Public Approval of Exception From Informed Consent in Emergency Clinical Trials

Feldman, William B.; Hey, Spencer Phillips; Franklin, Jessica M.; Kesselheim, Aaron S.

doi:10.1001/jamanetworkopen.2019.7591

Cited by 28 publications

(48 citation statements)

References 55 publications

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“…It remains unclear whether patients, proxies, health-care providers, administrators, or a general population should be con sidered to be the community. 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.…”

Section: Exception From Consentmentioning

confidence: 99%

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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%

“…68 Acceptance of the exception from informed consent procedure was high and varied by the specifics of the situation. 65,69…”

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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“…The Established Status Epilepticus Treatment Trial (ESETT) enrolled participants without prospectively provided consent and supported the finding that the phrasing of statements is important [35]. This is supported by studies showing acceptability varies when asked about personal or general enrolment using deferred consent [36]. In the ESETT trial, participants were asked if they were "glad that themselves or their family members were included in the study" [35].…”

Section: Attitudes Of Ethnic Minorities Towards Deferred Consentmentioning

confidence: 89%

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Raven-Gregg

Shepherd

2021

Trials

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Background Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, especially where a surrogate-decision maker may be unavailable to provide consent. Whilst deferred consent offers the potential to promote trial diversity by including under-served groups, it is ethically complex and views about its use amongst these populations require further exploration. The aim of this article is to build upon recent initiatives to improve inclusivity in trials, such as the NIHR INCLUDE project, and consider whether trials methodology research is inclusive, focusing on ethnic minority populations’ attitudes towards the use of deferred consent. Main text Findings from the literature suggest that research regarding attitudes toward recruitment methods like deferred consent largely fail to adequately represent ethnic minorities. Many studies fail to report the composition of patient samples or conduct analyses on any differences between specific patient groups. In those that do, the categorisation of ethnic groups is ambiguous. Frequently diversely different groups are considered as more homogenous than they are. Whilst deferred consent is deemed generally acceptable, analysis of patient sub-groups shows that this attitude is not universal. Those from racial and ethnic minority backgrounds reported higher levels of unacceptability, which was impacted by previous first or second-hand experience of its use and historical mistrust in research. However, whilst deferred consent was found to increase the numbers of black participants enrolled in some trials, their over-enrolment in other trials may raise further concerns. Conclusions Inclusivity in clinical trials is important, as highlighted by the COVID-19 pandemic. To improve this, we must ensure that methodological studies such as those exploring attitudes to research are inclusive. More effort is needed to understand the views of under-served groups, such as ethnic minorities, toward research in order to improve participation in clinical trials. Our findings echo those from the INCLUDE project, in that better reporting is needed and increasing the confidence of ethnic minority groups in research requires improving representation throughout the research process. This will involve diversifying research teams and ethics committees.

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“…The fact that only three studies reported any data on participant ethnicity brings the validity of the representativeness of this data for the general trauma population into question. A 2019 systematic review of studies employing a community consultation survey on the exception from informed consent (EFIC), relevant for many pre-hospital trauma trials, found that the survey respondents were not an accurate representation of the trial population demographic with African American individuals underrepresented [ 40 ]. This supports the argument for further consideration of ethnicity as an important factor in trial design to ensure the study populations are truly representative of the population which they aim to serve.…”

Section: Discussionmentioning

confidence: 99%

Randomised controlled trials in pre-hospital trauma: a systematic mapping review

Björklund

Cruickshank

Lendrum

et al. 2021

Scand J Trauma Resusc Emerg Med

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Background Trauma is a leading cause of morbidity and mortality worldwide with about 5.8 million deaths globally and the leading cause of death in those aged 45 and younger. The pre-hospital phase of traumatic injury is particularly important as care received during this phase has effects on survival. The need for high quality clinical trials in this area has been recognised for several years as a key priority to improve the evidence base and, ultimately, clinical care in prehospital trauma. We aimed to systematically map the existing evidence base for pre-hospital trauma trials, to identify knowledge gaps and inform decisions about the future research agenda. Methods A systematic mapping review was conducted first employing a search of key databases (MEDLINE, CINAHL, EMBASE, and Cochrane Library from inception to March 23rd 2020) to identify randomised controlled trials within the pre-hospital trauma and injury setting. The evidence ‘map’ identified and described the characteristics of included studies and compared these studies against existing priorities for research. Narrative description of studies informed by analysis of relevant data using descriptive statistics was completed. Results Twenty-three eligible studies, including 10,405 participants across 14 countries, were identified and included in the systematic map. No clear temporal or geographical trends in publications were identified. Studies were categorised into six broad categories based on intervention type with evaluations of fluid therapy and analgesia making up 60% of the included trials. Overall, studies were heterogenous with regard to individual interventions within categories and outcomes reported. There was poor reporting across several studies. No studies reported patient involvement in the design or conduct of the trials. Conclusion This mapping review has highlighted that evidence from trials in prehospital trauma is sparse and where trials have been completed, the reporting is generally poor and study designs sub-optimal. There is a continued need, and significant scope, for improvement in a setting where high quality evidence has great potential to make a demonstrable impact on care and outcomes.

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Public Approval of Exception From Informed Consent in Emergency Clinical Trials

Cited by 28 publications

References 55 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

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Randomised controlled trials in pre-hospital trauma: a systematic mapping review

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