Transparency during global health emergencies

Medical research and publishing communities have been admonished for the lack of transparency in the reporting of COVID-19 data, exemplified by two recent retractions of COVID-19 papers published in The Lancet and The New England Journal of Medicine. These studies reported proprietary data from electronic health records allegedly obtained from hundreds of hospitals around the world by the company, Surgisphere. Post-publication analysis of these papers revealed multiple inconsistencies in the data and questions about the provenance of the data sources. When these concerns were put to the authors of the papers, it was revealed that the data could not be shared with the public nor an independent auditor, and so the veracity of these data could not be guaranteed.
The Surgisphere misconduct case resulted in the loss of precious resources and time during a critical global emergency. The case also brought into sharp focus the desperate need to accelerate efforts for greater data oversight and transparency in medical research. Disclosure of raw data can protect against potential misconduct. More importantly, as Cosgriff and colleagues highlight, data sharing will enhance global collaboration and will promote real-time analysis for improved control of future outbreaks like COVID-19. So why is COVID-19 data not being shared with medical researchers?

Although data sharing is seen as an ethical and moral obligation for many researchers, Cosgriff and colleagues suggest that the main obstacles to data sharing are not so much the availability of technology or infrastructure, but the cultural and systemic challenges, such as pressures of “publish-or-perish” academia and data monetisation. In the USA, patient-level data are considered proprietary to the institution collecting it, not the scientific community nor the patients themselves. However, protection of proprietary interest in the ownership of data is thought to encourage further research and to mitigate concerns over misinterpretation of data.

Komorowski and colleagues discuss the challenges in sharing patient-level data, especially across geographical borders, highlighting issues of individual consent and anonymity assurance. A major deterrent to multinational data sharing is strict legal and ethical requirements to protect patient privacy. These requirements have been a particular issue of concern during the COVID-19 pandemic; for example, regarding the use of digital tools and mobile phone data for contact tracing. A Comment published in The Lancet Digital Health showed that, despite the benefits of big data in health care, there is substantial concern among the public regarding the growing commodification of patient data and the risks involved in data sharing. The authors indicate that the COVID-19 crisis could impose new risks to the public’s data privacy and security. In response, they call for public standards that secure regulation and transparency of data use and sharing and that support patient understanding of the data they provide.
Despite these challenges, open databases for COVID-19 research are available. For example, the Open COVID-19 Data Curation Group have released an international, deidentified, real-time dataset at the patient level. Furthermore, the pandemic has prompted a new and more urgent interest in sharing existing data, and in pooling resources as open data repositories receive an increase in submissions. To combat concerns regarding the erosion of ethics review and informed consent during emergencies, on Jan 28, 2020, before the WHO announcement of the COVID-19 pandemic, the Nuffield Council on Bioethics issued a Call for Action for a more ethical and collaborative approach to sharing data and doing research. The report highlights that during global emergencies, National Research Ethics Committees should lead on decisions about whether data can be stored and shared; and how to involve patient communities in these decisions.

The Nuffield report emphasises the role of journals as “duty-bearers” to support ethical research during emergencies. The Lancet Digital Health editors agree and, as such, all of our publications must adhere to basic principles of data sharing and reporting. Integrity of data and patient privacy are the most important considerations that underlie the success of a research paper. If privacy issues prevent the readers or reviewers from accessing the data underlying a paper’s results, the authors must endeavour to validate their conclusions with data that are accessible to readers, so that analyses can be reproduced.

The medical community must work towards rebuilding trust in science. The Lancet journals will continue to hold authors and editors accountable for the data published in our pages, and we encourage our readers to do the same.

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