Ethical Challenges and Guidance Related to Adolescent Pregnancy.

An emergency team was challenged with ethical issues while managing an unmarried adolescent girl who presented with an acute abdomen wherein a ruptured ectopic pregnancy was suspected. Consent remained at the center of this dilemma given the age of the patient and the nature of the issues. Herein, we deliberate upon the challenges faced by the treating team in accessing the reproductive history, obtaining consent for performing pregnancy tests and for therapeutic interventions.

Ethical considerations and concerns in the implementation of AI in pharmacy practice: a cross-sectional study.

BACKGROUND: Integrating artificial intelligence (AI) into healthcare has raised significant ethical concerns. In pharmacy practice, AI offers promising advances but also poses ethical challenges. METHODS: A cross-sectional study was conducted in countries from the Middle East and North Africa (MENA) region on 501 pharmacy professionals. A 12-item online questionnaire assessed ethical concerns related to the adoption of AI in pharmacy practice. Demographic factors associated with ethical concerns were analyzed via SPSS v.27 software using appropriate statistical tests. RESULTS: Participants expressed concerns about patient data privacy (58.9%), cybersecurity threats (58.9%), potential job displacement (62.9%), and lack of legal regulation (67.0%). Tech-savviness and basic AI understanding were correlated with higher concern scores (p < 0.001). Ethical implications include the need for informed consent, beneficence, justice, and transparency in the use of AI. CONCLUSION: The findings emphasize the importance of ethical guidelines, education, and patient autonomy in adopting AI. Collaboration, data privacy, and equitable access are crucial to the responsible use of AI in pharmacy practice.

Reporting of Ethical Considerations in Qualitative Research Utilizing Social Media Data on Public Health Care: Scoping Review.

BACKGROUND: The internet community has become a significant source for researchers to conduct qualitative studies analyzing users' views, attitudes, and experiences about public health. However, few studies have assessed the ethical issues in qualitative research using social media data. OBJECTIVE: This study aims to review the reportage of ethical considerations in qualitative research utilizing social media data on public health care. METHODS: We performed a scoping review of studies mining text from internet communities and published in peer-reviewed journals from 2010 to May 31, 2023. These studies, limited to the English language, were retrieved to evaluate the rates of reporting ethical approval, informed consent, and privacy issues. We searched 5 databases, that is, PubMed, Web of Science, CINAHL, Cochrane, and Embase. Gray literature was supplemented from Google Scholar and OpenGrey websites. Studies using qualitative methods mining text from the internet community focusing on health care topics were deemed eligible. Data extraction was performed using a standardized data extraction spreadsheet. Findings were reported using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. RESULTS: After 4674 titles, abstracts, and full texts were screened, 108 studies on mining text from the internet community were included. Nearly half of the studies were published in the United States, with more studies from 2019 to 2022. Only 59.3% (64/108) of the studies sought ethical approval, 45.3% (49/108) mentioned informed consent, and only 12.9% (14/108) of the studies explicitly obtained informed consent. Approximately 86% (12/14) of the studies that reported informed consent obtained digital informed consent from participants/administrators, while 14% (2/14) did not describe the method used to obtain informed consent. Notably, 70.3% (76/108) of the studies contained users' written content or posts: 68% (52/76) contained verbatim quotes, while 32% (24/76) paraphrased the quotes to prevent traceability. However, 16% (4/24) of the studies that paraphrased the quotes did not report the paraphrasing methods. Moreover, 18.5% (20/108) of the studies used aggregated data analysis to protect users' privacy. Furthermore, the rates of reporting ethical approval were different between different countries (P=.02) and between papers that contained users' written content (both direct and paraphrased quotes) and papers that did not contain users' written content (P<.001). CONCLUSIONS: Our scoping review demonstrates that the reporting of ethical considerations is widely neglected in qualitative research studies using social media data; such studies should be more cautious in citing user quotes to maintain user privacy. Further, our review reveals the need for detailed information on the precautions of obtaining informed consent and paraphrasing to reduce the potential bias. A national consensus of ethical considerations such as ethical approval, informed consent, and privacy issues is needed for qualitative research of health care using social media data of internet communities.

Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study.

BACKGROUND: The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial. METHODS: We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken. RESULTS: Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged. CONCLUSION: We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in.

Envisioning the Future of Personalized Medicine: Role and Realities of Digital Twins.

Digital twins have emerged as a groundbreaking concept in personalized medicine, offering immense potential to transform health care delivery and improve patient outcomes. It is important to highlight the impact of digital twins on personalized medicine across the understanding of patient health, risk assessment, clinical trials and drug development, and patient monitoring. By mirroring individual health profiles, digital twins offer unparalleled insights into patient-specific conditions, enabling more accurate risk assessments and tailored interventions. However, their application extends beyond clinical benefits, prompting significant ethical debates over data privacy, consent, and potential biases in health care. The rapid evolution of this technology necessitates a careful balancing act between innovation and ethical responsibility. As the field of personalized medicine continues to evolve, digital twins hold tremendous promise in transforming health care delivery and revolutionizing patient care. While challenges exist, the continued development and integration of digital twins hold the potential to revolutionize personalized medicine, ushering in an era of tailored treatments and improved patient well-being. Digital twins can assist in recognizing trends and indicators that might signal the presence of diseases or forecast the likelihood of developing specific medical conditions, along with the progression of such diseases. Nevertheless, the use of human digital twins gives rise to ethical dilemmas related to informed consent, data ownership, and the potential for discrimination based on health profiles. There is a critical need for robust guidelines and regulations to navigate these challenges, ensuring that the pursuit of advanced health care solutions does not compromise patient rights and well-being. This viewpoint aims to ignite a comprehensive dialogue on the responsible integration of digital twins in medicine, advocating for a future where technology serves as a cornerstone for personalized, ethical, and effective patient care.

Ethical guidance for conducting health research with online communities: A scoping review of existing guidance.

Online research methods have grown in popularity due in part to the globalised and far-reaching nature of the internet but also linked to the Covid-19 pandemic whereby restrictions to travel and face to face contact necessitated a shift in methods of research recruitment and data collection. Ethical guidance exists to support researchers in conducting online research, however this is lacking within health fields. This scoping review aims to synthesise formal ethical guidance for applying online methods within health research as well as provide examples of where guidance has been used. A systematic search of literature was conducted, restricted to English language records between 2013 and 2022. Eligibility focused on whether the records were providing ethical guidance or recommendations, were situated or relevant to health disciplines, and involved the use or discussion of online research methods. Following exclusion of ineligible records and duplicate removal, three organisational ethical guidance and 24 research papers were charted and thematically analysed. Four key themes were identified within the guidance documents, 1) consent, 2) confidentiality and privacy, 3) protecting participants from harm and 4) protecting researchers from harm with the research papers describing additional context and understanding around these issues. The review identified that there are currently no specific guidelines aimed at health researchers, with the most cited guidance coming from broader methodological perspectives and disciplines or auxiliary fields. All guidance discussed each of the four key themes within the wider context of sensitive topics and vulnerable populations, areas and issues which are often prominent within health research thus highlighting the need for unifying guidance specific for health researchers. Further research should aim to understand better how online health studies apply ethical principles, to support in informing gaps across both research and guidance.

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.

[Ethics of care: Assessment of the ethical issues in the protocols or consensuses on mechanical restraint in force in Spain]. / Ética de los cuidados: valoración de los contenidos éticos en los protocolos o consensos de contención mecánica vigentes en España.

INTRODUCTION: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain. METHOD: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II. RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75. CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.

Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints.

BACKGROUND: Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and potential response strategies for informed consent and study prioritization in a pandemic setting. METHODS: We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and potential response strategies was reached. RESULTS: We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main themes: consent challenges, impact of consent challenges on clinical research, and potential strategies for consent challenges. For the second topic prioritization of clinical studies, we identified two main themes: perceived benefit of prioritization and potential strategies for prioritization. All main themes are further specified with subthemes. A supplementary table provides original quotes from the interviews for all subthemes. DISCUSSION: Potential response strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core response strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.

Ethical Considerations in Endovascular Thrombectomy for Stroke.

INTRODUCTION: Stroke is a leading cause of morbidity and mortality globally. Endovascular mechanical thrombectomy is considered for patients with large vessel occlusion stroke presenting up to 24 hours from onset and is being increasingly utilized across diverse clinical contexts. Proactive consideration of distinctive ethical dimensions of endovascular thrombectomy (EVT) can enable stroke care teams to deliver goal-concordant care to appropriately selected patients with stroke but have been underexplored. METHODS: A narrative review with case examples was conducted. RESULTS: We explain and critically evaluate the application of foundational bioethical principles and narrative ethics to the practice of EVT, highlight key ethical issues that may emerge in neuroendovascular practice and develop an ethical framework to aid in the responsible use of EVT for people with large-vessel occlusive ischemic stroke. CONCLUSIONS: EVT for stroke introduces important ethical considerations. Salient challenges include decision-making capacity and informed consent, the telos of EVT, uncertainty, access to care, and resource allocation. An ethical framework focusing on combining patient values and preferences with the best available evidence in the context of a multidisciplinary care team is essential to ensure that the benefits of EVT are responsibly achieved and sustained.

Trust-building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent.

The coronavirus disease 2019 pandemic forced a wide range of medical practices to virtual formats, including the preoperative informed consent practice. However, virtual informed consent persists despite the pandemic being largely considered resolved. The continued use of virtual formats relies on a problematic "information transfer" model of informed consent. We suggest a "trust-building" model of consent as a better conceptualization of what is occurring during the consent process. Highlighting how virtual formats might fail to fulfill this fuller understanding of consent on both interpersonal and systemic levels, we offer an ethical structure for physicians to navigate this novel virtual space.

Ethical considerations for artificial intelligence in dermatology: a scoping review.

The field of dermatology is experiencing the rapid deployment of artificial intelligence (AI), from mobile applications (apps) for skin cancer detection to large language models like ChatGPT that can answer generalist or specialist questions about skin diagnoses. With these new applications, ethical concerns have emerged. In this scoping review, we aimed to identify the applications of AI to the field of dermatology and to understand their ethical implications. We used a multifaceted search approach, searching PubMed, MEDLINE, Cochrane Library and Google Scholar for primary literature, following the PRISMA Extension for Scoping Reviews guidance. Our advanced query included terms related to dermatology, AI and ethical considerations. Our search yielded 202 papers. After initial screening, 68 studies were included. Thirty-two were related to clinical image analysis and raised ethical concerns for misdiagnosis, data security, privacy violations and replacement of dermatologist jobs. Seventeen discussed limited skin of colour representation in datasets leading to potential misdiagnosis in the general population. Nine articles about teledermatology raised ethical concerns, including the exacerbation of health disparities, lack of standardized regulations, informed consent for AI use and privacy challenges. Seven addressed inaccuracies in the responses of large language models. Seven examined attitudes toward and trust in AI, with most patients requesting supplemental assessment by a physician to ensure reliability and accountability. Benefits of AI integration into clinical practice include increased patient access, improved clinical decision-making, efficiency and many others. However, safeguards must be put in place to ensure the ethical application of AI.

The use of artificial intelligence (AI) in dermatology is rapidly increasing, with applications in dermatopathology, medical dermatology, cutaneous surgery, microscopy/spectroscopy and the identification of prognostic biomarkers (characteristics that provide information on likely patient health outcomes). However, with the rise of AI in dermatology, ethical concerns have emerged. We reviewed the existing literature to identify applications of AI in the field of dermatology and understand the ethical implications. Our search initially identified 202 papers, and after we went through them (screening), 68 were included in our review. We found that ethical concerns are related to the use of AI in the areas of clinical image analysis, teledermatology, natural language processing models, privacy, skin of colour representation, and patient and provider attitudes toward AI. We identified nine ethical principles to facilitate the safe use of AI in dermatology. These ethical principles include fairness, inclusivity, transparency, accountability, security, privacy, reliability, informed consent and conflict of interest. Although there are many benefits of integrating AI into clinical practice, our findings highlight how safeguards must be put in place to reduce rising ethical concerns.

Financial ''risk-sharing'' or refund programs in assisted reproduction: an Ethics Committee opinion.

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient-informed consent. This document replaces the document of the same name, last published in 2016.