For contracts, noncompliance with the DMSP will be handled in accordance with the terms and conditions of the contract and applicable Federal Acquisition Regulation (FAR).
References:Frequently Asked Questions (FAQs) | Data Sharing
Data must be shared as soon as possible and no later than the time of publication or end of the award, whichever comes first.
• Scientific data includes any data needed to validate and replicate research findings.
• Scientific data does not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects such as laboratory specimens.
NIH funds can be used for software related to data management and sharing tasks such as curating datasets, preparing associated documentation, supporting data usage, etc. Software used for this purpose must be indicated in the DMSP and budget.
For software used in data analysis and processing that is not related to data management and sharing please, review your Funding Opportunity Announcement (FOA) for information.
References: Supplemental Policy Information: “Allowable Costs for Data Management and Sharing Plan”, Budgeting for Data Management & Sharing
• Address data management and sharing plans during the informed consent process to ensure prospective participants understand how their data will be managed and shared;
• Outline steps they will take for protecting the privacy, rights, and confidentiality of prospective participants (i.e., through de-identification,Certificates of Confidentiality, and other protective measures);
• Assess limitations on subsequent use of data and communicate these limitations to the individuals or entities (e.g., repositories) preserving and sharing the data; and
• Consider whether access to shared scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use. Sharing via controlled access may be specified by certain funding opportunity announcements (FOAs) or the funding NIH Institutes or Centers.
NIH strongly encourages investigators to plan for how data management and sharing will be addressed in the informed consent process. Investigators should communicate with prospective participants about how their scientific data are expected to be used and shared. Investigators should also consider whether scientific data derived from humans, even if de-identified and lacking explicit limitations on subsequent use, should be controlled.
References:Data Sharing Approaches, Supplemental Policy Information: “Protecting Privacy When Sharing Human Research Participant Data”
References:Frequently Asked Questions (FAQs) | Data Sharing
No. The DMS Policy applies to research that results in the generation of scientific data. Scientific data can result from secondary research, but researchers are not expected to share the existing, shared primary data used to conduct the secondary research. Researchers are, however, expected to maximize appropriate sharing of any new, derived data generated as a result of their research. Note that use of data obtained from repositories or other sources and derived data may be subject to limitations on sharing as a condition of access, which is a justifiable reason for limiting sharing under the DMS Policy.
References:Frequently Asked Questions (FAQs) | Data SharingNo. As of January 25, 2023, NIH will no longer be collecting separate GDS Plans. Genomic data sharing considerations, such as where and when genomic data will be shared, will be expected to be addressed in DMS Plans using the DMS Plan elements.
References: Implementation Details for the NIH Data Management and Sharing Policy, Implementation Changes for Genomic Data Sharing Plans
For grants, plans should be updated by researchers and reviewed by the NIH ICO during regular reporting intervals or sooner. For contracts, in accordance with the Contracting Officer’s Representative’s (COR) technical monitoring responsibilities, the COR would evaluate the post-award revision, in order to determine whether it is still considered acceptable.
NIH has a variety of sharing policies in place for research that it funds and has an online tool to assist you in determining which NIH policies apply to your particular project.
Each funding opportunity has its own unique set of application forms and the NIH has an online resource to help you locate the correct ones for your application.
