title: The human rights context for ethical requirements for involving people with intellectual disability in medical research.
abstract: BACKGROUND
  The history of ethical guidelines addresses protection of human rights in the face of violations. Examples of such violations in research involving people with intellectual disabilities (ID) abound. We explore this history in an effort to understand the apparently stringent criteria for the inclusion of people with ID in research, and differences between medical and other research within a single jurisdiction.
  
  
  METHODS
  The history of the Helsinki Declaration and informed consent within medical research, and high-profile examples of ethical misconduct involving people with ID and other groups are reviewed. The UN Convention on the Rights of Persons with Disabilities is then examined for its research implications. This background is used to examine a current anomaly within an Australian context for the inclusion of people with ID without decisional capacity in medical versus other types of research.
  
  
  RESULTS
  Ethical guidelines have often failed to protect the human rights of people with ID and other vulnerable groups. Contrasting requirements within an Australian jurisdiction for medical and other research would seem to have originated in early deference to medical authority for making decisions on behalf of patients.
  
  
  CONCLUSIONS
  Stringent ethical requirements are likely to continue to challenge researchers in ID. A human rights perspective provides a framework for engaging both researchers and vulnerable participant groups.
authors.affiliation: La Trobe Rural Health School, La Trobe University, Bendigo, Victoria, Australia. t.iacono@latrobe.edu.au
authors.forename: T
authors.initials: T
authors.lastname: Iacono
authors.forename: R
authors.initials: R
authors.lastname: Carling-Jenkins
mesh_terms: D001315:Australia; D035843:Biomedical Research / Q000941:ethics / Q000266:history*; D006233:Persons with Disabilities / Q000266:history; D004992:Ethics, Medical / Q000266:history*; D017408:Guidelines as Topic; D006381:Helsinki Declaration / Q000266:history; D049673:History, 20th Century; D049674:History, 21st Century; D006805:Human Experimentation / Q000941:ethics / Q000266:history*; D006806:Human Rights / Q000266:history*; D007258:Informed Consent / Q000266:history; D008607:Intellectual Disability / Q000266:history*; D028683:National Socialism / Q000266:history; D014480:United Nations / Q000266:history