Comments Submitted on Common Rule Sought to Ease Administrative Burden for Medical Researchers

The Office of Human Research Protections at the Department of Health and Human Services spent years considering changes to the Common Rule, which governs the conduct of medical research funded by 15 different federal agencies. The Common Rule protects individuals participating in clinical trials against abuses, but also creates large administrative burdens on researchers, leading to delay from the time of discovery to implementation of treatment for patients. Our comments, formulated with the assistance of JAI attorneys, sought to ease this administrative burden while improving privacy protection of patient identifiable information.

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The newly-adopted Common Rule incorporated the vast majority of ACS and ACS CAN’s recommendations.