Informed Consent in Emergency Medicine

Thewes, Jeffrey; FitzGerald, Denis J.; Sulmasy, Daniel P.

doi:10.1016/s0733-8627(05)70249-2

Cited by 19 publications

(17 citation statements)

References 5 publications

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“…They note that community consultation and notification are new to clinical trials. 7 Although much has been written about the ethics and experience researchers have had with waiver of consent, [8][9][10][11][12][13][14][15][16][17][18][19][20][21] little has been written about public opinion of the process. Smithline and Gerstle surveyed public willingness to be involved in research without consent in 1996, and found that willingness depended on income and the perceived risk of harm.…”

Section: Attitudes Of Emergency Department Patients and Visitors Regamentioning

confidence: 99%

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

et al. 2003

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Objective: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification. Methods: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001. Results: Five hundred thirty people completed the survey, with an 82% response rate. The mean age of the respondents was 41 years (range 18-95) with a standard deviation of 14.5; 46% were female and 64% white. Most (88%) believed that research subjects should be informed prior to being enrolled, while 49% believed enrolling patients without prior consent in an emergency situation would be acceptable and 70% (369) would not object to be entered into such a study without providing prospective informed consent. Informing and consulting the community as a substitute for patient consent in emergency research was thought to be reasonable by 45% of the respondents. Most respondents would prefer to be informed about a study using emergency exception from informed consent by radio and television media (42%). Two hundred fifty-eight respondents (49%) stated they would attend a community meeting; the less educated were more likely to attend than those with college degrees (OR ¼ 0.53; 95% CI ¼ 0.33 to 0.85, p ¼ 0.008). However, only 5% knew of ongoing studies in their community using emergency exception from informed consent. Conclusions: Most respondents disagreed with foregoing prospective informed consent for research participation even in emergency situations; however, many would be willing to participate in studies using emergency exception from informed consent. Most respondents would not attend community meetings, and would prefer to rely upon the media for information. Very few were aware of emergency exception from informed consent studies in their community. This suggests that current methods of community notification may not be effective.

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Section: Attitudes Of Emergency Department Patients and Visitors Regamentioning

confidence: 99%

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

et al. 2003

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“…Previous studies looking at the adequacy of informed consent for medical research have focused on the readability of the informed consent form or on the patient's memory of its content. [3][4][5] Standards for competency are usually described in terms of cognitive capacity. These standards are: evidencing a choice (realizing that there is a decision to be made), factual understanding of the issues, rational manipulation of information, and an appreciation of the nature of the situation.…”

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confidence: 99%

Do Patients with Acute Medical Conditions Have the Capacity to Give Informed Consent for Emergency Medicine Research?

Smithline

Mader

Crenshaw

1999

Academic Emergency Medicine

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Abstract. Objective: Because of stress and illness, conscious emergency medicine (EM) patients may be temporarily cognitively impaired and thus incapable of participating in the informed consent process for acute care research. This pilot study sought to assess the mental capacity of ED patients during their evaluation and treatment for acute myocardial infarction (AMI). Methods: A prospective observational design at a university tertiary referral center. EM patients with AMI from November 1996 to February 1997 were enrolled. While usual care was delivered, patients were administered three subtests of the Wechsler Adult Intelligence Scale-Revised (WAIS-R) test. Subtest scaled scores range from 1 to 19, with abnormal being less than 5. Demographic, historical, and environmental parameters were recorded. Patients assessed how serious they perceived their conditions; and rated their degrees of pain, nausea, breathlessness, and anxiety on 10-cm visual analog scales (VASs). Testing was repeated prior to hospital discharge. Results: Twenty-five patients were enrolled. Of these, two (8%) were suspected by their emergency physicians to have insufficient capacity to give informed consent. However, five (20%) scored less than 5 on all of the WAIS-R subtests (kappa = 0.5) and eight (32%) scored less than 5 on at least one of the subtests (kappa = 0.3). The initial median Digit Span, Comprehension, and Similarities subtest scores were 7, 5, and 6. By discharge, these improved to 8, 7, and 8, respectively. Conclusions: This pilot study suggests that some patients with AMI may have difficulty processing information necessary to give informed consent for acute care research. Routine clinical evaluation may not detect this cognitive defect. Key words: informed consent; capacity; competency; myocardial infarction; Wechsler Adult Intelligence Scale-Revised (WAIS-R) test. ACADEMIC EMERGENCY MEDICINE 1999; 6:776-780 T HERE is a concern among some acute care researchers that informed consent is not always possible in acutely ill patients. While this concern initially centered around the comatose patient suffering from head injury 1,2 or cardiac arrest, it also extends to the conscious and alert patient under significant physical and psychological stress, such as those with an acute myocardial infarction 9, 1998; revisions received January 15, 1999, and February 12, 1999; accepted February 19, 1999 (AMI). Previous studies looking at the adequacy of informed consent for medical research have focused on the readability of the informed consent form or on the patient's memory of its content. [3][4][5] Standards for competency are usually described in terms of cognitive capacity. These standards are: evidencing a choice (realizing that there is a decision to be made), factual understanding of the issues, rational manipulation of information, and an appreciation of the nature of the situation. 6,7 To the authors' knowledge, no study has assessed the patient's cognitive capacity in the context of informed consent for acute care resear...

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“…One model encourages physicians to assess the following: absence of any gross deficits in cognition, patient judgment, understanding, ability to choose between different options, ability to express a choice, and stability of the choice over time [4]. Another model, the MacArthur Competence Assessment Tool for Treatment, is a structured interview tailored to the patient's specific situation, which takes 20 minutes to administer and score [5].…”

Section: Commentarymentioning

confidence: 99%

Taking No for an Answer—Refusal of Life-Sustaining Treatment

Cooper

2010

AMA Journal of Ethics

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Informed Consent in Emergency Medicine

Cited by 19 publications

References 5 publications

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

Do Patients with Acute Medical Conditions Have the Capacity to Give Informed Consent for Emergency Medicine Research?

Taking No for an Answer—Refusal of Life-Sustaining Treatment

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