Ethical tradeoffs in trial design: case study of an HPV vaccine trial in HIV-infected adolescent girls in lower income settings.

摘要: The Declaration of Helsinki and the Council International Organization Medical Sciences provide guidance on standards care prevention in clinical trials. In current increasingly challenging research environment, ethical status a trial design depends not only protection participants, but also social value, feasibility, scientific validity. Using example study assessing efficacy vaccine to prevent human papilloma virus HIV-1 infected adolescent girls low resource countries without access vaccine, we compare several designs which rank lower some criteria higher others, giving rise difficult trade-offs. This case demonstrates need for developing more nuanced documents help researchers balance these often conflicting criteria.