JHM IRB CIRB Facilitated Review Procedures
October 2004

1.  SKCCC CRO Review:      It is the responsibility of the Institutions to ensure investigators and staff conducting the protocol are appropriately qualified and meet the Institution’s standards for eligibility to conduct research.  The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Research Office (CRO) is responsible for review of all proposed cancer treatment trials conducted by Hopkins’ faculty.  Therefore, the SKCCC CRO will conduct its review of all new proposed studies approved by CIRB in which faculty wish to participate and such review will assure investigators and staff are qualified and meet the Institutions standards. After SKCCC CRO review, the CIRB materials will be provided to the Office of Human Subjects Research (OHSR) designated staff members to initiate facilitated IRB review.  The designated OHS staff members are Beth Moran, Administrative Manager II, and LaSharon Holt, External IRB Liaison.

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 primary contact in the OHSR is:

Judith Carrithers, J.D.
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

The secondary contact is: 

Barbara Starklauf, MAS
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 Review Procedure: The procedure by which the JHM IRBs will receive and review CIRB materials for protocol review is as follows:

a.  The staff of the SKCCC CRO will approve conduct of the trial at the SKCC. Once approved by the CRO, the CRO staff will provide the complete CIRB application materials and the JHM CIRB Checklist to the designated OHSR staff. OHSR staff will determine and obtain the local context issues that must be addressed, which could include:

i.   CCOI review
ii.  CRRC review
iii.  IBC review

b.  There are four JHM IRBs that are available for review of CIRB materials:  IRB 1, IRB 2, IRB 3 and IRB 5.  OHSR staff will assign an IRB for review of CIRB materials and track the outcome of the review.

c.  The process for facilitated review by a JHM IRB will be as follows:

The Oncology member of the IRB and the IRB chair will review the CIRB materials.  If the project involves administration of drugs or biologics, the P&T member of the assigned IRB will review the drug related issues. Based on the review by the oncology member, and P&T member when necessary, the IRB chair will determine:

i.    CIRB review is acceptable and the consent form is acceptable with inclusion of Hopkins’ boilerplate language.  If accepted, an IRB consent specialist will modify the consent form to conform to the Hopkins template and develop a Hopkins required HIPAA authorization form. 
ii.    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 deemed crucial, the CIRB review will not be accepted.  The chair will document the rationale for the decision and request that staff begin the standard JHM IRB review process.  The PI will be notified that JHM IRB review will be conducted using the CIRB application materials.  The External IRB Liaison will forward the materials to the Director of OHSR for JHM IRB review.

d.   OHSR staff will report to CIRB the decision about local acceptance/rejection of the CIRB review.  The outcome will be reported using the Electronic Protocol Acceptance Form.

e.   After approval, designated OHSR staff will track the protocol status.  Amendments and continuing review applications are reviewed by the NCI CIRB.  Once amendments and continuing review materials are approved by the CIRB, the investigator, the CRO, and the JHM IRB will be notified and provided with updated documents.  The designated JHM IRB Chair (or Co-Chair) will review the amendment or continuing review materials and determine if the JHM IRB will continue to accept CIRB review.  If accepted, OHSR designated staff will complete and submit a CTSU IRB Certification form to CIRB.
 

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

4.   The Institutions will maintain an OHRP approved assurance for human subjects research.

5.   The Institutions will maintain JHM IRBs whose membership satisfies the requirements of 45 CFR 46.

6.   The Institutions will maintain a human subjects protection program as required by DHHS OHRP.

7.   The Institutions will ensure that IRB members and investigators receive proper initial and continuing education.

8.   The facilitated IRB review process will assure that CIRB approved protocols maintain compliance with additional state, local or institutional requirements related to human subjects.

9.   The Institutions have amended the relevant FWAs to delegate review authority to CIRB.

In November 2004, the Institutions will begin participation in the Pediatric CIRB initiative.  All requirements and procedures applicable to the original CIRB participation as outlined in this document will apply to the Pediatric CIRB initiative.