SUPPORT and informed consent

The SUPPORT study has been criticized for not obtaining adequate informed consent. A defense of the informed consent consent obtained during SUPPORT emphasizes the clinical uncertainty and equipoise that existed at the onset of the trial (both of which justify the trial) and the dangers of using hindsight to judge the informed consent process. This issue was first raised by a group called Public Citizen.

HHS-funded experiment exposed babies to risk of death and blindness without informing parents. Public Citizen.

Informed consent and SUPPORT. Drazen et al, 2013

Risk, consent and SUPPORT. Magnus and Caplan, 2013

Oxygen saturation targets in extremely preterm infants. Carlo et al, 2013

Suspend enrollment in baby trials. Public Citizen.

In support of SUPPORT – a view from the NIH

The OHRP and SUPPORT – letter by scholars and ethicists