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.

An epidemiologist advocates for vaccine equity.

Recent efforts by a private company to modify modern species with ancient DNA in the name of 'de-extinction' are both scientifically and morally suspect. A bright line requiring more than press releases as well as independent ethical oversight must be drawn before they are extended to distant human and hominid ancestors.

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.