Faculty Bibliography

Informed consent is an integral tenet of medical ethics. However, the United States lacks a standardized consent process for immunizations, with states and private companies instead reliant on Vaccine Information Statements (VISs) introduced by the 1986 National Childhood Vaccine Injury Act. VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer - the Centers for Disease Control and Prevention - itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all. Simply put, VISs do little to spark deliberation and increase vaccine confidence. This article recommends minor improvements to VIS content, delivery, and accountability mechanisms to ensure distribution. The authors argue that these patient-provider moments - for patients to better understand their health, the threat of disease, and the weight of their contribution to the public - should not be squandered.

Several unexpected fatalities in patients who received adeno-associated virus (AAV)-based gene therapies have recently occurred. These tragic events have cast a pall over the entire sector with some stakeholders suggesting that AAV is patently unsafe as a gene delivery platform and ought not to be pursued. This conclusion is not warranted.

This article reviews the development and evolution of Fogarty International Center-funded research ethics training programs in West Africa over the past decade. In response to local and global challenges in bioethics and biomedical research, these programs are fostering ethical awareness, shaping local and national ethics review systems, and enhancing bioethics capacity in the region. These efforts have expanded alongside increased democratic governance, technological advances, and significant increases in global research funding and international research collaborations, particularly related to HIV/AIDS and malaria. We believe that the West Africa Bioethics (WAB) Training Program in Nigeria played a central role in this growth, serving as a model for subsequent programs in Ghana, Mali, and The Gambia. This paper describes the nature, successes, and challenges of these programs. It also outlines an agenda and strategies for future work to enhance research ethics and bioethics capacities in the region, both in terms of education and governance.

Infertility patients and patient advocates have long argued for classifying infertility as a disease, in the hopes that this recognition would improve coverage for and access to fertility treatment. However, for many fertility patients, including older women, single women and same-sex couples, infertility does not represent a true disease state. Therefore, while calling infertility a 'disease' may seem politically advantageous, it might actually exclude patients with 'social' or 'relational' infertility from treatment. What is needed is a new conceptual framing of infertility that better reflects the profound significance of being infertile for many people and the importance of addressing infertility in order to improve their lives. In this paper, we argue that the capability approach provides this moral underpinning. The capability approach is concerned with what people are able to do, and whether they are able to act in a way that is in keeping with their own values and goals. The ability to procreate and build a family is a fundamental capacity and can be a major part of self-fulfilment, regardless of sexual orientation or family arrangement. Since the capability approach asks us to conceive of equality in terms of equal capabilities, it provides a strong ethical impetus for society to help those who cannot conceive on their own to do so with assisted reproduction.

The World Health Organization's (WHO) Framework of Engagement with Non-State Actors (FENSA), established in 2016, is designed to enhance transparency, impartiality, and conflict-of-interest safeguards by setting rigorous guidelines for WHO's interactions with private entities, particularly those in high-risk industries such as tobacco, alcohol, and arms. This paper briefly reviews the implementation and impact of FENSA, observing that, despite these safeguards, its application in academic contexts poses specific challenges. Universities, often reliant on diverse funding sources, may find the rules restrictive and misaligned with independent funding needs. The creation of the WHO Foundation in 2020 further complicates this landscape by enabling engagements with previously restricted private sector entities through an "arm's length" model. The authors advocate for a reassessment of FENSA to resolve inconsistencies and support essential academic collaborations, while upholding WHO's commitment to ethical standards.