Faculty Bibliography

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.

IMPORTANCE:Genetic testing of gamete donors is becoming increasingly comprehensive and now often includes expanded carrier screening. Some argue that testing has gone too far, whereas others propose that testing is not extensive enough. Thinking critically about how much genetic testing is appropriate for gamete donors is crucial for ensuring that market forces alone do not determine the level of testing that is performed. OBJECTIVE:The goal of this paper is to highlight contradictions in the current approach toward genetic testing of gamete donors and to suggest that we either embrace the value of preventing the birth of children with hereditary diseases and do so in a logical and consistent manner or consider reducing our level of genetic testing for gamete donors. EVIDENCE REVIEW:The Food and Drug Administration requires screening for infectious diseases and the American Society for Reproductive Medicine recommends screening for a small number of common recessive conditions. However, private donor banks are increasingly performing karyotype testing and expanded carrier screening. FINDINGS:There are 2 major inconsistencies in our current approach to genetic testing of gamete donors: (1) if genetic information is valued by gamete recipients, why should testing stop with recessive conditions, and not expand to dominant conditions or even polygenic risk scoring? (2) Why should gamete donors be asked to undergo testing that may or may not be reciprocated by gamete recipients? Addressing these inconsistencies requires us to consider the ultimate goal of testing gamete donors' genes. We argue that the present, default goal is empowerment of gamete recipients, whereas an alternative and more laudable mission is to avoid preventable, heritable disease in offspring. However, the latter brings its own ethical and practical challenges, including the issue of which diseases are worth preventing. CONCLUSION AND RELEVANCE:A more comprehensive and well-reasoned approach to genetic testing of gamete donors is needed. Otherwise, testing will continue to be haphazard and guided by the free market, rather than deeper societal values.

A physician warns of the broader implications of pandemic backlash.

Abstract In Tyranny of the Gene: Personalized Medicine and Its Threat to Public Health (Knopf, 2023), James Tabery traces the ascendance of personalized or precision medicine in America, arguing that America's emphasis on genetics offers more hype than transformational power. In his examination of the power struggles, social relationships, and technological advances that centered the gene in American health policy, Tabery demonstrates how an intensive focus on genetics draws attention away from both the fundamental causes of health disparities and more-effective changes that could be made to developmental, physical, and social environments. American policy-makers, health care institutions, funders, and bioethicists should not let the technological shine and attractive politics of personalized medicine continue to replace the hard but necessary work of addressing sociopolitical causes of disease and illness.

BACKGROUND:While all reproductive-aged individuals with cancer should be offered fertility preservation (FP) counseling, there is little guidance over offers to adolescent and young adults (AYA) with terminal diagnoses, especially when considering posthumous assisted reproduction (PAR). The Enriching Communication skills for Health professionals in Oncofertility (ECHO/ENRICH) trains Allied Health Professionals (AHPs) to improve communication with AYAs with cancer. Little is known about AHPs' role in assisting in FP and PAR decisions. METHODS:This is a cross-sectional survey of ECHO/ENRICH trainees' attitudes and experience with FP and PAR in AYA with terminal cancer. RESULTS:The response rate was 61% (365/601). While 69% felt comfortable discussing FP with terminal AYA after ECHO/ENRICH training, 85% desired further education. The majority (88%) agreed FP should be an option for AYA with cancer, though some agreed offering FP provided false hope (16%) or was a waste of resources (7%). Most shared that avoidance of FP discussions was common practice, especially in the medically fragile, late-stage disease, or among minors. Many attributed lack of conversations to oncology team goals. Only 9% had prior experience with PAR. Many were conflicted about how PAR reproductive material should be gifted and who should be permitted to use PAR. Several raised moral concerns for PAR, or discomfort advising family. Many voiced desire for additional PAR-specific education. CONCLUSION/CONCLUSIONS:ECHO/ENRICH trainees had varied levels of exposure to FP in terminal AYA and limited experiences with PAR. Many expressed uncertainties with PAR, which may be alleviated with further training and transparent institutional policies.