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I am planning a multi-site trial for a behavioral intervention for HIV. Does each site need a separate Certificate of Confidentiality?

April 26, 2017behavioral Certificate confidentiality intervention multi-site planning separate site trial

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I am planning a multi-site trial for a behavioral intervention for HIV. Does each site need a separate Certificate of Confidentiality?

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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. In addition, the lead site must indicate that it has on file a copy of the IRB approval and IRB-approved consent form from each site, which will be made available to the NIH upon request. The informed consent form for each site should contain appropriate language about the protections and limitations of the Certificate of Confidentiality.