CIRB emails to determine if any changes have occurred to local studies that have been opened through CIRB.  If so, the study coordinator will notify the IRB Administrator of the changes.  The changes will be reviewed by the IRB Administrator and the IRB Chair.  If no additional explanations are required, the CHS IRB will accept the submission as provided.

 

The CHS IRB will also review on-site adverse events and will be responsible for the local conduct of the study.  As such, the CHS IRB will conduct audits and provide compliance oversight.  In addition to any educational activities performed by CHS IRB, CCSB will assure the existence of an effective Human Research Protection Program as required for all FWA-holding institutions.

 

At the time of closure for a study opened under this procedure, the CCSB study coordinator will submit, in writing, notification of closure and assurance that no active subjects are remaining in the study.  The CHS IRB will generate a closure letter for the investigator and file the information in the study file.  The file will be closed and retained for six years.  After six years it will be purged, following investigator notification.

 

The CHS IRB currently has no limit on the number of studies it will support through the NCI CIRB program.  Nor will IRB fees be charged for studies opened under this agreement.  However, these issues will be re-evaluated as needed and may change at any time

5/11

 

COTTAGE HEALTH SYSTEM POLICY

RECOMMENDED BY: Leilani Price DATE: 2/05

ORIGINAL POLICY EFFECTIVE DATE: 8/05

APPROVED BY: 5/30/02 DATE: ..

DATE REVISED: 3/06, 5/11
DATE REVIEWED: 4/06, 1/08, 1/09