The regulation allows the conduct of research studies to test emergency treatments on patients with specific life-threatening medical conditions, such as head trauma, cardiac arrest and stroke, when patients cannot give informed consent because of their conditions, and family is not available to provide consent either.
Such emergency research has been allowed under very restricted circumstances since 1996 when FDA regulations went into effect providing for a narrow exception to the informed consent research requirements.
The review is taking place under the FDA’s Human Subject Protection and Bioresearch Monitoring Program (HSP-BIMO Program) aimed at strengthening the agency’s oversight and protection of patients in clinical trials and the integrity of resulting data.
On rare occasions and under carefully regulated circumstances, a person in a life-threatening situation will be enrolled in an emergency research study before arriving at a hospital (and may be treated in an ambulance) or in the emergency room of a hospital without being able to give his or her informed consent because of his or her medical condition.
The FDA said that it has received a sizable number of requests to conduct a clinical investigation under this regulation since it was introduced in 1996.
“On the 10-year anniversary of this regulation, it is appropriate that we review the regulation and get the perspectives of those who participated in such studies to make sure that emergency research is being carried out in a scientifically sound and ethical manner,” said Dr Janet Woodcock, FDA’s Deputy Commissioner for Operations.
“Unless the medical community can conduct studies in these life-threatening emergency situations we may not truly have scientifically validated solutions to benefit patients in these extremely difficult circumstances. It is critical that this type of research be conducted to help advance the practice of emergency medicine,” continued Dr Woodcock.