Variations in the application of exception from informed consent in a multicenter clinical trial

Abstract

Background-Exception from informed consent (EFIC) is allowed using federal regulations 21 CFR 50.24 and facilitates research on patients with critical conditions such as cardiac arrest. Little is known regarding the differences in the application of EFIC requirements such as community consultation (CC), public disclosure (PD) and patient notification. We sought to characterize variations in the fulfillment of EFIC requirements in a national multicenter clinical trial in the United States. Methods-We determined the strategies for fulfillment of EFIC requirements at five regional coordinating centers of the Pragmatic Airway Resuscitation Trial (PART), a cluster-crossover randomized trial comparing airway devices in out-of-hospital cardiac arrest. We collected information from the including site demographics, how CC and PD were implemented, methods undertaken by the site investigative team to meet the local IRB's interpretation, and patient notification timing (post-enrollment). We analyzed the data using descriptive statistics. Results-Sites had multiple approaches to CC, including social media advertising, random digit dialing surveys, working with city officials, and websites with embedded surveys. All sites used more than one approach for conducting CC. Public Disclosure activities included press releases through various means, website documentation, and letters to community members and local officials. Time from CC to study approval ranged from 42 days to 253 days. Conclusion-EFIC implementation varies across sites and highlight community and regional variation. Different EFIC approaches may be needed to effectively accomplish the goals of community consultation, public disclosure, and patient notification.

Ethical Considerations in Clinical Trials for Disorders of Consciousness

“…In other contexts involving acutely injured or critically ill patients, researchers and clinicians have worked closely with ethicists to design study paradigms balancing principles of respect for patient autonomy, beneficence, justice, and non-maleficence, whilst facilitating research inclusion. Alternative paradigms of consent that may ensure protection of subjects’ autonomy without restricting responsible participation in research include the following: (i) surrogate consent (by legally appointed or default proxy decision-maker), (ii) waiver of informed consent utilizing a federal exception from informed consent (EFIC), (iii) deferral of consent with retrospective debriefing, (iv) a consent substitute model, and (v) community consultation [ 79 , 80 , 81 , 82 , 83 , 84 , 85 ]. Elements of each of these paradigms might be variably integrated into a hierarchical, adaptive, or multimodal system of informed consent to be deployed in a DoC clinical trial where variation in participant capacity or surrogate availability is anticipated.…”

Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic

“…3 Community consultation methods have varied, with differing approaches to define the community of interest. [4] , [5] , [6] , [7] , [8] Several studies have surveyed crowds (e.g. at state fairs) as a less expensive and more time-efficient method of community consultation.…”

Integration of social media with targeted emails and in‐person outreach for exception from informed consent community consultation

“…9 Furthermore, significant variabilities in approach occur even within the sites of the same trial due to differences in interpretation by institutional review boards. 6,9,11 As such, little is known regarding the best strategies to implement EFIC community consultation. This problem became even more evident during the COVID-19 pandemic, during which direct contact with the community was substantially reduced due to social distancing and restrictions in human subjects research.…”