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Research ethics committees: what can we learn from the Western European and United States experience?

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Further References

  1. Fundamentals of Human Subject Research Clinical Research Workshop, 22 June 2000, Sponsored by University of Pittsburgh

  2. stet.

  3. UPMC Physician, July 2000, Vol. 9, No.7, UPMC Health System

  4. OPRR Reports Protection of Human Subjects Title 45 Code of Federal Regulations Part 46, Revised June 1991, Reprinted April 2 1996

  5. Human Research Report Protecting Researchers and Research Subjects Volume 15, No. 6, June 2000

  6. French Medicines Agency Guideline for Reporting of Serious Events and New Information during Clinical Trials conducted on Medicines, Translated and adapted from the French original version published on November 15th 1994

  7. Agence Francaise de Securite Sanitare des Produits de Sante Declaration d’intention pour toute investigation clinique portant sur des dispositifs medicaux Guide Practique Loi du 20 Decembre 1988 Modifiee sur la Protection des Personnes qui se pretant aux Recherches Biomedicales, 1997 Doin Editeurs/Assistance Publique-Hopitaux de Paris

  8. Medical and ethical review of drug research in the Netherlands: report of a study conducted by the Institute for Bioethics, Maastricht, Ron P Berghams, Ruud HJ ter Meulen and Maurice AM De Wachter, International Journal of Pharmaceutical Medicine 1997, 11:167–170

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  9. ‘Unresponsive’ NHS ranked 18th in world, Jeremy Laurance and Cherry Norton, 21 June 2000, The Independent

  10. World Medical Association Declaration of Helsinki, Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended in Tokyo 1975, in Venice 1983, in Hong Kong 1989 and in South Africa, October 1996

  11. Guideline for Good Clinical Practice ICH Harmonised Tripartite Guideline (EMEA Status as of June 1996)

  12. CCMO website: www.ccmo.nl

  13. ETHOX website: www.ethox.org.uk

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Authors and Affiliations

  1. The Alfred Hospital, Melbourne

    Rowan Frew

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  1. Rowan Frew
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Frew, R. Research ethics committees: what can we learn from the Western European and United States experience?. Monash Bioethics Review 20, S61–S77 (2001). https://doi.org/10.1007/BF03351257

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