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

P1073: Study of Immune Reconstitution Inflammatory Syndrome...

P1073 is a case controlled prospective, clinical, observational and pathogenesis study of HIV-infected infants and children...

Read More

A5314: Effect of LDMTX on Inflammation in HIV-infected...

A5314 is a phase II randomized, double-blind, placebo-controlled 36-week trial that will examine the safety and efficacy of...

Read More

A5300B/I2003B/PHOENIX, Protecting Households On Exposure to...

This study will compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing...

Read More

The Pharmacokinetics, Safety and Acceptability of New...

PK, safety and acceptability data and practical guidance on the optimal dosing of new more child-friendly formulations of...

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