Background In France, when a new medical technology is to be applied experimentally to human beings, it must adhere to the principles stipulated by the Huriet-Serusclat law on biomedical research. This law requires that the validation of a protocol applicable to human beings, with its corollary protection and information dimensions, is first submitted to a research committee, known as a Consultative Committee Protecting Persons in Biomedical Research (CCPPRB). We aimed to survey the competence of these committees in biotechnology, and whether or not intracytoplasmic sperm injection (ICSI) had been considered by the committees as being an innovative treatment.
Methods We presented each of France's 48 CCPPRBs with a questionnaire to assess the choices and criteria for making decisions that arose at the time ICSI was implemented in the different centres in each region.
Findings 36 committees took part.We found that ICSI had been largely introduced in settings outside the scope of the CCPPRBs and of the framework fixed by the law on biomedical research. Only three centres for medically assisted reproduction had submitted applications to a CCPPRB, although ICSI has been implemented in over 20 centres. 21 (58%) committees were of the opinion that the implementation of ICSI could have come under their supervision. 24 (67%) committees believed that, independently of their own involvement, evaluation procedures for ICSI should have been specified before centres decided to introduce it.
Interpretation We observed important differences in the way CCPPRBs handled ICSI as being within or outside the medical research field.The status of the research committees is legally and identically defined. However, committees did not agree on the definition of the limits of their action, and, therefore, their handling of the same issue differed. An inquiry is needed to define how, now that ICSI is done in many centres, it should adhere to principles of evaluation and safety already in existence for other medical technologies.