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Pharmaceutical research involving the homeless
Tom L Beauchamp1, Bruce Jennings, Eleanor D Kinney
1The Kennedy Institute of Ethics, Georgetown University, Washington, DC 20057, USA. beauchat@georgetown.edu
The Journal of Medicine and Philosophy
|December 4, 2002
Summary
Homeless individuals should not be excluded from drug research, but ethical guidelines for consent and compensation are crucial. A multi-stage consent process and balanced payment are recommended to protect vulnerable populations.
Area of Science:
- Bioethics
- Clinical Research Ethics
- Vulnerable Populations Research
Background:
- Historically, research involving vulnerable populations has overlooked the homeless.
- Participation in drug studies poses potential risks including discomfort, injury, and health emergencies for homeless individuals.
- Despite risks, there is no ethical basis for excluding homeless persons from research participation.
Purpose of the Study:
- To address the ethical considerations of including homeless populations in pharmaceutical research.
- To propose an appropriate framework for informed consent and compensation for homeless research subjects.
Main Methods:
- Advocates for a multi-staged informed consent process, moving beyond single oral or written agreements.
- This includes stages of disclosure, dialogue, and ongoing permission-giving.
- Examines the ethics of offering payments and inducements to homeless individuals for research participation.
Main Results:
- Argues against categorical exclusion of homeless individuals from drug studies.
- Proposes a balanced approach to compensation, ensuring it is not exploitative (underpayment) nor unduly influential (irresistible inducement).
- Emphasizes appraising research risks realistically, based on empirical literature, rather than overestimation.
Conclusions:
- Homeless individuals should be included in pharmaceutical research with appropriate ethical safeguards.
- A dynamic, multi-stage informed consent process is essential for this population.
- Careful consideration of compensation is necessary to avoid exploitation while encouraging participation.