International Regulations
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Good clinical practices of the International Conference on Harmonization containing the basic ethical principles, based on the Declaration of Helsinki.
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Nuremberg Code, August 20, 1947, the first document that explicitly stated the obligation to request Informed Consent, an expression of patient autonomy.
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UN Human Genetic Data. International Declaration on Human Genetic Data, October 16, 2003.
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Asturias Convention, Council of Europe Oviedo, April 4, 1997, to adopt appropriate measures in the field of the applications of biology and medicine that guarantee the dignity of the human being and the fundamental rights and freedoms of the individual.
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Ibero-Latin American Declaration on Law, Bioethics and the Human Genome. Manzanillo Declaration of 1996, revised in Buenos Aires in 1998 and in Santiago in 2001.
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Universal Declaration on Bioethics and Human Rights, October 19, 2005.
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Ethical Protocol Proposal. Model for the collection of DNA samples from the North American Committee of the Human Genome Diversity Project.
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Universal Declaration on the Genome and Human Rights, November 11, 1997.
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World Medical Association Declaration of Helsinki, Helsinki, Finland, June 1964 (last revised 2004), proposed ethical principles to guide physicians and others engaged in medical research involving human subjects.
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Belmont Report: Ethical Principles and Guidelines for the Protection of Human Research Subjects, April 18, 1979.
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Standards for the writing of Informed Consent, recommended by CIOMS.
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Ethical principles applied to epidemiology. International guidelines for the ethical evaluation of epidemiological studies. CIOMS
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CIOMS Ethical Guidelines.
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International Code of Medical Ethics, 1983.
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Recommendations for Public Health Research. Ministerial Declaration on the TRIPS Agreement and Public Health O.M.C.~DOHA.
National Regulations
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Political Constitution of the United Mexican States. Official Gazette of the Federation 05/02/1917. Last amendment published by DOF 28/05/2021.
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General Health Law, Mexico. New law published in the Official Gazette of the Federation 07/02/1984. Last amendment published by DOF 01/06/2021. Indicates the legal basis for genomic sovereignty, as well as the legal and patrimonial protection of the human genome (Title 5 BIS). Particularly, Articles 317 Bis and 317 Bis 1 of this law establish that the transfer of human tissue, which may be a source of genetic material (DNA) outside the national territory for the purpose of performing genomic study activities in the population, shall be subject to approval by an institution dedicated to science and obtain a permit from the Federal Minister of Health through national regulations.
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Federal Law of Administrative Responsibilities of Public Servants. DOF 19/11/2019
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General Law for the Protection of Personal Data in Possession of Obligated Subjects. DOF 26/01/2017.
Regulations and Guidelines
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Health Ministry Code of Conduct
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Charter of the general rights of doctors
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Charter of general rights of patients
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REGULATIONS of the General Law of Health on Health Research (Last amendment published DOF 02-04-2014)
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REGULATIONS of the General Health Law on the Provision of Health Care Services. (Last amendment published DOF 24-03-2014)
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National Guide for the integration and operation of Research Ethics Committees. 5th Edition
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National Guide for the integration and operation of Hospital Bioethics Committees. 5th Edition.
Official Mexican Standards
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NOM-017-SSA2-2012 For epidemiological surveillance, DOF 19/02/2013.
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NOM-004-SSA3-2012, Clinical Record (DOF 15-10-2012).
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NOM-012-SSA3-2012, which establishes the criteria for the execution of research projects for health in humans (DOF 04-01-2013).
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NOM-005-SSA1-2010 Establishing minimum infrastructure and equipment requirements for outpatient medical care facilities. DOF 03/27/2012
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NOM-007-SSA3-2011. For the organization and operation of clinical laboratories. DOF 27/03/2012.
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NOM-035-SSA3-2012. On health information. DOF 30/11/2012.
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NOM-253-SSA1-2012. For the disposal of human blood and its components for therapeutic purposes. DOF 26/10/2012.
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NOM-052-SEMARNAT-2005 which establishes the characteristics, identification procedure, classification and lists of hazardous wastes. DOF 22/10/1993. Modification DOF 06/23/2006.
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NOM-087-ECOL-SSA1-2002. Environmental protection-Environmental health-Environmental health-Biological-infectious waste-Classification and management specifications. DOF 09/10/2015.
