Project Description

The aim of the project

The overall aim of the project is to contribute substantially to the development of a European approach to synthetic biology. The agenda-setting in the US will be taken into account and analysed, but the diversity of cultures and ethics in Europe and the political specifics rule out a simple copy of US approaches.
The project aims at a proactive approach in which the specific European strengths and needs, relevant public values and potential societal concerns are taken into account in the development of synthetic biology so that its benefits are safeguarded for society while minimising social costs. Significant contributions are to be expected with regard to:

• a responsible development of synthetic biology in Europe with regard to ethical and societal values such as notions of life and concepts of nature, and also with regard to the question of the importance of biosecurity. Next to this, it will also take into account the overall goal to profit from the benefits of synthetic biology that are most promising in the European context;
• the shaping of a European community in which expertise from all relevant fields of research is systematically integrated in a normative analysis of the developments of synthetic biology;
• the broadening of ethically relevant research and activities, in particular with regard to synthetic biology’s “dual use” and comprehensive philosophical and societal aspects; and
• the facilitation of societal discourses, academic research and related networking activities, reflecting the specific situation in Europe, while taking into account and analysing the international debates.

The specific aims of the project are tailored to the topic of the FP7 call for proposals, i.e. “research on appropriate ethical frameworks of new technologies; research on foresight of ethical issues likely to emerge in the context of the societal embedding of new technologies.” The specific aims of the project are:

• to identify actual and emerging ethical issues raised by developments in synthetic biology and the embedding of the developed technologies in society;
• to trace and analyse the public discourse on these issues;
• to analyse whether these ethical issues, and the concerns raised in the public discourse, can be adequately dealt with the current normative frameworks existing in synthetic biology and in closely related fields such as nano- and biotechnology genetic engineering, and identify shortcomings; and
• to analyse topics in synthetic biology on which EU policy and regulation might be required and to make recommendations on these topics.

Strategy and general description

In order to attain the specific aims of the project, the following five research questions have been formulated:

• What are actual and newly emerging ethical issues and moral dilemmas in synthetic biology, in particular with respect to dual use and security aspects and with regard to broader questions such as challenges for our notions of life and nature?
• Which public and policy concerns are already raised by these issues or will likely be raised in the near future? How do European and international media and civil society actors perceive and discuss synthetic biology, its ethical aspects and governance?
• How does the emerging European synthetic biology community perceives and handles these issues and the concerns they raise? In particular, what normative frameworks (from what constituting fields of synthetic biology: genetic engineering, nanotechnology etc.) are applied?
• Are these current normative frameworks appropriate to deal with ethical issues and public and political concerns? What challenges are raised for existing normative frameworks?
• How could these challenges best be dealt with? How could the EU respond? What regulation, if any, might be appropriate? What could or should the synthetic biology community itself do?

The following staged approach will be followed:

• Identification and analysis of the ethical issues raised by synthetic biology, including workshops with synthetic biologists and other experts (WP 1)
• Selection of a number of ethical issues that will be investigated in further detail in the rest of the project which a special focus on 1) dual use and biosecurity and 2) Notions of life and the blurring of the line between natural and artificial (WP 1)
• Analysis of public discourse on the selected ethical issues (WP 1)
• Reconstruction of current normative frameworks in synthetic biology and closely related fields, in particular biotechnology and nanotechnology (WP 2)
• Identification of challenges posed by the current and emerging ethical issues and in public discourse for current normative frameworks (WP 3)
• Workshop with all relevant stakeholders and the formulation of recommendations for the synthetic biology community and EU policy making. (WP 4)

Work package 1

Objectives

• Identification of ethical issues raised by synthetic biology
• Assessment of how the European synthetic biology community is currently dealing with these issues
• Inventory of expert opinion on these issues
• In-depth analysis of a limited number of ethical issues (dual use, notions of life)
• Analysis and proposals with respect to public discourse on recent, emerging and potential developments in synthetic biology.
• Identification of potential tensions between public discourse, expert opinions and the way the European synthetic biology community is now dealing with ethical issues
• In depth analysis of public discourse on a number of specific ethical issues, esp. in relation to notions of life, conceptions of nature, problems of dual use and societal setting of application.

Research activities:

• Literature study on ethical issues in synthetic biology
• Session in Group Decision Room with synthetic biologists to identify ethical issues
• Interviews with synthetic biologists, experts and stakeholders
• Expert workshop with experts from other relevant EU and other projects. We will involve individuals from the new member states in this workshop
• Philosophical in-depth analysis of a number of relevant moral dilemmas in synthetic biology
• Tracing of debate in relevant media
• Analysis of data, including an analysis of potential tensions between public discourse, expert opinions and the way the European synthetic biology community is now dealing with ethical issues

Work package 2

Objectives

Identification and detailed description of current normative frameworks applying to ethical issues and public discourse in synthetic biology. This includes the normative frameworks developed in synthetic biology and in neighbouring areas like nano(bio)technology and genetic engineering. Attention will be paid to both formal and informal rules and regulations.

Research activities:

• Literature review of relevant regulations, codes and standards, EU directives, codes of conduct, (proposed) self-regulation
• Interviews with relevant policy makers, professional societies etc. with respect to current relevant regulations, codes and standards, EU directives, codes of conduct, (proposed) self-regulation. Where appropriate, we will involve individuals from the new member states in this exercise
• Interviews with synthetic biologists about how ethical frameworks influence their research decisions
• Coordination of interviews to avoid overlap of interviewees

Work package 3

Objectives

• Analysis of any potential gaps in, or shortcomings of the current normative frameworks, on basis of deliverable 1-2 and the chosen criteria for normative frameworks (as described in detail in section 1.1.1).
• If gaps or shortcomings of the current normative frameworks are identified, proposals how to deal with them will be developed.
• Prospective ethical analysis of emerging or possible future issues in synthetic biology.

Research activities:

• Internal workshop to make a first inventory of potential gaps in, or shortcomings of the current normative frameworks on basis of deliverable 1-2
• Detailed study, per ethical issue and public discourse, related to various relevant normative framework whether criteria for normative frameworks are met
• For issues for which criteria are not met: development of proposals for dealing with these issues in (a) public discourse, (b) policy making and (c) the synthetic biology community

Work package 4

Objectives

To identify ethical and regulatory challenges which are raised by synthetic biology and to formulate recommendations to the relevant communities, in particular the synthetic biology research community and the European Commission, for dealing with these challenges. Public dialogue events will be designed and organised to discuss these challenges in a broad public setting and validate our results before we finalise the recommendations.

Research activities:

• Identification of ethical and regulatory challenges
• Invite reactions by relevant stakeholders (synthetic biology research community, policy makers, NGOs and other civil society stakeholders) to deliverable 3 (gaps and shortcoming in current normative frameworks)
• International workshop with relevant experts and stakeholders, in which proposals formulated in deliverable 4 are discussed and reformulated
• Refinement of recommendations for (a) public discourse, (b) policy making and (c) the synthetic biology community

Other activities:

• Design of public dialogue events
• Organisation of public dialogue events
• Finalisation of recommendations

Work package 5

 Objectives

• Management and coordination of the project
• Meeting of all deadlines and production of all deliverables for the project
• Dissemination of project result to relevant target groups (synthetic biology community, policy makers, NGOs/public)

Coordination of the project:

• Organization of project team meetings
• Communication between partners (through intranet website)
• Set-up and maintenance of external website for the project
• Writing, production and distribution of leaflet/booklet with main results targeted at three target groups (synthetic biology community, policy makers, NGOs/public). These leaflets will be produced parallel to the writing of deliverable 5 (recommendations)
• An evaluation of the publications submitted to appropriate journals will be commenced, to ensure that the results of the project are widely disseminated in the scientific and ethics literature.