Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

Simple item page
dc.contributor.authorSlack, Catherineen_ZA
dc.contributor.authorStrode, Annen_ZA
dc.contributor.authorFleischer, Theodoreen_ZA
dc.contributor.authorGray, Glendaen_ZA
dc.contributor.authorRanchod, Chitraen_ZA
dc.date.accessioned2015-10-12T10:47:45Z
dc.date.available2015-10-12T10:47:45Z
dc.date.issued2007en_ZA
dc.description.abstractBACKGROUND: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.DISCUSSION: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.SUMMARY: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 commitees; and lobbying the National Regulatory Authority for guidance.en_ZA
dc.identifier.apacitationSlack, C., Strode, A., Fleischer, T., Gray, G., & Ranchod, C. (2007). Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa. <i>BMC Medical Ethics</i>, http://hdl.handle.net/11427/14160en_ZA
dc.identifier.chicagocitationSlack, Catherine, Ann Strode, Theodore Fleischer, Glenda Gray, and Chitra Ranchod "Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa." <i>BMC Medical Ethics</i> (2007) http://hdl.handle.net/11427/14160en_ZA
dc.identifier.citationSlack, C., Strode, A., Fleischer, T., Gray, G., & Ranchod, C. (2007). Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa. BMC Medical Ethics, 8(1), 5.en_ZA
dc.identifier.ris TY - Journal Article AU - Slack, Catherine AU - Strode, Ann AU - Fleischer, Theodore AU - Gray, Glenda AU - Ranchod, Chitra AB - 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.DISCUSSION: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.SUMMARY: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 commitees; and lobbying the National Regulatory Authority for guidance. DA - 2007 DB - OpenUCT DP - University of Cape Town J1 - BMC Medical Ethics LK - https://open.uct.ac.za PB - University of Cape Town PY - 2007 T1 - Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa TI - Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa UR - http://hdl.handle.net/11427/14160 ER - en_ZA
dc.identifier.uri10.1186/1472-6939-8-5en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14160
dc.identifier.vancouvercitationSlack C, Strode A, Fleischer T, Gray G, Ranchod C. Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa. BMC Medical Ethics. 2007; http://hdl.handle.net/11427/14160.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentCentre for Bioethicsen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Medical Ethicsen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcmedethics/en_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherVaccine trialsen_ZA
dc.subject.otherEthicsen_ZA
dc.titleEnrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africaen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
Slack_adolescents_in_HIV_vaccine_trials_2007.pdf
Size:
283.04 KB
Format:
Adobe Portable Document Format
Description:
Download
Collections
Journal Articles