Issues and obstacles to the sharing of sensitive data in Europe, who are the stakeholders and what are their responsibilities ?

Reducing the risk of misuse of data is particularly crucial in the context of research on highly pathogenic agents. But as demonstrated during the COVID19 crisis, sharing data of high quality is a sine qua non condition to compare research results at a large scale.

Our actual challenge is to ensure compliance with the FAIR principles while taking into account the dangers and pitfalls concerning dual use type data and samples (because there are often some good reasons to not share).

Dual Use Research of Concern (DURC) is defined by the United States Government Policy for Oversight of Life Sciences as ”Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat, with broad potential consequences, to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” 

Many countries or regions have adopted laws to regulate exchanges concerning DURC. As an example, in the European Union, dual use biological materials are listed in Council Regulation (EC) No 428/2009" [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R0428]. 

How can we take these aspects into account so that the respect of the FAIR principles is done while respecting these legislations? How to increase the possibilities of sharing dual use data, to reduce overlap, encourage collaboration on DURC while securing their uses? How to reward and credit back good practices?

For example, what data should be prohibited to share? Who should be prohibited from sharing or accessing data which may be classified as DURC?

DURC data typically falls into one or more of these categories:

• Demonstrate how to render a vaccine ineffective

• Enhance the harmful consequences of a pathogen or toxin or render a non-pathogen virulent 

• Increase the transmissibility of a pathogen 

• Alter the host range of a pathogen or toxin 

• Enable evasion of diagnostic or detection modalities 

• Enhance the susceptibility of a host population to a pathogen or toxin 

• Generate or reconstitute certain eradicated or extinct pathogens or toxins 

• Enable weaponization of a biological agent or toxin. 

This poster aims to present the landscape of DURC data in Europe, the main actors and their responsibilities. It underlines that pre-approved data sharing agreements is probably one major possible recommendation with highly secured repositories. Additionally, a consideration of DURC in actual Data stewardship should be developed. Conversely, another pitfall would be to be too careful and to classify all data in dual uses, and to prevent re-use despite public health issues. Indeed, reducing duplication of effort and improving trial design concerning Dual Use research is a challenge, at least inside a country or a community of countries (e.g. Europe) that need to identify actors and organize their interactions. We also recommend that for this dual use data sharing information and authorized metadata should be available centrally on an intergovernmental web page with explicit authority contact and / or be applied considering officials sharing conventions.