title: Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit.
abstract: Studying patients during the end of life is important, as it has the potential to lead to improvements in care for the dying. For patients who die after a controlled withdrawal of life-sustaining therapies in the intensive care unit, information about the natural history of death and the process of removing life support has additionally led to advances in practice for deceased organ donation. However, this unique population of severely critically ill and imminently dying patients has been difficult to study, largely due to assumptions made by research teams and ethics boards alike about the logistical difficulties of obtaining consent and completing research procedures before or during the process of withdrawal of life-sustaining therapies. In this paper, we describe the ethics substudy of the first prospective observational research study in Canada to obtain consent and collect clinical data on patients during the process of withdrawal of life-sustaining therapies in the intensive care unit. We describe in detail the process of protocol development, review by five institutional research ethics boards and bedside staff satisfaction with the study. We conclude that prospective research on a critically ill and imminently dying population is feasible and can be conducted in an ethical manner. Further information is needed about the experiences and motivations of families and substitute decision makers who provide consent for research on critically ill intensive care unit patients at the end of life.
authors.affiliation: Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.
authors.forename: Amanda
authors.initials: A
authors.lastname: van Beinum
authors.affiliation: Bertram Loeb Research Consortium in Organ and Tissue Donation, University of Ottawa, Ottawa, Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: Hornby
authors.affiliation: Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.|Division of Pediatric Critical Care, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada.
authors.forename: Sonny
authors.initials: S
authors.lastname: Dhanani
authors.affiliation: Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.
authors.forename: Roxanne
authors.initials: R
authors.lastname: Ward
authors.affiliation: McGill University Health Centre (retired), Montreal, Canada.|Ingram School of Nursing, McGill University, Montreal, Canada.
authors.forename: Jane
authors.initials: J
authors.lastname: Chambers-Evans
authors.affiliation: Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.|Division of Pediatric Critical Care, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada.
authors.forename: Kusum
authors.initials: K
authors.lastname: Menon
mesh_terms: D001291:Attitude of Health Personnel; D035843:Biomedical Research / Q000941:ethics*; D002170:Canada; D003422:Critical Care; D016638:Critical Illness / Q000401:mortality*; D003643:Death; D003657:Decision Making; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent; D007362:Intensive Care Units; D008020:Life Support Care; D064887:Observational Studies as Topic; D011446:Prospective Studies; D012107:Research Design; D013727:Terminal Care; D009927:Tissue and Organ Procurement; D028761:Withholding Treatment
keywords: Care of the Dying Patient; End-of-life; Research Ethics; Research on Special Populations; Third Party Consent/Incompetents