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Regulation and Oversight of Embryonic Stem Cell Research R. Alta Charo University of Wisconsin December 2004
Overview: Federal Laws & Regulations Governing ES Cell Research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Human Subjects Protections ,[object Object],[object Object],[object Object],[object Object],[object Object]
Human Subjects Protections: Basic Components ,[object Object],[object Object],[object Object],[object Object]
Derivation of New ES Cell Lines ,[object Object],[object Object],[object Object]
Human Subjects Protections and ES Cell Derivation ,[object Object],[object Object]
Regulation of Use of Cell Lines in Laboratory Experiments ,[object Object]
Cell lines without identifiers: ,[object Object],[object Object],[object Object]
Cell lines with Identifiers: ,[object Object]
Exception to Rule Concerning Cell Lines with Identifiers : ,[object Object],[object Object],[object Object],[object Object]
Recombinant DNA research and ES cells ,[object Object]
Genetic Alteration of Embryonic Stem Cell Lines ,[object Object]
IBC review ,[object Object]
Human Gene Transfer Research ,[object Object],[object Object]
Creation of transgenic or chimeric animals using ES cells ,[object Object]
USDA and the Animal Welfare Act ,[object Object],[object Object]
Animals not covered by the Animal Welfare Act ,[object Object],[object Object],[object Object]
Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. ,[object Object],[object Object]
FDA Good Laboratory Practice Regulations ,[object Object],[object Object]
Applicability of FDA Good Laboratory Practices Regulations ,[object Object],[object Object],[object Object]
FDA Regulation of Animal Drugs and ES cell research ,[object Object],[object Object],[object Object]
Clinical Research Using Cell Lines and Differentiated Tissue – HHS/FDA Regulation: ,[object Object],[object Object]
Clinical Research Using Cell Lines and Differentiated Tissue – HHS/FDA Regulation (cont): ,[object Object],[object Object],[object Object]
Cell-based therapies ,[object Object],[object Object],[object Object]
The Tissue Action Plan ,[object Object]
Components of the Tissue Action Plan for Manufacturers of Human Cell Therapy Products ,[object Object],[object Object],[object Object],[object Object],[object Object]
Establishment Registration ,[object Object]
Current Good Tissue Practice for HCT/P Establishments ,[object Object],[object Object]
Donor Suitability and Tracking ,[object Object],[object Object]
HIPAA ,[object Object],[object Object]
HIPAA and Research Uses of Medical Record Information ,[object Object],[object Object]
Clinical Research Involving Xenotransplantation: ,[object Object],[object Object]
Importation of Cell-Lines for Clinical Use ,[object Object],[object Object],[object Object]
Non-Federal Sources of Regulation or Oversight ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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