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

A5329: Interferon –Free Therapy for Chronic Hepatitis C...

A5329 is a study for people who are infected with both HIV and the Hepatitis C virus (HCV) and have never taken Hepatitis C...

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

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled...

P1078 is a Phase IV, randomized, double-blind, placebo-controlled study of HIV-infected pregnant women and the infants born to...

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