This paper explores the evolution of the Universal Declaration on Bioethics and Human Rights , which was adopted by the United Nations Educational, Scientific and Cultural Organization in 2005. While the draft UDBHR generated controversy among bioethicists, the process through which it evolved excluded mainstream bioethicists. The absence of peer review affects the declaration’s content and significance. This paper critically analyses its content, commenting on the failure to acknowledge socioeconomic and other factors that impede its implementation. The UDBHR outlines ideal (...) standards but fails to provide guidance that can be readily applied in different settings. It strives for universality but does not contribute to understanding of universal or global bioethics.The Universal Declaration on Bioethics and Human Rights was developed through multinational consultation over several years. It was officially adopted by the United Nations Educational, Scientific and Cultural Organization in October 2005.1 This paper explores the process of drafting the UDBHR, critically analyses its content and considers its status in the context of global bioethics. It comments on the UDBHR’s failure to acknowledge or respond to socioeconomic and other factors that impede attempts to implement it. The paper concludes that the process of drafting the declaration excluded a necessary group of stakeholders and that the UDBHR therefore fails to provide the guidance it aims to offer.Identifying a need to develop universally applicable ethical guidelines within a context of cultural pluralism, Unesco began developing a draft Declaration on Universal Norms on Bioethics. A near final draft was posted on Unesco’s website in February 2005 and replaced in June 2005 with the version subsequently adopted as the UDBHR. Stakeholder consultation on the draft involved hundreds of people in many diverse nations. These were seemingly limited to consultations with Unesco affiliates, however, and public comment was not solicited. …. (shrink)

Biobanking of patient-derived materials is routine in health care, research, and public health emergencies. Ethical guidelines for biobanking address concerns including some about genetic materials, informed consent, confidentiality, regulatory environments, and standards of governance. This chapter identifies some limitations of existing guidelines that were apparent to one author during an Ebola outbreak, and specifies five ethical concerns about biobanking that warrant additional attention: misconceptions about biobanking, unknown consequences for donors, socioeconomic inequities that compound vulnerabilities, lasting and proportional benefits in North-South (...) research, and contextual challenges to disclosure and understanding. These affect patients, donors, health systems, research, and policy, and are amplified during public health emergencies. (shrink)

Here are the 18 guidance points contained in the UNAIDS document on Ethical Considerations in HIV Preventive Vaccine Research, reproduced by kind permission of the Joint United Nations Programme on HIV/AIDS.