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

Area of Science:

• Emergency Medicine
• Clinical Research Ethics
• Public Health Communication

Background:

• Emergency departments (EDs) present unique challenges for recruiting participants in clinical research, especially when informed consent procedures need to be waived.
• Effective communication strategies are essential to inform potential participants about research opportunities and gather data on their willingness to participate.
• Previous methods for community notification in ED settings have not been consistently evaluated for their success.

Purpose of the Study:

• To evaluate an ED-based method for providing targeted, individualized consultation, community notification, and public disclosure.
• To collect data on patient willingness to participate in prospective resuscitation research requiring a waiver of consent.
• To assess the viability and success of community notification strategies in an urban ED setting.

Main Methods:

• A prospective survey of a convenience cohort was conducted in an urban ED.
• Patients with pulmonary disease were targeted for notification using posters, scripted oral presentations, and video demonstrations about an emergency intubation clinical trial.
• Data were collected on patient agreement, decline, or undecided status regarding participation.

Main Results:

• Approximately 10% of the annual ED census (6,936 subjects) enrolled in the study.
• Of 29 subjects also in a coincident endotracheal intubation study, 75.9% received community notification prior to intubation.
• Among those notified, 13 agreed to participate, six declined, and three were undecided; subsequent notification yielded similar results.

Conclusions:

• ED-based community notification and public disclosure are viable methods for informing target populations about research.
• Collecting feedback data is critical for ethical understanding and institutional review board approval, especially for research with waived informed consent.
• Requiring feedback data collection serves as a vital subject protection measure in emergency research settings.