Spielman Bethany
Southern Illinois University School of Medicine, 801 N. Rutledge St., Springfield, IL, 62702, USA,
J Bioeth Inq. 2015 Mar;12(1):101-6. doi: 10.1007/s11673-014-9596-2. Epub 2015 Jan 29.
This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.
本文探讨了离岸外包和业务外包与低收入国家非自愿全球药物试验之间的联系。在讨论了生物伦理学文献中可能忽视非自愿离岸临床试验这一话题的原因后，我认为，如今制药公司进行离岸临床试验时，非自愿试验往往是可预见的，并非仅仅是少数人违反道德行为的结果。临床试验的离岸外包结构使得试验能够以从东道国到制药公司的一种独特外包形式呈现为医疗保健。因此，生物伦理学家对离岸企业药物试验的风险和潜在益处的评估，不仅应系统地包括预期的益处和试验药物的风险，还应包括受试者未同意的风险，以及非自愿试验更广泛的国际后果。
