title: Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa.
abstract: BACKGROUND
  South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality.
  
  
  CONCLUSIONS
  This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research.
  
  
  CONCLUSIONS
  This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.
authors.affiliation: HIV AIDS Vaccines Ethics Group, School of Psychology, University of KwaZulu-Natal, Private Bag X01, Scottsville, 3209, Pietermaritzburg, South Africa. slackca@ukzn.ac.za
authors.forename: Catherine
authors.initials: C
authors.lastname: Slack
authors.forename: Ann
authors.initials: A
authors.lastname: Strode
authors.forename: Theodore
authors.initials: T
authors.lastname: Fleischer
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
authors.forename: Chitra
authors.initials: C
authors.lastname: Ranchod
mesh_terms: D016915:AIDS Vaccines; D000293:Adolescent; D002651:Child Advocacy / Q000941:ethics* / Q000331:legislation & jurisprudence*; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics; D017322:Clinical Trials, Phase II as Topic / Q000941:ethics; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence*; D007872:Legal Guardians; D033281:Nontherapeutic Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D033282:Parental Consent; D018907:Privacy / Q000331:legislation & jurisprudence; D013019:South Africa
chemical_list: D016915:AIDS Vaccines