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114.2 Organization Policy on Multi-Site Studies and Coordinating Center Responsibilities
It is the policy of the Organization that as part of the responsibility for safeguarding the rights and welfare of human participants JHM has the option of participating in cooperative research projects.
Communication among sites in a multi-site study promotes participant safety. The JHM IRBs will ask investigators to specify who is responsible for coordinating communication among the multiple sites, especially communication about human subject protection issues. If Hopkins is not the coordinating center, the eIRB system is the mechanism for JHM to collect information on the lead/coordinating center (including PI’s name, and contact information). When Hopkins serves as the coordinating center, the eIRB application will confirm that the following issues are addressed:
- Confirmation that each site will either secure their own IRB approval or will be relying on the JHM IRB for review.
- Method for assuring all sites have the most current version of the protocol.
- System to confirm that amendments to the protocol will be communicated to all sites.
- Plan for collection and management of data from all sites.
- Process for reporting and evaluating protocol events and deviations from participating sites.
Multi-site research conducted with Department of Defense funding awarded to JHUSOM will require a formal agreement between JHUSOM and the organizations serving as study sites. The agreement would specify the roles and responsibilities of each party. An agreement must be in place before an investigator may begin an IRB approved, multi-site research project for which Hopkins is the lead center.