Clinical Research News
OHRP publishes international protections info
Five countries added to compilation
The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services has published online its 2011 edition of the "International Compilation of Human Research Protections."
The 100-page document can be found at the OHRP website at http://www.hhs.gov/ohrp/ by clicking on the "international" link.
The compilation lists more than 1,000 laws, regulations, and guidelines from 101 countries. These are related to human subjects research and include standards from various international and regional organizations. The compilation's purpose is to offer information for investigators, IRBs, and others involved in international research.
The 2011 edition includes a new sub-section on the laws, regulations, and guidelines on medical device research under its "Drugs and Devices" section, and it includes the laws, regulations and/or guidelines for five new countries, including Belarus, Grenada, Pakistan, Rwanda, and Tunisia.
The compilation's table of contents lists each country and has these categories of standards:
- General, related to most or all types of human subjects research
- Drugs and Devices
- Privacy/Data Protection
- Human Biological Materials
- Genetic
- Embryos, Stem Cells, and Cloning.
- The information is organized into four columns, which are as follows:
- Key organizations, which include groups that issue regulations or guidelines or that serve in a national oversight role for human subjects protection
- Legislation, which includes statutes, statutory instruments, and legislative decrees, as well as constitutional provisions that relate to human subject protections
- Regulations, which refer to instruments that are created and issued under the name of governmental administrative bodies
- Guidelines that pertain to non-binding instruments.
Many of the listings in the online document include hyperlinks to the source document.
The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services has published online its 2011 edition of the "International Compilation of Human Research Protections."You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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