GREECE

Legislation

• Act 2071/1992 (NHS) establishment of National Council of Medical Ethics and Deontology
• Data Protection Act 2472/1997
• Act 2667/1998 : National Bioethics Commission
• Act 2619/1998: ratification of the Oviedo Convention
• Ministerial Decision DYG3/89292/31.12.2003 (incorporating Directive 2001/20/EE into domestic law)
• Act 3418/2005 Code of Medical Ethics and Deontology

Research Ethics Committees

Short description of RECs system

Biological Research in Greece is taking place mainly in Higher Educational Institutions, Research Institutes and Hospitals. Additionally it is carried out in pharmaceutical and biotechnology companies, According to data from the General Secretariat of Research and Technology (2005), 64% of science and technology research staff are employed in government agencies or universities. The biggest provider of funds for public research in Greece is the state. (Opinion on research ethics in the biological sciences, national Bioethics Commission (2008).

According to the Greek Constitution (Article 16) "Art and science, research and teaching shall be free and their development and promotion shall be an obligation of the State. Academic freedom and freedom of teaching shall not exempt anyone from his duty of allegiance to the Constitution..". Moreover, Law 3653/2008 on Research and Technology (Article 1) stipulates that "the development and promotion of scientific research, technology and innovation, as fields of vital national interest, shall be an obligation of the State which provides for the necessary resources…". The independence of research is thus, considered as a common good to be promoted and safeguarded. Most efforts in Greece, however, are directed towards financial and administrative support of research, but they lack behind as far as the specification of ethical rules of conduct are concerned. As a consequence, the National Bioethics Commission, has repeatedly emphasized that transparency, education in research ethics, publications of cases of unethical research and creation of Codes of Practice must become a priority.

The role of the National Bioethics Commission is important regarding research ethics in Greece, although the Committee does not evaluate research protocols. The Committee was established under the Act 2667/1998. According to this Act, “the Commission shall constitute an advisory organ of the State and its mission shall be to oversee continuously matters related to the possible applications of biological sciences and to explore their ethical, social and legal impact”. The Commission shall in particular: 1) investigate the ethical, social and legal aspects that arise from scientific advances in biology, biotechnology, medicine and genetics; 2) outline, in collaboration with the respective ministries, proposals of general policy and provides specific recommendations on related issues; 3) collaborate with international organizations and related bodies and represents Greece to international fora, and 4) inform the public on issues related to biotechnological advances and the impact of their applications promoting public awareness and dialogue. The National Bioethics Commission issues various opinions and reports related with the research issues (e.g. A Guide for Research Ethics Committees for Biological Research (2008), Report on research ethics in the biological sciences (2008), Opinion on conflict of interest in biomedical research (2011).

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.)

Networking between RECs

According to an important provision (Act 2667/1998 Article 11, Terms of reference), the National Bioethics Commission shall orientate and coordinate related governmental advisory bodies in the field of bioethics and more particularly those bodies attached to the Ministries of Environment, Development and Health. However, this competence has not been developed. Nevertheless, networking would be very important for Greece, as relevant initiatives do exist, but they lack central coordination. Networking may prove especially helpful as far as the general impact in the scientific community and the potential for increasing existing or for creating new research groups, are concerned.