Adult decision-making capacity and health research in Aotearoa New Zealand.

The Code of Health and Disability Services Consumers' Rights (the Code)1 and the Health and Disability Commissioner Act (the Act)2 are up for review. The Code currently applies to clinical care, teaching and research. When it was introduced, there were no national mechanisms to govern research, but since then the National Ethics Advisory Committee (NEAC) has developed detailed guidelines and established a network of ethics committees at various institutional levels. As currently written, the Code prohibits research on a patient who lacks capacity unless it is in their "best interests." This precludes some important research. The NEAC guidelines are more nuanced and measured, designed to balance the risks to the patient with the benefits to the community. We argue that the Code and the Act should be amended to allow decisions about research proposals on people who lack capacity to be made by an ethics committee set up by NEAC.

Pediatric Cardiac Xenotransplantation and Expanded Access: Ethical Considerations.

Due to the current organ shortage waitlist, alternatives to allotransplantation are necessary. Xenotransplantation is currently being pursued as one such alternative in adults in need of kidney or heart transplantation. Cardiac xenotransplantation of genetically modified pig hearts has been conducted twice in adults under the United States Food and Drug Administration (FDA) expanded access criteria. Because of the shortage of transplantable hearts for children as well as the lack of mechanical circulatory support in this population, pediatric researchers are exploring FDA expanded access in high-risk neonates and infants who lack alternative options for survival. The adult cardiac xenotransplantation experience with expanded access can provide lessons and highlight nuances for researchers preparing pediatric application. This includes aspects of informed consent, biosurveillance, and protection of bystanders from potential xenozoonoses.

Practices and attitudes of herbalists regarding informed consent in Uganda: a qualitative study.

BACKGROUND: Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. METHODS: To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were conducted. The data were analyzed thematically using NVivo version 12 software. RESULTS: Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine. CONCLUSION: This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists' practices and attitudes toward informed consent.

Patient and Physician Communication in the Allogeneic Transplantation Setting: Challenges and Potential Solutions.

Allogeneic hematopoietic cell transplantation is a challenging treatment characterized by multiple morbidities, the need for long-term care, and a significant mortality risk. Consequently, close patient and physician communication throughout treatment is crucial. We aimed to review the literature examining patient and physician communication around critical aspects experienced by allogeneic survivors over the transplantation trajectory, such as the informed consent process, transplantation-related morbidity (eg, psychosocial distress, cognitive dysfunction, sexuality), adherence to treatment, and the use of complementary and alternative medicine, as well as interventions and strategies to improve patient and physician communication. We found a paucity of studies examining communication on these topics. Nevertheless, there is evidence of significant communication gaps around morbidities often experienced by allogeneic survivors, such as psychosocial distress, fatigue, and sexual functioning, due to both patient and physician barriers. Similarly, there is a concern that gaps also exist when addressing the informed consent process, cognitive dysfunction, adherence to treatment, and use of complementary and alternative medicine. The use and discussion of patient-reported outcome measures as part of clinical care is associated with patient and physician satisfaction with communication and better detection and management of symptoms. Although other strategies, such as decision aids, question prompt lists, and communication skills training, have improved communication in oncology, they have not been tested in the allogeneic setting. Future research is clearly needed to examine patient and physician communication in the allogeneic transplantation setting and test strategies to improve communication during this challenging treatment.

Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study.

BACKGROUND: Giving information to trial participants who stop taking part could support them through what can be a difficult process. We previously developed guidance around the ethical acceptability of such information provision, and about how trialists can develop suitable communication materials. There is limited evidence about what research ethics committees think of this issue, and limited guidance about what level of oversight they should have over the proposed communications, or post-consent participant communications generally. We conducted a survey of UK ethics committee members to address these points. METHODS: The survey was co-developed by public contributors and trialists who had previously worked together on the communications guidance. We asked respondents if they agreed with the general idea of informing participants who stop taking part, if they had ever been requested to review similar communications, and what level of ethics committee review they might recommend. The survey was primarily conducted online. It was reviewed by three ethics committee members before finalisation and shared directly with all UK ethics committee members. We analysed quantitative questions descriptively and used inductive analysis for open questions to identify common themes. RESULTS: Ninety-one ethics committee members participated (nearly 10% of all UK members). The sample was similar to reported data about all members in terms of several personal characteristics. Most respondents (83%) agreed with our project's rationale. Only 23% of respondents reported having been asked to review an end-of-participation information sheet before. Respondents gave various answers about the level of ethics committee review required, but most supported a relatively proportionate review process. Common concerns were about the risk of coercion or making participants feel pressured. CONCLUSIONS: Our survey suggests that ethics committee members generally support providing information to trial participants who stop taking part, if risks to participants are mitigated. We believe our guidance already addresses the main concerns raised. Our respondents' lack of prior experience with end-of-participation information sheets suggests that participants are not getting information they want or need when they stop participating. Our results help clarify how ethics committee should oversee post-consent participant communications, but further guidance from research regulators could be helpful.

[SEAP-IAP recommendations for the collection, storage and use of biological materials of human origin and related data intended for research. Generic biobank consideration and ethical-legal review (Part II)]. / Recomendaciones de la SEAP-IAP para la recolección, el almacenamiento y el uso de materiales biológicos de origen humano y los datos relacionados, destinados a la investigación. Consideración genérica de biobanco y revisión ético-legal (Parte II).

The working group set up by the SEAP-IAP addresses in this Part II some general considerations and five particular considerations to be taken into account when a biological sample of human origin, coming from our archives, acquires a different destination from the usual one, in this case for research. From this moment on, we must follow mandatory legal and ethical rules, and the different recitals provide us with guidelines to ensure good practice, both for biological material and its associated data. The traditional task of custody given to the Pathological Anatomy is approached, as always, from the point of view of responsibility and, in this article, adjusted to its time.

Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care.

BACKGROUND: Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments. METHODS: Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed. RESULTS: Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning). CONCLUSIONS: For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns.

Why were so few randomized trials of public health and social measures conducted during the COVID-19 pandemic? The Norwegian experience.

BACKGROUND: Few randomized trials of public health and social measures were carried out during the COVID-19 pandemic. We report on the major barriers we faced when we tried to run such trials. METHODS: We reviewed all randomized trials proposed and initiated by the Centre for Epidemic Interventions Research in Norway during the COVID-19 pandemic. RESULTS: Of the 18 proposed trials, 11 trials were not implemented. One of the key legal and ethical barriers to conducting the trials was the Norwegian Health Research Act, which demands informed consent from all participants who are exposed to an intervention. A lack of sufficient political support was also a challenge, as was unpredictability, due to shifting disease incidence and changing recommendations from the authorities. CONCLUSION: Strengthening the evidence base for public health and social measures in pandemics will require political and public understanding and support and a legal framework that allows for the conduct of such trials.

Dentolegal aspects of dental implants.

Dentists providing implant dental treatment need to fully appreciate the legal and clinical issues that are relevant to implant dentistry. The legal aspects of implant dentistry, according to UK law, are described in this article. Suggestions for how the risks of implant treatment might be mitigated, with tips and examples are provided.

Healthy Sex: Contraception, Sexually Transmitted Infections, Media, Consent, and Confidentiality.

Adolescence is a natural time for sexual exploration; developmentally-appropriate sexual education is essential to promote healthy behaviors and prevent long-term morbidity. Adolescents may confide in their primary care clinicians, who are responsible for providing information and access to evidence-based care including family planning, contraception, and abortion. Clinicians are essential in sexually transmitted infection prevention, screening, treatment, risk mitigation, and harm reduction for sexually active adolescents. Clinics should pay special attention to electronic medical record settings and insurance procedures to prevent unexpected lapses in confidentiality.

Turnaway Study Report Unethically Violated Participants' Privacy and Misleads Public with a Non-Representative Sample, Selective Reporting, and Overstated Conclusions.

Results from the Turnaway Study, conducted by Advancing New Standards in Reproductive Health (ANSRH), have widely been represented as definitive proof that women denied access to abortion will suffer severe injury to their health and economic wellbeing. Yet a careful examination reveals that the study is based on a non-random, non-representative sample of women that grossly underrepresents the experiences of the majority of women undergoing abortions. In addition, a reanalysis of its reported results reveal that the effect size of the outcomes observed have been grossly overstated, leading to conclusions that are not supported by the results. There also appears to be selective reporting and misrepresentation of results previously published. In addition, inconsistencies in ANSRH's published record strongly suggest that the credit history reports of the Turnaway Study participants were obtained without their informed consent.

Integration of Trusted Third Party Software into an EDC System for Data Protection - Compliant Identity Management, Consent Management and Pseudonymization in Medical Research Studies.

INTRODUCTION: Medical research studies which involve electronic data capture of sensitive data about human subjects need to manage medical and identifying participant data in a secure manner. To protect the identity of data subjects, an independent trusted third party should be responsible for pseudonymization and management of the identifying data. METHODS: We have developed a web-based integrated solution that combines REDCap as an electronic data capture system with the trusted third party software tools of the University Medicine Greifswald, which provides study personnel with a single user interface for both clinical data entry and management of identities, pseudonyms and informed consents. RESULTS: Integration of the two platforms enables a seamless workflow of registering new participants, entering identifying and consent information, and generating pseudonyms in the trusted third party system, with subsequent capturing of medical data in the electronic data capture system, while maintaining strict separation of medical and identifying data in the two independently managed systems. CONCLUSION: Our solution enables a time-efficient data entry workflow, provides a high level of data protection by minimizing visibility of identifying information and pseudonym lists, and avoids errors introduced by manual transfer of pseudonyms between separate systems.

Distinguishing Therapeutic Misconception from Religious Belief.

In the context of early-phase clinical trials, research subjects often confuse the differences between clinical research and personal treatment. This phenomenon, known as therapeutic misconception, potentially undermines the validity of informed consent. Several interventions have been proposed to help mitigate therapeutic misconception, although few have considered the role of religious belief. This is a notable omission, given that an association between therapeutic misconception and religious belief has been shown to exist. This perspective calls for more research into the nature of the association between therapeutic misconception and religious belief and suggests a framework that may help clinicians and researchers distinguish between the two, thereby bolstering the informed consent process.

Deep brain stimulation for obsessive compulsive disorder: the functional neurosurgeon armamentarium.

Deep brain stimulation (DBS) is a neurosurgical procedure that utilizes implanted electrodes and electrical stimulation for the treatment of neurological disorders. In cases where patients present with severe functional impairment while being refractory to less invasive treatment options, DBS is considered "gold standard." Still, DBS-related work is still widely under investigation, with ethical issues arising that may impact a patient's physical and psycho-social status. These include patient selection, informed consent, patient autonomy, pre-operation counseling and professional psycho-social preparation and follow-up support. Bioethicists and philosophers have increasingly worked together with in clinicians and researchers to identify, address and present ethical consideration in both clinical practice and research to balance the risk-benefit ratio in DBS treatment for obsessive-compulsive disorder.

Patient Autonomy in Medical Education: Navigating Ethical Challenges in the Age of Artificial Intelligence.

The increasing integration of Artificial Intelligence (AI) in the medical domain signifies a transformative era in healthcare, with promises of improved diagnostics, treatment, and patient outcomes. However, this rapid technological progress brings a concomitant surge in ethical challenges permeating medical education. This paper explores the crucial role of medical educators in adapting to these changes, ensuring that ethical education remains a central and adaptable component of medical curricula. Medical educators must evolve alongside AI's advancements, becoming stewards of ethical consciousness in an era where algorithms and data-driven decision-making play pivotal roles in patient care. The traditional paradigm of medical education, rooted in foundational ethical principles, must adapt to incorporate the complex ethical considerations introduced by AI. This pedagogical approach fosters dynamic engagement, cultivating a profound ethical awareness among students. It empowers them to critically assess the ethical implications of AI applications in healthcare, including issues related to data privacy, informed consent, algorithmic biases, and technology-mediated patient care. Moreover, the interdisciplinary nature of AI's ethical challenges necessitates collaboration with fields such as computer science, data ethics, law, and social sciences to provide a holistic understanding of the ethical landscape.

The effect of video-assisted learning on pre-operative knowledge and satisfaction for total knee arthroplasty surgery: a randomised-controlled study.

INTRODUCTION: Traditionally, surgical procedures are explained through consultations between the surgeon and the patient to ensure informed consent. Patient education enhances engagement and knowledge, aiding informed decision-making. This study aimed to assess the effect of an educational video on preoperative patient knowledge and satisfaction in the context of total knee arthroplasty (TKA) as an adjunct to the consent process. METHODS: A prospective randomized controlled study involving 100 patients in dedicated elective orthopedic units in UK-based hospitals was conducted. After consultation with a dedicated knee surgeon and a preoperative education day for TKA run by dedicated orthopedic nurse specialists, patients were randomized into one of two limbs (video vs no video) at a 1:1 ratio. The treatment group (video group) was shown a video about the principles and steps of the procedure, including the recovery time. Following this, a 10-point knowledge test was completed, and patients rated their satisfaction with the preoperative education on a scale of 0-10. RESULTS: Patients in the video limb group had a significantly greater mean knowledge score and greater satisfaction with preoperative education than patients who did not view the video. The video group (n = 49) had a mean knowledge score of 8.73 +/- 0.159 compared to 7.68 +/- 0.281 for the nonvideo limb (n = 50) (p < 0.05). The video group had a mean satisfaction score of 9.00 +/- 0.123 compared to 8.40 +/- 0.121 for the nonvideo limb group (p < 0.05). CONCLUSION: Video-assisted consent in total knee arthroplasty improves preoperative knowledge and patient satisfaction when used as an adjunct in the consent process. A simple, standardized video, either pre- or post-consultation could reinforce information that the patient receives in a simple effective manner, allowing for true informed consent.