NOT-OD-23-180: Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) including Electronic Health Records, for NIH Supported Biomedical and Behavioral Research

“The purpose of this Request for Information (RFI) is to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research…. 

Researchers are increasingly using data collected in real-world settings to augment traditional research studies as well as develop more effective treatments and interventions for patients. These “real-world data (RWD)”, defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared.

Importantly, the National Institutes of Health (NIH) is committed to ensuring participant privacy and autonomy are protected in all NIH supported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data. Most recently, through an NIH Director Advisory Committee, NIH met with stakeholders to understand their perspectives on benefits and risks of combining and using human datasets, particularly from disparate sources (e.g., research and non-research settings) and how their data should be used in biomedical research. NIH will continue working to incorporate these perspectives in its research studies to build trust and honor participant preferences. Input requested on this RFI will be used to inform NIH’s continuing development of guidance on the use of RWD for research and assist in the planning for appropriate mechanisms and programs for research with RWD….”

Update on Access to Coronavirus-related Articles in PubMed Central (PMC) COVID-19 Collection After End of Public Health Emergency

“Early in the COVID-19 pandemic, the National Library of Medicine (NLM) collaborated with publishers and scholarly societies to expand access to coronavirus-related journal articles in PubMed Central (PMC), a digital archive of peer-reviewed biomedical and life sciences literature. Through this collaboration, more than 50 publishers made more than 350,000 coronavirus-related articles accessible under various article-level license terms through the PMC COVID-19 Collection (previously the PMC COVID-19 Public Health Emergency Initiative). This collaboration made a significant collection of coronavirus-related information immediately accessible to researchers to accelerate discoveries about COVID-19.

As COVID-19 emergency declarations expired in the United States and around the globe, so too did article-level license terms for use of some of these articles. Most of the articles deposited in the PMC COVID-19 Collection will remain available in PMC and available for bulk distribution and reuse, and all citations will remain searchable in PubMed; however, some publishers retained the right to remove their content and have requested to do so.

To assist PMC users in understanding these changes, NLM is making available, in downloadable format, lists of PMCIDs (PMC unique reference numbers) for any impacted articles.

NLM remains committed to providing perpetual public access to all articles deposited in the PMC COVID-19 Collection for which the copyright holder provides such permission. More information is available from the PMC COVID-19 Collection and PMC COVID-19 Collection FAQ webpages.”

Swapping Data Management Recipes – NLM Musings from the Mezzanine

“The 2023 DataWorks! Prize Challenge is underway, building off the successes of its first year. The challenge is sponsored by the NIH Office of Data Science Strategy, in partnership with the Federation of American Societies for Experimental Biology (FASEB).

The 2022 DataWorks! Prize saw over 100 teams, consisting of over 500 individuals, register to compete for the most innovative approaches to data sharing and reuse. It wasn’t just researchers who were excited about this challenge: Over 2,100 members of the data science community voted for their favorite projects, two of which were awarded the Federation of American Societies for Experimental Biology (FASEB) People’s Choice award.

This year’s challenge builds on the successes and insights from the 2022 prize. This challenge has the potential to make an enduring impact on the field of data science. Instead of novel data management techniques, this year’s prize will focus on best-practice “recipes” that advance biological and biomedical research activities by prioritizing practices that enable robust data management during the research process. This will enable the creation of an ongoing archive of best practices and resources that can be used by researchers to facilitate better data storage, sharing, and reuse.

This year’s prize offers up to 16 NIH-funded monetary awards, totaling up to $500,000, and up to two People’s Choice Awards, as determined by FASEB. Submissions will be evaluated based on:

Excellence in Data Sharing and Reuse
Innovative Impact on Human Health
Excellence in Communication and Adoption of Practices Outside of Original Context….”

A Year of Open Science, A Lifetime Commitment for NLM – NLM Musings from the Mezzanine

“In January 2023, the White House Office of Science and Technology Policy (OSTP) announced a federal Year of Open Science. NIH became one of more than a dozen agencies celebrating this Year of Open Science, which is designed to advance open and equitable science and promote access to the results of federally funded research. It has been a big year for NIH so far on the open science policy front with the NIH Data Management and Sharing (DMS) Policy going into effect in January and the announcement of the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research….

In February 2000, NLM launched PubMed Central, an open access repository of full-text biomedical and life sciences journal literature. By making these articles freely available, NLM ensures that researchers worldwide have unrestricted access to critical scientific findings—accelerating the pace of discovery and innovation. This open access helps democratize science by making the results of federally funded research available to all….


You may have noticed that I have referred to it as a Year of Open Science and not the Year of Open Science because our efforts toward providing equitable access to scientific research don’t end when the calendar flips to 2024. Open science is a long-term commitment for NLM, central to our mission to serve as a platform for biomedical discovery and data-powered health. As we continue to celebrate this Year of Open Science, how will you help open access to the results of scientific research?”

Results from the COGR Survey on the Cost of Complying with the New NIH DMS Policy | Council on Governmental Relations

“For mid-size to large research institutions, the annual projected cost impact is expected to exceed $500,000 at the central administrative level, while also exceeding $500,000 at the academic level––a total impact that exceeds $1 million per institution. Cost impact is measured both by new expenditures and reallocation of effort away from an individual’s current responsibilities. In the case of Researchers and Investigators, this results in a shift away from conducting science in the lab toward tasks that might be considered more administrative in nature. For smaller and emerging research institutions, the cost impact also is expected to be significant, and for these institutions, the disproportionate negative impact may discourage their participation in the federal research ecosystem.”

The Generalist Repository Ecosystem Initiative (GREI): First Year Momentum Leads to Exciting Future Plans | Data Science at NIH

“During the first year of the Generalist Repository Ecosystem Initiative (GREI), the effort has made noteworthy progress in fostering collaboration across the NIH generalist repository landscape. The GREI team has delivered on not only technical capabilities but on community outreach and engagement with a training webinar series, a community workshop, and conference presentations.

The GREI program brings together seven generalist repository awardees (Dataverse(link is external), Dryad(link is external), Figshare(link is external), Mendeley Data(link is external), Open Science Framework(link is external), Vivli(link is external), and Zenodo(link is external)) to work together in a “coopetition” (competition and cooperation) model of collaboration to reduce the barriers to NIH data sharing, discovery, and reuse. The coopetition effort has organized into functional working groups focused on use cases, metadata and search, metrics, and community engagement with the goals of enhancing interoperability across generalist repositories(link is external) and supporting the data needs of research communities….”

[SPARC response to the NIH public access plan]

“SPARC strongly supports the OSTP Memorandum’s emphasis on ensuring equity in contributing to, accessing, and benefitting from the results of federally funded research, and we appreciate NIH’s specific attention on how to ensure equity in publication opportunities for its funded investigators. As the research process has shifted to the digital environment, a wide variety of channels designed to support more rapid, frequent, and iterative communication of research findings have emerged. It is vital that researchers have compliance options that do not present them with financial barriers. To that end, NIH should make it clear that investigators can fully comply with its public access policy by depositing their author’s accepted manuscripts into PubMed Central (PMC) or any other agency-approved repository—and that there is no charge to do so. In its guidance, it is important for NIH to make clear that any fee that investigators may be asked to pay is a publication fee, and not a fee required by NIH to comply with its policy. It is critical that investigators do not conflate compliance with article processing charges (APCs), which create significant barriers for less-well-resourced investigators and institutions to make their research available….”

OASPA response to NIH RFI 2023 – OASPA

“This is OASPA’s response to the Request for Information based on this policy (with revisions) from the NIH as released on 21 Feb 2023.

OASPA (the Open Access Scholarly Publishing Association) represents a diverse community of organizations engaged in open scholarship and encourages and enables open access as the predominant model for scholarly outputs. 

OASPA wishes to ensure that open access is equitable and inclusive and is keen to explore with its publisher members and library stakeholders ways to increase equity in open access publishing. Why? Because the inclusion of all researchers, including authors from developing and transition countries, and indeed from all backgrounds and life stages, is essential for advancing human knowledge and also for a successful transition to open access. Without the development of new and more equitable approaches to open access, we will not benefit from its full potential….”

[COGR comments on the NIH public access plan]

“COGR is an association of over 200 public and private U.S. research universities and affiliated academic medical centers and research institutes. COGR concerns itself with the impact of federal regulations, policies, and practices on the performance of research conducted at our member institutions. As recipients of a significant portion of NIH extramural research programs, COGR’s member institutions value the opportunity to respond to this request. The White House Office of Science and Technology Policy (OSTP) memo1 sets forth requirements to increase access to publications and data resulting from federally funded research, and the NIH RFI NOT-OD-23-091 outlines NIH’s plans to address this directive. As recipients of federally funded research, ensuring public access to publications and research data resulting from supported research is core to our mission as research institutions and a responsibility we take seriously. COGR looks forward to continuing to engage with the community and the agencies on this important topic and offer the following comments….”

ARL Comments on NIH Plan to Enhance Public Access to Results of NIH-Supported Research – Association of Research Libraries

“On February 21, 2023, the US National Institutes of Health (NIH) released “Request for Information on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research.” The Association of Research Libraries (ARL) is pleased to offer the following comments in response to this request….”

Re: NIH RFI on Plan to Enhance Public Access to the Results of NIH-Supported Research | Blog

“tl;dr: The NIH should directly oppose a for-profit APC-driven publication system and cloud research infrastructure, and instead focus efforts on building truly public information infrastructures.

This is a response to: Request for Information on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research, an RFI for NOT-OD-23-091 and the 2022 Nelson open access memo….”

Data sharing in the context of community-engaged research partnerships – ScienceDirect



Data sharing policies should consider to whom benefits do and do not accrue.
Community Engaged Research Principles would increase community benefit.
Funders should develop mechanisms to ensure community benefit from data sharing.
Funders should track impact of data sharing on community-relevant outcomes….”