title: The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study.
abstract: BACKGROUND
  Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis.
  
  
  METHODS
  Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives.
  
  
  RESULTS
  Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise.
  
  
  CONCLUSIONS
  The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.
authors.affiliation: French National Conference of Research Ethics Committees, Lyon, France. francois.chapuis@chu-lyon.fr.
authors.forename: Evelyne
authors.initials: E
authors.lastname: Decullier
authors.forename: Véronique
authors.initials: V
authors.lastname: Lhéritier
authors.forename: François
authors.initials: F
authors.lastname: Chapuis
mesh_terms: D002985:Clinical Protocols / Q000145:classification; D002986:Clinical Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D015331:Cohort Studies; D003625:Data Collection; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000706:statistics & numerical data*; D035082:Federal Government; D005602:France; D006805:Human Experimentation; D006801:Humans; D016526:Workload