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USA to review clinical trial regulations

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USA to review clinical trial regulations

HHS announces proposal to improve rules protecting human research subjects

"Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight"

Comment is sought on the following:

  1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  3. Updating the forms and processes used for informed consent.
  4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  7. Providing uniform guidance on federal regulations.

more on: http://www.hhs.gov/news/press/2011pres/07/20110722a.html