Premature Babies Study Raises Debate Over Risks and Ethical Consent; New York Times, 9/7/15

Sabrina Tavernise, New York Times; Premature Babies Study Raises Debate Over Risks and Ethical Consent:

"Professor Annas said the ruling simply meant that the families could not prove the study had caused the injuries, but that did not mean that it had not or that the consent forms, which he argues played a small role in the case, were obtained properly.

A good analogy, he said, was the decision by a federal judge last week to throw out a four-game suspension of the New England Patriots quarterback Tom Brady over his role in the deflation of footballs.

“That decision does not mean Brady is innocent any more than the Bowdre decision means that informed consent was properly obtained,” he said.

But others said the lawsuit’s failure was important, because it tipped the scales in favor of the researchers.

“This decision will mean, from a policy and practical point of view, that this kind of research is going to move on,” said Arthur Caplan, head of the division of medical ethics at NYU Langone Medical Center. He said if the judge had agreed to hear the case, “we’d have research slowing down, everyone waiting to see the outcome of a trial before starting projects.”

As for the New England Journal of Medicine authors, “they are a little enthusiastic,” he said, “but they are mainly right because they are breathing a giant sigh of relief that the legal system didn’t find enough to call the Support study researchers to task.”

Even so, the issue remains unresolved. The federal government is trying to come up with more explicit guidance about the consent process. A final version is expected next year. And the office that first found the trial’s consent practices lacking stands by its conclusion."