Ethics in Research
The interest is focused on the consideration of ethical aspects in research, their nature and aims (respect for the dignity of human beings, autonomy of will, data protection – privacy and confidentiality –, animal well-being and environment preservation).
Research ethics requires scientific practise to be made in conformity with ethical principles that ensure the advancements of knowledge, the human comprehension and improvement of human condition, and the progress of society. It focuses on the interest in the moral perspective of research activity considering its ethical aspects, nature and ends (respect for the dignity of human beings, their autonomy of will, data protection – privacy and confidentiality – animal well-being and environmental preservation.

In view of the increasing importance of ethical implications within the scientific endeavour, as well as the varied legislation developed in this field, the ethics committees play a significant role contributing to make research from the scientific community realised following the current regulations with absolute respect to the principles, compromises, and bioethical and biosecurity demands in general.
Scope of Action. Bioethics and Biosecurity
Bioethics is a branch of ethics which defines a series of principles whose application allows to optimise, from different perspectives, human conduct within the field of the Life Sciences, meaning human actions concerning human, animal and plant life (human interaction with living creatures). Within the field of Biosecurity, the adoption of measures and the appliance of regulation to specific effects to preserve the security of living creatures and the environment acquires a special relevance upon concrete factors that may alter them, such as genetically modified organisms and risks of exposure to biological agents.
Regarding scientific practises at CSIC, there are four fields of action defined within the bioethics and biosecurity framework.
- Research involving human subjects, human samples and/or data proceeding from human populations that requiring protection.
- Research using animals.
- Research with genetically modified organisms (GMOs).
- Research involving risks of exposure to biological agents for human, animal and plant beings, and the environment.
Ethical Evaluation of the CSIC Research
- CSIC’s Ethics Committee has issued institutional instructions for requesting an evaluation of the CSIC’s ethics research.
Implementing Legislation. Documents of interest.
RESEARCH WITH HUMAN SUBJECTS
- Ley 14/2007, de 3 de julio
- Ley 41/2002, de 14 de noviembre
- Real Decreto 1716/2011, de 18 de noviembre (+ Orden ECC/1404/2013 – modificación)
- Real Decreto 1090/2015, de 4 de diciembre
- Real Decreto 65/2006, de 30 de enero(+ Orden SAS/3166/2009 – modificación anexos)
- Ley 30/1979, de 27 de octubre
https://www.boe.es/buscar/doc.php?id=BOE-A-1979-26445
http://noticias.juridicas.com/base_datos/Admin/l30-1979.html
- Ley 14/2006, de 26 de mayo
- Real Decreto 120/2003, de 31 de enero
- WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (1964)
- Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1978)
- Convention of Oviedo / Convention on Human Rights and Biomedicine / European Council Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997, ratified by Spain 23/07/1999)
https://www.boe.es/boe/dias/1999/10/20/pdfs/A36825-36830.pdf (Instrumento ratificación)
- 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
ANIMALS
- Real Decreto 53/2013, de 1 de febrero
- Real Decreto 1386/2018, de 19 de noviembre
- Ley 32/2007, de 7 de noviembre
Ley 6/2013, de 11 de junio
- Orden ECC/566/2015, de 20 de marzo
- 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
- Statement supporting European Directive 2010/63/EU (subscribed by CSIC)
http://eara.eu/en/campaigns/statement-supporting-european-directive-201063eu/
Real Decreto 65/2006, de 30 de enero (+ Orden SAS/3166/2009 – modificación anexos)
- Ley 8/2003, de 24 de abril
- Declaración de Basilea
- Acuerdo de transparencia sobre el uso de animales en experimentación científica en España (suscribed by CSIC)
http://www.cosce.org/pdf/Acuerdo_Transparencia_COSCE_2016.pdf
Declaración sobre la utilización de animales con fines científicos en el CSIC
https://www.csic.es/sites/default/files/declaracion_institucional_uso_animales.pdf
WORKERS PROTECTION
- Real Decreto Legislativo 5/2015, de 30 de octubre
- Ley 54/2003, de 12 de diciembre
- Ley 31/1995, de 8 de noviembre
- Real Decreto 664/1997, de 12 de mayo
- Guía técnica para la evaluación y prevención de los riesgos relacionados con la exposición a agentes biológicos
http://www.insht.es/InshtWeb/Contenidos/Normativa/GuiasTecnicas/Ficheros/agen_bio.pdf
- Ley 22/2011, de 28 de julio
ENVIRONMENTAL PROTECTION
- Ley 42/2007, de 13 de diciembre
- Ley 9/2003, de 25 de abril
- Real Decreto 178/2004, de 31 de enero, por el que se aprueba el Reglamento general para el desarrollo y ejecución de la Ley 9/2003, de 25 de abril
- Ley 43/2002, de 20 de noviembre
- Ley 30/2006, de 26 de julio
- Real Decreto 58/2005, de 21 de enero
- Real Decreto 401/1996, de 1 de marzo
http://noticias.juridicas.com/base_datos/Admin/rd401-1996.html
- Real Decreto 39/1998, de 16 de enero, por el que se modifica el Real Decreto 401/1996, de 1 de marzo https://www.boe.es/buscar/doc.php?id=BOE-A-1998-1002
- Convenio sobre la Diversidad Biológica
- Protocolo de Cartagena sobre Seguridad de la Biotecnología del Convenio sobre la Diversidad Biológica
- Tratado Internacional sobre los Recursos Fitogenéticos para la Alimentación y la Agricultura
- Tratado Antártico sobre Protección del Medio Ambiente (Protocolo de Madrid, BOE de 18 de febrero de 1998)
PERSONAL DATA PROTECTION
- Reglamento (UE) 2016/679 del Parlamento Europeo y del Consejo, de 27 de abril de 2016, por el que se deroga la Directiva 95/46/CE (Reglamento General de Protección de datos)
- Ley Orgánica 3/2018, del 5 de diciembre