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

Citation: Kennedy CE, Kass N, Myers RK, Fuchs EJ, Flexner C. When a serious adverse event in research occurs, how do other volunteers react? J Empir Res Hum Res Ethics. 2011 Jun;6(2):47-56. doi: 10.1525/jer.2011.6.2.47.

Access full article:

https://www.ncbi.nlm.nih.gov/pubmed/21680976

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.

Categories

CRS
Topics

Clinical Trials

A5384: A Phase II, Randomized, Open-Label Trial of a...

Study Description A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease...

Read More

A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Read More

P2001 (DAIDS ID 12026): Evaluating the Pharmacokinetics,...

TB is a major cause of illness and death in women of reproductive age. Pregnant and postpartum women with latent TB are at...

Read More

A5274: REMEMBER, Reducing Early Mortality and Early...

This study is being done in people who are starting HIV treatment and who live in areas where the TB infection rate is high. The...

Read More

A5327: Sofosbuvir + Ribavirin w/o Interferon for Treatment...

A5327 SWIFT-C is a Phase I, open-label, two-cohort clinical trial, in which between 44 and 50 acutely HCV-infected HIV-1...

Read More