ONE SOCIETY

Vision

In a rapidly changing world, an open science approach is vital. Regulatory science institutions need to embrace this opportunity if they want to remain relevant and prepared to address new challenges. Engaging with society and enhancing partnerships with stakeholders are also necessary to tackle increasingly complex questions of societal importance. Regulatory science must envisage a medium-term future in which scientific outputs will be routinely produced using a collaborative approach involving not only traditional scientific partnerships but also contributions from citizens. For this future to become a reality, a framework must be established that includes new processes and tools that allow greater collaboration and co-creation than is currently the case. In addition, the legal framework will need reviewing. This epochal transition from elitist to ‘open to all’ science has already started. For it to be achieved in the regulatory science community, a coordinated effort will be needed.

Background – Challenges and opportunities

Open science is one of the priorities of EU policy [1]. The open science movement calls for data and the results of research to be shared already at an early stage of the process, engaging citizens in the co-design and co-creation, making research more affordable, reducing duplication of work and increasing the relevance of the results for society. Open science also means making better use of the large variety of data – both structured and unstructured - from various sources, and increasing accessibility to human and computational resources. In this way, innovation will be accelerated, and societal trust increased due to wider public scrutiny. To achieve these ambitious goals, novel tools and collaborative ways of working are required. EU regulatory scientific institutions are already facing up to this challenge, which is pushing them to re-design their scientific processes. Some organizations have already started looking for ways to make the scientific process open to citizens’ contributions. The Cochrane collaboration uses a crowdsource platform for screening papers [2]. In 2017, the European Food Safety Authority (EFSA) launched a crowdsourcing initiative to collect ideas on how to visualise uncertainty in geospatial data. Recently, a consortium of institutions created an open access database to gather data on people that tested positive to COVID-19 [3]. These examples illustrate how society can be engaged in the scientific process. Lessons must be learnt from past experiences about obstacles that must be overcome but also about solutions that have proven to be successful in making the best use of big open data and citizens’ knowledge. In particular, the topic of causality, i.e. the potential for a causal association between the exposure to a substance, micro-organism or food ingredient and an adverse or beneficial effect, offers us an opportunity to showcase how to turn open science principles into practice. This scientific issue is extremely complex and is being addressed by several institutions. Open science tools and new initiatives could provide additional resources and new methodological approaches to address, for instance, the use of big data and the need to draw conclusions based on heterogeneous sources (Fedak 2015, EFSA, 2018). An open approach will also bring new challenges. We will need to set and assess standards to ensure the scientific rigour of data and the methods used by a community whose scientific reputation may be unknown. Other important issues to address include the protection of personal data in an open environment and the intellectual property of open contributions.  

Scope and objectives

This thematic session intends to advance the discussion on how the principles of open science can be routinely implemented in the scientific activities performed by the European Agencies/Institutions. Causality will be discussed as a case study topic. In fact, it is among the most challenging questions which EU institutions are required to answer.

To this scope the thematic session will discuss:

• Whether and how open data currently available in the food, feed, environmental, animal and human health can be used to address the assessment of causal association between an agent and an effect in the regulatory domain. What are possible benefits and challenges from their use.
• Concrete examples of citizen science initiatives to investigate causality issues and difficulties in implementing them along with benefits and achieved value from the perspective of both the organizers and the participants;
• How to guarantee that data and knowledge generated by an open science approach are accurate and reliable enough for use by regulatory science organisations;
• Which concrete actions need to be put in place to implement open science principles in the context of regulatory science;
• How to revise the legal framework to address new challenges related to personal data protection and intellectual property.

Reference:

EFSA  (European  Food  Safety  Authority)  and  Aguilera  J,  Aguilera-Gomez  M, Barrucci F, Cocconcelli PS, Davies H, Denslow N, Dorne JL, Grohmann L, Herman L, Hogstrand C, Kass GEN, Kille P, Kleter G, Nogué F, Plant NJ, Ramon M, Schoonjans R, Waigmann E and Wright MC 2018. EFSA  Scientific  Colloquium  24  –  ’omics  in  risk  assessment:  state  of  the  art  and  next  steps.  EFSA supporting publication 2018:EN-1512. 30 pp. doi:10.2903/sp.efsa.2018.EN-151

Fedak KM, Bernal A., Capshaw ZA and Gross S (2015): Applying the Bradford-Hill criteria in 21st century: how data integration has changed causal inference in molecular epidemiology. Emerg Themes Epidemiol, 12:14

Katrin Vohland K., Land-Zandstra A., Ceccaroni L., Lemmens R., Perelló J., Ponti M., Samson R., Wagenknecht K (2021): The science of citizen science. Springer: Cham, Switzerland

[1] https://ec.europa.eu/info/research-and-innovation/strategy/goals-research-and-innovation-policy/open-science_en

[2] https://crowd.cochrane.org

[3] https://global.health/

Part I - Nothing in isolation - universal risks, open solutions

Part II - Building together: insights from the other One society sessions

Part III - Moderated panel discussion “Towards viable open science – which standards for data and knowledge?”