title: Ethical review of research protocols: experience of a research ethics committee.
abstract: OBJECTIVE
  Since the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples. The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessment of research proposals involving human subjects.
  
  
  METHODS
  A descriptive study of the observations made on research projects registered between June 1, 2009 and June 30, 2010.
  
  
  RESULTS
  About two thirds of the projects evaluated in this period needed some type of amendment. Most of the comments were aimed at improving informed consent and procedures to ensure confidentiality (153 observations, 57.6%). Fifty (18.9%) observations related to the principles of beneficence and nonmaleficence. The remaining observations involved incomplete or incorrect documentation, or requests for additional information.
  
  
  CONCLUSIONS
  The largest number of observations related to the autonomy of research participants. It is important for researchers to be aware of the principle of autonomy in their interaction with study participants. Research ethics committees should therefore promote greater understanding of ethical issues on biomedical research.
authors.affiliation: Subdirección General de Terapia Celular y Medicina Regenerativa, Instituto de Salud Carlos III, Madrid, Spain. comartin@isciii.es
authors.forename: M Concepción
authors.initials: MC
authors.lastname: Martín-Arribas
authors.forename: Isabel
authors.initials: I
authors.lastname: Rodríguez-Lozano
authors.forename: Javier
authors.initials: J
authors.lastname: Arias-Díaz
mesh_terms: D003219:Confidentiality / Q000941:ethics; D004282:Documentation / Q000941:ethics; D026724:Ethical Review; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D026684:Personal Autonomy; D013030:Spain; D036302:Therapeutic Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence