Journal of Law and the Biosciences最新文献_第4页

Ethical, legal, and policy challenges in field-based neuroimaging research using emerging portable MRI technologies: guidance for investigators and for oversight. 使用新兴便携式核磁共振成像技术进行实地神经成像研究的伦理、法律和政策挑战：研究人员和监督指南。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-06-07 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsae008

Francis X Shen, Susan M Wolf, Frances Lawrenz, Donnella S Comeau, Kafui Dzirasa, Barbara J Evans, Damien Fair, Martha J Farah, S Duke Han, Judy Illes, Jonathan D Jackson, Eran Klein, Karen S Rommelfanger, Matthew S Rosen, Efraín Torres, Paul Tuite, J Thomas Vaughan, Michael Garwood

{"title":"Ethical, legal, and policy challenges in field-based neuroimaging research using emerging portable MRI technologies: guidance for investigators and for oversight.","authors":"Francis X Shen, Susan M Wolf, Frances Lawrenz, Donnella S Comeau, Kafui Dzirasa, Barbara J Evans, Damien Fair, Martha J Farah, S Duke Han, Judy Illes, Jonathan D Jackson, Eran Klein, Karen S Rommelfanger, Matthew S Rosen, Efraín Torres, Paul Tuite, J Thomas Vaughan, Michael Garwood","doi":"10.1093/jlb/lsae008","DOIUrl":"10.1093/jlb/lsae008","url":null,"abstract":"Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG's consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 1","pages":"lsae008"},"PeriodicalIF":2.5,"publicationDate":"2024-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11157461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141297330","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

Sorry you asked? Mayo, Myriad, and the battles over patent-eligibility. 对不起，你问了吗？Mayo、Myriad 和专利资格之争。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-06-04 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsae010

Robert Cook-Deegan, Janis Geary, Kara Hapke, Zuzana Skvarkova, Marina Filipek, Jillian Leaver

{"title":"Sorry you asked? Mayo, Myriad, and the battles over patent-eligibility.","authors":"Robert Cook-Deegan, Janis Geary, Kara Hapke, Zuzana Skvarkova, Marina Filipek, Jillian Leaver","doi":"10.1093/jlb/lsae010","DOIUrl":"10.1093/jlb/lsae010","url":null,"abstract":"Genetic testing for inherited cancer risk changed dramatically when the US Supreme Court handed down unanimous rulings in Mayo v. Prometheus (2012) and Myriad v. Association for Molecular Pathology (2013). Those decisions struck down claims to methods based on 'laws of nature' (Mayo) and DNA molecules corresponding to sequences found in nature (Myriad). Senators Thom Tillis (R-NC) and Christopher Coons (D-DE) introduced legislation that would abrogate those decisions and specify narrow statutory exclusions to patent-eligibility in §101 of the US Patent Act. What would be the consequences of doing so? The Supreme Court decisions coincided with changes in how genetic tests were performed, reimbursed and regulated. Multi-gene sequencing supplanted oligo-gene testing as the cost of sequencing dropped 10,000-fold. Payers dramatically changed reimbursement practices. Food and Drug Administration regulation was proposed and remains in prospect. Databases for clinical interpretation made data freely available, augmenting a knowledge commons. The spectacular implosion of Theranos tempered investment in molecular diagnostics. These factors all complicate explanations of why venture capital funding for molecular diagnostics dropped relative to other sectors. Restoring patent-eligibility would put renewed pressure on other patent doctrines, such as obviousness, enablement and written description, that were not raised in the Supreme Court cases.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 1","pages":"lsae010"},"PeriodicalIF":2.5,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11150977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261761","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

Erratum to: U.S. public perceptions of the sensitivity of brain data. 勘误：美国公众对大脑数据敏感性的看法。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-06-01 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsae009

引用次数: 0

Implementing the human right to science in the context of health-related data processing. 在与健康有关的数据处理中落实科学人权。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-03-16 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsae004

Fruzsina Molnár-Gábor

{"title":"Implementing the human right to science in the context of health-related data processing.","authors":"Fruzsina Molnár-Gábor","doi":"10.1093/jlb/lsae004","DOIUrl":"https://doi.org/10.1093/jlb/lsae004","url":null,"abstract":"This paper contributes to the exploration of the potential application of duties related to the diligent anticipation of the (imminent) harms and (potential) benefits to humans that scientific innovation engenders to health-related contexts. In particular, it addresses the intersection between the human right to science and health-related data processing, which plays a key role in the production, translation and implementation of biomedical knowledge. The first part of the paper provides a brief recap of the interpretation of the right to science based on Art. 15 (1) (b) of the United Nations International Covenant on Economic, Social and Cultural Rights (hereafter ICESCR or Covenant) and the resulting obligations for States in the context of health and related data processing. The second part of the paper defines the relevance of the ICESCR for EU Member States and the European Union. In the third part, theses are put forward on how the human right to science and the obligations under Art. 15 (1) (b) ICESCR influence the interpretation and application of the General Data Protection Regulation as secondary EU law. By examining the justifications for using the right to science to interpret EU data protection law and by providing interpretation and application guidance on the main data protection principles in the area of health-related data processing, taking this right into account, the aim is to shape the EU data governance framework to meet the requirements of this human right. In doing so, the paper aims to close the gaps in the interpretation and application of the main rules of EU data protection law. Such standardization in the health-related context can contribute to a coherent interpretation and application of existing rules by referring to this emerging human right. Against this background, the paper identifies governance measures that the EU legislator could take to guide the processing of health-related data in line with the requirements of the right to science.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 1","pages":"lsae004"},"PeriodicalIF":3.4,"publicationDate":"2024-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10943626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144677","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

Anticipation in the biosciences and the human right to science. 生物科学中的预期与科学人权。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-02-19 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsae002

Andrea Boggio

引用次数: 0

Purpose definition as a crucial step for determining the legal basis under the GDPR: implications for scientific research. 目的定义是根据 GDPR 确定法律依据的关键步骤：对科学研究的影响。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-02-01 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsae001

Regina Becker, Davit Chokoshvili, Adrian Thorogood, Edward S Dove, Fruzsina Molnár-Gábor, Alexandra Ziaka, Olga Tzortzatou-Nanopoulou, Giovanni Comandè

{"title":"Purpose definition as a crucial step for determining the legal basis under the GDPR: implications for scientific research.","authors":"Regina Becker, Davit Chokoshvili, Adrian Thorogood, Edward S Dove, Fruzsina Molnár-Gábor, Alexandra Ziaka, Olga Tzortzatou-Nanopoulou, Giovanni Comandè","doi":"10.1093/jlb/lsae001","DOIUrl":"https://doi.org/10.1093/jlb/lsae001","url":null,"abstract":"The General Data Protection Regulation (GDPR) of the European Union, which became applicable in 2018, contains a new accountability principle. Under this principle, controllers (ie parties determining the purposes and the means of the processing of personal data) are responsible for ensuring and demonstrating the overall compliance with the GDPR. However, interpretive uncertainties of the GDPR mean that controllers must exercise considerable judgement in designing and implementing an appropriate compliance strategy, making GDPR compliance both complex and resource-intensive. In this article, we provide conceptual clarity around GDPR compliance with respect to one core aspect of the law: the determination and relevance of the purpose of personal data processing. We derive from the GDPR's text concrete requirements for purpose specification, which we subsequently apply to the area of secondary use of personal data for scientific research. We offer guidance for correctly specifying purposes of data processing under different research scenarios. To illustrate the practical necessity of purpose specification for GDPR compliance, we then show how our proposed approach can enable controllers to meet their compliance obligations, using the example of the overarching GDPR principle of lawfulness to highlight the relevance of purpose specification for the identification of a suitable legal basis.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 1","pages":"lsae001"},"PeriodicalIF":3.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10834358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139681961","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

CRISPR-phage antibacterials to address the antibiotic resistance crisis: scientific, economic, and regulatory considerations. 应对抗生素耐药性危机的 CRISPR-噬菌体抗菌剂：科学、经济和监管方面的考虑因素。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-01-26 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsad030

Danielle M Pacia, Beatrice L Brown, Timo Minssen, Jonathan J Darrow

引用次数: 0

U.S. public perceptions of the sensitivity of brain data. 美国公众对大脑数据敏感性的看法。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-01-18 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsad032

Shenyang Huang, Umika Paul, Shikhar Gupta, Karen Desai, Melinda Guo, Jennifer Jung, Beatrice Capestany, William D Krenzer, Dylan Stonecipher, Nita Farahany

{"title":"U.S. public perceptions of the sensitivity of brain data.","authors":"Shenyang Huang, Umika Paul, Shikhar Gupta, Karen Desai, Melinda Guo, Jennifer Jung, Beatrice Capestany, William D Krenzer, Dylan Stonecipher, Nita Farahany","doi":"10.1093/jlb/lsad032","DOIUrl":"10.1093/jlb/lsad032","url":null,"abstract":"As we approach an era of potentially widespread consumer neurotechnology, scholars and organizations worldwide have started to raise concerns about the data privacy issues these devices will present. Notably absent in these discussions is empirical evidence about how the public perceives that same information. This article presents the results of a nationwide survey on public perceptions of brain data, to inform discussions of law and policy regarding brain data governance. The survey reveals that the public may perceive certain brain data as less sensitive than other 'private' information, like social security numbers, but more sensitive than some 'public' information, like media preferences. The findings also reveal that not all inferences about mental experiences may be perceived as equally sensitive, and perhaps not all data should be treated alike in ethical and policy discussions. An enhanced understanding of public perceptions of brain data could advance the development of ethical and legal norms concerning consumer neurotechnology.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 1","pages":"lsad032"},"PeriodicalIF":3.4,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10800024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139522220","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 regulation of health data sharing in Africa: a comparative study. 非洲健康数据共享监管：比较研究。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-01-18 eCollection Date: 2024-01-01 DOI: 10.1093/jlb/lsad035

Annelize G Nienaber McKay, Dirk Brand, Marietjie Botes, Nezerith Cengiz, Marno Swart

引用次数: 0

Defusing the legal and ethical minefield of epigenetic applications in the military, defense, and security context. 化解军事、国防和安全领域应用表观遗传学的法律和伦理雷区。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2023-12-13 eCollection Date: 2023-07-01 DOI: 10.1093/jlb/lsad034

Gratien Dalpé, Katherine Huerne, Charles Dupras, Katherine Cheung, Nicole Palmour, Eva Winkler, Karla Alex, Maxwell Mehlman, John W Holloway, Eline Bunnik, Harald König, Isabelle M Mansuy, Marianne G Rots, Cheryl Erwin, Alexandre Erler, Emanuele Libertini, Yann Joly

{"title":"Defusing the legal and ethical minefield of epigenetic applications in the military, defense, and security context.","authors":"Gratien Dalpé, Katherine Huerne, Charles Dupras, Katherine Cheung, Nicole Palmour, Eva Winkler, Karla Alex, Maxwell Mehlman, John W Holloway, Eline Bunnik, Harald König, Isabelle M Mansuy, Marianne G Rots, Cheryl Erwin, Alexandre Erler, Emanuele Libertini, Yann Joly","doi":"10.1093/jlb/lsad034","DOIUrl":"https://doi.org/10.1093/jlb/lsad034","url":null,"abstract":"Epigenetic research has brought several important technological achievements, including identifying epigenetic clocks and signatures, and developing epigenetic editing. The potential military applications of such technologies we discuss are stratifying soldiers' health, exposure to trauma using epigenetic testing, information about biological clocks, confirming child soldiers' minor status using epigenetic clocks, and inducing epigenetic modifications in soldiers. These uses could become a reality. This article presents a comprehensive literature review, and analysis by interdisciplinary experts of the scientific, legal, ethical, and societal issues surrounding epigenetics and the military. Notwithstanding the potential benefit from these applications, our findings indicate that the current lack of scientific validation for epigenetic technologies suggests a careful scientific review and the establishment of a robust governance framework before consideration for use in the military. In this article, we highlight general concerns about the application of epigenetic technologies in the military context, especially discrimination and data privacy issues if soldiers are used as research subjects. We also highlight the potential of epigenetic clocks to support child soldiers' rights and ethical questions about using epigenetic engineering for soldiers' enhancement and conclude with considerations for an ethical framework for epigenetic applications in the military, defense, and security contexts.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad034"},"PeriodicalIF":3.4,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10719446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138813228","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