Ethical Issues
GENERAL EUROPEAN GUIDELINES
According to Art.3 of the European Charter
of Fundamental Rights
1. Everyone has the right to respect for his or
her physical and mental integrity.
2. In the fields of medicine and biology,
the following must be respected in particular:
• the free and informed consent
of the person concerned, according to
the procedures laid down by law,
• the prohibition of eugenic practices,
in particular those aiming at the selection of persons,
• the prohibition on making the human body and
its parts as such a source of financial gain,
• the prohibition of the reproductive cloning of human beings.
Areas excluded from funding under FP 7
Art. 6 (2§):
A. Research activity aiming at human cloning for reproductive purposes.
B. Research activity intended to modify the genetic heritage of human beings which could make such changes heritable (Research related to cancer treatment of the gonads can be financed).
C. Research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.
Major changes from FP6 to FP7
• The Ethics Review will be carried out on the proposal submitted
• No additional information will be requested from the Consortium
• The Consortium is asked to submit drafts of Information Sheets and Consent Forms
• The Consortium does not need to submit copies of legislation
• Ethics review is automatic for proposals which include a research intervention on human beings, the use of human embryonic stem cells ( hESC ), or the use of non human primates
Main ethical issues:
I. Informed consent or voluntary participation.
Informed consent should be required in the following cases:
• when the research involves children or persons not able to give consent
• when the research involves human beings
• when the research uses human genetic material or biological samples
• when the research involves human data collection.
II. Data protection and privacy
The European 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 contains a number of key principles which must be complied with. Anyone processing personal data must comply with the eight enforceable principles of good practice. Data must be:
• fairly and lawfully processed
• processed for limited purposes
• adequate, relevant and not excessive
• accurate
• not kept longer than necessary
• processed in accordance with the data subject’s rights
• secure
• not transferred to countries without adequate protection.
III. Research on animals
The “three Rs” are guiding principles for the use of animals in research in many countries worldwide:
Reduction refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals,
replacement refers to the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aim,
refinement refers to methods that alleviate or minimise potential pain, suffering or distress, and enhance animal welfare for the animals still used.
IV. Dual use
Dual use is a term often used in politics and diplomacy to refer to technology which can be used for both peaceful and military aims, usually with regard to the proliferation of nuclear weapons. Regarding implications for the use and misuse of research and its products,
the following measures and strategies should be applied:
• the setting up of an advisory board to support research consortia in examining the societal, political and legal aspects of potential applications;
• the exploitation strategy of the study results should be reviewed by an advisory board;
• the dissemination and communication strategy of research results to a wider audience should be controlled by an advisory board (organisation of wider stakeholder discussions).
V. Research on human embryos
Dealing with research involving the use of hESC
Once the scientific evaluators confirm the necessity of using hESC in the research proposal, the Ethics Review panel:
• ascertains itself that the proposal does not include research activities which destroy embryos including for the procurement of stem cells;
• considers whether the consortium has taken into account the legislation, regulations, ethical rules and/or codes of conduct in place in the country(ies) where the research using hESC is to take place, including he procedures for obtaining informed consent;
• considers the source of the hESC;
• considers the measures taken to protect personal data, including genetic data, and privacy;
• considers the nature of financial inducements, if any.
VI. Research involving developing countries
Criteria to consider:
Does the research project provide benefits to the local community (in terms of access to
healthcare, education, allocation of property rights, capacity to access and use
modern technologies, whilst respecting the population’s own choices and needs, etc.)?
Does the research project use local resources (genetic resources, animal, and plants)?
IN THE CZECH REPUBLIC
All research activities must comply with Ethical principles for 7FP as well as Czech legislation and rules on ethics in research:
• in case the research activities are undertaken in another country the ethical principles and practise of that country must also be ensured;
• in case the research activity takes place in a country with weak regulation of ethical principles the ethical principles and practise of the Czech Republic will have to be followed.
In the Czech Republic there is no central law nor an ethical committee on the national level. Ethical committees exist only on the level of a research organisation and they control if all legislative requirements are in place as well as compliance with local, national and international standards in ethics are adhered to.
The Czech Republic has signed the European Convention on Human Rights and Biomedicine. Beside this there are several laws/public notes/etc. which regulate some research activities with respect to fundamental ethical principles. These are for example laws:
• on Research on hESC,
• on Protection of Personal Data,
• public notice on Medical Documentation,
• on Bacterial and Toxin Weapons,
• on Protection of Animals Against Torture,
• on Treatments of Genetically Modified Organisms and Product, etc.
Compliance with legislation of the Czech Republic and with the fundamental ethical principles is monitored by several institutions: ministries, specialised bureaus/offices/institutes, local ethical committees or local professional committees. Below is presented overview of the most important ethical committees and regulatory organisations in the Czech Republic :
• The Ministry of Education, Youth and Sports (control over research on hESC)
• The ministry is responsible for control over the research on hESC according to the Law on research on hESC and connected activities number 227/2006 Coll. The ministry is responsible for issuing, changing and cancelling permissions to perform research on hESC and to import hESC, keep register for hESC lines, registration of hESC lines and conduction a control of research organisation in order to ensure that there is no ongoing research on hESC which would be in contradiction to the Law 227/2006 Coll.
• The Ministry of the Environment (approval concerning genetic modifications)
• State institute for drug control (Informed consent and Use of biological samples and data)
• The Office for Personal Data Protection (Privacy and data protection)
• The office is responsible for: supervise observance of the legal obligations laid down for processing of personal data; maintain the register of notified data processing operations; deal with initiatives and complaints from citizens concerning breach of law and provide consultancy in personal data protection.
• Research on Animals - Relevant state institutions (issue approvals for the research activities if these are approved by the local professional committee)
• National institute of Nuclear Safety (Dual Use) - it controls for example use of high risk biological agents and toxins; it issues, changes and cancels permissions to use high risk biological agents and toxins in research; it keeps a record of all permission holders etc.
• Local ethical committees (for example Ethical committee of Faculty of Medicine of the Masaryk University)
• Local professional committees – must be established within an institutions which carries out research on animals according to the law n. 246/1992 Coll.
During the evaluation phase evaluators make a first check of ethical issues. In the end of the evaluation process all proposals which are recommended for funding must undergo an ethics screening.
• Proposals in the following areas of research: interventions on human beings, the use of human embryonic stem cells (hESC) and/or the use of nonhuman primates will be automatically referred to an Ethics review and will directly be sent for an Ethics Review to the European Commission/REA as required by the Guide for Applicants for COFUND projects. The proposals will be further processed (funded/rejected/modified) according to the decisions/recommendations of the Ethics Review carried out by EC/REA;
• In all other cases the Ethics review is done by an Ethical issues panel which consists of at least 3 ethical issue experts in the specific field of the Ethical issue(s) in question. Depending on the nature of the ethical issue(s) in question and number of projects needing Ethics Review more experts can be invited to the panel. The panel should reach a consensual conclusion. The conclusion of the panel is presented to the Steering Committee. The final decision power on compliance/noncompliance with required ethical principles lies within powers of the Steering Committee (with the exception of areas of research where the Ethics Review is carried out by EC/REA).
