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Should desperate volunteers be included in randomised controlled trials?
1University of Sheffield, Samuel Fox House, Northern General Hospital, Herries Road, Sheffield S5 7AU, UK. p.j.allmark@shef.ac.uk
Journal of Medical Ethics
|September 1, 2006
Summary
This study defends the ethics of recruiting desperate volunteers for randomized controlled trials (RCTs). It argues that equipoise, informed consent, and clinician obligations support this practice when expert consensus exists.
Area of Science:
- Medical Ethics
- Clinical Research
Background:
- Randomized controlled trials (RCTs) sometimes enroll participants with a strong desire for experimental treatments.
- Ethical concerns arise regarding the recruitment of such individuals.
Purpose of the Study:
- To defend the ethical practice of recruiting desperate volunteers for RCTs.
- To address arguments questioning the ethical validity of this recruitment strategy.
Main Methods:
- The paper analyzes three primary ethical objections to recruiting desperate volunteers.
- It proposes a framework for understanding equipoise based on expert knowledge and shared values.
- It examines the nature of therapeutic obligation in the context of clinical trials.
Main Results:
- The study argues that collective expert equipoise provides a prima facie ethical justification for RCTs.
- It posits that enrolling in a trial does not violate a clinician's therapeutic obligation, as individualized care with insufficient evidence is not optimal.
- It concludes that limiting access to experimental treatments is acceptable when equipoise is established, as desperation does not confer a right to treatment.
Conclusions:
- Recruiting desperate volunteers for RCTs is ethically permissible under conditions of established expert equipoise.
- Informed consent and the distinction between research and treatment are critical ethical considerations.
- The ethical justification for RCTs differs from that of standard clinical care.
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