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Simulated Misuse of Large Language Models and Clinical Credit Systems medRxiv. Med. Eth. Pub Date : 2024-09-16 James Anibal, Hannah Huth, Jasmine Gunkel, Susan Gregurick, Bradford Wood
Large language models (LLMs) have been proposed to support many healthcare tasks, including disease diagnostics and treatment personalization. While AI may be applied to assist or enhance the delivery of healthcare, there is also a risk of misuse. LLMs could be used to allocate resources via unfair, unjust, or inaccurate criteria. For example, a social credit system uses big data to assess trustworthiness
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Just because you're paranoid doesn't mean they won't side with the plaintiff: Examining perceptions of liability about AI in radiology medRxiv. Med. Eth. Pub Date : 2024-08-13 Michael H Bernstein, Brian Sheppard, Michael A Bruno, Parker S Lay, Grayson L Baird
Artificial Intelligence (AI) will have unintended consequences for radiology. When a radiologist misses an abnormality on an image, their liability may differ according to whether or not AI also missed the abnormality. U.S. adults viewed a vignette describing a radiologist being sued for missing a brain bleed (N=652) or cancer (N=682). Participants were randomized to one of five conditions. In four
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Transparency in the secondary use of health data: Assessing the status quo of guidance and best practices medRxiv. Med. Eth. Pub Date : 2024-08-11 Olmo van den Akker, Robert T. Thibault, John Ioannidis, Susanne G Schorr, Daniel Strech
We evaluated what guidance exists in the literature to improve the transparency of studies that make secondary use of health data. To find relevant literature, we searched PubMed and Google Scholar and drafted a list of health organizations based on our personal expertise. We quantitatively and qualitatively coded different types of research transparency: registration, methods reporting, results reporting
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Ethics in medical research: A quantitative analysis of the observations of Ethics Committees in research protocols. medRxiv. Med. Eth. Pub Date : 2024-06-24 Santiago Vasco-Morales, Gabriel Alejandro Vasco-Toapanta, Cristhian Santiago Vasco-Toapanta, Paola Toapanta-Pinta
Objective: To determine the frequency of observations made by Research Ethics Committees (RECs) regarding non-compliance with ethical principles in research. Methods: We searched for articles published up to November 30, 2023. In the databases: PubMed, Scopus and Google Scholar. Single-proportion meta-analyses were performed with the R V.3.6.1 program. PROSPERO Registry: CRD42021291893 Results: 9 publications
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Ethics practices associated with reusing health data: An assessment of patient registries medRxiv. Med. Eth. Pub Date : 2024-04-29 Olmo R. van den Akker, Susanne Stark, Daniel Strech
Background As routinely collected patient data have become increasingly accessible over the years, more and more attention has been directed at the ethics of using such data for research purposes. Patient data is often available to researchers through patient registries that typically collect data of patients with a specific disease. While ethical guidelines for using patient data are presented frequently
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Social Impacts of Multi-City HIV Research Participation Among Sexual and Gender Expansive Individuals in Kazakhstan medRxiv. Med. Eth. Pub Date : 2024-04-23 Vitaliy Vinogradov, Yong Gun Lee, Gulnara Zhakupova, Gaukhar Mergenova, Alissa Davis, Emily Allen Paine, Kelsey G. Reeder, Caitlin I. Laughney, Jimin Sung, Sholpan Primbetova, Assel Terlikbayeva, Jeremy Sugarman, Elwin Wu
Background Sexual and gender expansive (SGE) individuals in Kazakhstan are disproportionately affected by HIV yet stigma and discrimination pose ethical and practical challenges for HIV prevention research involving them. Although researchers are tasked with ensuring that risks of research participation are reasonable in relation to its benefits, participation-related risks and benefits—including negative
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A Qualitative Study of the Ethical Issues Encountered at End-of-life Care at a University Teaching Hospital in Nigeria medRxiv. Med. Eth. Pub Date : 2024-04-22 Nnenma Ndidiamaka Udeh, Idemili-Arounu Ngozi, Emmanuel R Ezeome
Background End-of-life (EOL) care involves providing quality medical attention to the dying patient. It is fraught with some ethical challenges, often under-explored in African settings. This communication presents a qualitative analysis of ethical issues encountered by caregivers and their patients who are receiving end-of-life care in a teaching hospital in Nigeria.
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A survey of experts to identify methods to detect problematic studies: Stage 1 of the INSPECT-SR Project medRxiv. Med. Eth. Pub Date : 2024-03-25 Jack D Wilkinson, Calvin Heal, Georgios A Antoniou, Ella Flemyng, Alison Avenell, Virgina Barbour, Esmee M Bordewijk, Nicholas JL Brown, Mike Clarke, Jo Dumville, Steph Grohmann, Lyle C Gurrin, Jill A Hayden, Kylie E Hunter, Emily Lam, Toby Lasserson, Tianjing Li, Sarah Lensen, Jianping Liu, Andreas Lundh, Gideon Meyerowitz-Katz, Ben W Mol, Neil E O'Connell, Lisa Parker, Barbara Redman, Anna Lene Seidler
Background Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods
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Challenges in Institutional Ethical Review Process and Approval for International Multicenter Clinical Studies in Lower and Middle-Income Countries: the case of PARITY Study medRxiv. Med. Eth. Pub Date : 2024-03-22 Eliana Lopez Baron, Qalab Abbas, Paula Caporal, Asya Agulnik, Jonah E. Attebery, Adrian Holloway, Niranjan Kissoon, Celia Isabel Mulgado-Aguas, Kokou Amegan-Aho, Marianne Majdalani, Carmen Ocampo, Havugarurema Pascal, Erika Miller, Aimable Kanyamuhunga, Atnafu Mekonnen Tekleab, Tigist Bacha, Sebastian Gonzalez, Adnan T. Bhutta, Teresa B. Kortz, Srinivas Murthy, Kenneth E. Remy
Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in low- and middle-income countries (LMICs) during the institutional review board (IRB) process of an international multicenter observational point prevalence study (Global PARITY). Design: A 16-question multiple-choice online survey was sent to site principal investigators (PIs) at PARITY study
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A Systematic Examination of Generative Artificial Intelligence (GAI) Usage Guidelines for Scholarly Publishing in Medical Journals medRxiv. Med. Eth. Pub Date : 2024-03-20 Shuhui Yin, Peiyi Lu, Zhuoran Xu, Zi Lian, Chenfei Ye, CHIHUA LI
Background A thorough and in-depth examination of generative artificial intelligence (GAI) usage guidelines in medical journals will inform potential gaps and promote proper GAI usage in scholarly publishing. This study aims to examine the provision and specificity of GAI usage guidelines and their relationships with journal characteristics. Methods From the SCImago Journal Rank (SJR) list for medicine
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Student Cognitive Enhancement with Non-Prescribed Modafinil. Is it Cheating? medRxiv. Med. Eth. Pub Date : 2024-03-04 Alexia Kesta, Philip M. Newton
Modafinil, a prescription-only drug, it is mainly used to treat narcolepsy and sleep disorders, but it is also used, without a prescription, as a cognitive enhancer by ~10% of UK University students. Previous research has focused on the prevalence of, and motivations for, these behaviours. Here we focused specifically on determining whether students view this behaviour as cheating. We used a scenario-based
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Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center medRxiv. Med. Eth. Pub Date : 2024-02-23 Delwen L Franzen, Maia Salholz-Hillel, Stephanie Müller-Ohlraun, Daniel Strech
Research transparency is crucial for ensuring the relevance, integrity, and reliability of scientific findings. However, previous work indicates room for improvement across transparency practices. The primary objective of this study was to develop an extensible tool to provide individualized feedback and guidance for improved transparency across phases of a study. Our secondary objective was to assess
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ETHICAL CONSIDERATIONS FOR CLINICAL CARE ON SHORT TERM MEDICAL MISSIONS IN LOW- AND MIDDLE-INCOME COUNTRIES: A SCOPING REVIEW medRxiv. Med. Eth. Pub Date : 2024-02-03 M. Smith, R. Graham, C. Vance, W. Coburn, D. Richards, J. Whitfield
Intro Despite short term medical missions (STMMs) to low- and middle-income countries (LMIC) becoming increasingly popular, ethical considerations for the provision of clinical care on STMMs are poorly defined. Clinicians are often unprepared to adapt care and ethical precepts to resource limited environments. There may be discord in interpretation of ethical principles between visiting providers and
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Legal Frameworks Upholding Deceased Individuals' Rights and Enabling the Use of Cadavers in Anatomy Education and Research: A Systematic Review medRxiv. Med. Eth. Pub Date : 2023-10-20 Sundip Charmode, Nishat Ahmed Sheikh, Kumar Satish Ravi, Simmi Mehra
The study of human cadavers is essential for teaching, advanced training, and research in medical and anatomical sciences. Medical institutions, around the globe presently face the scarcity of cadaver supply. For the majority of countries, unclaimed bodies are still the primary source of cadavers despite guidelines issued by the International Federation of Associations of Anatomists which discourage
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Fake Publications in Biomedical Science: Red-flagging Method Indicates Mass Production medRxiv. Med. Eth. Pub Date : 2023-10-18 Bernhard A. Sabel, Emely Knaack, Gerd Gigerenzer, Mirela Bilc
Background: Integrity of academic publishing is increasingly undermined by fake science publications massively produced by commercial "editing services" (so-called "paper mills"). They use AI-supported, automated production techniques at scale and sell fake publications to students, scientists, and physicians under pressure to advance their careers. Because the scale of fake publications in biomedicine
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Differences in predicted rates of vaginal births after cesarean across racial groups in a 'race-neutral' model medRxiv. Med. Eth. Pub Date : 2023-10-15 Anjali Suresh, Katie O'Nell
When physicians and pregnant patients make decisions about whether to pursue a vaginal birth or cesarean, there are many factors at play. While vaginal birth can have health benefits for both parent and child, there are significant safety risks. In order to minimize these risks, physicians use predictive models to determine how likely patients are to have successful vaginal births after cesareans (VBAC)
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Barriers and Facilitators to Trustworthy and Ethical AI-enabled Medical Care From Patient and Healthcare Provider Perspectives: A Literature Review medRxiv. Med. Eth. Pub Date : 2023-10-02 Maryam Mooghali, Austin M Stroud, Dong Whi Yoo, Barbara A Barry, Alyssa A Grimshaw, Joseph S. Ross, Xuan Zhu, Jennifer E Miller
Background: Artificial intelligence (AI) and machine learning (ML) are increasingly used for prevention, diagnosis, monitoring, and treatment of cardiovascular diseases. Despite the potential for AI/ML to improve care, ethical concerns and mistrust in AI-enabled health care exist among the public and medical community. To inform practice guidelines and regulatory policies that facilitate ethical and
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Patient consent for medical student pelvic exams under anesthesia: an exploratory retrospective chart review medRxiv. Med. Eth. Pub Date : 2023-10-02 Jessica A. Jushchyshyn, Lakeisha Mulugeta-Gordon, Cara Curley, Florencia Greer Polite, Jon F Merz
ABSTRACT Background: Legal requirements and clinical practices of securing patient consent for medical student pelvic examinations under anesthesia (EUA) vary widely, while ethical arguments and patients' preferences for being asked for consent are well known. Objective: This study was performed to examine patients' choices to permit or refuse medical student pelvic EUAs during planned gynecologic
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Resource conflicts leading to moral distress: A longitudinal study among physicians in Norway medRxiv. Med. Eth. Pub Date : 2023-09-29 Ingrid Miljeteig, Reidun Forde, Karin Ro, Fredrik Baathe, Berit Bringedal
Background: The scarcity of resources represents ethical challenges and involves moral distress for health professionals. There are no longitudinal studies of moral distress among representative samples of physicians. Method: Surveys of the Norwegian Physician Panel (NPP) compared the extent of moral distress in 2004 and 2021. Descriptive statistics and regression analysis were used in the study. Results:
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Study on Good Clinical Practices among Researchers in a Tertiary Healthcare Institute in India medRxiv. Med. Eth. Pub Date : 2023-08-02 Harshita, Prasan Kumar Panda
BACKGROUND Good Clinical Practice (GCP) is put in place to protect human participants in clinical trials as well as to ensure the quality of research. Non-adherence to these guidelines can produce research that may not meet the standards set by the scientific community. Therefore, it must be ensured that researchers are well-versed in the GCP. But not much is known about the knowledge and practices
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Medical student attitudes to patient involvement in healthcare decision-making and research medRxiv. Med. Eth. Pub Date : 2023-07-26 Jennifer O'Neill, Bronwyn Docherty Stewart, Anna XN Ng, Yamini Roy, Liena Yousif, Kirsty R McIntyre
Objective Patient involvement is used to describe the inclusion of patients as active participants in healthcare decision-making and research. This study aimed to investigate incoming Year 1 medical (MBChB) students attitudes and opinions regarding patient involvement in this context. Methods We established a staff-student partnership to formulate the design of an online research survey, which included
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Structured Ethical Review for Wastewater-Based Testing medRxiv. Med. Eth. Pub Date : 2023-06-14 Devin A. Bowes, Amanda Darling, Erin M. Driver, Devrim Kaya, Rasha Maal-Bared, Lisa M. Lee, Kenneth Goodman, Sangeet Adhikari, Srijan Aggarwal, Aaron Bivins, Zuzana Bohrerova, Alasdair Cohen, Claire Duvallet, Rasha A. Elnimeiry, Justin M. Hutchison, Vikram Kapoor, Ishi Keenum, Fangqiong Ling, Deborah Sills, Ananda Tiwari, Peter Vikesland, Ryan Ziels, Cresten Mansfeldt
Wastewater-based testing (WBT) for SARS-CoV-2 has rapidly expanded over the past three years due to its ability to provide a comprehensive measurement of disease prevalence independent of clinical testing. The development and simultaneous application of the field blurred the boundary between measuring biomarkers for research activities and for pursuit of public health goals, both areas with well-established
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Evaluating the Association of Depressive Disorder Symptoms and Moral Injuries in Healthcare Workers during COVID-19 Pandemic medRxiv. Med. Eth. Pub Date : 2023-05-21 Amirhossein Behnampour, Sedigheh Ebrahimi, Amir Bazrafshan, Amirhossein Kamyab, Majid Pakdin, Alireza Ebrahimi
Background Moral injury occurs when negative distressing emotions appear and are suppressed. This could lead to several mental health problems such as depression and post-traumatic stress disorder, and result in long-lasting emotional, behavioral, and social problems. Moral injury, a term more commonly used in war contexts, has come into the spotlight during COVID-19 pandemic. We aimed to evaluate
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Major UK non-commercial sponsors’ efforts to reduce research waste: a mixed methods study medRxiv. Med. Eth. Pub Date : 2023-05-05 Till Bruckner, Aminul Schuster, Belén Chavarría, Carolina Cruz, Karely Lizárraga, Ronak Borana, Tungamirai Ishe Bvute, Daniel Sánchez
This study provides a snapshot of the scale of legacy research waste in the UK. It assesses the current publication status of 145 clinical trials sponsored by ten major UK non-commercial sponsors that were completed or terminated in 2017. Following outreach to sponsors and short-term follow-up, 116/145 trials (80%) had fully reported results, and 11/145 trials (8%) had reported results in the grey
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What do Australians affected by cancer think about oncology researchers sharing research data: a cross-sectional survey medRxiv. Med. Eth. Pub Date : 2023-05-02 Daniel G. Hamilton, Sarah Everitt, Matthew J. Page, Fiona Fidler
Objectives To characterise the attitudes of Australians affected by cancer towards the sharing of de-identified research data with third parties, including the public.
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OVERVIEW OF ETHICS COMMITTEE REGISTRATION AND RE-REGISTRATION WITH THE DEPARTMENT OF HEALTH RESEARCH IN INDIA medRxiv. Med. Eth. Pub Date : 2023-04-20 Yash Kamath, Yashashri Shetty, Ankita Kulkarni
The Government of India requires all ethics committees (EC) to register themselves with the Department of Health Research (DHR) and the study aimed to analyze the same. Since post-graduation mandates research – necessitating the presence of EC in the institution – we aimed to analyze the status of registrations along with the presence of ECs in National Medical Council(NMC) and Dental Council of India(DCI)-permitted
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Experiment aversion among clinicians and the public — an obstacle to evidence-based medicine and public health medRxiv. Med. Eth. Pub Date : 2023-04-06 Randi L. Vogt, Patrick R. Heck, Rebecca M. Mestechkin, Pedram Heydari, Christopher F. Chabris, Michelle N. Meyer
Background Randomized controlled trials (RCTs) are essential for determining the safety and efficacy of healthcare interventions. However, both laypeople and clinicians often demonstrate experiment aversion: preferring to implement either of two interventions for everyone rather than comparing them to determine which is best. We studied whether clinician and layperson views of pragmatic RCTs for Covid-19
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An exploratory survey about using ChatGPT in education, healthcare, and research medRxiv. Med. Eth. Pub Date : 2023-04-03 Mohammad Hosseini, Catherine A. Gao, David Liebovitz, Alexandre Carvalho, Faraz S. Ahmad, Yuan Luo, Ngan MacDonald, Kristi Holmes, Abel Kho
Objective ChatGPT is the first large language model (LLM) to reach a large, mainstream audience. Its rapid adoption and exploration by the population at large has sparked a wide range of discussions regarding its acceptable and optimal integration in different areas. In a hybrid (virtual and in-person) panel discussion event, we examined various perspectives regarding the use of ChatGPT in education
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Bias Amplification in Intersectional Subpopulations for Clinical Phenotyping by Large Language Models medRxiv. Med. Eth. Pub Date : 2023-03-25 Ridam Pal, Hardik Garg, Shashwat Patel, Tavpritesh Sethi
Large Language Models (LLMs) have demonstrated remarkable performance across diverse clinical tasks. However, there is growing concern that LLMs may amplify human bias and reduce performance quality for vulnerable subpopulations. Therefore, it is critical to investigate algorithmic underdiagnosis in clinical notes, which represent a key source of information for disease diagnosis and treatment. This
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Reporting of Retrospective Registration in Clinical Trial Publications: a Cross-Sectional Study of German Trials medRxiv. Med. Eth. Pub Date : 2023-03-07 Martin Haslberger, Stefanie Gestrich, Daniel Strech
Objective: Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications, and investigated factors associated with transparent reporting. Design: We used a dataset of trials registered in ClinicalTrials
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Identifying High Priority Ethical Challenges for Precision Emergency Medicine - A Nominal Group Study medRxiv. Med. Eth. Pub Date : 2023-02-23 Christian Rose, Emily Shearer, Isabella Woller, Ashley Foster, Nicholas Ashenburg, Ireh Kim, Jennifer Newberry
OBJECTIVE: Precision medicine is a rapidly progressing avenue to providing the right care to the right patient at the right time and spans all medical fields and specialties. However, given its reliance on computation and timely, accurate information, actualizing precision medicine within the emergency department and its 'anyone, anywhere, anytime' approach presents unique challenges which could exacerbate
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A Mummers Farce - Retractions of Medical Papers conducted in Egyptian Institutions medRxiv. Med. Eth. Pub Date : 2023-02-21 Rahma Menshawey, Esraa Menshawey, Bilal A Mahamud
Abstract: Rationale and Objective Egypt currently holds a record for the most retractions in the continent of Africa according to the Retraction Watch database, and the 2nd highest of countries in the Middle East. The purpose of this study was to perform a specific analysis on retracted medical publications from Egyptian affiliations to outline or delineate specific problems and solutions. Materials
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Hidden changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German University Medical Centres: A meta-research study medRxiv. Med. Eth. Pub Date : 2023-02-21 Martin Holst, Martin Haslberger, Samruddhi Yerunkar, Daniel Strech, Lars G Hemkens, Benjamin G Carlisle
Objectives: To assess how often clinical trials exhibit primary outcome discrepancies within registry records that would not be caught by comparing results publications to the latest registry entry, but would require analysing the registration history. Design: Meta-research study. Setting: All 1746 randomised clinical trials with published results, registered in ClinicalTrials.gov or Deutsches Register
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Quality in Clinical Research: An Observational Study of Randomisation Techniques in Urological and General Surgical Studies medRxiv. Med. Eth. Pub Date : 2023-02-16 Nicholas Raison, Simone Giona, Oliver Brunckhorst, Alexander Cohen, Gordon Muir
Objectives To quantitatively test the quality of randomised controlled trials reported to international scientific meetings through a critical analysis of randomisation outcomes. Design and Main Outcome Measures All randomised controlled trials presented at international surgical and urological congresses using simple randomisation were identified. Primary analysis of randomisation technique was performed
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A Probabilistic Approach to Physician-Assisted Suicide medRxiv. Med. Eth. Pub Date : 2023-01-25 Oded Nov
Physician-Assisted Suicide (PAS) is considered by some patients who learn they are at risk for a cognitive decline owing to Alzheimer’s Disease. At the same time, the prospect of PAS may raise patients’ fear of imminent death. Can PAS be offered in a way that is preference-sensitive on one hand, and mitigates patients’ fear of imminent death on the other? A thought experiment of a Probabilistic Approach
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Leveraging open tools to realize the potential of self-archiving: A cohort study in clinical trials medRxiv. Med. Eth. Pub Date : 2023-01-05 Delwen L. Franzen
While Open Access (OA) is growing, many publications remain behind a paywall. This limits the impact of research and entrenches global inequalities by restricting access to knowledge to those that can afford it. Many journal policies allow researchers to make a version of their publication openly accessible through self-archiving in a repository, sometimes after an embargo period (green OA). Unpaywall
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The Gender Gap in Leading Medical Journals - a Computational Audit medRxiv. Med. Eth. Pub Date : 2022-12-21 Oscar Brück
Background Publication track record can impact careers of researchers. Therefore, monitoring gender representation in medical research is required to achieve equity in academia.
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The Geographical Gap in Leading Medical Journals - a Computational Audit medRxiv. Med. Eth. Pub Date : 2022-12-12 Oscar Bruck
Background: Auditing geographical representation in medical publishing could help to mitigate possible national and regional disparities. Methods: Using the Web of Science indexing database, we collected bibliometric data of original research articles published between 2010-2019 in The New England Journal of Medicine, Nature Medicine, Journal of the American Medical Association, The BMJ, and The Lancet
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Ethical reporting of research on violence against women and children during COVID-19: Analysis of 75 studies and recommendations for future guidelines medRxiv. Med. Eth. Pub Date : 2022-11-16 Amber Peterman, Karen Devries, Alessandra Guedes, Joht Singh Chandan, Sonica Minhas, Rachel Qian Hui Lim, Floriza Gennari, Amiya Bhatia
Changes in research practice during the COVID-19 pandemic necessitates renewed attention to ethical protocols and reporting for data collection on sensitive topics. We systematically searched journal publications from the start of the pandemic to November 2021, identifying 75 studies that collected primary data on violence against women and children. We assess the transparency of ethics reporting and
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The Nature of Race in Germany: A systematic literature review of human classifications in German life sciences medRxiv. Med. Eth. Pub Date : 2022-11-14 Isabelle Bartram, Laura Schnieder, Nils Ellebrecht, Florian Ruland, Tino Pluemecke, Andrea zur Nieden
The use of human diversity classifications like race, ethnicity, ancestry, or migration background entails a range of scientific as well as social consequences, therefore, a careful application is vital. In this article, we present results from a systematic literature review and subsequent quantitative content analysis based on 546 papers focusing on classifications applied in life sciences studies
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Informed consent and trial prioritization for human subject research during the COVID-19 pandemic. Stakeholder experiences and viewpoints. medRxiv. Med. Eth. Pub Date : 2022-11-01 Stefanie Weigold, Susanne Gabriele Schorr, Alice Faust, Lena Woydack, Daniel Strech
Background: Very little is known about the practice-oriented challenges and mitigation strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and mitigation strategies for informed consent and study prioritization in a pandemic setting. Methods: We performed
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Trials that turn from retrospectively registered to prospectively registered: A cohort study of retroactively prospective clinical trial registration using history data. medRxiv. Med. Eth. Pub Date : 2022-10-26 Martin R Holst, Benjamin Gregory Carlisle
Background. Prospective clinical trial registration is a methodological best practice, a moral requirement under the Declaration of Helsinki, and in many cases legally required. The US clinical trials register ClinicalTrials.gov allows for changes to a clinical trial registry entry at any time, including changes to the clinical trial start date, making it possible for a trial that was registered after
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It is bad because it limits capacity building here back at home Genetic and genomic researchers perspectives on biological sample sharing in collaborative research medRxiv. Med. Eth. Pub Date : 2022-10-21 Erisa Sabakaki Mwaka, David Kaawa Mafigiri, Deborah Sebatta Ekusai, Ian Guyton Munabi
Numerous ethical, legal and social issues arise with biological sample sharing. The study explored the perspectives of genetic/genomic researchers on the sharing of biological samples in international collaborative research. Qualitative in-depth interviews were conducted with 15 researchers. Participants expressed positive attitudes towards biobanking and appreciated the benefits of cross-border sharing
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"How about me giving blood for the COVID vaccine and not being able to get vaccinated?" A cognitive interview study on understanding of and agreement with broad consent for future use with cohort participants and guardians in Colombia and Nicaragua medRxiv. Med. Eth. Pub Date : 2022-10-17 Lauren Maxwell, Jackeline Bravo Chamorro, Luz Leegstra, Harold Suazo Laguna, María Consuelo Miranda Montoya
Informed consent (IC) is key to generating and maintaining research participants' trust and upholding the ethical principle of autonomy. Broad consent for future use, wherein researchers ask participants for permission to share participant-level data and samples collected within the study for purposes loosely related to the study objectives, is central to enabling ethical data and sample reuse. Ensuring
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A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule medRxiv. Med. Eth. Pub Date : 2022-08-24 Krista L. Snyder, Jon F. Merz
Background The US Food and Drug Administration and National Institutes of Health adopted the Exception from Informed Consent (EFIC) rule in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the federal government. The rule requires that prospective consent be sought when practicable from patients or their Legally Authorized Representative(s) (LAR)
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A Plagiarism Paperdemic - Plagiarism in infection journals in the era of COVID-19 medRxiv. Med. Eth. Pub Date : 2022-08-09 Rahma Menshawey, Esraa Menshawey, Ahmed Mitkees, Bilal A Mahamud
Abstract Background: The COVID-19 pandemic has caused drastic changes in the publishing framework in order to quickly review and publish vital information during this public health emergency. The quality of the academic work being published may have been compromised. One area of concern is plagiarism, where the work of others is directly copied and represented as ones own. The purpose of this study
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Exploring the knowledge and acceptance of reputed Authorship Criteria: A Pilot Study among medical researchers in India medRxiv. Med. Eth. Pub Date : 2022-06-14 Bhavik Bansal
Objectives: To determine knowledge and acceptance of authorship criteria among residents, PhD scholars and faculty involved in medical research in India. Design: A cross sectional survey was performed via Google forms (a web based platform). Results:A total of 117 participants responded to the survey, of whom 66 (56%) were faculty/professors, 23 (20%) residents and 28 (24%) PhD scholars. 33% respondents
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The Proportion of Randomized Controlled Trials That Inform Clinical Practice: A Longitudinal Cohort Study of Trials Registered on ClinicalTrials.gov medRxiv. Med. Eth. Pub Date : 2022-05-13 Nora Hutchinson, Hannah Moyer, Deborah A. Zarin, Jonathan Kimmelman
Background Prior studies suggest that clinical trials are often hampered by problems in design, conduct and reporting that limit their uptake in clinical practice. We have described “informativeness” as the ability of a trial to guide clinical, policy or research decisions. Little is known about the proportion of initiated trials that inform clinical practice.
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Feedback of Individual Genetic and Genomics Research Results: A Qualitative Study Involving Grassroots Communities in Uganda medRxiv. Med. Eth. Pub Date : 2022-04-16 Joseph Ochieng, Betty Kwagala, John Barugahre, Marlo Möller, Keymanthri Moodley
Background Genetics and genomics research (GGR) is associated with several challenges including, but not limited to, implications of sharing research findings with participants and their family members, issues of confidentiality, determining appropriate methods for providing genetic or genomic information to individuals tested, and ownership of DNA obtained from the samples. Additionally, GGR holds
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The “Trauma Pitch”: How stigma emerges for Iraq and Afghanistan veterans seeking disability compensation medRxiv. Med. Eth. Pub Date : 2022-04-16 Katinka Hooyer
Posttraumatic Stress Disorder continues to be a highly stigmatized disease for the veteran population and stigma continues to be identified as the main deterrent in treatment seeking. Little attention has been paid to how the process of obtaining service-connected disability status can amplify veterans’ perceptions of being stigmatized. The following ethnographic study identified how combat veterans
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Trans-border transfer of human biological materials in collaborative biobanking research: Perceptions and experiences of researchers in Uganda medRxiv. Med. Eth. Pub Date : 2022-04-05 Erisa Sabakaki Mwaka, Ian Guyton Munabi
Introduction The study aimed to explore researchers’ perceptions and experiences on the transfer of human biological materials in international collaborative research.
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Accuracy of Attestation Among Mohs and Dermatologic Surgery Diplomates medRxiv. Med. Eth. Pub Date : 2022-02-22 Clifford S. Perlis, Roy H. Perlis
Self-regulation is a key tenet of professionalism. We sought to assess the accuracy of self-attestation with respect to the administration of a newly defined field of board sub-specialization. One qualifying pathway to take the written examination for certification in Mohs and Dermatologic Surgery (MDS) is to self-attest to an active practice of Mohs Surgery. Utilizing publicly available data, we find
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Preclinical Efficacy in Investigator’s Brochures: Stakeholders’ views on measures to improve Completeness and Robustness medRxiv. Med. Eth. Pub Date : 2022-02-08 Martin Haslberger, Susanne Gabriele Schorr, Daniel Strech, Tamarinde Haven
Research ethics committees (RECs) and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator’s brochures (IBs). Recent studies have indicated that preclinical evidence presented in IBs is reported in a way that does not enable proper risk-benefit assessment. We interviewed different stakeholders
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Vital signs as a source of racial bias medRxiv. Med. Eth. Pub Date : 2022-02-04 Bojana Velichkovska, Hristijan Gjoreski, Daniel Denkovski, Marija Kalendar, Behrooz Mamandipoor, Leo Anthony Celi, Venet Osmani
Background racial bias has been shown to be present in clinical data, affecting patients unfairly based on their race, ethnicity and socio-economic status. This problem has the potential to be significantly exacerbated in the light of Artificial Intelligence-aided clinical decision making. We sought to investigate whether bias can be introduced from sources that are considered neutral with respect
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The impact of retracted randomised controlled trials on systematic reviews and clinical practice guidelines: a meta-epidemiological study medRxiv. Med. Eth. Pub Date : 2022-02-01 Yuki Kataoka, Masahiro Banno, Yasushi Tsujimoto, Takashi Ariie, Shunsuke Taito, Tomoharu Suzuki, Shiho Oide, Toshi A. Furukawa
Objectives To investigate whether and when the correction is done in Systematic Reviews (SRs) and Clinical Practice Guidelines (CPGs) when their included Randomised Controlled Trials (RCTs) have been retracted.
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Payments to key opinion leader physicians and drug sales of top pharmaceutical companies during the COVID-19 pandemic medRxiv. Med. Eth. Pub Date : 2022-01-10 José Luis Sandoval, Alex Friedlaender, Alfredo Addeo, Glen J. Weiss
Background The unprecedented context of the COVID-19 pandemic poses the opportunity to study several questions in circumstances that would probably not otherwise occur. We sought to determine the dynamics of pharmaceutical company drug sales revenue, market capitalization and payments to physicians during the pandemic, focusing on payments to so-called key opinion leaders (KOLs).
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A Cross-Sectional Examination of Conflict-of-Interest Disclosures of Physician-Authors Publishing in High-Impact US Medical Journals medRxiv. Med. Eth. Pub Date : 2022-01-01 James H. Baraldi, Steven A. Picozzo, Jacob C. Arnold, Kathryn Volarich, Michael R. Gionfriddo, Brian J. Piper
Objective To assess the accuracy of self-reported financial conflict-of-interest (COI) disclosures in the New England Journal of Medicine (NEJM) and Journal of the American Medical Association (JAMA) within the requisite disclosure period prior to article submission.
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How Informative Were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov medRxiv. Med. Eth. Pub Date : 2021-11-02 Nora Hutchinson, Katarzyna Klas, Benjamin G. Carlisle, Jonathan Kimmelman, Marcin Waligora
Background Early in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic.
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Factors affecting nurses’ duty to care during the COVID-19 pandemic medRxiv. Med. Eth. Pub Date : 2021-10-25 Hyerine Shin, Kyung hee Kim, Ji-su Kim, Yeun-hee Kwak
Background Although the demand for nursing care in disaster situations has grown, there has been a lack of discussion on nurses’ duty to care in these situations.
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Characterizing Potential Conflicts of Interest Among UpToDate and DynaMed Content Contributors medRxiv. Med. Eth. Pub Date : 2021-10-18 SooYoung H VanDeMark, Mia R Woloszyn, Laura A Christman, Michael Gatusky, Warren S Lam, Stephanie S Tilberry, Brian J Piper
BACKGROUND Financial conflicts of interest among physicians have the potential to negatively impact patient care. Physicians contribute content to two popular, evidence-based websites, UpToDate and DynaMed; while other physicians use these websites to influence their clinical decision making. Each website maintains a conflict-of-interest policy, and contributors are required to self-report a disclosure