When a Serious Adverse Event in Research Occurs, How Do Other Volunteers React

Bibliographic Data

ID12807015
AuthorsCaitlin E Kennedy (0000-0001-6820-063X, Johns Hopkins University, corresponding author), Norman Ka (0000-0003-3833-8456, Johns Hopkins University), R Kelly Myers (0000-0003-1998-8162, Johns Hopkins University), Edward J Fuchs (Johns Hopkins University), Charles Flexner (0000-0002-4495-5349, Johns Hopkins University)
Year2011
Volume6
Issue2
Pages47-56
Publication date2011-06-01
Open AccessYes
TypeARTICLE
VenueJournal of Empirical Research on Human Research Ethics (JOURNAL)
Journal identifiersISSN: 1556-2646 • E-ISSN: 1556-2654
PublisherSAGE Publishing (PUBLISHER • US)
DOI10.1525/jer.2011.6.2.47
PMID21680976
PMCIDPMC3303881
OpenAlexW2059622853
LanguageEN
References cited24

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

Adverse effect · Event (particle physics · Feeling · Institution · Narrative · Social science · Sociology · Volunteer · Ethics in Clinical Research · Ethics in medical practice · Medicine · Optimism, Hope, and Well-being · Psychology · Social Psychology

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