How does the ethical review process work in Greece and which are the designated ethics committees?
The first REC in Greece was established in 1965 at the Institute of Child Health and legislation was passed in 1973. The Legislative Decree 97/1973 concerned approval of clinical drug research and was followed in 1978 by a Ministerial Circular (A2/oik3061/5.6.1978) which imposed the establishment of RECs at a local level.
A National Council of Medical Ethics & Deontology was established in the early 90s (Law 2071/1992) whose main objectives included participation in the forming of policy of the Ministry of Health & Welfare, handing down opinions on medical ethics, consultation to settle disagreements in RECs and the establishment of a Centre of Medical Ethics.
A National Bioethics Commission was established by Law 2667/1998 which investigates ethical implications and provides recommendations on policy.
There is a National Committee of Deontology of Clinical Trials which is responsible for final approval of research projects. The ministerial decision providing for the by-laws regarding this committee was enacted on May 1st, 2004.
The actual REC system in Greece consists of:
- The National Ethics Committee of the National Organization for Medicines. This Committee was established in accordance with Directive 2001/20/EC regarding laws and regulations relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use and the requirement to issue a single opinion. Other types of biomedical research projects are reviewed in the respective local RECs of the institutions (hospital, research centre or higher education institution) in which the biomedical research project is planned to be conducted, as follows:
- local RECs in hospitals (in some hospitals RECs are not established and scientific councils established by the Act 2889/2001 have the responsibilities of RECs).
- local RECs in research centres (e.g. the Foundation for Research and Technology – FORTH, the Biomedical Research Foundation of the Academy of Athens – BRFAA – and other Research Institutes).
- local RECs in higher education institutions (e.g. Medical Faculties etc.)