Ethical, legal, social, and policy issues in the use of genomic technology by the U.S. Military

Maxwell J. Mehlman; Tracy Yeheng Li

摘要

The major current use of genomic technology by the military is collecting DNA from present and former members of the military in order to facilitate the identification of remains. The collection, called a biobank or biorepository, is the Armed Services Repository of Specimen Samples for the Identification of Remains (AFRSSIR), which was established in 1993. Every member of the military is required to submit a blood sample to the repository upon enlistment, and as of 2012, over 6.5 million blood samples have been collected and stored on bloodstain cards similar to those used for newborn screening.7 Under current policy, AFRSSIR can retain the samples for up to 50 years.8As noted earlier, the JASON report calls for DoD to create geno–phenobanks to ‘determine which phenotypes that might reasonably be expected to have a genetic component have special relevance to military performance and medical cost containment.' Once these genetic and genomic components are identified, genetic tests can be developed to identify which individuals possess genotypes that contain these components. Like their civilian colleagues, military physicians will develop and employ genomic technology not only to diagnose and predict but to prevent and treat both genomic and non-genomic diseases. A detailed description of the prospects for gene-based preventive measures and treatments is beyond the scope of this paper, but they include (1) the use of techniques such as recombinant DNA to manufacture drugs; (2) gene therapy, or the introduction or modification of endogenous or exogenous human DNA to provide an increased ability to combat injury or illness (for example, Jonathan Moreno cites the interest of the Defense Advanced Research Projects Agency in using genetic manipulation to improve the immune system28) or to correct or compensate for genomic abnormalities; and (3) altering the composition or characteristics of the microbiome, the non-human organisms found in the human digestive system and elsewhere that play a significant role in metabolism and human health. An especially controversial subject is germ line therapy, which entails making therapeutic alterations in an individual's DNA at such an early stage of development that the changes will be incorporated into eggs or sperm and therefore can be inherited by the individual's descendants. The military may be interested in germ line therapy, for example, in order to reduce the frequency and costs of care for heritable genomic disorders in military families. The military will be intensely interested in exploiting the association between genomics and human capabilities and performance. In 2001, the Committee on Opportunities in Biotechnology for Future Army Applications of the Board on Army Science and Technology at the National Research Council called on the Army to ‘lead the way in laying ground-work for the open, disciplined use of genomic data to enhance soldiers' health and improve their performance on the battlefield.'29 A 2002 report by DoD Information Assurance and Analysis Center observed that ‘because genomics [sic] information offers clues to improving human performance it could provide the Army with means of increasing combat effectiveness.'30 The JASON report notes that ‘both offensive and defensive military operations may be impacted by the applications of personal genomics technologies through enhancement of the … readiness, and performance of military personnel.'31As discussed earlier, the military may wish to conduct genomic research to obtain general information relating to human health or to obtain information of particular relevance to the military. There are two types of genomic research involving human subjects: clinical research, in which experiments are conducted on live humans, and non-clinical research, which is conducted on human biological material such as DNA samples. (DoD calls clinical research ‘research involving a human being as an experimental subject' to distinguish it from ‘research involving human subjects,' which includes both clinical and non-clinical research.42) The following discussion concerns clinical genomic research; a discussion of non-clinical genomic research appears in Balancing Risks and Benefits below. An axiom of research ethics is that a study may proceed only if the risks are outweighed by the potential benefits. In balancing research risks and benefits, civilian and military principles of bioethics function almost identically. In both regimes, the risks to the subjects can be outweighed either by the benefits to the subjects themselves or by the benefits, in the form of the knowledge gained, to others. Civilian research thus employs an approach similar to the military principle of proportionality in which the welfare of the individual can be subordinated to a greater good in appropriate circumstances. Civilian research also embraces the military principl

机译：军方目前主要使用基因组技术的目的是从现役军人和前任军人收集DNA，以便于鉴定遗体。该集合称为生物库或生物储存库，是于1993年建立的用于识别遗体的样本武装部队储存库（AFRSSIR）。入伍时，每名军人均需向储存库提交血液样本，截至2012年，已经收集了超过650万份血液样本并将其存储在类似于新生儿筛查所用的血迹卡上。 7 根据现行政策，AFRSSIR可以将样本保留长达50年。 sup> 8 如前所述，JASON报告呼吁国防部创建基因表型库，以“确定可以合理预期具有遗传成分的表型与军事表现和医疗费用控制特别相关”。一旦确定了这些遗传和基因组成分，便可以进行基因检测以鉴定哪些个体具有包含这些成分的基因型。像他们的平民同事一样，军事医师将开发和采用基因组技术，不仅可以诊断和预测，而且可以预防和治疗基因组和非基因组疾病。对基于基因的预防措施和治疗前景的详细描述超出了本文的范围，但其中包括（1）使用重组DNA等技术制造药物; （2）基因疗法，或引入或修饰内源性或外源性人类DNA以增强抵抗伤害或疾病的能力（例如，乔纳森·莫雷诺（Jonathan Moreno）引用了美国国防高级研究计划局的兴趣，希望利用基因操作来改善免疫系统 28 ）或纠正或补偿基因组异常; （3）改变微生物组，人类消化系统和其他地方发现的对人类新陈代谢和人类健康起重要作用的非人类生物的组成或特征。一个特别有争议的主题是种系疗法，它需要在个体的DNA发育的早期阶段进行治疗性改变，以使这些改变将被整合到卵子或精子中，因此可以被个体的后代继承。军人可能对种系疗法感兴趣，例如，以减少军人家庭中遗传性基因组疾病的护理频率和费用。军方将对利用基因组学与人类能力和绩效之间的关联非常感兴趣。 2001年，美国国家研究委员会陆军科学与技术委员会委员会的未来陆军应用生物技术机会委员会呼吁陆军“为奠定基础，以开放，规范的方式使用基因组数据奠定基础。 29 国防部信息保证和分析中心在2002年的一份报告中指出，“由于基因组学信息为改善人类绩效提供了线索，因此可以提供相关信息。 30 杰森报告指出：“个人基因组学技术的应用可能会通过提高战备状态和军事表现来影响进攻性和防御性军事行动。 31 如前所述，军方不妨进行基因组研究，以获得与人类健康有关的一般信息或获得有关人类健康的信息。与军事有关。有两种涉及人类受试者的基因组研究类型：临床研究和非临床研究，其中临床研究是在活的人类上进行的;非临床研究是在人类生物材料上进行的，例如DNA样本。（国防部称临床研究为“涉及作为实验对象的人类研究”，以区别于“涉及人类对象的研究”，其中包括临床研究和非临床研究。 42 ）临床基因组研究;下文的“平衡风险与收益”中出现了对非临床基因组研究的讨论。研究伦理的一个公理是，只有在风险被潜在利益所抵消的情况下，研究才能进行。在平衡研究风险和利益时，民用和军事生物伦理原则的功能几乎相同。在这两种情况下，对受试者的风险都可以通过对受试者自身的好处或以所获得的知识的形式对他人的好处来抵消。因此，平民研究采用与军事相称原则相似的方法，在这种情况下，个人的福利可以在适当的情况下服从更大的利益。平民研究也包含军事原理

Ethical, legal, social, and policy issues in the use of genomic technology by the U.S. Military

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