Greece - RECs and Medical Research

History

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 new National Committee of Deontology of Clinical Trials which will shortly be responsible for final approval of research projects. The ministerial decision providing for the by-laws regarding this committee was enacted on May 1st, 2004.

Summary of Greek RECs

Type of REC	National Committe of Deontology of Clinical Trials	Regional	Local
Where situated?	National Organisation for Medicines (EOF)	Governing Board of Regional health service	Hospital/Clinic
Who applies to them?	Regional RECs	Researchers, after approval locally	researchers
Formal/Informal	Formal	Formal	Formal
National/Regional	National	Regional	Local
Laws Involved	DYC3/89292 1973/31.12.2003	A2/oik3061/5.6.1978 A6/10983/1/12.12/1984 Law 2071/1992 Law 2519/1997 Data protection: 2472/1992	A2/oik3061/5.6.1978 A6/10983/1/12.12/1984 Law 2071/1992 Law 2519/1997 Data protection: 2472/1992
Guidance Involved	Declaration of Helsinki Oviedo Convention for the protection of human rights & dignity of the human being	Declaration of Helsinki Oviedo Convention for the protection of human rights & dignity of the human being	Declaration of Helsinki Oviedo Convention for the protection of human rights & dignity of the human being
Membership requirements	6 members, including a lawyer, a theologian, a scientist & health science professionals	-	5 members
Responsible/accountable to whom?	Ministry of Health	-	-
Approval or Advisory powers	Approval	Advisory, although approval is necessary	Advisory, although approval is necessary

Not submitting research or failing to follow review

Ethical approval is necessary for the research to go ahead and also for publication.

Which body, if not the REC itself takes this action, and how do they proceed?

Impact of Directive 2001/20 EC

This directive has been incorporated into Greek Law through Ministerial Decision DYC3/89292 and State Journal B' 1973/31.12.2003. For the first time a control mechanism of the ‘ethical appropriateness’ of a clinical trial is established through the 'National Committee of Deontology of Clinical Trials'. It is vested with decisive powers in deciding whether to permit research projects to go ahead.

Legal action that can be taken against RECs

Any person whose legal interest can be affected by a decision of an REC can bring an action against that committee. The courts would carry out an evaluation of harm.

Links section

Greek law
Ministry of Health & Welfare (in English & Greek)
National Bioethics Commission (in English & Greek)
National Organisation for Medicines (in English & Greek)
Garanis-Papadatos, T. and Dalla Vorgia, P. ‘Clinical trials in Greece: ethical review proceedings’ (2000) 7 European Journal of Health Law 441–447.

See the REC bibliography section for more links and papers