When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

Hepatic Ablation Technology: Assessment of Conflicts of Interest in Recent Literature.

INTRODUCTION: Collaboration between the health care industry and surgeons is critical in modern medicine. Conflict of interest (COI) has the risk of introducing bias into research studies. We investigated the accuracy of self-disclosed COI for studies that researched the use of microwave ablation for liver metastasis. METHODS: A literature search identified studies that investigated the use of microwave ablation for liver cancer between 2016 and 2022. We utilized the Open Payments Database to query individual authors' financial contributions from the industry. The accuracy of the disclosure statement and financial contribution for each study and author was calculated. We compared the amount of financial contribution authors received based on the accuracy of their COI statement. RESULTS: Twenty-five studies of interest were identified. The mean number of authors was 8.24. A disclosure statement was present in 52% of studies. Of those, 28% had an incongruent disclosure statement. 9/25 (36%) of studies had a conflict of interest based on financial payments provided by industry. Overall, authors received an average of $440,483.41 (SD $1,889,375.34). We did not find a difference in the financial contribution's value based on the disclosure statement's accuracy (P = .55). CONCLUSIONS: Over a quarter of studies in our review of microwave ablation literature had discrepancies in the reporting of conflicts of interest, highlighting the need for improved reporting of potential conflicts of interest to protect the integrity of clinical research. Compared to other fields of surgery, we found a lower rate of undisclosed COI, suggesting that the scope of cancer-directed surgery may be more resistant to industry influence.

Disclosing Results of Tests for Covert Consciousness: A Framework for Ethical Translation.

The advent of neurotechnologies including advanced functional magnetic resonance imaging and electroencephalography to detect states of awareness not detectable by traditional bedside neurobehavioral techniques (i.e., covert consciousness) promises to transform neuroscience research and clinical practice for patients with brain injury. As these interventions progress from research tools into actionable, guideline-endorsed clinical tests, ethical guidance for clinicians on how to responsibly communicate the sensitive results they yield is crucial yet remains underdeveloped. Drawing on insights from empirical and theoretical neuroethics research and our clinical experience with advanced neurotechnologies to detect consciousness in behaviorally unresponsive patients, we critically evaluate ethical promises and perils associated with disclosing the results of clinical covert consciousness assessments and describe a semistructured approach to responsible data sharing to mitigate potential risks.

Ethical perspective of covert medication in psychiatry.

Schizophrenic patients deny health care due to lack of insight in many cases. In such situations most of the psychiatrists opt for covert medication in consultation with the families. Covert medication has legal and ethical implications. Moreover, it has certain clinical implications for the patient. In addition, how long the covert medication can be continued and when should it be revealed to the patient are questions that cannot be answered in black and white. This article is a commentary on a real scenario of covert medication in ethical perspective.

Who's your daddy? An ethical argument for disclosure to donor conceived children.

To our knowledge, there have been few discussions in the andrology literature regarding the ethics of disclosure to donor conceived children. Our goal in this paper is to summarize the main reasons in favor of disclosure to engender more conversations about the ethics of donor conception in andrology circles. Specifically, we argue (1) transparency regarding gamete donation upholds the ethical principle of beneficence by improving the psychological health of donor conceived children; and (2) based on the ethical principle of autonomy, donor conceived children should have the right to know their donor status.

Physicians' perceptions of the factors influencing disclosure of secondary findings in tumour genomic profiling in Japan: a qualitative study.

Tumour genomic profiling (TGP), conducted in search of therapeutics, sometimes reveals potentially pathogenic germline variants as secondary findings (SFs). Physicians involved in TGP are often specialised in oncology and not in clinical genetics. To better utilise SFs, we explored issues physicians have during disclosure and the potential for collaborations with clinical genetics professionals. Semi-structured interviews were conducted with 14 physicians who had experience in handling outpatient TGP at designated core hospitals for cancer genomic medicine in Japan. The data were analysed thematically. The difficulties physicians experienced during informed consent (IC) included educating patients about SFs, providing detailed information on SFs, and explaining the impact of SFs on patients' family members. When SFs were detected, physicians had reservations regarding the relevance of the disclosure criteria. Confirmatory germline tests were performed using peripheral blood when tumour-only tests detected suspected SFs. Some physicians had reservations about the necessity of confirmatory tests when they did not affect the patients' treatment options. To encourage patients to receive confirmatory tests, improvements are necessary in the healthcare system, such as insurance reimbursements, education for physicians so that they can provide a better explanation to their patients, and genetic literacy of physicians and patients. The physicians offered insights into the challenges they experienced related to IC, disclosure of SFs, and expectations for active collaborations with clinical genetics professionals. Wider healthcare insurance coverage and better genetic literacy of the population may lead to more patients taking confirmatory tests when SFs are suspected.

Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician's duties of disclosure.

Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient's consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions.What could morally justify the physician's special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians' special duties from an argument in Kant's political philosophy. Kant argues that pre-legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as "consent" in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard.

Accuracy of Disclosed Financial Relationships between Radiologists and Industry at the 2018 RSNA Annual Meeting.

Online supplemental material is available for this article. See also the editorial by Grant in this issue.

The right to be forgotten versus the right to disclosure of gamete donors' id: ethical and legal considerations / El derecho al olvido frente al derecho a revelar la identificación de los donantes de gametos: consideraciones éticas y jurídicas / O direito ao esquecimento versus o direito à divulgação da identificação de dadores de gâmetas: considerações éticas e legais

Abstract: 15. The anonymity of gamete donors in the context of medically-assisted reproduction techniques (ART) and the right of the offspring to know their genetic or biological parents' identity is a controversial and widely debated topic in the scientific literature. The positions on the issue in each country are different. Sometimes they are in opposition to each other even in countries with strong similarities, such as those in the European Union (EU), in the framework of shared ethical values. Although some countries still enshrine the rule of anonymity, there is an undeniable tendency to guarantee the right to know one's origins by creating relevant exceptions or abolishing donor anonymity status altogether. 16. This article offers ethical and legal considerations of whether the so-called 'right to be forgotten' (RTBF) could be extended to include gamete donors' right to remain anonymous. This perspective goes against the general trend, certainly in Europe, of recognizing that offspring born from donor gametes have a right to access information relating to their genetic progenitors. The novel addition is to question whether the General Data Protection Regulation (GDPR) might provide fertile ground for questioning this approach, and effectively support those jurisdictions where anonymity is still possible.

Resumen: 20. El anonimato de los donantes de gametos en el contexto de las técnicas de reproducción médicamente asistida (RM) y el derecho de la descendencia a conocer su identidad genética o biológica es un tema controvertido y ampliamente debatido en la literatura científica. Las posiciones sobre el tema en cada país son diferentes. A veces se oponen entre sí, incluso en países con fuertes similitudes, como los de la Unión Europea (UE), en el marco de valores éticos compartidos. Aunque algunos países siguen consagrando la norma del anonimato, es innegable la tendencia a garantizar el derecho a conocer el propio origen creando las excepciones pertinentes o suprimiendo por completo el estatus de anonimato del donante. 21. Este artículo ofrece consideraciones éticas y jurídicas sobre si el llamado "derecho al olvido" podría ampliarse para incluir el derecho de los donantes de gametos a permanecer en el anonimato. Esta opinión es contraria a la tendencia general, ciertamente en Europa, de reconocer que los hijos nacidos de gametos donados tienen derecho a acceder a la información relativa a sus padres genéticos. La nueva adición consiste en debatir si el Reglamento general de protección de datos (RGPD) podría proporcionar un terreno fértil para cuestionar este enfoque y apoyar efectivamente a las jurisdicciones en las que el anonimato sigue siendo posible.

Resumo 25. O anonimato dos dadores de gâmetas no contexto das técnicas de reprodução medicamente assistida (RMA) e o direito da descendência a conhecer a sua identidade genética ou biológica é um tema controverso e amplamente debatido na literatura científica. As posições sobre a questão em cada país são diferentes. Por vezes estão em oposição umas às outras, mesmo em países com fortes semelhanças, como os da União Europeia (UE), no quadro de valores éticos partilhados. Embora alguns países ainda consagrem a regra do anonimato, existe uma tendência inegável para garantir o direito de conhecer as suas origens, criando exceções relevantes ou abolindo completamente o estatuto de anonimato dos dadores. 26. Este artigo oferece considerações éticas e legais sobre se o chamado "direito ao esquecimento" poderia ser alargado para incluir o direito dos dadores de gâmetas a permanecerem anónimos. Esta perspetiva vai contra a tendência geral, certamente na Europa, de reconhecer que os descendentes nascidos de gâmetas doadas têm o direito de aceder à informação relacionada com os seus progenitores genéticos. O novo aditamento é debater se o Regulamento Geral de Proteção de Dados (RGPD) poderá fornecer um terreno fértil para questionar esta abordagem, e apoiar efetivamente as jurisdições onde o anonimato ainda é possível.

Pharmaceutical company payments to authors of the Japanese guidelines for the management of hypertension.

ABSTRACT: Antihypertensive drugs have been of significant interest to the pharmaceutical industry due to increasing sales opportunities in a global market. The financial relationships between pharmaceutical companies and the Japanese Society of Hypertension (JSH) have a possible influence on clinical practices in Japan. This study examined the distribution of pharmaceutical payments made to the authors of the revised Guidelines for the Management of Hypertension (JSH2019) and the transparency of the Conflict of Interest disclosure that each author made.We retrospectively obtained publicly available data regarding payments made by Japanese pharmaceutical companies to all authors of the JSH2019 in 2016. We also collected data on individual financial disclosure of JSH2019 authors to investigate whether their self-reported financial relationship with companies were compliant to the financial disclosure policy of JSH2019.The total and mean payment values reported by pharmaceutical companies were $4,246,436 and $21,447, respectively. Of the 198 authors, 171 (86.4%) authors received at least 1 payment. Of 74 authors required to disclose their conflict of interest (COI) the authors, one-third failed to follow the COI policy covering the clinical guidelines.Major pharmaceutical companies selling antihypertensive drug products in the Japanese market had a significant financial connection with the JSH2019 authors. Financial relationships between pharmaceutical companies and authors or Japanese medical societies are raising significant concerns about the credibility of clinical guidelines and the potentially biases and undue influences that they may cause, especially with respect to adverse prescription patterns.

Unblinding in Randomized Controlled Trials: A Research Ethics Case.

A pregnant woman was enrolled in a double-blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention-whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision-making. We review information about the benefits and harms of unblinding.