{"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":"165 4","pages":"298-302"},"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\":\"165 4\",\"pages\":\"298-302\"},\"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}
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.
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.