Template of Code of Research Ethics for Biological Sciences CHAPTER ONE GENERAL PRINCIPLES Article 1 Responsibilities of the Researcher Research activities within the scope of biological, medical and biotechnological sciences must be carried out with utmost respect for human dignity and for the environment. Researchers are bound by the generally accepted principles for the protection of human rights, equality, protection of public health, protection of children and vulnerable people and for the protection of biodiversity1. Researchers should strive for making new knowledge accurately available to the general public. Article 2 Responsibilities of Research Institutions Research Institutions of biological sciences, i.e. Universities, Institutes and other public or private independent bodies performing scientific rese arch, take on considerable responsibilities towards society. They are responsible for protecting the independence of individual researchers, for auditing the accuracy of the results of scientific research performed and for ensuring the observance of good research practice guidelines as specified in the present Code. 1 These principles are described by various conventions and declarations as well as national legislation among which the Constitution of Greece, the European Convention on Human Rights, the United Nations “Convention on the Rights of the Child”, the UN Convention on Biological Diversity (Rio de Janeiro), the Carthagena Protocol on Biosafety, the Oviedo Convention on Human Rights and Biomedicine of the Council of Europe, its additional Protocols on Biomedical Research and on Reproductive Cloning, the Convention of the Council of Europe and EU Directive 95/46/EC “on the protection of individuals with regard to the processing of personal data and on the free movement of such data”, the UNESCO Declarations on Bioethics and Human Rights, on the Human Genome and Human Rights and on Human Genetic Data, the Helsinki Declaration on clinical and biomedical research, the EU Directive 86/609 on the protection of animals used for experimental purposes, greek laws 3418/2005 on the Code of Medical Ethics, 3089/2002 and 3305/2005 in Medically Assisted Reproduction etc. CHAPTER TWO INDEPENDENCE OF THE RESEARCHER Article 3 General Rule Researchers should enjoy their constitutional right to freedom of research. They must take all necessary measures to protect their independence from any political, ideological or other external intervention. Article 4 Funding Researchers should be aware of and publicize the sponsors of their research. When accepting funding for their research it is unacceptable to concede to any conditions that compromise their freedom in designing, performing or publicizing their research. CHAPTER THREE INTEGRITY OF THE RESEARCHER Article 5 Results of Scientific Research The design and the execution of a scientific project must observe the rules of scientific methodology. The researcher, the research team and the institution have the obligation to allow access to all the results obtained from a specific project. The selective publication of results that confirm the original hypothesis leads to misleading conclusions, may have adverse effects for science and possibly for society and, thus, should be discouraged. The fabrication or falsification of results are severe offences and should be punishable. The appropriation of results from the work of other individual(s) of the same or other team is also disapproved of and punishable action. Article 6 Observance of Health and Safety Regulations The researcher should strictly comply with all the health and safety regulations of the Research Institution. Article 7 Record Keeping The researcher should keep accurate records of the results obtained from a research project, in order to ensure the possibility to verify them, while the researcher’s intellectual property rights should be protected. CHAPTER FOUR RELATIONSHIPS BETWEEN RESEARCHERS Article 8 Respect- Equality Researchers should respect and treat each other equally. The personality of junior researchers should be respected and their abilities should be fairly judged. In turn they should respect their seniors and acknowledge their experience. Article 9 Cooperation – Mentoring Experienced researchers have the obligation to transmit to their juniors the methodology and ethos of research aiming at the advancement of Science. Article 10 Recognition of Personal Contribution The contribution of each researcher in team work should be recognized. It is the researcher’s right that his/her contribution is explicitly accredited in scientific publications or in any public presentation of the scientific project he/she took part in. All members of the team are responsible to ensure fair acknowledgement of each other’s contribution but the main responsibility lies with the project leader. CHAPTER FIVE COMPLIANCE WITH ETHICS IN SPECIFIC RESEARCH AREAS Article 11 General Rule Those conducting research in biological sciences should be aware of the ethical principles and the specific ethical issues that are relevant for their research area. The Research Institution is obliged to educate its researchers with every available means. Every research project in this field requires prior approval of the protocol from the Ethics Committee of the Research Institution. Article 12 Clinical Trials Researchers conducting clinical trials, including projects studying human behaviour, should observe the ethical principles of the field as they are acknowledged in relevant legislation and international guidelines2. Principles of outmost importance are those that concern informed consent of volunteers, protection of minors and vulnerable individuals or communities and the protection of sensitive personal data that might be collected and processed. Article 13 Research on Human Biological Samples Those conducting research on human biological samples should particularly observe the requirements for informed consent of the donors and protection of sensitive personal data. The donors should also be informed on policies regarding possible financial gains from patents. In this case additional consent should be obtained. Article 14 Research on the Human Embryo Research on the embryo should be conducted within the limits of the Law. Researchers are obliged to observe in particular the principles of informed consent of the donors of the gametes and of sensitive personal data protection. Article 15 Animal Research Research on animals should be carried out only when there is no available alternative for substitution, the number of animals used is limited to the minimum necessary to obtain meaningful data and researchers actively seek to minimize animal suffering. If euthanasia of animals is necessary it should be done painlessly. Living conditions of laboratory animals should mirror as much as possible the natural living conditions of the species.3 2 E.g. National Legislation (Greek legislation: acts 2619/1988, 3418/2005), EU Directive 2001/20 for clinical trials, Oviedo Convention for Human Rights in Biomedical Research, Helsinki Declaration, the CIOMS International Ethical Guidelines For Biomedical Research Involving Human Subjects et.c. CHAPTER SIX GROUP LEADER Article 16 Obligations for Information and Supervision Group Leaders, in addition to their obligations as researchers, they are responsible for informing their team members about their rights and responsibilities and regarding the regulations of the Research Institution, including the ethical regulations. Furthermore, they must ensure that all the above regulations are observed. Article 17 Work Environment The Group Leaders must ensure that the work environment is productive. They are required to resolve any problems or conflicts that arise in the work relations among the members of their team. CHAPTER SEVENTH OBLIGATIONS OF THE RESEARCH INSTITUTION Article 18 Ethics Regulations Every Research Institution undertakes to adopt specific research ethics regulations relevant to its activities and has also to ensure that these regulations are observed. Article 19 Ethics Committee Every Research Institution must establish an Ethics Committee and fully support its function. The composition of the Committee should be interdisciplinary. Representatives of the general public should participate and, depending on the field of research carried out, individuals not employed by the Research Institution can be appointed as members. 3 Animal experimentation in Greece is regulated by the Presidential Decree 160/1991 that ratifies EU Directive 86/609. Article 20 Independence and Transparency The Research Institution must guarantee the independence of the researchers, as defined in Chapter Two. It is also responsible for ensuring transparency in the financial resources and in particular with regards to the conditions for acceptance of public or private funding. Article 21 Labour Rights In order to guarantee the independence and integrity of the researchers, the Research Institution must protect their labour rights. The unveiling by an individual of actions that violate the ethics regulations or good research practice or of attempts to cover up such violations should not adversely affect their employment or future progress. Article 22 Health and Safety- Insurance Every Research Institution should establish safety regulations for the protection of its employees, the protection of public health and of the environment. The Research Institution is also responsible for the training of its employees on health and safety regulations. It also must ensure that all its employees are insured. Article 23 Advancement of the Employees The Research Institution should encourage and provide the means for the continuous education of its employees, including training on research ethics and keeping up to date with international scientific developments. Article 24 Intellectual Property Rights The Research Institution via its competent legal services has to protect not only its own intellectual property rights, but also the intellectual property rights of the individual researchers that result from the achievements of research projects carried out within the scope of their employment. Article 25 Dissemination of Scientific Knowledge The Research Institution should seek the dissemination of knowledge produced within the institution to the international scientific community. Along with individual researchers’ efforts, Research Institutions must also seek to transmit scientific knowledge to the general public by any appropriate means, in an accurate and comprehensible form.