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.

A Brief Educational Intervention May Increase Public Acceptance of Emergency Research Without Consent

“…Our survey was modeled after one of the largest, and used similar questions for comparison (18). We found that 98% of our subjects agreed that emergency research is important, compared with 50% in that population (18). In that study, 34% of subjects felt that research without consent was justifiable in some circumstances, whereas 42% of ours felt that way.…”

“…A number of other surveys have examined public opinion on this issue. Our survey was modeled after one of the largest, and used similar questions for comparison (18). We found that 98% of our subjects agreed that emergency research is important, compared with 50% in that population (18).…”

“…To calculate sample size, we assumed that patient willingness to be enrolled in trials involving a waiver of consent would be approximately 70%, based upon previous surveys (16,18). We hypothesized that increased information would result in approximately 85% of patients willing to agree to such studies.…”

Syndromic Surveillance and Patients as Victims and Vectors

“…If there is full public information about what surveillance is being done, as well as oversight through the political process, then the political process might be viewed as analogous to community consent of the form utilized in research when subjects cannot be identified in advance (McClure et al 2003). However, it is important to note that so-called "community consent" models as they are currently implemented may fail to communicate adequately with community members about planned research.…”

Ischemic Stroke Survivors’ Opinion Regarding Research Utilizing Exception from Informed Consent

“…The purpose of community consultation is to ensure that the research is respectful of the community in which it is conducted and as such, understanding community perceptions and opinions of the research is paramount [7,8]. While many studies have been conducted regarding patient opinions of EFIC research, including patients being evaluated in the emergency department [8,9,10,11,12], stroke patients have largely been excluded from these studies since most are cognitively impaired upon arrival in the emergency department. Also, few of these studies explored the impact of varying levels of invasiveness of the proposed research.…”