Zong Zhiyong
Department of Infectious Diseases, West China Hospital, Sichuan University, Chegdu 610041, China.
J Med Ethics. 2008 Mar;34(3):188-92. doi: 10.1136/jme.2006.018754.
The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and national guidelines. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility.
研究结束后继续提供有益的实验性干预措施的必要性在生物医学研究伦理中仍是一个有争议的话题。基于行善原则、互惠正义原则、对剥削和公平利益的关注，参与者应该能够在研究期之后继续获得益处。然而，对于来自发展中国家的参与者，试验后提供有益干预措施是否应成为强制性要求，目前尚无共识。本文总结了国际和国家指南中的建议。还讨论了与试验后提供相关的伦理原则和实际问题。总之，并非在所有情况下都需要试验后提供，本文提出了一套标准来确定在研究期之后应提供有益干预措施的情况。然而，对于那些仍然需要且能够从中受益但没有其他获取途径的人，应确保强制性地在试验后提供有益的实验性干预措施。强制性提供基于诸如行善和正义等普遍的生物伦理原则。此外，试验后提供措施实施过程中遇到的困难并非无法解决。提前进行仔细规划以及相关各方之间建立全面的伙伴关系，将非常有助于在实践中解决这些困难，因此不应将其作为逃避试验后责任的借口。
