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Ethical Tradeoffs in Trial Design: Case Study of an HPV Vaccine Trial in HIV ‐Infected Adolescent Girls in Lower Income Settings
Author(s) -
Lindsey J.C.,
Shah S.K.,
Siberry G.K.,
JeanPhilippe P.,
Levin M.J.
Publication year - 2013
Publication title -
developing world bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.398
H-Index - 27
eISSN - 1471-8847
pISSN - 1471-8731
DOI - 10.1111/dewb.12028
Subject(s) - clinical trial , human immunodeficiency virus (hiv) , medicine , randomized controlled trial , psychology , immunology
Abstract The D eclaration of H elsinki and the C ouncil of the I nternational O rganization of M edical S ciences 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.