ANALYSIS OF A SURVEY OF 36 FRENCH RESEARCH COMMITTEES ON INTRACYTOPLASMIC SPERM INJECTION

Background In France, when a new medical technology is to be applied e xperimentally to human beings, it must adhere to the principles stipul ated by the Huriet-Serusclat law on biomedical research. This law requ ires that the validation of a protocol applicable to human beings, wit h its corollary protection and information dimensions, is first submit ted to a research committee, known as a Consultative Committee Protect ing Persons in Biomedical Research (CCPPRB). We aimed to survey the co mpetence of these committees in biotechnology, and whether or not intr acytoplasmic sperm injection (ICSI) had been considered by the committ ees as being an innovative treatment. Methods We presented each of Fra nce's 48 CCPPRBs with a questionnaire to assess the choices and criter ia for making decisions that arose at the time ICSI was implemented in the different centres in each region. Findings 36 committees look par t. 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 biom edical research. Only three centres for medically assisted reproductio n had submitted applications to a CCPPRB, although ICSI has been imple mented in over 20 centres. 21 (58%) committees were of the opinion tha t the implementation of ICSI could have come under their supervision. 24 (67%) committees believed that, independently of their own involvem ent, 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 ha ndling 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 techn ologies.