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.

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.

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.

CLARA-MeD Tool - A System to Help Patients Understand Clinical Trial Announcements and Consent Forms in Spanish.

We present an NLP web-based tool to help users understand consent forms (CFs) and clinical trial announcements (CTAs) in Spanish. For complex word identification, we collected: 1) a lexicon of technical terms and simplified synonyms (14 465 entries); and 2) a glossary (70 547 terms) with explanations from sources such as UMLS, the NCI dictionary, Orphadata or the FDA. For development, we extracted entities from 60 CTAs, 60 CFs and 60 patient information documents (PIDs). To prepare definitions for new terms, we used ChatGPT and experts validated them (28.99% needed to be fixed). We tested the system on 15 new CTAs, 15 CFs, and 15 PIDs, and we achieved an average F1 score of 82.91% (strict match) and of 94.65% (relaxed). The tool is available at: http://claramed.csic.es/demo.

Use of E-Consent in Healthcare Settings: A Scoping Review.

Electronic consent is a technology-driven approach that remains challenging in various healthcare settings. Transitioning from paper-based to electronic consent (e-consent) has streamlined the consent process. This scoping review explores patients' electronic consent in different healthcare settings. We searched four databases and selected 14 studies that met our inclusion criteria. Our results show that E-consent is associated with key measures such as sufficient information, accuracy, enhanced shared decision-making, and efficiency. The majority of studies used a comparative design model to contrast paper-based consent with E-consent. Our findings provide an overview of the current state of E-consent use in healthcare settings.

Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study.

BACKGROUND: In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts. OBJECTIVE: This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers. METHODS: Semistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis. RESULTS: Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees. CONCLUSIONS: More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research.

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.

Compromised informed consent due to functional health literacy challenges in Chinese hospitals.

BACKGROUND: Medical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study's aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent. METHODS: In this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs -teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05. RESULTS: The median age (IQR and range) of participants was 35.5 (28 - 49 and 13 - 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments-teach-back, perception, and cognizance-was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent. CONCLUSIONS: This study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.

Ethics of deep brain stimulation for neuropsychiatric disorders.

Deep Brain Stimulation (DBS) has emerged as a revolutionary neurosurgical technique with significant implications for the treatment of various neuropsychiatric disorders. Initially developed for movement disorders like Parkinson's disease, DBS has expanded to psychiatric conditions such as obsessive-compulsive disorder, depression, anorexia nervosa, dystonia, essential tremor, and Tourette's syndrome. This paper explores the clinical efficacy and ethical considerations of DBS in treating these disorders. While DBS has shown substantial promise in alleviating symptoms and improving quality of life, it raises ethical challenges, including issues of informed consent, patient selection, long-term management, and equitable access to treatment. The irreversible nature of DBS, potential adverse effects, and the high cost of the procedure necessitate a rigorous ethical framework to guide its application. The ongoing evolution of neuromodulation requires continuous ethical analysis and the development of guidelines to ensure that DBS is used responsibly and equitably across different patient populations. This paper underscores the need for a balanced approach that integrates clinical efficacy with ethical considerations to optimize patient outcomes and ensure sustainable practice.

Surfactants and the importance of informed consent: Nurturing culturally competent care in healthcare settings.

BACKGROUND: Culturally competent healthcare improves patient satisfaction and clinical outcomes. Many drugs, dressings and implants have human or animal-derived content which may conflict with patients' religious beliefs, and may even have medicolegal implications. METHODS: This cross-sectional study (anonymous web-based survey) was done to understand the informed consent process followed by paediatricians and neonatologists in India, their views regarding disclosure pertaining to the animal origin of exogenous surfactants to patients' families, and their willingness and ability to provide alternative surfactants based on parental preferences. RESULTS: A total of 114 neonatologists/paediatricians involved in neonatal care and using surfactants in their practice responded to the survey. Although 61(53.5%) neonatal care units stocked two or more brands of surfactant in their inventory, only 38(33.3%) units had both bovine and porcine preparations. Most (104, 91.2%) of the doctors always take parental consent before administering surfactants; but only a few (12,10.5%) said they always inform parents about its animal origin. None of the respondents offer parents a choice between bovine or porcine-origin surfactants, most (73, 64%) presuming that it would be irrelevant for the parents. However, many respondents (27, 23.7%) mentioned that they want to offer the choice to parents but are unable to do so because they do not stock both bovine and porcine preparations. CONCLUSION: Although most parents might agree to a life-saving medicine in emergency situations, this does not mean they do not want to be informed. Healthcare professionals should not have a dismissive attitude to parental belief systems. They must use the antenatal period to take the cultural/spiritual history and the necessary consent.

Ethical issues and proposed solutions in conducting practical assessment of medical students involving patients.

Practical assessment involving patients plays a vital role in medical education, allowing students to demonstrate their clinical competencies. However, there are significant ethical concerns associated with these assessments that require careful consideration and resolution. The primary ethical concerns include violation of patient autonomy, lack of written informed consent, power dynamics, cultural differences, potential harm to patients, breach of privacy and confidentiality, discomfort to admitted patients, financial loss to patients, impact on other patients' care, and delays in workup/procedures. To address these concerns, measures such as respecting patient autonomy, obtaining written informed consent, ensuring patient safety, exploring alternative methods, providing reimbursement, resource planning, creating a supportive environment, developing cultural competency, putting in place a feedback system, prioritising patient care, and implementing ethical oversight and monitoring are recommended. The formulation of a guideline could be a crucial starting point, and it should be integrated into a broader ethical framework that encompasses education and training, ethical oversight, ongoing monitoring, and a culture that prioritises ethical conduct.

Informed consent form for platelet rich plasma injections: evidence-based and legally guide for orthopaedic surgeons.

Regarding medico-legal malpractice suits, lawyers and insurers focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for platelet-rich plasma (PRP) injections. The objective of the present study was to create a pre-designed, evidence-based informed consent form specifically for PRP injections. The current evidence on the medico-legal implications of PRP injections was accessed, as well as informed consent in general and specifically informed consent in PRP injections. Additionally, we interviewed orthopaedic surgeons and patients who had undergone PRP injections in the past year using a semi-structured approach. A legally valid and evidence-based informed consent form for PRP injections ensures rights, encouraging open communication and transparency between the patient and surgeon. Moreover, if a lawsuit arose, informed consent would be a critical document in surgeons' defence and would withstand scrutiny from lawyers and the judiciary. An evidence-based informed consent form for PRP injections was elaborated and reviewed by a legal expert to ensure adherence to legal proprieties. The final form of the informed consent for PRP injection was administered for one year and validated at our institution.

Towards an understanding of the ethics of electronic consent in clinical trials.

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial.

BACKGROUND: Electronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use. METHODS: SWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID-19 booster vaccination. Four hundred thirty-four healthcare workers aged 18-65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively. RESULTS: Participants found that group eConsent was an efficient method that it allowed them to hear each other's questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-five (46%) participants thought that group eConsent was suitable to recruit participants with diseases or conditions, while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population, and one-to-one conversation should always be available. Participants who had experienced both one-to-one and group eConsent shared different preferred consent formats for future studies. CONCLUSION: Group eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement. TRIAL REGISTRATION: ClinicalTrials.gov NCT05471440 (registered on 22nd of July, 2022).

A training protocol compliance of 13% was observed in a research study of clinical research professionals.

OBJECTIVE: We attempted to conduct a randomized controlled trial of three different informed consent training formats to evaluate their effectiveness. We recruited 503 clinical research professionals, who received $50 for participation. Incidental findings showed unexpectedly low rates of compliance with completing the study training protocols, resulting in insufficient statistical power to test our original hypotheses. In this report, we conducted a secondary analysis of the data in which we characterize and evaluate the observed low compliance. This involved using literature on average reading times, speed-reading times, and video play speeds to calculate the timeframes required to complete the three training formats. RESULTS: Only 13% of participants completed the training in a reasonable timeframe. Furthermore, only 46% of participants completed the training in the minimum possible timeframe. These findings lead us to ask whether online research training is effective, since no training can be effective if participants do not actually complete the training. Given extensive requirements for educational training among clinical research professionals, we feel the burden of proof is on training programs to demonstrate that they have positive effects.

Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital.

BACKGROUND: This study aims to investigate the integration of modern sources of patient information, such as videos, internet-based resources, and scientific abstracts, into the traditional patient informed consent process in outpatient elective surgeries. The goal is to optimize the informed consent experience, enhance patient satisfaction, and promote shared decision making (SDM) between patients and surgeons. By exploring different patient informed consent formats and their impact on patient satisfaction, this research seeks to improve healthcare practices and ultimately enhance patient outcomes. The findings of this study will contribute to the ongoing efforts to improve the informed consent process in public hospitals and advance patient-centred care. METHODS: Data collection occurred at the day care clinic of a prominent German public hospital, forming an integral component of a prospective clinical investigation. The study exclusively focused on individuals who had undergone surgical intervention for skin cancer. For the purpose of meticulous data examination, the statistical software SPSS version 21 was harnessed. In the course of this study, a chi-square test was aptly employed. Its purpose was to scrutinize the nuances in patient experiences pertaining to informed consent across four distinct categories, viz., oral informed consent discussion (Oral ICD), written informed consent discussion (Written ICD), video-assisted informed consent discussion (video-assisted ICD), and digitally assisted informed consent discussion (digital-assisted ICD). The primary dataset of this inquiry was diligently gathered via a structured questionnaire administered to a targeted cohort of 160 patients. Within this sample, a balanced representation of genders was observed, encompassing 82 males and 78 females. Their collective age span ranged from 18 to 92 years, with an average age of 71 years. A randomized selection methodology was employed to include participants in this study during the period spanning from July 2017 to August 2018. RESULTS: Significant differences were observed across the groups for all research questions, highlighting variations in patient responses. Video-assisted and digital-assisted IC were rated as superior in patient satisfaction with information compared to written and oral IC. Demographic profiles of the four study groups were found to be comparable. CONCLUSION: The findings of this study indicate that the incorporation of digital technologies in the informed consent process can enhance patient understanding during outpatient elective skin cancer surgeries. These results have important implications for increasing patient satisfaction and improving the SDM process within the hospital environment.

The Collaborative Biobank (CoBi): Donor and recipient samples & data to facilitate future research on hematopoietic cell transplantation.

Biobanking provides benefit for future generations by facilitating medical research and subsequent translation and application of research findings. Long-term storage and research involving biological material and associated data necessitate the proper implementation of ethical and legal standards. A key principle includes recognizing informed consent as a crucial element for legitimizing the collection of biological material and data. Furthermore, any collected material and data must be employed exclusively for the research framework that aligns with the explicit consent provided by the participants. Last but not least, data privacy and security are essential in biobanking. This review elucidates chances and limitations of biobanking in the field of allogeneic hematopoietic cell transplantation. We discuss the practical implementation of the requirements, illustrated by the Collaborative Biobank, a collaborative research platform for research in blood cancer.

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.