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

Abstract

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.

Who will participate in acute stroke trials?

“…Previous studies of chronic illness and prevention trials are inconsistent but suggest a possible influence of age, sex, race/ethnicity, and educational level. [11][12][13][14][15][16][17][18][19][20] In our study, we were unable to identify any such factors associated with trial consent. Further, we expected that subjects with more severe strokes would be more inclined to participate in the face of a more dire prognosis, but could not find any relationship between participation and stroke severity.…”

Who Will Consent to Emergency Treatment Trials for Subarachnoid Hemorrhage?

“…The results from previous studies are inconsistent, but suggest a possible influence of age, 23 education, 24 sex, 24,25 and race or ethnicity. 20,22,24,25 In our sample, we were unable to identify any factors associated with trial consent.…”

“…21 In a survey of adult ED patients and family members to assess their opinions about research conducted under an exception from informed consent, about two-thirds of respondents initially considered it unacceptable to be enrolled in a clinical trial without consent. 22 However, when the authors tested the same patients' willingness to participate in two different hypothetical studies without consent, results varied. For a hypothetical trial to assess the efficacy of public access to defibrillation, 62% of respondents stated that they would agree to be enrolled, while only 49% stated that they would agree to be enrolled in a trial of a new fluid-replacement therapy for life-threatening bleeding.…”

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

“…Consultation took place as part of the trial to explore the acceptability of deferred consent with participating families, although the findings of this consultation were never reported. Researchers in the USA using research consent waivers16 are required to use a community consultation approach whereby the researchers are required to consult with representatives of the community from which participants are derived, as well as post public notices of the study protocol, risks, benefits and results 16 17. However, the Food and Drug Administration (FDA) has recently issued guidance on conducting emergency research without consent18 in response to varied practice, including wide variations in the consultation methods used 19 20…”