title: Ethical tradeoffs in trial design: case study of an HPV vaccine trial in HIV-infected adolescent girls in lower income settings.
abstract: The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria.
authors.affiliation: Harvard School of Public Health – Center for Biostatistics in AIDS Research, 651 Huntington Avenue, Boston, MA 02115, USA. lindsey@sdac.harvard.edu
authors.forename: J C
authors.initials: JC
authors.lastname: Lindsey
authors.forename: S K
authors.initials: SK
authors.lastname: Shah
authors.forename: G K
authors.initials: GK
authors.lastname: Siberry
authors.forename: P
authors.initials: P
authors.lastname: Jean-Philippe
authors.forename: M J
authors.initials: MJ
authors.lastname: Levin
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000517:prevention & control*; D000293:Adolescent; D002986:Clinical Trials as Topic / Q000941:ethics*; D018849:Controlled Clinical Trials as Topic / Q000941:ethics; D018592:Cross-Over Studies; D003906:Developing Countries; D032984:Ethics, Research; D005260:Female; D006801:Humans; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage*; D011203:Poverty; D016032:Randomized Controlled Trials as Topic / Q000941:ethics; D015203:Reproducibility of Results; D012107:Research Design; D035842:Research Subjects
chemical_list: D053918:Papillomavirus Vaccines
keywords: clinical trials; public health; research ethics; standard of care; vaccines