establishing the XML-based Federal Register as an ACFR-sanctioned They also stressed the importance of data sharing to maximize the contributions of those who volunteer to participate in NIH-funded studies. While we agree with the importance of appropriate data security measures, we believe that technical provisions regarding data security are more appropriately addressed by the institutions and repositories preserving and sharing the scientific data. If no appropriate discipline or data-type specific repository is available, researchers should consider a variety of other potentially suitable data sharing options: i. 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. Managing and Sharing Scientific Data, Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan, Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing, Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research, I. Final Policy: The final DMS Policy maintains NIH Program Staff assessments of Plans' merits. We encourage reasonable efforts to digitize data, recognizing that digitizing data may be a technical factor that may limit the sharing of data. We recognize that some fields and researchers plan for sharing and prepare data for preservation and sharing as a regular practice. publication in the future. Importantly, the Draft Policy did not propose any new expectations for the conduct of research with human participants. documents in the last year, 111 The OFR/GPO partnership is committed to presenting accurate and reliable For some programs and types of data, NIH and/or NIH ICO policy(ies) and FOAs identify particular data repositories (or sets of repositories) to be used to preserve and share data. The Tribal Consultation process also led to valuable input that is informing NIH's implementation efforts, described further below. And importantly, we are aware that some patient communities prioritize openness to speed scientific progress and discovery. Rather, it focused on requiring submission of and compliance with a Data Management and Sharing Plan (Plan) that outlines how data will be managed and shared. G. Request Review: Makes use of an established and transparent process for reviewing data access requests. Considerations for Scientific Data Derived from Human Participants: NIH prioritizes the responsible management and sharing of scientific data derived from human participants. We emphasize that respecting participant autonomy and maintaining privacy of participants and confidentiality of their data can be consistent with data sharing. headings within the legal text of Federal Register documents. 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. NIH has provided additional information to assist in selecting suitable repositories for scientific data resulting from funded research. This final Policy is effective January 25, 2023. Draft Policy: The Draft Policy proposed that shared scientific data should be made accessible in a timely manner for use by the research community and the broader public. We also note that adherence with NIH ICO-approved Plans is a requirement of the final DMS Policy. the current document as it appeared on Public Inspection on Submission of a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations. The final DMS policy is set forth below. from 16 agencies, updated on 8:45 AM on Friday, December 11, 2020, 114 documents B. Commenters also suggested that NIH Program Staff review may lead to more consistent Plan assessment and decrease peer reviewer burden. Plan Assessment: The NIH ICO will assess the Plan, through the following processes: NIH expects that in drafting Plans, researchers will maximize the appropriate sharing of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical) that may affect the extent to which scientific data are preserved and shared. corresponding official PDF file on govinfo.gov. to the courts under 44 U.S.C. Data Management and Sharing Plan (Plan): A plan describing the data management, preservation, and sharing of scientific data and accompanying metadata. documents in the last year, 755 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. This prototype edition of the 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. While many scientific fields have developed and adopted common data standards, others have not. I. Any potential limitations on subsequent data use should be communicated to individuals or entities (e.g., data repository managers) that will preserve and share the scientific data. NIH Grants Policy Statement 2.3.11 Availability and Confidentiality of Information (October 2019) https://grants.nih.gov/​grants/​policy/​nihgps/​html5/​section_​2/​2.3.11_​availability_​and_​confidentiality_​of_​information.htm. offers a preview of documents scheduled to appear in the next day's First, we encourage investigators to consider, while developing their Plans, how to address data management and sharing in the informed consent process, such that prospective participants will understand what is expected to happen with their data. Commenters also requested guidance on best practices in communicating data sharing in informed consent. Draft Policy: The Draft Policy did not explicitly set a default expectation of data sharing. Enhanced Review Criteria ... Resource Sharing Plan(s) 23. In such cases, the Plan may indicate that no consensus data standards exist for the scientific data and metadata to be generated, preserved, and shared. should verify the contents of the documents against a final, official Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (e.g., before deposit into an established repository). Primary consideration should be given to data repositories that are discipline or data-type specific to support effective data discovery and reuse. Draft Policy: The Draft Policy proposed the submission of Plans at Just-in-Time for grants. Discussion of Public Comments on the Draft Supplemental Information: Elements of an NIH Data Management and Sharing Plan Page Limit and Template for Plans. For data generated from research subject to such policies or funded under such FOAs, researchers should use the designated data repository(ies). 2020-23674 Filed 10-29-20; 8:45 am], updated on 4:15 PM on Friday, December 11, 2020, 19 documents The NIH Tribal Consultation Report—NIH Draft Policy for Data Management and Sharing provides more detail on the Tribal Consultation process relative to the development of the final DMS Policy and NIH's response. Even those scientific data not used to support a publication are considered scientific data and within the final DMS Policy's scope. 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. 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. How the scientific data will be findable and identifiable, When the scientific data will be made available to other users (, Privacy and confidentiality protections (, Whether access to scientific data derived from humans will be controlled (, Any restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or anticipated agreements (. 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. Discuss potential problems, ... Resource Sharing Plan NIH Basic Instruction Guide. Document Drafting Handbook After the end of the funding period, non-compliance with the NIH ICO-approved Plan may be taken into account by NIH for future funding decisions for the recipient institution (e.g., as authorized in the NIH Grants Policy Statement, Section 8.5, Special Award Conditions, and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions)). Draft Policy: The Draft Policy acknowledged the applicability of laws, regulations, guidance, and policies that govern the conduct of research with human participants and how data derived from human participants should be used. 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. Public Comments: Commenters expressed concerns about how to safeguard participant privacy and confidentiality when sharing data, with some requesting information on de-identification practices. Some suggested timing of data sharing be connected to publication. In response to input from Tribal Nations, the final DMS Policy clarifies agency respect for Tribal sovereignty in the absence of written Tribal laws or polices. edition of the Federal Register. This site displays a prototype of a “Web 2.0” version of the daily Along with the Draft Policy proposal, NIH sought feedback on supplemental materials that could help researchers integrate effective data management and sharing practices into research, including “Elements of an NIH Data Management and Sharing Plan” and “Allowable Costs for Data Management and Sharing.” We note that a third document, “Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research,” was developed in response to public comments received on both the Draft Policy and the “Request for Public Comments on Draft Desirable Characteristics of Repositories for Managing and Sharing Data Resulting From Federally Funded Research,” which was released for public comment by the White House Office of Science and Technology Policy (OSTP) to promote consistency across federal agencies and reduce researcher burden (85 FR 3085). 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