Research

International Compilation of Human Research Protections

International Compilation of Human Research Protections
2011 Edition
Compiled By:
Office for Human Research Protections
U.S. Department of Health and Human Services

PURPOSE
This Compilation lists over 1,000 laws, regulations, and guidelines that govern human subjects research in 101 countries, as well as the standards from a number of international and regional organizations. This Compilation was developed for IRBs/Research Ethics Committees, researchers, sponsors, and others who are involved in international research. Its purpose is to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure these standards are followed appropriately.

In addition to numerous additions and updates to the 2010 Edition provided by in-country contact persons, the 2011 Edition features:
1. A new sub-section on the laws, regulations, and guidelines on medical device research, which is found in the “Drugs and Devices” section.
2. The laws, regulations, and/or guidelines for five new countries: Belarus, Grenada, Pakistan, Rwanda, and Tunisia.