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Can databases or registries be created under HIPAA? Can I create a research database without obtaining an authorization from every single research subject?

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Can databases or registries be created under HIPAA? Can I create a research database without obtaining an authorization from every single research subject?

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Yes. HIPAA allows for the creation of databases for research purposes. A research database can be created without obtaining individual authorizations but only with a IRB approved Waiver of Authorization. The proposal to the IRB must meet all of these waiver criteria, some of which you may already include as part of the confidentiality discussion in your research proposal.

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