Round-table discussion Session 4 Aime, Eugenijus and Asta NETWORKING OF THE BALTIC AND EUROPEAN RECs: THE NEEDS AND POSSIBILITIES Round-table discussion Session 4 Aime, Eugenijus and Asta

EUREC: a European Network of RECs EUREC - a network of national networks of RECs, open to representatives of national associations or bodies of RECs (The Conference on Research Ethics Committees in Europe “Facing the Future Together”, Brussels, 27/28 Jan 2005). The aim of EURECNET is to foster the EUREC as an infrastructural basis to promote awareness of specific working practices of RECs across Europe The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius Networking 2 interpretations of a “network”: Formal (legal entity, organised structure, association) Informal Dimensions of networking: - European: EUREC - Within the country (EST – 2 RECs, LT – 3 RECs, LV – 6 (8) RECs) - Wthin certain region (Baltic, Nordic-Baltic) The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

Needs and ways of collaboration identified by the Baltic-Nordic RECs Draft application to Nordforsk, 2005: - Development of an online research ethics training curriculum (EUREC) - Drafting the recommendations/guidelines on selected topics - Study visits - Consultations on controversial cases/questions/research protocols (e.g. consent for research on biomaterials, payment for research subjects) - Creation of the website (EUREC: http://www.eurecnet.org) The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

A short history of networking: common meetings (1) In collaboration with Nordic countries Norway-Baltic conference in Sigulda, 2002 Study visit to Norway, 2003 (Tromsø ) Meeting for drafting an application for Nordforsk, 2005 (Vilnius) In collaboration with international organisations In collaboration with CoE, 2004 (Vilnius) In collaboration with EC, 2006 (Riga) The 8th Global Forum on Bioethics in Research, 2007 (Vilnius) Patients rights in CEE (Open Society Fund), 2003, 2005 (Vilnius) The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

A short history of networking: common meetings (2) 2 meetings organised by and for the Baltic RECs themselves: Otepää, 2006 Riga, 2008 The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

A short history of networking: consultation on difficult cases Medical exposure (radiation) in research Research on deceased (consent) Advertising of clinical trials Publicity of information related to research Consent in research on minors Data protection in review of biomedical research (the role of State Data Protection authorities) The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

Is consultation on specific research protocols possible? Can RECs share information on specific protocols? If yes, what are the limitations, if any? How to learn that a protocol has been submitted to one of the Baltic RECs when the information is not available on the EudraCT? Are there any property rights problems when consulting on specific research protocols (e.g. identifying protocol title, name of an investigational product)? What could be the procedure (technical means)? The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

The problem of representation (1) EUREC(NET) More general (other institutions, networks, events) “For some countries it is still difficult to identify representatives of RECs that have a mandate to stand for their country within EUREC. Moreover, in some countries REC networks or associations do not exist at present so that there is no single body that can legitimately be part in EUREC for these countries”. “In some European countries RECs are not yet organised in any form of national network, association or working group. In order to meet the goal of linking REC from all European member states with EUREC it is necessary to support RECs in those countries to build up national networks or associations. This will, in return, strengthen the work of EUREC”. The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

The problem of representation (2) Models of representation: Formal: a body authorized by the law (e.g. NEC (Lithuania); representative delegated by the national association of RECs (e.g. France) Informal EUREC needs an “official” representative (i.e. meeting the criteria accepted at national level) The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius Capacity building to facilitate the development of national REC networks Objectives To identify countries in which no network of RECs exist so far To support members of RECs from those countries in establishing a national network To integrate new partners for EUREC To make known and provide existing training materials for the members of RECs To offer a platform for exchange experience on training materials The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

Capacity-building: 5 workshops (1) WS 1 (October, 2011) focusing on sharing of good practice with regard to national REC networking, discussing the existing forms of national REC networks, preparing the sketch of the Road-map WS 2 (March, 2012) inviting representatives from the countries without the REC networks introduction of possible models of REC representation (“good practice” of networking) The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

Capacity-building: 5 workshops (2) WS 3 (October, 2012) focusing on challenges of establishing the national REC networks in the countries joining the project WS 4 (April, 2013) summarizing the experiences drafting the advanced version of the Road-map for establishing national networks of RECs Final WS 5 (September, 2013) summarizing the results of integration of new partners testing the practical use of the newly established networks (using the networks on both national and international level to facilitate REC functioning, e.g., training, ethical review of multi-center clinical trials) The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius

Questions for discussion 1. What should be the role of a representative of RECs of the country in the EURECNET project? 2. What model of representation would be acceptable for each of the States? 3. How to build an efficient, sustainable and meaningful networking of REC within each of the Baltic States and among the Baltic States? 4. What are the most important reasons/needs for networking: consultation? training? common guidelines? The 3rd Baltic RECs meeting 13-14 May, 2011, Vilnius