LBH IRB Guide #18: Independent CIRB Evaluation and Facilitated Review Page 1 of 4

DEPARTMENT OF RESEARCH

LBH IRB Guide #18: Independent CIRB Evaluation and Facilitated Review Page 1 of 4

Version 2, 07-02-10

Institutional Review Board

Independent Central Institutional Review Board Evaluation and Facilitated Review

Guidelines

LifeBridge Health (LBH) investigators who conduct research must have all research protocols involving human subjects reviewed by the LBH Institutional Review Board (IRB). Local and federal regulations outlined in the Federal-Wide Assurance (FWA) that LBH has with the US Department of Health and Human Services Office for Human Research Protections states that LBH accepts and will follow all requirements outlined in the FWA and is responsible for ensuring that (a) the IRBs designated under the FWA agree to comply with these terms, and (b) the IRBs possess appropriate knowledge of the local research context for all research to which the FWA applies. It also states that any designation under the FWA of the IRB or another institution or organization (such as a central IRB) should be documented by a written agreement between the Institution holding the FWA and the IRB organization. This agreement must outline the relationship and include a commitment that the designated IRB will adhere to the requirements of our LBH FWA (see IRB Guide 21: Federal-Wide Assurance of Protection for Human Subjects).

On a protocol-by-protocol basis, the LBH IRB will consider allowing a Central Institutional Review Board (CIRB) to act as the IRB-of-Record for minimal and moderate risk studies. The CIRB’s primary function would be initial and continuing review of protocols. The local institution’s primary function after its initial review would be limited to the consideration of the local context of the informed consent document and the oversight of local performance for these protocols. The process for initiating LBH IRB facilitated review of CIRB-approved materials and protocol review procedures are outlined below.

A. Request to Recognize CIRB Authority

1. The Principal Investigator (PI) or Research Coordinator (RC) should submit copies* of the following to the Research Office:

a) Cover letter requesting LBH IRB recognition of CIRB review of a research protocol, including an explanation as to why CIRB review is needed and/or preferred.

b) Protocol, investigator brochure and/or package insert.

c) Information concerning the CIRB, including name, location, committee membership (name, expertise, and role), and webpage.

d) Optional: Completed and signed LBH IRB “Application for New Research” form.

*Call the research office for the number of copies needed for any particular submission.

2. The LBH IRB will review the proposed CIRB and study to determine if the former is acceptable and the latter is eligible for the facilitated review process. If the CIRB is approved, the following must be done prior to PI utilization of the approved CIRB:

a) A LBH IRB – CIRB Authorization Agreement must be established between the LBH IRB and the approved CIRB. This form is available on the LifeBridge Health Department of Research website.

b) The approved CIRB must be added to the LBH Federal–Wide Assurance (FWA).

3. After items 2a and 2b above are completed, the approved CIRB legally becomes the IRB-of-Record.

4. If the CIRB is not approved, the PI has two options:

a) Retire the protocol or submit an application for IRB review at a later date.

b) Request simultaneous review of the protocol via submission of the optional “Application for New Research” form.

B. LBH IRB-CIRB Facilitated Review Process for a Single-Protocol Submission to a CIRB

1. After full board approval for CIRB review of a single protocol, the IRB Coordinator will track the protocol status. The IRB-of-Record (i.e., CIRB) will review the initial application, amendments and continuing review applications. All consent forms submitted to the CIRB must be on LBH letterhead and must contain all local IRB-required consent form language. Once amendments and continuing review materials are approved by the CIRB, the PI/RC will submit one copy of the updated documents to the local IRB Coordinator. The LBH IRB Chair, Vice-Chair, or a designated IRB member will review the amendment or continuing review materials and determine if the LBH IRB will continue to accept CIRB review. If accepted, the IRB Coordinator will record and file this action. If the LBH reviewer does not deem an amendment or continuing review acceptable, the materials in question then go to the full board for review.

NOTE: LBH IRB post-approval responsibilities should be viewed as a screening backup to insure no local issues are impacted by the proposed changes. The LBH IRB would notify the investigator if a new unexpected problem arose, and would then initiate the necessary changes to allow the study to go forward from that point.

2. The PI/RC will report adverse events that occur at a LBH facility to the LBH IRB and CIRB per LBH IRB guidelines (see http://www.lifebridgehealth.org/workfiles/irb/irb_guide_3.doc). The IRB Chair, Vice-Chair, or designated IRB member will review adverse events. The CIRB will be notified immediately if a CIRB approved protocol is suspended or terminated locally.

3. The investigator will report personnel or site changes to the LBH IRB and CIRB immediately.

4. Any locally initiated alterations/updates (e.g., advertisement/s, etc.) should be submitted to the LBH IRB and CIRB for review.

C. LBH IRB-CIRB Facilitated Review Process for Multiple-Protocol Submissions to a CIRB

An LBH IRB-CIRB Subcommittee (LICS) will conduct facilitated reviews of CIRB approved protocols concentrating on local context issues. The LICS will decide on a submission-by-submission basis whether to accept the review of the CIRB, or to conduct a full board review of the protocol at the local level. The following are instructions for submitting CIRB-approved documents to the IRB for initial facilitated review:

1. The IRB chair or vice-chair and two IRB members will be charged with reviewing each protocol submission. Individuals with expertise beyond or in addition to that available on the IRB may be invited to assist in the review. Based on this review the IRB chair or vice-chair will determine either that:

a) The CIRB protocol review is acceptable and the CIRB consent form is acceptable with the inclusion of all LBH consent and HIPAA form components (i.e., use of LBH letterhead and LBH boilerplate language), or

b) The CIRB review is not acceptable. If consent modifications are deemed crucial, the chair/vice-chair will document the rationale for the decision to initiate the standard LBH IRB review process. The PI/RC will be notified that their CIRB application will undergo a full board review by the LBH IRB, and that the application should be submitted in time for the next appropriate IRB meeting following standard LBH IRB submission guidelines.

2. The LBH IRB Coordinator will report the decision about local acceptance/rejection of the CIRB review to the PI.

3. If accepted, the CIRB becomes the IRB-of-Record for this submission. This means that the local IRB no longer will perform amendment reviews, non-local SAE reviews, or continuing (ongoing) reviews for this protocol (see B above). Once the initial review is completed, the PI/RC needs only to provide the local IRB with 1) documentation of continuing review by the CIRB 2) annual and cumulative report of activity at LifeBridge Health, and 3) the consent forms, which will be stamped for continued use. An exception to this concerns amendments or any other actions requiring changes to the consent form. In this case, the IRB chair or vice-chair will determine whether review of the proposed changes can be expedited or require full facilitated review.

NOTE: Notification of LBH IRB review results will be communicated in the conventional manner. The LBH Research Office will maintain a hard copy file of the protocol, including subsequent reviews and other CIRB documentation.

NOTE: All initial protocols regardless of the designated IRB-of-Record must be submitted for LBH Administrative Review Board (ARB) review prior to initiation of any research study.

LBH IRB Guide #18: Independent CIRB Evaluation and Facilitated Review Page 1 of 4

Version 2, 07-02-10