International Regulations

The 2016 edition of the International Compilation of Human Research Standards has now been released and is available online.  The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 120 countries, as well as standards issued by a number of international and regional organizations.

The updated edition includes hundreds of updates from the previous edition. Seven new countries are included in the 2016 edition: Burkina Faso, Cote-d’Ivoire, Cuba, Sri Lanka, Trinidad and Tobago, United Arab Emirates, and Uzbekistan. 

The listings are organized into eight categories:

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

Many 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.