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Updated: May 31, 2026
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Published on: November 26, 2015
When a serious adverse event in research occurs, how do other volunteers react?
Caitlin E Kennedy1, Nancy Kass, Rachel K Myers
1Johns Hopkins University, Bloomberg School of Public Health, Department of International Health, Baltimore, MD 21205, USA. ckennedy@jhsph.edu
Summary
Serious adverse events in clinical research are rare. Even after a volunteer death, most healthy participants continued research, creating narratives to distance themselves from the event.
Area of Science:
- Clinical Research Ethics
- Participant Psychology
- Risk Perception in Research
Background:
- Serious adverse events (SAEs) in healthy volunteer research are infrequent but can profoundly impact participants.
- The psychological effects of SAEs on other healthy volunteers remain under-explored.
- Understanding volunteer responses to adverse events is crucial for ethical research conduct.
Purpose of the Study:
- To investigate the impact of a fatal serious adverse event on healthy research volunteers.
- To explore how knowledge of an SAE influences volunteers' perceptions and future participation.
- To identify psychological mechanisms underlying volunteer responses to research risks.
Main Methods:
- Conducted semi-structured interviews with 60 healthy volunteers at an institution where a research volunteer died.
- Assessed awareness of the event, changes in research attitudes, and future participation intentions.
- Analyzed qualitative data to understand narrative construction and psychological distancing strategies.
Main Results:
- 85% of volunteers had heard of the fatal event.
- Few reported changes in their decision to join research (17%), study approach (25%), or future participation (4%).
- Participants constructed narratives to distance themselves from the event and rationalize continued research involvement, influenced by social comparison and optimism bias.
Conclusions:
- Healthy volunteers may maintain participation in research despite awareness of serious adverse events by employing psychological distancing mechanisms.
- Effective communication regarding research risks and safety protocols is essential for informed consent and participant trust.
- Further research should explore the long-term psychological impact of SAEs on research populations.
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