title: Current outlook of ethics in research with human subjects.
abstract: In the last decades, medical care has been increasingly permeated by the concept of evidence-based-medicine, in which clinical research plays a crucial role in establishing diagnostic and treatment. Following the improvements in clinical research, we have a growing concern and understanding that some ethical issues must be respected when the subjects are human beings. Research with human subjects relies on the principles of autonomy, beneficence, no maleficence and justice. Ordinance 196/96 from the National Health Board adds to the Brazilian legislation such renowned bioethical principles.
  
  
  OBJECTIVE
  Discuss the main ethical aspects involved in research with human subjects.
  
  
  METHODS
  Critical analysis of Ordinance 196/96 and related literature.
  
  
  CONCLUSIONS
  Ordinance 196/96 rules research with human subjects; nevertheless, it requires more in-depth discussions regarding the informed consent, use of placebo, research with vulnerable populations and research in developing countries.
authors.affiliation: University Hospital, Medical School, University of São Paulo, Brazil.
authors.forename: Marystella Tomoe
authors.initials: MT
authors.lastname: Takahashi
authors.forename: Henrique Faria
authors.initials: HF
authors.lastname: Ramos
authors.forename: Carlos Diógenes
authors.initials: CD
authors.lastname: Pinheiro-Neto
authors.forename: Ivan Dieb
authors.initials: ID
authors.lastname: Miziara
authors.forename: Reynaldo Ayer de
authors.initials: RA
authors.lastname: Oliveira
mesh_terms: D001938:Brazil; D032984:Ethics, Research; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans