European Research Infrastructure Bio-Banking and Biomolecular Resources. SC Telephone Conference call August 25 th, 2010 at 9:00-10:00 Draft Minutes

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1 European Research Infrastructure Bio-Banking and Biomolecular Resources SC Telephone Conference call August 25 th, 2010 at 9:00-10:00 Draft Minutes Members present:, Georges Dagher (GD), Martin Fransson (MF), Michael Griffith (MG), Ulf Landegren (UL), Jan-Eric Litton, (JEL), Michaela Theresia Mayrhofer (MTM, secretary), Andres Metspalu (AM), Derick Mitchell (DM), Gert-Jan van Ommen (GJvO), Marcus Perola (MP), Jeanette Ridder-Numan (JR), Heli Salminen (HS, secretary), Eero Vuorio (EV, chair), Erich Wichmann (EW), Kurt Zatloukal (KZ) Agenda: 1. EP Hearing (October 26 th ) 2. BBMRI: Biobanking for Science Conference a. Status Report b. Prototype Meeting (September 22 nd ) c. SC Meeting 3. ERIC application 4. New applications for membership (EoIs) 5. other EV agreed to chair the meeting and welcomed all participants. Ad 1. EP hearing KZ informed the SC on details of the hearing at the European Parliament on October 26 th. (see Annex I: preliminary agenda). The aim of the meeting is to raise awareness for the necessity of a political support process for Research Infrastructures (RIs). The hearing is hosted by Dr Paul Rübig MEP, Chairman of STOA and member of the ITRE Committee at the European Parliament in Brussels. The hearing will be moderated by Clive Cookson, science editor of the Financial Times. The hearing will be attended by MEPs and senior officials from the European Parliament, the Council Secretariat and the Commission, as well as interested parties from the Member States, the industry and academia. Three examples of health-related research infrastructures will be presented during the hearing, namely BBMRI (Biobanking and Biomolecular Resources), ERINHA (High Security Laboratories) and ECRIN (Clinical Research). A dialogue amongst policy-makers will follow. 1

2 The hearing will be followed by a working lunch with MEPs and representatives from the industry. The afternoon will see three parallel sessions dealing with intellectual property, scientific research and health. A major scope of this hearing is to present how these infrastructures contribute to key health-related European strategic priorities, such as targeted measures to improve health care in eastern European countries, health challenges in ageing population, international standards for sample pre-analytics for biomarkers, an infrastructure for rapid evidence-based decision making for new epidemics, preventive measures against bioterrorism. Because of the global dimension of these issues policy support is needed in order to increase Europe s competitiveness in an internationally coordinated manner. The formal agenda and the invitation, including the registration requirements, will be issued by mid September, David Cox has contacted Francis Collins and Harold Vamus as potential speakers. A preparatory meeting will take place on August 27 th in Brussels, when Jean-Emmanuel Faure, EV, KZ, GD, ECRIN and ERINHA will meet Robert-Jan Smits and members of the cabinet of Commissioner Maire Geoghegan-Quinn. A first announcement shall be circulated within the coming days. Ad 2 BBMRI Biobanking for Science Conference Status: 150 people have registered for the conference. Registration is still open until September 3 rd and we expect about 200 participants. The invitation to the conference has been circulated through the BBMRI newsletter, website, BBMRI.NL, and ESF. Additionally, Jane Kaye shall be asked to circulate the announcement for the conference through her mailing list. Sponsoring: MTM informed the SC members that about 70 potential industry sponsors have been contacted. Thereof, Modul Bio, Thermofisher and Promega showed interest in sponsoring the event with 4500 each. SC members promised to assist in seeking further sponsors. Posters & abstracts: HS informed the SC that of the 25 abstracts received 6 are proposed for a short presentation. The deadline for submission of abstracts is still open until September 3 rd. Several SC members informed HS that their research groups will present further abstracts. WP 2 and WP3 meeting: EW reminded that a WP2 and WP3 meeting is organized to take place on September 22 nd before the BBMRI: Biobanking for Science Conference. A joint dinner will be organized. SC-meeting: EV recalled that the SC-Meeting is intended to wrap-up the deliverables of each WP in a 5 minutes presentation. Ad 3 ERIC application, statutes, business plan A final version of the statutes shall be circulated shortly. The business plan still needs to incorporate IT contribution and a more detailed description of access and ethical review. 2

3 KZ informed the SC that Norway committed 10 Mio and the Czech Republic 4,8 Mio for BBMRI/national biobanking activities. Ad 4 new applicants The Clinica Chirurgia II Tumour Tissue Biobank of the University of Padova was accepted as a new AO. The application of Karlsruhe Institute of Technology (European Zebrafish Resource Center) will be further discussed within WP4. All other applications will be discussed during the SC meeting in Amsterdam (September 23 rd ). Ad 5 other Partner Charta (Annex II): KZ has circulated a draft Partner Charta on common principles for BBMRI-ERIC partners. It was agreed that comments on the Partner Charta shall be provided via e- mail. The TC closed at 10:05 3

4 Annex I Annex II The European Research Infrastructure for Bio Banking and Biomolecular Resources Partner Charta (Draft version KZ ) The BBMRI ERIC Partner Charta should define the most important cornerstones for the participation of national biobanks or biological resource centres (Partners) in BBMRI ERIC to foster scientific excellence, guarantee interoperability, and compliance with ethical and legal requirements. The implementation of the Partner Charta should be binding for any Member State of the BBMRI ERIC and has to be agreed between national BBMRI ERIC nodes and the Partners. Participation of a Partner in BBMRI ERIC is non exclusive and has no effect on any activity of a Partner outside of BBMRI ERIC. Principles Primacy BBMRI ERIC acknowledges the primacy of national and European legislation and respect the jurisdiction of competent authorities. Access policy Samples need to be accessible through a clear access procedure compliant with the general access procedures of BBMRI ERIC. BBMRI ERIC will foster the establishment of scientific collaborations between 4

5 sample or data users and Partners whenever feasible. Special access policies can be established for industrial users. Access to samples and data will honour commitments to donors and follow the principles of fair access and scientific excellence. Access in the context of research projects performed within BBMRI ERIC will only be provided for specified research projects and after approval by a Research Ethics Committee (REC). Partners can decide whether access will be granted for a specific project. This decision, however, has to follow transparent decision making procedures. Data management and protection policy BBMRI ERIC and Partners will not disclose any information related to an individual sample donor on the internet website. Information or samples related to individual donors will only be made accessible to authenticated scientific users in a coded or anonymized fashion and upon approval of specific research projects by a competent Research Ethics Committee (REC) in compliance with national and EU legislation. Partners support integration of their data management system with that of BBMRI ERIC (J E Litton, please specify). No access will be provided for non scientific purposes (such as forensic, insurance or employment purposes), except pursuant to a court order. Informed consent BBMRI ERIC and Partners will, at any time, honour commitments owed to donors. Partners shall aim at prospectively implementing the OECD Guidelines for Human Biobanks and Genetic Research Databases for issues related to informed consent, as appropriate and subject to the primacy of national and EU legislation. Infrastructure and management Partners have to commit themselves for future implementation of the OECD best practice guidelines for Global Biological Resource centres Networks. These guidelines define in particular requirements concerning the following issues: Infrastructure (building, facility) Management (responsibilities and qualifications) Traceability Biosecurity Data protection Minimal and recommended datasets Quality management and certification Quality management All Partners should commit themselves to implement quality management /assurance procedures compliant with OECD best practice guidelines for Global Biological Resource Centres Networks. SOPs should be established and made publicly available for all processes related to sample collection, processing, storage and retrieval. It is recommended that SOPs should follow the procedures as specified in the WHO/IARC guidelines for biological resource centres for cancer research whenever feasible. A unique BBMRI biobank (collection) identifier should be provided (see Kauffman, F & Cambon Thomsen, A. Tracing biological collections: Between books and clinical trials. JAMA 2008, 299: ). Criteria for the identifier will be provided by BBMRI ERIC. Partners should allow external audits by BBMRI ERIC. Reporting Partners have to provide annual reports to the Director General of BBMRI ERIC on which research projects have been supported and what was the outcome (e.g., publications, patents). 5