Ethical reviews in evaluation procedures boosts quality and trust
"This procedure also provides greater assurance of Eurostars acceptability to peer researchers and the public”, says Davide Delaiti, process leader for ethics in Eureka. Together with his colleagues Jelena Vitic and Peter Lalvani, Davide Delaiti has written the Report on the treatment of ethics in EUREKA for PRO-Ethics.
Eureka is the world’s biggest public network for international cooperation in research, development and innovation (RDI), with a presence in more than 45 countries. Eureka offered to serve as a case study in the PRO-Ethics project because of its expertise in managing and handling the “Ethics Review” for its flagship programme Eurostars. Eurostars is a joint programme with the European Commission that funds international collaborative RDI projects. The majority of Eurostars’ participants are small and medium enterprises, but universities, research institutes and large companies are also eligible to participate. On top of this, Eureka runs the Ethics review, which is an evaluation procedure with external experts. Its aim is to ensure that all projects funded under Eurostars 2 are both ethically compliant as well as compliant with relevant national, international and EU legislation.
"The most common ethics issues are related to involvement of children, patients and vulnerable populations, use of human embryonic stem cells, privacy and data protection issues, research on animals, misuse and dual use, impact on the environment and informed consent," explains Davide Delaiti.
The report provides an analysis of the Ethics Review and discusses the opportunity to adopt a commonly shared European approach for the Ethics Review in funding schemes. The data sources used in the analysis derived from three empirical activities: an analysis on collected data from Eurostars calls 1 to 12, two surveys with Eurostars’ participants and ethics experts, and a PRO-Ethics workshop hosted by Eureka in September 2020.
"Our analysis reveals that even though the actors involved consider the Ethics Review an effective evaluation procedure, Eurostars’ participants still underestimate the ethics dimension related to research projects," says Davide Delaiti.
The report shows that the Ethics Review plays a significant role in identifying relevant legal aspects and other potential ethical issues not addressed in the project proposal. Participants and experts agreed that the process improves the scientific quality of affected projects. It also provides greater assurance of the projects' acceptability both to peer researchers and the public.
"Generally speaking, the ethics dimension is sometimes still unclear to Eurostars’ beneficiaries. This has to do with the majority of Eurostars’ participants being small and medium enterprises that lack resources and sometimes knowledge to identify and properly address ethics issues. The results indicate that consortia are less affected by ethics requirements when more structured entities, like universities, are involved in the projects. The reason could be that they are more accustomed to addressing ethical issues."
In addition, it seems like decision-makers, such as national project coordinators, are more confident in putting money into a programme that integrates an ethical review in its evaluation procedures.
"The Ethic Review boosts the levels of trust in the Eurostars programme and the projects that get funding," states Davide Delaiti.
Interestingly, it seems that research ethics is increasingly translated into the Ethics Review as legal advice and less as constructive dialogue between evaluators and researchers on ethical compliance.
"This is particularly evident when it comes to issues of data protection, with increasing attention to the legal compliance of research projects with GDPR regulation," says Davide Delaiti. He thinks the review might have become too focussed on legal compliance and that it would be important to take into greater consideration other ethical aspects of the research.
"Indeed, some ethics experts suggested that ethical reviews should focus more on those domains that are still not clearly regulated by law or where rules governing research are still unclear. This would positively impact the value evaluators add to reviews."
All stakeholders, including national project coordinators, Eurostars beneficiaries and ethics experts, agreed on the benefits that a common European approach for an ethical review would entail. Any steps towards a shared European approach would be welcomed. However, the stakeholders stressed that there are obstacles to tackle on the way, such as significant national differences when it comes to reproductive technologies and life sciences.
"It seems Europe is still not quite ready for a common review," says Davide Delaiti. "However, harmonisation would be considerably easier in personal data protection due to existing legislative frameworks, like GDPR regulation."
Another important learning for PRO-Ethics' work with developing its ethical framework for participation, is that "participation" is a broad concept with loose interpretation. Guaranteeing the participation of non-traditional stakeholders (such as NGOs, social entrepreneurs, etc.) in research funding organisations' activities requires an effort of translating the concept into concrete procedures and measurable outcomes.
"This is what the analysis on the Ethics Review told us: the importance of having a clear procedure, even though it is far from being perfect."
In the course of PRO-Ethics, the project is going to define various forms of "participation", to reduce confusion related to the concept.
Illustration photo by Ericcsson, from Ericsson Innovation Day 2016. Lisence: Creative Commons — Attribution-NonCommercial-NoDerivs 2.0 Generic — CC BY-NC-ND 2.0
Interview by Anne Winsnes Rødland