Ethical guidelines for birth defect prevention recommended by experts. / 出生缺陷预防的伦理指导原则专家建议.

China's maternal and child health work is still facing many challenges, such as unbalanced development and inadequate services. Since the adjustment of the family planning policy, the proportion of older and more productive sub-parturient women have increased, the risk for birth defects has increased, the demand for newborn safety has further increased, and the work of maternal and child health is facing new challenges. The experts from the medicine, medical ethics, sociology, and other fields put forward the principle of ethical guidance for birth defect prevention after full discussion and continuous revision based on expert proposals, which include the principle of life dignity, love, scientific principle, fair principle, respect for autonomy principle, the principle of beneficence and the principle of good privacy protection. The guideline can serve the birth defect prevention clinical practice, be better to respect and safeguard the legitimate rights and interests of people at childbearing age, eliminate ethics cognition pitfalls of birth defect prevention, and regulate the behavior of birth defect prevention-related ethics.

Guiding principles for rewilding.

There has been much recent interest in the concept of rewilding as a tool for nature conservation, but also confusion over the idea, which has limited its utility. We developed a unifying definition and 10 guiding principles for rewilding through a survey of 59 rewilding experts, a summary of key organizations' rewilding visions, and workshops involving over 100 participants from around the world. The guiding principles convey that rewilding exits on a continuum of scale, connectivity, and level of human influence and aims to restore ecosystem structure and functions to achieve a self-sustaining autonomous nature. These principles clarify the concept of rewilding and improve its effectiveness as a tool to achieve global conservation targets, including those of the UN Decade on Ecosystem Restoration and post-2020 Global Biodiversity Framework. Finally, we suggest differences in rewilding perspectives lie largely in the extent to which it is seen as achievable and in specific interventions. An understanding of the context of rewilding projects is the key to success, and careful site-specific interpretations will help achieve the aims of rewilding.

Recientemente ha habido mucho interés por el concepto de retorno a la vida silvestre como herramienta para la conservación de la naturaleza, pero también ha habido confusión por la idea que ha limitado su utilidad. Desarrollamos una definición unificadora y diez principios básicos para el retorno a la vida silvestre por medio de encuestas a 59 expertos en retorno a la vida silvestre, un resumen de las visiones de las organizaciones más importantes para el retorno a la vida silvestre y talleres que involucraron a más de 100 participantes de todo el mundo. Los principios básicos transmiten que el retorno a la vida silvestre existe en un continuo de escala, conectividad y nivel de influencia humana y que su objetivo es restaurar la estructura y las funciones del ecosistema para lograr una naturaleza autónoma autosustentable. Estos principios aclaran el concepto del retorno a la vida silvestre e incrementan su efectividad como herramienta para lograr los objetivos mundiales de conservación, incluyendo aquellos de la Década de la ONU para la Restauración de Ecosistemas y el Marco de Trabajo de la Biodiversidad Global post 2020. Finalmente, sugerimos que las diferencias en las perspectivas del retorno a la vida silvestre yacen principalmente en el grado al que es visto como factible y en intervenciones específicas. Un entendimiento del contexto de los proyectos de retorno a la vida silvestre es importante para el éxito, y las interpretaciones específicas de sitio ayudarán a lograr las metas del retorno a la vida silvestre. Principios Básicos para el Retorno a la Vida Silvestre.

Environmental health research and the COVID-19 pandemic: A turning point towards sustainability.

Based on a review of COVID-19 research from an environmental health perspective, this study theorizes the interdependence of the society, environment and health, and presents an integrated framework for environmental health problems arising due to COVID-19. Five guiding principles are proposed for conducting environmental health research, including employing a transdisciplinary approach, embracing complexity and uncertainty, addressing vulnerability, boosting resilience and promoting sustainable development. This study propagates that the pandemic could be an opportunity for sustainable transformation, wherein visionary leadership that facilitates sustainability policies based on environmental health science is required. This study can serve as a consolidated guide for professionals and stakeholders who conduct environmental health research in this challenging field.

Using research networks to generate trustworthy qualitative public health research findings from multiple contexts.

BACKGROUND: Qualitative research networks (QRNs) bring together researchers from diverse contexts working on multi-country studies. The networks may themselves form a consortium or may contribute to a wider research agenda within a consortium with colleagues from other disciplines. The purpose of a QRN is to ensure robust methods and processes that enable comparisons across contexts. Under the Self-Testing Africa (STAR) initiative and the REACHOUT project on community health systems, QRNs were established, bringing together researchers across countries to coordinate multi-country qualitative research and to ensure robust methods and processes allowing comparisons across contexts. QRNs face both practical challenges in facilitating this iterative exchange process across sites and conceptual challenges interpreting findings between contexts. This paper distils key lessons and reflections from both QRN experiences on how to conduct trustworthy qualitative research across different contexts with examples from Bangladesh, Ethiopia, Kenya, Indonesia, Malawi, Mozambique, Zambia and Zimbabwe. METHODS: The process of generating evidence for this paper followed a thematic analysis method: themes initially identified were refined during several rounds of discussions in an iterative process until final themes were agreed upon in a joint learning process. RESULTS: Four guiding principles emerged from our analysis: a) explicit communication strategies that sustain dialogue and build trust and collective reflexivity; b) translation of contextually embedded concepts; c) setting parameters for contextualizing, and d) supporting empirical and conceptual generalisability. Under each guiding principle, we describe how credibility, dependability, confirmability and transferability can be enhanced and share good practices to be considered by other researchers. CONCLUSIONS: Qualitative research is often context-specific with tools designed to explore local experiences and understandings. Without efforts to synthesise and systematically share findings, common understandings, experiences and lessons are missed. The logistical and conceptual challenges of qualitative research across multiple partners and contexts must be actively managed, including a shared commitment to continuous 'joint learning' by partners. Clarity and agreement on concepts and common methods and timelines at an early stage is critical to ensure alignment and focus in intercountry qualitative research and analysis processes. Building good relationships and trust among network participants enhance the quality of qualitative research findings.

[The Exploration of Extrapolation of Data from Adults to Pediatric Population].

Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.

Review of Recent US Value Frameworks-A Health Economics Approach: An ISPOR Special Task Force Report [6].

The sixth section of our Special Task Force (STF) report reviews and comments on recent US-oriented value assessment frameworks, specifically those published by the American College of Cardiology/American Heart Association, the Institute for Clinical and Economic Research, the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the Memorial Sloan Kettering Cancer Center. We review published commentaries that address the validity, reliability, and conceptual underpinnings of these frameworks. We find common themes of critique regarding the strengths and limitations across frameworks. Particular shortcomings of some frameworks pose greater threats to their face validity and utility compared with others. The most significant limitations include lack of clear perspective (e.g., patient vs. health plan) and poor transparency in accounting for costs and benefits. We then review how each framework adheres to core STF recommendations, with particular emphasis on whether the framework can be used to support coverage decisions by health insurers, and whether it adheres to core principles of cost-effectiveness analysis. The Institute for Clinical and Economic Research framework most closely adheres to core STF recommendations. Others have significant limitations that vary widely from framework to framework. We also review how the frameworks follow STF recommendations for addressing potentially relevant issues beyond cost-effectiveness analysis - for example, equity in resource allocation and patient heterogeneity. Finally, we review whether and how each framework uses value thresholds and addresses affordability concerns. We conclude with suggestions for further research, particularly in the areas of testing the measurement and use of novel elements of value and deliberative processes.

Assessing the use of HL7 FHIR for implementing the FAIR guiding principles: a case study of the MIMIC-IV Emergency Department module.

Objectives: To provide a real-world example on how and to what extent Health Level Seven Fast Healthcare Interoperability Resources (FHIR) implements the Findable, Accessible, Interoperable, and Reusable (FAIR) guiding principles for scientific data. Additionally, presents a list of FAIR implementation choices for supporting future FAIR implementations that use FHIR. Materials and methods: A case study was conducted on the Medical Information Mart for Intensive Care-IV Emergency Department (MIMIC-ED) dataset, a deidentified clinical dataset converted into FHIR. The FAIRness of this dataset was assessed using a set of common FAIR assessment indicators. Results: The FHIR distribution of MIMIC-ED, comprising an implementation guide and demo data, was more FAIR compared to the non-FHIR distribution. The FAIRness score increased from 60 to 82 out of 95 points, a relative improvement of 37%. The most notable improvements were observed in interoperability, with a score increase from 5 to 19 out of 19 points, and reusability, with a score increase from 8 to 14 out of 24 points. A total of 14 FAIR implementation choices were identified. Discussion: Our work examined how and to what extent the FHIR standard contributes to FAIR data. Challenges arose from interpreting the FAIR assessment indicators. This study stands out for providing a real-world example of a dataset that was made more FAIR using FHIR. Conclusion: To the best of our knowledge, this is the first study that formally assessed the conformance of a FHIR dataset to the FAIR principles. FHIR improved the accessibility, interoperability, and reusability of MIMIC-ED. Future research should focus on implementing FHIR in research data infrastructures.

Challenges for pumping station design in water industries: An overview of impacts from climate change and energy crisis.

Uncertain climate change and increasing energy cost become the pressing challenges for either new design or refurbishment of pumping stations in water and wastewater industries. These challenges make more complex to the design work for optimal solutions in meeting current scenarios, unplanned operational behaviors and unpredicted failure. The climate change affects the water level dramatically in dry and wet seasons, stressing and weakening the operation of pumping stations beyond its original flow capability and hydraulic performance. In addition, increasing energy cost from energy crisis poses another challenge on design work for planning the suitable pump sizing, type, configuration, and technologies to make pumping stations more energy and carbon efficient without degrading its full pumping capacity. By surveying relevant pumping-related journals or guidelines after 2000, this paper provides an overview and checklist of design considerations, engineering experience and essential comparisons to mitigate impacts from climate and energy scenarios that help engineers plan and design the most common raw water and sewage pumping stations with higher sustainability and better resilient in future.

The rationale and guiding principles to design a psychiatric curriculum for primary care nurses of India.

Background: The National Mental Health Survey reports a huge treatment gap for all mental disorders. There is an acute shortage of mental health professionals in India. Hence, there is a dire need to support task-shift interventions by nurses in providing non-pharmacological interventions for persons suffering from mental health issues. The traditional psychiatric nursing curriculum emphasizes nurses' knowledge and skills rather than their competency in providing mental health care. We designed an innovative, digitally driven, modular-based primary care psychiatry program for nurses (PCPP-N) to incorporate mental health with physical health and emphasize redesigning nursing practice. In this paper, we discuss the rationale and guiding principles behind designing the curriculum of PCPP-N. Discussion: The PCPP-N program is based on nine guiding principles to provide skill-based, pragmatic, and feasible modules of a higher collaborative care quotient (CCQ) and translational quotient (TQ) that are essential for upskilling primary care nurses. In this program, nurses are trained through telemedicine-based 'on-consultation training' augmented with collaborative video consultations. A tele-psychiatrist/tele-psychiatric nurse will demonstrate how to screen, identify, and plan treatment for patients with psychiatric disorders from patients coming for general medical care using the manual Clinical Schedules of Primary care psychiatry Nursing (CSP-N). The CSP-N manual includes a screener, simplified diagnosing guidelines relevant for nurses and primary care settings, nursing management, pharmacological management, and related side effects, counseling, and follow-up guidelines. This program helps the nurses in identifying the most commonly prevalent adult psychiatric disorders presenting to primary care. Conclusion: This PCPN curriculum contains pragmatic modules with higher CCQ and TQ. This curriculum is dynamic as the learning is interactive. Upskilling primary care nurses in integrating mental health with physical health may reduce the mental health burden. Further, the policymakers and administrators plan to integrate mental health along with physical health in national health programs.

European Achondroplasia Forum guiding principles for the detection and management of foramen magnum stenosis.

Foramen magnum stenosis is a serious, and potentially life-threatening complication of achondroplasia. The foramen magnum is smaller in infants with achondroplasia, compared with the general population, and both restricted growth in the first 2 years and premature closure of skull plate synchondroses can contribute to narrowing. Narrowing of the foramen magnum can lead to compression of the brainstem and spinal cord, and result in sleep apnoea and sudden death. There is a lack of clarity in the literature on the timing of regular monitoring for foramen magnum stenosis, which assessments should be carried out and when regular screening should be ceased. The European Achondroplasia Forum (EAF) is a group of clinicians and patient advocates, representative of the achondroplasia community. Members of the EAF Steering Committee were invited to submit suggestions for guiding principles for the detection and management of foramen magnum stenosis, which were collated and discussed at an open workshop. Each principle was scrutinised for content and wording, and anonymous voting held to pass the principle and vote on the level of agreement. A total of six guiding principles were developed which incorporate routine clinical monitoring of infants and young children, timing of routine MRI screening, referral of suspected foramen magnum stenosis to a neurosurgeon, the combination of assessments to inform the decision to decompress the foramen magnum, joint decision making to proceed with decompression, and management of older children in whom previously undetected foramen magnum stenosis is identified. All principles achieved the ≥ 75% majority needed to pass (range 89-100%), with high levels of agreement (range 7.6-8.9). By developing guiding principles for the detection and management of foramen magnum stenosis, the EAF aim to enable infants and young children to receive optimal monitoring for this potentially life-threatening complication.

Opportunities for improving data sharing and FAIR data practices to advance global mental health.

It is crucial to optimize global mental health research to address the high burden of mental health challenges and mental illness for individuals and societies. Data sharing and reuse have demonstrated value for advancing science and accelerating knowledge development. The FAIR (Findable, Accessible, Interoperable, and Reusable) Guiding Principles for scientific data provide a framework to improve the transparency, efficiency, and impact of research. In this review, we describe ethical and equity considerations in data sharing and reuse, delineate the FAIR principles as they apply to mental health research, and consider the current state of FAIR data practices in global mental health research, identifying challenges and opportunities. We describe noteworthy examples of collaborative efforts, often across disciplinary and national boundaries, to improve Findability and Accessibility of global mental health data, as well as efforts to create integrated data resources and tools that improve Interoperability and Reusability. Based on this review, we suggest a vision for the future of FAIR global mental health research and suggest practical steps for researchers with regard to study planning, data preservation and indexing, machine-actionable metadata, data reuse to advance science and improve equity, metrics and recognition.

Integrating knowledge and action: learnings from an implementation program for food security and food sovereignty with First Nations communities within Canada.

BACKGROUND: Collaborative approaches to knowledge translation (KT) are important for advancing community-engaged research. However, there is a need for examples of participatory approaches that have effectively supported public health research, program development, and implementation with First Nations communities. To strengthen KT with communities, we proposed a set of guiding principles for participatory planning and action for local food system change. Principles emerged from a cross-community analysis of Learning Circles: Local Healthy Food to School (LC:LHF2S) a participatory program (2015-2019) for Indigenous food system action. The objective was to identify guiding principles for participatory planning and action from key learnings and successes on scaling-up of the Learning Circles (LC) model vertically in Haida Nation, British Columbia (BC), and horizontally in three distinct community contexts: Gitxsan Nation, Hazelton /Upper Skeena, BC; Ministikwan Lake. The application of these principles is discussed in the context of our ongoing partnership with Williams Treaties First Nations to support community planning to enhance food security and sovereignty. METHODS: A cross-community thematic analysis was conducted and guided by an implementation science framework, Foster-Fishman and Watson's (2012) ABLe Change Framework, to identify key learnings and successes from adapting the LC approach. Information gathered from interviews (n = 55) and meeting reports (n = 37) was thematically analyzed to inform the development of guiding principles. Community sense-making of findings informed applicability in a new community context embarking on food systems work. RESULTS: Emergent guiding principles for participatory food system planning and action are described within four main areas: (1) create safe and ethical spaces for dialog by establishing trust and commitment from the ground up, (2) understand the context for change through community engagement, (3) foster relationships to strengthen and sustain impact, and (4) reflect and embrace program flexibility to integrate learnings. CONCLUSIONS: Emergent principles offer guidance to supporting Indigenous community-led research and mobilization of knowledge into action. Principles are intended to support researchers and health system administrators with taking a collaborative approach that fosters relationships and integration of community leadership, knowledge, and action for food system change. Application of principles with implementation frameworks can strengthen KT in Indigenous contexts by incorporating community protocols and perspectives in support of Indigenous self-determined priorities.

Journeying towards best practice data management in biodiversity genomics.

Advances in sequencing technologies and declining costs are increasing the accessibility of large-scale biodiversity genomic datasets. To maximize the impact of these data, a careful, considered approach to data management is essential. However, challenges associated with the management of such datasets remain, exacerbated by uncertainty among the research community as to what constitutes best practices. As an interdisciplinary team with diverse data management experience, we recognize the growing need for guidance on comprehensive data management practices that minimize the risks of data loss, maximize efficiency for stand-alone projects, enhance opportunities for data reuse, facilitate Indigenous data sovereignty and uphold the FAIR and CARE Guiding Principles. Here, we describe four fictional personas reflecting differing user experiences with data management to identify data management challenges across the biodiversity genomics research ecosystem. We then use these personas to demonstrate realistic considerations, compromises and actions for biodiversity genomic data management. We also launch the Biodiversity Genomics Data Management Hub (https://genomicsaotearoa.github.io/data-management-resources/), containing tips, tricks and resources to support biodiversity genomics researchers, especially those new to data management, in their journey towards best practice. The Hub also provides an opportunity for those biodiversity researchers whose expertise lies beyond genomics and are keen to advance their data management journey. We aim to support the biodiversity genomics community in embedding data management throughout the research lifecycle to maximize research impact and outcomes.

Business Strategy as Human Rights Risk: the Case of Private Equity.

In this article, we apply the UN Guiding Principles on Business and Human Rights to the private equity (PE) business model. PE firms often adopt a controversial, 'value extractive', business model based on high debt and extreme cost-cutting to generate investor returns. PE firms own large numbers of companies, including in many rights-related sectors. The model is linked to increased human rights risks to workers, housing tenants, and in privatized health and social care. We map these risks and analyse the human rights responsibilities of PE firms. Our analysis has major implications for understandings of human rights responsibility. We argue that value extractive methods are the root cause of eventual harm to human rights, even though they may not harm rights directly. To respect human rights, PE firms must mitigate the risks of these value extractive methods. We define how human rights due diligence (HRDD) could achieve this and argue that given the extent of harm and the lack of a business case for adopting such a view of human rights responsibility, business strategy level HRDD should be a core component of forthcoming HRDD laws.

Optimising the diagnosis and referral of achondroplasia in Europe: European Achondroplasia Forum best practice recommendations.

BACKGROUND: Achondroplasia is the most common form of skeletal dysplasia, with serious comorbidities and complications that may occur from early infancy to adulthood, requiring lifelong management from a multidisciplinary team expert in the condition The European Achondroplasia Forum guiding principles of management highlight the importance of accurate diagnosis and timely referral to a centre specialised in the management of achondroplasia to fully support individuals with achondroplasia and their families, and to appropriately plan management. The European Achondroplasia Forum undertook an exploratory audit of its Steering Committee to ascertain the current situation in Europe and to understand the potential barriers to timely diagnosis and referral. RESULTS: Diagnosis of achondroplasia was primarily confirmed prenatally (66.6%), at Day 0 (12.8%) or within one month after birth (12.8%). For suspected and confirmed cases of achondroplasia, a greater proportion were identified earlier in the prenatal period (87.1%) with fewer diagnoses at Day 0 (5.1%) or within the first month of life (2.6%). Referral to a specialist centre took place after birth (86.6%), predominantly within the first month, although there was a wide variety in the timepoint of referral between countries and in the time lapsed between suspicion or confirmed diagnosis of achondroplasia and referral to a specialist centre. CONCLUSIONS: The European Achondroplasia Forum guiding principles of management recommend diagnosis of achondroplasia as early as possible. If concerns are raised at routine ultrasound, second line investigation should be implemented so that the diagnosis can be reached as soon as possible for ongoing management. Clinical and radiological examination supported by molecular testing is the most effective way to confirm diagnosis of achondroplasia after birth. Referral to a centre specialised in achondroplasia care should be made as soon as possible on suspicion or confirmation of diagnosis. In countries or regions where there are no official skeletal dysplasia reference or specialist centres, priority should be given to their creation or recognition, together with incentives to improve the structure of the existing multidisciplinary team managing achondroplasia. The length of delay between diagnosis of achondroplasia and referral to a specialist centre warrants further research.

Optimising care and follow-up of adults with achondroplasia.

BACKGROUND: Achondroplasia is a genetic condition that can cause complications across the lifespan. While complications in childhood are well documented, the natural history of achondroplasia in adults has, until recently, been relatively lacking, and little is known about the care they receive or how they access it. The European Achondroplasia Forum undertook two exploratory surveys, one for healthcare professionals (HCPs) and one for patient advocacy group (PAG) representatives, to gain an understanding of current practices of the transition process of individuals with achondroplasia from paediatric to adult services and how adults perceive their care. RESULTS: Most HCP respondents followed up more children than adults, and 8/15 responded that individuals did not transition to an adult multidisciplinary team (MDT) after paediatric care. Of 10 PAG respondents, none considered the experience of transition to adult services as good or very good and 50% considered it to be poor or very poor. A total of 64% (7/11) described the coordination of transition to adult services as "Not satisfactory" or "Poor". HCPs and PAG representatives largely agreed on the core specialists involved in adult care (orthopaedic surgeons, physiotherapists, rehabilitation specialists, rheumatologists, clinical geneticists). However, there was a discrepancy in the understanding of healthcare needs outside of this, with PAG representatives selecting neurosurgeons and genetic counsellors, while HCPs selected pulmonologists and obstetricians/gynaecologists. There was agreement between HCP and PAG respondents on the key barriers to effective care of adults with achondroplasia, with lack of an adult MDT, lack of interest from individuals in accessing care, and less experience in adult than paediatric MDTs ranking highly. CONCLUSIONS: This study indicates that the care and follow up of adults with achondroplasia is challenging. Individuals are often lost to, or decline, follow up as they leave paediatric care, and it is largely unknown how, where, and why adults with achondroplasia access care later in life. Lifelong, multidisciplinary specialist care led by an identified physician should be accessible to all individuals with achondroplasia. It is important to ensure barriers to optimal care are addressed to enable access to appropriate care for all individuals with achondroplasia.

Principles to guide spinal cord injury research partnerships: a Delphi consensus study.

PURPOSE: To establish consensus regarding principles that should be used to guide spinal cord injury (SCI) research partnerships between researchers and research users. MATERIALS AND METHODS: A three-round Delphi consensus exercise was carried out with researchers and/or research users involved in one or more SCI research partnerships. Participants considered a list of 125 partnership principles. In rounds 1 and 2, participants rated their agreement that a principle should guide SCI research partnerships on an 11-point Likert scale. After each round, principles that received a mean score of ≥8.0 or 70% of participants rated the principle ≥8.0 were retained. In round 3, participants categorized principles as essential, desirable, irrelevant, or unsure. RESULTS: At least 20 individuals participated in each round. In round 1, 103 principles met consensus criteria and eight principles were added. In round 2, 93 principles met the criteria. In round 3, 29 principles were categorized as essential and eight as desirable. Recommended principles focused on the interpersonal, relational, and logistical aspects of partnerships. Principles that did not reach consensus related to social justice and actionable impact. CONCLUSIONS: Findings provide insight into 37 principles that could be used to combat tokenism and inform future guidance to meaningfully engage partners in SCI research.Implications for RehabilitationConsensus-based research partnership principles (i.e., norms or beliefs) were identified and could be prioritized to help support spinal cord injury (SCI) researchers and research users combat tokenism and meaningfully engage research users as partners in the co-creation of knowledge.The resulting list of recommended research partnership principles was used to inform the development of guidance to support quality partnerships between SCI researchers and research users within and outside the rehabilitation context (www.IKTprinciples.com).Guidance supporting meaningful research partnerships may accelerate the time between discovery and use of research in practice.

Aligning restricted access data with FAIR: a systematic review.

Understanding the complexity of restricted research data is vitally important in the current new era of Open Science. While the FAIR Guiding Principles have been introduced to help researchers to make data Findable, Accessible, Interoperable and Reusable, it is still unclear how the notions of FAIR and Openness can be applied in the context of restricted data. Many methods have been proposed in support of the implementation of the principles, but there is yet no consensus among the scientific community as to the suitable mechanisms of making restricted data FAIR. We present here a systematic literature review to identify the methods applied by scientists when researching restricted data in a FAIR-compliant manner in the context of the FAIR principles. Through the employment of a descriptive and iterative study design, we aim to answer the following three questions: (1) What methods have been proposed to apply the FAIR principles to restricted data?, (2) How can the relevant aspects of the methods proposed be categorized?, (3) What is the maturity of the methods proposed in applying the FAIR principles to restricted data?. After analysis of the 40 included publications, we noticed that the methods found, reflect the stages of the Data Life Cycle, and can be divided into the following Classes: Data Collection, Metadata Representation, Data Processing, Anonymization, Data Publication, Data Usage and Post Data Usage. We observed that a large number of publications used 'Access Control' and 'Usage and License Terms' methods, while others such as 'Embargo on Data Release' and the use of 'Synthetic Data' were used in fewer instances. In conclusion, we are presenting the first extensive literature review on the methods applied to confidential data in the context of FAIR, providing a comprehensive conceptual framework for future research on restricted access data.

FAIR Digital Twins for Data-Intensive Research.

Although all the technical components supporting fully orchestrated Digital Twins (DT) currently exist, what remains missing is a conceptual clarification and analysis of a more generalized concept of a DT that is made FAIR, that is, universally machine actionable. This methodological overview is a first step toward this clarification. We present a review of previously developed semantic artifacts and how they may be used to compose a higher-order data model referred to here as a FAIR Digital Twin (FDT). We propose an architectural design to compose, store and reuse FDTs supporting data intensive research, with emphasis on privacy by design and their use in GDPR compliant open science.

Business and Human Rights Regulation After the UN Guiding Principles: Accountability, Governance, Effectiveness.

Since the UN Guiding Principles on Business and Human Rights (UNGPs) were adopted by the UN Human Rights Council in 2011, they have diffused into policy frameworks, laws, and regulations across the globe. This special issue seeks to advance the interdisciplinary field of human rights research by examining key elements of the emerging transnational regime for the regulation of business and human rights. In seven original contributions, scholars from political science, law, accounting, and philosophy critically reflect on the theoretical foundations of the UNGPs, they analyze the effectiveness of implementation mechanisms and current regulatory practice, and they advance proposals for the future development of the business and human rights regime. In this introduction, we prepare the ground for these analyses, proceeding in three steps. Firstly, we argue that the adoption of the UNGPs has triggered a norm cascade which requires a distinctive, empirically oriented research agenda focusing on the scope, governance, and effectiveness of corporate human rights accountability norms and instruments. Secondly, we explain how the articles in this special issue contribute to that research agenda by addressing these themes. Thirdly, we provide an overview of the individual contributions and point out avenues for future research.