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.

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.

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.

Despite significant public health attention and investment, hundreds of thousands of individuals have suffered fatal opioid overdose since the onset of the opioid crisis. Risk of opioid overdose has been exacerbated by the influx of fentanyl, a powerful synthetic opioid, into the drug supply. The National Institutes of Health Helping End Addiction Long-term (HEAL) Initiative is supporting the development of vaccines targeting fentanyl to protect against overdose. If successful, a vaccine would induce anti-fentanyl antibodies to sequester fentanyl (but not other opioids) in the blood, preventing fentanyl from crossing into the brain and reaching the central nervous system where it can cause overdose. Introduction of an overdose preventing strategy that relies on a vaccine to confer passive protection may be impactful. However, vaccines are poorly understood by the public and politicized. Moreover, the overdose ecosystem is complex and extends across numerous social, economic, medical, and cultural systems. As such, optimal use of a vaccine strategy to address overdose may benefit from multidisciplinary consideration of the social, ethical, and systemic factors that influence substance use and overdose that may also impact the acceptability of a fentanyl vaccine and related implementation strategies. In March 2022, Dr. Elissa Weitzman convened a two-day conference at the Harvard Radcliffe Institute for Advanced Study on the Social Complexity of a Fentanyl Vaccine to Prevent Opioid Overdose. In all, 19 professionals from diverse disciplines (medicine, psychology, history, ethics, immunology, vaccinology, communications, policy) attended the conference and led discussions that centered on population health and epidemiology, history of medicine and frameworks for understanding substance use, ethics, decision-making and attitudes, and operational issues to the question of a novel immunotherapy targeting fentanyl overdose. Participants also debated the risks and benefits of vaccine administration in response to fictional clinical case vignettes. A summary of the conference presentations and discussions follows.