Requirement For Consent Research Articles

Delivery room dextrose gel for preterm hypoglycaemia (the GEHPPI study): a randomised placebo-controlled trial

ObjectiveEarly hypoglycaemia at the time of neonatal intensive care unit (NICU) admission is common in very/extreme preterm infants. This study aimed to determine whether buccal dextrose gel in the delivery...

Exploring Communication Barriers and Facilitators in School Vaccination: A Case Study in South Eastern Sydney, Australia

Background/Objectives: Given the discrepancies in immunisation coverage, the goal of this study was to explore the barriers and facilitators to effective communication across the school-based vaccination program in South Eastern Sydney schools. Methods: A qualitative study was undertaken with purposively selected immunisation staff, school coordinators, and parents of Year 7 students who had not received two vaccinations (dTpa and HPV) at school. A focus group with immunisation staff and interviews with school coordinators explored the barriers and facilitators to vaccination uptake, including communication across stakeholders. The parent interviews explored attitudes to vaccination and the school program and investigated the program communication methods. Results: Five immunisation staff, eleven school coordinators, and eleven parents participated in the study. The barriers to participation in the school vaccination program included low parent recall of vaccination information, challenges encountered by school staff in consent tracking, no communication channel between health staff and parents, a greater school focus on vaccination facilitation than student education, and limited communication between stakeholders about catch-up vaccinations. The facilitators included established school/parent relationships for vaccine communication, effective communication between health and school staff, and using multiple methods to promote clinic and consent requirements. Conclusions: Opportunities exist to increase program participation by enhancing vaccination information and education for students and parents, with better communication about vaccination catch-ups and consent.

Systematic review of ethical/methodological issues in transgender youth participative research

Abstract Background Understanding the experiences of transgender and gender-diverse (TGD) youth is essential for developing appropriate support services. However, studies focusing on TGD youth under 18 outside clinical settings are scarce, limiting effective support development. The requirement for parental consent in participatory research poses ethical and logistical challenges, impacting the safety, well-being, and privacy of adolescent participants. This dynamic complicates the balance between adolescents’ rights to autonomy and privacy and parental duties to protect their children. This review aims to illuminate the ethical and methodological challenges in participatory research with TGD youth. Methods A systematic review of bibliometric databases from 2006 to 2022 was conducted, focusing on transgender and gender non-conforming identities, adolescence, qualitative and participatory research methods, and consent issues. This review was registered with PROSPERO in November 2022 (CRD42022368360). Results Of 3,794 articles initially identified, 291 met the inclusion criteria, and 48 were extensively reviewed. Research with TGD youth commonly faces ethical tensions including parental inclusion in the consent process, safeguarding participant safety and privacy, ensuring confidentiality, and creating environments that allow TGD youth to express themselves and feel empowered. Methodological challenges include engaging public and stakeholders, recruiting participants, data collection, and maintaining research integrity. Conclusion & Implications The literature on participatory research with young transgender and gender-diverse individuals reveals intricate and often conflicting issues related to consent procedures, power dynamics, and the researcher’s role. These findings are applicable in various legal and geographical contexts, providing insights that can guide practices globally. Key messages • Research reveals ethical dilemmas in participatory research with transgender young people, highlighting difficulties around consent and the need for tailored support. • Understanding the complexities of research ethics enables better support for transgender and gender-diverse young people during research.

Normative Study of Law No. 27 of 2022 on the Protection of Personal Data and its Impact on the Fintech Industry in Indonesia

The enactment of Law No. 27 of 2022 on Personal Data Protection marks a pivotal moment in Indonesia’s regulatory framework, particularly for industries that handle significant amounts of personal data, such as the financial technology (fintech) sector. This study provides a normative juridical analysis of the PDP Law and examines its impact on the fintech industry. The research focuses on the law’s key provisions, including consent requirements, data breach notification, and data security obligations. Additionally, the study explores the operational challenges fintech companies face in complying with the law, such as the costs of compliance, technical requirements, and the need for employee training. While the PDP Law enhances consumer trust by offering greater protection and transparency, it also presents hurdles that fintech firms must overcome to ensure compliance. The analysis concludes with recommendations for fintech companies to balance legal obligations with innovation to maintain competitiveness in Indonesia’s evolving digital economy.

Nature positive infrastructure - habitat connectivity structures, a call to arms

‘Linear infrastructure, including the Strategic Road Network, fragments habitats and landscapes creating impassable barriers for flora and fauna. Where populations of animals can’t move from their home ranges they become isolated and vulnerable to local extinction through disease, extreme events and inbreeding. Isolation of habitats also makes them increasingly vulnerable to extinction from climate change. In the UK habitat connectivity structures that restore species movement and physical connection of habitats, such as green-bridges, mammal tunnels and underpasses are rare. Although, they are becoming increasingly common due to planning consent requirements. Nevertheless, on the 4,500 miles of Strategic Road Infrastructure in England habitat connectivity features are still few and far between. Mass restoration of habitat connectivity across a Strategic Nature Network and using wildlife crossing structures would be transformative for the UK public as well as our ecosystems. The UK is decades behind other nations in the application of habitat defragmentation structures. In the last 15 years the Dutch transport authority have built approximately 70 large green bridges and approximately 200 smaller interventions across its road and rail network, at time of writing National Highways have built 2. Designing and constructing structures for wildlife, as well as people, on a scale that will make meaningful difference to UK nature will require our industry to unite and innovate to deliver a lasting legacy of nature restoration.‘

Roadmap for Linking Registry Data with Health Services Data to Support Evidence-Informed Decision-Making.

ApproachAs part of a learning period to optimize the use of RWE for decision-making for drugs for rare diseases, the [organization name removed to allow for blind review] conducted an environmental scan to map real-world data in patient registries. Over 400 patient registries were identified, signaling the potential wealth of untapped information to support decision-making by linking registry data with health services data. To better understand the challenges faced by registry holders hoping to link registry data with health services data sources available in Canada, a series of interviews were conducted with several Canadian rare disease registries. In addition, a literature review was completed, and Canadian experts in epidemiology, privacy, record linkage, registry science, and health services research were consulted to inform the development of a roadmap to meet various stakeholder needs. ResultsThe resulting roadmap consists of 8 specific steps covering topics related to registry purpose, informed consent, ethical approval, participant privacy, governance, data linkability, participant identifiability and jurisdictional requirements. ConclusionThe roadmap is currently undergoing pilot testing by a pan-Canadian rare disease registry. A final [organization name] report and an accompanying roadmap in a checklist format to facilitate implementation will be finalized, disseminated across key stakeholders, and made publicly available. ImplicationsWhile developed for registries, the roadmap applies to the linkage of clinical trial or cohort study data, or other systematically gathered patient-level data to health services data.

Consent and refusal of procedures during labour and birth: a survey among 11 418 women in the Netherlands

BackgroundInformed consent for medical interventions is ethically and legally required; an important aspect of quality and safety in healthcare; and essential to person-centred care. During labour and birth, respecting consent...

Standardised cookie banner: a solution to the cookie consent problem

ABSTRACT Cookies are an essential part of today's internet. In the EU, the ePrivacy Directive (read with the EU GDPR) requires prior informed consent for using cookies. Usually, websites use cookie banners to meet the informed consent requirement. However, due to a lack of harmonisation of cookie law across the EU, varying cookie guidelines by data protection authorities of different member states, and varying implementation of cookie consent requirements by websites, users face differing cookie banners on different websites. Having to face differing cookie banners requires additional cognitive effort and time to read, understand, evaluate, and select options on each banner. Moreover, the way consent is sought remains deceptive. Websites use dark patterns, vague language, positive framing, and nudging to elicit user consent. This paper proposes standardised cookie banners to solve the various problems with cookie consent banners. The paper suggests that the standardised banner must have standardised timing of display, position on the website, text and language, presentation, consent options, and way of consenting.

Continuous vs Intermittent β-Lactam Antibiotic Infusions in Critically Ill Patients With Sepsis

Whether β-lactam antibiotics administered by continuous compared with intermittent infusion reduces the risk of death in patients with sepsis is uncertain. To evaluate whether continuous vs intermittent infusion of a β-lactam antibiotic (piperacillin-tazobactam or meropenem) results in decreased all-cause mortality at 90 days in critically ill patients with sepsis. An international, open-label, randomized clinical trial conducted in 104 intensive care units (ICUs) in Australia, Belgium, France, Malaysia, New Zealand, Sweden, and the United Kingdom. Recruitment occurred from March 26, 2018, to January 11, 2023, with follow-up completed on April 12, 2023. Participants were critically ill adults (≥18 years) treated with piperacillin-tazobactam or meropenem for sepsis. Eligible patients were randomized to receive an equivalent 24-hour dose of a β-lactam antibiotic by either continuous (n = 3498) or intermittent (n = 3533) infusion for a clinician-determined duration of treatment or until ICU discharge, whichever occurred first. The primary outcome was all-cause mortality within 90 days after randomization. Secondary outcomes were clinical cure up to 14 days after randomization; new acquisition, colonization, or infection with a multiresistant organism or Clostridioides difficile infection up to 14 days after randomization; ICU mortality; and in-hospital mortality. Among 7202 randomized participants, 7031 (mean [SD] age, 59 [16] years; 2423 women [35%]) met consent requirements for inclusion in the primary analysis (97.6%). Within 90 days, 864 of 3474 patients (24.9%) assigned to receive continuous infusion had died compared with 939 of 3507 (26.8%) assigned intermittent infusion (absolute difference, -1.9% [95% CI, -4.9% to 1.1%]; odds ratio, 0.91 [95% CI, 0.81 to 1.01]; P = .08). Clinical cure was higher in the continuous vs intermittent infusion group (1930/3467 [55.7%] and 1744/3491 [50.0%], respectively; absolute difference, 5.7% [95% CI, 2.4% to 9.1%]). Other secondary outcomes were not statistically different. The observed difference in 90-day mortality between continuous vs intermittent infusions of β-lactam antibiotics did not meet statistical significance in the primary analysis. However, the confidence interval around the effect estimate includes the possibility of both no important effect and a clinically important benefit in the use of continuous infusions in this group of patients. ClinicalTrials.gov Identifier: NCT03213990.

POTENTIAL CONFLICTS IN PERSONAL DATA PROTECTION UNDER CURRENT LEGISLATION IN VIETNAM COMPARED WITH EUROPEAN GENERAL DATA PROTECTION REGULATION

Background: Transatlantic data transfers are a critical component of the global digital economy, facilitating commerce and communication among countries worldwide. However, these transfers have been fraught with legal and regulatory challenges, particularly concerning protecting personal data due to the lack of a comprehensive global privacy law. Methods: This comparative, descriptive study exploits secondary resources by comparing and contrasting the principles of the European General Data Protection Regulation and the new Decree on personal data protection in Vietnam to provide deep insights into the differences between them. Results and Conclusions: Although the Decree takes advantage of many of the European General Data Protection Regulation's principles, i.e., the rights of data subjects, consent requirements, and the need for impact assessments, it has its provisions specific to the Vietnamese context, such as the absence of "legitimate interests" as a legal basis for processing and the unique enforcement mechanisms. Despite many similarities, the specific requirements around consent, data subject rights, breach notification, extraterritorial data transfers, and enforcement mechanisms might result in conflicts among these legislative documents. The Decree, which would become more effective, shall rely on its enforcement mechanisms and the ability to impose meaningful sanctions for non-compliance; thus, it should incorporate a more detailed sanctions regime to deter violations effectively.

Outcomes of a universal germline screening program in a community urology practice.

The role of germline genetic testing in urologic oncology has expanded in recent years. However, implementation of genetic testing in community practices remains a challenge, often due to limited access to qualified genetics trained providers. In this study, we report outcomes of a universal germline screening program in a community urology practice. Between November 2021 and September 2022, all patients referred for urology clinic visits at Frederick Health (Frederick, MD, USA) were provided an online genetics screening questionnaire prior to the visit. Responses were compared against National Comprehensive Cancer Network (NCCN) criteria for germline testing. Those who met criteria were provided educational materials at the end of the questionnaire, and then counseled by a trained urologic oncologist (HC) in the clinic or referred to a genetic counselor prior to testing. Testing was performed with a 36-gene pan-cancer panel (CancerNext) or a 14-gene targeted prostate cancer panel (ProstateNext), with or without additional RNA analysis (RNAinsight) (Ambry Genetics, CA, USA). Demographic and clinical parameters, as well as genetic testing results, were retrospectively collected under IRB approval. In the study period, 765 patients were seen over 1370 clinic visits. Of these, 505 patients (66.0%) completed the screening questionnaire. The majority were completed via email (54.5%) with the remainder (45.5%) via text message. Of the patients who completed screening, 125/505 (24.7%) met NCCN criteria for germline testing. 58/125 patients (46.4%) who met criteria underwent germline testing, of whom 5/58 (8.6%) had distinct pathogenic mutations identified. These included actionable mutations in BRCA1, BRCA2, and CHEK2, as well as an additional pathogenic mutation in NBN. Variants of unknown significance were identified in 8/58 patients (13.8%) in 11 total genes. Challenges to implementation of this program included meeting institutional requirements for genetic testing consent, facilitating specimen collection in clinic, and integration of results into the electronic health record. Genetic risk assessment for high-risk individuals is feasible as part of a universal screening program in a community urology practice. Approximately 8% of tested patients were found to have pathogenic germline mutations, which is consistent with contemporary tertiary referral cohorts.

Constitutional Safeguards for Digital Rights and Privacy

The digital rights and privacy protections are emerging human rights concerns in the digital age. Uzbekistan's newly enacted constitution provides a general framework for civil liberties, but lacks specificity regarding digital contexts. This research examines the effectiveness of Uzbekistan's constitutional safeguards for digital rights and privacy, and identifies potential areas for improvement. The aim is to ensure robust protections aligned with international norms. A qualitative methodology analyzes constitutional provisions, legislation through doctrinal review and phenomenological approaches. Results reveal significant gaps in areas like data protection, consent requirements, and oversight of state surveillance compared to frameworks like the EU's GDPR. Recommendations include constitutional amendments explicitly guaranteeing digital rights, an independent data protection authority, enhanced enforcement mechanisms, and legal reforms codifying principles of data minimization and individual control over personal information. Implementing such measures is crucial for Uzbekistan to uphold digital rights, promote trust in the digital ecosystem, and contribute to preserving human dignity and autonomy in the digital era.

The Contrafatto Affair: Law, Judicial Risk, and Consent

In Paris, France on October 15, 1827, 28-year old Sicilian priest Joseph Contrafatto was sentenced for raping 5-year old Hortense Le Bon. This article frames the rhetorical strategies of the prosecution and defense using Robert Cover’s notion of judicial innovation, developed in his Justice Accused. Both sides based their arguments on articles 331 and 332 of the Criminal code. The Contrafatto Affair was an extraordinary case for rape legislation; it was among the first if not the first trial in France when a perpetrator of attentat à la pudeur avec violence (violent, indecent assault), was sentenced and found guilty when the prosecution used the argument of la violence morale (a type of coercion or abuse of an individual’s trust or naivety) when the victim suffered no physical signs of violence. Later, la violence morale and the requirement of consent became constitutive parts of the rape statutes by 1853 (for children) and 1857 (for adults), which this article develops through contextualizing law, rhetoric, and interpretation. The background of the trial provides an overview of certain procedures and protocols of 19th-century France. An examination of the jurisprudence related to attentat à la pudeur sans violence (non-violent, indecent assault, art. 331), attentat à la pudeur avec violence and la violence morale will highlight how forward-looking and risky the prosecution’s arguments were in his interpretation of article 332.

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Open-door policy versus treatment-as-usual in urban psychiatric inpatient wards: a pragmatic, randomised controlled, non-inferiority trial in Norway

Open-door policy is a recommended framework to reduce coercion in psychiatric wards. However, existing observational data might not fully capture potential increases in harm and use of coercion associated with open-door policies. In this first randomised controlled trial, we compared coercive practices in open-door policy and treatment-as-usual wards in an urban hospital setting. We hypothesised that the open-door policy would be non-inferior to treatment-as-usual on the proportion of patients exposed to coercive measures. We conducted a pragmatic, randomised controlled, non-inferiority trial comparing two open-door policy wards and three treatment-as-usual acute psychiatric wards at Lovisenberg Diaconal Hospital in Oslo, Norway. An exemption from the consent requirements enabled inclusion and random allocation of all patients admitted to these wards using an open list (2:3 ratio) administrated by a team of ward nurses. The primary outcome was the proportion of patient stays with one or more coercive measures, including involuntary medication, isolation or seclusion, and physical and mechanical restraints. The non-inferiority margin was set to 15%. Primary and safety analyses were assessed using the intention-to-treat population. The trial is registered with ISRCTN registry and is complete, ISRCTN16876467. Between Feb 10, 2021, and Feb 1, 2022, we randomly assigned 556 patients to either open-door policy wards (n=245; mean age 41·6 [SD 14·5] years; 119 [49%] male; 126 [51%] female; and 180 [73%] admitted to the ward involuntarily) or treatment-as-usual wards (n=311; mean age 41·6 [4·3] years; 172 [55%] male and 138 [45%] female; 233 [75%] admitted involuntarily). Data on race and ethnicity were not collected. The open-door policy was non-inferior to treatment-as-usual on all outcomes: the proportion of patient stays with exposure to coercion was 65 (26·5%) in open-door policy wards and 104 (33·4%) in treatment-as-usual wards (risk difference 6·9%; 95% CI -0·7 to 14·5), with a similar trend for specific measures of coercion. Reported incidents of violence against staff were 0·15 per patient stay in open-door policy wards and 0·18 in treatment-as-usual wards. There were no suicides during the randomised controlled trial period. The open-door policy could be safely implemented without increased use of coercive measures. Our findings underscore the need for more reliable and relevant randomised trials to investigate how a complex intervention, such as open-door policy, can be efficiently implemented across health-care systems and contexts. South-Eastern Norway Regional Health Authority and The Research Council of Norway.

Pediatric Consent on FHIR.

Standardizing and formalizing consent processes and forms can prevent ambiguities, convey a more precise meaning, and support machine interpretation of consent terms. Our goal was to introduce a systematic approach to standardizing and digitizing pediatric consent forms, which are complex due to legal requirements for child and legal guardian involvement. First, we reviewed the consent requirements from the Arizona regulation, and we used 21 pediatric treatment consents from five Arizona health care organizations to propose and evaluate an implementation-agnostic Consent for Treatment Framework. Second, we assessed the adequacy of the Fast Healthcare Interoperability Resources (FHIR) to support the proposed framework. The resulting Consent for Treatment Framework supports compliance with the state consent requirements and has been validated with pediatric consent forms. We also demonstrated that the FHIR standard has the required expressiveness to compute the framework's specifications and express the 21 consent forms. Health care organizations can apply the shared open-source code and FHIR implementation guidelines to standardize the design of machine-interpretable pediatric treatment consent forms. The resulting FHIR-based executable models may support compliance with the law and support interoperability and data sharing.

Ethical considerations for real-world evidence studies.

Real-world evidence (RWE) studies are conducted on patient's data primarily collected for monitoring of health status of patients. The use of real-world data to generate evidence in academic research or for regulatory submission raises a variety of ethical issues such as privacy, confidentiality, data protection, data de-identification, data sharing, scientific design of study, and informed consent requirements. The investigators-researchers and sponsors should adhere to current standards of ethics whilst planning and conduct of RWE studies. The ethics committees should consider ethical issues specific to RWE studies before approval.

Domestic Violence, Sex, Strangulation and the ‘Blurry’ Question of Consent

A stand-alone strangulation offence was introduced in Queensland, Australia in 2016. One of the elements of the Queensland strangulation offence is that the victim did not consent to the strangulation. This paper reviews the harms and dangers associated with strangulation before overviewing the debates about the use of strangulation during sex. Drawing on focus group discussions conducted with domestic violence support workers and men's behaviour change workers, we discuss four overlapping themes identified in the discussions. These were perceptions that: strangulation during sex is normalised; consent is not informed; it happens in the context of coercive control; and the requirement of consent opens a loophole in the strangulation offence. Considering the issues raised, and the clear risks and harms, we suggest that consideration should be given to whether it is ever possible to consent to strangulation and we consider possible reforms such as following the two-tiered approaches to consent used in the England and Wales law and elsewhere in Australia. We also conclude that law reforms such as these are partial solutions and there is significant need for more community education about the risks and harms of strangulation.

Integrating Islamic Laws into Indonesian Data Protection Laws: An Analysis of Regulatory Landscape and Ethical Considerations

This study explores the intersection of personal data protection laws in Indonesia with Islamic principles, focusing on the regulatory landscape and ethical considerations surrounding data privacy. With the proliferation of digital technologies and data-driven processes, safeguarding personal information has become paramount. Drawing from legal frameworks, Islamic jurisprudence, and contemporary discussions on data privacy, this research investigates how Islamic principles inform and complement existing data protection measures in Indonesia. The analysis begins by examining the legal foundation of personal data protection in Indonesia, emphasizing key provisions of relevant legislation and constitutional mandates. It then delves into Islamic principles related to privacy, confidentiality, and ethical conduct, as derived from primary Islamic sources such as the Quran, Hadiths, and scholarly interpretations. The study evaluates the alignment between personal data protection laws and Islamic ethics, identifying areas of convergence and potential divergence. It explores the implications of Islamic principles for data handling practices, consent requirements, and accountability mechanisms within the Indonesian context. Furthermore, the research discusses the practical implications of integrating Islamic principles into data protection frameworks, considering challenges, opportunities, and best practices for ensuring compliance and ethical data governance. By bridging legal and ethical perspectives, this study contributes to a deeper understanding of personal data protection in Indonesia and offers insights into the role of Islamic principles in shaping contemporary approaches to privacy and confidentiality in the digital age. It underscores the importance of holistic and culturally approaches to data governance that respect both legal requirements and ethical norms derived from Islamic teachings.

Release of reclassified VUS results of now deceased patients to family members: Practices and opinions.

Variants of uncertain significance (VUS) are commonly identified in genetic testing. The rate at which a VUS is reclassified depends on multiple factors. However, as the amount of time it might take for a VUS to be reclassified varies, some patients with a VUS genetic testing result might have passed away before the VUS is reclassified. A VUS that is reclassified after the patient's death has clinical implications for the deceased patient's family members. The disclosure of reclassified VUS results for a deceased patient has complex legal and ethical implications. There are no established guidelines on how the reclassified VUS result for a deceased patient should be disclosed to at-risk relatives. An online survey was sent to members of the National Society of Genetic Counselors (NSGCs) to elicit practices and opinions regarding this issue. A total of 153 (4%) NSGC members completed the survey. Thirty-seven (24.2%) respondents reported having received a reclassified VUS for a deceased patient. Respondents were more likely to attempt disclosure if the variant was reclassified as pathogenic (93.5%) versus benign (76.5%), although the difference did not reach statistical significance (p = 0.06). Respondents more often reported the impact on family members (85.5%) than the decedent's right to privacy (15.0%) as extremely important when considering disclosure to family members. A legal mechanism to allow disclosure to relatives was supported by 70.6% of respondents and 97.4% felt the issue was important enough to pursue if such a process was in place. Only 9.8% of respondents supported a legal requirement of consent before disclosing to family members when a VUS is reclassified after the patient has passed away. Our results indicate that there is no consensus for how these results should be handled and a mechanism for disclosure of reclassified results to family members is supported.