European legislation impedes critical care research and fails to protect patients' rights.

Abstract:

:The European Clinical Trials Directive requires an informed consent from the patient or a proxy in drug trials. Although informed consent is a valuable tool to protect patients' rights in clinical trials, this requirement largely impedes research in critical care settings, and if pursued in this context, it does not provide the patient with adequate protection. Instead of insisting on informed consent, we suggest that the focus should be shifted towards two other ethically relevant elements in human experimentation: risk assessment and selection of research subjects. When reviewing protocols in which a waiver of consent is deemed necessary, the Ethical Review Board should ensure that non-therapeutic risks are minimal, that the research is specifically designed to benefit critically ill patients, and that it cannot be conducted under circumstances where an informed consent can be obtained. If the European Directive is changed accordingly, this permits clinical trials in critical care settings, while adequate protection from risky non-therapeutic procedures is ensured and exploitation of the patient as an easily accessible research subject is prevented.

journal_name

Crit Care

authors

Berg RM,Møller K,Rossel PJ

doi

10.1186/cc10113

subject

Has Abstract

pub_date

2011-01-01 00:00:00

pages

148

issue

2

eissn

1364-8535

issn

1466-609X

pii

cc10113

journal_volume

15

pub_type

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