Abstract
The NIH Policy for Data Management and Sharing will take effect on January 25, 2023. All NIH grantees will need to submit a data management and sharing plan as part of their grant application. Although data sharing is not mandated, NIH strongly encourages appropriate data sharing for subsequent secondary research. New data sharing practices should be integrated into informed consent processes and documents. Deidentified data, Big Data, and access to data by researchers not subject to federal research regulations are new informed consent issues. The expanded scope of informed consent will be enhanced by informed consent focusing less on details of the research and more on establishing a trust relationship.
Published Version
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