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Is a Certificate of Confidentiality necessary for data submitted to NDAR?

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No. The NIH strongly encourages, but does not require, institutions to obtain a Certificate of Confidentiality for eligible studies that plan to contribute research subject data to NDAR. The NIH considers a Certificate of Confidentiality to be an important but not mandatory research tool, available to assist research organizations in protecting the privacy of their research participants. Congress designed these certificates as a way of encouraging potential research participants to participate in studies, given a common concern that public knowledge of their participation could lead to potentially negative consequences.

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