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Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study.
Lika Nusbaum1, Brenda Douglas2, Karla Damus3
1Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Global Qualitative Nursing Research
|October 5, 2017
Summary
Informed consent experts highlighted challenges in communicating clinical trial risks and benefits. They emphasized the need for better education and training for research staff to improve the informed consent process.
Area of Science:
- Clinical research ethics
- Participant recruitment strategies
Background:
- Informed consent is crucial for clinical trial participation.
- Effective communication of risks and benefits presents significant challenges.
- Existing studies indicate major limitations in the informed consent process.
Purpose of the Study:
- To explore informed consent experts' views on communicating risks and benefits.
- To inform the development of a survey for research nurses.
- To understand perspectives on obtaining informed consent for clinical trials.
Main Methods:
- Qualitative exploration of informed consent experts' opinions and attitudes.
- Thematic analysis to identify key issues in risk/benefit communication.
- Focus on strategies, comprehension, and administrator preparation.
Main Results:
- Key themes included communication strategies, ensuring comprehension, and administrator preparation.
- Experts identified inadequate education and training as a major deficiency.
- Inconsistencies in expert opinions on current communication practices were noted.
Conclusions:
- Improved education and training for research staff are essential.
- Addressing expert critiques of communication practices requires further research.
- Enhancing the informed consent process is vital for participant protection.
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