I am planning a multi-site trial to study the efficacy of a new intervention. Does each site need a separate Certificate of Confidentiality?
No, for multi-site projects, a coordinating center or lead institution can apply for and receive a Certificate on behalf of all member institutions. In the application for a Certificate, multi-site applicants must list each participating unit, its address, and project director. If additional sites are added after the the Certificate is obtained, the lead site should maintain information about the additional sites in its files. In addition, the lead site should obtain signed assurances from each participating institution, as well as a copy of their IRB approval (http://grants.nih.gov/grants/policy/coc/appl_extramural.htm). These should be kept in the lead institutions’ files, to be made available to the NIH upon request. The lead site is also responsible for ensuring that each site’s IRB-approved consent forms contain appropriate language describing the Certificate of Confidentiality and should work with the appropriate NIH coordinator to review consent form language. To avoid confusion
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