FDA abandons the Declaration of Helsinki: The effect on the ethics of clinical trial conduct in South Africa and other developing countries
FDA abandons the Declaration of Helsinki: The effect on the ethics of clinical trial conduct in South Africa and other developing countries
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DOI：
10.7196/sajbl.222
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发表时间：
2012-12-01
影响因子：
0.9
通讯作者：
Pretorius, D.
中科院分区：
文献类型：
--
作者：
Burgess, L. J.;Pretorius, D.
四年前，美国食品和药物管理局 (FDA) 停止遵守在境外进行临床试验的赫尔辛基宣言 (DoH)（2000 年修订版及所有后续修订版）。相反，它裁定遵守国际协调会议 (ICH) 的良好临床实践 (GCP) 就足够了。然而，ICH-GCP 指南并未涉及 DoH 规定的某些道德要求，例如安慰剂的使用与标准治疗、试验后获得治疗以及参与者的其他好处；公开披露试验设计；公布试验结果； FDA 采用道德上不太严格的指导方针可能会鼓励制药公司走道德捷径。它还可能对发展中国家的试验伦理产生实际影响，特别是在这些国家，由于缺乏财力和人力资源，研究伦理委员会可能无法促进对临床试验参与者的高标准保护。制药公司还可能向研究伦理委员会施压，要求放宽指导方针和立法，以促进发展中国家和新兴国家未来的临床试验，这些国家缺乏资源对艾滋病毒/艾滋病等流行病进行自己的临床研究，艾滋病毒/艾滋病等流行病对其人口造成了毁灭性影响。
Four years ago, the US Food and Drug Administration (FDA) ceased compliance with the Declaration of Helsinki (DoH) (2000 revision and all subsequent revisions) for conduct of clinical trials outside its borders. It instead ruled that compliance with the Good Clinical Practices (GCP) of the International Conference of Harmonization (ICH) is sufficient. However, the ICH-GCP guidelines do not address certain ethical requirements stipulated in the DoH, such as the use of placebos v. standard therapy, post-trial access to treatment and other benefits for participants; public disclosure of trial design; publication of trial results; and disclosure of conflicts of interest.The FDA's adoption of less morally stringent guidelines could encourage pharmaceutical companies to take ethical short cuts. It could also have practical consequences for trial ethics in developing countries, especially where research ethics committees may not be promoting high standards of protection for participants in clinical trials, due to lack of financial and human resources.Pharmaceutical companies may also pressurise research ethics committees to relax guidelines and legislation, in order to facilitate future clinical trials in developing and emerging countries that lack the resources to conduct their own clinical research on epidemics such as HIV/AIDS, which have devastating effects on their populations.