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

Caitlin E. Kennedy, Nancy Kass, Rachel K. Myers, Edward J. Fuchs, Charles Flexner

Research output: Contribution to journalArticlepeer-review

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

Keywords

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

ASJC Scopus subject areas

  • Social Psychology
  • Education
  • Communication

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