[Research on "usual" care: new French legislation].
Research on standard or usual care is defined by the law to cover assessments of standard care, except for drug treatments but including medical devices. It involves research about basic health care that uses standard procedures and products. Authorization by the relevant authority (DGS or Afssaps) is not required; the only application is made to a new Comité de protection des personnes. This committee is more closely related than in the past to the institutional review boards and ethics committees required for international publications. Committee approval is required to begin the study. Patients must be informed. Their consent is not mandatory, but they may object to participating in the study.
Lemaire
François
F
Service de réanimation médicale, Hôpital Henri Mondor, AP-HP, et Université Paris-Val de Marne, Créteil.
D004864:Equipment and Supplies / Q000592:standards; D005602:France; D006296:Health Services / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D007258:Informed Consent; D007348:Insurance, Health / Q000191:economics; D005791:Patient Care / Q000191:economics / Q000592:standards*; D012106:Research / Q000331:legislation & jurisprudence* / Q000592:standards*