Marshall University
Huntington, WV

 

SUBJECT:  Central Institutional Review Board/Pediatric Central Institutional Review Board (CIRB/PCIRB)  

 

PURPOSE:  To establish guidelines with regard to the acceptance of the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) and Pediatric Central Institutional Review Board (PCIRB) protocols in accordance with DHHS regulations at 45 CFR 46.114.

 

POLICY:  To establish a system designating the IRB#1 Chairperson or his/her designee to conduct the "facilitated review" of CIRB/PCIRB studies that are submitted.

 

DEFINITIONS:

Central Institutional Review Board (CIRB)

The CIRB initiative is sponsored by the NCI in consultation with the Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP).  NCI's CIRB initiative is designed to help reduce the administrative burden on local IRBs and investigators when they participate in multi-center trials.  Marshall University's Office of Research Integrity (MU ORI) use of the CIRB facilitated review mechanism enables an investigator to enroll subjects into adult, Cooperative Group, Phase 3 clinical trials in a more expeditious manner.

Pediatric CIRB (PCIRB)

The PCIRB reviews all NCI approved Childrens Oncology Group (COG) Phase 2, 3, and Pilot protocols.

 

RESPONSIBILITIES:

 

The following division of responsibilities is based on the Memorandum of Understanding (MOU) to reflect that the CIRB's/PCIRB's primary functions are initial and continuing review of protocols and that MU's primary function is consideration of local context and oversight of local performance for these protocols.  MU, through the IRB#1 Chair or his/her designee, will decide on a protocol-by-protocol basis whether to accept the review of the CIRB/PCIRB or to conduct its own full board review of the protocol.

 

The responsibilities of the CIRB/PCIRB are to:

1. Perform initial reviews of new protocols, discuss any issues with the lead organization and study chair, and make a final decision of approval or disapproval of the protocol;

2. Maintain and make accessible to MU the CIRB/PCIRB application, protocol review, letters to study chairs, approvals and disapprovals, and minutes of the CIRB/PCIRB meetings;

3. Carry out Continuing Reviews, reviews of Serious Adverse Events, reviews of protocol amendments, reviews of Data Safety Monitoring Board (DSMB) reports, and reviews of any other documents submitted by the lead organization or study chair;

4. Notify MU of any new materials that have been reviewed for an active protocol and any changes in the protocol approval status;

5. Maintain an OHRP approved Assurance for human subjects research;

6. Maintain a Board membership that satisfies the requirements of 45 CFR 46 and provide special expertise as needed from Board members or consultants to adequately assess all aspects of each protocol;

7. Make available to MU the roster of CIRB/PCIRB membership and the Standard Operating Procedures and policies;

8. Notify MU immediately if there is ever a suspension or restriction of the CIRB/PCIRB's authorization to review protocols; and

9. Notify MU of any policy decisions or regulatory matters that might affect the institution's reliance on CIRB/PCIRB reviews or performance of the research at MU.

The responsibilities of MU are to:

1. Ensure the safe and appropriate performance of the research at its institution.  This includes, but is not limited to, monitoring protocol compliance, any major protocol violations, and any serious adverse events occurring at the institution, and providing a mechanism by which complaints about the research can be made by local study subjects or others.  Any actions taken as a result of problems that are identified in these areas should be shared with the CIRB/PCIRB and reported as required by the procedures established by the protocol's lead organization;

2. Ensure that the investigators and other staff who are conducting the protocol are appropriately qualified and meet the institution's standards for eligibility to conduct research;

3. Notify the CIRB/PCIRB immediately if there is a suspension or restriction of a local investigator;

4. Provide to the CIRB/PCIRB and keep current the names and addresses of local contact persons who have authority to communicate for the local IRB, such as the local IRB administrator;

5. Establish a procedure by which the MU IRB will receive and review the CIRB/PCIRB materials for protocols to be performed at the local institution.  For each CIRB/PCIRB reviewed protocol (approval or disapproval) that is submitted to the local IRB by a local investigator;

•   Review the CIRB's materials;

•   Determine if there are any local contest issues that must be addressed by the local IRB;

•   Determine if the CIRB review is acceptable to the local IRB;

•   Decide whether to accept the CIRB review or conduct a separate local IRB review;

•   Report to the CIRB the decision about local acceptance/rejection of the CIRB review; and

•   Notify the CIRB if there is ever a change in the acceptance/rejection of the CIRB review.

6. As appropriate, add local restrictions, stipulations, or substitutions to CIRB/PCIRB approved informed consents.  Deletion of CIRB/PCIRB approved requirements in the protocol and Informed Consent Form is not allowed, any substantive changes that affect the meaning of CIRB/PCIRB approved requirements are not allowed;

7. If MU accepts the CIRB/PCIRB approval of a protocol, maintain in their records documentation of the decision and evidence that it has received and considered all CIRB/PCIRB material relevant to the protocol;

8. Maintain an OHRP approved Assurance for human subjects research;

9. Maintain a IRB whose membership satisfies the requirements of 45 CFR 46;

10. Maintain a human subjects protection program, as required by the DHHS OHRP;

11. Ensure that IRB members and investigators receive proper initial and continuing education on the requirements related to human subjects protections;

12. Notify the CIRB/PCIRB immediately if there is ever a suspension or restriction of the IRB's authorization to review protocols; and

13. Maintain compliance with any additional state, local, or institutional requirements related to the protection of human subjects.

 

PROCEDURES:

 

The Office of Human Research Protection (OHRP) Policy and Guidance standards states that when an institution holding a Federal Wide Assurance (FWA) wishes to avoid duplication of effort, in accordance with DHHS regulations at 45 CFR 46.114, by relying upon the IRB review of another Assurance-holding institution:

 

(1)  The review arrangement must be approved in writing by the appropriate officials of the institutions involved.

 

(2)  The institution relying upon another institution's IRB has a responsibility to ensure that the particular characteristics of its local research context are considered through subsequent review by appropriate designated institutional officials, such as the Chairperson or other members of its local IRB.

 

In accordance with this OHRP guidance, the IRB#1 Chairperson or his/her designee will conduct a facilitated review of CIRB/PCIRB studies to determine one of the two following outcomes: 

 

(1)  The study is approved for acceptance under the MU IRB, or

 

(2)  The study is not approved for acceptance and is to be referred to IRB#1 for full board review.

 

The principal investigator submitting the protocol will be notified by ORI as to the outcome of the study.

 

Steps for Protocol Submission:  The studies will be submitted in accordance with the application procedures of IRB#1.  The application will include a copy of the IRB facilitated review packet from the CIRB website.  A cover letter should accompany the application packet stating the desire of the investigator to open the study under CIRB/PCIRB.

 

The IRB#1 Chair or his/her designee will review the informed consent of the protocol for local context which must include:

1. The name of the local institution in which the study will be conducted.

2. Local contact information for the principal investigator for questions about the research study.

3. Contact information for the IRB#1 Chair for questions concerning a subjects rights as a research subject.

Continuing Reviews:  The Continuing Review for CIRB/PCIRB studies will be conducted to correspond with the study expiration date set forth on the CIRB website.  A letter stating the request for a continuing review, along with the new informed consent, will be submitted to ORI prior to the expiration date.  The IRB#1 Chair or his/her designee will conduct the continuing review ensuring the new consent contains local context.

 

Any amendment or change to the protocol that requires a new informed consent must be acted upon immediately.  The new consent should be sent to ORI for review and approval by the IRB#1 Chair or his/her designee.

 

Review Date: November 2006

 

Follow Up Responsibility:  Director, Office of Research Integrity

 

 References:   45 CFR 46.

                        OHRP Policy and Guidance