NIH Checklist Note this checklist is a general guide for “R01” type grants. publication in the future. L. Retention Policy: Provides documentation on policies for data retention within the repository. Data Type: Briefly describe the scientific data to be managed, preserved, and shared, including: Related Tools, Software and/or Code: An indication of whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software. However, peer reviewers may comment on the proposed budget for data management and sharing, although these comments will not impact the overall score. Mailman School Research Resources (R2) Office NIH R21 Cheat Sheet Updated December 2012 3 13. NIH makes a list of such data repositories available (see https://www.nlm.nih.gov/​NIHbmic/​domain_​specific_​repositories.html). Description of Institutional Environment and Commitment to Training [1] NIH encourages data management and sharing practices to be consistent with the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles and reflective of practices within specific research communities. Confidentiality: Has documented capabilities for ensuring that administrative, technical, and physical safeguards are employed to comply with applicable confidentiality, risk management, and continuous monitoring requirements for sensitive data. There are a variety of data sharing policies, considerations, resources, and guidance available to support researchers in safely and efficiently sharing data from their studies. As such, this Policy affords NIH ICOs the opportunity to meet the goals of this Policy in ways that enhance their respective science. These can be useful Unique Persistent Identifiers: Assigns datasets a citable, unique persistent identifier (PID), such as a digital object identifier (DOI) or accession number, to support data discovery, reporting (e.g., of research progress), and research assessment (e.g., identifying the outputs of federally funded research). 1. During the funding period, compliance with the Plan will be determined by the NIH ICO. documents in the last year, 941 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 physical objects, such as laboratory specimens. documents in the last year, by the National Oceanic and Atmospheric Administration The largest group of respondents reported affiliation with universities, followed by nonprofit research organizations, professional associations (tied with “other”), as well as small percentages of respondents affiliated with government agencies, healthcare delivery organizations, and patient advocacy organizations. on NARA's archives.gov. developer tools pages. Principal Deputy Director, National Institutes of Health. Final Policy: While the final DMS Policy's language on this issue has not substantively changed from that of the Draft Policy, we have heard the concerns and intend to address them during the period of implementation planning prior to the DMS Policy's Effective Date. Until the ACFR grants it official status, the XML For D43, D71, U2R, K12, KL2 and all Training (T) only, For R01, R03, R21, and all other Applications, Page Limits * Related Extramural SOP: Data Sharing for Grants: Final Research Data This is an actual plan from a PI with [brackets] in place of identifying information. Namely, researchers may share data underlying publication during the period of award but may share other data that have not yet led to a publication by the end of the award period. A general summary of the types and estimated amount of scientific data to be generated and/or used in the research. NIA also provides data resources to the Alzheimer’s and aging research community. The effective date of the DMS Policy is January 25, 2023, including for: The NIH ICO may request additional or specific information to be included within the Plan in order to meet expectations for data management and data sharing in support of programmatic priorities or to expand the utility of the scientific data generated from the research. from 16 agencies, updated on 8:45 AM on Friday, December 11, 2020, 114 documents Draft Policy: The Draft Policy stated that “NIH encourages the use of established repositories for preserving and sharing scientific data.”. D. Additional Information: Research Support and/or Scholastic Performance – List separate sections for ongoing and completed (within the last 3 years) support relevant to the proposal. NIH strongly encourages researchers to plan for how data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared. A key practical concern with Just-in-Time Plan submission was difficulty submitting a budget at application that included requests for allowable data management and sharing costs prior to actually drafting the Plan. Intramural Research Projects: Compliance with and enforcement of the Plan will be consistent with applicable NIH policies established by the NIH Office of Intramural Research and the NIH ICO. This supplemental information outlines the elements to be addressed in a Plan within two pages or less. Consistent with 45 CFR 75.403 and the NIH Grants Policy Statement Section 7.4, budget requests must not include infrastructure costs that are included in institutional overhead (e.g., Facilities and Administrative costs) or costs associated with the routine conduct of research. Renewals: opt . H. Security and Integrity: Has documented measures in place to meet generally accepted criteria for preventing unauthorized access to, modification of, or release of data, with levels of security that are appropriate to the sensitivity of data. For example, the 2003 NIH Data Sharing Policy reinforced NIH's commitment to data sharing by requiring investigators to address data sharing in applications for large research awards. NIH will seek input from AI/AN communities on the development of the guidance, to ensure it serves the goals of guiding researchers while taking into account Tribal preferences and values. Refer to the Table of Page Limits website. NIH Strategic Plan for Data Science (June 2018) https://datascience.nih.gov/​sites/​default/​files/​NIH_​Strategic_​Plan_​for_​Data_​Science_​Final_​508.pdf. The DMS Policy represents the minimum requirements for the NIH, but NIH ICOs may expect more specificity in Plans. Last Reviewed on March 18, 2015 Page 1. [8] Public Comments: While commenters appreciated the flexibility afforded by this approach, they also expressed concern about its ambiguity. documents in the last year, 43 Long-Term Sustainability: Has a plan for long-term management of data, including maintaining integrity, authenticity, and availability of datasets; building on a stable technical infrastructure and funding plans; and having contingency plans to ensure data are available and maintained during and after unforeseen events. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. Draft Policy: The Draft Policy proposed the submission of Plans at Just-in-Time for grants. Researchers should decide which scientific data to preserve and share based on ethical, legal, and technical factors that may affect the extent to which scientific data are preserved and shared. The final NIH Policy for Data Management and Sharing requires applicants to submit a Data Management and Sharing Plan (Plan) for any NIH-funded or conducted research that will generate scientific data. Important research may never be published for a variety of reasons, not least of which because the results did not prove the hypothesis. Open for Comment, Economic Sanctions & Foreign Assets Control, National Oceanic and Atmospheric Administration, Pacific Northwest National Laboratory - PNNL, Procedures for Asylum and Withholding of Removal, Ensuring Access to United States Government COVID-19 Vaccines, Governance and Integration of Federal Mission Resilience, Discussion of Public Comments on the Draft NIH Policy for Data Management and Sharing, Clarifying Expectations for Sharing Scientific Data, Timing of Submission of Data Management and Sharing Plans, NIH ICO Consistency of Data Sharing Expectations, Discussion of Public Comments on the Draft Supplemental Information: Elements of an NIH Data Management and Sharing Plan, The Acceptability of “To Be Determined” as a Response to Plan Elements, The Use of Persistent Unique Identifiers (PIDs), Discussion of Public Comments on the Draft Supplemental Information: Allowable Costs for Data Management and Sharing, Timelines for Using Funds for Data Management and Sharing Activities, Discussion of Requests for Additional Guidance and Information, NIH Policy for Data Management and Sharing, Section VI. on If applicable, specify how needed tools can be accessed, (e.g., open source and freely available, generally available for a fee in the marketplace, available only from the research team) and, if known, whether such tools are likely to remain available for as long as the scientific data remain available. NIH R15 Checklist . In addition to the public comments submitted during the comment period, NIH received input from the Secretary's Advisory Committee on Human Research Protections (SACHRP). For D43, D71, U2R, K12, KL2 and all Training (T) only, Plan for Instruction in the Responsible Conduct of Research (Attachment 3 on PHS 398 Research Training Program Plan form) Document Drafting Handbook Provide the rationale for these decisions. In addition, commenters suggested that NIH provide a template for Plans, with Plans being machine-readable. Draft Policy: The scope of which data will be shared relies on the definition of “scientific data.” This term was defined in the Draft Policy as: “The recorded factual material commonly accepted in the scientific community as necessary to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Note: This page limit includes the Additional Educational Information required for F30 and F31 applications. We also note that adherence with NIH ICO-approved Plans is a requirement of the final DMS Policy. documents in the last year, 779 These tools are designed to help you understand the official document New Documents Researchers may wish to consult experts in their own institutions (e.g., librarians, data managers) for assistance in selecting among data repositories. We believe this will provide the necessary flexibility for researchers to accommodate the substantial variety in research fields, projects, and data types that this expectation will encompass. To assist individuals and entities subject to the final NIH Policy for Data Management and Sharing, this supplemental information outlines categories of allowable NIH costs associated with data management and sharing. The Public Inspection page (In general, NIH policy is that for each section of the research plan for a "U" award, applicants may submit additional information: 1 page for each 6 page section, 2 for each section up to a page limit of 12 pages, and for each 30 page section, they can submit a 3-page update.) B. Learn more here. Extent and type of data that will be shared. FOA supersedes), Introduction to Resubmission and Revision Applications, For all Activity Codes (including each applicable component of a multi-component application), For all Activity Codes that use an application form with the Specific Aims section (including each component of a multi-component application), For Activity Codes R03, R13, U13, R13, U13, R21,R35, R36, R41, R43, SC2, SC3, X011, X021, R50, UT1, For Activity Codes DP3, DP5, G08, G11, G13, RC2, RC4, RF1, R01,R15, R18, R21/R33, R24, R28, R33, R34, R42, R44, R61, R61/R33, RL1, SB1, SC1, SI2, UB1, UC2, UH2,UH3, UG1, UC4, UF1, UG3/UH3, UH2/UH3, U01, U18, U24, U2C, U34, U42, U44,UT2, X011, X021, For Activity Codes R42, R44, SB1, UT2, U44, UB1 (Attachment 7 on SBIR/STTR Information form), For all Activity Codes (including DP1 and DP2 which previously had special page limits), Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding, Applicant/Recipient COVID-19 Update History, Early Stage and Early Established Investigator Policies, Protecting U.S. Biomedical Intellectual Innovation, Office of Laboratory Animal Welfare (OLAW), Office of Policy for Extramural Research Administration (OPERA), Office of Research Information Services (ORIS), Strategic Management and Contracts Office, Office of Electronic Research Administration (eRA), Division of Communication & Outreach (DCO), Small Business Education and Entrepreneurial Development (SEED), Division of Biomedical Research Workforce (DBRW), Individual Career Development Award (K, excluding K12) Applications, Institutional Training (T), International Training (D43, D71, U2R), Institutional Career Awards (K12, KL2), and Research Education (, R01, R03, R21, and all other Applications, U.S. Department of Health and Human Services, Progress Report (for renewal applications). . This table of contents is a navigational tool, processed from the has no substantive legal effect. Further, it is important to acknowledge that NIH recognizes that expectations for robust data management and sharing practices will need to be met with investments in and evolution of accompanying data infrastructure. [FR Doc. Public Comments: Commenters expressed concerns about how to safeguard participant privacy and confidentiality when sharing data, with some requesting information on de-identification practices. In addition, while the DMS Policy sets the expectation that, through their Plans, researchers maximize the appropriate sharing of scientific data (acknowledging factors that may limit such sharing, as discussed above), the DMS Policy does not expect that the informed consent given by participants to be obtained in any particular way, such as through broad consent. documents in the last year, 755 A Notice by the National Institutes of Health on 10/30/2020. Unlike a requirement for submission of Plans, which can be implemented across various funding mechanisms and types of research with little variation, appropriate data sharing is likely to be varied and contextual. 2. Applicable federal, Tribal, state, and local laws, regulations, statutes, guidance, and institutional policies govern research involving human participants and the sharing and use of scientific data derived from human participants. Competing grant applications that are submitted to NIH for the January 25, 2023 and subsequent receipt dates; Proposals for contracts that are submitted to NIH on or after January 25, 2023; NIH Intramural Research Projects conducted on or after January 25, 2023; and. Data Management and Sharing Plans, Section VII. In the final supplemental information, we have noted the elements to be addressed in two pages or less, indicating that these descriptions need not be long narratives. Draft Supplemental Information: The Draft Supplemental Information asked for researchers to indicate how data will be findable and whether a persistent unique identifier or other standard indexing tools will be used. C. Contributions to Science – Describe up to 5 of their most significant contributions to science and may list up to 4 publications per contribution. Overall, commenters expressed the desire for more clarity. Sign in with your eRA Commons account. For the U01, the Research Strategy is limited to 6 pages. that agencies use to create their documents. As indicated in the final DMS Policy, researchers will have opportunities to update their Plans throughout the course of their awards, subject to NIH ICO approval. 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. Nothing in the final DMS Policy is intended to prevent these approaches, as long as participants are appropriately informed and prospectively agree to them. Proposers who feel that the plan cannot fit within the limit of two pages may use part of the 15-page Project Description for additional data management information. (if different from FOA, on FederalRegister.gov 5. If a page limit is not specified for a section (for example, Multiple PD/PI Leadership Plan, Resource Sharing Plan), there is no page limit. should verify the contents of the documents against a final, official Therefore, the concepts of validation and replication provide a standard for determining what constitutes scientific data and are not intended to limit uses of shared data. documents in the last year. 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