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Academia should stop using beall’s lists and review their use in previous studies

Authors : Jaime A. Teixeira da Silva, Graham Kendall

Academics (should) strive to submit to journals which are academically sound and scholarly. To achieve this, they could either submit to journals that appear exclusively on safelists (occasionally referred to as whitelists, although this term tends to be avoided), or avoid submitting to journals on watchlists (occasionally referred to as blacklists, although this term tends to be avoided).

The most well-known of these lists was curated by Jeffrey Beall. Beall’s Lists (there are two, one for stand-alone journals and one for publishers) were taken offline by Beall himself in January 2017.

Prior to 2017, Beall’s Lists were widely cited and utilized, including to make quantitative claims about scholarly publishing. Even after Beall’s Lists became obsolete (they have not been maintained for the past six years), they continue to be widely cited and used. This paper argues that the use of Beall’s Lists, pre- and post-2017, may constitute a methodological error and, even if papers carry a disclaimer or limitations section noting this weakness, their conclusions cannot always be relied upon.

This paper also argues for the need to conduct a detailed post-publication assessment of reports in the literature that used Beall’s Lists to validate their findings and conclusions, assuming that it becomes accepted that Beall’s Lists are not a reliable resource for scientific investigation.

Finally, this paper contends that any papers that have identified methodological errors should be corrected. Several lists that were cloned from Beall’s Lists have also emerged and are also being cited. These should also be included in any post-publication investigation that is conducted.

URL : Academia should stop using beall’s lists and review their use in previous studies

DOI : https://doi.org/10.47316/cajmhe.2023.4.1.04

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Contours of a research ethics and integrity perspective on open science

Authors : Tom Lindemann, Lisa Häberlein

This article argues that adopting a research ethics and integrity perspective could support researchers in operationalizing the open science guiding principle “as open as possible, as closed as necessary” in a responsible and context-sensitive manner.

To that end, the article points out why the guiding principle as such provides only a limited extent of action-guidance and outlines the practical value of ethical reflection when it comes to translating open science into responsible research practice.

The article illustrates how research ethics and integrity considerations may help researchers understand the ethical rationale underpinning open science as well as recognize that limiting openness is necessary or at least normatively permissible in some situations.

Finally, the article briefly discusses possible consequences of integrating open science into a responsibility-centered framework and implications on research assessment.

URL : Contours of a research ethics and integrity perspective on open science

DOI : https://doi.org/10.3389/frma.2023.1052353

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Creating research ethics and integrity country report cards: Case study from Europe

Authors : Andrijana Perković Paloš, Rea Roje, Vicko Tomić, Ana Marušić

Structures for and practices of research integrity (RI) and research ethics (RE) differ among countries. This study analyzed the processes and structures for RI and RE in Europe, following the framework developed at the World Conferences on Research Integrity.

We present RI and RE Country Report Cards for 16 European countries, which included the information on RI and RE structures, processes and outcomes. While some of the countries are front-runners when it comes to RI and RE, with well-established and continually developing policies and structures, others are just starting their journey in RI and RE.

Although RI and RE contextual divergences must be taken into account, a level of harmonization among the countries is necessary so that researchers working in the European area can similarly handle RI and RE issues and have similar expectations regardless of the organization in which they work. RI and RE Country Report Cards can be a tool to monitor, compare, and strengthen RE and integrity across countries through empowerment and inspiration by examples of good practices and developed systems.

URL : Creating research ethics and integrity country report cards Case study from Europe

DOI : https://doi.org/10.1080/08989621.2022.2163632

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Open science and conflict of interest policies of medical and health sciences journals before and during the COVID-19 pandemic: A repeat cross-sectional study

Authors : Antoni D. Gardener, Ellen J. Hick, Chloe Jacklin, Gifford Tan, Aidan G. Cashin, Hopin Lee, David Nunan, Elaine C. Toomey, Georgia C. Richards

Objectives

To audit the transparent and open science standards of health and medical sciences journal policies and explore the impact of the COVID-19 pandemic.

Design

Repeat cross-sectional study.

Setting

19 journals listed in Google Scholar’s Top Publications for health and medical sciences.

Participants

Blood, Cell, Circulation, European Heart Journal, Gastroenterology, Journal of Clinical Oncology, Journal of the American College of Cardiology, Nature Genetics, Nature Medicine, Nature Neuroscience, Neuron, PLoS ONE, Proceedings of the National Academy of Sciences, Science Translational Medicine, The British Medical Journal, The Journal of the American Medical Association, The Lancet, The Lancet Oncology, and The New England Journal of Medicine.

Main outcome measures

We used the Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts
of interest (COIs) to evaluate journals standards.

Results

TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 212.5) out of a possible 24 points in February 2020 to 7 (IQR: 4–12) in May 2021, but overall, scores were very low at both time points. Journal policies scored highest for their adherence to data transparency and scored lowest for preregistration of study protocols and analysis plans and the submission of replication studies. Most journals fulfilled all ICMJE provisions for reporting COIs before (84%; n = 16) and during (95%; n = 18) the COVID-19 pandemic.

Conclusions

The COVID-19 pandemic has highlighted the importance of practising open science. However, requirements for open science practices in audited policies were overall low, which may impede progress in health and medical research. As key stakeholders in disseminating research, journals should promote a research culture of greater transparency and more robust open science practices.

URL : Open science and conflict of interest policies of medical and health sciences journals before and during the COVID-19 pandemic: A repeat cross-sectional study

DOI : https://doi.org/10.1177/20542704221132139

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Publication by association: how the COVID-19 pandemic has shown relationships between authors and editorial board members in the field of infectious diseases

Authors : Clara Locher, David Moher, Ioana Alina Cristea, Florian Naudet

During the COVID-19 pandemic, the rush to scientific and political judgements on the merits of hydroxychloroquine was fuelled by dubious papers which may have been published because the authors were not independent from the practices of the journals in which they appeared.

This example leads us to consider a new type of illegitimate publishing entity, ‘self-promotion journals’ which could be deployed to serve the instrumentalisation of productivity-based metrics, with a ripple effect on decisions about promotion, tenure and grant funding, but also on the quality of manuscripts that are disseminated to the medical community and form the foundation of evidence-based medicine.

DOI : http://dx.doi.org/10.1136/bmjebm-2021-111670

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Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement

Authors : Valentin Danchev, Yan Min, John Borghi, Mike Baiocchi, John P. A. Ioann

Importance

The benefits of responsible sharing of individual-participant data (IPD) from clinical studies are well recognized, but stakeholders often disagree on how to align those benefits with privacy risks, costs, and incentives for clinical trialists and sponsors.

The International Committee of Medical Journal Editors (ICMJE) required a data sharing statement (DSS) from submissions reporting clinical trials effective July 1, 2018. The required DSSs provide a window into current data sharing rates, practices, and norms among trialists and sponsors.

Objective

To evaluate the implementation of the ICMJE DSS requirement in 3 leading medical journals: JAMA, Lancet, and New England Journal of Medicine (NEJM).

Design, Setting, and Participants

This is a cross-sectional study of clinical trial reports published as articles in JAMA, Lancet, and NEJM between July 1, 2018, and April 4, 2020. Articles not eligible for DSS, including observational studies and letters or correspondence, were excluded.

A MEDLINE/PubMed search identified 487 eligible clinical trials in JAMA (112 trials), Lancet (147 trials), and NEJM (228 trials). Two reviewers evaluated each of the 487 articles independently.

Exposure

Publication of clinical trial reports in an ICMJE medical journal requiring a DSS.

Main Outcomes and Measures

The primary outcomes of the study were declared data availability and actual data availability in repositories. Other captured outcomes were data type, access, and conditions and reasons for data availability or unavailability. Associations with funding sources were examined.

Results

A total of 334 of 487 articles (68.6%; 95% CI, 64%-73%) declared data sharing, with nonindustry NIH-funded trials exhibiting the highest rates of declared data sharing (89%; 95% CI, 80%-98%) and industry-funded trials the lowest (61%; 95% CI, 54%-68%).

However, only 2 IPD sets (0.6%; 95% CI, 0.0%-1.5%) were actually deidentified and publicly available as of April 10, 2020. The remaining were supposedly accessible via request to authors (143 of 334 articles [42.8%]), repository (89 of 334 articles [26.6%]), and company (78 of 334 articles [23.4%]).

Among the 89 articles declaring that IPD would be stored in repositories, only 17 (19.1%) deposited data, mostly because of embargo and regulatory approval. Embargo was set in 47.3% of data-sharing articles (158 of 334), and in half of them the period exceeded 1 year or was unspecified.

Conclusions and Relevance

Most trials published in JAMA, Lancet, and NEJM after the implementation of the ICMJE policy declared their intent to make clinical data available. However, a wide gap between declared and actual data sharing exists.

To improve transparency and data reuse, journals should promote the use of unique pointers to data set location and standardized choices for embargo periods and access requirements.

URL : Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement

DOI :10.1001/jamanetworkopen.2020.33972

Catégories
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Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study

Authors : Lasse Østengaard, Andreas Lundh, Tine Tjørnhøj-Thomsen, Suhayb Abdi, Mustafe H A Gelle, Lesley A Stewart, Isabelle Boutron, Asbjørn Hróbjartsson

Objective

To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally.

Design

Qualitative interview study.

Participants

Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed.

Setting

Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest.

Results

The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged.

Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results).

Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting.

Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage.

Conclusion

This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences.

The results indicated considerable variability in researchers’ understanding of what conflicts of interest are and when they should be reported.

URL : Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study

DOI : https://doi.org/10.1136/bmj.m3764