| Autor: |
McManus L; Lisa McManus is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She is a Ph.D. candidate in Sociology at North Carolina State University in Raleigh, NC, where she received her M.S. in 2012. Arlene M. Davis, J.D., is an associate professor at the University of North Carolina at Chapel Hill. She has more than 20 years of experience as a researcher on studies examining the ethical dimensions of study design, participation, and data collection. She has also served on institutional review boards and taught research ethics in a variety of settings as a faculty member in the Department of Social Medicine and Center for Bioethics at the UNC School of Medicine. Rebecca L. Forcier is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She received her B.A. in 2015 from Duke University in Durham, NC. Jill A. Fisher, Ph.D., is an associate professor in the Department of Social Medicine and Center for Bioethics at the University of North Carolina at Chapel Hill. She received her Ph.D. in 2005 in Science and Technology Studies from Rensselaer Polytechnic Institute in Troy, NY., Davis A; Lisa McManus is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She is a Ph.D. candidate in Sociology at North Carolina State University in Raleigh, NC, where she received her M.S. in 2012. Arlene M. Davis, J.D., is an associate professor at the University of North Carolina at Chapel Hill. She has more than 20 years of experience as a researcher on studies examining the ethical dimensions of study design, participation, and data collection. She has also served on institutional review boards and taught research ethics in a variety of settings as a faculty member in the Department of Social Medicine and Center for Bioethics at the UNC School of Medicine. Rebecca L. Forcier is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She received her B.A. in 2015 from Duke University in Durham, NC. Jill A. Fisher, Ph.D., is an associate professor in the Department of Social Medicine and Center for Bioethics at the University of North Carolina at Chapel Hill. She received her Ph.D. in 2005 in Science and Technology Studies from Rensselaer Polytechnic Institute in Troy, NY., Forcier RL; Lisa McManus is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She is a Ph.D. candidate in Sociology at North Carolina State University in Raleigh, NC, where she received her M.S. in 2012. Arlene M. Davis, J.D., is an associate professor at the University of North Carolina at Chapel Hill. She has more than 20 years of experience as a researcher on studies examining the ethical dimensions of study design, participation, and data collection. She has also served on institutional review boards and taught research ethics in a variety of settings as a faculty member in the Department of Social Medicine and Center for Bioethics at the UNC School of Medicine. Rebecca L. Forcier is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She received her B.A. in 2015 from Duke University in Durham, NC. Jill A. Fisher, Ph.D., is an associate professor in the Department of Social Medicine and Center for Bioethics at the University of North Carolina at Chapel Hill. She received her Ph.D. in 2005 in Science and Technology Studies from Rensselaer Polytechnic Institute in Troy, NY., Fisher JA; Lisa McManus is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She is a Ph.D. candidate in Sociology at North Carolina State University in Raleigh, NC, where she received her M.S. in 2012. Arlene M. Davis, J.D., is an associate professor at the University of North Carolina at Chapel Hill. She has more than 20 years of experience as a researcher on studies examining the ethical dimensions of study design, participation, and data collection. She has also served on institutional review boards and taught research ethics in a variety of settings as a faculty member in the Department of Social Medicine and Center for Bioethics at the UNC School of Medicine. Rebecca L. Forcier is a research assistant in the Department of Social Medicine at the UNC School of Medicine. She received her B.A. in 2015 from Duke University in Durham, NC. Jill A. Fisher, Ph.D., is an associate professor in the Department of Social Medicine and Center for Bioethics at the University of North Carolina at Chapel Hill. She received her Ph.D. in 2005 in Science and Technology Studies from Rensselaer Polytechnic Institute in Troy, NY. |
| Abstrakt: |
While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. |
