title: Shared responsibility for ensuring appropriate management of incidental findings: a case study from South Africa.
abstract: We report the case of an HIV prevention clinical trial participant who was referred to a local hospital for investigation and management of an incidental finding unrelated to her study participation. This case illustrates the complexities in the management of incidental findings within the context of clinical trials and highlights the importance of ethical oversight of trials.
  
  
  BACKGROUND
  Protocol number ISRCTN64716212.
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Yukteshwar
authors.initials: Y
authors.lastname: Sookrajh
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Sarita
authors.initials: S
authors.lastname: Naidoo
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000601:surgery / Q000821:virology; D002986:Clinical Trials as Topic; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007044:Hysterectomy / Q000379:methods; D033162:Incidental Findings; D008875:Middle Aged; D028681:Moral Obligations; D065006:Papanicolaou Test; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis*; D012017:Referral and Consultation; D012108:Research Personnel / Q000941:ethics*; D012941:Social Responsibility; D013019:South Africa; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000601:surgery / Q000821:virology
keywords: Clinical trials; Research Ethics