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Saturday, February 8, 2014

Watchdog agency criticizes ethics of study of premature infants

By David Brown
The Washington Post
Originally published April 10, 2013

A clinical experiment involving 1,300 premature infants at two dozen hospitals “failed to adequately inform parents” of the risks of the treatment, which included blindness, brain damage and death, according to a watchdog agency at the Department of Health and Human Services.

The description of the experiment that parents read before deciding whether to enroll their babies downplayed the risks and emphasized possible benefits of getting a less-than-average amount of supplementary oxygen in the critical weeks after birth.

“The consent form was written in a slanted way,” said Jerry A. Menikoff, director of the Office for Human Research Protections (OHRP), which found that the study was “in violation of the regulatory requirements for informed consent” required by federal law.

The entire story is here.