The Netherlands Standardization Institute (NEN) and Danish Standards (DS), in collaboration with partners in the EU-funded SATORI project, created the first international pre-standard, a CEN Workshop Agreement, addressing the role and procedures of the ethics committee and ethical impact assessment of research and innovation.
The CEN Workshop Agreement document includes perspectives from many EU countries, and several non-EU countries, i.e., US and China. The document is endorsed by EUREC, the European Network of Research Ethics Committees.
Why are ethics assessment standards important?
Taking into account the complexity of scientific research and impact of emerging technologies on life, it is of tremendous importance that scientific research and technology development is conducted in accordance with high ethical standards. Standards help us produce and introduce new technologies to the market, and at the same time help us properly assess their impact on environment and society.
The SATORI CEN Workshop Agreement has the following unique features:
- It is the first international standard document for ethics committees and ethical impact assessment of research and innovation;
- It is based on an extensive study of hundreds of existing guidelines, studies on ethics assessment and ethics committees, interviews and feedback from hundreds of stakeholders;
- It is comprehensive standard covering all fields, with special coverage of social sciences and humanities, natural sciences, engineering sciences, medical and life sciences, and computer and information sciences;
- It includes ethics assessment guidelines for research and technological innovation;
- It addresses procedures and guidelines for the establishment and composition of ethics committees, and their daily operations;
- It addresses quality assurance in ethics assessment;
- It contains a clear methodology for assessing the ethical impacts of research and technology development;
- It can be made compatible with, and adapted to different value systems and cultural contexts;
- It is applicable to different organisational contexts, including universities, medical hospitals, research funding organisations, industry etc.
The SATORI CEN Workshop Agreement (CWA 17145) consists of two parts.
Part 1, “Ethics Committee” contains core recommendations on ethics assessment and the role, composition and operations of ethics committees.
Part 2 contains an ethical impact assessment framework, which is a novel approach for anticipating and ethically assessing social and environmental consequences of research and innovation that combines ethics assessment, impact assessment and technology assessment.
This European CWA is the result of extensive investigations and broad consultation and mutual learning processes with hundreds of stakeholders.
Both documents can be downloaded for free at the SATORI project website: http://satoriproject.eu/publication_type/standards/
They can also be purchased from NEN, DS and all European national standards bodies.
The SATORI website (www.satoriproject.eu) also contains dozens of extensively researched reports on the current state of ethics assessment, and recommendations (e.g., in the form of policy briefs) for improving ethics assessment and ethical guidance in different fields and different types of organisations.
Use of the SATORI standard and feedback
CWA 17145 has a validity of 3 years. After three years, the document is reviewed for usefulness. When you download the documents please leave your name and contact details so we can follow up on the relevance of the document to you and collect data on how it could be improved. You are also invited to share your experiences and provide us with feedback on the use of the documents.
The SATORI project is a 45-month project on ethics assessment of research and innovation (R&I) supported by the European Commission through its FP7 funding scheme. SATORI aims to improve ethical assessment practices and strengthen respect for ethical principles. SATORI comprises 17 partners from 12 countries and is co-ordinated by the University of Twente in the Netherlands. Follow us on Twitter:@SATORI_EU
For more information or feedback, please contact:
University of Twente
Netherlands Standardization Institute
Netherlands Standardization Institute
SATORI Communication Officer
Center for the Promotion of Science