Table 1 Definitions
Area covered by the law | Every trial or experimentation involving human beings based on a procedure formalized in a protocol in order to develop biological or medical knowledge. |
CCPPRB | "Comités Consultatifs de Protection des Personnes se Prêtant à la Recherche Biomédicale", i.e., committees for the protection of human beings involved in biomedical research. |
Composition of REC | The committees gather 12 members and 12 replacements. The REC is made up of four persons competent in biomedical research (at least three physicians), a general practitioner, two pharmacists (at least one working in a hospital, a nurse, one person qualified in ethics, one social worker, one person qualified in psychology and one person qualified in the legal aspects of research. |
Studies without direct individual benefit | None of the participants could expect any individual and immediate benefit, e.g. research in physiology or phase I studies are typically considered as studies with no therapeutic benefit for subjects. |
Studies with direct individual benefit | Patients can potentially expect a therapeutic benefit from the research. |
Decision | RECs have four possibilities in their decisions: rejecting the protocol, accepting the protocol without any modifications, accepting the protocol with minor modifications or asking for revisions (major modifications) before approval. |
Time to decision | RECs must give their first answer within 5 weeks after the protocol application. |
Revision | Mandatory modification requested by the REC before protocol approval. |
Amendment | Modifications proposed by the investigator to the committee after approval |
Information | Investigators can send information concerning their study (state of inclusions, article, etc.). This information does not lead to a decision by the REC. |