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WASHINGTON — The National Academies of Sciences, Medicine, and Engineering are urging the Obama administration to withdraw its proposed changes to the federal rules governing human research in the United States.

Of particular concern: The administration’s plan to require scientists to get patient consent before doing most any research on biospecimens, such as blood or tissue, even when the samples are not linked with any information that could be used to identify the patients.

The proposal “would impose significant burdens and limitations on research institutions,” the academies wrote in an analysis released Wednesday. They also raised concern that many health institutions wouldn’t have the infrastructure or resources to comply with the proposed changes to research regulations, which are known as the Common Rule.


And they criticized the proposed changes generally for a lack of clarity.

Groups like the American Association for Cancer Research have also expressed some of the same concerns about the proposed changes.


Federal officials and some patient advocates defend the proposed revisions, arguing that consent requirements are necessary to protect patient privacy at a time when rapidly improving technology is making it possible to learn more and more about a person based on their genetic profile.

The national academies are urging Congress and the administration to instead convene an independent national commission to study and recommend changes to how human research is governed.

Some of the experts who have been following the administration’s proposal believe the academies’ recommendations released on Wednesday could have a significant impact.

“I think it would be surprising if the Common Rule agencies moved forward with a final rule in the face of the criticisms,” said Michael Carome, a former senior official in the US Department of Health and Human Services’ human research office who is now with the advocacy group Public Citizen.