Final Report Summary - EURECNET (European Research Ethics Committees’ Network) Executive Summary:EURECNET’s main goal is to build a strong network for national REC associations, networks or comparable initiatives. It also contributes to cooperations between RECs and other bodies relevant in the field of research involving human participants like National Ethics Councils and the European Commission’s ethical review system. Therefore EURECNET as a network of networks builds the infrastructure for European RECs and constantly promotes exchange and cooperation among RECs. EURECNET as a European organisation for RECs gathers information on national RECs in Europe and provides a vital platform of mutual exchange among REC members that supports their work and enables discussions on mutual problems and challenges.EURECNET fulfills two main objectives: (1) The consortium fills a gap of communication and representation of RECs in Europe and enables national REC members to discuss their concerns and challenges on a European level. The network enables an exchange across national borders and the EURECNET members are able to continue with a process of mutual learning.(2) EURECNET serves as a platform of exchange for its members and pursues the capacity building of the entire network and of the national REC systems located in the member states.As a strong network EURECNET provides the infrastructure for European RECs to encourage its members to be engaged in European debates and not only in national debates. To facilitate such a European exchange of knowledge and experience EURECNET gathers information on RECs in Europe and thus builds a basis for an extensive exchange. An important step in this field is to make training materials for REC members available and to provide them not only in local languages but also with respect to various national legal provisions.In the light of this process EURECNET has become an active part of the European REC discussion and can be seen much more as a long-term consortium than a (short-term) project. In fulfilling its central objective as a Coordinating Action EURECNET did develop the already existing network of European REC networks („EUREC“) into an essential group and has established a sustainable environment for REC Networks on the European level.Project Context and Objectives:The core objective of EURECNET was to further develop the already existing network of European REC networks (the antecedent project “EUREC”) and to establish EUREC as an association of RECs on the European level. As not all EU countries have a national REC network EURECNET supported the formation of such networks and encouraged its members to take part in vital discussions. EURECNET fostered the exchange among members about mutual problems and established new cooperative structures. The goals of EURECNET range from providing the necessary infrastructural basis to promote awareness of specific working practices of RECs across Europe. This is to enhance the shared knowledge about European RECs, to support coherent ethical reviews and opinions and to find tools to meet new challenges and emerging ethical issues.One of the first steps for the EURECNET project was to set up a well functioning secretariat and to develop a EUREC statute in order to officially register EUREC e.V. as an association. This highlights the importance of EURECNET within the EU, gives European RECs a supportive contact point and enables EU REC members to engage in discussions about mutual problems and challenges (such as the new EU regulation on clinical trials).Besides the general coordination of the network and further capacity building, one of EURECNET’s further objectives was to promote awareness of the specific working practices of RECs across Europe (i.e. procedures, tools, kind of members, schedules). To avoid legal difficulties it was important to develop a EUREC statute and register EUREC as an association. As this, EUREC e.V. has become a vital and visible consortium on the EU level and the national REC networks in Europe can now speak with one voice by operating a consistent contact point for their own members, for the European Commission and other relevant associations.EURECNET’s main objectives were:- Fostering a sustainable infrastructure for European RECs (including a statute/ constitution and a secretariat) to promote exchange and cooperation and to allow for international cooperation- Gathering information on RECs in Europe to build a basis for mutual exchange;- Making training materials for REC members accessible to enhance the quality of review- Conducting capacity building to facilitate the development of national REC networks (as future partners of EUREC);- Identifying areas of current significant ethical and legal difficulties to develop common understandings and identifying emerging ethical issues to stimulate the development of common solutions for challenges posed by new technologies and scientific methodologies by competent bodies.These five main objectives were delegated into five work packages. Work package 1 was concerned with the general management of the project as well as hosting an information portal and setting up a secretariat.The antecedent project “European Network of Research Ethics Committees” (EUREC) was organized and funded as EC project under FP6 (Specific Support Action). Therefore, the primal objective of the new project EURECNET was to continue and expand EUREC with new partners and to strengthen the links between European RECs by setting up an effective and sustainable infrastructure.The sustainability of the network was instantiated by setting-up a permanent secretariat and by formulating a statute to legally register EUREC e.V. as an association (together with WP 2). Apart from taking care of the network’s infrastructure WP 1 also handled the publishing of several electronic and printed Newsletters. These newsletters served as an effective tool to make the network and its work more public and to inform all members about current ethical or legal challenges.Besides the development of a EUREC statute WP 2 also helped in building a vital network infrastructure by supporting national REC representatives to strengthen their self-organization. For example, Poland and Spain did not have any national association of RECs at the beginning of EURECNET (with WP 4). EURECNET encouraged the Spanish and Polish RECs to proceed and establish a national association in their countries. Spanish REC members established the “Asociación Nacional de Comités de Ética de la Investigación” and in Poland the “Polish Association of the members and workers of the RECs” was founded. Both associations have been formally constituted in their countries in 2013. Besides that, WP 2 was also concerned with the acquisition of new network members and national REC-organizations in Europe. Since some of these organizations (e.g. CMEC (Latvia), SIFO (Italy) and NMEC (Slovenia)) could not be admitted into the EURECNET project as formal partners due to legal reasons, they were integrated as “invited experts” to various workshops and meetings organized by WP 2.These workshops were carried out to organize EUREC as a European platform as well as to exchange different experiences in reviewing research protocols and emerging ethical and legal challenges.Work package 3 was primarily concerned with the updating and dissemination of relevant information on RECs in Europe and maintaining the EURECNET-website. For a vital exchange and discussion between the network’s members, it was necessary to gather information from RECs across Europe specifically on their general structure and working procedures. National RECs have proven to be organized quite differently around Europe, however, they are all faced with comparable ethical challenges and often with similar legal difficulties. It was very important to get an overview on the national legal and ethical similarities and differences of RECs in Europe. With this overview, the network’s members have a basis for the discussion of current and emerging issues. An enormous challenge that concerned not only WP 3 but ultimately all WPs was the European Commission’s draft of the “New Regulation on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC” (No. 536/2014) and later on its adoption in April 2014.The new EU regulation on clinical trials will fundamentally change the way (national) RECs work in Europe: how they work on a local, national and EU-level basis, their general structure and working procedures (e.g. working with a new EU portal and database and make decisions under a tighter timescale). With this new regulation some national REC associations will have to entirely change their way of working and find new solutions to fit into this new framework. The detailed information provided by WP 3 will help many national REC associations to develop a new working procedure that will meet the new regulation’s requirements. EURECNET started cooperation with the Competent Authorities that are concerned with the regulation.Work package 4 was engaged in the capacity building for the network. This work was done by identifying and supporting new network members and by providing a wide range of training materials for members of RECs. One of the first steps was to identify countries in which no network of RECs existed (e.g. Spain and Poland). The project partners involved in WP 4 got in contact with members of (local) RECs form those countries and encouraged them to establish a national network (see above). WP 4 identified new partners for EUREC in order to have a legitimate representation of REC members on the European level.Besides acquiring new EUREC members WP 4 also provided a wide range of training materials for REC members in various languages. EURECNET closely collaborated with the TRREE project (“Training and Resources in Research Ethics Evaluation”) for these training materials. TRREE is an on-line training program on the ethics and regulation of health research involving human participants. Prof. Dominique Sprumont, Coordinator of TRREE and EURECNET project partner (IDS – Université Neuchâtel, Switzerland) would gurantee the synergy between EURECNET and TRREE. At this time, TRREE offers six e-learning modules (web-based learning programs with certification) and many national supplements for European (and African) countries. In these national supplements local experts explain requirements in their particular country. One of the big achievements for EURECNET was to offer various translations of these materials. In addition to the TRREE training materials, EURECNET also published an extensive overview of available national and international training materials for REC members on the project website (www.eurecnet.org).WP 5 was concerned with emerging scientific issues that have ethical and legal implications and are challenging the ethical review process of RECs in Europe. Besides many differences in working structure and decision-making, the challenges that RECs are faced with are quite similar. New technologies and scientific methodologies (e.g. nanotechnology and biobanking) raise ethical questions for which existing structures and guidelines are inadequate or do not exist at all. Therefore, one of the important objectives of WP 5 was to identify experts that may support networks of RECs to find adequate answers and strategies for emerging scientific issues that may challenge the work of RECs in the future.These experts were invited to conferences organized by WP 5 on current topics and debates that concern the work of RECs (e.g. on whole genome sequencing, on research in neurosciences and the ethical review system of the EC) and in order to stimulate the development of coherent practices to deal with emerging ethical issues in the future.Finally, WP 5 fostered the mutual exchange between REC networks on an international level. For example, EURECNET exchanged information and compared working procedures with the Partners of EULABOR (Latin-American) and the Chinese/Taiwanese representative Prof. Fan Chien-Te (Director of the Bioethics and Law Center, National Tsing Hua University, Taiwan).Project Results:EURECNET as a network of European REC associations and similar networks was established for two main reasons:For one, a network of RECs needs to pay close attention to the general protection of research subjects. Here are different challenges to be met: On the one hand, ethical research guidelines are not consistent all over Europe, since every country has developed their own national research guidelines in respect to their history, culture etc. Besides these national peculiarities research projects in the field of biomedicine are often carried out as multi-center studies that involve several institutions from more than one European or international country. These multi-center projects expose the significant cultural differences even more. The local, regional or national review systems do not have a reliable practice to meet those challenges. A more or less consistent point of view and coherent reviews across Europe seem to be advisable. Additionally research subjects in Europe have to be able to trust in consistent protection of their interests. However, coherent opinions and reviews can only be reached by a constant exchange of specific working practices and the shared knowledge of European RECs.Secondly, before the project started there was only an inadequate developed networking and cooperation of national RECs on the European level, e.g. to enable consistent reviews and to meet new challenges and emerging ethical issues. Even the antecedent project EUREC did not use all its potentials for networking. The EURECNET project effectively filled in this gap and not only established an infrastructure for a vital network, but acquired more members and made EUREC a sustainable network. As a sustainable network EUREC/EURECNET is able to develop and implement standards in ethical evaluation of research protocols and to stimulate REC related policies on the European level (e.g. in the debate and drafting on the new EU regulation on clinical trials). On the long run the vital network of EUREC could be the fundament of VHPs or SOPs of RECs that could be developed in a process of mutual learning in the future.The initiatives that made EUREC a sustainable and well recognized network were versatile. One of the first steps was the initiative to bring together a representative amount of national REC representative on the European level in addition to the project partners. By doing this EURECNET was able to gather an adequate quantity of members. National REC associations are effectively represented on a European level.However, at the beginning of EURECNET not all countries with possible project partners or network members had an official national REC association. In many European countries RECs were not organized on a central (i.e. national) level.It has been the major item by the original EC Call (Topic SiS-2009-1.1.2.2 Networking and capacity-building activities to support ethics committees) to support “Networking and capacity building activities between ethics committees across Europe” by involving actively ethics advisory and/or review bodies. This means that EURECNET needed to include the representatives of the national associations of RECs as beneficiaries in the project to establish the required network. At best one beneficiary per Member State ('appropriate comparative perspective and the largest possible European coverage in relation to the proposed action' p. 25/26).Therefore, EURECNET strived to include as many national REC representatives as possible. In countries with no official REC network EURECNET encourage national REC members to establish such a network and become EUREC members (two examples of good practice are Poland and Spain).EURECNET handled the requirements of new national networks effectively and has made some great progress in the capacity building of the networks. Finally, EURECNET was able to prevent further administrative difficulties that might have arisen due to the special nature of the project.On the EU level as well as in many member states there was no official registration of RECs or a REC network established, therefore, the legal situation was unclear and some problems (as to who is in charge and allowed to make decisions) arose in the process of the project. This challenge was known from the beginning of the project and the EURECNET Board along with its project partners and members tried to find reasonable solutions for these problems. Of course, EURECNET is not in the position to solve legal problems of the representation of RECs in EU Member States. But EUREC e.V. (as representation of European RECs) organized itself as a legally registered association and encouraged Member States to improve the formal organization of national associations of RECs. The EUREC representation has been legally implemented in 2012 (by the Work Packages 1 and 2) as activity of EURECNET. In particular this registration of EUREC e.V. as association has made an important impact: For the first time RECs have a representation on the European level.EUREC used the opportunity to become very actively involved in the scientific and political debate on the “New Regulation No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”. This activity will continue in the process of the implementation of the Regulation and the establishment of the European Portal for clinical trials. The draft and later adoption of the new regulation was an unforeseeable event at the beginning of the project and gave EURECNET the opportunity to work as strong network and to speak with one voice for all European RECs associations.In the first versions of this new regulation, Research Ethics Committees did not have an active or significant part in the research review procedure. There was no schedule as to how and when RECs should be involved in the review process. Therefore, EURECNET recognized that a new system could risk the safety standards of clinical trials when the role of RECs is being marginalized like it has been formulated in the draft of the new Regulation.EURECNET took the initiative to remedy this and got actively involved in the development and discussion of the new regulation. EURECNET published two statements and position papers on the EC’s proposal for a Regulation on Clinical Trials. The first one was formulated at the EUREC meeting in Oslo in September 2012 und was published shortly after. In this statement EUREC criticized the proposal’s direction of omitting the clear position of RECs in the review process and the unrealistic time scales that were given. Other driving concerns of the network were the different ethical standards applied by Member States. In the first draft of the new regulation Member States were given a wide discretion in constituting their national assessment processes. It would have been possible for a sponsor to choose which Member State to nominate as the reporting Member State. Therefore, it would have been very easy for a sponsor to choose a Member State with weak assessment regimes. This could run the risk of exaggerating the different standards in Member States. Another concern of EUREC was that there was no clear explanation of the Assessment Process in the first draft. On the other hand, EUREC welcomed the inclusion of informed consent in a Part 2 Assessment, however, the EUREC members were of the mind that the regulation should include the full range of ethical principles that were included in the antecedent Directive (2001/20/EC). By doing this the EC could continue to give a compulsory list of items that need to be addressed in the course of the ethical review process. Finally, EUREC offered to contribute actively to the development of this new regulation.After the first EUREC statement and other meetings and discussions the EC published a revised draft for a new regulation on clinical trials. EUREC welcomed this new draft. Many of the proposed changes were taken into account. For example, one of EUREC’s biggest concerns was that the new regulation would omit the clear position of RECs in the review process. In the revised draft there was significant progress made to reintroduce RECs in the assessment of clinical trials applications. In addition, there were some overall amendments proposed by the European Parliament that EUREC fully supported. In detail, the revised draft aimed at:- Strengthening the safety standards for vulnerable persons,- Forbidding sponsors to choose the reporting member state,- Making the results of all trials publicly available,- Encouraging cooperation between ethics committees and the sharing of best practices on ethical issues including the procedures and principles of ethical assessment (facilitated by the Commission).Nonetheless, EUREC still saw a critical need for further strengthening of independent ethical evaluation in the governance of clinical trials before the regulation will come into force. Some of the remaining concerns were that RECs still were not included as independent bodies but only as “consultation bodies in the authorization process”, that the timescales were still very short and the appropriate legal protection of persons involved in research in emergency clinical situations.The statements were published on the EURECNET website (www.eurecnet.org/news) and in the EURECNET Newsletters. Besides publishing statements to the new regulation, EURECNET also encouraged all of its members to contribute to discussions on a national and European level and participate in periodic EMA (European Medical Association) meetings where the new regulation was further discussed. EUREC was able to work as an association and to establish a well-defined position the light of the new regulation.The new regulation was adopted on April 16th, 2014 and became effective on June 16th, 2014. However, it will apply no earlier than May 28th, 2016. This will give EUREC and the national REC networks sufficient time to adjust their working procedures and (in some cases) their organizational structure to the new requirements. For example, RECs will have to be able to come to a decision in short timescales. This is a major challenge for some countries and their current RECs organization since most or all of their members are working in an honorary capacity.In the course of the project phase EUREC has become a sustainable network and will be able to counsel and support the national REC networks in matters of the new regulation and its challenges for the day-to-day work of RECs.Besides building a powerful and representative network, EUREC made some great progress in giving a clear overview of REC associations in Europe and in offering several training materials. The project management was able to use the official project website (http://www.eurecnet.org/) as a tool to inform all European REC members (and others interested) about the general structure of national REC associations or national bodies of RECs, their networking on a national level as well as the legislative framework regarding RECs on a national and European level. The Eurecnet.org website has become a ‘clearing house’ of information and gives an extensive overview of relevant information on RECs in Europe.One of EURECNET’s aims was to establish EUREC as a sustainable network. In addition to acquiring new members, this also meant to have well-informed members which are up-to-date about current research methods and emerging legal and ethical difficulties.EURECNET made several efforts to meet this aim. One was to publish an extensive overview of training materials and methods on the project website. EURECNET did not only make known already existing training materials, but also took care of several translations of training materials in a collaboration with TRREE (Training and Resources in Research Ethics Evaluation: http://elearning.trree.org/).Another effort to stay well-informed about current debates and emerging challenges for REC members could be achieved by the conferences and workshops organized by EURECNET.EURECNET hosted five major conferences during the course of the project. The first EURECNET Conference took place in Bratislava (Slovak Republic) and focused on the “Challenges of multicenter studies in Europe”. Multicenter studies have different challenges for REC members, sponsors and competent authorities. In order to get a good overview of the different challenges and perspectives, EURECNET invited experts to talk about the legal and ethical challenges of multicenter studies in Europe. Another item at the conference was the different perspectives of RECs, of authorities and of the European Commission on multicenter studies in Europe. There were talks and discussions with representatives of all three organizations. The second Conference (September 6-7, 2012) was about “Whole Genome Sequencing”. To get a particularly wide overview “Scientific, ethical and legal challenges for review by Research Ethics Committees” were considered. The Conference was divided into the following three parts:- Part 1: Whole genome sequencing: Overview and perspectives- Part 2: Clinical Genetic Research- Part 3: Biobank Research and EpidemiologyAnother EURECNET Conference (June 20-21, 2013) focused on “Research in Neuroscience: Scientific, ethical and legal challenges for review by Research Ethics Committees” and took place in Lisbon, Portugal.After three very successful scientific conferences, the fourth project conference dealt with “The Future of EURECNET”. It was certain at the beginning of the project, that EURECNET would be a special project and unlike many other EC funded projects. The main aim was to establish a sustainable network of European RECs. Apart from capacity building this also implies that the network will continue with its work and mission once the EURECNET project has reached its formal end. Besides some legal difficulties EUREC also had to look for alternative ways of funding. The network can only keep going when its members are in a constant exchange with each other and are able to come together for meetings and conferences.Conference 5 as a project roundup focused on “Ethics and the regulation of biomedical research” and in particular on the challenges and perspectives for the future of RECs in Europe.At many of the project conferences and meetings EURECNET closely collaborated with IMAGEN and IMAGEMEND. IMAGEN is a European research project on the risk taking behavior in teenagers and works with genetic testing. IMAGEMEND is a study with focus on development of effective imaging tools for diagnosis, monitoring and management of mental disorders. Both studies were faced with an extensive number of incidental findings in their research subjects. In the general definition Incidental findings are findings which are unrelated to the research area and have a significant meaning or the research subject’s health.Incidental findings are a relatively new challenge in imaging and genetic research, therefore, no clear guidelines as to how to handle them exist so far. EURECNET discussed this problem at several meetings and invited representatives of aforementioned studies for practical insights (amonst others: Prof. Dr. Marcella Rietschel, Central Institute of Mental Health Mannheim, Germany).Furthermore EUREC cooperated with the SATORI project on ethical assessment and the ethics groups of the Human Brain Project (HBP). It has been planned to organize a mutual meeting of EUREC and representatives of the HBP in spring 2015.Potential Impact:EUREC is now the essential and central body for RECs on the European level. It is recognized as a strong network and official representation of European RECs by the European Commission as well as by national REC networks and other relevant organizations.EUREC used its potential as a European Network to engage in the discussions about the “New EU Regulation on Clinical Trials”. This opportunity and task was unforeseeable at the beginning of the project. EUREC had to revise its work accordingly and published official statements on various drafts of the new regulation.EURECNET has successfully established “EUREC” as this central European network. Besides acquiring new members EUREC was also able to take a position to various questions on the working structures of RECs and to the new regulation. EUREC will outlive the funded project phase and will continue its work after the termination of the project.The next main objective for EUREC will be the expert monitoring of the implementation of the new regulation. Many national RECs will have to entirely change their way of working and EUREC will be a helpful and supportive partner in this transition phase. As the new regulation will apply no earlier than May 28th, 2016, EUREC and its members will have ample time to look into new challenges and prepare recommendations for REC networks and members. Besides the changes for national REC networks the new regulation requires also the creation of a EU portal and EU database for clinical trials. The functionality of the new EU portal and EU database is mandatory for the application of the Regulation. The European Medicines Agency (EMA) will prepare the functional specifications for the portal and database in collaboration with Member States and the European Commission. EUREC contributes to the preparation of this draft and actively encourages its members to do the same. It is of vital importance that the new EU portal and database are designed user-friendly and with future users in mind. As the official representation of European RECs,EUREC plays an important role in the creation of the portal and database in order to ensure its functionality for the day-to-day work of European RECs.During its meeting in Paris on November 3, 2014, and after diligent deliberation, EUREC requests that the EMA strongly recommend that Member States ensure that RECs have the necessary full and direct access to the application and data-base (including downloads) through the EU portal, from the time the application for a clinical trial is submitted. The necessary access could be achieved via the existing portal functionalities. The request has been jointly formulated by the EUREC members and has been provided for use by all European RECs involved in the national consultations and the consultations with EMA.Furthermore, EUREC will continue to host meetings and conferences on emerging scientific issues and will keep the network’s website up-to-date as it has proven to be a useful information tool for REC members.List of Websites:www.eurecnet.orglanzerath@eurecnet.org (PD Dr. Dirk Lanzerath, Coordinator)gueth@eurecnet.org (Dorothee Güth, Assistant Coordinator)heinrichs@eurecnet.org (PD Dr. Bert Heinrichs, Scientific Advisor)
