Ethics and law/original researchThe Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent
Introduction
In 1996, the Food and Drug Administration (FDA) and Department of Health and Human Services issued regulations allowing resuscitation research to take place without informed consent, providing specific criteria were met.1, 2 These regulations are commonly referred to as the Emergency Medicine Exception From Informed Consent. Specifically, this approach can be implemented only when the condition being studied is acute and life threatening, current therapies are inadequate, the window of opportunity for intervention is brief, it is not possible to obtain informed consent from the patient or legally authorized representative, there is the potential of direct benefit to the participant, and the risks of participation are reasonable in proportion to the potential benefit. Furthermore, these regulations stipulate that before initiation of the study, a process of community consultation and public disclosure must be undertaken. Community consultation is a process of direct consultation with the community from which potential research subjects will be drawn, after which the opinion of the community must be considered by institutional review boards when a determination is made about whether an exception from informed consent will be granted.3 In addition, the public must be notified of the trial, including the risks and potential benefits. Subsequent draft guidance from the FDA about implementation of the regulations suggests that the community in which the research will take place be defined geographically and the community from which the research subjects will be drawn be based on demographic characteristics of patients previously treated for the condition being studied.3
The explicit procedures used to implement community consultation are not specified but are left to investigators and local institutional review boards to define according to the particular needs of the local community. As a result, there has been variability in the practical application of these procedures in the studies conducted since these regulations were implemented.4, 5, 6 There are no standard criteria by which to gauge community involvement or support. Several reports have noted significant difficulty in engaging the community in the process of community consultation, and it has been observed that the process can be resource intensive.4, 7, 8, 9 The most common approach to community consultation has been the conduct of public meetings and forums, but the majority of these have been poorly attended and there is concern that those in attendance may not be representative of the community as a whole. We present an alternative or additional approach, which involves a more formal polling of community opinion by using a random dialing telephone survey. This approach was used in 5 diverse geographic communities in the United States in preparation for an out-of-hospital clinical trial of hypertonic resuscitation sponsored by the Resuscitation Outcomes Consortium.
This is the first detailed description of the use of the random dialing survey for community consultation and thus provides valuable information for researchers and institutional review boards seeking to implement trials under these regulations. In addition, the opportunity to compare data from similar surveys according to demographics in diverse communities across the United States provides insight about survey design and target populations.
The purpose of this project is to describe the methodology of using a random dialing survey as part of the community consultation process. In addition, we sought to compare the survey results across these 5 metropolitan regions in the United States and describe different responses according to population demographics. Recognition of differential responses according to demographics may guide investigators in defining target populations for additional consultation methods.
Section snippets
Study Design and Setting
The Resuscitation Outcomes Consortium is a clinical trials network funded by the National Institutes of Health and the Canadian Institute for Health Research (available at https://roc.uwctc.org/tiki/tiki-index.php). The mission of this network is to conduct phase 3 multicenter, clinical trials of promising therapeutic options for the management of out-of-hospital cardiac arrest and life-threatening traumatic injury. The network consists of 8 sites in the United States and 2 in Canada. The first
Results
The surveys were all conducted in 2006. Each of the surveys conducted by the Hebert Research firm involved full responses from more than 500 households. Telephone response rates ranged from 32.6% to 44.9%, requiring more than 1,000 calls at each site to obtain 500 responses. The maximum margin of error for these surveys was ±4.4%. Sampling weights of the survey were calculated for those that completed all survey questions, except for demographic variables, so we have complete outcome follow-up.
Limitations
The primary limitation of this study is that the survey questions and order in which the questions were asked varied among the sites, according to local institutional review board guidance. Although there were no substantial differences in the text of the questions, response may vary according to the order in which the questions were posed. In addition, 2 sites did not collect data for education, income, and race, which limits this analysis. The data from the Portland site were not weighted,
Discussion
Since their inception, the regulations surrounding the emergency exception from informed consent in resuscitation research have generated discussion and debate, including a consensus conference on the topic held in 2005 and an FDA public meeting in 2007.17, 18 Investigators and regulatory boards (institutional review boards) have struggled with the appropriate processes for community involvement. The 2 primary components of community involvement include community consultation and public
References (23)
- et al.
Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community
Ann Emerg Med
(2003) - et al.
Initial experience using the Food and Drug Administration guidelines for emergency research without consent
Ann Emerg Med
(1999) - et al.
Hypertonic resuscitation: design and implementation of a prehospital intervention trial
J Am Coll Surg
(2008) - et al.
Incidence and severity of anaphylactoid reactions to colloid volume substitutes
Lancet
(1977) - et al.
What's the relative risk?a method to directly estimate the risk rations in cohort studies of common outcomes
Ann Epidemiol
(2002) US Department of Health and Human Services Code of Federal Regulation, Protection of Human Subjects: informed consent and waiver of informed consent requirements in certain emergency research: final rules 21 CFRPart 50.24 and 45 CFR Part 46.101
Fed Reg
(1996)Code of federal regulations, title 21, part 50: protection of human subjects, exception from informed consent requirements for emergency research: 21 CFR section 50.24
Fed Reg
(1996)- et al.
A comparison of the responses to different methods of community consultation for a study using exception to informed consent
Acad Emerg Med
(2007) - et al.
Implementation of community consultation for waiver of informed consent in emergency research: one institutional review board's experience
J Investig Med
(2004)
Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification
Acad Emerg Med
Cited by (43)
Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers
2018, ResuscitationCitation Excerpt :In fourteen prior studies, eight [7,15–21] showed no relationship of age or educational level to study approval, however three [7,15,21] did note racial differences in EFIC approval. Two trials [11,22] showed greater EFIC acceptance among younger and more educated patients while two other trials [23,24] showed increased acceptance with increasing age, one [25] showed increased acceptance with less education, and several [26,27] showed increased acceptance with middle age, and less acceptance in the young and elderly groups as well as a racial difference in acceptance. Soliciting and obtaining an online group of respondents was the most expensive method of community consent at $15.63 per completed survey and was not time-efficient.
Design and implementation of the resuscitation outcomes consortium pragmatic airway resuscitation trial (PART)
2016, ResuscitationCitation Excerpt :In conformance with EFIC rules, measures to inform and protect potential subjects will include: (a) community consultation, (b) public disclosure, (c) independent data monitoring, (d) notification of a legally authorized representative or family members of a subject's enrollment in the trial as soon as feasible, with opportunity to discontinue trial participation, and (e) provision of an opt-out mechanism. Consistent with prior ROC experience, PART sites will conduct a range of activities to accomplish community consultation and public disclosure, community meetings, random-digit telephone surveys, and the use of internet social media.54–57 Comprised of lead investigators, representatives from NHLBI and appointed site representatives, a study monitoring committee will provide regular oversight of trial enrollment.
Learning from experience: A systematic review of community consultation acceptance data
2015, Annals of Emergency MedicineCitation Excerpt :However, the direction of the association was inconsistent. In 2 studies, younger people were more willing than older people to accept exception from informed consent research, but in 2 others, younger people were less accepting.10,12,15,19 In a fifth study, younger and older people had lower exception from informed consent acceptance than middle-aged people (Table 3).11
Enrollment in research under exception from informed consent: The Patients' Experiences in Emergency Research (PEER) study
2013, ResuscitationCitation Excerpt :There is a body of literature addressing attitudes toward EFIC, mostly in the context of community consultation efforts and surveys of the general public.4 Approval of the concept of EFIC ranges widely (from 36% to 81%).5–9 Acceptance of hypothetical personal EFIC enrollment scenarios has also varied significantly (from 45% to 94%).7,10,11
Supervising editor: Theodore R. Delbridge, MD, MPH
Author contributions: All authors were involved in conception and design of the study and data acquisition. EMB was responsible for data analysis and primary drafting of the article. AJC provided statistical support for data analysis. TAS, AJC, KJB, DEG, PJK, DD, BB, AHI, and TPA contributed to critical revision of the article. EMB takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This study was supported by a cooperative agreement (5U01 HL077863) with the National Heart, Lung and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, The Canadian Institutes of Health Research (CIHR)–Institute of Circulatory and Respiratory Health, Defense Research and Development Canada, and the Heart and Stroke Foundation of Canada.
Publication dates: Available online September 27, 2008.
Reprints not available from the authors.