Bioethics and Medical Ethics Commons^™

Interdisciplinary, Delphi-Driven Consensus Guidelines On The Use Of Intravenous Ketamine Infusions For Depressive Disorders From The American Society Of Ketamine Physicians, Psychotherapists, And Practitioners (Askp3), David S Mathai, Madeleine Cluck, Amna M Aslam, Erin Amato, Arsalan Azam, Michael Banov, Kathleen A Barrett, Carl J Bonnett, David Feifel, Nicolas Grundmann, H Samuel Ko, Rupert Mcshane, Sandhya Prashad, Tatiana Santini, Lowan H Stewart, Patrick Sullivan, Stefany D Wolfsohn, Jill O Robinson, Amy L Mcguire, L Alison Mcinnes

Center for Medical Ethics and Health Policy Staff Publications

Background: Off-label use of intravenous ketamine (IVK) for depression is a widespread practice with limited regulation in the United States. There is an urgent need for current, evidence-informed treatment guidelines to facilitate patient safety, clinical decision-making, and care quality in real-world contexts.

Methods: The American Society of Ketamine Physicians, Psychotherapists and Practitioners (ASKP3) convened an interdisciplinary working committee tasked with creating guidelines for use of IVK for depression in outpatient settings. Guideline development followed a two-stage process: 1) a hybrid systematic and targeted evidence review and preliminary drafting by the committee, and 2) consensus refinement through a modified Delphi method …

Towards Human-Centered Digital Health Interventions, Kristin M Kostick-Quenet, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

This article discusses the potential of digital health interventions (DHIs) in mental health care, emphasizing the importance of designing them to foster genuine humanistic care. It highlights current challenges in measuring engagement and outcomes, advocating for integrating human-centered endpoints such as dignity, autonomy, and therapeutic alliance into evaluation frameworks. The authors call for mechanistic research to identify effective engagement strategies and context-specific implementation approaches. Ultimately, successful DHIs should demonstrate both clinical efficacy and the preservation of humane, person-centered care, ensuring ethical and meaningful mental health support through technology.

Identifying And Addressing Problematic Studies In Allergy And Asthma Research: A Commentary, Alexandro W L Chu, Gordon H Guyatt, Jason W Busse, Romina Brignardello-Petersen, Xiajing Chu, Daniel G Rayner, Paul Oykhman, Vanessa Wong, Yetiani Roldan, Diane R Baker, Leonard B Bacharier, Lisa A Beck, Moshe Ben-Shoshan, Bradley Chipps, Flavia Hoyte, Elliot Israel, David M Lang, Sameer K Mathur, Sharmilee M Nyenhuis, Paul M O'Byrne, Eric T Oliver, John Oppenheimer, Tamara T Perry, Katherine Rivera-Spoljaric, Sarbjit S Saini, Javed Sheikh, Kaharu Sumino, Susan Waserman, Elissa M Abrams, Aikaterini Anagnostou, Jonathan A Bernstein, Anne K Ellis, David B K Golden, Caroline C Horner, Dennis K Ledford, Jay Lieberman, Giselle Mosnaim, Matthew A Rank, Marcus Shaker, Julie Wang, David A Khan, Derek K Chu

Center for Medical Ethics and Health Policy Staff Publications

Randomized controlled trials underpin evidence-based medicine, but a growing proportion of trials contain implausible, inaccurate, or fabricated data. When such studies are incorporated into systematic reviews, they distort effect estimates, inflate evidence certainty, and can mislead the guideline recommendations that the reviews aim to inform. Within 8 recent American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) systematic reviews, 17% of trials published between 2021 and 2024 were problematic, and in a network meta-analysis of antihistamines for chronic urticaria, 39% of recent trials were excluded because of …

Navigating Undone Science: The Search For Adequate Endometriosis Care, Heather Welty, Melanie Jeske

Center for Medical Ethics and Health Policy Staff Publications

Endometriosis is an estrogen-dependent disease in which tissue similar to the lining of the uterus grows elsewhere in the body leading to a variety of symptoms including heavy and prolonged menstruation, chronic pain, cysts, infertility, and gastrointestinal issues. Despite being one of the most common gynecologic conditions, much remains unknown about potential risk factors for endometriosis, its etiology, and treatment options. First and second-line biomedical treatment options, complementary and alternative medicine, and lifestyle changes are all treatment options that people living with endometriosis (PLE) leverage to manage their symptoms. This article draws on in-depth interviews with 52 people living with …

The Fiduciary Argument Against Conscientious Refusal In Healthcare, Michael Robinson

Philosophy Faculty Articles and Research

The question of when, if ever, healthcare professionals with conscientious objections should be accommodated by permitting them to refuse to provide medical interventions to which they morally object is a heated issue that has received significant attention in the medical ethics literature. While many professional medical associations have long held that such objections may be accommodated in a broad range of cases, a vocal and growing minority has been fervently arguing that the medical profession should cease accommodating conscientious objections and should rarely, if ever, permit clinicians to refrain from providing medical care merely because it conflicts with their conscience. …

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

Healthcare Provider's Perceptions Of Family Values When Making End-Of-Life Care Decisions For Their Children: Developing And Implementing A Survey Tool., Nithya Sivakumar, Stephanie Kukora, Cherie Ginwalla, Satyan Lakshminrusimha, Jennifer Rosenthal

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Healthcare providers help families navigate end-of-life care decisions in the neonatal intensive care unit (NICU) and pediatric intensive care unit (PICU); however, limited studies exist regarding what values providers perceive families utilize when in these situations.

OBJECTIVE: To evaluate providers' perceptions of values that families considered when making end-of-life care decisions for their child.

DESIGN: Develop a novel survey tool to understand providers' perceptions of values families considered when making end-of-life care decisions for their children and distribute the survey tool to providers in a single quaternary care children's hospital within a university hospital.

METHODS: The novel survey tool …

Perceived Sensitivity Of Sensor-Based Digital Health Data: Qualitative Interview Study, Christine Deeney, Anika Sonig, Meghan E Hurley, Birkan Tunç, Eric A Storch, John D Herrington, Jennifer Blumenthal-Barby, Kristin Kostick-Quenet

Center for Medical Ethics and Health Policy Staff Publications

Background: Digital health tools are increasingly used in mental health care to passively collect patient data and analyze health status outside of clinical settings. While technologies such as digital phenotyping, affective computing, and computational behavioral analysis offer new insights into symptom manifestation in daily life, they generate large volumes of potentially sensitive data that raise significant data privacy concerns, requiring high levels of patient awareness and consent. Empirical research is lacking on stakeholder understandings toward the sensitivity of these data and expectations for data stewardship, perspectives that are critical for developing robust informed consent and data protection policies for digital …

Elective Genomic Sequencing For Adults In Research, Clinical And Commercial Contexts, Michael D Linderman, Sophia M Adelson, Tala M Berro, Jennifer L Anderson, Scott D Crawford, Tshaka J Cunningham, Edward D Esplin, Altovise T Ewing-Crawford, Daiva E Nielsen, Stacey Pereira, Tara Schmidlen, Heather Andrighetti, Steven B Bleyl, George M Church, Eden V Haverfield, Madhuri Hegde, Lazaridis N Konstantinos, Paul Kruszka, Debra Leonard, Thomas May, Molly Mcginniss, Vaibhav Pandya, Eric E Schadt, Bastian Greshake Tzovaras, Bethany Zettler, Amy L Mcguire, Robert C Green

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Elective genomic sequencing (EGS) returns monogenic disease findings in multiple genes, including potentially novel variants, and may also provide participants with carrier status, pharmacogenomic and other health-related information. The PeopleSeq Study assessed participants' motivations for and concerns about EGS and the associated clinical and psychosocial outcomes across diverse EGS providers.

Methods: We administered a shared questionnaire to participants who chose to undergo EGS via 18 academic, clinical, or commercial EGS platforms.

Results: We enrolled 1575 participants, of whom 1147 (72.8%) completed a questionnaire after receiving their EGS results. A majority (60.3%) of the participants who completed a post-result questionnaire …

Clinical Ethics Training Needs Among Pediatricians And Pediatric Residents In Ethiopia: Conference-Based Cross-Sectional Survey., Betelehem Kassa, Addishiwot Melesse, Eyob Kebede Etissa, Bitseat W. Haile, Atnafu Mekonnen Tekleab, Stephanie Kukora

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Pediatricians encounter ethically challenging cases in clinical practice throughout the world. In Ethiopia, ethically distressing pediatric cases are heightened by limited resources, lack of ethical frameworks to guide clinical care and withdrawal of supportive therapies, absence of child protection laws, and dearth of trained ethics consultants or institutional ethics committees providing clinical ethics consultation. Ethics training remains limited in undergraduate medical programs and absent in the resident curriculum at most institutions.

METHODS: A survey of Pediatric Residents and Pediatricians attending the Ethiopian Pediatric Society's 24th Annual Conference on March 2023 was conducted using a self-administered, clinical ethics needs assessment. …

Parent Perspectives On Neonatal Research Without Prior Consent: A Mixed-Methods Interview Study., Stephanie A. Kraft, Abigail Brickler, Abril Beretta, Rishabh Jain, Andrea Kelsh, Kaashif A. Ahmad, Justin T. Clapp, Neal W. Dickert, Rebecca A. Dorner, Katherine F. Guttmann, Anup C. Katheria, Stephanie Kukora, Benjamin A. Mooso, Elliott Mark Weiss, Fam-Connect Collaborative

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Recruitment for clinical research in the neonatal intensive care unit (NICU) is difficult, which may lead to low enrollment rates, systematically skewed samples, and nongeneralizable results. Research without prior consent (RWPC), defined as obtaining consent only after infants have been randomized to a treatment arm, may improve enrollment but raises ethical challenges. There is a need to better understand how parents with lived experience of having an infant in the NICU consider RWPC’s impact on critical ethical values related to informed consent, including decision-making, respect, and trust. This mixed-methods study aimed to describe parental perceptions of the acceptability and …

Dementia, Advance Directives, And Second-Order Volitions, Rand Hirmiz

Research Collection School of Social Sciences

This paper contributes to the ongoing debate over the authority of advance directives in cases where patients with dementia express desires that conflict with their earlier wishes. Drawing on Harry Frankfurt’s concept of second-order volitions, I argue that the preferences of the pre-dementia self (the “then-self”) should, in most cases, take precedence over those of the post-dementia self (the “now-self”) –  particularly in instances where the now-self has lost the capacity to form second-order volitions and is no longer able to meaningfully repudiate prior values and commitments.

Public Attitudes Toward Cascade Genetic Screening In The United States, Hadley Stevens Smith, Emilie S Zoltick, Madison R Hickingbotham, Emily S Bonkowski, Stacey Pereira, Tara A Lavelle, David L Veenstra, Amy L Mcguire, Katherine E Bonini, Leila Jamal

Center for Medical Ethics and Health Policy Staff Publications

Introduction: After a patient receives genetic test results that indicate an actionable health condition, cascade genetic screening (CGS) is the process of evaluating the patient's relatives for a potentially elevated genetic risk of disease. The United States primarily relies on patients to communicate with their relatives, resulting in suboptimal rates of risk communication, familial genetic testing uptake, and risk-reducing interventions. There is ongoing debate about whether and how best to inform relatives of a potentially increased genetic risk.

Methods: We conducted a nationally representative survey of US adults to assess attitudes toward informing at-risk relatives, acceptability of system-mediated communication, and …

Rethinking Ethics For An Era Of Trusted Computational Tools, Kristin M Kostick-Quenet, Meghan Hurley, John Herrington, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Computer perception (CP) technologies are poised to deliver near real-time behavioral insights with high precision. As technical barriers recede, our field's ethical focus must shift from "Can we trust the data?" to "Should we use it here, and how?" We propose a contextual ethics framework that: (1) defines the appropriate scope of CP integration; (2) advocates codesigned roadmaps to manage expectations and epistemic conflict; (3) expands evaluation beyond performance metrics to humanistic outcomes; and (4) anticipates future high performance systems to safeguard dignity, empathy, and shared decision-making in clinical care.

Characterizing Core Outcomes Of Responsible Stewardship For Human Genomic Data In The Cloud, Vasiliki Rahimzadeh, Bronwyn Walsh, Heidi L Rehm, Mildred Cho, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

We present findings from a scoping review of the genomic data sharing literature used to inform a core outcomes set for responsible data stewardship in the cloud. Genomic and related health data stemming from government funded research have undergone mass migration to the cloud where they can be more securely stored, accessed, and analyzed within shared computing environments. While this migration reflects a shift in privacy and security infrastructure for cloud-based repositories as oversight becomes more globalized, it also necessitates new data stewardship responsibilities to align authorized data access with ethical data use. Responsible data stewardship refers to the ethical …

Preserving Life In An Age Of Autonomy: A Critique Of Physician-Assisted Suicide, Adeline Holcombe

Senior Honors Theses

This thesis critiques physician-assisted suicide (PAS) as a reflection of Western thought’s shift from a biblical sanctity-of-life ethic toward autonomy and relativism. Through analysis of biblical and historical foundations, major cases, and state PAS laws, it argues that legalization weakens the state’s interest in preserving life, normalizes suicide, and exposes vulnerable populations to coercion, inadequate safeguards, and legal expansion. The thesis concludes that PAS laws should be repealed and that palliative care, hospice, and mental health treatment provide more compassionate and ethically sound alternatives.

Mitigation Of Race-Based Antihypertensive Prescribing, Victoria Scaccia Msn Rn Cnl Dnp, Bridget O'Brien Dnp, Stephanie Crane Md, Amanda Bradke Md

North American Conference to End Race-Based Medicine

No abstract provided.

Six Steps To Squats: A Training Protocol To Guide Functional Rehabilitation Following Isolated Lower Extremity Fractures, Batoul Baydoun, Abdurrahman Ehsan, Manar Chebli, Zarrar Chauhdri, Ahmed Memon, Ahmad Almaat Bs, Omar Abdalla Bs, Haytham Alqasmi Bs, Ameen Suhrawardy Md, Rahul Vaidya Md

North American Conference to End Race-Based Medicine

No abstract provided.

Reconsidering The Use Of Race & Ethnicity In Clinical Decision-Making: The Path Towards Liberation Medicine, Donna Ahmadian Ms, Mph

North American Conference to End Race-Based Medicine

No abstract provided.

Sleeve Gastrectomy Vs. Glp-1 Agonists (Semaglutide): A Cost-Effectiveness Perspective On Long-Term Obesity Management, Naushad Khan, Luv Agarwal, Ritesh Sheth Md

North American Conference to End Race-Based Medicine

No abstract provided.

Contemplating Race In Clinical Algorithms: Educating The Physicians Of Tomorrow, Adam Gaetz

North American Conference to End Race-Based Medicine

No abstract provided.

Reimagining Black Maternal Health Narratives: Embracing A Vitality Framework For Joy, Liberation, And Healing, Ijeoma Nnodim Opara, Yasmine M. Elmi

North American Conference to End Race-Based Medicine

No abstract provided.

Voices From The Field: Provider Perspectives On The Implementation And Impact Of Race-Neutral Pfts, Kumbie Madondo Phd, Zoelene Hill Phd, Kimberly Murdaugh Md Ms, Natoushka Trenard Md

North American Conference to End Race-Based Medicine

No abstract provided.

Gender Disparities In Medical Student Clinical Experiences During Obstetrics And Gynecology Rotations In The Usa, Naushad Khan, Luv Agarwal, Ritesh Sheth Md, Rehana Sheikh

North American Conference to End Race-Based Medicine

No abstract provided.

Keratopigmentation: A Comparative Review Of Safety, Indications, And Clinical Outcomes, Emmy L. Colon Alamo

Undergraduate Scholarship and Creative Works

Throughout the years, there has been an upsurge in the quantity of cosmetic procedures aimed at changing eye color or appearance. This trend raises significant concerns about patient safety and visual health, as although many methods are promoted worldwide, their efficacy and, most importantly, safety varies greatly. This review looks at the safety of procedures that alter eye color or appearance, focusing mainly on cosmetic keratopigmentation, which is currently the only legally accepted method for changing eye color in the U.S.

A review of clinical studies was conducted to evaluate the outcomes and complications related to keratopigmentation. Then, these findings …

Justice, Autonomy, Beneficence, And Non-Maleficence: The Global Failure To Heed Ethical Mandates In Birth Spaces, Julia Dees

Richard T. Schellhase Essay Prize in Ethics

Respectful and safe care in all birthing spaces has long been an ideal that global communities fail to meet. Birthing people are disrespected, physically or emotionally harmed, or left to completely fend for themselves during a period of extreme emotional and medical vulnerability. Historically, autonomy especially has been ignored in birthing spaces with medical trends like the twilight sleep, where women were drugged into a state of unconsciousness during birth (Taylor, 2023), demonstrating the desire of western medicine, in particular, to reduce birthing people to bystanders in their own birth. While birth trends and medical treatments have changed throughout time, …

Ethical Controversies In Organ Procurement: A National Survey On Public Perceptions Of Thoracoabdominal Normothermic Regional Perfusion, Trevor M Bibler, Jill Oliver Robinson, Adam Omelianchuk, Tariq Nisar, Savitri Fedson, Ariel N Levchenko, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

Thoracoabdominal normothermic regional perfusion (TA-NRP) would likely expand the quantity and quality of organs procured after controlled circulatory death donation in the United States, yet its ethical permissibility remains contested. We surveyed a representative sample of US adults (n = 975) with the goal of assessing their perspectives on the ethical permissibility of TA-NRP. After reading a neutral description of TA-NRP, participants judged its permissibility, reviewed 5 critic and 5 supporter arguments (in random order), and chose which argument they found most convincing. Multivariable logistic regression examined predictors of agreeing with critics. Before exposure to the arguments, 51.5% stated that …

A Randomized Study Of Digital Versus Genetic Counselor Return Of Actionable Genetic Research Results To Biobank Participants (Respect3 Study), Anuja Rajendra Godbole, Elisabeth Wood, Brian Egleston, Lily Hoffman-Andrews, Sarah Brown, Sarah Howe, Sanjana Shastri, Rajia Mim, Justin Feng, Anjali Owens, Susan Domchek, Reed Pyeritz, Bryson Katona, Staci Kallish, Giorgio Sirugo, Joellen Weaver, Linda Fleisher, Kuang-Yi Wen, Elena Elkin, Katherine Nathanson, Daniel Rader, Angela Bradbury

Department of Medical Oncology Faculty Papers

BACKGROUND: There is consensus that research participants should be informed about plans for return of genetic research results. However, best practices for return of results in large biobank and cohort studies do not exist currently, and how best to communicate actionable genetic research results remains unclear. While having genetic counselors disclose these results may be ideal to ensure understanding, minimize distress, and optimize medical follow-up, genetic counselor (GC) workforce shortages and costs are barriers. The RESPECT3 study evaluates whether digital delivery alternatives for pre-disclosure education and return of actionable genetic research results is non-inferior to remote telehealth disclosure by a …

Editorial: Clinical Imaging, Neurophysiological, Neuropathology And Neuroethics Studies On Disorders Of Consciousness, Coma Mechanisms, And Theories Of Consciousness: A Unifying Attempt, Diego Iacono, Manuel Trachsel, Thanh Phan, Charlène Aubinet

Department of Neurology Faculty Papers

No abstract provided.

Post-Dobbs Realities: Ethical Imperatives For Data Transparency And Trust In Maternal Health Care, Faith E Fletcher, Sophie L Schott, Kelley Akhiemokhali, Kari White

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.