UNASSIGNED: The extensive utilization of personal health data is one of the key success factors of modern medical research. Obtaining consent to the use of such data during clinical care, however, bears the risk of low and unequal approval rates and risk of consequent methodological problems in the scientific use of the data. In view of these shortcomings, and of the proven willingness of people to contribute to medical research by sharing personal health data, the paradigm of informed consent needs to be reconsidered. The European General Data Protection Regulation gives the European member states considerable leeway with regard to permitting the research use of health data without consent. Following this approach would however require alternative offers of information that compensate for the lack of direct communication with experts during medical care. We therefore introduce the concept of \"health data literacy,\" defined as the capacity to find, understand, and evaluate information about the risks and benefits of the research use of personal health data and to act accordingly. Specifically, health data literacy includes basic knowledge about the goals and methods of data-rich medical research and about the possibilities and limits of data protection. Although the responsibility for developing the necessary resources lies primarily with those directly involved in data-rich medical research, improving health data literacy should ultimately be of concern to everyone interested in the success of this type of research.

UNASSIGNED: Medical ethics guidelines require of clinical trial investigators and sponsors to inform prospective trial participants of all known and potential risks associated with investigational medical products, and to obtain their free informed consent. These guidelines also require that clinical research be so designed as to minimize harms and maximize benefits.
UNASSIGNED: To examine Merck\'s scientific rationale for using a reactogenic aluminum-containing \"placebo\" in Gardasil HPV vaccine pre-licensure clinical trials.
UNASSIGNED: We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines.
UNASSIGNED: It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study\'s primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck\'s proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant \"placebo\" group.
UNASSIGNED: In our view, the administration of a reactive placebo in Gardasil clinical trials was without any possible benefit, needlessly exposed study subjects to risks, and was therefore a violation of medical ethics. The routine use of aluminum adjuvants as \"placebos\" in vaccine clinical trials is inappropriate as it hinders the discovery of vaccine-related safety signals.

UNASSIGNED: No previous study has evaluated patients attitudes towards inclusion in an ongoing cardiac arrest clinical trial. The aim of this study was to assess patientś willingness and motives to participate in the ongoing randomized controlled drug trial \"Vasopressin and Steroids in addition to Adrenaline in cardiac arrest\" (VAST-A trial) in case of an in-hospital cardiac arrest (IHCA).
UNASSIGNED: Hospitalized patients, men ≥ 18 and women ≥ 50 years, were asked for informed consent for inclusion in the VAST-A trial in case of an IHCA, the reason for approving or declining inclusion in the trial and baseline characteristics.
UNASSIGNED: Patients admitted to hospital were asked to give informed consent of inclusion in VAST-A in case of an IHCA during their hospital stay. Patients were also asked why they approved or declined inclusion as well as baseline characteristics questions.
UNASSIGNED: 1,064 patients were asked about willingness to participate in the VAST-A trial, of these 902 (84.8%) patients approved inclusion. A subgroup of 411 patients were, except willingness, also asked about motives to participate or not and basic characteristics. The main reason for approving inclusion was to contribute to research (n = 328, 83.9%). The main reason for declining inclusion was concerns regarding testing the drug treatment (n = 6, 30%).
UNASSIGNED: Among hospitalized patients the vast majority gave informed consent to inclusion in an ongoing randomized cardiac arrest drug trial. The main reason for approving inclusion was to contribute to research.

BACKGROUND: Institutional review boards (IRBs) have been criticised for delays in approvals for research proposals due to inadequate or inexperienced IRB staff. Artificial intelligence (AI), particularly large language models (LLMs), has significant potential to assist IRB members in a prompt and efficient reviewing process.
METHODS: Four LLMs were evaluated on whether they could identify potential ethical issues in seven validated case studies. The LLMs were prompted with queries related to the proposed eligibility criteria of the study participants, vulnerability issues, information to be disclosed in the informed consent document (ICD), risk-benefit assessment and justification of the use of a placebo. Another query was issued to the LLMs to generate ICDs for these case scenarios.
RESULTS: All four LLMs were able to provide answers to the queries related to all seven cases. In general, the responses were homogeneous with respect to most elements. LLMs performed suboptimally in identifying the suitability of the placebo arm, risk mitigation strategies and potential risks to study participants in certain case studies with a single prompt. However, multiple prompts led to better outputs in all of these domains. Each of the LLMs included all of the fundamental elements of the ICD for all case scenarios. Use of jargon, understatement of benefits and failure to state potential risks were the key observations in the AI-generated ICD.
CONCLUSIONS: It is likely that LLMs can enhance the identification of potential ethical issues in clinical research, and they can be used as an adjunct tool to prescreen research proposals and enhance the efficiency of an IRB.

Recent advancements in large language models (LMM; e.g., ChatGPT (OpenAI, San Francisco, California, USA)) have seen widespread use in various fields, including healthcare. This case study reports on the first use of LMM in a pretreatment discussion and in obtaining informed consent for a radiation oncology treatment. Further, the reproducibility of the replies by ChatGPT 3.5 was analyzed. A breast cancer patient, following legal consultation, engaged in a conversation with ChatGPT 3.5 regarding her radiotherapy treatment. The patient posed questions about side effects, prevention, activities, medications, and late effects. While some answers contained inaccuracies, responses closely resembled doctors\' replies. In a final evaluation discussion, the patient, however, stated that she preferred the presence of a physician and expressed concerns about the source of the provided information. The reproducibility was tested in ten iterations. Future guidelines for using such models in radiation oncology should be driven by medical professionals. While artificial intelligence (AI) supports essential tasks, human interaction remains crucial.

The issue of regulation of scope of practice (SOP) has recently been highlighted through the high-profile case of New South Wales-based neurosurgeon, Mr Charles Teo and specifically the finding of \'unsatisfactory professional conduct\' by the NSW Health Care Complaints Commission (HCCC) in Teo, Charles (2023) NSWMPSC 2 (12 July 2023). The HCCC decision went to two issues in Teo\'s practice: (1) his decision to perform a surgery not within the SOP of his profession [at 238]; and (2) his failure to gain patient informed consent for that surgery [at 245]. This paper explores the findings against Teo with respect to SOP and recommends a nuanced approach to the regulation of clinical innovation and SOP evolution.

AbstractOne factor that impedes medical students from speaking up about ethical situations is the lack of sufficient knowledge and skills in conflict resolution. This may also affect students\' decision and timing to intervene. This article will provide practical ways to effectively and efficiently address the medical student\'s ethical case presented in August A. Culbert et al.\'s \"Navigating Informed Consent and Patient Safety in Surgery: Lessons for Medical Students and Junior Trainees.\"

暂无摘要。

Vaccine mandates can take many forms, and different kinds of mandates can implicate an array of values in diverse ways. It follows that good ethics arguments about particular vaccine mandates will attend to the details of individual policies. Furthermore, attention to particular mandate policies-and to attributes of the communities they aim to govern-can also illuminate which ethics arguments may be more salient in particular contexts. If ethicists want their arguments to make a difference in policy, they should attend to these kinds of empirical considerations. This paper focuses on the most common and contentious vaccine mandate reform in the contemporary United States: the elimination of nonmedical exemptions (NMEs) to school and daycare vaccine mandates. It highlights, in particular, debates about California\'s Senate Bill 277 (SB277), which was the first successful recent effort to eliminate NMEs in that country. We use media, secondary sources, and original interviews with policymakers and activists to identify and evaluate three ethics arguments offered by critics of SB277: parental freedom, informed consent, and children\'s rights to care and education. We then turn to one ethics argument often offered by advocates of SB277: harm prevention. We note, however, that three arguments for mandates that are common in the immunization ethics literature-fairness/free-riding, children\'s rights to vaccination, and utilitarianism-did not play a role in debates about SB277.

BACKGROUND: This study determined the knowledge, attitudes, and behaviors of pediatricians and pediatric residents regarding issues of ethics, professional education, clinical ethical principles, and consent they encounter in health service delivery.
METHODS: Participants in the study were 134 pediatricians and pediatric residents from three hospitals in Ankara, Turkey. Participants were asked questions regarding their sociodemographic characteristics, their knowledge and views of ethics and ethical education, whether they had ever encountered an ethical problem, their beliefs about obtaining consent from pediatric patients and their families, and case-based questions. All data were collected and evaluated.
RESULTS: Of the participants in the study, 82 (61.2%) were residents, 41 (30.6%) were pediatricians, and 11 (8.2%) were faculty lecturers. The data revealed that 10% of the pediatricians and pediatric residents received ethical education, apart from medical ethics/deontology education at medical school, and 90.3% required further education on children and ethical problems. It was determined that 89% of residents and 78% of pediatricians needed help with the ethical problems they encountered during the diagnostic and treatment processes. Overall, 65.7% of the participants stated that the ethical problems they encountered affected the efficiency of health service delivery. It was observed that residents were more affected by ethical issues than pediatricians were. The present study revealed that pediatric residents and pediatricians need ethics education and there is a need to establish ethics counseling centers in hospitals. There is also a need for further studies in pediatrics and ethics.