Journal of Law Medicine & Ethics最新文献

Systematic reviewers are ideally placed to detect untrustworthy studies and decrease their use in decision making. The systematic review process already requires rigorous evaluation of an entire body of evidence related to a particular question. Excluding untrustworthy studies from systematic reviews can reduce their subsequent impact on evidence used for decisions and raise awareness of the problem among universities, journal editors, research funders and other stakeholders who can take appropriate action to eliminate them from the scientific literature.

This study characterizes 2008-2022 FDA advisory committee discussions of new supplemental indication applications that were not approved by FDA. Discussion themes included contextual concerns unique to already-approved drugs, including insights from prior experience and concerns about off-label use, and efficacy and safety concerns also observed for new drugs. These findings highlight advisory committees' role in transparency of regulatory decision-making, specifically for drugs already authorized for use.

Genome editing, prominently led by the revolutionary CRISPR-Cas9 technology, is a powerful tool with significant applications in diverse fields, particularly in medicine and agriculture. It empowers scientists with the ability to effect precise genetic modifications, thereby potentially paving the way for advanced treatments for genetic disorders such as Huntington's disease, hemophilia, and cystic fibrosis. Yet, the significant capabilities of this technology also brings to the fore a myriad of intricate bioethical, legal, and regulatory dilemmas. In light of these complexities, this article endeavors to conduct a comprehensive scoping review of the existing literature on the most significant ethical implications emanating from genome editing. In conducting this review, we utilized the power of software tools like EndNote and Rayyan to aid in the systematic and thorough review of the literature. EndNote, a reference management software, was instrumental in organizing and managing the references and bibliographies, while Rayyan, a web application designed for managing and screening records for systematic and scoping reviews, proved crucial in the import and management of text records for the review.The review identified as main aspects of ethical, bioethical and medico-legal interest the exacerbation of social inequalities, safety concerns such as off-target mutations and immunological risks, ecological and evolutionary implications, and challenges to human dignity. It highlights the necessity for equitable access, rigorous regulation, and public engagement to address these issues responsibly.The ultimate objective of this article is to underscore the importance of an informed and inclusive dialogue regarding genome editing. Such dialogue is pivotal for fostering responsible innovation in this rapidly advancing field, ensuring that scientific progress aligns with ethical considerations. By presenting a comprehensive examination of the ethical implications of genome editing, we aim to contribute to this ongoing dialogue and promote a balanced and nuanced understanding of this impactful technology.

Two key strategies that brand-name pharmaceutical manufacturers employ to limit generic competition are patent thickets and product hops. The former strategy entails obtaining numerous patents on peripheral features of products (not just the active ingredients), and the latter involves shifting active ingredients into reformulations with new patent protection that can extend periods of market exclusivity. These strategies have become particularly problematic for drug-device combinations like inhalers and glucagon-like peptide-1 receptor agonists, which contain pharmaceutical compounds that are sold together with their delivery devices. The Senate Judiciary Committee moved three bipartisan bills out of committee during the last legislative session aimed at facilitating more timely generic competition. Although these bills offer a valuable step forward, more is needed to limit the sort of patent gamesmanship that has become pervasive in the US pharmaceutical industry. Such reforms should include routine reexamination by the US Patent and Trademark Office of patents submitted for listing with the Food and Drug Administration (FDA), a greater role for the FDA in reviewing such listings, limits on the number of patents that brand-name firms can assert when suing for infringement following patent challenges, stronger incentives for patent challenges, and more flexibility for the FDA to approve complex generic drugs.

Journal editors often deal with allegations of research misconduct, defined by the Office of Research Integrity (ORI) in the United States as fabrication, falsification, and plagiarism. It is important that editors have a transparent and consistent process to deal with these allegations quickly and fairly. This process will include the authors and may include research integrity officers at the sponsoring institution as well as funders. Retractions may not be consistent with the ORI definition, for example, specifying inadequate peer-review and unreported conflict of interest, but nevertheless represent scientific misconduct.

I have been investigating and reporting on image manipulation in the bioscience literature since 2011. During this time, several new tools have emerged to streamline the processes of image analysis and reporting. When presenting and discussing examples of scientific image manipulation, a common question is "how do you find this stuff?" Herein, I outline common software and other utilities - a toolbox for discovery and reporting of problematic scientific images and other data. This may serve as a useful reference for those seeking to enhance the effective removal of problematic papers from the bioscience literature.

We present a training module in AI ethics designed to prepare a broad group of professionals to recognize and address potential ethical challenges of AI applications in healthcare. Training materials include a two-page checklist, a brief glossary, and three practical case studies. While we have developed and applied this framework for training Research Ethics Committee members in France and South Africa, it can also be helpful in university courses ranging from public health and healthcare law to biomedical engineering and applied ethics.

Multiple factors aligning in 2025 implicate challenges to vaccines as a primary public health intervention. Anti-vaccine proponents seek to recast immunization policies in promotion of perceived individual liberties. Recalibrating national vaccine approaches, however, runs counter to long-standing public health laws and policies grounded in a core truth: safe and effective vaccines save lives.

In Massachusetts, a proposed bill would reduce the sentence of those incarcerated who become living donors of either organs or bone marrow. We outline two concerns with such a proposal, which relate directly to the content of the proposal (as opposed to broader debates about payment for organs and validity of consent obtained from the incarcerated). The first of these concerns is about equality of opportunity. The proposal provides the opportunity for a sentence reduction for some but not for others - and the distribution of these opportunities reflects circumstances largely beyond the control of the incarcerated. The second concern is that the proposal may conflict with why we punish in the first place. The proposal is at odds with the non-consequentialist general deterrence defended by Tadros, retributivism, and communicative theories of punishment. Among the theories examined, only the purely consequentialist version of general deterrence might find the practice palatable. The upshot of the latter observation is that the proposal presupposes the truth of a purely consequentialist theory of punishment and sets aside others.