The 131st Annual Meeting (November 15-19, 2003) of APHA

Abstract #63195

Angus Dawson, Dr, Centre for Professional Ethics, Keele University, School of English and Philosophy, Keele, Staffordshire, ST5 5BG, United Kingdom, +44 1782 584082, a.j.dawson@keele.ac.uk

Objective: This paper will outline and explore some recent empirical evidence suggesting a potentially serious problem in attempting to obtain consent for participation in randomised controlled trials (RCTs) in a medical research context.

Method: The paper will proceed by outlining and discussing three issues. Firstly, the background will be sketched as to why RCTs provide such a useful methodology in a research context. Secondly, a series of recent empirical findings suggesting problems in the public's understanding of randomisation will be outlined. Thirdly, the possible implications of this evidence will be discussed.

Results: There are a number of possible conclusions that might be drawn from these studies (e.g. we should not perform any further RCTs; we should just carry on with partial consent; we should revise how we think about consent in an RCT framework). The implications of each of these will be explored.

Conclusion: Recent empirical evidence suggests an urgent need to think about the problem of obtaining consent to the randomisation-element of RCTs.

Learning Objectives:

At the conclusion of the session, the participant will be able to:
• Describe recent empirical studies about obtaining consent in the context of an RCT.
• Recognise the relevant ethical issues raised by these studies.
• List three possible ways of responding to these studies.

Keywords: Research, Ethics

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.