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Two concepts of therapeutic optimism.

Lynn A Jansen¹

¹Center for Ethics in Health Care, Oregon Health and Science University, 3181 SW, Sam Jackson Park, RD (UHN-86) Portland, OR 97239, USA. ljhomes@aol.com

Journal of Medical Ethics

|May 10, 2011

Summary

Participants in early phase clinical trials may express optimism for medical benefit. This study distinguishes between ethically benign and potentially worrisome forms of therapeutic optimism, crucial for ethical understanding.

Area of Science:

Medical Ethics
Clinical Trial Research
Participant Psychology

Background:

Concerns exist regarding participant expectations of direct medical benefit in early phase clinical trials.
Previous research focused on misunderstanding or misinformation regarding trial benefits.
Recent focus is on therapeutic optimism, the hope for personal medical benefit from trial participation.

Purpose of the Study:

To clarify the ethical significance of therapeutic optimism in clinical trial participants.
To differentiate between ethically benign and potentially worrisome forms of therapeutic optimism.
To resolve confusion among researchers discussing therapeutic optimism.

Main Methods:

Conceptual analysis of the term 'therapeutic optimism'.

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Distinguishing between two distinct phenomena associated with therapeutic optimism.

Review of existing literature on participant expectations and clinical research ethics.

Main Results:

Identified two distinct phenomena under the umbrella of 'therapeutic optimism'.
One form of therapeutic optimism is ethically benign.
The other form of therapeutic optimism presents potential ethical concerns.

Conclusions:

Distinguishing between these two forms of therapeutic optimism is essential for ethical evaluation.
Failure to differentiate leads to misunderstandings in ethical discourse.
A clear distinction clarifies the nature and ethical implications of participant hope in clinical trials.