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Introduction: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries., Materials and Methods: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability., Results: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented., Conclusions: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Current international standards in consent to surgery practices are usually derived from health systems in Western countries, while little attention has been given to other contexts such as sub-Saharan Africa (SSA), despite this region facing the highest burdens of disease amenable to surgery globally. The aim of this study was to examine how the concept of informed consent for surgery is interpreted and applied in the context of SSA, and factors affecting current practices., Methods: A systematic search of Medline, Embase and African Journal OnLine databases as well as grey sources was executed in May 2023 to retrieve relevant literature published since 2010 in English language against a set of given criteria. The socioecological framework for health was used for organising and summarising the identified evidence., Results: A total of 27 papers were included in the review. Findings revealed that consent to surgery practices is generally substandard across SSA and the process is not adequate. Patients' understanding of informed consent is limited, likewise awareness of their rights to decision-making. A range of factors at the individual, interpersonal, institutional and system/societal levels affect the informed consent process., Conclusion: There is a need to find more culturally acceptable and ethical ways to include the participation of patients in the decision-making process for surgical treatment in the SSA and define standards more closely aligned with the local context., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Many important questions in health professions education require datasets that are built from several sources, in some cases using data collected for a different purpose. In building and maintaining these datasets, project leaders will need to make decisions about the data. While such decisions are often construed as technical, there are several normative concerns, such as who should have access, how the data will be used, how products resulting from the data will be shared, and how to ensure privacy of the individuals the data is about is respected, etc. Establishing a framework for data governance can help project leaders in avoiding problems, related to such matters, that could limit what can be learned from the data or that might put the project (or future projects) at risk. In this paper, we highlight several normative challenges to be addressed when determining a data governance framework. Drawing from lessons in global health, we illustrate three kinds of normative challenges for projects that rely on data from multiple sources or involved partnerships across institutions or jurisdictions: (1) legal and regulatory requirements, (2) consent, and (3) equitable sharing and fair distribution., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

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.)

Background: Experts are currently investigating the potential applications of the metaverse in healthcare. The metaverse, a groundbreaking concept that arose in the early 21st century through the fusion of virtual reality and augmented reality technologies, holds promise for transforming healthcare delivery. Alongside its implementation, the issue of digital professionalism in healthcare must be addressed. Digital professionalism refers to the knowledge and skills required by healthcare specialists to navigate digital technologies effectively and ethically. This study aims to identify the core principles of digital professionalism for the use of metaverse in healthcare., Method: This study utilized a qualitative design and collected data through semi-structured online interviews with 20 medical information and health informatics specialists from various countries (USA, UK, Sweden, Netherlands, Poland, Romania, Italy, Iran). Data analysis was conducted using the open coding method, wherein concepts (codes) related to the themes of digital professionalism for the metaverse in healthcare were assigned to the data. The analysis was performed using the MAXQDA software (VER BI GmbH, Berlin, Germany)., Results: The study revealed ten fundamental principles of digital professionalism for the metaverse in healthcare: Privacy and Security, Informed Consent, Trust and Integrity, Accessibility and Inclusion, Professional Boundaries, Evidence-Based Practice, Continuous Education and Training, Collaboration and Interoperability, Feedback and Improvement, and Regulatory Compliance., Conclusion: As the metaverse continues to expand and integrate itself into various industries, including healthcare, it becomes vital to establish principles of digital professionalism to ensure ethical and responsible practices. Healthcare professionals can uphold these principles to maintain ethical standards, safeguard patient privacy, and deliver effective care within the metaverse., (© 2024. The Author(s).)

Consent bias is a type of selection bias in biomedical research where those consenting to the research differ systematically from those not consenting. It is particularly relevant in precision medicine research because the complexity of these studies prevents certain subgroups from understanding, trusting, and consenting to the research. Because consent bias distorts research findings and causes inequitable distribution of research benefits, scholars propose two types of schemes to reduce consent bias: reforming existing consent models and removing the consent requirement altogether. This study explores the possibility of waiving consent in observational studies using existing data, because they involve fewer risks to participants than clinical trials if privacy safeguards are strengthened. It suggests that data protection mechanisms such as security enhancement and data protection impact assessment should be conducted to protect data privacy of participants in observational studies without consent., (© 2024. The Author(s).)

Richard Griffith , Senior Lecturer in Health Law at Swansea University, discusses the importance of consent in nursing and outlines the key elements for ensuring the patient has given valid consent before providing treatment.

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: Although access to a professional medical interpreter is federally mandated, surgeons report underutilization during informed consent. Improvement requires understanding the extent of the lapses. Adoption of electronic consent (eConsent) has been associated with improvements in documentation and identification of practice improvement opportunities. The authors evaluated the impact of the transition from paper to eConsent on language-concordant surgical consent delivery for patients with limited English proficiency (LEP)., Methods: The study period (February 8, 2023, to June 14, 2023) corresponds to the period immediately following the institutional adoption of eConsents. Inclusion criteria included age > 18 years, documented preferred language other than English, and self-signed eConsent form. The authors assessed documentation of language-concordant interpreter-mediated verbal consent discussion and delivery of the written surgical consent form in a language-concordant template. Performance was compared to a preimplementation baseline derived from monthly random audits of paper consents between January and December 2022., Results: A total of 1,016 eConsent encounters for patients with LEP were included, with patients speaking 49 different languages, most commonly Spanish (46.5%), Chinese (22.1%), and Russian (6.8%). After the implementation of eConsent, overall documentation of language-concordant interpreter-mediated consents increased from 56.9% to 83.9% (p < 0.001), although there was variation between surgical services and between languages, suggesting that there is still likely room for improvement. Most patients (94.1%) whose preferred language had an associated translated written consent template (Spanish, Chinese, Russian, Arabic), received a language-concordant written consent., Conclusion: The transition to eConsent was associated with improved documentation of language-concordant informed consent in surgery, both in terms of providing written materials in the patient's preferred language and in the documentation of interpreter use, and allowed for the identification of areas to target for practice improvement with interpreter use., (Published by Elsevier Inc.)

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.

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.

Background: Patient informed consent is a crucial subject in preoperative care of patients before elective hand surgery, ensuring that patients have the necessary information and a comprehensive understanding to make autonomous decisions. The use of video-based informed consent systems is an innovative concept to enhance the consent process with multimedia tools. In addition to the conventional process, mostly relying on verbal communication and written documents, the video-based approach aims to present information in a standardized and visually appealing format., Methods: In this study, 33 patients were asked to watch a video on a tablet about the planned elective hand surgery after a conventional pre-treatment consultation including informed consent throughout verbal explanations and paper forms by an attending physician or resident. All patients were asked to complete a questionnaire after watching the video., Results: An overwhelming majority of participants, specifically 97.0%, stated that the video improved their understanding of the upcoming surgery. 90.9% of the participant would refer the video to other patients undergoing elective hand surgery, while 72.7% of participants indicated that they would have appreciated the opportunity to view an informational video before undergoing different types of surgeries in the past., Conclusion: The use of a video-based patient information system in elective hand surgery had a positive impact on patient education and satisfaction with the informed consent process. Therefore, it is a powerful tool in preoperative management to guarantee a standardized and educative informed consent., (© 2024. The Author(s).)

Background: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites., Methods: The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use. In addition, inquiries and feedback from a large number of stakeholders were evaluated., Results: The online surveys showed that 27 of the 32 sites have gradually introduced the consent documents productively, with a current total of 173,289 consents. The analysis of the implementation procedures revealed heterogeneous organizational conditions at the sites. The requirements of various stakeholders were met by developing and providing supplementary versions of the consent documents and additional information materials., Discussion: The introduction of the MII consent documents at the university hospitals creates a uniform legal basis for the secondary use of patient data. However, the comprehensive implementation within the sites remains challenging. Therefore, minimum requirements for patient information and supplementary recommendations for best practice must be developed. The further development of the national legal framework for research will not render the participation and transparency mechanisms developed here obsolete., (© 2024. The Author(s).)

Introduction: Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice., Methods: PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary., Results: Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including 'control', 'mock' and 'sham'., Conclusion: Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials., (© 2024. The Author(s).)

Background : Mental capacity is a fundamental aspect that enables patients to fully participate in various healthcare procedures. To assist healthcare professionals (HCPs) in assessing patients' capacity, especially in the mental health field, several standardized tools have been developed. These tools include the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), and the Competence Assessment Tool for Psychiatric Advance Directives (CAT-PAD). The core dimensions explored by these tools include Understanding, Appreciation, Reasoning, and Expression of a choice. Objective : This meta-analysis aimed to investigate potential differences in decision-making capacity within the healthcare context among groups of patients with bipolar disorders (BD) and schizophrenia spectrum disorders (SSD). Methods : A systematic search was conducted on Medline/Pubmed, and Scopus. Additionally, Google Scholar was manually inspected, and a manual search of emerging reviews and reference lists of the retrieved papers was performed. Eligible studies were specifically cross-sectional, utilizing standardized assessment tools, and involving patients diagnosed with BD and SSD. Data from the studies were independently extracted and pooled using random-effect models. Hedges' g was used as a measure for outcomes. Results : Six studies were identified, with three studies using the MacCAT-CR, two studies the MacCAT-T, and one the CAT-PAD. The participants included 189 individuals with BD and 324 individuals with SSD. The meta-analysis revealed that patients with BD performed slightly better compared to patients with SSD, with the difference being statistically significant in the domain of Appreciation (ES = 0.23, 95% CI: 0.01 to 0.04, p = 0.037). There was no statistically significant difference between the two groups for Understanding (ES = 0.09, 95% CI:-0.10 to 0.27, p = 0.352), Reasoning (ES = 0.18, 95% CI: -0.12 to 0.47, p = 0.074), and Expression of a choice (ES = 0.23, 95% CI: -0.01 to 0.48, p = 0.60). In the sensitivity analysis, furthermore, when considering only studies involving patients in symptomatic remission, the difference for Appreciation also resulted in non-significant (ES = 0.21, 95% CI: -0.04 to 0.46, p = 0.102). Conclusions : These findings indicate that there are no significant differences between patients with BD and SSD during remission phases, while differences are minimal during acute phases. The usefulness of standardized assessment of capacity at any stage of the illness should be considered, both for diagnostic-therapeutic phases and for research and advance directives. Further studies are necessary to understand the reasons for the overlap in capacity between the two diagnostic categories compared in this study.

Background: Due to surgical capacity pressures, induced by the COVID-19 pandemic, immediate bilateral simultaneous cataract surgery (ISBCS) has been utilised increasingly throughout the U.K. This surgical method comes with both novel risks and benefits, so the consent process must be modified. Prior randomised trials have demonstrated that appropriate online information may act as an adjunct to the surgical consent process. This study aims to assess the quality of available internet information for ISBCS., Methods: Terms searched were 'bilateral cataract surgery patient information', 'double cataract surgery patient information', and 'immediate sequential bilateral cataract surgery patient information'. The Google search engine was used. The DISCERN instrument and JAMA benchmarks were used to assess healthcare information for quality. The Flesch Reading Ease Score (FRE), Flesch Kincaid Grade (FKG) Level and Gunning Fog Score (GFS) were used to assess for readability. HONcode certification was used to assess transparency and quality., Results: Forty-six websites were found. The average DISCERN score was 41.3, meaning a "fair" quality which is below what many patients would anticipate discovering when trying to find information. National Healthcare Service websites had higher DISCERN scores than private healthcare-provided websites ( p  < 0.01; 95% CI: 1.13-1.88.)., Conclusions: Fair patient information for ISBCS has been demonstrated. Specific internet information sources with appropriate information should be further developed, with cited sources, and patients signposted to them if felt appropriate., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Informed consent for surgery is a complex process particularly in paediatrics. Complexity increases with procedures such as CHD surgery. Regulatory agencies outline informed consent contents for surgery. We assessed and described CHD surgical informed consent contents through survey dissemination to paediatric CHD centres across United States of America., Methods: Publicly available email addresses for 125 paediatric cardiac clinicians at 70 CHD surgical centres were obtained. Nine-item de-identified survey assessing adherence to The Joint Commission informed consent standards was created and distributed via RedCap® 14 March, 2023. A follow-up email was sent 29 March, 2023. Survey link was closed 18 April, 2023., Results: Thirty-seven surveys were completed. Results showed informed consent documents were available in both paper (25, 68%) and electronic (3, 8%) format. When both (9, 24%) formats were available, decision on which format to use was based on centre protocols (1, 11%), clinician personal preference (3, 33%), procedure being performed (1, 11%), or other (4, 45%). Five (13%) centres' informed consent documents were available only in English, with 32 (87%) centres also having a Spanish version. Review of informed consent documents demonstrated missing The Joint Commission elements including procedure specific risks, benefits, treatment alternatives, and expected outcomes., Conclusions: Informed consent for CHD surgery is a complex process with multiple factors involved. Majority of paediatric CHD surgical centres in the United States of America used a generic informed consent document which did not uniformly contain The Joint Commission specified information nor reflect time spent in discussion with families. Further research is needed on parental comprehension during the informed consent process.

Purpose: This study aimed to demonstrate the performance of the popular artificial intelligence (AI) language model, Chat Generative Pre-trained Transformer (ChatGPT) (OpenAI, San Francisco, CA, U.S.A.), in generating the informed consent (IC) document of blepharoplasty., Methods: A total of 2 prompts were provided to ChatGPT to generate IC documents. Four board-certified plastic surgeons and 4 nonmedical staff members evaluated the AI-generated IC documents and the original IC document currently used in the clinical setting. They assessed these documents in terms of accuracy, informativeness, and accessibility., Results: Among board-certified plastic surgeons, the initial AI-generated IC document scored significantly lower than the original IC document in accuracy ( p < 0.001), informativeness ( p = 0.005), and accessibility ( p = 0.021), while the revised AI-generated IC document scored lower compared with the original document in accuracy ( p = 0.03) and accessibility ( p = 0.021). Among nonmedical staff members, no statistical significance of 2 AI-generated IC documents was observed compared with the original document in terms of accuracy, informativeness, and accessibility., Conclusions: The results showed that current ChatGPT cannot be used as a distinct patient education resource. However, it has the potential to make better IC documents when improving the professional terminology. This AI technology will eventually transform ophthalmic plastic surgery healthcare systematics by enhancing patient education and decision-making via IC documents., Competing Interests: The authors have no financial or conflicts of interest to disclose., (Copyright © 2024 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.)

Background: Informed consent is a communication process of providing the patient/parents/guardians with relevant information regarding the diagnosis and the treatment so that they can make informed decisions. This study was to assess the practice of surgical informed consent in Addis Ababa., Methods: An institution-based cross-sectional study was undertaken in Addis Ababa in 2021. A total of 312 women who underwent cesarean section were interviewed immediately after their hospital discharge. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeons' standards of informed consent practices for surgical procedures., Results: Almost all (100 %) of the respondents were asked to provide written consent, and 96.2 % of them signed the consent form. Most women (89.4%) received information about the indication(s). Few (18.6%) respondents were informed about the type of anesthesia to be administered while only 9 %( n= 28) of them were given an opportunity to choose the option of anesthesia. Only 44.9% of the respondents have received at least six of the 13 components of SIC suggested by the investigators. In this, the most secured data was the signature of the patient which is 96 %. The least documented element of SIC was alternative treatment., Conclusion: A majority of women who underwent both elective and emergency cesarean section did not receive comprehensive information during the Surgical Informed Consent process in the study hospitals. There is a need that patients need to be counseled during antenatal visits, specifically when patients visit near term for antenatal checkups., (© 2023 Eskinder Kebede, et al.)

Bodies of deceased persons and human remains and their specimens (i.e., organs, bones, tissues, or biological samples) are essential in forensic research but ad hoc worldwide-recognized ethical standards for their use are still lacking. Such standards are needed both to avoid possible unethical practices and to sustain research in the forensic field. Pending consensus within the forensic science community regarding this topic, with this article we aim to stimulate a debate as to the applicability and usefulness of the Declaration of Helsinki in the field of forensic research involving human cadavers and remains. Considering the fundamental differences compared to clinical research involving human beings and the different moral obligations involved, we focus on the risks, burdens, and benefits of research, ethics committee approval, and informed consent requirements. The Declaration of Helsinki framework allows forensic researchers to focus on substantial ethical principles promoting the consistency, integrity, and quality of research. Consensus regarding ethical standards and the adoption of national and supranational laws that clearly regulate the use of human cadavers and remains, including those from autopsies, continues to be of primary importance for the forensic science community., (© 2022. The Author(s).)

Competing Interests: Competing interests: None declared.

In the past decade, the use of intraoperative neural monitoring (IONM) in thyroid and parathyroid surgery has been widely accepted by surgeons as a useful technology for improving laryngeal nerve identification and voice outcomes, facilitating neurophysiological research, educating and training surgeons, and reducing surgical complications and malpractice litigation. Informing patients about IONM is not only good practice and helpful in promoting the efficient use of IONM resources but is indispensable for effective shared decision making between the patient and surgeon. The International Neural Monitoring Study Group (INMSG) feels complete discussion of IONM in the preoperative planning and patient consent process is important in all patients undergoing thyroid and parathyroid surgery. The purpose of this publication is to evaluate the impact of IONM on the informed consent process before thyroid and parathyroid surgery and to review the current INMSG consensus on evidence-based consent. The objective of this consensus statement, which outlines general and specific considerations as well as recommended criteria for informed consent for the use of IONM, is to assist surgeons and patients in the processes of informed consent and shared decision making before thyroid and parathyroid surgery., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Wu, Huang, Randolph, Barczyński, Schneider, Chiang, Silver Karcioglu, Wojtczak, Frattini, Gualniera, Sun, Weber, Angelos, Dralle and Dionigi.)

The use of social media (SoMe) in medicine has demonstrated the ability to advance networking among clinicians and other healthcare staff, disseminate research, increase access to up-to-date information, and inform and engage medical trainees and the public at-large. With increasing SoMe use by vascular surgeons and other vascular specialists, it is important to uphold core tenets of our commitment to our patients by protecting their privacy, encouraging appropriate consent and use of any patient-related imagery, and disclosing relevant conflicts of interest. Additionally, we recognize the potential for negative interactions online regarding differing opinions on optimal treatment options for patients. The Society for Vascular Surgery (SVS) is committed to supporting appropriate and effective use of SoMe content that is honest, well-informed, and accurate. The Young Surgeons Committee of the SVS convened a diverse writing group of SVS members to help guide novice as well as veteran SoMe users on best practices for advancing medical knowledge-sharing in an online environment. These recommendations are presented here with the goal of elevating patient privacy and physician transparency, while also offering support and resources for infrequent SoMe users to increase their engagement with each other in new, virtual formats., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

In this article, we analyse the legal components of disclosing confidential patient information under the UK's common law duty of confidentiality (CLDoC) and processing personal (health) data under the UK's General Data Protection Regulation (GDPR) and Data Protection Act 2018. We describe the ostensible divide between the CLDoC and data protection law when it comes to the requirements of a valid signal of consent by a patient to use and disclose patient information, obtained by a health professional in the context of direct care, for health care and health research purposes. Ultimately, our analysis suggests that we are saddled, at least in the medium term, with two regimes operating with different standards of a valid consent-while putatively protecting similar interests. There is, however, opportunity for progress. It is possible to improve professional guidance on the interaction between the regimes and to achieve significant normative alignment without aligning the signalling standard for consent; this would promote consistent protection of reasonable expectations of patients across both regimes. Further coherence would require aligning not only the standard, but also the role played by consent under each regime. Here we argue that, in relation to direct care, any such shift should be away from consent as the normal justification. In relation to health research, on the contrary, it should be toward consent as the normal justification for use and disclosure of patient information under both the CLDoC and data protection law., (© The Author(s) 2021. Published by Oxford University Press.)

EU data protection law and medical research ethics overlap in scope and content in numerous instances in which personal data are processed in medical research. It is not always the case, however, that the conditions outlined by the two rule-sets precisely coincide. In the past few years, this lack of confluence has led to confusion as to how the two rule-sets should best relate to one another. This confusion has led to different approaches to the relationship being taken, on occasion leading to counter-intuitive conclusions. Unfortunately, there has hitherto been little effort to provide clarity to this confusion. In this regard, this article attempts to provide a general normative framework aimed at facilitating optimally cogent and just reconciliations of EU data protection law and medical research ethics., (© The Author(s) 2021. Published by Oxford University Press; All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R-T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions., Methods: A total of 185 forms from the university, R-T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated., Results: TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R-T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking., Conclusion: The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.

Objective: To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in randomized controlled trials (of healthcare interventions), the ELICIT Study., Study Design: International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting., Results: The literature review and stakeholder interviews (n = 25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n = 79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition., Conclusion: The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an randomized controlled trial. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders., Registration: COMET database - http://www.comet-initiative.org/Studies/Details/595., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Richard Griffith , Senior Lecturer in Health Law at Swansea University, considers the impact of errors and omissions in the forms required to lawfully authorise a deprivation of liberty under the Mental Health Act 2005.

Abstract: Law No 40/2004 regulates in Italy the matter of medically assisted procreation (MAP). Recently, the Tribunal of Capua Vetere expressed its position on the subject of informed consent in a case of MAP. In the specific case, a couple entered the preliminary stages of the PMA procedures, carrying out the fertilization of the ovum and the embryo production. Afterwards, the couple separated and the man denied consent to the continuation of the MAP. The woman, willing to proceed with the implantation, the woman made an urgent judicial appeal, obtaining the judge's permission to transfer the embryo to the uterus. This paper analyses the different bioethical positions on MAP's informed consent. In fact, on the one hand, the paper highlight what is set out in Law 219/2017 which provides for the possibility of the patient to revoke at any time the consent to the treatment given. On the other hand, it should be noted that Law 40/2004, willing to protect the embryo, establishes the irrevocability of the position of parental consent after fertilization. The judgment in question seems to favour this latter position, placing itself in the protection of the cryopreserved embryo and recall-ing the principle of entrustment following the fertilization of the egg. Nevertheless, the matter is controversial a consistent amount of legal developments are expected to arise in the next future.

Purpose: Informed consent is required prior to any medical procedure. In the context of cancer treatment, special efforts are needed to inform cancer patients properly about treatment, potential sequelae and alternative therapies. Little is known about the effectiveness of current informed consent strategies and patients' individual satisfaction. Given the heterogeneity in terms of age, education, sex and other factors, detailed understanding of patients' comprehension and perception is the basis for further optimization of the informed consent process, which was the aim of the current investigation., Methods: Patients with a new cancer diagnosis and recent informed consent were asked to complete a questionnaire about satisfaction, comprehension, time management, physician-patient relationship and other items of the informed consent process. Patients were followed for 6 months and invited to complete a follow-up questionnaire., Results: In total, 89 patients completed the first questionnaire and 52 the follow-up questionnaire. Subjective understanding was assumed high, however, this did not correlate with objective understanding. Age and education were identified as influencing factors for comprehension. 85% of the patients were satisfied with the information provided. A major gap was the information on alternative therapies. Moreover, not all patients perceived the consent dialog as such, and particularly the individual treatment intention partially remained unclear for some patients., Conclusions: To ensure that informed consent is based on solid understanding, informed consenting must be patient-centered and consider the individual expectations, needs and abilities of cancer patients. Further studies are required to develop tailored informed consent strategies.

Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls., Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting)., Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]., Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings., Competing Interests: None

In this paper we argue that 'informed' consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In addition, and using insights from philosophy of mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance-theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants' decision to consent. We do not prescribe a standard, formal approach to decision-making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front-line of genomic science., (© 2021 John Wiley & Sons Ltd.)

Recent reports suggest that the use of an outpatient-based procedure (pneumatic retinopexy, PR) for retinal detachment repair should be encouraged within the UK, especially in light of Covid-19 and possible restrictions/competing demands on access to operating theatres. It is therefore essential that patients receive comprehensive information about the risks and benefits of this approach compared with a formal surgical repair either by pars plana vitrectomy (PPV) and/or scleral buckling (SB). We report a retrospective case series of retinal detachments (RD) satisfying the strict selection criteria for PR but who were managed with formal surgery. Single-operation success rate for PPV/SB at six months follow-up was 93.8% in our study, higher than published primary success rates for PR (60-80%). When counselling patients for possible PR, the ease, speed and potentially reduced co-morbidity of an outpatient-based procedure needs to be balanced against its significantly higher failure rate in comparison with primary PPV/SB.

The wider availability of genomic sequencing, notably gene panels, in cancer care allows for personalised medicine or the tailoring of clinical management to the genetic characteristics of tumours. While the primary aim of mainstream genomic sequencing of cancer patients is therapy-focussed, genomic testing may yield three types of results beyond the answer to the clinical question: suspected germline mutations, variants of uncertain significance (VUS), and unsolicited findings pertaining to other conditions. Ideally, patients should be prepared beforehand for the clinical and psychosocial consequences of such findings, for themselves and for their family members, and be given the opportunity to autonomously decide whether or not to receive such unsolicited genomic information. When genomic tests are mainstreamed into cancer care, so should accompanying informed consent practices. This paper outlines what mainstream oncologists may learn from the ethical tradition of informed consent for genomic sequencing, as developed within clinical genetics. It argues that mainstream informed consent practices should focus on preparing patients for three types of unsolicited outcomes, briefly and effectively. Also, it argues that when the chance of unsolicited findings is very low, opt-out options need not be actively offered. The use of a layered approach - integrated in information systems - should render informed consent feasible for non-geneticist clinicians in mainstream settings. (Inter) national guidelines for mainstreaming informed consent for genomic sequencing must be developed., Competing Interests: Conflict of interest statement None declared., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

There has been little discussion of the way genomic research results should be returned and how to obtain informed consent for this. We systematically searched the empirical literature, identifying 63 articles exploring stakeholder perspectives on processes for obtaining informed consent about return of results and/or result delivery. Participants, patients and members of the public generally felt they should choose which results are returned to them and how, ranging from direct (face-to-face, telephone) to indirect (letters, emails, web-based delivery) communication. Professionals identified inadequacies in result delivery processes in the research context. Our findings have important implications for ensuring participants are supported in deciding which results they wish to receive or, if no choice is offered, preparing them for potential research outcomes.

Background: Under the Canadian Criminal Code , medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD., Methods: This qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus., Results: The 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only "yes" or "no" as an answer., Interpretation: The participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD., Competing Interests: Competing interests: None declared., (© 2021 Joule Inc. or its licensors.)

The complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.

Background: The informed consent discussion (ICD) is a compulsory element of clinical practice. Surgical residents are often tasked with obtaining informed consent, but formal instruction is not included in standard curricula. This study aims to examine attitudes of surgeons and residents concerning ICD., Materials and Methods: A survey regarding ICD was administered to residents and attending surgeons at an academic medical center with an Accreditation Council for Graduate Medical Education-accredited general surgery residency., Results: In total, 44 of 64 (68.75%) residents and 37 of 50 (72%) attending surgeons participated. Most residents felt comfortable consenting for elective (93%) and emergent (82%) cases, but attending surgeons were less comfortable with resident-led ICD (51% elective, 73% emergent). Resident comfort increased with postgraduate year (PGY) (PGY1 = 39%, PGY5 = 85%). A majority of participants (80% attending surgeons, 73% residents) believed resident ICD skills should be formally evaluated, and most residents in PGY1 (61%) requested formal instruction. High percentages of residents (86%) and attendings (100%) believed that ICD skills were best learned from direct observation of attending surgeons., Conclusions: Resident comfort with ICD increases as residents advance through training. Residents acknowledge the importance of their participation in this process, and in particular, junior residents believe formal instruction is important. Attending surgeons are not universally comfortable with resident-led ICDs, particularly for elective surgeries. Efforts for improving ICD education including direct observation between attending surgeons and residents and formal evaluation may benefit the residency curriculum., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.