Might the bioethical principle of individual decisional autonomy have a politically liberalizing effect on soft authoritarian communities?

According to the bioethical principle of individual decisional autonomy, the patient has a right of informed consent to any medical or experimental procedure. The principle is politically liberal by advocating significant individual freedom as guaranteed by law and secured by civil liberties. When practiced in illiberal communities, might it have a political liberalizing effect? I respond first by analyzing cross-national norms of individual decisional autonomy to identify tensions with illiberal community; second, by examining examining Singapore in a single case study to show that liberal bioethics does not promote political liberalization; and third, by showing that the possibility of practicing liberal bioethics in research, clinically as well as in education, does not require a democratic order, and that liberal bioethics is unlikely to encourage the liberalization of illiberal political communities. Hence, it may never contribute to the development of globally effective cross-national norms for the legal regulation of bioethical research and clinical practice. Fourth, to bolster this analysis, I anticipate several possible objections to various of its aspects.

[Key considerations in the process of assent in children and adolescents: an integrative review]. / Consideraciones claves en el proceso de asentimiento en niños, niñas y adolescentes: revisión integrativa.

The participation of children and adolescents in research requires bioethical measures to safeguard their autonomy and well-being through the application of the informed consent process. OBJECTIVE: To critically analyze the factors involved in the process of assent/consent in children and adolescents in research. METHODOLOGY: Integrative review of scientific evidence carried out between April and June 2023, from manuscripts published between 2014 and 2023 in Web of Science, PubMed, CUIDEN, and CINAHL databases, using the descriptors Process Assessment OR Assent AND Informed Consent AND Bioethics AND Minors OR Child OR Children AND adolescent OR teenage AND Pediatrics AND Research. Twenty primary articles were found, and the results were subjected to content analysis. RESULT: Three categories were identified: shared consent/assent; child-specific factors for giving assent (age of the child to give assent and autonomy of the child to give assent), and key aspects of the assent process (assent form format; assent form content, and context for applying the assent process). CONCLUSIONS: The assent process is a key tool for legal and ethical compliance with the rights of children and adolescents in clinical trial participation. In addition to favoring participation in informed decision-making together with the parents, it is also an instance where the participant's competencies, capacity for understanding, and autonomy are valued.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

What Is "Key Information"? Consideration of the Reasons People Do or Do Not Take Part in Research.

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

The Power of Proximity: Toward an Ethic of Accompaniment in Surgical Care.

Although the field of surgical ethics focuses primarily on informed consent, surgical decision-making, and research ethics, some surgeons have started to consider ethical questions regarding justice and solidarity with poor and minoritized populations. To date, those calling for social justice in surgical care have emphasized increased diversity within the ranks of the surgical profession. This article, in contrast, foregrounds the agency of those most affected by injustice by bringing to bear an ethic of accompaniment. The ethic of accompaniment is born from a theological tradition that has motivated work to improve health outcomes in those at the margins through its emphasis on listening, solidarity against systemic drivers of disease, and proximity to individuals and communities. Through a review of surgical ethics and exploration of a central patient case, we argue for applying an ethic of accompaniment to the care of surgical patients and their communities.

Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study.

OBJECTIVE: Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or 'lost in translation'. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages. DESIGN: We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data. SETTING: The study was based in Lusaka, Zambia. RESULTS: The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood. CONCLUSION: Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

Informed Consent for Psychotherapy: The Moderating Role of Therapeutic Alliance, Prior Knowledge and Autonomous Motivation on Decision-Making and Treatment Expectation.

BACKGROUND: Informed consent is an ethical prerequisite for psychotherapy. There are no routinely used standardized strategies for obtaining informed consent. A new optimized informed consent consultation (OIC) strengthened treatment-relevant aspects. It remains unclear which factors influence the OIC efficacy regarding clinical and decision-related outcomes. METHODS: N = 122 adults were included in a randomized controlled online trial. Participants received an information brochure on psychotherapy (TAU; n = 61) or OIC + TAU (n = 61). The main and interaction effects of group allocation, therapeutic alliance, prior knowledge about psychotherapy and treatment motivation on treatment expectations, decisional conflict and capacity to consent were tested. Floodlight analyses were conducted for significant interactions. RESULTS: Large interaction effects were shown between treatment motivation and group allocation on treatment expectations (ß = -0.53) and between prior knowledge and group assignment on capacity to consent (ß = 0.68). The interaction between treatment motivation and group allocation was significant up to a motivation score of 5.54 (range: 1-7). The interaction between prior knowledge and group assignment was significant up to a knowledge score of 14.38 (range: 5-20). CONCLUSION: Moderator analyses indicated varying efficacy degrees for the OIC regarding decisional outcomes and expectation. Especially patients with little treatment motivation or low prior knowledge benefited from optimized information about the efficacy and possible side effects of psychotherapy. TRIAL REGISTRATION: PsychArchives (https://doi.org/10.23668/psycharchives.4929): 17.06.2021.

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

INTRODUCTION: While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. METHODS: A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. RESULTS: There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. CONCLUSION: Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III.

BACKGROUND: The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and 'opt-out' are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct. METHODS: All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff. RESULTS: Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial. CONCLUSIONS: Consent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential.

IMPROVING ACCESS TO CARE AND CONSENT FOR TRANSGENDER AND GENDER DIVERSE YOUTH IN THE UNITED STATES.

Gender-affirming care (GAC) aims to benefit transgender and gender diverse (TGD) youth. GAC includes access to mental health, medical care, and surgical interventions. However, access to GAC and the youth's ability to consent to GAC is frequently contested. This editorial reviews access to care for TGD youth and discusses perspectives on youth consent for GAC. Pertinent challenges include the ability to provide informed consent within current medical and legal frameworks, mental health and parental concerns, and the long-term effects of GAC. Further research, advocacy, and patient education are warranted to ensure safe access to GAC for TGD youth.

Consent and Identifiability for Patient Images in Research, Education, and Image-Based Artificial Intelligence.

This survey study reports the perspectives and preferences of US adults regarding use of photographs of their skin in medical research, education, and development of image-based artificial intelligence (AI).

Gestational Carrier Pregnancies: Legal and Ethical Considerations for Pediatricians.

This case explores the legal and ethical considerations for pediatricians surrounding gestational carrier pregnancies in the United States. Because of high success rates for assisted reproduction, state laws supporting same-sex adoption and surrogacy, and established legal precedents, gestational carrier pregnancies are increasingly common. The case presented involves a gestational carrier in preterm labor at 30 weeks' gestation with malpositioned twins who declines a cesarean delivery. Three commentaries are presented. The first highlights the importance of understanding the ethical implications of gestational carrier pregnancies in prenatal counseling. The second commentary emphasizes the pregnant person's right to autonomy and bodily integrity, and discusses considerations in surrogacy pregnancies, including the authority to authorize a cesarean delivery, valid informed consent, and decision-making for neonates. The third commentary discusses autonomy, emphasizing the importance of contracts in surrogacy pregnancies, and suggests that, in the case of a conflict between the gestational carrier and the intended parent(s), the gestational carrier's preference should be decisive regarding medical care during pregnancy. These discussions highlight key concepts for ethically informed and family-centered care in gestational carrier pregnancies and deliveries.

Delirium screening instruments.

Delirium in patients has well-documented adverse physical and mental outcomes. Delirium impairs patients' capacity to grasp and retain information, thus affecting their right to informed consent and active participation in treatment and care decisions. In Danish hospitals, delirium afflicts up to 50% of the elderly patients, yet it often goes unreported due to the absence of systematic screening. The selection of a screening tool should be contextually relevant. This review gives an overview of delirium screening instruments available in Danish, each with distinct advantages and disadvantages.

From opt-out to opt-in consent for secondary use of medical data and residual biomaterial: An evaluation using the RE-AIM framework.

BACKGROUND: Patient records, imaging, and residual biomaterial from clinical procedures are crucial resources for medical research. In the Netherlands, consent for secondary research has historically relied on opt-out consent. For ethical-legal experts who purport passive consent undermines patient autonomy, opt-in consent (wherein affirmative action is required) is seen as the preferred standard. To date, there is little empirical research exploring patient feasibility, organizational consequences, and the potential risks for research based on secondary data. Thus, we applied the RE-AIM framework to evaluate the impact of migrating from an opt-out to an opt-in consent process. METHODS: This evaluation was carried out in Radboud University Medical Center, a large tertiary hospital located in the southeast of the Netherlands. All non-acute, mentally competent patients ≥16 years of age registered between January 13, 2020 and June 30, 2023 were targeted (N = 101,437). In line with the RE-AIM framework, individual and organizational consequences were evaluated across five domains: reach, efficacy, adoption, implementation, and maintenance. RESULTS: 101,437 eligible patients were approached of whom 66,214 (65.3%) consented, 8,059 (7.9%) refused consent and 27,164 (26.8%) had no response. Of the 74,273 patients with a response, 89.1% consented to secondary use. The migration to an opt-in consent system was modestly successful; yet notably, differential response patterns by key sociodemographic characteristics were observed. Adaptions to the process flow improved its effectiveness and resulted in a reasonable response over time. Implementation was most affected by budgetary restraints, thus impeding the iterative approach which could have further improved domain outcomes. CONCLUSION: This evaluation provides an overview of logistical and pragmatic issues encountered when migrating from opt-out to opt-in consent. Response bias remains a major concern. Though not always directly transferable, these lessons can be broadly used to inform other health care organizations of the potential advantages and pitfalls of an opt-in consent system.