Improving understanding of capacity to consent to sensitive HIV biomedical prevention research among adolescents and their parents or guardians in Rakai Uganda (ICARE): a quasi-experimental nonequivalent groups design protocol
For research on sensitive topics like HIV, it is critical to understand the capacity of adolescents to provide informed consent, as parental consent has been identified as the greatest barrier to adolescent participation in biomedical research. In many countries including low-and middle-income countries, where 90% of adolescents live, adolescents can consent to sexual and reproductive healthcare but require parent/guardian permission to participate in research before age 18 - leading to adolescent underrepresentation and systematic exclusion from biomedical and behavioral studies. Among adults, research has identified effective biomedical HIV prevention tools such as pre-exposure prophylaxis (PrEP) that have successfully decreased HIV transmission. Youth in East and Southern Africa have the highest HIV incidence in the world, yet less than 1% of biomedical HIV prevention trials include minor adolescents. Thus, developmentally tailored HIV prevention and care research for adolescents and young adults is urgently needed.
Voices from the ICU: a qualitative study of healthcare providers' decision-making experiences during the provision of life-sustaining treatment in intensive care units of public and private referral hospitals in Uganda
The overall goal of intensive care treatment is to ensure patients return to an acceptable functional state, and, the decision-making in administering life-sustaining treatment (LST) is a key determinant of patients' survival in intensive care units (ICUs). We explored the decision-making experiences and practices of healthcare providers (HCPs) regarding their use of LST in ICUs in Uganda.
How to improve informed consent processes in clinical trials with cancer patients: a qualitative analysis of multidisciplinary experts' perspectives
According to legal and ethical obligations, patients must be thoroughly informed about the trial in which they could enrol, requiring them to consider and digest a significant amount of complex information. Many cancer patients feel overwhelmed which hinders their ability to make informed decision regarding their care. There is a need for further evidence-based strategies on how to improve both physician-patient-communication and informed consent (IC) documents in this area. We explored the views of experts from various disciplines on communication in IC processes in oncology.
The euthanasia law from the perspective of healthcare professionals in Spain
Ethical challenges, responses and reasoning in co-creation for health promotion: a scoping review
People involved in co-creation act as embedded moral agents as they bear a relational responsibility. The approaches taken or decisions made by individuals when facing ethical challenges during co-creation have important ethical ramifications for the process. Literature in the field of co-creation lacks an in-depth and systematic exploration of individual responses and reasoning that shape ethical decision-making. The current scoping review aims to identify authors' responses and related moral reasoning as reported within the academic literature, to the ethical challenges encountered during co-creation for health promotion.
The missing disclosure: is generative AI use in bioethics scholarship going largely unreported?
Correction: To evaluate the effectiveness of health care ethics consultation based on the goals of health care ethics consultation: a prospective cohort study with randomization
Willingness of Dutch general practitioners to grant euthanasia and assisted suicide requests: a comparative study of physical and mental health conditions
The Netherlands legalised euthanasia and assisted suicide (EAS) in 2002, permitting requests from both physical and mental health conditions under strict conditions. However, physicians are not obliged to comply. General practitioners (GPs), who receive most EAS requests, play a central role in the process of evaluating and granting EAS requests from both patient groups. Although EAS for individuals with a physical health condition is common in the Netherlands, EAS for individuals with a mental health condition remains relatively rare and controversial, despite a growing number of requests. This study explores how Dutch general practitioners' willingness to grant and perform EAS requests differs between physical and mental health conditions and compares the underlying decision-making processes.
Research ethics and integrity challenges in accelerated clinical trials, an interview study
Accelerated clinical trials for drugs and vaccines during global health crises allow for rapid access but pose research ethics and integrity challenges. Understanding these challenges is crucial for preserving research participants' safety and supporting research fairness and trustworthiness. This study aims to explore the research ethics and research integrity challenges associated with the acceleration of clinical trials.
Research on issues in the protection of clinical trial human subjects in China: a Delphi study
This study aims to identify current deficiencies in the protection of human subjects participating in clinical trials in China and propose strategies for safeguarding their rights.
Ethical challenges in biomarker research and precision medicine - a qualitative study in dermatology
Over 300 million individuals worldwide live with Atopic Dermatitis and Psoriasis, which are among the most common chronic inflammatory skin diseases. Multimodal biomarkers are currently being developed using large-scale data and artificial intelligence to allow for more targeted prediction and to improve treatment of patients with Atopic Dermatitis/Psoriasis. Although this promises enormous benefits for patients, it comes with critical challenges. This article offers an in-depth analysis of the ethical challenges in research and application of data-driven biomarkers in chronic inflammatory skin disease, which, as recent work shows, has not yet been explored in depth.
Three ethical approaches to expanding newborn screening through genomics: a critical comparative analysis
The expansion of newborn bloodspot screening (NBS) programs through genomic sequencing is proposed as a way to revolutionise infant and lifelong healthcare. But for all its promise, profound ethical challenges arise too. Robust analysis of these ethical challenges, which include technological and commercial imperatives, as well as balancing individual rights with communal goods, first necessitates clarity as to which ethical approach is best suited to considering the use of genomics in NBS.
The ethics of a watch-and-wait diagnosis: an exploratory study on the experiences of patients with stage A chronic lymphocytic leukaemia
The diagnosis of chronic lymphocytic leukaemia (CLL) is often fortuitous. Stage A patients do not experience severe symptoms and therefore do not require initial treatment. Instead, they are placed under active surveillance in order to track disease deterioration over time. Around half of these patients will never need treatment. Diagnostic disclosure of Stage A CLL thus leads to a great deal of uncertainty. Accordingly, stage A patients' lives are sometimes more impacted by their diagnosis than by the disease itself. This study aimed to outline the ethical issues surrounding the diagnosis of potentially indolent CLL in stage A patients under active surveillance in France by investigating their experiences, needs, expectations and self-perceptions.
Implementing and evaluating visual key information pages compared to text-based key information: protocol for a stepped-wedge cluster randomized trial
Informed consent is a key aspect of conducting research studies, yet many participants do not understand critical study details after reviewing long, complex consent documents. The 2018 Common Rule aimed to address this challenge by requiring a key information section, a "concise and focused" presentation of important and relevant study information. In our ongoing work, we developed a template and toolkit to improve the presentation of key information by incorporating health literacy best practices, including color and visual icons. The goal of this study is to assess the impact of the visual key information (KI) pages at both the research coordinator and participant level.
The readiness of knowledge, attitude and confidence and associated factors of implementing living wills among healthcare professionals in Shenzhen: a cross-sectional study
On January 1st, 2023, Shenzhen became the first city to legalize living wills in China. However, less was known about the readiness of healthcare professionals (HCPs) to implement Article 78 of the Shenzhen Special Economic Zone Medical Regulations. Our team aimed to timely examine the HCPs' readiness in Shenzhen, including their knowledge, attitude and confidence as well as associated factors.
Medical gaslighting as a threat to beneficence and patient autonomy: a qualitative study
Medical gaslighting- a phenomenon where healthcare professionals dismiss or minimize patients' symptoms- has garnered increasing attention due to its potential to cause significant harm to patients. This study aims to examine the ethical ramifications and implications of medical gaslighting, and explore how patients interpret and experience interactions affected by medical gaslighting.
Qualitative study on ethics in paediatric Systemic Inflammatory Response Syndrome (SIRS) research: perspectives of Turkish legal guardians
Critical consideration towards broad consent by patient experts: results of a semi-structured interview study on the secondary use of medical data
Some would argue that there is a moral obligation to make the personal health data stored in databases and biobanks available for secondary research use. Yet, it is unclear what ways to gain consent to use the stored data for secondary research purposes are both effective and respectful of the patient’s autonomy. One prominent example under discussion is broad consent. As a form of consent in which specific study objectives are not defined, it is seen by many as an efficient alternative to the established consent of participants. Research on subjects' attitudes towards and their discursive reflections on broad consent is, however, limited. With our study, we aimed to gain deeper insights into the views and (normative) attitudes towards broad consent by members and representatives of patient organizations.
Navigating crisis: a qualitative exploration of medical social workers' responses to ethical issues during COVID-19
Medical social workers' (MedSWs) roles and responsibilities expanded during the COVID-19 pandemic. They experienced larger caseloads, restrictive protocols, new policies, and work outside of their professional scope, despite limited access to resources, support, or hazard compensation. As a result, MedSWs faced complex ethical situations, which they had to address in accordance with the profession's guiding principles.
A scoping review of ethical decisions and decision tools for experimental animal protocols
Scientific research projects involving animals are required to undergo ethical evaluation, generally known as harm-benefit analysis (HBA), to ensure that they address important ethical concerns related to animal welfare and the scientific quality of the research to maximize the likelihood of their potential benefits. Research continuously shows the challenges encountered by decision-makers, prompting researchers to review how HBA is conducted and to propose tools to aid decision-making. However, the extent to which such resources are currently available, their jurisdictions of applicability, and how they guide decision-making are not entirely clear.
Evaluation of the first standardized registry of approved research studies by the research ethics committees in Ecuador
Ethical regulation of biomedical research is essential to safeguard the rights and well-being of participants. In Ecuador, Research Ethics Committees (RECs) have undergone progressive growth. This study describes and evaluates the performance of the RECs of Ecuador using the first standardized registry of approved research studies implemented by the Ministry of Public Health.
