WASHINGTON-The FDA and NIH say clinical research can be ethical on unconscious patients.
They each issued rules to guide researchers on testing investigational drugs, devices, and procedures in ER and other life-threatening situations where informed consent isn’t possible.
The FDA previously had permitted emergency treatment with unapproved drugs, but not as part of formal trials. The new rules require that studies have a prior okay from an independent physician and an institutional review board.
ER and other patients can be enrolled in trials without their consent if available treatments are unproven or unsatisfactory, the research can’t be done in any other way, and it’s needed to prove safety and effectiveness.
The agencies would allow a study to go forward if the risks and benefits are “reasonable” compared with those associated with the patient’s condition and with standard therapy. FDA says its rules are slightly stricter than NIH’s.
At the behest of the American College of Emergency Physicians and others, NIH revised an earlier draft to cover both drugs and devices. The NIH had ruled out most invasive procedures on incapacitated patients, permitting such studies only if the risks to the patient were “extremely minimal.”
One of the first experiments to be conducted under the new rules is expected this fall, when an artificial blood will be tested in trauma patients.
Both policies also require that study proposals and their risks be made public and that the IRB gauge public reactions. Investigators will be required to notify the public of results once the study is done.
WASHINGTON-The FDA and NIH say clinical research can be ethical on unconscious patients.
