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U.S. Department of Health and Human Services

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January 27, 1981

Picture of two women - one on the table and the other one talking with her. The FDA and the Department of Health and Human Services issue revised regulations to better protect people participating in medical research studies. Changes include clarification of procedures for informing potential study participants about what the research involves and any potential risks


FDA in 2006


Hurricane Katrina, which devastated the Gulf Coast region in September 2005, has caused serious problems for many clinical research programs in the area. Hospitals and other institutions conducting clinical trials are confronting problems ranging from damaged or lost research records and investigational products, to the relocation of people participating in the studies who fled the storm. The FDA's good clinical practice program staff is reaching out to clinical trial sponsors to help them find ways to protect patients and continue valuable research.



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