“Here are my larger pieces of news and comment specifically on the adoption of the NIH policy. Chronological order.”
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.
“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….”
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.
“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….”
“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….”
“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….”
“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. …”
“HuBMAP (the Human BioMolecular Atlas Program) has released its inaugural data for use by the scientific community and the general public. Included in this release are detailed, 3D anatomical data and genetic sequences of healthy tissues from seven organ types, at the level of individual cells as well as many bulk tissue datasets. HuBMAP’s ultimate goal is to provide the framework required for scientists to create a 3D atlas of the human body.
HuBMAP’s tools and maps are openly available for research to accelerate understanding of the relationships between cell and tissue organization and function, as well as human health. Visitors can find the data at portal.hubmapconsortium.org.
HuBMAP is a consortium of 18 diverse collaborative research teams across the United States and Europe. HuBMAP values secure, open sharing and collaboration with other consortia and the wider research community. The consortium is managed by a trans-National Institutes of Health (NIH) working group of staff from the NIH Common Fund; National Heart, Lung, and Blood Institute; National Institute of Biomedical Imaging and Bioengineering; and the National Institute of Diabetes and Digestive and Kidney Diseases….”
“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 ClinicalTrials.gov, 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. …”