人体挑战试验的伦理治理探究

人体挑战试验有助于开发或测试针对传染病的疫苗，同时也引发了重要的伦理问题：故意感染健康参与者是否可以被接受，参与者承受较高的风险和负担并可能造成第三方的风险，如何取得参与者的知情同意，付款与不当引诱引发的伦理问题。针对人体挑战试验，全球已进行相关的伦理治理，并通过制定相关指南来规范人体挑战试验。围绕试验之前应注意的问题、政府层面应制定和完善科学的治理政策、建立评估体系与预防系统和研究机构应负的伦理责任四个方面初步为人体挑战试验的治理体系提供建议。

Research on Ethical Governance of Human Challenge Trials

Human challenge trials helps develop or test vaccines against infectious diseases, but they also raise important ethical issues: whether intentional infection of healthy participants is acceptable, participants bear high risks and burdens and may pose risks to third parties, how to obtain informed consent from participants, ethical issues arising from compensation and undue influence. Regarding human challenge trials, relevant ethical governance has been implemented globally, and relevant guidelines have been developed to standardize human challenge trials. Some preliminary suggestions for the governance system of human challenge trials are provided from four aspects: issues to be noted before testing, better governance policy formulation from the government level, evaluation and prevention system, and ethical responsibilities of research institutions.