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Report on Standardizing Operating Procedures in Ethics Assessment

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Report on Standardizing Operating Procedures in Ethics Assessment Report on standardizing operating procedures in ethics assessment Deliverable D7.1 Authors part I: Signe Annette Bøgh and Katrine Bergh Skriver (Danish Standards) Authors part II: Marlou Bijlsma and Thamar Zijlstra (NEN, Nederlands Normalisatie Instituut) Contributors: Rowena Rodrigues; Trilateral Research Ltd, Erich Griessler; Institut für Höhere Studien, Rok Benčin; ZRC SAZU: Research Centre of the Slovenian Academy of Sciences and Arts, July 2017 Contact details for corresponding author: Signe Annette Bøgh (Danish Standards), [email protected] Marlou Bijlsma (NEN, Nederlands Normalisatie Instituut), [email protected] This deliverable and the work described in it is part of the project Stakeholders Acting Together on the Ethical Impact Assessment of Research and Innovation - SATORI - which received funding from the European Commission’s Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 612231 Deliverable 7.1 Standardizing ethics assessment Content Content ....................................................................................................................... 1 Abstract ...................................................................................................................... 3 Executive Summary ..................................................................................................... 4 1. Introduction ............................................................................................................. 5 1.1 Objectives.............................................................................................................................. 5 Part I - General study of standardizing operating procedures ....................................... 6 2 Context and methodology .......................................................................................... 6 2.1 Standard ................................................................................................................................ 6 2.2 Standardization...................................................................................................................... 6 2.3 CEN Workshop Agreement .................................................................................................. 7 2.4 Methodology ......................................................................................................................... 7 3. Exploring standards and standardization ............................................................... 10 3.1 Searches for standards ......................................................................................................... 10 3.2 Search 1: non-formal standards........................................................................................... 10 3.2.1 General findings on non-formal standards ................................................................. 10 3.2.2 Recommendations for the CWA ................................................................................... 12 3.3 Search 2: formal standards .................................................................................................. 13 3.3.1 Database search .......................................................................................................... 13 3.3.2 Standards proposed by SATORI partners ................................................................... 13 3.3.3 Standards in JTC1 Information Technology ............................................................... 14 3.3.4 Findings ....................................................................................................................... 14 3.3.5 Recommendations for the CWA ................................................................................... 17 3.4 Interviews with standardization experts .............................................................................. 18 3.4.1 Main conclusion from interviews ................................................................................ 18 3.4.2 Facilitation of the CWA process ................................................................................. 18 3.4.3 Input for the structure of the CWA .............................................................................. 18 4. Moving ethical issues from research into standardization ........................................ 20 4.1 Possible limitations to standardizing ethics assessment ..................................................... 20 5. Conclusions Part 1 - Recommendations for SATORI CWA..................................... 21 5.1 Recommendations for writing the CWA ............................................................................ 21 5.2 Recommendations for the CWA process ............................................................................ 21 5.3 Recommendations for the CWA content ............................................................................ 22 Part 2 – Standardizing ethics assessment for research and innovation ......................... 23 6. Objectives and methodology ................................................................................... 23 6.1 Objectives............................................................................................................................ 23 6.2 Methodology ....................................................................................................................... 23 1 Deliverable 7.1 Standardizing ethics assessment 7. Standardization benefits and challenges ................................................................. 26 7.1 ISO standards as inspiration ................................................................................................ 26 7.2 Existing ethics assessment documents as inspiration ......................................................... 26 7.3 SATORI ethics assessment framework as inspiration ........................................................ 26 7.4 Concepts and definitions ..................................................................................................... 27 7.5 Aspirational versus practical ............................................................................................... 27 7.6 The role of researchers in ethical impact assessment ......................................................... 28 7.7 Communication, dissemination and support ....................................................................... 28 8. Conclusions ............................................................................................................ 30 Annex 1 – Search 1: full list of non-formal standards .................................................. 31 Annex 2 – Search 2: longlist of formal standards and formal standard documents ...... 34 Annex 3 – Resume of 7 selected formal standards ....................................................... 41 Annex 4 - Interviews with standardization experts ..................................................... 70 Annex 5 – The structure of a formal standard ............................................................ 75 Annex 6 - Workshop project plan ............................................................................... 76 Annex 7 – Internal review meeting comments table .................................................... 83 Annex 8 – Communication plan for the CWA public enquiry ................................... 122 Annex 9 – SATORI CWA Part 1 Ethics committee ................................................... 130 Annex 10 – SATORI CWA Part 2 Ethical impact assessment framework ................. 131 2 Deliverable 7.1 Standardizing ethics assessment Abstract Introduction: The attention for and urgency of ethics assessment has increased. Public discussions on the ethical desirability of several research projects or innovations, e.g. GMO, nanotechnology, big data & privacy, drones. Objectives: To assess the feasibility of developing a standard for ethics assessment of research and innovation. Methodology: SATORI analysis of good practices in ethics assessment resulted in a framework for ethics assessment, including ethical impact assessment. Simultaneously, the project’s workshops exchanged early findings with stakeholders to assess expectations and needs to standardize ethics assessment methodologies and practices. The standard procedure of the Comité Européen de Normalisation (CEN) Workshop Agreement was used to develop European consensus on the framework. The feasibility of standardizing ethics assessment was assessed by starting the standardization procedure, trying to reach consensus on the content. 75 experts from 15 European countries and 10 European organisations contributed. Results: The SATORI framework for ethics assessment has been developed into a CEN Workshop Agreement (CWA). This (pre-)standard has 2 parts. Part 1 provides information on the role and functioning of an ethics committee, including procedures, quality assurance and an approach to ethical principles. This is useful for setting up an ethics committee or reviewing the functioning of an ethics committee. Part 2 on ethical impact assessment describes procedures and methodologies that individual researchers and assessors will find useful to assess the ethical impact of a research proposal or innovation. The standard is less aspirational and less comprehensive compared to the SATORI framework and therefore it is expected to be more practical to use and less expensive to implement. Conclusions: SATORI succeeded in developing a pre-standard on ethics assessment for research and
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