Bioethics and Medical Ethics Commons^™

Pm25, Vegetation Density, And Childhood Cancer: A Case-Control Registry-Based Study From Texas 1995–2011, Lindsay A Williams, David Haynes, Jeannette M Sample, Zhanni Lu, Ali Hossaini, Laura A Mcguinn, Thanh T Hoang, Philip J Lupo, Michael E Scheurer

Center for Medical Ethics and Health Policy Staff Publications

Background: Air pollution is positively associated with some childhood cancers, whereas greenness is inversely associated with some adult cancers. The interplay between air pollution and greenness in childhood cancer etiology is unclear. We estimated the association between early-life air pollution and greenness exposure and childhood cancer in Texas (1995 to 2011).

Methods: We included 6101 cancer cases and 109 762 controls (aged 0 to 16 years). We linked residential birth address to census tract annual average fine particulate matter < 2.5 µg/m³ (PM2.5) and Normalized Difference Vegetation Index (NDVI). We estimated odds ratios (ORs) and 95% confidence intervals (CIs) between PM2.5/NDVI interquartile range increases and cancer. We assessed statistical interaction between PM2.5 and NDVI (likelihood ratio tests).

Results: Increasing residential early-life PM2.5 exposure was associated with all childhood cancers (OR = 1.10, 95% CI = 1.06 to 1.15), …

Developing An Ethics And Policy Framework For Psychedelic Clinical Care: A Consensus Statement, Amy L Mcguire, I Glenn Cohen, Dominic Sisti, Matthew Baggott, Yuria Celidwen, Nese Devenot, Sabrina Gracias, Charles Grob, Ifetayo Harvey, Brent Kious, Mason Marks, Michael Mithoefer, Elizabeth Nielson, Dost Öngür, Alexandra Pallas, Andrew Peterson, Eduardo E Schenberg, Paul Summergrad, Brett Waters, Monnica T Williams, David B Yaden

Center for Medical Ethics and Health Policy Staff Publications

Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice.

Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice.

Evidence review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 …

Covid-19 Ethics: Unique Aspects And A Review As Of Early 2024, Wayne X Shandera

Faculty, Staff and Students Publications

COVID-19 presents a variety of ethical challenges in a set of arenas, arenas not always considered in past pandemics. These challenges include issues related to autonomy, distributive ethics, and the establishment of policies of equity and justice. Methods are a literature review based on regular editing of an online textbook during the COVID-19 outbreak and a literature review using key ethical terms. Patients are confronted with new issues related to autonomy. Providers need to expand their concepts of ethical issues to include decisions based on proportionality and public health ethics. The public health sector needs to assess the beneficence of …

Latin American Trans-Ancestry Initiative For Ocd Genomics (Latino): Study Protocol, James J Crowley, Carolina Cappi, Marcos E Ochoa-Panaifo, Renee M Frederick, Minjee Kook, Andrew D Wiese, Diana Rancourt, Elizabeth G Atkinson, Paola Giusti-Rodriguez, Jacey L Anderberg, Latin American Trans‐Ancestry Initiative For Ocd Genomics, Brazilian Obsessive‐Compulsive Spectrum Disorder Working Group, Jonathan S Abramowitz, Victor R Adorno, Cinthia Aguirre, Gilberto S Alves, Gustavo S Alves, Naeshia Ancalade, Alejandro A Arellano Espinosa, Paul D Arnold, Daphne M Ayton, Izabela G Barbosa, Laura Marcela Barón Castano, Cynthia N Barrera, María Celeste Berardo, Dayan Berrones, John R Best, Tim B Bigdeli, Christie L Burton, Joseph D Buxbaum, Jennifer L Callahan, Maria Cecília B Carneiro, Sandra L Cepeda, Evelyn Chazelle, Jessica M Chire, Macarena Churruca Munoz, Pamela Claisse Quiroz, Journa Cobite, Jonathan S Comer, Daniel L Costa, Jennifer Crosbie, Victor O Cruz, Guillermo Dager, Luisa F Daza, Anabel De La Rosa-Gómez, Daniela Del Río, Fernanda Z Delage, Carolina B Dreher, Lucila Fay, Tomas Fazio, Ygor A Ferrão, Gabriela M Ferreira, Edith G Figueroa, Leonardo F Fontenelle, Diego A Forero, Daniele T H Fragoso, Bharathi S Gadad, Sheldon R Garrison, Andres González, Laura D Gonzalez, Marco A González, Polaris Gonzalez-Barrios, Wayne K Goodman, Dorothy E Grice, Jerry Guintivano, Daniel G Guttfreund, Andrew G Guzick, Matthew W Halvorsen, Joseph D Hovey, Hailiang Huang, Jonathan Irreño-Sotomonte, Reinhard Janssen-Aguilar, Matias Jensen, Alexandra Z Jimenez Reynolds, Joali Alexandra Juárez Lujambio, Nasim Khalfe, Madison A Knutsen, Caleb Lack, Nuria Lanzagorta, Monicke O Lima, Melanie O Longhurst, David A Lozada Martinez, Elba S Luna, Andrea H Marques, Molly S Martinez, Maria De Los Angeles Matos, Caitlyn E Maye, Joseph F Mcguire, Gabriela Menezes, Charlene Minaya, Tomás Miño, Sara M Mithani, Circe Montes De Oca, Alonso Morales-Rivero, Maria E Moreira-De-Oliveira, Olivia J Morris, Sandra I Muñoz, Zainab Naqqash, Ambar A Núñez Bracho, Belinda E Núñez Bracho, Maria Corina Ochoa Rojas, Luis A Olavarria Castaman, Trinidad Olivos Balmaceda, Iliana Ortega, Darpan I Patel, Ainsley K Patrick, Mariel Paz Y Mino, Jose L Perales Orellana, Bárbara Perdigão Stumpf, Tamara Peregrina, Tania Pérez Duarte, Kelly L Piacsek, Maritza Placencia, María Belén Prieto, Lucas C Quarantini, Yana Quarantini-Alvim, Renato T Ramos, Iaroslava C Ramos, Vanessa R Ramos, Kesley A Ramsey, Elise V Ray, Margaret A Richter, Bradley C Riemann, Juan C Rivas, Maria C Rosario, Camilo J Ruggero, Angel A Ruiz-Chow, Alejandra Ruiz-Velasco, Melisa N Sagarnaga, Aline S Sampaio, Leonardo C Saraiva, Russell J Schachar, Sophie C Schneider, Ethan J Schweissing, Laura D Seligman, Roseli G Shavitt, Keaton J Soileau, S Evelyn Stewart, Shaina B Storch, Emily R Strouphauer, Vissente Tapia Cuevas, Kiara R Timpano, Beatriz Treviño-De La Garza, Alexie Vallejo-Silva, Javier Vargas-Medrano, María I Vásquez, Guadalupe Vidal Martinez, Saira A Weinzimmer, Mauricio A Yanez, Gwyneth Zai, Lina M Zapata-Restrepo, Luz M Zappa, Raquel M Zepeda-Burgos, Anthony W Zoghbi, Euripedes C Miguel, Carolyn I Rodriguez, Mayra C Martinez Mallen, Pablo R Moya, Tania Borda, María Beatriz Moyano, Manuel Mattheisen, Stacey Pereira, Gabriel Lázaro-Muñoz, Karen G Martinez-Gonzalez, Michele T Pato, Humberto Nicolini, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder. Worldwide, its prevalence is ~2% and its etiology is mostly unknown. Identifying biological factors contributing to OCD will elucidate underlying mechanisms and might contribute to improved treatment outcomes. Genomic studies of OCD are beginning to reveal long-sought risk loci, but >95% of the cases currently in analysis are of homogenous European ancestry. If not addressed, this Eurocentric bias will result in OCD genomic findings being more accurate for individuals of European ancestry than other ancestries, thereby contributing to health disparities in potential future applications of genomics. In this study protocol paper, we …

Contextual Factors Influencing The Association Between The Affordable Care Act’S Medicaid Expansion And Veteran Va-Medicaid Dual Enrollment, Patrick N O'Mahen, Chase S Eck, Cheng Rebecca Jiang, Laura A Petersen

Center for Medical Ethics and Health Policy Staff Publications

Objective: To evaluate changes in dual enrollment after Affordable Care Act Medicaid expansion by VA priority group, (e.g., service connection), sex, and type of state expansion.

Study setting: Our cohort was all Veterans ages 18-64 enrolled in VA and eligible for benefits due to military service-connection or low income from 2011 to 2016; the unit of analysis was person-year.

Study design: Difference-in-difference and event-study analysis. The outcome was dual VA-Medicaid enrollment for at least 1 month annually. Medicaid expansion, VA priority status, whether a state expanded by a Section 1115 waiver, and sex were independent variables. We controlled for race, …

Phase Ii Study Of Ulixertinib In Children And Young Adults With Tumors Harboring Activating Mitogen-Activated Protein Kinase Pathway Alterations: Apec1621j Of The National Cancer Institute-Children's Oncology Group Pediatric Match Trial, Kieuhoa T Vo, Amit J Sabnis, P Mickey Williams, Sinchita Roy-Chowdhuri, David R Patton, Brent Coffey, Joel M Reid, Jin Piao, Lauren Saguilig, Todd A Alonzo, Stacey L Berg, Alok Jaju, Elizabeth Fox, Brenda J Weigel, Douglas S Hawkins, Margaret M Mooney, Naoko Takebe, James V Tricoli, Katherine A Janeway, Nita L Seibel, D Williams Parsons

Center for Medical Ethics and Health Policy Staff Publications

Purpose: The National Cancer Institute-Children's Oncology Group (NCI-COG) Pediatric MATCH trial assigns patients age 1-21 years with refractory malignancies to phase II treatment arms of molecularly targeted therapies on the basis of genetic alterations detected in their tumor. Patients with activating alterations in the mitogen-activated protein kinase pathway were treated with ulixertinib, an extracellular signal-regulated kinase (ERK)1/2 inhibitor.

Methods: As there were no previous pediatric data, ulixertinib was initially tested in a dose escalation cohort to establish the recommended phase II dose (RP2D) before proceeding to the phase II cohort. Ulixertinib was administered at 260 mg/m2/dose orally twice a day …

Addressing Or Reinforcing Injustice? Artificial Amnion And Placenta Technology, Loss-Sensitive Care And Racial Inequities In Preterm Birth, Sophie L Schott, Faith Fletcher, Alice Story, April Adams

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

A Qualitative Interview Study To Determine Barriers And Facilitators Of Implementing Automated Decision Support Tools For Genomic Data Access, Vasiliki Rahimzadeh, Jinyoung Baek, Jonathan Lawson, Edward S Dove

Center for Medical Ethics and Health Policy Staff Publications

Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic …

Ethical Concerns For Remote Computer Perception In Cardiology: New Stages For Digital Health Technologies, Artificial Intelligence, And Machine Learning, Kristin Kostick-Quenet, Jerry Estep, Jennifer S Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Public Attitudes, Interests, And Concerns Regarding Polygenic Embryo Screening, Rémy A Furrer, Dorit Barlevy, Stacey Pereira, Shai Carmi, Todd Lencz, Gabriel Lázaro-Muñoz

Center for Medical Ethics and Health Policy Staff Publications

Importance: Polygenic embryo screening (PES) is a novel technology that estimates the likelihood of developing future conditions (eg, diabetes or depression) and traits (eg, height or cognitive ability) in human embryos, with the goal of selecting which embryos to use. Given its commercial availability and concerns raised by researchers, clinicians, bioethicists, and professional organizations, it is essential to inform key stakeholders and relevant policymakers about the public's perspectives on this technology.

Objective: To survey US adults to examine general attitudes, interests, and concerns regarding PES use.

Design, setting, and participants: For this survey study, data were collected from 1 stratified …

Advancing Genomics To Improve Health Equity, Ebony B Madden, Lucia A Hindorff, Vence L Bonham, Tabia Henry Akintobi, Esteban G Burchard, Kellan E Baker, Rene L Begay, John D Carpten, Nancy J Cox, Valentina Di Francesco, Denise A Dillard, Faith E Fletcher, Stephanie M Fullerton, Nanibaa' A Garrison, Catherine M Hammack-Aviran, Vanessa Y Hiratsuka, James E K Hildreth, Carol R Horowitz, Chanita A Hughes Halbert, Michael Inouye, Amber Jackson, Latrice G Landry, Rick A Kittles, Jeff T Leek, Nita A Limdi, Nicole C Lockhart, Elizabeth O Ofili, Eliseo J Pérez-Stable, Maya Sabatello, Loren Saulsberry, Lorjetta E Schools, Jennifer L Troyer, Benjamin S Wilfond, Genevieve L Wojcik, Judy H Cho, Sandra S-J Lee, Eric D Green

Center for Medical Ethics and Health Policy Staff Publications

Health equity is the state in which everyone has fair and just opportunities to attain their highest level of health. The field of human genomics has fallen short in increasing health equity, largely because the diversity of the human population has been inadequately reflected among participants of genomics research. This lack of diversity leads to disparities that can have scientific and clinical consequences. Achieving health equity related to genomics will require greater effort in addressing inequities within the field. As part of the commitment of the National Human Genome Research Institute (NHGRI) to advancing health equity, it convened experts in …

Patients’ And Physicians’ Beliefs And Attitudes Towards Integrating Personalized Risk Estimates Into Patient Education About Left Ventricular Assist Device Therapy, Kristin M Kostick-Quenet, Benjamin Lang, Natalie Dorfman, Jerry Estep, Mandeep R Mehra, Arvind Bhimaraj, Andrew Civitello, Ulrich Jorde, Barry Trachtenberg, Nir Uriel, Holland Kaplan, Eleanor Gilmore-Szott, Robert Volk, Mahwash Kassi, J S Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

Background: Personalized risk (PR) estimates may enhance clinical decision making and risk communication by providing individualized estimates of patient outcomes. We explored stakeholder attitudes toward the utility, acceptability, usefulness and best-practices for integrating PR estimates into patient education and decision making about Left Ventricular Assist Device (LVAD).

Methods and results: As part of a 5-year multi-institutional AHRQ project, we conducted 40 interviews with stakeholders (physicians, nurse coordinators, patients, and caregivers), analyzed using Thematic Content Analysis. All stakeholder groups voiced positive views towards integrating PR in decision making. Patients, caregivers and coordinators emphasized that PR can help to better understand a …

Patient Interest In And Clinician Reservations On Polygenic Embryo Screening: A Qualitative Study Of Stakeholder Perspectives, D Barlevy, I Cenolli, T Campbell, R Furrer, M Mukherjee, K Kostick-Quenet, S Carmi, T Lencz, G Lázaro-Muñoz, S Pereira

Center for Medical Ethics and Health Policy Staff Publications

Purpose: We explored and compared perspectives of reproductive endocrinology and infertility specialists (REIs) and in vitro fertilization (IVF) patients regarding polygenic embryo screening (PES), a new type of preimplantation screening that estimates the genetic chances of developing polygenic conditions and traits in the future.

Methods: Qualitative thematic analysis of semi-structured interviews with US-based REIs and IVF patients.

Results: Clinicians and patients often held favorable views of screening embryos for physical or psychiatric conditions, though clinicians tended to temper their positive attitudes with specific caveats. Clinicians also expressed negative views about screening embryos for traits more frequently than patients, who generally …

Parent-Led Cognitive Behavioral Teletherapy For Anxiety In Autistic Youth: A Randomized Trial Comparing Two Levels Of Therapist Support, Andrew G Guzick, Sophie C Schneider, Minjee Kook, Julia Rose Iacono, Saira A Weinzimmer, Troy Quast, Sean M Olsen, Killian Rainey Hughes, Emily Jellinek-Russo, Amanda Perozo Garcia, Abigail Candelari, Leandra N Berry, Robin P Goin-Kochel, Wayne K Goodman, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Parent-led cognitive behavioral therapy (CBT) is an efficient, promising form of therapy that may be well suited for autistic youth with anxiety disorders, though to date it has been minimally tested. In this study, 87 autistic youth (7 to 13 years old) with anxiety disorders and their parents were randomized to two forms of parent-led CBT in which parents led their child through a guided CBT workbook across 12 weeks: one with low therapist contact (four 30-minute telehealth calls), and one with standard therapist contact (ten 60-minute telehealth calls). Anxiety, functional impairment, and autism features significantly declined across therapy, without …

Family Accommodation In Children And Adolescents With Misophonia, Eric A Storch, Andrew G Guzick, Johann D'Souza, Jane Clinger, Daphne Ayton, Minjee Kook, Conor Rork, Eleanor E Smith, Isabel A Draper, Nasim Khalfe, Catherine E Rast, Nicholas Murphy, Marijn Lijfijjt, Wayne K Goodman, Matti Cervin

Center for Medical Ethics and Health Policy Staff Publications

Family accommodation (e.g., reassurance, modifying routines, assisting avoidance) has not been explored among youth with misophonia but may have important clinical and intervention implications. We examined family accommodation in 102 children and adolescents with interview-confirmed misophonia and compared its frequency and content to family accommodation in 95 children and adolescents with anxiety disorders. Findings showed that family accommodation was ubiquitous in pediatric misophonia and may be even more frequent than in youth with anxiety disorders. Assisting the child, participating in misophonia-related behaviors, and modifying family routines were endorsed by more than 70% of parents of children with misophonia. Further, compared …

Zooming In On Justice: The Case For Virtual Bioethics Conferencing., Bruce P Blackshaw, Daniel Rodger, Daniel J Hurst

Rowan-Virtua School of Osteopathic Medicine Departmental Research

No abstract available.

We Are Not Okay: Moral Injury And A World On Fire, Keisha S Ray

Faculty and Staff Publications

No abstract provided.

Genetic Researchers' Use Of And Interest In Research With Diverse Ancestral Groups, Kaitlyn Jaffe, Amanda K Greene, Luyun Chen, Kerry A Ryan, Chris Krenz, J Scott Roberts, Brian J Zikmund-Fisher, Amy L Mcguire, J Denard Thomas, Erica E Marsh, Kayte Spector-Bagdady

Center for Medical Ethics and Health Policy Staff Publications

Importance: Genetic researchers must have access to databases populated with data from diverse ancestral groups to ensure research is generalizable or targeted for historically excluded communities.

Objective: To determine genetic researchers' interest in doing research with diverse ancestral populations, which database stewards offer adequate samples, and additional facilitators for use of diverse ancestral data.

Design, setting, and participants: This survey study was conducted from June to December 2022 and was part of an exploratory sequential mixed-methods project in which previous qualitative results informed survey design. Eligible participants included genetic researchers who held US academic affiliations and conducted research using human …

Analytical Challenges In Omics Research On Asthma And Allergy: A National Institute Of Allergy And Infectious Diseases Workshop, Supinda Bunyavanich, Patrice M Becker, Matthew C Altman, Jessica Lasky-Su, Carole Ober, Karsten Zengler, Evgeny Berdyshev, Richard Bonneau, Talal Chatila, Nilanjan Chatterjee, Kian Fan Chung, Colleen Cutcliffe, Wendy Davidson, Gang Dong, Gang Fang, Patricia Fulkerson, Blanca E Himes, Liming Liang, Rasika A Mathias, Shuji Ogino, Joseph Petrosino, Nathan D Price, Eric Schadt, James Schofield, Max A Seibold, Hanno Steen, Lisa Wheatley, Hongmei Zhang, Alkis Togias, Kohei Hasegawa

Center for Medical Ethics and Health Policy Staff Publications

Studies of asthma and allergy are generating increasing volumes of omics data for analysis and interpretation. The National Institute of Allergy and Infectious Diseases (NIAID) assembled a workshop comprising investigators studying asthma and allergic diseases using omics approaches, omics investigators from outside the field, and NIAID medical and scientific officers to discuss the following areas in asthma and allergy research: genomics, epigenomics, transcriptomics, microbiomics, metabolomics, proteomics, lipidomics, integrative omics, systems biology, and causal inference. Current states of the art, present challenges, novel and emerging strategies, and priorities for progress were presented and discussed for each area. This workshop report summarizes …

The Role Of Between-Session Homework In Cognitive-Behavioral Therapy For Comorbid Obsessive-Compulsive Disorder And Autism: A Case Vignette, Molly J Church, Katie H Mangen, Jordan T Stiede, Samuel D Spencer, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Objective: Cognitive-behavioral therapy (CBT), which includes a decided emphasis on exposure and response/ritual prevention (ERP) and between-session practice of treatment principles, has consistently demonstrated efficacy for the treatment of obsessive-compulsive disorder (OCD) and is a gold standard, recommended first-line treatment. CBT with ERP has been successfully adapted to fit the needs of autistic individuals with OCD. The present article provides a brief overview of CBT for OCD and outlines special considerations and adaptations needed when working with patients with OCD and comorbid autism, with an emphasis on the importance of between-session homework.

Method: A case vignette is presented.

Results: This …

Data Stewardship In Ftld Research: Investigator And Research Participant Views, Jalayne J Arias, Ana M Tyler, Laura M Beskow, Maria C Carillo, Susan Dickinson, Jill Goldman, Mary A Majumder, Michelle M Mello, Heather M Snyder, Jennifer S Yokoyama

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Federal policies and guidelines have expanded the return of individual results to participants and expectations for data sharing between investigators and through repositories. Here, we report investigators' and study participants' views and experiences with data stewardship practices within frontotemporal lobal degeneration (FTLD) research, which reveal unique ethical challenges.

Methods: Semi-structured interviews with (1) investigators conducting FTLD research that includes genetic data collection and/or analysis and (2) participants enrolled in a single site longitudinal FTLD study.

Results: Analysis of the interviews identified three meta themes: perspectives on data sharing, experiences with enrollment and participation, and data management and security as …

Antitumor Efficacy And Safety Of Unedited Autologous Cd5car T Cells In Relapsed/Refractory Mature T-Cell Lymphomas, Laquisa C Hill, Rayne H Rouce, Mengfen J Wu, Tao Wang, Royce Ma, Huimin Zhang, Birju Mehta, Natalia Lapteva, Zhuyong Mei, Tyler S Smith, Lina Yang, Madhuwanti Srinivasan, Phillip M Burkhardt, Carlos A Ramos, Premal Lulla, Martha Arredondo, Bambi Grilley, Helen E Heslop, Malcolm K Brenner, Maksim Mamonkin

Center for Medical Ethics and Health Policy Staff Publications

Despite newer targeted therapies, patients with primary refractory or relapsed (r/r) T-cell lymphoma have a poor prognosis. The development of chimeric antigen receptor (CAR) T-cell platforms to treat T-cell malignancies often requires additional gene modifications to overcome fratricide because of shared T-cell antigens on normal and malignant T cells. We developed a CD5-directed CAR that produces minimal fratricide by downmodulating CD5 protein levels in transduced T cells while retaining strong cytotoxicity against CD5⁺ malignant cells. In our first-in-human phase 1 study (NCT0308190), second-generation autologous CD5.CAR T cells were manufactured from patients with r/r T-cell malignancies. Here, we report safety …

Close Contacts Of Xenograft Recipients: Ethical Considerations Due To Risk Of Xenozoonosis, Daniel J Hurst, Luz Padilla, Daniel Rodger, Tamar Schiff, David K C Cooper

Rowan-Virtua School of Osteopathic Medicine Departmental Research

With decades of pre-clinical studies culminating in the recent clinical application of xenotransplantation, it would appear timely to provide recommendations for operationalizing oversight of xenotransplantation clinical trials. Ethical issues with clinical xenotransplantation have been described for decades, largely centering on animal welfare, the risks posed to the recipient, and public health risks posed by potential spread of xenozoonosis. Much less attention has been given to considerations relating to potentially elevated risks faced by those who may care for or otherwise have close contact with xenograft recipients. This paper examines the ethical and logistical issues raised by the potential exposure to …

Environmental Detection Of Parasites In The Marginalized Paiute Reservations Compared To A Nearby Area, Shannon Mckim, Kristen Kopystynsky, Nathaniel Wolf, Fahim A Akbar, Maria Elena Bottazzi, Peter J Hotez, Rojelio Mejia

Center for Medical Ethics and Health Policy Staff Publications

The amounts of parasite DNA in soil samples from different playgrounds and other public areas can help identify areas of possible microbe transmission and give indications of the possible occurrence of parasite infection in nearby communities. We collected 207 soil samples from parks in Paiute indigenous tribal areas in southwestern Utah and from the higher income city of St. George, Utah, and tested them for 11 parasites that can cause human disease. Molecular tests revealed an elevated odds ratio (OR) of 3.072 (range, 1.114-8.065) for detecting the helminth Trichuris trichiura and an elevated OR of 3.036 (range, 1.101-7.966) for any …

Improving Sexual Health Through Medical Education, Renee J Flores

Faculty and Staff Publications

No abstract provided.

Self-Sampling For Human Papillomavirus Testing: Acceptability In A Us Safety Net Health System, Susan L Parker, Trisha L Amboree, Shaun Bulsara, Maria Daheri, Matthew L Anderson, Susan G Hilsenbeck, Maria L Jibaja-Weiss, Mohammed Zare, Kathleen M Schmeler, Ashish A Deshmukh, Elizabeth Y Chiao, Michael E Scheurer, Jane R Montealegre

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Self-sampling for human papillomavirus testing is increasingly recognized as a strategy to expand cervical cancer screening access and utilization. Acceptability is a key determinant of uptake. This study assesses the acceptability of and experiences with mailed self-sampling kits for human papillomavirus testing among underscreened patients in a safety net health system.

Methods: A nested telephone survey was administered between 2021 and 2023 to a sample (n=272) of the 2,268 participants enrolled in the Prospective Evaluation of Self-Testing to Increase Screening trial. Trial participants include patients of a safety net health system aged 30-65 years who were not up to …

Building Effective Mentoring Relationships During Clinical Ethics Fellowships: Pedagogy, Programs, And People, Trevor M Bibler, Ryan H Nelson, Bryanna Moore, Janet Malek, Mary A Majumder

Center for Medical Ethics and Health Policy Staff Publications

How should clinical ethicists be trained? Scholars have stated that clinical ethics fellowships create well-trained, competent ethicists. While this appears intuitive, few features of fellowship programs have been publicly discussed, let alone debated. In this paper, we examine how fellowships can foster effective mentoring relationships. These relationships provide the foundation for the fellow's transition from novice to competent professional. In this essay, we begin by discussing our pedagogical commitments. Next, we describe the structures our program has created to assist our fellows in becoming competent ethicists. We then outline the kinds of knowledge, skills, and professional attributes mentors should possess. …

A Phase 1 Trial Utilizing A Pharmacokinetic Endpoint To Determine The Optimal Dose Of Ramucirumab In Children And Adolescents With Relapsed Or Refractory Solid Tumors, Including Central Nervous System Tumors, Kristy L Pilbeam, Kamnesh Pradhan, James Croop, Charles G Minard, Xiaowei Liu, Stephan D Voss, Emasenyie Isikwei, Stacey L Berg, Joel M Reid, Elizabeth Fox, Brenda J Weigel

Center for Medical Ethics and Health Policy Staff Publications

Background: Ramucirumab is a monoclonal antibody that binds the extracellular domain of vascular endothelial growth factor receptor (VEGFR-2) and prevents binding of VEGF ligands. Based on population pharmacokinetic (PK) analysis and correlation with efficacy in adults, a target steady state trough concentration (Css,min ) ≥ 50 µg/mL was established.

Procedures: This phase 1 trial (ADVL1416) used a rolling six design and a PK primary endpoint to define the recommended phase 2 dose (RP2D) of ramucirumab in children with recurrent/refractory solid tumors. Two dose levels (DL) were planned (DL1: 8 mg/kg, DL2: 12 mg/kg administered intravenously [IV] every 2 weeks). Toxicity …

Igg In The Trenches: Results Of An In-Depth Interview Study On The Practice, Politics, And Future Of Investigative Genetic Genealogy, Christi J Guerrini, Whitney Bash Brooks, Jill O Robinson, Stephanie M Fullerton, Emily Zoorob, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

Investigative genetic genealogy (IGG) is a new technique for identifying criminal suspects and unidentified deceased and living persons that has sparked controversy. In a criminal case, the technique involves uploading genetic information left by a putative perpetrator at the crime scene to one or more direct-to-consumer genetic genealogy databases with the intention of identifying the perpetrator's genetic relatives and, eventually, locating the perpetrator on the family tree. In 2018, IGG helped to identify the Golden State Killer, and it has since been used in hundreds of investigations in the United States. Here, we report findings from in-depth interviews with 24 …

Pretesting Discrete-Choice Experiments: A Guide For Researchers, Nicola B Campoamor, Christi J Guerrini, Whitney Bash Brooks, John F P Bridges, Norah L Crossnohere

Center for Medical Ethics and Health Policy Staff Publications

Discrete-choice experiments (DCEs) are a frequently used method to explore the preferences of patients and other decision-makers in health. Pretesting is an essential stage in the design of a high-quality choice experiment and involves engaging with representatives of the target population to improve the readability, presentation, and structure of the preference instrument. The goal of pretesting in DCEs is to improve the validity, reliability, and relevance of the survey, while decreasing sources of bias, burden, and error associated with preference elicitation, data collection, and interpretation of the data. Despite its value to inform DCE design, pretesting lacks documented good practices …