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Nov 17

2018 International Compilation of Human Research Standards

2018 Edition of International Compilation of Human Research Standards Now Available

The 2018 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html . The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 130 countries, as well as standards issued by a number of international and regional organizations.

The updated edition includes hundreds of updates from the previous year. Four new countries are included in the 2018 edition: Algeria, Madagascar, Mali, and Saint Lucia. For the first time, this year’s Compilation includes a section on Social-Behavioral Research.

The listings are organized into nine categories:

  1. General Research
  2. Drugs and Devices
  3. Clinical Trial Registries
  4. Research Injury
  5. Social-Behavioral Research
  6. Privacy/Data Protection
  7. Human Biological Materials
  8. Genetic Research
  9. Embryos, Stem Cells, and Cloning

Most of the listings include a hyperlink that allows the user to directly access 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. The Compilation was first published in 2005 and is updated annually.