The sharing of research data facing the COVID-19 pandemic | SpringerLink

Abstract:  During the previous Ebola and Zika outbreaks, researchers shared their data, allowing many published epidemiological studies to be produced only from open research data, to speed up investigations and control of these infections. This study aims to evaluate the dissemination of the COVID-19 research data underlying scientific publications. Analysis of COVID-19 publications from December 1, 2019, to April 30, 2020, was conducted through the PubMed Central repository to evaluate the research data available through its publication as supplementary material or deposited in repositories. The PubMed Central search generated 5,905 records, of which 804 papers included complementary research data, especially as supplementary material (77.4%). The most productive journals were The New England Journal of Medicine, The Lancet and The Lancet Infectious Diseases, the most frequent keyword was pneumonia, and the most used repositories were GitHub and GenBank. An expected growth in the number of published articles following the course of the pandemics is confirmed in this work, while the underlying research data are only 13.6%. It can be deduced that data sharing is not a common practice, even in health emergencies, such as the present one. High-impact generalist journals have accounted for a large share of global publishing. The topics most often covered are related to epidemiological and public health concepts, genetics, virology and respiratory diseases, such as pneumonia. However, it is essential to interpret these data with caution following the evolution of publications and their funding in the coming months.

From the body of the paper: “In global public health emergencies, it should be mandatory to disseminate any information that may be of value in fighting the crisis. For this to be done efficiently, there is a need to develop agreed global standards for sharing data and results for scientists, institutions and governments.”

Top health research funders’ guidance on… | F1000Research

“The majority (44/50) of sampled funders indicated funding health research. 38 (of 44, 86%) had publicly available information about disseminating funded research, typically called “policies” (29, 76%). Of these 38, 36 (95%) mentioned journal publication for dissemination of which 13 (36.11%) offer variable guidance on selecting a journal, all of which relate to the funder’s open access mandate. Six funders (17%) outlined publisher requirements or features by which to select a journal. One funder linked to a document providing features of journals to look for (e.g. listed in the Directory of Open Access Journals) and to be wary of (e.g., no journal scope statement, uses direct and unsolicited marketing).”

JAMA Publishes Trial Results Delayed 5 Years. Here’s Why

“A treatment for shortening the painful episodes of sickle cell disease (SCD) is not effective, results published in JAMA indicate. But the effort it took to publish the findings is an important part of the story and reveal problems with data ownership, company motivations, and public resources that go well beyond a single clinical trial or experimental agent….”

Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO

“ICMRA1 and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest….

Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used….

 

Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.”

 

 

Why some researchers oppose unrestricted sharing of coronavirus genome data

“Global-south scientists say that an open-access movement led by wealthy nations deprives them of credit and undermines their efforts….

But a growing faction of scientists, mostly from wealthy nations, argues that sequences should be shared on databases with no gatekeeping at all. They say this would allow huge analyses combining hundreds of thousands of genomes from different databases to flow seamlessly, and therefore deliver results more rapidly.

The debate has caught the attention of the US National Institutes of Health (NIH) — which runs its own genome repository, called GenBank — and the Bill & Melinda Gates Foundation, which has considered encouraging grantees to share on sites without such strong protections, Nature has learnt.

But many researchers — particularly those in resource-limited countries — are pushing back. They tell Nature that they see potential for exploitation in this no-strings-attached approach — and that GISAID’s gatekeeping is one of its biggest attractions because it ensures that users who analyse sequences from GISAID acknowledge those who deposited them. The database also requests that users seek to collaborate with the depositors….

Fears of inequitable data use are amplified by the fact that only 0.3% of COVID-19 vaccines have gone to low-income countries. “Imagine Africans working so hard to contribute to a database that’s used to make or update vaccines, and then we don’t get access to the vaccines,” says Christian Happi, a microbiologist at the African Centre of Excellence for Genomics of Infectious Diseases in Ede, Nigeria. “It’s very demoralizing.” …”

After the Pandemic: Has Medical Research Been Changed Forever? | MedPage Today

“medRxiv has been a terrific help to the scientific community during the pandemic. It has sped the communication of science and fostered interactions among scientists around the world. It is an open and rapid way to share pre-peer reviewed studies. For the most part, people seemed to have quickly realized that this is science in progress, and not to take it as truth — but as work open for comment. It has embedded the preprint culture in a way that I hope will be sustained and spread.

I am not aware of any harm that has accrued and I am aware that many good interactions have resulted from the sharing of the information. And it is certainly better than science by press release alone. Also, importantly, our screening process is intended to protect the public’s interest — safeguarding privacy, promoting registration, requiring ethics approval, and ensuring that dangerous claims are avoided….”

Data Sharing in Biomedical Sciences: A Systematic Review of Incentives | Biopreservation and Biobanking

Abstract:  Background: The lack of incentives has been described as the rate-limiting step for data sharing. Currently, the evaluation of scientific productivity by academic institutions and funders has been heavily reliant upon the number of publications and citations, raising questions about the adequacy of such mechanisms to reward data generation and sharing. This article provides a systematic review of the current and proposed incentive mechanisms for researchers in biomedical sciences and discusses their strengths and weaknesses.

Methods: PubMed, Web of Science, and Google Scholar were queried for original research articles, editorials, and opinion articles on incentives for data sharing. Articles were included if they discussed incentive mechanisms for data sharing, were applicable to biomedical sciences, and were written in English.

 

Results: Although coauthorship in return for the sharing of data is common, this might be incompatible with authorship guidelines and raise concerns over the ability of secondary analysts to contest the proposed research methods or conclusions that are drawn. Data publication, citation, and altmetrics have been proposed as alternative routes to credit data generators, which could address these disadvantages. Their primary downsides are that they are not well-established, it is difficult to acquire evidence to support their implementation, and that they could be gamed or give rise to novel forms of research misconduct.

Conclusions: Alternative recognition mechanisms need to be more commonly used to generate evidence on their power to stimulate data sharing, and to assess where they fall short. There is ample discussion in policy documents on alternative crediting systems to work toward Open Science, which indicates that that there is an interest in working out more elaborate metascience programs.

REPEAT (Reproducible Evidence: Practices to Enhance and Achieve Transparency)

“Replication is a cornerstone of the scientific method. Historically, public confidence in the validity of healthcare database research has been low. Drug regulators, patients, clinicians, and payers have been hesitant to trust evidence from databases due to high profile controversies with overturned and conflicting results. This has resulted in underuse of a potentially valuable source of real-world evidence.?…

Division of Phamacoepidemiology & Pharmacoeconomics [DoPE]

Brigham & Women’s Hospital and Harvard Medical School.”

What is RIAT? – RIAT Support Center

“RIAT is an international effort to tackle bias in the way research is reported with the goal of providing more accurate information to patients and other healthcare decision makers.

Randomized controlled trials are known as medicine’s “gold standard” for reliable evidence. However, they are falling short of that standard, in large part due to two fundamental problems:

MISREPORTING: many trials that are published are inaccurately or incompletely reported (misreported trials)
INVISIBILITY: not all trials conducted are published (unpublished trials)

When the original investigators or sponsors do not correct misreporting, or even leave the entire trial unpublished, they can be considered to have abandoned their trial. And the downstream effects can be substantial, drawing to false conclusions about the effectiveness and safety of medical interventions.

The RIAT initiative aims to address these problems by offering a methodology that allows other people to responsibly correct the record….”

Health research council moves to mandate immediate open access – Research Professional News

“Australia’s National Health and Medical Research Council has proposed that immediate open-access publication of research resulting from its grants should become mandatory.

The council already requires researchers to list their patents on the government’s SourceIP website, but its existing policy allows a 12-month delay to open-access publication of NHMRC-funded research.

The proposed reforms would involve researchers publishing in open repositories, circumventing publishers’ fees, as well as publishing in traditional journals. Authors would be required to retain the rights to publish and share their work. It would also encourage researchers to release non-peer-reviewed preprints.

The proposals are contained in a discussion paper released by the council in April and would take effect from the beginning of 2022….”