To learn what mothers know on newborn bloodspot screening (NBS), the procedure, and sources used, a pilot study was performed. An online questionnaire was developed, with a first part fo-cused on characteristics and the NBS procedure, a second on knowledge, information sources, and health care providers (HCP). This questionnaire was accessible until 200 answers were received. Characteristics of respondents were representative for the population. Mothers recalled verbal consent in 69.5%, 12.5% did not, 18% stated that no consent was requested. The ‘knowledge’ part contained 12 closed questions, 5 multiple-choice questions on sources, and assessment (5-point Likert) of the information transfer. The mean knowledge level was 7.2/12. Screening concepts (consequences, likelihood, sensitivity, carrier) and absence of notification of normal findings were well known. The fact that NBS is not compulsory and post-analysis sample handling were poorly known. Key HCPs were midwifes (80.5%) and nurses (38.5%). When the leaflet (44%) was pro-vided, the majority read it. Mean Likert scores were 3.36, 3.38, 3.11 and 3.35 (clarity, timing ap-propriateness, sufficiency, usefulness). The knowledge level and consent practices were reasonable well. Key HCP were midwives and nurses, leaflets were supporting. This should enable a quality improvement program to a sustainable NBS program in Flanders.

Background: Mental capacity is a fundamental aspect that enables patients to fully par-ticipate in various healthcare procedures. To assist healthcare professionals (HCPs) in assessing patients' capacity, especially in the mental health field, several standardized tools have been developed. These tools include the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), and the Competence Assessment Tool for Psychiatric Advance Directives (CAT-PAD). The core dimensions explored by these tools include Understanding, Appreciation, Reasoning, and Expression of a choice. Objective: This meta-analysis aimed to investigate potential differences in deci-sion-making capacity within the healthcare context among groups of patients with bi-polar disorder (BD) and schizophrenia spectrum disorder (SSD). Methods: A systematic search was conducted on Medline/Pubmed, and Scopus. Addi-tionally, Google Scholar was manually inspected, and a manual search of emerging re-views and reference lists of the retrieved papers was performed. Eligible studies were specifically cross-sectional, utilizing standardized assessment tools, and involving pa-tients diagnosed with BD and SSD. Data from the studies were independently extracted and pooled using random-effect models. Hedges g was used as a measure for outcomes. Results: Six studies were identified, with three studies using the MacCAT-CR, two studies the MacCAT-T, and one the CAT-PAD. The participants included 189 individuals with BD and 324 individuals with SSD. The meta-analysis revealed that patients with BD performed slightly better, and the difference was statistically significant, compared to patients with SSD, particularly in the domain of Appreciation (ES=0.23, 95% CI: 0.01 to 0.04, p=0.037). There was no statistically significant difference between the two groups for Understanding (ES=0.09, 95% CI: - 0.10 to 0.27, p=0.352), Reasoning (ES=0.18, 95% CI: - 0.12 to 0.47, p=0.074), and Expression of a choice (ES = 0.23, 95% CI: - 0.01 to 0.48, p=0.60). In the sensitivity analysis, furthermore, when considering only studies involving patients in symptomatic remission, the difference for Appreciation also resulted in non-significant (ES=0.21, 95% CI: -0.04 to 0.46, p=0.102). (ES=0.21, 95% CI: -0.04 to 0.46, p=0.102). Conclusions: These findings indicate that there are no significant differences between patients with BD and SSD during remission phases, while differences are minimal during acute phases. The usefulness of standardized assessment of capacity at any stage of the illness should be considered, both for diagnostic-therapeutic phases and for research and advance directives. Further studies are necessary to understand the reasons for the overlap in capacity between the two diagnostic categories compared in this study.

Introduction: The aim of this study was to prospectively evaluate parents’/guardians’ late recall of surgical procedures and risks of elective surgery after pre-operative interview with surgeons. Materials and Methods: All parents/guardians of patients <18 years of age undergoing elective procedures from January 15th to September 1st, 2022, were prospectively enrolled in the study. Before discharge, parents/guardians were asked to complete a questionnaire regarding the duration of the consent procedure, duration of the interview, quality of the informative handouts, and their ability to recall the type of disease, type of surgical procedure, and surgical risks. Answers were graded from 1 to 4. Results: One hundred and two questionnaires were returned. In all cases, informed consent was obtained between 24 and 72 hours prior to surgery. The following responses were collected: 98/102 (96%) parents/guardians reported that the duration of the consent process was adequate; 95/102 (93%) reported that the handouts were fully informative, and 7/102 (7%) reported that they were partially informative regarding explanation of the disease and surgical procedure; regarding complications, 93/102 (91%) perceived the handouts to be fully/partially informative, while 4/102 (4%) perceived the handouts to be poorly/non-informative, and 5/102 (5%) did not provide a response; 94/102 (92%) stated that they remembered the pathology, but only 87/94 (93%) recalled it correctly; 90/102 (88%) stated that they remembered the type of procedure, but only 76/90 (84%) recalled it correctly; and 53/102 (52%) stated that they remembered the surgical risks, but only 20/53 (38%) could recall more than one complication. Conclusions: Late recall of surgical complications by parents was poor despite the high perceived quality of the surgical risk handouts and medical interview.

Community peer review is a method that extends the ethics of consent into scientific practices. It gives communities affected by scientific research the ability to determine whether research may cause them harm and be part of determining how knowledge should best circulate to reduce or eliminate that harm. This paper introduces the method of community peer review by first looking at the concepts of consent and refusal, then outlining the steps to community peer review, using a case study of community meetings on a study of plastic ingestion by fish to elucidate the details of each step. Steps include: hiring a community member to the team; researching the social, cultural, and economic contexts of the community; identify the community; ensure skills for community conversation are in place; call the community meeting; conduct the community meeting; and analyze feedback for consent and refusal. Community peer review is premised on the idea that research is not inherently good and can cause harm, and that the best people to know whether and what kinds of harms are likely to occur are community members rather than researchers. The second premise is that the researcher’s “right” to research never supersedes a community’s right to not be harmed.

The 2020 revision of South Korea’s Personal Information Protection Act (PIPA) updated procedures for the use of medical data for research. The PIPA provision allowing “pseudonymized information” to be used without the consent of the data subject for scientific research introduced ambiguity regarding the applicability of the PIPA versus the Bioethics and Safety Act (BSA), which allows “anonymized information” to be used for research only after data-subject consent and IRB approval for human-subject research are obtained. The main points requiring clarification include the distinction between “human-subject” and “scientific” research, the definition of anonymization and pseudonymization, the requirements for data-subject consent, and the procedures for institutional review boards (IRBs) and data review boards (DRBs). After reviewing the legal concepts and processes, this article recommends clarification of the guidelines for the use of medical data in research by distinguishing the concept and, in the long run, categorizing medical data based on the degree of risk.

Personal Information Management Systems (PIMS) are acquiring a prominent role in the data economy by promoting services that help individuals to have more control over the processing of their personal data, in line with the European data protection law. One of the highlighted solutions in this area is Solid, a new protocol that is decentralizing the storage of data, through the usage of interoperable Web standards and semantic vocabularies, to empower its users to have more control over the processing of data by agents and applications. However, to fulfill this vision and gather widespread adoption, Solid needs to be aligned with the law governing the processing of personal data in Europe, the main piece of legislation being the General Data Protection Regulation (GDPR). To assist with this process, we analyze the current efforts to introduce a policy layer in the Solid ecosystem, in particular, related to the challenge of obtaining consent for processing personal data, focusing on the GDPR. Furthermore, we investigate if, in the context of using personal data for biomedical research, consent can be expressed in advance, discuss the conditions for valid consent and how it can be obtained in this decentralized setting, namely through the matching of privacy preferences, set by the user, with requests for data and whether this can signify informed consent. Finally, we discuss the technical challenges of an implementation that caters to the previously-identified legal requirements.

Men are perceived as significant barriers to the uptake of contraception in some communities, and lack of spousal communication regarding contraception is evident in some studies conducted in South-West and Northern Nigeria. The objective is to identify and discuss how husband consent to family planning (FP) and spousal communication influence family planning use among peri-urban dwellers in Nigeria. The study was limited to the primary dataset collected among young mothers that resides in peri-urban between the age of 15-30 years in South West, Nigeria. The result showed that the use of family planning was high among the respondents whose husband give consent to the use of family planning, and respondents who had appropriate spousal communication. Similarly, respondents whose spouse asks questions or whose husband advises on communication are likely to use FP. On the other hand, respondents whose husband didn’t give consent, respondents with inappropriate communication with the spouse, respondents whose spouses didn’t give advice, and those whose spouses didn’t ask questions are less likely to use FP.

Heritage conservation area designation is often resisted by communities due to concerns with overly strict regulations for property alterations and negative impacts on property values. This paper addresses these concerns by examining Freemans Bay and Onehunga – two Special Character Areas (SCAs) in Auckland, New Zealand. A property value analysis was used to assess the impact of SCA designation on property values and an online questionnaire survey gathered information on homeowners’ experiences and levels of satisfaction with living in an SCA. The results indicate that designated SCA properties have higher average values than non-designated properties and homeowners are overwhelmingly satisfied with living in a SCA. The main benefits are a sense of community and having certainty around the look and feel of their neighbourhood into the future. The main issue identified by respondents is the requirement for Resource Consent. The majority of people who had gone through the process found it to be a negative experience because of the high cost in terms of time and money. A historic urban landscape approach to the development of management plans and design guidelines is recommended to improve the implementation of the Special Character Areas in Auckland and beyond.

Aim: The overall aim of the study was to assess the reasons and experiences of participants involved in Antibody Mediated Prevention (AMP) HIV prevention clinical trial at University of North Carolina (UNC) Project, Lilongwe, Malawi. We determined the participants’ reasons for participating in HIV Prevention clinical trials; and the experiences of participants in HIV Prevention clinical trials. Methods: We adopted the qualitative cross-sectional study method. Data were collected using in-depth interviews (IDIs). Purposive sampling was used to select 12 study participants who consented to take part in the study. All participants were the ones taking part in the AMP HIV prevention study at the UNC Project. Data analysis was done concurrently with data collection using content analysis. Results: Individuals were motivated to participate in HIV research due to a range of perceived benefits. These included personal, health, and financial benefits. Participants' research experiences and their continued participation in HIV research were influenced by the research clinic context and the nature of their interactions with research staff. Conclusion: When the clinical trial study participants’ expectations are met through what they experience in the study, the chances of them adhering to the study visits and procedures are high. Even for those who did not have any expectations prior to the study, feeling welcomed and being able to open up to the study staff encouraged their continued participation. In the end, this outweighed the negative comments made by the people in their communities or their friends

From 2008 to 2024, the Newborn Screening Translational Research Network (NBSTRN), part of the National Institute of Child Health and Human Development (NICHD) Hunter Kelly Newborn Screening Program, served as a robust infrastructure to facilitate groundbreaking research in newborn screening (NBS), rare disease, and genomics. Over fifteen years, NBSTRN developed into a significant international network, supporting innovative research on novel technologies to screen, diagnose, treat, manage, and understand the natural history of more than 280 rare diseases. A key component of these efforts has been the development of resources and expertise for the newborn screening community in ethical, legal, and social issues (ELSI). This paper presents findings from a survey conducted by the NBSTRN team with input from one of theNBSTRN's expert workgroups, the Bioethics and Legal Workgroup. With responses from 88 members of the NBS community including researchers and state NBS programs, the survey found that individuals rely on internal and collegial ELSI resources and highlighted a substantial demand for structured, accessible training and resources. The survey’s insights emphasize the importance of privacy and informed consent in NBS research, and suggested a need for improved collaborative tools and educational programs focused on ELSI for the NBS community. The survey results may inform future efforts in ELSI and NBS research including the development of expanded ELSI tools that leverage digital platforms and consultative services.

Public trust in science was tested and relied on during the SARS-CoV-2 pandemic, which has shaped global events since the WHO declaration in March 11, 2020. Public trust has been impacted through the government recommendations and mandates informed by public health guidance, including non-pharmaceutical and pharmaceutical interventions. The free-flow of ideas and in-formation so essential to the functioning of science has faced unprecedented challenge from widespread censorship in both the media and in scientific journals. This has created a poisoned environment for the building of trust between science and society. Scientific norms and ac-countability must be restored in order to rebuild the vital relationship between scientists and the public they serve.

Child and adolescent sexual abuse (CSA) is an international public health problem. Despite the importance of the CSA, there is no consensus definition, and the lack of consensus is related to difficulties in conducting prevalence studies, as well as research in other areas. To establish a consensual definition, legal aspects such as the age of sexual consent and the difference in age or power between victim and aggressor, aspects related to sexual freedom and sexual indemnity must be considered. Therefore, the main goal of this research was to analyze the age of sexual consent in the legal systems of Spanish-speaking countries and to examine whether the Romeo and Juliet clause is established. To achieve the proposed aims, we employed the legal interpretation method, and we analyzed the current Criminal Codes of the 21 Spanish-speaking countries. From the results, it is found that the age of sexual consent varies between countries, establishing valid sexual consent between 13 and 18 years. In addition, only six countries have the Romeo and Juliet clause that protects sexual freedom in adolescents. Finally, we discussed the lack of consensus on the age of sexual consent and the limitations presented by the Romeo and Juliet clause.

All humans will experience the process of birth, old age, illness, and death. However, when faced with life-sustaining decisions, the families of patients are often faced with medical decisions as surrogates. In recent years, the families of patients have started to value the importance of the right to palliative care, although this often requires lengthy discussions. Therefore, this study explored the predictability of factors that affect the feeling experienced by patients’ families when signing Do-Not-Resuscitate Consent. This study used a cross-sectional study and interviewed 90 family members using a structural questionnaire. The study hypotheses were tested using a t-test, one-way analysis of variance, product–moment correlation, and hierarchical regression analysis. Attribute variables of family members, such as gender and whether they live with the patient, are predictors that affect the family member’s feeling experience when signing Do-Not-Resuscitate Consent. The emotional support from medical professionals to family members helps the family member to express their negative feelings on signing Do-Not-Resuscitate Consent; more informational support information provided to family members by medical professionals can alleviate negative feelings felt by family members when signing Do-Not-Resuscitate Consent. This study identified that family members’ knowledge about Do-Not-Resuscitate acquired from medical professionals is relatively low. It is suggested that critical care units regularly conduct training on hospice palliative care, implement standard care procedures of hospice palliative care at critical care units, and provide detailed medical information about advanced decisions to family members so as to reduce their emotional stress. This will ensure that intensive care units can also achieve the goal of critically ill hospice palliative care.

This study explores the complexities of risk communication practices in orthodontics, specifically examining the perspectives of orthodontists in Greece and Slovakia. Informed by the foundational importance of effective communication in health sciences, particularly in facilitating valid consent and shared decision-making, this research addresses gaps identified in the literature concerning the consistent communication of potential treatment risks based on demographic and cultural characteristics. The study identifies 15 potential critical risks with orthodontic treatment. These risks include root necrosis; temporary undesired changes to the occlusion; sleep difficulties; not achieving an ideal result; development of black triangles between teeth; taking additional X-rays; speech difficulties; using a protective splint during sports; duration of treatment; number of visits; transmission of infectious diseases; and swallowing orthodontic appliances. The questionnaire, distributed electronically to orthodontists in Greece (n=570) and Slovakia (n=210) from Sept. 2022 to Dec. 2022, aimed to assess risk communication practices, with consideration to country, gender, and degree-related variations. 168 valid questionnaires (91 from Slovakia and 77 from Greece) were obtained indicating significant disparities in the risks emphasized and preferred forms of consent. The Greek orthodontists focused more on the risks involved such as on relapse, root resorption, temporal occlusal changes, and failure of desired movement, while the Slovak practitioners tend to be interested more about sleeping difficulties, temporal occlusal changes and not achieving an ideal result. They also tend to obtain written or digital consent from patients or their parents/guardians more frequently than the Greek team. Male orthodontists discussed specific risks more frequently, including relapse and extractions, whereas females preferred written or digital consent. PhD-trained orthodontists prioritized certain risks, indicating the need for tailored approaches. This study underscores the dynamic nature of risk assessment in orthodontic practice, emphasizing its ethical and strategic dimensions. The findings advocate for tailored risk communication strategies, that recognize individual, contextual, and cultural factors and the need of an orthodontic informed consent protocol for tailored communication approach for patients to elevate the standard of care in European orthodontics. The reliance on digital tools reflects contemporary trends in enhancing patient understanding, thereby supporting ongoing innovation in orthodontic practices.