Article
Ethics
Jennifer Zhe Zhang, Stuart G. Nicholls, Kelly Carroll, Hayden Peter Nix, Cory E. Goldstein, Spencer Phillips Hey, Jamie C. Brehaut, Paul C. McLean, Charles Weijer, Dean A. Fergusson, Monica Taljaard
Summary: The study found that not obtaining consent in pragmatic trials seems to be increasing, and is associated with cluster randomization and pragmatic aims. However, cluster randomization and pragmatism are not currently accepted justifications for waivers of consent. Researchers and research ethics committees could consider alternative consent approaches to facilitate pragmatic trials while preserving patient autonomy and public trust in research.
JOURNAL OF MEDICAL ETHICS
(2021)
Article
Medicine, General & Internal
Matthew G. Wilson, Folkert W. Asselbergs, Ruben Miguel, David Brealey, Steve K. Harris
Summary: This study aims to investigate the feasibility of using computer prompts for flexible randomisation at the point of clinical decision making. It will compare the effectiveness of two prompt designs and explore the acceptability of two consent models for conducting comparative effectiveness research.
Review
Health Care Sciences & Services
Joan G. Carpenter, Connie Ulrich, Nancy Hodgson, Laura C. Hanson, Mary Ersek
Summary: Palliative care research faces ethical challenges in obtaining informed consent, prompting the exploration of alternative approaches to traditional consent methods. By innovating consent models, researchers aim to enhance recruitment, enrollment, and retention in clinical trials focused on palliative care. Further research is needed to evaluate the impact of these differing consent models on participants' understanding and engagement in research.
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT
(2021)
Article
Remote Sensing
Vyshnave Jeyabalan, Lorie Donelle, Patrick Meier, Elysee Nouvet
Summary: Drones are being introduced in healthcare delivery worldwide, particularly in remote areas with inadequate healthcare services. However, there is limited guidance on engaging communities in decision-making about drone use. This paper focuses on obtaining consent for implementing Drones for Health projects, highlighting ethical and practical challenges.
Article
Critical Care Medicine
Jonathan D. Casey, Laura M. Beskow, Jeremy Brown, Samuel M. Brown, Etienne Gayat, Michelle Ng Gong, Michael O. Harhay, Samir Jaber, Jacob C. Jentzer, Pierre-Francois Laterre, John C. Marshall, Michael A. Matthay, Todd W. Rice, Yves Rosenberg, Alison E. Turnbull, Lorraine B. Ware, Wesley H. Self, Alexandre Mebazaa, Sean P. Collins
Summary: Pragmatic trials, as a means to evaluate therapies already in common clinical use, can increase efficiency by allowing some or all trial procedures to be embedded into clinical care.
LANCET RESPIRATORY MEDICINE
(2022)
Article
Clinical Neurology
Ally Peabody Smith, Nader Pouratian, Ashley Feinsinger
Summary: As neurologically implanted devices become more widely used in clinical applications, there are increasing opportunities for intracranial investigations in human patients. In some cases, patients participate in research during their awake brain surgery, without potential therapeutic benefits. Ethical challenges arise in such intraoperative studies, conducted during a clinical intervention, in a clinical setting, and often by the treating clinician. The need for innovative informed consent methods in intraoperative research is a pressing concern, but current practices are insufficient in addressing participant understanding and trust between patient-participants and surgeon-researchers.
Article
Ethics
Soren Holm, Jonathan Lewis, Rafael Dal-Re
Summary: In response to the COVID-19 pandemic, research and pharmaceutical regulatory processes have accelerated, leading to the rapid introduction of effective COVID-19 interventions. However, this has also brought about more complex ethical issues. This paper discusses the ethical implications of authorizing and using the antiviral medicine molnupiravir in clinical trials.
JOURNAL OF MEDICAL ETHICS
(2023)
Article
Health Care Sciences & Services
Katja Voit, Tobias Skuban-Eiseler, Marcin Orzechowski, Florian Steger
Summary: Health crises like COVID-19 pose challenges to conducting clinical studies, especially regarding research ethics such as informed consent. This study examines whether proper informed consent procedures were followed in COVID-19 clinical studies at Ulm University from 2020 to 2022. A thematic analysis was conducted on the protocols of 98 COVID-19 studies, finding that informed consent was obtained through traditional written form, waived, obtained delay, or obtained by proxy.
Article
Ethics
Stephanie R. Morain, Stephanie A. Kraft, Benjamin S. Wilfond, Amy Mcguire, Neal W. Dickert, Andrew Garland, Jeremy Sugarman
Summary: This article proposes eight dimensions for demonstrating respect in pragmatic clinical trials, including engaging patients and communities in research design and execution, promoting transparency, maximizing agency, minimizing burdens, protecting privacy, valuing interpersonal interactions, providing compensation, and maximizing social value.
HASTINGS CENTER REPORT
(2022)
Article
Obstetrics & Gynecology
Summary: Informed consent is a process that involves supporting patients to understand medical options and make voluntary and autonomous decisions, considering the risks, benefits, and alternatives.
FERTILITY AND STERILITY
(2023)
Article
Ethics
Nut Koonrungsesomboon, Pimlak Charoenkwan, Rungrote Natesirinilkul, Kanda Fanhchaksai, Wannachai Sakuludomkan, Nimit Morakote
Summary: This study aimed to determine the elements and extent of information that child participants and their parents desire to read in an informed assent form/informed consent form of a pediatric drug trial. The results showed that risk-benefit aspects were perceived as the most concerning items. The findings can help stakeholders arrange essential information in order of importance and customize informed assent/consent forms for pediatric drug trials involving children with hematology or oncology diseases.
BMC MEDICAL ETHICS
(2022)
Review
Health Care Sciences & Services
Edwin Cohen, Bill Byrom, Anja Becher, Magnus Jornten-Karlsson, Andrew K. Mackenzie
Summary: This systematic review evaluates the effectiveness of electronic consent (eConsent) in enhancing patient understanding, engagement, and acceptability of clinical trial information. The results show that compared to traditional paper-based consent, eConsent allows patients to better understand trial information, engage more actively, and rate the consent process as more acceptable and usable.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Review
Health Care Sciences & Services
Edwin Cohen, Bill Byrom, Anja Becher, Magnus Jornten-Karlsson, Andrew K. Mackenzie
Summary: This systematic review examines the effectiveness of electronic consent (eConsent) compared to traditional paper-based consent. The findings show that patients using eConsent have a better understanding of study information, greater engagement with content, and find the consenting process more acceptable and usable. eConsent has the potential to address data quality concerns related to flawed consenting processes.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Article
Medicine, Research & Experimental
Tove Godskesen, Joar Bjork, Niklas Juth
Summary: This study explores the ethical challenges encountered by clinical research nurses (CRNs) in obtaining informed consent for clinical research. The findings highlight the threats to voluntariness faced by CRNs, the measures they take to safeguard voluntariness, and the questionable exclusion of certain groups. Time constraints, rushed decisions, and information overload pose challenges for CRNs, while overestimating therapeutic benefits in advanced illness stages can risk voluntariness. Proactive solutions, such as allowing ample decision-making time and supporting terminally ill patients, are outlined. Concerns are also raised about excluding individuals with language barriers or cognitive impairments. This study emphasizes the importance of refining the informed consent process, addressing participation challenges, and ensuring equitable inclusion in clinical studies.
Article
Medicine, General & Internal
Paul A. Monach, Westyn Branch-Elliman
Summary: Research finds that minimizing additional risk in clinical trials while allowing for monitoring mechanisms is essential for accelerating research progress. Pragmatic trials can simplify eligibility criteria, interventions, and outcome monitoring to reduce costs and speed up research progress.
Article
Psychiatry
Marie E. Nicolini, Chris Gastmans, Scott Y. H. Kim
Summary: The gender gap in the preponderance of women who request and receive euthanasia and assisted suicide based on psychiatric condition has not been thoroughly explored. This gap may provide insights into a key point of debate in the controversial practice, namely its conflict with suicide prevention.
BRITISH JOURNAL OF PSYCHIATRY
(2022)
Article
Ethics
Scott Y. H. Kim, Nuala B. Kane, Alexander Ruck Keene, Gareth S. Owen
Summary: Research has found that using a narrow definition of "understanding" and specifically enumerating the multiple rationales falling under the ability to "use or weigh" can make mental capacity assessments more transparent, accountable, reliable, and valid, and it can also help provide targeted support for decision making by vulnerable populations.
JOURNAL OF MEDICAL ETHICS
(2022)
Editorial Material
Ethics
Scott Y. H. Kim
AMERICAN JOURNAL OF BIOETHICS
(2022)
Article
Medicine, Research & Experimental
Scott Y. H. Kim, Jonathan Kimmelman
Summary: This study presents a practical four-step process for determining the research risk of pragmatic randomized clinical trials that compare standard interventions. It provides a transparent and systematic approach with low risk of bias.
Article
Geriatrics & Gerontology
Noah Berens, Scott Y. H. Kim
Summary: Depression is a common issue for terminally ill patients, and it may affect their decision to request physician-assisted death (PAD). Recent research has shown that certain treatments, such as ketamine, can rapidly relieve depressive symptoms in these patients. These treatments have important ethical implications, including their role in clarifying decision-making capacity, the tension between legal definitions and clinicians' ethical obligations, and the obstacles to treatment access and respect for patient autonomy.
AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
(2022)
Editorial Material
Geriatrics & Gerontology
David Wendler, Scott Y. H. Kim
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY
(2023)
Editorial Material
Psychology, Clinical
Brent M. Kious, Benjamin R. Lewis, Scott Y. H. Kim
Summary: Psychiatrists are obligated to trust their patients but there are concerns that they perpetrate epistemic injustice. While there is a risk of injustice, most concerns regarding psychiatry being epistemically unjust are unfounded. Psychiatrists should resist calls for changes to clinical practice based on this criticism.
PSYCHOLOGICAL MEDICINE
(2023)
Editorial Material
Pediatrics
Sarah Z. Raskoff, Audrey Thurm, Helga O. Miguel, Scott Y. H. Kim, Zenaide M. N. Quezado
Summary: Children and adolescents with severe intellectual disabilities face inequities in pain-related care, while there is little research focused on this population. This Viewpoint addresses the ethical challenges of conducting pain research in these individuals, including the lack of suitable assessment methods and the inability to obtain informed consent or assent. The existing ethical guidelines provide some guidance, but this Viewpoint highlights additional points for designing, conducting, reviewing, and evaluating pain research involving children and adolescents with severe intellectual disability.
LANCET CHILD & ADOLESCENT HEALTH
(2023)
Editorial Material
Ethics
Scott Y. H. Kim
AMERICAN JOURNAL OF BIOETHICS
(2023)
Editorial Material
Ethics
Scott Y. H. Kim
AMERICAN JOURNAL OF BIOETHICS
(2023)
Article
Medicine, Research & Experimental
Andrew J. Vickers, Emily A. Vertosick, Mia Austria, Christopher D. Gaffney, Sigrid Carlsson, Scott Y. H. Kim, Behfar Ehdaie
Summary: This study compared the effects of one-stage and two-stage informed consent on patient understanding, anxiety, and decisional quality. The results showed that two-stage consent slightly outperformed one-stage consent in terms of patient understanding, while the differences in anxiety and decisional outcomes were small.
Article
Ethics
Isabel Marie Astrachan, Alexander Ruck Keene, Scott Y. H. Kim
Summary: All contemporary frameworks of mental capacity emphasize the need to start from the presumption that an adult has capacity, in order to respect autonomy and prevent evaluator bias and paternalistic behavior. However, there are different interpretations and applications of this presumption that have resulted in harm to vulnerable individuals. Therefore, we should question the presumption of capacity itself.
JOURNAL OF MEDICAL ETHICS
(2023)
Article
Medicine, General & Internal
James Flory, Jessica S. Ancker, Scott Yung Ho Kim, Gilad Kuperman, Andrew Vickers
BMJ EVIDENCE-BASED MEDICINE
(2023)
Letter
Psychiatry
Noah Berens, Scott Y. H. Kim
JOURNAL OF THE ACADEMY OF CONSULTATION-LIAISON PSYCHIATRY
(2022)
Article
Psychiatry
Noah Berens, David Wasserman, Paul Wakim, Talia Bernhard, Scott Y. H. Kim
Summary: A minority of the US public supports physician-assisted death (PAD) for people with nonterminal illnesses (PAD-NT) in the context of inadequate resources. Support for PAD-NT is lower for mental illness than for physical disability.
JOURNAL OF THE ACADEMY OF CONSULTATION-LIAISON PSYCHIATRY
(2022)