Informed consent and autonomy

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents...

BACKGROUND: In May 2020, England moved to an opt-out organ donation system, meaning adults are presumed to be an organ donor unless within an excluded group or have opted-out. This change aims to improve organ donation rates following brain or circulatory death. Healthcare staff in the UK are supportive of organ donation, however, both healthcare staff and the public have raised concerns and ethical issues regarding the change. The #options survey was completed by NHS organisations with the aim of understanding awareness and support of the change...

OBJECTIVE: Aim: This article examines the legal challenges associated with opt-out and opt-in systems in transplantation cases. It focuses on the low public knowledge and awareness of the national transplantation system, assessing its compliance with international prerequisites for an opt-out system. The analysis centres on the "right to know" perspective and the effectiveness of opt-out in organ transplantation. . PATIENTS AND METHODS: Materials and Methods: The research methodology includes scientific principles, public surveys, relevant regulations from the Republic of Latvia and EU, and grey literature on the health system and organ donation in the EU...

Informed consent is a fundamental tenet of patient-centred clinical practice as it upholds the ethical principle of patient autonomy and promotes shared decision-making. In the medicolegal realm, failure to meet the accepted standards of consent can be considered as medical negligence which has both legal and professional implications. In general, valid consent requires three core components: (1) the presence of mental capacity - characterised by the patient's ability to comprehend, retain information, weigh options and communicate the decision, (2) adequate information disclosure - based on the 'reasonable physician' or 'reasonable patient' standards and (3) voluntariness in decision-making...

This analysis explores the principal regulatory concerns linked to nanomedicines and gene vaccines, including the complexities involved and the perspectives on how to navigate them. In the realm of nanomedicines, ensuring the safety of nanomaterials is paramount due to their unique characteristics and potential interactions with biological systems. Regulatory bodies are actively formulating guidelines and standards to assess the safety and risks associated with nanomedicine products, emphasizing the need for standardized characterization techniques to accurately gauge their safety and effectiveness...

BACKGROUND: Obstetricians often times find themselves in a conflict of right and duty with their patients, when these patients refuse recommended treatment. On the one hand, the obstetrician, aiming to fulfil the duty of care, recommends a treatment in the best interest of the woman. The woman, on the other hand, exercising her right of self-determination and autonomy, declines the recommended treatment. MATERIALS AND METHODS: A search was conducted for literature, articles and case reports on the subject on PubMed/MEDLINE and Google Scholar using the keywords: medical ethics, medical law, obstetric mortality, maternal medicine, foetal medicine, patient autonomy, informed consent, right to life and right to liberty...

UNLABELLED: 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...

BACKGROUND: The aim of this study was to explore how palliative care staff reason about the autonomy challenge that arises when a patient who has first said he wants full information appears to change his mind and rejects being informed. METHODS: The study had a qualitative and exploratory design. Participants (physicians, registred nurses, social workers, physiotherapists and occupational therapists) were recruited from palliative care teams in southern Sweden...

INTRODUCTION: By using a novel survey our study aimed to assess the challenges ECMO and Critical Care (CC) teams face when initiating and managing patient's ECMO support. METHODS: A qualitative survey-based observational study was performed of members of 2 Critical Care Medicine organizations involved in decision-making around the practice of Extracorporeal Membrane Oxygenation (ECMO). The range of exploratory questions covered ethical principles of informed consent, autonomy and goals of care discussions, beneficence, non-maleficence (offering life-sustaining treatments in end-of-life care), and justice (insurance-related limitations of treatment)...

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...

BACKGROUND: In a growing number of countries, patients are offered access to their full online clinical records, including the narrative reports written by clinicians (the latter, referred to as "open notes"). Even in countries with mature patient online record access, access to psychotherapy notes is not mandatory. To date, no research has explored the views of psychotherapy trainees about open notes. OBJECTIVE: This study aimed to explore the opinions of psychotherapy trainees in Switzerland about patients' access to psychotherapists' free-text summaries...

BACKGROUND: The nocebo effect is often disregarded in medical practice and is certainly much less known than the placebo effect, although, in reality, both can influence therapeutic decision making and the quality of life of patients. However, the nocebo effect raises a number of issues not only of a practical nature related to clinical activity but also ethical dilemmas related to the observance of the patient's autonomy, nonmaleficence, or informed consent and the information on which it is based...

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...

BACKGROUND: Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy. METHODS: Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT...

The medicalisation of childbirth has diminished the role of labouring people. We conducted an exploratory phenomenological qualitative study, using purposive sampling, and then conducted 17 semi-structured interviews between December 2016 and October 2017 with people who had recently given birth in a public hospital in the Northern Metropolitan area of Santiago, Chile. The sufficiency of the study group was determined according to saturation criteria. Triangulated content analysis was applied to explore the clinical relationship and processes of autonomy and decision-making...

AIM: (1) To determine the repartition of criteria which can be considered as marks of lack of assent by the child with intellectual disabilities from the dentist's point of view and whether that influences the decision to examine the patient or not. (2) To explain the decision of practitioners and determine the ethical implications of these practices. METHODS: An anonymous and structured questionnaire was distributed online using the scenario of a 9-year-old child with moderate cognitive impairment with eight different oppositional behaviours...

BACKGROUND: Second victim is the name given to the healthcare personnel-most often a nursing professional-involved with the error that led to the adverse event to a patient and who, as a result, have experienced negative psychological effects. Research with second victims has increased over the years, however concerns exist with regards to the ethical risks imposed upon these individuals. AIM: To explore the extent to which research with second victims of adverse events in healthcare settings adhere to ethical requirements...

INTRODUCTION: Artificial intelligence (AI) holds the potential to revolutionize medicine, offering vast improvements for plastic surgery. While human physicians are limited to one lifetime of experience, AI is poised to soon surpass human capabilities, as it draws on limitless information and continuous learning abilities. Nevertheless, as AI becomes increasingly prevalent in this domain, it gives rise to critical ethical considerations that must be addressed by professionals. MATERIALS AND METHODS: This work reviews the literature referring to the ethical challenges brought on by the ever-expanding use of AI in plastic surgery and offers guidelines for its application...

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...

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 also conducted...