August 5, 2022
RFA-HD-24-004 - Opportunities for Advancing Limb Regeneration Research (R01 Clinical Trial Not Allowed)
PAR-22-256 - Pragmatic Trials across the Cancer Control Continuum (UG3/UH3 Clinical Trial Required)
PAR-23-065 - NIAID Resource-Related Research Projects (R24 Clinical Trial Not Allowed)
PAR-23-038 - Testing Centers for Development of Somatic Cell Genome Editing in Model Organisms (U42) (Clinical Trials Not Allowed)
RFA-HD-24-006 - Using Archived Data and Specimen Collections to Advance Maternal and Pediatric HIV/AIDS Research (R21 - Clinical Trial Not Allowed)
RFA-MH-23-310 - Social Drivers of Mental Illnesses in Low- and Middle-Income Countries: Mechanisms and Pathways of Interventions for Youth (R01 Clinical Trial Optional)
PAR-23-051 - Mechanistic links between diet, lipid metabolism, and tumor growth and progression (U01 Clinical Trial Not Allowed)
PAR-23-052 - Mechanistic links between diet, lipid metabolism, and tumor growth and progression (UH2 Clinical Trial Not Allowed)
PAR-23-053 - Research Infrastructure Development for Interdisciplinary Aging Studies (R61/R33 - Clinical Trial Optional)
PAR-23-054 - Advanced-Stage Development and Utilization of Research Infrastructure for Interdisciplinary Aging Studies (R33 Clinical Trial Optional)
RFA-CA-23-020 - NCI Cancer Screening Research Network: ACCrual, Enrollment, and Screening Sites (ACCESS) Hub (UG1 Clinical Trial Required)
RFA-CA-23-021 - NCI Cancer Screening Research Network: Statistics and Data Management Center (UG1 Clinical Trial Required)
RFA-CA-23-022 - NCI Cancer Screening Research Network: Coordinating and Communication Center (UG1 Clinical Trial Required)
RFA-DA-23-059 - HEAL Initiative - Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program: Leadership and Data Co-ordinating Center (U01 Clinical Trial Optional)
RFA-DA-23-060 - HEAL Initiative - Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program: Leadership and Data Co-ordinating Center (U01 Clinical Trial Optional)
RFA-DA-24-002 - Exploratory studies to investigate mechanisms of HIV infection, replication, latency, and/or pathogenesis in the context of substance use disorders (R61/R33 - Clinical Trial Not Allowed)
PAR-23-047 - Engineering Next-Generation Human Nervous System Microphysiological Systems (R21 Clinical Trials Not Allowed)
PAR-23-046 - Engineering Next-Generation Human Nervous System Microphysiological Systems (R01 Clinical Trials Not Allowed)
November 8, 2022 - Transformative Educational Advancement and Mentoring Network (TEAM) (R25 Clinical Trial Not Allowed). See Notice RFA-CA-23-013
November 8, 2022 - Investigating the Effects of Addictive Substances on Brain Developmental Trajectories Using Innovative Scalable Methods for Quantification of Cell Identity, Lineage and Connectivity (R01 - Clinical Trial Not Allowed). See Notice RFA-DA-23-036
RFA-CA-23-019 - Precompetitive Collaboration on Liquid Biopsy for Early Cancer Assessment: Data Management and Coordinating Unit (U24 Clinical Trial Not Allowed)
PAR-23-041 - Functional Validation and/or Characterization of Genes or Variants Implicated in Substance Use Disorders (R21/R33 Clinical Trial Not Allowed)
PAR-23-040 - Development of Resources and Technologies for Enhancing Rigor, Reproducibility, and Translatability of Animal Models in Biomedical Research (R01))
PAR-23-039 - Development of Resources and Technologies for Enhancing Rigor, Reproducibility, and Translatability of Animal Models in Biomedical Research (R24 Clinical Trials Not Allowed)
NOT-OD-22-195 - Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed).
NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
RFA-DA-24-007 - Avenir Award Program for Chemistry and Pharmacology of Substance Use Disorders (DP1- Clinical Trial Not Allowed)
RFA-HD-24-002 - Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed).
NOT-OD-21-013- Final NIH Policy for Data Management and Sharing
NOT-OD-21-014– Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan
NOT-OD-21-015– Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing
NOT-OD-21-016– Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research
NOT-OD-22-195– New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
NOT-OD-22-198 – Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023
NATIONAL INSTITUTES OF HEALTH (NIH)
The purpose of this notice is to inform the extramural research community of implementation details for the NIH Policy for Data Management and Sharing (DMS Policy) affecting grant and cooperative agreement applications submitted for receipt dates on or after January 25, 2023. The specific changes to competing grant and cooperative agreement application instructions clarified below will be implemented with application form packages identified with a Competition ID of “FORMS-H” and incorporated into the forthcoming FORMS-H application guides.
Although the DMS Policy will apply also to Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions), the forms changes and other implementation details provided in this Notice apply only to NIH extramural grant and cooperative agreement activities. Details applicable to R&D contracts will be incorporated into the appropriate Requests for Proposals, and details applicable to Other Transactions will be incorporated into the appropriate Research Opportunity Announcement.
The below implementation details for the NIH DMS Policy are effective beginning with competing applications submitted for receipt dates on or after January 25, 2023.
The DMS Policy applies to all NIH research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. The DMS Policy does not apply to research and other activities that do not generate scientific data, for example: research training, fellowships, infrastructure development, and non-research activities. See Research Covered Under the Data Management & Sharing Policy for more details.
Beginning with receipt dates on or after January 25, 2023, competing applications submitted for activities subject to the DMS Policy will be required to submit a DMS Plan at the time of application for NIH grants or cooperative agreements. The following changes will be made to forms to accommodate the new DMS Plan:
Assessment of the DMS Plan and Budget
Program staff at the proposed NIH Institute or Center will assess DMS Plans to ensure the Elements of a DMS Plan have been adequately addressed and to assess the reasonableness of those responses. Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.
During peer review, reviewers will not be asked to comment on the DMS Plan nor will they factor the DMS Plan into the Overall Impact score, unless sharing data is integral to the project design and specified in the Funding Opportunity Announcement. On the proposed budget for data management and sharing, peer reviewers may provide comments on the reasonableness of the budget but these comments will not impact the score. Peer reviewers will only use the information found in the budget justification to determine whether the requested Data Management and Sharing Costs are reasonable and will not be provided with the separate DMS Plan attachment.
When Data Sharing is Integral to the Funding Opportunity Announcement
Program staff will assess the adequacy of the DMS Plan attachment for specific Funding Opportunity Announcements where data sharing is integral to the project design and tied to a scored review criterion. In these cases, peer reviewers will be able to view the DMS Plan attachment and may factor that information into the score as outlined in the evaluation criteria.
Processes for Plan Revisions Requested and Just-in-Time Submission Process
If the DMS Plan provided in the application cannot be approved based on the information provided, applicants will be notified that additional information is needed. This will occur through the Just-in-Time (JIT) process. Applicants will be expected to communicate with their Program Officer or Grants Management Specialist to resolve any issues that prevent the funding NIH Institute or Center from approving the DMS Plan, and potentially to submit a revised DMS Plan. Refer to NIH Grants Policy Statement Section 2.5.1 Just-in-Time Procedures for additional guidance.
Processes for Post-Award Plan Revisions and Submission Process
Following award, recipients are required to comply with the version of the DMS Plan that was approved by the funding NIH Institute or Center. DMS Plans may be updated during regular reporting intervals as part of the annual Research Performance Progress Report (RPPR) process. Refer to NIH Grants Policy Statement Section 8.4.1 Reporting for additional guidance. Changes to the DMS Plan must be approved by the funding NIH Institute or Center.
NIH Scientific Data Sharing Policy Implementation