SACHRP Meeting to Discuss Research Consent Issues


The Department of Health & Human Services’ Secretary’s Advisory Committee on Human Research Protections (SACHRP) has announced that it will be holding a 2-day public meeting centering on consent issues in clinical research.

Part of the meeting will be devoted to discussion of consent issues in the context of cluster randomized trials. Unlike “typical” clinical trials that randomly assign an individual research volunteer to receive one of two treatment options, or a treatment vs. a placebo, a cluster randomized trial (or CRT) randomly assigns groups of people to an intervention. These groups can include clinics, hospitals, city blocks, or whole healthcare systems. Because CRTs randomize groups rather than individuals, obtaining consent from the people involved in such research can present a number of challenging issues.

Meeting participants will also discuss a variety of other topics related to the application of regulations governing research conduct in the current era, as well as potential changes to such regulations.

The meeting, which will include programmed presentations as well as a period for public comment, will be held in Washington, DC, on March 12-13, 2014, at the U.S. Department of Health and Human Services, 200 Independence Avenue SW., Hubert H. Humphrey Building, Room 800. A full program of the meeting’s events is available here, and additional description and context are available from the Federal Register.


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