Emergency Experiments

When doctors may use experimental treatments in the emergency room, without getting the consent of a trauma victim, has been the subject of deliberations between the US Food and Drug Administration and the National Institutes of Health.

Consent to an experimental treatment may be waived when the therapy can save someone who cannot physically consent and has no better option, according to the FDA, but the NIH feels that experiments must pose no more risk than the patient would have in daily life.

While FDA Deputy Commissioner Mary Pendergast said the agency wants research to go forward ethically, she added there are no simple answers. The NIH's Gary Ellis said that even dying patients must be protected against unsafe experiments. The government has been asked by researchers to redefine its definition of experiments that are too risky for patients already threatened with death or disability.