A new clinical trial funded by the U.S. government exposes premature infants suffering from anemia to risks without fully informing their parents, according to the advocacy group Public Citizen.
Both complaints raise a big issue that's certain to get more attention beyond these particular studies.
Public Citizen wrote a letter to the U.S. Health and Human Services Secretary Kathleen Sebelius, urging them to put an end to recruiting for the trial. The purpose of the trial is to determine the best way to treat anemia in premature infants.
Public Citizen said the clinical trial exposes the infants to risks without fully informing their parents.
The NIH said it 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.
It also calls on HHS to notify parents of babies already enrolled in the trial of the potential risks.
The group said that of 17 IRB-approved consent forms it had obtained, only one mentions the foreseeable risk of death or disability, five say the research poses no risk and 16 equate the risks of the research to the risks of routine medical care.
