title: Informed consent for genetic research.
abstract: BACKGROUND
  Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research.
  
  
  OBJECTIVE
  To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome.
  
  
  METHODS
  Survey conducted between February 1, 2002, and March 31, 2003.
  
  
  METHODS
  Academic, tertiary free-standing children's hospital.
  
  
  METHODS
  A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed.
  
  
  METHODS
  Reasons for refusal.
  
  
  RESULTS
  Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study.
  
  
  CONCLUSIONS
  The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.
authors.affiliation: Edward Mallinckrodt Department of Pediatrics, Division of Newborn Medicine, Washington University School of Medicine and St Louis Children's Hospital, St Louis, MO 63110, USA. Hamvas@kids.wustl.edu
authors.forename: Aaron
authors.initials: A
authors.lastname: Hamvas
authors.forename: Katherine K
authors.initials: KK
authors.lastname: Madden
authors.forename: Lawrence M
authors.initials: LM
authors.lastname: Nogee
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Trusgnich
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Wegner
authors.forename: Hillary B
authors.initials: HB
authors.lastname: Heins
authors.forename: F Sessions
authors.initials: FS
authors.lastname: Cole
mesh_terms: D004651:Employment; D005260:Female; D036281:Genetic Research; D014644:Genetic Variation / Q000235:genetics; D019538:Health Care Surveys; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007348:Insurance, Health; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data; D008297:Male; D008923:Missouri; D010044:Outpatient Clinics, Hospital / Q000706:statistics & numerical data; D033282:Parental Consent / Q000706:statistics & numerical data*; D011498:Protein Precursors / Q000235:genetics; D011510:Proteolipids / Q000235:genetics; D045808:Refusal to Participate / Q000706:statistics & numerical data*; D012127:Respiratory Distress Syndrome, Newborn / Q000235:genetics*; D012306:Risk; D009626:Terminology as Topic
chemical_list: D011498:Protein Precursors; D011510:Proteolipids; C105511:surfactant protein B propeptide