New IRB reciprocity agreements

February 8, 2005

Dear Colleagues,

My purpose in writing is to inform you of new reciprocity agreements between the Johns Hopkins Medicine Institutional Review Boards and outside entities as well as to review those relationships that already exist. The purpose of these agreements is to minimize duplicative review of research protocols by multiple IRBs that adds little to protection of research participants. Since 2002, we have had IRB reciprocity agreements among the Johns Hopkins Medicine Institutions and with the Bloomberg School of Public Health. Additional agreements with external groups, some of which are new, and the process to avoid dual review are described below.

1. MedStar IRB and JHM IRB review process:

Effective May 1, 2004, faculty who wish to conduct new commercially funded projects that involve only Good Samarian Hospital (GSH) patients (or other MedStar system Hospital or clinical site patients) may submit applications to the MedStar IRB; JHM will accept MedStar review without a separate submission to a JHM IRB. Click here for a list of the MedStar system sites (http://irb.jhmi.edu/Guidelines/MedStar.html#MedStar).


New projects to be conducted by Hopkins faculty that are funded by federal agencies, non-profit foundations, non-profit societies, or that are not funded will undergo review by a JHM IRB. JHM IRB approval for such projects will be accepted by the MedStar IRB without separate submission to a MedStar IRB. Click here for the terms of the review agreement with MedStar (http://irb.jhmi.edu/Guidelines/MedStar.html).

2. National Institute on Aging Intramural Research Program (NIA IRP) and JHM IRB review process:

In April 2003, the NIA IRP relocated from the JHBMC campus to Harbor Hospital. Harbor Hospital is member of the MedStar system. Effective November 1, 2004, JHM entered into a new review agreement with NIA IRP that extends and modifies the MedStar IRB review agreement to cover collaborative projects conducted with NIA staff. Use of NIA facilities and the involvement of an investigational drug/device in collaborative NIA research projects govern whether IRB review will be conducted by the MedStar IRB or by a JHM IRB. Click here for the terms of the Review Agreement with NIA (http://irb.jhmi.edu/Guidelines/NIAagreement_2004.pdf).

3. National Institute on Drug Abuse (NIDA) IRB and JHM IRB review process:

Effective November 1, 2004, JHM entered into an IRB review agreement with NIDA to facilitate IRB review of projects conducted at the NIDA facilities located at JHBMC. Use of NIDA facilities and the involvement of an investigational drug/device in collaborative projects conducted by Hopkins faculty and NIDA staff govern whether IRB review will be conducted by the NIDA IRB or by a JHM IRB. Click here for the terms of the review agreement with NIDA (http://irb.jhmi.edu/Guidelines/NIDAagreement_2004.pdf ).

4. National Cancer Institute Central IRB (NCI CIRB adult)/National Cancer Institute Pediatric Central IRB (NCI PedCIRB) and JHM IRB review process:

Effective September 1, 2004, JHM began to participate in the NCI CIRB initiative for adult cooperative group oncology trials. JHM has agreed to conduct a facilitated local IRB review process for protocols that have CIRB approval. The facilitated IRB process is coordinated through the SKCCC Clinical Research Office and the Office of Human Subjects Research. Click here for details of the facilitated review process (http://irb.jhmi.edu/Guidelines/CIRB_SOP.html).

Effective November 1, 2004, JHM began to participate in the NCI Pediatric CIRB initiative for pediatric cooperative group oncology trials. JHM will conduct a facilitated local IRB review process for protocols that have PedCIRB approval. The details of the facilitated review process for pediatric group protocols are identical to that for the adult oncology group protocols (see above paragraph).

5. Bloomberg School of Public Health and JHM IRB review process:

The IRB Reciprocity Agreement between JHM and Bloomberg School of Public Health (BSPH) took effect on July 12, 2002. The agreement allows an IRB at JHM or one of the BSPH IRBs to approve a study for conduct at sites at either JHM or BSPH. Please Note: Approval by a JHM IRB or BSPH IRB only applies to the site(s) that are listed on an application. New sites may not be added automatically by an investigator without seeking an amendment to a study.

6. Howard County General Hospital (HCGH) and JHM IRB review process:

The JHM IRBs serve as the IRBs of record for HCGH; however, HCGH retained the right to require review and approval by their Medical Review Committee (MRC) before a project may begin at HCGH. In addition, JHH or JHBMC faculty physicians are not automatically provided with credentials that allow them to see patients or research participants who are at HCGH. The HCGH MRC meets once each month. Please take into account the MRC schedule and the need to obtain temporary credentials at HCGH when you plan to include HCGH as a site for a research project. Questions about conducting HCGH research should be emailed to the Office of Human Subjects Research at jhmirb@jhmi.edu.

7. Other entities for which JHM IRB conducts reviews:

The JHM IRBs serve as the IRBs of record for The Johns Hopkins University Schools of Medicine and Nursing, The Johns Hopkins Hospital, The Johns Hopkins Bayview Medical Center, The Kennedy Krieger Institute, The Johns Hopkins Community Physicians and the Applied Physics Laboratory. Since July 2002, multiple IRB applications and separate consent forms for each institution in the JHM system has not been required. Please Note: Approval by a JHM IRB only applies to the site(s) that are listed on an application. New sites may not be added automatically by an investigator without seeking an amendment to a study.

Please contact the Office of Human Subjects Research (jhmirb@jhmi.edu) if you have any questions or comments.

Sincerely,

Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation