InternationalCompilationofHumanResearchStandards.doc

International Compilation of Human Research Standards 2016 Edition Compiled By: Office for Human Research Protections U.S. Department of Health and Human Services PURPOSE The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines that govern human subjects research in 120 countries, as well as the standards from a number of international and regional organizations. This Compilation was developed for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research around the world. Content experts from around the world, listed at the back of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered into this Edition. Seven new countries are featured in the 2016 Edition: Burkina Faso, C?te-dIvoire, Cuba, Sri Lanka, Trinidad and Tobago, United Arab Emirates, and Uzbekistan. The 2016 Edition also contains a new category for Clinical Trial Registries. ORGANIZATION The Table of Contents is found on page 3. For each country, the standards are categorized by row as: General, i.e., applicable to most or all types of human subjects research Drugs and Devices Clinical Trial Registries Research Injury Privacy/Data Protection (also see Privacy International reports: /reports) Human Biological Materials Genetic (also see the HumGen International database: http://www.humgen.umontreal.ca/int/) Embryos, Stem Cells, and Cloning These eight categories often overlap, so it may be necessary to review the other standards to obtain a full understanding of the country’s requirements. The information is then organized into four columns: Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight role for human subjects research. Legislation – encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent const