Key policy recommendations and policy briefs

Transcription

1 Key policy recommendations and policy briefs Deliverable 9.3 Lead autors: Wessel Reijers, Agata Gurzawska and Emils Birkavs, University of Twente; Rowena Rodrigues, Trilateral Researc; Rok Benčin, Scientific Researc Centre of te Slovenian Academy of Sciences and Arts (ZRC SAZU); Ingrid Callies, UNESCO Contributors: Stépanie Gauttier, Pilip Brey, University of Twente David Wrigt, Trilateral Researc Eric Griessler, Institute for Advanced Studies Andrea Porcari, Associazione Italiana per la Ricerca Industriale (AIRI) Rossella Cardone, Ericsson Telecomunicazioni Professor Dr Elmar Doppelfeld, EUREC Ms Anke Reinardt, DFG (German Researc Foundation) Ms Ciara Giovannini, ANEC Contact details for corresponding autor: Wessel Reijers, University of Twente Tis deliverable and te work described in it is part of te project Stakeolders Acting Togeter on te Etical Impact Assessment of Researc and Innovation - SATORI - wic received funding from te European Commission s Sevent Framework Programme (FP7/ ) under grant agreement n

2 Contents 1 Abstract Executive Summary Introduction Key recommendations of te SATORI project General recommendations Raising awareness of etics assessment Supporting sustainable etics assessment Embedding etics assessment in cultural contexts Harmonising frameworks for etics and etical impact assessment (EIA) Risk-benefit analysis of etics assessment Education and training Stakeolder participation and engagement Quality assurance Institution-Specific Recommendations Governmental policies for universities Governmental policies for Researc Etics Committees (RECs) Governmental policies for National Etics Committees (NECs) Governmental policies for National Science Academies (NSAs) Governmental policies for Researc Funding Organisations (RFOs) Governmental policies for Industry Governmental policies for Civil Society Organisations (CSOs) Policy briefs Summaries of SATORI policy briefs Policy brief: Responsible and etical governance of researc and innovation in te context of globalisation Policy brief: Improving te organisation of researc etics committees (RECs) Policy brief: Etical Impact Assessment enancing responsible researc and innovation (R&I) Policy brief: Supporting etics assessment in researc and innovation (R&I) Policy brief: Industry and Researc and Innovation: Towards Etical, Responsible and Sustainable R&I Policy brief: Maximising te potential of etics assessment of researc and innovation: a call to researc funding organisations Callenges wit drafting te policy briefs Dissemination strategy & impact Conclusion Annex: Te Satori Policy Briefs

3 1 ABSTRACT Tis deliverable offers an overview of te key recommendations tat resulted from te SATORI projects. Additionally, it presents six policy briefs tat were written to condense te main findings of te SATORI project into sort, compreensive texts tat allow for tese findings to be translated into actual policy for etics assessment in researc and innovation (R&I). Te first part of te deliverable presents te key recommendations according to different tematic foci in te project. Te second part of te deliverable provides summaries of te six policy briefs and presents te policy briefs temselves. Te final policy briefs are included in te Annex. 3

4 2 EXECUTIVE SUMMARY Tis deliverable provides sort and compreensive overviews of te key SATORI project recommendations and teir translation into six policy briefs. For detailed information about all te recommendations, we would like to direct te reader to te full texts of te SATORI deliverables 1. Recommendations are te suggested courses of action, in terms of policy making, to be followed based on te results of bot te teoretical and empirical work carried out witin te SATORI project. Tey are key outcomes formulated in order to facilitate te uptake of te findings by policy-makers and create real life impact. Tis deliverable terefore performs a crucial function in te SATORI project. First, tis deliverable starts out wit providing an overview of te key recommendations resulting from te work undertaken in te SATORI project. Tese recommendations for instance focus on organising stakeolder participation, or on guidance for te implementation of te SATORI framework for sared etics assessment practices. Second, it discusses ow te recommendations were used as input for te policy briefs, and describes ow te draft policy briefs were produced, e.g. ow te process and review was organised. Tis deliverable provides summaries of te six policy briefs tat were produced, on te topics of Responsible and etical governance of researc and innovation in te context of globalisation, Improving te organisation of researc etics committees (RECs), Etical Impact Assessment enancing responsible researc and innovation (R&I), Supporting etics assessment in researc and innovation (R&I), Industry and Researc and Innovation: Towards Etical, Responsible and Sustainable R&I and Maximising te potential of etics assessment of researc and innovation: a call to researc funding organisations. Finally, tis deliverable concludes wit discussing callenges encountered during te process of producing te policy briefs and te dissemination strategy of te policy briefs and its impact. It also includes an annex wit te final policy briefs tat ave been publised on te SATORI website. 1 See: SATORI. All Deliverables ttp://satoriproject.eu/work_packages/comparative-analysis-of- 4

5 3 INTRODUCTION Tis deliverable provides an overview of te key policy recommendations from te SATORI project. Te SATORI project as provided a compreensive overview of etics assessment practises in R&I across countries, organisations, scientific fields, and cultures 2. Based on tis overview, it formulated a framework for etics assessment in R&I in te EU and beyond 3. Stakeolder engagements and researc activities ave brougt very promising results suc as te CEN Worksop Agreement 4 for etics assessment in R&I, conformity assessment recommendations to support etics assessment 5, procedures for measuring te impacts of etics assessment practices 6 and a eritage strategy to ensure te sustainability of te work done in te project 7. However, te SATORI outputs can only be translated into actual R&I practice once te critical step towards developing supportive policies and implementation is made. For tis purpose, te SATORI project as formulated key recommendations (suggested courses of action to be followed based on te results of bot te teoretical and empirical work carried out) in te reports it produced, wic togeter can guide te armonisation of etics assessment practises in R&I in te EU and beyond, all of wic are brougt togeter ere. Te development of te SATORI policy briefs, except for te first one 8, involved four distinct steps: (1) agreeing on a general structure for te policy briefs, (2) creating a first draft, based on te SATORI deliverables, (3) conducting an internal review and (4) submitting te final draft to select SATORI Advisory Board members for external review. Tis deliverable as two main sections. First, we provide a sort overview of te key recommendations formulated in SATORI. Second, we provide a sort overview of te policy briefs developed in SATORI and a description of te process involved in teir preparation. It also as an annex, in wic te final policy briefs are included tat were publised on te SATORI website. 4 KEY RECOMMENDATIONS OF THE SATORI PROJECT Te SATORI project as produced a variety of recommendations aimed at policy making for improving te organisation and implementation of etics assessment of R&I. Tese recommendations ave resulted from te tematically organised work packages of te SATORI project. Below, we provide an overview of te key recommendations (wic, sould be stressed, is not an exaustive overview of all SATORI recommendations). Te key 2 See: SATORI. Comparative Analysis of Etics Assessment Practices ttp://satoriproject.eu/work_packages/comparative-analysis-of-etics-assessment-practices/ 3 See: SATORI. Roadmap for a Common Etics Assessment Framework ttp://satoriproject.eu/work_packages/roadmap-for-a-common-eu-etics-assessment-framework/ 4 SATORI, Etics assessment for researc and innovation, CEN Worksop Agreement, May ttp://satoriproject.eu/publication_type/standards/ 5 Rodrigues, Rowena, Micael Madary, Andrea Porcari, Elvio Mantovani, Exploring te potential of conformity assessment tecniques to support etics assessment, SATORI Deliverable 7.2, February SATORI. Measuring te Impacts of Etics Assessment ttp://satoriproject.eu/work_packages/measuring-te-impacts-of-etics-assessment/ 7 SATORI. Heritage (Sustainability) ttp://satoriproject.eu/work_packages/eritage-sustainability/ 8 Te first policy brief was developed in te context of Work Package 3 in 2015 and was not part of te concerted effort to create standardised policy briefs, wic is part of Work Package 9 and started in

6 recommendations ave been selected on te basis of (1) teir central role in translating te main findings in te SATORI project into concrete policies and (2) teir general nature. Te overview of key recommendations as been organised according to general and institutionspecific recommendations. Te recommendations proposed by te SATORI project are aimed at a wide range of stakeolders tat are engaged in R&I activities. Notably, tese are supranational (EU), national and regional governments, researc-performing organisations (RPO), researc funding organisations (RFO), national science academies, civil society organisations (CSOs), and commercial entities. 4.1 GENERAL RECOMMENDATIONS A number of recommendations are general in nature, wic means tat tey sould be taken up by different types of institutions involved in etics assessment. Tese general recommendations are terefore relevant for all actors involved in policy making for etics assessment Raising awareness of etics assessment Generally, organisations involved in etics assessment sould be incentivised to engage in continuous awareness raising about te significance of etics assessment in R&I and of te positive impacts it can ave on society. One way tat is recommended for addressing tis is by identifying communication needs and participatory processes regarding critical temes concerning R&I in society, suc as stem cell researc. Anoter way in wic tis can be acieved is by concretely communicating te positive effects of etics assessment wen it is integrated in R&I processes, suc as communicating design interventions or funding decisions. Concerning ways for organising etics assessment, it is recommended tat etics assessors sould be familiarised wit te SATORI framework and principles Supporting sustainable etics assessment National governments and intergovernmental organisations sould legally and financially support te institutional networks for etics assessment and provide te necessary impetus for armonisation of etics assessment practices 9. Anoter recommendation is tat countries in a relatively weak economic position sould be supported in setting up proper etics assessment, not only financially but also troug guidance focusing on good practices. In order to ensure te sustainability of te work done in te SATORI project, a temporary secretariat sould be establised tat could support multi-stakeolder collaboration on etics assessment in R&I 10. Tis secretariat sould be involved in pilot implementations of te SATORI framework and related standard, experimenting wit testing te impacts of practices recommended troug te SATORI project, enabling dialogues wit cavity society, furter developing te SATORI framework and supporting activities aimed at building systemic infrastructures for common European approaces to etics assessment. Furtermore, 9 SATORI. Comparative analysis of etics assessment practices, ttp://satoriproject.eu/work_packages/comparative-analysis-of-etics-assessment-practices/ Te countries were selected to enable SATORI to present an international comparison of te etics assessment infrastructure in te respective countries, wit a focus on understanding tose structures and agents tat comprise te etics assessment landscape. 10 SATORI. Heritage (Sustainability) ttp://satoriproject.eu/work_packages/eritage-sustainability/ 6

7 SATORI recommends tat tere is an effort for supporting voluntary collaboration on te evaluation and advancement of te SATORI CEN standard for etics assessment. More generally, etics assessment sould be recognised as a crosscutting priority for te H2020 and FP9 programs to deal wit etics assessment, researc integrity, and oter relevant issues Embedding etics assessment in cultural contexts Generally, policy and legal frameworks sould be implemented for supporting te development and implementation of etics assessment, bot at te national and at te EU level. One recommendation for setting up suc scemes is tat differences in value systems sould be taken into account for etics assessment activities 11. Most notably, tis implies paying attention to differences between traditional and rational-secular values and between informal normative frameworks suc as tose dominant in Anglo-Saxon countries, and formal frameworks tat are more dominant on te European continent. Anoter recommendation is tat economic and political pre-conditions for te armonisations of etics assessment policies be considered, suc as te need for political stability for te armonisation efforts to be successful Harmonising frameworks for etics and etical impact assessment (EIA) It is recommended tat procedures for etics assessment activities (suc as procedures governing te activities of researc etics committees) be armonised across countries and institutions (e.g. European universities adopting a common standard for te organisation of etics assessment). For tis, government actors sould support te use of te SATORI CWA part 1. Generally, SATORI recommends tat te use of EIAs in R&I projects is increased by including tem in legal and regulatory frameworks, and tat policy makers sould raise awareness of te EIA framework and te corresponding CWA. SATORI also recommends tat an EIA sould become an essential part of te management and organisation of R&I processes. Finally, it is recommended tat a discussion and a mutual learning process be facilitated about EIA, bot at te EU and national levels Risk-benefit analysis of etics assessment Cost-effectiveness and risk-benefit analyses sould be conducted in te context of R&I programs (e.g. te H2020 program) 12. In line wit tis, it is recommended tat policy makers incentivise assessors to take into account tat R&I value cains in Europe span across organisation types, wic bear different risks and enjoy different types of benefits. Moreover, it is recommended tat te value of systematic analysis sould not be overstated, since metrics for evaluation remain ambivalent in most cases. Oter recommendations focus on metodology for conducting risk-benefit analyses. In tis regard, it is recommended tat policy makers provide assessors wit a typology of relations between costs and effects of etics assessment, in order to enable comparability between approaces wit similar objectives. Additionally, tools sould be offered for assessors to reflect on te risks imposed by teir coice of objectives, metods and modes of organisation. Finally, it is recommended 11 SATORI. Legal Aspects and Impacts of Globalisation ttp://satoriproject.eu/work_packages/legalaspects-and-impacts-of-globalization/ 12 SATORI. Risk-benefit analysis of etics assessment activities. ttp://satoriproject.eu/work_packages/riskbenefit-analysis-of-etics-assessment-activities/ 7

8 tat policy makers ensure tat assessors take into account organisational and territorial embeddedness of etics assessment wen considering risks and benefits Education and training In general, more attention sould be paid to investing in education and training for etics assessment and to public outreac to inform people about te importance of etics assessment of R&I. Te need for suc education and training sould be more intensively discussed at te EU and national levels. More specifically, it is recommended tat researcers working in R&I processes are educated in etics assessment and in ways to conduct EIAs. In line wit tis, it is recommended tat appropriate efforts be directed to te creation of suitable presentations and information materials on te teme of etics assessment. Also, training activities sould be monitored and standards for te organisation and implementation of training activities for etics assessment sould be set up Stakeolder participation and engagement One of te main recommendations for policy makers concerns moving away from participation in etics assessment understood as consultation towards a broader understanding tat focuses on te engagement of stakeolders in te process of etics assessment in co-constructing te targets of R&I processes and te relevant decision-making. In line wit tis, te SATORI project recommends tat participation be organised in a bottom-up fasion wen appropriate, meaning tat stakeolders can actively contribute to te goals and design of te participatory process 13. An important issue to take into account in tis respect is te balance between openness (te ease wit wic stakeolders can access te etics assessment process) and te formal structure of etics assessment Quality assurance Quality assurance of etics assessment sould include normative objectives tat underscore te political caracter of assessment practices, and it sould be proactive by assessing te dynamism of assessment practices and improving training opportunities 14. Furtermore, SATORI recommends tat policy makers sould adopt metods for assessment of etics assessment tat distinguis between procedural, substantive, transactive and normative effectiveness, tat tey sould be embedded in a broader context looking at case-to-case particularities and related literature - and tat tey sould make use of sared, weiged assessment criteria. Additionally, it is recommended tat etics assessors be encouraged to use te SATORI metodology to inquire into te impacts of teir etics assessment practices 15. In general, te transparency, credibility, reliability, and consistency of te etics assessment and te review process sould be improved. For tis, it recommends tat conformity assessment tecniques are used to ceck, evaluate, or assess aderence to te SATORI CWA standard specifications 16. A conformity assessment of etics assessment 13 SATORI. Dialogue and Participation ttp://satoriproject.eu/work_packages/dialogue-andparticipation/ 14 SATORI. Measuring te Impact of Etics Assessment. ttp://satoriproject.eu/work_packages/measuringte-impacts-of-etics-assessment/ 15 Koivisto, R., A. Tuominen, M. Kari, K. Hyytinen, M. Ylonon, D. Douglas, W. Reijers, P. Brey, L. Bitsc, J. Romare, D. Trescer, D. Ovadia. Report on measuring te impact of etics assessment. Deliverable D SATORI. Standardising Operating Procedures and Certification for Etics Assessment ttp://satoriproject.eu/work_packages/standardizing-operating-procedures-and-certification-for-eticsassessment/ 8

9 sould be carried out in a way tat simplifies procedures and reduces bureaucracy. Furtermore, it is recommended tat te implementation and review of standardisation sould allow for different approaces tat are case-based - e.g., specific to a certain researc performing institution - ranging from simple and fast implementations to detailed and time consuming ones in case te circumstances call for it - e.g., wen te etics assessment practices need to be implemented from scratc. 4.2 INSTITUTION-SPECIFIC RECOMMENDATIONS Te findings of te SATORI project include recommendations to organise a framework for etics assessment tat offers consistent regulation across institutional settings. Bringing te SATORI framework to life requires from governmental actors tat tey provide or amend te legal statuses of etics committees and establis policies concerning etics assessment for a wide range of researc-related institutions Governmental policies for universities Te role of universities is to ensure proper etical assessment of te researc conducted by teir researcers. Governments must incentivize te creation of a researc etics committee (REC) in eac university. Tese RECs sould be centralised and interdisciplinary as possible so as to guarantee a ig quality of etics assessment and at te same time to ensure tat te specificities of eac discipline are taken into account. Furter instruments can increase te consistency and quality of etics assessment across universities at te national scale, suc as codes for etical beaviour. Te SATORI list of etical principles 17 can be used as a basis to develop suc codes Governmental policies for Researc Etics Committees (RECs) Government policies on te composition and functioning of te RECs are required in order to guarantee te creation of a consistent system at te national level. First, legal provision sould be made for wen RECs are to be included in te etics assessment practice. Second, policies sould specify te multidisciplinary caracter of RECs, te types of expertise required from teir members, and ow researcers can appeal decisions. However, it is recommended to avoid a juridification of te etics assessment process itself, as te role of RECs goes beyond cecking for legal compliance. Wen incentivizing te creation of RECs, governments sould make provisions for te creation of a network for RECs to excange experience and solutions Governmental policies for National Etics Committees (NECs) Policy sould be formulated to coordinate RECs at te national level, troug a National Etics Committee (NECs). Establising a pan-european system to expand etics assessment to oter disciplines requires a series of actions. First, NECs need to be establised were tey do not yet exist. Second, NECs need to be provided wit legal statuses tat widen teir scope to sciences beyond life sciences, and tat underline teir independent, multidisciplinary, and pluralist caracter. An equal gender representation sould be compulsory. Te structure of NECs must reflect its multidisciplinary caracter. Sub-committees for different disciplines 17 Jansen, P., W. Reijers, D. Douglas, A. Gurzawska, A. Kapeller, P. Brey, R. Bencin, Z. Warso. A reasoned proposal for sared approaces to etics assessment in te European context. Deliverable D

10 must be establised, and a platform to discuss etics related issues between disciplines and stakeolders must be establised. Tird, te scope of work of NECs sould include te elaboration of procedures to be followed by RECs, as well as procedures for monitoring RECs activities. Fourt, te national level can serve as a court of appeal of decisions formulated by RECs, a mecanism for wic legal provisions need to be made. Were national governments set up NECs, it is recommended tat tey require NECs to engage different stakeolders in te etics assessment process. Tis involves te creation of a temporary sub-committee to investigate ow to best include citizens, civil society organisations, external experts and possibly oter groups in etical decision-making process. NECs must develop organisational structures tat allow for te consultation of citizens, civil society organisations, external experts and possibly oter external groups based on te investigation results. Finally, NECs would benefit from excanging teir findings troug an international platform Governmental policies for National Science Academies (NSAs) National governments sould be establising compliance officers for NSAs, as a measure meant to monitor te compliance to etics assessment across universities. Governments sould provide sufficient funding for tis and ensure te participation of NSAs in international excange platforms Governmental policies for Researc Funding Organisations (RFOs) RFOs play an important role in incentivizing te compliance wit etics assessment. As suc, government policies sould aim at improving te capabilities of RFOs to perform etics assessment sould be improved. Tis means tat provisions sould be made for RFOs to acquire te institutional organisation necessary to perform etics assessment, establising independent, multidisciplinary and pluralist etics committees to perform etics assessment. Second, RFOs capabilities would be reinforced by regular discussion and excange of information among RFOs at te national and international levels on te topic of etics assessment of new and emerging tecnologies. Government policies needs to consider organising suc forums Governmental policies for Industry Generally, it is recommended tat etical beaviour in te private sector be strengtened by more precise rules and legal regulations. Regular consultations wit companies, industry associations and oter relevant stakeolders sould be organised to discuss te relevance of etics assessment of R&I and EIA. SATORI also recommends tat its framework be, as far as possible, integrated in already existing CSR (corporate social responsibility) frameworks and tat SMEs and start-ups are specifically supported in organising etics assessment Governmental policies for Civil Society Organisations (CSOs) In order to organise te voice of civil society as a stakeolder to etics and researc, SATORI recommends tat government take measures for te development and funding of an independent CSO tat would focus on assessing public researc and innovation agendas and cooperate wit oter CSOs in developing strategies of teir own. Oter CSOs sould be encouraged to from dedicated working groups or etics assessment related networks. Tese networks could vary in terms of structure, level of interdependence, and aims. Te purpose 10

11 of networking would be to excange information (knowledge and experience) and learn from eac oter (troug saring best practices, coordinating activities, obtaining common funding, organising advocacy campaigns, influencing te adoption of new regulative acts, etc.). CSOs performing etics assessment sould be trained to do tis. National policies, but also European funded projects tat concern Etics in R&I and RRI could organise tis training. At te internal level, CSOs sould take measures improve teir expertise in etics assessment by engaging experts in te EA procedures, establising expert groups and engage in etics capacity building. 5 POLICY BRIEFS Te SATORI partners ave written six policy briefs tat capture te breadt of te work done in te SATORI project. Te aim of tese policy briefs is to make te extensive work carried out in te project accessible to policy-makers wo can elp turn te proposals of te SATORI project into concrete solutions tat enance etics assessment of R&I in te EU. Te SATORI policy briefs, terefore, cover aspects suc as: ow do we support te implementation of te SATORI etical impact assessment framework? How do we support te armonisation of good practices for etics committees? Wat are te callenges tat need to be addressed in EU-level etics assessment? All te policy briefs are available on te SATORI website 18. Te following caracteristics summarise te main structure of te policy briefs and te way in wic tey were drafted. General structure: te general structure of te policy briefs, except for te first policy brief tat was drafted at an early pase in te SATORI project, was based on te EU document Communicating Researc for Evidence-Based Policy Making 19 of te European Commission. Eac policy brief as an introduction of te teme, covers and main callenges and/or provides a description of te topic, followed by a section wit key observations based on te SATORI deliverables, and a final section wit recommendations for policy-makers and a presentation of te project identity. Getting to te first draft: We assigned eac policy brief to one SATORI partner wo was responsible for putting togeter a first draft, wic contained skeletons of texts of te main sections. Te responsible partner consulted te relevant SATORI deliverables and condensed te findings from tose deliverables in an easy-tounderstand format. Conducting an internal review: Once te responsible SATORI partner finised te first draft, it was sent for internal review. First, all partners working on te policy briefs reviewed te draft, provided feedback on te structure and main findings of te policy brief and made suggestions for textual canges, were appropriate. Second, te responsible partner amended te draft. Submitting te final draft for external review: After a policy brief was internally reviewed and a final draft prepared, it was sent to several SATORI partners and members of te SATORI Advisory Board for additional feedback and comments. Some feedback was also provided during te SATORI worksop eld in Brussels on 18 ttp://satoriproject.eu/publication_type/policy-briefs/ 19 European Commission Directorate General for Researc, Communicating Researc for Evidence Based Policy Making, ttp://booksop.europa.eu/en/communicating-researc-for-evidence-based-policymakingpbkina24230/ 11

12 23 May Te feedback was addressed during te final revision of te policy briefs. In te following sections, we provide a sort overview of te six SATORI policy briefs. Additionally, we discuss callenges encountered during te process of writing te policy briefs and elucidate te dissemination strategy applied and its potential impact. 5.1 SUMMARIES OF SATORI POLICY BRIEFS Tis section presents sort summaries of te six policy briefs Policy brief: Responsible and etical governance of researc and innovation in te context of globalisation Tis policy brief contextualises te work done in te SATORI project in te setting of global researc and innovation (R&I) practices. It addresses six central issues in globalised R&I: (1) responsible supply cain governance, (2) scientific misconduct, (3) respect for traditional and indigenous knowledge, (4) te outsourcing of emissions of greenouse gasses, (5) te brain drain of skilled scientists and (6) standards for clinical researc and trials. For eac of tese key issues, te policy brief offers recommendations. Tis policy brief is publicly available at te following link: ttp://satoriproject.eu/publications/policy-and-legal-options-for-developing-researc-eticswitin-te-context-of-globalisation/ Policy brief: Improving te organisation of researc etics committees (RECs) Tis policy brief provides guidelines for drafting policies tat support te armonisation of good practices concerning te organisation of RECs. It, first, discusses wat RECs are, and wat key callenges tey face, suc as dealing wit sortages of resources and dealing wit personal biases of REC members. It also discusses callenges wit regards to globalisation of R&I, suc as te strong influence of economic and political circumstances on te functioning of RECs and cross-cultural agreement about moral limits of R&I. It, finally, offers recommendations for (1) te proper governance of RECs, (2) te armonisation of procedures for RECs, (3) ensuring quality control of RECs and (4) ensuring adequate funding for RECs. Tis policy brief is publicly available at te following link: ttp://satoriproject.eu/publications/improving-te-organisation-of-researc-eticscommittees-recs/ Policy brief: Etical Impact Assessment enancing responsible researc and innovation (R&I) Tis policy brief provides guidance for te process of Etical Impact Assessment (EIA), wic is a non-prescriptive process of assessing te etical impacts of R&I activities, outcomes and tecnologies. It provides for a rationale for implementing an EIA, wic 12

13 centres around te increasing impact of R&I on society and te fast pace of tecnological advancements. It presents te SATORI EIA framework, illustrating its use in different contexts and outlining its key steps: (1) te tresold analysis, (2) te preparation of an EIA plan, (3) identification of etical impacts, (4) etical impacts evaluation, (5) formulation and implementation of remedial actions, and (6) te review and audit of te EIA. It discusses some on-going callenges for te implementation of te EIA, related to te compatibility between te EIA framework and oter legal, etical and social metods for ensuring etical R&I. Finally, it presents recommendations to support and incentivise te implementation of EIAs. Tis policy brief is publicly available at te following link: ttp://satoriproject.eu/publications/maximising-te-potential-of-etics-assessment-ofresearc-innovation-a-call-to-researc-funding-organisations/ Policy brief: Supporting etics assessment in researc and innovation (R&I) Tis policy brief provides guidance for supporting and enancing etics assessment. It first discusses te importance and callenges of etics assessment, underlining te need to deal wit new etical issues related to R&I activities and amongst oter te problem of a lack of awareness of etical issues. It ten lays out requirements for a support system for etics assessment, wic are: (1) a national institutional network, (2) sufficient resources, (3) a clear regulatory framework, (4) proper oversigt, (5) platforms for discussion and (6) trainings for REC members. Finally, it provides recommendations to support etics assessment for different stakeolders: national governments, supranational and inter-governmental organisations, national etics committees, researc etics committees and oter stakeolders. Tis policy brief is publicly available at te following link: ttp://satoriproject.eu/publications/supporting-etics-assessment-in-researc-and-innovation/ Policy brief: Industry and Researc and Innovation: Towards Etical, Responsible and Sustainable R&I Tis policy brief provides guidance for te organisation of etics assessment for R&I performed by commercial entities. It discusses te current lack of means for integrating etics responsibility and sustainability in business R&I contexts and introduces ow SATORI addresses tis problem. It presents some key statistics, wic sow tat a large sare of R&I is performed by companies, making tem crucial stakeolders in responsible R&I. It presents key findings of te SATORI project concerning etics assessment of R&I and CSR (corporate social responsibility) policies, te institutional setup of etics assessment in companies and te procedures for etics assessment in industry. Te brief discusses some core callenges and drivers for etics assessment in industry, wic finally culminate in an overview of recommendations for policy-makers suc as saring of good practices and setting up a learning portal for etical impact assessment. Tis policy brief is publicly available at te following link: ttp://satoriproject.eu/publications/etical-impact-assessment-enancing-responsibleresearc-innovation/ 13

14 5.1.6 Policy brief: Maximising te potential of etics assessment of researc and innovation: a call to researc funding organisations Tis policy brief provides guidance for improving etics assessment in te context of researc funding organisations (RFOs). It discusses te most relevant aspects of te SATORI framework for te armonisation of etics assessment practices. It discusses te use of tools and training to advance etics assessment. Te brief offers recommendations based on te SATORI roadmap, concerning (1) system-level capabilities, (2) professional norms, (3) use of te SATORI framework, (4) promotion of etics assessment tools and te framework and (5) te promotion of professional attitudes and norms. Tis policy brief is publicly available at te following link: ttp://satoriproject.eu/publications/industry-and-researc-and-innovation-ri-towards-eticalreponsible-and-sustainable-ri/ Callenges wit drafting te policy briefs Te process of drafting and reviewing te policy briefs encountered some callenges, i.e., Adjusting te language of te SATORI deliverables to be more generally accessible to non-specialist audience. Summarising findings of lengty SATORI deliverables witout losing crucial information terein. Structuring te policy briefs in a way tat is easy for te readers to understand and access te most crucial information in a glance. Te SATORI partners developing te policy briefs worked ard to ensure tese difficulties were addressed and mitigated, in dialogue wit one anoter Dissemination strategy & impact In tis section, we briefly discuss te dissemination strategy and te expected impact of te policy brief, in terms of number of relevant people reaced. Target audiences For most of te policy briefs, we targeted a broad range of stakeolders most of wic overlapped wit te SATORI stakeolders. Tese were policy-makers, science academies, researc funding organisations, national etics committees, and oters. For some policy briefs, te target audience was more specific. E.g., te target audiences for te policy brief on responsible R&I in business are commercial entities engaged in R&I activities; te target audiences for te Maximising te potential of etics assessment of researc and innovation policy brief are researc funding organisations. Dissemination strategy Our dissemination strategy consists of publication of te policy briefs in different places and by means of different communication cannels: Publication of te policy briefs on te SATORI website ttp://satoriproject.eu/publication_type/policy-briefs/ 14

15 Presentation at SATORI events: worksops in Ljubljana (January-February 2017), policy worksop at UNESCO, Brussels (23 May 2017) and te final conference in Brussels (18-19 September 2017), wic features a range of stakeolders (international, EU and national). Distribution of te briefs to te SATORI mailing list, policy briefs contact list and te SATORI partner networks. Publicity of te policy briefs in te SATORI newsletters. Link to te policy briefs and publicity via SATORI and partner social media feeds e.g., Twitter and Facebook. Acieving impact At te time of writing tis report, te full impact of te policy briefs cannot be completely determined, toug tey seem to ave been well-received based on feedback from te Brussels policy worksop. Te SATORI consortium will strive to acieve te following impacts: Education and awareness of policy-makers Sensitisation to results of SATORI Sensitisation to te need to enance etics assessment in R&I Wider engagement wit etics of R&I Better acknowledgement of etics assessment in R&I policy making. Feeding into policymaking, furter impetus to supporting etics in R&I. As feasible, between te date of writing and te close of te project, te consortium will continue to make efforts to support good impact for te policy briefs. 15

16 6 CONCLUSION Tis deliverable provided an overview of te key recommendations tat resulted from te SATORI project. Additionally, it provided an overview of te policy briefs tat ave transformed te SATORI results into policy documents. It summarised te policy briefs and provided an overview of teir drafting process. Te final policy briefs, as tey were publised on te SATORI website, are included in te annex. 16

17 7 ANNEX: THE SATORI POLICY BRIEFS List of te policy briefs displayed below: 1. Improving te organisation of researc etics committees (RECs) 2. Etical Impact Assessment enancing responsible researc and innovation (R&I) 3. Supporting etics assessment in researc and innovation (R&I) 4. Industry and Researc and Innovation: Towards Etical, Responsible and Sustainable R&I 5. Maximising te potential of etics assessment of researc and innovation: a call to researc funding organisations 6. Responsible and etical governance of researc and innovation in te context of globalisation 17

18 Policy Brief: Improving te organisation of researc etics committees (RECs) Te Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation (SATORI) project, funded by te European Commission (FP7 sceme), aims to develop a common framework of etical principles and practical approaces. It also aims to strengten sared understandings among actors involved in te design and implementation of researc etics. Wo is tis policy brief for? For policymakers and oter stakeolders wo set guidelines for, or make recommendations to researc etics committees. Wy was it prepared? To foster and support good practices in etics committees across Europe. Sare te message. Please sare tis policy brief wit people in your network wo migt be interested in best practices for etics committees, and etics assessment in general. SATORI website: ttp://satoriproject.eu/ Tis policy brief was prepared by te University of Twente on bealf of te SATORI consortium. SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

19 EXECUTIVE SUMMARY Etics assessment in R&I faces many callenges, wic impacts te functioning of researc etics committees (RECs). SATORI stakeolders perceived problems suc as lack of clarity regarding legal competencies of RECs and inconsistencies in te appointment process of REC members. SATORI proposes ow to improve te governance of RECs, armonise REC procedures, ensure quality control and ensure adequate funding for good practices. Key recommendations: Guidelines sould be in place for te composition of RECs, to ensure tat REC members ave te relevant types of expertise (wic may include te expertise of laypersons). Guidelines for procedures prior to an assessment sould be in place; tese sould minimally include (a) a standard application for researcers in wic crucial information is recorded, and (b) a means for researcers to conduct a self-assessment before being assessed by te REC. A system of appeal sould be in place for researcers to callenge te decisions made by RECs. Countries in a relatively weak economic situation, and looking to arness RECs to facilitate more etical R&I sould be supported not only troug finance but good practice guidance. SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

20 INTRODUCTION Te SATORI project aims at supporting mutual learning in etics assessment and guidance across stakeolders, and armonising etics assessment in Europe and beyond. Researc etics committees (RECs) form a crucial part of any framework for etics assessment. Terefore, te SATORI project studied good practices in RECs aims, organisation and procedures across different institutions and jurisdictions. RECs assess, evaluate and review researc activities, on te basis of legal and etical requirements. Tey assess researc or innovation goals, researc project proposals, researc practices suc as experiments wit uman subjects, and many oter researc and innovation (R&I) related practices. Tey may offer advice for proper etical conduct, and make decisions about compliance of R&I projects wit national and international laws. However, etical assessment of R&I faces many callenges. It currently lacks unity, recognised approaces, professional standards and proper recognition in some sectors of society. Tese problems are relevant for RECs, since te ways in wic tey are organised differ widely between countries and institutions. In a context of globalising R&I, tis situation is increasingly problematic because te work of etics committees can become ineffective wen R&I activities cross borders and ave a strong international dimension. Tese problems come at a time of rapid expansion of etics assessment in different sectors of researc, particularly te umanities and social sciences. An increasing number of universities and researc institutes are instituting RECs in addition to researc integrity offices. At te same time, differences across institutions and jurisdictions in ow RECs are organised may cause inconsistencies in etics assessment and incompatibilities between practices. Tis as an adverse impact on te quality of etics assessment and reliance upon it to safeguard etical principles. Terefore, tere is a need to draft policies to armonise te organisation of RECs. In tis policy brief, we present some recommendations tat can guide te drafting of suc policies. SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

21 KEY OBSERVATIONS Te SATORI project as been te first of its kind to survey te entire etics assessment landscape in te EU and beyond, by conducting more tan 230 stakeolder interviews and engaging in in-dept and multiple-country case studies of different institutions involved in te etics assessment process. Of te interviews, tirty were conducted wit REC representatives from nine different countries and five wit representatives of REC associations. From tis compreensive study, te SATORI project drew several key observations pertaining to te workings of etics committees. Wat are RECs? Wat callenges do tey face? RECs are usually multidisciplinary, independent groups of individuals tat are cosen or appointed to assess etical issues in R&I. Tey are, for instance, present in universities were tey assess te etical acceptability of proposals for uman subject experiments. RECs are important actors in some researc funding organisations, and tey assess weter researc proposals sould be funded or not, based on etical considerations. Te SATORI project identified te following types of RECs: Local RECs are linked to researc performing institutions, suc as universities and ospitals, and assess R&I activities witin tese institutions. Regional RECs are instituted by different regional bodies (regional autorities, medical associations, etc.) and assess R&I activities witin a certain geograpical area. National RECs supervise local and regional RECs, assess specific types of R&I activities, and may serve as appeal bodies. RECs ave been establised in te field of biomedical researc in te 1950s, and since tat time, ave been extensively regulated. For RECs in tis field, te European Commission as been active in setting guidelines tat complement national regulations. Additionally, te Steering Committee on Bioetics of te European Council as publised a Guide for researc etics committees, wic specifically addresses RECs for biomedical researc. During te last years, owever, RECs expanded teir scope to many oter fields of R&I suc as te engineering sciences and computer science. Tis rapid expansion is accompanied by a growing need for guidance and armonisation of practices of RECs. Additionally, it presents a need for improved training of REC members and quality assurance. SATORI REC interviewees expressed tat we need RECs amongst oters to ensure tat researc is in line wit national and international standards, to offer etical guidance to researcers, to ensure te safety of researc subjects and to make etical beaviour part of te everyday routine of researcers. According to a significant number of interviewees, te biggest obstacles for armonisation of etics assessment are differences between countries, cultures, etical values SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

22 and pilosopies, and differences between scientific fields. Te awareness of tese differences led to te conclusion tat any proposed framework for etics assessment sould be of a general nature and sould leave room for flexibility. Noneteless, te wis for armonisation of etics assessment, particularly at te European level, is sared across most of te SATORI stakeolders. In dealing wit te armonisation of etics assessment, REC interviewees expressed tey face a variety of problems, suc as: Perceived sortages of resources, wic are needed to properly organise te work of RECs. Inconsistencies in te conditions for appointment of REC members. Te lack of clarity regarding te legal competences of RECs. Te narrow scope of etics assessment in certain cases, were focus is only on compliance and no allowance is made for etical reflection. Te difficulty of dealing wit personal bias in te work of RECs. Te limited mandates of RECs, wic often leads to fragmentary etics assessment. Te lack, for some RECs, of any clear procedural structure. Te general lack of (self-) evaluation of RECs. RECs in a globalising world of R&I R&I as become a global endeavour, wit researc projects being carried out at te multi-national level and cross-cultural collaborations flourising. Accordingly, etics assessment and te organisation of etics committees needs to keep up wit tis trend. For tis reason, te SATORI project conducted an in-dept comparison of value-systems of different cultures and of regulatory systems across te world. Te comparison of legal systems mainly revealed an inconsistent application of international standards of etics assessment across jurisdictions. Tis again sows te urgent need for armonisation efforts. Te main conclusion from te compreensive comparison of value-systems is tat tere are no differences in values between global value systems tat would categorically inder armonisation of practices in etics assessment. However, some important observations were made tat sould guide te armonisation process of etics committees: More orizontal forms of organisation of etics committees could lead to more responsible beaviour from members. Due to te general support of democratic values across cultures, decision-making processes in etics committees would benefit from an incorporation of democratic principles. Economic and political circumstances ave a strong influence on te value-system in wic etics committees operate. In te EU, people generally agree tat certain moral limits sould apply to scientific researc, especially in te field of biotecnology. Tis indicates tat te work of etics committees is generally welcomed. SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

23 RECOMMENDATIONS FOR POLICY MAKERS Based on te key findings in of te SATORI project, we present a number of recommendations for promoting good practices in RECs. Policy makers can utilise tese recommendations to improve te functioning of RECs and to armonise te organisation of RECs across institutions and countries. Proper governance of RECs: We recommend tat policy makers set certain guidelines for te proper governance of RECs. Tis pertains to te composition of RECs, te appointment of members and teir training. To ensure proper governance of RECs, we recommend tat: Guidelines are in place for te composition of RECs, to ensure tat REC members ave te relevant types of expertise (wic may include te expertise of laypersons). Policy makers sould also encourage RECs to include non-experts in teir decision-making processes, to make sure tat broader views in society are taken into account. Proper guidelines are in place to ensure tat REC members are appointed in a transparent and democratic manner. Adequate training is provided for te REC members to enable tem to be sufficiently capable of dealing wit te relevant type of etics assessment. Harmonisation of procedures of RECs: We recommend tat guidelines be set up to armonise te working of RECs across institutions and countries. Tis would imply tat a minimum set of guidelines are proposed, tat sould be followed. Good practices tat surpass tese minimum requirements sould be encouraged. Regarding tese minimum requirements, we recommend tat: Guidelines for procedures prior to an assessment are in place; tese sould minimally include (a) a standard application for researcers in wic crucial information is recorded, and (b) a means for researcers to conduct a self-assessment before being assessed by te REC. Guidelines for procedures tat sape te actual assessment are in place, wic sould minimally include (a) appropriate decision-making procedures and (b) an appropriate transparency of decision-making. Guidelines for procedures after te assessment, ensuring proper follow-up, wic sould minimally include (a) a written judgement tat is send to te researcers in a timely manner, (b) an appeal procedure and (c) a follow-up mecanism tat ensures tat te decision of te REC is respected. SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

24 Ensuring quality control of RECs: Finally, we recommend tat guidelines for quality control of RECs sould be put in place. Tese guidelines would ensure tat RECs tat are not functioning optimally or sub-optimally, can take appropriate remedial actions. To ensure quality control in RECs, we recommend tat: A supervising body is in place, wic sould preferably be an independent body to prevent bias in te quality control process. A plan for remedial actions is in place, wic would ensure tat te functioning of an REC could be improved wen tis is deemed unsatisfactory. A system of appeal is in place for researcers to callenge te decisions made by RECs. Te value of te work of RECs is sared wit te general public. Adequate funding for good practices and armonisation: We recommend tat policy makers responsible for setting guidelines for RECs sould ensure adequate funding and support is made available. Adequate funding is needed to facilitate better organisation and good practices in RECs. Some of te SATORI REC interviewees indicated very clearly tat a lack of funding obstructs te proper functioning of RECs and stated tat negative socio-economic pressures can ave a negative effect on RECs. Tus, werecommend tat: Policy makers sould garner and make adequate funding available to support te work of, and good practices in RECs. Policy makers sould specifically attend to te needs of institutions tat do not ave establised REC mecanisms Countries in a relatively weak economic situation, and looking to arness RECs to facilitate more etical R&I sould be supported not only troug finance but good practice guidance. FURTHER READING SATORI, Etical Assessment of Researc and Innovation: A Comparative Analysis of Practices and Institutions in te EU and selected oter countries, ttp://satoriproject.eu/media/d1.1_etical-assessment-of-ri_a-comparative-analysis.pdf SATORI, A reasoned proposal for sared approaces to etics assessment in te European context, SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

25 PROJECT IDENTITY Project name: SATORI: Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation. Coordinator: Pilip Brey Consortium: Airi nanotec IT Funding Sceme: European Commission s Sevent Framework Programme (FP7/ ) under grant agreement n Duration: 01/01/ / For more information: p.a.e.brey@utwente.nl Website: ttps://satoriproject.eu/ SATORI Policy Brief: Improving te organisation of researc etics committees (RECs) January

26 Policy Brief: Etical Impact Assessment enancing responsible researc & innovation Te Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation (SATORI) project, funded by te European Commission (FP7 sceme), aims to develop a common framework of etical principles and practical approaces. It also aims to strengten sared understandings among actors involved in te design and implementation of researc etics. For wom is tis policy brief? Policy-makers, researc organisations, policy advisors, government researc and innovation (R&I) departments interested in etical impacts of researc and innovation, private companies, R&I departments, national etics committees, researc etics committees, researcers. Wy was it prepared? To publicise te SATORI etical impact assessment (EIA) framework, foster its widespread adoption and enance responsible researc and innovation (RRI). Sare te message. Please sare tis policy brief wit your networks and contacts wo migt be interested in tools to address te etical impacts of researc and innovation (R&I). SATORI website: ttp://satoriproject.eu/ Tis policy brief was prepared by Trilateral Researc Ltd. on bealf of te SATORI consortium. SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

27 EXECUTIVE SUMMARY Key recommendations: Increase te general use of EIAs. Raise awareness of te SATORI EIA framework and its benefits. Promote te conduct of good quality and transparent EIAs. Support EIA (as a tool to address etical impacts) as an essential part of te management of an organisation s researc and innovation process. Facilitate discussion and mutual learning about EIA at te EU and national levels. SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

28 INTRODUCTION Etical impact assessment (EIA) is a non-prescriptive process of assessing te etical impacts of R&I activities, outcomes and tecnologies. 1 Etical impacts concern or affect uman rigts and responsibilities, benefits and arms, justice and fairness, well-being and te social good. 2 Specific examples include: negative impact on uman rigts (e.g., discrimination, inequality), problematic genetic modifications, safety risks, privacy violations resulting from unautorised collection and processing of personal data, accessibility restrictions, armful interference wit te environment, targeting of vulnerable groups, dual use, misrepresentation of cultural eritage, etc. Te SATORI consortium collaboratively constructed te SATORI EIA framework, in dialogue wit a wide range of stakeolders. Te framework provides a means to determine and address te etical impacts of researc and innovation activities and outcomes 3. It is a result of a syntesis of literature on EIA and foresigt studies its final formulation is based on extensive consultation (written and face to face) wit etics and impact assessment stakeolders from several EU countries, scientific disciplines, and organisations. SATORI presented and discussed te EIA framework in five mutual learning worksops in Belgrade, London, Milan, Utrect and Warsaw in 2016 (after wic te framework was refined). NEED FOR AND VALUE OF EIAs Te need for EIA metods emerges not only from te evolving etical risks from R&I activities, but also from te increasing focus on responsible researc and innovation (RRI) in policy contexts, collaborative efforts by te scientific community to identify and mitigate etical impacts, and from new (ard and soft) legal trusts for RRI at te European level. Te increasing impact of researc and innovation on society and te fast pace of tecnological advancements calls for a considered reflection, and addressing of suc impacts. An EIA can elp bridge te gap between etical principles and actionable guidance to promote te etical conduct of researc. All researc and innovation activities ave etical impacts to a greater or lesser extent. For example, artificial intelligence (AI) tecnologies migt adversely affect uman autonomy (i.e., umans may pass powers on to AI or lose decision-making rigts altogeter in some respects). Robotics may perpetuate or increase asymmetries of power. Human genome editing carries risks of errors, oter unintended effects, or lead to ealt inequality. Data analytics may ave adverse impacts in terms of increasing surveillance of people, or migt feed wrongful 1 Wrigt, David, A Framework for te Etical Impact Assessment of Information Tecnology, Etics and Information Tecnology, Vol. 13, No. 3, September 2011, pp SATORI, Etics assessment for researc and innovation Part 2: Etical Impact Assessment Framework, CEN Worksop Agreement, SATORI, May We recognise tat wile some etical principles may be sared across countries and scientific disciplines as SATORI researc as sown, tere are also significant differences in teir interpretation and application. EU-level application migt differ from national applications. National level requirements and sensitiveness to etical issues and impacts also varies. SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

29 decisions based on inaccurate data. Neuro-enancement researc may support objectionable pysical and social canges in uman beings. Security researc and innovations migt be open to misuse and carry a risk of severe arm to uman beings. Te dynamism and fast-canging nature of researc and innovation activities in a project s lifecycle call for a more proactive approac to identify and address on an ongoing basis any etical risks tat migt arise. Identifying, assessing and resolving etical impacts wile a project is being undertaken and before project deployment can elp an organisation avoid grief (e.g., public backlas, regulatory action, penalties, media censure, rejection of results) downstream. It elps reduce te cost and time needed to fix complex and serious etical risks. Engaging te rigt stakeolders in a consultative EIA process can elp minimise liability. An EIA can also elp an organisation or project avoid reputational damage. It can boost transparency and build end user and public trust. For tose carrying out an EIA, it is a good opportunity to reflect and work collaboratively wit stakeolders to identify and mitigate etical risks. For te policy-making community, an EIA as multiple benefits: First, an EIA makes te goal of responsible researc and innovation (RRI) less elusive as it elps implement and document RRI witin a project in a systematic, and practical manner. Second, public institutions can better justify te allocation of public money to researc and innovation projects because an EIA makes explicit bot te benefits and te possible negative risks for society. For commercial entities, an EIA can provide insigts about te potential negative impacts of researc and innovation initiatives and consequently allow for an outreac to clients and consumers to sow ow suc impacts ave been mitigated. THE SATORI ETHICAL IMPACT ASSESSMENT FRAMEWORK As SATORI researc as determined, so far, no armonised framework for conducting EIA as in practice been agreed upon or implemented at te EU-level. Different approaces to EIA exist. However, etics assessment is increasingly becoming a requirement for obtaining funding in R&I projects. Te lack of a structured and armonised approac to carry out EIAs makes it arder to assess te effectiveness and quality of te current EIAs. Te SATORI EIA Framework presents a compreensive structured metodology for conducting an EIA in researc and innovation (R&I) projects, wic reflects bot te existing literature, and R&I impact assessment practices, tailoring it to te way R&I projects are organised. Te Framework lays down clear steps, criteria and options for adapting EIAs to fit various types of R&I projects. SATORI defines an EIA as te process of judging te etical impacts of researc and innovation activities, outcomes and tecnologies, in consultation wit stakeolders. 4 Tis process involves identifying and evaluating te etical impacts and developing guidelines or making recommendations for remedial actions to mitigate etical risks and enance etical benefits. 4 SATORI, Etics assessment for researc and innovation Part 2: Etical Impact Assessment Framework, CEN Worksop Agreement SATORI, May SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

30 Wit te aim of enancing te overall benefit of researc and innovation for society, te SATORI EIA elps determine weter a project raises any etical risks, identify and evaluate etical impacts using different metods and tools, and facilitates taking remedial actions to mitigate negative etical impacts of te project. EIAs may be useful in all fields of researc and innovation bot traditional (e.g., medical or engineering researc) and emerging (e.g., socio-tecnical researc, uman-macine interactions etc.). Te diagram below illustrates areas of potential use for te SATORI EIA framework: Information and communication tecnologies Future and emerging tecnologies European researc infrastructures Space Science wit and for society Innovation in small and medium-sized enterprises SATORI ETHICAL IMPACT ASSESSMENT FRAMEWORK Nanotec, advanced materials, manufacturing and processing, biotec Secure societies Secure, clean and efficient energy Climate action, environment, resource efficiency and raw materials Food security, agriculture and forestry, marine and maritime and inland water researc Smart, green and integrated transport Healt, demograpic cange and wellbeing Inclusive, innovative and reflective societies Figure 1: Areas of potential use for te SATORI EIA (based on Horizon 2020 EU Framework Programme for Researc and Innovation) SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

31 An EIA may be carried out by an individual or team, e.g., administrator(s) at a researc institute, project researcers, or independent consultants. Te timing of te EIA depends on te nature of te R&I project or activity. KEY STEPS IN THE SATORI EIA Tere are six key steps in te SATORI EIA, as illustrated in te figure below: Figure 2: Steps in te SATORI EIA Conduct an EIA tresold analysis Prepare an EIA plan Identify etical impacts Evaluate te etical impacts Formulate and implement remedial actions Review and audit te EIA Te tresold analysis determines weter an EIA is needed. Te EIA plan sets out te scale of te EIA, budget, team composition, criteria for EIA review, criteria for re-visiting te EIA, and plans for stakeolder consultation. Te etical impact identification stage aims to identify and describe te etical impacts of te R&I project and place tese impacts in a temporal perspective, anticipating sort, medium and long-term impacts. It includes an identification of potential (future) etical impacts troug literature reviews of te etical impacts in similar projects, and furter specification and identification of additional potential etical impacts via te use of foresigt metods and etical impact analysis metods. Te etical impact evaluation stage assesses te relative importance, te likeliood of occurrence and te possible value conflicts of etical impacts tat ave been determined in te etical impact identification stage. Bot te etical impact identification and evaluation steps migt be done in consultation wit stakeolders. Te remedial actions stage, involves te formulation of remedial actions to minimise and overcome any negative etical impacts. Te review and audit stage ensures independent evaluation of te EIA process and, if necessary, independent intervention to ensure its goals are met. Te full EIA framework is documented in te SATORI CEN Worksop Agreement Etics assessment for researc and innovation Part 2: Etical impact assessment framework and te SATORI report Outline of a common etics assessment framework (Deliverable 4.2). 5 ONGOING CHALLENGES Wile an EIA is a good tool to support te R&I community in stimulating etical tougt and action, its application faces callenges, wic must be considered in te design, use and implementation of EIAs. Te callenges (along wit te nature of te R&I) ave a bearing on weter metods oter tan an EIA, e.g., a broader etical, legal, social analysis (ELSA), sould support etical researc and innovation and ow te EIA framework could be made compatible wit oter frameworks in use. 5 See ttp://satoriproject.eu/work_packages/ SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

32 One major callenge is tat EIAs are still in teir infancy as it stands, EIAs are used on an ad oc basis to address etical impacts in R&I. Wile tis can be considered normal for a process tat is still in development, it is far from ideal as it impacts teir generalisability and adaptability. Tis callenge will become less significant wit te wider use of EIAs and saring of good practice. However, new researc metods and tecnologies will continuously introduce new etical issues and tus any EIA framework will need to be continuously updated and adapted. Anoter callenge is institutional support and attitudes to EIAs. A good level of support from institutional management is necessary to enance and optimise EIAs. Support from management can elp ensure tat an EIA exercise is not taken ligtly, adequate resources are allocated to it, te process is well supported (its quality is assured and it is not mismanaged), and te results are implemented. Sometimes tere is resistance to te idea of an EIA because it is perceived as a mere formality, its purpose and benefits are not understood, and/or EIA assessors are not trained in te process but carged wit te responsibility of conducting one. Anoter callenge for EIAs is te effective implementation of its recommendations i.e., measures to mitigate etical impacts. Te danger is tat many a times te results of a EIA migt become mere tick-box exercises and te EIA itself migt become a paper tiger. To avoid tis, te recommendations of an EIA sould ave an owner (responsible party), and tere sould be a monitoring mecanism to ceck weter te recommendations are being considered. Here independent review and audit becomes critical. Yet anoter callenge is te lack of saring ( closed doors ) of etical impact assessment good practice. Researcers, academics, and private consultants carry out different forms of etical impacts analysis 6 in EU or national R&I projects. Eac of tese may adopt different, yet valuable practices (depending on scope of teir analysis and sector of application), yet often wat is missing is a common portal or means of cross-project and actor saring of good practices and procedures to advance te process. Making EIA reports (or teir redacted summaries) publicly available could go some way to address tis callenge and advance te future use of EIA. Policy-makers sould aim to take actions to support transparency in EIAs. Decision-makers sould also address te quality of an EIA. A good quality EIA benefits te organisation conducting it (i.e., via increased awareness of etical impacts, adoption of good etical practices) and te party tat relies on it i.e., it promotes good decision-making, supports responsible R&I and boosts public trust. EIAs of questionable quality demonstrate one or more of te following sortcomings: tey lack transparency and openness; tey do not adequately identify etical risks and appropriate resolutions; risk resolutions lack specificity; or tey do not consider te views of affected stakeolders, etc. Te recommendations in te next section aim at tackling and addressing tese callenges. 6 E.g., some of suc activities are classed under ELSA. SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

33 SUPPORTING AND INCENTIVISING EIAs: CALL TO ACTION Tere are many ways in wic policy-makers and private R&I organisations can support and facilitate te wider use of EIA. Te following table outlines te SATORI recommendations and actions. 7 Table 1: How policy-makers can support te SATORI EIA SATORI recommendations Raise awareness about te SATORI EIA framework and its benefits in R&I contexts Increase te general use of EIAs Promote te conduct of good quality and transparent EIAs Facilitate discussion and mutual learning about EIA at te EU and local levels Wat policy-makers can do Publis te SATORI EIA framework in official communication cannels Organise consultations wit stakeolders to discuss te relevance, use of te framework and ow it could complement existing etical frameworks Sare experiences in using te framework Mandate EIAs via inclusion in legal frameworks Specify legal criteria for mandatory EIAs Create opportunities, embody in soft law (general or sectoral guidelines, policy declarations or codes of conduct) Include conduct of EIA as a criterion in R&I procurement policies and grant funding conditions, or subsidies. Support independent peer review and audit of EIAs Incentivise te certification of EIA and accreditation of certification bodies or agencies certifying EIA of projects (Regular) training for etical impact assessors Encourage publication of EIA reports (or summaries) Create a registry of etical impact assessment reports Set up EIA peer review publication platform 7 Set up an EIA mutual learning portal or community at EU and/or national level Create a registry of etical impact assessment reports Develop EIA guidance based on te results of SATORI. 7 As recommended in SATORI Deliverable 7.2. Rodrigues, Rowena, et al., Exploring te potential of conformity assessment tecniques to support etics assessment, SATORI Deliverable 7.2, SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

34 Table 2: How private R&I organisations can support te SATORI EIA 8 SATORI recommendations Support EIA (as a tool to address etical impacts) as an essential part of te management of an organisation s R&I process Encourage and facilitate te use of te SATORI EIA Support te furter development of te SATORI EIA (and cross-organisational learnings) Wat private R&I organisations can do Integrate te framework into researc management and/or corporate social responsibility procedures and practices Set up internal procedures for conducting an EIA 8 in R&I projects Dedicate resources (uman, financial, time) for carrying out EIAs and teir review. Download and circulate copies of te SATORI EIA to R&I teams. Provide guidance and support to te R&I teams planning to use te SATORI EIA. Provide feedback to te SATORI CWA Secretariat relating to te use of te SATORI EIA Publis EIA reports. FURTHER READING Callies, Ingrid, et al, SATORI Outline of an Etics Assessment Framework, V.1.1, Deliverable 4.2, December Jansen, Pilip et al, A reasoned proposal for sared approaces to etics assessment in te European context, Deliverable 4.1, December Reijers, Wessel, Pilip Brey, Pilip Jansen, Rowena Rodrigues, Raija Koivisto and Anu Tuominen, A Common Framework for Etical Impact Assessment, SATORI, Deliverable 4.1, Annex 1, October Rodrigues, Rowena et al., Exploring te potential of conformity assessment tecniques to support etics assessment, SATORI Deliverable 7.2, SATORI, Etics assessment for researc and innovation Part 1: Etics committee, CEN CWA SATORI, SATORI, Etics assessment for researc and innovation Part 2: Etical Impact Assessment Framework, CEN CWA SATORI, See SATORI project website: ttp:// SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

35 PROJECT IDENTITY Project name: SATORI: Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation. Coordinator: Pilip Brey Consortium: Airi nanotec IT Funding Sceme: European Commission s Sevent Framework Programme (FP7/ ) under grant agreement n Duration: 01/01/ / For more information: p.a.e.brey@utwente.nl Website: ttps://satoriproject.eu/ SATORI Policy Brief: Etical Impact Assessment enancing responsible researc & innovation June

36 Policy Brief: Supporting etics assessment in researc and innovation Te Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation (SATORI) project, funded by te European Commission (FP7 sceme), aims to develop a common framework of etical principles and practical approaces. It also aims to strengten sared understandings among actors involved in te design and implementation of researc etics. Wo is tis policy brief for? National and international policy makers and advisors, science academies, national etics committees, networks of researc etics committees, academic and professional associations, university associations, researc funding organisations, civil society organisations. Wy was it prepared? Tis policy brief aims at publicising te SATORI etical impact assessment framework and fostering its widespread adoption to enance responsible researc and innovation. Sare te message. Please sare tis policy brief wit your networks and contacts. SATORI website: ttp://satoriproject.eu/ Tis policy brief was prepared by Researc Centre of te Slovenian Academy of Sciences and Arts (ZRC-SAZU) on bealf of te SATORI consortium. SATORI Policy Brief: Supporting etics assessment in researc and innovation June

37 EXECUTIVE SUMMARY Ensuring tat R&I follows ig etical standards by reliable and efficient assessment procedures requires well-functioning national systems of etics assessment based on internationally armonised principles, wic also facilitate international researc collaboration. Key recommendations: National governments can support etics assessment by providing te legal framework and by establising and funding te institutional network for etics assessment. Intergovernmental organisations can provide te impetus for te armonisation of etical guidelines at te international level. National etics committees, science academies, university associations, professional associations and oter stakeolders can contribute to te development of etical guidelines and assessment procedures in all scientific fields as well as organising trainings and raising awareness on etical issues in R&I. SATORI Policy Brief: Supporting etics assessment in researc and innovation June

38 INTRODUCTION Te SATORI project promotes a vision of a well-developed practice of etics assessment at te European level, wic seeks to ensure tat te European researc and innovation (R&I) community follows ig etical standards. Te project partners ave studied etics assessment practices and principles in different EU and non-eu countries, scientific fields and different types of institutions and ave consulted an array of stakeolders troug interviews and worksops. Based on te project s findings and consultations, SATORI as developed an etics assessment framework and proposed a set of recommendations for improving various aspects of etics assessment. Tis policy brief presents an overview of ways in wic etics assessment of R&I can be supported and enanced. It provides a set of recommendations for different types of actors to implement support structures for etics assessment in institutional settings. THE IMPORTANCE AND CHALLENGES OF ETHICS ASSESSMENT PRACTICES Etics assessment, as an institutionalised review or appraisal of researc and innovation (R&I) based on etical principles, was establised decades ago to safeguard te wellbeing of researc participants. Today, te advancement of R&I continues to raise etical issues e.g., related to genetics, big data, environmental protection, etc. Etics assessment is tus an important part of advancing te beneficial role of R&I in society by ensuring its integrity and social responsibility. SATORI interviews wit various stakeolders identified several problems and callenges wit etics assessment systems and practices. Among te problems most often reported by etics assessment organisations were: a sortage of resources (financial, personnel, time allocation, infrastructure), an absence of clear and armonised procedures and guidelines, a lack of awareness of etical issues, resistance to etics assessment among researcers, insufficient attention to compliance monitoring. Oter stakeolders voiced concerns over increased bureaucratisation and lack of respect of cultural differences and te specifics of etical issues in individual scientific fields. Te compreensive approac of te SATORI project contributed to te realisation tat te resolution of tese problems and tus te furter development of etics assessment practices calls for te involvement of an array of actors wo are in a position to make a specific and important contribution. National and international policy makers, academies of sciences, national etics committees (NECs), networks of researc etics committees (RECs), academic and professional associations, university associations, researc funding organisations and civil society organisations all ave a role to play in improving etics assessment. SATORI Policy Brief: Supporting etics assessment in researc and innovation June

39 Figure 1: Actors supporting etics assessment University assoc. National etics committees Researc funding org. Intergovernmental org. Researc etics committees Science academies Professional assoc. National governments CSOs TOWARDS A SUPPORT SYSTEM FOR ETHICS ASSESSMENT Ensuring tat R&I follows ig etical standards by reliable and efficient assessment procedures requires well-functioning national systems of etics assessment based on internationally armonised principles, wic also facilitate international researc collaboration. Tis can only be acieved by establising and maintaining institutional networks, regulatory frameworks and supportive practices tat foster good etics assessment practices. Etics assessment requires a national institutional network composed of a national etics committee to oversee te practice of etics assessment and of a sufficient number of researc etics committees to carry out te assessments. Adequate resources (i.e., funding, time allocation, infrastructure, personnel, etc.) sould be provided for te proper functioning of tis network. Etics assessment can only be carried out in a transparent and efficient way if it is based on a clear regulatory framework. Tis entails a grounding in national legislation, and clear etical guidelines and assessment procedures. Policy makers, national etics committees and science academies can support tese efforts. In an age of globalised and igly cross-border collaborative R&I, efforts to acieve international regulatory frameworks (or at least armonise national ones) are most welcome. Te work of researc etics committees sould be overseen by a national body (most suitably a national etics committee) to assure te quality and independence etics assessments. Procedures to monitor compliance wit etical guidelines and assessments sould also be in place. Te stakeolders involved in R&I and etics assessment would benefit from aving platforms for discussion on recurring and emerging etical issues. Suc discussion forums sould operate at several levels: national and international, general and field-specific. SATORI Policy Brief: Supporting etics assessment in researc and innovation June

40 Etics assessment sould be carried out in all scientific fields in wic etical issues occur. Te etics assessment procedure sould take into account te differences between disciplines. Trainings for RECs members and te familiarisation of researcers and students wit etical issues in R&I would elp improve etics assessment practices and raise awareness of etical issues. Etical issues in R&I ave a major societal impact; individuals sould tus participate in etical discussions. Civil society organisations can play an important role in raising public awareness of etical issues in R&I and act as intermediaries in te inclusion of citizens in te etics debate. Figure 2: Elements of te support system for etics assessment of R&I Participation Scope: all scientific fields Discussion Institutional network Regulatory framework Resources & infrastructure Quality ceck & monitoring compliance Training & awareness WAYS OF SUPPORTING ETHICS ASSESSMENT Te vision of a well-developed practice of etics assessment can only be acieved at a system-level by cooperation of various actors. Te following recommendations describe te role of individual actors and suggest specific actions tey can take to support etics assessment. NATIONAL GOVERNMENTS can support etics assessment by providing te legal framework and by establising and funding te institutional network for etics assessment. Pass and implement legislation and regulations tat clarify te status and responsibilities of researc etics committees and individuals and organisations tat carry out R&I. Establis and support (wit te necessary funding, resources and impetus) national level institutions (e.g., national etics committee, national science academies) wit a clear mandate to develop etics assessment guidelines, procedures and awareness activities. Support te procurement of R&I products and services tat ave undergone etics assessment SUPRANATIONAL AND INTERGOVERNMENTAL ORGANISATIONS can provide te impetus for te armonisation of etical guidelines at te international level. Establis (multi-stakeolder) international platforms to armonise etical guidelines and discuss emerging etical issues and responses to tem. SATORI Policy Brief: Supporting etics assessment in researc and innovation June

41 NATIONAL ETHICS COMMITTEES can develop etics assessment frameworks and advise on emerging etical issues. NECs could do more to regulate te work of individual researc etics committees as well as expand teir scope to include etical issues in non-medical scientific fields. Develop etical guidelines and assessment procedures to be implemented by individual RECs. Encourage multi-stakeolder discussions and participatory processes. (Consider cooperating wit national academies and professional associations.) Coordinate and monitor te work of RECs. Provide advice to RECs; act as a court of appeal in cases wen RECs decisions are being disputed. Broaden te scope of etics assessment to include all scientific fields; institute special sub-committees for different disciplines. Organise debate on emerging etical issues. (Consider cooperating wit national academies and professional associations.) Consider organising etics training for REC members. Develop procedures for monitoring of compliance wit etical advice, guidelines and RECs decisions. Join or establis international networks to armonise etical guidelines and discuss emerging issues. RESEARCH ETHICS COMMITTEES carry out etics assessment of R&I. By networking, RECs can excange good practices and provide bottom-up solutions for etics assessment frameworks. Join, establis or liaise wit national and international networks to discuss good practices and propose bottom-up solutions for etics assessment frameworks based on day-to-day practices. Encourage dialogue wit researcers to ease resistance to etics assessment and promote te benefits of etics assessment for te excellence of researc. NATIONAL SCIENCE ACADEMIES can develop etical guidelines and raise awareness by organising public discussions on etical issues in R&I. Develop etical guidelines and advise on emerging etical issues. Encourage multi-stakeolder discussions and participatory processes. (Consider cooperating wit national etics committees, professional associations and civil society organisations.) Organise public discussions on etical issues in R&I; Organise and disseminate awareness raising activities and materials. SATORI Policy Brief: Supporting etics assessment in researc and innovation June

42 ACADEMIC AND PROFESSIONAL ASSOCIATIONS can develop etical guidelines for teir field and raise awareness of etical issues among teir members. Associations active in specific scientific fields or disciplines sould encourage reflection on etical issues among professional peers and develop discipline-specific etical guidelines. Liaise wit international, regional, and national etics guidance bodies for mutually beneficial learnings in etics assessment UNIVERSITY ASSOCIATIONS can play a big role in supporting etics assessment by adopting etical frameworks and policies to be implemented by member universities. Develop an etics assessment framework to be implemented by member universities. (Consider cooperating wit NECs, national academies and professional associations.) Encourage te establisment of RECs and researc integrity boards at member universities. Include reflection on etical issues in university curricula to raise awareness among young researcers Consider organising trainings for academics and researcers. RESEARCH FUNDING ORGANISATIONS ave an important role in ensuring tat te researc tey fund is etically assessed. Consider etical issues of te funded researc and encourage reflection on etical issues as an integral part of researc projects. Ensure tat te funded researc goes troug a process of etics assessment; to tis end, liaise wit etics committees or consider conducting your own etics assessment procedures. CIVIL SOCIETY ORGANISATIONS can play an important role in bridging te gap between society and R&I by being more involved in etics assessment practices. Become more involved in researc etics committees as representatives of a specific vulnerable group (e.g., consumers, or patients, cildren) or spokespersons for a specific cause (e.g., animal welfare, environment, rigts of minorities). Establis networks to build internal structures for etics assessment. Identify furter needs for etics assessment in R&I and monitor compliance wit establised etical principleswit establised etical principles. FURTHER READING Etical Assessment of Researc and Innovation: A Comparative Analysis of Practices and Institutions in te EU and selected oter countries, SATORI D1.1, ttp://satoriproject.eu/media/d1.1_etical-assessment-of-ri_a-comparative-analysis.pdf A reasoned proposal for sared approaces to etics assessment in te European context, SATORI D4.1, fortcoming SATORI Policy Brief: Supporting etics assessment in researc and innovation June

43 PROJECT IDENTITY Project name: SATORI: Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation. Coordinator: Pilip Brey Consortium: Airi nanotec IT Funding Sceme: European Commission s Sevent Framework Programme (FP7/ ) under grant agreement n Duration: 01/01/ / For more information: p.a.e.brey@utwente.nl Website: ttps://satoriproject.eu/ SATORI Policy Brief: Supporting etics assessment in researc and innovation June

44 Te Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation (SATORI) project, funded by te European Commission (FP7 sceme), aims to develop a common framework of etical principles and practical approaces. It also aims to strengten sared understandings among actors involved in te design and implementation of researc etics. For wom is tis policy brief? Policy-makers, policy advisors, government R&I departments interested in researc and innovation (R&I), private companies, industry associations, CSR and sustainability officers and departments. Wy was it prepared? To publicise te SATORI frameworks for etics assessment and etical impact assessment of R&I, foster teir widespread adoption and enance etical, responsible and sustainable R&I. Sare te message. Please sare tis policy brief wit your networks and contacts wo migt be interested in tools for addressing etical issues and impacts of R&I. SATORI website: ttp://satoriproject.eu/ Tis policy brief was prepared by University of Twente, on bealf of te SATORI consortium. SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

45 EXECUTIVE SUMMARY Despite various efforts, SATORI findings sow tat etics, responsibility and sustainability of R&I in te business context, ave not yet been sufficiently addressed by policy makers and industry. Building on tis, tis policy brief: discusses implications and suggests to policy-makers ow to improve te design of deployment policies and navigates businesses in policy-induced markets, provides tools to elp policy-makers and industry to foster etical, responsible and sustainable R&I in industry, namely etics assessment (EA) and etical impact assessment (EIA) of R&I. SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

46 INTRODUCTION Industry is focusing on researc and innovation (R&I) to improve its financial performance and market sare. At te same time, companies are increasingly improving teir corporate social responsibility (CSR) practices to gain greater social acceptance of teir activities. However, te processes of innovation are not necessarily governed by etics assessment. Wile te EU sees opportunities in R&I to contribute valuable solutions to societal callenges, suc as te climate cange, demograpic cange and wellbeing, energy security, and food safety, it also strives for R&I tat is etically acceptable and socially desirable 1. Te issue is tat te concepts of etics, responsibility and sustainability of R&I in industry are not necessarily embedded in tangible procedures. Tis can lead to societal and environmental issues, wic in turn can drain economic resources and decrease te competitive advantage of European companies. Te SATORI project investigated te forms of assessment carried out and identified directions in wic policy is needed. Te main recommendations of te SATORI project are for policy-makers to: Raise awareness and use of te SATORI Etics Assessment (EA) and Etical Impact Assessment (EIA). Promote good quality and transparent procedures of EA and EIA Facilitate dialogue about tem to make tem part of management practices 1 See e.g.: Science Wit And For Society (SWAFS) and Responsible Researc and Innovation (RRI): ttp://ec.europa.eu/researc/swafs/index.cfm?pg=ome SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

47 FACTS AND NUMBERS Researc and R&D development (R&D) is a major driver of innovation. R&D expenditure and intensity are two of te key indicators used to monitor resources devoted to science and tecnology worldwide. Te EU strives for R&I tat takes societal expectation into account wit te aim to foster te design of inclusive and sustainable R&I. 79% Some 79% of companies tat introduced at least one innovation since 2011 experienced an increase of teir turnover by more tan 25% by Science and tecnology contribute new innovations tat are essential to Europe s international competitiveness. INDUSTRY PLAYS A CRUCIAL ROLE IN THE EU EFFORTS TO BETTER ALIGN BOTH THE PROCESS AND OUTCOMES OF R&I WITH THE VALUES, RULES, NEEDS AND EXPECTATIONS OF EUROPEAN SOCIETY. Te 64% business enterprise sector in EU is te main sector in wic R&D expenditure is spent, accounting for 64% of total R&D condudted in Industry is crucial for EU competitiveness, and researc and innovation (R&I) is a key factor in tis regard. Sources: Eurostat, innobarometer, ttp://ec.europa.eu/growt/industry/innovation_en ttp://ec.europa.eu/programmes/orizon2020/en/2020-section/responsible-researc-innovation SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

48 BASIC TERMS SATORI claims tat etical aspects or implications of R&I sould be assessed and evaluated wit te goal of influencing R&I processes to make tem more etical, and to ensure tat tey ave more etical outcomes, for te benefit of society and te greater good. Different forms of assessment exist and can be defined as follows: Etics assessment (EA) is any kind of assessment, evaluation, review, appraisal or valuation of researc or innovation tat makes use of etical principles. Etical principles are criteria tat aim to determine weter certain actions or developments are rigt or wrong. Tey define individual rigts e.g., rigts to freedom and privacy, and include principles of justice and principles tat say tat arms to individuals and society sould be avoided and benefits for tem sould be promoted. Etical guidance is different from etics assessment in tat it does not concern an evaluation of practices and products of R&I tat ave already occurred, but rater presents rules, codes, and recommendations to wic future scientific practices, innovation practices, and developments in science and tecnology are expected or recommended to adere. Etical impact assessment (EIA) is a non-prescriptive process of assessing te etical impacts of R&I activities, outcomes and tecnologies. Etical impacts concern or affect uman rigts and responsibilities, benefits and arms, justice and fairness, well-being and te social good. Specific examples include: negative impact on uman rigts (suc as discrimination, inequality), problematic genetic modifications, safety risks, and privacy violation. KEY FINDINGS Te SATORI findings and results are based on an extensive inventorisation of etics assessment practices, literature reviews of etics and CSR policies and codes of conduct. Additionally, tey are based on interviews focusing on etics assessment of R&I wit 25 representatives of multinational corporations (different brances, including e.g., parmaceutics, ITC, nanotecnology, automotive industry), SMEs, consultancy firms, cambers of commerce, national and international organisations and non-governmental organisations (NGOs) engaged in uman rigts. Te interviewees came from ten different countries and at te EU and global international level (Austria, France, Germany, te Neterlands, Poland, Serbia, Spain, te United Kingdom, te US and Cina). Etics assessment of R&I by industry: Prevalence and aims Companies are increasingly using structured approaces to monitor economic, environmental and societal impacts of teir activities, taking SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

49 into account etical principles and values acknowledged by stakeolders and society. Tese approaces are broadly known as Corporate Social Responsibility (CSR) 2. Most corporations ave policies, and officers, or divisions, for CSR. A CSR policy is intended to function as a self-regulating mecanism for business to ensure its compliance not just wit laws, but also wit te spirit of te law, wit international norms, and wit etical standards. Small and medium sized enterprises (SMEs) typically do not ave CSR structured strategies. SMEs are constrained by te lack of financial and uman resources, wic lead tem to ave relatively sort-term and profit-oriented goals and impairs teir ability to undertake researc and development as well as teir and potential commercialisation of innovation. Etics assessment of R&I and CSR CSR strategies and activities can be perceived as a form of etics assessment or etics guidance. However, CSR is broader tan etics assessment of R&I. It is because CSR does not exclusively relate to companies R&I activities. CSR covers all aspects of a company s activity, including R&I. CSR is, in large part, a form of etics assessment and etics guidance tat empasises impacts on te society and environment. Companies tat also conduct uman subjects researc and/or biomedical researc often carry out additional etics assessment of suc researc: an etics committee or etics officer evaluates etical considerations and measures In practice, etics assessment of R&I in companies is eiter part of CSR, or a combination of tat part of CSR tat is concerned wit R&I and etics assessment for biomedical or uman subjects researc. Procedures for Etics Assessment Companies use te term etics in a narrow context referring to a professional beaviour e.g., anti-corruption. Companies do not use te term etics assessment. Preferably, tey refer to responsibility, responsible beaviour, sustainability, and sustainable beaviour. Companies often refer to innovating and doing researc in a responsible way. Te assessment conducted by companies is not owever strictly an etics assessment, but it rater focuses on applicable CSR instruments. Troug CSR initiatives, companies also engage in etics guidance. 2 European Commission, Communication from te Commission to te European Parliament, Te Council, Te European Economic and Social Committee and te Committee of Regions: A renewed EU strategy for Corporate Social Responsibility, Brussels, 25 October 2011, COM(2011) 681 final. SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

50 Te most common assessment procedure tat companies implement is impact assessment (IA). IA is a process of identifying te future consequences of a current or proposed action (impact prediction/ forecasting), and an assessment of te social significance of tose impacts (impact evaluation). 3 Te IA may concern te effects of actions on environment, society, or more specifically on ecology, biodiversity, uman rigts, ealt, culture, gender, etc. Companies terefore use different types of impact assessment, e.g., environmental impact assessment (EIA), uman rigts impact assessment (HRIA) and social impact assessment (SIA). Institutional setup of etics assessment of R&I Te level of institutionalisation of etics assessment in industry varies greatly across different countries, and companies and industry sectors. Te etics assessment and etical guidance of R&I in te context of industry relates to companies CSR strategies. CSR tools include standards, principles, codes of conduct, and reporting initiatives to provide quantitative data on CSR performances. Multi-stakeolder initiatives play a key role in te diffusion of CSR policies in industry. In te last two decades, tese ave supported te development of sared practices and metodologies (standards) to define, apply, measure and report CSR actions and performances. Standardisation plays an important role in companies activity, as it provides clear requirements on development and implementation of management strategies. Te advantage of te standards system is its compatibility and applicability in every organisation regardless of sector or size. 4 See e.g. ISO on social responsibility; Social Accountability 8000; OHSAS regarding ealt and safety of employees and minimizing te risk of accidents; ISO and Eco-Management and Audit Sceme (EMAS) on environmental management. EU policy initiatives aim to stimulate companies to endorse CSR initiatives suc as te United Nations Global Compact; te United Nations Guiding Principles on Business and Human Rigts; ISO Guidance Standard on Social Responsibility; International Labour Organization Tripartite Declaration of Principles concerning Multinational Enterprises on Social Policy; and te OECD Guidelines for Multinational Enterprises. 5 3 Te International Association for Impact Assessment, ttp:// aspx?page=impactassessment&revision=1 4 Konstantinos Iatridis, Identification of CSR tools related to RRI principles, publised 27 Marc 2015, Deliverable for te Responsible Industry Project, ttp:// dissemination/deliverables 5 ttp://ec.europa.eu/enterprise/policies/sustainable-business/corporate-socialresponsibility/index_en.tm SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

51 Implementation of etics assessment of R&I Companies and industry associations ave various roles in te implementation of etics assessment of R&I. First, tey engage in te regulation and guidance troug CSR policies intended to function as a self-regulating mecanism for business. Second, tey carry out etics assessment of R&I (e.g., internal CSR officers or divisions and external CSR consultancy). Tird, tey engage in dissemination and awareness raising of CSR, e.g., business and industry associations and Cambers of Commerce facilitate networking, knowledge-saring and collaboration among companies. CHALLENGES AND DRIVERS SATORI as identified callenges and drivers for industry in performing assessment of etical, societal and environmental impacts of teir activities. Tese elp us understand te industry s perspective and will elp create effective policies and incentives to enance etical, responsible and sustainable R&I. CHALLENGES Additional bureaucracy, eventual extra costs Heterogeneity in approaces and guideline implementation (variety of CSR initiatives and standards) Lack of awareness of etics issues Lack of structured approaces Lack of resources (financial, uman, time, knowledge, particularly for SMEs) Inability to implement non-binding guidelines (failures of selfregulation) Problem accepting etical criteria in te R&I community (beyond wat is provided for by law) Possible slowdown of innovation Additional etical constraints may limit creativity Etics is culture-sensitive (requirements migt cange depending on context) DRIVERS Improve product sustainability, desirability and acceptability, quality, safety and reliability Increase customer satisfaction Positive effect on quality of life and ealt of customers Create value, build corporate image and reputation, give competitive advantage Motivate workers, improve ealt and safety standards Improve community relations Reduce environmental impacts Reduce costs (e.g., use of resources, efficiency of te decision-making process) Market penetration Profit, access to financial support, minimisation of te risk of lower financial performances Compliance wit regulations SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

52 To respond to tese callenges and drivers, tere sould be an incentive structure and te mecanisms in place taking into account te interplay between regulations, voluntary actions, incentives and sanctions. CSR global initiatives, standards and principles can successfully support responsible R&I among companies. At te same time, tere is a need for tools tat are better tailored to te specific caracter of RRI. SATORI offers a new tool for Etical Impact Assessment (EIA) wic brings togeter te variety of etical issues and metods of impact assessment to enable an organisation mitigate negative etical impacts of it R&I activities and better manage te R&I process. Te use of tis tool needs to be incentivized by policy-makers. SATORI ETHICS ASSESSMENT AND ETHICAL IMPACT ASSESSMENT (EIA) Etics Assessment Te SATORI Etics Assessment provides common basic etical principles and joint approaces and practices wit te objective of armonising and improving etics assessment practices of researc and innovation. Te SATORI etics assessment makes recommendations for te composition, role, functioning and procedures of etics committees. Etics committees include, but are not limited to, researc etics committees, institutional review boards, etical review committees, etics boards, and units consisting of one or more etics officers. Te full etics assessment framework is documented in te SATORI CEN Worksop Agreement Etics assessment for researc and innovation Part 1: Etics committee and te SATORI report A reasoned proposal for set of sared etical values and principles for etics assessment in te European context. 6 Wile te SATORI etics assessment may not be fully applicable to companies due to te private caracter of teir activities, it can assist policy-makers and companies in developing specific R&I mecanisms in industry to enric general CSR instruments. Tis is because SATORI etics assessment provides common basic etical principles and definition of tese principles, suc as scientific freedom, conflict of interests or dual use. Terefore, SATORI etics assessment can elp companies strengten and/or improve te etics assessment of teir R&I projects. Etical Impact Assessment (EIA) SATORI defines an EIA as te process of determining and addressing te etical impacts of researc and innovation activities, outcomes and tecnologies in consultation wit stakeolders. Wit te aim of enancing te overall benefit of researc and innovation for society, te SATORI EIA assists in determining weter an R&I project raises any etical risks, elps identify and evaluate etical impacts 6 See ttp://satoriproject.eu/publications/cwa-part-1/ SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

53 using different metods and tools, and facilitates taking remedial actions to mitigate negative etical impacts of te project. EIAs may be useful in all fields of researc and innovation bot traditional (e.g., medical researc) and emerging areas (e.g., uman-macine interactions). Te full EIA framework is documented in te SATORI CEN Worksop Agreement Etics assessment for researc and innovation Part 2: Etical impact assessment framework. 7 SATORI as also publised a policy brief on EIA: enancing responsible researc & innovation 8. Policy makers and companies can use SATORI EIA as a tool for determining and addressing te etical impacts of industrial R&I activities, outcomes and tecnologies. It can be part of companies CSR strategies. Te advantage of EIA in te industry context, is its compreensiveness. Wile tere is a variety of tools and metods tat elp to address impact of te activities of companies, SATORI EIA is a compreensive metodology for addressing a wole range of etical impacts tat concern or affect uman rigts and responsibilities, benefits and arms, justice and fairness, well being and te social good. CALL FOR ACTION SATORI RECOMMENDATIONS Raise awareness about te SATORI Etics Assessment and Etical Impact Assessment (EIA) frameworks and teir benefits in researc and innovation (R&I) contexts. Increase te general use of etics assessment and EIA WHAT POLICY-MAKERS CAN DO Organise consultations wit companies (including SMEs), industry associations and oter stakeolders to discuss te relevance, use of te etics assessment of R&I and EIA frameworks and ow it could complement existing CSR frameworks. Sare industry experiences and good practices for etical, responsible and sustainable R&I. Create soft law for etics assessment (general or specific guidelines, policy declarations or codes of conduct). A model for etics assessment and guidance in industry sould be integrated witin already exciting CSR framework (CSR global initiatives, standards and principles). Include etics assessment and EIA as criteria in R&I procurement policies and grant funding conditions, or subsidies. 7 See ttp://satoriproject.eu/publications/cwa-part-2/ 8 See ttp://satoriproject.eu/publication_type/policy-briefs/ SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

54 SATORI RECOMMENDATIONS Promote te conduct of good quality and transparent etics assessment and EIA Support etics assessment and EIA (as tools to address etical issues and impacts) as an essential part of te management of a company s R&I process Facilitate discussion and mutual learning about etics assessment and EIA at te EU and local levels WHAT POLICY-MAKERS CAN DO Incentivise te certification of socially responsible R&I and accreditation of certification bodies or agencies certifying etics assessment and EIA of projects. Organise European Awards for etical, responsible and sustainable R&I and ensure recognition and visibility for tese awards. Put a special focus on SMEs and start-ups Encourage publication of etics assessment and EIA reports (or summaries) as part of companies non-financial reporting. Integrate etics assessment and EIA into researc management and/or corporate social responsibility procedures and practices. Dedicate resources (uman, financial, time) for carrying out etics assessment and EIAs and teir review. Pay a special attention to SMEs and start-ups. Encourage publication of etics assessment and EIA reports (or summaries) as part of companies non-financial reporting. Set up an etics assessment and EIA mutual learning portal or community at EU and/or national level. Create a platform to discuss and excange experiences between EU institutions tat are responsible for business, economy, finance and Researc and Innovation. Develop etical, responsible and sustainable R&I guidance in te industry context based on te results of SATORI. SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

55 FURTHER READING Callies, Ingrid, et al, SATORI Outline of an Etics Assessment Framework, V.1.1, Deliverable 4.2, December Gurzawska A., Porcari A., A reasoned proposal for a set of sared etical values and principles for etics assessment in European context; Annex 7: Models for etics assessment and guidance in industry, Deliverable 4.1., Marc 2016, available online: ttp://satoriproject.eu/media/d4.1_annex_7_industry.pdf Gurzawska A., et al., Etical Assessment of R&I: A Comparative Analysis; Annex 3: Etics Assessment In Different Types of Organisations: Industry, Deliverable 1.1, June 2015, available online: ttp://satoriproject.eu/media/3.-industry.pdf SATORI, CEN Worksop Agreement Etics assessment for researc and innovation, CWA SATORI, May Please add te current weblink were te CWA is downloadable from SATORI, Etics assessment for researc and innovation Part 1: Etics committee, Secretariat, NEN, SATORI, Etics assessment for researc and innovation Part 2: Etical Impact Assessment Framework, Secretariat, NEN, Trilateral Researc Ltd., Policy Brief: Etical Impact Assessment: enancing responsible researc & innovation, May SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

56 PROJECT IDENTITY Project name: SATORI: Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation. Coordinator: Pilip Brey Consortium: Airi nanotec IT Funding Sceme: European Commission s Sevent Framework Programme (FP7/ ) under grant agreement n Duration: 01/01/ / For more information: p.a.e.brey@utwente.nl Website: ttps://satoriproject.eu/ SATORI Industry and Researc and Innovation (R&I): Towards Etical, Responsible and Sustainable R&I August

57 Policy Brief: Maximising te potential of Etics Assessment of Researc & Innovation: a call to Researc Funding Organisations Te Stakeolders Acting Togeter on te etical impact assessment of Researc and Innovation (SATORI) project, funded by te European Commission (FP7 sceme), aims to develop a common framework of etical principles and practical approaces. It also aims to strengten sared understandings among actors involved in te design and implementation of etics in researc. For wom is tis policy brief? For all researc funding organisations, international, EU-level and at Member State level. Wy was it prepared? To promote good practices in researc and innovation and enance responsible researc and innovation (RRI); To facilitate te work of researc funding organisations in setting ig etics assessment standards; To publicise te SATORI etics assessment and etical impact assessment of researc and innovation frameworks, foster teir widespread adoption and enance etical, responsible and sustainable researc and innovation. Sare te message. Please sare tis policy brief wit your networks and contacts wo migt be interested in tools for addressing etical issues and impacts of R&I. SATORI website: ttp://satoriproject.eu/ Tis policy brief was prepared by UNESCO in bealf of te SATORI consortium. SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

58 EXECUTIVE SUMMARY Tis policy brief focuses on Researc Funding Organisations (RFOs). Key recommendations relevant to RFOs: RFOs sould adopt te SATORI framework for etics assessment in R&I activity. RFOs sould generate/promote general awareness of etics and etical issues among researcers and innovators. Improve te capabilities of RFOs to perform etics assessment. Enable regular discussion and excange of information among RFOs at te national and international levels on te good practices in etics assessment of R&I. RFOs could insist on te requirement tat tose wo receive funding sould adere to a specified code of etics. Standardise te review and audit procedures of SATORI s etics assessment and etical impact assessment metodologies as muc as possible to decrease te administrative burden on RFOs. Set adequate criteria and procedures for in-ouse etics review and monitoring of proposals and projects. Train etics assessors in applying te SATORI framework and principles. SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

59 INTRODUCTION RFOs, especially te European Commission, troug teir various funding programmes ave a major leverage effect on ow etics is addressed in researc and innovation. Etics assessment at te European Union and Member States level as existed for decades in te field of clinical trials on drugs and medical devices. However, tis as not been te case in oter fields of researc and innovation (R&I). Te SATORI project interviewed a range of stakeolders (across organisations (including researc-funding bodies), scientific fields, and countries) about teir expectations, te need for a sared European framework for etics assessment (EA) of researc and innovation and teir support for it. 51.6% of interview respondents tougt it would be desirable to ave a sared European framework for etics assessment. An additional 30% of respondents were conditionally positive about te desirability of suc a framework. RFOs do not primarily assess etics, but fund researc wit private or public funds. RFOs aim to promote developments in science and innovation. 1 In selecting wic proposed researc to fund, etics assessment (or etics review) plays an important part. 2 Since RFOs evaluate concrete products and procedures of researc, SATORI classes tem as etics assessors. 3 Te SATORI EA framework aims to pave te way towards improved consistency in EA procedures witin and between scientific fields, different kinds of organisations, and countries. Te need of te our is furter development of practices to implement EA in different kinds of organisations. RFOs due to teir strategic position are optimally placed to support tis. 1.1 A FRAMEWORK FOR BASIC ETHICAL PRINCIPLES AND JOINT APPROACHES AND PRACTICES Te SATORI framework 4 is concerned wit etics assessment: tat is, an institutional form of applying (primarily) etical principles and criteria to assess, review, appraise or evaluate researc and innovation (R&I) activity. Tis activity may include basic researc, applied researc, or product development and testing. It 1 Wolfslener, Doris Etics assessment and guidance in different types of organisations. Researc Funding Organisations. SATORI D1.1, June 2015, p. 15. ttp://satoriproject.eu/media/3.c-researc-funding-organisations.pdf 2 Some RFOs conduct etics assessment activities, oters require etics assessment to be carried out to a specified standard by te researc performing institution itself. 3 Selley-Egan Clare Etical Assessment of Researc and Innovation: A Comparative Analysis of Practices and Institutions in te EU and selected oter countries SATORI D1.1, Marc 2016, p Callies Ingrid and Pilip Brey (Editors), Outline of an Etics Assessment Framework. Part of te SATORI D4.1. p36; Jansen, P., W. Reijers, D. Douglas, A. Gurzawska, A. Kapeller, P. Brey, R. Benčin, and Z. Warso, A reasoned proposal for sared approaces to etics assessment in te European context. SATORI D4.1, December 7, 2016, p 182. ttp://satoriproject.eu/media/d4.1_proposal_etics_assessment_framework.pdf; CWA SATORI-1:2016. Etics assessment for researc and innovation Part 1: Etics assessment unit, A CEN draft, NEN SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

60 is an institutionalised or formal metod of assessment as it is performed witin an institutional setting, wit defined procedures, by an organisation or a specific unit witin a larger organisation. Suc assessment may be performed by researc etics committees (RECs), universities, industry, RFOs, civil society organisations (CSOs), or oter organisations wit an interest in R&I activity. Etics assessment is distinct from etics guidance wic seeks to produce advice, codes of conduct or guidelines for etical beaviour. Te SATORI project developed a framework for basic etical principles and joint approaces and practices wit te objective to armonise and improve etics assessment practices of researc and innovation. Tese researc findings are te basis of a CEN Worksop Agreement (CWA). Te CWA 5 consists of two parts. Part 1 sets recommendations for te composition, role, functioning and procedures of etics committees. Organisations can use part 1 to strengten and/or improve te etics assessment of teir researc and innovation projects. Part 2 provides researcers and organisations wit guidance on etical impact assessment - a compreensive approac for etically assessing actual and potential mid and long term impacts of researc and innovation on society. Researcers and etics committees will find tis information useful as it describes etical impact assessment in different stages of te etical assessment. Part 2 is applicable to all researcers and innovators, regardless of te context tey are working in, or researc and innovation area. Te most important aspect of te institutional perspective is to create te systemlevel capabilities for a systematic and armonised implementation of etics assessment structures and procedures. Te SATORI project contributes to tis outcome by finalising an Etics Assessment (EA) standard (in te CWA), wic is a strong starting point in building te capabilities. Te standard promotes a armonised understanding of EA of R&I across disciplines, countries and actors, and is aimed at improving its various (institutional) structures and procedures. Te SATORI framework aims to pave te way towards improved consistency in EA procedures witin and between scientific fields, different kinds of organisations, and countries. Furter development of practices to implement etics assessment in different kinds of organisations is needed. Tis is especially te case for organisations, suc as RFOs, performing etics assessment tat are not researc etics committees USE OF TOOLS AND IMPROVED SKILLS IN ETHICS ASSESSMENT Training is anoter means to improve te consistency between different fields and kinds of actors. Systematic and continuous training is necessary to generate proper 5 CWA SATORI-1:2016. Etics assessment for researc and innovation Part 1: Etics assessment unit. NEN P 35 and 37; CWA SATORI-2:2016. Etics assessment for researc and innovation Part 2: Etical impact assessment framework. NEN p37. 6 Leinonen, Anna Roadmap towards adoption of a fully developed etics assessment framework, SATORI D4.3, June p24. ttp://satoriproject.eu/work_packages/roadmap-for-a-common-eu-etics-assessment-framework/ SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

61 skills in EA among different actors, particularly te ones tat do not ave establised committees, or well-developed processes and procedures. Furtermore, te need for etics training in general sould be discussed at te EU level and at te national level: te survey in SATORI 7 revealed tat te meaning of etics in practice is unclear especially in engineering and business environments even toug it is taken into consideration under different names. In te long run te researc community as accepted te respect for new criteria called for by RFOs if tey ave been well introduced to te community and ave been accompanied by training measures. 8 RFOs ave terefore a major role to play wit regard to training. 1.3 SATORI ROADMAP 9 RECOMMENDATIONS FOR RESEARCH FUNDING ORGANISATIONS Te aim of te SATORI roadmap process was to work out ow te SATORI etics assessment framework can be implemented in practice. Te timespan of te roadmap was set at 10 years. First, it formulates a vision of a future in wic te SATORI framework can be implemented. Teories about te implementation of new social practices were subsequently studied, and a model for te implementation of te SATORI framework was constructed. Tis model was ten used to identify steps (or outcomes) tat need to be taken to realise te vision. Finally, tese steps were flesed out by listing recommendations and associated actions tat need to be taken by various stakeolder groups tat are involved in etics assessment of R&I. We list ere te recommendations relevant to RFOs Recommendations for system-level capabilities Improve te capabilities of RFOs to perform etics assessment: Large RFOs sould ave te institutional capacity necessary to perform regular in-ouse etics review of researc proposals (or assess te quality of etics reviews) submitted to tem. Tey sould establis independent, multidisciplinary and pluralist etics committees to perform etics assessment. Enable regular discussion and excange of information among RFOs at te national and international levels on te (good practices in) etics assessment of R&I (including new and emerging tecnologies). 7 Selley-Egan, C., P. Brey, R. Rodrigues, D. Douglas, A. Gurzawska, L. Bitsc, D. Wrigt and K. Wadwa, Etical Assessment of Researc and Innovation: A Comparative Analysis of Practices and Institutions in te EU and selected oter countries, SATORI D1.1 including 5 annexes, June ttp://satoriproject.eu/work_packages/comparative-analysis-of-etics-assessment-practices/ 8 Wolfslener, Doris Etics assessment and guidance in different types of organisations. Researc Funding Organisations. SATORI D1.1, June 2015, p. 15. ttp://satoriproject.eu/media/3.c-researc-funding-organisations.pdf 9 Leinonen, Anna Roadmap towards adoption of a fully developed etics assessment framework, SATORI D4.3, June ttp://satoriproject.eu/work_packages/roadmap-for-a-common-eu-etics-assessment-framework/ SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

62 1.3.2 Recommendation for stronger professional norms Recognise responsibility for etical professional beaviour: Universities and companies sould implement codes of conduct and practice for teir students and employees. RFOs could insist on te requirement tat tose wo receive funding sould adere to a specified code of etics (and take into account te SATORI etics assessment framework) Recommendations for use of SATORI etics assessment tools and framework Standardise te review and audit procedures of SATORI s etics assessment and etical impact assessment metodologies as muc as possible to decrease te administrative burden on RFOs. Tis can be done, for instance, by creating an online submission system tat te assessor can use to submit is or er findings from te etics assessment or etical impact assessment process. Set adequate criteria and procedures for in-ouse etics review and monitoring of proposals and projects: Establis detailed procedures for in-ouse etics review and monitoring (based on SATORI s etical impact assessment metodology set out in te CWA Part 2). Tese criteria and procedures must go beyond etics assessment as required by law, and sould also include aspects relating to researc integrity, and scientific misconduct. Integrate establised etics review and monitoring procedures in RFOs proposal selection procedures Recommendations for te promotion of te use of etics assessment tools and frameworks Train etics assessors in applying te SATORI framework and principles: Institution and coordination of training programs Training programs for etics assessors sould be developed on ow to properly apply te SATORI framework and general etical teories and principles. Develop easy-to-understand online resources for training programs. Adopt te SATORI framework for etics assessment in R&I activity. SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

63 1.3.5 Recommendations for te promotion of positive attitudes and professional norms Generate/promote general awareness of etics and etical issues among researcers and innovators: Set up programs to educate researcers on te etical implications of teir researc troug presentations and information materials. Provide information on te etical implications of R&I and possibilities for etics assessment online. FURTHER READING Leinonen, Anna Roadmap towards adoption of a fully developed etics assessment framework, SATORI D4.3, June ttp://satoriproject.eu/work_packages/roadmapfor-a-common-eu-etics-assessment-framework/ CWA SATORI-1:2016. Etics assessment for researc and innovation Part 1: Etics assessment unit. NEN CWA SATORI-2:2016. Etics assessment for researc and innovation Part 2: Etical impact assessment framework. NEN SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

64 PROJECT IDENTITY Project name: SATORI: Stakeolders Acting Togeter On te etical impact assessment of Researc and Innovation. Coordinator: Pilip Brey Consortium: Airi nanotec IT Funding Sceme: European Commission s Sevent Framework Programme (FP7/ ) under grant agreement n Duration: 01/01/ / For more information: p.a.e.brey@utwente.nl Website: ttps://satoriproject.eu/ SATORI Maximising te potential of Etics Assessment of R&I: a call to Researc Funding Organisations July

65 Policy Brief: Responsible and Etical Governance of Researc and Innovation in te Context of Globalization Te Stakeolders Acting Togeter on te etical impact assessment of Researc and Innovation (SATORI) project, funded by te European Commission (FP7 sceme), aims to develop a common framework of etical principles and practical approaces. It also aims to strengten sared understandings among actors involved in te design and implementation of researc etics. Now in mont 20 of te four-year project, te SATORI consortium of 17 partners as collected empirical insigts to elp formulate proposals for improved and more armonised etics assessment witin scientific fields and among different kinds of etics assessors and countries. Te consortium is paying particular attention to etics assessment in te context of globalisation. In June 2015, consortium partners, leading autorities and experts met at a conference at UNES- CO Headquarters in Paris to deliberate on te project s findings so far and to develop policy and legal options for developing etics assessments for researc and innovation witin te context of globalisation. Te conference generated recommendations in six areas: Responsible Supply Cain Scientific Misconduct Traditional and Indigenous Knowledge Te Outsourcing of CO 2 Emissions Te Brain Drain Clinical Researc and Trials ttp:// September 2015

66 Introduction In recent decades, researc and innovation ave become global enterprises. Emerging economies ave invested eavily in R&I, tere as been a significant outsourcing of R&I activities from ig-income to middle- and lower-income countries, and researc organizations and firms ave ave developed global alliances or ave become multinational temselves. Tese developments ave benefited R&I overall, but tere are also significant social, etical and regulatory callenges tat still ave to be met. Researc and innovation practices in different countries and regions are subject to divergent, or altogeter lacking, regulatory and governing standards and practices, and burdens and benefits of te globalisation of researc and innovation are being unequally spread across te globe. In tis context, te globalization of R&I raises important etical issues tat sould be addressed by all involved parties. Tese issues concern ow te practice and impact of globalized R&I could and sould respect civil and uman rigts, promote well-being, economic development and sustainability, and involve a just distribution of benefits and burdens, bot witin countries and between iger, middle and lower income countries. We old tat all parties involved governments, industry, public researc institutions, civil society, as well as individual scientists and engineers, ave a responsibility to promote and upold te etical conduct of researc innovation in a global setting all te way from agenda setting to researc, innovation, production and sales. We call on all parties to ensure procedures and mecanisms by wic etical issues are considered in globalized R&I activities, in particular respect for civil and uman rigts, protection of te environment, and saring te benefits of researc and innovation between peoples and nations. We ave identified six key issues in te globalised R&I for wic we ave developed specific recommendations. All texts, including background documents listed below, are available for viewing and download at ttp:// September 2015

67 Responsible Supply Cain Governance European industry often makes use of global supply cains tat involve organizations and resources in many different countries. It is increasingly recognized tat supply cains sould be governed to address morally problematic issues, suc as environmentally unsustainable practices, cild labour, repression of freedom of association and collective bargaining, and unfair wages and price levels. Serious efforts are terefore needed for responsible supply cain governance. Two models of responsible supply cain governance are te following: Government dominates one model. In te oter, industries regulate temselves (self-regulation). In te first case, te government would establis te standards and expect companies fulfil tem. If a company did not comply wit te standards, te government would take appropriate action. However, te models are problematic: Today, tere are various standards and tools wic confuses industry. Industry (and oter stakeolders) prefer armonization of tese different frameworks. We recommend tat governments create a multi-stakeolder platform on a global level, in wic te UN, OECD, and te EU could collaborate in pursuit of a armonized etics assessment framework for etical supply cains. Conference participants noted tat te EU needed bot ard and soft law to remove excesses in te marketplace and to be te basis of standards. Te EU sould base its actions on te EU Carter of Fundamental Rigts and EU Regulations, but can also reference te principles of oter organisations (e.g., UN, OECD). Taking into consideration policy coerence, te EU sould include te responsible supply cain governance and te proposed platform on its corporate social responsibility (CSR) agenda. Te EU can motivate companies not only by adopting a naming and saming approac, but also by creating incentives for responsible companies (tax allowance, responsibility awards). Te EC could put more attention on consumer awareness and capacity building in regard to etical values and etical impact assessment. Education is crucial in two ways. First, tere is a need to include training on responsible supply cain management in te university curricula. Second, education is a part of te supply cain, for example, as manifested by citizens of developing countries wo come to Europe or te USA, and ten return to teir countries were tey use te acquired knowledge. Tere is a responsibility to ensure te knowledge is gained and sared in te native countries. Background reading available at ttp://satoriproject.eu: SATORI Responsible Supply Cain Case Study SATORI Responsible Supply Cain Background Document September 2015

68 Scientific Misconduct Scientific misconduct is increasingly recognized as a global problem wit great economic costs and arms to society. It is in te interest of EU countries to develop a global approac to scientific misconduct tat recognizes te global practice and organization of researc. Capacity-building at an early stage is critical to long-term etical researc conduct; tus specific provisions must be included at te local level to include positive mentoring of good etical scientific standards. Te European Commission and te European Researc Council policies on Etics for researcers and A compreensive strategy on ow to minimise researc misconduct and te potential misuse of researc. Temper te pressure for rapid cutting-edge publications as a prerequisite for funding and job status, wic can place an undue influence leading to scientific misconduct. Instead, promote te focus on etical science. Te European Commission sould consider ways tat existing guidelines can be better promulgated. Background reading available at ttp://satoriproject.eu: SATORI Scientific Misconduct Case Study SATORI Scientific Miscondut Background Document Traditional and Indigenous Knowledge It is increasingly recognized tat R&D sould respect and reward te traditional & indigenous knowledge and biological resources from indigenous communities and ensure tat commercial exploitation tat draws from indigenous knowledge and resources is not exploitative but beneficial to te group in question. Not enoug is done yet, owever, to ensure tat suc exploitation does not occur. Te European Commission sould develop a framework directing etical conduct specifically for EU researcers wo are involved wit or conducting researc or trials related to traditional knowledge of te groups tat possess tis knowledge. Background reading available at ttp://satoriproject.eu: SATORI Traditional and Indigenous Knowledge Case Study SATORI Traditional and Indigenous Knowledge Background Document September 2015

69 Te Outsourcing of CO 2 Emissions Te outsourcing of CO 2 emissions by ig-income countries to low- and middle-income countries is increasingly recognized as an impediment to solutions for global warming. To address tese problem, we make te following recommendations: Governments sould take responsibility for addressing te outsourcing of CO 2 emissions: Governments are responsible for providing a framework tat requires inclusion of te carbon footprint in eac part of te supply cain. Te EU sould encourage oter countries to reduce emissions by requiring companies to include offsore emissions in oter countries in mandatory government reporting. Companies ave a responsibility to encourage teir suppliers to reduce CO 2 emissions: Companies sould bencmark te reductions in emission levels. Government and industry sould establis an autority to regulate CO 2 emission outsourcing tat is sector-specific, independent and as oversigt over suc outsourcing. Tis autority sould be transparent and provide information about te regulatory process. Government and industry sould consider armonisation wit existing institutions. On te EU Level: Te EU sould introduce a regulatory framework tat requires companies to consider teir entire car bon footprint, including tat of teir suppliers. Te outcome of te Paris climate cange negotiations may assist tese efforts. Companies need incentives, for example: o Tax allowances and trade allowances. o Base awards and competitions on strict criteria (Eco-Design is a good example to follow). o Provide greening taxation, including iger taxation for non-green activities and lower taxation for green activities. o Establis clear, unified bencmarks (like Eco-labels) o Certify environmentally friendly products and services (like Fair Trade certification) Background reading available at ttp://satoriproject.eu: SATORI Te Outsourcing of CO 2 Emissions Case Study SATORI Te Outsourcing of CO 2 Emissions Background Document September 2015

70 Te Brain Drain Te emigration of igly skilled scientists and engineers from low- and middle-income countries outside te EU to te EU, were tey ave better employment possibilities, deprives countries of origin of uman capital tat cannot be easily replaced. Extra efforts are required to alt or compensate for suc brain drain : EU policy-makers sould make researc more attractive in specific countries in order to address te brain drain and retain skilled individuals. International funding bodies can elp tese countries build and maintain a scientific infrastructure. Policy-makers sould remove urdles in soft law tat affect te brain drain, for example, citing fair access to researc as a framework for immigration. Policy-makers sould promote global researc excanges (for example, Erasmus catered to a Nort-Sout bridging policy) as well as gender-focused programmes. Policy-makers could support programmes for young researcers tat include a strong foundation of training, so tat te researcers can engage creatively in giving back. Funds from global foundations sould include provisions to encourage beneficiaries to return to teir countries of origin. Te EU sould promote policies aimed at ensuring tat tere are appropriate jobs for individuals wen tey return to teir countries of origin. Te EU sould facilitate double professorsips, wereby individuals can ave a position at a university in teir ome country and in an institution in anoter country as a way to facilitate trans-national contact, engagement and collaboration. Te EU could incentivise teacing staff to teac abroad, wic te EU can encourage troug grant stipulations and oter incentives. Non-European countries sould also institute tese policies to minimise te brain drain. Background reading available at ttp://satoriproject.eu: SATORI Brain Drain Case Study SATORI Brain Drain Background Document September 2015

71 Clinical Researc and Trials Te conduct of clinical researc and trials by EU researcers in non-western countries involves delicate questions regarding te etical standards tat are put in place. International soft law as well as regional laws address clinical etics trials; tus, owever, policy-makers need to streamline and optimise existing policies. Wen policy-makers develop new policies, tey sould take into account global perspectives on clinical etics. Intergovernmental bodies (responsible for framework development, training and capacity-building) and national level regulators to apply a globally coesive framework of etics evaluation Tis must also involve better communication between. Collaboration sould also involve public and private funders of te researc, wose discretion can ensure tat etically-sound researc is allowed to proceed, as well as individual researcers wo can ensure tat teir own researc is aderent to etical protocol. We suggest policies tat focus on educating people about te process of reviewing researc wile keeping in mind te relevant values of te researc. Communities, wit support from te EU, sould put empasis on capacity-building, specifically building preparedness infrastructure for ealt crises. Policies sould also sift to etics monitoring, rater tan etics review. In tis way, etics will be engaged trougout te researc process. Furtermore, te responsibilities to te subject population post-trial, suc as equitable access to treatments, sould also be at te forefront of policy application. Te EU and oter stakeolders sould support generalised training for etics regulators and one-on-one etics training in parallel wit efforts to acieve best outcomes. Furtermore, SATORI partners and stakeolders could benefit from concrete tool, suc as a cecklist, to ensure a competent review of etical issues. Te EU, te SATORI consortium, international researc partners and oter stakeolders sould find a common ground for developing a globally consistent etics policy. Tis must be done judiciously, owever, witout over legislating. Background reading available at ttp://satoriproject.eu: SATORI Clinical Researc and Trials Case Study SATORI Clinical Researc and Trials Background Document Tis policy brief was compiled by UNESCO, a partner in te SATORI consortium. September 2015