Where science & ethics meet. The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe and Beyond

Transcription

1 Where science & ethics meet The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe and Beyond Question 21 What training programmes are available for REC members in the country? Austria Hungary Romania Belgium Iceland Russia Bulgaria Ireland Serbia Croatia Italy Slovakia Cyprus Latvia Slovenia Czech Republic Lithuania Spain Denmark Luxemburg Sweden Estonia Malta Switzerland Finland Netherlands Turkey France Norway United Kingdom Germany Poland Greece Portugal

2 Austria There are some institutions such as the Vienna School of Clinical Research, an international Vienna based institution where a special international 4 days course in English language for Ethics in Medical Research has been held regularly twice a year since There are also other institutions which provide specific courses and seminars on this subject, e.g. the yearly course Ethik in der Medizin of the Academy of the Province Lower Austria (Niederösterreichische Landesakademie) is a special two-day educational course for members of Austrian Ethics Committees. The Ethics Committee of the Medical University of Vienna offers an electronic training program for members. Belgium There are none. Bulgaria Training courses in GCP organized by the Association for Good Clinical Practice and Research Development and the Bulgarian Association for Clinical Research. Croatia There is no regular, formal training programme specified in the regulation, both for the Central EC and ECs at institutions. Cyprus Through the network of cooperation with other national bioethics committees and also with other bioethical organisations that the Cyprus National Bioethics Committee has established, its secretariat receives information about new seminars and conferences around the world. Based on the subjects to be examined in each seminar/conference, members of the Cyprus National Bioethics Committees and/or of the Review Bioethics Committees may attend such seminars / conferences. Additionally, the Cyprus National Bioethics Committee organises in-house training courses for its members and for the members of the Review Bioethics Committees. Czech Republic The Forum of Ethics Committees organises meetings twice a year and there is a 4 day Summer School of Medical Ethics. Competent authority (SÚKL) organises regular seminars for members of ethics committees. Question 21-2

3 Denmark The Danish National Committee on Biomedical Research Ethics has established a 1 day educational programme for new members. Estonia Relatively few: there is a two-day seminar each year with both medical research EC members and some rare possibilities to attend international conferences. Finland The hospital districts and the national committee (TUKIJA) organise training. National seminars are held twice yearly (one by (TUKIJA) and one by one of the university hospital region ethics committees). The national committee also issues instructions and recommendations in ethical issues related to research. France There is a national conference of the CPP s which gives training during an annual meeting and workshops. Germany In addition to the above mentioned seminars the Permanent Working Party of German Research Ethics Committees organises twice a year a workshop to discuss difficult ethical issues and to exchange experiences. In addition, it is helpful and possible for REC members to participate at seminar/workshops for investigators and sponsors, initiated by universities and institutes. Greece None. Hungary University-organised courses on GCP. Iceland None specifically for EC members, an Applied Bioethics program is taught at the University of Iceland. Question 21-3

4 Ireland There are none. However, the Irish Council for Bioethics booklet entitled Operational Procedures for Research Ethics Committees: Guidance 2004 is generally available. Italy At the moment, no formal training programme has been defined, but many courses, seminars and meetings are organized both by governmental and private institutions. Latvia Only on GCP and on local legislation. Lithuania National and international discussions, seminars and conferences on research ethics organised by different institutions (e.g. Universities, LBEC, etc.) several times a year might be considered as the main training activities for EC members. Luxemburg Every year, a day of training is organised by the CNER and other partner institutions about clinical research, the ethical aspects of research and the standard procedures in biomedical research. Malta None. Netherlands Some University Hospitals (i.e., the VUmc Amsterdam) are organising training courses for committee members and their staff. The CCMO supports these initiatives by providing speakers and cases for workshops in which a research file is being discussed. Norway There are programs developed and available at the University of Oslo and at the University of Bergen. Poland There is no formal training programme specified in the Regulations, but course are organised by the GCP Society and by the Bioethics Committees themselves. The Question 21-4

5 Bioethics Center of the Polish Medical Council will start training courses for members from June During the next 2 years it is expected that all members of Polish bioethics committees will be offered training. All interested persons may attend post graduate studies: 1. Conducting and monitoring clinical trials Kozminski University Warsaw, rowadzenie_i_monitorowanie_bada/. 2. Metodology of clinical trials Medical University of Warsaw, Private companies organise many payable trainings or seminars dealing with these topics. They are prepared for monitors, workers from pharmaceutical companies, researchers. Members of RECs may attend these courses or seminars as well. Portugal Academic training on clinical ethics, bioethics, pharmacology and epidemiology is available in the Universities of Lisbon, Oporto and Coimbra. Yet to be developed is an annual training programme for CEIC members. However, before each plenary, training sessions are provided to the Committee members (these training sessions are publicly available at CEIC website). Romania There are no training programmes for REC members in Romania. Russia There are the courses in the main Universities. Thirty working days for review documents, decision making and approval (not depending on the number of sites). Serbia GCP courses organised by the ACRP, by the Serbian Health Care Organisation and by individual sponsors. Slovakia The ministerial guidelines pending should provide backing for an introductory and continuous education of EC members. At present, a state-accredited study program in clinical investigation and Good Clinical Practice is hosted at the Institute of Pharmacology and Clinical Pharmacology of the Slovak Medical University (SMU) in Bratislava. After passing the program, and Question 21-5

6 subsequent state board exam, a state certificate is awarded. The web page of SMU is There are also postgraduate courses in bioethics organized by the Institute of Medical Ethics and Bioethics n.f. (IMEB). Since 2007, a continuous education program for ECs members and users, developed by IMEB, is published in the journal Medical Ethics & Bioethics and on the IMEB s web page Since 2002, annual meetings of ECs in Slovakia are organised by the Ethics Committee of the Ministry of Health, usually in collaboration with IMEB. Slovenia None. Spain Nowadays training programmes are not standardized. Currently, the CC-CEIC and the Health Authorities responsible for the CEICs accreditation are working together to improve the situation. Sweden Regional Boards for Research Ethics Review have a budget including this. There are also annual meetings when all Regional Boards for Research Ethics Review meet and discuss new regulations and difficult cases. Switzerland These are the responsibility of AGEC. Besides the regular courses a web-based selftraining programme is in preparation. Turkey Some of the pharmaceutical companies organize ICH-GCP trainings for investigators and EC members. On the other hand, starting from mid 2009 the MoH also conducts ICH-GCP training programmes for ECs. United Kingdom Training is a key priority for NRES and is fundamental to the delivery of the business plan. The Health Research Authority delivers a comprehensive training programme to NRES and the wider research community. This includes training events for new and existing REC members and staff, NRES staff and those carrying out research. The training is held at both regional and national level. The programme includes induction training, training for Chairs and workshops addressing particular ethical issues and Question 21-6

7 types of research (including a training day on CTIMPs). April EFGCP aisbl all rights reserved Question 21-7