The battle of Helsinki: Two troublesome paragraphs in the Declaration of Helsinki are causing a furore over medical research ethics

EMBO Reports

Volumn 7, Issue 7, 2006, Pages 670-672

  Wolinsky, Howard ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

ARTICLE; CLINICAL PROTOCOL; CONSENSUS DEVELOPMENT; DEVELOPING COUNTRY; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG RESEARCH; EXPERIMENTAL DESIGN; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; GOVERNMENT; HEALTH CARE ACCESS; HEALTH CARE QUALITY; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; RESEARCH ETHICS; RISK BENEFIT ANALYSIS; UNITED STATES; VIRUS TRANSMISSION; VOLUNTEER;

ETHICS, RESEARCH; HELSINKI DECLARATION; HUMAN EXPERIMENTATION; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33745616515     PISSN: 1469221X     EISSN: 14693178     Source Type: Journal    
DOI: 10.1038/sj.embor.7400743     Document Type: Article

References (11)

1. Anonymous (1949) Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol 2. Washington, DC, USA: Government Printing Office
2. CIOMS (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: Council for International Organizations of Medical Sciences
3. EC (2001) 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. Brussels, Belgium: European Commission
4. EC (2005) Commission Directive 2005/28/EC of 8 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. Brussels, Belgium: European Commission
5. EGE (2003) Ethical Aspects of Clinical Research in Developing Countries. Brussels, Belgium: European Group on Ethics in Science and New Technologies
6. ICH (1996) Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance. Geneva, Switzerland: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
7. Lie RK, Emanuel E, Grady C, Wendler D (2004) The standard of care debate: The Declaration of Helsinki versus the international consensus opinion. J Med Ethics 30: 190-193
8. Lurie P, Wolf SM (1997) Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 337: 853-855
9. Nuffield Council on Bioethics (2002) The Ethics of Research Related to Healthcare in Developing Countries. London, UK: Nuffield Council on Bioethics
10. PhRMA (2001) PhRMA Discussion Paper on the Declaration of Helsinki as Revised in October 2000. Washington, DC, USA: Pharmaceutical Research and Manufacturers of America
11. WMA (2004) World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Ferney-le-Voltaire, France: World Medical Association