Should desperate volunteers be included in randomised controlled trials?. Issue 9 (30th August 2006)

• Record Type: Journal Article
• Authors: Allmark, P; Mason, S
• Is Part Of: Journal of medical ethics. Volume 32:Issue 9(2006)
• Page Start: 548
• Page End: 553
• Publication Date: 2006-08-30
• Subjects: DMEC, Data Monitoring and Ethics Committee -- RCT, randomised controlled trial; Medical ethics -- Periodicals; 174.2
• DOI: 10.1136/jme.2005.014282
• Languages: English
• ISSNs: 0306-6800

Abstract

Abstract : Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguements that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.