Compromised informed consent due to functional health literacy challenges in Chinese hospitals.

BACKGROUND: Medical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study's aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent. METHODS: In this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs -teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05. RESULTS: The median age (IQR and range) of participants was 35.5 (28 - 49 and 13 - 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments-teach-back, perception, and cognizance-was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent. CONCLUSIONS: This study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.

Biospecimen research and the law.

In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

An Ethical Framework for Disclosing the Training Status and Roles of Resident-Level Surgeons to Patients.

The concept of informed consent includes disclosure of all information that a reasonable patient would need to make a well-informed decision about whether to undergo a surgical procedure. This has traditionally been defined as including diagnosis, details about the procedure, prognosis, potential risks, and alternative treatments. The operating surgeon has final say and responsibility for the case, but the actual operation may be done (under supervision) by a surgeon in training. In this paper, we discuss the ethical dimensions of disclosing resident involvement, reviewing considerations such as established legal and professional standards, consequences for patients and for the surgical educators responsible for preparing future generations of surgeons, and patient rights. We conclude by offering a novel ethical framework intended to serve as a guide to disclosing resident involvement as part of the overall consent process.

Ethics of Preanesthesia Mandatory Laboratory Testing.

Some practices require mandatory preoperative laboratory testing for select patients presenting for anesthesia and surgery. Such mandatory preanesthesia laboratory testing has significant ethical implications related to informed consent and patient autonomy. Assumptions that a patient provides "presumed consent" by merely presenting for a test are flawed because such consents are often not informed and do not acknowledge patient autonomy. By placing a condition on access to a medical treatment, mandatory preanesthesia testing may not be ethically justifiable. Not all laboratory tests are "ethically equal"; several raise specific questions regarding informed consent, related to their potential to cause significant harm.

Ethical Care of Pregnant Patients During Labor, Delivery, and Nonobstetric Surgery.

The 4 basic principles of ethics (beneficence, nonmaleficence, autonomy, and justice) can guide clinical decision-making for the pregnant patient during labor and delivery, as well as when undergoing nonobstetric surgery. An evidence-based decision-making conversation with the patient facilitates obtaining informed consent. When maternal-fetal conflict arises, both during labor and delivery and nonobstetric surgery, beneficence-based obligations to both parties should be considered, with discussions and decisions well documented. Labor is not an impediment to women providing consent for care. A careful balance between evidence-based clinical judgment and patient autonomy is necessary when addressing cesarean delivery.

Better Conversations for Better Informed Consent: Talking with Surgical Patients.

For more than sixty years, surgeons have used bioethical strategies to promote patient self-determination, many of these now collectively described as "informed consent." Yet the core framework-understanding, risks, benefits, and alternatives-fails to support patients in deliberation about treatment. We find that surgeons translate this framework into an overly complicated technical explanation of disease and treatment and an overly simplified narrative that surgery will "fix" the problem. They omit critical information about the goals and downsides of surgery and present untenable options as a matter of patient choice. We propose a novel framework called "better conversations." Herein, surgeons provide context about clinical norms, establish the goals of surgery, and comprehensively delineate the downsides of surgery to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm shift meets the standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of treatment.

A reactogenic "placebo" and the ethics of informed consent in Gardasil HPV vaccine clinical trials: A case study from Denmark.

BACKGROUND: Medical ethics guidelines require of clinical trial investigators and sponsors to inform prospective trial participants of all known and potential risks associated with investigational medical products, and to obtain their free informed consent. These guidelines also require that clinical research be so designed as to minimize harms and maximize benefits. OBJECTIVE: To examine Merck's scientific rationale for using a reactogenic aluminum-containing "placebo" in Gardasil HPV vaccine pre-licensure clinical trials. METHODS: We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines. RESULTS: It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study's primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck's proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant "placebo" group. CONCLUSION: In our view, the administration of a reactive placebo in Gardasil clinical trials was without any possible benefit, needlessly exposed study subjects to risks, and was therefore a violation of medical ethics. The routine use of aluminum adjuvants as "placebos" in vaccine clinical trials is inappropriate as it hinders the discovery of vaccine-related safety signals.

Rethinking Informed Consent as an EPA in Surgery.

ABSTRACT: Over the past decade, entrustable professional activities (EPAs) have become an important element in the competency-based medical education movement. In this Commentary, the authors explore informed consent as an EPA within resident surgical training. In doing so, they foreground the concept of culture and reexamine the nature of trust and entrustment decisions from within a cultural framework. The authors identify role modeling and professional identity formation as core elements in the training process and suggest that faculty are sometimes better off using these tools than uncritically adopting a formal EPA framework for what is, in essence, a professionally oriented and values-based moral enterprise. They conclude that EPAs work best when they are developed at a local level, stressing the unique culture of specialty and program as well as the care that must be taken when attempting to transfer notions of entrustment from the undergraduate medical education level to graduate medical education settings.

What Are the Real Issues in Providing Extracorporeal Membrane Oxygenation (ECMO) Support: A Survey.

INTRODUCTION: By using a novel survey our study aimed to assess the challenges ECMO and Critical Care (CC) teams face when initiating and managing patient's ECMO support. METHODS: A qualitative survey-based observational study was performed of members of 2 Critical Care Medicine organizations involved in decision-making around the practice of Extracorporeal Membrane Oxygenation (ECMO). The range of exploratory questions covered ethical principles of informed consent, autonomy and goals of care discussions, beneficence, non-maleficence (offering life-sustaining treatments in end-of-life care), and justice (insurance-related limitations of treatment). Questions also covered pragmatic practice and quality improvement areas, such as exploring whether palliative care or ethics teams were involved in such decision-making. RESULTS: 305 members received the survey links, and a total of 61 completed surveys were received, for an overall response rate of 20% among all eligible members. Only 70% of the participants who manage ECMO patients are involved in the ECMO initiation decision process. The majority do not involve Ethics or Palliative care at the initial ECMO initiation decision step. Of the ethical and moral dilemmas reported, the majority revolved around 1. Prognostication of patients receiving VV and VA ECMO support, 2. Lack of knowledge of patient's wishes and goals, 3. Disconnect between expectations of families and outcomes and 4. Staff moral distress around when to stop ECMO in case of futility. CONCLUSION: Our survey highlights areas of distress and dilemma which have been stressed before in the initiation, management, and outcomes of ECMO patients, however with the increasing use of this modality of cardiopulmonary mechanical support being offered, the survey results can offer a guidance using sound ethical principles.

Informed Consent and Digit Replantation: Current State and Recommendations for Ethical Patient Care.

The importance of informed consent and the value of shared decision-making in hand surgery are well-established and particularly critical in the setting of digit amputation when considering replantation. Informed consent requires an understanding of not only the immediate and long-term risks and benefits of surgery, as well as the risks and alternatives involved, but also the capacity of the patient to make a medical decision. However, patients who have acutely sustained a disfiguring trauma are often in distress and may not fully process the consent discussion. Digit replantation is an "elective emergency"-the decision must be made immediately but is not lifesaving-which poses a difficult dilemma: are surgeons acting in patients' best interests by pursuing replantation if we engage those patients in informed consent discussions when they may not have capacity? This article explores the relevant bioethical principles associated with digit replantation, summarizes updated literature regarding informed consent and shared decision-making, and provides recommendations for patient education materials to standardize informed consent discussions for surgeons approaching patients at this unique intersection of considering revision amputation versus replantation.

Perception of Polish patients with cancer of the ethical and legal issues related to biobank research.

BACKGROUND: Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating. MATERIALS AND METHODS: To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer. RESULTS: While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence. CONCLUSIONS: Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns.

Ethics for AI in Plastic Surgery: Guidelines and Review.

INTRODUCTION: Artificial intelligence (AI) holds the potential to revolutionize medicine, offering vast improvements for plastic surgery. While human physicians are limited to one lifetime of experience, AI is poised to soon surpass human capabilities, as it draws on limitless information and continuous learning abilities. Nevertheless, as AI becomes increasingly prevalent in this domain, it gives rise to critical ethical considerations that must be addressed by professionals. MATERIALS AND METHODS: This work reviews the literature referring to the ethical challenges brought on by the ever-expanding use of AI in plastic surgery and offers guidelines for its application. RESULTS: Ethical challenges include the disclosure of use of AI by caregivers, validation of decision-making, data privacy, informed consent and autonomy, potential biases in AI systems, the opaque nature of AI models, questions of liability, and the need for regulations. CONCLUSIONS: There is a lack of consensus for the ethical use of AI in plastic surgery. Guidelines, such as those presented in this work, are needed within each discipline of medicine to respond to important ethical considerations for the safe use of AI. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Ethical considerations for artificial intelligence in dermatology: a scoping review.

The field of dermatology is experiencing the rapid deployment of artificial intelligence (AI), from mobile applications (apps) for skin cancer detection to large language models like ChatGPT that can answer generalist or specialist questions about skin diagnoses. With these new applications, ethical concerns have emerged. In this scoping review, we aimed to identify the applications of AI to the field of dermatology and to understand their ethical implications. We used a multifaceted search approach, searching PubMed, MEDLINE, Cochrane Library and Google Scholar for primary literature, following the PRISMA Extension for Scoping Reviews guidance. Our advanced query included terms related to dermatology, AI and ethical considerations. Our search yielded 202 papers. After initial screening, 68 studies were included. Thirty-two were related to clinical image analysis and raised ethical concerns for misdiagnosis, data security, privacy violations and replacement of dermatologist jobs. Seventeen discussed limited skin of colour representation in datasets leading to potential misdiagnosis in the general population. Nine articles about teledermatology raised ethical concerns, including the exacerbation of health disparities, lack of standardized regulations, informed consent for AI use and privacy challenges. Seven addressed inaccuracies in the responses of large language models. Seven examined attitudes toward and trust in AI, with most patients requesting supplemental assessment by a physician to ensure reliability and accountability. Benefits of AI integration into clinical practice include increased patient access, improved clinical decision-making, efficiency and many others. However, safeguards must be put in place to ensure the ethical application of AI.

The use of artificial intelligence (AI) in dermatology is rapidly increasing, with applications in dermatopathology, medical dermatology, cutaneous surgery, microscopy/spectroscopy and the identification of prognostic biomarkers (characteristics that provide information on likely patient health outcomes). However, with the rise of AI in dermatology, ethical concerns have emerged. We reviewed the existing literature to identify applications of AI in the field of dermatology and understand the ethical implications. Our search initially identified 202 papers, and after we went through them (screening), 68 were included in our review. We found that ethical concerns are related to the use of AI in the areas of clinical image analysis, teledermatology, natural language processing models, privacy, skin of colour representation, and patient and provider attitudes toward AI. We identified nine ethical principles to facilitate the safe use of AI in dermatology. These ethical principles include fairness, inclusivity, transparency, accountability, security, privacy, reliability, informed consent and conflict of interest. Although there are many benefits of integrating AI into clinical practice, our findings highlight how safeguards must be put in place to reduce rising ethical concerns.

Trust-building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent.

The coronavirus disease 2019 pandemic forced a wide range of medical practices to virtual formats, including the preoperative informed consent practice. However, virtual informed consent persists despite the pandemic being largely considered resolved. The continued use of virtual formats relies on a problematic "information transfer" model of informed consent. We suggest a "trust-building" model of consent as a better conceptualization of what is occurring during the consent process. Highlighting how virtual formats might fail to fulfill this fuller understanding of consent on both interpersonal and systemic levels, we offer an ethical structure for physicians to navigate this novel virtual space.

Practical Guide to Ethics in Surgical Education Research.

This Guide to Statistics and Methods describes ethical considerations when a study population includes learner participants.

Should Obtaining Informed Consent Be Considered an Entrustable Professional Activity? Insights From Whether and How Attendings Entrust Surgical Trainees.

PURPOSE: Because residents are frequently delegated the task of obtaining consent early in their training, the American Association of Medical Colleges describes "obtaining informed consent" as a core entrustable professional activity (EPA) for medical school graduates. However, prior studies demonstrated that residents frequently perform this task without receiving formal instruction or assessment of competency. This study sought to understand how attending physicians decide to delegate obtaining informed consent for surgical procedures to trainees. METHOD: The authors conducted a survey of attending surgeons at a university-based health care system of 6 affiliated teaching hospitals (October-December 2020) to collect data about current entrustment practices and attendings' knowledge, experience, and attitudes surrounding the informed consent process. Summary statistics and bivariate analyses were applied. RESULTS: Eighty-five attending surgeons participated (response rate, 49.4%) from diverse specialties, practice types, and years in practice. Fifty-eight of 85 (68.2%) stated they "never" granted responsibility for the consent conversation to a trainee, and 74/81 (91.4%) reported they typically repeated their own consent conversation whenever a trainee already obtained consent. The most common reasons they retained responsibility for consent were ethical duty (69/82, 84.1%) and the patient relationship (65/82, 79.3%), while less than half (40/82, 48.8%) described concerns about trainee competency. Reflecting on hypothetical clinical scenarios, increased resident competency did not correspond with increased entrustment ( P = .27-.62). Nearly all respondents (83/85, 97.7%) believed residents should receive formal training; however, only 41/85 (48.2%) felt additional training and assessment of residents might change their current entrustment practices. CONCLUSIONS: Attendings view informed consent as an ethical and professional obligation that typically cannot be entrusted to trainees. This practice is discordant with previous literature studying residents' perspectives. Furthermore, resident competency does not play a predominant role in this decision, calling into question whether informed consent can be considered an EPA.

Ética de las nuevas inteligencias: Memorias de las ponencias 2do Congreso de Ética en Investigación / Ethics of new intelligences: Reports of the presentations 2nd Congress of Research Ethics

Memoria de las ponencias del 2do Congreso de Ética en Investigación, realizado en la Ciudad de Buenos Aires en septiembre de 2023, y organizado por el Comité Central de Ética en Investigación del Ministerio de Salud de esta ciudad. Se presentan las ponencias del congreso, organizadas en los capítulos: Inteligencia Artificial y Datos en la investigación; Conducta responsable en investigación e integridad científica; y Mecanismos alternativos para la instrumentación del consentimiento informado en investigaciones en salud.

Introducción al Capítulo III: El consentimiento informado en la era digital: Desafíos éticos y tecnológicos en medicina e investigación / Introduction to Chapter III: Informed consent in the digital age: Ethical and technological challenges in medicine and research

El consentimiento (CI) es un proceso dinámico y continuo en el cual la progresión de la información se establece mediante un diálogo esclarecedor entre las partes interesadas. Este, se basa en el respeto mutuo entre los profesionales y los pacientes o los posibles participantes en una investigación. (COPILOT IA, 2024) Numerosos tratados de ética médica y de investigación, publicados en libros, conferencias y medios electrónicos, abordan los distintos modelos, usos y metodologías para obtener y proporcionar un consentimiento informado. Si en la actualidad buscamos el término 'consentimiento informado' en Google, obtenemos más de 32.000.000 de resultados en varios idiomas. Esto demuestra que el tema se discute ampliamente en distintos ámbitos y desde diferentes perspectivas, lo que puede ayudarnos a comprender el proceso con mayor profundidad. En la era digital, el uso del consentimiento informado ha cobrado gran relevancia, especialmente en el ámbito de la investigación. Las herramientas digitales facilitan que los pacientes comprendan los detalles de una intervención y acepten mediante su firma electrónica. Sin embargo, resulta crucial garantizar que el contenido no se altere después de la firma y que el documento pueda recuperarse para demostrar autenticidad e integridad. (AU)

Algunos interrogantes a la no presencialidad y la mediación tecnológica en el proceso de consentimiento informado / Some questions regarding non-presence and mediation technology in the informed consent process

Frente a los grandes desafíos que se nos presenta con los avances tecnológicos nos interrogamos sobre la posibilidad del uso de las nuevas tecnologías para la obtención del consentimiento informado. Sin perder de vista la necesidad de agilizar estos procedimientos pero puesta la mirada en el sujeto, parte de la investigación, ¿se protege su dignidad y su autonomía con el uso de estas nuevas formas? O pensarlo de modo contrario, ¿con el tradicional procedimiento de consentimiento informado, se protege al sujeto que participa en el proyecto de investigación? (AU)

El consentimiento Informado en la era de las tecnologías de información y comunicación / Informed consent in the age of information and communication technologies

Introducción: La emergencia sanitaria evidenció una carencia de alternativas para la toma del consentimiento informado (CI) en investigaciones biomédicas. Algunos países elaboraron nuevas normativas, utilizando tecnologías de información y comunicación (TICs) para obtener consentimiento. Materiales y métodos: se revisó bibliografía de los últimos 3 años y las normativas vigentes, argentinas e internacionales, sobre modalidades del CI en investigación biomédica. Resultados: Las investigaciones sobre comprensión, legibilidad y longitud de la información de los formularios de CI muestran que debe mejorarse la presentación al sujeto para su correcta comprensión. En EEUU se utilizan TICs para informar y obtener CI, resguardando la autonomía del sujeto por la intervención de un testigo. Las normas de la República Argentina sólo aprueban el proceso por escrito. Conclusiones:La emergencia por COVID-19 ha planteado desafíos para investigar. Se requiere mayor estudio sobre la adecuación de contenidos de CIs para investigaciones, y revisión de las normativas nacionales. (AU)