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.” …”

Frontiers | Open Science for private Interests? How the Logic of Open Science Contributes to the Commercialization of Research | Research Metrics and Analytics

Abstract:  Financial conflicts of interest, several cases of scientific fraud, and research limitations from strong intellectual property laws have all led to questioning the epistemic and social justice appropriateness of industry-funded research. At first sight, the ideal of Open Science, which promotes transparency, sharing, collaboration, and accountability, seems to target precisely the type of limitations uncovered in commercially-driven research. The Open Science movement, however, has primarily focused on publicly funded research, has actively encouraged liaisons with the private sector, and has also created new strategies for commercializing science. As a consequence, I argue that Open Science ends up contributing to the commercialization of science, instead of overcoming its limitations. I use the examples of research publications and citizen science to illustrate this point. Accordingly, the asymmetry between private and public science, present in the current plea to open science, ends up compromising the values of transparency, democracy, and accountability.

 

NFTs and AI Are Unsettling the Very Concept of History | WIRED

“But now the survival of archives as we know them is uncertain. Whether we know it or not, we all rely on a patchwork of chronically underfunded public and private institutions that hold the world’s histories and cultural heritages in trust for all of us and make them accessible….

It was only a matter of time before the market figured out a way to manufacture and sell digital scarcity, and the marketplace for cultural objects has moved well past the archival ecosystem. Artists, gamers, entertainers, athletes, and executives now sell NFTs, tokenized digital objects whose authenticity is said to be assured by the reverse traceability of blockchain transactions. The combination of Covid-19 isolation and cryptocurrency profits created a powerful incentive for digital-positive collectors to compete for these NFTs, and some creators are raking in Ethereum….

Nothing could be a greater cultural and ethical shock to archives than NFTs. Prevailing archival ethics generally dictate that all users are treated equally, and that archival materials aren’t exposed or sold only to high bidders. And once archives select materials for retention, they consider themselves in most cases ethically bound to do so permanently….

As poor a fit with archival DNA as tokenizing archive collections as NFTs may be, the possibility of leveraging digital scarcity by selling NFTs while retaining physical materials is a hefty temptation. The archival world is a world of inadequate budgets and financial constraint, filled with underpaid workers and massive, poorly resourced projects like digital preservation, and the challenging task of digitizing analog materials. Will archives be tempted by the potential upside of NFTs and tokenize digital representations of their crown jewels (or the rights to these assets)? This would worsen an already bad situation…

One working solution is for cultural and historical institutions like archives to run their own trusted registries of digital objects. But this is expensive, and it creates further incentives for archives to monetize their holdings and become less accessible to noncommercial users, like genealogists, the group that uses archives more than anyone else. …”

The Impact of the German ‘DEAL’ on Competition in the Academic Publishing Market by Justus Haucap, Nima Moshgbar, Wolfgang Benedikt Schmal :: SSRN

Abstract:  The German DEAL agreements between German universities and research institutions on the one side and Springer Nature and Wiley on the other side facilitate easy open access publishing for researchers located in Germany. We use a dataset of all publications in chemistry from 2016 to 2020 and apply a difference-in-differences approach to estimate the impact on eligible scientists’ choice of publication outlet. We find that even in the short period following the conclusion of these DEAL agreements, publication patterns in the field of chemistry have changed, as eligible researchers have increased their publications in Wiley and Springer Nature journals at the cost of other journals. From that two related competition concerns emerge: First, academic libraries may be, at least in the long run, left with fewer funds and incentives to subscribe to non-DEAL journals published by smaller publishers or to fund open access publications in these journals. Secondly, eligible authors may prefer to publish in journals included in the DEAL agreements, thereby giving DEAL journals a competitive advantage over non-DEAL journals in attracting good papers. Given the two-sided market nature of the academic journal market, these effects may both further spur the concentration process in this market.

 

Recent Findings Indicate that Country-Level Open Access Frameworks Are Likely to Increase Concentration in the Publishing Market | Open Research Community

By sampling data in the field of chemistry, the working paper by Haucap et al. (2021) suggests that the Project DEAL agreement between German universities and institutes and large international publishers, e.g., Springer Nature, is likely to contribute to their market power.

Decolonizing Open Access in Development Research Journal Open Access and Plan S: Solving Problems or Shifting Burdens?

This academic thought piece provides an overview of the history of, and current trends in, publishing practices in the scientific fields known to the authors (chemical sciences, social sciences and humanities), as well as a discussion of how open access mandates such as Plan S from cOAlition S will affect these practices. It begins by summarizing the evolution of scientific publishing, in particular how it was shaped by the learned societies, and highlights how important quality assurance and scientific management mechanisms are being challenged by the recent introduction of ever more stringent open access mandates. The authors then discuss the various reactions of the researcher community to the introduction of Plan S, and elucidate a number of concerns: that it will push researchers towards a pay-to-publish system which will inevitably create new divisions between those who can afford to get their research published and those who cannot; that it will disrupt collaboration between researchers on the different sides of cOAlition S funding; and that it will have an impact on academic freedom of research and publishing. The authors analyse the dissemination of, and responses to, an open letter distributed and signed in reaction to the introduction of Plan S, before concluding with some thoughts on the potential for evolution of open access in scientific publishing.

AMWA-EMWA-ISMPP joint position statement on medical publications, preprints, and peer review

“The potential value of rapid publication should be weighed against the potential harm of inadequate validation of the final output. There is a danger that lowering the threshold of publication oversight sets a precedent that cannot be easily reversed, potentially eroding standards and public trust in medical science2.

We have joined in a multi-party consortium among three eminent professional organizations for medical communication professionals – AMWA, EMWA, and ISMPP – to advocate for the adoption of standards by all stakeholders to better ensure the integrity of published scientific and medical information. Thus, the following Joint Position Statement has been developed to provide practical and implementable suggestions to uphold data integrity and quality, and the transparency of medical publications….”

Addressing the Alarming Systems of Surveillance Built By Library Vendors – SPARC

“On April 2nd, news broke that RELX subsidiary LexisNexis signed a multi-million dollar contract with U.S. Immigration and Customs Enforcement (ICE). According to reporting on the ICE contract by the Intercept, LexisNexis’ databases “offer an oceanic computerized view of a person’s existence” and will provide the agency with “the data it needs to locate people with little if any oversight.” 

While this contract may be new, it is just the latest development in an alarming trend that SPARC is following. Two major library vendors—RELX and Thomson Reuters—have been building sophisticated, global systems of surveillance that include online tracking technologies, massive aggregation of user data, and the sale of services based on this tracking, including to governments and law enforcement. 

Dollars from library subscriptions, directly or indirectly, now support these systems of surveillance. This should be deeply concerning to the library community and to the millions of faculty and students who use their products each day and further underscores the urgency of privacy protections as library services—and research and education more generally—are now delivered primarily online. …

As alarming as these surveillance technologies are in their own right, they may already be crossing into academic products. Surveillance researcher Wolfie Christl has reported ThreatMetrix tracking code is now embedded in the ScienceDirect website, raising serious questions about what patron information is being collected and toward what purposes….

The Library Freedom Project’s Vendor Privacy Scorecard highlights the many privacy concerns across a wide selection of library vendors….”

The Changing Landscape of Open Access Publishing: Can Open Access Publishing Make the Scholarly World More Equitable and Productive?

Abstract:  Almost 50% of scholarly articles are now open access in some form. This greatly benefits scholars at most institutions and is especially helpful to independent scholars and those without access to libraries. It also furthers the long-standing idea of knowledge as a public good. The changing dynamics of open access (OA) threaten this positive development by solidifying the pay-to-publish OA model which further marginalizes peripheral scholars and incentivizes the development of  sub-standard and predatory journals. Causal loop diagrams (CLDs) are used to illustrate these interactions.