Ethical regulations, codes, conventions etc.

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This sub-division presents a selection of publications on ethical regulations, codes and conventions relevant to HTA:

  1. Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO). International ethical guidelines for epidemiological studies. Geneva: CIOMS; 2008. [Further reference details] [Full text]

  2. Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research: Explanatory report. Paris: Council of Europe; 1997. [Further reference details] [Full text]

  3. Council of Europe. Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. Strasbourg, 25.I.2005. Paris: Council of Europe; 2005. [Further reference details] [Full text]

  4. Council of Europe. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. Oviedo, 4.4.1997. Paris: Council of Europe; 1997. [Further reference details] [Full text]

  5. Ehni HJ, Wiesing U. International ethical regulations on placebo-use in clinical trials: A comparative analysis. Bioethics 2008; 22(1): 64-74. [Further reference details] [Full text]

  6. European Group on Ethics in Science and New Technologies {EGE). Statement of the European Group on Ethics in Science and New Technologies {EGE) on the Proposal for a Regulation of the European Parliament and the Council on Clinical Trials on Medicinal Products for Human Use, and repealing Directive 2001/20/EC {COM 2012) 369 final. Bruxelles: European Commission. [Further reference details] [Full text]

  7. European Parliament. Directive 2001/20/EC of the European Parliament and of 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. Official Journal of the European Communities 2001; 1.5.2001: L 121/34-L 121/44. [Further reference details] [Full text]

  8. Health Professions Council of South Africa. General ethical guidelines for health researchers. Pretoria: HPCSA; 2008. [Further reference details] [Full text]

  9. Idänpään-Heikkilä JE, Fluss S. The CIOMS view on the use of placebo in clinical trials. Sci Eng Ethics 2004; 10(1): 23-28. [Further reference details] [Full text]

  10. Lo B, Field MJ (Ed). Conflict of Interest in Medical Research, Education, and Practice. Washington: National Academies Press; 2009. [Further reference details] [Full text]

  11. Nuffield Council on Bioethics. Public health: ethical issues. London: Nuffield Council on Bioethics; 2007. [Further reference details] [Full text]

  12. Snyder L; American College of Physicians Ethics, Professionalism, and Human Rights Committee. American College of Physicians Ethics Manual: Sixth edition. Ann Intern Med 2012; 156(1 Pt 2): 73-104. [Further reference details] [Full text]

  13. UK Screening Committee. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme [online]. London: UK NSC. [Further reference details] [Full text]

  14. Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication. J Pharmacol Pharmacother 2010; 1(1): 42–58. [Further reference details] [Full text]

  15. Wager E, Wiffen PJ. Ethical issues in preparing and publishing systematic reviews. J Evid Based Med 2011; 4(2): 130-4. [Further reference details] [Full text]

  16. World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: WHO; 2011. [Further reference details] [Full text]

  17. World Medical Association. Medical Ethics manual. Ferney-Voltaire: WMA; 2009. [Further reference details] [Full text]

  18. World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013; 310(20): 2191-2194. [Further reference details] [Full text]
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