Initiatives, Concepts, and Implementation Practices of FAIR (Findable, Accessible, Interoperable, and Reusable) Data Principles in Health Data Stewardship Practice: Protocol for a Scoping Review.

Data stewardship is an essential driver of research and clinical practice. Data collection, storage, access, sharing, and analytics are dependent on the proper and consistent use of data management principles among the investigators. Since 2016, the FAIR (findable, accessible, interoperable, and reusable) guiding principles for research data management have been resonating in scientific communities. Enabling data to be findable, accessible, interoperable, and reusable is currently believed to strengthen data sharing, reduce duplicated efforts, and move toward harmonization of data from heterogeneous unconnected data silos. FAIR initiatives and implementation trends are rising in different facets of scientific domains. It is important to understand the concepts and implementation practices of the FAIR data principles as applied to human health data by studying the flourishing initiatives and implementation lessons relevant to improved health research, particularly for data sharing during the coronavirus pandemic. This paper aims to conduct a scoping review to identify concepts, approaches, implementation experiences, and lessons learned in FAIR initiatives in the health data domain. The Arksey and O'Malley stage-based methodological framework for scoping reviews will be used for this review. PubMed, Web of Science, and Google Scholar will be searched to access relevant primary and grey publications. Articles written in English and published from 2014 onwards with FAIR principle concepts or practices in the health domain will be included. Duplication among the 3 data sources will be removed using a reference management software. The articles will then be exported to a systematic review management software. At least two independent authors will review the eligibility of each article based on defined inclusion and exclusion criteria. A pretested charting tool will be used to extract relevant information from the full-text papers. Qualitative thematic synthesis analysis methods will be employed by coding and developing themes. Themes will be derived from the research questions and contents in the included papers. The results will be reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews) reporting guidelines. We anticipate finalizing the manuscript for this work in 2021. We believe comprehensive information about the FAIR data principles, initiatives, implementation practices, and lessons learned in the FAIRification process in the health domain is paramount to supporting both evidence-based clinical practice and research transparency in the era of big data and open research publishing. PRR1-10.2196/22505.

Inau ET ，Sack J ，Waltemath D ，Zeleke AA ... -  《JMIR Research Protocols》

Initiatives, Concepts, and Implementation Practices of the Findable, Accessible, Interoperable, and Reusable Data Principles in Health Data Stewardship: Scoping Review.

Thorough data stewardship is a key enabler of comprehensive health research. Processes such as data collection, storage, access, sharing, and analytics require researchers to follow elaborate data management strategies properly and consistently. Studies have shown that findable, accessible, interoperable, and reusable (FAIR) data leads to improved data sharing in different scientific domains. This scoping review identifies and discusses concepts, approaches, implementation experiences, and lessons learned in FAIR initiatives in health research data. The Arksey and O'Malley stage-based methodological framework for scoping reviews was applied. PubMed, Web of Science, and Google Scholar were searched to access relevant publications. Articles written in English, published between 2014 and 2020, and addressing FAIR concepts or practices in the health domain were included. The 3 data sources were deduplicated using a reference management software. In total, 2 independent authors reviewed the eligibility of each article based on defined inclusion and exclusion criteria. A charting tool was used to extract information from the full-text papers. The results were reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. A total of 2.18% (34/1561) of the screened articles were included in the final review. The authors reported FAIRification approaches, which include interpolation, inclusion of comprehensive data dictionaries, repository design, semantic interoperability, ontologies, data quality, linked data, and requirement gathering for FAIRification tools. Challenges and mitigation strategies associated with FAIRification, such as high setup costs, data politics, technical and administrative issues, privacy concerns, and difficulties encountered in sharing health data despite its sensitive nature were also reported. We found various workflows, tools, and infrastructures designed by different groups worldwide to facilitate the FAIRification of health research data. We also uncovered a wide range of problems and questions that researchers are trying to address by using the different workflows, tools, and infrastructures. Although the concept of FAIR data stewardship in the health research domain is relatively new, almost all continents have been reached by at least one network trying to achieve health data FAIRness. Documented outcomes of FAIRification efforts include peer-reviewed publications, improved data sharing, facilitated data reuse, return on investment, and new treatments. Successful FAIRification of data has informed the management and prognosis of various diseases such as cancer, cardiovascular diseases, and neurological diseases. Efforts to FAIRify data on a wider variety of diseases have been ongoing since the COVID-19 pandemic. This work summarises projects, tools, and workflows for the FAIRification of health research data. The comprehensive review shows that implementing the FAIR concept in health data stewardship carries the promise of improved research data management and transparency in the era of big data and open research publishing. RR2-10.2196/22505.

Inau ET ，Sack J ，Waltemath D ，Zeleke AA ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Ethics of Procuring and Using Organs or Tissue from Infants and Newborns for Transplantation, Research, or Commercial Purposes: Protocol for a Bioethics Scoping Review.

Since the inception of transplantation, it has been crucial to ensure that organ or tissue donations are made with valid informed consent to avoid concerns about coercion or exploitation. This issue is particularly challenging when it comes to infants and younger children, insofar as they are unable to provide consent. Despite their vulnerability, infants' organs and tissues are considered valuable for biomedical purposes due to their size and unique properties. This raises questions about the conditions under which it is permissible to remove and use these body parts for transplantation, research, or commercial purposes. The aim of this protocol is to establish a foundation for a scoping review that will identify, clarify, and categorise the main ethical arguments regarding the permissibility of removing and using organs or tissues from infants. The scoping review will follow the methodology outlined by the Joanna Briggs Institute (JBI), consisting of five stages: (1) identifying the research question, (2) developing the search strategy, (3) setting inclusion criteria, (4) extracting data, and (5) presenting and analysing the results. We will include both published and unpublished materials that explicitly discuss the ethical arguments related to the procurement and use of infant organs or tissues in the biomedical context. The search will cover various databases, including the National Library of Medicine, Web of Science, EBSCO, and others, as well as grey literature sources. Two raters will independently assess the eligibility of articles, and data from eligible studies will be extracted using a standardised form. The extracted data will then be analysed descriptively through qualitative content analysis. There has been debate about how to respect the rights and interests of organ and tissue donors since the beginning of transplantation practice, given the moral risks involved in procuring parts of their bodies and using them for transplantation or research. A major concern has been to ensure that, at a minimum, donation of organs or other bodily tissues for transplantation or research is done under conditions of valid informed consent, so as to avoid coercion or exploitation among other moral harms. In the case of infants and younger children, however, this concern poses special difficulties insofar as infants and younger children are deemed incapable of providing valid consent. Due to their diminutive size and other distinctive properties, infants' organs and tissues are seen as valuable for biomedical purposes. Yet, the heightened vulnerability of infants raises questions about when and whether it is ever permissible to remove these body parts or use them in research or for other purposes. The aim of this protocol is to form the basis of a systematic scoping review to identify, clarify, and systematise the main ethical arguments for and against the permissibility of removing and using infant or newborn (hereafter, "infant") organs or tissues in the biomedical context (i.e. for transplantation, research, or commercial purposes). Our scoping review will broadly follow the well-established methodology outlined by the Joanna Briggs Institute ( Peters et al., 2020). We will follow a five-stage review process: (1) identification of the research question, (2) development of the search strategy, (3) inclusion criteria, (4) data extraction, and (5) presentation and analysis of the results. Published and unpublished bibliographic material (including reports, dissertations, book chapters, etc.) will be considered based on the following inclusion criteria: the presence of explicit (bio)ethical arguments or reasons (concept) for or against the procurement and use of organs or tissues from infants, defined as a child from birth until 1 year old (population), in the biomedical domain, including transplantation, research, and commercial development (context). We will search for relevant studies in the National Library of Medicine (including PubMed and MEDLINE), Virtual Health Library, Web of Science, Google Scholar, EBSCO, Google Scholar, PhilPapers, The Bioethics Literature Database (BELIT), EthxWeb as well as grey literature sources (e.g., Google, BASE, OpenGrey, and WorldCat) and the reference lists of key studies to identify studies suitable for inclusion. A three-stage search strategy will be used to determine the eligibility of articles, as recommended by the JBI methodological guidelines. We will exclude sources if (a) the full text is not accessible, (b) the main text is in a language other than English, or (c) the focus is exclusively on scientific, legal, or religious/theological arguments. All articles will be independently assessed for eligibility between two raters (MB & XL); data from eligible articles will be extracted and charted using a standardised data extraction form. The extracted data will be analysed descriptively using basic qualitative content analysis. Ethical review is not required as scoping reviews are a form of secondary data analysis that synthesise data from publicly available sources. Our dissemination strategy includes peer review publication, presentation at conferences, and outreach to relevant stakeholders. The results will be reported according to the PRISMA-ScR guidelines. An overview of the general data from the included studies will be presented in the form of graphs or tables showing the distribution of studies by year or period of publication, country of origin, and key ethical arguments. These results will be accompanied by a narrative summary describing how each included study or article relates to the aims of this review. Research gaps will be identified and limitations of the review will also be highlighted. A paper summarising the findings from this review will be published in a peer-reviewed journal. In addition, a synthesis of the key findings will be disseminated to biomedical settings (e.g., conferences or workshops, potentially including ones linked to university hospitals) in the UK, USA, Türkiye, and Singapore. They will also be shared with the academic community and policy makers involved in the organ procurement organisations (OPO), which will potentially consider our recommendations in their decision-making processes regarding infant tissue/organ donation practice in these countries. The use of a rigorous, well-established methodological framework will ensure the production of a high-quality scoping review that will contribute to the bioethics literature.A comprehensive search of disciplinary and cross-disciplinary databases will be undertaken to ensure coverage of all possible sources that meet the inclusion criteria for the review.This review will focus exclusively on infant tissue/organ procurement/use in biomedical contexts, providing a comprehensive and reliable source of ethical arguments for future debates on this sensitive topic.The review will be limited to articles published in English, which increases the risk of missing relevant sources published in other languages.The review will be limited to articles for which the full text is available, which increases the risk of missing relevant sources that otherwise may have been included in the scoping review had the full text been accessible.

Barış M ，Lim X ，T Almonte M ，Shaw D ，Brierley J ，Porsdam Mann S ，Nguyen T ，Menikoff J ，Wilkinson D ，Savulescu J ，Earp BD ... -  《-》

Approaches and Criteria for Provenance in Biomedical Data Sets and Workflows: Protocol for a Scoping Review.

Provenance supports the understanding of data genesis, and it is a key factor to ensure the trustworthiness of digital objects containing (sensitive) scientific data. Provenance information contributes to a better understanding of scientific results and fosters collaboration on existing data as well as data sharing. This encompasses defining comprehensive concepts and standards for transparency and traceability, reproducibility, validity, and quality assurance during clinical and scientific data workflows and research. The aim of this scoping review is to investigate existing evidence regarding approaches and criteria for provenance tracking as well as disclosing current knowledge gaps in the biomedical domain. This review covers modeling aspects as well as metadata frameworks for meaningful and usable provenance information during creation, collection, and processing of (sensitive) scientific biomedical data. This review also covers the examination of quality aspects of provenance criteria. This scoping review will follow the methodological framework by Arksey and O'Malley. Relevant publications will be obtained by querying PubMed and Web of Science. All papers in English language will be included, published between January 1, 2006 and March 23, 2021. Data retrieval will be accompanied by manual search for grey literature. Potential publications will then be exported into a reference management software, and duplicates will be removed. Afterwards, the obtained set of papers will be transferred into a systematic review management tool. All publications will be screened, extracted, and analyzed: title and abstract screening will be carried out by 4 independent reviewers. Majority vote is required for consent to eligibility of papers based on the defined inclusion and exclusion criteria. Full-text reading will be performed independently by 2 reviewers and in the last step, key information will be extracted on a pretested template. If agreement cannot be reached, the conflict will be resolved by a domain expert. Charted data will be analyzed by categorizing and summarizing the individual data items based on the research questions. Tabular or graphical overviews will be given, if applicable. The reporting follows the extension of the Preferred Reporting Items for Systematic reviews and Meta-Analyses statements for Scoping Reviews. Electronic database searches in PubMed and Web of Science resulted in 469 matches after deduplication. As of September 2021, the scoping review is in the full-text screening stage. The data extraction using the pretested charting template will follow the full-text screening stage. We expect the scoping review report to be completed by February 2022. Information about the origin of healthcare data has a major impact on the quality and the reusability of scientific results as well as follow-up activities. This protocol outlines plans for a scoping review that will provide information about current approaches, challenges, or knowledge gaps with provenance tracking in biomedical sciences. DERR1-10.2196/31750.

Gierend K ，Krüger F ，Waltemath D ，Fünfgeld M ，Ganslandt T ，Zeleke AA ... -  《JMIR Research Protocols》

Harm reduction for perinatal cannabis use: protocol for a scoping review of clinical practices.

The American College of Obstetricians and Gynaecologists recommends against cannabis use during pregnancy and lactation ('perinatal cannabis use') given its association with negative parent-child health outcomes. However, cannabis is becoming increasingly available and used during pregnancy, and perceptions of safety are correspondingly increasing. For individuals who are unable or unwilling to cease use during pregnancy and lactation, harm reduction is the best available evidence-based practice to promote health. Further, there have been calls for increased employment of harm reduction for perinatal cannabis use. However, the field currently lacks understanding of what harm reduction for this population looks like in practice. Likely contributing to this lack of understanding is the fact that the concept of harm reduction is not consistently defined, and strategies that comprise harm reduction may not always be labelled as such. This makes it challenging to comprehensively collect articles using search terms meant to pull for harm reduction specifically. The aim of this scoping review is to collect all articles discussing perinatal cannabis use published since the discovery of the endocannabinoid system, and then screen for references that describe concrete clinical practices that comprise harm reduction for this population. The Joanna Briggs Institute (JBI) Manual for Evidence Synthesis and the Arksey and O'Malley methodology for scoping reviews, as updated by Levac and colleagues, guide this review. The protocol is reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR). A systematic search of the literature was initially conducted to identify English-language articles authored between January 1990 and 2023 present in these databases as of 22 September 2023: PubMed (National Library of Medicine), Embase (Elsevier), Web of Science Core Collection (Clarivate), APA PsycINFO (EBSCO), CINAHL(EBSCO) and Cochrane Central Register of Controlled Trials (CENTRAL) (Wiley). Preceding submission of the results for publication, the search will be run again in order to ensure capturing later publications relevant for this review. Google search results will also be hand-searched for patient-facing materials. Additional grey literature sources include clinical trials, preprints and conference proceedings that were not excluded from the database search results. We will 'bookend' our search from 1990 to the present, as the 1990s saw the discovery of the endocannabinoid system, and the first passing of legalised medical cannabis in the USA. Literature will be eligible for inclusion if it includes a description of clinical approaches that comprise harm reduction for perinatal cannabis use. Two reviewers will independently complete title/abstract screening followed by full-text screening of the references that meet title/abstract criteria. Data, including the description of the clinical practice(s), dates of data collection, when and where the reference was published, legal status of cannabis in the place where the data was collected and any reported outcomes associated with the use of the harm reduction practice(s), will be extracted from the studies that remain eligible after full-text review. The studies will also be appraised for quality using the Mixed Methods Appraisal Tool (MMAT). Ethics approval was not sought as this review does not constitute data collection on human subjects (no information or specimens were collected from interaction or intervention with an individual). This scoping review will systematically examine the scope and coverage of existing clinical harm-reduction approaches for perinatal cannabis use in research and clinical practice. Findings will inform practice and elucidate future directions for research. The scoping review study team includes individuals who are themselves actively engaged in treating perinatal patients and they will participate in dissemination activities that allow review findings to reach patients and other providers (eg, presentations, publications). Registered with the Open Science Framework (OSF Registries; https://osf.io/wb3jc).

Albanese AM ，Littlewood A ，Creamer A ，Rogers B ，Elwy AR ... -  《BMJ Open》