Ethical challenges in qualitative sociology: a systematic literature review.

Qualitative researchers often encounter ethical challenges during their research process. Due to the large number of papers in which researchers reflect on specific and various ethical challenges within their projects, it proves difficult to keep track of them. To capture these reflexive practices, we conducted a literature review of 72 papers in sociology. Our review shows who reflects on research ethics and when and where such reflections occur. We identify 11 ethical issues that sociologists reflect on. Some issues address the challenges of implementing established ethical principles, such as (1) informed consent, (2) voluntary participation, (3) avoiding harm, (4) anonymization, and (5) confidentiality. Others go beyond these principles and refer to (6) the relationship between researchers and participants, (7) power asymmetries, (8) protecting yourself as a researcher, (9) deviant actions, (10) covert research, and (11) leaving the field. Our findings help researchers gain an overview of ethical challenges, enhancing their reflexivity.

Challenges in Paediatric Xenotransplantation: Ethical Components Requiring Distinct Attention in Children and Obligations to Patients and Society.

The transplantation of non-human organs into humans, or xenotransplantation (XTx), has recently garnered new attention and is being developed to help address the problem of organ scarcity in transplantation. Ethical issues surrounding XTx have been studied since initial interest arose decades ago and have experienced renewed discussion in the literature. However, the distinct and relevant differences when applied to children has largely been overlooked with few groups attending to the concerns that XTx in children raises. In this paper, we explore ethical challenges to be expected in paediatric XTx, in particular exploring organ sizing concerns, infectious risks, psychological burdens, and issues of moral hazard. We review these domains with the aim of highlighting the implications of pursuing paediatric XTx and the cross-disciplinary approach needed to solve these issues. Children require a unique analysis from a bioethical perspective to best prepare for the issues XTx presents.

A thin line between consent and abuse - Reflections on sexual experiences among Swedish young adults with intellectual disabilities.

Research shows that young adults with intellectual disabilities struggle to understand the social codes embedded in sexual situations. This may lead to an incomprehension of sexual consent, or when consenting to sex may lead to abuse. This qualitative study aimed to gain an in-depth understanding of sexual experiences and perceptions about sexual consent among Swedish young adults with intellectual disabilities. The data comprise 22 semi-structured interviews with young adults aged 18-35 with intellectual disabilities, thematically analyzed using sexual script theory as a theoretical framework. Four themes emerged from the analysis: Setting the sexual scene, Sexual self-awareness, Sexual communication and the necessity of clarification and Striving for a balance. The results show that the participants had a variety of sexual experiences and challenges associated with sexual consent, but also an agency that favors sexual situations. Further research is necessary to understand the complexities of sexual consent in this population.

Enhancing patient-provider encounters when proposing SDF therapy by utilizing a qualitative analysis of parental feedback.

Purpose: Silver Diamine Fluoride (SDF) is a minimally invasive option for caries arrest, part of a paradigm shift in the management of pediatric dental caries. The perspective of parents regarding the long-term pros and cons of this therapy should be understood in order to achieve optimal patient-centered care. Methods: This study used Constant comparative analysis as an analytic approach, applying the Precaution-Adoption Process Model (PAPM) as the Grounded Theory framework in the qualitative analysis of 30 parental unformatted, spontaneous comments collected at the end of a questionnaire to evaluate their satisfaction with treatment provided at a University Clinic. Results: Our analysis provided important insights about the factors that influenced the parents' decision to act and have their child receive SDF therapy, their perception of the outcomes, the necessary follow-ups after the therapy, and what impacted on their overall satisfaction with the completed procedure. Both positive and negative themes were identified. The positive themes point to SDF treatment's ease of application and addressing the immediate treatment needs on children with limited cooperation. The negative themes identified the adverse consequences of SDF treatment, specifically, the duration and appearance of the cosmetic consequences, as well as the parents' misunderstandings and incorrect expectations of the long-term sustainability of the treatment, which in many instances requires further interventions. It was also evident from the parents' comments that they needed additional educational guidance on other aspects of the treatment, such as the necessity for clinical follow-ups, information that impacted parents' overall satisfaction with the treatment their child received. Conclusion: Our results highlight the need to discuss the short and long term benefits of the treatment, as well as, its short and long-term limitations. Specifically, while it is important to discuss immediate outcomes and consequences, such as the ease of treatment and the resultant staining, to ensure that parental consent for the treatment is truly well-informed, it is also important to prepare parents, when this procedure is initially proposed, of the likely need for additional oral care interventions in the future.

Dentolegal aspects of dental implants.

Dentists providing implant dental treatment need to fully appreciate the legal and clinical issues that are relevant to implant dentistry. The legal aspects of implant dentistry, according to UK law, are described in this article. Suggestions for how the risks of implant treatment might be mitigated, with tips and examples are provided.

Biobank consent under the GDPR: are potential sample donors informed about all lawful uses of biobank data?

This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data.

Practices and attitudes of herbalists regarding informed consent in Uganda: a qualitative study.

BACKGROUND: Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. METHODS: To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were conducted. The data were analyzed thematically using NVivo version 12 software. RESULTS: Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine. CONCLUSION: This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists' practices and attitudes toward informed consent.

Capturing sources of health system legitimacy in fragmented conflict zones under different governance models: a case study of northwest Syria.

INTRODUCTION: Legitimacy and trust are crucial for resilient health systems in fragmented conflict zones. This study evaluates the legitimacy of health systems in northwest Syria under different governance models. METHODS: Using a deductive and inductive mixed-methods approach, the research team developed a framework with an index, 4 sub-indices and 18 indicators to assess the legitimacy of health systems using different governance models - top-down, bottom-up, and hybrid - in the context of the response to the earthquake that hit Syria in February 2023. The study includes surveys, workshops, stakeholder consultations, and an expert panel conducted in northwest Syria and online. RESULTS: The findings indicate that bottom-up health governance model is perceived as the most legitimate, followed by the mixed model, while top-down model is perceived as the least legitimate. This preference is measured across all legitimacy source sub-indices, including legality, justification, consent and performance and across the overall Health System Legitimacy Index (HSLI). However, the hybrid governance approach showed limited superiority at two indicator levels regarding long-term health system response. CONCLUSION: This study highlights the importance of considering the legitimacy of the health system in fragmented conflict zones. It helps explain the effectiveness of the bottom-up approach and community-based governance in enhancing trust, cooperative behaviour, health interventions and achieving sustainability. Additionally, the study highlighted the role of legitimate health systems in practising civic virtue and promoting social justice, thus contributing to peace-building efforts. These insights are crucial for policymakers and development donors to strengthen health systems in challenging contexts.

Consent in Limb Lengthening Surgery: Predicting the True Incidence of Material Risk.

Aim: The consent process involves supported decision-making between the surgeon and the patient. Both potential benefits and material risks of the procedure require explanation, with adequate time for reflection. The complexity of limb reconstruction surgery includes the potential for multiple types of complications. In an attempt to delineate the material risks in lower limb lengthening, a literature review was undertaken to ascertain the published rates of complications. Materials and methods: A review of articles from 2003 to 2023 via PubMed and Google Scholar, including keywords 'lengthening', 'tibia', 'lengthening nail' and 'external fixator' was undertaken. Studies with a minimum of 20 patients, undergoing lengthening of the femur, tibia, or both by an external fixator and/or an intramedullary lengthening nail were included for analysis. Complications were reported according to Paley's problems, obstacles, and complications. Results: Twenty-two papers met the inclusion criteria. The commonest complications listed following lengthening using an external fixator were pin site infections (52% in the femur and 18.8% in the tibia), delayed consolidation (8.3%), bone re-fracture (13%), and joint stiffness (18.8%). Following femoral lengthening using the intramedullary lengthening nails reported complication rates were lower, including implant issues (8%) and delayed consolidation (6%). Conclusion: Patients require a full understanding of both benefits and potential harms when undergoing any surgical intervention. Our study has identified the published rates of complications following lower limb lengthening. These figures can be used to guide the consultation and enable surgeons to audit their own surgical results against the published literature. How to cite this article: Makvana S, Robertson A, Britten S, et al. Consent in Limb Lengthening Surgery: Predicting the True Incidence of Material Risk. Strategies Trauma Limb Reconstr 2024;19(2):61-66.

eConsent administered by Community Health Workers in a study using the Trials within Cohorts (TwiCs) design-Experiences from the Community-Based chronic Care Lesotho (ComBaCaL) project.

Improving access to essential health services requires the development of innovative health service delivery models and their scientific assessment in often large-scale pragmatic trials. In many low- and middle-income countries, lay Community Health Workers (CHWs) play an important role in delivering essential health services. As trusted members of their communities with basic medical training, they may also contribute to health data collection. Digital clinical decision support applications may facilitate the involvement of CHWs in service delivery and data collection. Electronic consent (eConsent) can streamline the consent process that is required if the collected data is used for the scientific purposes. Here, we describe the experiences of using eConsent in the Community-Based chronic Care Lesotho (ComBaCaL) cohort study and multiple nested pragmatic cluster-randomized trials assessing CHW-led care delivery models for type 2 diabetes and arterial hypertension using the Trials within Cohorts (TwiCs) design. More than a hundred CHWs, acting both as service providers and data collectors in remote villages of Lesotho utilize an eConsent application that is linked to a tailored clinical decision support and data collection application. The eConsent application presents simplified consent information and generates personalized consent forms that are signed electronically on a tablet and then uploaded to the database of the clinical decision support application. This significantly streamlines the consent process and allows for quality consent documentation through timely central monitoring, facilitating the CHW-led management of a large-scale population-based cohort in a remote low-resource area with continuous enrollment-currently at more than 16,000 participants.

Role of procedure-specific consent forms in clinical practice: a systematic review.

INTRODUCTION: Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria. METHODS: This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using 'RoB 2' and 'ROBINS-I'. Meta-analysis was not possible because of the results' heterogeneity. FINDINGS: We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%-100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF. CONCLUSIONS: The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

Chemsex and its impact on gay and bisexual men who have sex with men: Findings from an online survey in Belgium.

OBJECTIVES: The study aimed to estimate the prevalence of sexualized drug use, or chemsex, in a wide group of gay, bisexual and other men who have sex with men (gbMSM) in Belgium. It examined which drugs gbMSM used before and during sex, the frequency with which they used it, whether they experienced non-consensual sex, and evaluated the impact of chemsex on the health and professional and social lives of respondents. METHODS: We conducted an online survey among Belgian gbMSM. Five specific questions on chemsex were included in the survey. These questions assessed whether gbMSM engaged in chemsex. If they did, they were asked to provide information on which drugs they had used and how often. We asked whether their and their partners' boundaries had been respected and whether and how engaging in chemsex had affected a range of life domains. RESULTS: Of 836 respondents, 258 (30.9%) self-reported having had sex under the influence of substances ("chemsex") in the previous 6 months. Of these, 227 (88%) were considered chemsex users according to the definition used for the analysis. Poppers (73%), gamma-hydroxybutyrate/gamma-butyrolactone (GHB/GBL; 69%) and cathinones (68%) were the most commonly reported substances. Almost half of respondents (45%) engaging in chemsex were high on drugs during at least half of their sexual encounters. Nearly 1 in 10 (9%) reported that boundaries had not been respected, suggesting non-consensual sexual activities. The 82 respondents experiencing negative impacts from their chemsex use reported that mental health (65%), physical health (40%) and sexual health (38%) were most impacted. DISCUSSION: Our findings provide a snapshot of the current chemsex situation in Belgium. The frequency of chemsex is concerning because several health, professional and social aspects are impacted. Almost 1 in 10 respondents using chemsex reported that chemsex impacted consent around sex, requiring additional efforts to eradicate these non-consensual sexual experiences. Therefore, larger scale research focusing on respected boundaries and consent during chemsex and the frequency of drug use for sex seems required. Additionally, sensitisation, as well as care and support programmes are critical.

Prevalence of pelvic examinations on anesthetized patients without informed consent.

CONTEXT: The pelvic examination is a fundamental tool for the evaluation and diagnosis of women's health conditions and an important skill for all medical students to learn as future physicians for the early detection of treatable conditions such as infection or cancer. Although the American College of Obstetricians and Gynecologists (ACOG) asserts that performing pelvic examinations under anesthesia for educational purposes should only occur if the patient provides explicit and informed consent, there still have been reports of medical students performing pelvic examinations on anesthetized patients across the country, and many states are now starting to pass bills requiring informed patient consents to conduct pelvic examinations under anesthesia. OBJECTIVES: The objectives of this study are to evaluate the prevalence of pelvic examinations performed by osteopathic medical students on anesthetized patients without consent while fulfilling their third-year OB-GYN clerkship requirements. METHODS: The survey was administered and distributed to all osteopathic medical schools in the country via the Student Osteopathic Medical Association's (SOMA's) chapter emails, outreach emails, and SOMA's social media accounts to collect data. Inclusion criteria included third- or fourth-year osteopathic medical students who completed their OB-GYN clerkship rotations when taking the survey. The exclusion criteria included any osteopathic medical student who had not completed their OB-GYN clerkship rotation. We utilized descriptive analysis to summarize the final data. RESULTS: We received 310 responses. The final number of responses was 291 after meeting the exclusion criteria. Most osteopathic medical students (94.2 %, n=274) considered the practice of performing pelvic examinations on anesthetized patients without their explicit consent unethical. Among the participants, 40.9 % (n=119) admitted to performing pelvic examinations on patients under anesthesia while on OB-GYN rotations, but most of them (57.1 %, n=68) did so without obtaining prior consent from the patients. Notably, the number of pelvic examinations performed by medical students on patients under anesthesia ranged widely from 1 to 25 with a median number of 10. Moreover, 58.9 % (n=70) indicated that they had not been properly educated to obtain specific consent before performing pelvic examinations under anesthesia. Many participants cited efficiency of practice, lack of policy awareness and personal education by medical students, and failure to refuse to perform pelvic examinations on anesthetized patients as trainees when asked by their seniors or preceptors. CONCLUSIONS: This study demonstrates that although most osteopathic medical students consider performing pelvic examinations on anesthetized patients unethical, many still admit to practicing pelvic examinations on patients under anesthesia, while on OB-GYN rotations for efficiency of practice, lack of policy awareness and personal education, and being in unique positions in which grades are determined by seniors and preceptors for their willingness to do what is asked even if the practice does not align with their conviction. This study highlights the importance of ongoing research and implementation of policies at institutional and state levels that will procure the value of pelvic examinations while protecting and upholding the ethics of patients' rights and autonomy of medical students.

Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care.

BACKGROUND: Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments. METHODS: Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed. RESULTS: Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning). CONCLUSIONS: For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns.

Beyond neural data: Cognitive biometrics and mental privacy.

Innovations in wearable technology and artificial intelligence have enabled consumer devices to process and transmit data about human mental states (cognitive, affective, and conative) through what this paper refers to as "cognitive biometrics." Devices such as brain-computer interfaces, extended reality headsets, and fitness wearables offer significant benefits in health, wellness, and entertainment through the collection and processing and cognitive biometric data. However, they also pose unique risks to mental privacy due to their ability to infer sensitive information about individuals. This paper challenges the current approach to protecting individuals through legal protections for "neural data" and advocates for a more expansive legal and industry framework, as recently reflected in the draft UNESCO Recommendation on the Ethics of Neurotechnology, to holistically address both neural and cognitive biometric data. Incorporating this broader and more inclusive approach into legislation and product design can facilitate responsible innovation while safeguarding individuals' mental privacy.

Clients prefer collaborative decision-making with veterinarians regardless of appointment type.

OBJECTIVE: To determine clients' preferences for veterinarians' communication during decision-making in relation to 3 clinical contexts: preventive care, general problem (eg, illness or injury), and urgent appointments. METHODS: A cross-sectional online questionnaire was distributed by use of snowball sampling to veterinary clients owning a pet. Demographic information was collected, and participants were then randomly assigned to a scenario reflecting one of the following clinical contexts (appointment types): preventive, general problem, or urgent. Discrete choice exercises were used to solicit client preferences for 5 aspects of veterinarians' communication approach to decision-making with clients in clinical contexts: amount of information, presentation of plan (options or a recommendation), communication of value, nature of client involvement, and communication of financial cost. Relative-preference scores were calculated using hierarchical bayesian modeling. RESULTS: Responses for 1,614 participants were included in the final analysis. The majority were female, lived in Canada, and were financially stable. Across clinical decision-making contexts, participants preferred to collaborate with the veterinarian, be offered options with a clear recommendation, be informed of present and future costs, and have benefits of any action regarding their pet's health explained to them. For the general-problem context, participants preferred veterinarians' communication to focus solely on concerns; in contrast, in preventive care and urgent contexts, participants preferred that communication include both normal findings and concerns. CONCLUSIONS: Irrespective of clinical decision-making context, participants preferred collaborative decision-making with a veterinarian. CLINICAL RELEVANCE: Veterinary professionals should consider, when possible, communication that supports a collaborative approach to decision-making with clients.

Incidental findings in research brain MRI: Definition, prevalence and ethical implications.

Radiological incidental findings (IFs) are previously undetected abnormalities which are unrelated to the original indication for imaging and are unexpectedly discovered. In brain magnetic resonance imaging (MRI), the prevalence of IFs is increasing. By reviewing the literature on IFs in brain MRI performed for research purposes and discussing ethical considerations of IFs, this paper provides an overview of brain IF research results and factors contributing to inconsistencies and considers how the consent process can be improved from an ethical perspective. We found that despite extensive literature regarding IFs in research MRI of the brain, there are major inconsistencies in the reported prevalence, ranging from 1.3% to 99%. Many factors appear to contribute to this broad range: lack of standardised definition, participant demographics variance, heterogenous MRI scanner strength and sequences, reporter variation and results classification. We also found significant discrepancies in the review, consent and clinical communication processes pertaining to the ethical nature of these studies. These findings have implications for future studies, particularly those involving artificial intelligence. Further research, particularly in relation to MRI brain IFs would be useful to explore the generalisability of study results.

Does implementing opt-out solve the organ shortage problem? Evidence from a synthetic control approach.

In light of the persistent shortage of organ donations needed to save precious human lives, several countries have modified their organ donation laws by introducing an opt-out system, making every deceased a potential organ donor unless the person has objected. This study examines the impact of adopting opt-out on organ donation rates. Using a panel dataset covering a 21-year period, I apply a synthetic control approach to focus on countries that changed their prevailing organ donation legislation from opt-in to opt-out. I compare them to a synthetic counterfactual from countries that have kept their legislation the same since 1999. Synthetic control estimates show that Argentina and Wales achieved substantially higher organ donation rates with the shift from an opt-in to an opt-out system than without the reform taking place. My findings suggest that as one strategy among others, implementing opt-out cannot solve the organ shortage problem entirely but effectively contributes to reducing it considerably.

Bibliometric analysis of publications that cited the CIOMS 2016 "International ethical guidelines for health-related research involving humans".

The CIOMS book "International Ethical Guidelines for Health-related Research Involving Humans", published in 2016 (IEG2016), provides information to assist research ethics committee members and research practitioners with pragmatically implementing ethical considerations while planning and conducting their research. To identify which aspects of research IEG2016 has had the greatest impact since its publication, we analyzed metadata from 942 papers that cited IEG2016 (English language title only) from Web of Science (WoS, Clarivate). Using VOSviewer, we mapped the co-occurrence of keywords to derive the network of all keywords that co-occurred at least five times in the set of citing papers. We found that the keywords ethics, research ethics, informed consent, and clinical trials had high co-occurrence scores in this set of publications. Strong links were also observed between ethics, research ethics, and informed consent. We identified fifteen human-related (HR) keyword nodes in this keyword network. Analysis of the subset of 273 IEG2016-citing articles containing these fifteen HR keywords showed later-date publications were focused on the youngest humans (children, adolescents, young people, minors) and the humans typically responsible for those youngest humans, namely women and parents. Seventy-nine of the 110 networked countries/regions associated with IEG2016-citing articles were home to HR keyword articles. We conclude that IEG2016 has had significant impact in health and medical science literature and has served as a foundation for health-related research around the world in the areas of ethics, informed consent, and research ethics and the linkage of these topics to under-represented populations in such research.