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Sharing clinical research data in the United Statesunder the Health Insurance Portability and Accountability Act and the Privacy Rule

Sharing of final research data from clinical research is an essential part of the scientific method. The United States National Institutes of Health require some grant applications to include plans for sharing final research data, which it defines as the factual materials necessary to document, support, and validate research findings. In the United States, however, the Privacy Rule adopted under the Health Insurance Portability and Accountability Act impedes the sharing of final research data. In most situations, final research data may be shared only where all information that could possibly be used to identify the subject has been deleted, or where the subject has given authorization for specific research, or an Institutional Review Board has granted a waiver.

Posted in: Open Access Journal Articles on 11/20/2010 | Link to this post on IFP |
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