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Stakeholders Acting Together On the ethical impact assessment of Research and Innovation

Periodic Report Summary 3 - SATORI (Stakeholders Acting Together On the ethical impact assessment of Research and Innovation)

Project Context and Objectives:
The SATORI project aimed to develop a common European framework for the ethical assessment of research and innovation (R&I). It was a 45-month project comprising 17 partners from 13 European countries, including an intergovernmental organization. The project was launched in January 2014 and ended at the end of September 2017. The project gathered private and public stakeholders from Europe and beyond in an intensive process of research and dialogue regarding the ethical assessment of research and innovation, both actors who engage in ethics assessment themselves and those who otherwise have a stake in it. Examples of actors involved in the design and implementation of research and innovation ethics assessment are research ethics committees, national ethics committees, governmental councils, research funding organizations, professional organizations for scientists and engineers, civil society organisations, and industry. The ethical issues involved in ethics assessment of R&I include issues related to human subjects research, animal experimentation, scientific integrity, social responsibility, environmental and social impacts, and impacts on human rights, amongst others.

The SATORI project aimed to identify common principles, protocols, procedures and best practices for ethics assessment, and to identify areas where different approaches are necessary. It aimed to achieve mutual learning between different stakeholders so as to advance the practices of, and appreciation for, ethics assessment of research and innovation. Its results would not only strengthen ethics assessments overall, but would also contribute to more responsible processes and outcomes of research and innovation.

We formulated our main objective as follows: Development of a framework for ethics assessment of R&I, consisting of common basic ethical principles and joint approaches and practices that are supported and shared by all the main actors involved in the design and application of research ethics, ethics of technology and innovation standards and principles, including scientists, regulators, civil society, industrial actors, public bodies, research ethics committees in the Member States, relevant international bodies and other stakeholders in society, including the public.

Our project is distinct in considering for this purpose both research and innovation, and all scientific fields (both the natural sciences, engineering sciences, medical and life sciences, social sciences and humanities) and all actors who engage in ethics assessment (research ethics committees, national ethics committees, government actors, industry, CSOs, etc.). We also consider approaches within different countries (in the EU and associated states, the US and China, in particular) and we pay special attention to developing better approaches for giving shape to social responsibility and considering social and environmental impacts in ethics assessment, in what we call “ethical impact assessment”.

During the first period of the project, months 1–18, the emphasis has been on dialogue, mutual learning, and the collection of data about the way in which ethics assessment is actually practiced by different organizations, in different fields, and in different countries, as well as the constraints imposed on ethics assessment through legal developments and developments in globalization.

During the second phase of the project, months 18-36, the emphasis has been on creating frameworks for good practices in ethics assessment, including proposals for the development of ethics assessment units, the protocols of these units, and recommendations for specific types of organisations and scientific fields. In addition, our aims were to standardise our framework and to devise recommendations for assessing the risk-benefit and impact of ethics assessment.

During the third (and last) phase of the project, months 37-45, the emphasis was on further testing and finalising our work on general principles and frameworks for ethics assessment in the EU, on communicating our proposals, and on ensuring the sustainability (heritage) of the work carried out in the SATORI project.

A further description of the SATORI project, as well as its deliverables, can be found at http://www.satoriproject.eu.
Project Results:
The SATORI project aims to develop a common European framework for the ethical assessment of research and innovation (R&I). It is a 45-month project comprising 17 partners from 13 European countries, including an intergovernmental organization. The project was launched in January 2014. The project gathers private and public stakeholders from Europe and beyond in an intensive process of research and dialogue regarding the ethical assessment of research and innovation, both actors who engage in ethics assessment themselves and those who otherwise have a stake in it. Examples of actors involved in the design and implementation of research and innovation ethics assessment are research ethics committees, national ethics committees, governmental councils, research funding organizations, professional organizations for scientists and engineers, civil society organisations, and industry. The ethical issues involved in ethics assessment of R&I include issues related to human subject research, animal experimentation, scientific integrity, social responsibility, environmental and social impacts, and impacts on human rights, amongst others.

The SATORI project aims to identify common principles, protocols, procedures and best practices for ethics assessment, and to identify areas where different approaches are necessary. It aims to achieve mutual learning between different stakeholders so as to advance the practices of, and appreciation for, ethics assessment of research and innovation. Its results would not only strengthen ethics assessments overall, but would also contribute to more responsible processes and outcomes of research and innovation.

We formulate our main objective as follows: Development of a framework for ethics assessment of R&I, consisting of common basic ethical principles and joint approaches and practices that are supported and shared by all the main actors involved in the design and application of research ethics, ethics of technology and innovation standards and principles, including scientists, regulators, civil society, industrial actors, public bodies, research ethics committees in the Member States, relevant international bodies and other stakeholders in society, including the public.

Our project is distinct in considering for this purpose both research and innovation, and all scientific fields (both the natural sciences, engineering sciences, medical and life sciences, social sciences and humanities) and all actors who engage in ethics assessment (research ethics committees, national ethics committees, government actors, industry, CSOs, etc.). We also consider approaches within different countries (in the EU and associated states, the US and China, in particular) and we pay special attention to developing better approaches for giving shape to social responsibility and considering social and environmental impacts in ethics assessment, in what we call "ethical impact assessment".

During the first period of the project, months 1-18, the emphasis was on dialogue, mutual learning, and the collection of data about the way in which ethics assessment is actually practiced by different organizations, in different fields, and in different countries, as well as the constraints imposed on ethics assessment through legal developments and developments in globalization.

During the second phase of the project, months 18-36, the emphasis has been on creating frameworks for good practices in ethics assessment, including proposals for the development of ethics assessment units, the protocols of these units, and recommendations for specific types of organisations and scientific fields. In addition, our aims were to standardise our framework and to devise recommendations for assessing the risk-benefit and impact of ethics assessment.

During the third (and last) phase of the project, months 37-45, the emphasis was on further testing and finalising our work on general principles and frameworks for ethics assessment in the EU, on communicating our proposals, and on ensuring the sustainability (heritage) of the work carried out in the SATORI project. A further description of the SATORI project, as well as approved deliverables so far, can be found at http://www.satoriproject.eu.

Description of work performed and main results

During the first period of the project, months 1 - 18, we have completed the largest work package in the project, WP1 Comparative analysis of ethics assessment practices, which aimed to produce an up-to-date and detailed comparative analysis of EU and international practices related to ethics assessment in scientific research and innovation. Our major findings for WP1 include that there is significant diversity in approaches to ethics assessment in different fields, organizations, and countries, and not a lot of mutual communication and learning, but that there are also recurring themes and approaches.

We also completed WP2 Dialogue and participation, although deliverable D2.3 was completed 1 month beyond the evaluation period and part of WP3 Legal aspects and impacts of globalisation, namely deliverables D3.1 and D3.3.

Although the majority of SATORI's activity in its first eighteen months has focused on WPs 1, 2 and 3, we have also done work for several other WPs. For WP1O, Communication, we have established a communication strategy (D10.1) and have delivered the SATORI website, as well as its logo and a flyer (D10.2). We have also started using social media to promote SATORI, and are working on press releases for our recent deliverables. For WP12, Evaluation, the independent evaluator of SATORI, DMU, has completed three deliverables, D12.1 D12.2 and D12.3 that jointly constitute an evaluation and reflection strategy for SATORI. We have also made a start with WP4 (Roadmap for a common EU ethics assessment framework) and WP7 (Standardizing operating procedures and certification for ethics assessment).

During the second period of the project (months 19-36), we used the data and analyses obtained during the previous 18 month to develop a comprehensive ethics assessment framework for European Union member states. This was done as a part of the project's WP4 (Roadmap for a common EU ethics assessment framework). At the core of our efforts has been the development of proposals for good practices for ethics assessment, including the development of ethics assessment units and the protocols of these units. We have developed a general toolkit for such assessment, as well as specialised tools and toolkits for specific types of organisations and scientific fields. In addition to our proposals for improved ethics assessment, we also worked on deliverable D4.3 a roadmap towards the full adoption of our framework, and conducted a total of nine “mutual-learning” sessions across Europe.

We also completed WP5 (Risk-benefit analysis of ethics assessment activities). In this work package, we have developed a methodology to analyse the cost-effectiveness and risk-benefit of ethics assessment activities. During the second 18 months, we also worked on WP6 (Measuring the impact of ethics assessment). During this period, we also completed most of WP7 (Standardizing operating procedures and certification for ethics assessment). We also did some work for several other WPs, including completion of WP3, and policy monitoring and publishing policy newsletters for WP9, and communication activities for WP1O.

During the third period of the project (months 37-45), we completed WPs 8, 9, 10 and 12, as well as the remaining tasks from WPs 4, 6, and 7. Specifically, as part of WP8 (Sustainability strategy), we developed a strategy the function of which is to ensure the sustainability of the work carried out in the SATORI project and give future participants wishing to pursue this work the means to efficiently implement the MML recommendations. We identified potential leaders that could take on the implementation of the sustainability strategy and potential funding sources to proceed to implementation.

We also completed WP9 (Policy watch and policy recommendations). Specifically, as part of task 9.1 we completed our monitoring of initiatives and policy developments at local, national and European levels. For task 9.2 we continued posting newsletters and blog posts, containing news of relevant policy developments within EU and beyond. For task 9.3 we presented the SATORI consortium’s recommendations and its integrated assessment framework.

In the last 9 months of the project, we also continued and completed our work for WP10 (Communication), including work on journal articles and presentations at third-party conferences. Our communication activities reached their conclusive part with the organisation of the final SATORI conference (Ethics Assessment of Research and Innovation: Looking into the Future), which took place in September 2017 in Brussels. Also, as part of WP10, we finalised the project’s final report on communication and dissemination activities undertaken during the 45 months of the SATORI project.

During this period, we also completed WP12 by finalising the deliverable D12.4 (SATORI Evaluation, Reflection and Remedy report), which presented a synthesis of the 6 monthly evaluation reports which were developed beginning from month 24 of the project. The report describes the methodology used for evaluation, and gives a summative evaluation of each SATORI work package. It then highlights some of the lessons that can be learned from the SATORI project.

Although the larger part of the project activities focused on WPs 8, 9, and 10, during this period we also finalised the deliverables that came unfinished from the previous project period. Specifically, we finalised deliverable D4.3 a roadmap towards the full adoption of our framework (This roadmap was submitted several months late due to tardiness from leading partner VTT). We also finalised and submitted deliverable D4.4 that reports on the mutual-learning sessions (The delay in this report was approved by our PO, since the training/mutual learning sessions on which it is based were delayed from early to late 2016, in order to better benefit from project results). We also completed deliverables D6.1 and D6.2 (The delays in the submission of these reports appeared to have been due to insufficient action by WP and task leaders VTT and DBT during the 2nd period of the project).

Although we completed most of the tasks of WP7 in the second 18 months of the project, their deliverables D7.1 and D7.2 were delivered in time right after the reporting period, before the end of February 2017. D7.1 assesses the feasibility of developing a standard for ethics assessment of research and innovation. D7.2 explores whether conformity assessment and certification could be useful in in facilitating and improving the use and quality of ethics assessment in R&I. It was concluded that having a standard for ethics assessment of R&I is indeed feasible and different forms of conformity assessment could be helpful. The conclusions have led to the creation of the so-called SATORI CEN Workshop Agreement (CWA), the world’s first (pre-)standard for ethics assessment of R&I.

Thus, despite a few setbacks encountered in the previous reporting period (chiefly among them, the departure of two of the partners, ISCIII and ABC, which caused several months of delay as we had to (temporarily) divide their work over other partners), most of the deliverables were completed and submitted by the end of the third period, and the remainder were completed in the months after the official end of the project.


Potential Impact:
The ultimate expectation for the project is to arrive at specific analyses and proposals on how to improve ethics assessment practices and institutions so as to make them more efficient and effective, for the betterment of research and innovation in Europe and beyond. Such an improvement in ethics assessment will not only ensure that research and innovation in the EU is in accordance with shared European and moral values, but will also help ensure that the outcomes of research and innovation will make a better fit with the needs and expectations of society and will in this way also have indirect economic benefits by ensuring a better fit between supply and demand and by helping to reduce environmental, safety and health risks and harms of research and innovation. In addition, results of the project could inspire countries outside the EU and help them improve their activities in ethics assessment.

What we have achieved over the first 18 months of the project's duration is the creation of comprehensive data collections and analyses on ethics assessment in different scientific fields, organizations, and countries. The project's 47 reports belonging to WP1 make available state-of-the-art and detailed information on ethics assessment principles, approaches, practices, institutions and organizations in the EU, and beyond. Our comparative analysis presents new insights on how ethics assessment in different scientific fields, organizations, and countries compares to one another. We have also identified for the first times the interests, attitudes and needs of different types of organizations regarding ethics assessment. And we have, for the first time, mapped the legal context of ethics assessment, and have done the most extensive study yet of ethical issues in the globalization of research and innovation. These results have great potential use to inform the activities of ethics assessors, policy makers, and academics. We have conducted a major PR offensive in September 2015 to draw attention to these results of the first 18 months of the project.

What we have achieved over the second 18 months of the project's duration, first and foremost, is the creation of a comprehensive framework and approach for ethics assessment that should be of use for different types of organizations, different scientific fields, and different countries. Our proposals include standards and best practices for creating ethics committees and for the operations of ethics committees; the first comprehensive list of ethical principles for different fields of scientific research and innovation; the creation of a novel ethical impact assessment methodology that uses foresight to anticipate ethical impacts of R&I; recommendations for how to structure ethics assessment and ethical guidance in specific types of organizations, including research funding organizations, universities, industry, national ethics committees and CSOs; recommendations for creating strong ethics assessment and guidance institutions and regulations at the national and EU level; and the creation of the world's first ISO/CEN (pre-) standard for ethics assessment of R&I.

What we have achieved during the last 9 months of the project is the completion of policy recommendations and policy briefs that take results of the project into the policy realm; completion of recommendations for the improvement of the H2020 ethics review process; completion of a sustainability strategy for the project to carry its results forward after completion of the project; and significant efforts at communication and dissemination to inform stakeholders of the results of our project.

The last nine months of the project ended with the final SATORI conference – Ethics Assessment of Research and Innovation: Looking to the Future (Brussels, September 2017). The final conference lasted 2 days, and attracted on both days more than 150 people from around the world. The success of the conference indicates a heightened interest in the proposals and findings of the SATORI project from various institutions and organisations, including stakeholders from industry, CSOs, NGOs, as well as national and international policy-makers.

Among its impacts, the project has inspired the start of a new organization, Intersection (http://www.intersection.rs/) which is an action tank dedicated to the integration of responsible research and innovation (RRI) into policy agendas in Serbia and other SEE countries. As a representative of the centre has written to us, the initiation of this centre was directly inspired by the SATORI project by former members in the consortium. Also, our standard for ethics assessment is currently being used as a model for the restructuring of the ethics committees at the University of Twente, and has gained a lot of interest from other organizations as well. We regularly receive requests for information about the results of the project, and invitations to publish out findings in academic books and journals. SATORI results are currently being used in other projects, including ENERI, SIENNA and SHERPA. People attached to the former project remain committed to promoting its results into the future.

List of Websites:
http://satoriproject.eu/