Research in ICU: consent and information. Part II: practical and legal aspects

Abstract

According to Law 2004-806 of the French Public Health Code, any subject enrolled in medical research has to provide consent. The way of giving consent depends on the type of research. Accordingly, with respect to research in humans, interventional biomedical studies require written and freely signed well-informed consent, whereas observational and current care interventional studies require simple information, the person being given the option to refuse participation. Intensivists rarely draw up consent forms but often write the information note on research. This information note is designed for the layperson and therefore has to be honest, explanatory, and easily understandable. Approval of the research by the French Intensive Care Society’s Ethics Committee is highly recommended in order to publish the research results in international journals. However, its recommendation is advisory and deals only with ethical considerations. It does not exempt investigators from legal and regulatory duties.