title: The views of Alzheimer disease patients and their study partners on proxy consent for clinical trial enrollment.
abstract: OBJECTIVE
  To examine the views of Alzheimer disease (AD) patients and their study partners on the ethics of proxy consent for clinical research.
  
  
  METHODS
  Cross-sectional interview.
  
  
  METHODS
  At the 13 study sites of a randomized and placebo controlled study of simvastatin for the treatment of AD.
  
  
  METHODS
  Patients with mild-to-moderate AD and their study partners enrolled in an Alzheimer's Disease Cooperative Study trial of simvastatin.
  
  
  METHODS
  Interviews to assess how participants made the decision to enroll in a randomized controlled trial and their attitudes on proxy consent.
  
  
  RESULTS
  Study partners of patients judged not capable of providing informed consent reported the same degree of patient involvement in the decision to enroll as the study partners of patients capable of providing informed consent. Most study partners and patients supported proxy consent for this clinical trial and nearly all patients chose their study partner as their proxy. Study partners generally made research enrollment decisions based on what they thought would maximize the patient's well-being as opposed to a substituted judgment.
  
  
  CONCLUSIONS
  Patients and their study partners who were enrolled in a clinical trial supported proxy consent both for themselves and as a matter of policy. Our findings suggest that policies that require substituted judgments may not accord with the views of the people currently participating in AD clinical trials.
authors.affiliation: Department of Medicine, Alzheimer's Disease Center, Leonard Davis Institute for Health Economics, University of Pennsylvania, School of Medicine, Philadelphia, PA 19104, USA. Jason.karlawish@uphs.upenn.edu
authors.forename: Jason
authors.initials: J
authors.lastname: Karlawish
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
authors.forename: David
authors.initials: D
authors.lastname: Knopman
authors.forename: Christopher H
authors.initials: CH
authors.lastname: van Dyck
authors.forename: Bryan D
authors.initials: BD
authors.lastname: James
authors.forename: Daniel
authors.initials: D
authors.lastname: Marson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy / Q000523:psychology*; D001290:Attitude; D017028:Caregivers / Q000523:psychology; D003430:Cross-Sectional Studies; D032984:Ethics, Research; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D010358:Patient Participation; D035842:Research Subjects / Q000523:psychology*; D019821:Simvastatin / Q000627:therapeutic use; D020458:Third-Party Consent / Q000941:ethics*
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin