BOOST II consent form controversy

In a recent BMJ article US health lobbyist Sidney Wolfe expressed surprise that Australian authorities had not “investigated the adequacy” of consent forms used in the NHMRC-funded BOOST II trial.

The trial was designed to evaluate the effects of using two different oxygen saturation ranges (85—89% and 91—95%) on disability-free survival at two years in infants born before 28 weeks’ gestation.

It was developed in response to an emerging trend of using lower