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The critical state of patients admitted to the emergency department (ED) and short windows of opportunity for therapeutic/research interventions render informed consent challenging in the emergency medicine space. Following the 1981 release of Common Rule which elevated informed consent from the pinnacle of bioethics to legislation, emergency medicine research became obsolete given the ED’s poor conduciveness to informed consent. In 1996 the U.S. adopted 21 CFR 50.24 in response to emergency medicine (EM) clinicians’ grievances that many EM therapies were unproven or insufficient due to the lack of research. 21 CFR 50.24 permits exception from informed consent (EFIC) research in emergency medicine given that particular criteria are met. The criteria include two prerequisites for EFIC intervention deployment: 1) community consultation (CC -- a process by which clinician scientists elicit feedback about the proposed clinical trial from communities at-risk for enrollment) and 2) public disclosure (PD -- a process by which clinician scientists inform communities at-risk for enrollment about the study). However, the policy offers no guidance about how to engage lay populations in scientific research via CC and PD. To elucidate how medical decision makers put CC and PD into practice, interpret their purpose, and perceive their utility, I conducted nearly 30 interviews with EFIC research clinical coordinators and principal investigators from major U.S. academic hospitals. I also observed IRB meetings wherein members discussed research with persons of reduced capacity to consent. My data illustrates that EFIC research, and more specifically CC and PD, challenge clinician scientists to negotiate tensions between public health ethics, biomedical research ethics, and clinical ethics. I am currently modeling these negotiations to offer insight into how medical decision makers such as EM clinician scientists and IRB members construct their personal identities in the biomedical professional context.

This project maintains a strict ethnographic orientation which stands in stark contrast to other interdisciplinary projects that I have led. Not only did I hone my interviewing skills through this project, I began to develop an ethical code for interviewing: When and how do I probe about what? To what extent do I let the interviewee drive the interview versus curate the interview narrative myself by adhering strictly to a script? How do I reconcile my own positionality as the researcher with what the interviewee elects to tell me, or not to tell me? As I pursue my interest in public anthropologies (anthropology projects which address public priorities and involve lay publics in knowledge production), I will continue to introspect on the way that I understand expertise, as this project has spurred me to consider. I will continue to hone my interview ethics, and to iterate upon my understanding of what conclusions one can reasonably draw from data. I have extended this project into research proposals for PhD programs, and plan to further the work in graduate school.

The critical state of patients admitted to the emergency department (ED) and short windows of opportunity for therapeutic/research interventions render informed consent challenging in the emergency medicine space. Following the 1981 release of Common Rule which elevated informed consent from the pinnacle of bioethics to legislation, emergency medicine research became obsolete given the ED’s poor conduciveness to informed consent. In 1996 the U.S. adopted 21 CFR 50.24 in response to emergency medicine (EM) clinicians’ grievances that many EM therapies were unproven or insufficient due to the lack of research. 21 CFR 50.24 permits exception from informed consent (EFIC) research in emergency medicine given that particular criteria are met. The criteria include two prerequisites for EFIC intervention deployment: 1) community consultation (CC -- a process by which clinician scientists elicit feedback about the proposed clinical trial from communities at-risk for enrollment) and 2) public disclosure (PD -- a process by which clinician scientists inform communities at-risk for enrollment about the study). However, the policy offers no guidance about how to engage lay populations in scientific research via CC and PD. To elucidate how medical decision makers put CC and PD into practice, interpret their purpose, and perceive their utility, I conducted nearly 30 interviews with EFIC research clinical coordinators and principal investigators from major U.S. academic hospitals. I also observed IRB meetings wherein members discussed research with persons of reduced capacity to consent. My data illustrates that EFIC research, and more specifically CC and PD, challenge clinician scientists to negotiate tensions between public health ethics, biomedical research ethics, and clinical ethics. I am currently modeling these negotiations to offer insight into how medical decision makers such as EM clinician scientists and IRB members construct their personal identities in the biomedical professional context.

This project maintains a strict ethnographic orientation which stands in stark contrast to other interdisciplinary projects that I have led. Not only did I hone my interviewing skills through this project, I began to develop an ethical code for interviewing: When and how do I probe about what? To what extent do I let the interviewee drive the interview versus curate the interview narrative myself by adhering strictly to a script? How do I reconcile my own positionality as the researcher with what the interviewee elects to tell me, or not to tell me? As I pursue my interest in public anthropologies (anthropology projects which address public priorities and involve lay publics in knowledge production), I will continue to introspect on the way that I understand expertise, as this project has spurred me to consider. I will continue to hone my interview ethics, and to iterate upon my understanding of what conclusions one can reasonably draw from data. I have extended this project into research proposals for PhD programs, and plan to further the work in graduate school.