Will this change really help mitigate scientific misconduct? I doubt these measures are strong enough.Changes to the signed declarations by authors in the author statements form will require that more than one author has directly accessed and verified the data reported in the manuscript. We will require that the authors who have accessed and verified underlying data are named in the contributors' statement. For research Articles that are the result of an academic and commercial partnership, one of the authors named as having accessed and verified data must be from the academic team. In addition, all authors will be asked to sign the author statements form to confirm they had full access to the data reported in their Article, and accept responsibility for submitting the Article for publication.
Data validity
During peer review, editors and reviewers have access to methods, results, and discussion provided by the authors in the submitted research articles, including any appendices. However, Lancet journals do not have access to, nor do they store, raw data related to research studies, and data verification remains the responsibility of the authors who have conducted the original research.
Lancet journals will now require all research papers, irrespective of method, to include a data-sharing statement that details what data will be shared, whether additional documents will be shared (eg, the study protocol), when data will become available, and by what access criteria data will be shared. Investigators should be aware that editors will take data-sharing statements into account when making editorial decisions.
All Lancet journals will now introduce additional peer-review requirements for papers based on large, real-world datasets. Editors will ensure that at least one peer reviewer is knowledgable about the details of the dataset being reported and can understand and comment on its strengths and limitations in relation to the research question being addressed. For studies that use very large datasets, editors will ensure that in addition to statistical peer review, a review from an expert in data science is obtained.
https://www.theguardian.com/world/2...ter-hydroxychloroquine-covid-study-retractionOne of the world’s leading medical journals, the Lancet, has reformed its editorial policies following a shocking case of apparent research misconduct involving the study of hydroxychloroquine as a treatment for Covid-19.
In May, the Lancet published a peer-reviewed study about the controversial drug hydroxychloroquine, which concluded Covid-19 patients who received the drug were dying at higher rates and experiencing more heart-related complications than other virus patients.
The large observational study analysed data purported to be from nearly 15,000 patients with Covid-19 who received the drug alone or in combination with antibiotics, comparing this data with 81,000 controls who did not receive the drug.
This data was recorded by hospitals around the world in a database by a US data analytics company known as “Surgisphere”, the Lancet paper said. The findings prompted the World Health Organization to halt its clinical trials of the drug, given the paper’s findings that it was linked with deaths and complications.
But days after the paper was published, Guardian Australia revealed issues with the Australian data in the study. Figures on the number of Covid-19 deaths and patients in hospital cited by the authors did not match up with official government and health department data. Senior clinicians involved in Covid-19 research told Guardian Australia they had never heard of the Surgisphere database.
Researchers from other countries identified similar issues with the data from their hospitals, and a further Guardian Australia investigation revealed doubts over whether the database used by the study authors even existed. Sapan Desai was a co-author of the paper and founder of the Surgisphere database. Following the revelations, information about Surgisphere was deleted from the internet.
It was also revealed that none of the co-authors of the paper had seen the Surgisphere data for themselves, and they said that Desai did not give them access to it even after questions about the paper were raised by Guardian Australia and the research community. The paper’s co-authors, which included a highly respected vascular surgeon, supported the retraction of the paper and distanced themselves from the data.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31958-9/fulltextThe publication and subsequent retraction
1
,
2
in June, 2020, of the Article Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, based on an alleged dataset associated with Surgisphere, prompted us to examine The Lancet's peer-review processes to identify ways of further reducing risks of research and publication misconduct. As a result of this review, with immediate effect, we have made changes to the declarations we seek from authors, the data sharing statements we require for published research papers, and the peer-review process for similar papers based on large datasets or real-world data.
Changes to the signed declarations by authors in the author statements form will require that more than one author has directly accessed and verified the data reported in the manuscript. We will require that the authors who have accessed and verified underlying data are named in the contributors' statement. For research Articles that are the result of an academic and commercial partnership, one of the authors named as having accessed and verified data must be from the academic team. In addition, all authors will be asked to sign the author statements form to confirm they had full access to the data reported in their Article, and accept responsibility for submitting the Article for publication.
• View related content for this article
Journals that adhere to guidance from the International Committee of Medical Journal Editors require a data-sharing statement for papers that report results of a clinical trial.
3
Lancet journals will now require all research papers, irrespective of method, to include a data-sharing statement that details what data will be shared, whether additional documents will be shared (eg, the study protocol), when data will become available, and by what access criteria data will be shared. Investigators should be aware that editors will take data-sharing statements into account when making editorial decisions.
All Lancet journals will now introduce additional peer-review requirements for papers based on large, real-world datasets. Editors will ensure that at least one peer reviewer is knowledgable about the details of the dataset being reported and can understand and comment on its strengths and limitations in relation to the research question being addressed. For studies that use very large datasets, editors will ensure that in addition to statistical peer review, a review from an expert in data science is obtained. Finally, we will explicitly ask reviewers if they have concerns about research integrity or publication ethics regarding the manuscript they are reviewing.
Throughout the COVID-19 pandemic the work of the research community in generating new knowledge has resulted in rapid advances in our understanding of severe acute respiratory syndrome coronavirus 2 and COVID-19. As trusted sources of information, the Lancet journals are committed to ensuring that our editorial processes will continue to be as robust as possible.