Ethics Committee Experience with Emergency Exception from Informed Consent Protocols

Deiorio, Nicole M.; McClure, Katie B.; Nelson, Maria J.; McConnell, K. John; Schmidt, Terri A.

doi:10.1525/jer.2007.2.3.23

Cited by 12 publications

(12 citation statements)

References 18 publications

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“…In the United States, regulators experienced protocols including waived consent as more complex and time consuming to review [ 78 , 79 ], with one study reporting a mean time of 8.8 h, compared with 2.3 for studies not conducted under EFIC [ 79 ]. A key challenge in applying the law involved determining what constitutes adequate community consultation and public notification [ 78 ].…”

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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“…Unfortunately, many IRBs at the local level lack sufficient experience and expertise in research involving exception from informed consent. A recent survey of IRB chairpersons31 found that 25 of 52 had reviewed such a study, while 42 felt prepared to do so. Even if an institution had previous experience with exception from informed consent, many IRB members may not feel adequately trained to review these protocols 32…”

Section: Informed Consentmentioning

confidence: 99%

Regulatory Challenges for the Resuscitation Outcomes Consortium

Tisherman

Powell²,

Schmidt³

et al. 2008

Circulation

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“…Future studies correlating IRB members’, EMS providers’, and researchers’ perspectives on community consultation would be very valuable. Currently, very limited data exist regarding these important stakeholders’ views of community consultation (12–14). …”

Section: Discussionmentioning

confidence: 99%

Community Consultation for Prehospital Research: Experiences of Study Coordinators and Principal Investigators

Dickert

Govindarajan

Harney

et al. 2014

Prehospital Emergency Care

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Objective To assess principal investigators’ and study coordinators’ views and experiences regarding community consultation in a multi-center trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings. Methods Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included: 1) perceived goals of community consultation; 2) experiences with and views of community consultation methods used; 3) interactions with IRB regarding community consultation; and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data. Results Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median= 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings. Conclusions Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.

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Ethics Committee Experience with Emergency Exception from Informed Consent Protocols

Cited by 12 publications

References 18 publications

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

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

Regulatory Challenges for the Resuscitation Outcomes Consortium

Community Consultation for Prehospital Research: Experiences of Study Coordinators and Principal Investigators

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