Capstone Symposium Booklet 2021-2

MASTER OF BIOETHICS C A P S TONE SYMP O SIUM M AY 6, 2021

Symposium Agenda Welcome Rebecca Weintraub Brendel, MD, JD Director, Master of Bioethics Degree Program, Associate Director, Center for Bioethics, and Assistant Professor of Psychiatry, Harvard Medical School; Director of Law and Ethics, Center for Law, Brain, and Behavior, and Psychiatrist, Massachusetts General Hospital

Reflections on the Capstone Program Melissa Abraham, PhD, MSc Co-Director of the Capstone program, Center for Bioethics; Assistant Professor of Psychology, Harvard Medical School; Psychologist, Massachusetts General Hospital Department of Psychiatry and Division of Clinical Research David Sontag, JD, MBE Co-Director of the Capstone program, Center for Bioethics; Lecturer on Medicine, Harvard Medical School; Managing General Counsel, Beth Israel Lahey Health Co-Chair, Ethics Advisory Committee, Beth Israel Deaconess Medical Center

Invitation to Poster Presentations Brooke Tempesta, EdD Associate Director, Master of Bioethics Degree Program; Associate Director of Education, Center for Bioethics; Research Fellow in Global Health and Social Medicine, Harvard Medical School

Poster Presentations group 1 What Do Bioethicists Do? Edward M. Hundert, MD Dean for Medical Education, Daniel D. Federman, M.D. Professor in Residence of Global Health and Social Medicine and Medical Education, Associate Director, Center for Bioethics, Harvard Medical School

Poster Presentations group 2 Wrap-up and Celebration

What Do Bioethicists Do? Keynote:

Edward M. Hundert MD Dean for Medical Education, Harvard Medical School

Edward M. Hundert is the Dean for Medical Education and the Daniel D. Federman, MD Professor in Residence of Global Health and Social Medicine and Medical Education at Harvard Medical School.

Dr. Hundert also serves as Associate Director of the Center for Bioethics at HMS. Over the past 25 years, he has served as President of Case Western Reserve University, Dean of the University of Rochester School of Medicine and Dentistry, and Associate Dean for Student Affairs at Harvard Medical School.

Dr. Hundert earned his bachelor’s degree in mathematics and the history of science and medicine, summa cum laude, from Yale University, where he received Yale’s Chittenden Prize “to the graduating senior with highest standing in mathematics or the natural sciences.” He attended Oxford University as a Marshall Scholar, receiving the Batterbee Prize from Hertford College for “highest first class honours in philosophy, politics and economics.” Four years later he earned his MD from Harvard Medical School, receiving the Sanger Prize for “excellence in psychiatric research.”

He completed his psychiatric residency at McLean Hospital, where he served as chief resident. He has received numerous teaching, mentoring, and diversity awards, and he was voted the “faculty member who did the most for the class” by Harvard Medical School graduates in five different years.

Dr. Hundert is a member of the board of TIAA. He co-chaired the Institute of Medicine’s National Summit on Health Professions Education.

Dr. Hundert has written dozens of articles and chapters on a variety of topics in psychiatry, philosophy, medical ethics, and medical education, as well as two books: Philosophy, Psychiatry and Neuroscience: Three Approaches to the Mind (Oxford University Press) and Lessons from an Optical Illusion: On Nature and Nurture, Knowledge and Values (Harvard University Press).

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Fatima Alhamar Capstone Mentor: K. Babu Krishnamurthy, MD, MBE Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Neurology, Harvard Medical School; System Director of Epilepsy and Ethics Associate, Steward Medical Group; Ethics Committee Chair, St. Elizabeth’s Medical Center Faculty Advisor: Jonathan M. Marron, MD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Instructor in Pediatrics, Harvard Medical School; Attending Physician, Dana-Farber Cancer Institute and Boston Children’s Hospital; Ethics Committee Chair, Boston Children’s Hospital Developing a Palliative Care Educational Module and Remote Consultation Framework for Medical Students and Resident Doctors in Kuwait In Kuwait, palliative care is an emerging medical specialty focused on providing physical and emotional relief for patients living with chronic illness, yet it is often confused with hospice and end-of-life care. Palliative care however, is a distinct medical specialty that centers on patient autonomy and beneficence with a holistic approach to patients rather than a disease-focused approach. In Kuwait, the stigma surrounding palliative care runs deep within the medical community and the public alike. Most health care professionals in Kuwait are not aware of palliative care as a specialty or the patient and family benefits it can provide. With a population of about 4 million people and only 3 palliative care consultants in the country, access to palliative care through consultation is extremely limited in Kuwait. Consequently, patients suffer unduly because access to appropriate symptom relief that might otherwise be available is limited. This situation denies patients access to good healthcare. This capstone experience consisted of a literature review to inform the development of a teaching module to explain what palliative care is, how palliative care principles can be used to address chronic symptoms, and how palliative care can benefit all patients at any time during their disease trajectory. The live, in-person, or remote, slide-based module was designed for medical students and resident doctors. Towards the end of the teaching module, a proposal for virtual consultations using telehealth modalities was introduced to address the issue of limited access to palliative care providers in Kuwait.

Fatima Alhamar, MBChB, is a family medicine physician-intraining at the Kuwait Institute for Medical Specialization.

She received her MBChB from the University of Leeds, United Kingdom. Observing cultural differences in approaches to ethical issues — including end-of-life care — in her Kuwaiti clinic and during training in the UK led her to pursue formal bioethics study. She is interested in teaching medical students and plans to focus on advancing the scope and quality of bioethics education in Kuwait, with the aim of enhancing ethical practice in the region. After completion of the MBE program, Fatima plans to pursue a fellowship position in Palliative Care.

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Marie-Laura Allirajah Capstone Mentor: Justin J Sanders, MD, MSc, FAAHPM Instructor in Medicine, Harvard Medical School and Brigham and Women’s Hospital; Attending Physician, Dana-Farber Cancer Institute; Associate Director of Innovation, Ariadne Labs.

Faculty Advisor: Jonathan M. Marron, MD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Instructor in Pediatrics, Harvard Medical School; Attending Physician, Dana-Farber Cancer Institute and Boston Children’s Hospital; Ethics Committee Chair, Boston Children’s Hospital

Implications of African American Bioethics for Racial Disparities in Cancer Care: A scoping review Black and Brown patients in the United States (US) and United Kingdom (UK) experience disparities in all aspects of cancer care, from prevention and diagnosis to treatment and palliative care. These disparities are more surprising in the UK than in the US, as patients experience fewer structural barriers to accessing healthcare in the UK. Bioethics provides a moral framework for the application of medical treatments. Despite including principles of justice and non-maleficence, bioethics has failed to provide clear guidance about how to address disparities. Although there is no hierarchy among the four bioethical principles in theory, clinicians and policymakers have nonetheless elevated autonomy and non-maleficence in ways that play an outsized role in patient care. African American bioethics is a branch of bioethics that considers different cultural norms. For this capstone, we conducted a scoping review of African American bioethics to identify potential implications for addressing cancer care disparities in other national contexts. Common themes identified in the literature include: the importance of acknowledging race and anti-racism in bioethical quandaries, using a lens of intergenerational and reparative justice, and rethinking the individualistic approach of autonomy in medical ethics.

A focus on intergenerational justice prompts bioethicists and the medical community to consider the unique history and conditions of Black patients when treating them.

These findings aided in creating a framework for bioethical practice to address racial disparities in cancer care in diverse healthcare settings.

Marie-Laura Allirajah is a fourth-year medical student at the University of Liverpool in the UK, where she is a 2022 MBChB candidate. For her medical degree, Laura undertook research regarding toxicity caused by immunotherapy in melanoma patients and presented her findings at the NCRI Cancer Conference. Her interest in bioethics stems from her desire that one day all patients will be treated equitably.

Laura wishes to address racial disparities within healthcare especially pertaining to the prognosis and treatment of Black, Asian, and Minority Ethnic (BAME) oncology patients. Following this MBE, she plans to finish medical school and continue to work on addressing health equity.

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Asma Alzaidy Capstone Mentor: Stephen D. Brown, MD Course Instructor, Harvard Medical School Center for Bioethics; Associate Professor of Radiology, Harvard Medical School; Attending Radiologist, Boston Children’s Hospital Faculty Advisor: Jonathan M. Marron, MD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Instructor in Pediatrics, Harvard Medical School; Attending Physician, Dana-Farber Cancer Institute and Boston Children’s Hospital; Ethics Committee Chair, Boston Children’s Hospital

The Challenges of Limited Healthcare Access for Undocumented Residents in Saudi Arabia During Covid-19 The purpose of this capstone project was to explore the practical and ethical challenges created by limited healthcare access for undocumented residents in Saudi Arabia during the COVID-19 pandemic. As a matter of public policy, this subpopulation of non-citizens who do not possess valid visas or residency permits is offered only emergency care and treatment of infectious diseases. During the COVID-19 pandemic, a royal decree granted them free treatment and exempted them from deportation, but the action commonly resulted in their involuntary confinement.

After reviewing the literature to elucidate the social, economic, and environmental challenges unique to this population prior to and during the pandemic, the project assessed the conditions that necessitated an involuntary confinement policy and its implications for this population. Confinement policies were then analyzed from a contemporary and Islamic bioethics perspective addressing the ethical tension between autonomy and the public interest. The analysis found that contemporary ethics focuses on personal interest while Islamic bioethics places primary emphasis on the general public’s benefit (Maslahah). Yet, both allow confinement under certain conditions. The project further examined claims of health as a human right. It contrasted the individualistic basis for rights in contemporary bioethics with Islamic understanding of rights as circumscribed by conformity to higher objectives of Sharia (Islamic law), including preservation of life. The project concluded that policy makers should consider innovative solutions for inclusive healthcare accessibility in the context of the Saudi 2030 transformation programs.

Asma Alzaidy, MBBS, is a physician in the Saudi Ministry of Health and a member of the Saudi Society for Healthcare Ethics. After receiving her MBBS from King Abdulaziz University in Saudi Arabia, she joined the New York University Langone Medical Center as a research associate.

Asma has served as a member of the medical staff during Hajj pilgrimage season for the past five years. She is a recipient of the Dubai Harvard Foundation award. She is interested in the theoretical foundations of Islamic bioethics and the implementation of its principles in regional policies.

After graduation, Asma will join the current pioneering efforts to expand the field of bioethics in Saudi Arabia.

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Sravya Chary Capstone Mentor: Roberta Driscoll, JD, MBE Director, Ethics, Risk, and Compliance, Novartis Institutes for Biomedical Research Faculty Advisor: Melissa Abraham, PhD, MSc Co-Director of the Capstone Program, Harvard Medical School Center for Bioethics; Assistant Professor of Psychology, Harvard Medical School; Psychologist, Massachusetts General Hospital Department of Psychiatry and Division of Clinical Research

Enhancing Patient Trust in the Pharmaceutical Industry through the Improvement of Readability Scores Patient mistrust in the pharmaceutical industry is prevalent, in part, due to low levels of health literacy that can make public communications released by pharmaceutical manufacturers difficult to understand. This project analyzed the 10 most recent web-based communications (excluding social media) as of May 5, 2021 for the top 10 pharmaceutical manufacturers by revenue in 2020 (n=100). A Flesch-Kincaid score was calculated for each communication, which was then converted to a U.S. school reading level equivalent. A preliminary analysis of the 100 most recent web-based communications released by pharmaceutical manufacturers showed a mean Flesch-Kincaid readability index equivalent to a college reading level. All 10 manufacturers had individual mean readability indices equivalent to a college or college graduate reading level. The average reading level across the most recent web-based communications released by the top 10 pharmaceutical manufacturers by 2020 revenue indicates a need for improvement. Pharmaceutical manufacturers have a moral obligation to communicate clearly with the general public and maintain a trusting relationship to uphold patient autonomy and justice. Steps to enhancing communication, and therefore trust, include standardizing pharmaceutical web-based communications by improving readability scores to an 8th grade level, defining scientific terminology, and including easily digestible video content. The framework developed in this project to enhance web-based communications can guide manufacturers without compromising the robustness and scientific integrity of web-based communications.

Sravya Chary, MS, is a data architect at Novartis Pharmaceuticals Corporation supporting the Managed Markets Finance department. She is currently a student fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Sravya graduated with honors from Rutgers University with a BS in supply chain and marketing science and earned an MS in supply chain analytics at Rutgers Business School. Her academic interests lie at the intersection of pharmaceuticals, health law, and ethics.

Her current research involves evaluating hydroxychloroquine as a case study to establish new risk/benefit guidelines for revoking emergency use authorizations. Following graduation from the MBE, Sravya plans to attend law school.

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Tiffany Chen Capstone Mentors: Andrea Merrill, MD Assistant Professor of Surgery, Boston University School of Medicine Louise P. King, MD, JD Director of Reproductive Ethics, Harvard Medical School Center for Bioethics; Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School; Surgeon, Division of Minimally Invasive Surgery, Brigham and Women’s Hospital Ava Kwong, MBBS, BSc, PhD Daniel C K Yu Professor in Breast Cancer Research and Clinical Professor, the University of Hong Kong; Chief of Division of Breast Surgery, Queen Mary Hospital Hong Kong, Tung Wah Hospital Hong Kong and the University of Hong Kong-Shenzhen Hospital Faculty Advisor: Kelsey Berry, PhD Postdoctoral Research Fellow, Harvard Medical School, Harvard Medical School Center for Bioethics Comparing US and Far East Decision Making for Contralateral Prophylactic Mastectomy in Non-genetic Breast Cancer Patients — A Systematic Review Contralateral Prophylactic Mastectomy (CPM) is a medically unnecessary intervention with almost no benefit in non-genetic breast cancer patients. Yet, many patients in the US and Far East still prefer CPM out of fear of recurrence, contributing to a tension between personal autonomy and doctors’ recommendations. This Capstone project studied the cultural differences between the US and the Far East through a systematic review in 2 stages: (1) the comparison of general medical decision making (DM), serving as the hypothesis for (2) the comparison of CPM DM. Stage (1) showed more active participation in autonomous DM in American patients and DM deference to family or doctors in Eastern patients generally. Body-intactness was prominent in the East while inconspicuous in the US, which may discourage CPM in the East. Stage (2) rejected the abovementioned first claim with largely individualized CPM DM in the East and accepted the second claim in which body intactness did discourage CPM coupled with breast reconstruction in the East. Potential reasons to explain Eastern areas’ apparent “westernization” in CPM DM included globalization and consumerism.

Stage (2) literature’s exclusive focus on motivating factors raised questions of whether Alfred Tauber’s term “sick autonomy” — autonomy to patients’ unintended detriment — was at play, and what a doctor’s duty should be in guiding their patients from irrational fear of recurrence to rational DM in CPM. These results warrant further investigation into what a doctor’s duty should be.

Tiffany Chen is a third-year medical student at the University of Hong Kong (HKU) and a 2024 MBBS degree candidate. She is a student ambassador to the HKU Li Ka Shing Faculty of Medicine and a student volunteer at United Christian Hospital Hong Kong and Hong Kong Sanatorium & Hospital. She is interested in the bioethics of cultural comparisons of contralateral prophylactic mastectomy. At HKU, Tiffany received the Medical Dean’s Scholarship, Janet McClure Kilborn Prize in Biochemistry, and H.C. Liu Prize in Anatomy. After completing the MBE program, Tiffany will continue her medical education at HKU and her work at the Center in a joint project between Harvard and HKU. 6

Samantha Chong Capstone Mentor: Kaila Rudolph, MD, MPH, MBE Assistant Professor, Boston University School of Medicine; Attending Consultation Liaison Psychiatrist, Boston Medical Center Faculty Advisor: Elaine C. Meyer, PhD, RN, MBE Course Instructor, Harvard Medical School Center for Bioethics; Associate Professor of Psychology, Department of Psychiatry, Harvard Medical School; Senior Associate Psychologist, Boston Children’s Hospital

Examining the Impact of Culture on Perceptions towards the Role of Family during End-of-Life Care Among Older Adults in Boston and Hong Kong There has yet to be a direct comparison analyzing the attitudinal differences between Eastern and Western cultures regarding the role family plays during the end-of-life period. Thus, the purpose of this study was to examine the cultural differences between Boston and Hong Kong specialist physicians’ perspectives concerning the role of family during end-of-life decision making. Additionally, while the Chinese diaspora is often characterized as a monolithic entity, its intracultural nuances are variable and influence patient preferences. For example, Hong Kong research shows a high acceptance of patient autonomy by physicians and laymen, contrasted with traditional Chinese collectivism. Considering that Chinese immigrants make up 5.5% of America’s foreign-born population, improving the cultural competence of Western practitioners is needed to enhance quality of care. A 14-question survey was developed and reviewed by IRBs at both Harvard Medical School and Boston University. The survey focused on topics such as assessing the amount of familial involvement during end-of-life care and identifying specific family members typically included in the process. The goal has been to recruit 40 elder care specialists, mainly geriatricians, practicing at either Boston Medical Center or Queen Mary Hospital, Hong Kong for analysis. It is anticipated that the data will assist physicians with providing more culturally competent care to geriatric patients and their families during the end-of-life period. The research is ongoing.

Samantha Chong is a third-year medical student at the University of Hong Kong. With a passion for social justice and global health, she dedicated her first 2 years at medical school as a Human Rights National Officer and represented Hong Kong as National Member Organization President within the International Federation of Medical Students’ Associations. She is currently working as a Human Rights Education Intern at a local NGO alongside her MBE studies.

Samantha is interested in challenging the generalized characterization of Asian ethics within mainstream Western end-of-life and reproductive bioethics conversations. She plans to complete her medical degree and work towards improving bioethical awareness within Hong Kong.

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Frédérique Couture-Carrier Capstone Mentor: Insoo Hyun, PhD Director of Research Ethics, Harvard Medical School Center for Bioethics; Senior Lecturer, Harvard Medical School; Professor, Department of Bioethics and Director of the Undergraduate Bioethics Program, Case Western Reserve University School of Medicine Faculty Advisor: Brendan Abel, JD Course Instructor, Harvard Medical School Center for Bioethics; Director of Advocacy & Government Relations, Massachusetts Medical Society

Mapping Consciousness: Building a Common Understanding of the Landscape for Moral Concern in Brain Organoid Research Brain organoids are three-dimensional structures grown in culture from pluripotent stem cells or adult progenitor cells that self-organize into brain tissue and model aspects of neural development and disease with bioengineering’s help. While brain organoids currently are nowhere near recapitulating our entire brain structure or function, they are growing increasingly complex, prompting questions regarding their capacity for consciousness and associated implications for their moral status and use in research. How can scientists, bioethicists, regulators, and the public collaborate to address those issues proactively and effectively, however, if no consensus exists on which of the manifold meanings of consciousness is under discussion? This capstone project aimed to help address this challenge by exploring what forms of brain organoid consciousness might trigger our moral concern through a literature review of definitions of consciousness found in philosophy, biology, neuroscience, cognitive science, and artificial intelligence. This research highlighted three broad categories of consciousness – access to information, sentience, self-awareness – and their potential applicability to brain organoids. It also raised questions for further consideration about understanding consciousness as emergent and/or embodied, the role brain organoids’ (non-)human cellular origin plays in our ethical intuitions, and whether to attend to cognition rather than consciousness.

The hope is to adapt this conceptual map into a visual aid linking theory with science that institutional review boards can reference when reviewing brain organoid research to build a common understanding of the landscape for moral concern.

Frédérique Couture-Carrier, JD, received her BA in history from Brown University and her JD from Harvard Law School, where she was a Chayes International Public Service Fellow and managing editor of the Harvard Human Rights Journal. She formerly practiced law in the global transactions group of Freshfields Bruckhaus Deringer in New York City. Her ethical and legal interests in emerging biotechnologies, medical research, and health as a human right stem from her personal experience navigating different health care systems and clinical studies. In her final year of the MBE program, Frédérique looks forward to continuing to explore how a collaborative approach to bioethics can help anticipate and address such issues.

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Stephanie Dephoure Capstone Mentor: Brian Cummings, MD Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Pediatrics, Massachusetts General Hospital and Harvard Medical School; Pediatric Intensivist and Vice-Chair, Department of Pediatrics, and Executive Director, Clinical Process Improvement Leadership Program (CPIP), Mass General Brigham Faculty Advisor: Anthony Breu, MD Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Medicine and Co-Director, Essentials of the Profession, Program in Medical Education, Harvard Medical School; Director of Resident Education and Hospitalist, VA Boston Healthcare System Decision Aids as Tools to Facilitate Shared Decision Making in Neonatal Care: A Standardization Analysis Neonatal practice involves complex decision making that prioritizes different ethical principles than adult care, with a particular focus on beneficence and the best interests standard, as well as respect for parental autonomy. Respecting autonomy and best interests are facilitated through shared decision making (SDM). Decision aids (DA)s are educational, evidence-based tools designed to facilitate SDM between patients, caregivers, and healthcare professionals. The development and evaluation of existing neonatal DAs have been variable, with as yet unestablished effectiveness and generalizability. Standard frameworks allow neonatal DAs to be evaluated for completeness and elucidate areas of opportunity to better promote the ethical goals of SDM. DAs were included in analysis based on a comprehensive search strategy focusing on neonatal topics, and then evaluated for compliance with both the Standards for UNiversal reporting of patient Decision Aid Evaluations checklist (SUNDAE) and the Systematic Development Process (SDP). Compliance with SUNDAE and SDP were inconsistent in currently published neonatal DAs. SUNDAE evaluation revealed gaps in visual and numerical probability factors, values clarification exercises, and provision of tailored information to meet parental needs, overall limiting the potential of informed and adaptable SDM. SDP evaluation showed little evidence of engaging steering committees and a lack of preliminary alpha and beta testing with clinicians and parents to promote inclusive and more impactful development. In order to maximize SDM and support ethical decision making honoring parental autonomy and best interests standard in neonates, a holistic framework for DA development and reporting is needed to maximize their clinical impact.

Stephanie Dephoure, BHSc, received her BHSc with a specialization in global health from McMaster University in Hamilton, Ontario, Canada. As an undergraduate, she engaged in pediatric stroke, urology, and global health research projects, which largely founded her interests in pediatric ethics. Her bioethical interests surround applications of pediatric ethics, including shared decision making strategies between families and clinical teams, and the significance of the altered form of autonomy present in pediatric settings.

Following graduation, Stephanie hopes to continue engaging in bioethics work while pursuing medical school.

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Bijal Desai Capstone Mentor: Lisa S. Lehmann, MD, PhD, MSc Associate Professor of Medicine (part-time), Harvard Medical School; Associate Professor of Health Policy and Management (part-time), Harvard T.H. Chan School of Public Health; Head of Bioethics, Google Faculty Advisor: Jonathan M. Marron, MD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Instructor in Pediatrics, Harvard Medical School; Attending Physician, Dana-Farber Cancer Institute and Boston Children’s Hospital; Ethics Committee Chair, Boston Children’s Hospital

Social Needs Screening during Covid-19: Identifying Opportunities for Responding to Veterans’ Social Needs Social determinants of health (SDoH) have a significant impact on health outcomes.

The COVID-19 pandemic has exacerbated and disproportionately affected the health outcomes of those who are vulnerable and those who are already facing poor health outcomes. Veterans have unique experiences such as military-related trauma and post-traumatic stress disorder (PTSD), which exacerbate poor outcomes related to SDoH. A lack of attention to health-related social needs places Veterans at heightened risk for relapse of psychiatric symptoms, addiction, and PTSD. Healthrelated social needs screening within the Veteran Affairs (VA) health system may further help overcome the “don’t ask, don’t tell” stigma that is prevalent among Veteran populations and acts as a barrier in seeking support. The purpose of this capstone project was to develop a health-related social needs screening tool to investigate the specific impact the pandemic has had on Veterans so that the VA can respond appropriately to their needs. As screening for social needs is not yet standard clinical practice, this study investigates the ethical considerations surrounding its implementation, remote delivery, and accessibility during the pandemic. This screening tool will help the VA to identify at-risk Veterans and determine the prevalence of identified social needs and sociodemographic characteristics associated with screening positively for these needs. It is anticipated that the data from this study will assist the VA in understanding and addressing barriers to health.

Bijal Desai, BHSc (Hons), received her BHSc with a specialization in Child Health from McMaster University, Hamilton, Ontario, Canada. As an undergraduate, she volunteered as a licensed personal trainer for students with disabilities; facilitated knowledge translation in a provincial child health study; co-founded Project Pulse, Canada’s largest student-led healthcare organization; and received a University Senate Scholarship. Her academic interests include exploring social determinants of health and their intersection with healthcare outcomes. Bijal plans to attend medical school following graduation from the MBE program.

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Jess Gordon Capstone Mentor: Julian Willard, PhD Bioethics Fellowship Alumnus, Harvard Medical School Center for Bioethics, Harvard Medical School; Chair of Interdisciplinary Studies Department, The Rivers School, Weston, MA Faculty Advisor: Louise P. King, MD, JD Director of Reproductive Ethics, Harvard Medical School Center for Bioethics; Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School; Surgeon, Division of Minimally Invasive Surgery, Brigham and Women’s Hospital

Creating a Bioethics & Health Literacy Curriculum for High School Students: A Pilot The United States Department of Education does not mandate bioethics or health literacy education for K-12 students, though organizations like the National Institutes of Health (NIH) have recommended it as beneficial. The goal of this project was to pilot a Bioethics and Health Literacy curriculum that can be built upon and eventually implemented by high schools (grades 9-12) across the United States.

The project hypothesized that exposure to these subjects would teach students an array of skills such as: complex problem solving, improved communication (via engaging in difficult or complex discussions), improved decision making, and better understanding as to how to navigate the healthcare system as a whole. These skills are important for flourishing in adulthood and were thoughtfully injected into each module in a developmentally appropriate manner. Furthermore, opportunities for simulation in the role of both ethicist and patient were embedded with each module, along with a self-reflection component for students to self-measure understanding of topics. The first module, which focused on adolescent decision making and respect for persons, was piloted over 2 sessions (one hybrid, one virtual) in March 2021 with a group of 11th and 12th graders at The Rivers School in Weston, Massachusetts.

Students were surveyed about the experience, as well as the delivery of the curriculum through simulation and virtual learning. Preliminary results show that students appreciated the experience, and recommended additional sessions and time per session for future modules.

Jess Gordon, BA, is an educator and researcher in adolescent and young adult health care. Jess received her BA in English and Education Studies from Lake Forest College and continued graduate work in Education Policy and Leadership (EPOLS) at the University of Illinois. Jess is currently working to create a Bioethics and Health Literacy curriculum for high school students. Her interests include the implementation and expansion of bioethics and civics education for young adults, using simulation and technology for ethics education, and furthering partnerships between healthcare and school systems. After graduation, she plans to continue developing her bioethics curriculum.

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Douglas W. Hanto Capstone Mentors: Nancy E. Oriol, MD Faculty Associate Dean for Community Engagement in Medical Education, Lecturer on Global Health and Social Medicine, Associate Professor of Anaesthesia, Harvard Medical School Will Ross, MD, MPH Associate Dean for Diversity, Professor of Medicine, Division of Nephrology Washington University School of Medicine, St. Louis Faculty Advisor: Christine Mitchell, RN, MS, MTS Executive Director, Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, Harvard Medical School Healthcare Reparations for African Americans: Ethical Rationale and Practical Framework Although the international community has accepted healthcare as a universal human right, the United States has not. Healthcare in this country is not anchored in health equity or social justice, but in the ability to pay. Consequently, achieving a state of optimal health can be elusive, more so for some than for others. This work proposed an ethical argument and practical framework for healthcare reparations to remedy this injustice as it pertains to African Americans. A literature review of the history of slavery, structural racism, social determinants of health, and harms caused by healthcare disparities was performed. Restorative justice theory was applied to healthcare reparations. This literature review showed that African Americans have consistently had a lower life expectancy than Whites. Other disparities include disproportionately higher rates of infant and maternal mortality and of being uninsured or underinsured. COVID-19 infection and mortality rates are markedly higher among African Americans. Healthcare disparities are related to social determinants of health rooted in slavery and structural racism. Restorative justice theory provides a rationale for healthcare reparations through its focus on: wrongful harms and community needs that express concern for victims’ experiences and needs for repair, obligations of offenders to accept responsibility and accountability, and engagement of the victims and offenders who have active roles in the justice process. Finally, reparations can be provided by the government, healthcare institutions, and healthcare providers through free access to Affordable Care Act and private health insurance plans, by Medicaid expansion, and by an activist commitment to healthcare equality.

Douglas W. Hanto, MD, PhD, is a transplant and general surgeon, Deputy Chief of Surgery at the VA St. Louis Health Care System, and Lewis Thomas Professor of Surgery Emeritus at Harvard Medical School. He received his BS from St. Olaf College, MD from the University of Arizona, and PhD from the University of Minnesota. He has been a clinician-scientist for 35 years with interests in post-transplant malignancies, ischemia-reperfusion injury, and transplant ethics. His current bioethics interests include medical aid in dying, healthcare disparities and reparations, and using fiction to discuss ethical controversies. He is completing his first novel and plans to write, teach bioethics, and work for healthcare equality.

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Isabella Hernandez Capstone Mentor: Brendan Abel, JD Course Instructor, Harvard Medical School Center for Bioethics; Director of Advocacy & Government Relations, Massachusetts Medical Society Faculty Advisor: Aaron S. Kesselheim, MD, JD, MPH Director of Health Policy and Bioethics, Harvard Medical School Center for Bioethics; Professor of Medicine, Harvard Medical School; Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

Reducing Maternal Mortality in Massachusetts by Extending MassHealth Postpartum Coverage to One Year While the postpartum period lasts until 12 months post-delivery, MassHealth provides pregnancy-related coverage only until 60 days post-delivery. Between day 60 and 365, many women lose their eligibility and become uninsured.

One-third of pregnancy-related deaths occur in the postpartum period. Although maternal mortality is historically low in Massachusetts, the issue continues to disproportionately impact Black, Indigenous, people of color (BIPOC), who make up 52.6% of MassHealth members. Additionally, the opioid and substance use problems within the state directly impact maternal health. From 2011 to 2014, the proportion of pregnancy-associated deaths related to substance use in Massachusetts increased from 14% to 41%. The highest rates of opioid overdose occur between 6 months and 1 year post-delivery. To reduce maternal mortality in this period, this capstone project aimed to advocate for the extension of MassHealth coverage to 1 year postdelivery. Conducting background research about postpartum maternal health and a literature review of existing U.S. legal obligations promoting maternal health revealed that the state and federal government need to provide additional protection during this vulnerable period. With the passage of the American Rescue Plan Act, which allows states to opt in to extending postpartum Medicaid coverage to a year, there is a clear opportunity for Massachusetts to provide this needed care. Thus, the next step of the capstone is to submit formal public comment to MassHealth and the Secretary of Massachusetts Health and Human Services, urging opting into the extended postpartum coverage.

Isabella Hernandez, BA, was a paralegal for 2 years at Cravath, Swaine and Moore, LLP before joining the MBE program full time. She received her BA in philosophy and anthropology from Skidmore College in New York. As an undergraduate, she wrote her philosophy capstone about how Buddhist compassion reframes the Western abortion debate. She is interested in the social determinants of health and hopes to work at the intersection of law and bioethics. Isabella will attend law school in the fall.

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Josh Hyatt Capstone Mentors: Janet Barnes, JD, BSN, CPPS, CPHRM Vice President, Quality and Patient Safety, North Shore Medical Center Evan G. DeRenzo, PhD Senior Clinical Ethicist, John J. Lynch MD Center for Ethics; Editor–in–Chief, Journal of Hospital Ethics, Medstar Washington Hospital Center, Washington, DC Faculty Advisor: Aaron S. Kesselheim, MD, JD, MPH Director of Health Policy and Bioethics, Harvard Medical School Center for Bioethics; Professor of Medicine, Harvard Medical School; Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital Moral Healthcare Risk Management: Ethical Decision Making Models to Inform Just Healthcare Risk Management The risk of patient harm and malpractice litigation is mitigated by doing the “right” thing in terms of ethical behavior in patient care. Bioethics and healthcare risk management are interdisciplinary and supportive professions that consult with direct care providers on issues of patient-centered care, moral conflicts, and patient safety.

Both endeavor to make right and just recommendations in the best interests of the patient, institution, and stakeholders. Though their goals are often normative and values-based, their approaches are iterative and can seemingly conflict, thereby inhibiting interprofessional collaboration. This challenge can result in moral distress, burnout, decreased collegiality, reduced patient advocacy and patient safety, and paternalism. Ultimately, these features minimize the patient’s voice in treatment, increase liability for the institution, and contribute to a culture that is not patientcentered. This capstone project explored the overlapping natures of bioethics and healthcare risk management, ethical decision making models that inform risk management decision making, and didactic educational models for both clinical ethicists and clinical risk managers. The capstone included a robust literature review and analysis of practical ethical decision making models applicable to healthcare risk managers and the development of an educational module to enhance interprofessional collaboration. The endpoint included a forum for these fields to find commonalities and opportunities for collaboration, and to develop an appreciation of the unique perspectives each brings to enhance patient-centered care.

Josh Hyatt, DHSc, MHL, is a clinical risk manager at Coverys and an adjunct professor at Massachusetts College of Pharmacy and Health Sciences in the Doctor of Health Science program. He received his Doctor of Health Science and Master of Health Law degrees at Nova Southeastern University. He has worked in health care risk management and as a professor for nearly 30 years. His academic interests focus on the relationships between healthcare risk management/patient safety and bioethics, moral distress, and LGBT health. His most recent publication was for the AMA Journal of Ethics (November 2020). After graduation, he will continue to write and lecture on patient safety, risk management, and intersections in healthcare.

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Adelaida Jasperse Capstone Mentor: Mason Marks, MD, JD Edmond J. Safra Center and Petrie-Flom Center Fellow in Ethics of Technological and Biomedical Innovation Faculty Advisor: Rebecca Weintraub Brendel, MD, JD Director, Master of Bioethics Degree Program, and Assistant Professor of Psychiatry, Harvard Medical School; Director of Law and Ethics, Center for Law, Brain, and Behavior, and Psychiatrist, Massachusetts General Hospital

Protecting Personal Health Information in an Age of Datafication: Establishing an Ethical Framework and Filling the Current Regulatory Vacuum Fitness trackers, online platforms containing health information, and other digital technologies have facilitated a health information marketplace enabling individuals to manage their health outside of traditional healthcare sectors. These technologies, however, also permit extraction of personal health information (“PHI”), often without user consent or awareness, and frequently for profit. These developments reveal a vacuum in current ethical and regulatory frameworks, highlighting an urgent need for cures to safeguard privacy rights and protect people from harm caused by health data misuse. To address these gaps, this Capstone had 3 chief aims: (1) to catalog prevailing categories of health data harms, (2) to establish an ethical framework for safeguarding digital health data, and (3) to provide a regulatory proposal for their protection. A non-exhaustive list of harms includes medical identity theft, reputational injury, surveillance, and employment, credit, housing or insurance discrimination. To address these harms and privacy concerns, the proposed ethical framework draws upon applied ethics’ core principles — justice, non-maleficence, beneficence, and autonomy — and reframes the following main instrumental principles: purpose limitation, data minimization, fiduciary duty, transparency, and meaningful consent. This framework employs a justice-centric approach, undergirded by instrumental principles of ethical design, fairness, and accountability. As a next step, this capstone envisions the proposal of new regulatory provisions for governing PHI that are currently beyond the scope of HIPAA. The proposal addresses safeguarding PHI held by mHealth technologies (personal health records and cloud-based or mobile software tools), health social media, and direct-to-consumer genomic testing entities through amending HIPAA or, alternatively, drafting new legislation.

Adelaida (Adele) Jasperse, JD, is an attorney with the Commonwealth of Massachusetts. Adele has been practicing law in Massachusetts for 7 years focusing, primarily, on appellate advocacy in the area of child welfare. Her interest in bioethics includes exploring issues concerning underserved communities’ access to healthcare. She is also interested in the intersection of law, neurotechnologies, and genomics. In 2017, she was the recipient of Manuel Carballo Governor’s Group Recognition Award for Excellence in Public Service. After graduating from the MBE program, Adele will continue her work in the public sector incorporating her bioethics education with her law practice.

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Shika Kalevor Capstone Mentor: Jennifer McGuirl, MBE, DO Faculty Member of the Harvard Medical School Center for Bioethics; Lecturer on Pediatrics part-time, Harvard Medical School; Neonatologist, Grand Rounds Faculty Advisor: Christine Mitchell, RN, MS, MTS Executive Director, Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, Harvard Medical School

Disparity Remediation Utilizing Innovative Care Delivery Services Self-Reported Health Status (SRHS) is an effective and reliable tool used by researchers to predict morbidity, mortality, and healthcare utilization. Grand Rounds (GR) is an innovative healthcare navigation company whose mission is to provide access to quality healthcare for everyone, everywhere. The Connected Care Program (CCP) within GR primarily serves a population of members of lower socioeconomic status and aims to provide longitudinal care and case management. The purpose of this study was to demonstrate that entities like GR can improve SRHS and thus reduce healthcare utilization through improved health to ultimately close the gap in preventable health disparities. Members in CCP were asked their baseline SRHS at the start of their care plan and then every 2 to 3 months. Individual chart reviews of 110 members who had baseline and follow-up SRHS values, new provider or subspecialist referrals, and other assistive services were conducted. Based on this composite, a baseline and follow–up Likert value were assigned (1= poor, 2= fair, 3=good, 4= very good, 5 = excellent). Paired one-tailed t-tests were conducted and revealed significant SRHS improvement among members (p< .01). Innovative healthcare navigation companies like GR can improve SRHS. Future opportunities include an in-depth narrative review of member charts. Further investigation is warranted to identify which interventions are most effective to reduce disparities and to optimize long-term healthcare utilization.

Shika Kalevor, BSN, RN is a neonatal intensive care unit (NICU) nurse from the Pacific Northwest. She received her Bachelor of Science in Nursing from Seattle University with a Spanish Minor. She served as a Bioethics Liaison in the NICU at Seattle Children’s Hospital and served on the hospital-wide Bioethics Committee. She is interested in exploring the intersection of bioethics and health equity, focusing on racial bias and disparities. Shika received the Sister Mary Niehoff Award for Excellence in Nursing from Seattle University and the Excellence in Evidence-Based Research Award from Seattle Children’s Hospital. Shika will begin a fellowship in Pediatric Ethics at Mercy Children’s Hospital in Kansas City, MO in July 2021.

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Douglas Knittel Capstone Mentors: John Hammond, MS Brigadier General, United States Army (retired); Executive Director, Red Sox Foundation Home Base Program, and Massachusetts General Hospital John Bradley, MD Colonel, Medical Corps, United States Army (retired); Associate Professor of Psychiatry, Harvard Medical School; Director, Mental Health Service and Chief of Psychiatry VA Boston Healthcare System Faculty Advisor: John Wesley Boyd, MD, PhD Faculty Member of the Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, Part-time, Harvard Medical School; Professor of Medical Ethics and Psychiatry, Baylor College of Medicine Military Physicians as Mandated Reporters of Human Rights Abuses A fundamental aspect of military service for physicians is “dual agency”: ethical responsibilities deriving from roles both as physicians and military officers. While these roles are typically congruent in peacetime, they can be irreconcilable during times of war. This dissonance is acknowledged in training, but there is a paucity of definitive guidance once discordance arises. This issue of dual agency has been brought to the fore in the recent Global War on Terror because of the treatment of detainees at Guantanamo Bay, Cuba, where a military physician was involved in the development of interrogation procedures, in contravention of United States and International tenets and codes of medical ethics. Furthermore, interrogation procedures undertaken by other United States personnel have been deemed by outside reviewers to constitute torture. This Capstone project used child abuse mandated reporting laws as a model to expand on current Department of Defense policies. Under this proposal, military physicians would be mandated reporters of human rights abuses, with defined reporting channels external to the military unit. This policy would have several advantages over current policy, including the presence in each unit of an observer lacking discretion regarding the reporting of any human rights abuses. In addition, it would make the role of military physicians in wartime more in keeping with medical ethics principles and the Geneva Conventions, regardless of the circumstances. This proposal was recently presented in a conference at the Defense Medical Ethics Center in Bethesda, Maryland, for further study by the Department of Defense.

Douglas Knittel, MD is a physician at the Naval Medical Center in Portsmouth, Virginia. He received his MD from the Uniformed Services University of the Health Sciences in Bethesda, Maryland where he was elected to the Alpha Omega Alpha Honor Medical Society. Doug holds board certifications in Psychiatry and Pathology and is currently a Clinical Assistant Professor at the Eastern Virginia Medical School in Norfolk, Virginia. He is a retired Navy Captain with 29 years of active duty service including deployments to Iraq and Afghanistan. His bioethical interests center on physicians’ role conflicts in crisis environments. After graduation, Doug will return to the practice of medicine with a special focus on hospital bioethical issues. He will also serve as a Bioethical Consultant to the Defense Medical Ethics Center.

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Anna Krotinger Capstone Mentors: Martha Montello, PhD Course Instructor, Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, Harvard Medical School Rebecca Weintraub Brendel, MD, JD Director, Master of Bioethics Degree Program, and Assistant Professor of Psychiatry, Harvard Medical School; Director of Law and Ethics, Center for Law, Brain, and Behavior, and Psychiatrist, Massachusetts General Hospital Faculty Advisor: Louise P. King, MD, JD Director of Reproductive Ethics, Harvard Medical School Center for Bioethics; Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School; Surgeon, Division of Minimally Invasive Surgery, Brigham and Women’s Hospital Literature and Epidemic: Narrative as a Moral Guide during COVID-19 From Boccaccio’s Decameron to Albert Camus’s The Plague, epidemics have long been featured in literature, detailing characters’ experiences of disease, contagion, and death. This capstone aimed to explore how literature affected clinicians’ experiences throughout the COVID-19 pandemic. Through interviews with practicing clinicians, this capstone queried what they read during the past year, what topics and forms of writing attracted them, what they took away from their reading, and what they wished they could be reading more. Thus far, patterns in clinicians’ reading experiences has largely mirrored patterns in literary writing about plague. First, because COVID-19 has disproportionately affected communities of color and low-income communities, clinicians were inspired to read fiction and non-fiction focusing on racial and socioeconomic injustice. This finding directly reflects the focus of plague narratives on how epidemics exacerbate inequalities between rich and poor and suburban and urban populations. Second, some clinicians found that narratives helped them reflect on how they interact with patients, examining the role of humility in the clinical space.

In the same way, characters in plague narratives often change how they think and care about others during epidemics. Ultimately, almost all clinicians interviewed recognized positive impacts of their reading. Non-fiction narratives—specifically those highlighting race and injustice—carried marked ethical weight, shaping perspectives and practices clinicians believe will endure after the pandemic. The majority of clinician-readers also expressed a desire to read more fiction, underscoring the role of stories, in the words of Jill Lepore, as both salve and consolation.

Anna Krotinger, BA, is a grant writer and research assistant at OPENPediatrics, a subdivision of Boston Children’s Hospital, and teaches dance for persons with Parkinson’s disease. She received her BA in neuroscience from Wesleyan University, where her thesis investigated potential factors influencing the impact of dance on Parkinson’s symptoms. While at Wesleyan, she directed a dance group, was elected to Phi Beta Kappa, and received the George H. Acheson and Grass Foundation Prize in Neuroscience.

After completing the MBE program, Anna will pursue an MD at Harvard Medical School, and will continue exploring narrative ethics and the ethics of end-of-life care as she studies to become a physician.

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Kathy Lee Capstone Mentor and Faculty Advisor: David Sontag, JD, MBE Co-Director of Capstone Program, Harvard Medical School Center for Bioethics; Lecturer on Medicine, Harvard Medical School; Managing General Counsel, Beth Israel Lahey Health; Co-Chair, Ethics Advisory Committee, Beth Israel Deaconess Medical Center

Lessons from Beth Israel Lahey Health: Should There Be Ethics Coordination at the System Level?

In 2019, Beth Israel Lahey Health (BILH) was formed, bringing 13 hospitals together into one health system. Since then, BILH has been actively identifying and consolidating departments to efficiently provide services throughout the system.

However, ethics has not been coordinated across the enterprise, and each hospital administers its own ethics committee, as required by the Joint Commission, without any overarching guidance, funding, or oversight at the system level. This project aimed to learn about each ethics committee, including but not limited to its structure, consultative services, educational plans, policies, and needs through a series of semi-structured interviews. The interview results were carefully analyzed, and a summary memorandum was created to inform and guide leadership regarding common enterprise-wide themes and identified needs and limitations of the various hospital ethics committees. Specifically, most hospitals agreed that they lack the resources to provide necessary education to members, including those who conduct consultations. Further, hospitals identified that learning across the system and from each other would be helpful. Hospitals also indicated that the lack of trained ethicists available to provide support had created problems with respect to complex cases and stated that assistance from formally-trained ethicists would be beneficial.

In summary, this capstone project showed that there are obvious and actionable opportunities for BILH to provide enterprise-wide resources and to support to ethics committees, such as appointing a coordinator at the system level.

Kathy Lee, LLM received her LLB (Honors) from Durham University, United Kingdom, and her LLM in Health Law from Loyola University Chicago. She is also certified in Healthcare Compliance. During her LLM, she was a legal extern at Rush University Medical Center and wrote her thesis on whether mandatory arbitration is a better alternative to trial in resolving medical malpractice claims in a universal healthcare system. Kathy is especially interested in bioethical issues surrounding informed consent and the intersection between law, ethics, and medicine. Following the MBE program, Kathy will work as a Contracts Specialist at Weill Cornell Medicine in New York City before taking the New York State State Bar Exam.

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Connie Lu Capstone Mentor: Jonathan M. Marron, MD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Instructor in Pediatrics, Harvard Medical School; Attending Physician, Dana-Farber Cancer Institute and Boston Children’s Hospital; Ethics Committee Chair, Boston Children’s Hospital Faculty Advisor: Louise P. King, MD, JD Director of Reproductive Ethics, Harvard Medical School Center for Bioethics; Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School; Surgeon, Division of Minimally Invasive Surgery, Brigham and Women’s Hospital A Novel Toolkit for Allocating Intravenous Immunoglobulin at a Pediatric Hospital Drug shortages have occurred frequently in the past decade, costing hundreds of millions of dollars annually and causing significant harm to patients and barriers to patient care. Intravenous immunoglobulin (IVIG) is a blood plasma-derived product used by many specialties for treatment of a wide variety of pediatric and adult clinical indications. Many of these indications are off-label and are not evidencebased. Due to multiple factors that have decreased supply and increased demand, IVIG has been in shortage nationwide since 2018, with no clear indication of when the shortage will end. As such, pediatric institutions that have been affected by the shortage need a plan for operationalizing IVIG allocation. The purpose of this capstone project was to assemble a text-based procedural toolkit for allocating IVIG at a large children’s hospital. The first stage was to identify the unique features of pediatric hospitals and of IVIG that pertain to allocation. Then, a literature review was conducted with the goal of identifying the most commonly referenced principles and strategies for allocation. Finally, the conclusions from the literature review were used to construct a 3-part strategy for IVIG allocation. Each stage of the project yielded relevant information for allocation, and the toolkit organized this information in a straightforward stepwise process. This toolkit provides a beginner’s guide for operationalizing IVIG allocation at pediatric hospitals that can be easily referenced by hospital administrators and customized to specific institutions.

Connie Y. Lu, MD, received her undergraduate degree in neuroscience from Brown University and her MD from Warren Alpert Medical School at Brown. In medical school, she was involved in multiple research projects centered around improving care and advocacy for breast cancer surgery patients. Her areas of interest in bioethics include resource allocation, neuroethics, medical ethics education, and health equity. Her work has been presented at the Society of Surgical Oncology International Conference. After completing the MBE program, Connie will begin residency at the Portsmouth Regional Hospital/Tufts University School of Medicine Internal Medicine Program.

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Joan Gakii Masunga Capstone Mentor and Faculty Advisor: Bizu Gelaye, PhD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Psychiatry, Massachusetts General Hospital and Harvard Medical School; Assistant Professor of Psychiatric Epidemiology, Harvard T. H. Chan School of Public Health

Challenges Experienced When Prioritizing the Elimination of Neglected Tropical Diseases.

The World Health Organization classifies Neglected Tropical Diseases (NTDs) as a diverse group of 20 communicable diseases that disproportionately affect one billion of the world’s poorest inhabitants. Most people affected by NTDs reside in 149 low-and middle-income countries. These diseases are caused by a variety of pathogens, including viruses, protozoa, and helminths carried via various vectors.

NTDs occur because of the dire environmental and socioeconomic living conditions of those who are affected by them. They cause immense suffering and contribute to global health inequities and cost developing economies billions of dollars annually.

Because those affected by these diseases are some of the world’s poorest, they wield the least power to advocate for the issues that affect them. This capstone project aimed to understand the ethical issues present in the efforts to eliminate NTDs by administering a questionnaire in the form of an interview with key stakeholders working on NTDs. The project investigated the ethics of the prioritization of global health issues and the way global health policies are implemented in relation to the socio-economic status of the affected populations. Through an ethics lens, it also sought to understand the challenges faced by scientists while conducting research and the factors that influenced the availability of vaccines and drugs to treat NTDs. By uncovering these challenges that hamper the NTD community’s efforts to achieve elimination, the study now provides valuable information to further inform the elimination efforts.

Joan Gakii Masunga, MS, received her BS in Biology from Capital University, Ohio and her MS in Global Health and Development from Northeastern University. At Northeastern, she studied models employed by Kenya and Bangladesh to eliminate Leishmaniasis, to understand what drives disparate outcomes, and to generate innovative solutions. At HMS, she is investigating the ethics around the prioritization of Neglected Tropical Diseases on global health agendas and policy implementation. Prior to graduate school, she worked with research groups studying chronic disease epidemiology, cardiovascular disease, and cancer. After graduation, she plans to continue her research while working in the biotechnology industry to learn more about innovation.

She plans to pursue a doctorate in public health.

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Mary McCarthy-Tiella Capstone Mentors: Tamryn Gray, PhD, RN, MPH Instructor in Medicine, Harvard Medical School; Clinical Nurse Specialist, Division on Stem Cell Transplantation and Cellular Therapies, Department of Medical Oncology, Dana Farber Cancer Institute, and Brigham and Women’s Hospital Michelle C. Jacobo, PhD Assistant Professor, Harvard Medical School; Director, Psychology Services, Dana Farber Cancer Institute Faculty Advisor: Christine Mitchell, RN, MS, MTS Executive Director, Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, Harvard Medical School Mindfulness Practices for Mitigating Unconscious Bias with a Focus on Palliative Care Understanding and addressing unconscious bias is important in medicine because of its relationship to unjust healthcare disparities. For example, unequal treatment of traditionally marginalized and stigmatized persons by clinicians is a healthcare disparity that can result from unconscious, or implicit, bias. Identifying ways to mitigate unconscious bias on the individual and systems levels is necessary to facilitate more equitable healthcare. This project studied the application of mindfulness practices to mitigate unconscious bias in medicine with a focus on unconscious bias in palliative care, a field where health disparities have been described. A review of the literature identified multiple studies linking mindfulness practices to decreases in implicit race and age bias as measured by the Implicit Association Test (IAT). Evidence suggests that mindfulness and meditation can reduce the effects of unconscious bias by decreasing reliance on automatic thoughts, allowing for a more deliberate consideration of choices. For example, with the S.T.O.P. method a clinician stops, takes a deep breath, observes their feelings and assumptions, then proceeds with patient care. Mindfulness techniques provide a potential pathway for palliative care clinicians to engage in patientcentered communication that is bias aware, thereby breaking down barriers and contributing to the delivery of more equitable approaches. Additional research is warranted on how mindfulness practices could augment facilitators of palliative care, such as cultural humility training with language-appropriate messaging, open communication, and shared decision making.

Mary McCarthy-Tiella, BSN is a nurse with a diverse career of clinical experience including frontline work in Boston communities during the HIV epidemic and, most recently, 9 years in hospice and palliative care in both rural and urban New Hampshire. She received her Bachelor of Science in Nursing from St. Anselm College. After graduation from the MBE program, her goal is to continue working in the field of bioethics with focus on: decision making during the dying process, the application of mindfulness-based practices to mitigate unconscious (implicit) bias in healthcare, and the ethics of compensation for long-term care healthcare workers.

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Meera Midha Capstone Mentor: Rebecca H. Li, PhD Course Instructor, Harvard Medical School Center for Bioethics; Executive Director, Vivli Center for Global Clinical Research Data Faculty Advisor: Aaron S. Kesselheim, MD, JD, MPH Director of Health Policy and Bioethics, Harvard Medical School Center for Bioethics; Professor of Medicine, Harvard Medical School; Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

Sharing Raw Clinical Trial Data: A Case for Moving from Data Ownership to Data Access In the current data-driven age, data is the key to unlocking value and creating actionable insights. Raw data collected in clinical trials, also known as individual participant data (IPD), is no exception. This capstone project aimed to evaluate the ethics, law, and policy behind the IPD-sharing landscape and to compare data ownership with data access in this setting through a literature review. Literature review showed that IPD sharing leads to medical advances, scientific cooperation, and public health improvements. Although ethics may require that IPD be shared, various influences have dictated if, when, and how it is shared. Despite the contributions of many stakeholders with differing priorities, at present only one entity claims absolute ownership and control over a trial’s IPD. In this manner, the current framework for IPD ownership does not acknowledge the clinical trial landscape’s complex nature or contributing parties. A shift away from the concept of data ownership towards a framework for data access would better acknowledge the contributions that make the clinical trial environment possible. With data access, information would be held for productive research purposes, in accordance with why it was originally collected. Replacing the idea of ownership with access would further IPD sharing, as well as encourage collaboration, treat all stakeholders and contributors more equitably, produce better health outcomes, and better support the fundamental goals of biomedical research.

Meera Midha, BS, received her BS in Bioengineering summa cum laude from the University of California, Los Angeles (UCLA) with a certificate in computational genomics. She is also a JD student at Harvard Law School.

At UCLA, Meera worked in multiple biomedical research laboratories and was a Dean’s Scholar, Regents Scholar, and Alumni Scholar. Meera was a Consultant at Deloitte, specializing in strategy and analytics in the healthcare industry. Her bioethical interests lie along the intersection of health policy, technology, and law. After completing her MBE, Meera will return to Harvard Law School to complete her final year, and after graduation plans to join an international law firm focusing on business, innovation, and technology.

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Walker Morrell Capstone Mentors: Anthony Weiss, MD, MSc, MBA Faculty Member of the Harvard Medical School Center for Bioethics; Associate Professor of Psychiatry, Harvard Medical School; Chief Medical Officer, Beth Israel Deaconess Medical Center Carmel Shachar, JD, MPH Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School Faculty Advisor: Rebecca Weintraub Brendel, MD, JD Director, Master of Bioethics Degree Program, and Assistant Professor of Psychiatry, Harvard Medical School; Director of Law and Ethics, Center for Law, Brain, and Behavior, and Psychiatrist, Massachusetts General Hospital Independent, Collaborative, or Supervised? The Relevance of Nurse Practitioner Regulations to the Oversight of Artificial Intelligence Technologies in Healthcare Current medical device regulations are likely inadequate for the oversight of artificial intelligence technologies that autonomously diagnose and/or treat disease (AI-ADs) after these technologies are approved for use in the clinical setting.

Medical device regulations aim to ensure that devices produce safe, effective, and reliable outcomes. The abundance of uncontrolled and unknown variables in the clinical setting makes it difficult, if not impossible, to ensure the quality of clinical decision makers via outcomes, regardless of whether the decision maker is software-based or human. This capstone project proposed a process-based approach to the regulation of AI-ADs that builds upon the process-based approaches to nurse practitioner (NP) regulations in Massachusetts, Arkansas, and Florida.

This project reviewed and summarized the NP regulations in these states, distilling key features that may inform AI-AD regulations. The resulting framework for the regulation of AI-ADs is based upon the risk posed by an AI-AD’s failure to correctly diagnose or treat a patient. AI-ADs that make low-risk decisions may be allowed to operate independently, AI-ADs that make medium-risk decisions must operate in collaboration with a physician, and AI-ADs that make high-risk decisions must operate under the supervision of a physician. This regulatory framework increases the potential that AI-ADs will expand patient access to routine care without sacrificing appropriate oversight. Future work may further develop the criteria that determine whether diagnosis and treatment decisions by an AI-AD are categorized as low-risk, medium-risk, or high-risk.

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Walker Morrell, BS, is a project manager at the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard. He received his BS in chemistry from Centre College in Kentucky. At the MRCT Center, Walker organizes discussions on emerging bioethical issues in clinical research and develops academic manuscripts, decision trees, points-to-consider documents, and other deliverables related to these discussions. Recent project topics include decentralized clinical trials, master protocols, and mobile health technologies in clinical research. Through these projects and others, Walker has been able to explore his interest in the ethics of emerging technologies in health care and clinical research. Upon graduation, Walker intends to continue working at the MRCT Center before entering law school in the fall of 2022.

Phoebe Ozuah Capstone Mentors: Leonor Fernández, MD Assistant Professor, Harvard Medical School; Director, Patient Engagement, Healthcare Associates; Member, Beth Israel Lahey Health Vaccine Command and Beth Israel Lahey Health Diversity Equity and Inclusion Council Daniele Ölveczky, MD, MS Assistant Professor of Medicine, Harvard Medical School; Interim Physician Director of the Center for Diversity Equity and Inclusion; Inclusion Officer, Department of Medicine, Harvard Medical Faculty Physicians, Beth Israel Deaconess Medical Center Faculty Advisor: Charlene Galarneau, PhD, MAR Faculty Member of the Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, Harvard Medical School; Associate Professor Emerita, Women’s and Gender Studies Department, Wellesley College Filling the Gap: Mitigating Patient Dehumanization through Understandings of How Patients Feel Heard and Understood Many patients feel dehumanized in healthcare settings, negatively affecting the patient-provider relationship and patients’ well-being and capacity to follow medical recommendations. In addition, patients with some demographics experience dehumanization in their healthcare more than others. To address this dehumanization, this capstone project used a mixed inductive/deductive qualitative analysis to explore what factors help patients feel heard and understood as important dimensions of reducing dehumanization. Two semi-structured group interviews were held with 8 patients and 3 physicians from the same hospital to identify gaps and overlaps between patient and physician perspectives. Thematic analysis demonstrated overlapping barriers and facilitators of patients feeling heard and understood. Both patients and physicians emphasized the importance of physician preparation, attention, and emotional availability or presence. Patient themes included physician appearance and clinic environment to help “set the tone,” and evidence of physician attention in the interview and office notes. Physician themes assigned importance to attending to non-verbal cues and naming emotions for patients to feel heard and understood. Two additional overlapping facilitators were patient preparation and the use and interpretation of non-verbal communication such as physical touch. A nonoverlapping facilitator for physicians was gratitude from patients and, for patients, the decor of the waiting room. Further research with larger focus groups and a larger, more diverse sample size could provide greater insight into this topic. The information gathered from this study has implications for facilitating patient humanization through both patient and physician actions.

Phoebe Ozuah, AB, received her AB in sociology from Princeton University. As an undergraduate, she served as president of Pi Beta Phi sorority, sustainability chair for Cannon Dial Elm, and a clinical research intern at Montefiore Medical Center. She wrote her senior thesis on conspicuous consumption, social stratification, and their impact on quality of life. In the field of bioethics, Phoebe is interested in the intersection of the social determinants of health and social justice, as well as patient-clinician communication. After completing her MBE, she will attend medical school.

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Phani Paladugu Capstone Mentors: Robert D. Truog, MD Director, Harvard Medical School Center for Bioethics, Frances Glessner Lee Professor of Medical Ethics, Professor of Anaesthesia and Pediatrics, Harvard Medical School; Senior Associate in Critical Care Medicine, Boston Children’s Hospital Roger Daglius Dias, MD, MBA, PhD Instructor in Emergency Medicine, Harvard Medical School; Director of Research & Innovation and Director of the Medical Simulation Fellowship, STRATUS Center for Medical Simulation, Department of Emergency Medicine, Brigham and Women’s Hospital Faculty Advisor: Anthony Breu, MD Co-Director, Essentials of the Professions, Harvard Medical School Center for Bioethics; Assistant Professor of Medicine, Harvard Medical School; Director of Resident Education and Hospitalist, VA Boston Healthcare System Considerations for a Next Generation Ethical Framework for Human Space Exploration In November 2020, NASA released an updated Human Research Program Integrated Research Plan (HRPIRP), which acknowledged a greater likelihood for medical challenges and increased risk to astronauts in future human missions to the Moon and Mars. As a result of the updated HRPIRP, NASA expressed an immediate need for a new ethical framework. This study aimed to analyze and compare several existing ethical frameworks regarding occupational and human research perspectives on the protection of persons and risk mitigation to NASA’s Bioastronautics Roadmap and HRPIRP in an integrative literature review. The study highlighted key shortcomings in NASA’s current policies and concluded that the risk and research nature of long-duration space missions are incomparable to other high-risk terrestrial jobs and research programs. As a result, NASA should formulate a novel ethical framework that addresses astronaut risk with both research and occupational perspectives by reframing astronauts as healthy human research participants and their occupation of conducting long-duration space missions as a form of high-risk human research. In developing its recommendations to NASA’s new ethical framework for future long-duration space missions, this study used considerations including: whether some types or degrees of risk to which astronauts are exposed should be considered impermissible, whether the consent of astronauts is enough to justify all kinds or just some degrees of risk, and whether it could be beneficial to apply the multiphase approach of terrestrial clinical trials to longduration space missions.

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Phani Srivatsav Paladugu, MS is a Biomedical Engineering Researcher at Brigham and Women’s Hospital and Massachusetts General Hospital Departments of Orthopedic Surgery as well as a Human Factors Researcher at Brigham’s STRATUS Center. Phani received his BS Magna Cum Laude in Biomedical Engineering and his MS in Biomedical Science from Rutgers University. Phani’s primary areas of research are in orthopedic medical device engineering and human factors engineering in the context of orthopedic robotic surgery. From these experiences, Phani aims to apply bioethics principles in the context of high-risk clinical research. Phani plans to attend medical school next year and has a dream of applying his research to medicine and NASA in the future.

Soojin Park Capstone Mentors: Al Ozonoff, PhD, CPPS Associate Professor of Pediatrics, Harvard Medical School; Associate Director, Precision Vaccines Program, Division of Infectious Diseases, Boston Children’s Hospital Bizu Gelaye, PhD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Psychiatry, Massachusetts General Hospital and Harvard Medical School; Assistant Professor of Psychiatric Epidemiology, Harvard T. H. Chan School of Public Health Faculty Advisor: Anthony Breu, MD Co-Director, Essentials of the Professions, Harvard Medical School Center for Bioethics; Assistant Professor of Medicine, Harvard Medical School; Director of Resident Education and Hospitalist, VA Boston Healthcare System Ethical Considerations Regarding the Overlap between Surveillance and Research Activities amid Unprecedented Times During the COVID-19 pandemic, one issue that has become increasingly relevant to public health activities has been the Common Rule exclusion for surveillance activities from research oversight. The exception allows for a gray space in which various activities of scientific investigation are difficult to define clearly. This capstone work addressed how, in the context of bioethics, research activities and surveillance activities differ in the ethical standards and oversight that they require, as surveillance activities are not subjected to the same strict standards that research activities must meet to uphold ideals of informed consent, privacy, and confidentiality. In particular, there is reduced Institutional Review Board oversight. Researchers and IRB committee members therefore should be thoughtful in applying this exception to the Common Rule in deeming certain activities as surveillance rather than research, as inappropriate determinations may leave these activities open to criticism and undermine public trust. There are specific ethical considerations that ought to be examined when determining whether an activity should be defined as surveillance or research. This ethical framework aims to organize the key questions that should be explored when deciphering the distinction between surveillance and research. Other features of this work include exploring the roles of the Office of Human Research Protections and the IRB in these determinations, various ethical tensions observed in public health activities that may become heightened in surveillance, and the contextual and circumstantial factors that may require attention, especially in unprecedented times.

Soojin Park, BA, received her BA in biology and sociology from Boston College. As an undergraduate, she worked as a health policy intern at the AdMeTech Foundation, a nonprofit organization focused on closing the racial gap in prostate cancer mortality rates. Last year, she worked as a researcher in South Korea through the Fulbright Program, where she examined the influence of social structures and health policies on the country’s ultra-low fertility rate. She is particularly interested in bioethical considerations in constructing effective laws and policies. After completing her MBE, Soojin plans to attend law school.

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Fiona Pat Capstone Mentors: Anna Gosline, MS Executive Director, Massachusetts Coalition for Serious Illness Care David Sontag, JD, MBE Co-Director of Capstone Program, Harvard Medical School Center for Bioethics; Lecturer on Medicine, Harvard Medical School; Managing General Counsel, Beth Israel Lahey Health; Co-Chair, Ethics Advisory Committee, Beth Israel Deaconess Medical Center Faculty Advisor: Insoo Hyun, PhD Director of Research Ethics, Harvard Medical School Center for Bioethics; Senior Lecturer, Harvard Medical School; Professor, Department of Bioethics and Director of the Undergraduate Bioethics Program, Case Western Reserve University School of Medicine Medical Decision Making for the Unrepresented: Recommendations for a Healthcare Proxy Volunteer Program A significant number of people do not have someone to name as a decision maker in their healthcare proxy (HCP) during incapacitating illnesses. Unfortunately, the lack of representation can lead to medical decision making that does not honor the goals, values, and preferences of the incapacitated patient, which fails to meet the ethical ideal of respecting patient autonomy. With the Massachusetts Coalition for Serious Illness Care, this project examined potential frameworks for a HCP program that would match volunteers with people at risk of unrepresentation, such as solo agers and adult orphans. First, a review of existing literature elucidated the current state of advance care planning in Massachusetts, characteristics of high-risk individuals, and comparable volunteer guardianship and decision making programs in other states. Second, interviews with these program directors showed that the Coalition’s proposed volunteer program could be implemented through hospital systems, local community organizations, and human services agencies that work with members of vulnerable communities. Identified implementation challenges included recruiting suitable volunteers, matching them with at-risk individuals, identifying the scope of volunteers’ responsibilities, and addressing potential conflicts of interest. Based on these findings, this capstone project made the following recommendations for the Coalition: 1) attach the volunteer HCP program to organizations that are already well-connected with people at risk of unrepresentation; 2) establish a role dedicated to managing the program, especially its legal and financial aspects; and 3) provide robust, ongoing training and support for volunteer decision-makers pursuant to HCPs. Fiona Pat, BS, is an aspiring physician-scientist with an interest in medicine and law. She received her BS with honors in neuroscience and medicine, science, and the humanities from Johns Hopkins. There, she served as head volunteer of the Johns Hopkins Hospital’s adult emergency department, wrote for the Hippocrates Med Review, conducted research on the neural basis of reward seeking, and chaired the Counseling Center’s student advisory board. Her interest in bioethics stems from her passion for patient advocacy and the improvement of care through a humanistic approach. After she graduates from the MBE program, Fiona plans to attend medical school.

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Samara Peters Capstone Mentor: John Wesley Boyd, MD, PhD Faculty Member of the Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, part-time, Harvard Medical School; Professor of Medical Ethics and Psychiatry, Baylor College of Medicine Faculty Advisor: Robert D. Truog, MD Director, Harvard Medical School Center for Bioethics, Frances Glessner Lee Professor of Medical Ethics, Professor of Anaesthesia and Pediatrics, Harvard Medical School; Senior Associate in Critical Care Medicine, Boston Children’s Hospital State Medical Boards as a Barrier to Solving the Physician Mental Health Crisis Physicians experience alarming levels of mental health concerns, burnout, and suicidality, but exact data are elusive. Longitudinal studies are non-existent, at least in part due to physicians’ fear of repercussions if diagnoses or concerns of mental health problems are linked to them. Some suggest that state medical boards (SMBs) might inadvertently exacerbate the fears of physicians who need mental health services because many SMB licensing processes aggressively seek to identify physicians with these conditions. The purpose of this Capstone project was to characterize the current state of SMBs initial applications by qualitatively analyzing the content of questions relating to mental health status. We accomplished this aim by accessing the application questionnaires of 17 Allopathic SMBs, 17 Osteopathic SMBs, and 36 combined SMB’s from all states, the District of Columbia, Guam, and Puerto Rico. Independent assessment of the quality of the questions was determined and correlated between reviewers. The results showed that many SMB application questions reach beyond concerns of current impairment, reflecting a pervasive culture of punitive treatment of individuals who are or were suffering from a mental health disorder, rather than focusing on safety to practice. Physicians opted to reject mental health care rather than to answer questions mining their mental health histories or question their competency to practice medicine. It is unjust to implicitly deny healthcare to physicians or presume incompetence due to current or historical illness without supporting evidence of inability to practice safely. Ethical treatment of physicians should encourage treatment, work to reduce stigma against mental health diagnoses, and support physicians to continue practicing, rather than punish physicians who dare to seek mental health care.

Samara Peters, DO, is a pediatrician with Children’s Hospital of Philadelphia at Virtua. She received her DO from the Arizona College of Osteopathic Medicine at Midwestern University. She completed her internship and residency in general pediatrics at the Oklahoma State University Medical Center. Her career includes time spent in active duty with the U.S. Army, and in pediatric hospital-based care as a civilian. Her interests in bioethics focus on clinical ethics for pediatric patients and ethical policies about physician mental healthcare. She has published in the Hastings Center Blog about pandemic medical care access. After graduation, she plans to continue her advocacy work for physician mental health and clinical bedside ethics.

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Khoa Pham Capstone Mentors: David Duong, MD, MPH Director of the Program in Global Primary Care and Social Change and Instructor in Global Health and Social Medicine, Harvard Medical School; Instructor in Medicine, Brigham and Women’s Hospital Nhi-Ha Trinh, MD, MPH Associate Director, Harvard Medical School Holmes Society and Assistant Professor of Psychiatry, Harvard Medical School; Director of Department of Psychiatry Center for Diversity, Director of Multicultural Studies, Director of Clinical Services in the Depression Clinical and Research Program, Massachusetts General Hospital Faculty Advisor: Bizu Gelaye, PhD, MPH Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Psychiatry, Massachusetts General Hospital and Harvard Medical School; Assistant Professor of Psychiatric Epidemiology, Harvard T. H. Chan School of Public Health A Review of the Vietnamese Bioethics Curriculum in Medical Education Bioethical debates in East Asian countries have largely been influenced by Confucian perspectives. The English language literature on Confucianism as it relates to bioethics contains limited publications regarding the field of bioethics in Viet Nam. This study elucidated knowledge gaps in Vietnamese bioethics, as well as provided information about Vietnamese education system approaches to include and teach bioethics in the medical curriculum. The researcher did a literature review in both English and Vietnamese, conducted key informant interviews (n=5), and then applied thematic analysis. Qualitative data were derived from conducting structured interviews with senior faculty at five medical schools in Viet Nam. The participants were selected based on the expertise of their bioethics teaching experience. Four key findings emerged: 1) there was a difference in teaching bioethics since medical education reform in 2016, 2) there was a general awareness of the educational gaps in preparing faculty to teach bioethics, 3) there was a willingness to incorporate Western bioethics principles, adapting them for the cultural and legal context in Viet Nam, and 4) assessment of bioethics skills remained an issue with students due to a lack of methodology. Given these findings, there may be benefits to integrating and adapting a bioethics curriculum, like the one offered by The United Nations Educational, Scientific and Cultural Organization (UNESCO), into the Vietnamese medical education system.

There is ample opportunity for continued research in this area.

Khoa Pham, MBA is an American Society for Clinical Pathology board-certified histotechnologist. He earned a BS from University of Texas MD Anderson Cancer Center School of Health Professions and an MBA from the University of Texas, Tyler Soules College of Business.

Through his research in bioethics, he seeks to understand how ethical principles prevalent in Western societies apply to East Asian cultures. Through his capstone project on cross-cultural ethical analysis, he hopes to contribute to medical education reform in Vietnam. He will begin podiatry medical school in the fall of 2021, and it is his goal throughout his career to be a caring physician who consistently practices bioethics.

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Paul Pouzet Capstone Mentor: Ameet Sarpatwari, PhD, JD Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Medicine, Harvard Medical School; Associate Epidemiologist and Assistant Director of the Program on Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.

Faculty Advisor: David Sontag, JD, MBE Co-Director of Capstone Program, Harvard Medical School Center for Bioethics; Lecturer on Medicine, Harvard Medical School; Managing General Counsel, Beth Israel Lahey Health; Co-Chair, Ethics Advisory Committee, Beth Israel Deaconess Medical Center Bioethical Considerations in the Sharing of “Deidentified” Genetic Data – Is Broad Consent Sufficient?

Current United States legal guidelines do not require consent from patients when their secondary biospecimens are collected for unrelated research provided that the specimens are “deidentified.” However, organizations such as the National Institutes of Health recognize the importance of obtaining consent to show respect for donors’ autonomy and their contributions to science. The current standard, “broad consent,” applies to an unspecified range of future research with few restrictions. However, broad consent is generally obtained only at the time of sample collection, does not provide project specifics, and does not sufficiently define the risks of reidentification of genetic data. This project aimed to analyze the legal and ethical frameworks employed in the US and Europe to propose policy reforms to the consent process that would show greater respect for donors’ autonomy. This project arrived at 4 policy proposals, recognizing that a compromise is necessary between idealism and pragmatism in scientific research: (1) broad consent with a notification system that would let donors know when their data is going to be used for research; (2) tiered consent, which would allow for opting into specific categories of research rather than employing broad consent; (3) dynamic consent, which is an online platform that enables study-specific consent; and (4) a shared governance model that would emphasize community engagement and representation to protect and benefit members of marginalized groups in society. Each of these proposals would be an improvement over the status quo of broad consent.

Paul Pouzet, BA, BSc, is a case assistant at the law firm of Quinn Emanuel Urquhart & Sullivan, LLP, in London, England. He received his double major in cellular/molecular biology and political science from McGill University, Canada. He has worked on cases in the DNA synthesis, sequencing, and genomics industries and is particularly interested in the legal issues that surround genomic data privacy and access to this data for research purposes. Paul is also interested in intellectual property and trade secret law and plans to attend law school after completing the MBE degree to focus on these areas.

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Eva Regel Capstone Mentors: Ellen Robinson RN, PhD, HEC-C, FAAN Nurse Ethicist, Office of Quality, Safety, and Practice; Co-chair, Optimum Care (Ethics) Committee, Massachusetts General Hospital Andrew Courtwright MD, PhD, HEC-C Research Program Consultant, Optimum Care Committee, Massachusetts General Hospital Faculty Advisor: Steve O’Neill, LICSW, BCD, JD Course Instructor, Harvard Medical School Center for Bioethics; Social Work Manager and Behavioral Health Specialist, Beth Israel Deaconess Medical Center Evaluation of Ethics Consultation Process: Assessment of Consultee Satisfaction and Perceived Effectiveness of Ethics Consultations The Massachusetts General Hospital (MGH) Optimum Care (Ethics) Committee (OCC) was established in 1973 by Dr. Ned Cassem as one of the first ethics consultation committees in North America. This capstone project aimed to develop and implement an institutional survey tool to evaluate OCC consultees’ experiences with and perceptions of the effectiveness of its ethics consultation process. The American Society for Bioethics and Humanities Core Competencies for Health Care Ethics Consultations identifies this type of outcomes evaluation as a key metric for a successful ethics consultation service. A survey tool containing Likert scale-based, dichotomous, and free text questions was developed in collaboration with the OCC team and outside experts. Survey questions were developed after a systematic review of the literature on ethics consultations surveys. Some questions were adapted directly from previously published or existing surveys, while others were formulated to assess specific objectives of this study directly. The survey is organized along 3 conceptual domains: (i) consultees’ discipline (training) and experience with ethics consultations, (ii) consultees’ perception of consultants’ professional proficiencies and knowledge, (iii) effectiveness of consultants’ recommendations and overall consultees’ experiences with ethics consultations. The REDCap platform was used for anonymity, distribution, and data collection purposes.

At present, surveys continue to be distributed and are undergoing analysis. Future work includes ongoing data collection, validation of the survey tool, and analyses of emerging themes. This quality improvement project offers great potential to enhance the OCC’s ethics consultations.

Eva Regel, LICSW, MSW, MS, is a clinical social worker at Massachusetts General Hospital. Eva received her BS in science with a concentration in biophysics from Moscow State University, Russia. She received her MS in economics from the University of Houston, and her MSW in clinical social work from Boston College. Eva works on the guardianship team and the Optimum Care (Ethics) Committee and its consultation services. Eva’s clinical interests in bioethics focus on the intersection of clinical, legal, and ethical issues. After graduation, Eva plans to extend her education in bioethics through the pursuit of a doctoral degree.

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Emily Schumacher Capstone Mentor: William Shaw, JD Senior Director, Office for Technology Transfer and Industry Collaboration at Tufts University; former Executive Director, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital Faculty Advisor: Insoo Hyun, PhD Director of Research Ethics, Harvard Medical School Center for Bioethics, Senior Lecturer, Harvard Medical School; Professor, Department of Bioethics and Director of the Undergraduate Bioethics Program, Case Western Reserve University School of Medicine

Bioethics Educational Toolkit: Highlighting Instances of Racial Bias As It Arises in Healthcare Applications of Artificial Intelligence Undergraduate computer and data science curricula commonly lack ethics and bioethics training and course requirements. Although not unreasonable for this line of study, healthcare applications currently being developed by biotechnology companies often yield ethical dilemmas that would benefit from formal ethics attention. Particularly in the development of artificial intelligence (AI) platforms, issues of bias arise frequently. Application and software developers are ill-equipped to recognize and address these bioethical issues. To encourage proactive rather than reactive solutions to these issues, educational materials are needed to equip healthcare-focused computer and data scientists with the tools needed to mitigate racial bias in healthcare applications of AI. This project aimed to understand the gaps in bioethical education for undergraduate computer and data science students and to develop a bioethics educational toolkit for these students. Students from Harvard University, the Massachusetts Institute of Technology, and Tufts University were surveyed to establish a baseline knowledge of bioethics. A literature review identified the most pressing and compelling issues of racial bias in AI. After this research was completed, a set of multimedia educational tools were constructed based on the aggregated research. Three lecture-style videos were made for students to review. The videos define bioethics and its importance in developing AI, review the issues of racial bias, and dive deeper into the technicalities of developing ethical AI in healthcare. Finally, a simulation exercise was developed wherein students can personally adjust data labels and skew data sets to see how racial bias can arise in a simple machine learning algorithm.

Emily Schumacher, BS, is a health and life sciences account executive at Intel Corporation. She received her BS in both chemical and biological engineering from Oregon State University. Emily works alongside the Information Technology (IT) communities at Mass General Brigham Health and Beth Israel Deaconess Medical Center to design their IT infrastructure and implement innovative Artificial Intelligence (AI) solutions. Her primary bioethical interest is in the protecting patient data and ensuring use of ethical, unbiased algorithms for assisted decision making in the clinical setting. After graduation, Emily is moving to Washington D.C., where she will continue her role at Intel and join their Ethics in AI policy working group.

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Ally Sterling Capstone Mentor: Joseph T. Giacino, PhD Course Instructor, Harvard Medical School Center for Bioethics; Professor of Physical Medicine and Rehabilitation, Harvard Medical School; Director of Rehabilitation Neuropsychology, Spaulding Rehabilitation Hospital; Consulting Neuropsychologist, Department of Psychology, Massachusetts General Hospital Faculty Advisor: Rebecca Weintraub Brendel, MD, JD Director, Master of Bioethics Degree Program, and Assistant Professor of Psychiatry, Harvard Medical School; Director of Law and Ethics, Center for Law, Brain, and Behavior, and Associate Psychiatrist, Massachusetts General Hospital Assessing Decision Making Capacity in Patients with Acquired Brain Injury: A Toolkit of Ethical Guidelines Decision making capacity is a threshold determination for the ability to consent to medical treatment or research participation. Lack of decision making capacity in health care settings in Massachusetts requires appointment of a guardian or health care proxy for surrogate decision making. Consistently assessing and monitoring capacity in patients with acquired brain injury can be challenging and cumbersome because brain function often evolves over the recovery course. Currently, little guidance is available as to how, when, and under what circumstances decision making capacity should be assessed and monitored after acquired brain injury.

Motivated by a desire to improve provider knowledge of the construct of capacity and ensure a more consistent approach to assessment, this capstone project aimed to clarify and refine existing institutional policies in the service of supporting patients’ rights to self-determination (including participation in research) after acquired brain injury. A semi-structured interview script and Likert scale survey were developed to investigate stakeholder knowledge and perspectives on decision making capacity among physicians, investigators, hospital administrators, legal counsel, psychologists, case managers, nurses, social workers, caregivers, and patients.

Constant comparative method analysis was conducted to identify themes across and within stakeholder groups. Findings were compiled and recommendations were made to refine existing hospital policies concerning decision making capacity and to develop an educational toolkit for use by providers responsible for implementing these procedures.

Ally Sterling, ScM, received a dual BA in neuroscience from Columbia University and Talmud from The Jewish Theological Seminary of America, followed by an ScM in medical sciences from Brown University. As an undergraduate, she completed the Sherwin B. Nuland Summer Institute in Bioethics at Yale University and received honors for her senior thesis on the Talmudic ethics of using neurotechnologies in courtrooms. Ally is particularly interested in neuroethics, clinical ethics, and medical decision making. In the upcoming year, Ally plans to apply to medical school while continuing research with patients who have been hospitalized due to acquired brain injuries.

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Sarah Sullivan Capstone Mentor: Vardit Ravitsky, PhD, FCAHS Course Instructor, Harvard Medical School Center for Bioethics; Senior Lecturer on Global Health and Social Medicine, Harvard Medical School (part-time); Professor, Bioethics Program, Department of Social and Preventive Medicine, School of Public Health, University of Montreal Faculty Advisor: Melissa Abraham, PhD, MSc Co-Director of the Capstone Program, Harvard Medical School Center for Bioethics; Assistant Professor of Psychology, Harvard Medical School; Psychologist, Massachusetts General Hospital Department of Psychiatry and Division of Clinical Research Hotel Germline Editing: Participants Can Check Out, But Generations Can Never Truly Leave If the world decides to move forward with human germline editing (HGE), first-in-human editing will occur in the context of research, making subsequent descendants part of an extraordinary experiment. The international consensus is that intergenerational monitoring (IGM) will be necessary to determine the safety and efficacy of the experimental edit. The first participant, their offspring, and their offspring’s offspring, etc. will need to be monitored throughout their lifetimes.

But what does this mean for a child who will be born a research participant?

This capstone sought to explore the ethical justifiability and practicality of IGM, as it relates to research ethics (e.g., parental permission, assent, and the right to withdraw). A conceptual analysis revealed a unique ethical tension between a participant’s right to withdraw from IGM and inability to withdraw from the inherited experimental edit. Due to potential heritable harms, the time has come to identify what HGE participants (the first generation and their descendants) will be owed. This capstone puts forth the normative argument that IGM will become an intergenerational ethical commitment beginning the moment a germline edited baby is born. Researchers will have obligations to the health and well-being of generations, regardless of withdrawal. If such obligations cannot be met, HGE may be impermissible. Implicit in these obligations is the reality that children will be born research participants who have checked into Hotel Germline Editing but can never check out.

Sarah Sullivan, BA, is a clinical research manager at the Wyss Institute for Biologically Inspired Engineering.

She received her BA in psychology and anthropology/ sociology from Kalamazoo College, Michigan, and is a certified clinical research professional through the Society of Clinical Research Associates. Sarah has extensive experience in human subjects research, from biobanks and pharmacogenomics to robotic engineering. Working at the forefront of innovative technologies, Sarah now manages clinical research at the Wyss and is interested in the ethics of translational research. After graduation, Sarah plans to continue her work at the Wyss Institute.

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Giselle Vitcov Capstone Mentor: Christy Cummings, MD Faculty Member of the Harvard Medical School Center for Bioethics; Assistant Professor of Pediatrics, Harvard Medical School; Physician in Medicine, Division of Newborn Medicine, Boston Children’s Hospital Faculty Advisor: Robert D. Truog, MD Director, Harvard Medical School Center for Bioethics, Frances Glessner Lee Professor of Medical Ethics, Professor of Anaesthesia and Pediatrics, Harvard Medical School; Senior Associate in Critical Care Medicine, Boston Children’s Hospital

Parental Perspectives on the Moral Equivalence Thesis in the Neonatal Intensive Care Unit Withholding or withdrawing life sustaining treatment (LST) in the neonatal intensive care unit (NICU) may be permissible for neonates with a life-limiting diagnosis or extremely poor prognosis affecting perceived quality of life. The moral equivalence thesis (ET) posits that there is no moral difference between withholding and withdrawing LST. Studies have explored parental perspectives on withholding or withdrawing LST in the NICU more broadly, but have not addressed parental views specifically on the ET. Understanding parental perspectives on limiting LST in the NICU is essential to improve clinical care and ethical decision making at the end of life. Applying advance care planning to the NICU setting may help establish parental goals of care for their infant ahead of rapid deterioration or emergent situations. This capstone project, a sub-aim of this single center, mixed methods, cross-sectional study on advance care planning in the NICU, sought to describe parental perceptions of the ET via survey. A modified version of a questionnaire by DeCourcey et. al. was developed including de novo questions addressing parental views on the ET. After IRB approval, the survey underwent cognitive interview testing by parents and staff in the NICU to improve clarity and validity. The survey will be revised accordingly and then administered to bereaved parents at least 6 months after the loss of their newborn in the NICU. This study’s ultimate aim is to fill an important gap in the bioethics literature on parental perspectives on the ET in the NICU and to aid clinicians in shared decision making with families of critically ill neonates.

Giselle Vitcov, BA, received her BA in philosophy from Dartmouth College. As an undergraduate, she did research at the University of California, Berkeley on the ethics of using virtual reality and augmented reality to teach empathy across differences. She also completed a senior independent study on the ethics of abortion at Dartmouth.

She is particularly interested in ethical dilemmas that arise in neuroethics, reproductive ethics, and end-of-life decision making. She has previously published in the journal Stem Cells and in the Journal of Investigative Dermatology.

After completing her MBE, Giselle plans to attend medical school and law school.

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Katherine (Katie) Wang Capstone Mentor: Sarah M. Bannon, PhD Clinical Psychologist and Post-Doctoral Research Fellow, Massachusetts General Hospital Faculty Advisor: Insoo Hyun, PhD Director of Research Ethics, Harvard Medical School Center for Bioethics, Senior Lecturer, Harvard Medical School; Professor, Department of Bioethics and Director of the Undergraduate Bioethics Program, Case Western Reserve University School of Medicine

In It Together: Ethical Considerations Regarding Couples’ Treatment Preferences after a Diagnosis of Young-Onset Dementia Young-onset dementias (YODs) are defined by symptom onset prior to age 65.

Accordingly, YOD diagnosis is a life-altering event for persons with dementia (PWDs) and their spousal caregivers (CGs), who each experience high rates of emotional distress after diagnosis. Relative to later-onset dementias, symptom onset in YOD occurs during an active life stage, creating unique stressors. Despite this reality, a critical lack of YOD psychosocial interventions remains. To develop clinicallymeaningful interventions to address couples’ needs, a thorough understanding of their treatment preferences is warranted. This capstone therefore conducted a meta-synthesis of the qualitative literature exploring PWD and CG treatment preferences after diagnosis analyzed through a bioethical lens. Findings from this systematic review pertained to 3 domains determined a-priori: (1) characteristics of providers, (2) format and delivery modality, and (3) desired content. PWDs and CGs predominantly expressed common treatment preferences, with some unique to their care-partnership roles. Bioethical themes derived from these domains included respect for patient autonomy, and desires for meaning making and communication skills, thus indicating the importance of relational autonomy and narrative perspectives in YOD interventions. Finding meaning in the diagnosis and understanding its interpersonal impact aided in the integration of YOD into the coconstructed narratives of couples, thus moving PWDs and CGs towards acceptance and narrative consonance. Taken together, these findings suggest that psychosocial interventions involving couples’ simultaneous participation may help preserve PWD autonomy and optimize quality of life for both partners.

Katherine (Katie) Wang, BA, received her BA from Harvard College in integrative biology with a minor in psychology.

She has enjoyed exploring a diversity of topics during her time in the MBE program, as well as partnering with the Integrated Brain Health Clinical and Research Program at MGH for her capstone. Though her bioethical interests are broad, throughout the year she has become particularly interested in neuroethics and cognition, global health inequities, political determinants of health, environmental ethics, and clinical ethics practice. After graduating from the program, she plans to attend medical school and integrate her bioethical experiences into her future education and practice.

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Indigo Weller Capstone Mentor: David K. Urion, MD, Faculty Member of the Harvard Medical School Center for Bioethics; Associate Professor of Neurology, Harvard Medical School; Director of Ethics Support Service, Beth Israel Deaconess Medical Center; Director of Behavioral Neurology Clinics and Programs, Boston Children’s Hospital Faculty Advisor: Martha Montello, PhD Course Instructor, Harvard Medical School Center for Bioethics; Lecturer on Global Health and Social Medicine, Harvard Medical School

Tracing the Perils and Promises of the Healthcare-Hero during COVID-19 Throughout the pandemic, the media attempted to make sense of the scale and competing urgencies of COVID-19 as a narrative of war, with healthcare providers becoming heroes working “in the trenches.” While well-intentioned rituals like the daily clap emerged alongside banners that stated “Heroes Work Here” in cities like Boston and New York, providers soon disavowed their heroism to highlight the disconnect between their purported value and the absence of workplace safety measures. This Capstone project mapped the range of provider responses to their “heroism” during COVID-19 in 3 interrelated ways. First, it distinguished between the hero as a political attribution and physicians’ use of the hero’s journey, first coined by Joseph Campbell (1949), to describe their aspirations and moral development in medicine. Second, performing an extensive literature review, the project documented the reactions to the healthcare-hero and its broader effects on provider identity during the pandemic. Lastly, this Capstone explored how the healthcare-hero reconfigures bioethical conversations of burnout and moral injury in healthcare and medical education. These findings informed the preliminary design of a survey to ascertain the attitudes toward the hero across healthcare and wove these threads together to move the field forward by asking which interventions might be ethically justified to support providers, both systemically and within their immediate workplace, in the aftermath of COVID-19.

Indigo Weller, MS, MFA, is a qualitative researcher and writer currently working with the Child Study Center at Yale. He received his BA in psychology and literature from Naropa University, Colorado, his MFA in creative writing at California Institute of Arts, and his MS in narrative medicine at Columbia University. His research ranges from physician burnout and moral distress to patient simulation and mapping child psychiatrists’ adaptions during COVID-19. His interests in bioethics center on the challenges of medical decision making at the end of life.

Indigo plans to deepen his insights gathered from his year at Harvard within a doctoral program to design arts-based interventions for caregivers navigating progressive loss.

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Si Yeung (Samson) Yu Capstone Mentor: Lauren A. Taylor, PhD, MDiv Post-Doctoral Fellow, Department of Population Health, New York University Grossman School of Medicine Faculty Advisor: Robert D. Truog, MD Director, Harvard Medical School Center for Bioethics, Frances Glessner Lee Professor of Medical Ethics, Professor of Anaesthesia and Pediatrics, Harvard Medical School; Senior Associate in Critical Care Medicine, Boston Children’s Hospital

Virtue Ethics, Narratives, and Addictive Products: Beyond Control and Consent As an increasing number of commercial products are being perceived as addictive by the public, alongside movements for legalization of all addictive products, there is a need to rethink the obligations of distributors of these products. Existing literature focuses on the contentious debate between perceiving addictive product use as a disease where consumers use it uncontrollably and therefore that any sales are impermissible, or merely as a strong appetitive behavior in which case the desire for preference-satisfaction should be respected. The dichotomizing understanding of addiction as either disease or choice, however, fails to capture the range of moral attitudes surrounding these products. This Capstone presented an account for moral intuitions surrounding the use of addictive products through the lens of virtue ethics, and presented the view that consumption should be discouraged only when it constitutes a vice. It asked that use of addictive products be considered vicious when consumption is not tethered to standards of excellence, and when the pursuit of pleasure hinders the achievement of excellence in other projects the user prioritizes, given the user’s narrative unity of life. Far from lacking applicability, this framework presented an obligation for distributors to articulate how these products are intended to be consumed, an opportunity to identify correlates of vicious consumption, and could generate guidance for rectifying business practices to meet stated ends.

Practices surrounding distribution can no longer be defended merely on the basis of preference-satisfaction but must be evaluated by what good they do for consumers.

Si Yeung (Samson) Yu is a third-year medical student at the University of Hong Kong (HKU). As a medical student, he has worked on issues relating to health-seeking behavior of immigrant domestic workers and asylum seekers. He also served as the director of the academic department in the Hong Kong chapter of the Asian Medical Students Association. His interest in bioethics focuses on culturally informed discourses that shape medical decision making processes. Samson received the medical humanities prize at HKU for creating a tabletop game exploring health care accessibility. After completing his MBE, he wishes to create spaces in Hong Kong for discussions of values in healthcare, taking into account local socio-cultural contexts.

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Minghao (Oliver) Zhao Capstone Mentor: David A. Diamond, MD Faculty Member of the Harvard Medical School Center for Bioethics; Professor of Surgery (Urology) and Alan B Retik Chair and Professor of Surgery, Harvard Medical School; Senior Associate, Department of Urology and Clinical Ethicist, Boston Children’s Hospital Faculty Advisor: Anthony Breu, MD Co-Director, Essentials of the Professions, Harvard Medical School Center for Bioethics; Assistant Professor in Medicine, Harvard Medical School; Director of Resident Education and Hospitalist, VA Boston Healthcare System

A Decision-Tree Model of Integrated Care for Transgender Patients Transgender patients are marginalized in the health care system due to inadequate specialized health information and unjust health care access. According to the 2011 National Transgender Discrimination Survey, over 6000 trans-patients across all 50 states experienced delayed (28%), incompetent (50%), and denial of care (19%).

A system-wide approach has not yet been well established across the spectrum of transgender care, from mental health, LGBTQ primary care, and hormonal therapy to gender-affirming surgery. To navigate these complex medical waters, patients need high-quality guidance to help them make voluntary decisions when seeking genderaffirming services or specialized long-term care after the transition. Therefore, this project aimed to design a patient-oriented decision-tree model to integrate and simplify complex medical information pertaining to all aspects of transgender care.

First, the spectrum and elements of an integrated transgender care model were identified by studying various medical centers’ website information and services.

Literature search and reference to the World Professional Association for Transgender Health guidelines were used to resolve discrepancies among providers regarding the combination, sequence, and timeline of procedures. Next, a sequence diagram was designed to clarify the flow of key therapeutic steps and incorporate decision nodes based on patients’ common concerns and confusions. As a result, this decision-tree model will be a powerful add-on for transgender patient consultation and education, enhancing patients’ understanding, facilitating informed consent, and promoting autonomous decision making. Lastly, this decision-tree chart will be continuously optimized through patient surveys and clinician interviews.

Minghao (Oliver) Zhao, MS, is a medical student at Peking University, China. He received his BS in exercise and sport science from the University of San Francisco and his MS in global health science from the University of California, San Francisco. His work experiences include cosmetic surgery consultation and geriatric care administration. Oliver is passionate about serving vulnerable patient populations with bioethics in mind. He has published papers about aging and received the 2016 American Geriatrics Society top score for student research. After graduation, he will join the University of Oxford to study evidence-based healthcare, scaling up his capstone project of transgender healthcare throughout his PhD and career in medicine.

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David Zuckerman Capstone Mentor: Yelena G. Bodien, PhD Site Specific Project Principal Investigator, Spaulding Research Institute Faculty Advisor: Robert D. Truog, MD Director, Harvard Medical School Center for Bioethics, Frances Glessner Lee Professor of Medical Ethics, Professor of Anaesthesia and Pediatrics, Harvard Medical School; Senior Associate in Critical Care Medicine, Boston Children’s Hospital

Severe Traumatic Brain Injury: What is a Favorable Outcome?

Following a severe traumatic brain injury (TBI), some patients remain with a disorder of consciousness (DoC, a state of impaired awareness) for an unpredictable length of time. The outcome of such a catastrophic injury varies widely from persistent DoC to complete recovery of independence. Despite years of advances, characterizing and predicting outcomes after severe TBI remains strikingly imprecise. The Glasgow Outcome Scale-Extended (GOSE), an 8-category measure that ranges from vegetative state to good recovery, is the most commonly used outcome measure in TBI clinical trials. Typically, researchers will dichotomize this scale into “favorable” and “unfavorable” outcomes. In this Capstone, a thorough literature review was conducted to shed light on discrepancies in how “favorable” outcomes are defined. This research demonstrated that in studies published since 2014, there have been at least 6 different approaches to using the GOSE to define “favorable” outcome. The minimum functional level consistent with a “favorable” outcome ranged from GOSE 3 (lower severe disability) to GOSE 7 (lower good recovery).

None of the studies provided an empirical rationale for choosing the GOSE cutoff for dichotomizing outcome. Patients and families are usually the ones most affected by the consequences of TBI, yet they are often not involved in defining a “favorable” versus an “unfavorable” outcome. Patient and family perspectives should be included in outcome metrics. In future work, patient and family views on what a “favorable” outcome is should be compared to researchers’ and clinicians’ perspectives.

David Zuckerman, BS, received his BS in neuroscience from Yale College. He conducted undergraduate research in the neuroscience lab, helping to contribute to an understanding of consciousness in animal models and humans. He is particularly interested in assisting patients with disorders of consciousness; currently, he is researching ways to work with these patients and their families to best define what a “favorable” outcome looks like. He has published in the journal Cerebral Cortex for his work studying focal limbic seizures. After completing the MBE program, David plans to attend medical school.

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Acknowledgements Capstone Mentors and Faculty Advisors Brendan Abel, JD Melissa Abraham, PhD, MSc Sarah M. Bannon, PhD Janet Barnes, JD, BSN Kelsey Berry, PhD John Bradley, MD Yelena G. Bodien, PhD Jon Wesley Boyd, MD, PhD Rebecca Weintraub Brendel, MD, JD Anthony Breu, MD Stephen D. Brown, MD Andrew Courtwright MD, PhD Brian Cummings, MD Christy L Cummings MD Evan G. DeRenzo, PhD David A. Diamond, MD Roger Daglius Dias, MD, MBA, PhD Roberta Driscoll, JD, MBE David Duong, MD, MPH Leonor Fernández, MD Charlene Galarneau, PhD, MAR Bizu Gelaye, PhD, MPH Joseph T. Giacino, PhD Anna Gosline, MS Tamryn Gray, PhD, RN, MPH John Hammond, MS Insoo Hyun, PhD Michelle C. Jacobo, PhD Aaron S. Kesselheim, MD, JD, MPH Louise P. King, MD, JD K. Babu Krishnamurthy, MD

Ava Kwong, MBBS, BSc, PhD Lisa S. Lehmann, MD, PhD, MSc Rebecca H. Li, PhD Jeantine E Lunshof, PhD Jonathan M. Marron, MD, MPH Mason Marks, MD, JD Jennifer McGuirl, DO, MS Andrea Merrill, MD Elaine C. Meyer, PhD, RN, MBE Christine Mitchell, RN, MS, MTS Martha Montello, PhD Daniele Ölveczky, MD, MS Steve O’Neill, LicSW, JD Nancy E. Oriol, MD Al Ozonoff, PhD, CPPS Vardit Ravitsky, PhD Ellen Robinson RN, PhD Will Ross, MD, MPH Kaila Rudolph, MD, MPH, MBE Justin J Sanders, MD, MSc Ameet Sarpatwari, JD, PhD Carmel Shachar, JD, MPH William Shaw, JD David Sontag, JD, MBE Lauren A Taylor, PhD, MDiv Nhi-Ha Trinh, MD, MPH Robert D. Truog, MD, MA David K. Urion, MD, FAAN Anthony Weiss, MD, MSc, MBA Julian Willard, PhD

Capstone Faculty Melissa Abraham, PhD, Capstone Program Co-Director David Sontag, JD, MBE, Capstone Program Co-Director Stephen D. Brown, MD Bizu Gelaye, PhD, MPH Louise P. King, MD, JD Elizabeth Levey, MD Elaine Meyer, PhD, MBE Lisa Moses, VMD Steve O’Neill LicSW, BCD, JD Matthew Riley III, MDiv, MBE Brooke S. Tempesta, EdD

Master of Bioethics Leadership Rebecca Weintraub Brendel, MD, JD, Master of Bioethics Program Director Brooke Shinnamon Tempesta, EdD, Master of Bioethics Program Associate Director Amanda Chieco, MS, Education Program Coordinator

Center for Bioethics Leadership Robert D. Truog, MD, MA, Director Christine Mitchell, RN, MS, MTS, Executive Director Rebecca Weintraub Brendel, MD, JD, Associate Director Edward Hundert, MD, Associate Director Mildred Z. Solomon, EdD, Director, Fellowship in Bioethics Genevieve Saphier, RN, MSN, WHNP, Director of Administration

Center for Bioethics Staff Lisa Bastille, MS, Program and Financial Administrator Amanda Chieco, MS, Education Program Coordinator Ashley Trautmann, Event Program Coordinator Kyle Amato, Staff Assistant Laura Gallant, Communications Assistant Julie Tomas, Graphic Designer – contractor

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