March 2007

The Johns Hopkins University School of Medicine and the Baltimore City Health Department (BCHD) entered into an IRB Authorization Agreement on January 30, 2006, allowing the JHM IRB to serve as the IRB of record for human subjects research conducted using BCHD sites or facilities, or for which BCHD personnel serve a research role. Research applications that involve BCHD from the start of a study, or which are revised to include BCHD after study initiation, should clearly identify the BCHD site(s), facilities, or personnel involved.  The JHM IRBs will review the application. At the completion of the IRB review process, the IRB may issue approval for all sites except BCHD and notify BCHD about the action taken. If BCHD sites are the only locations for the conduct of the study, the IRB will approve the study, but not the BHCD involvement, until the BCHD review is completed.

The BCHD will conduct a review to determine if the study is consistent with the public health mission of the health department.  The review decision may result in either BCHD permission to proceed or a decision not to approve a study. The Office of Human Subjects Research (OHSR) staff and the principal investigator will be notified when BCHD review is complete.

Changes in research to studies already approved by BCHD may be reviewed and approved for all sites by the JHMIRB. BCHD reserves the right to review these changes after JHMIRB approval and notify the investigator if they do not approve the changes. In such cases, the investigator must revise the application submitted to the IRB to remove BCHD. 

Questions regarding the BCHD/JHUSOM IRB review agreement may be directed to either Megan Singleton, Assistant Dean for Human Research Protection, or Barbara Scherer, Director of Operations for the OHSR.