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This scoping review maps research ethics and integrity challenges and best practices encountered by research actors in the DACH countries (Germany, Austria, and Switzerland), including researchers, funders, publishers, research ethics committees, and policymakers, during the COVID-19 pandemic. The COVID-19 pandemic brought research and, in turn, research ethics and integrity, into public focus. This review identified challenges related to changing research environments, diversity in research, publication and dissemination trends, scientific literacy and trust in science, recruitment, research redundancy and study termination, placebo and human challenge studies, data management, and informed consent. These challenges are linked to two crucial factors: first, actors in the DACH research ecosystem lacked a sound knowledge base to assess the risks and benefits of research during the COVID-19 pandemic. Second, researchers in the DACH region faced pressure from policymakers, funders, and the public to generate relevant, timely, and consistent findings to mitigate the impacts of the COVID-19 pandemic. In addition, this review highlights best practices to mitigate the effects of future crises on research ethics and integrity, including enhanced cooperation among actors, continuous ethics assessments, and support for public scientific literacy.

The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19 prevention and treatment fueled an embrace of risks--to research participants and to the reliability of the science itself--as allegedly necessary costs to speed scientific progress. Scientists and (even) ethicists supported overturning longstanding norms protecting healthy volunteers in human challenge trials to speed vaccine development, but these trials led to no vaccines. Physicians, with the approval of research ethics committees, designed hundreds of unblinded, single-center clinical trials at high risk of bias to speed the identification of new treatments. But these clinical trials led to no treatments. The lesson for future pandemics is that the acceptance of greater risks to participants or science does not reliably lead to progress. We are better served by science that upholds the highest ethical and methodological standards.

Global health emergencies often lead to a proliferation of health-related research and resultant data, which is shared across borders to help control the outbreak of disease and support decision-making regarding public health interventions. However, efforts to share data can be hindered by diverse international ethical and legal frameworks. The frameworks aim to govern coordinated processing, sharing and transfer of health data across borders thus placing burdens on researchers who are willing or obligated to share data. In this paper, we investigate ethical values and legal principles that can be applied to ensure a more streamlined approach in the governance of cross-border health data sharing during global health emergencies. A scoping review approach was used to better understand emerging evidence about issues related to the ethical and legal governance of cross-border health data sharing. We first highlight the challenges of sharing health data across borders. We then discuss how the challenges might be overcome through the application of ethical values and legal principles that have been identified in literature. This is followed by a proposal for possible ways of streamlining the governance of health data sharing from ethical and legal perspectives in a bid to better prepare for future global health emergencies and promote the responsible sharing of health data.

3D scanning and printing technologies are quickly evolving and offer great potential for use in gross anatomical education. The use of human body donors to create digital scans and 3D printed models raises ethical concerns about donor informed consent, potential commodification, and access to and storage of potentially identifiable anatomical reproductions. This paper reviews available literature describing ethical implications for the application of these emerging technologies, existing published best practices for managing and sharing 2D imaging, and current adherence to these best practices by academic body donation programs. We conclude that informed consent is paramount for all uses of human donor and human donor-derived materials and that currently there is considerable diversity in adherence to established best practices for the management and sharing of 3D digital content derived from human donors. We propose a new and simplified framework for categorizing donor-derived teaching materials and the corresponding level of consent required for digital sharing. This framework proposes an equivalent minimum level of specific consent for human donor and human donor-derived materials relative to generalized, nonidentical teaching materials (i.e., artificial plastic models). Likewise, we propose that the collective path forward should involve the creation of a centralized, secure repository for digital human donor 3D content as a mechanism for accumulating, regulating, and controlling the distribution of properly consented human donor-derived 3D digital content that will also increase the availability of ethically created human-derived teaching materials while discouraging commodification.

The growing importance of researching online activities, such as cyber-deviance and cyber-crime, as well as the use of online tools (e.g. questionnaires, games, and other interactive tools) has created new ethical and legal challenges for researchers, which can be even more complicated when researching adolescents. In this article, we highlight the risks emerging from the current European legal and ethical landscape when researching potentially vulnerable groups, with a special focus on online research. It is not always clear how to differentiate research ethics consent from consent for data processing activities: when can an adolescent independently consent to research, or when is parental consent needed? Additional problems emerge when parents do not consent to research activities, but their adolescent children do. A serious ethical challenge can arise when the parents do not communicate with researchers, but the adolescent wishes to participate, especially when weak parental oversight is coupled with research on sensitive topics. We offer some guidance on what to keep in mind when conducting online research with adolescents and highlight possible ways that these issues can be dealt with in pan-European projects.

The increasing ubiquity of gamification in everyday life normalizes it as a motivational tool. While much scholarship supports gamification, labor sociologists have long problematized the phenomenon. In this mixed-methods action research study, we explore the results of gamifying a lesson on gamification in a sociology of work course. We designed two gamified activities with varying degrees of consent that followed a lesson on gamification and consent. Students rated how problematic a series of gamified work scenarios were before and after the intervention. Our quantitative data did not show a significant increase in students' ability to identify consent after the intervention, but we did discover that students took either an employee or employer's perspective in their rating justifications. Furthermore, these findings were gendered. This article highlights the need for a more critical take on gamification in the classroom. We conclude by suggesting ways practitioners can teach about gamification in other contexts.

Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals (n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.

Background: School-based health centers (SBHCs) have the capability to overcome youth barriers to care. Virtual care programs (VCP) facilitate connection between school nurse and off-site SBHC providers and can increase the reach of SBHCs. This project aimed to examine Denver Public School nurses' perspectives of a pilot VCP. Methods: Thirteen semi-structured qualitative interviews were conducted and coded using an inductive approach to identify key themes. Results: Four major themes emerged: (1) obtaining consent, finding space, and capacity are challenges and nurses have suggestions; (2) nurses enjoy feeling like a valued member of a health care team, and providing additional resources to students; (3) nurses perceive benefits in providing free, efficient, higher level of care; (4) adopting novel technology is a facilitator and challenge; limitations included space and privacy. Conclusions: Key findings can be utilized to further inform practice.

To meet the diverse needs of school-aged children, school psychologists often must collaborate with other professionals within and outside the school setting. Despite potential benefits, challenges exist related to interprofessional collaboration, including ethical challenges. This article explores some of the most salient ethical dilemmas that school psychologists are likely to face when collaborating with other professionals. Specifically, ethical issues related to competence, multiple relationships, informed consent/assent, privacy/confidentiality, assessment, and therapy are examined. Using vignettes, recommendations for navigating common ethical issues that may arise when engaging in interprofessional collaboration are offered. Suggestions are contextualized within the ethical principles and standards outlined in the American Psychological Association's "Ethical Principles of Psychologists and Code of Conduct" (2017) and the National Association of School Psychologists Professional Standards (2020), which includes the Principles for Professional Ethics.

Human body donors play a crucial role in anatomical education, research, and clinical skills training, and those interested in anatomical donation may bequeath their bodies to body donation programs (BDPs). The purpose of this study was to evaluate the perspective of body donors on the donation process in order to make recommendations for improvement that align with donor values. A survey was administered via email to 2145 individuals that had enrolled in The Ohio State University's BDP and yielded a 40% response rate. Results showed that a majority of registered donors do not place high importance on detailed consent options during the enrollment process, but do value BDP oversight, such as through the use of an oversight committee to supervise the program. Only 9.1% of donors felt that their loved ones should be permitted to make changes to their consent forms after they have passed. Although 96.2% of participants would allow photos/videos to be taken of their donated bodies, females were significantly less likely to consent to this than males (p = 0.001), as well as less likely to allow their donations to be utilized for anatomy outreach (p = 0.023). Racial minorities were significantly less trusting of the university to treat their donation with dignity and respect compared to White registrants (p = 0.034). Suggestions for improving BDP protocols include the implementation of an annual newsletter for registrants, improving methods to spread awareness about donation, increasing transparency during the consent process, and creating resources for donors' families.

Gaining ethical approval for qualitative health research and implementing all the planned research processes in a proposed study are not straightforward endeavours. The situation becomes more complex when qualitative research is conducted in a cross-national healthcare and academic context. Also, it is even exhausting when the study is student-based, as student researchers may be considered novices and inexperienced researchers, especially for field-based research. Our aim in this reflective paper is to present, reflect, and discuss the experiences of a doctoral researcher in dealing with two independent institutional review boards in Canada and Ghana during an interdisciplinary Ph.D. project and the ethical dilemmas encountered while collecting data in Ghana. Based on the researcher's experiences, it became apparent that consent and its documentation can have cultural implications in different settings; hence, institutional review boards must exercise reflexivity in their protocol review practice. Also, sharing research data with participants and institutional leaders while maintaining participant confidentiality and privacy in institutional ethnographic research requires sensitivity to bi-lateral ethical values. With the experiences shared in this paper, we advocate for a dialogic ethical review process in qualitative research where researchers and research ethics boards engage in ongoing dialogue rather than the usual prescriptive format research ethics reviews often assume.

Typically, parents or other legal guardians are asked for an active declaration that the participation of their child in scientific research is informed and voluntary. However, asking for active parental consent leads to lower quality studies and passive parental consent might be preferable. In this study, we used an online survey in which parents (N = 156) watched video vignettes of multiple types of research in the classroom and asked them to rate the appropriateness of using active and passive parental consent. The results indicated that parents perceived active consent procedures as more appropriate in most types of research. However, particularly for secondary school children passive consent was rated as comparably appropriate for several types of research (e.g. observation and questionnaire studies). Other aspects of providing consent are displayed in a supplementary online dashboard. We conclude with recommendations for parental consent procedures for social science research in the school context.

As Twitter's (or X's) influence permeates aspects of education, researchers must consider how to ethically and effectively leverage the unique types of data that this social media platform offers. This paper provides recommended methodological practice considerations for working with qualitative Twitter data toward the advancement of education research. To inform our methodological protocol, we draw from a larger study that investigated disability disclosure during graduate school on Twitter. We use examples from our study to highlight similar protocol considerations that future researchers might take when working with qualitative Twitter data, including use of the website's advanced search feature and use of multifaceted analysis approaches for capturing this data's often unique complexity. We further provide ethical considerations for conducting social media research in education. Finally, we discuss the utility of the practices described in this article for moving education research forward via qualitative Twitter data.

As our modern world has become increasingly digitalized, various types of data from different data domains are available that can enrich survey data. To link survey data to other sources, consent from the survey respondents is required. This article compares consent to data linkage requests for seven data domains: administrative data, smartphone usage data, bank data, biomarkers, Facebook data, health insurance data, and sensor data. We experimentally explore three factors of interest to survey designers seeking to maximize consent rates: consent question order, consent question wording, and incentives. The results of the study using a German online sample (n = 3,374) show that survey respondents have a relatively high probability of consent to share smartphone usage data, Facebook data, and biomarkers, while they are least likely to share their bank data in a survey. Of the three experimental factors, only the consent question order affected consent rates significantly. Additionally, the study investigated the interactions between the three experimental manipulations and the seven data domains, of which only the interaction between the data domains and the consent question order consistently showed a significant effect.

As a result of the growing commercial marketplace for teachers' digital data, a new organization that includes educational data brokers has evolved. Educational data brokerage is relatively intangible due to the ease of de-identified data being collected and sold via educational technology. There is an urgent need to expose how the brokerage of educational data relates to the commercial mediation of consent and privacy in educational settings. It is difficult due to a lack of consistent terminology about organizations that buy and sell data. This paper offers an extensive analysis of the social learning platform Edmodo and provides evidence that justifies the term 'educational data broker'. The results aim to provide new terminology to a largely obfuscated process in educational settings and bring to light a concrete example of brokerage activity focusing on teachers' online activity.

Educational psychologists (EPs) have a legal and ethical obligation to gain informed consent prior to any psychological involvement. As EPs work across the 0 to 25 age range, the person giving consent may vary according to the needs of the individual service user and so it is necessary to be aware of relevant legislation and case law. This study explored what might be considered best practice for EPs in gaining consent across the 0 to 25 age range by conducting semi-structured interviews with six professionals as part of an expert reference group. The interviews were thematically analysed using a hybrid inductive-deductive approach. Six main themes were identified: ethical obligations; children's rights; legal obligations; partnership; informed consent; and, barriers to best practice. There was considerable overlap between some of the main themes, reflecting the complexity of the issue. The findings are discussed in relation to literature in other areas of psychological practice. Implications for practice for individual EPs and EP services are considered, such as the possibility of developing a guidance document for use across the profession, as well as directions for further research.

Peer support has been an undeveloped pathway for filling the service gap and to generate employment opportunities for autistic individuals. Peer supports have been deployed widely in mental health and among veterans and understanding the utility of this service modality among autistic individuals illuminates opportunities for research, policy, and practice. This study examined characteristics of participants in an autistic-delivered peer support program and reports on use of and satisfaction with the program. Half of autistic participants had a co-occurring mental health diagnosis. Participants reported multiple areas of unmet needs and participant satisfaction with the program was high (90%). The findings of this study point toward autistic-delivered peer support as a promising avenue for future development.

Professional organization ethical codes are adopted to protect the public by educating their members to standards of conduct and by facilitating resolution of ethical complaints. Given that the last survey on ethics in school psychology was conducted over a decade ago, the aim of this study was to investigate the ethical dilemmas practitioners face today, along with their preparedness for resolving these dilemmas. We also examined workplace resources and whether preparedness and resolution were related to background variables (i.e., degree, setting, ethics training). Results indicated most school psychologists experienced at least one ethical dilemma over the past year, mostly in the areas of assessment and administrative pressure. Although most participants felt prepared to face ethical dilemmas, relatively few used a systematic decision-making model to resolve them. Last, most school psychologists reported feeling relatively unprepared for ethically delivering psychological services via telehealth. Implications for research and practice are discussed.

The global scale of COVID-19 has constrained academics from conducting much person-facing research. Reactively, trend is increasing for digital-based methodologies capturing already existing online data. Scholars often 'scrape' user-postings from internet forums using coding algorithms and text capture tools, before analysing data, drawing conclusions and publishing findings. The online social news aggregation and discussion website Reddit is a particularly rich source of data for researchers. The public nature of Reddit materials may suggest rationale for user-data to be replicated, analysed and archived; indefinitely and in multiple locations, for scholarly research. However, this position overlooks several key ethical considerations. This paper presents an overview and explanation of Reddit, followed by an exploration of studies that use Reddit-acquired data. Arising ethical issues are discussed, and solutions to salient dilemmas presented. This is to enhance awareness of potential problems and improve protections for those whose data is unknowingly used for research.

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements/Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research.

The last decade has seen a rise in big data approaches, including in the humanities, whereby large quantities of data are collected and analysed. In this paper, we discuss long-form audio recordings that result from individuals wearing a recording device for many hours. Linguists, psychologists and anthropologists can use them, for example, to study infants' or adults' linguistic behaviour. In the past, recorded individuals and communities have resided in high-income countries (HICs) almost exclusively. Recognising the need for better representation of all cultures and linguistic experiences, researchers have more recently started to collect long-form audio recordings in low- and middle-income countries (LMICs). We aim to help researchers to collect, analyse and use these recordings ethically. To do so, we identify four main ethical challenges linked to research that relies on long-form recordings in LMICs. We provide recommendations to overcome these challenges. These considerations should be useful to researchers employing other big data techniques collected via wearables.

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.

Protective face masks were one of the central measures to counteract viral transmission in the COVID-19 pandemic. Prior research indicates that face masks impact various aspects of social cognition, such as emotion recognition and social evaluation. Whether protective masks also influence social avoidance behavior is less clear. Our project assessed direct and indirect measures of social avoidance tendencies towards masked and unmasked faces in two experiments with 311 participants during the first half of 2021. Two interventions were used in half of the participants from each sample (Experiment 1: protective face masks; Experiment 2: a disease prime video) to decrease or increase the salience of the immediate contagion threat. In the direct social avoidance measure, which asked for the deliberate decision to approach or avoid a person in a hypothetical social encounter, participants showed an increased willingness to approach masked as opposed to unmasked faces across experiments. This effect was further related to interindividual differences in pandemic threat perception in both samples. In the indirect measure, which assessed automatic social approach and avoidance tendencies, we neither observed an approach advantage towards masked faces nor an avoidance advantage for unmasked faces. Thus, while the absence of protective face masks may have led to increased deliberate social avoidance during the pandemic, no such effect was observed on automatic regulation of behavior, thus indicating the relative robustness of this latter behavior against changes in superordinate social norms.

Background: Historically the voices of people with intellectual disability have been occluded by barriers imposed by research practice. More recently, adaptive research approaches have been proposed to enhance the inclusion of people with intellectual disability in qualitative research. Method: This article presents an adaptive interviewing approach employed with five people ageing with intellectual disabilities in rural South Australia. The interviews were conducted within a broader participatory action research project in which tools and resources were co-designed for post-parental care planning. Results: We describe our adaptive interviewing approach incorporating multiple methods: (i) responsive communication techniques; (ii) the inclusion and support of family carers; (iii) visual tools; (iv) walking interviews. Conclusion: Findings contribute knowledge about how an adaptive interview approach supports the participation of people with an intellectual disability in qualitative research.

To explore issues surrounding re-consenting youth in longitudinal studies as they reach legal adulthood interviews were conducted with 46 parents plus 13 autistic teens enrolled in the Simons Foundation Powering Autism Research for Knowledge (SPARK) study. Qualitative analysis focused on family sensitivities regarding guardianship decisions, transition concerns, and the re-consenting process. Questions regarding guardianship were difficult for parents unsure of a teen's future status. Mothers were key facilitators of re-consenting for soon-to-be-independent teens. As legal adulthood approached, parents were willing to assist teens with re-consenting but needed support, asking for multiple contacts, transition resources, and explanatory materials from the research team. Most teens were not cognizant of SPARK but willing to continue participation once made aware.

In the realm of psychology and related fields, like school psychology, obtaining informed consent from clients or participants who are 18 years old or older is mandatory for researchers. However, if the individuals are below 18 years old or under a conservatorship, their assent is crucial even if their parent or legal guardian has provided formal consent. Despite the widespread recognition of the importance of assent during research, there is a lack of research and guidelines on how to obtain it effectively. To bridge this gap, we conducted a review and created a summary of research published in school psychology journals on gaining assent during research studies. The articles were categorized based on the experimental design, population, and level of assent described. Our findings offer a comprehensive overview of the current state of research on gaining assent in school psychology, which will enhance transparency in research methods.

The management of human fetal and embryological collections presents an ethical challenge that can be explored from different perspectives, particularly when considering informed consent. The "micro ethics" level focuses on parties engaged in giving and receiving human tissue while the "macro ethics" level focusses on the collective responsibility of the discipline and society. Additionally, adopting a framework, where ways of working are designed with relevant communities, requires understanding the perspectives of individuals, communities, and organizations. The aim of this study therefore was to assess the perceptions of education-focused Australian stakeholders. A survey collected the perspectives of 198 participants. The majority of participants (61.6%; n = 122/198) indicated that human fetal and embryological remains obtained prior to era of informed consent should be retained for use in education/research. It is likely that their perspective is based on the notion that if human fetal and embryological collections are used for good, then disposing of them would deny this benefit. Women (p < 0.001) indicated a preference for obtaining fetuses and embryos with informed consent for education and research (38.4%; n = 76/198). Majority were in favor of recording both maternal (MI) (59.6%; n = 118/198) and paternal information (PI) (58.1%; n = 115/198) with each donation. Majority (56.1%; n = 111/198) expressed that donations should be accepted from both parental sources. Consideration of stakeholder perspectives is important in developing guidelines regarding these collections. The results from this study demonstrate a level of discomfort with respect to collections without informed consent, which should be considered at the macro ethical and micro ethical level.

Background: People with severe to profound intellectual disabilities experience similar or higher levels of depression than those with more mild intellectual disabilities. Yet, there is an absence of evidence about how to adapt existing psychological therapies for this population. Method: A behavioural activation intervention (BeatIt) for people with mild to moderate intellectual disabilities was adapted for people with severe to profound intellectual disabilities and depression. Key considerations include: (i) beginning with a more in-depth assessment process; (ii) including the person in session activities and developing a relationship with them; (iii) formulation and the use of film to document the link between activity and mood; and (iv) addressing barriers to change at an individual and inter-personal level and considering how the carer could support the person's engagement in activity. Results: Successfully adapting BeatIt represents a first step towards gathering evidence about the effectiveness of behavioural activation for people with severe to profound intellectual disabilities.

There has been a paucity of literature discussing how to address consent procedures as part of ethics, practitioner development, and best practice in applied sport psychology. Several researchers have addressed ethical challenges (e.g., out-of-session contact, overidentification, time, and space). However, none have substantially considered the sport-specific issues related to consent, which sits at the heart of best practice. The scarcity of discussing consent is limiting sport psychology's potential to establish itself as a more recognized profession. This article highlights some contextual issues that challenge the idea and efficacy of informed consent. It proposes adapting consent procedures in the collaboration between sport psychology practitioners and clients to better address the current contextual challenges in applied sport psychology. In doing so, the current paper introduces Empowered Consent, which is specifically designed to empower athletes and address challenges related to choosing interventions, contractual obligations, visibility in the environment, and staff trying to gain insights into confidential information. The author offers a model to enhance applied practice for those collaborating with athletes and other clients in sport. [ABSTRACT FROM AUTHOR]

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 patients 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 systems 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.

BACKGROUND: Persons who speak languages other than English are underrepresented in clinical trials, likely in part because of inadequate multilevel resources. We conducted a survey of institutions affiliated with the Childrens Oncology Group (COG) to characterize current research recruitment practices and resources regarding translation and interpretation services. METHODS: In October 2022, a 20-item survey was distributed electronically to institutions affiliated with COG to assess consent practices and resources for recruiting participants who speak languages other than English to COG trials. Descriptive statistics were used to summarize responses; responses were compared by institution size and type as well as respondent role. RESULTS: The survey was sent to 230 institutions, and the response rate was 60% (n = 139). In total, 60% (n = 83) of those respondents had access to short-form consent forms. Full consent form translation was required at 50% of institutions, and 12% of institutional review boards restricted use of centrally translated consent forms. Forty-six percent (n = 64) of institutions reported insufficient funding to support translation costs; 19% (n = 26) had access to no-cost translation services. Forty-four percent (n = 61) were required to use in-person interpreters for consent discussions; the most frequently cited barrier (56%) to obtaining consent was lack of available in-person interpreters. Forty-seven percent (n = 65) reported that recruiting persons who speak languages other than English to clinical trials was somewhat or very difficult. CONCLUSIONS: Institutions affiliated with COG face resource-specific challenges that impede recruitment of participants who speak languages other than English for clinical trials. These findings indicate an urgent need to identify strategies aimed at reducing recruitment barriers to ensure equitable access to clinical trials.

INTRODUCTION: Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence. METHODS: We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexicos cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations. RESULTS: The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care. CONCLUSION: While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.

Somatic gene therapy will be one of the most exciting practices of genetic medicine in Africa and is primed to offer a new life for persons living with sickle cell disease (SCD). Recently, successful gene therapy trials for SCD in the USA have sparked a ray of hope within the SCD community in Africa. However, the high cost, estimated to exceed 1.5 million USD, continues to be a major concern for many stakeholders. While affordability is a key global health equity consideration, it is equally important to reflect on other ethical, legal and social issues (ELSIs) that may impact the responsible implementation of gene therapy for SCD in Africa. These include informed consent comprehension, risk of therapeutic misestimation and optimistic bias; priorities for SCD therapy trials; dearth of ethical and regulatory oversight for gene therapy in many African countries; identifying a favourable risk-benefit ratio; criteria for the selection of trial participants; decisional conflict in consent; standards of care; bounded justice; and genetic tourism. Given these ELSIs, we suggest that researchers, pharma, funders, global health agencies, ethics committees, science councils and SCD patient support/advocacy groups should work together to co-develop: (1) patient-centric governance for gene therapy in Africa, (2) public engagement and education materials, and (3) decision making toolkits for trial participants. It is also critical to establish harmonised ethical and regulatory frameworks for gene therapy in Africa, and for global health agencies to accelerate access to basic care for SCD in Africa, while simultaneously strengthening capacity for gene therapy.

OBJECTIVE: We implemented a chatbot consent tool to shift the time burden from study staff in support of a national genomics research study. MATERIALS AND METHODS: We created an Institutional Review Board-approved script for automated chat-based consent. We compared data from prospective participants who used the tool or had traditional consent conversations with study staff. RESULTS: Chat-based consent, completed on a users schedule, was shorter than the traditional conversation. This did not lead to a significant change in affirmative consents. Within affirmative consents and declines, more prospective participants completed the chat-based process. A quiz to assess chat-based consent user understanding had a high pass rate with no reported negative experiences. CONCLUSION: Our report shows that a structured script can convey important information while realizing the benefits of automation and burden shifting. Analysis suggests that it may be advantageous to use chatbots to scale this rate-limiting step in large research projects.

New treatment modalities for mental illness are deeply needed, and emerging therapeutic agents such as psychedelics, ketamine, and neuromodulatory technologies have been welcomed by many researchers and patients. These treatment approaches have also been observed to raise novel ethical questions, and to pose new and different versions of familiar ethical questions in clinical treatment and research. We present an overview and introduction to these issues organized around three specific domains of ethical concern: informed consent, the role of expectancy in clinical response, and distributive justice.

Background: To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies. Methods: Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes. Results: Review identified 30 relevant studies. We identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies. Conclusions: This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies. Trial Registration: This trial was not registered as scoping reviews can not be registered as per updated PROSPERO guidelines. [ABSTRACT FROM AUTHOR]

Background: Informed consent is considered to be the standard method for respecting the autonomy of individual participants in research and practices and is thought to be based on several conditions: (1) providing information on the purpose of the research or a specific treatment, what it will entail, (2) the participants being mentally competent to understand the information and weigh it in the balance, and (3) the participants to be free from coercion. While there are studies of informed consent in other countries, especially Low and Middle Income Countries (LMICs), this study explored the experiences of clinicians regarding the process of obtaining informed consent to participate in a Randomised Controlled Trial (RCT) in particular and treatment in general in healthcare settings, both general and mental health, specifically focusing on the tension between individualistic concept of autonomy and collectivist values in cultures such as Pakistan. Methods: Qualitative interviews with 20 clinicians from healthcare settings in Pakistan who also served as recruiters in a suicide prevention RCT in Pakistan. The interviews were guided by semi-structured topic guide. All interviews were audio-recorded and transcribed verbatim. Results: The interviews revealed that shared decision making was more morally important than individual autonomy, the role of the family played a dominant part in the consent-taking procedure, the decision of the elder and/or family patriarch took prominence, and that clinician-researchers encountered significant challenges in consent process in Pakistan, while recruiting patients into the trial as well as during routine treatment processes in healthcare settings. Four distinct themes emerged which were (1) Family deciding for patients, (2) Benefits of involving family in consent process, (3) Gender disparity in consent process, (4) Challenges experienced by clinician-researchers during consent process in Pakistan. Conclusions: The concept of consent is generally considered important in many cultures, however, there are two strands of understanding. There seems to be consensus that participant agreement is necessary to protect the participant but with regards to autonomy there are significant cultural differences whether it is the right for autonomy of the individual (individualistic concept) or family, community, or expert authority in other cultures. In Pakistan clinician-researchers sometimes preferred one approach and sometimes the other as they appreciated the interests of the patient to be. [ABSTRACT FROM AUTHOR]

We report on an experiment in a supplemental web survey as part of a longitudinal study in the United Kingdom where we ask survey respondents to consent to two forms of data linkage to health records and to consent to be mailed a serology kit. We varied the placement (early, early in context, or late in the survey) and order (linkage first or serology first) of the consent requests. We also examine reasons for consent or non-consent. We find that order of the requests does not make much difference, but making the requests early in the survey significantly increases consent rates over asking them after a series of content-related questions (by 3.4 percentage points) or later in the survey (by 7.2 percentage points). This is consistent with previous research showing that early requests for consent in a survey have a positive effect. The main reason chosen for not consenting related to the personal nature of the information requested. [ABSTRACT FROM AUTHOR]

To maximize the value of the data while minimizing respondent burden, survey data are increasingly linked to administrative records. Record linkage often requires the informed consent of survey respondents and failure to obtain consent reduces sample size and may lead to selection bias. Relatively little is known about how best to word and format consent requests in surveys. We conducted a series of experiments in a probability household panel and an online access panel to understand how various features of the design of the consent request can affect informed consent. We experimentally varied: (i) the readability of the consent request, (ii) placement of the consent request in the survey, (iii) consent as default versus the standard opt-in consent question, (iv) offering additional information, and (v) a priming treatment focusing on trust in the data holder. For each experiment, we examine the effects of the treatments on consent rates, objective understanding of the consent request (measured with knowledge test questions), subjective understanding (how well the respondent felt they understood the request), confidence in their decision, response times, and whether they read any of the additional information materials. We find that the default wording and offering additional information do not increase consent rates. Improving the readability of the consent question increases objective understanding but does not increase the consent rate. However, asking for consent early in the survey and priming respondents to consider their trust in the administrative data holder both increase consent rates without negatively affecting understanding of the request. [ABSTRACT FROM AUTHOR]

The recent pandemic spurred interest in innovative design for clinical trials. In particular, constraints on the public's ability to gather led to an increase in remote or decentralized clinical trials (DCTs). DCTs present an opportunity to extend the benefits of research to underserved populations, decrease burdens, increase access to trials, and fill knowledge gaps surrounding rare conditions, though they are not without their own unique challenges and risks. These risks are far from irremediable, and the advantages are significant enough to merit attention. There is a scientific and moral case to increase the use of DCTs beyond the context of public health emergencies. [ABSTRACT FROM AUTHOR]

AbstractParticipation in research is supposed to be voluntary and informed. Yet it is difficult to ensure people are adequately informed about the potential uses of their biological materials when they donate samples for future research. We propose a novel consent framework which we call “demonstrated consent” that leverages blockchain technology and generative AI to address this problem. In a demonstrated consent model, each donated sample is associated with a unique non-fungible token (NFT) on a blockchain, which records in its metadata information about the planned and past uses of the sample in research, and is updated with each use of the sample. This information is accessible to a large language model (LLM) customized to present this information in an understandable and interactive manner. Thus, our model uses blockchain and generative AI technologies to track, make available, and explain information regarding planned and past uses of donated samples. [ABSTRACT FROM AUTHOR]

AbstractBackgroundMethodsMain resultsAuthors’ conclusionsThe informed consent process in neurosurgery aims to support patient autonomy and provide comprehensive information for decision-making. However, gaps in communication and understanding between patients and surgeons persist, that need to be addressed. This systematic review examined the interventions and strategies which to enhance the process of consent in neurosurgery.A comprehensive search of databases and relevant sources to identify relevant studies for inclusion. Systematic review of prospective and retrospective studies that assess the effect of interventions which improve the consent process. Data collection and analysis involved independent reviewers assessing eligibility, study quality, and risk of bias. Findings from the included studies were used to write the review.The reviewed identified seven studies notably revealed an educational and interactive consent process involving strategies like booklets, videos, multiple interviews, and interactive websites showed improvements in patient knowledge. Recall of risks decreased over time, and factors like age, education, and timing of consent influenced recall.To maximise informed consent, neurosurgeons should consider various strategies. Tailoring communication-based on patient’s health literacy and treatment knowledge, involving their support system, and using a bullet-point consent form is essential. Utilising multiple modalities like verbal, static, and dynamic visuals improve information retention. Creative and memorable visual aids enhance comprehension. Allowing time for questions and team approach is superior. [ABSTRACT FROM AUTHOR]

Purpose: Access to high-quality and comprehensible patient information is crucial. However, information provided by increasingly prevalent Artificial Intelligence tools has not been thoroughly investigated. This study assesses the quality and readability of information from ChatGPT regarding three index ENT operations: tonsillectomy, adenoidectomy, and grommets. Methods: We asked ChatGPT standard and simplified questions. Readability was calculated using Flesch-Kincaid Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Gunning Fog Index (GFI) and Simple Measure of Gobbledygook (SMOG) scores. We assessed quality using the DISCERN instrument and compared these with ENT UK patient leaflets. Results: ChatGPT readability was poor, with mean FRES of 38.9 and 55.1 pre- and post-simplification, respectively. Simplified information from ChatGPT was 43.6% more readable (FRES) but scored 11.6% lower for quality. ENT UK patient information readability and quality was consistently higher. Conclusions: ChatGPT can simplify information at the expense of quality, resulting in shorter answers with important omissions. Limitations in knowledge and insight curb its reliability for healthcare information. Patients should use reputable sources from professional organisations alongside clear communication with their clinicians for well-informed consent and making decisions. [ABSTRACT FROM AUTHOR]

Hendricks' pregnancy rescue case (PRC) tries to show that abortion is typically morally wrong. I argue here that there are at least two morally relevant differences between the abortion in PRC and the typical abortion so that the latter isn't morally wrong even if the former is morally wrong. I develop five modifications to PRC to show that these two differences are morally important. First, in PRC we don't know whether the person gives informed consent to the abortion, nor does the medical professional who will perform the abortion, and so the abortion can't be performed because the patient gives informed consent to it. Second, not preventing the death of the fetus in PRC brings about the death of an additional fetus gestating in a separate pregnant person, whereas most abortions don't entail the termination of another's pregnancy. [ABSTRACT FROM AUTHOR]

Under-awareness of Interventional Radiology (IR) care by the public has been reported. The aim of this study is to evaluate the impact of educational videos to facilitate better patient understanding during the informed consent process. Educational videos for six common IR procedures including chemoembolization, radioembolization, ablation, tunneled central venous catheter placement, port placement, and port removal were developed for educating patients in the pre-procedural setting. One hundred and eighty patients referred to a tertiary academic institution were randomly selected to participate, including 30 patients per procedure type. Anonymous seven question, five-point Likert-scale assessments were administered to the participants before and after engaging with the videos. The survey evaluated patients' perceived understanding of IR procedures and satisfaction with the videos as educational tools. One hundred and eighty patients completed the survey. Comparing post-video to pre-video ratings, there was an increase in patients' understanding of the involved anatomy (4.5 vs 3.3; p < 0.01), understanding of procedure benefits (4.6 vs 3.7; p < 0.01), understanding of procedural risks (4.5 vs 3.3; p < 0.01), understanding of procedural alternatives (3.4 vs 2.7; p < 0.01), and overall procedural understanding (4.7 vs 3.4; p < 0.01). Additionally, patients had a positive impression of the videos with a mean overall satisfaction rating of the video-assisted explanation of 4.80. A patient-centric video-assisted informed consent for IR procedures enhances patients' understanding and results in high patient satisfaction. [ABSTRACT FROM AUTHOR]

Capitalising on the hype surrounding regenerative medicine, there are clinics worldwide marketing unproven stem cell-based therapies to patients. Some patients have travelled overseas to access treatments they believe are safe and effective. This practice, known as stem cell tourism, could result in adverse effects in some patients. This paper seeks to examine how the industry could threaten the validity of the patient's informed consent. The vulnerable groups include adults, minors and incompetent patients. Since patients are exposed to exaggerated claims and inaccurate information, this article argues that each cohort may not truly consent to such therapies. While each group hopes to obtain a miracle cure, the reality is that these purported medical treatments may not enable patients to give their informed consent, which thereby inhibits good decision-making. Accordingly, states could restrict patients’ access to unproven stem cell-based therapies to control the problem. This paper illustrates how the regulatory framework in countries such as Australia and the United States (U.S.) has allowed the industry to thrive. Recommendations on how states can take a restrictive stance against this complex phenomenon are proposed. [ABSTRACT FROM AUTHOR]

Informed consent is a cornerstone of ethical medical practice, particularly in obstetrics where procedures like labor induction carry significant risks and require clear patient understanding. Despite legal mandates for patient materials to be accessible, many consent forms remain too complex, resulting in patient confusion and dissatisfaction. This study explores the use of Generative Artificial Intelligence (GAI) to simplify informed consent for labor induction with oxytocin, ensuring content is both medically accurate and comprehensible at an 8th-grade readability level. GAI-generated consent forms streamline the process, automatically tailoring content to meet readability standards while retaining essential details such as the procedure’s nature, risks, benefits, and alternatives. Through iterative prompts and expert refinement, the AI produces clear, patient-friendly language that bridges the gap between medical jargon and patient comprehension. Flesch Reading Ease scores show improved readability, meeting recommended levels for health literacy. GAI has the potential to revolutionize healthcare communication by enhancing patient understanding, promoting shared decision-making, and improving satisfaction with the consent process. However, human oversight remains critical to ensure that AI-generated content adheres to legal and ethical standards. This case study demonstrates that GAI can be an effective tool in creating accessible, standardized, yet personalized consent documents, contributing to better-informed patients and potentially reducing malpractice claims. [ABSTRACT FROM AUTHOR]

Background: In Europe and elsewhere in the world, activities are taking place to improve the awareness of children and adolescents (hereinafter: adolescents) regarding their rights and obligations in autonomous decision-making about their own medical treatment and participation in clinical research. Methods: The cross-sectional survey of adolescents was carried out using an anonymous online questionnaire. We obtained consent from the Commission of the Republic of Slovenia for Medical Ethics. Participating young people were invited through the network of primary and secondary schools, the Society of Dystrophy of Slovenia and through the dissemination of electronic messages. The online questionnaire was open from April 25 to May 6, 2023. Young people aged 13 to 20 joined the survey. The association between several factors and awareness of the minimum age limit was tested by univariate logistic regression. All statistical testing was performed at a significance level of 0.05. Results: The responses of 458 respondents were analysed, of which 281 were male. Only 8.3% of participating adolescents knew the age limit set by law for autonomous decision-making about medical treatment at 15 years old. Most answered that a medical institution should inform them about their rights (62.4%). Only 5.02% responded that they do not need their parents' consent when making decisions; 2.6% of respondents answered that they autonomously decided to undergo treatment without their parents' knowledge. The majority obtained information about treatment from a doctor (more than 70%); 42.8% were in favour of new forms of treatment, especially chronic patients (more than 70%); 44.8% had already heard about clinical research, most of them through the media (55.4%); 70% of the respondents answered correctly about making an autonomous decision about participation in research at the age of 18. About three-quarters (75.6%) of respondents who had heard of clinical research believe that an individual should be paid for participating. Conclusions: Our research showed insufficient awareness of the age limit of adolescents regarding medical treatment decisions and clinical research. The prevailing view is that health professionals should inform young people more about their rights. Most adolescents believe they should be paid to participate in clinical research. [ABSTRACT FROM AUTHOR]

Simple Summary: Our research addresses the challenges in informed consent in postoperative radiotherapy for breast cancer. Traditional consent processes often rely on verbal explanations of sometimes complicated treatment options, which can overwhelm patients and lead to misunderstandings. To improve this fundamental process, we developed an educational video using a modified Delphi method, incorporating input from experts and former patients to ensure comprehensive and patient-friendly content. With our study, we demonstrated that this video, if viewed by breast cancer patients prior to their subsequent verbal consultation, can significantly improve patients' understanding and speed up the informed consent process without compromising patients' satisfaction. To conclude, this innovation supports a more comprehensive and efficient informed consent process, which is in line with evolving healthcare practices that prioritise patient engagement and education. Background/Objectives: Informed consent is crucial in medical practice, especially for complex treatments such as postoperative radiotherapy for patients with breast cancer. Conventional consent procedures are often based on verbal declarations with a highly condensed but nevertheless large amount of information, which can exceed the recording capacity of patients and lead to misunderstandings. The aim of this study was to develop and test an educational video on breast cancer patients to enhance the informed consent process by improving patients' understanding and reducing the duration of the subsequent consultation. Methods: The educational video was created after the underlying content was determined by a modified Delphi method in which a panellist of radiation oncologists, nurses, radiation therapists, and former patients participated in successive rounds of topic scoring. After achieving content consent, the video included 19 items to cover key aspects of postoperative radiotherapy in a patient-friendly manner. Fifty breast cancer patients scheduled for postoperative radiotherapy were randomised to watch the video prior to their verbal consultation (n = 25) or to the control group participating in the traditional informed consent process only (n = 25). The duration of the informed consent processes in both arms was recorded. To assess the educational effect of the video, a multiple-choice test was created. In addition, patients' satisfaction was recorded using a separate questionnaire. Both questionnaires were completed by the patients one to two hours after signing the consent form. Results: The patients in the video group evidenced significantly higher knowledge scores than those who received standard verbal explanations (median number of correct answers 9 vs. 8 out of 10, p = 0.0039). The whole informed consent process was also completed faster in the video group (mean duration 34.7 vs. 46.2 min, p < 0.001). Median satisfaction scores were high in both groups (34 vs. 33 out of 35 points), with no significant differences observed (p > 0.05). Conclusion: The educational video effectively improved patient understanding and streamlined the informed consent process without compromising patients' satisfaction. This approach also helps to standardise the delivery of complex medical information, and it can also be adapted to improve the informed consent process for other cancer treatments. [ABSTRACT FROM AUTHOR]