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A multistakeholder dialogue providing inputs to implement the European Code of Conduct for Nanosciences & Nanotechnologies (N&N) research

Final Report Summary - NANOCODE (A multistakeholder dialogue providing inputs to implement the European code of conduct for Nanosciences and nanotechnologies (N&N) research)

Executive summary:

NANOCODE is a European project funded under the 'Capacities' programme, in the area 'Science in society', within the Seventh Framework Programme (FP7). The objective of NANOCODE was to define and develop a framework (MasterPlan) aimed at improving and strengthening awareness and supporting the successful integration and wider implementation of the European Commission code of conduct (EC-CoC) for responsible Nanosciences and nanotechnologies (N&N) research at European level and beyond, integrated with an implementation assistance tool (CodeMeter).

The project rested on four pillars:

1. Analysis of existing / proposed codes of conduct, voluntary measures and practices for a responsible Research and development (R&D) in N&N and identification of the relevant stakeholders (WP1).
2. Consultation of stakeholders to assess attitudes, expectations, needs and objections regarding the EC-CoC through a survey (electronic questionnaire and structured interviews) to more than 400 stakeholders worldwide (WP2).
3. Design of a MasterPlan and a performance assessment tool (CodeMeter) enabling the implementation and articulation of the EC-CoC, based on the WP2 consultation phase, a series of national workshops in partner countries and a final international conference (WP3).
4. Communication in a suitable form and to the widest possible audience of project objectives, findings and outcomes (WP4).

The project brought together 11 partners representing 8 European countries, plus Argentina, South Africa and South Korea (associated member).

The two main final outcome of the project have been the MasterPlan and the CodeMeter. They build on the insights gained from encompassing stakeholder consultations in eight European countries, as well as at international level. The consultations, made by an electronic survey, structured interviews and focus groups, involved more than 400 stakeholders worldwide, to assess attitudes, expectations, needs and objections regarding the EC-CoC. Results of the consultation were used to prepare a first draft of the MasterPlan and CodeMeter that have been then thoroughly debated in national workshops in all partner countries and a final international conference that leads to the designing of the final version of these documents.

The MasterPlan provides a portfolio of options, ideas and recommendations for the further development and implementation, at European level and beyond, of the EC-CoC. The MasterPlan is intended to:

- point out the level of awareness as well as criteria and indicators of the level of implementation and application of the EC-CoC;
- indicate the need for future changes to the EC-CoC;
- identify best practices, incentives and disincentives to foster widespread adoption of the EC-CoC.

The CodeMeter is a practical tool that break the EC-CoC's general principles and guidelines down into concrete, easily comprehensible criteria which can be answered through a questionnaire. The tool is designed to enhance the practicability of the EC-CoC, support reflection and learning and allow individual stakeholders self-assess their performance in relation to the EC-CoC principles and guidelines.

The MasterPlan, the CodeMeter and all other reports detailing outcomes of the different project activities are available on www.NANOCODE.eu.

Project context and objectives:

The unique characteristics of nanotechnologies could potentially lead to a huge range of valuable new applications and benefits, but may also pose novel challenges in terms of managing the technological and societal implications associated with them. The CoC for responsible N&N research promoted by the EC (EC-CoC) aims to cope with these challenges.

The EC-CoC collects most of the concepts and values that have emerged in recent years from the debate on the governance and ethics of nanotechnologies, and is an important reference point concerning the principles that should underpin research activities, the interaction amongst key stakeholders and, in general, 'good governance' for the responsible development of nanotechnologies.

The objective of NANOCODE has been to define and develop a framework aimed at supporting the successful integration and implementation, at European level and beyond, of the EC-CoC proposed by the EC.

The NANOCODE project aimed to facilitate a multistakeholder dialogue on the EC-CoC at European level and in selected associated countries, to improve and strengthen the awareness about the EC-CoC, promote trust-building amongst stakeholders and, as an ultimate goal, develop the above mentioned framework to favour the wider application of the EC-CoC.

The project was structured in the following 5 Work packages (WP)s:

- WP1: Analysis of existing / proposed CoC, voluntary measures and practices for a responsible R&D in N&N and identification of the relevant stakeholders.
- WP2: Consultation of stakeholders to assess attitudes, expectations, needs and objections regarding the EC-CoC.
- WP3: Design and development of a EC-CoC MasterPlan (the framework) enabling the implementation and articulation of the EC-CoC, including future changes, criteria and indicators of the level of application, best practices, incentives / disincentives and a performance scheme (CodeMeter) for the adoption of the EC-CoC.
- WP4: Communicate in a suitable form and to the widest possible audience project objectives, findings and outcomes.
- WP5: Project management.

The project brought together 11 partners representing 8 European countries, plus Argentina, South Africa and South Korea (associated member).

Main milestones / outputs of the project have been:

1. Analysis of existing / proposed CoC, voluntary measures and practices for a responsible R&D in N&N and identification of the relevant stakeholders (WP1):
a. condensed in 10 country reports for each of the consortium countries, funnelled in a publishable synthesis report;
b. wide catalogue of International stakeholders, including contact information and person profile, with a well-balanced composition in terms of researchers, business, institutions and civil society representatives.

2. Consultation of stakeholders to assess attitudes, expectations, needs and objections regarding the EC CoC (WP2):
a. survey through an electronic questionnaire and structured interviews (to a restricted number of them), involving more than 400 stakeholders in some 20 different countries;
b. outcomes condensed in 10 country reports for each of the consortium countries plus a report on International stakeholders and reviewed in a publishable 'Synthesis' report.

3. Design and development of a CoC MasterPlan (the framework) and a CodeMeter enabling the implementation and articulation of the CoC (WP3):
a. organisation of 10 national workshops in all partners' county to discuss the MasterPlan and the CodeMeter (the results have been condensed in specific national workshop reports);
- b. publication of the final NANOCODE MasterPlan and CodeMeter identifying and prioritising actions and recommendations for the further revision of the EC-CoC and providing a tool for the assessment of the compliance with the current version of the EC-CoC.

4. Communicate in a suitable form and to the widest possible audience project objectives, findings and outcomes (WP4):
a. project website, with information on project activities and outcomes, news and links to further information on most important initiatives, documents, references and positions made public by policy makers, businesses, researchers and civil society on a global basis on the CoC and on issues related to the responsible development of N&N;
b. organisation of the international conference 'Promoting responsible innovation: The future of the European CoC for nanotechnologies' (Brussels, 29 September 2011) to present the final draft of the NANOCODE MasterPlan and CodeMeter (videoing and presentations available on the project website);
c. organisation of national conferences and other dissemination activities in all partner countries, to present and discuss at national level the MasterPlan and CodeMeter (a summary of conferences outcomes has been included in the final project Newsletter);
d. publication of the NANOCODE Newsletter planned (3 issues in total);
e. Dissemination of project activities and outcomes through partners contribution to a number of publications and events devoted to nanotechnologies and emerging technologies in general.

All activities and public deliverables of the project are available on the project website www.NANOCODE.eu.

Project results:

The final scope of NANOCODE has been to develop a strategic framework (called MasterPlan) guiding the further development and implementation of the CoC for responsible N&N research (CoC). The development of a practical tool (the CodeMeter) to help stakeholders assess their performance in complying with the CoC's principles form a key element of the framework.

The design of the MasterPlan and CodeMeter builds on the insights gained from encompassing stakeholder consultations in eight European countries as well as at international level. The consultation involved stakeholders from seven European Union (EU) Member States (Italy, UK, France, Spain, The Netherlands, Czech Republic and Germany) and three non-EU countries (Switzerland, Argentina and The Republic of South Africa). In each of the partner countries, representatives from research, institutions, business and civil society organisations contributed to the quantitative survey. Additionally, a series of qualitative interviews and focus groups have been organised to deepen the country-specific attitudes and to develop detailed recommendations. Furthermore, a group of participants from international organisations based in Australia, Austria, Belgium, Brazil, China, Denmark, India, Korea, Liechtenstein, Mexico, Norway, Portugal and the United States answered the survey and completed the colourful picture of comments and recommendations for the further development of the EC CoC. Overall, the consultations involved more than 400 stakeholders worldwide. The findings of the consultation are summarised in dedicated reports (NANOCODE WP2 'Country and synthesis' reports, available at www.NANOCODE.eu) giving insights into stakeholder's patterns of awareness, their expectations, attitudes and appraisals. The survey analyses the degree of compliance and commitment, identifies recommendations for the communication, possible incentives, disincentives and monitoring of the EC-CoC.

The NANOCODE stakeholder consultation unveiled that awareness and implementation of the EC-CoC remain very limited to date due to:

- Lack of legitimacy: It was questioned whether N&N (still) deserve their own CoC.
- Difficult practicability: Deriving concrete and verifiable actions in practice is hampered by the all-embracing and unspecific character of the principles and guidelines of the EC-CoC.
- Stumbling blocks: Specific contents, formulations and requirements in the EU-CoC have led to a rejection of parts or the entire EC-CoC amongst some of its target groups.
- Lack of pressure: Many deemed it necessary to associate the EC-CoC with incentives, disincentives or penalties (in case of non-compliance) to encourage stakeholders to adopt and comply.
- Poor communication: Communication and dissemination by the EC and Member States do not make the impression that the EC-CoC is of high priority.
- Inadequate commitment: commitment, coordination and lead have been lacking in the light of the very different structural preconditions applying for the implementation of the EC-CoC in different national contexts.

In the light of the identified flaws, stakeholders expressed the need for a fundamental revision of the current EC-CoC and the development of an implementation strategy. This can build up on some unambiguous positive aspects of the EC-CoC identified during the consultation:

- The EC-CoC principles: stakeholders largely agree they are essential aspects to be taken into consideration in the development of nanotechnologies (as well as in emerging technologies in general).
- The voluntary character: the EC-CoC, though acknowledging some weaknesses associated to its voluntary character, is seen as appropriate tool to implement these principles, favouring trust building and confidence amongst stakeholders.
- The broad scope: the EC-CoC encourages dialogue amongst stakeholders and acts as an early warning system for relevant safety and societal issues.

The universal character of the principles is expected to offer necessary flexibility for adaptation to particular scope and target groups.

Summary of MasterPlan results:

The MasterPlan relies on the outcomes unveiled by the consultation outlined above. It provides selected ideas, options and recommendations concerning revision and implementation of the EC-CoC, with a focus on stakeholder preference, practicability, need for structural and substantial changes of the EC-CoC, and compatibility with the governance context of the existing EC-CoC. It provides a number of options and recommendations related to three main features of the code:

- role and scope: extending the code from N&N to research and innovation in general, from a framework of behaviours to a standard;
- format and contents: improvement of structure, language and guidelines;
- implementation: options to provide assistance tools, identify incentives / disincentives, improve awareness and dissemination.

The first draft of this MasterPlan and the CodeMeter prototype were deliberated during national workshops with national stakeholders in all partner countries. Some 120 experts took part, overall, on these events. A final draft of these documents was then discussed during the international conference 'Promoting responsible innovation: the future of the European CoC for nanotechnologies' (Brussels, 29 September 2011).

In order to solve the legitimacy issue of the EC-CoC, it was suggested to extend the scope of the EC-CoC in two dimensions. It was agreed that the principles and most of the guidelines of the EC-CoC are valid universally, beyond N&N research. It is therefore recommended to extend the scope of the EU-CoC (e.g. emerging technologies, or science in general), encompassing perspectives along a product's elaboration and life cycle stages (e.g. an 'Innovation CoC') in alignment with the Innovation Union flagship initiative.

Although the present EC-CoC is considered suitable in principle to provide a foundation for a reflection process on responsible research, it is also considered to be of difficult practicability, for the EC-CoC does not offer practical criteria to determine what is good enough and how compliance can be achieved. This renders statements of compliance subject to ambiguity and they remain difficult to be verified.

The recommendation is to revise the EC-CoC with the intention to shift its functionality from being a general framework of behaviours to a voluntary, verifiable standard. Agreeing on concrete criteria thus represents a prerequisite to allow any meaningful form of adoption, verification and monitoring of compliance. Those criteria should be developed in close cooperation with stakeholders and experts and be integrated into the revised EC-CoC. The CodeMeter prototype as well as benchmarking of other standards provides a starting point for the development of such criteria.

A number of content-related, formal and structural issues seem to be stumbling blocks preventing broader stakeholder acceptance and more widespread adoption of the EU-CoC. In particular, the French and the German translations of the 'accountability' principle as 'responsibility' earned mistrust as they were interpreted with a connotation of implying legal liabilities as well as suggesting that scientists are held responsible for what is done with their work by decision outside their control or by other actors in the future. This was considered inappropriate in the context of the voluntary EC-CoC. In addition, large parts of the EC-CoC are written in a distinct Commission language which may create problems of understanding. The order of the content elements of the EC-CoC booklet puts a lot of emphasis on the political process rather than on the principles and guidelines themselves. These points represent barriers to an intuitive approach to the EC-CoC which could be improved quite easily.

Another fundamental decision must be taken regarding the future role of the EC-CoC in the broader context of governance. The current EC-CoC has been designed as a voluntary measure, thereby with no means to be verified, monitored or enforced, that cause a lack of pressure. It is recommended to keep the EC-CoC voluntary. But by increasing its specificity and practicability with the aforementioned criteria, it could be aligned to play a role as a voluntary standard. Linking, for example, compliance with the EU-CoC to a priority in the allocation of public funding (e.g. in the framework programme) seems to represent a possible, though controversial option for the EC to set up a strong incentive to comply with the (revised) EC-CoC. Again, criteria and tools are required to reliably and reproducibly assess compliance with the EC-CoC.

On the level of the EC and Member State governments almost complete poor and uncoordinated communication, dissemination and awareness-raising about the EC-CoC was observed. Strengthening dissemination of the current EC-CoC in order to foster its implementation seems pointless in the light of the proposed fundamental revision of the EC-CoC, nevertheless transparency and information should immediately be improved. It is recommended to immediately launch an official EC-CoC information platform, independent from strategic and content-related changes which the EC-CoC might undergo. This platform is to inform about past, ongoing and upcoming activities and transparently document the consultation and revision process. It could later serve to host the CodeMeter. Other means of communication (e.g. development of 'marketing' and educational materials) should be envisaged later, depending on the outcomes of the ongoing revision, and be closely coordinated with the (to-be-renewed) dissemination activities. Due to the interdisciplinary character of the EC-CoC, now and even more after a revision, multiagency collaborations are needed to coordinate and lead the dissemination. A clear and unambiguous commitment at EU level, accompanied by a series of (policy) actions to foster Member States and stakeholders to adopt the EC-CoC is necessary to push countries which lack particular coordination actions and clear responsibilities at national level on nanotechnology-related issues. Activities should be clearly assigned to the EC, Member State governments and agencies.

Therefore, the analysis carried out has highlighted specific issues related to the role and scope, the format and contents and the implementation of the EC-CoC. These are summarised below together with a number (25) of recommendations / options. More detailed information can be found in the MasterPlan report.

MasterPlan: Overview and Recommendations

Stakeholder awareness of the EC-CoC

Situation

- Awareness of the existence of the EC-CoC among N&N research stakeholders and N&N experts is rather low. Only about half of the relevant stakeholders from research, industry and public authorities had heard about the EC-CoC previously. This can (partly) be attributed to the low effectiveness of the communication and dissemination activities by the EC along the dissemination pathways originally envisaged in the EU-CoC.

Recommendations

1. Intensifying the dissemination of the EC-CoC with the aim to foster its implementation is not considered useful until the revision process has resolved the identified issues (see sections 3.2 3.3 and 3.4). In the meantime, it is recommended to develop and implement information and awareness - raising activities to ensure proper and effective stakeholder engagement and transparency in the revision process as well as in the (further) implementation of the EC-CoC (see section 3.4.3).
2. The large pool of experts collected and involved in the NANOCODE project should be used in the revision process, in particular those who are more sensitive to the issues of applying the EC-CoC.

Support for the basic idea of the EC-CoC and Status of Implementation

Situation

- A high level of agreement with the EC's approach of a voluntary CoC and with the underlying general principles was observed. However, the good agreement with the idea of the EU-CoC does not currently translate into high rates of adoption.
- Many N&N stakeholders indicated that the EC-CoC's principles are 'implicitly adopted' in their organisations by other means than the EC-CoC guidelines, and many declared their intention to adopt the EU-CoC in the future. In addition, respondents were over-optimistic about the degree of implementation of the EC-CoC amongst Member States and governments.

Recommendations

3. The positive attitude towards the principles of the EC-CoC and its voluntary character should be taken as a solid basis to build on during the envisaged revision of the EC-CoC while some aspects of the EC-CoC need to be revised and adapted (see section 3.3).
4. The tendency of stakeholders to consider the EU-CoC implemented 'implicitly' (through other standards and guidelines) must be addressed in the light of the future role and scope of the EC-CoC after revision (section 3.2.2).

From N&N Research to an 'Innovation' code

Situation

- It has been contested whether a dedicated CoC for N&N research is (still) needed. On the other hand, it is agreed that the principles and guidelines of the EU-CoC are universally valid and do not only apply to N&N research. It seems therefore possible to derive general principles for 'emerging technologies' or, more generally, 'responsible innovation' from the existing ones and extend the scope of the EC-CoC to other disciplines and along the entire chain of a product's elaboration and life cycle stages.
- There are a set of strategic options in terms of scope of the EC-CoC, which seem all viable in their corresponding governance context, defined by the combination of the two possible lines of actions. Action line 1: Extend the scope of the EC-CoC to include other disciplines (e.g. all emerging technologies or science in general). Action line 2: Include a more encompassing life cycle perspective (e.g. an 'innovation CoC'). The situation is summarised in figure 2 From the NANOCODE consultation, a preference towards extending the scope of the EC-CoC beyond N&N (action line 1) was identified, while the opinion about an 'innovation CoC' (action line 2) seems to be less viable.
- The extension of the scope of the EC-CoC has to satisfy the unambiguous demand for increasing its specificity and practicability. In all of the above cases (N&N research, science or innovation code), fundamental revision of the current EU-CoC is required to align it to its future role.

Recommendations

5. Whether to extend the scope of the EU-CoC beyond N&N research to emerging technologies, science or innovation remains a strategic decision which must be brought in line with the future role of the EU-CoC in its governance context (e.g. the Innovation Union flagship initiative 2). This decision should be taken before any further steps with the current EC-CoC contents are initiated.
6. Revision of the EC-CoC is recommended to be directed towards an extension of the scope beyond N&N (action line 1). The extension along the entire chain of a product's elaboration and life cycle stages (action line 2) remains a controversial issue.
7. It seems reasonable to retain the general principles of the current EC-CoC (see section 3.1.2) and combine and integrate them with the type of extension chosen. The extension of the scope of the EC-CoC has to satisfy the unambiguous demand for increasing its specificity and practicability and a better focus of the target groups of the EC-CoC should be aspired.

From a framework of behaviours to a standard

Situation

- As long as the EC-CoC does not offer practical criteria and guidance about how to put its principles into practice and how to measure compliance, both implicit and explicit adoption of the EC-CoC remain a lip service. The development and integration of concrete criteria into the EC-CoC represents a prerequisite to allow any meaningful form of adoption of the EC-CoC.
- Instead of detailing the EC-CoC itself with concrete criteria, another viable option seems to complement it with implementation assistance tools. These assistance tools may be tailored to different target groups, technologies or application sectors, in order to provide the appropriate level of specificity and practical guidance.
- Amending the EC-CoC with criteria could effectively convert it to a verifiable standard. Compliance with the criteria of the standard has to be explicitly demonstrated. Whether the 'standard' approach can be realised critically depends on the level of specificity that will be aspired with the revision of the EC-CoC's guidelines.

Recommendations
8. The EC-CoC should be revised with the intention to shift its functionality from the current general framework of behaviour to a voluntary standard. The need for explicit adoption should be part of the scope of the EC-CoC and should be taken into account in defining tools for its implementation.
9. Concrete criteria should be developed in close cooperation with stakeholders and experts taking into consideration existing initiatives and the experiences made with the CodeMeter prototype (section 3.4.2).
10. Accompanying the EC-CoC with implementation assistance tools (CodeMeter) could help providing the adequate level of specificity and practical guidance to the EC-CoC. The CodeMeter should be developed and evaluated in parallel to the revision of the EC-CoC.

Structure and language of the EC-CoC

Situation

- Large parts of the EU-CoC are written in a distinct 'Commission language' which is sometimes difficult to fully understand. The order of the content elements of the EC-CoC booklet puts a lot of emphasis on the political process which led to the EU-CoC rather than on the principles and guidelines which are only found in the annex. There is no introduction, outlining who should be addressed and what the benefits of using the EC-CoC are. These points present a barrier to an intuitive approach to the EC-CoC for most of its target groups.
- There is a lack of correlation between the principles and the guidelines in the EC-CoC. The guidelines are not ordered according to the seven principles, but arranged under different subtitles. This complicates a structured top-down approach from the general perspective (principles) to the applied measures (guidelines).

Recommendations

11. Both the choice of the wording used and the particular structure of the content elements in the EC-CoC booklet should be addressed in the revision of the EC-CoC and be better adapted to the primary target audiences of the EC-CoC in an easy, simple and short manner. An introduction, outlining who is addressed and what the benefits of using the EC-CoC are, should be added. A proposal for the structure is presented in annex 4.1.
12. The lack of correlation between the principles and the guidelines is inherent to the entire EC-CoC and could only be removed through fundamental revision of all guidelines. If such deep revision is envisaged, ordering the guidelines according to the topics of the principles is recommended.

The 'accountability' principle

Situation

- Many stakeholders involved in the NANOCODE consultation have indicated reluctance to hold researchers accountable for negative impacts that their research may impose on future generations. This is perceived to be beyond the influence and accountability of individual researchers.
- The French and the German translations of the 'Accountability' principle earned particular mistrust amongst non-English speaking stakeholders. Many interpreted it with a connotation of implying legal liabilities which was considered inappropriate in the context of the voluntary EC-CoC. It was therefore suggested to replace the term 'accountability' by 'responsibility'.
- Some stakeholder communities made a fundamental revision of the 'accountability' principle a precondition to reconsider implementation of the EU-CoC as a whole.

Recommendations

13. The explicit attribution of accountability to N&N researchers for potential impacts of their research on future generations seems unacceptable. The EU-CoC should be more specific so that it is clear who needs to do what to be 'accountable'. Scientists remain accountable for adopting good scientific practice, but not for what is done with their work by others in the future.
14. It is crucial to recognise that criticism about the understanding of the 'accountability' principle has contributed to an overall rejection of the EC-CoC among a considerable number of N&N stakeholders. Fundamental revision and / or clarification of this principle is therefore pivotal to the success of the revision and further implementation of the EC-CoC. The objecting stakeholders should be included in the revision and reformulation of this principle. Particular care is needed in the translation of the term in the various languages.

The 'innovation' principle

Situation

- The role of the 'innovation' principle in the EC-CoC remains unclear. It is considered too general and not addressed to specific stakeholder groups. Moreover, the EC-CoC does not seem to present specific guidelines to mention concrete actions to be taken to fulfil the 'innovation' principle.
- Since 'responsible innovation' is discussed as a possible extension of the scope of the EC-CoC beyond N&N research, this aspect deserves particular attention (section 3.3.3).

Recommendations

15. A clarification of the roles of the different target groups of the EC-CoC and further specification of suggested actions in relation to the 'innovation' principle should be provided.
16. It is recommended to establish unambiguous links between the 'innovation' principle and the guidelines section. Some of the keywords mentioned in the 'innovation' principle ('novelty', 'creativity', 'flexibility', 'planning ability') could therefore be taken up again in the guidelines section.

Embedding the EC-CoC in the governance context: incentives and disincentives

Situation

- Although the instrument of a voluntary CoC and its principles were regarded adequate, some external motivation or pressure is considered necessary to support widespread implementation of the voluntary EC-CoC.
- Linking the EC-CoC to incentives or enforcing mechanisms requires monitoring and evaluation procedures to be in place which stands in contrast to the concept and design of the current EC-CoC. The general and unspecific guidelines of the EC-CoC are not appropriate to derive unambiguous, verifiable requirements.

Recommendations

17. The EU-CoC should be kept voluntary and it should not become a surrogate for enforceable (legal) regulations.
18.A number of implementation options have been identified, from weak forms of incentives to strong enforcing and monitoring mechanisms. These include: Introducing a label on EC-CoC compliance; giving priority to research complying with the EC-CoC in the public research funding process; developing a white list / black list of EC-CoC applicants; making compliance with the EU-CoC a precondition to receive public funding for research; or turning the EC-CoC into a standard for quality control.
19. Objective monitoring and verification need to be enabled by revising its guidelines in order to become more specific, practical and verifiable, or by providing implementation assistance tools.

Prototype of an implementation assistance tool: The CodeMeter

Situation

- A prototype of the CodeMeter has been developed. It breaks down the general principles and guidelines of the EC-CoC into more concrete criteria and indicators. As a voluntary tool for self-assessment and implementation assistance, the CodeMeter would support researchers in reflecting ethical, legal and societal consequences of their research.
- The CodeMeter has been in general, well received. Its practicability, explanatory notes on key aspects of the EC-CoC (e.g. definitions, further information, and examples) and hints how to improve, are regarded helpful.
- The need for a simple and well-structured implementation assistance tool is expected to persist beyond the revision of the EC-CoC, and the CodeMeter prototype offers the necessary flexibility to be adapted to the revised EU-CoC.

Recommendations

20. Due to the appreciation of the CodeMeter approach, it is recommended to follow up on this concept. The CodeMeter should be adapted to the results of the on-going revision of the EU-CoC, to the feedbacks from the prototype testing and be developed in parallel to the revised EU-CoC.

Organising the dissemination process of the EC-CoC

Situation

- To date, awareness amongst the EC-CoC target groups is moderate and there are only few sources of information on the EC-CoC. There is no (official) EU-CoC platform or webpage. Awareness of the EC-CoC is a precondition and the first step on the path to implementation.
- Dissemination did not effectively reach the target groups of the EC-CoC. There is a limited awareness of dissemination activity concerning the EC-CoC, which refers to the entire dissemination chain (EC, Member States, governmental bodies, organisations and individual N&N stakeholders). Key reasons have been poor commitment and lack of clear responsibilities for dissemination as well as controversial content elements of the EC-CoC.
- Recent and ongoing consultations regarding the EC-CoC lack transparency in terms of the impacts they have on the further development of the EC-CoC.

Recommendations

21.As a primary communication measure, an official EC-CoC platform should be launched, independent from strategic and content-related changes to the EC-CoC (see sections 3.2 and 3.3). This platform should inform about past, ongoing and upcoming activities and transparently document the consultation and revision process. It could later host the CodeMeter (section 3.4.2).
22. Other means of communication should also be developed, depending on the outcomes of the on-going revision, and be closely coordinated with the (renewed) dissemination activities. A number of options, related to different target groups, could be used: development of marketing materials, dissemination through European technology platforms, initiatives on education and professional formation.
23. Dissemination activities should be supported by a reference point for the dissemination of the EC-CoC at the level of the EC, as well as in each of the Member States.
24. A clear and unambiguous commitment at EU level, accompanied by a series of (policy) actions to foster Member States and stakeholders to commit to and adopt the EC-CoC is necessary, in particular to push countries which lack particular coordination actions and clear responsibilities at national level on nanotechnology-related issues. These are key barriers for the implementation of a tool such as the EC-CoC. Former dissemination structures (duties, responsibilities, coordination and monitoring) should thus be reviewed to identify the reasons for the lack of success at EU and Member State level.
25. Explicit responsibilities and goals for a targeted communication about the EC-CoC should be identified. Due to the interdisciplinary character of the EC-CoC, multi-agency collaborations are needed. Activities should be coordinated between EC and Member States government agencies.

A mapping exercise presenting a selection of the key issues ('hot topics') and the options identified to promote the adoption and the implementation of the CoC has been proposed in the MasterPlan (see report). They refer to the entire 'value chain' of the CoC and a number of possible path forward are shown, implying a different degree of complexity, as well as a different level of commitment (EU, national and individual stakeholders level). The directions chosen have to be closely related to what is the overarching role (vision) set for the EC-CoC (e.g. a reference document, a voluntary standard, the international Code on responsible innovation) and some of them rely, ultimately, on a political decision.

As the experience with the EC-CoC provided by some of the non EU countries (such as South Africa and Argentina) has shown, the EC-CoC could represent a tool to accompany and support emerging technologies since the beginning of their development. From a political point of view, the challenge is to define a widely accepted and acknowledged tool, aiming to foster (not hinder) innovation.

Summary of CodeMeter results

Within the NANOCODE project the CodeMeter is designed as a self-assessment and learning tool to support stakeholders engaging with the principles and values of the EC on responsible N&N (EU-CoC) on a voluntary basis. In principle, the CodeMeter could allow also the comparison of performances among stakeholders and over time, thus fostering a more profound and continuous engagement with the principles and values of the EC-CoC on responsible N&N research.

The CodeMeter tool wants to walk the user through the EC-CoC by using a more structured and comprehensive form of presentation. To this end the CodeMeter breaks down the EU-CoC's general principles and guidelines in form of questions with multiple option answers. Depending on responses given a scoring profile shows up at the end of the CodeMeter course so enabling the assessment of individual stakeholders' performance in relation to the EC-CoC principles and guidelines for action. Suggestions on how compliance with the EC-CoC could be improved are also provided for each of the CodeMeter question.

The NANOCODE surveys and intensive stakeholder consultations, has highlighted that the EC-CoC is perceived as too vague and general by many stakeholders that find it impractical. There is a strong need for supporting materials to assist stakeholders in interpreting and implementing the EC-CoC in their respective research environment. It was also criticised that, although stakeholders indicated awareness of the principles of the EC-CoC, there is no way to assess compliance or performance in relation to the EC-CoC. The CodeMeter offers a viable option to address these issues.

As said above, the CodeMeter has been thought as a tool for self-assessment, but its use could be wider. For examples, it could be integrated (if politically desired) in the procedure of research funding to serve as:

- a tool to evaluate submitted N&N research proposals with reference to their compliance with the EC-CoC;
- a tool for self-assessment for researchers planning to request funding for N&N research.

This use would, of course, make necessary a clear request by those organisations involved in research funding declaring the EC-CoC an official benchmark and the compliance with it be part of the evaluation of research proposals, as well as the setting of target levels of compliance.

The CodeMeter is structured as a 23 questions questionnaire, linked to 13 guidelines of the EC- CoC (the guidelines related to research performing organisations), a number of information and hints to assess / improve performances and a set of functions to visualise the score respect the EC-CoC principles. It has been designed to be clear and comprehensible, specific to the target group considered and with a limited number of yes / no questions to avoid long compilation timing.

The 23 questions have a score assigned to them. The scores of each question is then loaded in one (or several) of the EC-CoC principles, providing a total score for each principle. After a normalisation procedure, the final outcome of the CodeMeter is presented in the form of a spider net having the EC-CoC principles sitting on each axis. The spider-net chart visualises the level of performance against the principles of the EC-CoC.

During the filling-out of the CodeMeter questions the spider graph is permanently displayed and changes simultaneously with the answers given, so that the user learns how the given (or not given) answer affects the individual CodeMeter score along the dimensions of the spider net. In this way, the relation between the general principles, the guidelines on action to be taken and the individual behaviour becomes more transparent. For each questions the CodeMeter also provides:

- concrete hints on how to improve or about what should be done to achieve a better score in relation to a specific principle / guideline of the EC-CoC (automatically displayed in the tool);
- further information about the topics of the respective guideline as well as relevant information links (in a separated file.

The CodeMeter complements the MasterPlan, but since it is based on the current version of the EC-CoC it will need to be adapted to any eventual revision of it. However, methodology and structure proposed can likely remain unchanged and the CodeMeter developed can be considered a model / prototype to start with for a revised EC-CoC.

Potential impact:

A key strengths of the NANOCODE project has been the involvement of partners from 11 countries, in Europe and beyond. This wide spread has ensured that the project was able to collect input from and carry out surveys amongst a wide and representative range of stakeholder groups internationally, adding a great deal of value to the information obtained.

Besides the different consultation activities (survey, interviews, workshops) carried out for gathering inputs for the design of the MasterPlan and CodeMeter, several dissemination activities have been undertaken by the project.

The NANOCODE international conference gathered the interest of some 100 key experts coming from Europe, as well as outside Europe. Videos and presentations of the event made public on the website allowed a larger audience to follow the conference discussion and results.

The project culminated at the end of November 2011 with a series of national conferences or workshops , held in its member partner countries with the aim of disseminating the results of the project, as well as contributing, on a national basis, towards initiatives promoting responsible innovation. The conferences have been very effective to further stimulate the debate on the EC-CoC and responsible innovation within national representative of the research, industry, policy making and civil society.

A total of 43 events (conferences, workshops, seminars) organised by third parties organisations have been attended by project partners with presentation of project activities, dissemination via discussion, posters flyer, during the two years of project. Some 20 publications including contributions by project partners related to the project activities and results have been produced during the two years of project in different media, such as articles in Journals, Newsletters, conference proceedings and websites. The audience was both national and international and could be related to the following categories:

-Nanotechnology and science and technology stakeholders, including people from research, business, government bodies and other policy makers, civil society organisations, interested public . The number of attendees to the events varies between 30 up to 300 people.
- A detailed list of these publications and events is included below (and in the annex of the first year and second year annual reports to the EC).

In conclusion, the project supported, through a number of analysis, consultation and dissemination actions:

- increasing of knowledge about the CoC to the wide community of nanotechnology stakeholders, and emerging technologies in general;
- gathering of a number of precise inputs and recommendations for the further articulation, implementation and extension of the CoC, at national, EU level and international level;
- raising awareness on the CoC and toward responsible research and innovation of nanotechnologies, and emerging technologies in general.

It is envisaged that final outcomes of the project will be a rich resource for all parties involved in both nanotechnology research and in responsible innovation activities in general, and will provide a firm basis for ongoing initiatives and discussions on these topics.

List of websites: www.NANOCODE.eu project coordinator: Elvio Mantovani, mantovani@nanotec.it