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Human Subjects Division (HSD)

Regulatory Updates

OHRP: 2011 Edition of the International Compliation of Human Subject Protections Now Available

Dec 20, 2010 at 8:35am

The 2011 edition of the International Compilation of Human Subject Protections has just been released and is now available on-line. The document can be seen at: http://www.hhs.gov/ohrp/international/intlcompilation/hspcompilation-v20101130.pdf

The updated Compilation includes a listing of over 1,000 laws, regulations, and guidelines on human subject protections in 101 countries and from several international organizations. The new Compilation also features the standards regarding device research, which were identified in 44 countries. These laws, regulations, and guidelines are classified into six categories:

  • General
  • Drugs and Devices
  • Privacy/Data Protection
  • Human Biological Materials
  • Genetic issues
  • Embryos, Stem Cells, and Cloning

New countries included in this year's edition are Belarus, Grenada, Pakistan, Rwanda, and Tunisia. Many of the listings include a hyperlink, allowing the reader to link directly to the law, regulation, or guideline of interest.

Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world.