NIH Data Management and Sharing (DMS) Policy: Select FAQs for ELSI Research Program
Notes:
For questions with “*”, FAQ developed using select text from responses to more than one NIH FAQ or other NIH webpages regarding the DMS Policy
For questions with “**”, FAQ developed by NHGRI ELSI Research Program and aligned with the DMS Policy
For remaining questions, responses to NIH FAQs are as of April 2023.
Follow links for any updates.
Resources
** Given the large number of resources available regarding the DMS Policy, where should I start?
NIH resources regarding the DMS Policy are available on the NIH Scientific Data Sharing site. Consider starting with the e-Learning Webinars, Slide Sets and Overviews on policy requirements, the NIH-wide list of FAQs, and the optional template for DMS plan submission. In addition, NHGRI has released some Considerations for Sharing Non-Genomic Data from Human Research Participants.
Policy Scope
How does the DMS Policy fit in with other NIH data sharing policies and requirements (e.g., individual NIH Institute/Center or Office (ICO) funding polices, the NIH Genomic Data Sharing (GDS) Policy, the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information)?
The DMS Policy establishes the foundation for NIH’s data management and sharing expectations, which NIH ICOs and programs may build upon to meet their programmatic needs (e.g., designated repositories, specific data collection standards). Current NIH policies specific to certain types of research (e.g., clinical trials, research generating large-scale genomic data) continue to apply and complement the goals of the new DMS Policy. In the event that another applicable policy has more detailed expectations than that of the DMS Policy, those expectations should be followed in addition to the DMS Policy.
Am I expected to share all data generated during my research?
No. Under the DMS Policy, researchers are expected 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 during NIH-supported research will constitute scientific data under the DMS Policy. Specifically, the DMS Policy does not expect researchers to share:
- Data that are not necessary for or of sufficient quality to validate and replicate the research findings,
- Laboratory notebooks,
- Preliminary analyses that are not necessary for or of sufficient quality to validate and replicate the research findings,
- Completed case report forms,
- Drafts of scientific papers,
- Plans for future research,
- Peer reviews,
- Communications with colleagues, or
- Physical objects, such as laboratory specimens.
**Would a K99 application submitted prior to the policy be required to submit a DMS plan when converting to a R00 after the policy?
No, the transition from the K99 phase to the R00 phase after implementation of the DMS policy does not require submission of a DMS plan. The initial K99/R00 application covers both phases and the transition to the R00 phase is non-competing. Therefore, the DMS Policy would not apply because the competing K99/R00 application was submitted for a receipt date that predated the DMS Policy.
Both K99 and R00 are applicable activity codes under the DMS Policy, so competitive K99/R00 applications with receipt dates on or after January 25, 2023 will require a DMS Plan.
Do administrative supplements and competing revisions (i.e., Type 3s) need to include a separate Data Management and Sharing Plan?
No. Administrative supplements and competing revisions are not subject to the DMS Policy. However, if an awarded supplement request, including competing revision, changes the parent award’s approved approach to data management and sharing, the DMS Plan of the parent award should be updated.
Scientific Data from Human Participants
Does the DMS Policy expect that informed consent obtained from research participants must allow for broad sharing and the future use of data (either with or without identifiable private information)?
No. Informed consent for participation in research remains the cornerstone of trust between researchers and research participants and thus the DMS Policy does not dictate how this process is achieved. Rather, researchers’ intention for scientific data management and sharing, as proactively described in Plans, is strongly encouraged to be part of the informed consent process. The DMS Policy does not expect that informed consent given by participants will be obtained in any particular way.
**Does NHGRI expect investigators to obtain informed consent for broad data sharing in all cases?
No. NHGRI has long expressed a preference for the inclusion of broad data sharing in informed consent. However, NHGRI acknowledges that there may be technical, legal, informed consent or ethical factors that necessitate limited sharing or controlled access for qualitative or sensitive data. Investigators should consider whether there are justifiable limitations to sharing data under the DMS policy and the impact of de-identification or limited sharing on scientific utility. Investigators are not expected to share data if 1) the privacy or safety of research participants would be compromised or would place them at greater risk of re-identification or suffering harm, and 2) protective measures such as de-identification and Certificates of Confidentiality would be insufficient.
Investigators and their local IRBs should determine the appropriate scope and manner of data sharing; and when appropriate, should make these determinations in consultation with members of the communities who are represented in or most directly impacted by the proposed research. NHGRI encourages investigators to engage with communities affected by the research and the sharing of sensitive data to discuss approaches for informed consent, appropriate use, risk mitigation and benefit sharing.
NHGRI expects all researchers to review the DMS policy and address any questions to their program officer.
See additional information from NHGRI regarding considerations for sharing non-genomic data from human research participants.
Managing and Sharing Scientific Data
Does the DMS Policy apply to social and behavioral scientific research? Can qualitative data be “scientific data”?
Yes, NIH-supported social and behavioral scientific research that results in the generation of scientific data are subject to the DMS Policy. Qualitative data may constitute scientific data if it meets the definition in the DMS Policy.
**What types of ELSI research activities or projects may not result in scientific data?
Research disciplines and methods used in ELSI Research Program funded projects are highly diverse – including, but not limited to, data-generating qualitative and quantitative approaches, legal, economic and normative analyses, and other types of analytical and conceptual research methodologies. Most ELSI projects will produce scientific data. Please contact your program officer if you have questions about a particular data type.
*What are acceptable ways to share data?
NIH strongly encourages investigators to use an established repository when sharing data. As outlined in NIH's Supplemental Policy Information: Selecting a Repository for Data Resulting from NIH-Supported Research, using a quality data repository generally improves the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data. When selecting a repository, investigators should consider factors such as the sensitivity of the data, the size and complexity of the dataset, and the volume of requests anticipated.
All data derived from human research participants, including both quantitative and qualitative data, should be adequately de-identified prior to sharing to ensure adequate protection of research participants, maintain privacy, and mitigate risk.
NHGRI recognizes that methods for de-identification of qualitative data are developing, and existing tools may have limitations. Investigators are encouraged to review and consider the merits of various tools for data de-identification, such as those listed by the Johns Hopkins Libraries or the UK Data Archive. Investigators are also encouraged to review NIH’s resource on Repositories for Sharing Scientific Data, which includes a listing of generalist repositories that accepts all data types, Nature’s Data Repository Guidance, and the global Registry of Research Data Repositories.
**Do I have to use AnVIL or any specific repository to share data?
No, neither NIH nor NHGRI require investigators to use a particular repository unless specified in the notice of funding opportunity. Investigators are encouraged to review NIH’s resource on Repositories for Sharing Scientific Data, which includes a listing of generalist repositories that accepts all data types, Nature’s Data Repository Guidance, and the global Registry of Research Data Repositories.
NHGRI encourages use of Genomic Analysis, Visualization and Informatics Lab-space (AnVIL) for scientific data sharing. AnVIL supports submission of a variety of data types (not limited to genomic data) and supports controlled-access when such a model is needed. Data access requests are reviewed by the NHGRI Data Access Committee.
*Can I serve as my own data repository and not share with a third party?
Maybe; however, individual investigators may find it challenging to meet desirable characteristics for a repository of data resulting from Federally funded research. When sharing data, NIH strongly encourages investigators to use an established repository with good data management practices. Proper data management helps maintain scientific rigor and research integrity.
See Data Management best practices for more information.
*How long must shared data be available?
Per Section 8.4.2 of the NIH Grants Policy Statement, grantee institutions are required to keep the data for 3 years following closeout of a grant or contract agreement. Contracts may specify different time periods. Please note that the grantee institution may have additional policies and procedures regarding the custody, distribution, and required retention period for data produced under research awards.
Researchers are encouraged to consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidance for the minimum time frame that scientific data should be made available, which researchers may extend.
See Data Management best practices for more information.
What are potentially justifiable reasons for limiting sharing of data?
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 sets are considered to be too small
- researchers anticipation that data will not be widely used
- data are not thought to have a suitable repository
Submitting a DMS Plan
** How should projects involving community engagement or input to inform data management and sharing approach a DMS Plan?
Investigators are encouraged to engage with representatives of relevant communities about data sharing prior to submission of their grant application. When prior engagement is not possible, cannot be completed prior to submission, or where such engagement is a key component of the proposed research, the DMS plan should describe briefly when and how the community engagement will occur, if the application is funded. The plan should specify which communities will be involved and how the engagement will inform plans for data management and sharing. If known, applicants should describe the potential approaches for data management and sharing for which they plan to seek community input. If the application is funded, investigators should submit an updated plan once community input is received and approaches to data management and sharing are solidified.
**Do I still need to submit a Resource Sharing Plan? How does the DMS Plan differ from the Resource Sharing Plan?
The DMS Plan is submitted in response to NIH’s DMS Policy (Notice NOT-OD-21-013). The plan focuses on the sharing and management of all scientific data generated by a project. Generally speaking, peer reviewers will not see the DMS Plan unless data sharing functions are a key feature of either the funding opportunity or the individual application. DMS Plans will be reviewed and assessed administratively by program staff.
Resource Sharing Plans are submitted in response to notice of funding opportunity requirements. The Resource Sharing plan focuses on the sharing of research products not addressed in the DMS Plan or required by other sharing policies (e.g., software, websites, research tools). The Resource Sharing Plan also should address how findings or other information arising from the project will be disseminated, whether through national conferences, peer reviewed journals, policy briefs, websites, town halls, or other modalities. Investigators may also state their plan to comply with NIH’s DMS Policy for generated scientific data. Peer reviewers will see Resource Sharing Plans and may provide comments on them. In most cases, resource sharing plans are not part of the priority score, although applicants should check NOFO requirements.
Use Resource Sharing Plan Attachment field on PHS 398 Research Plan, PHS 398 Career Development Supplemental Form, or PHS Fellowship Supplemental Form to submit your Resource Sharing Plan.
Of note, Genomic Data Sharing Plans were previously a component of the Resource Sharing Plans. With the new DMS Policy, plans for sharing large-scale genomic data should now be included in DMS Plans (Notice NOT-OD-22-198).
Are applications for awards that support a variety of activities or generate many data types limited to a DMS Plan of two pages or less?
No. Some research projects may propose a larger number of activities or generate a larger number of data types, which may necessitate more detail in a DMS Plan. NIH provides an optional DMS Plan format page, but use of this format page is not required. NIH will accept DMS Plans longer than the recommended two pages as long as Plans provide sufficient information for NIH program staff to assess the Plan.
**What level of detail is required in DMS plans?
DMS Plans are typically recommended to be two pages or less in length. Investigators should carefully review the optional template for DMS plans and address all applicable elements. The level of detail provided should be commensurate with the complexity of the proposed project and the scientific data generated under the project.
For Element 1, DMS plans should provide a level of detail that would allow program staff to understand 1) the different types of data, 2) the estimated amounts of data (e.g., 20 children, 1,000 adults, 75 documents), and 3) corresponding data tools that will be generated and used during the project; and assess the appropriateness of proposed plans. The description of data types should clearly delineate and label each data type (e.g., focus group data, quantitative content analysis data, interview transcripts, sociodemographic variables, whole exome sequencing data).
For the remaining elements, DMS plans should account for each data type delineated in Element 1. Data type labels should be used consistently throughout the plan for clarity.
Investigators that propose controlled, limited, or no sharing of data should include a clear rationale for the approach that addresses 1) the impact of the proposed approach on scientific utility and 2) the interests of research participants.
**What if I have different types of data that require different levels of sharing?
If the approach to data management and sharing varies by data type, investigators should describe each approach and indicate the data type(s) that fall under each approach. The plan should include a justification for why different levels of sharing are proposed and why that level of sharing is appropriate for the corresponding data type(s).
**If not sharing data is justifiable under the DMS policy, do I still need to submit a DMS plan?
Yes, all research that results in the generation of scientific data must submit a DMS plan. Investigators that propose controlled, limited or no data sharing should include a clear rationale that addresses 1) the impact of the proposed approach on scientific utility and 2) the interests of research participants.
**Where can I find examples of DMS Plans?
Sample DMS plans developed across NIH Institutes are available online. NIH guidance on writing a DMS plan is also available.
DMS Plan Review
**What happens if my DMS Plan is considered inadequate or unacceptable?
DMS Plans will be reviewed administratively by program staff. If a DMS plan is considered inadequate or unacceptable, the assigned program officer will contact the investigator to discuss concerns. Investigators will be asked to submit a revised plan responsive to program officer feedback. Over the course of a project, investigators may need to submit an updated plan to address new or additional information received that may impact informed consent, study design or implementation, or data collection.
Budget/Costs
How do I reflect data management and sharing (DMS) costs in the detailed R&R Budget form of my application?
All direct costs for data management and sharing activities, including personnel costs specific to those activities, must be included in the single line item on the budget form. The line item must be titled "Data Management and Sharing Costs" (without quotation marks but following exact phrasing and spacing). Do not combine DMS costs with any "Other" costs. If no cost will be incurred, enter "0" in the "Funds Requested" column. Supporting details must be outlined in the budget justification attachment in a section clearly labeled "Data Management and Sharing Justification". The recommended length of the justification should be no more than half a page.
What do I do if I don’t anticipate any direct costs associated with implementing my Data Management and Sharing Plan?
If there are no anticipated data management and sharing costs, this should be noted in the budget justification. Also include a line item titled "Data Management and Sharing Costs" in section F. Other Direct Costs of the R&R Budget Form and enter “0" in the "Funds Requested" column.
Can the data management and sharing costs listed in my budget include the cost of long-term preservation and sharing beyond the award period?
All allowable costs submitted in budget requests must be incurred (e.g., curation fees, data repository fees) during the performance period, even for scientific data and metadata preserved and shared beyond the award period.
Reasonable, allowable costs may be included in NIH budget requests when associated with curating data and developing supporting documentation, local data management considerations, and preserving and sharing data through established repositories.
Do I need to submit a Data Management and Sharing Plan with a non-competitive renewal?
No, the DMS policy does not apply to non-competitive renewals (Type 5), only competing (Type 1 & 2) applications.
Last updated: July 26, 2023