A blood transfusion hopes to use newborn subjects, and the consumer group Public Citizen is strongly opposed to the study's methods.
The study, called Transfusion of Premature (TOP), will test a transfusion method on 1,800 premature infants. The purpose of the treatment would be to cure anemia, and other early-birth-related problems, NPR reported.
What Public Citizen is concerned about is that one of the study groups will not receive the treatment until their anemia has become severe. The other group will receive the transfusion when the condition is still mild.
A 2010 study, conducted by the same company called Neonatal Research Network, tested two methods of oxygen treatment for newborns. The point of the study was to see which method was less likely to cause blindness and death.
Public Citizen argues TOP fails to inform parents of the risks associated with their child's specific scenario and method of treatment.
In a letter to the U.S. Department of Health and Human Services, Public Citizen asked them to stop the study from happening because of "the serious deficiencies in the consent forms and unresolved questions about the ethics of the study design," NPR reported.
The National Institutes of Health is in favor of the study.
"NIH is committed to ensuring that prospective research participants - and the people who speak for and love them - are given clear, complete and accurate information about the risks and benefits of participating in research," the institute said in a statement, according to NPR.
Public Citizen claimed the TOP consent forms contained the phrases "This study does not carry any additional risk to your baby," "There are no known risks at this time to participation in this study," and risks "are exactly the same risks that exist in current medical practice," according to NPR.
Public Citizen argued parents should also be informed if their child will not receive the treatment that would be typical of their condition.
"You have to make sure parents understand what you're asking them to do," ethicist George Annas, of Boston University, said, according to NPR ."The primary thing is you're giving up your right to a physician who makes decisions based on what he or she thinks is in the best interest of your child rather than flipping a coin.
