title: Ethics of genetic and biomarker test disclosures in neurodegenerative disease prevention trials.
abstract: OBJECTIVE
  Prevention trials for neurodegenerative diseases use genetic or other risk marker tests to select participants but there is concern that this could involve coercive disclosure of unwanted information. This has led some trials to use blinded enrollment (participants are tested but not told of their risk marker status). We examined the ethics of blinded vs transparent enrollment using well-established criteria for assessing the ethics of clinical research.
  
  
  METHODS
  Normative analysis applying 4 key ethical criteria-favorable risk-benefit ratio, informed consent, fair subject selection, and scientific validity-to blinded vs transparent enrollment, using current evidence and state of Alzheimer disease (AD) and other prevention trials.
  
  
  RESULTS
  Current evidence on the psychosocial impact of risk marker disclosure and considerations of scientific benefit do not support an obligation to use blinded enrollment in prevention trials. Nor does transparent enrollment coerce or involve undue influence of potential participants. Transparent enrollment does not unfairly exploit vulnerable participants or limit generalizability of scientific findings of prevention trials. However, if the preferences of a community of potential participants would affect the rigor or feasibility of a prevention trial using transparent enrollment, then investigators are required by considerations of scientific validity to use blinded enrollment.
  
  
  CONCLUSIONS
  Considerations of risks and benefits, informed consent, and fair subject selection do not require the use of blinded enrollment for AD prevention trials. Blinded enrollment in AD prevention trials may sometimes be necessary because of the need for scientific validity, not because it prevents coercion or undue influence.
authors.affiliation: From the Department of Bioethics, Clinical Center (S.Y.H.K., B.E.B.), National Institutes of Health, Bethesda, MD; and the Departments of Medicine and Medical Ethics and Health Policy (J.K.), University of Pennsylvania, Perelman School of Medicine, Philadelphia. scott.kim@nih.gov.
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
authors.affiliation: From the Department of Bioethics, Clinical Center (S.Y.H.K., B.E.B.), National Institutes of Health, Bethesda, MD; and the Departments of Medicine and Medical Ethics and Health Policy (J.K.), University of Pennsylvania, Perelman School of Medicine, Philadelphia.
authors.forename: Jason
authors.initials: J
authors.lastname: Karlawish
authors.affiliation: From the Department of Bioethics, Clinical Center (S.Y.H.K., B.E.B.), National Institutes of Health, Bethesda, MD; and the Departments of Medicine and Medical Ethics and Health Policy (J.K.), University of Pennsylvania, Perelman School of Medicine, Philadelphia.
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Berkman
mesh_terms: D000544:Alzheimer Disease / Q000235:genetics / Q000517:prevention & control*; D015415:Biomarkers; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D018579:Patient Selection / Q000941:ethics*; D014342:Truth Disclosure / Q000941:ethics*
chemical_list: D015415:Biomarkers