/Docs/G/US-NIH/Policy-for-Data-Management-and-Sharing/Sec/Data/0.md
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Ti = Data Management and Sharing Plans
1.sec = Researchers with NIH-funded or conducted research projects resulting in the generation of scientific data are required to submit a Plan to the funding NIH ICO as part of Just-in-Time for extramural awards, as part of the technical evaluation for contracts, as part of the NIH Intramural Annual Report, or prior to release of funds for other funding agreements. Plans should explain how scientific data generated by a research study will be managed and which of these scientific data will be shared. Plans may be updated by researchers (with appropriate NIH ICO approval) during regular reporting intervals if changes are necessary or at the request of the NIH ICO to reflect changes in the previously documented approach to data management and data sharing throughout the research project, as appropriate. NIH encourages shared scientific data to be made available as long as it is deemed useful to the research community or the public. Plans should also identify strategies or approaches to ensure data security and compliance with privacy protections are in place throughout the life of the scientific data. NIH may make Plans publicly available.
2.sec = NIH prioritizes the responsible management and sharing of scientific data derived from human participants. Applicable Federal, Tribal, state, and local laws, regulations, statutes, guidance, and institutional policies dictate how research involving human participants should be conducted and how the scientific data derived from human participants should be used. Researchers proposing to generate scientific data derived from human participants should outline in their Plans how human participants' privacy, rights, and confidentiality will be protected, i.e., through de-identification or other protective measures. NIH recognizes that certain factors (e.g., legal, ethical, technical) may limit the ability to preserve and share data. Plans should include consideration of these factors, when applicable, in describing the approach to data management and data sharing. NIH encourages the use of established repositories for preserving and sharing scientific data.
3.sec = Plan Elements: Consider addressing specific elements outlined in DRAFT guidance (see below, Supplemental DRAFT Guidance: Elements of An NIH Data Management and Sharing Plan).
4.sec = Plan Assessment: The funding NIH ICO will assess the Plan, through the following processes:
5.sec = Extramural Awards: Plans will undergo a programmatic assessment by NIH staff within the proposed funding NIH ICO. NIH encourages potential awardees to work with NIH staff to address any potential concerns regarding the Plan prior to submission.
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6.sec = Contracts: Plans will be included as part of the technical evaluation performed by NIH staff.
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7.sec = Intramural Research Projects: Plans will be assessed by the Scientific Director (or designee) or Clinical Director (or designee) of the researcher's funding NIH ICO.
8.sec = Other funding agreements: Plans will be assessed in the context of other funding agreement mechanisms (e.g., Other Transactions).
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