Rosemarie De La Cruz Bernabe

Background Open Science aims at improving the quality of research, transparency, and data sharing through open-access platforms, data sharing, inclusion of citizen scientists, making research results accessible to both professionals and citizens. As science becomes increasingly data-driven, responsible open science practices enable collaboration, reduce barriers in multisectoral teams, and support integrative approaches such as One Health. In response to the rise of zoonotic diseases globally, many countries have adopted the One Health approach, fostering collaboration across the human–animal–environment interface. However, open practices such as data sharing within One Health is not always implemented. Objective To explore perceived barriers to engaging in Open Science practices in the One Health community in South Asia. Methods An online survey was conducted among One Health stakeholders in South Asia, including academic researchers, healthcare professionals, veterinarians, and policymakers. A 22-item semi-structured questionnaire was distributed via the Nettskjema platform of the University of Oslo (UiO) using a snowball sampling technique. The study was preregistered in the Open Science Framework registry. Results We received 90 responses with the majority being from India (55.6%), followed by Pakistan (17.8%), Nepal and Sri Lanka (6.7% each), Afghanistan and Bangladesh (5.6% each), and Bhutan (1.1%). Levels of awareness and practices of Open Science were mixed: while 60% engaged in open-access publishing, 27.8% shared data, 23.3% supported citizen science, and 12.2% used preprints. Reported barriers included lack of awareness, inadequate government support, institutional restrictions, to name a few. Despite these, the participants highlighted major benefits in practicing Open Science. Conclusion The survey highlights key opportunities and challenges in engaging with Open Science for One Health in South Asia. Greater government and institutional support, improved data-sharing and infrastructure, inclusion of veterinary and environmental sectors, capacity-building, and international collaboration are essential to overcome barriers and strengthen One Health globally.

This article presents the BEYOND Guidelines for Preventing and Addressing Research Misconduct. The Guidelines are grounded in the BEYOND project’s evidence-based, behavioural, and complexity-informed approach to research misconduct (RM), viewing the latter not through the simplistic and plainly individualistic “bad apples” approach but from a research ecosystem perspective. In this manner, the project and the Guidelines view research behaviour as shaped by the interaction of individual factors with organisational structures, incentives, norms, cultures, and wider social and institutional conditions. Based on these considerations, the Guidelines promote a multi-stakeholder and shared-responsibility approach to preventing and addressing RM, involving researchers, research performing organisations (RPOs), research funding organisations (RFOs), research ethics and research integrity (RE/RI) bodies, publishers, policymakers, citizen scientists, and other actors across the research ecosystem. They also emphasise prevention and effective responses to RM while addressing the socio-economic consequences of RM, and promoting researcher health and well-being, public trust, supportive research cultures, and the need for clear, accessible, and context-sensitive RE/RI policies. The Guidelines provide principles for the fair, independent, timely, and proportionate handling of RM allegations; safeguards for whistleblowers and others involved in proceedings; institutional learning from RM cases; and measures to address politically sensitive allegations and prevent misuse of investigative processes. They also acknowledge rehabilitation and reintegration as potentially appropriate responses following RM, subject to considerations of proportionality and appropriateness in light of the circumstances of the case, and emphasise institutional support, mentoring, training, and opportunities to rebuild trust. Finally, the Guidelines highlight preventive behavioural and educational approaches, including ethically designed nudges and RE/RI training that is reflective, participatory, context-sensitive, and subject to meaningful evaluation. Taken together, the Guidelines propose a prevention-to-reintegration approach to RM that combines individual and institutional responsibility and seeks to foster more supportive, fair, trustworthy, and resilient research environments across diverse European research contexts.

Background Many African countries have established national pharmacovigilance (PV) centers under their medicines regulatory authorities, but multiple barriers still limit system performance. Comprehensive, well-enforced PV regulations are often lacking, and the reporting culture among healthcare professionals and patients remains weak due to limited awareness, heavy workloads, and fear of legal consequences. The limited uptake of digital tools also leads to continued reliance on paper-based reporting, undermining data management and analysis. This manuscript summarizes an Africa–Europe roundtable where regulators discussed experiences, challenges, and priorities for strengthening PV systems. Methods The Center for Medical Ethics at the University of Oslo, in collaboration with Gispen4Regulatory Science, organized an in-person, two-day Europe-Africa roundtable discussion on June 5-6, 2025, focusing on global reflections on PV. This manuscript synthesizes discussions from a high-level Africa-Europe drug regulators, researchers and policy experts on the development and integration of PV. The roundtable brought together 30 experts for a cross-regional dialogue on drug regulation. This exchange illuminated common goals and significant asymmetries in infrastructure, capacity, and policy implementation across regions. Results The event fostered critical discussions on real-world safety monitoring, regulatory practices, and differences in health systems through short, problem-focused presentations based on active research and field practice. The roundtable discussion revealed disparities in technological and infrastructural capacity, human-resource challenges and sustainability, funding stability, community and patient engagement, and the utilization of data. It also highlighted gaps in regional harmonization, and institutional models. The study also emphasized shared values, the development of mechanisms for mutual learning and coordinated approaches. Conclusion Drawing on shared experiences, participants formulated a series of actionable recommendations aimed at fostering sustainable, collaborative, and technology- supported PV systems in Africa. The insights inform future strategies for harmonization and mutual learning within global drug safety governance.

Background: Post-trial provisions (PTP), including post-trial access (PTA), are core obligations under international guidelines, yet often weakly specified and inconsistently documented. We examined their public verifiability in COVID-19 trials reviewed in Brazil. Methods: We conducted a documentary audit of interventional COVID-19 trials approved by Brazil’s National Research Ethics Commission (CONEP) in 2020–22, identified through the Observatório Plataforma Brasil. From publicly accessible sources only, we sought protocols and informed consent forms (ICFs), distinguishing document availability, public verifiability of PTP (affirmative or negative information in retrieved documents), and substantive commitments. Associations were estimated as prevalence ratios (PRs; Poisson regression with robust variance). Findings: Of 297 trials, no protocol or ICF was publicly available for 258 (86·9%); documents were retrieved for 39 (13·1%), of which 29 (9·8%) contained PTP information. Availability was higher in vaccine than non-vaccine trials (PR 2·46, 95% CI 1·37–4·42) and lower for repurposed drugs than new molecular entities (8·3% vs 19·8%); chloroquine, hydroxychloroquine, or azithromycin trials were least available (1/26). The commonest content was that no PTA would be provided (n=15) or no PTP information (n=10); two vaccine trials offered the study vaccine to placebo recipients after emergency-use authorisation; none documented unconditional post-trial supply. Interpretation: Most trials had no publicly available protocol or ICF, and PTP were verifiable for fewer than one in ten—an accountability gap centralised ethics oversight alone does not close. Public access to protocols and ICFs as a condition of approval is needed to make post-trial obligations auditable.

Although some countries in sub-Saharan Africa have strengthened their systems and reached WHO GBT Maturity Level 3, important gaps remain. Addressing these gaps is critical for strengthening clinical research oversight and preparedness. This open letter highlights that ethics and regulatory systems are often fragmented. National ethics committees, regulatory authorities, and institutional review boards do not always have clear roles or strong coordination. Reviews can therefore be slow and inconsistent, especially for multi-site and multi-country trials. Joint inspections because there are few shared procedures, common guidelines, or formal agreement between regulators. Limited staff and funding worsen these problems and weaken oversight of complex, multi-site trials. Many clinical research sites are not well prepared for emergencies. They may struggle to quickly adapt their work and maintain safety and compliance when a public health crisis occurs, putting ongoing trials at risk. Digital systems for review and follow-up are also underdeveloped. Many committees and authorities lack integrated online submission platforms, linked databases, and pharmacovigilance e-portals. Safety reporting systems are often weak and scattered, and there is too little expertise in detecting and analysing safety signals. Links between ethics review, regulatory inspections, and safety monitoring are limited, making it harder to manage risks across the trial lifecycle. Information on the distribution and capacity of clinical trial sites is patchy, hindering rapid mobilisation during outbreaks. Training efforts are typically short term, fragmented, and poorly coordinated regionally, with insufficient emphasis on twinning and long-term mentorship to sustain skills. This affects the quality and timeliness of reviews, especially for complex, innovative, or multi-country protocols. Practical mechanisms to implement post-trial access commitments are often absent, which can erode participants’ trust. In response, this letter sets out recommendations and proposed actions for policymakers, regulators, research institutions, and ethics bodies to strengthen policies, systems, and day to day practices.

Background Open Science aims at improving the quality of research, transparency, and data sharing through open-access platforms, data sharing, inclusion of citizen scientists, making research results accessible to both professionals and citizens. As science becomes increasingly data-driven, responsible open science practices enable collaboration, reduce barriers in multisectoral teams, and support integrative approaches such as One Health. In response to the rise of zoonotic diseases globally, many countries have adopted the One Health approach, fostering collaboration across the human–animal–environment interface. However, open practices such as data sharing within One Health is not always implemented. Objective To explore perceived barriers to engaging in Open Science practices in the One Health community in South Asia. Methods An online survey was conducted among One Health stakeholders in South Asia, including academic researchers, healthcare professionals, veterinarians, and policymakers. A 22-item semi-structured questionnaire was distributed via the Nettskjema platform of the University of Oslo (UiO) using a snowball sampling technique. The study was preregistered in the Open Science Framework registry. Results We received 90 responses with the majority being from India (55.6%), followed by Pakistan (17.8%), Nepal and Sri Lanka (6.7% each), Afghanistan and Bangladesh (5.6% each), and Bhutan (1.1%). Levels of awareness and practices of Open Science were mixed: while 60% engaged in open-access publishing, 27.8% shared data, 23.3% supported citizen science, and 12.2% used preprints. Reported barriers included lack of awareness, inadequate government support, institutional restrictions, to name a few. Despite these, the participants highlighted major benefits in practicing Open Science. Conclusion The survey highlights key opportunities and challenges in adopting Open Science for One Health in South Asia. Greater government and institutional support, improved data-sharing and infrastructure, inclusion of veterinary and environmental sectors, capacity-building, and international collaboration are essential to overcome barriers and strengthen One Health globally.

Background Research ethics and ethical research practice are essential for protecting research participants. However, opportunities for practical ethics learning are often limited, making it difficult to apply ethical principles in real-world research. This study explored students’ and faculty’s experiences and perspectives on ethical research conduct and learning in Rwandan medical and health sciences education. Methods An exploratory qualitative design was employed, using in-depth interviews with nineteen students and seventeen faculty staff between March and September 2024 at a medical and health sciences college of the University of Rwanda. Data were analysed and three themes were developed using reflexive thematic analysis: research ethics learning context, superficial understanding of research ethics concepts and principles, and barriers to translating knowledge of research ethics into practice. The constructivist and phenomenological frameworks were used to interpret the findings. Results While students recognized the importance of research ethics, their learning experiences were fragmented, procedural, and often burdensome. Challenges included overcrowded classes, inconsistent guidance, limited exposure to ethics materials, and lecturers’ lack of confidence in teaching ethics. Institutional inefficiencies, financial constraints, and pressures to meet academic timelines further hindered students’ preparedness for ethical research. In practice, students navigated complex situations, including populations unfamiliar with their rights, students and community expectations, and misunderstandings related to compensation for research participants, which complicated consent and blurred ethical boundaries. Conclusions The findings suggest that meaningful ethics learning occurs when ethical reasoning is embedded in day-to-day research practice and supported by mentorship, dialogue, and opportunities for real-world research engagement. Considering these results, the University of Rwanda can strengthen supervision, streamline review, ethical approval and ethical follow-up processes, and foster an environment that rewards ethical reflection. Aligning ethics education with students lived realities and experiences, and the structural constraints identified can help develop reflective, resilient practitioners equipped to navigate the complex ethical demands.

Background Open Science aims at improving the quality of research, transparency, and data sharing through open-access platforms, data sharing, inclusion of citizen scientists, making research results accessible to both professionals and citizens. As science becomes increasingly data-driven, responsible open science practices enable collaboration, reduce barriers in multisectoral teams, and support integrative approaches such as One Health. In response to the rise of zoonotic diseases globally, many countries have adopted the One Health approach, fostering collaboration across the human–animal–environment interface. However, open practices such as data sharing within One Health is not always implemented. Objective To identify key barriers affecting the adoption of Open Science practices in the One Health community in South Asia. Methods An online survey was conducted among One Health stakeholders in South Asia, including academic researchers, healthcare professionals, veterinarians, and policymakers. A 22-item semi-structured questionnaire was distributed via the Nettskjema platform of the University of Oslo (UiO) using a snowball sampling technique. The study was preregistered in the Open Science Framework registry. Results We received 90 responses with the majority being from India (55.6%), followed by Pakistan (17.8%), Nepal and Sri Lanka (6.7% each), Afghanistan and Bangladesh (5.6% each), and Bhutan (1.1%). Levels of awareness and practices of Open Science were mixed: while 60% engaged in open-access publishing, 27.8% shared data, 23.3% supported citizen science, and 12.2% used preprints. Reported barriers included lack of awareness, inadequate government support, institutional restrictions, to name a few. Despite these, the participants highlighted major benefits in practicing Open Science. Conclusion The survey highlights key opportunities and challenges in adopting Open Science for One Health in South Asia. Greater government and institutional support, improved data-sharing and infrastructure, inclusion of veterinary and environmental sectors, capacity-building, and international collaboration are essential to overcome barriers and strengthen One Health globally.

Background The COVID-19 pandemic disrupted research globally, placing unprecedented pressure on regulatory systems. In Uganda, research ethics committees (RECs) and regulatory bodies faced challenges in maintaining oversight, ethical compliance, and continuity of research. Specifically, the study explored stakeholder experiences and perceptions of how Uganda’s clinical research policies and guidelines were implemented and how they influenced the conduct of ethical and safe research during the COVID-19 pandemic. Methods A qualitative descriptive study was conducted across seven districts, involving all UNCST-accredited RECs. Data were collected through in-depth interviews, focus group discussions, and key informant interviews with 56 participants, including REC Chairpersons, administrators, researchers, and representatives from research regulatory authorities in Uganda. Purposive sampling ensured recruitment of participants with relevant expertise. Virtual interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Ethical approval and informed consent were obtained. Results Uganda’s research policies and guidelines were reported by participants to support continuity of research through strengthened collaboration, including joint protocol reviews and coordinated regulatory processes. Standardization and adaptive measures, such as digital submissions, virtual meetings, remote monitoring, and hybrid consent models, were perceived to enhance efficiency and facilitate study adjustments. However, constraints including increased workload, limited oversight due to movement restrictions, and financial challenges persisted, highlighting the need for more adaptable and resilient regulatory systems. Conclusions Uganda’s research policies and guidelines were perceived to supported continuity of ethical research during the pandemic through strengthened collaboration and standardized yet adaptable regulatory processes. However, operational and resource constraints highlighted gaps in system resilience. Strengthening digital infrastructure, institutionalizing collaborative review mechanisms, embedding adaptable procedures, and securing emergency research funding will be critical to enhance the responsiveness and resilience of Uganda’s research regulatory system in future public health emergencies.

The XR4Human Code of Conduct was developed over a 12-month period using a participatory co-design approach that combined multi-disciplinary expert workshops with members of the consortium followed by stakeholder and public consultations. The process was intentionally iterative. Drafting, review, and revision were guided by reflective equilibrium to reconcile empirical inputs from the project deliverables, normative principles, and practical constraints. The final Code is organised into nine domains that consolidate core principles relevant to the responsible design, development, and deployment of XR systems. These principles are made more concrete through seven articles that specify actionable obligations. To support real-world adoption, the Code is operationalised via an Ethical Impact Assessment and a companion Compliance Checklist aligned to the core principles and articles.