Differences in regulatory frameworks governing genetic laboratories in four countries.
The purpose of this article is to determine how the heterogeneity of the different regulatory frameworks governing genetic laboratories in Australia, France, the United Kingdom, and the United States hinder the international availability of genetic tests. We conclude that a better understanding of the various national standards governing genetic laboratories may help health professionals choose laboratories for referral in an evidence based manner in order to protect the patient's best interests.
Tassé
Anne Marie
AM
Bioethics Program, Department of Preventative and Social, Medicine, University of Montreal, Canada.
Petit
Elodie
E
Godard
Béatrice
B
D000068:Accreditation / Q000592:standards; D001315:Australia; D002568:Certification / Q000592:standards; D005161:Facility Regulation and Control / Q000592:standards; D005602:France; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D007391:International Cooperation; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D006113:United Kingdom; D014481:United States