Elsevier

Social Science & Medicine

Volume 66, Issue 6, March 2008, Pages 1379-1392
Social Science & Medicine

Defining the “community” in community consultation for emergency research: Findings from the community VOICES study

https://doi.org/10.1016/j.socscimed.2007.10.022Get rights and content

Abstract

This article explores the application of the concept “community consultation” in the context of emergency medical research. Emergency medicine researchers are permitted, by the World Medical Association regulations and in the United States by U.S. Federal Regulations, to conduct emergency medical research on individuals with a life-threatening condition without obtaining their consent or that of their surrogates if certain conditions are met. Among these conditions is the requirement that researchers observe a number of special protections for the participants, including “community consultation and notification” prior to the initiation of such studies. The term “community” is not defined clearly and the process for conducting community consultations is not specified in these regulations. This study explores the feasibility of conducting community consultation in the context of emergency medical research by examining: research participant's definitions of community in New York, the factors that help shape their definitions of community and the people they would authorize to render participation decisions on their behalves. Findings from this study suggest that participants' definitions of community vary as a function of the purpose of the definition and the demographics of the respondents. Most significantly, this study reveals that although respondents can identify potential spokespersons for their communities, these community spokespersons were rarely identified as those who should have decision-making authority in medical emergencies. Finally, this article explores the implications of these findings for the definition of community as it applies to community consultation for emergency medical research.

Introduction

Research in Emergency Medicine (EM) often involves testing new treatment procedures or medications for patients with life-threatening conditions such as cardiac arrests or severe head trauma (Abramson et al., 1986, Richardson, 2005, Spivey, 1989). In many such studies, patients are incapacitated due to their medical condition and unable to consent to participate in the experimental treatment or procedure. Frequently, the proposed experimental treatment must be administered without delay to maximize a successful outcome, leaving little time to locate a surrogate who has the authority to give consent on behalf of the patient (Rhodes, Richardson, & Moros, 2005).

A decade ago, U.S. Federal Regulations (Federal Regulations, 1996) were promulgated that allow EM researchers to proceed with this type of emergency research without obtaining the consent of the patient or their surrogate so long as certain conditions are met. These regulations, known as the Final Rule, amended the Common Rule, also referred to as the Federal Policy for the Protection of Human Subjects, which stipulated that research involving human subjects required the prospective informed consent of all participants (Federal Regulations, 1991). The Final Rule, which parallels the regulations first adopted by the World Medical Association (WMA, 2000), states that emergency medical research may be conducted without informed consent if all of the following conditions have been met: the patient is experiencing a life-threatening condition for which existing treatments are deemed either unsatisfactory or unproven; further evidence is needed to determine an experimental treatment's safety or efficacy; the participant is incapable of consent due to their medical condition; intervention is necessary before an authorized representative can be consulted; and if researchers have observed a number of special protections including “community consultation” (Biros et al., 1998, Schmidt et al., 2006). According to the National Institutes of Health (2002), community consultation serves as a “vehicle to listen to the community's interests and concerns, to address ethical issues and to communicate information about the research to the community.” This consultation benefits the community by providing an opportunity for the community to learn more about the study and to act as “partners rather than simply as subjects” (NIH, 2002). It benefits researchers also, by allowing them to obtain input on the study design from the community. Community consultation, however, does not give the community the right to veto or overrule the proposed study. It is a required step but bears no sway on whether the study proceeds.

Unfortunately, the regulations, and guidance documents from federal agencies do not provide either a clear definition of “communication” or useful direction for conducting “community consultation.” As a result, EM researchers have employed a variety of definitions of community, and utilized very different practices and procedures, to consult the community (Dix et al., 2004, Godard et al., 2004, Shah and Sugarman, 2003) all of which meet the standard for “community consultation” under U.S. law.

Social scientists, geneticists and community-based participatory researchers have debated and explored extensively the definition of community for over 50 years and have identified a number of structural characteristics that are associated with this concept (Godard et al., 2004, Grady et al., 2006, Haimes and Whong-Barr, 2004, Hillery, 1955, Jewkes and Murcott, 1996, Marshall and Berg, 2006). These include: an intermediate size group (one that is neither very large nor small), key institutional settings, relative stability, concreteness and significant primary and secondary interaction (Rubin, Rubin, Grush, & Dobson, 1983). In essence, researchers have concluded that a community must contain sufficient social interaction, structure and permanence to allow an individual to identify as a member of that community.

Sociologists also contend that individuals who consider themselves to be a member of a community accept, as part of that affiliation, that their community “… assume[s] a collective responsibility for community decisions” (Suliman, 1983) that often are made by a sample of the community. A deliberative process that engages a sample of the community is consistent with a democratic process. Thus, the requirement for community consultation, in a setting where individual informed consent is not possible, rests on a host of presumptions and assumes acceptance of democratic principles of community decision-making.

Our purpose in this paper is to examine the application of this concept of community consultation in the context of emergency medical research. Specifically, we seek to explore whether it is appropriate to invest moral authority in community consultation in emergency medical research. We shall explore this issue by examining: research participants' definition of “community;” the factors that help shape their definition of community; who they would authorize to speak for them; and the conditions in which they would authorize community spokespersons to represent their community and its members.

Our study was conducted as a follow-up to the Public Access Defibrillation (PAD) Trial, a community-based, randomized controlled study conducted in 24 cities in the United States and Canada to assess the effectiveness of training lay-persons to respond to cardiac arrests occurring outside of a hospital, by using Automated External Defibrillators (AEDs) (The PAD Trial Investigators, 2004). These use electric shocks to return the heart to its normal rhythm after a cardiac arrest, a major cause of death in the United States (Engelstein & Zipes, 1998).

The goal of the PAD Trial was to train a cohort of community volunteers to respond to sudden cardiac arrest victims in their communities using AEDs. AEDs have been shown to be both an effective and safe strategy for reducing mortality from out-of-hospital cardiac arrests when used by trained medical personnel or emergency responders (Myerburg et al., 2002, Valenzuela et al., 2000). Prior to the PAD Trial, however, the effectiveness and safety of AEDs used by lay-persons to treat out-of-hospital cardiac arrest in a general community setting had not been demonstrated. Therefore, PAD, which used lay-persons to administer such treatment, was considered experimental and the PAD Trial was a research study designed to evaluate its safety and effectiveness. Since it is impossible to obtain informed consent from someone in cardiac arrest, the PAD Trial was conducted under the regulations allowing for an exception from informed consent. Consistent with these regulations, before performing this study researchers were required to engage the community through consultations and public disclosure.

Investigators at each of the sites were faced with the question: “Who is the “community?”” In New York City (NYC), one of the 24 participating sites in the international PAD study, the PAD Trial investigators defined “community” as a physical facility which “…had a history of at least one witnessed out-of-hospital cardiac arrest every two years, on average” or had at least 250 adults, 50 years of age or older (The Public Access Defibrillation Trial Investigators, 2004, Richardson et al., 2005), a permissible definition of community given U.S. regulations. Thus, the current study explores the concept of community and community consultation in the context of the NYC PAD Trial which is an example of emergency medical research.

Section snippets

Method

New York City (NYC) PAD Trial study participants were eligible for the current study entitled, “Community Views on Informed Consent in Emergency Situations” (Community VOICES). “Participants” in the PAD Trial were defined both as a physical location, specifically buildings known as Units, and as individuals. Just under half (47%) of NYC's 8,000,000 residents live in multiple family dwellings of 20 or more families (US Census Bureau, 2000). As such, the majority of sites selected to participate

Results

Thirty-one of the 35 recruited PAD buildings agreed to participate in the current study. Two declined to participate during the data collection phase of the study, and two failed to respond to repeated attempts to solicit participation.

Interviews were obtained from 288 residents and 68 employees for a total of 355 interviews. One participant was both a resident and employee in the same building. The mean number of interviews per building were 11.5, ranging from 2 to 25 per building. The target

Discussion

The goal of this exploratory study was to inform our approach to community consultation for emergency medicine by understanding people's understanding of key concepts on which it is based: research participants' definition of “community;” the factors that help shape their definition of community; and the groups that they would endorse as spokespersons for community consultation to discuss emergency research on behalf of their community or its members.

This study yielded five core definitions of

Acknowledgement

The authors gratefully acknowledge Maggi Rodriguez, Jeidy Carrasco and Jon Chamberlain for their assistance with this study and preparation of this article.

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    The study was funded by a grant entitled “Research Without Consent” (Grant # 1R01HL073387) from the National Heart, Lung and Blood, Institute of the National Institutes of Health.

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