Industry price guarantees for publicly funded medicines: learning from Project NextGen for pandemics and beyond.

The affordability of publicly funded medicines has been a longstanding concern. In 2023, the Biden administration took several steps on this front, including incorporation of a price constraint in an agreement between the US Biomedical Advanced Research and Development Authority (BARDA) and Regeneron Pharmaceuticals, Inc. to develop a new COVID-19 monoclonal antibody.

Big Mistake: Knowing and Doing Better in Patient Engagement.

Pushing back on policies favored by dying patients is a challenging endeavor, requiring tact, engagement, openness to bidirectional learning, and willingness to offer alternative solutions. It's easy to make missteps, especially in the age of social media. Holly Fernandez Lynch shares her experience learning with and from the amyotrophic lateral sclerosis (ALS) community, first as a caricature of an ivory tower bioethicist and more recently as a trusted advisor, at least for some.

Ethically cleared to launch?

Rules are needed for human research in commercial spaceflight.

Devil in the Details: Physician Duties and Expanded Access.

Vermeulen et al. suggest a moral duty exists for physicians to inform patients of "relevant opportunities" for Expanded Access. Such a duty is likely both too broad, leading to important practical challenges, and too narrow, without further steps to promote patient access.

Pressing regulatory challenges for psychedelic medicine.

Policy must support generation of evidence on safety and effectiveness.

Effects of Obesity on Medial Tibiofemoral Cartilage Mechanics in Females-An Exploration Using Musculoskeletal Simulation and Probabilistic Cartilage Failure Modelling.

This study examined the effects of obesity on cartilage mechanics and longitudinal failure probability at the medial tibiofemoral compartment, using combined musculoskeletal simulation and probabilistic failure modelling approaches. The current investigation examined twenty obese females (BMI > 30.0 kg/m) and 20 healthy weight (BMI < 25.

Journeying to Ixtlan: Ethics of Psychedelic Medicine and Research for Alzheimer's Disease and Related Dementias.

In this paper, we examine the case of psychedelic medicine for Alzheimer's disease and related dementias (AD/ADRD). These "mind-altering" drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; the impact of "ego dissolution" on persons experiencing a pathology of self; how psychedelics might impact caregiving; the potential exploitation of patient desperation; institutional review boards' orientation to psychedelic research; and methods to mitigate inequity.

Diversity in IRB Membership: Views of IRB Chairpersons at U.S. Universities and Academic Medical Centers.

Background: Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S.

Institutional Review Board Use of Outside Experts: A National Survey.

Background: Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.

Aspiring to Reasonableness in Accelerated Approval: Anticipating and Avoiding the Next Aducanumab.

The US Food and Drug Administration's decisions about drug approval-though guided by science, as well as relevant statutes, regulations, and guidance documents-reflect normative judgments about how the agency should exercise its discretion. This is particularly true in the context of the "accelerated approval" pathway, where the agency must balance speeding to market drugs for patients with unmet needs before they have been proven to work and ensuring confidence about the benefits and risks of those drugs. A key challenge in evaluating normative judgments such as these is that reasonable people can disagree, rendering it difficult to proclaim with certainty that a particular decision is right or wrong.

INTRODUCTION Health Law and Anti-Racism: Reckoning and Response.

Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with attention to policing in the context of mental health, schools, and substance use disorders; industry and the environment in the context of food advertising, tobacco regulation, worker safety, and environmental racism; health care and research in the context of infant mortality, bias in medical applications of AI, and diverse inclusion in research; and anti-racist teaching and practice in the context of building an interprofessional curriculum and medical-legal partnerships.

Institutional Review Board Use of Outside Experts: What Do We Know?

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality.

Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.

The US Food and Drug Administration (FDA) approval of the biologics license application for the Pfizer-BioNTech coronavirus disease 2019 vaccine (Comirnaty) on August 23, 2021, opened the door to the off-label vaccination of children younger than the age range currently covered by either the biologics license application (16 years old and older) or the emergency use authorization (12 to 15 years old). Although prescribing medications at doses, for conditions, or in populations other than those approved by the FDA is generally legal and is common in pediatrics, the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics have recommended against off-label prescription of the coronavirus disease 2019 vaccine. Several commentaries consider a case in which parents ask their child's pediatrician to prescribe the vaccine for their 11-year-old with special health care needs before approval or authorization in her age group.

Curbside Consults in Clinical Medicine: Empirical and Liability Challenges.

In most U.S. jurisdictions, clinicians providing informal "curbside" consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship.

A snapshot of U.S. IRB review of COVID-19 research in the early pandemic.

Background/objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered.

Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies.

Covid-19 raised many novel ethical issues including regarding the allocation of opportunities to participate in clinical trials during a public health emergency. In this article, we explore how hospitals that have a scarcity of trial opportunities, either overall or in a specific trial, can equitably allocate those opportunities in the context of an urgent medical need with limited therapeutic interventions. We assess the three main approaches to allocating trial opportunities discussed in the literature: patient choice, physician referral, and randomization/lottery.

"We measure what we can measure": Struggles in defining and evaluating institutional review board quality.

There has been a persistent lack of clarity regarding how to define and measure the quality of Institutional Review Boards (IRBs). To address this challenge, we interviewed 43 individuals designated as IRB Stakeholders, including leaders in research ethics oversight, policymakers, investigators, research sponsors, and patient advocates, about their views regarding key features of IRB quality and how those features could be measured. We also interviewed 20 U.