Bioethics and Medical Ethics Commons^™

Assessment Of Biotransformation Rates, Biomagnification, And Bioconcentration Factors Of Difficult-To-Test Substances Using In Vitro Rainbow Trout Liver Subcellular Fractions, Mark A Cantu, Beatrice Chee, Talia R Cole, Yung-Shan Lee, Frank A P C Gobas

Faculty and Staff Publications

In vitro hepatic biotransformation assays have been proposed as methods for expediting and improving bioaccumulation assessment for substances that are difficult to test in conventional in vivo bioaccumulation assays and to reduce animal testing. However, to date, there has been no convincing evidence to demonstrate the ability and limitations of in vitro assays to estimate in vivo biotransformation rates and corresponding bioconcentration and biomagnification factors of difficult-to-test substances in fish. The present study presents the first measurements of in vitro biotransformation rates of superhydrophobic and highly volatile linear and cyclic siloxanes in rainbow trout liver S9 subcellular fractions and the …

The Conservative Approach To Informed Consent: The Evidentiary Model And An Antidote To The Problem Of Framing Effects In Medical Decision-Making, James D. Polk

Honors Theses

Since the latter part of the 20th century, there has been a gradual but significant shift of the doctor-patient relation from paternalism to a more patient-centric approach. As such, informed consent – the legal and moral requirement that a physician fully disclose relevant details to their patient and gain their consent – is a central doctrine to patient-centric care. Gone are the days of the doctor governing the patient: the patient is now considered a valuable and important decision-maker. Achieving informed consent is the foundation of patient centric medicine. Therefore, it is of the utmost importance that philosophical consideration be …

Inside The Mad Mind: Medical Ethics In 19th Century Fiction, Danielle Dentremont

College Honors Program

The professionalization of medicine in mid-to-late 19th century America and Britain corresponded with heightened critical scrutiny of the ethics of doctor-patient relationships in contemporary fiction. With ethics frameworks of the century focused primarily on good fellowship between practitioners, it was difficult to charge practitioners with bad ethics. Yet, the broader debates of vivisection and women’s rights brought to light power imbalances between men and women that novelists began to suggest were present in medicine as well. Wilkie Collins’ Heart and Science weighs in on the danger of the doctor-scientist encroaching on women’s rights with the suggestion that women will be …

Lack Of Patient-Centered Care Relative To Evidence-Based Practice In Clinical Diagnosis And Treatment Of Endometriosis In The U.S.: A Review, Piper E. Scoskie

Honors Theses

This scoping review examines the impact of combining Patient-Centered Care (PCC) and Evidence-Based Care (EBC) on clinical outcomes and patient satisfaction in the diagnosis and treatment of endometriosis in the United States. In particular, the review aims to (1) examine the body of research from the United States to learn more about the connection between PCC and EBC and their collective impact on patient satisfaction and clinical outcomes in the treatment of endometriosis; (2) identify the gaps in existing research and practice, specifically regarding PCC procedures, varying patient populations, and longitudinal investigations; and (3) provide recommendation for future research and …

Germline Pathogenic Drosha Variants Are Linked To Pineoblastoma And Wilms Tumor Predisposition, Peter N Fiorica, Lisa Golmard, Jung Kim, Riyue Bao, Frank Y Lin, Angshumoy Roy, Allison Pribnow, Melissa R Perrino, Julien Masliah-Planchon, Sophie Michalak-Provost, Jennifer Wong, Mathilde Filser, Dominique Stoppa-Lyonnet, Franck Bourdeaut, Afane Brahimi, Olivier Ingster, Giselle Saulnier Sholler, Sarah A Jackson, Mark M Sasaki, Trent Fowler, Anita Ng, Ryan J Corbett, Rebecca S Kaufman, Jeremy S Haley, David J Carey, Kuan-Lin Huang, Sharon J Diskin, Jo Lynne Rokita, Hussam Al-Kateb, Rose B Mcgee, Joshua D Schiffman, Kenneth S Chen, Douglas R Stewart, D Williams Parsons, Sharon E Plon, Kris Ann P Schultz, Kenan Onel

Center for Medical Ethics and Health Policy Staff Publications

Purpose: DROSHA, DGCR8, and DICER1 regulate miRNA biogenesis and are commonly mutated in cancer. Although DGCR8 and DICER1 germline pathogenic variants (GPV) cause autosomal dominant tumor predisposition, no association between DROSHA GPVs and clinical phenotypes has been reported.

Experimental design: After obtaining informed consent, sequencing was performed on germline and tumor samples from all patients. The occurrence of germline DROSHA GPVs was investigated in large pediatric and adult cancer datasets. The population prevalence of DROSHA GPVs was investigated in the UK Biobank and Geisinger DiscovEHR cohorts.

Results: We describe nine children from eight families with heterozygous DROSHA GPVs and a …

A Narrative Review Of Military Reverse Triage., Daniel J Hurst

Rowan-Virtua School of Osteopathic Medicine Departmental Research

INTRODUCTION: Military reverse triage has been described at several points in the literature. However, an extensive review of the concept and any gaps that may exist has not been conducted. This narrative review seeks to understand how reverse triage is used in the military literature and how it might be implemented in practice, as well as the documented historical applications of reverse triage.

MATERIALS AND METHODS: Four databases were searched manually for English-language articles: PubMed, SCOPUS, JSTOR, and Worldwide Political Science Abstracts. In addition, a manual search of references, U.S. DoD, and NATO doctrine, as well as other published works …

The Ethics Of Gene Editing Hereditary Deafness, Jasmine Borie

Richard T. Schellhase Essay Prize in Ethics

Gene editing has been a hot topic of interest in the field of science, and many gene editing solutions for heritable diseases are in the works. In most cases, gene editing is done with good intentions, but there are some instances where it would not be favorable for reasons that may not be inherently obvious to everyone. Several forms of deafness and hearing loss can be inherited, meaning that it can be passed down from parent to offspring. Curing hereditary deafness using gene editing may seem like a good idea, but it can lead to unintentional discrimination and further stigmatization …

The Structural Inequality Of Status Quo Clinical Communication, Joelle Robertson-Preidler

Faculty and Staff Publications

No abstract provided.

Classic Philosophers On Modern Issues: The Ethics Of Germline Editing, Grace O. Decostanza

Richard T. Schellhase Essay Prize in Ethics

The prospect of using CRISPR-Cas-9 technology to edit human embryos in a process called germline editing has the potential to irreparably change the world as we know it. Many pose the question: if you could save your child from having a disease, would you? But I argue that is not the only—or even, real—question we should be asking. Instead, I ask you, should we be changing humanity as we know it in ways that elude even our foremost scientists? Should we decide what disabilities make people not worth being people? Should we introduce a technology knowing full well that it …

Beyond Politics: Rethinking The Conversation On Gender-Affirming Care For Youth, Olivia Sanders

Mercer Law Review

According to a study conducted in June of 2022 by the Williams Institute School of Law, nearly 300,000 youth members in the United States identify as transgender. According to these calculations, this statistic indicates that “[t]he number of young people who identify as transgender has nearly doubled in recent years.” Gender‑affirming healthcare is usually administered to treat gender dysphoria, which is defined as “a state of distress or discomfort that may be experienced because a person’s gender identity differs from that which is physically and/or socially attributed to their sex assigned at birth.” A 2021 study conducted by Reuters exposed …

Crispr/Cas9 Gene Therapy Increases The Risk Of Tumorigenesis In The Mouse Model Of Hereditary Tyrosinemia Type I, Tong Chen, Mercedes Barzi, Nika Furey, Hyunjae R Kim, Francis P Pankowicz, Xavier Legras, Sara H Elsea, Ayrea E Hurley, Diane Yang, David A Wheeler, Malgorzata Borowiak, Beatrice Bissig-Choisat, Pavel Sumazin, Karl-Dimiter Bissig

Center for Medical Ethics and Health Policy Staff Publications

Background & aims: The therapeutic potential of CRISPR gene editing has been demonstrated in various animal models; however, little is known about its long-term consequences. This study seeks to bridge this gap by investigating the lasting consequences of CRISPR gene therapy in an animal model of hereditary tyrosinemia type I (HT-I). We compared the standard of care-nitisinone, a small molecule inhibitor of hydroxyphenylpyruvate dioxygenase (HPD)-with the deletion of the Hpd gene by CRISPR gene therapy. Both treatments block flux through tyrosine catabolism and thereby prevent the accumulation of toxic catabolites in HT-I.

Methods: We assessed the efficacy and safety of …

Ethical Considerations For Sharing Aggregate Results From Pragmatic Clinical Trials, Stephanie R Morain, Abigail Brickler, Joseph Ali, Patricia Pearl O'Rourke, Kayte Spector-Bagdady, Benjamin Wilfond, Vasiliki Rahimzadeh, Caleigh Propes, Kayla Mehl, David Wendler

Center for Medical Ethics and Health Policy Staff Publications

A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no prior work has examined these issues in the context of pragmatic clinical trials. Several characteristics of pragmatic clinical trials may complicate both the ethics and the logistics of sharing aggregate results. Among these characteristics include that pragmatic clinical trials may affect the rights, welfare, and interests of not only patient-subjects but also clinicians, meaning that results may be owed to a broader range of groups than typically considered in other research contexts. In addition, some pragmatic clinical trials are …

A Novel Method For Semi-Quantitative Detection Of Hpv16 And Hpv18 Mrna With A Low-Cost, Open-Source Fluorimeter, Kathryn A Kundrod, Mary E Natoli, Chelsey A Smith, Jackson B Coole, Megan M Chang, Emilie Newsham Novak, Elizabeth Chiao, Elizabeth A Stier, Jane R Montealegre, Michael E Scheurer, Philip E Castle, Kathleen M Schmeler, Rebecca R Richards-Kortum

Center for Medical Ethics and Health Policy Staff Publications

Despite global calls to eliminate cervical cancer, rates of cervical cancer incidence and mortality remain high in resource-limited settings, where it is challenging to implement and sustain screening, diagnosis, and treatment programs. The presence of high-risk HPV mRNA in cervical cells is a sensitive and specific biomarker of cervical precancer. Yet, current testing methods are too costly and complex for use in resource-limited settings. Here, we present a novel method for semi-quantitative detection of HPV16 and HPV18 mRNA with minimal infrastructure requirements. The assay relies on isothermal reverse transcription recombinase polymerase amplification (RT-RPA) with real-time fluorescence readout, demonstrated on rugged, …

Amniocentesis In Pregnancies At Or Beyond 24 Weeks: An International Multicenter Study, Roni Zemet, Mohamad Ali Maktabi, Alexandra Tinfow, Jessica L Giordano, Thomas M Heisler, Qi Yan, Roni Plaschkes, Jenny Stokes, Jennifer M Walsh, Siobhán Corcoran, Erica Schindewolf, Kendra Miller, Asha N Talati, Kristen A Miller, Karin Blakemore, Kate Swanson, Jana Ramm, Ivonne Bedei, Teresa N Sparks, Angie C Jelin, Neeta L Vora, Juliana S Gebb, David A Crosby, Michal Berkenstadt, Boaz Weisz, Ronald J Wapner, Ignatia B Van Den Veyver

Center for Medical Ethics and Health Policy Staff Publications

Background: Amniocentesis for genetic diagnosis is most commonly done between 15 and 22 weeks of gestation but can be performed at later gestational ages. The safety and genetic diagnostic accuracy of amniocentesis have been well-established through numerous large-scale multicenter studies for procedures before 24 weeks, but comprehensive data on late amniocentesis remain sparse.

Objective: To evaluate the indications, diagnostic yield, safety, and maternal and fetal outcomes associated with amniocentesis performed at or beyond 24 weeks of gestation.

Study design: We conducted an international multicenter retrospective cohort study examining pregnant individuals who underwent amniocentesis for prenatal diagnostic testing at gestational ages …

Intraoperative Code Status: Moving From Misinformation To Respect For Patient Autonomy, Jacob Applegarth, Jacob M. Morton, Nathan M. Novotny, Ngan Nguyen, Abram Brummett

Conference Presentation Abstracts

Introduction: Intraoperative code status represents a complicated topic for patients and providers. Prior studies demonstrated a lack of understanding of intraoperative code status, specifically do not resuscitate (DNR) orders. This misunderstanding appears common despite clear professional recommendations. A recent survey of surgery residents at our institution showed variability in understanding of intraoperative code status policy despite clear institutional guidelines. Few studies utilized simulated education for surgeons and surgical residents to navigate intraoperative DNR status. This project aims to create a simulation-based program for residents to navigate intraoperative DNR status ethically and to assess its impact on learning, practice patterns and …

Brief Of 76 Scholars Of Law, Business, Economics, And Medicine As Amici Curiae, Charles Duan

Amicus Briefs & Court Filings

No abstract provided.

Association Of Messenger Rna Coronavirus Disease 2019 (Covid-19) Vaccination And Reductions In Post Covid Conditions Following Severe Acute Respiratory Syndrome Coronavirus 2 Infection In A Us Prospective Cohort Of Essential Workers, Josephine Mak, Sana Khan, Amadea Britton, Spencer Rose, Lisa Gwynn, Katherine D Ellingson, Jennifer Meece, Leora R Feldstein, Harmony Tyner, Laura J Edwards, Matthew S Thiese, Allison Naleway, Manjusha Gaglani, Natasha Solle, Jefferey L Burgess, Julie Mayo Lamberte, Meghan Shea, Taryn Hunt-Smith, Alberto Caban-Martinez, Cynthia Porter, Ryan Wiegand, Ramona Rai, Kurt T Hegmann, James Hollister, Ashley Fowlkes, Meredith Wesley, Andrew L Philips, Patrick Rivers, Robin Bloodworth, Gabriella Newes-Adeyi, Lauren E W Olsho, Sarang K Yoon, Sharon Saydah, Karen Lutrick

Center for Medical Ethics and Health Policy Staff Publications

Background: Data are limited on whether vaccination reduces post COVID conditions (PCCs) risk after less severe nonhospitalized coronavirus disease 2019 (COVID-19). This study assessed whether COVID-19 vaccination protected against PCCs in persons with mild initial infections during Delta and Omicron variant predominance.

Methods: This study utilized a case-control design, nested within the HEROES-RECOVER cohort. Participants aged ≥18 years with test-confirmed severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) between 28 June 2021 and 14 September 2022 were surveyed for PCCs, defined by symptoms lasting >4 weeks after initial infection. Cases self-reported PCCs and controls self-reported no PCCs. The exposure was …

Use Of A Taqman Array Card For Identification Of Enterotoxins And Colonization Factors Directly From Stool Samples In An Enterotoxigenic E Coli Vaccine Study, Jie Liu, T Sakari Jokiranta, Nils Carlin, Suzanne Stroup, Jixian Zhang, Bjorn Sjostrand, Ann-Mari Svennerholm, Eric R Houpt, Anu Kantele

Faculty and Staff Publications

Enterotoxigenic Escherichia coli (ETEC) is a leading cause of childhood and travelers' diarrhea. The vaccine candidate ETVAX encompasses several ETEC colonization factors (CFs) with a hybrid LT (heat-labile toxin)/cholera toxin B subunit adjuvanted with a double-mutant LT. Stool samples from a Phase 2b ETVAX trial were tested by a PCR-based customized TaqMan Array Card (TAC), including three ETEC toxin genes (LT and heat-stable toxins, STh and STp) and 18 ETEC CFs. Stool samples were also tested with the molecular platform Amplidiag and culture, followed by GM1-enzyme-linked immunosorbent assay (ELISA) and inhibition GM1-ELISA for LT and ST and dot blot for …

Evaluating Industry Relationships And Transparency: Insights From Orthopedic Surgeons In The Cms Open Payments Database, Anesu K. Murambadoro, Mario Keko, Edward Rodriguez, John J. Wixted

Research Symposium

Introduction: Industry payments to physicians may risk introducing bias into patient care. The Open Payments (OP) database, established by Physician Payments Sunshine Act, reports these payments to promote transparency. Orthopedic surgeons receive the highest industry payments especially in the category of royalties/licensing, prompting questions about conflicts of interest and whether the database accurately reflects the status across the specialty. We hypothesize that the OP database underrepresents the relationships that orthopedic surgeons have with industry. We seek to assess the validity of reported industry payments, particularly in the categories of royalties and licensing payments to determine how to improve transparency and …

Emerging Technologies For Forensic Genetic Identification, Lilly Llanos

Senior Honors Theses

There are many new innovations in forensic science that are being developed for the identification of biological evidence. These techniques include next-generation DNA sequencing, DNA phenotyping, and forensic genetic genealogy. This thesis will explore each, as well as newer applications of proteomics. The methodologies, reliability, practicality of cost and training, moral implications, and past research of each will be discussed. Finally, some ideas for future research and steps to drive growth and greater understanding will be suggested. This will encourage further innovations and the increased acceptance of forensic evidence in court. Each method was found to have both advantages and …

Rates Of Minimally Invasive Surgery After Introduction Of Robotic-Assisted Surgery For Common General Surgery Operations, Zhi Ven Fong, Elizabeth Wall-Wieler, Shaneeta Johnson, Richard Culbertson, Brian Mitzman

School of Public Health Faculty Publications

Importance: Many patients who would benefit from minimally invasive surgery (MIS) have open surgery; robotic-assisted surgery (RAS) addresses some of the limitations of laparoscopic surgery and could increase rates of MIS across different patient populations. Objective: To determine whether the introduction of RAS increases MIS rates and whether increases are seen across different patient populations undergoing common general surgery procedures. Design: A retrospective cohort study was performed to compare rates of MIS in the year before and after the index date for hospitals that did and did not introduce RAS. Generalized estimating equation regression models were used to compare rates …

Patient Consent And The Right To Notice And Explanation Of Ai Systems Used In Health Care, Meghan E Hurley, Benjamin H Lang, Kristin Marie Kostick-Quenet, Jared N Smith, Jennifer Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

Given the need for enforceable guardrails for artificial intelligence (AI) that protect the public and allow for innovation, the U.S. Government recently issued a Blueprint for an AI Bill of Rights which outlines five principles of safe AI design, use, and implementation. One in particular, the right to notice and explanation, requires accurately informing the public about the use of AI that impacts them in ways that are easy to understand. Yet, in the healthcare setting, it is unclear what goal the right to notice and explanation serves, and the moral importance of patient-level disclosure. We propose three normative functions …

Navigating Your Us Bioscience Career Into The 2030s, Peter J Hotez

Center for Medical Ethics and Health Policy Staff Publications

The coming decade might see major cuts to the United States Government funding for biomedicine and the mainstreaming of pseudoscience. But your biosciences PhD gives you the problem-solving skills to navigate this maelstrom, especially if you maintain flexibility, optimism, and enthusiasm for uncharted paths.

Family Genetic Risk Communication And Reverse Cascade Testing In The Babyseq Project, Melissa K Uveges, Hadley Stevens Smith, Stacey Pereira, Casie Genetti, Amy L Mcguire, Alan H Beggs, Robert C Green, Ingrid A Holm

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Genomic sequencing of newborns can initiate disease surveillance and therapy for children and may identify at-risk relatives through reverse cascade testing. We explored genetic risk communication and reverse cascade testing among families of newborns who underwent exome sequencing and were identified as having a risk for an autosomal dominant disease.

Methods: We conducted semistructured interviews with parents of newborns enrolled in the BabySeq Project who had a pathogenic or likely pathogenic variant associated with an autosomal dominant childhood- and/or adult-onset disease returned. We used directed content analysis to derive themes.

Results: From 11 families, all first-degree relatives (n = …

Ethical Considerations Of Percutaneous Endoscopic Gastrostomy Tube Placement In A Patient With Creutzfeldt-Jakob Disease And Advanced Dementia, Toni Habib, Niamh Siobhán Mulrooney, Yisroel Grabie, Mohammad Maruf, Sophia Kasapira

HCA Healthcare Journal of Medicine

Background

Creutzfeldt-Jakob disease (CJD) is a rapidly progressive neurodegenerative condition that is not easily diagnosed and has no curative treatments available, essentially requiring palliative measures, including tube feeding. Nonetheless, data shows that the endoscope used for percutaneous endoscopic gastrostomy (PEG) tube insertion can be a vector for CJD transmission.

Case Presentation

We discuss the case of an elderly patient diagnosed with CJD, requiring tube feeding. Multiple specialists were consulted, and they were unable to reach an agreement on the best approach. Eventually, the hospital ethics committee intervened, and the family agreed to comfort measures only. This case report sheds light …

Let’S Be Cool About It: Anticipating Proper, Whole-Human Cryopreservation And The Necessary Oversight For Adequate Consumer Protection, Peter Lyon

Minnesota Journal of Law, Science & Technology

No abstract provided.

Media Through The Lens Of Scientific Reductionism: The Gene-Ius Of Genetic Determinism In Gattaca, Asmita Lehther

Kentucky Undergraduate Journal for the Health Humanities

This essay examines the construct of scientific reductionism within the framework established by Andrew Niccol’s film Gattaca, illustrating how genetic determinism shapes social hierarchies and opportunities. By analyzing Vincent's struggle as an "in-valid" in a society that equates genetic superiority with worth, the essay critiques the reduction of individual potential to biological labels, revealing the oppressive nature of such systems.

Religion And Attitudes Toward Xenotransplantation: Results Of A Nationwide Survey In The United States., Daniel J Hurst, Luz A Padilla, Amanda Zink, Brendan Parent, Laura L Kimberly

Rowan-Virtua School of Osteopathic Medicine Departmental Research

Religious viewpoints have been shown to influence the ways in which many persons approach medical decision-making and have been noted as a potential barrier to xenotransplantation acceptance. This study sought to explore how attitudes toward xenotransplantation differ among various religious beliefs. A national Likert-scale survey was conducted in 2023 with a representative sample in the United States. Religious belief was self-reported. Regression analysis was used to identify associations with religious belief and hesitations about xenotransplantation. Five thousand and eight individuals across the United States responded to the survey. The two biggest concerns about xenotransplantation across religious groups were the current …

Anesthesia And Pain Management In Conflict-Affected Regions: Addressing Global Health Barriers To Access And Quality Of Care​, Naeel Uddin, Sierra Brown, Maria Easler, Ayanda Mkhize, Marwa Hamdam, Chandu Goli, Lauren Draper

Annual Research Symposium

This poster examines how to deliver safe, effective anesthesia and pain control in areas with limited resources and ongoing security threats. Focusing on portable technology, ketamine-based protocols, and telemedicine, we highlight ethical considerations, training needs, and global collaborations. Our findings outline a pathway to reduce suffering and improve surgical outcomes in vulnerable populations by addressing challenges unique to conflict settings.

Artificial Intelligence (Ai) In Pharmacy, Giang Nguyen, Elizabeth Sartschev, John Reyes, Allie Honigford, Marisa Petrunich, Kiley Devoll, Brianna Lu, Joshua Honaker, T'Bony M. Jewell

Pharmacy and Wellness Review

Artificial Intelligence (AI) has transformed the pharmaceutical field by enabling computer software systems to learn and perform human behavior. Specifically, AI has revolutionized chronic diabetes management through continuous glucose monitoring, showcasing its immense potential in healthcare. However, alongside its transformative impact, AI’s increasing role in healthcare has prompted concerns over privacy and its premature integration. Despite these challenges, AI offers limitless opportunities to improve medication management and treatment regimens, driving advancements across various domains. From improving CT imaging to enhancing adenoma detection in colonoscopies and facilitating medication adherence, AI’s impact on healthcare is profound. Furthermore, AI plays a pivotal role …