The Policy covers all NIH-supported research regardless of funding level, including extramural grants, extramural contracts, intramural research projects, and other funding agreements. NIH has made available a list of all NIH activity codes that generally require applicants to submit a DMS plan.
It applies to research that results in the generation of scientific data, which is defined as data commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications.
Grant applicants who anticipate to generate scientific data have to submit a DMS plan as part of the funding application. NIH staff are responsible for the review and approval of the plans prior to award.
Grantees are to manage and share their research data as described in the approved DMS plans and as a term and condition of award. Also, they have to provide updates on DMS activities in their annual research performance progress reports.
More information is available from the frequently asked questions about the Policy and the following NIH Webinar. Expectations about DMS plans, research data sharing, and data cost estimation can be found below the video.
Scientific data should be made available, preferably through an established online repository most suitable for the data type and discipline, no later than the release of an associated publication or the end of the funding period, whichever comes first. NIH supports a host of data repositories that are appropriate for sharing various types of research data.
Grantees must comply with applicable laws, regulations, statutes, guidance, or institutional policies that protect the privacy, rights, and confidentiality of the human participants in the research. They must also consider whether restrictions on access to de-identified scientific data derived from human participants are in order.
This document is made available to help researchers secure human subjects' informed consent for the downstream sharing of their data and biospecimens.
Although investigators submit DMS plans before research begins, their plans may need revision over the course of a project; for example, if the type(s) of data generated change(s), if a more appropriate data repository becomes available, or if the sharing timeline has shifted.
A revised DMS plan has to be approved by the relevant NIH unit. NIH staff will monitor compliance with approved DMS plans during the annual progress report process.
The University of Chicago Privacy Office provides consultation and resources regarding the use of personal data. Additionally, Johns Hopkins University Libraries maintains a page of tools for the de-identification of human subject research data.
In light of the potential costs incurred by making data accessible and reusable, investigators may request funds to cover DMS activities in the budget and budget justification sections of their grant applications. A helpful resource for estimating such costs is Life-Cycle Decisions for Biomedical Data: The Challenge of Forecasting Costs published by the National Academies National Academies of Sciences, Engineering, and Medicine.