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 Participants, 2024 NEW![EN] [FR] [DE] [PT] [PL] [BR] [正體中文]
- WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 2013 (Rescinded!)
- 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 - Guideline for Good Clinical Practice E6(R2), November 2016
[EN] [FR] [DE] [PT] [PL] [BR]
- 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[EN] [FR] [DE] [PT] [PL] [BR]
- WHO, International Clinical Trials Registry Platform (ICTRP)
- WHO, UNAIDS, Ethical considerations in biomedical HIV prevention trials - Additional guidance, 2012[EN] [FR] [DE] [PT] [PL] [BR]
- WHO, Research Ethics in International Epidemic Response, 2009[EN] [FR] [DE] [PT] [PL] [BR]
- 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 Guidelines on good governance practice for research institutions, 2023[EN] [FR] [DE] [PT] [PL] [BR] NEW!
- CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 2002
- CIOMS, International Ethical Guidelines for Epidemiological Studies, 2009[EN] [FR] [DE] [PT] [PL] [BR]
- 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[EN] [FR] [DE] [PT] [PL] [BR]
- U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP), International Compilation of Human Research Standards[EN] [FR] [DE] [PT] [PL] [BR]
- 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.[EN] [FR] [DE] [PT] [PL] [BR]
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, 2018
- European & Developing Countries Trials Partnership (EDCTP), EDCTP Guidelines on Ethics [EN] [FR] [DE] [PT] [PL] [BR]
- South Africa, Department of Health, Ethics in Health Research: Principles, Structures and Processes, Research Ethics Guidelines, 2015[EN] [FR] [DE] [PT] [PL] [BR]
- 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[EN] [FR] [DE] [PT] [PL] [BR]
- UK Wellcome Trust, Research involving human participants: guidance notes on research involving people living in low and middle income countries[EN] [FR] [DE] [PT] [PL] [BR]
- US, Advisory Committee on Human Radiation Experiments: final report, 1995[EN] [FR] [DE] [PT] [PL] [BR]
- US, National Institutes of Health (NIH): NIH Grants Policy Statement, 2010[EN] [FR] [DE] [PT] [PL] [BR]
Other reference documents | Autres références | Andere Verweise | Outros documentos de referência | Inne dokumenty | Outros documentos de referência
- Amdur R., Bankert E., Institutional review board: member handbook, 3rd ed., Sudbury, Mass.: Jones & Bartlett, 2011
- Beecher H., Ethics and Clinical Research, New England Journal of Medicine, 1966, vol. 274, no. 24, p. 1354-1360
- Caws P., Committees and consensus: how many heads are better than one?, Journal of Medicine and Philosophy, 1991, vol. 16, no. 4, p. 375-391
- Durand G., Introduction générale à la bioéthique : Histoire, concepts et outils, Montréal & Paris : FIDES CERF, 1999
- Emanuel E.J., Lemmens T., Elliot C., Should society allow research ethics boards to be run as for-profit enterprises?, PLoS Medicine, 2006, vol. 3, issue 7, p. 941-944
- Ezekiel E.J., Wendler D., Killen J., Grady C., What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research, Journal of Infectious Diseases, 2004, vol. 189, Issue 5, p. 930-937
- Freedman B., Equipoise and the Ethics of Clinical Research, New England Journal of Medicine, 1987, vol. 317, no. 3, p. 141-145
- Freedman B., Scientific value and validity as requirements for research: a proposed explication, IRB: Ethics & Human Research, 1987, vol. 9, no. 6, p. 7-10
- Freedman B., Fuks A., Weijer C., Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research, Clinical Research, 1992, vol. 40, no. 4, p. 653-660
- Glass K.C., Lemmens T., Conflict of Interest and Commercialization of Biomedical Research: What is the Role of Research Ethics Review?, in: T. Caulfield, B. William-Jones (eds.), The Commercialization of Genetic Research : Ethical, Legal and Policy Issues, New York: Kluwer, 1999
- Ijsselmuiden C., Matlin S., Why Health Research?, Research for Health: Policy Briefings A series jointly published by Council on Health Research for Development and Global Forum for Health Research, 2006
- Glazer J.W., Hospital Ethics Committees: One of Many Centers Responsibility, Theoretical Medicine, 1989, vol. 10, no. 4, p275-288
- Jennings B., Possibilities of Consensus: Toward Democratic Moral Discourse, Journal of Medicine and Philosophy, 1991, vol. 16, issue 4, p. 447-463
- Katz J. (ed.), Experimentation with Human Beings, New York, Russel Sage Foundation, 1972
- Levine R.J. "The Need to Revise the Declaration of Helsinki." New England Journal of Medicine, 1999, vol.341, issue 7, p. 531-534.
- Lurie P., Wolfe. S.M., "Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries", New England Journal of Medicine, 1997, vol. 377
- Moreno J.D., Consensus, Contracts, and Committees, Journal of Medicine and Philosophy, 1991, vol. 16, issue 4, p. 393-408
- Moreno J.D., Ethics by Committee: The Moral Authority of Consensus, Journal of Medicine and Philosophy, 1988, vol. 13, issue 4, p. 441-431
- Thompson D., Understanding financial conflicts of interest, New England Journal of Medicine, 1993, vol. 329, no. 8, p. 573-576
- Varmus H., "Testimony before the Subcommittee on Human Resources, Committee on Government Reform and Oversight", U.S. House of Representatives. May 8, 1997. Washington, D.C.
- Varmus H., Satcher, D. "Ethical Complexities of Conducting Research in Developing Countries." New England Journal of Medicine, 1997, vol.337, issue 7, p. 1003-1005
- Weijer C., Miller P., When are research risks reasonable in relation to anticipated benefits?, Nature Medicine, 2004, 10, p. 570-573
- Wilfert, C.M., et al. "Consensus Statement: Science, Ethics, and the Future of Research into Maternal Infant Transmission of HIV-1." The Lancet, 1999, vol. 353, p. 832-835
- Williams J.R., Medical Ethics Manual, World Medical Association, 3rd ed., 2015
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Ultima modificare: marți, 22 octombrie 2024, 13:52