Ethics in research demand that scientific practice be performed according to ethical principles that ensure the advancement of knowledge, understanding and improvement of the human condition and the progress of society. Interest is focused on consideration of the ethical aspects of research, its nature and purposes (respect for human dignity, free-will, protection of data - privacy, confidentiality -, animal welfare and preservation of the environment).
Given the growing importance of ethical implications of scientific endeavour, as well as the diverse legislation in this area, the Ethics Committee plays a fundamental role, contributing to ensuring that research undertaken by the scientific community is carried out in accordance with current regulations, fully respecting bioethical principles, commitments and requirements and conforming to biosafety in general.
Scope of action: Bioethics and biosafety
Bioethics is a branch of ethics that establishes a set of principles, which when applied optimize human behaviour, from different perspectives, in the field of Life Sciences - namely, human actions affecting human, animal and plant life (human interaction with living beings). In the field of biosafety, particular importance is placed on the adoption of measures and the application of standards to preserve the safety of living beings and the environment from certain factors that could alter them, such as genetically modified organisms and hazardous biological agents.
With respect to scientific practices at the CSIC, four areas of action are defined within the framework of bioethics and biosafety:
- Research involving human subjects, human samples and / or data from human populations requiring protection
- Animal research
- Research involving genetically modified organisms (GMOs)
- Research with biological agents that pose a risk to humans, animals, plants and the environment
Ethical evaluation of the CSIC research
- The CSIC Ethics Committee has issued institutional guidelines regarding applications for the ethical evaluation of research at the CSIC, which are available on the institutional intranet.
Applicable regulations. Documents of interest
RESEARCH INVOLVING HUMAN BEINGS
- Law 14/2007, 3 July, on Biomedical Research
- Law 41/2002, 14 November, basic regulation on patient autonomy, and rights and obligations in terms of information and clinical documentation
- Royal Decree 1716/2011, 18 November, establishing the basic requirements for the authorisation and operation of biobanks for biomedical research, and for the treatment of biological samples of human origin, also regulating the organization and operation of the National Register of Biobanks for biomedical research (+ Orden ECC/1404/2013 – modificación)
- Royal Decree 1090/2015, 4 December, regulating clinical trials with medicines, Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies
- Royal Decree 65/2006, 30 January, establishing requirements for the import and export of biological samples (+Order SAS /3166/2009 – amendment annexes)
- Law 30/1979, 27 October, on organ extraction and transplantation
https://www.boe.es/buscar/doc.php?id=BOE-A-1979-26445
http://noticias.juridicas.com/base_datos/Admin/l30-1979.html
- Law 14/2006, 26 May, on assisted reproduction techniques in humans
- Royal Decree 120/2003, 31 January, which establishes the requirements to perform controlled experiments for reproductive purposes, fertilization of previously frozen oocytes or ovarian tissue, related to assisted human reproduction techniques
- WMA Declaration of Helsinki of the World Medical Association. Ethical principles for medical research involving human subjects (1964)
- Belmont Report. Ethical principles and guidelines for the protection of human subjects in research (1978)
- • Oviedo Convention or Convention on Human Rights and Biomedicine or Council of Europe Convention for the protection of human rights and dignity of the human being with regard to the applications of biology and medicine (1997 – ratified by Spain on 23 July 1999)
https://www.boe.es/boe/dias/1999/10/20/pdfs/A36825-36830.pdf (Instrumento ratificación)
- UNESCO Universal Declaration on the human genome and human rights (1997)
http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html
RESEARCH INVOLVING ANIMALS
- Royal Decree 53/2013, 1 February, establishing the basic legislation applicable to the protection of animals used for experimentation and for other scientific purposes, including teaching
- Royal Decree 1386/2018, 19 November, amending Royal Decree 53/2013, 1 February, establishing the basic rules applicable to the protection of animals used in experimentation and for other scientific purposes, including teaching
- Law 32/2007, 7 November, for the care of animals regarding their exploitation, transport, experimentation and slaughter
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Law 6/2013, 11 June, amending Law 32/2007, of 7 November, for the care of animals, regarding their exploitation, transport, experimentation and slaughter
- Order ECC/566 / 2015, 20 March, establishing the training requirements to be met by personnel handling animals used, bred or supplied for experimental and other scientific purposes, including teaching
- Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
- Declaration of support for European Directive 2010/63 / EU on the protection of animals used for scientific purposes (signed by the CSIC)
http://eara.eu/en/campaigns/statement-supporting-european-directive-201063eu/
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Royal Decree 65/2006, 30 January, establishing requirements for the import and export of biological samples (+SAS Order/3166/2009 – amendment annexes)
- Law 8/2003, 24 April, on animal health
- Basel declaration
- Transparency agreement on the use of animals in scientific experimentation in Spain (signed by the CSIC)
http://www.cosce.org/pdf/Acuerdo_Transparencia_COSCE_2016.pdf
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Declaration on the use of animals for scientific purposes at the CSIC
https://www.csic.es/sites/www.csic.es/files/declaracion_institucional_uso_animales.pdf
WORKERS' PROTECTION
- Royal Decree 5/2015, 30 October, approving the revised text of the Law on the Basic Statutes for Public Employees
- Law 54/2003, 12 December, on the reform of the regulatory framework for occupational hazard prevention
- Law 31/1995, 8 November, Occupational hazard prevention
- Royal Decree 664/1997, 12 May, on the protection of workers against occupational hazards related to exposure to biological agents
- Technical guide for risk assessment and prevention related to exposure to biological agents
http://www.insht.es/InshtWeb/Contenidos/Normativa/GuiasTecnicas/Ficheros/agen_bio.pdf
- Law 22/2011, 28 July, on waste and contaminated soils
ENVIRONMENTAL PROTECTION
- Law 42/2007,13 December, on Natural Heritage and Biodiversity
- Law 9/2003, 25 April, establishing the legal framework for the contained use, voluntary release and marketing of genetically modified organisms
- Royal Decree 178/2004, 31 January, approving the General Regulations for the development and implementation of Law 9/2003, 25 April
- Law 43/2002, 20 November, on plant health
- Law 30/2006, 26 July, on nursery seeds and plant genetic resources
- Royal Decree 58/2005, 21 January, adopting protection measures on the introduction and dissemination in Spain and in the EC of organisms harmful to plants or plant products, as well as export, and transit to third countries
- Royal Decree 401/1996, 1 March, establishing the conditions for introducing into Spain certain harmful organisms, plants, plant products and other objects, for scientific testing purposes and for selecting variants
http://noticias.juridicas.com/base_datos/Admin/rd401-1996.html
- Royal Decree 39/1998 16 January, amending Royal Decree 401/1996, 1 March
https://www.boe.es/buscar/doc.php?id=BOE-A-1998-1002
- Convention on Biological Diversity
- Cartagena Protocol on Biosafety to the Convention on Biological Diversity
- International Treaty on Plant Genetic Resources for Food and Agriculture
- Antarctic Treaty on the Protection of the Environment (Madrid Protocol, BOE 18 February 1998)
PROTECTION OF PERSONAL DATA
- Regulation (EU) 2016/679 of the European Parliament and of the Council 27 April 2016 on the protection of individuals with regard to the personal data processing and on the free movement of such data, and repealing Directive 95/46/EC (General Regulation of data Protection)
- Organic Law 3/2018, 5 December, on the Protection of Personal Data and guarantee of digital rights