Faculty Bibliography

After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask "where's our Operation Warp Speed?" and "why isn't Emergency Use Authorization an option for our health crises?" Although this pandemic bears a number of unique features, the response to COVID-19 offers translatable lessons, in both its successes and failures, for non-pandemic diseases. These include the importance of collaborating across sectors, supporting the highest-priority research efforts, adopting rigorous and innovative trial designs, and sharing reliable information quickly. In addition, the regulatory response to the pandemic demonstrates that lowering standards for marketing authorization can result in increased safety concerns, missed opportunities for research and treatment, and delays in determining what works. Accordingly, policymakers and patient advocates seeking to build on the COVID-19 experience for non-pandemic diseases with unmet treatment needs should focus their efforts on promoting robust and efficient research designs, improving access to clinical trials, and facilitating use of the Food and Drug Administration's existing Expanded Access pathway.

Solid organ transplant (SOT) candidates and recipients were not included in the COVID-19 vaccine trials that have justified vaccine administration to millions worldwide and will be critical to ending the pandemic. The risks of COVID-19 for SOT candidates and recipients combined with data about this population's response to other vaccines has led to transplant centers recommending vaccination for their candidates and recipients in accordance with guidance from major transplant organizations. Relevant ethics considerations include: weighing the low risk of vaccination causing transplant complications against potentially limited antibody response of vaccines for transplant recipients; the equitable distribution of vaccines among vulnerable populations; the duty to steward and respect organs as limited resources; the duty to support vaccination; and patient autonomy. Vaccinated transplant patients and candidates should also consider participating in research studies to better understand the efficacy and potential long-term risks in this patient population. There are difficult scenarios, like timing transplant after second vaccine dose, when to administer the second dose to a partially vaccinated candidate who gets an organ match, whether to vaccinate a recent transplant recipient with low exposure risk and which vaccine to use. Here we provide ethics considerations for vaccinating different groups within the transplant population.

OBJECTIVE: Offering fertility preservation (FP) prior to gonadotoxic therapy is standard of care. Periodically, parents and children disagree about whether to pursue FP for the minor. This study reviews existing literature on parent-child disagreements regarding FP, weighs relevant rights and interests, and offers recommendations for how to navigate these ethically challenging situations. MATERIALS AND METHODS: The scoping review follows the PRISMA-ScR checklist and is registered with the Open Science Framework. A comprehensive literature search was performed in February 2021. Abstracts were screened using Covidence based on predefined criteria. Full-text articles were assessed for: 1) evidence that parentchild discordance about FP exists, 2) data on how parents or children want their views incorporated, 3) examples of how discord has been resolved, or 4) suggestions for how to handle discordance. For the ethical analysis, rights and interests identified in the review were explored and recommendations for resolving disagreement were developed.
RESULT(S): 689 abstracts were screened, 109 were selected for full-text review and 29 papers were included in the final analysis. Studies emphasized that parents and adolescent minors desire information about FP, and there was broad consensus that the views' of minors nearing adulthood should be more heavily weighted.1 However, there was a range in parent comfort with allowing minor participation in FP decision-making.2 Some authors highlighted the default stance that minors must assent to FP, while others argued that older adolescents may be able to fully consent.3 Some posit that if parents decline FP, the physician should persuade them to reconsider,4 while others proposed that parents should be able to decline, especially given the high cost.5 The ethical analysis weighs rights and interests including: minor's autonomy, minor's best interest, right to an open future, and parental autonomy. It concludes that when medically appropriate, FP is generally in a minor's best interest because it promotes future choice. Therefore, both parents and minors should be encouraged to pursue FP. If a younger minor refuses, whether FP is performed should depend on the minor's maturity, reason for refusing, and whether FP is likely to provide significant benefit. Older adolescents should be able to refuse out of respect for their autonomy. Special application of these recommendations is needed for transgender minors because of their unique concerns, including the possibility of FP inducing gender dysphoria.
CONCLUSION(S): This scoping review supports the conclusions that minors should be included in FP discussions and should have increasing decision- making authority as they near adulthood. When parents and minors disagree about FP, who should ultimately decide depends on the minor's age, maturity, whether the minor or parent declines FP, and whether FP is likely to provide significant benefit. IMPACT STATEMENT: This study offers a rigorous scoping review, ethical analysis and recommendations for navigating parent-child disagreement regarding FP in minors

In the book Exploiting Hope: How the Promise of New Medical Interventions Sustains Us-and Makes Us Vulnerable, Jeremy Snyder takes on the dominant theory that exploitation in research ethics involves culpable inequity in transactions between parties. He rightly dismisses that economic explanation as inadequate. His theory of exploitation argues that it happens when those who have a duty of beneficence to someone take advantage of their hope. Exploitation is not just an unfair transaction; it is a betrayal of an obligation owed to the vulnerable, weak, or dependent to protect them. Snyder is persuasive. But only to a point. He helps us understand the betrayal involved in exploiting hope. But much more remains to be debated about hope and exploitation. Exploitation in health care is not just a matter of schemers and ne'er-do-wells playing fast and loose with ever-hopeful patients. Sometimes it involves patient groups looking for the right to try any intervention, no matter how dangerous or outlandish, at government expense.

Study question: Periodically, parents and children disagree about whether to pursue fertility preservation (FP). How should medical teams navigate these ethically complex situations? Summary answer: Several considerations must be weighed, including the minor's age, the burden of the proposed procedure, and whether the minor or parent seeks to decline FP. What is known already: As reproductive technology advances, FP prior to gonadotoxic therapy has become the standard of care. Periodically, parents and children disagree about whether to pursue FP. To date, there is no clear guidance on how to navigate these difficult situations. Prior studies have demonstrated that adolescents undergoing gonadotoxic therapy want their views regarding FP to be taken into account, and also that most children and adolescents are comfortable with parental involvement in decision-making. However, transgender adolescents pursue FP at lower rates than adolescents with cancer, and more research is required to elucidate the unique needs and barriers of transgender youth. Study design, size, duration: This study involves a scoping review and ethical analysis about parent-child disagreement regarding FP in minors. The review analyzes papers that either demonstrate that parent-child disagreement occurs, describe the preferences of parents or children regarding decision-making around FP, or provide recommendations that can be used to resolve parent-child conflicts. The ethical analysis weighs relevant rights and interests, including the child's best interest, the right to an open future, the child's autonomy, and parental autonomy. Participants/materials, setting, methods: A search string was developed to identify all relevant published manuscripts on the topic of FP in minors, including studies on decision-making, family relations and ethical challenges. The search was run through several databases, abstracts were screened using Covidence, and data were extracted from full texts. Data abstracted from the review and existing literature on general medical decision-making for minors were used to construct an ethical framework for parent-child disagreements regarding FP in minors. Main results and the role of chance: Published work directly on the topic of parent-child disputes regarding FP is limited, however a number of studies tangentially discuss parent-child disagreements and provide insight into the desires of parents and children regarding decision-making around FP. Studies suggest that adolescents desire to have their views taken into account, and a minority of adolescents believe their wishes alone should be followed. The age of the minor is a crucial factor, and some propose that as adolescents approach adulthood, their autonomy should increase. At the same time, in practice, legal and financial constraints often render parents the ultimate decision-makers. Our ethical analysis weighs competing considerations, including the child's best interest, the right to an open future, the child's autonomy, and parental autonomy. It concludes that who prevails should depend on contextual factors, including the minor's age, the burden of the proposed procedure, and whether the minor or parent seeks to decline FP. There may also be special considerations for transgender adolescents, some of whom might have deeply personal reasons for pursuing or forgoing FP that are not well-understood by cisgender parents. Limitations, reasons for caution: The scoping review captured a variety of results, including survey and interview studies, society guidelines, and ethical analyses. As such, we were unable to define a uniform quality metric. However, we aimed to be more rather than less inclusive because of the limited results directly pertaining to parent-child disagreements. Wider implications of the findings: This study provides a robust review of decision-making for FP in minors and offers an ethical framework for weighing countervailing considerations when parents and children disagree about whether to pursue FP. The conclusions can be used to inform guidance for clinicians presented with this challenging ethical dilemma

BACKGROUND:This review explores the bioethical implementation of artificial intelligence (AI) in medicine and in ophthalmology. AI, which was first introduced in the 1950s, is defined as "the machine simulation of human mental reasoning, decision making, and behavior". The increased power of computing, expansion of storage capacity, and compilation of medical big data helped the AI implementation surge in medical practice and research. Ophthalmology is a leading medical specialty in applying AI in screening, diagnosis, and treatment. The first Food and Drug Administration approved autonomous diagnostic system served to diagnose and classify diabetic retinopathy. Other ophthalmic conditions such as age-related macular degeneration, glaucoma, retinopathy of prematurity, and congenital cataract, among others, implemented AI too. PURPOSE/OBJECTIVE:To review the contemporary literature of the bioethical issues of AI in medicine and ophthalmology, classify ethical issues in medical AI, and suggest possible standardizations of ethical frameworks for AI implementation. METHODS:Keywords were searched on Google Scholar and PubMed between October 2019 and April 2020. The results were reviewed, cross-referenced, and summarized. A total of 284 references including articles, books, book chapters, and regulatory reports and statements were reviewed, and those that were relevant were cited in the paper. RESULTS:Most sources that studied the use of AI in medicine explored the ethical aspects. Bioethical challenges of AI implementation in medicine were categorized into 6 main categories. These include machine training ethics, machine accuracy ethics, patient-related ethics, physician-related ethics, shared ethics, and roles of regulators. CONCLUSIONS:There are multiple stakeholders in the ethical issues surrounding AI in medicine and ophthalmology. Attention to the various aspects of ethics related to AI is important especially with the expanding use of AI. Solutions of ethical problems are envisioned to be multifactorial.