Can conformity assessment enhance ethics assessment practices?

Rowena Rodrigues, Trilateral Research Ltd

Conformity assessment can help organisations build trust, develop and foster compatibility with a variety of standards across organisations. Conformity assessment helps demonstrate that specified requirements relating to a product, process, system, person, or body are fulfilled (ISO/IEC 17000). SATORI explored whether conformity assessment, and specifically certification (which is one method of demonstrating conformity), could help facilitate and improve the use and quality of ethics assessment in research and innovation (R&I).SATORI studied how various tools of conformity assessment could support the application of the SATORI CEN Workshop Agreement (CWA).

SATORI reviewed many ISO certification standards, some address ethical aspects, e.g., food safety, societal security, environmental responsibility, and social responsibility. The review revealed various challenges faced in the use of such standards, i.e., 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 (e.g., from management) and resources available for SMEs; lack of guidelines on how to accomplish the ‘continuous improvement’ elements of a standard. These are all relevant to consider in developing a certification standard for ethics assessment. 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.

The overall conclusion of the stakeholders engaged via SATORI workshops and interviews was that certification might not be effective for ethics assessment; standardisation is more relevant. Stakeholders at the SATORI Delft workshop strongly discouraged the presumed obvious link between standardisation process of ethics assessment and the certification process. Participants felt the certification discussion was premature and should not be further developed in the SATORI project.

Several interviewed research ethics committees and national ethics committee members thought conformity assessment and certification could benefit ‘ethics assessment procedures’, by improving transparency, credibility, confidence, reliability, and consistency of the ethics review process. But it is essential that conformity assessment is carried out in a way that simplifies procedures, and reduces (not increases) bureaucracy. A conformity assessment and certification system should allow for differential approaches in different cases, ranging from a simple and fast exercise to detailed and time-consuming process depending on the specific situation and needs (levels of risk).

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. SATORI presents how self-declaration of conformity, peer review (or peer assessment), certification, and accreditation can play out in relation to Parts 1 and 2 of the SATORI CWA informed by the study’s literature review and the stakeholder engagement.

The assessment considers potential target(s) of evaluation, target stakeholder, conformity issuer, relying party (i.e., a natural or legal person that relies upon the conformity assessment results), how would it play out, benefits, risks, challenges, and business case. However, as highlighted by our stakeholders, 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.

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