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Perceived Challenges to Obtaining Informed Consent for a Time-sensitive Emergency Department Study of Pediatric Status Epilepticus: Results of Two Focus Groups |
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| Authors: | James M. Chamberlain MD Kathleen Lillis MD Cheryl Vance MD Kathleen M. Brown MD Olubunmi Fawumi Shari Nichols Colleen O. Davis MD MPH Tasmeen Singh MPH EMT-P Jill M. Baren MD MBE the Pediatric Emergency Care Applied Research Network |
| Affiliation: | From the Departments of Pediatrics and Emergency Medicine, George Washington University School of Medicine and Health Sciences, Children's National Medical Center (JMC, KMB), Washington, DC;Pediatrics and Emergency Medicine, State University of New York at Buffalo School of Medicine, Women and Children's Hospital of Buffalo (KL), Buffalo, NY;Emergency Medicine and Pediatrics, University of California at Davis (CV), Sacramento, CA;the Department of Emergency Medicine, University of Michigan Health System (OF), Ann Arbor, MI;University of California at Davis (SN), Sacramento, CA;Pediatrics, University of Rochester School of Medicine, Strong Memorial Hospital (COD), Rochester, NY;EMSC National Resource Center, Children's National Medical Center (TS), Washington, DC;and the Emergency Medicine and Pediatrics, University of Pennsylvania School of Medicine (JMB), Philadelphia, PA. |
| Abstract: | Objectives: The objective was to describe the perspective of research personnel on issues of informed consent in a time-sensitive clinical study under emergency circumstances. Methods: The authors convened concurrent focus groups of research staff and investigators involved in a pharmacokinetic study of lorazepam for status epilepticus (SE). Moderators led discussion with open-ended questions on selected issues of parental consent, communication and understanding, patient assent, and comparison to other types of studies. Focus group transcripts were analyzed to identify themes and subthemes from the discussions. Results: Most themes and subthemes were identified in both research staff and investigator focus groups. Focus group discussion points were categorized into three main themes: barriers to and enablers of informed consent, barriers to and enablers of actual enrollment, and overall ethical concerns about the research. Many of the issues identified were unique to emergency research. Conclusions: From the perspectives of research staff and investigators enrolling patients in a time-sensitive emergency department study, the authors identified several areas of concern that should be addressed when planning future emergency studies. |
| Keywords: | informed consent clinical research consent documents research ethics |