Was it enough for doctors to tell the parents of extremely premature infants that there was “no additional risk” to their babies if they enrolled them in a randomized trial? One treatment group, in which the preemies were maintained with higher blood oxygen, risked eye damage. The other kept the babies at lower oxygen levels, risking brain damage and perhaps death. Both were within the range of care that the babies would have received anyway.
That’s one of the loaded questions that senior US health officials grappled with today at an unusual public meeting convened by the National Institutes of Health (NIH) and the Office for Human Research Protections (OHRP), which polices the ethics of NIH-funded clinical trials.