Mandating access: assessing the NIH’s public access policy | Economic Policy | Oxford Academic

Abstract:  In April 2008, the National Institutes of Health (NIH) implemented the Public Access Policy (PAP), which mandated that the full text of NIH-supported articles be made freely available on PubMed Central – the NIH’s repository of biomedical research. This paper uses 600,000 NIH articles and a matched comparison sample to examine how the PAP impacted researcher access to the biomedical literature and publishing patterns in biomedicine. Though some estimates allow for large citation increases after the PAP, the most credible estimates suggest that the PAP had a relatively modest effect on citations, which is consistent with most researchers having widespread access to the biomedical literature prior to the PAP, leaving little room to increase access. I also find that NIH articles are more likely to be published in traditional subscription-based journals (as opposed to ‘open access’ journals) after the PAP. This indicates that any discrimination the PAP induced, by subscription-based journals against NIH articles, was offset by other factors – possibly the decisions of editors and submission behaviour of authors.


New NIH Preprint Pilot Librarian Toolkit Available. NLM Technical Bulletin. 2020 Nov–Dec

“NLM has created a new resource for librarians: the NIH Preprint Pilot Librarian Toolkit. This toolkit provides information and resources about the NIH Preprint Pilot, NLM’s latest project to increase the early discoverability of NIH-supported research results.

What’s a preprint? A preprint is a complete and public draft of a scientific document that has not yet gone through peer review. During this pilot, NLM is making preprints that result from research funded by NIH available via PubMed Central (PMC) and PubMed. The first phase of the pilot focuses on preprints about COVID-19.

The NIH Preprint Pilot Librarian Toolkit has a variety of resources for librarians and other health professionals to learn about the role, access, and use of preprints. The toolkit includes an overview of the preprint pilot project, information for NIH investigators, preprint educational materials, journal preprint policies, and preprint peer review tools….”

Reflections on the Evolving World of Periodicals – PubMed

Abstract:  Data-Sharing Rule Finalized: Beginning in January 2023, all biomedical researchers newly funded by the U.S. National Institutes of Health (NIH) will be required to share data from their studies or explain why they are unable to do so. The new policy updates a 2003 requirement. Challenges in Achieving Replicability: The replicability of evidence for scientific claims is an important element in achieving scientific progress. Knowledge accumulation depends on reliable past findings to generate new ideas and extensions that can advance understanding. Disappearing Journals: Scholarly journals are supposed to provide a lasting record of science. Over the past two decades, however, 176 open-access journals and many papers appearing in them have disappeared from the Internet. The Conundrum of Academic Publishing: Academic publishing is in flux. Historically, dissemination of research through academic journals has been based on paid library or institutional subscriptions, with most content held behind a paywall. That is now changing with a global call for open access, a model of scholarly communication intended to increase accessibility of research results to the reader.


NOT-OD-21-013: Final NIH Policy for Data Management and Sharing

“The National Institutes of Health (NIH) is issuing this final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. 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. It also emphasizes the importance of good data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. This Policy applies to research funded or conducted by NIH that results in the generation of scientific data….”

Statement on Final NIH Policy for Data Management and Sharing | National Institutes of Health (NIH)

“The extraordinary effort to speed the development of treatments and vaccines in response to the COVID-19 pandemic has put into sharp relief the need for the global science community to share scientific data openly. As the world’s largest funder of biomedical research, NIH is addressing this need with a new NIH Policy for Data Management and Sharing. This policy requires researchers to plan prospectively for managing and sharing scientific data generated with NIH funds. This policy also establishes the baseline expectation that data sharing is a fundamental component of the research process, which is in line with NIH’s longstanding commitment to making the research it funds available to the public….”

Hahnel Argues for Making Data as Open as Possible | NIH Record

“Speaking virtually from London to a group of more than 120 NIH employees at a recent NIH Data Science Town Hall sponsored by the Office of Data Science Strategy, Dr. Mark Hahnel said, “To get the most out of science, research data needs to be as open as possible, as closed as necessary.”

For Hahnel, “open as possible” means data that is published openly and well-described. It also means educating researchers on the importance of data-sharing and the tools available to them….”

The Case for Making Data as Open as Possible | Data Science at NIH

“In July 2020 the Office of Data Science Strategy (ODSS) at the National Institutes of Health (NIH) completed the NIH Figshare Instance project, a one-year pilot with existing generalist repository Figshare to determine how biomedical researchers may use a generalist repository for sharing and reusing NIH-funded data.

To mark the conclusion of this project, ODSS invited Figshare founder and CEO Mark Hahnel, Ph.D., to share some of the pilot outcomes, his perspective on lessons learned from the project, and his thoughts on the future of data sharing at the NIH Data Science Town Hall, a monthly meeting for NIH employees interested in data science activities across the agency. The recording(link is external) of his presentation is now available. …”

NIH warns drug and device companies to post missing trial data 

“Hundreds of drug companies, medical device manufacturers, and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned last week.

New rules issued last week in the wake of a federal court ruling in February instructed clinical trial sponsors to submit missing data for trials conducted between 2007 and 2017 “as soon as possible.” For years, many trials conducted during that span have largely been exempted from reporting their data to, a public database, meaning a decade of data about approved drugs and medical devices has never been made public.

The court’s ruling, and the federal government’s decision not to appeal it and instead to urge trial sponsors to submit the missing information, represent a major win for transparency advocates, who for years have fought to recover the decadelong gap in publicly available clinical trial data. …

The court ruling, and the resulting change in federal policy, come after years of reporting that has detailed how federal research agencies routinely fail to enforce their own rules regarding clinical trial transparency — which advocates say is critical for the public’s understanding of a given medicines’s safety and efficacy. …”

Open-Access Data and Computational Resources to Address COVID-19 | Data Science at NIH

“COVID-19 open-access data and computational resources are being provided by federal agencies, including NIH, public consortia, and private entities. These resources are freely available to researchers, and this page will be updated as more information becomes available. 

The Office of Data Science Strategy seeks to provide the research community with links to open-access data, computational, and supporting resources. These resources are being aggregated and posted for scientific and public health interests. Inclusion of a resource on this list does not mean it has been evaluated or endorsed by NIH….”