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 Slide 1

National Regulations and Guidelines

Throughout the world, countries where research is taking place are at various stages in the development of national human research ethics regulations or guidelines and the establishment of an infrastructure to supervise such research. The rapid rise in the amount of research conducted in low-resource settings has further exposed the need for the creation of national regulations and for the appropriate support of its implementation.

Many countries—such as Brazil, Canada, India, Mexico, Nepal, South Africa, Thailand, and Uganda— have national regulations on the conduct of human research. However, many countries still lack or are developing formal regulations. While existing international recommendations, such as the Declaration of Helsinki or the CIOMS International Ethical Guidelines, are important references, they are not a substitute for national or local regulations.

The U.S. Office for Human Research Protections maintains the International Compilation of Human Subject Research Protections, which it describes as “a listing of the laws, regulations, and guidelines that govern human subjects research in many countries around the world.” As of 2010, the listing included information from 96 countries.

Learner/Facilitator Note: Does your country have established guidelines for the conduct of research? Does your local institution?

The International Compilation of Human Subject Research Protections may be viewed on the Internet. The URL is included in the Additional Resources section under Useful Internet Sites, U.S. Department of Health and Human Services.

 
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