Patients as subjects for research: ethical dilemmas for the primary care clinician-investigator.
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 five 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.


RESULTS
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 patient. They bear the ethical responsibility of scrutinizing study design and methods and planning communication with patients from the inception of a study.
Slatkoff
S F
SF
Department of Family Medicine, University of North Carolina, Chapel Hill 27599-7595.
Curtis
P
P
Coker
A
A
D000328:Adult; D002584:Cervix Uteri / Q000473:pathology; D002986:Clinical Trials as Topic; D032962:Consent Forms; D035061:Control Groups; D015344:DNA Probes, HPV; D030881:Disclosure; D004992:Ethics, Medical; D005260:Female; D005500:Follow-Up Studies; D006805:Human Experimentation; D006801:Humans; D033281:Nontherapeutic Human Experimentation; D065006:Papanicolaou Test; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000473:pathology; D010348:Patient Care Team; D010353:Patient Education as Topic; D018579:Patient Selection; D010819:Physician's Role; D010817:Physician-Patient Relations; D011320:Primary Health Care; D035842:Research Subjects; D012307:Risk Factors; D014412:Tumor Virus Infections / Q000473:pathology; D002583:Uterine Cervical Neoplasms / Q000473:pathology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000473:pathology
D015344:DNA Probes, HPV