New NIH Data Management and Sharing policy will be effective on Jan 25, 2023.
The NIH has released new policy for Data Management and Sharing (effective January 25, 2023) that applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. The Syracuse University Libraries and Office of Research Development have developed the following guidance to aid researchers on adhering to the new policies.
Under the DMS policy, NIH expects that investigators and institutions:
Researchers applying for NIH funding must create and submit to the NIH a Data Management and Sharing Plan (a “Plan”) outlining how scientific data and any accompanying metadata used in research will be managed and shared, considering any potential restrictions or limitations. A Plan should include a brief summary of:
Researchers should consider how to maximize appropriate sharing of data, while acknowledging existing legal, ethical, or technical factors that may call for justified limitations or exceptions.
In particular, NIH highlights the importance of informed consent and emphasizes that researchers should clearly communicate with prospective subjects how their scientific data are expected to be used and shared.
The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.
Syracuse University Resources
Research Data Services can assist you in creating a data sharing plan by determining what data can or will be shared as well as in what formats and where the data will be stored. Contact Research Data Services to schedule an appointment.
Budgeting for DMS Activities
The new DMS Policy allows researchers to budget for data management and sharing activities. Reasonable costs may be included in NIH budget requests for:
Costs must be incurred during the performance period.
The Proposal PI is required to monitor and manage the DMS plan, with at least yearly examination and oversight of data sharing and storage at the time of the RPPR, to ensure compliance with NIH DMS guidelines. The Office of Sponsored Programs verifies the inclusion of the DMS plans with new proposals. Any changes to the DMS plan will be communicated to NIH by the PI through the Office of Sponsored Program as required.
Sample language: PI _[name]_, will be responsible for the day-to-day oversight of lab/team data management activities and data sharing. Broader issues of DMS Plan compliance oversight and reporting will be handled by the PI and Co-I team as part of Syracuse University’s general stewardship, reporting, and compliance
How will the new DMS Plan be reviewed?
Peer Review will not see or review DMS Plans, but will consider any related budget items. NIH program staff will review the DMS Plan for acceptability and may request modifications prior to award as appropriate.
How is this different than a Data Sharing Plan from before 2023?
Information for this guide provided by the following resources:
NIH Scientific Data Sharing. https://sharing.nih.gov/
University of Michigan National Institutes of Health - Data Management & Sharing Plan Research Guide. https://guides.lib.umich.edu/c.php?g=682739&p=6631766
Brown University NIH Policy for Data Management and Sharing. https://www.brown.edu/research/conducting-research-brown/nih-policy-data-management-and-sharing
Virginia Commonwealth University NIH Data Sharing Research Guide. https://guides.library.vcu.edu/nihdmsp
University of Illinois Library Research Data Service NIH Data Management and Sharing Policy. https://researchdataservice.illinois.edu/nih-data-management-and-sharing-policy-goes-into-effect-soon/
Two divisions of the Health and Human Services Administration, the Centers for Disease Control (CDC) and the Agency for Healthcare Research and Quality (AHRQ) will be implementing new policies regarding public access to publications and data generated from grants awarded by the two agencies. These policies were mandated for all federal agencies awarding grants by the White House Office of Science and Technology Policy in 2013 for the purpose of making research funded, ultimately, by the public available to the public.
Beginning in October 2015, both the CDC and the AHRQ will require all publications resulting from research funded by either agency to be deposited in PubMed Central (PMC). PMC is a repository of scholarly articles published in the biomedical and life sciences fields. Both agencies will require the articles to be submitted within one year of publication.
Additionally, both agencies will require that any data generated by the research will also need to be made public. Researchers must include a Data Management Plan (DMP) in their grant proposal which outlines how the data will be collected, processed, safeguarded and, ultimately, made publicly accessible. The CDC indicates that it will work to identify repositories for data with the possibility of using their existing archives administered by the National Center for Health Statistics. The AHRQ says that it will partner with a commercial archive to provide a place for data.
These requirements for making publications and data publicly available are not all that new. What is new, however, is the increased emphasis on compliance. Both agencies make it clear that the Data Management Plan will be reviewed with the rest of the proposal and could negatively impact the score assigned to the proposal. Until now, the DMP was reviewed separately from the rest of the proposal and was commented on, but did not affect the final funding decision. Additionally, new awards will not be made if the terms of previous awards, such as publishing the data or following the DMP as stated, had not been fulfilled.
The CDC’s plan is CDC Plan for Increasing Access to Scientific Publications and Digital Scientific Data Generated with CDC Funding, and the AHRQ plan is AHRQ Public Access to Federally Funded Research.