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Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment. 评估联邦政策以减少临床试验登记的经济障碍。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-05-23 DOI: 10.1017/jme.2025.61
Daniel Albert-Rozenberg, David Peloquin, Joseph Liss, Erika Hanson, Barbara E Bierer
{"title":"Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment.","authors":"Daniel Albert-Rozenberg, David Peloquin, Joseph Liss, Erika Hanson, Barbara E Bierer","doi":"10.1017/jme.2025.61","DOIUrl":"https://doi.org/10.1017/jme.2025.61","url":null,"abstract":"<p><p>The risk of losing access to crucial means-tested programs - like Medicaid, Supplemental Security Income (SSI), the Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF) - poses a barrier to the enrollment of low-income Americans in clinical trials. This burden likely disproportionately affects members of racial and ethnic minority groups, people with disabilities, elderly individuals, and rural populations, and may frustrate efforts to reflect the US population in clinical trial enrollment. To help achieve representative clinical trials for myriad conditions, Congress should pass legislation excluding payments to clinical trial participants from gross income and expand the clinical trial compensation exclusions for means-tested programs established in the Ensuring Access to Clinical Trials Act of 2015.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-10"},"PeriodicalIF":1.6,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144129176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Academic Research Integrity Investigations Must be Independent, Fair, and Timely. 学术研究诚信调查必须独立、公正、及时。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-05-22 DOI: 10.1017/jme.2025.38
Matthew Schrag, Kevin Patrick, Elisabeth Bik
{"title":"Academic Research Integrity Investigations Must be Independent, Fair, and Timely.","authors":"Matthew Schrag, Kevin Patrick, Elisabeth Bik","doi":"10.1017/jme.2025.38","DOIUrl":"https://doi.org/10.1017/jme.2025.38","url":null,"abstract":"<p><p>Our national scientific enterprise has a crisis of reproducibility. While this phenomenon has many contributors, one is the proliferation of data manipulation. Data manipulation may range from seemingly innocuous to brazen to the point of verging on criminal. This latter category has recently received more attention, stimulating a debate about the handling of such unpleasant matters. We co-authors have instigated and interacted with numerous research integrity investigations and believe the current model of handling potential violations of research integrity standards is deeply flawed. Institution-led investigations are fundamentally conflicted because of the potential for institutional reputational damage and financial harm from a finding of research misconduct. Concerns are often handled with secrecy, lethargy, and limited technical analysis. Integrity lapses are frequently handled with a lack of openness, accountability and proportional consequences, which have weakened public trust in the scientific enterprise.We propose that research integrity violations of substantial scale should be independently investigated by appropriately resourced specialists. Such investigations should be completed within a time frame that facilitates meaningful corrective action when required or exoneration of the accused party when appropriate; completion of an investigation should rarely extend beyond one year and the results of the investigation should be made public.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-4"},"PeriodicalIF":1.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144120701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Origin of "Conscientious Objection" in Health Care: How Care Denials Became Enshrined into Law Because of Abortion. 医疗保健中“良心反对”的起源：由于堕胎，医疗拒绝如何成为法律。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-05-09 DOI: 10.1017/jme.2025.46
Christian Fiala, Joyce Arthur, Amelia Martzke
{"title":"Origin of \"Conscientious Objection\" in Health Care: How Care Denials Became Enshrined into Law Because of Abortion.","authors":"Christian Fiala, Joyce Arthur, Amelia Martzke","doi":"10.1017/jme.2025.46","DOIUrl":"10.1017/jme.2025.46","url":null,"abstract":"<p><p>The United Kingdom was the first country to legalize the refusal to provide health care in the name of \"conscientious objection\", allowing doctors to refuse to provide abortions based on personal or religious beliefs.A historical review into the origins and motivation behind the \"conscientious objection\" clause in the 1967 Abortion Act found that Parliamentarians and the medical profession wanted to preserve doctors' authority over patients, protect objecting doctors from liability, and appease religious anti-abortion beliefs.These factors point to an unprincipled basis for the introduction of \"conscientious objection\" into healthcare, which ultimately came at the expense of patients' rights and health. The \"conscience clause\" also represented a negation of basic ethical directives in medical practice including patient autonomy and physicians' fiduciary duty to patients. The term \"conscientious objection\"- borrowed from the military but misapplied to healthcare - helped mask the practice as a moral \"right\" of doctors, even while it disregarded patients' health and dignity.Refusing to provide treatment on the basis of \"conscience\" is harmful and discriminatory, and should be phased out gradually using disincentives and other measures to encourage objectors to choose other fields.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-14"},"PeriodicalIF":1.6,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179533/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct. 管理研究不端案件中的多机构管辖权。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-04-28 DOI: 10.1017/jme.2025.36
Leslie Thornton, Devin Cohen, Mark Barnes, Barbara E Bierer
{"title":"Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct.","authors":"Leslie Thornton, Devin Cohen, Mark Barnes, Barbara E Bierer","doi":"10.1017/jme.2025.36","DOIUrl":"10.1017/jme.2025.36","url":null,"abstract":"<p><p>Multi-institutional scientific research projects are increasingly common. Nevertheless, regulations and guidelines do not yet adequately address which entity should assume responsibility for research misconduct proceedings in multi-institutional research. This article explores the challenges of determining jurisdictional roles in research misconduct matters in collaborative science and proposes the application of a \"jurisdictional interests test\" as a framework for determining jurisdiction in multi-institutional research misconduct proceedings.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-6"},"PeriodicalIF":1.6,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144013324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Certification Marks for Supporting Generic Drug Quality. 支持仿制药质量的认证标志。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-04-28 DOI: 10.1017/jme.2025.56
Lars Lindgren, Aaron S Kesselheim, S Sean Tu
{"title":"Certification Marks for Supporting Generic Drug Quality.","authors":"Lars Lindgren, Aaron S Kesselheim, S Sean Tu","doi":"10.1017/jme.2025.56","DOIUrl":"https://doi.org/10.1017/jme.2025.56","url":null,"abstract":"<p><p>Certification marks are a type of trademark used to show that a product or service meets specific standards or qualities set by an independent organization (not by the manufacturer or seller). Certification marks could enhance the quality perception and oversight of generic drugs. Despite the FDA's rigorous regulatory framework, skepticism about generic drug quality persists among patients and prescribers, partly due to the FDA's limited ability to inspect manufacturing facilities. Independent certification marks - similar to USDA Organic or Energy Star labels - could help communicate drug quality information more effectively to consumers, incentivize manufacturers to exceed baseline standards, and bolster trust in generics. Such a system could operate without legislative changes and offer a cost-effective supplement to existing FDA inspections, particularly given the challenges posed by an increasingly globalized drug supply chain and current FDA resource constraints.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-3"},"PeriodicalIF":1.6,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144043413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Plea Bargains as Drivers of Incarceration-Related Health Outcomes. 辩诉交易是监禁相关健康结果的驱动因素。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-04-21 DOI: 10.1017/jme.2025.58
Riley Smith
{"title":"Plea Bargains as Drivers of Incarceration-Related Health Outcomes.","authors":"Riley Smith","doi":"10.1017/jme.2025.58","DOIUrl":"10.1017/jme.2025.58","url":null,"abstract":"<p><p>The discipline of public health has begun to recognize the structural inequities of the carceral system as drivers of poor individual and population health. The number of people incarcerated and the length of their incarceration determine the scope and gravity of their exposure to these individual and public health effects. Plea bargains all but guarantee a period of incarceration, often for many years, because prosecutors have significant bargaining power against defendants who often do not fully understand their rights or the likelihood of receiving the sentences that prosecutors would be seeking in trial. I propose and analyze several pathways through which to eliminate or severely restrict the practice of plea bargaining to minimize the health effects associated with incarceration. I conclude that state legislation would be most feasible and effective at eliminating plea bargains but, without concurrent interventions addressing mandatory minima and/or bail, would not fundamentally address the primary concerns of sentence length and overcrowding.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-9"},"PeriodicalIF":1.6,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144023046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Global Legal Environment for LGBTQ+ Sexuality and Public Health. LGBTQ+性与公共卫生的全球法律环境。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-04-21 DOI: 10.1017/jme.2025.60
Matthew M Kavanagh, Varsha Srivatsan, Florence Riako Anam, Ludo Bok, Luis Gil Abinader, Agrata Sharma, Catherine Grant, Yu Wei Chen, Sharonann Lynch
{"title":"Global Legal Environment for LGBTQ+ Sexuality and Public Health.","authors":"Matthew M Kavanagh, Varsha Srivatsan, Florence Riako Anam, Ludo Bok, Luis Gil Abinader, Agrata Sharma, Catherine Grant, Yu Wei Chen, Sharonann Lynch","doi":"10.1017/jme.2025.60","DOIUrl":"10.1017/jme.2025.60","url":null,"abstract":"<p><p>In 2023 the Supreme Court of Mauritius cited human rights and public health arguments to strike down a colonial-era law criminalizing consensual same-sex sex. The parliament of Singapore recently did the same through legislative means. Are these aberrations or a shifting global consensus? This article documents a remarkable shift international legal shift regarding LGBTQ+ sexuality. Analysis of laws from 194 countries across multiple years demonstrates a clear, ongoing trend toward decriminalization globally. Where most countries criminalized same-sex sexuality in the 1980s, now two-thirds of countries do not criminalize under law. Additionally, 28 criminalizing countries in 2024 demonstrate a de facto policy of non-enforcement, a milestone towards legal change that all of the countries that have fully decriminalized since 2017 have taken. This has important public health effects, with health law lessons for an era of multiple pandemics. But amidst this trend, the reverse is occurring in some countries, with a counter-trend toward deeper, harsher criminalization of LGBTQ+ sexuality. Case studies of Angola, Singapore, India, Botswana, Mauritius, Cook Islands, Gabon, and Antigua and Barbuda show many politically- and legally-viable pathways to decriminalization and highlight actors in the executive, legislative, and judicial arenas of government and civil society engaged in legal change.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-19"},"PeriodicalIF":1.6,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174810/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Negotiating Medicare Drug Prices: A New Attempt to Control Purchase Prices. 协商医疗保险药品价格：控制采购价格的新尝试。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-04-21 DOI: 10.1017/jme.2025.59
Marc A Rodwin
{"title":"Negotiating Medicare Drug Prices: A New Attempt to Control Purchase Prices.","authors":"Marc A Rodwin","doi":"10.1017/jme.2025.59","DOIUrl":"10.1017/jme.2025.59","url":null,"abstract":"<p><p>The Inflation Reduction Act (IRA) creates a new process to cap Medicare Part D branded drug prices. It prohibits Medicare from paying more than a specified discount from average private market prices and requires that CMS negotiate with manufacturers to agree on a maximum fair price that Medicare will pay that is lower than the specified discount. This article analyzes the cause of high drug prices and how negotiations to set the maximum fair price might unfold. It compares Medicare's new pricing process to the way drug prices are set in Medicaid, the Veterans Administration, U.S. private insurers, and European nations. It analyzes how negotiations to set the maximum fair price might unfold in light of negotiation theory and the practices to negotiate prices employed in Europe. It draws inferences from the initial published data on the first round of negotiated prices.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-11"},"PeriodicalIF":1.6,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179530/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144042555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions. 研究不当行为引致的诽谤索偿：院校的最佳做法。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-04-21 DOI: 10.1017/jme.2025.37
Nathaniel Jaffe, Minal Caron, Lauren Walsh, Barbara Bierer, Mark Barnes
{"title":"Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions.","authors":"Nathaniel Jaffe, Minal Caron, Lauren Walsh, Barbara Bierer, Mark Barnes","doi":"10.1017/jme.2025.37","DOIUrl":"10.1017/jme.2025.37","url":null,"abstract":"<p><p>Researchers involved in research misconduct proceedings are increasingly threatening or bringing legal defamation claims against the institutions, complainants, and publications involved in the proceedings. Although defamation claims do not often succeed, they can nevertheless be costly and lengthy. This article analyzes certain defamation cases in the research misconduct space and provides advice for institutions and other involved parties seeking to minimize potential defamation liability associated with research misconduct proceedings.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-8"},"PeriodicalIF":1.6,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Why Universities Should Make Misconduct Reports Public. 为什么大学应该公开不当行为报告。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-04-14 DOI: 10.1017/jme.2025.39
Ivan Oransky, Adam Marcus
{"title":"Why Universities Should Make Misconduct Reports Public.","authors":"Ivan Oransky, Adam Marcus","doi":"10.1017/jme.2025.39","DOIUrl":"10.1017/jme.2025.39","url":null,"abstract":"<p><p>This paper reflects on the availability of a key document in the research integrity landscape: Reports of institutional and university misconduct investigations. It reviews how universities have typically responded to calls for disclosure, offers suggestions to mitigate concerns, and argues that the failure to release such reports creates a critical evidence gap. It closes with a call for disclosure of such reports as a default.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-5"},"PeriodicalIF":1.6,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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