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.
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.
Authors: E P Sloan; M Koenigsberg; J Houghton; D Gens; M Cipolle; J Runge; M N Mallory; G Rodman Journal: Acad Emerg Med Date: 1999-12 Impact factor: 3.451
Authors: Terri A Schmidt; David Salo; Jason A Hughes; Jean T Abbott; Joel M Geiderman; Catherine X Johnson; Katie B McClure; Mary Pat McKay; Junaid A Razzak; Raquel M Schears; Robert C Solomon Journal: Acad Emerg Med Date: 2004-10 Impact factor: 3.451
Authors: Brian E Bunnell; Gina Sprague; Suparna Qanungo; Michelle Nichols; Kathryn Magruder; Steven Lauzon; Jihad S Obeid; Leslie A Lenert; Brandon M Welch Journal: Telemed J E Health Date: 2019-02-20 Impact factor: 3.536
Authors: Valerie Shilling; Paula R Williamson; Helen Hickey; Emma Sowden; Michael W Beresford; Rosalind L Smyth; Bridget Young Journal: PLoS One Date: 2011-07-12 Impact factor: 3.240
Authors: Nina H Gobat; Micaela Gal; Nick A Francis; Kerenza Hood; Angela Watkins; Jill Turner; Ronald Moore; Steve A R Webb; Christopher C Butler; Alistair Nichol Journal: Trials Date: 2015-12-29 Impact factor: 2.279
Authors: Jeremy Furyk; Kris McBain-Rigg; Bronia Renison; Kerrianne Watt; Richard Franklin; Theophilus I Emeto; Robin A Ray; Franz E Babl; Stuart Dalziel Journal: BMC Med Ethics Date: 2018-11-20 Impact factor: 2.652