Thompson Alison, Komparic Ana, Smith Maxwell J
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, ON, Canada M5T 3M7; University of Toronto Joint Centre for Bioethics, 155 College Street, Toronto, ON, Canada M5T 3M7.
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2; University of Toronto Joint Centre for Bioethics, 155 College Street, Toronto, ON, Canada M5T 3M7.
Vaccine. 2014 Dec 12;32(52):7171-4. doi: 10.1016/j.vaccine.2014.10.016. Epub 2014 Oct 23.
The objective of this paper is to identify and articulate ethical considerations to help guide decision-making around the regulation and monitoring of vaccines post-licensure. While these considerations are not intended to be an exhaustive account of the ethical concerns, they can facilitate the explicit examination of ethical issues in this context. We identify the protection of public from harm as the primary consideration, and identify others that help in the discharging of this governmental obligation. Others include: transparency, a publicly acceptable risk-benefit profile, public trust, minimization of stigma, and special obligations to vulnerable populations. Regulators and researchers can use these ethical considerations to help enhance their reasoning and to improve the accountability of their decision-making. These considerations can be used to inform rational deliberations about how to balance the obligation to protect the public from harm with other relevant considerations such as the need to be transparent, while taking into account the contextual features of the situation. Further research and debate on the relevance and refinement of these ethical considerations is desirable.
本文的目的是识别并阐明伦理考量因素，以帮助指导疫苗获得许可后的监管和监测方面的决策。虽然这些考量并非旨在详尽阐述所有伦理问题，但它们有助于在此背景下对伦理问题进行明确审视。我们将保护公众免受伤害视为首要考量因素，并确定有助于履行这一政府义务的其他因素。其他因素包括：透明度、公众可接受的风险效益状况、公众信任、耻辱感最小化以及对弱势群体的特殊义务。监管机构和研究人员可利用这些伦理考量因素来增强其推理能力，并提高其决策的问责性。这些考量因素可用于为有关如何在保护公众免受伤害的义务与其他相关因素（如透明度需求）之间取得平衡的合理审议提供信息，同时考虑到具体情况的背景特征。对这些伦理考量因素的相关性和完善进行进一步的研究和辩论是很有必要的。
