Regulation of the transition from research to clinical practice in human assisted conception.
This review discusses the place of regulation in the transition from research to clinical practice in human assisted conception, with particular emphasis on the United Kingdom and the role of the Human Fertilisation and Embryology Authority (HFEA). A contrast is drawn between advances in other areas of medical practice, in which the evidence base is considerable, and in assisted conception, in which it is often weak. This comparison leads to the central issue: how to balance the needs of patients with the need to ensure safety and efficacy in the introduction of new techniques. Comfort is derived from biological considerations that indicate that early human embryos are remarkably resilient and adaptable to challenges to their physiology. Regulatory practice in other countries is considered briefly. The review concludes that there are no easy rules or answers in managing the transition from research into the clinic, but that bodies such as the HFEA have a responsibility to: (i) encourage research to widen the evidence base and (ii) err on the side of caution when faced with decisions on licensing new techniques.
Leese
H J
HJ
Department of Biology, University of York, PO Box 373, York YO10 5YW, UK.
Whittall
H
H
D000818:Animals; D001709:Biotechnology; D004622:Embryo, Mammalian / Q000502:physiology; D005260:Female; D006801:Humans; D023421:Models, Animal; D011247:Pregnancy; D027724:Reproductive Techniques, Assisted / Q000331:legislation & jurisprudence*; D012106:Research; D006113:United Kingdom