Andanda Pamela, Awah Paschal, Ndebele Paul, Onigbogi Olanrewaju, Udatinya Daniel, Mwondela Malala
a University of the Witwatersrand , Private Bag 3, Wits 2050 , Johannesburg , South Africa.
Afr J AIDS Res. 2011 Dec;10(4):451-63. doi: 10.2989/16085906.2011.646660.
Ethical and legal frameworks are important for ensuring that the goals of scientific research are realised while at the same time the rights and welfare of human participants are adequately protected. A balance in attaining these two goals can be achieved if such frameworks provide for legally binding structures and processes to oversee, regulate, and monitor research on human participants according to accepted norms and standards. From 2007 to 2009, an ethical/legal audit, sponsored by the WHO/UNAIDS Ethics, Law and Human Rights Working Group of the African AIDS Vaccine Programme (AAVP ELH), was conducted in regard to five African countries (Cameroon, Malawi, Nigeria, Rwanda and Zambia) to determine whether these countries have adequate laws, ethical guidelines and policies in place to regulate HIV-vaccine research. This article discusses the findings of the audit with a view to highlighting key lessons that can be learnt from these countries. The article provides the context of the audit by highlighting its rationale, aims and methods. We discuss the general findings of the audit and the complex issues arising from HIV-vaccine research, specifically. Lastly, we propose specific ways in which the ethical/legal frameworks guiding research with human participants in these countries can be improved.
伦理和法律框架对于确保科学研究目标得以实现，同时充分保护人类受试者的权利和福祉而言至关重要。如果此类框架提供具有法律约束力的结构和程序，以便根据公认的规范和标准监督、管理和监测针对人类受试者的研究，那么在实现这两个目标时就能达成平衡。2007年至2009年期间，由世界卫生组织/联合国艾滋病规划署非洲艾滋病疫苗计划伦理、法律与人权工作组（AAVP ELH）发起，针对五个非洲国家（喀麦隆、马拉维、尼日利亚、卢旺达和赞比亚）开展了一次伦理/法律审计，以确定这些国家是否具备适当的法律、伦理准则和政策来规范艾滋病毒疫苗研究。本文讨论了审计结果，旨在突出可从这些国家吸取的关键经验教训。文章通过强调审计的基本原理、目标和方法来介绍审计背景。我们具体讨论了审计的总体结果以及艾滋病毒疫苗研究中出现的复杂问题。最后，我们提出了可改进这些国家指导人类受试者研究的伦理/法律框架的具体方法。
