Bioethics Committee

Code of Conduct

Application for Research Approval

Ethical Guidelines

Publications

Useful Links

Events

News

BIOETHICS COMMITTEE

PRESIDENT:

Nancy Papalexandri, Emeritus Professor of Human Resource Management, Department of Marketing and Communication, Athens University of Economics and Business

VICE PRESIDENT:

Dr. Aristidis Charonis, Physician - Scientific Collaborator, Center for Clinical, Experimental Surgery & Translation Research, BRFAA

REGULAR MEMBERS:

Dr. Michael Karatsiolis, member of the Legal Advisory to the State

Dr. Nikolaos G. Kostomitsopoulos, Staff Research Scientist – Professor Level, Head of the Laboratory Animal Facility, BRFAA

Dr. Olga Tzortzatou, Lawyer, BRFAA

ADDITIONAL-SUBSTITUTE MEMBERS:

Dr. George Vassilopoulos, Professor, School of Health Sciences, University of Thessaly

Dr. Konstantinos Samitas, Physician, Sotiria Hospital

Dr. Sofia Chatziioannou, Associate Professor, University of Athens Medical School

BRFAA CODE OF CONDUCT

Article 1
Scope

The present Code is applied in all research and development activities which are conducted under the responsibility or with the participation of the scientific personnel of the Biomedical Research Foundation of the Academy of Athens (BRFAA), either within or outside its premises, with or without funding.

Article 2
Principles of Bioethics

Scientists conducting biomedical research should be informed about the principles of Bioethics and the specific requirements of ethics governing their field.
The BRFAA has the obligation to educate the researchers in the most expedient manner.

Any research in this field presupposes the approval of its protocol by the Bioethics Board of the BRFAA.

Article 3
Basic research principles

Research in Biology, Medicine and Biotechnology should be conducted with absolute respect to the scientific truth and the value of all human beings and natural environment. During research, any discrimination against citizens on grounds of nationality, race, ethnic origin, language, gender, personal life, religion, physical fitness or socioeconomic status should be avoided.

Article 4
Value of research and independence of the researcher

Research is both a social and individual commodity. As a social commodity, research promotes human knowledge and innovation, contributing to the improvement of life quality and the social well-being. As an individual commodity, the process of research is inextricably associated with the freedom of researchers and in that sense also constitutes an individual commodity, which is constitutionally safeguarded. Researchers should take all necessary measures to protect research from any external political, ideological or other pressures and interventions.

Article 5
Responsibility of the researcher

The researchers are restricted by the generally recognized principles of protection of human rights, of equality, of the protection of public health, of the protection of the child and vulnerable groups, as well as the protection of biodiversity. The researchers should ensure that the general public is properly informed.

Article 6
Principal investigator

The principal investigator of the research should

1. comply with the provisions of current legislation, the fundamental ethical principles, the rules of professional ethics, as well as the present Research Code of Bioethics, and
2. ensure the compliance of his partners with the aforementioned rules during the conduction of research.

The principal investigator should under no circumstances use the research findings and/or conclusions for self-promotion or to present findings and/or conclusions of the research as his /her own work.

Any partial outsourcing of the research or any auxiliary research activities assigned to third parties shall be conducted under the responsibility and the supervision of the principal investigator of the study.

In case there is more than one researcher responsible for the study, each responsible researcher should also comply with all requirements of the present Code.

Article 7
Obligations of partners

Research partners should exercise their research activity with the main objective of the expansion of scientific knowledge in the interests of society, in compliance with the legal provisions that govern research and the codes of ethics of the profession, including the current Code.

During the conduction of research, partners have the freedom of thought and expression of their opinion; they should, however, respect the limitations in this freedom, which are imposed for the organization and the guidance of research activity by the principal investigator of the study. The severe violation of the provisions of the present Code might result in researcher substitution.

Article 8
Compliance with safety rules

The researchers should apply all recognized safety rules in the corresponding scientific field, as well as all rules that are specifically defined for the protection of humans, animals and the environment. In case that the compliance with safety rules is dependent upon an issue related to infrastructure / equipment, the researchers should inform the personnel in charge, so that the necessary measures will be immediately taken.

Article 9
Research in human biologic material

Researchers conducting research in human biologic material are restricted by the principles of informed consent of the donor, and the protection of sensitive personal data that are collected and subjected to processing.

Article 10
Embryo research

Embryo research is conducted solely to the extent strictly allowed by the law. Researchers are restricted by the principles of informed consent of gamete donors, and the protection of sensitive personal data that are collected and subjected to processing.

Article 11
Laboratory animal research

Laboratory animal research should always be conducted in compliance with the principle of 3Rs (Reduction, Refinement, Replacement), so as to ensure the reduction of the number of animals used, the improvement of laboratory techniques and the living conditions of animals, so that they experience the lowest degree of pain or discomfort. The possibility of partial or complete substitution of laboratory animals by other media (in vitro or in silico) or other lower organisms, who have less developed nervous system and experience pain to a lower degree, such as plants, microorganisms and metazoan, should also be explored.

 
Article 12
Clinical Studies

The researchers should comply with the principles governing clinical studies, including human behavioral studies, as detailed in relevant legislative ethics texts.

Principles of general application which should be carefully taken into consideration include, among others, those of informed consent, the protection of children and vulnerable groups, as well as the protection of personal data that are collected and processed.

Article 13
Results of research

The design and the conduction of a research project should follow the rules of scientific evidence / documentation. The investigator and the research group in which he/she works are obliged to provide access to the BRFAA to all results derived from a particular research programme. The investigator should keep a complete archive of the progress and the results of a project, so that it will be possible to check the archive, while concomitantly safeguarding intellectual property rights. The arbitrary generation or falsification of research findings is a serious offence and shall be punished. The appropriation of results derived from the research effort of other researcher(s) of the same or different research unit should be also controlled and punished in accordance with the principles of protection of intellectual property rights.

Article 14
Dissemination of knowledge

The BRFAA guarantees the dissemination of knowledge produced in the context of its activities to the international scientific community.

The BRFAA ensures the contribution of its researchers to the dissemination of knowledge to the public by any appropriate means and in a comprehensible and responsible manner.

Article 15
Respect of intellectual property

During the conduction of their research, the researchers should take into account and by no means violate intellectual property rights of third parties.

The BRFAA, through its competent legal services, shall safeguard the intellectual property rights of the Foundation, as well as the protection of relevant rights of researchers with respect to results of studies conducted in the context of the activities of researchers within the Foundation.

Article 16
Bioethics Board

The Bioethics Board, which is a consultative / advisory body of the BRFAA, is appointed by the Board of Trustees of the Foundation, and its responsibilities are as follows:

1. The preparation of a Research Code of Bioethics, as well as its amendments.
2. The evaluation of research proposals of the investigators of the BRFAA.
3. The organization of seminars and discussions concerning research bioethics with the aim of educating researchers about developments in relevant issues both at a local and international level.

Decisions of Bioethics Board are taken by an absolute majority of members who are present after making every possible effort to achieve unanimity.

The Bioethics Board may invite researchers to submit any document considered to be essential or to request the physical presence of researchers for clarifications / elucidations.

APPLICATION FOR RESEARCH APPROVAL

Complete this checklist before you start your research study.
Send the electronically completed and  signed form to bioethics@bioacademy.gr, BRFAA Legal Office

ETHICAL GUIDELINES

1 Oviedo Convention

Biomedical Research Protocol

Cloning Protocol

Genetics Tests Protocol

Transplantation Protocol

PUBLICATIONS

Ethical, legal and Social Implications in Research Biobanking: A checklist for Navigating Complexity, Olga Tzortzatou-Nanopoulou et al., Developing World Bioethics (under publication)

https://www.researchgate.net/publication/357270114_Mapping_European_RECs_ethics_review_processes_for_biobank-based_research

https://www.researchgate.net/publication/357270133_Glossary_Mapping_European_Research_Ethics_Committees_ethics_review_processes_for_biobank-based_research

https://www.researchgate.net/publication/356996638_Biobanking_and_risk_assessment_a_comprehensive_typology_of_risks_for_an_adaptive_risk_governance

https://link.springer.com/article/10.1057/s41292-023-00299-7

https://edpl.lexxion.eu/article/EDPL/2018/3/8

https://pubmed.ncbi.nlm.nih.gov/36269885/

https://pubmed.ncbi.nlm.nih.gov/34903285/

https://lsspjournal.biomedcentral.com/articles/10.1186/s40504-021-00117-7

https://www.sciencedirect.com/science/article/pii/S1044579X21002947

https://link.springer.com/book/10.1007/978-3-030-49388-2

https://www.mdpi.com/2072-6694/13/3/493

https://www.ocelotos.gr/επιστημεσ-men-gr/1887-παιδί-και-πληροφορία

https://papazissi.gr/product/vioithikoi-problimatismoi-iv/

https://www.sakkoulas.gr/en/editions/authors/olga-g-tzortzatou/

http://www.bioacademy.gr/news-details/XsaNtDXU/video-biobanking-ethical-legal-issues-conference

Open Access

https://zenodo.org/record/3928410#.ZBH45C81u8U

https://zenodo.org/record/3928389#.ZBH5Ey81u8U

https://zenodo.org/record/4066659#.ZBH5VS81u8U

https://zenodo.org/record/4580480#.ZBH5lC81u8U

https://zenodo.org/record/3928385#.ZBH7ay81u8U

USEFUL LINKS

UNESCO Bioethics

WHO Bioethics

The European Group on Ethics in Science and New Technologies

Council of Europe Bioethics

Data Protection

EVENTS

Workshop, "Biobanking: Ethical & legal Issues"

The Workshop on Ethical & Legal Issues Concerning Biobanking took place on Tuesday, June 20 2017 at the Biomedical Research Foundation of the Academy of Athens.

The workshop aimed to increase awareness on ethical & legal issues that immerge within the context of biomedical research.  Experts representing key institutions across Europe & Greece analyzed the changes that the new General Data Protection Regulation (GDPR) will bring to biomedical research.  Key insights concerning the various ways that certain EU countries plan to implement the GDPR in their respective legislations were explored.

The workshop was open to all. Researchers, bioethicists, lawyers, students, as well as members of the general public who wished to get informed on ethical & legal issues concerning biobanking attended.

Ημερίδα, "Ηθική Προβληματισμοί στην Βιοϊατρική Έρευνα"

Την Τετάρτη 21 Ιουνίου 2017, πραγματοποιήθηκε με επιτυχία, Ημερίδα με θέμα, «Ηθικοί Προβληματισμοί στην Βιοϊατρική Έρευνα», η οποία διοργανώθηκε από το Ίδρυμα Ιατροβιολογικών Ερευνών της Ακαδημίας Αθηνών.

Ο Γενικός Γραμματέας της Ακαδημίας Αθηνών κ. Βασίλειος Πετράκος απηύθυνε χαιρετισμό εκ μέρους του Προέδρου της Ακαδημίας Αθηνών κ. Λουκά Παπαδήμου και ακολούθως απηύθυνε δικό του χαιρετισμό. Ο Πρόεδρος της Βιοηθικής Επιτροπής του ΙΙΒΕΑΑ, Καθηγητής-Ακαδημαϊκός κύριος Μιχάλης Σταθόπουλος απηύθυνε χαιρετισμό εκ μέρους του Προέδρου του ΙΙΒΕΑΑ Καθηγητή-Ακαδημαϊκού κ. Γρηγορίου Σκαλκέα και συνέχισε με δικό του χαιρετισμό. Ακολούθησαν ομιλίες από Ακαδημαϊκούς και εκλεκτούς επιστήμονες.

NEWS

Διεπιστημονικό Συνέδριο «Ιατρική Ευθύνη και Βιοηθική V 2018 - Δεδομένα Υγείας και Γενετικά Δεδομένα»

Παρασκευή 19 Ιανουαρίου 2018,
Aίθουσα 'Ευρώπη', Νομική Βιβλιοθήκη, Μαυρομιχάλη 23
 
Το Ιόνιο Πανεπιστήμιο, Eργαστήριο Τεχνολογιών της Πληροφορίας της Σχολής Επιστήμης της Πληροφορίας και Πληροφορικής, το Εργαστήριο Εφαρμοσμένης Φιλοσοφίας του ΕΚΠΑ, το Ερευνητικό Κέντρο Έρευνας σε Θέματα Βιοηθικής και Δικαίου του Παντείου Πανεπιστημίου, το Κέντρο Βιοπολιτικής του Παντείου Πανεπιστημίου, η Ένωση για την Προστασία της Ιδιωτικότητας και των Προσωπικών Δεδομένων και η Ένωση Ε-themis διοργανώνουν το 5ο Συνέδριο Ιατρικής Ευθύνης και Βιοηθικής-Δεδομένα Υγείας και Γενετικά Δεδομένα. Το Συνέδριο θα διεξαχθεί στη Νομική Βιβλιοθήκη, Μαυρομιχάλη 23, αίθουσα ‘Ευρώπη’, Παρασκευή 19 Ιανουαρίου 2018.