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Trauma patients, community say they support exception from informed consent research
Date:2/1/2013

tions, 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.

Instead, the EFIC guidelines call for a community consultation and notification process to make the target community aware that the research will be taking place, including information on how to opt out of the study. But progress in trauma and other disciplines has been hampered by the difficulties of conducting research under these regulations, partly because it can be difficult to define the intended patient population and engage with them during the consultation process. While research on a condition such as epilepsy would call for meeting with patient advocacy groups dedicated to that particular illness, EFIC research for traumatic injuries which, in the case of things such as car accidents, can strike anyone at anytime presents more challenges.

To obtain more insights about how EFIC research may be perceived by prospective patients and the community at large, the Penn Medicine team studied the community consultation process associated with an upcoming Penn trial known as AVERT Shock, which will investigate the effect of using the hormone vasopressin during resuscitation of patients who have lost a large amount of blood. The team conducted interviews with 309 Hospital of the University of Pennsylvania trauma patients and their families, as well as members of community organizations and churches in the neighborhood surrounding the hospital, in West Philadelphia.

The overwhelming majority of the participants more than 95 percent supported the need for more trauma research, and indicated tha
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Contact: Holly Auer
holly.auer@uphs.upenn.edu
215-349-5659
University of Pennsylvania School of Medicine
Source:Eurekalert

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