A systematic review of Federal Drug Administration Docket for community consultation and public disclosure in exception from informed consent trials

Haggins, Adrianne; Harney, Deneil; Scott, Sara; Silbergleit, Robert

doi:10.1177/1740774517737318

Cited by 8 publications

(15 citation statements)

References 11 publications

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“…Recognizing and honoring local variation in implementing CC and PD may be crucial to optimize these processes locally. A 2018 study systematically reviewed FDA-reported CC and PD activities for 34 trials 27 , indicating similar variability as our study, and concluded that there is a need to identify best practices and less uncertainty as to the implementation of CC and PD. With the current local variation in implementing CC and PD processes, there may be misunderstandings of what is required for CC and PD between local and centralized IRBs.…”

Section: Discussionsupporting

confidence: 72%

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

et al. 2019

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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.

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Section: Discussionsupporting

confidence: 72%

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

et al. 2019

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“…More work is needed to understand the gamut of community consultation activities and public disclosure activities that are documented and submitted to the FDA. One recent review of material submitted to the FDA docket 95S-0158 4 attempted to catalog these activities. However, that review examined online material only (with 177 official documents containing 6998 pages) rather than the full docket available by in-person request (with 177 official documents and 289 draft documents containing 15 958 pages at the time of this review).…”

Section: Discussionmentioning

confidence: 99%

Public Approval of Exception From Informed Consent in Emergency Clinical Trials

et al. 2019

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Key Points Question How does the public view emergency research conducted with an exception from informed consent (EFIC)? Findings In this systematic review of survey data from 27 emergency clinical trials with responses from 42 448 individuals submitted by EFIC trial organizers to the US Food and Drug Administration, public attitudes regarding EFIC varied: 58.4% approved of EFIC in principle, 68.6% approved of family-member enrollment, 73.0% approved of personal enrollment, and 86.5% approved of community inclusion. Groups surveyed with higher proportions of African American and male respondents had lower rates of EFIC approval, and these groups were underrepresented in surveys relative to their enrollment in EFIC trials. Meaning The US Food and Drug Administration should aim to build greater public consensus around the appropriate use of EFIC.

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“…We started with the trial samples identified by Klein et al, 7 Feldman et al, 8 Armstrong et al, 9 and Dhamanaskar & Merz. 12 We then examined the papers in the reviews of community engagement activities conducted in support of EFIC trials by Haggins et al, 10 and Dickert et al 11 as an indirect way of identifying trials. Other articles and reviews were examined to ensure we were capturing proposed and completed EFIC trials.…”

Section: Methodsmentioning

confidence: 99%

“…They identified 34 trials. 10 Most recently, Neal Dickert and colleagues performed a scoping review, identifying 27 articles reporting results of community engagement activities for planned EFIC trials. 11…”

mentioning

confidence: 99%

A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule

Snyder

Merz

2022

Preprint

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Background: The US Food and Drug Administration and National Institutes of Health adopted the Exception from Informed Consent (EFIC) rule in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the federal government. The rule requires that prospective consent be sought when practicable from patients or their Legally Authorized Representative(s) (LAR), and for those enrolled without consent, the patient or their LAR must be given information and an opportunity to opt-out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used. Methods: We conducted a multi-pronged search to try and identify all trials conducted under the EFIC rule, drawing on numerous reviews, Medline and Google searches (including of the clinicaltrials.gov registry), examination of the FDA's docket, posting an inquiry on the IRB Forum, and email requests to lead authors of all published EFIC trials and related review articles. We describe the trials, when they were started and completed, and whether they were terminated early. Results: We identified a total of 105 trials as of April 1, 2022: 77 complete, 10 recruiting, 10 registered on clinicaltrials.gov but not yet recruiting, 5 trials that were abandoned before enrolling any subjects, and 3 trials in early planning. Nine of the 77 completed trials were pilot or feasibility trials. Of 68 completed full trials, 30 (44.1%) were terminated early. The most common reason for early termination was futility or safety (17 trials, 25.0%) followed by poor recruitment (9 trials, 13.2%). The rate of conduct of trials has been remarkably constant since 2001, with roughly 18 trials started in each 5-year period. Conclusions: The rate of early termination of EFIC trials for futility or safety appears higher than for other kinds of clinical research. We provide the list of trials in a Supplement for further in-depth data collection and analysis of this set of trials.

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A systematic review of Federal Drug Administration Docket for community consultation and public disclosure in exception from informed consent trials

Cited by 8 publications

References 11 publications

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

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

Public Approval of Exception From Informed Consent in Emergency Clinical Trials

A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule

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