title: Ethical challenges and solutions regarding delirium studies in palliative care.
abstract: BACKGROUND
  Delirium occurs commonly in settings of palliative care (PC), in which patient vulnerability in the unique context of end-of-life care and delirium-associated impairment of decision-making capacity may together present many ethical challenges.
  
  
  OBJECTIVE
  Based on deliberations at the Studies to Understand Delirium in Palliative Care Settings (SUNDIPS) meeting and an associated literature review, this article discusses ethical issues central to the conduct of research on delirious PC patients.
  
  
  METHODS
  Together with an analysis of the ethical deliberations at the SUNDIPS meeting, we conducted a narrative literature review by key words searching of relevant databases and a subsequent hand search of initially identified articles. We also reviewed statements of relevance to delirium research in major national and international ethics guidelines.
  
  
  RESULTS
  Key issues identified include the inclusion of PC patients in delirium research, capacity determination, and the mandate to respect patient autonomy and ensure maintenance of patient dignity. Proposed solutions include designing informed consent statements that are clear, concise, and free of complex phraseology; use of concise, yet accurate, capacity assessment instruments with a minimally burdensome schedule; and use of PC friendly consent models, such as facilitated, deferred, experienced, advance, and proxy models.
  
  
  CONCLUSIONS
  Delirium research in PC patients must meet the common standards for such research in any setting. Certain features unique to PC establish a need for extra diligence in meeting these standards and the employment of assessments, consent procedures, and patient-family interactions that are clearly grounded on the tenets of PC.
authors.affiliation: Division of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Bruyère Research Institute, Ottawa, Ontario, Canada.
authors.forename: Lisa
authors.initials: L
authors.lastname: Sweet
authors.affiliation: Research and Academic Institute of Athens, Athens, Greece. Electronic address: dimaadamis@yahoo.com.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Adamis
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada; Cognitive Impairment Research Group, Department of Psychiatry, Graduate Entry Medical School, University of Limerick, Limerick, Ireland.
authors.forename: David J
authors.initials: DJ
authors.lastname: Meagher
authors.affiliation: Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.
authors.forename: Daniel
authors.initials: D
authors.lastname: Davis
authors.affiliation: Discipline of Palliative and Supportive Services, Bedford Park, South Australia, Australia; Flinders Centre for Clinical Change, Flinders University, Bedford Park, South Australia, Australia.
authors.forename: David C
authors.initials: DC
authors.lastname: Currow
authors.affiliation: Division of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Bruyère Research Institute, Ottawa, Ontario, Canada; Palliative Care Unit, Bruyère Continuing Care, Ottawa, Ontario, Canada.
authors.forename: Shirley H
authors.initials: SH
authors.lastname: Bush
authors.affiliation: Division of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Palliative Care Unit, Bruyère Continuing Care, Ottawa, Ontario, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Barnes
authors.affiliation: Division of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Critical Care Response Team, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Hartwick
authors.affiliation: Discipline of Palliative and Supportive Services, Bedford Park, South Australia, Australia; Department of Palliative Care, Braeside Hospital, HammondCare, Sydney, New South Wales, Australia; South West Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
authors.forename: Meera
authors.initials: M
authors.lastname: Agar
authors.affiliation: Division of Palliative Medicine, Department of Oncology and Department of Internal Medicine, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Jessica
authors.initials: J
authors.lastname: Simon
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA; Department of Psychiatry, Weill Medical College of Cornell University, New York, New York, USA.
authors.forename: William
authors.initials: W
authors.lastname: Breitbart
authors.affiliation: Department of Oncology, McGill University, Montreal, Quebec, Canada.
authors.forename: Neil
authors.initials: N
authors.lastname: MacDonald
authors.affiliation: Division of Palliative Care, University of Ottawa, Ottawa, Ontario, Canada; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada; Bruyère Research Institute, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Lawlor
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D003469:Culture; D003693:Delirium / Q000523:psychology / Q000628:therapy*; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D038622:Internationality; D010166:Palliative Care / Q000941:ethics* / Q000379:methods*; D035862:Vulnerable Populations
keywords: Ethics; delirium; palliative care; research