Reproductive Justice Beyond Borders: Global Feminist Solidarity in the Post-Roe Era.

The global impact of Dobbs v. Jackson Women's Health Organization and the backlash towards reproductive justice that it represents warrant a global feminist response informed by broad theoretical and geopolitical lenses. We consider how a solidaristic, transnational feminist movement might learn from Latin American feminist movements that have been successful in uniting broad coalitions in the fight for reproductive justice as situated within far-reaching political goals. The success of such a global movement must be decolonial and must contend with the fact that overlapping realities of global inequality, severe poverty, extractivism, and western-backed violence are fundamentally implicated in reproductive justice.

Ethical research when abortion access is legally restricted.

Risks and benefits of some clinical research may be altered.

Not just a tragic compromise: The positive case for adolescent access to puberty-blocking treatment.

Within bioethics as well as in broader clinical practice, support for transgender and gender-questioning adolescent access to pubertal suppression has often relied heavily on the desire to prevent risky, self-destructive, and suicidal behavior. We argue that framing justifications for access to puberty suppression in this way can actually be harmful to both individual patients as well as to the broader trans population. This justification for access to care makes such access precarious, limits its scope, and introduces perverse incentives to the patient population that is being served. We go on to offer an alternative, positive defense of access to puberty-blocking treatment for transgender youth grounded in the child's right to an open future. We argue that decisions related to pubertal suppression are both importantly weighty and potentially irreversible, and show why this justification is preferable to so-called "informed consent" approaches.

Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California.

California has focused on health equity in the state's COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California's 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier's test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans.

Danielle M. Wenner Replies.

The author replies to a letter to the editor from Felicitas Sofia Holzer concerning Wenner's article "The Social Value Requirement in Research: From the Transactional to the Basic Structure Model of Stakeholder Obligations," in the Hastings Center Report's January-February 2019 issue.

The Social Value Requirement in Research: From the Transactional to the Basic Structure Model of Stakeholder Obligations.

The history of research ethics includes ethical norms that do not neatly fit into a rubric of "human subjects protections" but that are nevertheless seen as fundamental ethical dictates. Among these norms is the so-called social value requirement for clinical research. Recently, however, the ethical foundation for the social value requirement has come under criticism. I seek to clarify the terms of this foundational debate. I contend that much of this discussion-both critiques of the social value requirement as well as recent defenses-is predicated on a framework of research ethics that I refer to as the "transactional model of stakeholder obligations." I argue that this model does not fully capture the ethical considerations that ought to inform the design and conduct of clinical research, and I introduce and defend an alternative framework that I call the "basic structure model of stakeholder obligations." The basic structure model is grounded in a claim that clinical research plays a direct role in establishing the justice or injustice of our social organization and should therefore be governed more explicitly by justice-based considerations. As such, the model explicitly accounts for the fundamentally social nature of the research enterprise itself. In addition to defending the basic structure model, I show how it provides a more stable foundation for the social value requirement, and I consider some worries about whether the model may be too demanding in practice.

The Social Value of Knowledge and the Responsiveness Requirement for International Research.

Ethicists have long recognized that two necessary features of ethical research are scientific validity and social value. Yet despite a significant literature surrounding the validity component of this dictate, until recently there has been little attention paid to unpacking what the social value component might require. This article introduces a framework for assessing the social value of research, and in particular, for determining whether a given research program is likely to have significant social value of the kind necessary to fulfill the social value requirement. The article goes on to illustrate how this framework can provide a clearer account of the responsiveness requirement, an ethical dictum that is oft-repeated but whose content and value as a guideline in international research remains contested. Although I introduce this conception of social value in the context of the responsiveness requirement, the account offered can, and is intended to, stand alone as a tool for the assessment of the social value of research. As such it can be usefully applied to discussions about the value of comparative effectiveness trials, the assessment of the continued proliferation of me-too drugs and the research done to develop them, the demand for public access to study-generated data, and persistent deficits in the publication of negative results.

Barriers to Effective Deliberation in Clinical Research Oversight.

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call "deliberative pathologies," or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research.

Against Permitted Exploitation in Developing World Research Agreements.

This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both research sponsors and host communities benefit from the resulting agreements. I show that defenders of the claim that exploitation ought to be permitted rely on a mischaracterization of certain forms of interference as unjustly paternalistic and two dubious empirical assumptions about the results of regulation. The view I put forward is that by evaluating a system of constraints on international research agreements, rather than individual transaction-level interference, we can better assess the alternatives to permitting exploitative research agreements.

The Social Value of Knowledge and International Clinical Research.

In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings.

Diversion effects, incentive effects, and the goals of research ethics promulgations.

It was with great sadness that the philosophical and ethical communities noted the recent passing of Alan Wertheimer. It is not possible to engage in serious work regarding international research ethics (nor much of political philosophy more broadly) without encountering and wrestling with his careful contributions. He was welcoming of discussion and generous with his intellectual energies. Ongoing work in these areas will be so much the poorer for his absence.

Trials and tribulations: the professional development of surgical trialists.

BACKGROUND: Regulatory and professional bodies issue an ever-increasing number of guidance documents on the ethics and methods of clinical trials, but the quality of clinical trials of invasive therapeutic procedures continues to be a concern. We interviewed aspiring and accomplished surgical trialists to understand how they use guidance documents and other resources in their work. METHODS: We performed a qualitative research study involving semistructured interviews of a diverse sample of 15 surgical trialists. RESULTS: Professional development as a surgical trialist was haphazard, inefficient, and marked by avoidable mistakes. Four types of resources played constructive roles: formal education; written materials on clinical trials; experience with actual trials; and interpersonal interactions with peers, experts, collaborators, and mentors. Recommendations for improvement centered on education, mentoring, networking, participating in trials, and facilitation by department chairs. CONCLUSIONS: The haphazard and unstructured nature of the current system is adding unnecessarily to the numerous challenges faced by surgical trialists.

Conflicts among multinational ethical and scientific standards for clinical trials of therapeutic interventions.

Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.

BACKGROUND: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. METHODS: The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. FINDINGS: Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. CONCLUSIONS: The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.