Preventing and addressing research misconduct demands more than imploring scientists to do better. It is also essential to address the structural issues that allow misconduct to flourish. With these structural factors in mind, this Special Issue explores the institutional obligations of journals and publishers, research institutions, funders, and the government to promote scientific integrity and advance trust in science. Articles from researchers affected by fraud, science “sleuths,” systematic reviewers, journal editors, academic officials, regulators, and leading experts on research integrity offer a range of ideas for responding to the research misconduct crisis, including increased transparency, stronger journal processes for review and retraction, improved scientific lab culture, and efforts to hold investigators prospectively accountable for scientific integrity, among several others.

The tenth anniversary of the publication of Lawrence Gostin’s seminal treatise Global Health Law affords us the opportunity to reflect on his enduring legacy as a preeminent scholar, and one of the field’s founding thought leaders.

People use advance directives to express preferences that direct their future care when they lack decision-making capacity. One form of advance directive, a “dementia directive,” records preferences about living in various stages of dementia. This is important because many Americans want to avoid living with advanced progressive dementia. Unfortunately, traditional advance directives cannot dependably achieve this goal. In contrast, some dementia directives can achieve this goal, by directing cessation of manually assisted feeding and drinking.

While many dementia directives have been published, most have gaps and omissions that thwart the goal of avoiding extended intolerable life in advanced dementia. To overcome these problems, we formulated a new dementia directive. This article explains the value of this new directive. We proceed in six stages. First, we review the prevalence of advanced dementia. Second, we identify the disadvantages of another option for accomplishing the goal of not living into advanced dementia, preemptive VSED. Third, we distinguish notable court cases where dementia directives were unsuccessful. Fourth, we review nine prominent dementia directives, noting how the Northwest Justice Project’s Advance Directive for VSED remedies those shortcomings. Fifth, we review this directive’s legal status. Sixth, we articulate its ethical justification.

The objective of this paper is to devise a set of principles and practices that can break with the temporalities of current pharmaceutical markets, and on this basis sketch a social contract for a new (temporal) political economy of pharmaceuticals. Pharmaceutical futures are, in my analysis, doubly predetermined by standard arguments around pharmaceutical patenting and pricing: they are narrated as a consequence of “past” investments to be recouped, but they are also predetermined on a particular “future perfect,” where past investment successes and promises to maintain the status quo determine the course of action of future investors. This double colonization of the future, in my analysis, eliminates any scope for meaningful change. Making this often implicit temporality of pharmaceutical markets explicit may allow to better take into account multiple temporalities in regulating this space. Chiefly among them are patients’ temporalities, which typically get overridden by the peculiar timelines of patent-based markets. The mRNA vaccine market serves as an illustration of the theoretical arguments raised, and I discuss four strategies that could lead toward a new temporal political economy of pharmaceutical markets: temporally sensitive policymaking; decolonizing the future through narrower patents; delinking patents from their asset condition; and pharmaceutical commons.

The extent to which EU competition law applies in the healthcare context remains a contested question. The contemporaneous publication of the European Commission’s Evaluation of State Subsidy rules for health and social services of general economic interest (SGEI) in December 2022, and of the Court of Justice of the European Union’s April 2023 judgment in Casa Regina Apostolorum regarding state support to hospitals in Italy, underscore uncertainty and appear to indicate an impasse. These publications unfold against the backdrop of two tensions: between state and market, and between the EU and national levels. Hospitals illustrate these tensions well due to the expansion of competition mechanisms into the hospital sector (notably expanding private provider delivery of public hospital services, often supported by “patient choice” policies), and of hospitals remaining typically local or regional in character rather than supranational. This article provides a timely and original analysis of the Casa Regina Apostolorum judgment in light of Commission policy regarding SGEI and hospitals and how EU Member States engage with this. It offers insights into the potential legacy of Casa Regina Apostolorum, and indicates where future legal challenges may focus.

The field of global health law has evolved over the past decade to describe new legal and policy instruments that apply to a changing set of public health threats, non-state actors, and regulatory norms that structure the global response to public health challenges. This special issue—bringing together the O’Neill Institute for National & Global Health Law and the Global Health Law Consortium—examines the expansive evolution of the field of global health law and its continuing development to face new health threats.

I will describe how a fraudulent paper developed and offer insights into the institutional changes that are needed. I was a co-author on a paper described as a “clusterfake” due to at least two frauds allegedly occurring in the same paper. I will use my knowledge of behavioral ethics and my experience as a co-author on a fraudulent paper to explore changes that are needed to improve research integrity.

In their article, Pope and colleagues examine the ethical, legal, and practical complexities associated with the use of advance directives (ADs) to pursue voluntarily stopping eating and drinking (VSED) in the context of patients with advanced dementia. The authors detail the shortcomings of current VSED ADs, and they review a new VSED AD that they argue addresses these shortcomings and provides a better solution to the complexities associated with implementing VSED ADs. While the authors make a robust argument for the overall need and supportability of VSED ADs, this commentary highlights a problem that still persists even with the new VSED AD, specifically the absence of a robust ethical justification for continuing to honor the VSED AD even when the advanced dementia patient is requesting to eat or drink in the context of distress and suffering. Without this robust ethical justification, moral distress of family and caregivers is likely to occur, which could jeopardize the larger implementation of the VSED AD. Rather than pursue this more extreme measure without robust ethical justification, the commentary argues that the authors’ alternative proposal of minimal comfort feeding is the more practical and ethical strategy that best balances the patient’s longer- and shorter-term interests.

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.

A tribute to Professor Larry Gostin for a special issue of the Journal of Law, Medicine, and Ethics to mark the 10th anniversary of the launch of "Global Health Law".

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.

In the ethics literature, concern about financial compensation has largely focused on the question of how payment could distort research participants’ perception of risk. Such concern about “undue inducement” has particularly occupied institutional review boards (IRBs) and has often led to conservative judgments about how much financial compensation participants can be offered in exchange for their participation in research. Increasingly, bioethics scholars have argued that such approaches to financial compensation in research could exploit participants, on one hand, or create a barrier to their enrollment, on the other. Despite the vast literature on financial compensation for research, there has been substantially less attention to the potential risk that such payment may pose to research participants. The current system of taxing research compensation is one important example of the financial risks to research participants that warrants more analysis and legislative action.

As both human longevity and diagnostic ability improve, more individuals are being diagnosed with Alzheimer’s dementia disease (Alzheimer’s). Yet there is a paucity of new Alzheimer’s research trials. One obstacle to research is the large number of Alzheimer’s patients deemed incapable of providing informed consent for clinical research. Research advance directives (RADs) offer patients the opportunity to provide informed consent before incapacity occurs. However, critics question whether RADs guarantee informed consent, claiming that due to the nature of the disease, the consenting agent is no longer the same person after becoming incapacitated. This paper assesses the debate while using a conception of personhood, informed by the latest Alzheimer’s research, which does not reduce the concept of personhood to psychological capacities. It explains how personal identity can persist despite Alzheimer’s, such that RADs can and should suffice for informed consent.

Equitable access to medicines is vital for people with disabilities to receive effective, affordable, and quality treatment, helping preserve functionality, prevent further disability, and promote social and economic inclusion. This paper explores the specific medicine needs of people with disabilities in low- and middle-income countries (LMICs), focusing on the European Union’s (EU) extraterritorial legal obligations under the Convention on the Rights of Persons with Disabilities (CRPD). As the first regional international organization to accede to a UN human rights treaty, the EU offers a unique case for examining how international legal commitments extend beyond its borders. The paper outlines a legal framework based on the CRPD to assess the EU’s responsibilities for ensuring access to medicines globally. This framework is applied to two case studies: the EU’s internal joint COVID-19 vaccine procurement strategy and its external BioNTainer initiative for vaccine production in Africa under Team Europe. The analysis finds that the EU falls short of its CRPD obligations, particularly in areas of technology transfer and intellectual property sharing, which are essential for equitable global vaccine access. The paper concludes that the EU’s current actions do not fulfill its human rights commitments to people with disabilities in LMICs.

European institutions are widely recognized as wielding regulatory power in a globalized market, exporting its standards across borders and between sectors. This paper asks what institutional dynamics catalyze European external regulatory impact on pharmaceutical governance in low- and middle-income countries (LMICs). The research focuses on two European regulatory bodies, the European Medicines Agency (EMA) and the European Patent Office (EPO), and explores the dynamics of their technocratic outreach beyond European borders. We find that trust is a key underlying institutional dynamic facilitating some forms of European external relations. The agencies extend their influence through technical assistance, collaboration, and work-sharing with LMIC regulators, fostering a one-sided relationship of “technocratic trust.” This trust, reinforced by international regulatory frameworks that position the EMA and EPO as “trustworthy” regulators, enables these agencies to expand their regulatory influence beyond Europe. By critically examining the impact of this trust-building on LMICs’ regulatory autonomy, this research contributes to the broader discourse on European regulatory power in global health governance and highlights potential implications for pharmaceutical markets and access in LMICs.

Retracted research publications reached an all-time high in 2023, and COVID-19 publications may have higher retraction rates than other publications. To better understand the impact of COVID-19 on the research literature, we analyzed 244 retracted publications related to COVID-19 in the PubMed database and the reasons for their retraction. Peer-review manipulation (18.4%) and error (20.9%) were the most common reasons for retraction, with time to retraction occurring far more quickly than in the past (13.2 mos, compared with 32.9 mos in a 2012 study). Publications focused on controversial topics were retracted rapidly (mean time to retraction 10.8 mos) but continued to receive media attention, suggesting that retraction alone may be insufficient to prevent the spread of scientific misinformation. More than half of the retractions resulted from problems that could have been detected prior to publication, including compromise of the peer review process, plagiarism, authorship issues, lack of ethics approvals, or journal errors, suggesting that more robust screening and peer review by journals can help to mitigate the recent rise in retractions.

The article examines the historical development of global health from its genesis in colonial-era tropical medicine, to the creation of the World Health Organization – formed to advance health rights for all. The authors call for continued reforms to the global health governance system to mitigate the enduring impact of colonialism.

In his widely anthologized article on the therapy-enhancement distinction, Resnik argues that, from a moral point of view, the claim that something is not health related cannot be a dispositive argument against the permissibility of enhancements. He further states how the permissibility of an intervention will depend on considerations like the intention for its use and the likely consequences that will ensue, and whether these violate any moral standards. Within this framework, in this paper I first argue that enhancements may be morally permissible on autonomy grounds (its political conception); and secondly, that this permissibility does not dissolve a moral distinction between therapies and enhancements, with the reason being that there is still a difference between something being generally permissible (i.e., therapies) and something being conditionally permissible (i.e., enhancements). But that is not all that is important for a moral therapy-enhancement distinction. I also argue that the distinction — apart from being about “permissibility” (at the level of regulation of individual use) — is also about regarding justice more broadly (at the level of what is owed to individuals). What captures the moral distinction more fully is that therapies are, generally speaking, not only morally permissible but also owed to persons (due to being enablers of social cooperation and competition), whereas, at this stage, enhancements can only be morally permissible. I demonstrate the appeal of this view by considering its stability and usefulness across specialized bioethical contexts and across various kinds of enhancements and show that its practical value for policy lies in its legitimizing / anticipatory and prioritizing functions.

Clinical research for Alzheimer’s disease is essential, yet ethically complex, as cognitive impairment often hinders the informed consent process for the required human subjects. Research advance directives (RADs), which allow individuals to document future research wishes while capacitated, are often proposed to protect precedent autonomy. Some scholars have championed RADs, but we contend that upholding patient autonomy relies on a "tripod" of interrelated components. First, capacity assessment is essential to determine when a research advance directive takes effect or if a patient retains the ability to rescind it. Second, surrogate decision-making remains indispensable. Surrogates must navigate the difficult substituted judgment standard for complex trials and are crucial for interpreting a patient’s best interests or resolving conflicts when an incapacitated patient’s current preferences diverge from their past directive. Third, the research advance directive itself serves as vital evidence of the patient’s values. We conclude that research advance directives must function alongside robust capacity assessment and active surrogate involvement to balance patient legacy interests with their current well-being, facilitating ethical research.