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CEI

Research Ethics Committee

Research Ethics Committee

Legislation affecting projects

PROJECTS ON HUMAN SUBJECTS TESTING

Spanish legislation

  • Organic Law 1/1982, of May 5, 1982, on the civil protection of the right to honor, personal and family privacy and self-image. LINK
  • Organic Law 5/1992, of October 29, 1992, regulating the automated processing of personal data. LINK
  • Royal Decree 994/1999 of June 11, 1999, which proves the regulation of security measures for automated files containing personal data. LINK
  • Law 14/2007 of July 3, 2007 on Biomedical Research. LINK
  • Royal Decree 1090/2015 of December 4, 2015, which regulates clinical trials with medicinal products, the Ethics Committees for Research with medicinal products and the Spanish Registry of Clinical Studies. LINK – ENLLAÇ

European legislation

  • Directive 2001/20/EC of the European Parliament and of the Council of the European Union of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. LINK
  • Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data. LINK

Statements

  • Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations, December 10, 1948. LINK
  • Declaration of Helsinki: Recommendations for the Guidance of Physicians in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964; Revised by the 29th World Medical Assembly, Tokyo, Japan, 1975; Amended by the 35th World Medical Assembly, Venice, Italy, 1983. LINK
  • Universal Declaration on the Human Genome and Human Rights; UNESCO, 11 November 1997. LINK
  • Universal Declaration on Human Genetic Data, UNESCO, October 16, 2003. LINK
  • International Declaration on Bioethics and Human Rights, UNESCO, October 19, 2005. LINK

Other ethical guidelines of interest

  • Council of Europe Convention on Human Rights and Biomedicine, signed in Oviedo on April 4, 1997, and its Additional Protocols. LINK
  • International Ethical Guidelines for Health-Related Research Involving Human Subjects, approved by the CIOMS Executive Committee on November 29, 2016. LINK
  • Guidelines and Operational Guidance for the Ethical Review of Health Research Involving Human Subjects, World Health Organization, 2011. LINK

PROJECTS ON THE USE OF CELLS AND TISSUES OF HUMAN EMBRYONIC ORIGIN OR CELL LINES DERIVED THEREFROM

Spanish legislation

  • Law 14/2006, of May 26, 2006, on assisted human reproduction techniques. LINK
  • Law 14/2007 of July 3, 2007 on Biomedical Research. LINK

PROJECTS INVOLVING CLINICAL TRIALS

Spanish legislation

  • Royal Decree 561/1993 of April 16, 1993, which establishes the requirements for conducting clinical trials with drugs. LINK
  • Royal Decree 223/2004 of February 6, 2004, which regulates clinical trials with drugs; LINK
  • Law 29/2006, of July 26, 2006, on guarantees and rational use of medicines and health products. LINK
  • Law 14/2007 of July 3, 2007 on Biomedical Research. LINK
  • Royal Decree 1090/2015 of December 4, 2015, which regulates clinical trials with medicinal products, the Ethics Committees for Research with medicinal products and the Spanish Registry of Clinical Studies. LINK – ENLLAÇ

European legislation

  • Directive 2001/20/EC of the European Parliament and of the Council of the European Union of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. LINK

Statements and other ethical guidelines of interest

  • Declaration of Helsinki: Recommendations for the Guidance of Physicians in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964; Revised by the 29th World Medical Assembly, Tokyo, Japan, 1975; Amended by the 35th World Medical Assembly, Venice, Italy, 1983. LINK
  • Council of Europe Convention on Human Rights and Biomedicine, signed in Oviedo on April 4, 1997, and its Additional Protocols. LINK
  • Universal Declaration on the Human Genome and Human Rights; UNESCO, 11 November 1997. LINK
  • ICH E6 (R2) Good clinical practice – Scientific guideline, European Medicines Agency. LINK

RESEARCH PROJECTS INVOLVING ANIMAL EXPERIMENTATION

Spanish legislation

  • RD 1201/2005 of October 10, 2005 on the protection of animals used for experimental and other scientific purposes. LINK
  • Law 32/2007 of November 7 for the care of animals in their exploitation, transport, experimentation and slaughter. LINK
  • Royal Decree 53/2013, of February 1, establishing the basic rules applicable to the protection of animals used in experimentation and other scientific purposes, including teaching. LINK – ENLLAÇ
  • Law 6/2013, of June 11, amending Law 32/2007, of November 7, for the care of animals, in their exploitation, transport, experimentation and slaughter. LINK – ENLLAÇ
  • Order ECC/566/2015, of March 20, establishing the training requirements to be met by personnel handling animals used, bred or supplied for experimental and other scientific purposes, including teaching. LINK
  • Royal Decree 1386/2018, of November 19, amending Royal Decree 53/2013, of February 1, establishing the basic rules applicable to the protection of animals used in experimentation and other scientific purposes, including teaching. LINK – ENLLAÇ

European legislation

  • Instrument of Ratification of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes, done at Strasbourg on March 18, 1986. LINK
  • Protocol amending, on July 7, 1998, the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes. LINK
  • Commission Recommendation of 18 June 2007 on guidelines for the housing and care of animals used for experimental and other scientific purposes. LINK
  • Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes. LINK

GENETICALLY MODIFIED ORGANISM AND RISK AGENT PROJECTS

Spanish legislation

  • Law 31/1995 of November 8, 1995 on the prevention of occupational risks, and in the Royal Decrees that develop them with regard to risks related to exposure to biological agents. LINK
  • Royal Decree 664/1997, on the protection of workers against risks related to exposure to biological agents at work. LINK
  • Law 9/2003, of April 25, 2003, on the Contained Use, Voluntary Release and Commercialization of Genetically Modified Organisms. LINK
  • Royal Decree 178/2004, of January 30, 2004, approving the general regulations that develop it. LINK
    • Consolidated text with the amendments of RD 367/2010 and RD 191/2013: LINK

Subsequent royal decrees have amended Law 9/2003. An exhaustive list can be found here: LINK

Autonomous Community Legislation

  • Decree 69/2006, of May 19, 2006, of the Consell, by which the Valencian Committee for the Control of Genetically Modified Organisms is created. LINK

European legislation

  • Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms. LINK
  • Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified microorganisms. LINK
  • Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms in their territory. LINK

More European legislation on the subject of GMOs can be found here: LINK

RESEARCH PROJECTS IN NATURAL AREAS OR WITH GENETIC RESOURCES

Spanish legislation

  • Law 30/2006, of July 26, 2006, on Nursery Seeds and Phytogenetic Resources. LINK – ENLLAÇ
  • Law 42/2007 on Natural Heritage and Biodiversity, after its amendment by Law 33/2015. LINK
  • Royal Decree 124/2017, of 24 February, on access to genetic resources from wild taxa and control of utilization. LINK – ENLLAÇ

European legislation

  • Regulation (EU) 511/2014 of the European Parliament and of the Council of 16 April 2014 on user compliance measures under the Nagoya Protocol on access to genetic resources and fair and equitable sharing of benefits arising from their utilization in the Union. LINK

Statements and other ethical guidelines of interest

  • Convention on International Trade in Endangered Species of Wild Fauna and Flora, CITES, 1973. LINK
  • Convention on Biological Diversity, UN, 1992. LINK
  • International Plant Protection Treaty, FAO – IPPC, 1997. LINK
  • International Treaty on Plant Genetic Resources for Food and Agriculture, FAO, 2001. LINK
  • Nagoya Protocol on Access to Genetic Resources, UN, 2014. LINK

RESEARCH PROJECTS SUPPORTED BY ARTIFICIAL INTELLIGENCE

Spanish legislation

  • Royal Decree 729/2023, of August 22, which approves the Statute of the Spanish Agency for the Supervision of Artificial Intelligence. LINK
  • Royal Decree 817/2023, of November 8, establishing a controlled test environment for testing compliance with the proposed Regulation of the European Parliament and of the Council laying down harmonized standards on artificial intelligence. LINK

European legislation

  • Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive (EU) 2018/2001 of the European Parliament and of the Council, Regulation (EU) 2018/1999 of the European Parliament and of the Council and Directive 98/70/EC of the European Parliament and of the Council as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/652. LINK
  • Artificial Intelligence Regulation. European Parliament legislative resolution of 13 March 2024 on the proposal for a regulation of the European Parliament and of the Council laying down harmonized rules in the field of artificial intelligence (Artificial Intelligence Act) and amending certain legislative acts of the Union (COM(2021)0206 – C9-0146/2021 – 2021/0106(COD)). LINK

Other ethical guidelines of interest

  • “Ethical Guidelines for Trustworthy AI” by the Independent High Level Expert Group on Artificial Intelligence of the European Commission, 2019. LINK
  • European Commission White Paper on Artificial Intelligence, 2020. LINK
  • PILOT PROPOSAL: AI regulatory sandbox in Spain: Bringing the AI Regulation forward, 2022. LINK


Environmental Legislation

Link

You can find the complete list for download here:

Legislation projectsDownload

Bibliography

Cebolla Cornejo, J. (2022) Ethics in Research: Contexts. PoliMedia [Video file]. Retrieved from https://media.upv.es/player/?id=00778140-5442-11ed-bb57-df46f0ad2433

Ministry of Agriculture, Fisheries and Food (n.d.). Plant genetic resources for agriculture and food. Retrieved from International and National Scope of the PGRFA (mapa.gob.es)

Ministry for Ecological Transition and the Demographic Challenge (n.d.). Spanish legislation on genetically modified organisms (GMOs). Retrieved from https://www.miteco.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificados-geneticamente-omg-/legislacion-general/legislacion_espaniola.html

TRREE. (n.d.). TRREE’s Training Programme on the Ethics and Regulation of Health Research Involving Human Participants. Retrieved from https://elearning.trree.org/course/index.php?categoryid=1

University of Seville (n.d.). Guidelines and legislation in research. Retrieved from https://research.uoc.edu/portal/_resources/CA/documents/recerca/Directrices_Legislacion_USevilla.pdf

Autonomous University of Barcelona (n.d.). Legislation and guidelines on animal experimentation. Retrieved from https://www.uab.cat/web/experimentacio-amb-animals/legislacion-y-guias-1345736970421.html

University de València (n.d.). Regulations applicable to animal welfare experimentation. Retrieved from https://www.uv.es/comision-etica-investigacion-experimental/es/experimentacion-bienestar-animal/normativas-aplicables.html

University of Valencia (n.d.). Regulations applicable to ethics in human research. Retrieved from https://www.uv.es/comision-etica-investigacion-experimental/es/etica-investigacion-humanos/normativas-aplicables.html

Universitat Politècnica de Catalunya (s. f.). Legislation and regulations. Ethics Committee of the UPC. Retrieved from https://comite-etica.upc.edu/ca/documentacio/legislacio-i-normativa-de-referencia

Universitat Politècnica de València (s.f.). Policy of good practices and scientific integrity in research. Retrieved from: http://www.upv.es/entidades/VINV/menu_urlc.html?/entidades/VINV/info/U0904697.pdf

Universitat Politècnica de València (s.f.). Project legislation, Universitat Politècnica de València Research Ethics Committee. Retrieved from http://www.upv.es/entidades/VINV/menu_urlc.html?/entidades/VINV/info/U0491053.pdf