Steve Biko Centre for Bioethics.
S Afr Med J. 2010 Nov 9;100(11):712-6.
In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level research ethics review in South Africa is in many cases equivalent to the US institutional review board (IRB) and Office for Human Research Protections (OHRP) oversight system, is wider reaching, and has no exclusions.
针对南非临床试验的伦理审查受到的批评，我们对比了美国的《普遍规则》与南非的研究伦理要求。在美国，《普遍规则》并不适用于所有的健康研究，并且允许对伦理审查和知情同意豁免进行许多豁免。在结构层面上，南非的研究伦理审查在许多情况下等同于美国机构审查委员会（IRB）和人类研究保护办公室（OHRP）的监督系统，其涉及范围更广，不存在排除情况。
