Health Policy Commons^™

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 …

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 …

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 …

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 …

Mobilizing Prevention And Early Detection Of Alzheimer's Disease And Related Dementias (Adrd) In Allegheny County Through The Area Agency On Aging (Aaa), Laiba N. Mirza

Public Health Capstone Projects

1. Objectives: In collaboration with the Department of Human Services (DHS): the Area Agency on Aging (AAA) using the Healthy Brain Initiative (HBI), my capstone project will involve the development of a comprehensive literature review examining the impacts of Alzheimer’s disease and related dementias (ADRD) on patients and their caregivers. The project aims to help the AAA focus on strategies to delay the onset of ADRD in Allegheny County. It also seeks to evaluate and enhance early detection programs for ADRD established by the AAA in communities within the county. Additionally, the project will explore how public health initiatives can …

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 = …

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.

Longitudinal Phage-Bacteria Dynamics In The Early Life Gut Microbiome, Michael J Tisza, Richard E Lloyd, Kristi Hoffman, Daniel P Smith, Marian Rewers, Sara J Javornik Cregeen, Joseph F Petrosino

Center for Medical Ethics and Health Policy Staff Publications

Microbial colonization of the human gut occurs soon after birth, proceeds through well-studied phases and is affected by lifestyle and other factors. Less is known about phage community dynamics during infant gut colonization due to small study sizes, an inability to leverage large databases and a lack of appropriate bioinformatics tools. Here we reanalysed whole microbial community shotgun sequencing data of 12,262 longitudinal samples from 887 children from four countries across four years of life as part of the The Environmental Determinants of Diabetes in the Young (TEDDY) study. We developed an extensive metagenome-assembled genome catalogue using the Marker-MAGu pipeline, …

Improving Individualized Rhabdomyosarcoma Prognosis Predictions Using Somatic Molecular Biomarkers, Mark Zobeck, Javed Khan, Rajkumar Venkatramani, M Fatih Okcu, Michael E Scheurer, Philip J Lupo

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Molecular markers increasingly influence risk-stratified treatment selection for pediatric rhabdomyosarcoma (RMS). This study aims to integrate molecular and clinical data to produce individualized prognosis predictions that can further improve treatment selection.

Methods: Clinical variables and somatic mutation data for 20 genes from 641 patients with RMS in the United Kingdom and the United States were used to develop three Cox proportional hazard models for predicting event-free survival (EFS). The Baseline Clinical (BC) model included treatment location, age, fusion status, and risk group. The Gene Enhanced 2 (GE2) model added TP53 and MYOD1 mutations to the BC predictors. The Gene …

Figg At 5: An Update On Us Public Perspectives On Forensic Investigative Genetic Genealogy Five Years After Its Introduction To Criminal Investigations, Christi J Guerrini, Jill O Robinson, Mohamed I Elsaid, Whitney Bash Brooks, Ariel Levchenko, Stephanie M Fullerton, Sara Huston, Norah L Crossnohere, John F P Bridges, Jacklyn M Dahlquist, Louiza Kalokairinou, Diana Madden, Cece Moore, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

In 2018, after law enforcement announced it had used a technique called forensic investigative genetic genealogy (FIGG) to identify the Golden State Killer, we conducted a U.S. general population survey and found most respondents supported using FIGG to solve violent crimes. Since then, FIGG has helped close hundreds of criminal cases, but it also has weathered controversies. On FIGG's fifth anniversary, we conducted an expanded, follow-up survey with U.S.-based participants to determine if public opinion had changed and found continued support for FIGG across most applications. The same proportion (91 %) of respondents in the 2018 and 2023 surveys endorsed …

Revisiting What Constitutes A Neglected Tropical Disease?, Paul J Brindley, Peter J Hotez, Shaden Kamhawi

Center for Medical Ethics and Health Policy Staff Publications

PLOS Neglected Tropical Diseases (PLOS NTDs) publishes research devoted to pathogenesis and other clinical aspects, epidemiology, prevention, diagnosis, treatment, and control of the neglected tropical diseases (NTDs), as well as work relevant to public health policy. We define NTDs as poverty-promoting infectious diseases that can negatively impact the quality of life in rural areas and poor urban areas of low- and middle-income countries but which can also affect specific communities within high-income countries. The poverty-inducing effects of the NTDs operate by impairing child health and development, pregnancy outcomes for both mother and child, worker productivity, and quality of life. The …

Incidence And Survival Of Children And Adolescents With Wilms Tumor, United States, 2001-2020, Andres F Espinoza, Ekene Onwuka, David A Siegel, Shifan Dai, Sanjeev A Vasudevan, Michael E Scheurer, Philip J Lupo

Center for Medical Ethics and Health Policy Staff Publications

Background: Wilms tumor (WT) is the most common pediatric malignancy of the kidney. Past studies describing WT incidence and survival used surveillance data with < 30% of the US population. We evaluated differences in WT incidence and survival comparing demographic groups and tumor characteristics.

Methods: We analyzed new cases of WT among patients aged < 20 years at diagnosis by using incidence data from US Cancer Statistics (USCS) for 2003-2020 and 5-year relative survival (RS) data from the National Program of Cancer Registries (NPCR) for 2001-2019. To assess incidence trends, average annual percent change (AAPC) was calculated by using joinpoint regression. Relative survival (RS) and all-cause survival were calculated overall and by demographic and clinical variables.

Results: During 2003-2020, 8218 cases of WT were reported in USCS, which represented an age-adjusted incidence rate of 5.7 cases per million. Rates were the highest among females (6.3), children aged 0-4 years (17.2), and non-Hispanic Black patients (7.1). Overall, trends remained stable (AAPC = -0.4, 95% CI: -1.4 to 0.4). Among 7567 cases of WT in NPCR, 5-year RS was 92.6%. Patients with the lowest …

Ethical Governance For Genomic Data Science In The Cloud, Vasiliki Rahimzadeh, Sarah C Nelson, Adrian Thorogood, Jonathan Lawson, Stephanie M Fullerton

Center for Medical Ethics and Health Policy Staff Publications

Cloud platforms offer distinct advantages, but questions remain about how to ethically and efficiently manage human genomic data in the cloud. Data governance needs to be adapted to ensure transparency and security for research participants, as well as equitable and sustainable access for researchers.

Resilience And Coping: A Qualitative Analysis Of Cognitive And Behavioral Factors In Adults With Osteogenesis Imperfecta, Hannah E Cho, Whitney S Shepherd, Gianna M Colombo, Andrew D Wiese, W Conor Rork, Kristin M Kostick, Dianne Nguyen, Members Of The Bbdc, Chaya N Murali, Marie-Eve Robinson, Sophie C Schneider, Justin H Qian, Brendan Lee, V Reid Sutton, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Purpose: The aim of this qualitative study was to investigate resilience among adults with Osteogenesis Imperfecta (OI).

Materials and methods: Semi-structured interviews were conducted with 15 adults with OI. Transcripts were coded and subsequently abstracted, yielding themes specific to resilience and coping. Interview guides covered broad topics including pain challenges specific to OI, mental health issues related to OI, and priorities for future interventions for individuals with OI.

Results: Participants described resilience in the context of OI as the ability to grow from adversity, adapt to challenges resulting from OI-related injuries, and find identities apart from their condition. Psychological coping …

Fairs - A Framework For Evaluating The Inclusion Of Sex In Clinical Algorithms, Katherine E Goodman, Jennifer Blumenthal-Barby, Rita F Redberg, Diane E Hoffmann

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Gut Microbial Changes Associated With Obesity In Youth With Type 1 Diabetes, Heba M Ismail, Dimuthu Perera, Rabindra Mandal, Linda A Dimeglio, Carmella Evans-Molina, Tamara Hannon, Joseph Petrosino, Sara Javornik Cregeen, Nathan W Schmidt

Center for Medical Ethics and Health Policy Staff Publications

Context: Obesity is prevalent in type 1 diabetes (T1D) and is problematic with higher risk for diabetes complications. It is unknown to what extent gut microbiome changes are associated with obesity and T1D.

Objective: This work aimed to describe the gut microbiome and microbial metabolite changes associated with obesity in T1D. We hypothesized statistically significant gut microbial and metabolite differences in lean T1D youth (body mass index [BMI]: 5%-< 85%) vs those with obesity (BMI: ≥95%).

Methods: We analyzed stool samples for gut microbial (using metagenomic shotgun sequencing) and short-chain fatty acid (SCFA) differences in lean (n = 27) and obese (n = 21) T1D youth in …

A Caution Against Customized Ai In Healthcare, Kristin M Kostick-Quenet

Center for Medical Ethics and Health Policy Staff Publications

This article critiques the shift towards personalized AI in healthcare and other high-stakes domains, cautioning that without careful deliberation, customized AI systems can compromise the diversity and reach of human knowledge by restricting exposure to critical information that may conflict with users' preferences and biases. Customized AI should be applied with caution and intention where access to a wide and diverse range of perspectives is essential for impartial, informed decision making.

Us Military Veterans’ Perceived Concordance With Their Providers Regarding Persistent Physical Symptoms Prospectively Predicts Satisfaction With Care And Adherence To Care Plans, L Alison Phillips, Laura M Lesnewich, Katharine Bloeser, Yong Lin, Rachel L Boska, Justeen K Hyde, Peter J Bayley, Helena K Chandler, Matthew J Reinhard, Susan L Santos, Rachel Stewart, Drew A Helmer, Lisa M Mcandrew

Center for Medical Ethics and Health Policy Staff Publications

Background: Medically unexplained, persistent physical symptoms and syndromes are commonly seen in primary care. These are debilitating for patients and difficult to treat, causing frustration for patients and providers.

Purpose: This study investigates how well US military veterans with multiple persistent physical symptoms (PPS), called Gulf War illness (GWI), agree with their healthcare providers about their illness. This agreement, called perceived concordance, is hypothesized to influence veterans' satisfaction with care, adherence to care plans, and disability levels.

Methods: Participants were 230 veterans with GWI deployed to the 1990-1991 Gulf War who were recruited from Veteran Affairs primary care and War …

Ethical, Legal, And Social Issues In Metaverse-Enabled Healthcare, Kristin M Kostick-Quenet, Vasiliki Rahimzadeh

Center for Medical Ethics and Health Policy Staff Publications

Metaverse is heralded by some as the next iteration of the internet. It offers three-dimensional, immersive virtual spaces, where users, represented as avatars, can synchronously work, play, interact, and transact. Initially developed within the realm of massive multiplayer online role-playing games, the metaverse now extends into sectors such as music, entertainment, retail, real estate, and, more recently, healthcare. Users engage in the metaverse using augmented reality or virtual reality (AR/VR) headsets that interoperate with other sensory devices to integrate biofeedback and multimodal data streams.1 In this article, the authors offer a conceptual synthesis and anticipatory policy analysis grounded in …

Moving Beyond Simplistic Research Design In Health Professions Education: What A One-Group Pretest-Posttest Design Will Not Prove, S Beth Bierer, Gary Beck Dallaghan, Nicole J Borges, Sam Brondfield, Cha Chi Fung, Kathryn N Huggett, Cayla R Teal, Satid Thammasitboon, Colleen Y Colbert

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Educational research presents unique study design challenges. Novice researchers in health professions education (HPE) frequently misuse the one-group pretest-posttest design, highlighting the need for improved training in research design. This workshop aimed to enhance understanding of research design among novice HPE researchers, specifically addressing the inherent limitations of the one-group pretest-posttest design and offering alternative approaches.

Methods: Experienced HPE researchers developed this workshop to address common misunderstandings of research design. Leaders from the AAMC Medical Education, Scholarship, Research, and Evaluation section facilitated 60-75-minute workshops conducted at the four 2024 regional meetings hosted by the AAMC Group on Educational Affairs …

Examining Treatment Options In Youth With Major Depressive Disorder: Observations From The Tx-Ydsrn Registry Study, Emine Rabia Ayvaci, Karabi Nandy, Ryan Becker, Laura Stone, Abu Minhajuddin, Holli Slater, Lynnel C Goodman, Sarah M Wakefield, Eric A Storch, Joseph C Blader, Cesar A Soutullo, Graham J Emslie, Madhukar H Trivedi

Center for Medical Ethics and Health Policy Staff Publications

Objective: Treatment decisions for depression are a complex process, influenced by factors such as clinical characteristics, socioeconomic factors, and patient/caregiver preferences. This study examines the characteristics of treatment options during the first month of enrollment among depressed youth.

Methods: Data for 646 depressed youth were extracted from the Texas Youth Depression and Suicide Research Network study. Participants' treatments during the first month were categorized as no treatment (NT), psychotherapy only (THER), pharmacotherapy only (MED), or a combination of psychotherapy and pharmacotherapy (COMB). Sociodemographic and clinical features were compared across these treatment types.

Results: 7% were on NT, 5% on THER, …

Different Responses Involving Tfh Cells Delay Parasite-Specific Antibody Production In Trypanosoma Cruzi Acute Experimental Models, Ana Carolina Leão, Maria Jose Villar, Rakesh Adhikari, Cristina Poveda, Leroy Versteeg, Gregório Almeida, Peter J Hotez, Maria Elena Bottazzi, Kathryn M Jones

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Chagas disease (CD), caused by the parasite Trypanosoma cruzi, affects millions globally. Despite treatment options in the acute phase, most infections progress to a chronic indeterminate form or develop severe cardiac/gastrointestinal complications. Understanding the immune response is crucial for the development of vaccines and more efficient drugs for the disease control.

Methods: This work investigates the immune response to T. cruzi H1 K68 strain infection in female BALB/c and C57BL/6 mice to characterize differences in Tfh and B cell responses that may be involved in the poor parasite-specific antibody production during acute infection. For this, mice were euthanized …

A Hybrid Cloud Data Lake Architecture Supporting The Integration Of Clinical And Genomics Data, Apollo Mcowiti, Heidi Dowst, Fei Zheng, Susan Hilsenbeck, Christopher Amos

Center for Medical Ethics and Health Policy Staff Publications

Objective: Cancer centers must quickly integrate clinical genomics data from different vendors for oncology operations and research. Clinical data warehouse architectures are costly to construct and brittle, and they are not readily amenable to the rapid changes in oncology research. We introduce a cost-effective hybrid cloud Data Lake architecture for storing clinical genomic data from different vendors, aiding both clinical and research workflows.

Methods: We created a Data Lake architecture based on the zone architecture, with four layers: ingestion, storage, transformation, and interaction. The layers are implemented with a hybrid cloud architecture. Rich metadata created from patient and genomic data …

Methadone For Critically Ill Patients Under Mechanical Ventilation In The Intensive Care Unit: A Systematic Review, Sérgio Martins Pereira, Megan Abbott, João Francisco Figueiredo Marcondes Ferraz, Akash Goel, Andrea Rigamonti, Charmaine De Castro, Lisa Burry, Airton Leonardo De Oliveira Manoel, Michael Chaim Sklar

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Pain may pose significant challenges in the intensive care unit, especially in mechanically ventilated patients. Methadone has recently emerged as an alternative option for eliciting acute analgesia. In this systematic review, we evaluated the use of methadone in mechanically ventilated patients in the intensive care unit.

Source: We searched MEDLINE, EMBASE, Wiley's Cochrane Library, CINAHL, PubMed (non-MEDLINE), Scopus, and LILACS databases from inception to January 24th, 2025. Eligible studies included randomized controlled trials and observational studies that compared the use of methadone to the standard of care or to other analgosedation strategies in mechanically ventilated patients in the intensive …

Impact Of Personalized Risk Scores On Shared Decision Making In Left Ventricular Assist Device Implantation: Findings From A Qualitative Study, Holland Kaplan, Kristin Kostick-Quenet, Benjamin Lang, Robert J Volk, Jennifer Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

Objective: To assess stakeholders' perspectives on integrating personalized risk scores (PRS) into left ventricular assist device (LVAD) implantation decisions and how these perspectives might impact shared decision making (SDM).

Methods: We conducted 40 in-depth interviews with physicians, nurse coordinators, patients, and caregivers about integrating PRS into LVAD implantation decisions. A codebook was developed to identify thematic patterns, and quotations were consolidated for analysis. We used Thematic Content Analysis in MAXQDA software to identify themes by abstracting relevant quotes.

Results: Clinicians had varying preferences regarding PRS integration into LVAD decision making, while patients and caregivers preferred real-time discussions about PRS with …

Survivorship From Pediatric And Adult Brain Tumors: The 2024 Brain Tumor Epidemiology Consortium Meeting Report, Scott L Coven, Roberta Mckean-Cowdin, Michael E Scheurer, Kimberly J Johnson, Luc Bauchet, Carol Kruchko, Ching C Lau, Quinn T Ostrom, John Villano, Yan Yuan, Friederike Erdmann

Center for Medical Ethics and Health Policy Staff Publications

The Brain Tumor Epidemiology Consortium (BTEC) is an international organization with membership of individuals from the scientific community with interests related to brain tumor epidemiology, including surveillance, classification, methodology, etiology, and factors associated with morbidity and survival. The 2024 annual BTEC meeting entitled “Survivorship from Pediatric and Adult Brain Tumors” was held in Mainz, Germany, USA, on May 15–17, 2024. The meeting gathered scientists from Africa, Australia, Europe, and North America and included 4 keynote sessions focusing on brain tumor survivorship across the age spectrum. The meeting included 3 abstract sessions, which also included scientific talks around brain …

A Landscape Analysis Of Psychedelic Retreat Organizations Advertising Online, Logan Neitzke-Spruill, Caroline S Beit, Jill Oliver Robinson, Nikita Singh, Srijith Kambala, Rishi Ramesh, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

Research into psychedelics' clinical potential has corresponded to a growth in public interest and adult use. One common pathway to accessing psychedelics is through psychedelic retreats. While individual retreats have been characterized in the anthropological literature, no systematic evaluation of the psychedelic retreat industry exists. Assessing the characteristics of the psychedelic retreat industry is critical to understanding the associated ethical, legal, and social implications and ensuring consumer safety. To this end, we conducted a landscape analysis of online, publicly available information to capture and characterize a broad range of organizations offering psychedelic retreats and marketing to English-speaking consumers. From July …

Advancing Medical Applications Of Cancer Nanotechnology: Highlighting Two Decades Of The Nci's Nanotechnology Characterization Laboratory Service To The Research Community, Rachael M Crist, Yechezkel Barenholz, Ahuva Cern, Kate N Clark, Pieter R Cullis, Cheryl Dean, Neil Desai, Mauro Ferrari, Matthieu Germain, Carmen A Giacomantonio, Emma Grabarnik, Piotr Grodzinski, Atara Hod, Barry E Kennedy, Ruvanthi N Kularatne, Glen S Kwon, Emmanuel Loeb, Erin B Noftall, Len Pagliaro, Morteza Rasoulianboroujeni, Alexander Roth, Darren Rowles, Kulbir Singh, Nicole F Steinmetz, Zhanna Yehtina, Yao Zhang, Daniel Zilbersheid, Jeffrey D Clogston, Stephan T Stern, Marina A Dobrovolskaia

Center for Medical Ethics and Health Policy Staff Publications

The Nanotechnology Characterization Laboratory (NCL) is a US federally funded resource providing characterization and expertise to the cancer nanomedicine research community. Founded as a formal partnership among the US National Cancer Institute (NCI), the US Food and Drug Administration (FDA), and the US National Institute of Standards and Technology (NIST), the NCL has spent two decades developing a one-of-a-kind service with broad multidisciplinary expertise to meet the needs of a rapidly evolving drug development field. To mark the 20th anniversary of the lab's founding, the NCL hosted a symposium to highlight the achievements of the cancer nanomedicine field, showcase novel, …

When Families Bridge The Research-Clinical Divide: An Exploration Of Values Regarding Cascade Screening In Genomic Research, Katherine E Bonini, Lauren R Desrosiers-Battu, Ann Katherine M Foreman, Nuriye N Sahin-Hodoglugil, Mary A Majumder, Candice R Finnila, Stephanie A Kraft, Laura M Amendola, Eimear E Kenny, Stephanie M Fullerton, Sara L Ackerman, Benjamin S Wilfond, Amy L Mcguire, Hadley Stevens Smith

Center for Medical Ethics and Health Policy Staff Publications

Purpose: Genetic results are important for both patients and their biological relatives. However, cascade screening (CS) uptake is low, especially when testing occurs through research programs and not clinical care. Ethical guidance is needed for CS implementation when individuals receive clinical genetic results through research.

Methods: We conducted focus groups with 3 groups of individuals in the Clinical Sequencing Evidence-Generating Research Consortium: clinicians, patient representatives, and scholars of the ethical, legal, and social implications of genomics. We used inductive thematic and comparative analyses to analyze data within and across the groups.

Results: All participants (n = 27) agreed that …

On Minimizing Risk And Harm In The Use Of Psychedelics, Jules Evans, Marc Aixalà, Brian T Anderson, William Brennan, Rebecka Bremler, Joost J Breeksema, Lisa Burback, Abigail E Calder, Robin L Carhart-Harris, Katherine Cheung, Neşe Devenot, Ingmar Gorman, Jakub Greń, Peter S Hendricks, Brian Holoyda, Edward Jacobs, Joy Krecké, Daniel J Kruger, David Luke, Tomislav Majić, Amy L Mcguire, Nicky J Mehtani, David S Mathai, Kristin Nash, Tehseen Noorani, Roman Palitsky, Oliver C Robinson, Otto Simonsson, Elin Stahre, Michiel Van Elk, David B Yaden

Center for Medical Ethics and Health Policy Staff Publications

Objective: This article outlines recommendations from 30 psychedelic researchers on how to create a better psychedelic safety net.

Methods: A survey of 30 psychedelic researchers asked them to identify key critical research gaps around psychedelic harm and safety.

Results: The critical research gaps identified by the authors included defining the main types of psychedelic harm, the predictors of those harms, and the most effective way to treat those harms. They also call for better support for those experiencing post-psychedelic difficulties, including better online information, peer support groups, affordable therapy, and psychiatric consultation and medication. Finally, the authors call for better …