Data Management & Sharing

No. The key is to maximize the appropriate sharing of scientific data, which is defined as data commonly accepted in the scientific community as being of sufficient quality to validate and replicate the research findings. Not all data generated in research will constitute shareable scientific data under the DMS policy. Under this policy, scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues or laboratory specimens. NIH expects that researchers will take steps to maximize scientific data sharing but acknowledges that certain ethical, legal, or technical factors may necessitate limiting sharing e.g., data related to human subjects, proprietary data, and laws and regulations that prohibit data sharing. These limitations should be outlined in the DMS Plan.

Scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first.

NIH strongly encourages the use of established repositories that are most appropriate for your data type and discipline. As much as possible, the NIH would like to avoid situations where data is stored only by the researcher or institution and provided on request. Click here for NIH-supported Scientific Data Repositories and Generalist Repository Ecosystem Initiative, including Dryad, Dataverse, Figshare, Mendeley Data, Open Science Framework, Vivli.

UMB has a membership in some scientific repositories for faculty on this campus, such as ICPSR or QDR for social science or qualitative data, and OSF for small non-sensitive datasets.

Shared scientific data should be available as long as it is useful to the research community or the public.

Yes, fees for data preservation and sharing are allowable in the funding application budget, but funds for these activities must be spent during the performance period. NIH funds cannot legally be spent after the award period. Personnel costs required to perform the DMS activities are also allowable. Budget requests should not include infrastructure costs which are supposed to be included in indirect costs. Click here for details regarding allowable costs for DMS.

Yes, as long as the unpublished data are considered scientific data and within the final DMS Policy’s scope. Scientific data underlying null and negative findings are important to share even though these key findings are not always published.

No, but not including a DMP plan in your application submitted after January 25, 2023 could lead to rejection of the application. NIH does not expect researchers to necessarily have all DMS details worked out at the application stage, but you are required to write a DMS Plan to the best of your knowledge and ability. Plans will be reviewed by NIH staff. If a proposal is deemed to have an inadequate DMS plan but NIH wishes to fund it, the Plan will need to be modified at the JIT stage. Awards will not be made until the DMS Plan is considered acceptable.

The DMS plan will not be reviewed in the study section by peer reviewers, but they may comment on a proposed budget for the DMS. These comments will not impact the overall score. NIH Program Staff will review Plans, updates, and compliance monitoring, and consider peer reviewer comments on the budget requests for DMS costs.

The key is to maximum the appropriate sharing of “scientific data”, which is the data commonly used in the scientific community as necessary to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, and communications with colleagues or laboratory specimens.

The new NIH policy applies to competing applications with deadline dates on or after January 25, 2023. While the NIH encourages data sharing, there is not currently a retroactive requirement for all active grants.

For existing consent forms, if it prohibits sharing or limits the scope or extent of sharing and future research use, NIH honors appropriate limitations in data sharing as long as researchers convey such factors in their plans and justify reasons for limiting sharing data.

 For future consent forms, NIH encourages investigators to consider how to address DMS in the informed consent process, so that prospective participants will understand what is expected to happen with their data. NIH has developed a resource for developing informed consent language in research studies where data and/or biospecimens will be stored and shared for future use.

The DMS Policy is not designed to set any new standards for institutional data security practices. NIH believes that technical provisions regarding data security are more appropriately addressed by the institutions and repositories preserving and sharing the scientific data. The Supplemental Information to the NIH Policy for DMS outlines characteristics of suitable repositories.

The online resource DMPTool has developed an NIH DMS Plan template in response to the requirements of the NIH’s new policy (see here for more information.) If you need assistance developing a DMS plan or using DMPTool, please schedule a consultation with the Center for Research Data Management Services at the UMB Health Sciences and Human Services Library.