Saturday, April 29, 2017 Print page
 
Centre of Inflammation and Metabolism (CIM)
 

Publications

To read the abstract, please click on the title of the publication of interest. If you want to access the publication on PubMed, please click on the PubMed ID.
To find specific publications, please use the sort and search functions. Please enter one word only as search term.

Click here to see all publications

90European legislation impedes critical care research and fails to protect patients' rights.
Berg RM; Moller K; Rossel PJ
Crit Care 2011; 15(2): 148
PubMed ID: 21542880

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. Berg, Ronan M G



 
© 2017 Centre of Inflammation and Metabolism
www.inflammation-metabolism.dk