The 2017 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 126 countries, as well as standards issued by a number of international and regional organizations.
The updated edition includes hundreds of updates from the previous year. Six new countries are included in the 2017 edition: Benin, Bermuda, Democratic Republic of the Congo, Dominican Republic, Guyana, and Senegal.
The listings are organized into eight categories:
- General Research
- Drugs and Devices
- Clinical Trial Registries
- Research Injury
- Privacy/Data Protection
- Human Biological Materials
- Genetic Research
- 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.
The International Compilation of Human Research Standards is available in PDF format:
- Part 1 (PDF 1.3MB): – PDF International and Europe (pages 1-105)
- Part 2 (PDF 1.1MB): – PDF Asia/Pacific, Middle East, Latin America and the Caribbean, Africa, and Acknowledgements (pages 106-168)
Disclaimer: Though this Compilation contains information of a legal nature, it has been developed for informational purposes only and 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.
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