Quality Control: Human Research Subjects

All members of our research teams, when working with human subjects, adhere to the ethical principles and guidelines specified by The Belmont Report, The Declaration of Helsinki, the Code of Federal Regulations: Protection of Human Subjects, and the FDA ICH Good Clinical Practice Consolidated Guideline. Below are links to these documents.

• The Belmont Report
  Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979.
   
• The Declaration of Helsinki
  Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964,
  amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975,
  the 35th WMA General Assembly, Venice, Italy, October 1983,
  the 41st WMA General Assembly, Hong Kong, September 1989,
  the 48th WMA General Assembly, Somerset West, South Africa, October 1996,
  and the 52nd WMA General Assembly, Edinburgh, Scotland, UK, October 2000.
   
• The Code of Federal Regulations
  Title 45, Public Welfare, Department of Health and Human Services,
  National Institutes of Health Office for Protection from Research Risks,
  Part 46, Protection of Human Subjects,
  Revised November 13, 2001, Effective December 13, 2001.
   
• FDA ICH Good Clinical Practice Consolidated Guideline
  Department of Health and Human Services, Food and Drug Administration,
  International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline.

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