Access to medically-assisted procreation: the withdrawal of paternal consent in the maze of law n. 40/2004.

Abstract: The law (No.40/2004) stipulates that consent to Medically Assisted Procreation (MAP) remains irrevocable post ovum fertilization. Cryo-preservation introduces complexities, enabling embryo implantation requests after a couple's separation and the dissolution of the original parenthood plan. Constitutional Court Ruling No.161 in 2023 affirmed that the prohibition of revoking consent to MAP aligns with the Italian Constitution and the jurisprudence of the European Court of Human Rights. This delicate equilibrium of conflicting interests upholds human freedom, allowing consent revocation prior to ovocyte fertilization. Permitting revocation until implantation could inflict more significant harm: the infertile woman can in fact miss the opportunity to become a mother, impacting her psychophysical well-being and freedom of self-determination. Moreover, the embryo loses the chance to live, remaining in cryopreservation, which violates its dignity. Addressing this issue requires thorough communication by medical profession-als to inform couples about the limitations on consent revocation. An element of objectivity in terms of standards and evidence-based guidelines, from which norms must originate, is of utmost importance. Relying on broadly shared rules, especially at the international level, is vital in light of the unremitting scientific advances in MAP, as in other areas of medicine, which will open up new opportunities for which current legal/regulatory frameworks are inadequate.

Informed consent of the patient for medical intervention for conducting biomedical research.

OBJECTIVE: Aim: is to find out the peculiarities of informed consent of the patient for medical intervention during biomedical research. PATIENTS AND METHODS: Materials and Methods: The dialectical method was used as a universal and general scientific method, which made it possible to consider the peculiarities of the content of the patient's informed consent. Using the logico-semantic method, the essence and features of biomedical research with the patient's participation were determined. The formal-legal method is used to analyze adaptation processes of biomedical research. System-structural method were applied when comparing the content of the patient's informed consent in separate legislation. The work also used such methods of cognition as comparative-legal, systemic-logical, and logical-legal. CONCLUSION: Conclusions: "Informed consent" includes not only the concept of consent itself, i.e. the free decision of a person, but also an explanation of a specific case or research procedure. And it largely depends on the specialist. Will he be able to convey and explain the patient's problem, illness, actions correctly, fully and in an accessible form? Yes, free consent is given by a person, but the doctor also influences this decision to some extent. Patients' freedom in choosing medical care methods is somewhat limited.

[The Italian law 219/2017: informed consent and advance directives. When the patient-doctor communication time is law, but it is forgotten]. / Legge 219/2017: consenso informato e disposizioni anticipate di trattamento. Quando il tempo della comunicazione medico-paziente è legge, ma viene dimenticato.

The Italian law 217/2019 on "Informed consent and advance directives" is an important step forward in the redefinition of patient-doctor relationships. The law points out the principles of the decisional autonomy and freedom of the patient to choose the treatment options. However, it is underestimated and largely unapplied by the Italian cardiologists. The main elements of patient-doctor communication are present in the law. The most important is the time devoted to the patient-doctor relationship, necessary to ease the disease awareness. This time is clearly emphasized in the law, but the healthcare institutions did not arrange for the appropriate organizational procedures. Through the advance directives (ADs) the patients may express their own wishes about healthcare treatments, as well as their consent or refusal regarding the diagnostic or therapeutical doctors' suggestions, allowing their respect in case they become incompetent. This right is supported by the patients' designation of a healthcare proxy, who can interact for them with the healthcare team. However, after 6 years since the law enactment, only 0.4% of the Italian citizens signed ADs, due to insufficient information and organization by the healthcare authorities. In the Law, the advance care planning is closely related to ADs. In this process, the adults can understand and share their personal values, life goals and preferences, in order to define the potential future medical care and to discuss all the issues with family and physicians. These processes can be integrated in a broader shared decision-making, a strong tool of the patient-doctor alliance.

Clinical Teaching and Consent: An Analysis of New Zealand's Legal Requirements for Obtaining Consent to Clinical Teaching Involving Consumers of Health and Disability Services.

Student involvement in patient care without consent has attracted recent attention in New Zealand. New Zealand's Code of Health and Disability Services Consumers' Rights (Code) gives patients the right to give or refuse consent to participate in clinical teaching, but its practical application to clinical teaching, particularly postgraduate, is unclear. This article explores the history and precedent of the Code and ethical considerations, to inform where amendment to the Code is desirable in the interests of clarity, pragmatism, and to reflect better the legislature's intent.

Dentists' perspectives, practices, and factors associated with informed consent process for fixed prosthodontic treatment: a cross-sectional study of kampala metropolitan area, Uganda.

BACKGROUND: Dentists have a legal and ethical obligation to obtain informed consent from patients before carrying out treatment. In Uganda, the process of obtaining informed consent in dentistry is not well documented. The aim of the present study was to determine dentists' perspectives and practices regarding informed consent to fixed prosthodontic treatment (FPT) in Kampala Metropolitan, Uganda. METHODS: A quantitative cross-sectional study was conducted among 153 dentists from July to September 2023. Data were collected using a semi-structured self-administered questionnaire that included both closed- and open-ended questions. The questionnaire included items on participants' sociodemographic information, perspectives, and practices about informed consent for FPT. Perspectives were rated using ten items on a five-point Likert scale. The minimum possible total score was 10, and the maximum possible score was 50. Descriptive statistics and Poisson regression were used to summarize and analyze the quantitative data, and the significance level was set at p < 0.05. Open-ended items were analyzed using content analysis. RESULTS: The majority (83.9%) of the participants were general dentists with working experience ranging from 1 to 38 years and a median of 8 years. The majority were familiar with the concept of informed consent and had positive perspectives regarding its use for FPT. The mean score for perspectives was 39.27 (SD, 5.42). However, there were variations in the practices of the dentists. More than three-quarters (87.6%) reported that they always obtained the patient's informed consent before FPT. Less than a third (29.4%) obtained written consent for FPT. About half of the dentists provided information regarding the procedure, benefits, and risks of treatment during the consent process. Bivariate analysis showed that the use of written consent for FPT was significantly (p < 0.05) associated with having a work experience of more than 10 years and having had training involving informed consent after undergraduate studies. CONCLUSION: The present study provides baseline data regarding perspectives and practices regarding informed consent for FPT among dentists in Uganda. It is recommended that regular training courses be developed to highlight the importance of improved informed consent practices for patient protection and to instruct dentists about obtaining valid informed consent. There is a need for future research to streamline guidelines for the informed consent process in dental care in Uganda.

Pre-Mortem Interventions for the Purpose of Organ Donation: Legal Approaches to Consent.

The administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we describe the legal analysis surrounding consent to PMIs, drawing on existing legal commentary and identifying key legal problems. We provide an overview of the approaches in several jurisdictions that have chosen to explicitly address PMIs within codified law. We then provide, as an example, a detailed exploration of how PMIs are likely to be addressed in one jurisdiction where general medical consent law applies because there is no specific legislation addressing PMIs - the province of Ontario in Canada.

Lowering the Age of Consent for Vaccination to Promote Pediatric Vaccination: It's Worth a Shot.

This paper challenges historically preconceived notions surrounding a minor's ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent decision-making, and offers rebuttals to anticipated ethical counterarguments.

Minor Consent for Vaccination: Ethically Justified, Politically Fraught.

Policies allowing some minors to consent to receive recommended vaccines are ethically defensible. However, a policy change at the federal level expanding minor consent for vaccinations nationwide risks triggering a political backlash. Such a move may be perceived as infringing on the rights of parents to make decisions about their children's health care. In the current post-COVID environment of heightened anti-vaccination activism, changes to minor consent laws may be unadvisable, and policy makers should proceed with caution.

Prevention of infective endocarditis in at-risk patients: how should dentists proceed in 2024?

National Institute for Health and Care Excellence (NICE) guidelines are ambiguous over the need for patients at increased risk of infective endocarditis (IE) to receive antibiotic prophylaxis (AP) prior to invasive dental procedures (IDPs), and this has caused confusion for patients and dentists alike. Moreover, the current law on consent requires clinicians to ensure that patients are made aware of any material risk they might be exposed to by any proposed dental treatment and what can be done to ameliorate this risk, so that the patient can decide for themselves how they wish to proceed. The aim of this article is to provide dentists with the latest information on the IE-risk posed by IDPs to different patient populations (the general population and those defined as being at moderate or high risk of IE), and data on the effectiveness of AP in reducing the IE risk in these populations. This provides the information dentists need to facilitate the informed consent discussions they are legally required to have with patients at increased risk of IE about the risks posed by IDPs and how this can be minimised. The article also provides practical information and advice for dentists on how to manage patients at increased IE risk who present for dental treatment.

Implant maintenance in general dental practice: dento-legal considerations for the general dental practitioner.

Before implants are placed, the patient, as part of the consent process, should understand the risks of the treatment but also the importance of a lifelong maintenance programme. This is particularly important if the patient is at risk of periodontitis. There should be arrangements in place for the patient's ongoing care and general dental practitioners who look after the patient need to appreciate their duty of care in monitoring the implants. Excellent record-keeping and valid consent are important factors in delivering care and can also very much help assist a defence in the event of a civil claim or a regulatory investigation.

Road To Deceased Donor Transplantation in Egypt.

In Egypt, there is presently a growing need to have a deceased donor transplant program. Egypt conducted its first kidney transplant from a living donor in 1976 and a first partial liver transplant in 2001. Since 2009, the Egyptian Health Authorities Combat Transplant Tourism in concordance with ethics codes and the Declaration of Istanbul Custodian Group has been in place. The Egyptian Transplantation Law of 2011 mentions that organs could be procured from deceased donors based on a will and on family consent. This law has had many critics, including religious authorities who have stressed that organs cannot be taken from a person with brain death because, in their view, life ends with death of all organs. Many intensivists disagree over the definition of death. In addition, the media has communicated contradicting and sometimes misleading health care information. Mummification is rooted in pharos practice and linked to religious beliefs. The ancient Egyptians believed that, by burying the deceased with their organs, they may rejoin with them in the afterlife. Since 2019, the transplant community in Egypt has started collaborations with international transplant organizations and campaigns with doctors and celebrities to donate their organs after death, which have stressed that a deceased donor program could help against end-stage organ mortality. In November 2022, after communications with politicians, President Abdelfattah El Sisi directed the government to establish a regional center for organ transplantation, which aimed to be the biggest in the Middle East and North Africa region. The new center will be part of a new medical city that would replace Nasser Medical Institution in Cairo, Egypt. The Ministry of Health issued an official form to be signed by a person before his death, accepting use of organs, to give hope and support to other patients in need.

Protecting Privacy of Pregnant and LGBTQ+ Research Participants.

This Viewpoint summarizes existing federal regulations aimed at protecting research data, describes the challenges of enforcing these regulations, and discusses how evolving privacy technologies could be used to reduce health disparities and advance health equity among pregnant and LGBTQ+ research participants.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Essentials of Informed Consent to Psychedelic Medicine.

Importance: Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system. Observations: Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings. Conclusions and Relevance: Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

[Psychiatry without coercion-Exclude the coercion or the patients?] / Psychiatrie ohne Zwang ­ den Zwang ausschließen oder Patient:innen?

BACKGROUND: With reference to the United Nations Convention on the Rights of Persons with Disabilities (UN CRPD), a fundamental change in psychiatric care in Germany was proposed in 2019 by Zinkler and von Peter, supported by a legal perspective from Kammeier, which has since led to controversial debates. Essentially, the aim is not only to reduce coercion in psychiatry to a minimum, but also to fundamentally exclude it in a psychiatry that only provides care. The function as an agent of social control is to be returned from psychiatry to state institutions. Psychiatric hospitals will only admit patients with their consent; patients who refuse therapy will not be admitted regardless of their capacity for self-determination and will remain untreated or, if they have committed a criminal offence or threaten to commit a criminal offence, they will be taken into custody or imprisoned in accordance with the legal regulations applicable to all people. There they will receive psychiatric care if they so wish. AIM OF THE PAPER: The paper outlines the background of this concept, including international sources, traces the discussion in German specialist literature and takes a critical look at it. RESULTS: The criticism is primarily directed against the fact that responsibility for a relevant proportion of psychiatric patients would be handed over to the police and judiciary and that, as a result, two realities of care would be established that would considerably differ in terms of quality. CONCLUSION: Arguments are put forward in favor of retaining the function of social control and considerations are suggested as to how caring coercion can be largely minimized.

Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance.

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research.

Comparative study on informed consent regulation in health care among Italy, France, United Kingdom, Nordic Countries, Germany, and Spain.

The information and subsequent expression of will, so-called informed consent, have become the essential element of health right, understood as the right to autonomous choice in health, based on the fiduciary relationship between physician and patient. This gradually leads European Countries to adopt special legislations and to issue frequent judgments on the subject. However, new challenges in daily clinical practice call for further study of legal solutions. The authors analyse and compare the regulations on informed consent in health care of Italy, France, the United Kingdom, the Nordic Countries, Germany, and Spain. The health and legal contexts, existence of special regulations on informed consent and their characteristics are discussed. Informed consent resulted a mandatory requirement. Clear communication about treatment, therapeutic alternatives, and major risks, discussed in conversation, but preferably documented in writing, are agreed upon. The possibility of dissent and withdrawal of consent are also included. There is a growing interest in involving and regulating the entire health team in information and consent. Lowering the age of consent for minors or analysing the maturity of minors are attempts to increase their participation in health decisions. On another side, the protection of adult incapables persons requires greater involvement of family and fiduciaries to better adapt to changing health needs. Health policy must take responsibility for training health professionals and citizens about the value of health information and communication as a shared choice in care planning, to strengthen the bond of trust with the healthcare system and users.

Retrospective Analysis of US Litigations Involving Dermatologists From 2011 to 2022.

BACKGROUND: Physician malpractice lawsuits are climbing, and the reasons underlying litigation against dermatologists are unclear. OBJECTIVE: To determine the reasons patients pursue litigation against dermatologists or dermatology practices. MATERIALS AND METHODS: A retrospective analysis of all state and federal cases between 2011 and 2022 was performed after a query using "Dermatology" and "dermatologist" as search terms on 2 national legal data repositories. RESULTS: The authors identified a total of 48 (37 state and 11 federal) lawsuits in which a practicing dermatologist or dermatology group practice was the defendant. The most common reason for litigation was unexpected harm (26 cases, 54.2%), followed by diagnostic error (e.g. incorrect or delayed diagnoses) (16 cases, 33.3%). Six cases resulted from the dermatologist failing to communicate important information, such as medication side effects or obtaining informed consent. Male dermatologists were sued at a rate 3.1 times higher than female dermatologists. CONCLUSION: Although lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed diagnoses and ensure critical information is shared with patients to safeguard against easily avoidable litigation.