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Extracorporeal life support systems (ECLS) are life-sustaining measures for severe cardiovascular diseases, serving as bridging treatment either until cardiovascular function is restored or alternative treatment, such as heart transplantation or the implantation of permanent ventricular assist devices is performed. Given the insufficient evidence and frequent urgency of implantation without initial patient consent, the ethical challenges and psychological burden for patients, relatives and the interprofessional intensive care team are significant. As with any treatment, an appropriate therapeutic goal for ECLS treatment based on the indications and patient informed consent is mandatory. In order to integrate the necessary ethical considerations into everyday clinical practice, a structured algorithm for handling ECLS is proposed here, which takes ethical aspects into due account., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

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., Competing Interests: Disclosures All authors assert that they have no commercial or financial interests concerning this publication and have received no funding., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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., Competing Interests: Disclosure This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. No conflicts of interest are disclosed., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: Adolescent participation in health research studies is critical yet complex given the lack of clarity around issues such as consent. This study aimed to understand how those conducting research in Australia navigate research ethics in health research involving adolescents, through qualitative interviews., Methods: Purposive sampling was used to recruit 23 researchers involved in adolescent health research using semi-structured in-depth interviews. Interviews were conducted via Zoom and audio-recorded after obtaining informed consent. Thematic analysis was used to construct themes and data were organised using NVivo., Results: Two contrasting positions emerged from the data: (1) framing of adolescents as inherently vulnerable, their participation in research understood in terms of risk and protection and (2) adolescent engagement in research is understood in terms of empowerment, emphasising their capacity to make decisions about research participation. We traced these positions through three key themes, particularly in relation to the role of ethics committees: (1) competing positions as a result of inferior or superior knowledge about adolescent lives, (2) competing positions resulting in a risk averse or an empowerment approach, and (3) reflections on processes of obtaining consent which involves gatekeeping and tokenism., Discussion: Our study highlights the contentious topic of navigating ethics committee requirements for the needs of adolescents. Majority of participants felt the current research ethics establishment is not favourable for researchers or adolescents themselves. While it is imperative that perceptions of ethics committees also be studied in the future, our study provides preliminary understanding of how experiences and perceptions shape how researchers interact with the research ethics establishment., (Copyright © 2024 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

3D scanning and printing technologies are quickly evolving and offer great potential for use in gross anatomical education. The use of human body donors to create digital scans and 3D printed models raises ethical concerns about donor informed consent, potential commodification, and access to and storage of potentially identifiable anatomical reproductions. This paper reviews available literature describing ethical implications for the application of these emerging technologies, existing published best practices for managing and sharing 2D imaging, and current adherence to these best practices by academic body donation programs. We conclude that informed consent is paramount for all uses of human donor and human donor-derived materials and that currently there is considerable diversity in adherence to established best practices for the management and sharing of 3D digital content derived from human donors. We propose a new and simplified framework for categorizing donor-derived teaching materials and the corresponding level of consent required for digital sharing. This framework proposes an equivalent minimum level of specific consent for human donor and human donor-derived materials relative to generalized, nonidentical teaching materials (i.e., artificial plastic models). Likewise, we propose that the collective path forward should involve the creation of a centralized, secure repository for digital human donor 3D content as a mechanism for accumulating, regulating, and controlling the distribution of properly consented human donor-derived 3D digital content that will also increase the availability of ethically created human-derived teaching materials while discouraging commodification., (© 2024 The Author(s). Anatomical Sciences Education published by Wiley Periodicals LLC on behalf of American Association for Anatomy.)

Competing Interests: Dr. Eversmann has disclosed that he does not have any potential conflicts of interest.

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics., (© 2023 John Wiley & Sons Ltd.)

Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that an informed consent approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large., (© 2024. The Author(s).)

Background: Since the creation of legal requirements for advance directives by the legislator in 2009, special aspects of their application in the treatment of people with mental illnesses have been discussed., Goal of the Paper: Important questions on dealing with advance directives in everyday life will be answered in a practice-oriented manner., Results: Among other things, this document answers the question of the conditions under which a patient can refuse or consent to hospitalization and treatment in advance, and in particular how to deal with advance directives whose implementation would also affect the rights of third parties. The German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) has addressed these and other questions in the present document and added practical advice on how to formulate advance directives for people with mental illnesses and how to deal with psychiatric advance directives., Discussion: The DGPPN has developed an advance directive for the area of mental health and published it on its website together with detailed explanations. With the help of this advance directive, people can decide on their treatment in phases of incapacity to consent in the context of a mental crisis or illness., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Biobanks' activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first-hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU., (© 2023 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

A complex network of ethico-legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the NHA into alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements., (© 2023 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

Background: The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this approach may be useful in terms of ensuring the autonomy of data subjects in personal health data usage., Methods: This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles-including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items., Results: A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use., Conclusions: Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

The practice of medicine-and especially the patient-doctor relationship-has seen exceptional shifts in ethical standards of care over the past few years, which by and large originate in occidental countries and are then extrapolated worldwide. However, this phenomenon is blind to the fact that an ethical practice of medicine remains hugely dependent on prevailing cultural and societal expectations of the community in which it serves. One model aiming to conceptualise the dichotomous efforts for global standardisation of medical care against differing sociocultural expectations is the individualism-collectivism model, with the 'West' being seen as individualistic and the 'East' being seen as collectivistic. This has been used by many academics to explain differences in approach towards ethical practice on key concepts such as informed consent and patient autonomy. However, I argue that this characterisation is incomplete and lacks nuance into the complexities surrounding cross-cultural ethics in practice, and I propose an alternative model based on the ethics of clinical care in Hong Kong, China. Core ethical principles need not be culture-bound-indeed, their very existence mandates for them to be universal and non-derogable-but instead cultural alignment occurs in the particular implementation of these principles, insofar as they respect the general spirit of contemporary ethical standards., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research., (© 2024. The Author(s).)

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.

Background: Obstetricians often times find themselves in a conflict of right and duty with their patients, when these patients refuse recommended treatment. On the one hand, the obstetrician, aiming to fulfil the duty of care, recommends a treatment in the best interest of the woman. The woman, on the other hand, exercising her right of self-determination and autonomy, declines the recommended treatment., Materials and Methods: A search was conducted for literature, articles and case reports on the subject on PubMed/MEDLINE and Google Scholar using the keywords: medical ethics, medical law, obstetric mortality, maternal medicine, foetal medicine, patient autonomy, informed consent, right to life and right to liberty., Results: Opinions have historically differed on whether maternal or foetal rights should be deferred to in situations where pregnant women refuse obstetric interventions. So also have legal decisions on the issue. The general consensus is, however, to respect a woman's refusal of recommended medical treatment, in deference to her right of self-determination and autonomy. The obstetric outcomes in such instances are however, often times, unfavourable., Conclusion: The ethics of patient care in the face of conflicting rights deserves renewed examination and discourse., (© The Author(s) 2024. Published by Oxford University Press on behalf of Fellowship of Postgraduate Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts., Objective: This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers., Methods: Semistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis., Results: Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees., Conclusions: More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research., (©Svenja Wiertz, Joachim Boldt. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 07.08.2024.)

Though artificial intelligence (AI) is being widely implemented in gastroenterology (GI) and hepatology and has the potential to be paradigm shifting for clinical practice, its pitfalls must be considered along with its advantages. Currently, although the use of AI is limited in practice to supporting clinical judgment, medicine is rapidly heading toward a global environment where AI will be increasingly autonomous. Broader implementation of AI will require careful ethical considerations, specifically related to bias, privacy, and consent. Widespread use of AI raises concerns related to increasing rates of systematic errors, potentially due to bias introduced in training datasets. We propose that a central repository for collection and analysis for training and validation datasets is essential to overcoming potential biases. Since AI does not have built-in concepts of bias and equality, humans involved in AI development and implementation must ensure its ethical use and development. Moreover, ethical concerns regarding data ownership and health information privacy are likely to emerge, obviating traditional methods of obtaining patient consent that cover all possible uses of patient data. The question of liability in case of adverse events related to use of AI in GI must be addressed among the physician, the healthcare institution, and the AI developer. Though the future of AI in GI is very promising, herein we review the ethical considerations in need of additional guidance informed by community experience and collective expertise., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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., Competing Interests: Conflicts of Interest No benefits in any form have been received or will be received related directly to this article., (Copyright © 2024 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 the Association of American Medical Colleges.)

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., (Copyright © 2024 the Association of American Medical Colleges.)

Background: Health and care research involving people who lack capacity to consent requires an alternative decision maker to decide whether they participate or not based on their 'presumed will'. However, this is often unknown. Advance research planning (ARP) is a process for people who anticipate periods of impaired capacity to prospectively express their preferences about research participation and identify who they wish to be involved in future decisions. This may help to extend individuals' autonomy by ensuring that proxy decisions are based on their actual wishes. This qualitative study aimed to explore stakeholders' views about the acceptability and feasibility of ARP and identify barriers and facilitators to its implementation in the UK., Methods: We conducted semi-structured interviews with 27 researchers, practitioners, and members of the public who had participated in a preceding survey. Interviews were conducted remotely between April and November 2023. Data were analysed thematically., Results: Participants were supportive of the concept of ARP, with differing amounts of support for the range of possible ARP activities depending on the context. Six main themes were identified: (1) Planting a seed - creating opportunities to initiate/engage with ARP; (2) A missing part of the puzzle - how preferences expressed through ARP could help inform decisions; (3) Finding the sweet spot - optimising the timing of ARP; (4) More than a piece of paper - finding the best mode for recording preferences; (5) Keeping the door open to future opportunities - minimising the risk of unintended consequences; and (6) Navigating with a compass - principles underpinning ARP to ensure safeguarding and help address inequalities. Participants also identified a number of implementation challenges, and proposed facilitative strategies that might overcome them which included embedding advance research planning in existing future planning processes and research-focused activities., Conclusions: This study provides a routemap to implementing ARP in the UK to enable people anticipating impaired capacity to express their preferences about research, thus ensuring greater opportunities for inclusion of this under-served group, and addressing the decisional burden experienced by some family members acting as proxies. Development of interventions and guidance to support ARP is needed, with a focus on ensuring accessibility., (© 2024. The Author(s).)

Background: Informal mHealth is widely used by community health nurses in Ghana to extend healthcare delivery services to clients who otherwise might have been excluded from formal health systems or would experience significant barriers in their quest to access formal health services. The nurses use their private mobile phones or devices to make calls to their clients, health volunteers, colleagues or superiors. These phone calls are also reciprocal in nature. Besides, the parties exchange or share other health data and information through text messages, pictures, videos or voice clips. There are some ethical dimensions that are inherent in these practices that ought to be critically scrutinised by bioethicists., Objective: The author has argued in this paper that informal mHealth at large scale adoption in Ghana is associated with some bioethical challenges., Methods: This essay was largely based on an analysis of an empirical study published by Hampshire et al in 2021 on the use of informal mHealth methods in Ghana., Results: Widespread adoption of Informal mHealth in Ghana is associated with privacy invasion of both the nurses and their clients, breaches confidentiality of the parties, discredits the validity of informed consent processes and may predispose the nurses to some other significant aggregated harms., Conclusion: The author affirms his partial support for a formalised adoption process of informal mHealth in Ghana but has reiterated that the current ethical challenges associated with informal mHealth in Ghana cannot escape all the debilitating bioethical challenges, even if it is formalised., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

The temptation to use prospective observational studies (POS) instead of conducting difficult trials (RCTs) has always existed, but with the advent of powerful computers and large databases, it can become almost irresistible. We examine the potential consequences, were this to occur, by comparing two hypothetical studies of a new treatment: one RCT, and one POS. The POS inevitably submits more patients to inferior research methodology. In RCTs, patients are clearly informed of the research context, and 1:1 randomized allocation between experimental and validated treatment balances risks for each patient. In POS, for each patient, the risks of receiving inferior treatment are impossible to estimate. The research context and the uncertainty are down-played, and patients and clinicians are at risk of becoming passive research subjects in studies performed from an outsider's view, which potentially has extraneous objectives, and is conducted without their explicit, autonomous, and voluntary involvement and consent., (© The Author(s) 2024. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

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., (© The Author(s) 2024. Published by Oxford University Press.)

Practical assessment involving patients plays a vital role in medical education, allowing students to demonstrate their clinical competencies. However, there are significant ethical concerns associated with these assessments that require careful consideration and resolution. The primary ethical concerns include violation of patient autonomy, lack of written informed consent, power dynamics, cultural differences, potential harm to patients, breach of privacy and confidentiality, discomfort to admitted patients, financial loss to patients, impact on other patients' care, and delays in workup/procedures. To address these concerns, measures such as respecting patient autonomy, obtaining written informed consent, ensuring patient safety, exploring alternative methods, providing reimbursement, resource planning, creating a supportive environment, developing cultural competency, putting in place a feedback system, prioritising patient care, and implementing ethical oversight and monitoring are recommended. The formulation of a guideline could be a crucial starting point, and it should be integrated into a broader ethical framework that encompasses education and training, ethical oversight, ongoing monitoring, and a culture that prioritises ethical conduct.

Background: Culturally competent healthcare improves patient satisfaction and clinical outcomes. Many drugs, dressings and implants have human or animal-derived content which may conflict with patients' religious beliefs, and may even have medicolegal implications., Methods: This cross-sectional study (anonymous web-based survey) was done to understand the informed consent process followed by paediatricians and neonatologists in India, their views regarding disclosure pertaining to the animal origin of exogenous surfactants to patients' families, and their willingness and ability to provide alternative surfactants based on parental preferences., Results: A total of 114 neonatologists/paediatricians involved in neonatal care and using surfactants in their practice responded to the survey. Although 61(53.5%) neonatal care units stocked two or more brands of surfactant in their inventory, only 38(33.3%) units had both bovine and porcine preparations. Most (104, 91.2%) of the doctors always take parental consent before administering surfactants; but only a few (12,10.5%) said they always inform parents about its animal origin. None of the respondents offer parents a choice between bovine or porcine-origin surfactants, most (73, 64%) presuming that it would be irrelevant for the parents. However, many respondents (27, 23.7%) mentioned that they want to offer the choice to parents but are unable to do so because they do not stock both bovine and porcine preparations., Conclusion: Although most parents might agree to a life-saving medicine in emergency situations, this does not mean they do not want to be informed. Healthcare professionals should not have a dismissive attitude to parental belief systems. They must use the antenatal period to take the cultural/spiritual history and the necessary consent.

Competing Interests: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NCCIH, NIAID, NCI, NIA, NHLBI, NINR, NIMHD, NIAMS, OBSSR, or ODP or the NIH or its HEAL Initiative.

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research., (© 2024 The Authors. Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

Background: Artificial intelligence (AI) is considered the fourth industrial revolution that will change the evolution of humanity technically and relationally. Although the term has been around since 1956, it has only recently become apparent that AI can revolutionize technologies and has many applications in the medical field., Areas of Uncertainty: The ethical dilemmas posed by the use of AI in medicine revolve around issues related to informed consent, respect for confidentiality, protection of personal data, and last but not least the accuracy of the information it uses., Data Sources: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2022) using combinations of keywords, including: AI, future in medicine, and machine learning plus ethical dilemma., Ethics and Therapeutic Advances: The ethical analysis of the issues raised by AI used in medicine must mainly address nonmaleficence and beneficence, both in correlation with patient safety risks, ability versus inability to detect correct information from inadequate or even incorrect information. The development of AI tools that can support medical practice can increase people's access to medical information, to obtain a second opinion, for example, but it is also a source of concern among health care professionals and especially bioethicists about how confidentiality is maintained and how to maintain cybersecurity. Another major risk may be related to the dehumanization of the medical act, given that, at least for now, empathy and compassion are accessible only to human beings., Conclusions: AI has not yet managed to overcome certain limits, lacking moral subjectivity, empathy, the level of critical thinking is still insufficient, but no matter who will practice preventive or curative medicine in the next period, they will not be able to ignore AI, which under human control can be an important tool in medical practice., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them. Methods: We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa. Results: Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model. Conclusions: A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

Technological and computer advances have led to a "new era" of Surgery called Digital Surgery. In it, the management of information is the key. The development of Artificial Intelligence requires "Big Data" to create its algorithms. The use of digital technology for the systematic capture of data from the surgical process raises ethical issues of privacy, property, and consent. The use of these out-of-control data creates uncertainty and can be a source of mistrust and refusal by surgeons to allow its use, requiring a framework for the correct management of them. This paper exposes the current situation of Data Governance in Digital Surgery, the challenges posed and the lines of action necessary to resolve the areas of uncertainty that have arisen in the process, in which the surgeon must play a relevant role., (Copyright © 2023. Published by Elsevier España, S.L.U.)

Importance: Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials., Objective: To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type., Design and Setting and Participants: Cross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer ( N  = 334)., Main Outcome Measures: Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type., Results: Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT., Conclusions and Relevance: Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

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., (Copyright © 2024 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Behavioural nudges are often criticised because they "work best in the dark". However, recent experimental evidence suggests that the effectiveness of nudges is not reduced when they are delivered transparently. Most people also endorse transparent nudges. Yet, transparent nudging may undermine human autonomy-a minority may oppose to being nudged and feel manipulated, even if they know what is happening. We propose an alternative way of maintaining autonomy that is not reducible to transparency: individuals can be asked if they consent in advance to being nudged. To assess whether consensual nudges are effective, we ask consent from 1518 UK citizens to be nudged. Subsequently, we default all participants into donating to a charity of their choice, irrespective of self-reported consent. We find that the default nudge is equally effective for both consenting and non-consenting individuals, with negligible difference in average donations. However, non-consenting individuals report higher levels of resentment and regret and lower levels of happiness and support compared to the consenting group. Based on these findings, we argue that ignoring consent can have serious ethical ramifications for policy-making with nudges., (© 2024. The Author(s).)

Sexual violence constitutes a form of gender-based violence, to the extent that the victims are mainly women. Other groups of vulnerable people are also more affected, in particular gender and sexual diversity persons. Sexual and gender-based violence can also occur in healthcare. To respect the legal framework and people's rights, but also to promote safety and quality in healthcare, it is essential to obtain and respect consent. Consent must be informed, explicit, freely given, and reiterated throughout the consultation. This article reviews the concept of consent and offers practical tools for its application in healthcare., Competing Interests: Les auteures n’ont déclaré aucun conflit d’intérêts en relation avec cet article.

Resnik and Pugh recently explored the ethical implications of routinely integrating environmental concerns into clinical decision-making. While we share their concern for the holistic well-being of patients, our response offers a different clinical and bioethical stance on green informed consent and patient autonomy. Contrary to the authors' lack of data to support their concerns about provider and patient willingness to engage in climate-related conversations, we provide evidence supporting their sustainability engagement and stress the importance of a proactive, anticipatory approach in healthcare to align with evolving societal values. If climate change is perceived as a politicised issue, though it is not inherently so, healthcare providers are professionally trained to address sensitive subjects and have a duty to inform patients about potential health risks. Recognising the environmental crisis as a health crisis underscores the direct connection between environmental hazards and patients' well-being. Our perspective advocates for integrating individual considerations, societal responsibilities and systemic changes to promote environmentally sustainable healthcare., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

The overwhelming weight of legal authority in the USA and Canada holds that consent is not required for brain death testing. The situation in England and Wales is similar but different. While clinicians in England and Wales may have a prima facie duty to obtain consent, lack of consent has not barred testing. In three recent cases where consent for brain death testing was formally presented to the court, lack of consent was not determinative, and in one case the court questioned whether the clinicians were even required to seek consent from the parents of a child at all., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

How could we better use public inquiries to stem the recurrence of healthcare failures? The question seems ever relevant, prompted this time by the inquiry into how former nurse Letby was able to murder newborns under National Health Service care. While criminality, like Letby's, can be readily condemned, other factors like poor leadership and culture seem more often regretted than reformed. I would argue this is where inquiries struggle, in the space between ethics and law-with what is awful but lawful. In response, we should learn from progress with informed consent. Inquiries and civil litigation have seen uninformed 'consent' shift from being undesirable to unlawful. If better leadership and culture were sole drivers here, we would likely be doing far better in many other areas of healthcare too. Instead, one could argue that progress on consent has been made by reducing epistemic injustice -by naming and addressing epistemic issues in ways that enhance social power for patients. If this is an ingredient that transforms clinician-patient working, might it also shift conduct within other key relationships, by showing up what else should become unlawful and why? Naming medical paternalism may have helped with consent reform, so I continue this approach, first naming two areas of epistemic injustice: management feudalism and legal chokeholds Remedies are then considered, including the democratisation of management and reforms to legal ethics, legislation and litigation. In brief, public inquiries may improve if they also target epistemic injustices that should become unlawful. Focus on informed consent and epistemic relationships has improved the medical profession. Likewise, it could help healthcare leaders shift from fiat towards consent, and their lawyers from a stifling professional secrecy towards the kind of candour a prudent public expects., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Green bioethics is an area of research and scholarship that examines the impact of healthcare practices and policies on the environment and emphasises environmental values, such as ecological sustainability and stewardship. Some green bioethicists have argued that healthcare providers should inform patients about the environmental impacts of treatments and advocate for options that minimise adverse impacts. While disclosure of information pertaining to the environmental impacts of treatments could facilitate autonomous decision-making and strengthen the patient-provider relationship in situations where patients have clearly expressed environmental concerns, it may have the opposite effect in other situations if makes patients feel like they are being judged or manipulated. We argue, therefore, that there is not a generalisable duty to disclose environmental impact information to all patients during the consent process. Providers who practice green bioethics should focus on advocating for system-level changes in healthcare financing, organisation and delivery and use discretion when bringing up environmental concerns in their encounters with patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Canada has recently published a new Clinical Practice Guideline on the diagnosis and management of brain death. It states that consent is not necessary to carry out the interventions required to make the diagnosis. A supporting article not only sets out the arguments for this but also contends that 'UK laws similarly carve out an exception, excusing clinicians from a prima facie duty to get consent'. This is supplemented by the claim that recent court decisions in the UK similarly confirm that consent is not required, referencing two judgements in Battersbee We disagree with the authors' interpretation of the law on consent in the UK and argue that there is nothing in Battersbee to support the conclusion that consent to testing is not necessary. Where there is a disagreement about testing for brain death in the UK, court authorisation is required., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice., Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice., Evidence Review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group., Findings: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified., Conclusions and Relevance: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.

In medical care, the obtaining of informed consent is taken to be required prior to treatment in order to ensure that patients sufficiently understand the potential risks and benefits of a given medical procedure. In this paper, I begin by looking at the history of informed consent and consider how the norms and laws in medicine have evolved away from benevolent paternalism and toward a blanket obligation to obtain informed consent. In so doing, I consider what values might be taken to underpin such a requirement. After dismissing some unsatisfactory answers, I offer a positive view as to the constellation of values I think informed consent ought to be protecting. I call these bodily self-sovereignty, which I take to be a coupling of two groups of values: autonomy and non-domination on the one hand, and self-ownership and personal integrity on the other. Given the connection between autonomy and responsibility, autonomy is both required for the act of consenting, and respected by allowing it. And, because of our special and inescapable relationship to our own bodies, this authorization is particularly important when our bodies are involved. So, I suggest that informed consent protects our self-sovereignty over our own bodies., (© 2024. The Author(s) under exclusive licence to Monash University.)

COVID-19 presents a variety of ethical challenges in a set of arenas, arenas not always considered in past pandemics. These challenges include issues related to autonomy, distributive ethics, and the establishment of policies of equity and justice. Methods are a literature review based on regular editing of an online textbook during the COVID-19 outbreak and a literature review using key ethical terms. Patients are confronted with new issues related to autonomy. Providers need to expand their concepts of ethical issues to include decisions based on proportionality and public health ethics. The public health sector needs to assess the beneficence of alternative modes of disease control. The research community needs to redefine the concept of informed consent in emergent conditions. All elements of the medical spectrum-physicians, scientists, and the community-at-large including the pharmaceutical industry-need to consider the multifaceted methods for preventing future pandemics. This will require giving particular emphasis to public health funding and ending the documented discrimination that exists in the provision of proven therapies. The developing world is especially at risk for most of the ethical issues, especially those related to equity and justice. The ethical issues associated with the COVID-19 outbreak are not unique but provide a diverse set of issues that apply to patients, providers, social groups, and investigators. The further study of such issues can help with preventing future outbreaks., (© 2024. The Author(s).)