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June 6, 2001

The Role of Local Institutional Review Boards in Protecting Human Research Subjects—Reply

Author Affiliations

Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001

JAMA. 2001;285(21):2713. doi:10.1001/jama.285.21.2713

In Reply: We suggested improving the current system of protecting human subjects in clinical research through simplified reports and harmonized regulations to ensure better communication among the parties responsible for oversight of such research. Drs Burman and Schooley call for more radical change; in an interesting twist on a much rehearsed proposal, they would charge central IRBs and DMCs with oversight responsibility in multicenter trials. They base their suggestion on observations that having multiple IRBs do similar work is inefficient and ineffective, and that IRBs are already overburdened.

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