New rules ease consent requirements for scientists using patient specimens image

STAT, January 18, 2017
Sharon Begley, quoting Holly Fernandez Lynch (Executive Director)


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From the article:

Allowing researchers to study such biospecimens without written consent “is the most substantive change from the proposed regulation,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. Although the group had supported the effort to require such consent, Carome called the final rule “clearer, simpler, easier to understand, and appropriate.”

“This is a big win for science and therefore a big win for patients,” said bioethicist Holly Fernandez Lynch of Harvard Law School.

The proposed changes to the “Common Rule,” which has been in place in its current form since 1991 and governs research on people and human biological specimens, drew just over 2,100 comments during the 90-day public comment period after they were released in September 2015. Many raised what the Department of Health and Human Services, which oversees most federally funded research, called “concerns.” [...]

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bioethics biotechnology fda health law policy holly fernandez lynch human subjects research pharmaceuticals public health regulation research