Section 10: Ethics Assessment and Policy

This work focused on policy initiatives and policy developments at the global, European, and national levels related to ethics assessment of research and innovation (R&I), covering the period 2014-2017. It primarily drew on the research and findings of the SATORI policy watch and policy engagement activities, and the project’s comparative analysis of ethics assessment practices. The monitoring of policy developments (global, EU, and national sources) took place on a frequent basis between May 2016 to April 2017 (some sources were monitored daily, others were accessed once or twice a week). The countries actively monitored were: Austria, Finland, France, Germany, Italy, Netherlands, Poland, Russia, UK and the USA. The most relevant items were presented via the SATORI newsletter.

At the EU-level, there have been several good policy developments in ethics of R&I, including proposals for regulations and regulatory amendments; issue and publication of hard or soft guidance, official decisions and opinions and expert group/committee reports; adoption of bilateral agreements; public stakeholder consultations; organisation of events; commissioning of research; and scientific and technical research reports.

There are some potential challenges or barriers to be overcome in introducing the SATORI ethics assessment framework. These include: the need to improve the visibility of the framework through multi-lingual translations; finding the political will to support the use and implementation of the framework; financial costs; political challenges to any mandatory, top down prescriptions of the framework; shortage of resources; national and local differences; scope of ethics assessment activities and limited mandates; the ad hoc nature of ethical impact assessments (EIAs); lack of institutional support and positive attitudes to EIAs; ineffective implementation of EIA recommendations; lack of sharing of EIA good practice.

The survey of policy developments at the national level showed some key good practice developments policy developments in ethics of R&I, such as the creation of new laws and institutions; amendments to existing laws, review of ethics codes and guidance, increasing engagement with stakeholders, and fostering ethical awareness. These developments need to be supported and sustained. There are several challenges at the national level that need to be addressed, including lack of resources, low levels of awareness, narrow understanding of ethics, fragmentation, institutional resistance, insufficient legitimisation of frameworks, lack of support, etc. However, there are also significant opportunities for intervention at the national level. All these require further funding, support and encouragement by policy-makers at the EU and national level.

As part of the policy activities, the SATORI project produced policy briefs with the aim of making the extensive work carried out in the project accessible to policy-makers who can help turn the proposals of the project into concrete solutions that enhance ethics assessment of R&I in the EU. As such, 6 policy briefs have been issued regarding the responsible and ethical governance of R&I, organisational improvement of research ethics committees, ethical impact assessment, and maximising the potential of ethics assessment of R&I.