Participation of ICUs in Critical Care Pandemic Research

Burns, Karen E. A.; Rizvi, Leena; Tan, Wylie; Marshall, John C.; Pope, Karen L.

doi:10.1097/ccm.0b013e318275d061

Cited by 11 publications

(22 citation statements)

References 34 publications

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“…We identified just one paper specific to pandemic research [ 52 ]. In a Canadian cross-sectional survey, 74 % of 39 research coordinators and 51 % of 139 administrators with experience of conducting research during the H1N1 pandemic agreed that alternatives to third-party consent prospective were required in order to effectively recruit participants to pandemic research studies [ 52 ]. Just 14.4 % of 39 of research coordinators and 5.1 % 139 of administrators disagreed with this concept.…”

Section: Resultsmentioning

confidence: 99%

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Gobat

Gal

Francis

et al. 2015

Trials

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BackgroundA rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research.MethodsWe conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis.ResultsWe screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented.ConclusionsThird-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes.PROSPERO protocol registration numberCRD42014014000Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1110-6) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Gobat

Gal

Francis

et al. 2015

Trials

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“…Political impediments to global collaborative networking and a lack of global coordination of funding and efforts were the key challenges encountered [1,15,20,21,27,33,42]. Delays in mobilising funding [15,27,36,37], with approval sometimes taking longer than the outbreak duration, was a challenge during the H1N1 pandemic in HICs [15,37] and again during the Ebola outbreak in LMICs [36].…”

Section: Political and Economic Solutions Identified (Table 4)mentioning

confidence: 99%

“…There were many calls for dedicated funding for emergency research [1,15,19,26,27,32,35,37], with financial mechanisms for rapid release of funds [1,15,20,21,26,27,33,42]. Maintaining political awareness of the threat of infectious diseases to global health security (GHS) [35,63] and an integrated approach to research was recommended to help marshal resources [1,38].…”

Section: Establish Dedicated Funding Sources and Accelerated Funding mentioning

confidence: 99%

“…An example from the UK showed that through an emergency policy activation that allowed expedited funding, approvals and the redeployment of research staff, it was possible to launch a national, multi-site clinical trial within 12 weeks during the 2009 H1N1 pandemic [41,53]. Administrative, regulatory and logistic solutions identified (Table 4) Administrative and regulatory procedures and limited access to staff with research training were persistent challenges in LMICs and HICs [2,3,22,29,37,43,49,50,52]. Medical evacuation insurance requirements [42] and delays in recruiting international staff [38] posed additional challenges in LMICs.…”

Section: Establish Dedicated Funding Sources and Accelerated Funding mentioning

confidence: 99%

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Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

Sigfrid

Maskell

Bannister

et al. 2020

BMC Med

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Background: Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic appraisal of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges to clinical research responses to emergency epidemics and solutions identified to address these. Methods: A scoping review. We searched six databases (MEDLINE, Embase, Global Health, PsycINFO, Scopus and Epistemonikos) for articles published from 2008 to July 2018. We included publications reporting PEARLES challenges to clinical research responses to emerging epidemics and pandemics and solutions identified to address these. Two reviewers screened articles for inclusion, extracted and analysed the data. Results: Of 2678 articles screened, 76 were included. Most presented data relating to the 2014-2016 Ebola virus outbreak or the H1N1 outbreak in 2009. The articles related to clinical research responses in Africa (n = 37), Europe (n = 8), North America (n = 5), Latin America and the Caribbean (n = 3) and Asia (n = 1) and/or globally (n = 22). A wide range of solutions to PEARLES challenges was presented, including a need to strengthen global collaborations and coordination at all levels and develop pre-approved protocols and equitable frameworks, protocols and standards for emergencies. Clinical trial networks and expedited funding and approvals were some solutions implemented. National ownership and community engagement from the outset were a key enabler for delivery. Despite the wide range of recommended solutions, none had been formally evaluated.

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“…Planning for the care of patients in pandemics or large scale disasters suffers from a lack of existing evidence as well as barriers to future and real time study (37,38). This paucity of data is even more evident when planning for the care of critically ill children.…”

Section: Spacementioning

confidence: 99%