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

HPTN 078: Enhancing Recruitment, Linkage to Care and...

The purpose of this study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable...

Read More

HPTN083: A Phase 2b/3 Double Blind Safety and Efficacy Study...

HPTN 083 is a study being done to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for...

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

A5324: A Randomized, Double-Blinded, Placebo-Controlled...

ACTG A5324 is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC)...

Read More

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate...

This study is currently on hold. The study is designed to characterize the pharmacokinetics of DLM using a model-based...

Read More