This section outlines the SATORI work on standardisation of ethics assessment of R&I. The objective was to assess the feasibility of developing a standard for ethics assessment of research and innovation (R&I) and develop such a standard. We conducted workshops to discuss its findings on ethics assessment with stakeholders and to better understand their expectations and needs regarding standardisation of ethics assessment methodologies and practices. We also conducted a general study on standards and standardisation efforts on assessment procedures, ethics and social responsibility which resulted in recommendations and inspiration for the content and process of the standardisation efforts in SATORI.
The standard procedure of the Comité Européen de Normalisation (CEN) Workshop Agreement (CWA) was used to develop European consensus on the SATORI ethics assessment framework (including ethical impact assessment). Seventy-five experts from fifteen European countries and ten European organisations contributed to the CWA.
The SATORI CWA (pre-)standard has two parts. Part 1 provides information on the role and functioning of an ethics committee, including procedures for assessment, quality assurance and ethical principles. This is useful for setting up an ethics committee, or reviewing the functioning and procedures of an ethics committee. Part 1 of the CWA is applicable to all ethics committees, regardless of their size, scope, or research and innovation area. Part 2 provides researchers with guidance on ethical impact assessment. Ethical impact assessment is the process of judging the ethical impacts of R&I activities, outcomes and technologies. It involves the following steps: planning, identification of impacts, evaluation of impacts, formulation and implementation of remedial actions, and review and audit. Part 2 is applicable to all researchers, innovators, and ethics committees, regardless of the context they are working in.
SATORI has succeeded in developing a pre-standard on ethics assessment for R&I. The CWA may, in the future and based on its use, be further developed into a European standard if supported by stakeholders.
We also explored whether conformity assessment, and specifically certification, could be helpful in facilitating and improving the use and quality of ethics assessment in research and innovation. We conducted literature review and stakeholder engagement to investigate how various tools of conformity assessment could be used to support the application of the SATORI CWA. Our study revealed various challenges facing the use of such standards, such as: misinterpretation of the certification requirements; underestimation of the efforts and resources required; costs (training, audit fees, audits); overdevelopment of the quality system; excessive documentation and control; apparent erosion of the perceived benefits over time; lack of support and resources available for SMEs; and lack of guidelines on how to accomplish the ‘continuous improvement’ elements of a standard. Critical success factors include: market and legal incentives; consumer demand for use of certification; widespread support, use and adoption of the scheme; sustainability; and internationalisation.
It was found that most conformity assessment techniques could be used to check, evaluate, or assess adherence to the SATORI CWA specifications, either exclusively, or in combination with others, depending on what is to be assessed, the context, and the specific characteristics to be assessed. We have presented how self-declaration of conformity, peer review, certification, and accreditation might play out in relation to Parts 1 and 2 of the SATORI CWA. Their ability to be successfully implemented and have an impact depends on three key things:
- Policy and legal frameworks that support the development and implementation of such schemes, whether at the EU or national level;
- Incentives and subsidies to undertake conformity assessment activities; and
- Usefulness and ability of conformity assessment techniques to deliver their goals vis-a-vis improving the quality of ethics assessment and ethical impact assessment.