Ethical issues identified by applicants and ethics experts in Horizon 2020 grant proposals – How do they differ?

Authors: Ivan Buljan, David Pina & Ana Marušić Background: Identifying and addressing ethics issues in grant proposals is key for ensuring the quality of funded research. Systematic evaluation of ethics issues is performed within the EU’s Horizon 2020 research and innovation framework programme, but there is little evidence on the outcomes of these exercises. We assessed the ethics review process in proposals evaluated under the Marie Skłodowska-Curie Actions (MSCA-IF) and the European Research Council (ERC). Methods: We analyzed anonymized datasets for 4,249 MSCA-IF, 459 MSCA-ITN and 1,682 ERC funded projects over four years (2016 to 2019). The datasets included the information on the outcome of the scientific evaluation, ethics issues identified by applicants, those identified by ethics experts during the ethics review, and the ethical requirements they listed. We analyzed the data both at the proposal level – where issues are identified by applicants – and at ethics review level – where issues are identified by ethics experts. Results: Overall, most of the identified ethics issues, for applicants and ethics experts combined, were in the Humans, Protection of personal data, Environment, health and safety, and Non-EU countries categories and those remained the same over time. The ethics experts identified twice as more ethical issues compared to applicants. Host country, scientific panels or year of the calls did not significantly predict the higher number of issues in proposals, identified by applicants or ethics experts. For funded proposals, there was still a significant number of ethical requirements due before the start of the projects; median (Md) number of requirements per proposal was Md=2 (Interquartile range (IQR)=1-3) for IF, Md=3 (IQR 2-4) for ITN and Md=8 (4-14) for ERC grants. Conclusions: Grant applicants are not sufficiently aware of ethics issues in their grant proposals; almost three quarters of the proposals did not resolve issues related with protection of personal data or treatment of human subjects. There is a need for better education and increased awareness of researchers about ethics issues in research and further development of grant proposal ethics evaluation to ensure responsible research. Disclaimer: All views expressed in this description are strictly those of the authors and may in no circumstances be regarded as an official position of the Research Executive Agency or the European Commission.