FORTH Ethics Committee

 

Τhe FORTH Ethics Committee (FEC), created in 2005, is an advisory and auxiliary instrument of the research personnel of FORTH and is appointed by the Board of Directors of FORTH ('FORTH BoD').

Its mission is:

  • To consider research proposals submitted by the research personnel of FORTH for ethical review and ensure they are compliant with the provisions of applicable national and EU legislation as well as the standards of good research practice. Such ethical review shall take place should an entity, funding the particular research proposal, require a protocol of ethical review to be issued by FEC.
  • To inform the research personnel of FORTH on statutory developments regarding ethical issues.
  • To carry out any other action or provide consultancy on ethical issues in response to such request addressed by FORTH BoD.

More specifically, the research proposals that may require ethical review by FEC may involve research activities that raise any of the following issues:

  • Protection of medical and genetic data of persons, as regulated by Law 2619/1998 and Law 2472/1997, protective of all personal data, especially sensitive data, such as medical and genetic data, as well as the Declaration of UNESCO on human genetic data. Issues of protection of other sensitive personal data such as political, religious or philosophical convictions, national origin, health, etc.
  • Clinical studies on pharmaceuticals, regulated by Ministerial Decision (MD) AOA/89292 of 2003 and the EC Directive 2005/28.
  • Human Embryonic Stem Cell ISSCR Guidelines (version I, December 21, 2006)
  • Protection of experimental animals, as provided for by Presidential Decree (PD) 160/1991, that harmonizes national legislation with the EC Directive 1986/609, and Law 2015/2001, incorporating in the national legislation the European Council’ s Convention on vertebrate animals used for research and other scientific purposes.
  • Biodiversity, i.e. biotechnology applications for the creation of Genetically Modified Organisms (GMOs). Relevant issues are regulated by the UN Convention that has been incorporated into national legislation through laws 2204/1994 and regulation 1946/2003, as well as relevant EU regulations. Such issues are also regulated by the EC Directive 2001/18 on the deliberate release into the environment of GMOs, as incorporated into national legislation through MD 38639/ 20017 of 2005 as well as the MD ΗΠ/11648/1943 of 2002 that incorporates into national legislation the EC Directive 98/81, regarding the limited use of GMOs.

Τhe current members of FEC (appointed by the FORTH BoD on 22 November, 2014) are the following:

  • Ν.Tavernarakis, IMBB (Coordinator)
  • G. Garinis, IMBB
  • A. Karantanas, ICS
  • D. Kardasis, IMBB
  • K. Kourouniotis, IMBB
  • K. Marias, ICS
  • K. Tsakona, FORTH Legal Service
  • T. Fotsis, IMBB-BS

Function of the committee - Procedure for ethical review of research proposals

  • Research proposals or technical annexes that require ethical review/approval by FEC are electronically submitted to the committee (to Mrs. Maria papadaki mariapap@iacm.forth.gr, tel. 2810-391800). The submitted proposals must include all related documents, i.e. the documents for approval of the experimental or research protocols to be signed by FEC as well as all supporting documentation. In the case of research on animals, a copy of the license issued by the Veterinarian Authority of the responsible Municipality concerning the space where experimental animals are kept must be included, as well as a license for the realization of the proposed research, based on PD 160/91. The proposals must be submitted by the 1st day of each month. FEC will meet within the first fortnight of every month following receipt of such documents in order to review the particular proposals if so deemed necessary.
  • Research proposals submitted to FEC are assigned to a reviewer, who is a member of the committee with the most relevant expertise and who shall then report back to the committee. Should there be any remarks on behalf of the reviewer, they are to be addressed to the researcher concerned within 7 working days. The researcher must reply within 5 working days and only once, following which, the FEC shall decide whether it shall approve or reject the proposal concerned, taking into account the reviewer’ s remarks and the researcher's reply. If no remarks are made by the reviewer, the FEC’s decision shall be issued taking into consideration the reviewer's report.
  • In order to avoid a conflict of interest, any member of the committee participating in the concerned proposal shall refrain from the entire ethical review procedure and process.