Social work and social science

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Risk, Trust and the Construction of Rational Consent in Healthy Volunteer Involvement in Clinical Trials

Shadreck Mwale, Senior Lecturer, SASS, University of Brighton
Social Science Forum Presentation 21st October 2015 in Checkland Building Room E424

Risk, Trust and the Construction of Rational Consent in Healthy Volunteer Involvement in Clinical Trials

Debates about the role of healthy volunteers in clinical trials in relation to risk, focus on volunteers’ management of risk, based on their category as ‘non’ vulnerable participants and their individual liberties (Hayden et al. 2007). Bioethical and socio-economic understandings of individuals as actors draw on medical understandings of vulnerability and rationalism as the guiding principles of human thought and action (Hale 2007). Within bioethics, healthy volunteers, as adults and free of mental and physical impairment, are seen as capable of rational thought, thus able to understand the contracts they sign to take part in clinical trials. Thus information provision is seen as a solution to ethical dilemmas in human involvement in clinical trials (Corringan 2003). Drawing on a qualitative research on healthy volunteer involvement in clinical trials, this paper critiques ‘informed consent’ as a concept and practice in healthy volunteer trials, by exploring its relationship to financial rewards, corporate interests, relationships between different actors and how these influence risk conception and perception in clinical trials. It argues that while information provision is useful, the participants’ financial vulnerability and relationships with researchers compromises rational consent. The paper adds that more should be done to ensure that financially vulnerable individuals do not bear more risk than they are capable of and the need for a broader understanding of vulnerability (Fineman 2008; Turner 2010) in these trials that goes beyond the focus on medical definitions of vulnerability.

 

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