Should desperate volunteers be included in randomised controlled trials?
- 1Northern General Hospital, University of Sheffield, Sheffield, UK
- 2Clinical Trials Research Unit, University of Leeds, Leeds, UK
- Correspondence to: P Allmark University of Sheffield, Samuel Fox House, Northern General Hospital, Herries Road, Sheffield S5 7AU, UK;
- Received 5 September 2005
- Accepted 28 December 2005
- Revised 21 December 2005
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.
Competing interests: None.
Contributors: PA conducted and transcribed the interviews cited at the outset of the paper and participated in writing this paper. SM participated in writing this paper.
Ethical approval: This study is not a report of empirical research. The North West Multi-centre Research Ethics Committee, UK, granted approval (MREC 03/8/9, on 27 March 2003) for the study from which the initial quotes are taken. All necessary local research ethics committees and trust research and development departments gave appropriate local approval.
The quotes in this paper are taken from a qualitative substudy on an RCT.