PMID- 31298107
OWN - NLM
STAT- MEDLINE
DCOM- 20201105
LR  - 20201105
IS  - 1748-720X (Electronic)
IS  - 1073-1105 (Print)
IS  - 1073-1105 (Linking)
VI  - 47
IP  - 2
DP  - 2019 Jun
TI  - Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse 
      Events.
PG  - 323-333
LID - 10.1177/1073110519857289 [doi]
AB  - 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.
FAU - McManus, Lisa
AU  - McManus L
AD  - 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.
FAU - Davis, Arlene
AU  - Davis A
AD  - 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.
FAU - Forcier, Rebecca L
AU  - Forcier RL
AD  - 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.
FAU - Fisher, Jill A
AU  - Fisher JA
AD  - 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.
LA  - eng
GR  - R01 GM099952/GM/NIGMS NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PL  - England
TA  - J Law Med Ethics
JT  - The Journal of law, medicine & ethics : a journal of the American Society of Law, 
      Medicine & Ethics
JID - 9315583
CIN - J Law Med Ethics. 2019 Jun;47(2):334-335. PMID: 31298104
MH  - Adult
MH  - *Clinical Trials, Phase I as Topic
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Healthy Volunteers/*psychology
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Narration
MH  - Qualitative Research
PMC - PMC6661148
MID - NIHMS1042201
EDAT- 2019/07/13 06:00
MHDA- 2020/11/06 06:00
PMCR- 2020/06/01
CRDT- 2019/07/13 06:00
PHST- 2019/07/13 06:00 [entrez]
PHST- 2019/07/13 06:00 [pubmed]
PHST- 2020/11/06 06:00 [medline]
PHST- 2020/06/01 00:00 [pmc-release]
AID - 10.1177/1073110519857289 [doi]
PST - ppublish
SO  - J Law Med Ethics. 2019 Jun;47(2):323-333. doi: 10.1177/1073110519857289.