Thursday, April 11, 2013

The "Truth Dump"

"Omitting risks from a consent form these days is relatively rare, experts said, as institutions often want to reduce the chances that they will be sued. The result is voluminous forms that do more to protect the institution than to empower the potential subject." One medical ethics person calls this the "truth dump".

Yet, Sabrina Tavernise, reports to us, that in a study conducted on premature babies, parents were not informed that eye disease, blindness and death could result from their child's participation in the study. They were informed however that a possible abrasion to the baby's skin could occur from an oxygen monitoring device.

Reporter Tavernise goes on to note that in a 13 page letter from the Office of Human Research Protections investigating the study, researchers were aware of possible consequences.

I don't have a problem with the study, because I have no expertise to criticize it, but the informed consent form was, in my opinion, a deliberate scheme to keep parents ignorant of the risks. The University of California at San Diego was the institution that actually wrote the consent form but it was reviewed and approved by all 23 institutions involved in the study.

So to make everything okay, Dr. Richard B. Marchase, said: "… he had assured the office [Office of Human Research Protections] that in the future, “we will to the best of our ability let the subjects or their parents know as thoroughly as possible what previous studies suggest in terms of risk.” He added, “We are going to be very sensitive to that going forward as we look at these consent forms.”

I think we will be hearing more on this.
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