International Research Guidelines

Compilation of International Policies Provided by the Office of Human Research Protections (OHRP)

The International Compilation of Human Subject Research Protections is prepared by the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services. The Compilation, which is updated annually, is a listing of more than 1,000 laws, regulations, and guidelines on human subjects protections in 101 countries and from several international organizations. It is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world.

The Compilation includes laws, regulations and guidelines which are classified into six (6) categories: General, Drugs and Devices, Privacy/Data Protections, Human Biological Materials, Genetic Issues, Embryos, Stem Cells, and Cloning. In addition, standards regarding Device Research which were identified in more than 40 countries are also included.

Although the Compilation contains information of a legal nature, it was developed for informational purposes only. The Office of Human Research Protections (OHRP) reminds investigators who are about to engage in research outside the United States that the information provided does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction.

In addition, because new laws, regulations, and guidelines are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to international human subject research protections. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research activities.