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.
- OHSR staff will assign the CIRB study to IRB 1, IRB 2, IRB 3, IRB 5 or IRB 6 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 staff 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.
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 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.
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