Emergency medical service providers' attitudes andexperiences regarding enrolling patients in clinical research trials

Objective: The purpose of this study was to evaluate Emergency Medical Services (EMS) providers' attitudes andexperiences about enrolling patients in clinical research trials utilizing the federal rules for exception from informed consent. We hypothesized that Emergency Medical Technicians (EMTs) would have varied attitudes about research using an exception from informed consent which could have an impact on the research. Methods andsetting: Since January 2007, the EMS system has been participating in a randomized, multi-center interventional trial in which out-of-hospital providers enroll critically injured trauma patients using exception from informed consent.A voluntary, anonymous, written survey was administered to EMS providers during an in-service. The survey included demographics andLikert-type questions about their experiences with andattitudes towards research in general, andresearch using an exception from informed consent for an out-of-hospital clinical trial. Results: The response rate was 79.3 (844/1067). Most respondents, 93.3, agreed that "research in EMS care is important." However, 38.5 also agreed that individual EMTs/paramedics should maintain the personal right of refusal to enroll patients in EMS trials. Fifty-four percent of respondents agreed with the statement that "the right of research subjects to make their own choices is more important than the interests of the general community." In response to statements about the current study, 11.3 agreed that "the study is unethical because the patient cannot consent" and69.2 responded that they would personally be willing to be enrolled in the study before they were able to give consent if they were seriously injured. Those who had not enrolled a patient into the study (681 respondents) were asked their reasons: 76.8 had not encountered an eligible patient or did not work for an agency that carried the fluid; 4.3 did not have time; 4.1 forgot and1.1 stated that they were opposed to enrolling patients in studies without their consent. Conclusion: The majority of EMS personnel in one community support EMS research andthis specific out-of-hospital clinical trial being conducted under an exception from informed consent. Potential barriers to enrollment were identified. Further study in other systems is warranted to better understand EMS provider perspectives about exception from informed consent research.