Significant Changes to Institutional Review Boards Proposed: Government May Issue First Changes in Decades to the Common Rule on Human Subjects Research

For the first time in more than 20 years, the federal government has recently proposed changes to a regulation that has been a mainstay of scientific research in the United States. The proposal came in July 2011, when the Department of Health and Human Services (HHS) published an advance notice of proposed rule making in the Federal Register [1]. The notice, titled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” announced the desire of the agency, along with the Office of Science and Technology Policy, to change long standing rules concerning medical experiments involving humans.