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Consent is not enough—putting incompetent patients first in clinical trials

2003; Elsevier BV; Volume: 361; Issue: 9375 Linguagem: Inglês

10.1016/s0140-6736(03)13728-2

1474-547X

Oonagh Corrigan, Bryn Williams–Jones,

Ethics in medical practice

In February, 2003, the UK Medicines Control Agency (MCA) initiated a consultation on proposed legislation, The Medicines for Human Use (Clinical Trials) Regulations, 1 Medicines Control AgencyConsultation letter: MLX 287. http://www.mca.gov.uk/whatsnew/consultletters/consultletters.htm#mlx287Date: 2003 Google Scholar to implement the European Union (EU) Clinical Trials Directive. 2 European Parliament and of the Council of the European UnionDirective 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. May 1, 2001. http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf Google Scholar The UK draft statute proposes the establishment of powers and procedures for representatives to make decisions on behalf of incompetent patients (ie, those unable to give informed consent) about consent in clinical trials. We are particularly concerned by the underlying premise that incompetent patients should necessarily be participants in clinical trials and that they are best protected by obtaining informed consent from personal or legal representatives. The draft statute states that “the interests of the patient always prevail over those of science and society”. In keeping with this, we argue that because informed consent offers no protection to the incompetent person but simply gives legal protection to those conducting the trial, proxy consent is totally unsatisfactory from an ethical perspective and that other means of protecting such participants must be given priority.