What is the overall goal of this policy?
The NIH encourages data sharing in order to:
- Increase public access to federally funded research
- Enable transparency and reproducibility of research results
- Make data available for discovery and reuse
Which grants are covered by this policy?
The policy applies to all NIH grants that generate scientific data including research projects, some career development awards (Ks), Small Business SBIR/STTR, and Research Centers.
It does not apply to grants for Training (T), Fellowships (F), Construction (C06), Conferences (R13), Resource (Gs), and Research-Related Infrastructure Programs (S06).
See the complete list of activity codes covered by the policy.
What is considered "scientific data" for the purposes of this plan?
The final NIH Policy defines Scientific Data as: “The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings"
Researchers are not expected to share: data that are not necessary for or of sufficient quality to validate and replicate the research findings, 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
Are there justifiable reasons not to share my data?
Yes. NIH expects that researchers will take steps to maximize scientific data sharing, but may acknowledge in Plans that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. Foreseeable limitations should be described in DMS Plans. Per the supplemental information “Elements of an NIH Data Management Sharing Plan,” a compelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH.
Potential examples of justifiable factors include:
- informed consent will not permit or will limit the scope or extent of sharing and future research use
- existing consent (e.g., for previously collected biospecimens) prohibits sharing or limits the scope or extent of sharing and future research use
- privacy or safety of research participants would be compromised or place them at greater risk of re-identification or suffering harm, and protective measures such as de-identification and Certificates of Confidentiality would be insufficient
- explicit federal, state, local, or Tribal law, regulation, or policy prohibits disclosure
- restrictions imposed by existing or anticipated agreements (e.g., with third party funders, with partners, with repositories, with Health Insurance Portability and Accountability Act (HIPAA) covered entities that provide Protected Health Information under a data use agreement, through licensing limitations attached to materials needed to conduct the research)
- datasets cannot practically be digitized with reasonable efforts
Examples of reasons that would generally not be justifiable factors limiting scientific data sharing include:
data are considered to be too small
data that researchers anticipate will not be widely used
data are not thought to have a suitable repository
What is included in a Data Management and Sharing Plan?
In the max two-page documents, researchers will describe their:
- Data type
- Related tools, software, and/or code
- Data preservation, access, and associated timelines
- Access, distribution, or reuse considerations
- Oversight of data management and sharing
How should I be sharing my data? Can I make it available upon request?
No. NIH prefers that scientific data be shared and preserved through data repositories rather than kept by a researcher and provided upon request
What data repository should I use?
NIH encourages the use of established repositories. To select a repository relevant to your data consider:
- Is there a specific NIH repository named in the funding announcement?
- Is there a data repository specific to your discipline?
- If not, is there a general data repository you can use?
When do I need to make my data available?
NIH encourages scientific data be shared as soon as possible, and no later than time of an associated publication or end of the performance period, whichever comes first.
What is a standard? What standards are relevant to my research?
A standard specifies how exactly data and related materials should be stored, organized, and described. In the context of research data, the term typically refers to the use of specific and well-defined formats, schemas, vocabularies, and ontologies in the description and organization of data. However, for researchers within a community where more formal standards have not been well established, it can also be interpreted more broadly to refer to the adoption of the same (or similar) data management-related activities, conventions, or strategies by different researchers and across different projects.
What data management and sharing costs can I include in my grant?
Allowable costs can include:
- data curation and developing documentation (formatting data, de-identifying data, preparing metadata, curating data for a data repository)
- data management considerations (unique and specialized information infrastructure necessary to provide local management and preservation before depositing in a repository)
- preserving data in data repositories (data deposit fees)
Read more about budgeting for data management.
How will the plans be assessed?
NIH program staff will assess the DMS plans but peer reviewers may comment on the proposed budget for data management and sharing.
What happens if I do not comply with the NIH policy or make my data available as described in the DMS policy?
NIH Program Staff will be monitoring compliance with the policy during the funding period. “Noncompliance with Plans may result in the NIH ICO adding special Terms and Conditions of Award or terminating the award. If award recipients are not compliant with Plans at the end of the award, noncompliance may be factored into future funding decisions.”
Where can I learn more about this new policy?
NIH has released 2 webinars about the policy. Watch the recordings