"No consent" clinical trials are an ethical headache for the USA's FDA

The US Food and Drug Administration is planning to hold a public hearing or a public workshop on improving public notification before companies begin so-called "no consent" trials, according to the Chicago Tribune. The paper noted that drug and device companies have conducted 10 such trials since 1996.

The current discussion, however, is being prompted by a Northfield Laboratories study of a blood substitute, Poly-heme, where, for the past two years, trauma patients in 18 states have been given the product in place of saline or blood, without first giving their consent. Many trauma victims who experience severe blood loss are unable to give their consent. PolyHeme contains hemoglobin pro-cessed from expired blood donations and is designed to be given to trauma victims in place of blood or saline solution. It is designed to be used as a temporary measure when there is a large blood loss and no readily available blood supply, the company noted.

1996 FDA guidelines allow "no consent" trial