Traumatic injury – including car accidents, gunshot wounds, and stabbings – is the leading cause of death for people younger than 40 years old in the United States, but despite the toll of these injuries, few emergency medical interventions considered to be the standard of care for these injuries have been rigorously studied in clinical trials, because patients and their families are typically unable to consent to participate in research. A new study from the Perelman School of Medicine at the University of Pennsylvania sought to examine peoples’ willingness to be enrolled in these types of studies under the federal provisions that allow patients with time-sensitive illnesses and injuries to be part of clinical trials without their express consent. The study revealed that those surveyed expressed high levels of approval and willingness to be part of these types of trials, both for themselves and their family members and friends. The findings provide important clues for increasing the number of studies aimed at improving care for this patient population.
The study is published this month in the Journal of Trauma and Acute Care Surgery.
“We’re trying to advance care and really change the mortality rates associated with these injuries, but we will never really be able to do that until we can apply the scientific method,” says the study’s lead author, Carrie A. Sims, MD, MS, an assistant professor and the director of Research in Penn Medicine’s division of Traumatology, Acute Care Surgery, and Surgical Critical Care. “We don’t have all the answers, but we can get closer by conducting more of the same rigorous studies that have led to improvements in care for diseases from cancer to cardiovascular disease.”
Since many trauma patients are unconscious and unable to consent to be part of a clinical trial, this research must be conducted under the Food and Drug Administration’s Exception from Informed Consent (EFIC) regulations, which were established in 1996. These stipulations, designed to protect patients, govern how physicians can ethically study time-sensitive conditions like traumatic injuries and illnesses including cardiac arrest and stroke. All of these scenarios require instant medical intervention, without the typical discussion of the risks and benefits associated with participation in a study which would typically comprise the informed consent process.
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