STUDY OBJECTIVES: The emergency department (ED) provides an arena for patient enrollment into a variety of research studies even for non-critically ill patients. Given the types of illness, time constraints and sense of urgency that exists in the ED environment, concern exists about whether research subjects in the ED can provide full consent for participation. We sought to identify enrolled research subjects' perspectives on the informed consent process for research conducted in the ED. METHODS: This was a prospective, observational study of ED subjects, 18 years or older, who had been approached to participate in research in the ED and who were judged to have decision-making capacity. Exclusions were critical illness and refusal to participate. Subjective were followed up within 1 week after enrolling using structured phone interviews by trained interviewers. RESULTS: During the study period, 229 eligible patients were approached to participate in both a target study and this study. Of these, 66% (150/229) agreed to participate in this study, at least to the extent of allowing us access to their demographic data. The study participant group was similar in terms of gender to this particular ED's patient population but had significantly more African-Americans and persons older than 45. CONCLUSION: Despite rigorous time constraints and rapid throughput times, the majority of subjects who consented to research participation in the ED felt that they were sufficiently informed and had adequate time to decide to participate.
STUDY OBJECTIVES: The emergency department (ED) provides an arena for patient enrollment into a variety of research studies even for non-critically ill patients. Given the types of illness, time constraints and sense of urgency that exists in the ED environment, concern exists about whether research subjects in the ED can provide full consent for participation. We sought to identify enrolled research subjects' perspectives on the informed consent process for research conducted in the ED. METHODS: This was a prospective, observational study of ED subjects, 18 years or older, who had been approached to participate in research in the ED and who were judged to have decision-making capacity. Exclusions were critical illness and refusal to participate. Subjective were followed up within 1 week after enrolling using structured phone interviews by trained interviewers. RESULTS: During the study period, 229 eligible patients were approached to participate in both a target study and this study. Of these, 66% (150/229) agreed to participate in this study, at least to the extent of allowing us access to their demographic data. The study participant group was similar in terms of gender to this particular ED's patient population but had significantly more African-Americans and persons older than 45. CONCLUSION: Despite rigorous time constraints and rapid throughput times, the majority of subjects who consented to research participation in the ED felt that they were sufficiently informed and had adequate time to decide to participate.
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