Literature DB >> 21680976

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

Caitlin E Kennedy1, Nancy Kass, Rachel K Myers, Edward J Fuchs, Charles Flexner.   

Abstract

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.

Entities:  

Mesh:

Year:  2011        PMID: 21680976      PMCID: PMC3303881          DOI: 10.1525/jer.2011.6.2.47

Source DB:  PubMed          Journal:  J Empir Res Hum Res Ethics        ISSN: 1556-2646            Impact factor:   1.742


  20 in total

Review 1.  Ethical issues in the design and conduct of randomised controlled trials.

Authors:  S J Edwards; R J Lilford; D A Braunholtz; J C Jackson; J Hewison; J Thornton
Journal:  Health Technol Assess       Date:  1998-12       Impact factor: 4.014

2.  Legal liability for injury to research subjects.

Authors:  K C Glass; B Freedman
Journal:  Clin Invest Med       Date:  1991-04       Impact factor: 0.825

Review 3.  Optimistic biases about personal risks.

Authors:  N D Weinstein
Journal:  Science       Date:  1989-12-08       Impact factor: 47.728

Review 4.  A model designed to enhance informed consent: experiences from the HIV prevention trials network.

Authors:  Cynthia Woodsong; Quarraisha Abdool Karim
Journal:  Am J Public Health       Date:  2005-03       Impact factor: 9.308

5.  Injury to research volunteers--the clinical-research nightmare.

Authors:  Alastair J J Wood; Janet Darbyshire
Journal:  N Engl J Med       Date:  2006-05-04       Impact factor: 91.245

6.  Motivations, understanding, and voluntariness in international randomized trials.

Authors:  Nancy E Kass; Suzanne Maman; Joan Atkinson
Journal:  IRB       Date:  2005 Nov-Dec

7.  Adverse events in phase-I studies: a report in 1015 healthy volunteers.

Authors:  M Sibille; N Deigat; A Janin; S Kirkesseli; D V Durand
Journal:  Eur J Clin Pharmacol       Date:  1998-03       Impact factor: 2.953

8.  Unrealistic optimism about susceptibility to health problems: conclusions from a community-wide sample.

Authors:  N D Weinstein
Journal:  J Behav Med       Date:  1987-10

Review 9.  Improvement of informed consent and the quality of consent documents.

Authors:  Michael Jefford; Rosemary Moore
Journal:  Lancet Oncol       Date:  2008-05       Impact factor: 41.316

10.  Balancing justice and autonomy in clinical research with healthy volunteers.

Authors:  N E Kass; R Myers; E J Fuchs; K A Carson; C Flexner
Journal:  Clin Pharmacol Ther       Date:  2007-04-04       Impact factor: 6.875

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