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How clinical trials really work rethinking research ethics
Debra A DeBruin1, Joan Liaschenko, Anastasia Fisher
1Center for Bioethics, University of Minnesota, USA.
Kennedy Institute of Ethics Journal
|June 24, 2011
Summary
This study reveals the daily ethical challenges in clinical trials, highlighting a need to improve oversight systems and rethink trial ethics. Understanding the practical work is key to addressing these issues.
Area of Science:
- Clinical Trials
- Bioethics
- Research Ethics
Background:
- Ethical conduct in clinical trials is a significant concern.
- However, the practical, day-to-day ethical challenges encountered during trials remain largely unexamined.
Purpose of the Study:
- To investigate the daily work and emergent ethical challenges within clinical trials.
- To assess the adequacy of current oversight systems in addressing these practical ethical issues.
Main Methods:
- Qualitative study exploring the day-to-day operations of clinical trials.
- Analysis of ethical challenges arising from practical trial conduct.
Main Results:
- Identified specific, often overlooked, ethical challenges inherent in the daily workflow of clinical trials.
- Current oversight mechanisms do not fully capture or address these practical ethical realities.
Conclusions:
- Clinical trial oversight requires refinement to incorporate an understanding of daily operational realities.
- A fundamental rethinking of clinical trial ethics is necessary to address challenges beyond the scope of current oversight systems.
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