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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 Institution 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 NCI adult and pediatric 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. 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 (firstname.lastname@example.org). OHSR staff will obtain the local context issues that must be addressed, which could include but are not limited to CCOI review, CRRC review or IBC review.
3. JHM IRB Continuing Annual Renewal and Amendment Approvals:
JHM IRB will not review continuing annual renewals or amendments for CIRB studies. Signature of the Principal Investigator (PI) or designee is acceptable to acknowledge these actions. The OHSR is aware that the CIRB will perform these reviews on their behalf, and continues to use the CIRB as the IRB of record for adult and pediatric CIRB studies.
4. 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 OHSR staff will immediately notify the CIRB if a CIRB approved protocol is suspended or terminated locally.
5. 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 have amended the relevant FWAs to delegate review authority to CIRB.
6. Local Contacts:
The OHSR provided to NCI the name and address of the local contact who has the authority to communicate for the JHM IRBs.
The OHSR contact is:
Judith Carrithers, J.D.
Assistant Dean for Human Research Protection
Director, Human Research Protection Program
1620 McElderry Street
Reed Hall, Suite B-130
Baltimore, MD 21205-1911