National Guidelines

•  Canada
  • Guideline for Good Clinical Practice (ICH Harmonized Tripartite Guideline) (1997)
  • Animal to human transplantation - A public consultation on xenotransplantation - Canadian Public Health Association (2001)
  • Canada - Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research

   

•  Switzerland

  • Swiss Academy of Medical Sciences - Medical-Ethical Guidelines for Somatic Gene Therapy in Humans (1998)

  • Swiss Academy of Medical Sciences - Collaboration Between the Medical Profession and Industry (2002)

   

   

•  United Kingdom

  • The Royal Society UK 2005 - Personalized medicines: hopes and realities

  • The Influence of the Pharmaceutical Industry - House of Commons Health Committee (2004–05)

  • Human Genetic Databases - Challenges and Opportunities 2001

  • Genetics and Insurance 2001

  • The Implications of Genetic Testing for Employment HGAC July 1999

  • Government Response to HGAC Report on Genetic Testing and Employment 2000
  • United Kingdom Xenotransplantation Interim Regulatory Authority
  • UK Guidelines for Living Donor Kidney Transplantation
  • United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA)

  • UK House of Lords - Stem Cell Research (2002)

   

•  USA

  • Code of Federal Regulations - Title 45 - Public Welfare Part 46 Protection of Human Subjects

  • Code of Federal Regulations - Title 21 - Food and Drugs CHAPTER I--FDA Part 50 -Protection of Human Subjects

  • Guidance's and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials

  • FDA - Clinical Laboratory Improvement Amendments (CLIA)

  • Guideline for Industry - Structure and Content of Clinical Study Reports - 1996

  • Federal Register: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration - 7/21/2000
  • Draft National Institutes of Health Guidelines for Research Involving Human Pluripotent Stem Cells (December 2001) 
  • Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs May 20, 1994 / 43(RR-8);1-17 MMWR
  • American Society of Clinical Oncology (ASCO) Policy Statement Update: Genetic Testing for Cancer Susceptibility (2003)
  • Stem Cell Research – U.S. Federal Policy (2004)

  • Xenotransplantation Action Plan - Approach to the Regulation of Xenotransplantation