Informed consent for and regulation of critical care research.
OBJECTIVE
Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20.


RESULTS
This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research.


CONCLUSIONS
Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.
Lemaire
François
F
Délégation à la recherche clinique, AP-HP, et Université Paris 12, France. francois.lemaire@hmn.aphp.fr
D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D003422:Critical Care / Q000331:legislation & jurisprudence* / Q000592:standards; D003657:Decision Making; D005060:Europe; D005602:France; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence* / Q000592:standards