When a serious adverse event in research occurs, how do other volunteers react

Research output: Contribution to journalArticle

Abstract

serious adverse events in research involving healthy volunteers are rare, but their impact on other volunteers is unknown. We conducted semi-structured interviews with 60 healthy volunteers at an institution where a healthy research volunteer died. Most volunteers (85%) had heard of the event, but few said it changed their thoughts about joining research (17%), approach to studies or questions asked (25%), or future participation (4%). Despite knowing few facts, respondents created narratives about the case that served to distance them from the event and justify their continued participation in research. Downward social comparison theory, optimistic bias, and feelings of responsibility and control may help explain these narratives. Findings underscore the importance of communication and understanding of research risks and protections.

Original languageEnglish (US)
Pages (from-to)47-56
Number of pages10
JournalJournal of Empirical Research on Human Research Ethics
Volume6
Issue number2
DOIs
StatePublished - Jun 2011

Fingerprint

Volunteers
event
Healthy Volunteers
Research
theory comparison
risk research
narrative
participation
research approach
responsibility
Joining
communication
trend
interview
Emotions
Communication
Interviews

Keywords

  • Adverse events
  • Bioethics
  • Downward social comparison theory
  • Healthy volunteers
  • Narratives
  • Optimistic bias

ASJC Scopus subject areas

  • Education
  • Communication
  • Social Psychology
  • Law

Cite this

@article{327f7c7ced5747699fb9c886da4e449e,
title = "When a serious adverse event in research occurs, how do other volunteers react",
abstract = "serious adverse events in research involving healthy volunteers are rare, but their impact on other volunteers is unknown. We conducted semi-structured interviews with 60 healthy volunteers at an institution where a healthy research volunteer died. Most volunteers (85{\%}) had heard of the event, but few said it changed their thoughts about joining research (17{\%}), approach to studies or questions asked (25{\%}), or future participation (4{\%}). Despite knowing few facts, respondents created narratives about the case that served to distance them from the event and justify their continued participation in research. Downward social comparison theory, optimistic bias, and feelings of responsibility and control may help explain these narratives. Findings underscore the importance of communication and understanding of research risks and protections.",
keywords = "Adverse events, Bioethics, Downward social comparison theory, Healthy volunteers, Narratives, Optimistic bias",
author = "Kennedy, {Caitlin E} and Kass, {Nancy E} and Myers, {Rachel K.} and Edward Fuchs and Flexner, {Charles Williams}",
year = "2011",
month = "6",
doi = "10.1525/jer.2011.6.2.47",
language = "English (US)",
volume = "6",
pages = "47--56",
journal = "Journal of Empirical Research on Human Research Ethics",
issn = "1556-2646",
publisher = "University of California Press",
number = "2",

}

TY - JOUR

T1 - When a serious adverse event in research occurs, how do other volunteers react

AU - Kennedy, Caitlin E

AU - Kass, Nancy E

AU - Myers, Rachel K.

AU - Fuchs, Edward

AU - Flexner, Charles Williams

PY - 2011/6

Y1 - 2011/6

N2 - serious adverse events in research involving healthy volunteers are rare, but their impact on other volunteers is unknown. We conducted semi-structured interviews with 60 healthy volunteers at an institution where a healthy research volunteer died. Most volunteers (85%) had heard of the event, but few said it changed their thoughts about joining research (17%), approach to studies or questions asked (25%), or future participation (4%). Despite knowing few facts, respondents created narratives about the case that served to distance them from the event and justify their continued participation in research. Downward social comparison theory, optimistic bias, and feelings of responsibility and control may help explain these narratives. Findings underscore the importance of communication and understanding of research risks and protections.

AB - serious adverse events in research involving healthy volunteers are rare, but their impact on other volunteers is unknown. We conducted semi-structured interviews with 60 healthy volunteers at an institution where a healthy research volunteer died. Most volunteers (85%) had heard of the event, but few said it changed their thoughts about joining research (17%), approach to studies or questions asked (25%), or future participation (4%). Despite knowing few facts, respondents created narratives about the case that served to distance them from the event and justify their continued participation in research. Downward social comparison theory, optimistic bias, and feelings of responsibility and control may help explain these narratives. Findings underscore the importance of communication and understanding of research risks and protections.

KW - Adverse events

KW - Bioethics

KW - Downward social comparison theory

KW - Healthy volunteers

KW - Narratives

KW - Optimistic bias

UR - http://www.scopus.com/inward/record.url?scp=79959481906&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79959481906&partnerID=8YFLogxK

U2 - 10.1525/jer.2011.6.2.47

DO - 10.1525/jer.2011.6.2.47

M3 - Article

C2 - 21680976

AN - SCOPUS:79959481906

VL - 6

SP - 47

EP - 56

JO - Journal of Empirical Research on Human Research Ethics

JF - Journal of Empirical Research on Human Research Ethics

SN - 1556-2646

IS - 2

ER -