Premature Infants Die and Are Blinded: How Do We Balance the Risks to Study Participants With the Advancement of Medicine?
What a coincidence — just days after I sent the final edits of my book FOR THE GOOD OF MANKIND? THE SHAMEFUL HISTORY OF HUMAN MEDICAL EXPERIMENTATION to my editor at Lerner Publishing, the New York Times reported today about yet another clinical trial gone awry. In this case, the parents of premature infants were not adequately informed about the risks associated with a clinical study where oxygen was administered to the babies. Sadly, many of the infants died or were blinded.
As Sabrina Tavernise reported, “The underlying ethical question remains: How do researchers balance protecting these most vulnerable patients from the risks of medical studies with the potential benefits of such research for all premature babies?” This is the fundamental balancing test explored in my new book, and one which bioethicists continually debate.
Dr. Jerry Menikoff, Director of the Office of Human Rights Protections (OHRP), severely criticized the 23 hospitals involved in the trials, and said that it was “deeply troubling” that none of the doctors adequately warned the parents. “My goal is to make sure the parents are appropriately protected. It’s not too much to expect,” Dr. Menikoff said.
When I interviewed Dr. Menikoff for my book, he emphasized the need to make consent forms clearer, so that study participants truly understand the risks of an experiment. I’m happy to see he continues to watch over us.
