Informed consent and coercion in recruitment advertisements for oocyte donors.

BACKGROUND: As the use of donor eggs for in vitro treatment has increased, both medically affiliated and private donor egg agencies have turned to online advertisements to recruit donors. The American Society for Reproductive Medicine provides recommendations encouraging ethical recruitment of donors, however there is no formal regulation for the informed consent process for egg donor recruitment and compensation. Underrepresentation of risks and targeted financial incentives may pose a risk to the informed consent process. METHODS: Data from online advertisements for egg donors active between January 1 - August 31, 2020, were collected to analyze content related to risks, Covid-19 precautions, donor payment, and desired donor characteristics. Advertisements for egg donors on Google, Craigslist, and social media were analyzed. Primary outcomes included the mention of the risks of egg donation, including the risk of Covid-19 exposure, in donor egg advertisements. Secondary outcomes included language targeting specific donor characteristics and financial compensation. RESULTS: 103 advertisements were included. 35.9% (37/103) of advertisements mentioned some risk of the egg donation process, and 18.5% (19/103) mentioned risks or precautions related to Covid-19 exposure. Of advertisements for private donor egg agencies, 40.7% (24/59) mentioned any risk, compared to 29.6% (13/44) of medically affiliated egg donation programs; the difference was not statistically significant (p-value = 0.24). Agencies targeting students and donors of a specific race were more likely to offer payments over $10,000 for an egg donation cycle. Among advertisements offering over $20,000 for donor compensation, 72.7% (8/11) recruited women under the age of 21. CONCLUSION: Egg donor recruitment advertisements, for both medically affiliated programs and private agencies, were unlikely to mention risks including the risk of exposure to Covid-19. Non-medically affiliated private donor egg agencies were more likely to violate multiple American Society for Reproductive Medicine ethics guidelines, including offering higher than average compensation, and recruiting donors from young and vulnerable populations.

Deep brain stimulation for obsessive compulsive disorder: the functional neurosurgeon armamentarium.

Deep brain stimulation (DBS) is a neurosurgical procedure that utilizes implanted electrodes and electrical stimulation for the treatment of neurological disorders. In cases where patients present with severe functional impairment while being refractory to less invasive treatment options, DBS is considered "gold standard." Still, DBS-related work is still widely under investigation, with ethical issues arising that may impact a patient's physical and psycho-social status. These include patient selection, informed consent, patient autonomy, pre-operation counseling and professional psycho-social preparation and follow-up support. Bioethicists and philosophers have increasingly worked together with in clinicians and researchers to identify, address and present ethical consideration in both clinical practice and research to balance the risk-benefit ratio in DBS treatment for obsessive-compulsive disorder.

Distinguishing Therapeutic Misconception from Religious Belief.

In the context of early-phase clinical trials, research subjects often confuse the differences between clinical research and personal treatment. This phenomenon, known as therapeutic misconception, potentially undermines the validity of informed consent. Several interventions have been proposed to help mitigate therapeutic misconception, although few have considered the role of religious belief. This is a notable omission, given that an association between therapeutic misconception and religious belief has been shown to exist. This perspective calls for more research into the nature of the association between therapeutic misconception and religious belief and suggests a framework that may help clinicians and researchers distinguish between the two, thereby bolstering the informed consent process.

Integration of Trusted Third Party Software into an EDC System for Data Protection - Compliant Identity Management, Consent Management and Pseudonymization in Medical Research Studies.

INTRODUCTION: Medical research studies which involve electronic data capture of sensitive data about human subjects need to manage medical and identifying participant data in a secure manner. To protect the identity of data subjects, an independent trusted third party should be responsible for pseudonymization and management of the identifying data. METHODS: We have developed a web-based integrated solution that combines REDCap as an electronic data capture system with the trusted third party software tools of the University Medicine Greifswald, which provides study personnel with a single user interface for both clinical data entry and management of identities, pseudonyms and informed consents. RESULTS: Integration of the two platforms enables a seamless workflow of registering new participants, entering identifying and consent information, and generating pseudonyms in the trusted third party system, with subsequent capturing of medical data in the electronic data capture system, while maintaining strict separation of medical and identifying data in the two independently managed systems. CONCLUSION: Our solution enables a time-efficient data entry workflow, provides a high level of data protection by minimizing visibility of identifying information and pseudonym lists, and avoids errors introduced by manual transfer of pseudonyms between separate systems.

Assessment of decision-making autonomy in chronic pain patients: a pilot study.

BACKGROUND: Patient decision-making autonomy refers to the patients' ability to freely exert their own choices and make their own decisions, given sufficient resources and information to do so. In pain medicine, it is accepted that appropriate beneficial management aims to propose an individualized treatment plan shared with the patients, as agents, to help them live as autonomously as possible with their pain. However, are patients in chronic pain centers sufficiently autonomous to participate in the therapeutic decisions that concern them? As this question still remains unanswered, a pilot study was set up to that aim. METHODS: Over a 2-month period, first-time patients within a tertiary multidisciplinary pain center underwent a systematic evaluation of their autonomy using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), considered the benchmark tool for measuring a patient's ability to consent to treatment. Demographic data and pain characteristics of the patients were collected and their respective attending pain physicians were asked to clinically assess their patients' degree of autonomy. Another physician, who had not participated in the initial patient evaluation, subsequently administered the MacCAT-T questionnaire to the same patients. RESULTS: Twenty-seven patients were included during the study period (21 women and 6 men), with an average age of 50 years. The average duration of pain was 8 years. Based on their clinical experience, the 4 different pain physicians in charge of these patients considered that out of 25 assessed patients, 22 of them (89%) had full decision-making capacity, with no deficit in autonomy. According to the MacCAT-T results, only 13 of these 25 patients (48%) had no deficit, while 7 (26%) had a major deficit in autonomy. The only patient characteristic that appeared to be related to autonomy was pain type, specifically nociplastic pain. The average time taken to complete the test was 20 min, and patients were very satisfied with the interview. CONCLUSION: Results from the present pilot study suggest that patients suffering from chronic pain do not appear to be entirely autonomous in their decision to consent to the proposed treatment plan according to the MacCAT-T questionnaire, and physicians seem to find it difficult to properly assess this competence in a clinical setting. Further studies with larger samples are needed to better evaluate this concept to improve the complex management of these patients.

Patient Autonomy in Medical Education: Navigating Ethical Challenges in the Age of Artificial Intelligence.

The increasing integration of Artificial Intelligence (AI) in the medical domain signifies a transformative era in healthcare, with promises of improved diagnostics, treatment, and patient outcomes. However, this rapid technological progress brings a concomitant surge in ethical challenges permeating medical education. This paper explores the crucial role of medical educators in adapting to these changes, ensuring that ethical education remains a central and adaptable component of medical curricula. Medical educators must evolve alongside AI's advancements, becoming stewards of ethical consciousness in an era where algorithms and data-driven decision-making play pivotal roles in patient care. The traditional paradigm of medical education, rooted in foundational ethical principles, must adapt to incorporate the complex ethical considerations introduced by AI. This pedagogical approach fosters dynamic engagement, cultivating a profound ethical awareness among students. It empowers them to critically assess the ethical implications of AI applications in healthcare, including issues related to data privacy, informed consent, algorithmic biases, and technology-mediated patient care. Moreover, the interdisciplinary nature of AI's ethical challenges necessitates collaboration with fields such as computer science, data ethics, law, and social sciences to provide a holistic understanding of the ethical landscape.

Ethical Considerations for Enrolling "Invested Parties" in Large-Scale Clinical Studies: Insights from the RECOVER Initiative.

Research institutions often lack policies addressing the risks and benefits of enrolling "invested parties" such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes.

The First- and Second-Order Ethical Reasons Approach: The Case of Human Challenge Trials.

At the height of the Covid pandemic, there was much discussion in the literature about using human challenge trials (HCTs) to expedite the development of effective Covid-19 vaccines. Historically, reluctance to fully accept HCTs has largely been due to potential conflicts with the principle of nonmaleficence in bioethics. Only a few commentators have explored this topic in depth. In this paper, we claim that to address ethical concerns regarding HCTs, two types of ethical reasons should be identified and investigated: first-order reasons that can be given to claim that a practice in itself is in direct conflict with the principles of bioethics; and second-order reasons that take into consideration how a practice is carried out and its consequences. We argue that understanding these ethical reasons is crucial for guiding the implementation of HCTs. We investigate a first-order reason against HCTs when the practice is in conflict with the principle of nonmaleficence, and when it is not. Following this argument and assuming there is no first-order reason based on nonmaleficence that hinders using HCTs, we argue there may be second-order reasons to guide implementation of this practice, such as difficulty in obtaining informed consent; protection of the weaker party; and trust in the scientific enterprise.

Polymedia Literacy and Other Ethical Considerations for Online Ethnographic Research on Social Networking Sites.

Drawing on the authors' own ethnographic research, this article discusses the importance of developing polymedia literacy as a key step toward ethical online research on social networking sites (SNS). Polymedia literacy entails the ability to critically analyze the vast landscape of SNS, their affordances, and users' social motivations for choosing specific SNS for their interactions. Internet researchers face several ethical challenges, including issues of informed consent, "public" and "private" online spaces, and data protection. Even when research ethics committees waive the need for a formal ethics approval process, researchers of online spaces need to ensure that their studies are conducted and presented in an ethical and responsible manner. This is particularly important in research contexts that pertain to vulnerable populations in online communities.

Termo de consentimento livre e esclarecido e sua relação com os procedimentos de preenchimento labial / Free and informed consent terms and its relationship with lip filling procedures

Introdução: Na medida em que envelhecemos os lábios estreitam-se, ocasionando perda de volume e contorno e como forma de minimizar este efeito fisiológico o preenchimento labial de escolha utilizado é o ácido hialurônico. É possível perceber efeitos adversos advindos do emprego deste material, e pelo fato da informação ao paciente ser assegurada pelo Código de Defesa do Consumidor e pelo fato da necessidade dos Cirurgiões-Dentistas terem de esclarecer seus pacientes, o Termo de Consentimento Livre e Esclarecido tornase necessário. Objetivo: identificar, por meio de aplicação de questionário, a percepção de profissionais que trabalham com Harmonização Orofacial em relação a necessidade do emprego do Termo de Consentimento Livre e Esclarecido (TCLE). O questionário apresentou 6 perguntas objetivas, que foram disponibilizadas na plataforma Google Forms®. Material e Método: os dados obtidos foram tabulados em uma planilha eletrônica do programa Microsoft Excel e após analisados descritivamente através de tabelas de frequência, porcentagens e gráficos estatísticos. Resultados: dentre os entrevistados foi constatado que a maioria, 87,5% dos especialistas em Harmonização Orofacial realizam o procedimento de preenchimento labial em sua rotina clínica, e 12,5% não. Conclusão: no presente estudo identificamos que os especialistas realizam o emprego do TCLE, em sua maioria, porém, alguns destes ainda negligenciam o seu uso(AU)

Introduction: As we age, the lips become thinner and to minimize this effect, the lip filler used is hyaluronic acid. It is possible to notice adverse effects arising from the use of this material, and it is extremely important that Dental Surgeons have to clarify their patients, the Free and Informed Consent Form becomes necessary. Objective: to identify, through the application of a questionnaire, the perception of professionals who work with Orofacial Harmonization in relation to the need to use the Free and Informed Consent Form (TCLE). The questionnaire presented 6 objective questions, which were made available on the Google Forms® platform. Materials and Methods: the data obtained were tabulated in a Microsoft Excel spreadsheet and then analyzed descriptively using frequency tables, percentages and graphs. Results: among those interviewed, it was found that the majority, 87.5% of specialists in Orofacial Harmonization perform the lip filling procedure in their clinical routine, and 12.5% do not. With the high percentage of 59.4%, it was possible to verify that the majority of professionals perform 1 to 3 procedures per month; 31.3% perform 4 to 9 procedures per month; and 9.4% of 10 or more monthly procedures. Conclusion: in the present study it was possible to identify that the majority of specialists in Orofacial Harmonization use the informed consent form, however, some of them still neglect its use(AU)

Distributed management of patient data-sharing informed consents for clinical research.

BACKGROUND: The consent protocol is now a critical part in the overall orchestration of clinical research. We aimed to demonstrate the feasibility of an Ethereum-based informed consent system, which includes an immutable and automated channel of consent matching, to simultaneously assure patient privacy and increase the efficiency of researchers' data access. METHOD: We simulated a multi-site scenario, each assigned 10000 consent records. A consent record contained one patient's data-sharing preference with regards to seven data categories. We developed a blockchain-based infrastructure with a smart contract to record consents on-chain, and to query consenting patients corresponding to specific criteria. We measured our system's recording efficiency against a baseline design and verified accuracy by testing an exhaustive list of possible queries. RESULTS: Our method achieved ∼3-4% lead with an average insertion speed of ∼2 s per record per node on either a 3-, 4- or 5-node network, and 100 % accuracy. It also outperformed other solutions in external validation. DISCUSSION: The speed we achieved is reasonable in a real-world system under the realistic assumption that patients may not change their minds too frequently, with the added benefit of immutability. Furthermore, the per-insertion time did improve slightly as the number of network nodes increased, attesting to the benefit of node parallelism as it suggests no attrition of insertion efficiency due to scale of nodes. CONCLUSIONS: Our work confirms the technical feasibility of a blockchain-based consent mechanism, assuring patients with an immutable audit trail, and providing researchers with an efficient way to reach their cohorts.

Safe Ketamine Use and Pregnancy: A Nationwide Survey and Retrospective Review of Informed Consent, Counseling, and Testing Practices.

Objective: Ketamine is contraindicated in pregnancy given the lack of knowledge about potential effects on a developing fetus. This study aimed to characterize current clinical practices specific to pregnancy and reproduction related to the use of ketamine for the treatment of psychiatric illness.Methods: Online surveys were sent to outpatient ketamine clinics across the United States inquiring about practices related to pregnancy. Responses were collected between September and November 2023. Additionally, a retrospective medical record review was conducted to ascertain the frequency of pregnancy testing and contraception use with ketamine treatments administered at a large academic health system. Online, publicly available informed consent documents were also reviewed for language related to pregnancy.Results: Fewer than half of survey respondents (n = 126) discuss specific risks related to pregnancy and fetal ketamine exposure during the informed consent process. Twenty percent of clinics require pregnancy tests prior to treatment, and 10.5% require subsequent testing during treatment; however, 22.9% of clinics do not have a standard process for testing. Only 13.7% of clinics specifically recommend or require use of contraception. Retrospective record review revealed that all patients who received intravenous ketamine for psychiatric indications in an academic medical center were pregnancy tested weekly, but only half were using contraception during treatment.Conclusion: Many women with the potential to become pregnant are treated with ketamine for psychiatric illness. Results of the present study reveal that risks of fetal ketamine exposure are often overlooked, indicating a need for increased awareness about reproductive concerns when prescribing ketamine for the treatment of psychiatric disorders.

Ethics of Wearable-Based Out-of-Hospital Cardiac Arrest Detection.

Out-of-hospital cardiac arrest is a major health problem, and immediate treatment is essential for improving the chances of survival. The development of technological solutions to detect out-of-hospital cardiac arrest and alert emergency responders is gaining momentum; multiple research consortia are currently developing wearable technology for this purpose. For the responsible design and implementation of this technology, it is necessary to attend to the ethical implications. This review identifies relevant ethical aspects of wearable-based out-of-hospital cardiac arrest detection according to four key principles of medical ethics. First, aspects related to beneficence concern the effectiveness of the technology. Second, nonmaleficence requires preventing psychological distress associated with wearing the device and raises questions about the desirability of screening. Third, grounded in autonomy are empowerment, the potential reidentification from continuously collected data, issues of data access, bystander privacy, and informed consent. Finally, justice concerns include the risks of algorithmic bias and unequal technology access. Based on this overview and relevant legislation, we formulate design recommendations. We suggest that key elements are device accuracy and reliability, dynamic consent, purpose limitation, and personalization. Further empirical research is needed into the perspectives of stakeholders, including people at risk of out-of-hospital cardiac arrest and their next-of-kin, to achieve a successful and ethically balanced integration of this technology in society.

Opportunities and challenges of a dynamic consent-based application: personalized options for personal health data sharing and utilization.

BACKGROUND: The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this approach may be useful in terms of ensuring the autonomy of data subjects in personal health data usage. METHODS: This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles-including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items. RESULTS: A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use. CONCLUSIONS: Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages.

Biospecimen research and the law.

In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

Designing e-consent protocols for pragmatic clinical trials: case studies from a UKCRC clinical trials unit.

BACKGROUND: Interest in and use of electronic consent (e-consent) in the conduct of academic clinical trials has increased since the COVID-19 pandemic. E-consent offers advantages including increased efficiency and accessibility, and reduced burden on site staff, which can be appealing to academic trialists anticipating challenges in recruitment to complex trial designs or with limited funding. However, there are many options to consider when using e-consent in a study protocol. This paper presents five case studies from Norwich Clinical Trials Unit, demonstrating how e-consent models can be effectively tailored to the needs of different trials. These examples illustrate the options around and benefits of e-consent, the acceptability of e-consent by participants, and the design considerations that were made during the development of the trial protocols. CASE STUDIES: Five randomised trials are presented, selected from a range of different trial designs, disease areas, interventions, and patient populations. E-consent was either offered as an alternative to paper consent, according to participant preference, or as the sole method of consent. E-consent was generally used to facilitate remote consent in decentralised trials but was also chosen to increase efficiency and reduce burden in an emergency department setting. The technical implementation of e-consent and detailed participant procedures were tailored to the needs of the trial settings and patient populations. For example, accompanying participant information sheets were provided in paper or electronic form, and electronic signatures could be typed or drawn. Administrative data on uptake of e-consent is presented where available. CONCLUSION: This paper demonstrates that the operational and technical aspects of implementing e-consent in clinical trials can be influenced by the trial design, the needs and characteristics of the trial population, financial/efficiency considerations, and level of risk. E-consent is not a one-size-fits-all tool for trials, and its use should be carefully considered during the development of the trial protocol, in conjunction with patient and public involvement contributors, site staff and other trial stakeholders.