EBHC Library > Methodology of Research > Clinical Research > International Standards

Page last update: 29/09/2012

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• Declaration of Helsinki

  • World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2000;284:3043-5

  • Versione Italiana

  • World Medical Association 

  • Comments

    • Lie RK, Emanuel E, Grady C, et al. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics 2004;30:190-3.

      • Schuklenk U. The standard of care debate: against the myth of an "international consensus opinion". J Med Ethics 2004;30:194-7.

    • [No authors listed] Dismantling the Helsinki declaration. CMAJ 2003;169:997

    • Lewis JA, Jonsson B, Kreutz G, et al. Placebo-controlled trials and the Declaration of Helsinki. Lancet 2002;359:1337-40

    • Tollman SM, Bastian H, Doll R, et al. What are the effects of the fifth revision of the Declaration of Helsinki? BMJ 2001;323:1417-23

    • Forster HP, Emanuel E, Grady C. The 2000 revision of the Declaration of Helsinki: a step forward or more confusion? Lancet 2001;358:1449-53

    • Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics. BMJ 2001;322:747-8

    • Riis P. Perspectives on the Fifth Revision of the Declaration of Helsinki. JAMA 2000;284:3045-6

    • Vastag B. Helsinki discord? A controversial declaration. JAMA 2000;284:2983-5

    • Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics. BMJ 2001;322:747-8

    • Riis P. Perspectives on the Fifth Revision of the Declaration of Helsinki. JAMA 2000;284:3045-6

    • [No authors listed] A fifth amendment for the Declaration of Helsinki. Lancet 2000;356:1123.

    • Rothman KJ. Declaration of Helsinki should be strengthened. BMJ 2000;321:442-5

    • Stockhausen K. The Declaration of Helsinki: revising ethical research guidelines for the 21st century. Med J Aust 2000;172:252-3.

    • Loff B, Black J. The Declaration of Helsinki and research in vulnerable populations. Med J Aust 2000;172:292-5.

  • Call for revision

    • Rothman, K J. Declaration of Helsinki should be strengthened. BMJ 2000:321:442-445

    • Levine RJ. The need to revise the Declaration of Helsinki. N Engl J Med 1999;341:531-4

    • Brennan TA. Proposed revisions to the Declaration of Helsinki--will they weaken the ethical principles underlying human research? N Engl J Med 1999;341:527-31

• Good Clinical Practice

  • International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • Guideline for Good Clinical Practice
  • Good Clinical Practice in FDA-Regulated Clinical Trials
  • EMEA- Guideline for Good Clinical Practice. 2002
  • MRC Guidelines for Good Clinical Practice in Clinical Trials 1998
  • Grimes DA, Hubacher D, Nanda K, et al. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet 2005;366:172-4.