Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers

Eubank, Louis; Lee, Kwan S.; Seder, David B.; Strout, Tania D.; Darrow, Matthew; Macdonald, Courtney; May, Teresa; Riker, Richard R.; Kern, Karl B.

doi:10.1016/j.resuscitation.2018.06.031

Cited by 13 publications

(17 citation statements)

References 29 publications

(42 reference statements)

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“…63 Although some reports are positive and participants satisfied, 64,65 community consultation and public disclosure are also challenging, time consuming, and costly. 66,67 A study 68 reviewed 28 completed and published acute care studies between 1996 and 2018, that used exception from informed consent or waiver of informed consent. 68 Only 359 (0•6%) of 63 947 study enrolments were withdrawn or did not provide consent for continued study participation.…”

Section: Exception From Consentmentioning

confidence: 99%

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Kompanje

Dijck

Chalos

et al. 2020

The Lancet Neurology

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Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.

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Section: Exception From Consentmentioning

confidence: 99%

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Kompanje

Dijck

Chalos

et al. 2020

The Lancet Neurology

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“…There were relatively few reports including assessments of effort and resources for conducting community consultation 32,42,53,54 . Where reported, costs ranged widely ($1,500 to >$80,000 per site) 41,54 .…”

Section: Resultsmentioning

confidence: 99%

Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent

Dickert

Metz

Fetters

et al. 2021

Academic Emergency Medicine

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Background Exception from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature. Methods Scoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories. Results Among 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two‐way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what “communities” to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy. Conclusions Multiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.

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“…Dickert et al reported that increased community consultation methods were associated with increased acceptance of EFIC and greater recall of study information but lower recall of risks [21]. Others have noted that public canvassing, in-person community consultation, and targeted community outreach to individuals most at risk of inclusion in the trial were the most successful methods and yielded greater acceptance rates [9,22,23].. Public disclosure and community consultation for the PAMPer trial was conducted from 2012 to 2013 and included use of radio, newspaper, and random digit dialing to zip codes eligible for enrollment, online websites, YouTube videos, and flyering. We found that while most (81.7%) participants believed community consultation was important, none of the patients or surrogates could recall being informed of PAMPer via community consultation, and none were aware of opt out procedures.…”

Section: Discussionmentioning

confidence: 99%

“…The US Food and Drug Administration also requires a public disclosure and community consultation phase prior to beginning the trial to inform communities of the proposed study and provide ways in which individuals wishing to opt out may be excluded. It is known that the general population is largely accepting of EFIC enrollment [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20], and community consultation practices have been associated with increased acceptance [9,[21][22][23][24]. However, there is a paucity of studies that have characterized the experiences of patients or surrogates enrolled in the actual EFIC studies [25][26][27][28][29][30], and none have been conducted following interventions that focus on traumatic hemorrhage.…”

Section: Introductionmentioning

confidence: 99%

Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial

et al. 2020

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Objectives With increased focus on early resuscitation methods following injury to improve patient outcomes, studies are employing exception from informed consent (EFIC) enrollment. Few studies have assessed patients’ opinions following participation in an EFIC study, and none have been conducted within the realm of traumatic hemorrhage. We surveyed those patients and surrogates previously enrolled in the Prehospital Air Medical Plasma (PAMPer) Trial to clarify their opinions related to consent and emergency research. Methods Telephone calls were made between January–June 2019 to all patients who were enrolled under EFIC in the PAMPer study at the Pittsburgh site (169 of the 501 total patients enrolled, May 2014-Oct 2017) and their surrogates. Questions gauging approval of EFIC enrollment were asked before discussion of PAMPer trial outcomes, after disclosure of positive outcomes, and after a hypothetical negative trial outcome was proposed. Results Of the total 647 telephone calls made, ninety-three interviews, reflecting 70 of 169 patient enrollments, were conducted. This included 13 in which only the patient was interviewed, 23 in which the patient and a surrogate were interviewed, and 34 in which only a surrogate was interviewed. Nearly half (48.4%) of respondents did not recall their personal or family member enrollment in the study. No patients or surrogates recalled hearing about the study through community consultation or being aware of opt out procedures. Patients and surrogates were glad they were enrolled (90.3%), agreed with EFIC use for their personal enrollment (88.17%), and agreed with the general use of EFIC for the PAMPer study (81.7%). Disclosure of the true positive PAMPer study outcome resulted in a significant increase in opinions regarding personal enrollment, EFIC for personal enrollment, and EFIC for general enrollment (all p < 0.001). Disclosure of a hypothetical neutral or negative study outcome resulted in significant decreases in opinions regarding EFIC for personal enrollment (p = 0.003) and EFIC for general enrollment (p < 0.001). Conclusions Clinical trial participants with traumatic hemorrhagic shock enrolled with EFIC, and surrogates of such participants, are generally accepting of EFIC. The results of the trial in which EFIC was utilized significantly affected patient and surrogate agreement with personal and general EFIC enrollment.

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Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers

Abstract: Canvassing at public events was the most efficient mode of performing CC, with approval rates similar to mailings, online surveys, and canvassing in other locations. Print advertisements in local papers had a low yield and cost more than other approaches.

Cited by 13 publications

References 29 publications

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent

Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial

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