Friday, April 12, 2013

HEALTH - Parents of Preemies Not Fully Informed in Clinical Study?

"Hospitals Dispute Failure to Disclose Clinical Study Risks for Premature Infants" PBS Newshour 4/11/2013

Excerpt

JUDY WOODRUFF (Newshour):  Now the questions surrounding a research trial with newborn babies that allegedly didn't provide adequate disclosure to parents.

The trial involved 1,300 infants at 23 hospitals who were born extremely prematurely between 2004 and 2009.  Doctors were trying to better determine the right amount of supplemental oxygen they need to give to preemies.  If the oxygen level is too low, babies can die.  But if the rate is too high, it can lead to eye disease and blindness.

In the trial, half of the babies were assigned to a lower dose, half to a higher amount.   But, last month, the federal Office of Human Research Protections concluded that there wasn't appropriate informed consent.  In a letter to the centers, it said hospitals failed to "describe adequately the reasonably foreseeable risks of blindness, neurological damage, and death."

The nonprofit watchdog group Public Citizen brought that letter to light this week.

And we get more now with David Brown.  He's a reporter for The Washington Post.

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