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1 International Compilation of Human Research Standards 2018 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 (collectively referred to as standards) that go vern human subjects research in 1 30 countries, as well as 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. Cont ent 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 in this Edition. Four new countries are featured in the 2018 Edition: Algeria, Madagascar, Mali, and Saint Lucia. For the first time, a section on Social-Behavioral Research. ORGANIZATION The Table of Contents is on pages 3-4. For each country, the standards are categorized by row as: 1. General, i.e., applicable to most or all types of human subjects research 2. Drugs and Devices 3. Clinical Trial Registries 4. Research Inju ry 5. Social-Behavioral Research 6. Privacy/Data Protection (also see Privacy International reports: www.privacyinternational.org/reports ) 7. Human Biological Materials 8. Genetic (also see the HumGen International database : www.humgen.umontreal.ca/int/ ) 9. Embryos, Stem Cells, and Cloning These nine categories often overlap, so it may be necessary to review the other standards to obtain an accur ate understanding of the The information is then organized into four columns: 1. Key Organizations include those groups that issue regulations or guidelines, or serve in a national oversight role for human subjects research. 2. Legislation encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent constitutional provisions. 3. Regulations refer to instruments that are created and issued in the name of governmental administrative bodies. 4. Guidelines pertain to non-binding instruments.
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