International Regulations



The 2015 edition of the International Compilation of Human Subjects Protections is available online.

The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 113 countries, as well as standards issued by a number of international and regional organizations. Six new countries are included in the 2015 edition: Ghana, Guinea, Liberia, Malaysia, Saudi Arabia, and Sierra Leone.  The 2015 edition also includes hundreds of updates from the previous 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 Research
7.    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.