Salas Sofía P
Facultad de Medicina, Universidad del Desarrollo, Santiago, Chile.
Rev Med Chil. 2018 May;146(5):653-659. doi: 10.4067/s0034-98872018000500653.
The Global Forum on Bioethics in Research annually convenes a number of researchers, bioethicists and stakeholders with a shared interest in the ethics of conducting research in low and middle-income countries (LMIC). It provides a useful platform to discuss ethical issues that affect research practice in different scenarios, promoting ethically conducted research, global development for health research ethics and partnerships between the global north and south. As participant of the last three meetings, in this article the author analyzes the main ethical issues that were discussed in this forum, namely "Emerging epidemic infections and experimental medical treatments" (Annecy, France, 2015); "Ethics of research in pregnancy" (Buenos Aires, Argentina, 2016), and "The ethics of alternative clinical trial designs and methods in LMIC research" (Bangkok, Thailand, 2017). Local research ethics committees are not well prepared to face the new ethical challenges associated with research conducted in emergency situations or in pregnant women, or to evaluate new methods, such as alternative clinical trial designs (cluster randomized trials, adaptive platforms, or controlled human infection models, among others). According to this scenario, research ethics committees should be trained to carefully assess the risks and benefits of approving this type of research. In this context, it is necessary to harmonize local regulations with the new international standards in research ethics.
全球研究伦理生物伦理论坛每年都会召集一批对在低收入和中等收入国家（LMIC）开展研究的伦理问题有着共同兴趣的研究人员、生物伦理学家和利益相关者。它提供了一个有益的平台，用于讨论影响不同场景下研究实践的伦理问题，促进符合伦理的研究、全球卫生研究伦理发展以及全球南北之间的伙伴关系。作为过去三次会议的参与者，作者在本文中分析了该论坛讨论的主要伦理问题，即“新出现的流行病感染与实验性医学治疗”（2015年，法国安纳西）；“妊娠研究伦理”（2016年，阿根廷布宜诺斯艾利斯），以及“LMIC研究中替代临床试验设计和方法的伦理”（2017年，泰国曼谷）。当地研究伦理委员会尚未做好充分准备，难以应对与在紧急情况下或孕妇中开展的研究相关的新伦理挑战，也难以评估新方法，如替代临床试验设计（整群随机试验、适应性平台或人体感染对照模型等）。在这种情况下，研究伦理委员会应接受培训，以便仔细评估批准此类研究的风险和益处。在此背景下，有必要使当地法规与研究伦理方面的新国际标准相协调。
