New International Ethical Guidelines for Research Involving Human Subjects
Authors: Robert J. Levine
Journal: Annals of Internal Medicine (1993)

Editorials15 August 1993New International Ethical Guidelines for Research Involving Human SubjectsRobert J. LevineRobert J. LevineYale University School of Medicine, New Haven, CT 06510.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-119-4-199308150-00016 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In March 1993, the Council of International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO), issued their International Ethical Guidelines for Biomedical Research Involving Human Subjects [1]. This document, an extensive revision of the CIOMS-WHO guidelines published in 1982 [2], provides guidance for the proper application of the principles of the Declaration of Helsinki [3, 4] and focuses particularly on research sponsored by or initiated in developed countries and carried out in developing countries.The first international code of ethics for research involving human subjects, the Nuremberg Code, was developed from 1947 to 1949 by ...References1. CIOMS/WHO. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS; 1993. Google Scholar2. CIOMS/WHO. Proposed International Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS; 1982. Google Scholar3. Perley S, Fluss SS, Bankowski Z, Simon F. The Nuremberg Code: an international overview. In: The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. Annas GJ, Grodin MA, eds. New York: Oxford University Press; 1992: 149-73. Google Scholar4. Levine RJ. Ethics and Regulation of Clinical Research. 2d edition. Baltimore, Maryland: Urban & Schwarzenberg; 1986. Google Scholar5. Levine, RJ. Keynote address, XXVIth CIOMS Conference. In: Ethics and Research on Human Subjects: International Guidelines. Bankowski Z, Levine RJ, eds. Geneva: CIOMS; 1993: 4-10. Google Scholar6. Angell, M. Ethical imperialism? Ethics in international collaborative clinical research (Editorial). N Engl J Med. 1988; 319:1081-3. Google Scholar7. IJsselmuiden CB, Faden RR. Informed consent and public health research in Africaanother look. N Engl J Med. 1992; 326:830-4. Google Scholar8. Levine RJ. Informed consent: some challenges to the universal validity of the Western model. Law, Med Health Care. 1991; 19:207-13. Google Scholar9. Christakis NA. Ethics are local: engaging cross-cultural variation in the ethics for clinical research. Soc Sci Med. 1992; 35:1079-91. Google Scholar10. Barry M. Ethical considerations of human investigations in developing countries: the AIDS dilemma. N Engl J Med. 1988; 319: 1083-5. Google Scholar Author, Article, and Disclosure InformationAffiliations: Yale University School of Medicine, New Haven, CT 06510.Acknowledgments: Several passages in this editorial are derived from a lecture presented at the Eleventh Annual Meeting of the International Clinical Epidemiology Network (INCLEN), Cairo, Egypt, 26 January 1993, and from a commentary to be published in the INCLEN Newsletter. The CIOMS/WHO International Ethical Guidelines for Biomedical Research Involving Human Subjects can be obtained from CIOMS, c/o World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited ByA limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelinesBioethics criteria in Dentistry research of humansThe Magnitude and Impact of Bullying among School Pupils in Muscat, Oman: A Cross-Sectional StudyEthical Considerations in PharmacogenomicsBarriers to discharge of patients from a government-run day-care psychiatric rehabilitation center in IndiaInformed Consent in International Health ResearchStatistics and ethics in medical researchIntroduction to Clinical TrialsEthical issues in clinical trials 15 August 1993Volume 119, Issue 4Page: 339-341KeywordsDrug therapyDrugsMedical servicesPerceptionResearch designResearch ethicsResearch fundingResearch reporting guidelinesSafetyVaccines Issue Published: 15 August 1993 CopyrightCopyright © 1993 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...