Journal of Law and the Biosciences最新文献_第2页

Putting the L in ELSI: legal methods for bioethics research. 将L放入ELSI：生物伦理学研究的法律方法。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-02-12 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag002

Anya E R Prince, Benjamin Berkman, Donald Ford, Dov Fox, Christi Guerrini, Amy Koopmann, Natalie Ram, Jessica L Roberts, Kayte Spector-Bagdady, Sonia Suter

{"title":"Putting the L in ELSI: legal methods for bioethics research.","authors":"Anya E R Prince, Benjamin Berkman, Donald Ford, Dov Fox, Christi Guerrini, Amy Koopmann, Natalie Ram, Jessica L Roberts, Kayte Spector-Bagdady, Sonia Suter","doi":"10.1093/jlb/lsag002","DOIUrl":"10.1093/jlb/lsag002","url":null,"abstract":"Lawyers and law professors are increasingly involved in interdisciplinary scientific teams and grant research to answer ethical, legal and policy questions related to biomedical topics. Yet, the methods that lawyers use to conduct legal research and analysis are not always familiar to scientists and social scientists conducting peer review of a proposed project with legal aims or a publication reporting a legal study. To better facilitate interdisciplinary ethical, legal, and social implications collaboration, there is a need to better explain how legal research methodologies can provide robust tools to address a range of nuanced biomedical questions. This paper explores legal research and analysis methodologies relevant to federally funded research and scientific inquiry. It sets out different ways that legal research and analysis can advance and support biomedical, bioethics, and health law research and then demonstrates how these benefits can be realized using case studies from existing literature.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsag002"},"PeriodicalIF":2.4,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146203898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Will the EU AI Act help to mitigate dataset bias in medical AI? 欧盟人工智能法案是否有助于减轻医疗人工智能中的数据集偏差？

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2026-02-12 eCollection Date: 2026-01-01 DOI: 10.1093/jlb/lsag001

Emilia Niemiec, Peter A E Davis, Mathias K Hauglid

{"title":"Will the EU AI Act help to mitigate dataset bias in medical AI?","authors":"Emilia Niemiec, Peter A E Davis, Mathias K Hauglid","doi":"10.1093/jlb/lsag001","DOIUrl":"https://doi.org/10.1093/jlb/lsag001","url":null,"abstract":"The aim of this article is to provide an overview and analyze the implications of the provisions on dataset quality and bias in the AI Act (AIA). The AIA requires providers of AI systems to take measures to identify, prevent, and mitigate biases as part of the data governance practices. The AIA also explicitly prescribes certain characteristics required of training, validation, and testing datasets. These include notions widely considered as best practice such as representativeness as well as consideration of characteristics particular to the \"geographical, contextual, behavioural or functional setting\" which might expand the scope of considerations already common among AI developers. The AIA also aims to address the legal limitations on access to sensitive data by introducing the so called \"debiasing exception,\" which under certain conditions permits the processing of sensitive data for debiasing purposes. To ensure enforcement of the data governance provisions, the AIA grants notified bodies and enforcement authorities access to training, validation, and testing datasets; however, further efforts may be needed to reconcile data protection concerns with these enforcement powers. The AIA's requirements will likely help mitigate bias in medical AI systems. Associated soft law instruments should contribute to the effective implementation of these requirements.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsag001"},"PeriodicalIF":2.4,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900071/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146203921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms? 当前针对直接面向消费者的微生物组检测的监管框架是否足以保护消费者免受医疗、经济和尊严损害？

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-12-24 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf024

Diane E Hoffmann, Felicia D Langel, Erik C von Rosenvinge, Francis B Palumbo, Mary-Claire Roghmann, Jacques Ravel

{"title":"Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?","authors":"Diane E Hoffmann, Felicia D Langel, Erik C von Rosenvinge, Francis B Palumbo, Mary-Claire Roghmann, Jacques Ravel","doi":"10.1093/jlb/lsaf024","DOIUrl":"https://doi.org/10.1093/jlb/lsaf024","url":null,"abstract":"This article offers a thorough analysis of an important public health issue-the lack of regulation of companies selling direct-to-consumer (DTC) microbiome-based tests. These companies invite curious consumers and desperate patients to submit stool and/or vaginal secretion samples to them for analysis. Purchasers receive a report about the composition of their gut and/or vaginal microbiomes with recommendations to change their diet or take certain dietary supplements. The piece is grounded in a study the authors conducted of DTC microbiome testing company websites and their practices, which are often misleading to consumers. Moreover, the tests lack analytical and clinical validity. This means they may have many \"false positive\" or \"false negatives\" and can harm consumers who rely on them as a basis for determining their health status The current regulatory framework for these tests has significant gaps. These include the lack of proficiency testing under the Clinical Laboratory Improvement Amendments (CLIA) and the lack of regulation by FDA as a medical device. Although FDA has distinguished DTC tests from other Laboratory Developed Tests and asserted that they may pose unique risks because they are ordered outside of a physician-patient relationship, they have largely ignored this group of tests, likely because they view them as low risk, general wellness tests and exempted from regulation as medical devices under the software exemptions in the 21st Century Cures Act (Cures Act). The authors conclude, however, that many of these tests are not low risk general wellness tests, nor do they meet the exemptions under the Cures Act and as a result should be more stringently regulated.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf024"},"PeriodicalIF":2.4,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12728816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145835298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Heritable human genome editing and the politics of law: the South African case study. 可遗传的人类基因组编辑和法律政治：南非案例研究。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-12-23 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf029

Donrich Thaldar, Sheetal Soni, Larisse Prinsen, Ntokozo Mnyandu, Marietjie Botes, Julian Kinderlerer

{"title":"Heritable human genome editing and the politics of law: the South African case study.","authors":"Donrich Thaldar, Sheetal Soni, Larisse Prinsen, Ntokozo Mnyandu, Marietjie Botes, Julian Kinderlerer","doi":"10.1093/jlb/lsaf029","DOIUrl":"https://doi.org/10.1093/jlb/lsaf029","url":null,"abstract":"Heritable human genome editing (HHGE) has emerged as one of the most contested frontiers of bioscience, where law is mobilized as a political instrument. This article uses South Africa as a case study in the politics of law in HHGE governance, showing how even a substantively strong regulatory framework can collapse when procedurally fragile and politically contested. The National Health Research Ethics Council's 2024 guidelines established a regulated pathway for HHGE research and anticipated the eventual possibility of clinical application. The guidelines were aligned with constitutional rights and contained various ethical safeguards. Yet their adoption was procedurally weak: consultation was confined to research ethics committees, excluding broader scientific and public engagement. This lack of participatory legitimacy left the guidelines vulnerable. Critics seized on the fact that the guidelines contemplated children being born with edited genomes, collapsing anticipation into permission. These critiques were amplified by institutional actors, culminating in the repeal of the guidelines in 2025 and their replacement with an indefinite placeholder. The South African case highlights a lesson of global significance: that the governance of HHGE, and of emerging biotechnologies more broadly, depends not only on substantive ethical safeguards but also on inclusive procedures that can withstand political contestation.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf029"},"PeriodicalIF":2.4,"publicationDate":"2025-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12722161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145829170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Indian regulatory framework and the surge of unproven stem cell therapies-a call for diagnosis. 印度的监管框架和未经证实的干细胞疗法的激增——呼吁诊断。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-11-20 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf027

Vaishnav M

{"title":"The Indian regulatory framework and the surge of unproven stem cell therapies-a call for diagnosis.","authors":"Vaishnav M","doi":"10.1093/jlb/lsaf027","DOIUrl":"10.1093/jlb/lsaf027","url":null,"abstract":"Stem cell science lies at the heart of regenerative medicine; it is believed to have the potential to address several otherwise incurable diseases. However, even though stem cell interventions are at the experimental stage, they are advertised as a panacea for various human maladies. India, like other jurisdictions across the globe, has witnessed the mushrooming of 'experts' and 'clinics' selling (unproven) stem cell therapies to vulnerable and desperate patients. The unscrupulous activities in the stem cell industry endanger patients and hinder legitimate scientific progress. In light of the crisis of unproven stem cell therapies, I seek to comprehensively study the Indian regulatory framework on stem cells. The article identifies multiple issues in the framework-the inherent ambiguity in the governing laws, the unscientific functioning of the regulatory institutions, the poor implementation of the existing laws, and the seemingly consequent rise of India as an unregulated stem cell tourism hub. The suggested reforms broadly include streamlined funding, consolidated clinical regulation, and public engagement. The policymakers shall consider redefining their playbook to facilitate a conducive atmosphere for the growth of stem cell science.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf027"},"PeriodicalIF":2.4,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12632954/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145589805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The future of AI regulation in drug development: a comparative analysis. 药物开发中人工智能监管的未来：比较分析。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-11-07 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf028

Gabriela Lenarczyk, Timo Minssen, Nicholson Price, Arti Rai

{"title":"The future of AI regulation in drug development: a comparative analysis.","authors":"Gabriela Lenarczyk, Timo Minssen, Nicholson Price, Arti Rai","doi":"10.1093/jlb/lsaf028","DOIUrl":"10.1093/jlb/lsaf028","url":null,"abstract":"As artificial intelligence (AI) transforms drug development, regulatory frameworks are evolving to oversee its implementation, particularly at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This paper makes three contributions to understanding emerging regulatory approaches. First, we offer a comparative analysis of how these agencies have responded to AI-driven advances, incorporating new US executive orders and the European Union (EU)'s AI Act. Second, we propose a novel analytical framework to understand regulatory divergence: the FDA's flexible, dialog-driven model contrasts with the EMA's structured, risk-tiered approach, reflecting broader institutional and political-economic differences. While the former encourages innovation via individualized assessment, it can create uncertainty about general expectations; by contrast, the EMA's clearer requirements may slow early-stage AI adoption but provide more predictable paths to market. Third, we examine whether AI applications-spanning target identification, generative chemistry, and clinical trial 'digital twins'-are mature enough for standardized regulation, particularly amid shifting US policies and the EU's structured oversight regime. Our analysis reveals patterns of convergence on risk-based principles but persistent transatlantic implementation differences, compounded by diminished US engagement in international cooperation. We conclude that heightened regulatory uncertainty in the USA under a new administration's 'America First' stance and more stable, formalized rules in Europe both pose opportunities and challenges to AI-driven innovation in drug development.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf028"},"PeriodicalIF":2.4,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12598624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145497527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Ensuring vaccine access through local production: the need for a harmonized and sustainable approach. 确保通过当地生产获得疫苗：需要一种协调和可持续的方法。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-10-31 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf020

Chimdessa Tsega

{"title":"Ensuring vaccine access through local production: the need for a harmonized and sustainable approach.","authors":"Chimdessa Tsega","doi":"10.1093/jlb/lsaf020","DOIUrl":"https://doi.org/10.1093/jlb/lsaf020","url":null,"abstract":"Local vaccine and pharmaceutical production has transitioned from a mere policy option to an essential requirement in the aftermath of the COVID-19 pandemic. Developed countries' vaccine nationalism and hoarding through bilateral agreements with manufacturers left African countries with minimal access to vaccines. As Africa strives for self-sufficiency in vaccine development and pharmaceutical manufacturing by aiming to produce 60 percent of the continent's vaccine doses through indigenous manufacturing by 2040, it is crucial to examine existing initiatives and the roles of foreign players, especially China. In the first section, this article examines and evaluates regional initiatives aimed at promoting local production in Africa, focusing on efforts at global, continental, and regional levels to boost the manufacturing of vaccines and pharmaceuticals on the continent. The second section shifts focus to China's role in Africa's healthcare sector and highlights Chinese-backed pharmaceutical companies involved in vaccine and pharmaceutical production on the continent. The paper concludes by advocating for a harmonized and sustainable approach to local manufacturing. Specifically, the article argues that for these initiatives, whether government-backed or private investment, to succeed, there is a critical need to harmonize regulations, streamline procurement, diversify production, and address the challenge posed by intellectual property rights.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf020"},"PeriodicalIF":2.4,"publicationDate":"2025-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12575107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145432753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Clades, classifications, and claims: evolution of organisms and their nomenclature in life science patents. 分支、分类和权利要求：生命科学专利中生物体的进化及其命名法。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-10-30 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf026

Nathan T Jacobs

{"title":"Clades, classifications, and claims: evolution of organisms and their nomenclature in life science patents.","authors":"Nathan T Jacobs","doi":"10.1093/jlb/lsaf026","DOIUrl":"https://doi.org/10.1093/jlb/lsaf026","url":null,"abstract":"Organisms are complex biological entities that are less easily defined by specific structures or sequences than molecules, nucleic acids, and antibodies. Nor are they necessarily fixed in time or reproducible by repeatable methods, given their capacity for replication and mutation. Like organisms themselves, names and classifications also change over time as scientists better understand extant biodiversity. Taxonomy is the field of evolutionary biology concerned with classifying, naming, and identifying organisms, while phylogenetics concerns organisms' evolutionary history and relatedness. Here, I review the challenges evolution poses for patentees, using the examples of evolving influenza viruses and bacterial classifications, and Federal Circuit decisions relevant each issue. I conclude that careful consideration of organisms' evolutionary histories and the systematics underlying their classification in specification drafting allows patentees to: (i) mitigate the impact of scientific disagreement (such as the 'species problem' in microbiology) in claim construction; (ii) limit the effects of changing classifications on infringement analysis; (iii) describe generic categories of related organisms to encompass later-arising ones; and (iv) bolster compliance with the written description and enablement requirements of 35 U.S.C. § 112(a). Accordingly, patentees might address the challenges that evolutionary uncertainty poses for organism-centered patents by embracing these areas of evolutionary biology.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf026"},"PeriodicalIF":2.4,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12573242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145432730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Cross-border health data sharing between Singapore and Switzerland: controlling for competing regulatory requirements. 新加坡和瑞士之间的跨境卫生数据共享：控制相互竞争的监管要求。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-10-28 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf021

James Scheibner, Hui Yun Chan

{"title":"Cross-border health data sharing between Singapore and Switzerland: controlling for competing regulatory requirements.","authors":"James Scheibner, Hui Yun Chan","doi":"10.1093/jlb/lsaf021","DOIUrl":"https://doi.org/10.1093/jlb/lsaf021","url":null,"abstract":"Research in biomedical and health sciences using data-intensive methods increasingly involve multi-party cross-border institutional collaborations. Regulatory complexities governing international data flow remain challenging to navigate, particularly where differing legal standards in relation to data and privacy protections exist in the respective jurisdictions. In this paper, we use the example of a use case from a joint health research program between Singapore and Switzerland to illustrate the possibility of cross-border data flow for these two jurisdictions with no reciprocal adequacy recognition standards. We have therefore compared data privacy and biomedical research ethics laws in both jurisdictions to help determine when cross-border data sharing could occur that are compliant with data privacy laws. Our comparison makes reference to when technical and organizational measures including privacy enhancing technologies are appropriate to support data sharing. This paper has the potential to inform researchers collaborating with international institutions in navigating similar privacy regulatory considerations in their research and in developing their collaborative agreements.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf021"},"PeriodicalIF":2.4,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12560764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145403089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Reimagining criminal accountability: microbial and omics perspectives in the evolution of legal responsibility. 重新构想刑事责任：法律责任演变中的微生物和组学观点。

IF 2.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-10-28 eCollection Date: 2025-07-01 DOI: 10.1093/jlb/lsaf022

Pragya Mishra, Alan C Logan, Susan L Prescott

{"title":"Reimagining criminal accountability: microbial and omics perspectives in the evolution of legal responsibility.","authors":"Pragya Mishra, Alan C Logan, Susan L Prescott","doi":"10.1093/jlb/lsaf022","DOIUrl":"https://doi.org/10.1093/jlb/lsaf022","url":null,"abstract":"Recent advances in microbiome science and omics technologies are reshaping our understanding of human behavior, suggesting that microbial communities significantly influence cognition, impulse control, and aggression. Emerging studies in neuromicrobiology, including fecal transplant studies, are pointing toward a causal role for gut microbes and their metabolites in human cognition and behavior. This essay introduces the legalome-a framework integrating microbial perspectives, including microbiome and omics sciences, into the courts and larger criminal justice system. We argue that the legalome is on a trajectory that will move the field of neurolaw forward, and challenge traditional doctrines of mens rea and culpability. Drawing on recent court decisions related to auto-brewery syndrome, and neuro-microbiological research, we examine how subtle biological processes influence behavior in ways overlooked by current legal standards. Recent findings raise questions about criminal intent, biological determinism, and equitable access to scientific defenses. At the same time, emergent research also suggests potential for microbiome-based rehabilitative interventions. Despite methodological challenges, we advocate for interdisciplinary collaboration to harmonize biological research with legal principles, creating a more nuanced framework for justice in the twenty-first century. The legalome provides concrete implementation protocols and assessment tools that demonstrate practical utility for courts, practitioners, and policymakers.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 2","pages":"lsaf022"},"PeriodicalIF":2.4,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12560750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145403103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0