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Review of Policy Research

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Review of Policy Research

The official journal of the STEP section is the  Review of Policy Research (RPR).   RPR  is an international peer-reviewed journal devoted to the publication of research and analysis examining the politics and policy of science and technology. These may include issues of science policy, environment, resource management, information networks, cultural industries, biotechnology, security and surveillance, privacy, globalization, education, research and innovation, development, intellectual property, health and demographics. The journal encompasses research and analysis on politics and the outcomes and consequences of policy change in domestic and comparative contexts.

The audience for  RPR  comprises members of the academic community, as well as members of the policy community, including government officials, NGOs and advocacy groups, research institutes and policy analysts.

The  Review of Policy Research  (RPR) invites original articles that apply and/or develop theoretical approaches to public policy. This includes established as well as emerging perspectives that originate from diverse political and national contexts and/or are located at the intersection of similar disciplines such as political science, public administration, political psychology, and political economy. The journal is open to different research designs, methodological approaches and combinations. RPR is published six times a year under the aegis of the Policy Studies Organization (PSO) and in cooperation with Wiley. As the official journal of the Science, Technology, and Environmental Politics (STEP) section of the American Political Science Association (APSA), RPR has a special interest in STE politics and policy but is open to every other policy field.

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Rapid literature review: definition and methodology

Beata smela.

a Assignity, Cracow, Poland

Mondher Toumi

b Public Health Department, Aix-Marseille University, Marseille, France

Karolina Świerk

Clement francois, małgorzata biernikiewicz.

c Studio Slowa, Wroclaw, Poland

Emilie Clay

d Clever-Access, Paris, France

Laurent Boyer

Introduction: A rapid literature review (RLR) is an alternative to systematic literature review (SLR) that can speed up the analysis of newly published data. The objective was to identify and summarize available information regarding different approaches to defining RLR and the methodology applied to the conduct of such reviews.

Methods: The Medline and EMBASE databases, as well as the grey literature, were searched using the set of keywords and their combination related to the targeted and rapid review, as well as design, approach, and methodology. Of the 3,898 records retrieved, 12 articles were included.

Results: Specific definition of RLRs has only been developed in 2021. In terms of methodology, the RLR should be completed within shorter timeframes using simplified procedures in comparison to SLRs, while maintaining a similar level of transparency and minimizing bias. Inherent components of the RLR process should be a clear research question, search protocol, simplified process of study selection, data extraction, and quality assurance.

Conclusions: There is a lack of consensus on the formal definition of the RLR and the best approaches to perform it. The evidence-based supporting methods are evolving, and more work is needed to define the most robust approaches.

Introduction

A systematic literature review (SLR) summarizes the results of all available studies on a specific topic and provides a high level of evidence. Authors of the SLR have to follow an advanced plan that covers defining a priori information regarding the research question, sources they are going to search, inclusion criteria applied to choose studies answering the research question, and information regarding how they are going to summarize findings [ 1 ].

The rigor and transparency of SLRs make them the most reliable form of literature review [ 2 ], providing a comprehensive, objective summary of the evidence for a given topic [ 3 , 4 ]. On the other hand, the SLR process is usually very time-consuming and requires a lot of human resources. Taking into account a high increase of newly published data and a growing need to analyze information in the fastest possible way, rapid literature reviews (RLRs) often replace standard SLRs.

There are several guidelines on the methodology of RLRs [ 5–11 ]; however, only recently, one publication from 2021 attempted to construct a unified definition [ 11 ]. Generally, by RLRs, researchers understand evidence synthesis during which some of the components of the systematic approach are being used to facilitate answering a focused research question; however, scope restrictions and a narrower search strategy help to make the project manageable in a shorter time and to get the key conclusions faster [ 4 ].

The objective of this research was to collect and summarize available information on different approaches to the definition and methodology of RLRs. An RLR has been run to capture publications providing data that fit the project objective.

To find publications reporting information on the methodology of RLRs, searches were run in the Medline and EMBASE databases in November 2022. The following keywords were searched for in titles and abstracts: ‘targeted adj2 review’ OR ‘focused adj2 review’ OR ‘rapid adj2 review’, and ‘methodology’ OR ‘design’ OR ‘scheme’ OR ‘approach’. The grey literature was identified using Google Scholar with keywords including ‘targeted review methodology’ OR ‘focused review methodology’ OR ‘rapid review methodology’. Only publications in English were included, and the date of publication was restricted to year 2016 onward in order to identify the most up-to-date literature. The reference lists of each included article were searched manually to obtain the potentially eligible articles. Titles and abstracts of the retrieved records were first screened to exclude articles that were evidently irrelevant. The full texts of potentially relevant papers were further reviewed to examine their eligibility.

A pre-defined Excel grid was developed to extract the following information related to the methodology of RLR from guidelines:

• Definition,
• Research question and searches,
• Studies selection,
• Data extraction and quality assessment,
• Additional information.

There was no restriction on the study types to be analyzed; any study reporting on the methodology of RLRs could be included: reviews, practice guidelines, commentaries, and expert opinions on RLR relevant to healthcare policymakers or practitioners. The data extraction and evidence summary were conducted by one analyst and further examined by a senior analyst to ensure that relevant information was not omitted. Disagreements were resolved by discussion and consensus.

Studies selection

A total of 3,898 records (3,864 articles from a database search and 34 grey literature from Google Scholar) were retrieved. After removing duplicates, titles and abstracts of 3,813 articles were uploaded and screened. The full texts of 43 articles were analyzed resulting in 12 articles selected for this review, including 7 guidelines [ 5–11 ] on the methodology of RLRs, together with 2 papers summarizing the results of the Delphi consensus on the topic [ 12 , 13 ], and 3 publications analyzing and assessing different approaches to RLRs [ 4 , 14 , 15 ].

Overall, seven guidelines were identified: from the World Health Organization (WHO) [ 5 ], National Collaborating Centre for Methods and Tools (NCCMT) [ 7 ], the UK government [ 8 ], the Oxford Centre for Evidence Based Medicine [ 9 ], the Cochrane group [ 6 , 11 ], and one multi-national review [ 10 ]. Among the papers that did not describe the guidelines, Gordon et al. [ 4 ] proposed 12 tips for conducting a rapid review in the right settings and discussed why these reviews may be more beneficial in some circumstances. The objective of work conducted by Tricco et al. [ 13 ] and Pandor et al. [ 12 ] was to collect and compare perceptions of rapid reviews from stakeholders, including researchers, policymakers, industry, journal editors, and healthcare providers, and to reach a consensus outlining the domains to consider when deciding on approaches for RLRs. Haby et al. [ 14 ] run a rapid review of systematic reviews and primary studies to find out the best way to conduct an RLR in health policy and practice. In Tricco et al. (2022) [ 15 ], JBI position statement for RLRs is presented.

From all the seven identified guidelines information regarding definitions the authors used for RLRs, approach to the PICOS criteria and search strategy development, studies selection, data extractions, quality assessment, and reporting were extracted.

Cochrane Rapid Reviews Methods Group developed methods guidance based on scoping review of the underlying evidence, primary methods studies conducted, as well as surveys sent to Cochrane representative and discussion among those with expertise [ 11 ]. They analyzed over 300 RLRs or RLR method papers and based on the methodology of those studies, constructed a broad definition RLR, one that meets a minimum set of requirements identified in the thematic analysis: ‘ A rapid review is a form of knowledge synthesis that accelerates the process of conducting a traditional systematic review through streamlining or omitting a variety of methods to produce evidence in a resource-efficient manner .’ This interpretation aligns with more than 50% of RLRs identified in this study. The authors additionally provided several other definitions, depending on specific situations or requirements (e.g., when RLR is produced on stakeholder’s request). It was additionally underlined that RLRs should be driven by the need of timely evidence for decision-making purposes [ 11 ].

Rapid reviews vary in their objective, format, and methods used for evidence synthesis. This is a quite new area, and still no agreement on optimal methods can be found [ 5 ]. All of the definitions are highlighting that RLRs are completed within shorter timeframes than SLRs, and also lack of time is one of the main reasons they are conducted. It has been suggested that most rapid reviews are conducted within 12 weeks; however, some of the resources suggest time between a few weeks to no more than 6 months [ 5 , 6 ]. Some of the definitions are highlighting that RLRs follow the SLR process, but certain phases of the process are simplified or omitted to retrieve information in a time-saving way [ 6 , 7 ]. Different mechanisms are used to enhance the timeliness of reviews. They can be used independently or concurrently: increasing the intensity of work by intensifying the efforts of multiple analysts by parallelization of tasks, using review shortcuts whereby one or more systematic review steps may be reduced, automatizing review steps by using new technologies [ 5 ]. The UK government report [ 8 ] referred to two different RLRs: in the form of quick scoping reviews (QSR) or rapid evidence assessments (REA). While being less resource and time-consuming compared to standard SLRs, QSRs and REAs are designed to be similarly transparent and to minimize bias. QSRs can be applied to rather open-ended questions, e.g., ‘what do we know about something’ but both, QSRs and REAs, provide an understanding of the volume and characteristics of evidence on a specific topic, allowing answering questions by maximizing the use of existing data, and providing a clear picture of the adequacy of existing evidence [ 8 ].

Research questions and searches

The guidelines suggest creating a clear research question and search protocol at the beginning of the project. Additionally, to not duplicate RLRs, the Cochrane Rapid Reviews Methods Group encourages all people working on RLRs to consider registering their search protocol with PROSPERO, the international prospective register of reviews; however, so far they are not formally registered in most cases [ 5 , 6 ]. They also recommend involving key stakeholders (review users) to set and refine the review question, criteria, and outcomes, as well as consulting them through the entire process [ 11 ].

Regarding research questions, it is better to structure them in a neutral way rather than focus on a specific direction for the outcome. By doing so, the researcher is in a better position to identify all the relevant evidence [ 7 ]. Authors can add a second, supportive research question when needed [ 8 ]. It is encouraged to limit the number of interventions, comparators and outcomes, to focus on the ones that are most important for decision-making [ 11 ]. Useful could be also reviewing additional materials, e.g., SLRs on the topic, as well as conducting a quick literature search to better understand the topic before starting with RLRs [ 7 ]. In SLRs researchers usually do not need to care a lot about time spent on creating PICOS, they need to make sure that the scope is broad enough, and they cannot use many restrictions. When working on RLRs, a reviewer may spend more or less time defining each of the components of the study question, and the main step is making sure that PICOS addresses the needs of those who requested the rapid review, and at the same time, it is feasible within the required time frame [ 7 ]. Search protocol should contain an outline of how the following review steps are to be carried out, including selected search keywords and a full strategy, a list of data sources, precise inclusion and exclusion criteria, a strategy for data extraction and critical appraisal, and a plan of how the information will be synthesized [ 8 ].

In terms of searches running, in most cases, an exhaustive process will not be feasible. Researchers should make sure that the search is effective and efficient to produce results in a timely manner. Cochrane Rapid Reviews Methods Group recommends involving an information specialist and conducting peer review of at least one search strategy [ 11 ]. According to the rapid review guidebook by McMaster University [ 7 ], it is important that RLRs, especially those that support policy and program decisions, are being fed by the results of a body of literature, rather than single studies, when possible. It would result in more generalizable findings applied at the level of a population and serve more realistic findings for program decisions [ 7 ]. It is important to document the search strategy, together with a record of the date and any date limits of the search, so that it can easily be run again, modified, or updated. Furthermore, the information on the individual databases included in platform services should always be reported, as this depends on organizations’ subscriptions and must be included for transparency and repeatability [ 7 , 8 ]. Good solution for RLRs is narrowing the scope or searching a limited number of databases and other sources [ 7 ]. Often, the authors use the PubMed/MEDLINE, Cochrane Library, and Embase databases. In most reviews, two or more databases are searched, and common limits are language (usually restricted to English), date, study design, and geographical area. Some RLRs include searching of grey literature; however, contact with authors is rather uncommon [ 5 , 8 ]. According to the flexible framework for restricted systematic review published by the University of Oxford, the search should be run in at least one major scientific database such as PubMed, and one other source, e.g., Google Scholar [ 9 ]. Grey literature and unpublished evidence may be particularly needed and important for intervention questions. It is related to the fact that studies that do not report the effects of interventions are less likely to be published [ 8 ]. If there is any type of evidence that will not be considered by the RLRs, e.g., reviews or theoretical and conceptual studies, it should also be stated in the protocol together with justification [ 8 ]. Additionally, authors of a practical guide published by WHO suggest using a staged search to identify existing SLRs at the beginning, and then focusing on studies with other designs [ 5 ]. If a low number of citations have been retrieved, it is acceptable to expand searches, remove some of the limits, and add additional databases and sources [ 7 ].

Searching for RLRs is an iterative process, and revising the approach is usually needed [ 7 ]. Changes should be confirmed with stakeholders and should be tracked and reflected in the final report [ 5 ].

The next step in the rapid review is the selection of studies consisting of two phases: screening of titles and abstracts, and analysis of full texts. Prior to screening initiation, it is recommended to conduct a pilot exercise using the same 30–50 abstracts and 5–10 full-texts for the entire screening team in order to calibrate and test the review form [ 11 ]. In contrast to SLRs, it can be done by one reviewer with or without verification by a second one. If verification is performed, usually the second reviewer checks only a subset of records and compares them. Cochrane Group, in contrast, recommends a stricter approach: at least 20% of references should be double-screened at titles and abstracts stage, and while the rest of the references may be screened by one reviewer, the excluded items need to be re-examined by second reviewer; similar approach is used in full-text screening [ 11 ]. This helps to ensure that bias was reduced and that the PICOS criteria are applied in a relevant way [ 5 , 8 , 9 , 11 ]. During the analysis of titles and abstracts, there is no need to report reasons for exclusion; however, they should be tracked for all excluded full texts [ 7 ].

Data extraction and quality assessment

According to the WHO guide, the most common method for data extraction in RLRs is extraction done by a single reviewer with or without partial verification. The authors point out that a reasonable approach is to use a second reviewer to check a random sample of at least 10% of the extractions for accuracy. Dual performance is more necessary for the extraction of quantitative results than for descriptive study information. In contrast, Cochrane group recommends that second reviewer should check the correctness and completeness of all data [ 11 ]. When possible, extractions should be limited to key characteristics and outcomes of the study. The same approach to data extraction is also suggested for a quality assessment process within rapid reviews [ 5 , 9 , 11 ]. Authors of the guidebook from McMaster University highlight that data extraction should be done ideally by two reviewers independently and consensus on the discrepancies should always be reached [ 7 ]. The final decision on the approach to this important step of review should depend on the available time and should also reflect the complexity of the research question [ 9 ].

For screening, analysis of full texts, extractions, and quality assessments, researchers can use information technologies to support them by making these review steps more efficient [ 5 ].

Before data reporting, a reviewer should prepare a document with key message headings, executive summary, background related to the topic and status of the current knowledge, project question, synthesis of findings, conclusions, and recommendations. According to the McMaster University guidebook, a report should be structured in a 1:2:20 format, that is, one page for key messages, two pages for an executive summary, and a full report of up to 20 pages [ 7 ]. All the limitations of the RLRs should be analyzed, and conclusions should be drawn with caution [ 5 ]. The quality of the accumulated evidence and the strength of recommendations can be assessed using, e.g., the GRADE system [ 5 ]. When working on references quoting, researchers should remember to use a primary source, not secondary references [ 7 ]. It would be worth considering the support of some software tools to automate reporting steps. Additionally, any standardization of the process and the usage of templates can support report development and enhance the transparency of the review [ 5 ].

Ideally, all the review steps should be completed during RLRs; however, often some steps may need skipping or will not be completed as thoroughly as should because of time constraints. It is always crucial to decide which steps may be skipped, and which are the key ones, depending on the project [ 7 ]. Guidelines suggest that it may be helpful to invite researchers with experience in the operations of SLRs to participate in the rapid review development [ 5 , 9 ]. As some of the steps will be completed by one reviewer only, it is important to provide them with relevant training at the beginning of the process, as well as during the review, to minimize the risk of mistakes [ 5 ].

Additional information

Depending on the policy goal and available resources and deadlines, methodology of the RLRs may be modified. Wilson et al. [ 10 ] provided extensive guidelines for performing RLR within days (e.g., to inform urgent internal policy discussions and/or management decisions), weeks (e.g., to inform public debates), or months (e.g., to inform policy development cycles that have a longer timeline, but that cannot wait for a traditional full systematic review). These approaches vary in terms of data synthesis, types of considered evidence and project management considerations.

In shortest timeframes, focused questions and subquestions should be formulated, typically to conduct a policy analysis; the report should consist of tables along with a brief narrative summary. Evidence from SLRs is often considered, as well as key informant interviews may be conducted to identify additional literature and insights about the topic, while primary studies and other types of evidence are not typically feasible due to time restrictions. The review would be best conducted with 1–2 reviewers sharing the work, enabling rapid iterations of the review. As for RLRs with longer timeline (weeks), these may use a mix of policy, systems and political analysis. Structure of the review would be similar to shorter RLRs – tabular with short narrative summary, as the timeline does not allow for comprehensive synthesis of data. Besides SLRs, primary studies and other evidence may be feasible in this timeframe, if obtained using the targeted searches in the most relevant databases. The review team should be larger, and standardized procedures for reviewing of the results and data extraction should be applied. In contrast to previous timeframe, merit review process may be feasible. For both timeframes, brief consultations with small transdisciplinary team should be conducted at the beginning and in the final stage of the review to discuss important matters.

For RLRs spanning several months, more comprehensive methodology may be adapted in terms of data synthesis and types of evidence. However, authors advise that review may be best conducted with a small review team in order to allow for more in-depth interpretation and iteration.

Studies analyzing methodology

There have been two interesting publications summarizing the results of Delphi consensus on the RLR methodology identified and included in this review [ 12 , 13 ].

Tricco et al. [ 13 ] first conducted an international survey and scoping review to collect information on the possible approaches to the running of rapid reviews, based on which, they employed a modified Delphi method that included inputs from 113 stakeholders to explore the most optimized approach. Among the six most frequent rapid review approaches (not all detailed here) being evaluated, the approach that combines inclusion of published literature only, a search of more than one database and limitations by date and language, study selection by one analyst, data extraction, and quality assessment by one analyst and one verifier, was perceived as the most feasible approach (72%, 81/113 responses) with the potentially lowest risk of bias (12%, 12/103). The approach ranked as the first one when considering timelines assumes updating of the search from a previously published review, no additional limits on search, studies selection and data extraction done by one reviewer, and no quality assessment. Finally, based on the publication, the most comprehensive RLRs can be made by moving on with the following rules: searching more than one database and grey literature and using date restriction, and assigning one reviewer working on screening, data extraction, and risk of bias assessment ( Table 1 ). Pandor et al. [ 12 ] introduced a decision tool for SelecTing Approaches for Rapid Reviews (STARR) that were produced through the Delphi consensus of international experts through an iterative and rigorous process. Participants were asked to assess the importance of predefined items in four domains related to the rapid review process: interaction with commissioners, understanding the evidence base, data extraction and synthesis methods, and reporting of rapid review methods. All items assigned to four domains achieved > 70% of consensus, and in that way, the first consensus-driven tool has been created that supports authors of RLRs in planning and deciding on approaches.

Six most frequent approaches to RLRs (adapted from Tricco et al. [ 13 ]).

Haby et al. [ 14 ] run searches of 11 databases and two websites and developed a comprehensive overview of the methodology of RLRs. With five SLRs and one RCT being finally included, they identified the following approaches used in RLRs to make them faster than full SLRs: limiting the number and scope of questions, searching fewer databases, limited searching of grey literature, restrictions on language and date (e.g., English only, most recent publications), updating the existing SLRs, eliminating or limiting hand searches of reference lists, noniterative search strategies, eliminating consultation with experts, limiting dual study selection, data extraction and quality assessment, minimal data synthesis with short concise conclusions or recommendations. All the SLRs included in this review were consistent in stating that no agreed definition of rapid reviews is available, and there is still no final agreement on the best methodological rules to be followed.

Gordon et al. [ 4 ] explained the advantages of performing a focused review and provided 12 tips for its conduction. They define focused reviews as ‘a form of knowledge synthesis in which the components of the systematic process are applied to facilitate the analysis of a focused research question’. The first tip presented by the authors is related to deciding if a focused review is a right solution for the considered project. RLRs will suit emerging topics, approaches, or assessments where early synthesis can support doctors, policymakers, etc., but also can direct future research. The second, third, and fourth tips highlight the importance of running preliminary searches and considering narrowing the results by using reasonable constraints taking into account the local context, problems, efficiency perspectives, and available time. Further tips include creating a team of experienced reviewers working on the RLRs, thinking about the target journal from the beginning of work on the rapid review, registering the search protocol on the PROSPERO registry, and the need for contacting authors of papers when data available in publications are missing or incongruent. The last three tips are related to the choice of evidence synthesis method, using the visual presentation of data, and considering and describing all the limitations of the focused review.

Finally, a new publication by Tricco et al. from 2022, describing JBI position statement [ 15 ] underlined that for the time being, there is no specific tool for critical appraisal of the RLR’s methodological quality. Instead, reviewers may use available tools to assess the risk of bias or quality of SLRs, like ROBIS, the JBI critical appraisal tools, or the assessment of multiple systematic reviews (AMSTAR).

Inconsistency in the definitions and methodologies of RLR

Although RLR was broadly perceived as an approach to quicken the conduct of conventional SLR, there is a lack of consensus on the formal definition of the RLR, so as to the best approaches to perform it. Only in 2021, a study proposing unified definition was published; however, it is important to note that the most accurate definition was only matching slightly over 50% of papers analysed by the authors, which underlines the lack of homogeneity in the field [ 11 ]. The evidence-based supporting methods are evolving, and more evidence is needed to define the most robust approaches [ 5 ].

Diverse terms are used to describe the RLR, including ‘rapid review’, focused systematic review’, ‘quick scoping reviews’, and ‘rapid evidence assessments’. Although the general principles of conducting RLR are to accelerate the whole process, complexity was seen in the methodologies used for RLRs, as reflected in this study. Also, inconsistencies related to the scope of the questions, search strategies, inclusion criteria, study screening, full-text review, quality assessment, and evidence presentation were implied. All these factors may hamper decision-making about optimal methodologies for conducting rapid reviews, and as a result, the efficiency of RLR might be decreased. Additionally, researchers may tend to report the methodology of their reviews without a sufficient level of detail, making it difficult to appraise the quality and robustness of their work.

Advantages and weaknesses of RLR

Although RLR used simplified approaches for evidence synthesis compared with SLR, the methodologies for RLR should be replicable, rigorous, and transparent to the greatest extent [ 16 ]. When time and resources are limited, RLR could be a practical and efficient tool to provide the summary of evidence that is critical for making rapid clinical or policy-related decisions [ 5 ]. Focusing on specific questions that are of controversy or special interest could be powerful in reaffirming whether the existing recommendation statements are still appropriate [ 17 ].

The weakness of RLR should also be borne in mind, and the trade-off of using RLR should be carefully considered regarding the thoroughness of the search, breadth of a research question, and depth of analysis [ 18 ]. If allowed, SLR is preferred over RLR considering that some relevant studies might be omitted with narrowed search strategies and simplified screening process [ 14 ]. Additionally, omitting the quality assessment of included studies could result in an increased risk of bias, making the comprehensiveness of RLR compromised [ 13 ]. Furthermore, in situations that require high accuracy, for example, where a small relative difference in an intervention has great impacts, for the purpose of drafting clinical guidelines, or making licensing decisions, a comprehensive SLR may remain the priority [ 19 ]. Therefore, clear communications with policymakers are recommended to reach an agreement on whether an RLR is justified and whether the methodologies of RLR are acceptable to address the unanswered questions [ 18 ].

Disclosure statement

No potential conflict of interest was reported by the author(s).

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Children’s Participation in Child Welfare: A Systematic Review of Systematic Reviews

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Paul McCafferty, Esther Mercado Garcia, Children’s Participation in Child Welfare: A Systematic Review of Systematic Reviews, The British Journal of Social Work , Volume 54, Issue 3, April 2024, Pages 1092–1108, https://doi.org/10.1093/bjsw/bcad167

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The objective of this research was to conduct a systematic review of systematic reviews related to Article 12 of the UN Convention on the Rights of the Child (UNCRC) as it relates to children and young people involved with child welfare agencies. This systematic review sought to comply with the guidance from the JBI Manual for Evidence Synthesis on umbrella reviews. Fourteen databases were searched using predefined terms. Six hundred seventy-four original hits were retrieved for title and abstract searching after independent searching by the authors. Of those, fourteen were included for full independent reads and all fourteen were selected after discussion. Each systematic review was appraised using an eleven-point quality checklist from JBI. A thematic review was conducted to ascertain the themes across all systematic reviews. Three themes emerged (i) children’s voice is not taken seriously; (ii) relationships are an important determining factor in (un)successful participation; and (iii) the context of participation is important. Our conclusion is that despite mandated UNCRC requirements to involve children and young people within the child protection system, the possibilities for children and young people to express their views remain restricted.

Article 12 of the UN Convention on the Rights of the Child (UNCRC) stipulates that children have the right to express their views and to participate in decisions that directly affect them. Uncomplicated enough one would have supposed, intuitive in fact, for who could possibly argue against children and young people (C&YP) having a voice in decisions that affect them—the most basic of human rights. After all, adults enjoy this right. And for the authors of the Convention, this inalienable right must have seemed obvious too, fundamental almost in its inherent assumption that it is just the right thing to do.

But the reality of successfully applying Article 12 has bedevilled legislators, policymakers and practitioners alike since the inception on the Convention on the Rights of the Child (the Convention) as they struggle to decipher and apply their Article 12 obligations to practice ( McCafferty, 2021 ). Consequently, the practice reality regarding enacting Article 12 obligations has created something of a legislative, policy and practice duality; one in which States and state actors are mandated to listen, involve and respond to C&YP’s voice but find doing so exceptionally taxing. What we call the practice reality/legislative mandate duality has arguably led to unintended obfuscation in the participatory landscape with a parallel diminution of the voice of C&YP. This duality is nowhere more apparent than in child welfare, the result of which has generated a disappointing stasis where the voice of arguably society’s most vulnerable C&YP is lost ( McCafferty, 2021 ).

Whilst research in the social work field may have been to some extent sluggish to explore children’s participation, it has increased more recently in both quality and quantity with a growing number of scholars paying greater attention to this field of study. Both empirical and theoretical studies are beginning to enrich our understanding of the opportunities and challenges Article 12 presents for C&YPs participation in child welfare. This increased interest is fuelled by a feeling that we in social work are somehow just not getting it right and we stand accused of persistent failures to involve children fully in decisions affecting them (e.g. Department for Education (DfE), 2020 ).

General themes emerging from research broadly suggest two things. First, that challenges exist at practitioner, managerial, organisational, systems and societal level that frustrate the full actualisation of C&YP’s right to be heard. For example, Toros (2021a,b ) in two systematic reviews suggests that children are not able to participate in decision-making processes often enough and their voices are either not being heard or not taken seriously. Faced with the unenviable task of protecting children in an ever increasingly complex world, child welfare professionals are entrusted both ethically and legally with acting in children’s best interests and deciding where and how those best interests are met. However, these best interest decisions are recognised as being amongst the most testing decisions a child welfare worker is likely to make due to their challenging and contested nature (McCafferty, 2020). In this environment, research by McCafferty et al. (2021) suggests that child welfare practitioners are making increasingly more protectionist and interventionist decisions and that this process instinctively reduces C&YP’s agentic status as individuals capable of forming a view and for that view to be heard. ‘As a result of this deficit archetype based on difference, children tend to be granted protection in social work which excludes them from decisions, deprives them of their autonomy, assumes incompetence and emphasises dependence on adults’ ( McCafferty, 2017 , p. 333).

Secondly, when done well, involving C&YP in decisions that affect their life trajectory has beneficial outcomes for them and evidence of this exists across a range of disciplines such as in health, education and policy making ( van Bijleveld et al. , 2015 ; Kennan et al. , 2018 ). Furthermore, participation in decision-making results in beneficial developmental effects ( Falch‐Eriksen et al ., 2021 ) as well as potentially improving decision-making processes and outcomes by ensuring that decisions are more inclusive, responsive and tailored to specific needs. C&YP’s participation increases the likelihood of assessments being more accurate and outcomes more in line with what C&YP need, contributing to more accurate assessment outcomes, as it increases the accuracy of the understanding of the child’s emotional state, thoughts, feelings and hopes for the future.

So, we know that since 1989 when the UNCRC was first enacted, social work has studied C&YPs participation in child welfare, and several systematic reviews have already been conducted. Collectively they provide a large body of relevant evidence, one so large, however, that it is not easy to summarise the patterns in their findings. This makes it challenging for decision makers, researchers, academics and practitioners to utilise the best available evidence to inform their decisions. The time is right therefore to draw thirty-three years’ worth of data into one study so that we can take stock of where we are at in terms of our knowledge, drawing all the disparate systematic reviews into one place.

The purpose of this systematic review is to condense data from all the existing systematic reviews into one overarching review and deliver a meticulous summary of all the available research from systematic reviews of C&YPs participation in child welfare. Called an umbrella review by Aromataris and Munn (2020) , this umbrella review will appraise and collate all relevant empirical evidence gathered from existing systematic reviews into one place to provide a complete interpretation of research results. Doing so will identify questions for which the available evidence provides clear answers and thus for which further research is not necessary. The review will also identify research gaps in our current understanding of the field and help set the short- to medium-term research priorities for scholars going forward.

Search strategy

The characteristics of a systematic review are well-defined and internationally accepted and they generally agree that the defining characteristics of a systematic review are that it must have (i) clearly articulated objectives and questions to be addressed; (ii) an inclusion and exclusion criteria stipulated a priori that determine the eligibility of studies; (iii) a comprehensive search to identify all relevant studies, both published and unpublished; (iv) an appraisal of the quality of included studies, assessment of the validity of their results, and reporting of any exclusions based on quality; (v) analysis of data extracted from the included research; (vi) a presentation and synthesis of the findings extracted and (vii) a transparent reporting of the methodology and methods used to conduct the review ( Higgins et al., 2022 ). This review sought to comply with the guidance from JBI Manual for Evidence Synthesis (Aromataris and Munn, 2020), specifically Chapter 10, Umbrella Reviews, and Evidence-Based Practice ( Aromataris et al. , 2020 ).

In the process of creating a search formula, the topic addressed by this review was converted into four key concept groups as agreed by both authors: <participation> AND <social work> AND <child welfare> AND <children and young people>. For each concept, search terms reflecting its main characteristics were identified and combined into a search formula by both authors in consultation with the subject specialist librarian from Queen’s University Belfast over three meetings. This generic formula was reviewed and later adjusted by both authors along with the subject librarian to fit the databases’ particular facilities. The selection of electronic bibliographic databases was informed by both pragmatic and methodological considerations relating to databases’ quality appraisal, relevance and accessibility. The searches took place over a two-week period between 15 and 29 August 2022.

Overall, fourteen electronic bibliographic databases were selected:

Child Development.

Directory of Open Access Journals (DOJA).

International Bibliography of the Social Sciences (IBSS).

Social Care Online.

Social Policy and Practice.

Social Science Citation Index.

Social Services Abstracts.

Sociological Abstracts.

Campbell Collaboration.

CINAHL Plus.

Cochrane Central Register of Controlled Trials (CENTRAL).

Google Scholar.

Inclusion and exclusion criteria

Beginning with quality criteria, this umbrella review was restricted to articles published in peer-reviewed journals. Doing so ensures that there was an independent standard of quality applied that goes beyond the knowledge base of the authors and incorporates the expertise of journal reviewers ( Alfandari and Taylor, 2022 ). Regarding relevance criteria, to be included in our umbrella review, studies needed to be (i) a systematic review of relevant papers pertaining to the topic, (ii) the topic needed to relate to C&YP’s participation in child welfare social work, (iii) to qualify as a systematic review, reviews needed to (a) employ a systematic, recognised, explicit and replicable processes for searching the literature to retrieve research related to the topic, and (b) report on empirical research that is based on either quantitative, qualitative or mixed methods research designs—action research or single case study methods that impose greater challenges for determining quality ( Taylor et al. , 2015 ) theoretical material, editorials, government papers and policy documents were all excluded from this review. In addition, the time frame of the search was from 1989 when the UNCRC was enacted to ensure we gained a full representation of every review published since that time. Finally, for practical reasons, the search was restricted to publications in the English language.

Search outcome and screening

There were two rounds of searches, both done independently by each author. Bibliographic data about the studies derived was imported into an Excel spreadsheet with separate pages for each database and when combined there was a total of 889 searches retrieved. Through discussion, 215 duplicates were agreed upon and removed leaving 674 original hits. When agreement was reached about the removal, initial titles and abstract screening against the inclusion criteria took place, again independently. Based on a structured colour coding scheme developed by the authors, each study was tagged with one of four possible colours: (i) blue for inclusion; (ii) red for exclusion; (iii) green in cases of uncertainties that required more discussion; and (iv) grey, in cases of uncertainties that required additional information when bibliographic data were incomplete. Studies coloured red were also recorded by the reasons for their exclusion, which were chosen from our inclusion criteria. The authors then came together and agreed on ninety-eight studies for full-text assessment for inclusion with eligibility carried out independently by the authors. When disagreements arose, they were thoroughly discussed between the authors until a consensus was reached. Of these ninety-eight studies, eighty-four were removed leaving fourteen studies included for the umbrella review.

Once this first round was complete, each author completed an independent review of each study’s reference list by hand. One further study was identified through this search for a full read but was discounted by agreement having not met the inclusion criteria.

The review’s selection process is outlined in Figure 1 using the PRISMA diagram ( Page et al. , 2021 ).

Flowchart of the search and screening process.

Data analysis

Data analysis summarised the included reviews focusing on number of reviews published, type of review (e.g. systematic review, systematic scoping, literature review), aim, period, number of articles, place of publication, analysis and findings. When articles specified the PRISMA flow diagram was used, it was specified. For data analysis, the authors reviewed all the articles and developed three themes—(i) children’s voice is not taken seriously, (ii) relationships are an important determining factor in (un)successful participation and (iii) the context of participation is important.

Included studies

Data analysis is based on fourteen studies published from 1989 to 2022. The characteristics of included studies provided an overview of the existing literature on the subject (see Table 1 ).

Summary of studies analysed.

Quality appraisal

Studies identified as meeting the inclusion criteria were appraised for quality against the JBI Checklist for Systematic Reviews and Research Synthesis by Aromataris et al. (2015) using an eleven-point quality assessment tool to determine the quality of each of the systematic reviews selected for inclusion. The authors independently scored each of the items before jointly discussing them and coming to a consensus about quality. Discussions focused on what was considered acceptable to the aims of the review in terms of the specific study characteristics and what represented an adequate search strategy or appropriate methods of synthesis. Discussions took place prior to this appraisal so we agreed on what constituted acceptable levels of information to allocate a positive appraisal compared with a negative, or response of ‘unclear’. All fourteen studies were included.

Umbrella review

Data analysis revealed three main themes.

Theme 1: Children’s voice is not taken seriously

Studies show children’s participation in the child protection system is significantly diminished in practice ( Skauge et al ., 2021 ; Toros, 2021a ). Children have the right to be heard and to make decisions about their own lives, but their voices have been weakened and they find that being authentically heard and to exercise their right to participation is challenging ( Brummelaar et al ., 2018 ; Collins et al. , 2021 ; McPherson et al ., 2021 ). This is particularly evident in residential settings ( McPherson et al. , 2021 ; van Bijleveld et al ., 2015 ), child maltreatment ( Bartelink et al. , 2015 ) and within mental health services ( Davies and Wright, 2008 ).

This research indicates that despite the recognised importance of children’s rights and participation ( Falch-Eriksen et al. , 2021 ), children are often unable to participate in decision-making processes and that their voices are not taken seriously or heard ( Toros, 2021b ). Kennan et al. (2018) , however, showed how the use of advocates could encourage participation in such contexts, especially with younger children who feel more dissatisfied ( Brummelaar et al ., 2018 ).

Theme 2: Relationships are an important determining factor in (un)successful participation

The relationship between social workers and children is essential to the promotion of participation. McPherson et al. (2021) address the central role of the relationship and relational practice in the process of facilitating participation. Findings across studies suggest several factors influence this relationship and the process and success of participation. First, the age of the child ( Brummelaar et al. , 2018 ; Toros, 2021a ); secondly, protectionist approaches adopted by professionals and welfare agencies ( Toros, 2021a ; van Bijleveld et al. , 2015 ); thirdly, the quality of the professional relationship ( van Bijleveld et al. , 2015 ; Brummelaar et al. , 2018 ; Kennan et al. , 2018 ; Strømland et al. , 2022 ); fourthly, professionals’ attitude towards participation—positive or negative ( Brummelaar et al., 2018 ); fifthly, stigmatising and impairment-focused practices ( Toros et al., 2018 ) and, finally, professional qualities ( Davies and Wright, 2008 ; van Bijleveld et al ., 2015 ). From the perspective of C&YP themselves within the child protection system itself, the study by Wilson et al. (2020) emphasises that C&YP’s early experiences of child welfare relationships are felt as frightening due to the pressure of the investigation process, the invasiveness of professionals and that this decreases participatory activity.

In this sense, professionals may have conflicting attitudes towards children’s views and perceptions ( Brummelaar et al ., 2018 ), differences in the interpretation of participation and the weight given to C&YP opinions in the decision-making process exist ( van Bijleveld et al ., 2015 ; Skauge et al ., 2021 ), ambivalence towards professional participatory intervention also exists ( Davies and Wright, 2008 ), whilst children’s perspectives differ from that of professionals ( Toros et al., 2018 ).

Theme 3: The context of participation is important

The concept of participation is confusing ( Collins et al ., 2021 ). The lack of full recognition and operationalisation of children’s right to be sufficiently heard is one of the main challenges in the context of participation ( Strømland et al ., 2022 ). This may be because child protection systems are very heterogeneous in terms of legislation, approaches and working methods ( Skauge et al. , 2021 ). Ideas about participation are underpinned by policies in which different cultural and organisational contexts underlie and limit participation itself ( Brummelaar et al ., 2018 ; Jensen et al ., 2020 ; Skauge et al ., 2021 ). Despite attempts to follow processes such as the use of advocates, a child’s attendance at an assessment, planning or review meeting, Family Welfare Conferences and recording a child’s views in writing, spaces are neither inclusive nor conducive to fostering such participation ( Kennan et al ., 2018 ). In the study of Toros et al. (2018) , studies suggest that protection concerns and bureaucratised and authority-based systems limit such a participatory context.

These organisational challenges are related to government perceptions and media representations of public awareness ( Davies and Wright, 2008 ; van Bijleveld et al ., 2015 ) and risk assessment of children ( Davies and Wright, 2008 ; Bartelink et al ., 2015 ). The lack of quality time to work directly with C&YP has also been cited as one of the main problems social workers encounter when trying to involve C&YP ( van Bijleveld et al., 2015 ).

Participation has become firmly rooted in child rights discourse, public policy and research around the world ( Skauge et al ., 2021 ). Within the child protection system, it has been considered an important issue, but despite the CRC guidelines, possibilities to express their views and needs are restricted ( Toros, 2021a ).

Cultural conceptions, the adult-centric worldview of social work professionals, age discrimination, denial of opportunities and unhelpful participatory efforts remain a major challenge ( Collins, 2017 ; Strømland et al ., 2022 ). How this power is exercised is influenced by ideology, attitudes and beliefs ( Wilson et al ., 2020 ; McPherson et al ., 2021 ). As such, conceptualisations of protection continue to reflect traditional approaches to participation in child welfare that indicate a reductionist paternalistic attitude that privileges protection over empowerment ( Collins, 2017 ; Collins et al ., 2021 ). The findings found in this article evidence that the fragmented view of children through polarised thinking via dichotomous positions rather than a holistic view may be due to the complexity of child protection work ( Jensen, 2020 ). The poor relationship between professionals and children may be influenced by bureaucratisation, lack of resources and lack of knowledge ( van Bijleveld et al ., 2015 ; Falch-Eriksen et al ., 2021 ; Skauge et al ., 2021 ).

Based on the three main themes of this article, several implications can be drawn. First, care and professional systems can break down the division between everyday life decisions and important decisions in children’s lives ( McPherson et al ., 2021 ). Structured and shared methods of assessment and decision making are therefore needed ( Bartelink et al ., 2015 ). Secondly, the role of social workers and their relationship with the child is crucial in fostering the right to participation ( Brummelaar et al., 2018 ). To improve the quality of relationships between workers and children, therefore, a paradigm shift and methods are needed to help professionals increase their competence and confidence to engage children effectively ( Toros et al ., 2018 ). Thirdly, ensuring the best interests of children means that their voices are not silenced and that access to information and helping them to express their views must be one of the tasks of both professionals and child protection systems ( Davies and Wright, 2008 ; Strømland et al ., 2022 ). Therefore, the process of participation involves understanding the importance of the child’s experience in the context of everyday life ( Skauge et al ., 2021 ).

Limitations

In terms of the methodology of the review search, we used the largest number of electronic bibliographic databases that it was feasible to use in the circumstances (i.e. all the databases available in the first author’s library at Queen’s University Belfast), but a funded review might retrieve additional papers. Quality appraisal was affected by restricting inclusion to publications in peer-reviewed journals, but we cannot exclude the possibility of the review having some publication bias. Grey literature was not searched for example, which may have uncovered theses in this area and there is a plethora of evaluations of participatory practice in child welfare agencies that are neither published nor easily accessed. Already recognised by van Bijleveld et al. (2015) , there are still problems with the search terms that challenged us given the variety of terms used across agencies, cultures and countries to describe participation, so greater homogeneity in language would be helpful going forward to reduce the chance of missing valuable research. To reduce this risk, we consulted with the specialist librarian at Queen’s University Belfast and conducted our own initial scoping exercise to identify core terms, which we subsequently used in this research.

To avoid homogenising C&YP as one group, it is important to disaggregate them across age, culture, class, gender, ethnic background, etc., to understand them, not as one amorphous mass but as individuals with different identities, needs and ways of being seen and heard. It is also important to move away from small-scale micro studies that ignore the macro-political, sociocultural, economic, philosophical and geographic influences that are brought to bear on the micro participatory landscape, for these influences (not always benign) undoubtedly impact the opportunities for authentic participation. Finally, we see the importance of large-scale efficacy studies to determine the effectiveness of participatory interventions to develop a more informed evidence base of what works, in what circumstances, why and for who. This of course will necessitate more funding being made available and in a competitive funding landscape this will require funders to realise the importance of this area of study—we remain hopeful.

We would like to thank Norma Menabney for the specialist librarian support provided.

This study has been funded by José Castillejo Programme for mobility abroad youth doctor and carried out by Prof. Dr Mercado at Queen’s University of Belfast (reference number CAS21/0254).

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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole . Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus. [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

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[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

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[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

[8] Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011), citing 45 C.F.R. 46.204(b) and [42 U.S.C. § 289g(b)]. https://www.cadc.uscourts.gov/internet/opinions.nsf/6c690438a9b43dd685257a64004ebf99/$file/11-5241-1391178.pdf

[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

[10] National Archives and Records Administration. (2009, March 9). Executive order 13505 -- removing barriers to responsible scientific research involving human stem cells . National Archives and Records Administration. https://obamawhitehouse.archives.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells

[11] Hurlbut, W. B. (2006). Science, Religion, and the Politics of Stem Cells.  Social Research ,  73 (3), 819–834. http://www.jstor.org/stable/40971854

[12] Akpa-Inyang, Francis & Chima, Sylvester. (2021). South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study. BMC Medical Ethics . 22. 10.1186/s12910-021-00678-4.

[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

[15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324

[16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa.  Stem Cell Res Ther   4 , 54 (2013). https://doi.org/10.1186/scrt204 ; Pew Research Center. (2014, May 1). Public health a major priority in African nations . Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/

[17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024 . National Health Research Strategy. https://www.health.gov.za/wp-content/uploads/2022/05/National-Health-Research-Priorities-2021-2024.pdf

[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia . UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

[20] Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction.  Frontiers in pharmacology ,  13 , 1013740. https://doi.org/10.3389/fphar.2022.1013740

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[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan.  Curr Stem Cell Rep   1 , 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production . NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work.  Nature . https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life . Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association , 12 (4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52.  https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA.  Reproductive biomedicine online ,  18 (5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

[72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.  Clinical trials (London, England) ,  3 (3), 306–313. https://doi.org/10.1191/1740774506cn150oa

[73] Veatch, Robert M.  Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict . Georgetown University Press, 2012.

[74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity.  Research Ethics ,  14 (3), 1-17.  https://doi.org/10.1177/1747016117739939

[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

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Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

Article Details

This work is licensed under a Creative Commons Attribution 4.0 International License .

What's in a name? Edmonton builds database and will review renaming policy

A full accounting of the names of Edmonton’s parks, streets, neighbourhoods and civic buildings is underway and the city will review how new names for old infrastructure are chosen.

City staff are busy fleshing out a public database of all the municipal entities named in Edmonton in the past two decades. Monikers are being added to the already lengthy list compiled using research from the 2004 book Naming Edmonton: From Ada to Zoie . There were 1,455 entries for roads, bridges, recreation centres, ravines, cemeteries and other civic infrastructure dating back to the late 1700s by mid-May.

Councillors at Wednesday’s urban planning committee meeting had questions on how the work on the database and policy is proceeding, and potential costs, in light of some recent high-profile shifts — such as rebranding the Oliver neighbourhood as Wîhkwêntôwin .

While Ward O-day’min Coun. Anne Stevenson was supportive of the plan overall, she offered some “caution or consideration” to city administration as they proceed.

“I worry that there could be a perception of — for lack of a better word — a bit of a witch hunt in terms of going out, and that erasure of community history,” she said, but adding the plan seems like a sensible approach.

The city’s naming committee last fall recommended the database be updated and checked for both “accuracy and appropriateness.” But according to a staff report, the city doesn’t have the resources for this fact-checking and analysis.

Cory Sousa, a principal planner, said that after the dataset is finished city staff will reach out to the naming committee again to figure out how best to proceed.

“It could certainly be looking at more significant features, such as river valley parks, district parks or, as you suggested, city-owned facilities,” he said.

“We will have to look at the different assets and different types of names, and also confront some of the names that are known to be problematic.”

Overall, Stevenson said the plan is an “exciting way to include Edmontonians in discussions about our history and help them experience in a day-to-day way.”

It also has the support of the Edmonton Heritage Council.

Executive director David Ridley — whose group has been involved in past renamings such as changing the Grandin LRT station name to Government Centre — said his group supports city administration’s recommended work plan. The heritage council, he said, can help administrators with this work, such as offering historians, support for research, engagement and education for the community around name changes.

Other aspects of the naming review include developing ways to solicit feedback from the community, as well as a dedicated Indigenous naming process. An existing list of approved names for new infrastructure is also under review.

Future costs unknown

Council approved renaming to Wîhkwêntôwin in February for $680,000. Internal staff costs make up the largest expense, but the bill also includes significant charges for replacing signage ($120,000) and for communication, education and promotion ($80,000).

Ward Anirniq Coun. Erin Rutherford wanted to know if future changes may have a similar price tag.

“It’s such a beautiful story with that renaming, but if these recommendations are done and we make it easier for the community-led initiatives to be bringing forward renamings, and they’re going to come with a half-a-million-dollar price tag per renaming, that’s significant when we don’t even have the budget to finish all of these recommendations,” she said.

“What’s the scale and scope of the renaming and does it need to be … (considered in the next) four-year budget? I don’t want to continually be surprised with these price tags in the committee meetings.”

Administrative staff told councillors they don’t have an estimate for future costs and such financing isn’t currently in city budgets.

The Oliver Community League earlier this year announced it had petitioned the city to change the neighbourhood’s name to Wîhkwêntôwin (we-kwen-to-win) which is Cree for “a circle of friends.”

The change was announced after a years-long process and amid debate over the racist legacy of Frank Oliver, the settler politician and newspaperman the neighbourhood was named after. Oliver, a minister in Wilfred Laurier’s cabinet, opposed immigration of non-British and non-white people, drafted a bill banning Black immigrants, and took racist positions regarding Ukrainians, Slavs, French-Canadians and Asians.

Current policy

Edmonton’s current policies outline how and when renamings might happen.

The naming committee can apply to rename municipal infrastructure if there’s proof an existing name is discriminatory, derogatory, or has negative or offensive connotations; or if the person’s name “no longer reflects Edmonton’s current community values of equity and inclusion.”

Names can also be changed if there’s strong support from the community impacted by the name.

Changing road names is a bit trickier. Unless the city makes the request, road names will only be changed from a number to a named road if 75 per cent of property owners and business owners directly affected support it, and if applicants pay for the costs of the changes.

City council has final approval for renaming “significant municipal assets.”

– With files from Jonny Wakefield

[email protected]

• Study protocol
• Open access
• Published: 21 May 2024

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya

• Elena Marbán-Castro   ORCID: orcid.org/0000-0002-9715-0595 1 ,
• Lorrein Muhwava 1 ,
• Yvonne Kamau 1 ,
• Elvis Safary 1 ,
• Paul Rheeder 2 ,
• Maria Karsas 2 ,
• Tanja Kemp 2 ,
• Johanè Freitas 2 ,
• Michelle Carrihill 3 ,
• Joel Dave 4 ,
• Daniel Katambo 5 ,
• Joan Kimetto 5 ,
• Razana Allie 2 ,
• Kenya ACCEDE study group ,
• South Africa ACCEDE study group ,
• Joseph Ndungu 1 ,
• Ntombi Sigwebela 1 ,
• Dorcas Akach 1 ,
• Sarah Girdwood 1 ,
• Berra Erkosar 1 ,
• Brooke E. Nichols 1 ,
• Cathy Haldane 1 ,
• Beatrice Vetter 1 &
• Sonjelle Shilton 1  

Trials volume  25 , Article number:  331 ( 2024 ) Cite this article

Metrics details

Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries.

This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years).

This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries.

Trial registration

NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.

Peer Review reports

Administrative information

Introduction, background and rationale {6a}.

Self-monitoring of glucose via regular daily fingerstick glucose testing is an essential component of managing people with type 1 diabetes (T1D) [ 1 ]. However, in recent years the development of continuous glucose monitoring (CGM) devices has provided an alternative option for optimising insulin dosing and glycaemic control in people with T1D [ 2 ]. A systematic review of the use of real-time CGM and intermittent CGM showed that CGM was associated with a reduction in glycated haemoglobin (HbA1c; weighted mean difference: -0.17% [95% confidence interval {CI} -0.29, -0.06]), and an increase in the time users spent with daily glucose levels ‘in-range’ (usually 70–180 mg/dL; weighted mean difference: + 70.7 min [95% CI +46.7, +94.8]) [ 1 ]. Of the two CGM schedules assessed, real-time CGM use was shown to provide the greatest reduction in HbA1c (weighted mean difference: -0.23% [95% CI -0.36, -0.10]) and the greatest increase to the time ‘in-range’ (weighted mean difference: +83.5 min [95% CI +52.7, +114.3]) [ 1 ]. These findings have also been supported by the results of several individual studies, where CGM was found to improve glycaemic control in people with T1D and reduce the frequency of hypoglycaemic events [ 2 , 3 , 4 ].

However, this body of evidence consists primarily of studies conducted in the United States (US) [ 1 , 3 , 4 ], Europe [ 1 , 2 ], or Australia [ 1 ], and there are limited data on the effects of CGM on clinical outcomes in low- and middle-income countries (LMICs), where CGM devices may not be readily available. A recent scoping review of CGM in LMICs did not identify any randomised trial conducted in Sub-Saharan Africa [ 5 ], and to our knowledge only one study on the use of CGM in people with T1D has been conducted in the region, which was a feasibility study in Kenya and Uganda and not a randomised control trial [ 6 ]. Similarly, we have identified no randomised trials conducted in South Africa that have evaluated the impact of CGM compared with standard of care glucose monitoring on HbA1c (and other clinical outcomes) in people with T1D, with the majority of the evidence base consisting of qualitative, mixed methods, and perception studies [ 7 , 8 , 9 , 10 ]. Overall, there exists a substantial evidence gap on the use of CGM in people with T1D in LMICs, particularly those in Sub-Saharan and Southern Africa, and while some devices have received US Food and Drug Administration (FDA) approvals or European Commission “Conformité Européenne” CE marks [ 11 ], further empiric evidence is needed to inform policy decision around their use in these countries as evidence generated in higher resource settings may not be applicable [ 11 , 12 , 13 ].

The rationale for selecting Kenya and South Africa as study locations is rooted in different reasons. In South Africa, 31,500 people live with T1D, with an annual growth rate of 6.1% [ 14 ]. In Kenya, there are 23,100 people living with T1D, with an annual growth rate of 4.2% [ 15 ]. There are different levels of care provision for T1D in both countries, which translates into different approaches to T1D management. Additionally, there are different levels of CGM availability in both countries.

Here we present the protocol for a pragmatic trial that aims to assess the impact of continuous or periodic CGM device use on glycaemic control (and other clinical, quality of life, and health economic outcomes) in people with T1D in South Africa and Kenya. The trial was co-designed by diabetes stakeholders in South Africa and Kenya and are sponsored by FIND. The trial was designed to incorporate CGM use within the routine care in diabetes clinics in multiple centres, necessitating slight variations in design for each centre as routine care differed. The trial has been designed in accordance with the principles of the Declaration of Helsinki and country-specific regulatory and ethics requirements and has been approved by all relevant Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs).

Objectives {7}

The overall objective of this trial is to assess the impact of CGM (Intervention) on glucose levels (Outcome) compared with standard of care (Comparator) in people with T1D in South Africa and Kenya (Population).

The primary objective is to evaluate the impact of continuous and periodic CGM on changes to HbA1c levels in people with T1D in South Africa and Kenya, compared with standard of care.

Secondary objectives are as follows (versus standard of care where appropriate):

To evaluate the impact of continuous or periodic CGM device use on glucose variability.

To evaluate the impact of continuous or periodic CGM device use on the number of unplanned visits to outpatient clinics and/or hospitals as a result of diabetes complications.

To evaluate the acceptability and feasibility of continuous or periodic CGM device use from the perspective of the participant, caregiver, and healthcare provider.

To evaluate the cost of continuous or periodic CGM device use from a user and provider perspective.

Trial design {8}

This trial is a pragmatic, parallel-group, open-label, multicentre, three-arm, superiority randomised (1:1:1) controlled trials of continuous or periodic CGM device use (the Abbott Freestyle Libre 1 device) versus standard of care in people with T1D in Kenya and South Africa. The primary endpoint is the mean change in HbA1c levels. The trial was designed using the PRECIS-2 tool, a nine-domain tool intended to be used in the trial design phase, which is intended to align design decisions with applicability of trial results [ 16 ].

The trial is expected to take approximately 18 months to complete (September 2023 to April 2025 in South Africa, and February 2024 to July 2025 in Kenya), including trial set-up, recruitment, and follow-up for all participants.

Methods: Participants, interventions, and outcomes

Study setting {9}.

The trial in Kenya will be conducted at three public sector clinics that are part of the ‘Changing Diabetes in Children’ program: the Kenya Diabetes Management and Information Centre, and the Machakos and Kiambu level five referral hospitals. This program was launched in 2012 to improve T1D care in children and young adults (under the age of 18), by working with the Kenyan Ministry of Health to build capacity and strengthen the local health system through the provision of medical equipment, point-of-care glucose meters, healthcare training, and dissemination of best practice methods [ 17 ].

The trial in South Africa will be conducted at three public sector clinics: the diabetes clinic at Groote Schuur Hospital in Cape Town; the paediatric diabetes clinic at Red Cross War Memorial Children’s Hospital in Cape Town; and the adult and paediatric diabetes clinic at Steve Biko Academic Hospital in Pretoria.

Eligibility criteria {10}

Inclusion criteria.

Participants meeting all of the following criteria will be eligible for enrolment in the trials:

People with T1D attending one of the clinics for regular diabetes care, with a current (within the past 3 months in South Africa and 18 months in Kenya) HbA1c level of ≥10%/86 mmol/mol and no record of an HbA1c < 8%/ <64 mmol/mol within the past 9 months.

Caregivers of children or adolescents with T1D will be eligible for inclusion in the trial (for acceptability and feasibility assessments) only if the child or adolescent is also enrolled in the trial.

Healthcare providers will be eligible for inclusion in the trial (for acceptability and feasibility assessments) only if they are engaged in trial-related diabetes care at one of the trial clinics (trial Investigators are excluded).

Exclusion criteria

Participants will be excluded from the trial if they meet any of the following criteria:

People with T1D under 4 years old, as per the trial CGM device (Abbott Freestyle Libre) manufacturer’s instructions for minimum age of use.

People diagnosed with T1D within the past 2 years.

People who have used a CGM device within 18 months (in Kenya) and 6 months (in South Africa) of trial enrolment.

People who anticipate they would have access to a CGM device through means outside of the trial, during the duration of the trial (15 months).

People with type 2 diabetes.

People with known pregnancy at the time of trial enrolment.

People who are not willing to agree to the CGM device (Abbott Freestyle Libre) terms and conditions.

Who will take informed consent? {26a}

The trial Investigator or his/her representative will explain the nature of the trial to all participants who meet the inclusion criteria (or their legally authorised representative) and answer all questions they may have about the trial. After being informed that their participation is voluntary and being given ample time to decide whether they wish to take part in the trial, any participants (or their legally authorised representative) who do wish to enrol will be required to sign and date a statement of informed consent that meets the requirements of local regulations and relevant IRB/IECs. For children and adolescents aged 7–17 years (inclusive), they will also be required to sign and date a statement of informed assent that meets the requirements of local regulations and the relevant IRB/IEC. All written informed consent and informed assent must be obtained before the participant is enrolled and any trial-related procedures are performed.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

The informed consent form includes a statement that all information obtained during the course of the trial will be regarded as confidential, that only the site trial team will be able to identify participants, that results will be published or presented in such a fashion that participants remain unidentifiable, and that hard copies of all participant records will be kept for 10 years in a locked facility at the trial site.

Consent for biological specimens is not applicable as no samples collected for HbA1c measurement will be stored.

Interventions

Explanation for choice of comparators {6b}.

The comparator is standard of care diabetes management at each trial clinic (glucose monitoring) by participants assigned to Arm 3, their HbA1c levels and all the data collected from their case report forms (CRFs).

Intervention description {11a}

The intervention is a CGM device (Abbot Freestyle Libre), which is considered low risk to trial participants as it is approved by the FDA, has the CE mark and is prescribed in both countries by private healthcare providers for the management of diabetes. It consists of a small interstitial fluid glucose sensor that is applied on the back of the upper arm, and a hand-held reader that collects glucose data when placed within 1.5 inches (4 cm) of the sensor. In the continuous CGM trial arm, participants will wear the CGM device all the time for the 9 months (replacing it every 2 weeks, concurrent with senor wear time). In the periodic CGM trial arm, participants will wear the CGM device for 2 weeks, scheduled to start 1 week before each clinic visit (except for the enrolment visit), and for 1 week after each clinic visit (except for the final follow-up visit).

Criteria for discontinuing or modifying allocated interventions {11b}

A participant may discontinue CGM device use and be withdrawn for safety or administrative reasons at any time at the discretion of the Investigator. A participant may also decide to withdraw from the trial at any time. If a participant becomes pregnant, they will be permitted to remain in the trial to ensure external validity of the data.

Strategies to improve adherence to interventions {11c}

An education session on the use of the CGM device will be provided for each participant during the enrolment visit (Day 1), which will be conducted by a qualified instructor and include guidance on how to self-apply the device, how to correctly interpret the information collected by the device, diabetes health and management, and awareness and management of potential adverse events. In addition, all clinicians (including registrars, nurse educators and research assistants) involved in the trial will receive an education package on clinical management and use of the CGM device.

Relevant concomitant care permitted or prohibited during the trial {11d}

As this is a pragmatic trial embedded in routine clinical care, participants will be permitted to receive any concomitant care as clinically required. Potential confounding treatments will be assessed in a ‘Medical events and medical resources’ survey and include acetaminophen, ascorbic acid, intravenous vitamin C, sulphonamide antibiotics, and oxygen therapy, among others.

Provisions for post-trial care {30}

As standard of care diabetes treatment is permitted during the studies, this will be continued once the trial has been completed. Any decision on whether to use a CGM device after the trial sits entirely with the participant and their attending clinician.

Outcomes {12}

Primary outcome.

The primary endpoint will be the mean change from baseline (pre-CGM device use) HbA1c at various timepoints up to 15 months (percentage and mmol/mol). This will be assessed in all trial arms and presented as absolute values and percentage changes, together with summary statistics and statistical comparisons (between group).

Secondary outcomes

Unless otherwise stated, the secondary outcomes listed below will be presented using descriptive statistics (i.e., means, standard deviations) or as intervention effects with 95% CI.

CGM device outputs: (i) Coefficient of variation (%CV) for glucose levels; (ii–iv) the time spent ‘in-range’, below-range’, and ‘above range’ (percentage per day and absolute values [hours/minutes]).

Number of hospitalisations due to diabetes complications.

Health-related quality of life (HRQoL): (i) mean change from baseline in EQ-5D-Y/EQ-5D/EQ-5D-interviewer-administration scores [ 18 , 19 , 20 ]; (ii) mean change from baseline in type 1 diabetes distress (T1D-DDS) scores for participant and parent (where possible) [ 21 ]; (iii) qualitative assessment using focus group discussions with participants and caregivers.

Adherence to CGM device use: the proportion of scheduled time registered using the CGM device (automatic device output).

Acceptability: (i) mean change from baseline in Glucose Monitoring Satisfaction Survey for T1D (GMSS-T1D) score; [ 22 ] (ii) qualitative assessment using semi-structured interviews with healthcare providers and focus group discussions with participants.

Cost: surveys will capture both direct and indirect costs of diabetes care at follow-up Visits 3 to 6 for trial participants, their caregivers (if possible), and healthcare providers. Incremental cost-effectiveness ratios (ICERs) and quality adjusted life years (QALYs) will be used for between-group comparisons.

Exploratory outcomes

In Kenya, the accuracy of the HbA1c point-of-care device used at each participating clinic will be assessed using a laboratory-based HbA1c method as reference. Mean relative bias, 95% limits of agreement and regression estimates will be presented. In South Africa, there are no exploratory outcomes, HbA1c test results analysed for the trial will be the ones used as per routine care.

Safety outcomes

Safety will be assessed by the recording of adverse events (AEs) and serious adverse events (SAEs) occurring during the trial period, as defined by the Common Terminology Criteria for Adverse Events (CTCAE). Given the pragmatic nature of the studies, reporting will be limited to SAEs. All events of grade 3 or above will be considered an SAE.

Participant timelines {13}

The duration for each participant will be 15 months, consisting of 9 months of intervention followed by 6 months’ follow-up. There will be six scheduled trial visits in total, at Day 1, Visit 2 (Week 1), and at 3 (Week 11/12), 6 (Week 23/24), 9 (Week 35/36), and 15 months (Week 57/58); Fig.  1 ).

Study timeline schematic. *Enrolment is expected to take from 3 to 8 months. Q, quarter

Sample size {14}

Assuming a change in HbA1c levels of 2% after continuous use of a CGM device (determined by expert consultation) and an effect size of 0.2, a sample size of 246 participants (82 in each arm) would be required to achieve 80% power to detect within- and between-group differences at the 5% significance level (using repeated measures analysis of variance [ANOVA]).

For qualitative assessments, sample sizes will be pragmatically derived and will vary based on the number of available respondents and attainment of information/thematic saturation. In Kenya, the target populations will be 30 for focus group discussions and HRQoL surveys (10 in each arm) and 10 for semi-structured healthcare provider interviews. In South Africa, the target populations will be 45 for focus group discussions and HRQoL surveys (15 in each arm) and 10 for semi-structured healthcare provider interviews.

Recruitment {15}

Recruitment will be staggered over a period of 4 weeks or until the target sample size has been reached. Participants will be recruited using purposive sampling at each of the sites, based on eligibility criteria. To raise awareness of the studies, recruitment flyers, which will contain basic trial information (purpose, inclusion criteria), as well as the contact details for the Principal Investigator and/or trial staff will be distributed to potential participants. Trial staff will contact eligible participants via phone and invite them to an information session at the clinic, or consecutively explain study procedures at their routine clinic visit. At that visit eligibility screening and informed consent/assent will take place. Reasons for refusal to participate will be recorded in the screening and enrolment logs and reviewed regularly by trial staff, so that strategies to maximise recruitment can be developed (if required).

The caregiver of every child or adolescent enrolled will be invited to participate in the HRQoL surveys and will be considered for inclusion in the focus group discussions. Parents of children under 8 years of age will also be asked to complete the surveys. All healthcare providers involved in the trial will be invited in person or via phone/email to take part in the semi-structured acceptability discussions.

Assignment of interventions: allocation

Sequence generation {16a}.

Upon enrolment, each participant will be assigned a unique randomisation number in ascending numerical order, which determines their assignment to one of the three arms (1:1:1) according to the randomisation schedules generated prior to the trial by the FIND trial statistician. As this is an open-label trial, in order to minimise the risk of bias research assistants will be required to log into an electronic database (OpenClinica), where they will enter the participant’s unique randomisation number and the system will then inform them of the participant’s arm.

Concealment mechanism {16b}

Only the trial statistician who generated the allocation sequences will have access to the allocation sequences.

Implementation {16c}

As detailed in ‘ Sequence generation {16a} ’ section, the allocation sequences will be generated prior to trial initiation by the FIND trial statisticians. Trial Investigators/staff will enrol participants into the trial and assign them their randomisation numbers, which will determine their trial group based on the allocation sequences.

Assignment of interventions: blinding

Who will be blinded {17a}.

As pragmatic, open-label trial, no blinding will be required.

Procedure for unblinding if needed {17b}

As this will be open-label trial, unblinding will not be required.

Data collection and management

Plans for assessment and collection of outcomes {18a}.

Trial outcomes are defined in the ‘ Outcomes {12} ’ section. All outcomes data relating to glucose levels will be extracted directly from the CGM device, as will data on adherence to CGM device use. However, in order to minimise bias in the intervention effect assessment, source data verification (from direct laboratory reports) will be implemented for the primary outcome measure (HbA1c). Other assessments will take place at the trial visits and timepoints outline in Table  1 and Table  2 . Focus group discussions (~ 1 h) and semi-structured interviews (~ 1 h) will be conducted by trained staff at the Month 9 visit.

Plans to promote participant retention and complete follow-up {18b}

To minimise participant drop out (and also improve adherence to CGM device use, as new CGMs will be provided at each trial visit), participants will be enrolled in the trial who are already receiving T1D care at the participating clinics, and reminders will be sent to participants before the scheduled visits. In addition, travel reimbursement will be provided for each trial visit to minimise the chance that socio-economic issues may influence participant dropout and adherence to CGM device use. Should a participant miss a trial visit, the sites will attempt to contact them and reschedule the missed visit as soon as possible, as well as counsel the participant on the importance of maintaining the assigned visit and CGM device schedule.

Data management {19}

The trial sponsor (FIND) will be responsible for the data management, including risk-based monitoring, quality control checks, data cleaning, and protocol compliance. Clinical data and laboratory results will be captured by site staff onto paper-based CRFs during trial visits and entered onto an electronic case report form designed by FIND in the electronic data capture (EDC) system. Site staff will undergo a training session provided by FIND on the use of the EDC system, and will be responsible for entering their data from a paper CRF into the EDC system whenever direct capture into EDC is not possible. The trial Investigators will be responsible for verifying that data entries are accurate and correct, and that data entered in EDC are consistent with the source documents (or the discrepancies adequately explained). Records and documents, including signed informed consent forms, pertaining to the conduct of the trial will be retained by the Investigators for the time mandated by local regulations and institutional policies, and no records may be transferred to another location or party without written permission from FIND.

Confidentiality {27}

All information obtained will be regarded as strictly confidential and handled and stored according to all relevant Data Protection laws. Only the trial site staff directly involved in the conduct of the trial will be able to identify participants, and any data will be transferred for analysis or published in such a way that participants cannot be identified. Hard copies of all participant records will be kept for 10 years in a locked facility at all sites.

Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in the trial/future use {33}

No biological specimens will be collected, unless they are collected as part of standard of care at each participating diabetes clinic.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}.

A separate Statistical Analysis Plan will provide a detailed description of the planned statistical analyses and only a brief outline will be presented here. Please see the ‘ Outcomes {12} ’ section for definitions of the primary, secondary and exploratory outcomes and for further details on data presentation.

For the purposes of this trial, the following populations will be defined:

Enrolled population: all participants enrolled in the trial who completed informed consent.

Assigned population: all participants who have been assigned to a trial arm and completed all Day 1 trial visit procedures.

Fully Complied: all participants who fully complied with the protocol.

Partly Complied: all participants who recorded HbA1c values at Visit 1 and 5 (at least).

Intervention: all participants in the CGM device arms who fully complied with the protocol.

Safety: all participants who have been assigned to a trial arm.

Between-group analyses of the primary outcome will be conducted using the Fully Complied or Partly Complied populations and two-way repeated-measures ANOVA with time and arm as independent variables.

Glucose variation will be assessed using the Intervention population, with %CV calculated as the ratio of the standard deviation to the mean. HRQoL outcomes will be analysed using the Fully Complied or Partly Complied populations and two-way repeated-measures ANOVA with time and arm as independent variables. Within-group mean GMSS scores will be analysed using t-tests and between-group scores using repeated-measures two-way or one-way ANOVA (depending on the availability of data) with time and arm as independent variables (all using the Fully Complied or Partly Complied populations).

All other secondary outcomes will be analysed using descriptive statistics: hospitalisations using the Partly Complied population, adherence using the Intervention population, and cost surveys using the Fully Complied or Partly Complied population.

For the cost analysis, standard bottom-up costing methods from a partial societal perspective will be used to estimate the costs of both direct and indirect resources utilised by participants over the trial period. Unit costs will be assigned to these resource outputs using values sourced from public sources: laboratory test costs from the relevant national laboratory service, staffing costs from the Salaries and Renumeration Commission, medicine and supply costs from Kenya Medical Supplies Authority (KEMSA)/Mission for Essential Drugs (MEDs), minimum wage data from the relevant government agency, and the cost of procedures and in-patient hospital stays from the National Health Insurance Fund. Where necessary, unit costs will be sourced from other publicly available resources and the literature. ICERs will be calculated using the primary outcome measure and the time ‘in-range’, and QALYs will be calculated from the HRQoL outcomes.

In Kenya, the HbA1c point-of-care device accuracy analysis will be conducted using Bland–Altman plots (mean relative bias), 1.96*standard deviations (limits of agreement), and Passing Bablok regression.

Qualitative analysis

Focus group discussions and semi-structured interviews will be recorded, transcribed and coded. Following this, a thematic analysis will be completed on the responses using inductive and deductive coding.

Interim analyses {21b}

No interim analyses of primary, secondary or safety outcomes will be performed.

Methods for additional analyses (e.g. subgroup analyses) {20b}

No prespecified subgroup analyses are planned. However, sensitivity analyses will be performed to assess the uncertainty surrounding cost estimates and to identify the key assumptions that drive those costs, by adjusting various input parameters.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

Every effort will be made to collect full follow-up data for all participants, so it is expected that missing data will be minimal. Procedures to account for protocol non-adherence and missing, unused, or spurious data will be detailed in separate Statistical Analysis Plans, which will be developed and finalised before any analyses are performed.

Plans to give access to the full protocol, participant-level data and statistical code {31c}

For the data analysis, only the statistician will have full access to the whole dataset and the code to manage the data (cleaning and analysis) while the trial is ongoing. At the end of the studies, site-specific data will be made available to the research teams at the trial sites. In addition, reasonable requests for the protocol and/or trial data from academic parties will be considered by the corresponding author of this manuscript, and data may be made available in line with the data-sharing policies of FIND.

Oversight and monitoring

Composition of the coordinating centre and trial steering committee {5d}.

As a pragmatic trial with central data management performed by the sponsor (FIND), no coordinating centres or trial steering committees will be required on site.

Composition of the data monitoring committee, its role and reporting structure {21a}

Ethical review committees in South Africa and Kenya determined that a Data Monitoring Committee was not required, as this trial involves medical devices that already have stringent regulatory approval.

Adverse event reporting and harms {22}

As outlined in the ‘ Outcomes {12} ’ section, safety in the trial will be assessed by the recording of AEs and SAEs occurring during the trial periods (from consent up to the final follow-up visit), as defined by CTCAE criteria. All SAEs will be recorded and reported to the trial sponsor (FIND) or their designee within 24 h, and to the IRB/IEC within the required timeframe per IRB/IEC protocols. FIND will comply with all country-specific regulatory requirements relating to safety reporting, to the relevant regulatory authority, and Investigators. All SAEs will be followed until resolution, stabilisation, the event is otherwise explained, or the participant is lost to follow-up, and the Investigator will report any further information regarding the SAE to FIND within 24 h of it being available.

Medical device incidents (limited to the CGM) will also be reported to FIND within 24 h of the Investigators determining that the event meets the Kenya Pharmacy and Poisons Board or South African Health Products Regulatory Authority definition of a medical device incident. All medical device incidents involving an SAE will be followed-up and reported in the same manner as an SAE.

FIND has established an internal Medical Review Board with the overarching role to collaborate actively with the Investigators to protect the safety of trial participants. Monitoring visits will be conducted to assess the implementation of trial procedures, coordination of staff and resources, and data source verification.

The trial sponsor (FIND) will be responsible for the monitoring of recruitment, trial-related training, and central data management, including risk-based monitoring, regular quality control checks, data cleaning, and protocol compliance. The site research teams will be responsible for conducting all trial-related activities at their recruitment sites, and for entering their data into the central EDC system. The trial Investigators will be responsible for verifying that these data entries are accurate and correct, and that the data entered in the EDC system are consistent with the source documents (or the discrepancies adequately explained). Each trial site will be responsible for performing regular quality control checks on the data they generate.

Frequency and plans for auditing trial conduct {23}

Group meetings will be held weekly to provide updates on the protocol implementation at various sites and to discuss any challenges encountered during this process. Each site will also conduct weekly meetings with selected members of our team to ensure ongoing communication and problem-solving. The Project Management Group will convene quarterly with the whole team at FIND, to review the trial's progress, overall conduct, and integrity. Every three months, a Collaborative Case Study Forum will be organized with all team members from all countries to discuss challenges faced across all sites, facilitating a shared learning environment. The Ethics Committees will meet annually to review the study's progress report, ensuring that ethical standards are maintained throughout the trial. While an external audit is not planned for this trial, FIND will perform risk-based monitoring and scheduled monitoring visits at all sites. This approach will ensure oversight and adherence to trial standards without an external audit.

Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}

Any amendments to the trial protocols or to other relevant documents (e.g. informed consent forms) must be submitted to an IRB/ERC by the Investigator. Once approved by the sponsor (FIND), amended trial protocols will then be re-signed by the Investigators.

Dissemination plans {31a}

The results will be communicated to participants, healthcare providers and the scientific community. This study was co-created from a multi-stakeholder workshop including civil societies, Ministries of Health, healthcare professionals, private funders and stakeholders in both countries. During the implementation phase, we will host workshops with the stakeholder groups in each country. Once the study is completed, the results will be shared/presented at local congresses, e.g., the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA), the Kenya Diabetes Study Group (KDSG) and the East Africa Diabetes Study Group (EADSG) congresses, and local civil society interventions such as South Africa Diabetes Advocacy and Young Unsweet podcasts. Additionally, national dissemination meetings are planned to take place in both countries, including national stakeholders, community representatives, and local staff members. The results will also be disseminated to the scientific community via peer-reviewed publications and presentations at national and international conferences. Manuscripts will be published in open access journals. Dissemination to participants will be via a lay summary with key study findings, to make it understandable and available to all participants; this will be distributed at study sites. Due to previous experiences with restrictions from ethics committees on publishing data in public repositories without explicit participant consent, we will consider the use of a public data repository with the local ethical committees that approved the protocols. Nonetheless, all anonymised data will be available from the corresponding author upon reasonable request. Lastly, in response to the evolving nature of our trial, we commit to regularly updating the online trial registers when there are substantial changes to be reported.

As described earlier in the ‘ Background and rationale {6a} ’ section, there exists a substantial evidence gap on the use of CGM in people with T1D in LMICs. Results from this trial will help to fill this evidence gap, by providing robust data on the impact of CGM device use in people with T1D in South Africa and Kenya and establishing how CGM compares with standard of care with regard to glycaemic control and HRQoL outcomes. It is also hoped that the empiric evidence provided by this trial will help inform policy decisions, decision-making and treatment practices in these regions.

Trial status

The current versions of the protocols are version 4.0 (4 September 2023; Kenya), version 1.1 (16 July 2023; Pretoria, South Africa) and version 1.2 (28 September 2023; Cape Town, South Africa). In South Africa, Steve Biko Academic Hospital in Pretoria started recruitment in September 2023. In South Africa, the diabetes clinic at Groote Schuur Hospital and the paediatric diabetes clinic at Red Cross War Memorial Children’s Hospital in Cape Town started recruitment in January 2024. The study in Kenya will start recruitment in June 2024. Study completion is expected in December 2025.

Availability of data and materials {29}

The only individual with access to the full dataset during the conduction of the trial will be the statistician at FIND. At the end of the trial, site-specific data will be made available to the research teams at the trial sites.

Reasonable requests for the trial data from academic parties will be considered by the corresponding author, and data may be made available in line with the data-sharing policies of FIND.

Abbreviations

Coefficient of variation

Adverse event

The African Medical and Research Foundation

Analysis of variance

European Comission, from “Conformité Européenne”

• Continuous glucose monitoring

Confidence interval

Case report form

Common Terminology Criteria for Adverse Events

Diabetes distress score

Electronic data capture

Economic and Social Research Council

US Food and Drug Administration

Glucose Monitoring Satisfaction Survey for type 1 diabetes

Glycated haemoglobin

Health-related quality of life

Incremental cost-effectiveness ratio

Independent Ethics Committee

Institutional Review Board

low- and middle income countries

National Commission for Science, Technology and Innovation

Quality adjusted life year

Serious adverse event

Type 1 Diabetes

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Acknowledgements

We thank all participants from the ACCEDE co-creation workshops held in South Africa (Amanda Mashego, Ayanda Mbuli, Bilqees Sayed, Kirsten de Klerk, Lindiwe Mbekeni, Margot Mc Cumisky, Mogambal Naicker, Neil Martin Meiring, Nicole van Wyk, Patrick Ngassa Piotie, Salih Hendricks, and Susan Lin) and in Kenya (Arvi Kalsi, Caroline Cheruiyot, Catherine Munaji, George Achuka, Jacinta Mutegi, James Nduati, Kaushik Ramaiya, Nduku Kiko, Patricia Njiri, Rachel Nyamu, Rosemary Kihoto, Sam Nyongesa, Tim Theuri, Zipporah Ali, Dawn Maranga, Kinuthia Bubi, Millicent Terure).

This trial is sponsored by FIND, with a grant from The Leona M. and Harry B. Helmsley Charitable Trust. As per the funding contract between The Leona M. and Harry B. Helmsley Charitable Trust and FIND the funders have reviewed the manuscript before submission with a focus on wording relating to the funding source.

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Authors and affiliations.

FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland

Elena Marbán-Castro, Lorrein Muhwava, Yvonne Kamau, Elvis Safary, Joseph Ndungu, Ntombi Sigwebela, Dorcas Akach, Sarah Girdwood, Berra Erkosar, Brooke E. Nichols, Cathy Haldane, Beatrice Vetter & Sonjelle Shilton

University of Pretoria Diabetes Research Centre, Gezina, Pretoria, South Africa

Paul Rheeder, Maria Karsas, Tanja Kemp, Johanè Freitas & Razana Allie

Red Cross Childrens Hospital, Paediatric Clinic, Cape Town, South Africa

Michelle Carrihill

Division of Endocrinology, Groote Schuur Hospital and the University of Cape Town, Cape Town, South Africa

Kenya Diabetes Management and Information Centre, Nairobi, Kenya

Daniel Katambo & Joan Kimetto

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Kenya ACCEDE study group

• Nancy Ngugi
• , Gaman Muhammed
• , Eva Njenga
• , Catherine Karekezi
• , Nancy Kunyiha
• , Newton Ngugi
•  & Elizabeth Onyango

South Africa ACCEDE study group

• Amanda Mashego
• , Kirsten De Klerk
• , Salih Hendriks
•  & Bilqees Sayed

Contributions

EMC, LM, YK, ES, SG, BEN, CH and SS are the Scientists in the study. PR is the Principal Investigator of the study in Steve Biko Hospital, Diabetes Clinic adult population in Pretoria, South Africa. MK is the Principal Investigator of the study in Steve Biko Hospital, Diabetes Clinic and adolescent population in Pretoria, South Africa. MC is the Principal Investigator of the study in Red Cross Childrens Hospital, Paediatric Clinic in Cape Town, South Africa. JD is the Principal Investigator of the study in Groote Schuur Hospital, Diabetes Clinic in Cape Town, South Africa. DK is the Principal Investigator of the study to be conducted in Kenya. JK is the coordinator of the study to be conducted in Kenya. JN and NS are senior scientists at FIND. DA and BE are data experts from the Data Science Unit at FIND. BV is the Lead Scientist of the Non-Communicable Diseases at FIND. LM, YK, ES, SG, BN, CH, PR, MC, JD, SS and BV conceptualised the study. SS designed the protocol incorporating the feedback from the co-creation workshops. CH and BV provided funding acquisition. EMC and CH provided overall coordination and project management. EMC, LM and YK provide technical support to implementing sites. DA provided technical guidance to prepare the CRFs and the database. BE calculated the same size, supported the design of the outcomes, and is preparing the analysis plan. All authors were involved in the drafting and revising the manuscript and approved the final version for submission. Editorial assistance in the preparation of the manuscript was provided by Stuart Wakelin and funded by FIND.

Corresponding author

Correspondence to Elena Marbán-Castro .

Ethics declarations

Ethics approval and consent to participate {24}.

The protocol for the trial to be conducted in Kenya was approved by the African Medical and Research Foundation (AMREF) Ethical and Scientific Review Committee (ESRC) and the National Commission for Science, Technology and Innovation in Kenya (NACOSTI). The protocol for the trial to be conducted in South Africa was approved by the Faculty of Health Sciences Research Ethics Committee at the University of Pretoria and the Human Research Ethics Committee at the University of Cape Town.

Written, informed consent to participate in the trial will be obtained from all participants and/or their parents/caregivers.

Consent for publication {32}

No participant details, images, or videos are included in this trial protocols. This section is therefore not applicable. The participant information materials and informed consent form are available from the corresponding author on reasonable request.

Competing interests {28}

There are no competing interests to declare.

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Marbán-Castro, E., Muhwava, L., Kamau, Y. et al. Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya. Trials 25 , 331 (2024). https://doi.org/10.1186/s13063-024-08132-7

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Received : 18 January 2024

Accepted : 22 April 2024

Published : 21 May 2024

DOI : https://doi.org/10.1186/s13063-024-08132-7

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