title: Revisiting "freely given informed consent" in relation to the developing world: role of an ombudsman.
abstract: BACKGROUND
  Establishment of Sri Lankan Twin Registry demanded development of ethical guidelines, as an effective ethical framework was not available in Sri Lanka.
  
  
  METHODS
  Objectives were to find out whether the ombudsman concept exists in current informed consent practices and to investigate opinion about ombudsmen. We searched Pub Med, conducted a postal survey, and monitored Internet discussion.
  
  
  RESULTS
  The responses were categorized into current practices and existing models in informed consent process, reservations expressed about current practices, arguments supporting the concept, concerns and issues, alternatives, and how to implement the proposal. The concept of a third person is not entirely novel. How to find a truly independent person, the financial implication, confidentiality, obligations, and liabilities of ombudsmen, also emerged.
  
  
  CONCLUSIONS
  The concept of an ombudsman is conceptually and ethically sound and acceptable but the challenges posed by this very same solution to creating a better process of informed consent will have to be faced.
authors.affiliation: Kings College, University of London, United Kingdom.
authors.forename: Athula
authors.initials: A
authors.lastname: Sumathipala
authors.forename: Sisira
authors.initials: S
authors.lastname: Siribaddana
mesh_terms: D003219:Confidentiality; D003906:Developing Countries; D004995:Ethics, Professional; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards; D010344:Patient Advocacy / Q000191:economics / Q000941:ethics / Q000592:standards; D012042:Registries / Q000592:standards*; D012107:Research Design; D013188:Sri Lanka; D011795:Surveys and Questionnaires; D018433:Twin Studies as Topic