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

P2010: Phase III Study of the Virologic Efficacy and Safety...

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a...

Read More

ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients...

Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease...

Read More

HPTN 069: A Phase II Randomized, Double-Blind, Study of the...

HPTN 069 is a phase II, four-arm, multisite, randomized, double-blinded trial. To assess the safety and tolerability of four...

Read More

P1070, Dose-Finding and Pharmacogenetic Study of Efavirenz...

Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in adults and children older than 3 years...

Read More

A5128: Consent for Use of Stored Patient Specimens for...

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other...

Read More