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Lawyers’ fees are one of the main causes of complaint by clients and of continued public concern about the ethicality of the profession. Charging ‘fairly and reasonably’ (the legal standard) and in compliance with the detailed legislative requirements imposed on a practitioner can be tricky. Even the most honest and conscientious lawyers may have trouble explaining fees to clients and controlling their increase. Organisational and personal pressures and adversarial approaches can lead to questionable billing practices and place pressure on individual lawyers to behave unethically.
Informed consent remains a persistent challenge in clinical research, as traditional processes often fail to ensure participant understanding and voluntariness. We developed and evaluated an artificial intelligence (AI)-driven consent process utilizing large language models to conduct interactive, participant-centered consent conversations. The system’s scalability, auditability, and capacity to tailor communication may address barriers to informed consent. In silico testing with simulated participants demonstrated high rates of successful teach-back across consent concepts, with auditability and adherence to predefined ethical and procedural safeguards. These simulation-based results support pilot testing of AI-driven consent processes to evaluate their potential to enhance participant understanding, autonomy, and trial accessibility.
The litigation brought by the Estate of Henrietta Lacks against Thermo Fisher Scientific, Ultragenyx Pharmaceutical, and Novartis Pharmaceuticals reframes benefit-sharing from voluntary institutional ethics into an enforceable legal duty. By pleading a single equitable claim — unjust enrichment — the Estate seeks to bypass the property and informed-consent doctrines that have defeated comparable tissue-appropriation suits, while accepting distinctive risks involving remoteness, limitations, causation, and apportionment. This commentary examines the strategy’s strengths and vulnerabilities through the still-pending Ultragenyx case, and considers its implications for research consent, prospective benefit-sharing frameworks, and bioethics pedagogy. Whether or not the remaining claim succeeds, the litigation has already altered the conversation about who should profit from human biological materials.
This chapter outlines the fundamental steps common to psychiatric prescribing, from introducing yourself to the patient, to follow-up and documentation. It closes with some critiques of prevalent current practice, which the remainder of the book attempts to address.
Existing consent-based legal and ethical frameworks assume a level of human involvement, predictability, and understanding that may not be present in applications of AI in health care. New frameworks are necessary to ensure that core ethical principles like autonomy are preserved even as AI evolves and its use expands across health care.
This commentary provides context and commentary on the article by April Dworetz et al., “Ethical and Legal Dilemmas in Prolonged Physiologic Support after Brain Death in Previable Pregnancy,” The Journal of Law, Medicine & Ethics (2026).
Providing care in the perinatal period brings medical practice to the essence of what it means to be human: fertility, birth, death, dignity, personhood, parenthood, and beyond. Such a shifting technological and moral landscape necessitates practitioners to develop an adaptable ethical framework to address complex, emotionally charged, value-laden decisions. As the border of viability is pushed earlier in gestational life and we improve treatment of conditions that were once considered untreatable, areas for ethical inquiry and potential moral distress grow. Our ethical examinations of such advances often lag, evolving as the shortcomings of those leaps become apparent. Projected neurologic function often lies at the heart of ethical questions that emerge in the neonatal period. Despite rigorous efforts in research, reliable, evidence-based guidance is lacking. We must investigate many elements of the decision-making process concerning medical practitioners, families, and the courts. We must balance the rights of the patient and surrogate decision-makers, the duties of the physician and care team, legal precedent, and questions revolving around quality and quantity of life. Recent controversies highlight the challenge of communicating with desperate parents, the delicate balance involved in respecting family preferences today, and research that yields valuable evidence for superior care tomorrow.
This chapter examines how traditional consent frameworks fail to address generative AI systems creating content from personal data. While individuals can consent to initial data use for AI training, they cannot meaningfully consent to the vast array of potential outputs or their subsequent use and distribution. We identify three core challenges creating a "consent gap": the scope problem (inability to predict all possible outputs), the temporality problem (consent cannot cover future unknown uses), and the autonomy trap (consenting to uses that may undermine personal autonomy). These issues are problematic when AI-generated content creates new forms of personal representation beyond original consent boundaries. Current legal frameworks inadequately protect individual autonomy, identity rights, and social responsibility in AI contexts. By connecting these consent limitations to broader responsible AI principles (fairness, transparency, accountability, and autonomy), we argue for evolving ethical and legal approaches that better address generative AI’s challenges to traditional consent models.
The U.S. Food and Drug Administration (FDA) recently harmonized its regulatory criteria for waivers and alterations of informed consent with the U.S. Common Rule. We conducted a systematic review of clinical trials in the two highest-impact clinical journals in the U.S. to better understand practice-changing trials that are being conducted in the U.S. without prospective written informed consent. One in ten trials in our sample were conducted without prospective written informed consent. Such trials accounted for 93.1% of patient-subjects in our sample, enrolling nearly 3 million individuals. Further guidance would support socially valuable research while ensuring appropriate oversight.
JCAHO is the most common organization to assess a hospital. CMS accreditation is basic before reimbursements from Medicare and Medicaid are paid. Annually, new goals are featured but often focus on identification of the patient, preventing infection, labeling drugs, and communication. Available equipment and credentialed staff listed for tasks are both critical, cataloged for each types of resuscitation events, or else accreditation will be lost. The leadership hierarchy must be clear in the hospital for methods to resolve clinical and financial problems. The patient’s bill of rights must be respected and the patient must be given a truly informed consent by the person performing a procedure.
Edited by
Katherine Warburton, California Department of State Hospitals, University of California, Davis, USA,Stephen M. Stahl, University of California, Riverside, USA
Anosognosia, commonly understood as a lack of insight, renders individuals with schizophreniaand schizoaffective disorder unable to understand that they are living with a disease, often resulting in a refusal to accept treatment. Typically, to impose involuntary commitment in an effort to obtain treatment, an individualmust be a danger to others or themselves. Even if involuntary commitment is imposed, however, an individualmay remain competent to refuse medication—despite symptoms of anosognosia and an inability to understand that they are ill. This article examines the existing legal theories of competency and informed consent and proposes a statutory definition of competency that encompasses the specific needs of people with anosognosia, while considering the significant interests at stake when taking away an individual’s right to choose or refuse treatment.
Medical providers involved in child abuse cases will encounter a variety of issues with legal implications, including informed consent, appropriate documentation, confidentiality, mandated reporting and potential liability. Consequently, all medical providers who may become involved in child abuse cases should have a fundamental understanding of child maltreatment laws in their jurisdiction. While informed consent is a well-established medicolegal doctrine in many countries, there are often jurisdiction-specific variations in cases of suspected child maltreatment. Complete, accurate and objective medical documentation is also imperative, as medical reports are frequently submitted in legal proceedings. Care should be taken, however, to ensure appropriate release and retention of medical records in accordance with country-specific legislation (e.g., Health Insurance Portability and Accountability Act and 21st Century Cures Act in the United States). Finally, medical providers should understand their responsibility to report to the appropriate protective services agency if there is reasonable suspicion that child maltreatment has occurred. A practitioner’s failure to adhere to statutory requirements may result in negative actions against the provider.
This memorial essay introduces the Journal of Law, Medicine, and Ethics special issue on supported decision-making in research by honoring David T. Wasserman (1953–2025), a major organizer of the NIH workshop from which the issue emerged and a coauthor of two papers in the volume. It situates supported decision-making in research as an emerging approach that aims to make participation by people with cognitive disabilities possible without displacing their agency through default reliance on legally authorized representatives. The essay highlights Wasserman’s distinctive contribution to this developing area. He sought a position that is respectful while remaining clear eyed about exploitation risks and about well-intentioned practices that can undermine a participant’s interests, especially in hard cases where meaningful authorization is fragile. Drawing on the two coauthored papers in the issue and on colleagues’ recollections, the essay emphasizes Wasserman’s commitment to conceptual clarity, workable institutional design, and mentorship through collaboration. It closes by reflecting on his intellectual virtues, humor, and lasting influence on disability bioethics and research ethics.
Electronic consent (eConsent) and procedure-specific consent forms have been highlighted as methods of improving the consent process. In this two-cycle audit, we assessed the quality of consent documentation pre- and post-implementation of eConsent.
Methods
We reviewed paper (first cycle) and eConsent (second cycle) forms for discussion of benefits, risks and alternatives for septorhinoplasty and functional endoscopic sinus surgery. A survey which included the System Usability Scale was distributed to clinicians.
Results
Post-implementation of eConsent, there was a statistically significant increase in the number of risks documented in septorhinoplasty (p-value < 0.001) though this was not the same for functional endoscopic sinus surgery. Feedback was generally positive with a System Usability Scale score of 85.3 indicating high usability.
Discussion
The implementation of eConsent with procedure-specific consent forms in our centre was well received with significant improvements in septorhinoplasty documentation and more modest improvements in FESS.
In recent decades, theorists of disability rights have made the moral and legal case for supported decision-making. Whereas surrogate decision-making, the long upheld legal standard, looks to a third party to make a decision for a person deemed to lack the capacity to make that decision for themselves, support in decision-making empowers that person to make their own decisions. In this article, we argue for a significant shift in the norms governing enrollment in clinical trials. Rather than assume that support is only appropriate for individuals who cannot independently make sufficiently informed enrollment decisions, we propose “support in decision-making for all” when research protocols are beyond a certain risk threshold. Drawing inspiration from the universal design movement and feminist insights about autonomy, we argue that making support in decision-making the presumption has substantial expressive and practical benefits, and better empowers all potential research participants to make more informed, autonomous decisions.
Effective communication of risks and benefits is essential to ethical clinical trial recruitment, yet clinical research coordinators (CRCs) often lack formal training in how to navigate participant uncertainty. This study examined whether targeted communication training could enhance CRCs’ ability to disclose risks and benefits clearly and ethically.
Approach or Design:
A mixed-methods, pre–post design compared CRCs who received communication training with those in a control group.
Twenty-four CRCs participated across intervention and control groups.
Intervention:
A communication training program grounded, focusing on transparent disclosure, benefit framing, and participant engagement strategies.
Method:
Qualitative content analysis of SP interaction transcripts guided by uncertainty management theory examined risk disclosure, mitigation strategies, benefit framing, and engagement. Frequency analysis tracked changes in the number and specificity of risk/benefit mentions over time.
Results:
CRCs in the intervention group demonstrated more structured and transparent risk disclosure, greater use of participant-centered benefit framing, and improved interpersonal engagement. Frequency analysis showed significant increases in both the number and specificity of risk and benefit mentions post-training. Control group CRCs showed minimal change.
Conclusion:
Targeted communication training enhances CRCs’ ability to manage participant uncertainty, improving both ethical standards and informed consent quality in clinical trial recruitment.
This chapter illustrates a challenging clinical ethics case involving a twenty-something trauma patient experiencing dysphagia who declined recommendations for artificial nutrition and wanted to be allowed to take food and fluid by mouth. Capacity assessment was complicated by disagreements over clinical facts. The Ethics consultation process was impacted by limited consultant bandwidth and lack of institutional support. Moral distress was experienced by many team members including clinical ethicists who found themselves wondering how this consult went wrong, and whether withholding food from a decisionally capable patient was in fact within the rights of the healthcare team.
This article examines the governance challenges of human genomic data sharing. The analysis builds upon the unique characteristics that distinguish genomic data from other forms of personal data, particularly its dual nature as both uniquely identifiable to individuals and inherently collective, reflecting familial and ethnic group characteristics. This duality informs a tripartite risk taxonomy: individual privacy violations, group-level harms, and bioterrorism threats. Examining regulatory frameworks in the European Union (EU) and China, the article demonstrates how current data protection mechanisms—primarily anonymisation and informed consent—prove inadequate for genomic data governance due to the impossibility of true anonymisation and the limitations of consent-based models in addressing the risks of such sharing. Drawing on the concept of “genomic contextualism,” the article proposes a nuanced framework that incorporates interest balancing, comprehensive data lifecycle management, and tailored technical safeguards. The objective is to protect individuals and underrepresented groups while maximising the scientific and clinical value of genomic data.
Diagnosing, treating, and caring for individuals with dementia-related syndroms raises unique legal and ethical questions. Individuals with dementia may be more likely to lack decision-making capacity. Additionally, along with their families, individuals with dementia will face complicated health care related decisions – complicated by limited therapy options. This chapter identifies key legal and ethical questions that come up in the clinical and non-clinical setting relevant to dementia-related syndromes.