The Expansion of NIHs Genomic Data Sharing Policy. E. Luetkemeier, K. Langlais, R. Baker, C. Fomous, T. Paine, D. Paltoo Office of Science Policy, Office of the Director, NIH, Bethesda, MD.

   Sharing research data supports the NIH mission and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. In 2014, NIH will expand its genomic data sharing policy to apply to all large-scale human and non-human genomic data generated from NIH-supported research, regardless of funding level or mechanism. The NIH Genomic Data Sharing (GDS) Policy, which extends the NIH Policy on Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies), will be effective in January 2015 and apply to research being funded in fiscal year 2016. The GDS Policy sets forth expectations that ensure the broad and responsible sharing of non-human and human genomic data. Its main provisions involve the responsibilities of investigators submitting data, responsibilities of investigators accessing and using data, and intellectual property. During the development of the policy, NIH sought input from a broad range of stakeholders through a public comment process. Comments were received from academic institutions, professional and scientific societies, disease and patient advocacy groups, tribal organizations, state public health agencies, health care providers, and the general public. Comments addressed the general role and value data sharing and as well as specific aspects of the draft Policy, e.g., scope and applicability, data sharing plans, timelines for data submission and release, and informed consent standards. This session will review the elements of the Policy and how they were shaped by public perspectives. Information about the implementation of the Policy will also be provided. The authors of this analysis are employed by the Office of Science Policy, Office of the Director, NIH.

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