Department of Radiology, Areteion Hospital, University of Athens.
SAHARA J. 2009 Sep;6(2):46-57. doi: 10.1080/17290376.2009.9724930.
BACKGROUND/RATIONALE: Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research.
The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women.
A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms 'HIV/AIDS', 'informed consent', 'clinical trials', 'developing world'.
Ethical complexities such as participants' diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information.
Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives.
International investigators of HIV human research should bear in mind these ethical issues and their potential solutions, when trying to ensure ethical research conduct, based on a truly informed and culturally relevant consent.
背景/理由：发展中国家艾滋病毒/艾滋病人体研究的伦理问题仍在不断评估中；一个令人关注的关键领域包括知情同意。本文回顾了发展中国家艾滋病毒研究中知情同意的几个最重要的伦理和实际方面。提高对这些关键问题的整体认识，可能会促进未来研究的更高伦理标准。
主要目的是讨论非西方社会，特别是在受影响成年人的艾滋病毒临床试验中的人体研究中的知情同意。次要终点包括在资源有限的国家中，如儿童、青少年和妇女等弱势群体的艾滋病毒研究中的同意复杂性。
使用 MEDLINE 和 EMBASE 从 1998 年至 2008 年 12 月对已发表的文献进行了系统回顾，使用的搜索词是“HIV/AIDS”、“知情同意”、“临床试验”、“发展中国家”。
在 44 项综述研究中，确定了伦理复杂性，例如参与者自主权减弱、胁迫或金钱诱因、语言困难、文盲或对整个研究缺乏真正理解、主要由于社群主义和社会多样性造成的文化障碍。弱势群体的知情同意必须根据其性别和发育年龄进行调整，同时咨询是基础。必须确保儿童和青少年的同意。应使用当地语言，而可信赖的社区领导人和当地文化代表可以传达信息。
尽管研究存在异质性，但也存在相似之处。提供充分和全面的信息并评估对研究的真正理解是基本前提。关注领域的潜在解决方案包括同伴咨询以及与当地社区领导或当地文化代表的会议。
当试图确保基于真正知情和文化相关同意的伦理研究行为时，艾滋病毒人体研究的国际研究人员应牢记这些伦理问题及其潜在解决方案。
