Kolopack Pamela A, Lavery James V
Dalla Lana School of Public Health, and Joint Centre for Bioethics, University of Toronto, Toronto, ON, M5T 3M7, Canada.
Hubert Department of Global Health, Rollins School of Public Health, and Center for Ethics, Emory University, Atlanta, GA, 30322, USA.
Gates Open Res. 2017 Dec 11;1:14. doi: 10.12688/gatesopenres.12771.1.
The US National Academies' (NAS) recent report 'Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values' examines the requirements of responsible conduct in research involving gene drives in non-human organisms. Many of the complex ethical issues raised by the introduction of gene drive technologies for mosquito population control have been anticipated during the development and field-testing of earlier-generation genetic engineering approaches with mosquitoes. One issue-the requirement for informed consent in field trials-is not addressed explicitly in the NAS' report. Some commentators have presumed that informed consent should play a role as a protection for research participants in studies of genetically modified mosquitoes. Others have argued that there are no human subjects of field trials, so the informed consent requirement does not apply. It is both ethically and practically important that these presumptions are adequately scrutinized to ensure that any applications of informed consent in these trials are properly justified. We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the judgment of Institutional Review Boards.
美国国家科学院（NAS）最近发布的报告《即将出现的基因驱动：推进科学、应对不确定性以及使研究与公共价值观保持一致》探讨了在涉及非人类生物基因驱动的研究中负责任行为的要求。在早期针对蚊子的基因工程方法的开发和实地测试过程中，就已经预见到了引入基因驱动技术来控制蚊子种群所引发的许多复杂伦理问题。美国国家科学院的报告没有明确提及一个问题，即在实地试验中对知情同意的要求。一些评论家认为，知情同意应作为对转基因蚊子研究中研究参与者的一种保护措施。另一些人则认为，实地试验不存在人类受试者，因此知情同意的要求并不适用。对这些假设进行充分审查在伦理和实践上都很重要，以确保在这些试验中对知情同意的任何应用都有合理依据。我们认为，在基因驱动试验中，可能需要个体研究参与者的知情同意：（1）当从他们身上收集血液和其他形式的临床数据时，一些涉及流行病学终点（如登革热和疟疾新感染发病率）的研究可能会出现这种情况；（2）当他们参与涉及完成调查问卷的社会科学和/或行为研究时；或者（3）当进入他们的住所或财产并将位置记录为释放或收集蚊子的空间变量时，因为出于昆虫学原因，家庭的确切位置很重要，而这些数据在家庭层面构成了可识别的私人信息。重要的是，大多数法规和指南允许根据机构审查委员会的判断在不同程度上放弃或修改这些要求。
