Faculty Bibliography

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.

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.

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.

The celebrated 1980 announcement that smallpox had been eradicated was made using the following definition of eradication: "Permanent reduction to zero of the worldwide incidence of infection caused by a specific agent as a result of deliberate efforts: intervention measures are no longer needed." Public health around the world works with this definition of "eradication," setting it as a goal for other infectious disease control programs. The definition is simple. Its application, however, has produced long-running and complex public health campaigns that threaten the commitment of funders, health care providers, and governments. In this paper, the authors demonstrate the disease-specific challenges of eradication through the example of the Global Polio Eradication Initiative (GPEI). While many deem eradication worth its high costs because it is the end of morbidity and mortality from a disease, it does not mean the end of disease control efforts. Public health must be prepared for the possibility of disease reoccurrence in the form of undetected natural reservoirs of disease, lab leaks from stored samples, bioterror attacks using stolen samples, and the synthetic recreation of microbes. This paper clarifies the role of reoccurrence prevention in eradication, calling for its addition in the definition of eradication.