JHM IRB CIRB Facilitated Review Procedures

January 2011

The JHUSOM joined the National Cancer Institute Central IRB (NCI CIRB) initiative in September 2004 and joined the NCI Pediatric CIRB initiative in November 2004.  As a participant, the Institutions amended the FWAs on file with OHRP to include CIRB as a designated review board for collaborative oncology projects.  The process for initiating facilitated JHM IRB review of CIRB approved protocols is outlined below.

1.  SKCCC CRO Review:      The Sidney Kimmel Comprehensive Cancer Center Clinical Research Office (CRO) will review all new CIRB studies in which Hopkins’ faculty plan to participate. After CRO review, the CIRB materials will be provided to the Office of Human Subjects Research (OHSR) to initiate facilitated IRB review. 

2.  Local Contacts:      The OHSR provided to NCI the names and addresses of the local contact people who have the authority to communicate for the JHM IRBs.

The OHSR contacts are: 

Judith Carrithers, J.D. (Primary contact)
Director, OHSR
1620 McElderry Street
Reed Hall, Suite B-130
Baltimore, MD  21205-1911
Phone: 443-287-0204
FAX: 410-955-4367; email: jcarrit1@jhmi.edu

Barbara Starklauf, MAS  (Secondary contact)
Assistant Dean for Human Subjects Research Compliance
1620 McElderry Street
Reed Hall, Suite B-130
Baltimore, MD  21205-1911
Phone:  410-955-1875
FAX:  410-955-4367;  email:  bstark@jhmi.edu

3.   JHM IRB Initial Review Procedure: 

After CRO approves the study, the CRO staff will email the complete CIRB application materials, the JHM CIRB Checklist and the HIPAA Consent Form Addendum to the OHSR (jhmirb@jhmi.edu). OHSR staff will obtain the local context issues that must be addressed, which could include CCOI review, CRRC review or IBC review.

• OHSR staff will assign the CIRB study to IRB 1, IRB 2, IRB 3 or IRB 5 for review.
• The Chair or co-Chair of the assigned IRB will review the CIRB study. If the study does not include drug administration, a single reviewer is sufficient. If the study includes drug administration, the P&T member of the assigned IRB will review the drug related issues.  Based on these reviews, the outcome recorded may be:
  • CIRB review is acceptable and the consent form is acceptable, or  
  • CIRB review is not acceptable.
• The JHM IRB may not modify any of the approved language in the CIRB consent document.  If consent modifications are required, the CIRB review will not be accepted and the rationale for this decision will be documented on the review form. 
• OHSR will notify the CRO about local acceptance/rejection of the CIRB review.  If accepted, OHSR will issue an approval memo and a stamped HIPAA Consent Form Addendum for the study.  The stamped HIPAA Consent Form Addendum must be attached to each consent form.
• OHSR staff will report the decision about local acceptance/rejection of the CIRB review to CIRB using the Electronic Protocol Acceptance Form.

4.    OHSR Acknowledgment of Amendments and Continuing Reviews.  Amendments and continuing review applications are reviewed by the NCI CIRB.  Once amendments and continuing review materials are approved by the CIRB, the CRO will submit the approved documents to the OHSR.  The OHSR will acknowledge the submission by return email to the CRO.  JHM IRB facilitated review of amendments and continuing review applications is not required; they will only be acknowledged.  

5.  Adverse Events.    Adverse events that occur locally at a Hopkins’ facility will be reported by the investigator to the CRO for transmission to the JHM IRB and the CIRB.  Adverse events will be reviewed by the Chair and P&T member of the JHM IRB of record for the study. The CIRB will be notified immediately if a CIRB approved protocol is suspended or terminated locally.  

6.   Additional Requirements.  The Institutions will maintain an OHRP approved assurance for human subjects research. The Institutions will maintain JHM IRBs whose membership satisfies the requirements of 45 CFR 46.

• The Institutions will maintain a human subjects protection program as required by DHHS OHRP.
• The Institutions will ensure that IRB members and investigators receive proper initial and continuing education.
• The facilitated IRB review process will assure that CIRB approved protocols maintain compliance with additional state, local or institutional requirements related to human subjects.
• The Institutions have amended the relevant FWAs to delegate review authority to CIRB.