A Novel Emergency Department‐based Community Notification Method for Clinical Research Without Consent

• Published in: Academic emergency medicine Vol. 24; no. 6; pp. 721 - 731
• Main Authors: O'Malley, Gerald F., Giraldo, Patricia, Deitch, Kenneth, Aguilera, Elizabeth Andrea, Cadar, Sorin, Lares, Claudia, O'Malley, Rika Nagakuni, Oqroshidze, Nino, Verma, Manisha, Chudnofsky, Carl, Yadav, Kabif
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.06.2017
• Subjects: Biomedical Research - methods; Consent; Data Collection - methods; Disclosure - ethics; Emergency medical care; Emergency Service, Hospital; Female; Humans; Informed Consent - ethics; Intubation; Male; Prospective Studies; Sex offenders
• ISSN: 1069-6563; 1553-2712; 1553-2712
• DOI: 10.1111/acem.13173

Objective We used an emergency department (ED)‐based method to provide targeted, individualized consultation; community notification; and public disclosure and collect data regarding willingness to participate in prospective resuscitation research requiring waiver of consent. Methods We conducted a prospective survey of convenience cohort in an urban ED. We targeted the community of ED patients with pulmonary disease for individualized notification and public disclosure using a 1) large poster, 2) scripted oral presentation describing an emergency intubation clinical trial, and 3) video demonstration. Results Approximately 10% of our annual ED census, 6,936 subjects, enrolled. Of that total, 29 were also subjects in a prospective coincident endotracheal resuscitation intubation study, which enrolled a total of 262 subjects. ED community notification was provided to 22 of the 29 (75.9%) subjects prior to the visit during which they were intubated (13 agreed to participate, six declined, and three undecided) and seven of the 29 subjects subsequent to enrollment in the intubation study (five agreed to participate and two undecided). Fourteen of the 29 patients who participated in both projects had undergone endotracheal intubation at least once prior to community notification: 10 agreed to participate in the study, two declined, and two were undecided. Conclusions Emergency department–based community notification and public disclosure is a viable way to provide information to a target population and collect data about the success of the notification. Feedback data collection is critical to an ethical understanding of the success of community notification for the institutional review board and investigators. Collection of feedback data should be required as a subject protection for exception from informed consent in emergency settings.