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Article
Patients as Subjects for Research: Ethical Dilemmas for the Primary Care Clinician-Investigator
Journal of the American Board of Family Practice (1994)
  • Susan F. Slatkoff, University of North Carolina at Chapel Hill
  • Peter Curtis, University of North Carolina at Chapel Hill
  • Ann L. Coker, University of South Carolina - Columbia
Abstract
Background: Past studies suggested an association between human papillomavirus (HPV) and cervical intraepithelial neoplasia (CIN). In 1987, University of North Carolina (UNC) Hospitals Family Practice Center clinicians were approached for a control population to study this association. Methods: One hundred fives patients attending the UNC Hospitals Neoplasia Clinic with biopsy-proven CIN 2 or 3 and 268 control patients attending the UNC Family Practice Center for a routine Papanicolaou smear were enrolled in this case-control study. Case and control patients consented to having an additional cervical specimen taken and to being interviewed. The cervical specimens were classified by the Southern blot and polymerase chain reaction techniques for HPV. Resuilts: Early results suggested the control patients who had HPV were at high risk of developing CIN. Interventions were made to inform these patients of this risk and need for closer follow-up, causing a wide range of patient reactions. The final results showed no association of HPV with CIN, indicating the early interventions were premature. Conclusions: Physicians engaged in research need to be prepared to deal with the discovery of health risks in the otherwise "normal" control patients. They bear the ethical responsibility of scrutinizing study design and methods and planning communications with patients from the inception of a study.
Keywords
  • human papillomavirus,
  • cervical intraepithelial neoplasia,
  • ethics,
  • research with patients
Publication Date
May, 1994
Citation Information
Susan F. Slatkoff, Peter Curtis and Ann L. Coker. "Patients as Subjects for Research: Ethical Dilemmas for the Primary Care Clinician-Investigator" Journal of the American Board of Family Practice Vol. 7 Iss. 3 (1994)
Available at: http://works.bepress.com/anncoker/75/