“NIH is committed to making findings from the research that it funds accessible and available in a timely manner, while also providing safeguards for privacy, intellectual property, security, and data management. For instance, NIH-funded investigators are expected to make the results and accomplishments of their activities freely available within 12 months of publication. NIH also encourages investigators to share results prior to peer review, such as through preprints, to speed the dissemination of their findings and enhance the rigor of their work through informal peer review. A robust culture of data sharing is critical to continued progress in science, maximizing NIH’s investment in research, and assurance of the highest levels of transparency and rigor. To this end, NIH will continue to promote opportunities for data management and sharing while allowing flexibility for various data types, sharing platforms, and strategies. Additionally, NIH is implementing a policy requiring that all applications include data sharing and management plans that consider input from stakeholders….”
“The National Institutes of Health (NIH) released today a Request for Information (RFI) on streamlining access to controlled data from NIH data repositories (NOT-OD-21-157). Responses are due Aug. 9.
The NIH is requesting input on strategies for harmonizing, simplifying, and streamlining mechanisms for accessing data in NIH-supported controlled-access data repositories that continue to uphold robust data privacy and security protections. In particular, NIH would like to understand better researchers’ experiences in finding and accessing controlled access data housed in NIH-supported repositories and the extent to which existing NIH policies address aggregation and linkage of controlled access data….”
“Ten months into the NIH Preprint Pilot, more than 2,100 preprints reporting NIH-supported research on COVID-19 are now discoverable in PubMed Central (PMC) and PubMed. Through early April 2021, these records have been viewed more than 1 million times in each of these databases (1.4 million in PMC; 1 million in PubMed). Of the preprints included in the pilot, ~60% are currently discoverable only as a preprint version, having not yet been linked to a published article. All articles are clearly identified as preprints. Preprints may be selected or excluded in searches by using the preprint filter.
The pilot launched in June 2020 with preprint records from medRxiv, bioRxiv, arXiv, ChemRxiv, Research Square, and SSRN. Phase 1 has focused on improving the discoverability of preprints relating to the ongoing public health emergency and accelerating dissemination of NIH-supported research on the SARS-CoV-2 virus and COVID-19. This narrowly scoped first phase has allowed the National Library of Medicine (NLM) to streamline curation and ingest workflows for NIH-supported preprints and refine the details of implementation with a set of articles for which there has been high demand for accelerated access and discovery. Since launching the pilot, NLM has made display of preprint records in PubMed search results more transparent. We have also automated checks for new preprint versions and preprint withdrawals, and reduced the steps required to report preprints as products of awards in My Bibliography….”
“Researchers who receive federal help consistently fail to report their results to the public. The government should hold them accountable….
Researchers using federal funds to conduct cancer trials — experiments involving drugs or medical devices that rely on volunteer subjects — were sometimes taking more than a year to report their results to the N.I.H., as required. “If you don’t report, the law says you shouldn’t get any funding,” he said, citing an investigation I had published in Stat with my colleague Talia Bronshtein. “Doc, I’m going to find out if it’s true, and if it’s true, I’m going to cut funding. That’s a promise.”
It was true then. It’s true now. More than 150 trials completed since 2017 by the N.I.H’s National Cancer Institute, which leads the $1.8 billion Moonshot effort, should have reported results by now. About two-thirds reported after their deadlines or not at all, according to a University of Oxford website that tracks clinical trials regulated by the Food and Drug Administration and National Institutes of Health. Some trial results are nearly two years overdue. Over all, government-sponsored scientists have complied less than half the time for trial results due since 2018. (A spokeswoman for the N.I.H. said, “We are willing to do all measures to ensure compliance with ClinicalTrials.gov results reporting.”)…
In 2016, Dr. Francis Collins, the director of the National Institutes of Health, announced that the agency would begin penalizing researchers for failing to comply with its reporting requirements. “We are serious about this,” he said at the time. Yet in the years since, neither the F.D.A. nor N.I.H. has enforced the law. …”
“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. …”
“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. …”
“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….”
“Recognizing the growing interest in preprints, NLM is today launching the first phase of the NIH Preprint Pilot, which will test the viability of making preprints searchable in PubMed Central (PMC) and, by extension, discoverable in PubMed, starting with COVID-19 preprints reporting NIH-supported research.
To be clear, NLM is not building a preprint server for NIH investigators, nor are we developing a comprehensive preprint discovery resource. Rather, through this pilot, we plan to add a curated collection of preprints from eligible preprint servers to our established literature resources. In doing so, our goal is to improve scholarly communications by accelerating and expanding the findability of NIH research results.
With the encouragement of NIH leadership, NLM has been exploring ways to leverage its literature databases to help accelerate the discoverability and maximize the impact of NIH-supported research via preprints. The planned pilot builds on guidance released by NIH in March 2017, which encouraged NIH investigators to use preprints and other interim research products to speed the dissemination of research and enhance the rigor of their work through public comments and new scientific collaborations….”