Innovative framework to strengthen research ethics in European science
How can we ensure that R&I performed by universities, industry and other institutions adheres to the ethical standards that Europeans find important, such as respect for humans and animals, privacy and data protection, sustainability, equality and freedom? According to Prof. Philip Brey, this is the fundamental question raised and addressed by the EU-funded SATORI project. ‘Science and technology have a major impact on our lives, but if the two aren’t developed in an ethical way, then society suffers,’ says the project’s coordinator. European framework for ethics assessment of R&I SATORI developed a framework of common basic ethical principles and joint approaches and practices that are supported and shared by all the key actors involved in the design and application of research ethics standards and principles. It presents an international standards and best practices for creating and operating ethics committees. This is especially useful for organisations that currently do not have an ethics committee and find themselves needing one, which is nowadays often the case in fields other than medicine. The framework contains the first comprehensive list of ethical guidelines for different fields of scientific R&I, and a novel ethical impact assessment methodology that uses foresight to anticipate ethical impacts of R&I. Prof. Brey explains that one of the framework’s major accomplishments was development of the world’s first European (CEN) ISO-compliant pre-standard for R&I ethics assessment. This pre-standard is endorsed by the European Network of Research Ethics Committees (EUREC). Other key content includes a set of recommendations that outline how to structure ethics assessment and ethical guidance in specific types of organisations, including research funding organisations, universities, industry, national ethics committees and civil society organisations. Another set formulates ideas on how to create strong ethics assessment and guidance institutions and regulations at national and EU levels, as well as a roadmap to further develop ethics assessment in the EU. In all, 49 reports describe the current state of play of ethics assessment and its legal regime in different scientific fields, organisations, Member States and beyond. Researchers also investigated and compared national and international legislation for ethics assessment, different value systems around the world and their implications for ethics assessment, and how ethics assessment is practiced and governed at EU and international levels. An extensive study examined how R&I has become a global enterprise, and how this globalisation brings specific ethical challenges. Team members reviewed international policies and actions to mitigate the undesirable and unethical consequences of R&I globalisation, followed by specific policy recommendations. They discussed issues like the international dimensions of scientific misconduct, the ethical treatment of indigenous knowledge in R&I, and the ethics of clinical research and trials in low- and middle-income countries. Also debated were the development of responsible supply chains, the ethics of outsourcing CO2 emissions, and benefit sharing of low- and middle-income countries in R&I outcomes. Towards more responsible R&I processes and outcomes A variety of organisations are already benefiting from the framework. ‘Actionable methods, guidelines, approaches and recommendations were created for a broad range of R&I stakeholders, including regulators and policymakers,’ says Prof. Brey. ‘Ultimately, the framework will ensure that R&I outputs are consistent with the moral values, needs and expectations of society as a whole.’ Even though the project officially ended in September 2017, an extensive strategy has been launched to secure its sustainability. Several EU-funded projects have committed to taking SATORI forward, either by using, further developing or applying its results. Lastly, the European Commission is working towards making ethics a cross-cutting priority in the next Framework Programme (FP9), and will look to SATORI to frame some of the issues. The Commission also intends to use the results to improve its ethics review of project proposals under Horizon 2020.
Keywords
SATORI, ethics, R&I, ethics assessment, research, research ethics, ethics committees, ethical impact assessment
