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How does the NIH Data Management & Sharing Policy affect my work with human subjects?

In an effort to promote the sharing of scientific data, NIH has issued the Data Management and Sharing policy (effective January 25, 2023). A key part of responsible data sharing practices is protecting the privacy of research participants. NIH has developed Principles and Best Practices for Protecting Participant Privacy to help researchers proactively assess how best to guard research participant privacy. NIH has also outlined certain considerations for scientific data derived from human participants and provided a resource for developing informed consent language when the DMS policy applies.

For additional information on informed consent options, please see the FAQ located here.


NIH Scientific Data Sharing:

Protections of Human Subjects Regulations Sections 45 CFR 46. 116 and 117.

Office for Human Research Protections Informed Consent FAQs on Waiver of Informed Consent.