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Specific guidelines on gene therapy
in the world
(Authors: M. Sneyers and M. Goossens - Last revised:
August 19, 2010
)
European Union
- EMA scientific guidelines on Gene Therapy (link to web site of EMA)
UK
- Gene Therapy Advisory Committee : reports and guidelines (link to web site of GTAC)
- The Scientific Advisory Committee on Genetic Modification (SACGM) Compendium of guidance - Part 6: Guidance on the use of genetically modified microorganisms in a clinical setting (January 2007) (Link)
USA
- U.S. Food and Drug Administration - Cellular and Gene therapy Guidance documents (link to web site of FDA)
- GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (NIH Guidelines) April 2002 Appendix M. Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into One or More Human Research Participants (Points to Consider) (Link)
Canada
- Canadian Institutes of Health Research: Tri-Council Policy Statement: Ethical Conduct for Research involving humans, Section 8: Human Genetic Research, 1998 (with 2000, 2002, 2005 updates) (link)
Australia
- National Health and medical research
Council: Guidelines for Ethical Review of Research Proposals for
Human Somatic Cell Gene Therapy and Related Therapies (1/01/2000)
(Link)
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