The Specific Aims do NOT count toward your Research Strategy, which has a 6 page limit. What are the page limits? documents in the last year, 755 Accordingly, we have included in the final DMS Policy an expectation that researchers will maximize appropriate data sharing when developing Plans. C. Contributions to Science – Describe up to 5 of their most significant contributions to science and may list up to 4 publications per contribution. This supplemental information is intended to help researchers choose data repositories suitable for the preservation and sharing of data (i.e., scientific data and metadata) resulting from NIH-funded and conducted research. For R25, R38 and DP7 applications only, Program Plan (Attachment 2 on PHS 398 Research Training Program Plan form) NIH expects that reasonable efforts will be made to digitize all scientific data.”. FOA supersedes), Introduction to Resubmission or Revision Application (when applicable), Applicant's Background and Goals for Fellowship Training, Training in the Responsible Conduct of Research, Letters of Support from Collaborators, Contributors, and Consultants. Concisely state the goals of the proposed research. Even those scientific data not used to support a publication are considered scientific data and within the final DMS Policy's scope. Lyric Jorgenson, by email at (email@example.com), or telephone at 301-496-9838. The final DMS Policy does not preclude the open sharing of data from human participants in ways that are consistent with consent practices, established norms, and applicable law. the Federal Register. For the U54, the Overall component is limited to 12 pages; the Administrative Core is 3 pages; the Shared Resource Cores (optional, up to 2) are 3 pages per core; the Research Projects (2–3) are 6 pages per project. The Specific Aims page is not included in the page limits for the Research Strategy of each component. be one page or less in length, unless specified otherwise in the FOA. Therefore, we have added to the definition that the data should be of sufficient quality to validate and replicate research findings. Extramural Awards: The Plan will become a Term and Condition of the Notice of Award. If you are using public inspection listings for legal research, you NIH does not intend to provide a comprehensive list of suitable repositories outside of those supported or stewarded by NIH. NIH considered all feedback in the development of the final DMS Policy, and a discussion of the public comments on topics follows below. Some pointed to special populations with preferences on data sharing issues, such as AI/AN populations, and asked how sharing of data from these participant populations is expected to be handled. Costs associated with data management and data sharing may be allowable under the budget for the proposed project (see Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing). Discuss potential problems, ... Resource Sharing Plan NIH Basic Instruction Guide. 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. F. Violations: Has procedures for addressing violations of terms-of-use by users and data mismanagement by the repository. Public Comments: While commenters were generally supportive of the overall scope of the Draft Policy, many requested NIH make an explicitly stronger commitment to expecting data sharing from the research community. This includes research funded or conducted by extramural grants, contracts, Intramural Research Projects, or other funding agreements regardless of NIH funding level or funding mechanism. 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. It is not an official legal edition of the Federal If no page limit is listed in the table below or in Section IV of the FOA under Page Limitations, you can assume the attachment does not have a limit. For the purposes of the DMS Policy, terms are defined as follows: Scientific Data: The recorded factual material commonly accepted in the Start Printed Page 68897scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Link it to your NCBI account or create one. Final Policy: We have indicated a framework for helping researchers think through a minimum time period for data availability. D. Curation and Quality Assurance: Provides, or has a mechanism for others to provide, expert curation and quality assurance to improve the accuracy and integrity of datasets and metadata. better and aid in comparing the online edition to the print edition. to list and/or summarize these publications in the appropriate sharing plan (Data Sharing Plan, Genomic Data Sharing Plan, Model Organism Sharing Plan Resource Sharing Plan… Final Supplemental Information: The final Supplemental Information eliminates the language that a response of “to be determined” is acceptable. has no substantive legal effect. NIH anticipates that the broader repository ecosystem will continue to evolve over time, providing different options for researchers as their data sharing needs continue to evolve. NIH Basic Instruction Guide. Note: This page limit includes the Additional Educational Information required for F30 and F31 applications. Primary consideration should be given to data repositories that are discipline or data-type specific to support effective data discovery and reuse. Commenters also suggested that NIH Program Staff review may lead to more consistent Plan assessment and decrease peer reviewer burden. In respect and recognition of Tribal sovereignty, NIH also initiated Tribal Consultation on its Draft Policy proposal, in accordance with the HHS Tribal Consultation Policy and the NIH Guidance on the Implementation of the HHS Tribal Consultation Policy. Applications for Concurrent Support (when applicable), For Individual Career Development Award (K, excluding K12) Applications, Candidate Information and Goals for Career Development and Research Strategy, Candidate's Plan to Provide Mentoring (Include only when required by the specific FOA, e.g., K24 and K05), Plans and Statements of Mentor and Co-mentor(s), Institutional Commitment to Candidate's Research Career Development, For institutional Training (T), International Training (D43, D71 , U2R), Institutional Career Development (K12, KL2), and Research Education (R25, UE5, R38,DP7) Applications, Introduction to Resubmission Application (when applicable), Introduction to Revision Application (when applicable), Specific Aims (Attachment 2 on PHS 398 Research Plan form; applies only to R25 , R38 and DP7), Research Education Program Plan (uploaded via the Research Strategy on PHS 398 Research Plan form) Public Comments: Commenters expressed uncertainty about how the concept of usefulness would be Start Printed Page 68895determined, and who would determine usefulness. Extent and type of data that will be shared. Register, and does not replace the official print version or the official For D43, D71, U2R, K12, KL2 and all Training (T) only, For R01, R03, R21, and all other Applications, Page Limits * Finally, the Draft Policy acknowledged that certain factors may limit the ability to share data and proposed that these factors be described in the Plan. NIH incorporated feedback over the course of several years to develop a data management and sharing policy proposal and released its Request for Comments on the Draft NIH Policy for Data Management and Sharing and Draft Supplemental Guidance on November 8, 2019 (84 FR 60398, comment period closing on January 10, 2020). With public input, NIH has worked to develop and refine this DMS Policy, the goal of which is to increase the sharing of scientific data generated from NIH-funded research to ultimately enhance health, lengthen life, and reduce illness and disability. 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). Public Comments: Commenters emphasized the importance of data security. documents in the last year, 43 J. 10. 10/29/2020 at 8:45 am. This prototype edition of the The additional characteristics outlined in this section are intended for repositories storing human data, which are also expected to exhibit the characteristics outlined in Section I, particularly with respect to confidentiality, security, and integrity. 4. documents in the last year, by the Comptroller of the Currency Suggestions included requiring data sharing and indicating that data sharing should be the default, with well justified exceptions being permitted. Draft Supplemental Information: The Draft Supplemental Information proposed that if certain elements of a Plan have not been determined by the time of Plan submission, an entry of “to be determined” may be acceptable if a justification is provided along with a timeline or appropriate milestone at which a determination will be made. documents in the last year, 347 Formatting Instructions. Public Comments: Commenters focused on a variety of aspects of the definition of “scientific data.” They suggested that the concept of data quality be included, as data that may otherwise meet the definition but, if uninterpretable, are not of value. Costs associated with collecting or otherwise gaining access to research data (e.g., data access fees) are considered costs of doing research and should not be included in scientific data management and sharing budgets. ® has developed a variety of useful materials and information. The final DMS policy is set forth below. Existing requirements and expectations set forth through, for example, applicable record retention requirements, repository policies, and journal policies may guide researchers as they seek to define minimal periods for data availability. However, NIH recognizes the need for providing a way to help researchers determine what characteristics make for a suitable repository for the preservation and sharing of data from NIH-funded research. Data Preservation, Access, and Associated Timelines: Plans and timelines for data preservation and access, including: Access, Distribution, or Reuse Considerations: NIH expects that in drafting Plans, researchers maximize the appropriate sharing of scientific data generated from NIH-funded or conducted research, consistent with privacy, security, informed consent, and proprietary issues. We note that data carrying explicit limitations on subsequent use require access controls to manage such limitations. Data Repository Selection: NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data. Reduce Screen Time Tools and Resources. 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. Commenters who favored submitting Plans at Just-in-Time frequently cited decreased burden on applicants, because with Just-in-Time, only those applicants likely to be funded would be required to submit Plans, rather than all applicants. 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. Extramural Awards: Plans will undergo programmatic assessment by NIH as determined by the proposed NIH ICO. The DMS Policy is consistent with federal regulations for the protection of human research participants and other NIH expectations for the use and sharing of scientific data derived from human participants, including the NIH's 2014 Genomic Data Sharing (GDS) Policy, 2015 Intramural Research Program Human Data Sharing Policy, and 45 CFR 46. This document has been published in the Federal Register. This Policy applies to research funded or conducted by NIH that results in the generation of scientific data. This Policy establishes the requirements of submission of Data Management and Sharing Plans (hereinafter Plans) and compliance with NIH Institute, Center, or Office (ICO)-approved Plans. These tools are designed to help you understand the official document 1. NIH promotes the use of established data repositories because deposit in a quality data repository generally improves the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data. For the U01, the Research Strategy is limited to 6 pages. 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. 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. documents in the last year, 309 Mailman School Research Resources (R2) Office NIH R21 Cheat Sheet Updated December 2012 3 13. Researchers may wish to consult experts in their own institutions (e.g., librarians, data managers) for assistance in selecting among data repositories. We do not expect researchers to necessarily have all details at the application stage, but we encourage researchers to fill out Plans to the best of their knowledge and ability, so the Plans may be appropriately assessed. The DMS Policy is intended to establish expectations for Data Management and Sharing Plans, which applicable NIH Institutes, Centers and Offices (ICO) may supplement as appropriate. Reasonable, allowable costs may be included in NIH budget requests when associated with: 1. from 44 agencies. In addition to the Supplemental Information discussed here, we intend to provide frequently asked questions and other information to aid in implementation, prior to the DMS Policy's Effective Date. are not part of the published document itself. the official SGML-based PDF version on govinfo.gov, those relying on it for 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) As a steward of the nation's investment in biomedical research, and in accordance with 42 U.S.C. To address some of the other themes and comments we heard from both AI/AN communities as well as public commenters who expressed interest in agency efforts to promote responsible and respectful engagement of AI/AN populations, we are developing supplemental information for researchers who wish to work with AI/AN communities. Respondents typically identified themselves as scientific researchers, while another sizeable section self-identified as “other.” Remaining respondents identified as institutional officials, with smaller percentages self-identified as bioethicists or social science researchers, government officials, patient advocates, and members of the public. For example, open sharing of a compilation of a population's genotype at a particular locus may be an acceptable and established practice if consistent with informed consent. 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. Resource Sharing Plan May be included for multiple reasons: Data Sharing Plan – included when seeking $500,000 or more in direct costs in any budget period. documents in the last year, 9 (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.) 12/11/2020, 300 The Draft Policy also included recognition of that fact that certain factors (i.e., legal, ethical, or technical) may limit the ability to preserve and share data. Important research may never be published for a variety of reasons, not least of which because the results did not prove the hypothesis. For example, NIH ICOs and Programs may wish to promote, via specific Funding Opportunity Announcements (FOAs) or across their research portfolios, the use of particular standards to enable interoperability of datasets and resources. Federal Register. Commenters suggested guidance to facilitate NIH ICO consistency and suggested that NIH provide a centralized location of NIH ICO-specific expectations to help researchers navigate variations, particularly when subject to more than one NIH ICO's data sharing policies. Register (ACFR) issues a regulation granting it official legal status. C. Metadata: Ensures datasets are accompanied by metadata to enable discovery, reuse, and citation of datasets, using schema that are appropriate to, and ideally widely used across, the community(ies) the repository serves. Document page views are updated periodically throughout the day and are cumulative counts for this document.  The NIH’s mission is to improve the health of the public through support of biomedical research and the training of biomedical scientists. However, through this Policy and associated supplemental information and other activities, NIH promotes thoughtful practices regarding the treatment of data derived from human participants. We were swayed by the logistical concerns expressed in comments, namely how applicants could submit budgets appropriately reflective of data management and sharing when not yet required to submit the Plan that is intended to help them consider these issues. Description of Institutional Environment and Commitment to Training Finally, we have removed the expectation for digitizing scientific data. C. Privacy: Implements and provides documentation of appropriate approaches (e.g., tiered access, credentialing of data users, security safeguards against potential breaches) to protect human subjects' data from inappropriate access. 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