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114.2 Organization Policy on Cooperative Research and Multi-Center Studies
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 by entering into joint IRB review arrangements, relying upon the review of another qualified IRB, or making similar arrangements to avoid duplication of effort. Learn more about JHM agreements.
Communication among sites in a multi-center 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:
- Central review of each site’s local IRB approval documents and consent forms.
- For federally funded research, confirmation that each participating site has on file an FWA with OHRP.
- 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-center 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-center research project for which Hopkins is the lead center.
All IRB review agreements must be governed by a written document to which both JHM and the reviewing organization must sign. Review documents are kept on file in the OHSR.