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.
authors.affiliation: Johns Hopkins University, Bloomberg School of Public Health, Department of International Health, Baltimore, MD 21205, USA. ckennedy@jhsph.edu
authors.forename: Caitlin E
authors.initials: CE
authors.lastname: Kennedy
authors.forename: Nancy
authors.initials: N
authors.lastname: Kass
authors.forename: Rachel K
authors.initials: RK
authors.lastname: Myers
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Fuchs
authors.forename: Charles
authors.initials: C
authors.lastname: Flexner
mesh_terms: D000328:Adult; D000368:Aged; D001290:Attitude; D035843:Biomedical Research; D003643:Death; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008606:Mental Processes; D008875:Middle Aged; D012108:Research Personnel / Q000523:psychology*; D012306:Risk; D020377:Self Efficacy; D012931:Social Environment; D012961:Sociology / Q000379:methods; D014838:Volunteers / Q000523:psychology*; D055815:Young Adult