A Naturalistic Study of Consecutive Agitated Emergency Department Patients Treated With Intramuscular Olanzapine Prior to Consent

Damsa, Cristian; Adam, E.; Lazignac, Coralie; Mihai, Adriana; Gregorio, François De; Lejeune, Jean-Philippe; Maris, Stella; Clivaz, Emmanuel; Allen, Michael

doi:10.1176/appi.ajp.2007.07060946

Cited by 4 publications

(3 citation statements)

References 9 publications

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“…They frequently receive concomitant medical treatment and they might have somatic comorbidity complicating treatment. Thus, for clinicians it is of interest, how effective and safe acute treatment is, when administered to non-selected patients in acute psychiatric settings (22).…”

Section: Resultsmentioning

confidence: 99%

Treatment of agitation in the acute psychiatric setting. An observational study of the effectiveness of intramuscular psychotropic medication

Bauer¹,

Stenborg²,

Lodahl³

et al. 2016

Nordic Journal of Psychiatry

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Section: Resultsmentioning

confidence: 99%

Treatment of agitation in the acute psychiatric setting. An observational study of the effectiveness of intramuscular psychotropic medication

Bauer¹,

Stenborg²,

Lodahl³

et al. 2016

Nordic Journal of Psychiatry

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“…This is because it is simply impossible to ask (temporarily) incapacitated patients for informed consent [ 1 , 5 , 23 , 33 , 34 , 36 , 38 , 40 , 43 , 45 , 47 – 95 ]. Patient populations often mentioned in this context are those with acute head or brain injuries [ 5 , 25 , 34 , 38 , 39 , 74 , 96 ], and comatose, unconscious or sedated patients [ 49 , 92 ], although a much wider range of relevant patient populations has also been named [ 40 , 58 , 60 , 63 , 65 , 66 , 97 – 105 ].…”

Section: Resultsmentioning

confidence: 99%

Exceptions to the rule of informed consent for research with an intervention

et al. 2016

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BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB.

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“…Furthermore, consent obtained under such conditions may be similar to involuntary submission (Lewin et al 2006). Other investigators evaluating treatments for acute agitation have also acknowledged the difficulty in obtaining meaningful and truly informed consent prior to enrolment into the study (Damsa et al 2008;Nobay et al 2004;Martel et al 2005;Knott et al 2006;TREC Collaborative Group, 2003).…”

Section: Acutely Agitated Patients In the Ed Settingmentioning

confidence: 99%

May I have your consent? Informed consent in clinical trials — feasibility in emergency situations

Chan

Taylor

Phillips

et al. 2011

Journal of Psychiatric Intensive Care

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Clinical researchers in acute emergency settings are commonly faced with the difficulty of satisfying the conventional ethical requirement of obtaining informed consent, whilst ensuring a representative group of patients is recruited into studies. We discuss our own experience in addressing institutional ethical requirements to obtain informed consent in a multi-centre trial, recruiting highly agitated patients in the emergency setting in Melbourne, Australia. We suggest that, through the application of existing ethical and legal frameworks and pre-emptive communication with the key stakeholders in ethics committees, hospital insurers and legal representatives, a balance can be struck between ethical and legal requirements on the one hand, and the integrity of the research question, on the other.

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A Naturalistic Study of Consecutive Agitated Emergency Department Patients Treated With Intramuscular Olanzapine Prior to Consent

Cited by 4 publications

References 9 publications

Treatment of agitation in the acute psychiatric setting. An observational study of the effectiveness of intramuscular psychotropic medication

Treatment of agitation in the acute psychiatric setting. An observational study of the effectiveness of intramuscular psychotropic medication

Exceptions to the rule of informed consent for research with an intervention

May I have your consent? Informed consent in clinical trials — feasibility in emergency situations

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