Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent

Biros, Michelle H.; Dickert, Neal W.; Wright, David W.; Scicluna, Victoria M.; Harney, Deneil; Silbergleit, Robert; Denninghoff, Kurt R.; Pentz, Rebecca D.

doi:10.1111/acem.12602

Cited by 14 publications

(13 citation statements)

References 4 publications

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“…As more studies have been completed using EFIC, greater focus has been spent understanding stakeholder impact of CC and PD, including EMS providers 12 and IRBs 13,14 , and examinations of ethical implications of this research. 15,16 Previous work has described EFIC application in multi-site trials. 3,[17][18][19][20] The methods described in these previous trials include newspaper, radio, or television advertisements, direct letters to community groups or individuals, presentations at community meetings or health fairs, random digit dialing surveys, and, more recently, the inclusion of technology and social media through internet advertising, web-based surveying and comment collection, and specifically-targeted Facebook advertising.…”

Section: Discussionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 99%

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

et al. 2019

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“…Phone consent is important when no proxy is available within the time window due to geographic constraints. (36,50) However, it can be challenging to reach patient families with distressing information and ask for All rights reserved. No reuse allowed without permission.…”

Section: Logistics Of Obtaining Informed Consentmentioning

confidence: 99%

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

Bellomo

Fokas

Anderson

et al. 2020

Preprint

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Introduction: Obtaining informed consent from acute ischemic stroke patients poses many challenges, especially in the context of a research setting. Specifically, consenting for alternative acute ischemic stroke treatments to the standard of care, Tissue Plasminogen Activator (tPA), can cause delays leading to increased time to reperfusion and worse outcomes. Objectives: We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tPA in order to identify the approaches and challenges in obtaining informed consent in this unique patient population. Methods: Out of 401 articles evaluated, 14 trials met inclusion criteria of patients receiving IV tPA vs alternative treatment within 4.5 hours of onset of symptoms for acute ischemic stroke. Trial representatives were emailed by the study team with a request for a copy of their patient consent form, other documents related to informed consent, and to complete a survey concerning aspects of the consent process. Results: Of the 6 trials conducted across 6 continents that completed the survey in its entirety, 2 were ongoing, 4 were published between 2009 and 2016, and the median NIHSS for each published trial was at least an 8. All published trials in the sample stated that informed consent was obtained, but only half reported involvement of a research ethics committee. Although 3 trials performed in Europe or Asia reported directly consenting 75-100% of enrolled patients, the median NIHSS for these trials represented a moderate stroke. Trials with 75-100% of patients directly consented had shorter door to treatment (DTT) times than trials that directly consented less than 50% of enrolled patients. 5 trials allowed consent by proxy, but only 2 of those trials also required patient assent. 4 trials had translators available and translated consent documents, and these trials had longer DTT times. All trials relied on experienced providers or dedicated research coordinators to obtain informed consent; however, only 2 of 6 trials mentioned specific training with regards to informed consent skills. Conclusions: The current informed consent process is not transparent and poses challenges to investigators in the USA directly comparing tPA to an alternative treatment. International differences in the standards of informed consent, such as deferred consent, may have allowed more patients with moderate strokes to provide direct consent after treatment administration without delaying DTT time. While targeted and innovative approaches for informed consent are needed to improve patient outcomes, we must balance protecting the autonomy of individuals whose willing involvement enables such pivotal discoveries. The stroke community must aim for efficiency, transparency, and inclusion of patients of diverse backgrounds in the informed consent process so that therapeutic advances are possible.

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“…These issues are not merely academic. One recent publication described related challenges during a traumatic brain injury trial 4. Investigators encountered surrogates who were misrepresented, intoxicated, reluctant, and geographically distant.…”

Section: Introductionmentioning

confidence: 99%

Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research

Vorholt

Dickert²

2018

J Med Ethics

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Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.

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Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent

Cited by 14 publications

References 4 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

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research

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