英美军事医学研究:知情同意的挑战。

Q2 Medicine
Journal of the Royal Army Medical Corps Pub Date : 2019-08-01 Epub Date: 2018-10-15 DOI:10.1136/jramc-2018-001023
Michael L Gross
{"title":"英美军事医学研究:知情同意的挑战。","authors":"Michael L Gross","doi":"10.1136/jramc-2018-001023","DOIUrl":null,"url":null,"abstract":"<p><p>Military medical research requires informed consent from test subjects, which is difficult to obtain for deployed (in-theatre) or prehospital studies where patients are incapacitated and legal representatives are not available. Although US and UK regulations make provisions for exceptions to informed consent, these are rarely used, thereby hindering trauma research and prospective experimental studies of new devices, surgeries or drugs. In their place, a survey of research articles published in the <i>Journal of the Royal Army Medical Corps</i> and <i>Military Medicine</i> between 2004 and 2018 shows how researchers turned to clinical surveys and retrospective, case or animal studies instead. The reluctance to enrol military personnel in interventional studies stems from past instances of abuse and current misperceptions of soldiers as a particularly vulnerable class of research subjects. Increasing the pool of research subjects to facilitate interventional studies to improve combat casualty care requires honing military medical ethics in two ways. First, it is important to implement existing informed consent regulations without special regard for the status of service personnel. This will expedite approval of waivers of informed consent. Second, aggressively recruiting civilians for military-related medical research increases the number of subjects available for trauma research. Community consultation and public discourse are the proper venues to deliberate on each recommendation.</p>","PeriodicalId":17327,"journal":{"name":"Journal of the Royal Army Medical Corps","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2019-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/jramc-2018-001023","citationCount":"2","resultStr":"{\"title\":\"Military medical research in Britain and the USA: the challenge of informed consent.\",\"authors\":\"Michael L Gross\",\"doi\":\"10.1136/jramc-2018-001023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Military medical research requires informed consent from test subjects, which is difficult to obtain for deployed (in-theatre) or prehospital studies where patients are incapacitated and legal representatives are not available. Although US and UK regulations make provisions for exceptions to informed consent, these are rarely used, thereby hindering trauma research and prospective experimental studies of new devices, surgeries or drugs. In their place, a survey of research articles published in the <i>Journal of the Royal Army Medical Corps</i> and <i>Military Medicine</i> between 2004 and 2018 shows how researchers turned to clinical surveys and retrospective, case or animal studies instead. The reluctance to enrol military personnel in interventional studies stems from past instances of abuse and current misperceptions of soldiers as a particularly vulnerable class of research subjects. Increasing the pool of research subjects to facilitate interventional studies to improve combat casualty care requires honing military medical ethics in two ways. First, it is important to implement existing informed consent regulations without special regard for the status of service personnel. This will expedite approval of waivers of informed consent. Second, aggressively recruiting civilians for military-related medical research increases the number of subjects available for trauma research. Community consultation and public discourse are the proper venues to deliberate on each recommendation.</p>\",\"PeriodicalId\":17327,\"journal\":{\"name\":\"Journal of the Royal Army Medical Corps\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1136/jramc-2018-001023\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the Royal Army Medical Corps\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/jramc-2018-001023\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2018/10/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the Royal Army Medical Corps","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/jramc-2018-001023","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2018/10/15 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 2

摘要

军事医学研究需要获得试验对象的知情同意,而在部署(战区)或院前研究中,由于病人无行为能力且没有法律代表,很难获得知情同意。尽管美国和英国的法规对知情同意的例外情况做出了规定,但这些规定很少被使用,从而阻碍了创伤研究和新设备、手术或药物的前瞻性实验研究。取而代之的是,一项对2004年至2018年发表在《皇家陆军医疗队和军事医学杂志》上的研究文章的调查显示,研究人员是如何转向临床调查和回顾性、病例或动物研究的。不愿将军事人员纳入介入研究源于过去的虐待事件和目前对士兵作为一个特别脆弱的研究对象的误解。增加研究对象以促进介入研究以改善战斗伤员护理,需要从两个方面磨练军事医学伦理。首先,重要的是在不特别考虑服务人员地位的情况下执行现有的知情同意条例。这将加快批准放弃知情同意。第二,积极招募平民从事与军事有关的医学研究,增加了可供创伤研究的对象数量。社区谘询和公众讨论是讨论每项建议的适当场所。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Military medical research in Britain and the USA: the challenge of informed consent.

Military medical research requires informed consent from test subjects, which is difficult to obtain for deployed (in-theatre) or prehospital studies where patients are incapacitated and legal representatives are not available. Although US and UK regulations make provisions for exceptions to informed consent, these are rarely used, thereby hindering trauma research and prospective experimental studies of new devices, surgeries or drugs. In their place, a survey of research articles published in the Journal of the Royal Army Medical Corps and Military Medicine between 2004 and 2018 shows how researchers turned to clinical surveys and retrospective, case or animal studies instead. The reluctance to enrol military personnel in interventional studies stems from past instances of abuse and current misperceptions of soldiers as a particularly vulnerable class of research subjects. Increasing the pool of research subjects to facilitate interventional studies to improve combat casualty care requires honing military medical ethics in two ways. First, it is important to implement existing informed consent regulations without special regard for the status of service personnel. This will expedite approval of waivers of informed consent. Second, aggressively recruiting civilians for military-related medical research increases the number of subjects available for trauma research. Community consultation and public discourse are the proper venues to deliberate on each recommendation.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Journal of the Royal Army Medical Corps
Journal of the Royal Army Medical Corps MEDICINE, GENERAL & INTERNAL-
CiteScore
1.50
自引率
0.00%
发文量
0
期刊介绍: The Journal of the Royal Army Medical Corps aims to publish high quality research, reviews and case reports, as well as other invited articles, which pertain to the practice of military medicine in its broadest sense. It welcomes material from all ranks, services and corps wherever they serve as well as submissions from beyond the military. It is intended not only to propagate current knowledge and expertise but also to act as an institutional memory for the practice of medicine within the military.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信