Implementing the NIH Data Management and Sharing (DMS) Policy

Implementing the NIH Data Management and Sharing (DMS) Policy June 2023

POLICY APPLICABILIT Y

NIH has a longstanding commitment to making the results of research available. Data Management and Sharing Policy will create a consistent minimum expectation for all research supported by agency.

Policy Effective Dates The DMS Policy applies to all NIH funding mechanisms Extramural Competing applications submitted for Jan 25, 2023, and subsequent receipt dates Contracts Proposals submitted on or after Jan 25, 2023 Intramural Projects conducted on or after Jan 25, 2023 Other funding agreements (e.g., Other Transactions) Executed on or after Jan 25, 2023, unless otherwise stipulated by NIH 4

Scope of DMS Policy Applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of "scientific data“. "Scientific data" is defined as: "the recorded factual material 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."

Potential Examples of Scientific Data Scientific data will vary depending on the project and the context. Scientific data might include: Single-cell RNA sequencing (scRNA-seq) of T lymphocytes or other immune cells in a study of HIV/AIDS Electrophysiological recordings and fMRI images in a study of a rodent model of PTSD Step activity from a wearable device in a study of cardiovascular health

Scientific data do not include: Exclusions from the DMS Policy Data not necessary for or of sufficient quality to validate and replicate 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, (e.g., laboratory specimens)

Activities Subject to the DMS Policy APPLIES TO DOES NOT APPLY TO All research generating scienti fic data, including but not limited to: Research projects not generating scientific data or non-research projects, including but not limited to: Research Projects Training (Ts) Certain Career Development Awards (Ks) Fellowships (Fs) Small Business SBIR/STTR Research Centers Construction (C06) Conference Grants (R13) Resources (Gs) See Research Covered Under the Data Management & Sharing Policy

Policy Requirement s Submission of Data Management & Sharing Plan with all applications for funding beginning January 25, 2023 Compliance with the Data Management and Sharing Plan approved by the funding NIH Institute, Center, or Office

PLANNING & BUDGETING

Elements of a DMS Plan Data type Identifying data to be preserved and shared Data Type Oversight of Data Managemen t and Sharing Related tools, software, code Related tools, Software and/or Code Data preservation, access, timelines Standards Data Preservation, Access and Associated Timelines Standards Standards to be applied to scientific data and metadata Plan Elements Access, Distribution, or Reuse Considerations Tools and software needed to access and manipulate data Repository to be used, persistent unique identifier, and when/ how long data will be available Access, distribution, reuse considerations Description of factors for data access, distribution, or reuse Oversight of data management and sharing Plan compliance will be monitored/ managed and by whom See Writing a Data Management & Sharing Plan for details

Format of a DMS Plan ü Plan recommended not to exceed 2 pages in length Optional format page will be available DMS Plan Format Page

DMS Plan Submission A new “Other Plan(s)” field added to the PHS 398 form to collect a single PDF attachment Data Sharing Plans and Genomic Data Sharing Plans will no longer be submitted to the “Resource Sharing Plan(s)” field

DMS Plan Assessment NIH Program staff: Ensure Elements of a DMS Plan have been adequately addressed and assess the reasonableness of those responses Applications will only be funded when Plan is complete and acceptable Peer reviewers: Consider if budget is reasonable See Writing a Data Management & Sharing Plan

Resolving Plan Issues Before Award DMS Plan must be approved prior to award If additional details needed, communicate with NIH staff to resolve issues with DMS Plan Will occur through standard Just-In-Time (JIT) process Provide additional information and potentially a revised DMS Plan See Writing a Data Management & Sharing Plan

Monitoring Compliance Approved Plan becomes a Term and Condition of Award Grantee reports progress of approved DMS Plan in RPPR* Failure to comply may result in an enforcement action and affect future funding decisions. NIH reviews compliance annually *RPPR: Research Performance Progress Report (RPPR) - Annual, Interim, and Final

Data Management and Sharing Costs ALLOWABLE COSTS: UNALLOWABLE COSTS: Curating data/developing supporting documentation Infrastructure costs typically included in indirect costs Preserving/sharing data through repositories Costs associated with the routine conduct of research (e.g., costs of gaining access to research data) Local data management considerations IMPORTANT: Must be incurred during the performance period See Budgeting for Data Management & Sharing for details

Submitting DMS Budgets Include DMS costs in the appropriate cost category(ies), e.g., personnel, equipment, supplies, and other expenses, following standard budget form instructions. Direct costs to support the activities proposed in the DMS Plan must be identified and explained in the appropriate budget justification attachment, along with a brief summary of the DMS Plan, in a section labeled “Data Management and Sharing Costs.” R&R Budget Form: Budget Justification attachment PHS 398 Modular Budget Form: Additional Narrative Justification attachment

SHARING SCIENTIFIC DATA

Finding and Selecting a Repository Established repositories encouraged NIH ICs may designate specific data repository(ies) Recommend using a data-type or discipline-specific repository if available Other suitable options include: Institutional repositories PubMed Central (small datasets only) Generalist repositories See Selecting a Data Repository for details

Finding and Selecting a Repository: NIH & Other Resources NIH-Supported Repositories Filterable list of 70 NIH Repositories Other Repository Resources Generalist repositories Nature's Data Repository Guid ance Registry of Research Data Rep ositories See Repositories for Sharing Scientific Data

When should I share my data? As soon as possible! No later than the time of a publication of findings in a peer-reviewed journal OR at the end of the award, whichever comes first Collection Analysis/ Curation Sharing Storage Access/ Archive

Limitations on Sharing DMS Plans should maximize appropriate sharing Justifiable ethical, legal, and technical factors for limiting sharing include: Informed consent will not permit or limits scope of sharing or use Privacy or safety of research participants would be compromised and available protections insufficient Explicit federal, state, local, or Tribal law, regulation, or policy prohibits disclosure Restrictions imposed by existing or anticipated agreements with other parties

ADDITIONAL POLICIES & EXPECTATION S

Is my research also subject to other NIH data sharing policies? DECISION TOOL NIH INSTITUTE AND CENTER DATA SHARING POLICIES

Harmonization: Research Subject to DMS and Genomic Data Sharing (GDS) Policies 1. DMS Plan: Include a single Plan that addresses GDS and DMS policies 2. DMS Plans Review: Plan Assessment conducted by program staff, not by peer reviewers 3. Budget Considerations: Detailed budget should include allow allowable costs for all data types 4. Compliance: Monitoring handled in accordance with DMS policy compliance and enforcement terms 5. Timing of Data Sharing: GDS policy provides specific timelines, the latest possible time to submit data will be at the end of the award performance period NOT-OD-22-198

PROTECTING PRIVACY WHEN SHARING PARTICIPANT DATA

Best Practices for Protecting Privacy When Sharing Human Research Participant Data 1. De-identify to the greatest extent while maintaining scientific utility; Use Common Rule and HIPAA Privacy Rule standards Consider risks from information even when de-identified Share identifiable data only with explicit consent 2. Use agreements for transferring data Communicate limitations on use, include prohibitions on re-identification or recontact 3. Understand applicable legal protections and limitations on disclosure NOT-OD-22-213

Factors to Consider: Type of Access Sharing through controlled access if Explicit limitations on sharing Sharing through unrestricted access if . Data pose particular risks to participants or groups Explicitly consented for unrestricted sharing Data cannot be sufficiently deidentified De-identified and institutional review finds unrestricted sharing poses very low risk Unanticipated risks are discovered after initial planning

Best Practices for Responsible Management and Sharing of AI/AN Participant Data Understand Engage Establish Agree Consider Understand Tribal sovereignty and laws, regulations, policies, and preferences Engage early with Tribes when developing a data management and sharing plan, before research begins, and continue throughout research Establish mutually beneficial partnerships Agree who will manage data (e.g., Tribe, researcher, trusted 3rd party) Consider additional protections, as necessary NOT-OD-22-214

RESOURCES

You Can Prepare Now Familiarize yourself with the DMS Policy and resources available at sharing.nih.gov Identify existing resources and expertise within your institution that may be able to assist you, such as data librarians Try drafting a Data Management and Sharing Plan for your work based on the recommended elements (NOT-OD-21-014) Review your past data sharing practices to meet other funder or publisher expectations and consider what you may need to update for the new Policy in the future

Scientific Data Sharing Website Sharing Website

Frequently Asked Questions FAQs

Featured Webinars Implementing the New NIH Data Management and Sharing Policy: 2-part Series NNLM Data Management and Sha ring Series Data Curation Network Series GREI Collaborative Series: Genera list Repositories FASEB DataWorks! Salons

Stay in the loop! LISTSERVS BLOGS Extramural Nexus Under the Poliscope Open Mike NIH Guide to Grants & Contr acts Office of Science Policy New s SOCIAL MEDIA NIH Scientific Data Sharing News & Events @NIHGrants @NIH OSP News & Events