title: Research subject privacy protection in otolaryngology.
abstract: BACKGROUND
  Health Insurance Portability and Accountability Act regulations, which took effect on April 14, 2003, placed new constraints on the use of protected health information for research purposes.
  
  
  OBJECTIVE
  To review practices of research subject privacy protection in otolaryngology in order to determine steps necessary to achieve compliance with Health Insurance Portability and Accountability Act regulations.
  
  
  METHODS
  Literature review.
  
  
  METHODS
  Articles appearing in 2001 in 3 widely circulated otolaryngology journals were classified according to study design. The "Methods" section of each article was reviewed to determine whether the informed consent and institutional review board processes were clearly documented.
  
  
  RESULTS
  Descriptive studies involving case reports and case series were more common than observational studies that include a control group (66% vs 11%). Few case series documented the consent process (18%) and institutional review board process (19%). Observational designs demonstrated better documentation of the consent process (P<.001) and the institutional review board exemption and approval process (P<.001).
  
  
  CONCLUSIONS
  Methods used to protect subject privacy are not commonly documented in case series in otolaryngology. More attention needs to be given to research subject privacy concerns in the otolaryngology literature in order to comply with Health Insurance Portability and Accountability Act regulations.
authors.affiliation: Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina, Charleston 29425, USA.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Noone
authors.forename: K Christian
authors.initials: KC
authors.lastname: Walters
authors.forename: M Boyd
authors.initials: MB
authors.lastname: Gillespie
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D010036:Otolaryngology / Q000331:legislation & jurisprudence*; D010506:Periodicals as Topic; D012107:Research Design; D035842:Research Subjects; D014481:United States