Aggregated News
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.
The meeting was called after OHRP set off a firestorm this spring when it told investigators from the multi-site, NIH-funded SUPPORT trial that its consent forms failed to describe “the reasonably foreseeable risks of blindness, neurological damage and death” to the 1,316 infants that participated. (SUPPORT stands for “Surfactant, Positive Pressure, and Oxygenation Randomized Trial”, and the paper that resulted from...
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.
The meeting was called after OHRP set off a firestorm this spring when it told investigators from the multi-site, NIH-funded SUPPORT trial that its consent forms failed to describe “the reasonably foreseeable risks of blindness, neurological damage and death” to the 1,316 infants that participated. (SUPPORT stands for “Surfactant, Positive Pressure, and Oxygenation Randomized Trial”, and the paper that resulted from...