NIH issues a seismic mandate: share data publicly

“In January 2023, the US National Institutes of Health (NIH) will begin requiring most of the 300,000 researchers and 2,500 institutions it funds annually to include a data-management plan in their grant applications — and to eventually make their data publicly available.

Researchers who spoke to Nature largely applaud the open-science principles underlying the policy — and the global example it sets. But some have concerns about the logistical challenges that researchers and their institutions will face in complying with it. Namely, they worry that the policy might exacerbate existing inequities in the science-funding landscape and could be a burden for early-career scientists, who do the lion’s share of data collection and are already stretched thin….

Such a seismic shift in practice has left some researchers worried about the amount of work that the mandate will require when it becomes effective….

Others worry that data-management activities will further sap funds from under-resourced labs. Although the policy outlines certain fees that researchers can add to their proposed budgets to offset the costs of compliance with the mandate, it doesn’t specify what criteria the NIH will use to grant these requests….

Despite its potential pitfalls, Ross thinks that the policy will have a ripple effect that will persuade smaller funding agencies and industry to adopt similar changes. “This policy establishes what people expect from clinical research,” he says. “It’s essentially saying the culture of research needs to change.” ”

Belgium discloses penalties for failing to report clinical trial results

“In the latest move to crack down on wayward clinical trial sponsors, Belgium may now fine companies, hospitals, and universities that fail to publicly disclose study results, a sign that more European regulators are growing concerned about a lack of transparency surrounding medical data….”

Today publication of drug trial results becomes mandatory in 30 European countries

“The European Union today launches its new clinical trial registry, marking a watershed in medical research transparency.

 

 

Companies, universities and hospitals are now legally obliged to make the results of drug trials public within one year completing a trial.

All 27 European Union countries plus Norway, Iceland and Liechtenstein have integrated the regulation into their national legal frameworks, meaning that sponsors that fail to share trial results will be in violation of national law.

 

 

 

 

 

Each country has also adopted penalties for violating this transparency requirement. Penalties vary from one country to the next. …”

 

New deposit obligation as of 1 January 2022 – Open Science

“As of 1 January 2022 the KU Leuven deposit obligation has been extended: in addition to journal articles, KU Leuven authors are now also required to deposit in Lirias a full text of every book chapter and conference proceeding they publish. Uploading the full texts of other publication types is strongly encouraged. When you select the ‘public access’ license, the Open Access Support Desk will monitor the publisher’s OA policy and the Belgian OA legislation and will apply the correct accessibility. …”

Incentivising research data sharing: a scoping review

Abstract:  Background: Numerous mechanisms exist to incentivise researchers to share their data. This scoping review aims to identify and summarise evidence of the efficacy of different interventions to promote open data practices and provide an overview of current research.

Methods: This scoping review is based on data identified from Web of Science and LISTA, limited from 2016 to 2021. A total of 1128 papers were screened, with 38 items being included. Items were selected if they focused on designing or evaluating an intervention or presenting an initiative to incentivise sharing. Items comprised a mixture of research papers, opinion pieces and descriptive articles.

Results: Seven major themes in the literature were identified: publisher/journal data sharing policies, metrics, software solutions, research data sharing agreements in general, open science ‘badges’, funder mandates, and initiatives.

Conclusions: A number of key messages for data sharing include: the need to build on existing cultures and practices, meeting people where they are and tailoring interventions to support them; the importance of publicising and explaining the policy/service widely; the need to have disciplinary data champions to model good practice and drive cultural change; the requirement to resource interventions properly; and the imperative to provide robust technical infrastructure and protocols, such as labelling of data sets, use of DOIs, data standards and use of data repositories.

Planetary Data System: Information for Data Proposers

“In response to a 2013 federal mandate the NASA Plan for Increasing Access to the Results of Scientific Research was developed to guide the management of and access to research data and peer-reviewed publications. Accordingly, the NASA Guidebook for Proposers describes the requirement that all proposals submitted under a NASA funding opportunity are required to submit a Data Management Plan. This website contains information and links that NASA’s Planetary Data System (PDS) believes will be helpful in preparing your proposal and your Data Management Plan, or simply as you develop a plan for archiving your data even if not as part of a funded proposal. If you have additional questions contact either the PDS or the relevant NASA Program Officer.

The intent of this website is to provide potential data providers with an overview of the appropriateness of the PDS as an archive for their data, the procedure for requesting letters of support for grant proposals, and the steps that a data provider would take in the generation of a PDS-compliant archive….”

Last updated October 2021.

Press release: COVID-19 research freely accessible, but research data sharing and preprinting are low – OASPA

“Levels of COVID-19 research data sharing have remained low during the pandemic, and preprinting of research on the virus has been lower than two initiatives tried to ensure it would be. This is according to a new report that examines the effectiveness of initiatives taken by players in the research ecosystem to promote sharing of COVID-19 research by stepping up open science approaches.

While the efforts of scientific publishers and the research community have speeded up publication times for COVID-19 research, and made much of it freely accessible, more effort is needed if society is to truly benefit from open science, the Scholarly Communication in Times of Crisis: The response of the scholarly communication system to the COVID-19 pandemic report says.

The sharing of the SARS-CoV-2 genome is seen as the poster child for open science, and the pandemic held up as a turning point for open science. Yet the report finds this has only partly been realised. It makes a series of key recommendations, three of which focus on opening up data, encouraging preprinting and strengthening collaboration across the scholarly communication ecosystem:

Only joint efforts will improve the availability and quality of research data sharing. Common data policy templates should be developed to require data sets and software to be posted to a trusted, FAIR-enabling repository, and to require formal citations to data sets and software.
Mandating preprinting and rewarding researchers who use preprints could shift the needle.  Publishers should include posting of preprints in their submission workflows and leaders should advocate for preprints.
Publishers and other scholarly communication organisations should intensify their joint efforts to improve the availability and quality of data and metadata on scholarly publishing, allowing for robust evidence-informed approaches to innovation in scholarly communication….”

FAPESP reformulates its policy of open access to publications | AGÊNCIA FAPESP

“FAPESP [Fundação de Amparo à Pesquisa do Estado de São Paulo] has reformulated its open-access policy, implemented in 2008, according to which scientific papers originating in research projects funded by it and approved for publication must be deposited in institutional repositories. Ordinance no. 37, issued on October 27 by FAPESP’s Executive Board (CTA), now mandates open access within 12 months of publication.

With the establishment of a deadline, it will be possible to verify compliance with FAPESP’s open-access mandate on the part of researchers it supports, using such tools as Google Scholar, which tracks whether research papers covered by funders’ public-access mandates are free to read. FAPESP expects this measure to enhance the visibility of the research it funds, and to increase the scientific, economic and social impact of published papers.

Researchers who are unable to comply for legal or contractual reasons must advise FAPESP of this impediment and justify it in the scientific reports required for the grants or scholarships associated with the publications, or via the contact section Converse com a FAPESP.”

The State of Open Data 2021

Key findings from this year’s survey

73% support the idea of a national mandate for making research data openly available
52% said funders should make the sharing of research data part of their requirements for awarding grants
47% said they would be motivated to share their data if there was a journal or publisher requirement to do so
About a third of respondents indicated that they have reused their own or someone else’s openly accessible data more during the pandemic than before
There are growing concerns over misuse and lack of credit for open sharing

How (not) to incentivise open research | The Bibliomagician

“Lizzie Gadd makes the case for open research being required not rewarded.

There’s no glory associated with running due diligence on your research partners and following GDPR legislation won’t give you an advantage in a promotion case. These are basic professional expectations placed on every self-respecting researcher. And whilst there are no prizes for those who adhere to them, there are serious consequences for those that don’t.  Surely this is what we want for open research? Not that it should be treated as an above-and-beyond option for the savvy few, but that it should be a bread-and-butter expectation on everyone.

Now I appreciate there is probably an interim period where institutions want to raise awareness of open research practices (as I said before, they need to be enabled before they can be incentivised).  And during this period, running some ‘Open Research Culture Awards’ or offering ‘Open research hero badges’ to web pages might have their place. But we can’t dwell here for long.  We need to move quite rapidly to this being a basic expectation on researchers. We have to define what open research expectations are relevant to each discipline. Add these expectations to our Codes of Good Research Practice. Train researchers in their obligations. Monitor (at discipline/HEI level) engagement with these expectations. And hold research leads accountable for the practices of their research groups.”

NIHR Open Access policy – for publications submitted on or after 1 June 2022

“Open access makes published academic research freely, immediately and permanently available online for anyone to read, share and reuse. This maximises the societal, academic, and economic impact of publicly funded research, and enhances the integrity and rigour of research through greater openness and transparency. This policy supports the Government R&D Roadmap and our commitment to adding value in research, one aspect of which is ensuring that research results are published in full in an accessible and unbiased report. Through the NIHR Journals Library and NIHR Open Research, we enable findings, including negative findings, from all NIHR funded research to be made open access.

The NIHR Open Access Policy is focused on our expectations in relation to publishing academic, peer-reviewed journal articles – but this is just one way in which our researchers may choose to disseminate their research findings. We recognise and encourage a diversity of approaches to disseminating research findings so that people can make use of them. We are also committed to making sure that when we assess research outputs during funding decisions, we consider the intrinsic merit of the work and not the journal in which it is published (see our position on responsible use of metrics).

This policy applies to peer-reviewed articles describing NIHR funded research findings submitted on or after 1 June 2022, when it will supersede the NIHR open access policy introduced in 2014. The revised open access policy follows extensive engagement with a wide range of stakeholders including the academic, publishing and health and care sectors and patients and the public. This included an open survey in autumn 2020 to inform the future of NIHR open access policy, public contributor workshops to capture the views of patients, carers, service users and the public on this agenda, a roundtable for health and social care organisations in collaboration with Health Education England, and an independent report on the challenges and opportunities of open access in Low- and Middle-Income Countries. Find out more about the Review and its supporting evidence. Key terms are explained in the glossary….

All in-scope articles must be published under the Creative Commons attribution licence (CC BY), or Open Government Licence (OGL) when subject to Crown Copyright, to ensure maximum impact. This will permit all users of NIHR-funded articles to disseminate and build upon the material for any purpose without further permission or fees being required….”