Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
권호 표지

The Revised Declaration of Helsinki and Clinical Research

개정 헬싱키 선언과 임상연구

  • Shin, Hee-Young (Department of Biomedical Science, Chonnam National University Medical School, Clinical Trial Center, Chonnam National University Hospital)
  • 신희영 (전남대학교 의과대학 의생명과학교실, 전남대학병원 임상시험센터)
  • Received : 2009.12.09
  • Accepted : 2009.12.17
  • Published : 2009.12.30

⟨ Previous Next ⟩

Abstract

The Declaration of Helsinki was originally adopted by the World Medical Association (WMA) in 1964, and has undergone six revisions. The most recent revision was made in October 2008 in Seoul, Korea. The Declaration of Helsinki is the most widely known international guideline to provide the ethical principles for medical research involving human subjects. As the number of clinical researches has been increasing markedly in Korea, there are growing expectations and concerns about the research ethics related to the protection of human subjects. Physicians conducting the clinical research are supposed to know and understand the content of the Declaration, and they should follow the guideline in their researches. The current structure of the Declaration has three parts: Introduction; Basic Principles for All Medical Research; and Additional Principles for Medical Research Combined With Clinical are. It includes essential elements of the ethical principles for clinical research, such as informed consent, research ethics committee, and risk-benefit assessment. Although there have been continuing controversial issues in the Declaration of Helsinki, it will remain to be the cornerstone of research ethics.

Keywords

References

  1. The World Medical Association. Declaration of Helsinki (6th ed.). 2008
  2. Nuremberg Military Tribunal. The Nuremberg Code. 1947
  3. Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: CIOMS and WHO; 2002.
  4. International Committee of Medical Journal Editors. Uniform Requirement for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2006
  5. World Health Organization. International Clinical Trials Registry Platform. Available from: http://www.who.int/ictrp/en/
  6. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. E6 Guideline for Good Clinical Practice. 1996
  7. Killen J, Grady C, Folkers GK, Fauci AS. Ehics of clinical research in the developing world. Nat Rev Immunol 2002;2:210-215. https://doi.org/10.1038/nri745
  8. Orentlicher D. Universality and its limits: When research ethics can reflect local circumstances. J Law Med Ethics 2002;30:403-410. https://doi.org/10.1111/j.1748-720X.2002.tb00409.x
  9. Greco DB. Revising the Declaration of Helsinki: Ethics vs. economics or the fallacy of urgency. Can HIV AIDS Policy Law Rev 2000;5:94-97.
  10. Resnik DB. The ethics of HIV research in developing nations. Bioethics 1998;12:286-306. https://doi.org/10.1111/1467-8519.00118