May 2005 It is the policy of the Organization that as part of the responsibility for safeguarding the rights and welfare of human participants, the JHM IRBs have the option of participating in cooperative research projects by entering into joint review arrangements, relying upon the review of another qualified IRB, or making similar arrangements for avoiding duplication of effort. Current JHM IRB agreements include: MEDSTAR, National Cancer Institute Central IRB (NCI CIRB), National Cancer Institute Pediatric Central IRB (NCI PedCIRB), National Institute on Aging Intramural Research Program (NIA IRP), National Institute on Drug Abuse (NIDA) IRB, and the Bloomberg School of Public Health. 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 a lead site or coordinating center, the JHM IRBs will ask the Hopkins PI to explain how important human subjects protection issues will be communicated to the Hopkins site. When Hopkins serves as the coordinating center, the IRB should confirm that the application indicates how 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.
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