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US proposes sweeping changes to guidance on human research

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d4939 (Published 01 August 2011) Cite this as: BMJ 2011;343:d4939
  1. Jeanne Lenzer
  1. 1New York

The US government has proposed an extensive list of changes to current guidelines on studies involving human participants, in a bid to keep pace with substantial change in the nature of such research and the way it is conducted.

If adopted, the changes will be the first in two decades to the “Common Rule” (a part of the Code of Federal Regulations) that regulates almost all federally funded human research. They would apply not only to studies directly funded by the government but also to all research conducted at institutions receiving federal funds, so as to “extend the protections afforded by these …

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