May 12, 2022 NIH released Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing. This document is intended to provide sample language to investigators and IRBs when developing consent for secondary use of data/biospecimens.
June 6, 2022 DataWorks! Prize – Incentives for building a culture of data sharing and reuse
DataWorks! is a $500,000 ($100,000 each for five winners) prize purse, to reward data sharing and reuse in biomedical research. It is a partnership between the NIH Office of Data Science Strategy and the Federation of American Societies for Experimental Biology (FASEB).
August 25, 2022 NIH Data Management & Sharing Webinar Series
NIH is providing webinars on the new policy around data management and sharing of data. One was held on August 11, but the recording and slide deck are available on the website. At the end of the slide deck are all the links to the resources discussed. The second webinar is on September 22, 2022. They last 1.5 hours.
August 25, 2022 The White House Office of Science and Technology Policy (OSTP) new sharing guidelines
OSTP announced an update to the policy on public access to publications and data resulting from Federally funded research. The 12-month embargo is to be removed and data needs to be made available at the time of the publication. Federal agencies have been asked to create a plan to accomplish this by 2026.
The National Academies Press has a number of publications related to research. Here they have listed under subject headings
Contaxis, N. et al. 2022. Ten Simple rules for improving research data discovery. PLOS.
This library guide was created by
Daureen Nesdill, MS MLIS
Research Data Mgmt Librarian
Daureen is retired as of August 31, 2022, and will no longer be updating this library guide. Please go to sharing.nih.gov for updates.
The date is Jan 25, 2023, but some centers and institutes have earlier dates so check with them.
Any researcher submitting a proposal to NIH on or after January 25, 2023. This includes researchers from all over the University of Utah campus. All research funded (in part or entirely) by NIH, e.g. extramural grants, contracts, intramural research grants, or any other NIH funding mechanisms. The policy does not apply to grants not generating data, i.e., training grants and infrastructure development. In addition, new policies exist for specific situations:
à Genomic Data Sharing Policy
à Model Organisms Sharing Policy
à Research Tools Policy
à Human Data Sharing including the Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov
The Data Management and Sharing Plan, DMS is documentation of how you will manage and share your scientific data and any accompanying metadata while taking into account any potential restrictions or limitations. The plan is expected to be dynamic, i.e., changes may need to be made while conducting the research. The funding institute or center will need to approve the changes. Speak to your Program Officer.
The 2003 NIH Data Sharing Policy required a plan for sharing the data or justification for not sharing the data. NIH has expanded that policy to include documentation of how you will manage research outcomes during the project and after it has been completed. In addition, the policy for sharing publications resulting from the research has been as is still in effect since 2003. For a refresher on sharing publications see When and How to Comply.
The DMS plan is the documentation of the work you have always performed prior to submitting any other NIH grant to determine costs and timeline, for example:
Add data preservation considerations, select an appropriate subject-based repository, and develop timelines for sharing. NIH has assembled information on the best practices for scientific data management for your education.
In short, the NIH believes that sharing scientific data accelerates biomedical research discovery, in part, by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies. In addition, the world has been moving towards open research/science which means freely sharing the results of all research. UNESCO signed the Recommendation on Open Science in November 2021.
It is the same as the White House, Office of Management and Budget definition recorded in Circular A-110: 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. 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.
Read the NIH overall instructions for your Data Management and Sharing Plan. In addition (1) check the funding institute or center to see if they have additional requirements, (2) determine where you will publish articles resulting from the work and check the journal’s requirements for the data and metadata, and (3) determine which repository you will submit your data/metadata to and learn of their requirements (see Repositories for Sharing Scientific Data).
The DMS plan should be included in the proposal as follows:
Allowable costs include:
Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing Notice Number: NOT-OD-21-015
The National Academies of Sciences Engineering and Medicine produced a report Life-Cycle Decisions for Biomedical Data: The Challenge of Forecasting Costs you can acquire from the National Academies Press. You can pay for a hard copy or download a free pdf. Login required.
In addition, NIH has produced a guide notice, Supplemental Policy Information: Allowable Costs for Data Management and Sharing Notice Number: NOT-OD-21-015 describing allowable costs. Also see Budgeting for Data Management and Sharing
From the NAP report: ASSESSING RESEARCH DATA COSTS A Checklist for Administrators at Research Institutions
On August 11, 2022, NIH announced that they are working on a template for the DMS. It is still in the planning stages but a draft is available. The DMPTool will be updated when the draft is finalized. See PREVIEW: Data Management and Sharing Plan Format Page at NIH Forms & Applications for updates.
The University has access to the California Digital Library DMPTool to assist in writing the NIH DMS. Quick Start Guide is provided. Sign in with your UU email. Plans are listed under:
WARNING: NIH will still be finalizing their policy, therefore the DMPTool templates will be updated to reflect the changes. Do not assume once you have created a template you can use it for all grant submissions in the future.
In general the plan should describe what data will be generated and how the research group will manage, store, and disseminate data generated (from Notice Number: NOT-HS-20-011):
After submission of the grant proposal peer reviewers may comment on the plan as part of the budget, but no score will be provided. Instead NIH program staff will assess the submitted plan.
At this point in time the NIH is saying:
NIH will monitor compliance with Plans over the course of the funding period during regular reporting intervals (e.g., at the time of annual Research Performance Progress Reports (RPPRs)). Noncompliance with Plans may result in the NIH ICO adding special Terms and Conditions of Award or terminating the award. If award recipients are not compliant with Plans at the end of the award, noncompliance may be factored into future funding decisions.
Both the University and the PI are responsible for complying with the new policy.
NIH expects researchers to maximize the sharing of their data but realizes ethical, legal, or technical concerns may limit sharing. NIH presents potential examples of justifiable factors including:
Examples of reasons that would generally not be justifiable factors limiting scientific data sharing include:
NIH respects and recognizes Tribal sovereignty and American Indian and Alaska Native (AI/AN) communities’ data sharing concerns, and NIH has proposed additional considerations when working with Tribes and AI/AN communities.
These DMS plans are not expected to be long narratives so 2-pages or less is appropriate.