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Informed consent in clinical research: Medico-legal standards, ethical challenges and forensic implications in UK and EU frameworks. 临床研究中的知情同意:英国和欧盟框架中的医学法律标准、伦理挑战和法医影响。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-23 DOI: 10.1177/00258024251408947
Deborah Bonifacio, Rosaria La Licata, Giovanni Tarditi, Giovanni Romeo, Diego Romeo, Guido Attilio Condorelli

BackgroundInformed consent (IC) is a legal and ethical cornerstone in clinical research involving humans. While it embodies the principle of decisional autonomy, its implementation faces significant challenges.ObjectivesThis narrative review aims to critically analyse the ethical, legal and regulatory aspects of IC in clinical research, with a specific focus on UK and European Union (EU) jurisdictions. Particular attention is given to medico-legal defensibility, the treatment of vulnerable populations and the emerging forensic implications of consent-related failures.MethodsKey international instruments (Declaration of Helsinki, Council for International Organizations of Medical Sciences Guidelines), UK statutes (Mental Capacity Act 2005, Human Tissue Act 2004) and data protection regulations (Regulation (EU) 2016/679 (EU GDPR) and its post-Brexit counterpart, the UK GDPR) were examined alongside relevant case law. Empirical findings, audit reports and forensic literature were integrated to assess procedural vulnerabilities and regulatory expectations.ResultsThe review identifies major risks associated with invalid or poorly documented consent, including therapeutic misconception, capacity fluctuation and coercion in hierarchical or cross-cultural contexts. It highlights the increasing role of forensic medicine in assessing consent adequacy and outlines innovative models such as dynamic and electronic consent, evaluating their medico-legal relevance.ConclusionsRobust, participant-centred consent frameworks are essential to uphold ethical integrity and legal compliance in clinical research. Regulatory harmonisation, institutional preparedness and forensic awareness are critical to mitigating liability, safeguarding participant rights and maintaining public trust in biomedical science.

知情同意(IC)是涉及人类临床研究的法律和伦理基石。它体现了决策自主的原则,但其实施面临着重大挑战。本叙述性综述旨在批判性地分析临床研究中IC的伦理、法律和监管方面,特别关注英国和欧盟(EU)司法管辖区。特别关注医疗法律上的可辩护性、弱势群体的待遇以及与同意有关的失败所产生的法医影响。方法主要国际文书(赫尔辛基宣言、国际医学科学组织理事会指南)、英国法规(《2005年精神能力法》、《2004年人体组织法》)和数据保护法规(《欧盟条例》2016/679(欧盟GDPR)及其脱欧后对应的英国GDPR)以及相关判例法进行了审查。实证研究结果、审计报告和法医学文献被整合起来,以评估程序脆弱性和监管期望。结果:本综述确定了无效同意或文件不完整同意相关的主要风险,包括治疗误解、能力波动和等级或跨文化背景下的胁迫。报告强调了法医在评估是否充分同意方面日益重要的作用,并概述了动态同意和电子同意等创新模式,评估了它们的医学法律相关性。结论:健全的、以参与者为中心的同意框架对于维护临床研究的道德完整性和法律合规性至关重要。监管协调、机构准备和法医意识对于减轻责任、保障参与者权利和维持公众对生物医学科学的信任至关重要。
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引用次数: 0
Trends and prevalence of suicide among children and young people in Türkiye. 日本儿童和青少年自杀的趋势和流行程度。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-23 DOI: 10.1177/00258024251408637
Emre Nuri İgde, Burak Tastekin

Suicide among youth is a major public health issue, and each country has implemented different suicide prevention policies and strategies throughout the years. This study aims to analyse the frequency of suicides and changing of suicide methods among children and young people in Türkiye during the last 15 years. Annual data provided by the Turkish Statistical Institute (TURKSTAT) were utilised retrospectively in this study. Data about suicide rate and methods were analysed by the Joinpoint Regression Program. Over the years between 2009 and 2023, changes in suicide rate and trends in suicide methods were revealed. There were 12,745 suicide deaths among children and young people. These comprised 25.07% of total suicide deaths last 15 years. The age-specific suicide death rates increased with an average annual percent change of 1.46%. Hanging was the most used suicide method in total (n = 5313; 41.69%) and in both sexes (n = 3591, 44.26% in males; n = 1722, 37.18% in females), followed by using firearms in second place and jumping from heights in third, overall. Suicide death rates caused by jumping increased significantly by 6.9% per year. In contrast, suicide deaths by hanging decreased approximately 1.45% annually. Determining the prevalence and trends of suicide methods is crucial for identifying high-risk populations. This knowledge is essential for formulating and executing effective suicide prevention strategies.

青少年自杀是一个重大的公共卫生问题,多年来,每个国家都实施了不同的自杀预防政策和战略。本研究旨在分析过去15年来基耶省儿童和青少年自杀的频率和自杀方式的变化。本研究回顾性地使用了土耳其统计研究所(TURKSTAT)提供的年度数据。采用关节点回归程序对自杀率和自杀方法进行分析。2009年至2023年间,自杀率的变化和自杀方式的趋势被揭示出来。儿童和年轻人中有12,745人自杀死亡。这占过去15年自杀死亡总数的25.07%。按年龄划分的自杀死亡率上升,年平均变化幅度为1.46%。总体而言,上吊是最常用的自杀方式(n = 5313, 41.69%),男女自杀方式(n = 3591,男性44.26%;n = 1722,女性37.18%),其次是使用枪械,跳高则排在第三位。跳楼自杀死亡率以每年6.9%的速度大幅上升。相比之下,上吊自杀的死亡率每年下降约1.45%。确定自杀方法的流行程度和趋势对于确定高危人群至关重要。这些知识对于制定和执行有效的自杀预防策略至关重要。
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引用次数: 0
AI in the criminal justice system: From 'AI ethics' to 'hermeneutic risk'. 刑事司法系统中的人工智能:从“人工智能伦理”到“解释性风险”。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-22 DOI: 10.1177/00258024251407531
Karen McGregor Richmond, Charlotte Primeau
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引用次数: 0
Calculating post-mortem interval by using the morphological changes in leucocytes. 利用白细胞形态变化计算死亡时间。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-22 DOI: 10.1177/00258024251408955
Mahaluxmi Saravanamurugan, Jayanthi Yadav, Arneet Arora

The changes in the internal environment of the body after death due to lack of oxygen result in certain morphological changes in the blood cells. This study tests the hypothesis that after we take out blood from live individuals and store it in-vitro there will also be an anoxic environment which will result in morphological changes like what happens in-vivo after death. The idea was to simulate the anoxic in-vivo condition in-vitro, by storing the blood sample taken from live persons in a vial and to look for sequential changes with respect to time and to develop a scale to see how this scale of morphological changes correlates with the time since death in post-mortem samples collected. Blood samples preserved in EDTA was taken from 186 live volunteers and 60 cadavers whose exact time of death was known. Blood smear was made and stained with Leishman stain and observed under an oil immersion microscope. Cells were classified into four stages based upon the nuclear changes - normal, pyknosis (shrunken nucleus), vacuolated and fragmented nucleus and complete lysis. The sequence of change remained same in both in-vitro stored samples and cadaver in-vivo samples. But the changes in the cadaver samples were appearing rapidly as compared to the in-vitro stored samples. It is hard to completely refute the hypothesis that in-vitro and cadaver conditions would be similar, and changes exhibited would also be similar based on this single study. Further studies with much larger sample size need to be conducted to completely refute or prove the above hypothesis. Also, other co-existing factors which can affect morphology of the cells should be considered.

人死后由于缺氧而引起体内环境的变化,使血细胞发生一定的形态变化。这项研究验证了这样一个假设,即我们从活的个体中取出血液并在体外储存后,也会有一个缺氧的环境,这将导致像死后在体内发生的形态变化。这个想法是模拟体外缺氧的体内条件,通过将从活人身上提取的血液样本储存在一个小瓶子里,寻找与时间有关的顺序变化,并制定一个尺度,看看这种形态变化的尺度与死后收集的样本中死亡时间的关系。保存在EDTA中的血液样本取自186名活的志愿者和60具确切死亡时间已知的尸体。取血涂片,利什曼染色,油浸显微镜下观察。根据细胞核的变化将细胞分为四个阶段:正常、固缩(细胞核萎缩)、空泡化和碎片化以及完全溶解。在体外储存的样品和体内的尸体样品中,变化的顺序保持相同。但与体外储存的样本相比,尸体样本的变化出现得很快。很难完全反驳体外条件和尸体条件相似的假设,并且根据这一单一研究显示的变化也会相似。需要进一步进行更大样本量的研究来彻底反驳或证明上述假设。此外,还应考虑影响细胞形态的其他共存因素。
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引用次数: 0
A first comprehensive picture of the mental health issues of female prisoners in Paraguay: Prevalence and associated factors. 第一次全面了解巴拉圭女囚犯的心理健康问题:流行情况和相关因素。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-22 DOI: 10.1177/00258024251404779
Julio Torales, Gisselle Velázquez, Gladys Estigarribia, Andrew Forrester, Diego Amarilla, Patricia Ríos Mujica, Gloria Aguilar, Anthon Daniel Torres-Romero, Nicolás López, Sofía Gauto, Marcelo O'Higgins, Tomás Caycho-Rodríguez, Antonio Ventriglio, João Mauricio Castaldelli-Maia, Iván Barrios

This is the first study to examine mental health issues, substance use, and suicide risk among incarcerated women in Paraguay, aiming to identify factors associated with these conditions, such as age and medical history. A cross-sectional study was conducted on 215 incarcerated women. Participants were assessed using the Symptom Checklist-90-Revised (SCL-90-R) to evaluate mental health symptoms, Columbia Suicide Severity Rating Scale (C-SSRS) for suicide risk, and MULTICAGE CAD-4 to measure alcohol and drug addiction. The chi-square test and odds ratios were applied to identify associations between mental health outcomes and associated factors, with a significance level of 5%. Our findings revealed that 40% of the participants had some level of suicide risk. Alcohol consumption was reported by 36.7% of the participants; 59.5% screened positive for alcohol-related problems, and 45.6% used drugs, with 73.5% screening positive for drug-related problems. Depression (23.7%) and somatization (21.4%) were the most frequent dimensions of mental health symptoms. Younger women (aged 18-38 years) were significantly more vulnerable to hostility, psychoticism, and interpersonal sensitivity. The study also identified a significant relationship between substance use and suicide risk, with substance users more likely to exhibit suicidal tendencies. Our study highlights the urgent need for integrated mental health and substance use interventions in Paraguayan prisons, especially for younger women who are at higher risk of mental health disorders. Suicide prevention strategies should be prioritized by incorporating mental health and substance use treatments. Further research is needed to explore these issues longitudinally and in different prison environments.

这是对巴拉圭被监禁妇女的精神健康问题、药物使用和自杀风险进行调查的第一项研究,旨在确定与这些状况相关的因素,如年龄和病史。对215名被监禁的女性进行了一项横断面研究。使用症状检查表-90-修订版(SCL-90-R)评估参与者的心理健康症状,使用哥伦比亚自杀严重程度评定量表(C-SSRS)评估自杀风险,使用MULTICAGE CAD-4评估酒精和药物成瘾。采用卡方检验和优势比来确定心理健康结果与相关因素之间的关联,显著性水平为5%。我们的研究结果显示,40%的参与者有一定程度的自杀风险。36.7%的参与者报告饮酒;59.5%的人酒精相关问题筛查呈阳性,45.6%的人吸毒,其中73.5%的人吸毒相关问题筛查呈阳性。抑郁(23.7%)和躯体化(21.4%)是最常见的心理健康症状。年轻女性(18-38岁)明显更容易产生敌意、精神病和人际敏感。该研究还确定了药物使用与自杀风险之间的重要关系,药物使用者更有可能表现出自杀倾向。我们的研究强调,巴拉圭监狱迫切需要综合心理健康和药物使用干预措施,特别是对精神健康障碍风险较高的年轻妇女。自杀预防战略应优先纳入心理健康和药物使用治疗。需要进一步的研究来纵向和在不同的监狱环境中探讨这些问题。
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引用次数: 0
Genetic diversity and phylogenetic characteristics of 38 Y-STR Loci in Lisu population from Kunming, Yunnan Province, Southwest China. 云南昆明傈僳族38个Y-STR基因座的遗传多样性及系统发育特征
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-17 DOI: 10.1177/00258024251399257
Xinjian Zheng, Wei Wei, Yue Wang, Chongchong Xu, Shixu Wang, Jiahui Peng, Chaojie Xiang, Yujie Fan, Shurong Zhong

Y-Chromosomal short tandem repeat polymorphism (Y-STR) plays an important role in forensic practice due to its unique patrilineal inheritance pattern. Y-STRs of male individuals from different regions differ in terms of relevant forensic parameters and phylogenetic relationships. Although a large number of scholars have reported studies on the Y-STRs of different groups in different regions, there are still insufficient data on the Y-STR population genetics of the Lisu population in Kunming. To enrich the relevant research, a total of 801 healthy male participants from the Lisu ethnic group in Kunming, Yunnan Province, Southwest China, were included in this study. The DeepTyper Y41 Human DNA Typing Kit was used to co-amplify the 38 Y-STR loci. Haplotypes and associated forensic parameters were analyzed. Multidimensional scaling and neighbor-joining (N-J) phylogenetic tree were performed to complete the phylogenetic analyses based on the genetic distance (Rst) values in the Y-STR Haplotype Reference Database. 656 haplotypes were observed among the 801 male individuals. The value of haplotype diversity, haplotype matching probability and discrimination capacity was 0.9991, 0.0022 and 0.8190, respectively. Phylogenetic analyses showed that the Kunming Lisu population was closer to the Yunnan Han, the Liangshan Yi and the Yunnan Dai in phylogenetic relationship. Overall, this study enriches the research on population genetics on Y-STRs in Chinese ethnic minorities. The data can be utilized for population genetics and forensic research, specifically in the construction of genealogical databases.

y染色体短串联重复多态性(Y-STR)因其独特的父系遗传模式在司法鉴定中发挥着重要作用。不同地区男性个体的y - str在相关法医学参数和系统发育关系上存在差异。虽然已有大量学者报道了不同地区不同类群的Y-STR的研究,但昆明傈僳族群体Y-STR群体遗传学的资料仍然不足。为丰富相关研究内容,本研究共纳入云南省昆明市傈僳族801名健康男性受试者。使用DeepTyper Y41 Human DNA分型试剂盒对38个Y-STR基因座进行共扩增。单倍型及相关法医学参数分析。基于Y-STR单倍型参考数据库的遗传距离(Rst),采用多维尺度和邻居连接(N-J)系统发育树进行系统发育分析,801个雄性个体共检测到656个单倍型。单倍型多样性、单倍型匹配概率和辨别能力分别为0.9991、0.0022和0.8190。系统发育分析表明,昆明傈僳族与云南汉族、凉山彝族和云南傣族的亲缘关系更接近。总体而言,本研究丰富了中国少数民族y - str群体遗传学研究。这些数据可用于群体遗传学和法医学研究,特别是族谱数据库的建设。
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引用次数: 0
Specialist board autopsies in alleged medical negligence: An urgent necessity for India. 专家委员会对涉嫌医疗疏忽的尸检:印度迫切需要。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-12 DOI: 10.1177/00258024251407503
Deepak H D'Souza
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引用次数: 0
Use of roster charts in the investigation and prosecution of nurses suspected of inflicting deliberate harm on patients. 在调查和起诉涉嫌故意伤害病人的护士时使用花名册。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-09 DOI: 10.1177/00258024251404604
John O'Quigley

When there are no witnesses, no substantive material evidence, no plausible motive, and, moreover, nothing beyond speculation to indicate that a crime has even occurred, then the prosecution of suspected serial killer nurses will be difficult. It will lean heavily on statistical arguments. There are two pillars to these arguments; the first is to show, on the basis of a believed inexplicable spike of deaths and life-threatening events, that the best explanation is that of criminal activity. While identifying a cluster is an awkward statistical question, it is not the one we address here. Our focus is on the second pillar of the argument, one that aims to show the accused as the most likely culprit in the light of roster chart evidence. The basis of this evidence comes from what is judged to be an unusually high correlation of the accused's presence with the events when they took place. We show that such roster chart evidence is unreliable. A visual inspection of any chart will be misinterpreted, the reader coming to an erroneous conclusion. We consider a recent case and, via careful calculation, show that what was believed to be strong evidence of culpability is, in truth, anything but. The often heard statement "whenever something went wrong, the nurse was always there," has no basis in fact.

如果没有证人,没有实质性的物证,没有合理的动机,而且,除了猜测之外,没有任何证据表明犯罪已经发生,那么起诉涉嫌连环杀手护士将是困难的。它将严重依赖于统计论据。这些论点有两个支柱;首先,在死亡人数和危及生命事件令人费解的激增的基础上,证明犯罪活动是最好的解释。虽然识别集群是一个棘手的统计问题,但这不是我们在这里要解决的问题。我们的重点是论点的第二个支柱,其目的是根据花名册证据显示被告是最有可能的罪犯。这一证据的基础是,据判断,被告的在场与事件发生时的高度相关。我们证明这样的花名册证据是不可靠的。任何图表的目视检查都会被误解,读者会得出错误的结论。我们考虑最近的一个案例,并通过仔细的计算,表明那些被认为是有罪的有力证据,实际上根本不是。经常听到的说法“无论什么时候出了问题,护士总是在那里”,这是没有事实依据的。
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引用次数: 0
Dental methods of post-mortem interval estimation. A pilot study on Feulgen reaction for DNA integrity on teeth pulp. 估计死亡间隔的牙科方法。Feulgen反应对牙髓DNA完整性的初步研究。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-12-01 DOI: 10.1177/00258024251399246
Ilenia Bianchi, Martina Focardi, Annalidia Seclì, Emanuele Capasso, Regina Rensi, Barbara Gualco, Laura Calosi, Daniele Bani, Vilma Pinchi

The estimation of late post-mortem intervals (PMIs) represents a challenge for the routine forensic pathologist's practice. Few studies have evaluated the reliability of teeth as stable and protected matrices rich in DNA. The pilot study aims to verify the feasibility of Feulgen reaction colorimetric measurement on odontoblastic cells from the dental pulp of extracted teeth as a useful tool to estimate late PMIs. Ten teeth obtained from healthy patients who underwent tooth avulsion for clinical reasons were included in the sample and crown pulps were extracted at five different PMIs (T0-baseline, 14 days, 1 month, 1.5 months, and 2 months). The PMI was assumed as the time elapsed from the tooth avulsion up to the pulp extraction. The Feulgen reaction and the colorimetric analyses with ImageJ software on odontoblastic cells of dental pulps were pursued in order to measure the residual dental DNA integrity according to the PMls. The study provides evidence for the persistence of odontoblasts up to 2 months post-mortem in a recognizable organization, hence useful in late PMIs. The method based on Feulgen reaction could be a reliable tool for estimating the late PMI, correctly distinguishing between PMI 0 and 14 days, but also between PMI 14 days and 2 months. To the best of our knowledge, the Feulgen reaction has never been applied to study the possible correlation of the dental pulp cells' integrity and the PMI. Preliminary results suggest the feasibility of the proposed method for estimating the time elapsed since death, but further research is needed.

估计晚死后的时间间隔(pmi)代表了常规法医病理学家的做法的挑战。很少有研究评估牙齿作为富含DNA的稳定和保护基质的可靠性。本初步研究旨在验证Feulgen反应比色法测定拔牙牙髓成牙细胞作为评估晚期pmi的有用工具的可行性。从临床原因发生脱脱牙的健康患者中获得10颗牙齿作为样本,并在5个不同的PMIs(0-基线、14天、1个月、1.5个月和2个月)提取冠髓。PMI是假定从牙齿撕脱到拔牙的时间。采用Feulgen反应和ImageJ软件对牙髓成牙细胞进行比色分析,根据pml测定残余牙DNA的完整性。该研究为成牙细胞在死后可识别的组织中持续存在2个月提供了证据,因此对晚期pmi有用。基于Feulgen反应的方法可以作为估计晚期PMI的可靠工具,正确区分PMI 0和14天,以及PMI 14天和2个月。据我们所知,Feulgen反应从未被应用于研究牙髓细胞完整性与PMI的可能相关性。初步结果表明,所提出的估算死亡时间的方法是可行的,但还需要进一步的研究。
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引用次数: 0
Persistence of inorganic gunshot residue in the hyponychium: Tackling post-shooting hand cleaning challenges. 无机射击残留物在下颌骨的持久性:解决射击后的手部清洁挑战。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-11-21 DOI: 10.1177/00258024251399241
Ramazan Akçan, Mahmut Şerif Yıldırım, Derya Demircioğlu, Emre Erkan, Merve Çapaci, Ali Rıza Tümer, Necdet Sağlam

PurposeGunshot residue (GSR) analysis is a crucial forensic application in the investigation of firearm-related crimes. This analysis traditionally relies on samples collected from the hands of suspected shooters. However, post-shooting activities such as hand cleaning can significantly diminish the presence of GSR on the hands, which compromise the use of routine sampling techniques. This study explores the potential of the hyponychium - a sheltered anatomical region beneath the free edge of fingernail - as an alternative GSR sampling site that may retain particles longer despite post-shooting hand cleaning activities.MethodsUsing six participants, samples were collected from both hands and the hyponychium following firearm discharge, with GSR particle counts analyzed via scanning electron microscopy (SEM) coupled with energy-dispersive X-ray spectrometry (EDX). Post-shooting activities including hand wiping with paper towels, wet wipes, rinsing with water, and washing with soap and water were performed to evaluate GSR persistence in the hyponychium.ResultsObtained results demonstrated that the dorsum of the right hand initially contained the highest GSR particle count. However, all post-shooting cleaning methods significantly reduced the particle numbers on the hands, with washing with soapy water nearly eliminating detectable GSR. In contrast, the hyponychium consistently retained GSR particles, albeit at reduced levels, even after washing.ConclusionFindings suggested that the hyponychium is a promising supplementary sampling site for GSR analysis, particularly when conventional hand samples are compromised by post-shooting hand cleaning methods. This alternative approach may improve analytical accuracy in cases where critical evidence might otherwise be lost.

目的枪弹残留分析是涉枪犯罪调查中重要的法医学应用。传统上,这种分析依赖于从枪手嫌疑人手中采集的样本。然而,射击后的活动,如洗手,可以显著减少手上的GSR的存在,这损害了常规采样技术的使用。本研究探索了下甲层的潜力——在指甲自由边缘下的一个隐蔽的解剖区域——作为一种替代的GSR采样点,尽管在射击后进行了手部清洁活动,但可能会保留更长时间的颗粒。方法采集6名受试者的双手和火器放电后的下丘脑样本,通过扫描电镜(SEM)和能量色散x射线光谱(EDX)分析GSR颗粒计数。拍摄后的活动包括用纸巾、湿巾擦手、用水冲洗、用肥皂和水清洗,以评估下甲中GSR的持久性。结果实验结果表明,右手背初始含GSR粒子数最高;然而,所有拍摄后的清洁方法都显著减少了手上的颗粒数量,用肥皂水清洗几乎可以消除可检测到的GSR。相比之下,即使在洗涤后,低钾也会持续保留GSR颗粒,尽管含量有所降低。结论下钾是一种很有前途的GSR分析补充取样点,特别是在常规手部样本因射击后的手部清洁方法而受损的情况下。在关键证据可能丢失的情况下,这种替代方法可以提高分析的准确性。
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