Communication and miscommunication in informed consent to research

Area of Science:

• Biomedical Ethics
• Clinical Research
• Sociology of Science

Background:

• Biomedical ethics mandate that research participants understand experimental versus therapeutic intent.
• The distinction between research and treatment is often misunderstood, termed the therapeutic misconception.
• Despite extensive study, the therapeutic misconception remains prevalent among research subjects.

Purpose of the Study:

• To identify overlooked factors contributing to the persistence of the therapeutic misconception.
• To critique the idealized communication model in current informed consent theory.
• To propose an alternative approach to studying informed consent in research.

Main Methods:

• Analysis of informed consent session transcripts from a cancer research trial.
• Examination of communication practices beyond explicit verbal content.
• Focus on the social context of informed consent discussions.

Main Results:

• The theoretical paradigm guiding informed consent often neglects crucial social context.
• Communication in informed consent involves more than just the words spoken.
• The manner and source of communication significantly impact subject understanding.

Conclusions:

• Rethinking informed consent requires acknowledging the social and contextual elements of communication.
• An alternative approach focusing on "how" and "by whom" information is conveyed is necessary.
• Addressing the therapeutic misconception necessitates a deeper understanding of research communication dynamics.