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

t the AVERT Shock Trial was an important study to perform. When queried on the appropriateness of enrolling patients if neither they nor a legally authorized representative could provide consent, 67 percent of participants agreed it would be acceptable to enroll a family member, 77 percent said it would be OK to enroll them personally, and 84 percent said it would be acceptable to enroll a member of their community. These results are in contrast to previous studies that show much lower support for research conducted under EFIC regulations. Only 63 percent of those interviewed, however, agreed that it was important to involve the community in making decisions on behalf of potential patients.

"We see the community consultation process required for EFIC research as serving an important educational need in our trauma community by engaging with members of the public on these issues, we are able to provide information about these injuries as well as the specific trials we are planning, which helps to improve support for our research efforts," Sims said. "We recognize that our patients are especially vulnerable, having been injured with no warning or knowledge of the medical care they will require, and we are eager to find ways to provide comfort and information that can help people during these frightening experiences."

The AVERT Shock Trial is designed to improve the standard of care for the 10 percent or so of trauma patients whose tremendous blood loss puts them at the highest risk of dying as a result of their injuries. The study, slated to begin this spring, will compare the use of normal saline the standard practice during resuscitation of trauma victims who have lost a substantial amount of blood with infusions of vasopressin, a hormone that's necessary to maintain blood pressure. Sims and her team will explore whether using vasopressin during resuscitations improves patient outcomes, by cutting complications, requiring less blood products duri
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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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