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Human Subjects Division (HSD)

Regulatory Updates

OHRP: 2014 Edition of International Compilation of Human Research Standards Now Available

Dec 3, 2013 at 5:44am

The 2014 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/index.html.

The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 107 countries, as well as standards issued by a number of international and regional organizations. The standards address such issues as informed consent, research ethics committee review, reporting requirements, vulnerable populations, and more.

Three new countries are spotlighted in the 2014 edition: Cameroon, Mozambique, and Zambia. The 2014 edition also includes hundreds of updates from the 2013 edition.

The listings are organized into seven categories:

  1. General Research
  2. Drugs and Devices
  3. Research Injury
  4. Privacy/Data Protection
  5. Human Biological Materials
  6. Genetic
  7. Embryos, Stem Cells, and Cloning

Many of the listings include a hyperlink, allowing the user to link directly to the law, regulation, or guideline of interest. The Compilation is available in both PDF and MS Word versions.

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. The Compilation was first published in 2005 and is updated annually.