Forschung und Ethik in der Notfallmedizin : Empfehlungen eines Workshops.
Traduction en anglais : Research and ethics in emergency medicine.
Prerequisites for experimental study designs are extremely difficult to realise under prehospital emergency conditions.
Results obtained in animal experiments always need validation with prehospital or inhospital patient studies.
Investigations related to emergency medicine are, however, an ethical obligation on behalf of the patient.
A retrospective analysis of the available literature should be considered a prerequisite for prospective randomised and controlled studies.
Frequently, a pilot study or feasibility trial needs to precede the actual study.
Informed consent must be obtained for all patient studies.
However, under emergency conditions informed consent cannot always be obtained due to unconsciousness, etc.
Nevertheless, the following principles should be observed :
(a) randomised studies are essential, even in emergency medicine ;
(b) they are ethically acceptable if the treatment provided for the study group is at least equivalent to the therapy for the control group ;
(c) only these preconditions guarantee that the patient always receives treatment in accordance with the standard of treatment.
If the patient is unconscious or otherwise unable to give informed consent, the principle of deferred consent is acceptable.
The deferred consent principle should be carefully documented.
A prospective randomized study represents the gold standard for an investigation, even under emergency conditions.
There are different principles of randomization : tele...
Mots-clés Pascal : Recherche scientifique, Ethique, Médecine, Urgence, Essai clinique, Consentement éclairé, Allemagne, Europe, Homme
Mots-clés Pascal anglais : Scientific research, Ethics, Medicine, Emergency, Clinical trial, Informed consent, Germany, Europe, Human
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 96-0275734
Code Inist : 002B30A09. Création : 199608.