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

Periodic Report Summary 2 - SATORI (Stakeholders Acting Together On the ethical impact assessment of Research and Innovation)

Project Context and Objectives:
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 subjects 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 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.

In the remaining months, our emphasis will be 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
Project 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 WP10, 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 has been 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 have been working on – and recently submitted – deliverable D4.3 a roadmap towards the full adoption of our framework. Furthermore, we have recently been conducting 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. Over the past 18 months, we have also been working 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 have also done work for several other WPs, including completion of WP3, and policy monitoring and publishing policy newsletters for WP9, and communication activities for WP10.

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.
Although it is still early in the project to point to already realized impacts of the project, it is telling that the project has already inspired the start of a new organization, Intersection ( 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.
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