Core reference documents | Référence principales | Hauptverweise | Referências Principais | Podstawowe dokumenty | Referências Principais | Bibliografia

International

  • WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 2013
  • WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, 2016
  • WMA, Regulations in Times of Armed Conflict and others situations of violence, 2012
  • ICH International Conference on Harmonization - Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), November 2016
  • ICH International Conference on Harmonization - Good Clinical Practice E6(R1), 1996
  • The Nuremberg Code, Health & Humans Services, Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law no. 10, vol. 2, pp. 181-182. Washington D.C. : U.S. Government Printing Office, 1949
  • Materials on the 1949 Trial of Former Servicemen of the Japanese Army Charged with Manufacturing and Employing Bacteriological Weapons (Khabarovsk Trials), Foreign Languages Publishing House, Moscow 1950
  • WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva, 2000
  • WHO, Surveying and Evaluating Ethical Review Practices, Geneva, 2002
  • WHO, Ethics and Health, Ethical standards and procedures for research with human beings
  • WHO, International Clinical Trials Registry Platform (ICTRP)
  • WHO, UNAIDS, Ethical considerations in biomedical HIV prevention trials - Additional guidance, 2012
  • WHO, Research Ethics in International Epidemic Response, 2009
  • UNESCO, International Declaration on Human Genetic Data, 2003
  • UNESCO, Universal Declaration on Bioethics and Human Rights, 2005
  • UNESCO, Universal Declaration on the Human Genome and Human Rights, 1997
  • UN, The Universal Declaration of Human Rights, 1948
  • CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 2002
  • CIOMS, International Ethical Guidelines for Epidemiological Studies, 2009
  • CIOMS, International Ethical Guidelines for Heatlh-related Research involving Humans, approved on 29 November 2016

Europe

  • Council of Europe, Convention for the Protection of Human Rights and Dignity of the the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997
  • Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, 2005
  • 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, and repealing Directive 95/46/EC (General Data Protection Regulation), 2016
  • Regulation (EU) No. 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use, 2014
  • Directive (EU) 2001/20/EC of the European Parliament and the Council 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, 2001
  • Commission Directive (EU) 2005/28/CE of April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products, 2005

United States

  • U.S., Code of Federal Regulations, Title 45 Public Welfare Department of Health and Human Services, Part 46 Protection of Human Subjects - Common Rule
  • U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP), International Compilation of Human Research Standards
  • U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP), The Belmont Report, 1979
  • US, National Bioethics Advisory Commission, Ethical and Policy Issues in International Research Clinical Trials in Developing Countries, Chapter 1: Ethical Issues in International Research – Setting the Stage, Volume I, April 2001, p.2.

Other reference documents | Autres références | Andere Verweise | Outros documentos de referência | Inne dokumenty | Outros documentos de referência

  • Brasil, Ministry of Health, National Council of Health, Operational Standard No. 001/2013
  • Brasil, Ministry of Health, National Council of Health, Resolution No. 466 of 12 December 2012
  • Canada, Tri-Council Policy Statement, Research Involving The First Nations, Inuit And Métis Peoples Of Canada, ch. 9, 2012
  • Canada, Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans, 2nd Edition, 2010
  • European & Developing Countries Trials Partnership (EDCTP), EDCTP Guidelines on Ethics
  • South Africa, Department of Health, Ethics in Health Research: Principles, Structures and Processes, Research Ethics Guidelines, 2004
  • UK, Nuffield Council on Bioethics, The ethics of research related to healthcare in developing countries, 2002
  • UK, Nuffield Council on Bioethics, The ethics of research related to healthcare in developing countries, a guide to the Report
  • UK Wellcome Trust, Research involving human participants: guidance notes on research involving people living in low and middle income countries
  • US, Advisory Committee on Human Radiation Experiments: final report, 1995
  • US, National Institutes of Health (NIH): NIH Grants Policy Statement, 2010

Other reference documents | Autres références | Andere Verweise | Outros documentos de referência | Inne dokumenty | Outros documentos de referência



[EN:English] [FR:French] [DE:German] [PT:Portuguese] [PL:Polish] [BR:Brazilian]


For reference purposes only – documents should not be considered official versions / Pour consultation seulement – ces documents n’ont pas de valeur officielle / Nur zu Referenzzwecken – Dokumente sollten nicht als offizielle Versionen betrachtet werden / Para consulta apenas – os documentos não deverão ser considerados versões oficiais / Teksty do stosowania wyłacznie jako odwołania - nie należy traktować ich jako oficjalnych wersji dokumentów / Para fins únicos de refêrencia – Os documentos não devem ser considerados versões oficiais.

Last modified: Monday, 27 March 2017, 12:08 PM