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Analyzing early child development, influential conditions, and future impacts: prospects of a German newborn cohort study

• Sabine Weinert 1 ,
• Anja Linberg 2 ,
• Manja Attig 3 ,
• Jan-David Freund 1 &
• Tobias Linberg 3  

International Journal of Child Care and Education Policy volume  10 , Article number:  7 ( 2016 ) Cite this article

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The paper provides an overview of a German cohort study of newborns which includes a representative sample of about 3500 infants and their mothers. The aims, challenges, and solutions concerning the large-scale assessment of early child capacities and skills as well as the measurements of learning environments that impact early developmental progress are presented and discussed. First, a brief overview of the German regulations related to early child education and care (ECEC) and parental leave as well as the study design are outlined. Then, the assessments of domain-specific and domain-general cognitive and socio-emotional indicators of early child functioning and development are described and the assessments of structural, orientational, and process quality of the children’s learning environment at home and in child care are presented. Special attention is given to direct assessments and their reliability and validity; in addition, some selected results on social disparities are reported and the prospects of data analyses are discussed.

Early childhood and early child education are an important basis for later development, educational performance, and pathways as well as for lifelong learning and well-being. This important claim has been made repeatedly (Caspi et al. 2003 ; Noble et al. 2007 ), and even critical phases of development have been suggested (e.g., Mayberry et al. 2002 ). Nevertheless and despite the existence of quite a few longitudinal studies addressing this issue, empirical evidence concerning effective conditions, differential child progress, and how the early phases of life impact future development and prospects is still rare.

From an educational and political point of view, it is alarming that various studies have documented profound disparities in child development according to family background when children are merely 3 years of age (Brooks-Gunn and Duncan 1997 ; Dubowy et al. 2008 ; Hart and Risley 1995 , 1999 ; Weinert et al. 2010 ). Even in the first year of life, very early roots of social disparities have been demonstrated which increased substantially over the next few years (Halle et al. 2009 ). In addition, some studies show a high stability of interindividual differences and social disparities from age three onward across preschool (Weinert and Ebert 2013 ; Weinert et al. 2010 ) and school age (Law et al. 2014 ). Notably, the stability of individual differences in children’s test performance has been shown to be even more pronounced in educationally dependent domains of development, like language and factual knowledge, than in more domain-general and less culture-dependent facets of children’s cognitive functioning, as indicated by non-verbal intelligence test scores (Weinert et al. 2010 ).

Drawing on a bioecological model of development (Bronfenbrenner and Morris 2006 ), developmental progress and child education are influenced from early on by the interaction between (developing) child characteristics, skills, and competencies and the quality of structural and process characteristics of the learning environment at the child’s home (Bakermans-Kranenburg and van Ijzendoorn 2011 ; Bradley and Corwyn 2002 ; Ebert et al. 2013 ; Weinert et al. 2012 ) as well as in child care (Anders et al. 2013 ). Longitudinal studies shed light on these interactions and how they impact later development and education, which is of great importance for gaining a better understanding of the underlying processes and influential conditions. It is important to note that the form and organization of the various learning environments are affected by state regulations, which differ between countries, resulting in different support systems, offers and regulations for parents from child birth until her/his formal school enrolment (Waldfogel 2001 ).

Regulations in Germany

Maternity leave regulations in Germany prescribe a period of 14 weeks for maternity leave which is divided into two phases: 6 weeks before and 8 weeks after birth. Mothers receive maternity pay from public funds in addition to their employer’s contribution which amounts to 100 % of their former income. After this period, parents are offered various options for taking parental leave until the child’s third birthday. Specifically, parents may interrupt their employment to provide child care and are legally protected from dismissal during this 3-year period; parents also receive parental pay during their parental leave (substitution of income) amounting to two-thirds of her/his prior salary (ranging from € 300.- up to € 1800.-) for a maximum period of 14 months.

Governments also support families through child care policies. The German early child education and care (ECEC) system covers institutional care and education before and alongside elementary and secondary school. Since 1993 children from age of three onward have had a legal right to institutional child care which is primarily organized by local communities and welfare organizations providing care to mainly age-mixed groups at centers with varying opening hours (Linberg et al. 2013 ). However, during the last decade, there has been growing demand for ECEC for children under the age of three that led to the enactment of laws on the demand-driven expansion of child care (“Tagesbetreuungsausbaugesetz TAG”) and the expansion of child care infrastructure for infants and children (“Kinderförderungsgesetz KiföG”) in 2005 and 2008, respectively. Additionally, the legal right to institutional ECEC was expanded in 2013 to include 1-year-old children and political leaders from local, state, and federal levels agreed to provide enough places for 35 % of the children.

Accordingly, the actual use of child care for young children under the age of three has rapidly changed during recent years: Within 8 years (2005–2013), the child care rates for the under 3-year olds increased from 7 to 23 % in the Western states of Germany and from 36 to 47 % in the Eastern states, which have their own distinct tradition and infrastructure concerning early care and education (Kreyenfeld and Krapf 2016 ). In 2015, the nation-wide care rate amounted to 32.9 % with mean values of 28.2 % for the Western and 51.9 % for the Eastern states (Statistisches Bundesamt 2016 ).

However, despite rising rates of early education, a child’s family still is the first and often only environment for developmental processes during the first years of life. Thus, there is a substantial need for analyzing the decision mechanisms as well as the effects of the various options available for early child care.

To summarize, longitudinal studies that provide a basis for analyzing the conditions which significantly contribute to early developmental progress are of great importance for the individual child as well as for society. These studies produce relevant knowledge on how children’s abilities, skills, and competencies develop based on individual resources and conditions; how learning opportunities influence their development in different contexts; how disparities emerge early in life; and how all this impacts educational careers, lifelong learning, well-being, and participation in society.

The German National Educational Panel Study

(NEPS) Footnote 1 has been set up to substantially contribute to these issues (Blossfeld et al. 2011 ). The idea of a multicohort panel study was brought up by the German Federal Ministry of Education and Research (BMBF). A nation-wide interdisciplinary scientific network of researchers was established to develop this idea further and to prepare a proposal for a longitudinal representative large-scale educational study to investigate, monitor, and compare competence development and educational processes in Germany. In light of the specific challenges associated with sampling and measurement of early child characteristics, a newborn cohort study was not initially included in the main NEPS program, but was planned to be conducted as an associated add-on project. However, the study was incorporated into the NEPS study design on behalf of the international evaluation committee organized by the German Research Foundation (DFG) for two main reasons: the growing research on the importance of early child development and education and the rapid changes taking place in early child care, including new social policies being implemented in Germany (see above).

The NEPS is carried out by a network of excellence. It features a longitudinal multicohort sequence design and comprises more than 60,000 target persons as well as 40,000 context persons. In particular, the NEPS design encompasses six longitudinal panel studies conducted simultaneously, which cover a wide range of ages and educational stages. NEPS data are disseminated in a user-friendly way to the scientific community. According to the sensitivity of data, the access is given by a web download, a remote access solution, or on-site in a secure environment. All data are documented in English and are available for use by national and international researchers. In addition to providing substantial analyses of the data themself, it can be used as a benchmark for intervention research, international comparison, and for evaluating issues such as the differences and changes in the use of institutional child care.

At the moment, more than 1100 researchers from more than 700 projects are drawing on the NEPS data already published. The data are used for research in a variety of scientific disciplines and also for educational monitoring—especially, the indicator-based National Report for Education. In order to facilitate access to results for a wide range of professions interested in education—including policy, administration, and practice—scientific papers with important conclusions and empirical evidence are currently summarized by the Leibniz Institute for Educational Trajectories (LIfBi) for public communication and information beyond science and are distributed via the NEPS webpage. Moreover, results are regularly fed back to these groups by presentations and newsletters.

The present paper provides an overview of the NEPS newborn cohort study and its analytic potential. First, the design of the study will be presented with a special emphasis on the aims, challenges, and solutions for the assessment of child characteristics and learning environments. We will then report a few selected results (a) concerning the validity and reliability of the measures used and (b) on early social disparities.

Design of the newborn cohort study of the NEPS: a brief overview

Like all other cohort studies of the NEPS, the cohort study of newborns addresses five research perspectives (Blossfeld et al. 2011 ). Drawing on a theoretical framework, various domain-specific as well as domain-general indicators of early child capacities, characteristics, and developments are assessed as well as measures of structural and process characteristics of their (different) learning environments and their social, occupational, and educational family background. In addition, there is a special focus on families with a migration background, on educational decisions (e.g., concerning child care), and—especially in the newborn cohort study—on patterns of coparenting and child care arrangements. By combining direct observational measures, interview data, and questionnaires, the newborn cohort study allows for in-depth analyses of developmental progress and influential conditions that affect the development of educationally relevant competencies and the stability or changes of interindividual differences. Therefore, it provides insight into the mechanisms through which social disparities emerge, change, and impact children’s future prospects and returns to education.

Sampling strategy

To ensure a representative sample, a two-stage procedure was implemented: 84 German municipalities were used as primary sampling units, explicitly stratified according to three strata of urbanization (via the number of inhabitants; see Aßmann et al. 2015 ). Within these municipalities, addresses were sampled and divided into two birth tranches (infants born between February and April 2012 and between May and June 2012) in order to guarantee a small age range for the infant sample. Starting from a gross sample of about 8500 families, a total of about 3500 families (response rate 41 %) took part in the first assessment wave. In the second wave, the realized sample still included about 2850 families (panel stability 83 %).

Assessment waves and data collection

During the very early phases of child development, three successive assessment waves were carried out when children were on average 7 months (wave 1), 17 months (wave 2), and 26 months of age (wave 3). In the first and third wave video-taped observations and computer-assisted personal interviews (CAPI) were conducted at the family’s home for the entire sample. In the second wave, families were surveyed by computer-assisted telephone interviews (CATI), while video-taped observational measures at the child’s home were only assessed in half of the sample (subsample approx. 1500) in accordance with the study’s design. After wave 3 (i.e., from age two onward) children and their context persons were and will be surveyed every year. Data are collected by trained interviewers. Mothers are the primary respondents, as they can provide valid information about conditions and feelings during and after their pregnancy. Each assessment wave is preceded by a longitudinal pilot study, which runs 1 year before the main study is conducted, to test all instruments and procedures.

Measuring early child characteristics: aims, challenges, and solutions

The assessment of a child’s capacities, characteristics, and early development is pivotal for analyzing the effects of environmental conditions and the impact of early child development and education on later development, educational achievement, career, and life satisfaction or other outcomes and returns. In particular, measuring child characteristics is essential to the modeling of intra-individual progress and changes in interindividual differences, including the emergence of social disparities in various domains of development across childhood. At the same time, it is crucial for analyzing the mechanisms of change, the effects of learning environments and opportunities, and their interactions with the individual capacities and characteristics of the children, while taking the risk or protecting factors of the individual child and his/her environment into account, as well as for controlling for basic interindividual differences if necessary.

However, measuring early child characteristics is a major challenge for longitudinal studies, especially large-scale studies. This is due to various issues and questions, such as which aspects and indicators of early child development should be assessed, how should they be measured, and how can the standardization and validity of measurements be ensured in large-scale assessments of very young children.

Early child development: domain-specific challenges for the child

Developmental psychology has convincingly documented for a long time that neither the development of children nor the development of infants is a homogeneous endeavor. Since the time of Piaget’s ( 1970 ) overarching stage theory of development, it has been empirically demonstrated that development is domain-specific, i.e., demands, prerequisites, effective environmental stimulations differ according to the developmental domain under study (e.g., the acquisition of language, of mathematical competencies, of competencies in natural science, or of an intuitive psychology) (Karmiloff-Smith 1999 ). Even in infancy domain-specific precursors of e.g., mathematical and psychological knowledge and competencies are observable (Goswami 2008 ). Determining how educationally relevant competencies emerge from the interplay of these domain-specific precursors and domain-general basic capacities of the child (like basic reasoning abilities, speed of information processing, or executive functions including cognitive flexibility, inhibition, working memory) on the one hand and of the environmental conditions in the family and in child care on the other is an important issue to be addressed by educational studies. It is important to note that (interindividual differences in) basic capacities also change with age and environmental conditions, although not to the same extent as culture- and education-dependent competencies, and that stimulation of and progress in one developmental domain may enhance, hinder, or compensate for those in other domains.

General NEPS framework for assessing competencies

Within the NEPS, a general framework for assessing educationally relevant abilities and competencies has been developed (Weinert et al. 2011 ). Specifically, the assessments include (a) domain-general cognitive abilities/capacities captured by the constructs of “fluid intelligence” (Cattell 1971 ) or “cognitive mechanics” (Baltes et al. 2006 ); these refer to performance differences in speed of basic cognitive processes, the capacity of working memory, and the ability to apply deductive or analogical thinking in new situations (Brunner et al. 2014 ); (b) domain-specific cognitive competencies, e.g., language competencies, mathematical competencies, and natural science competencies are to be assessed longitudinally and as coherently as possible; and not least (c) meta-competencies, including self-regulation (in the cognitive, behavioral, and emotional domain) and socio-emotional competencies are to be measured (see Weinert et al. 2011 for an elaborated rational of the assessments).

Selecting and measuring relevant and predictive indicators of early child development: a challenge for research

As already mentioned, even in infancy and early childhood, there is no overall indicator for children’s capacities and development. Considering the fact that there are thousands of studies into infant competencies, the indicators have to be carefully selected—not least because of the limited study time and other constraints associated with large-scale assessments, especially those concerning infants and young children who cannot be tested in group settings and whose attentional capacities are still limited. Within the NEPS, the selection draws on the general framework outlined above, including domain-general basic capacities, domain-specific precursors and early roots of language and mathematics as well as indicators of socio-emotional development and early self-regulation.

However, deciding on how to measure these early child characteristics and developments is a major challenge for theoretically sound educational large-scale assessments. Just relying on parents’ reports is problematic since the parents’ judgements might be affected, for example, by their (different) knowledge of child development, by possible restrictions/differences in how they observe the child, and by their particular cultural and individual beliefs and biases. In addition, major aspects of domain-general and domain-specific cognitive functioning and development are not easily observable and need sophisticated assessment methods developed in infancy research.

If newborn cohort studies took direct measures into consideration in addition to interviews and questionnaires, they often relied on the Bayley Scales of Infant Development (Bayley 2006 ; Schlesiger et al. 2011 for a brief overview). However, the NEPS feasibility and pilot studies revealed that the standardized administration of test items (using an educationally sound selection of items) turned out to be highly error-prone for trained interviewers who are usually experts in administering interviews but not tests. In addition, the sensorimotor indicators of developmental status measured by the Bayley Scales have been shown to be rather instable across situations (Attig et al. 2015 ) and infancy (McCall et al. 1977 ) and were hardly predictive for later cognitive functioning (e.g., Fagan and Singer 1983 ). Therefore, an indicator of basic information processing abilities was introduced within the NEPS newborn cohort study which has predominantly been used in baby lab studies, namely, the children’s visual attention and speed of habituation within a habituation–dishabituation paradigm. Within this paradigm, the child’s visual attention and the decrease of her/his visual attention when being presented with a series of identical or categorically similar stimuli are used as indicators of the child’s ability to build up a cognitive representation of a stimulus or a stimulus category (Pahnke 2007 ; Sokolov 1990 ). In addition, a new stimulus (or a stimulus from a new category) is presented in the dishabituation phase of the paradigm and a new increase of the child’s visual attention is interpreted as a signal of her/his ability to distinguish stimuli or categories presented during the two phases of the paradigm and to show a preference toward new information. These measures have been shown to be highly predictive of later intelligence scores or other indicators of cognition and language (Bornstein and Sigman 1986 ; Fagan and Singer 1983 ; Kavšek 2004 ). Thus, this paradigm was used to assess early domain-general information processing/categorization abilities; it was also used to measure early precursors of numeracy and word learning (see Table  1 ). To assure standardization and reliability, pictures were presented on a computer screen and the child’s looking behavior (look at/away from the respective stimulus) was video-taped (as were all other direct measures) and coded afterward on a 30 frames per second basis. A third direct indicator of early child characteristics relevant to learning and education is her/his interactional behavior (cognitive, behavioral, and socio-emotional aspects) in mother–child interaction (see “ Assessment of mother–child interaction: direct measurement of the home-learning environment and of the child’s characteristics in mother–child interaction ” section). Table  1 summarizes the measurements of child characteristics and development assessed in the first three waves of the NEPS newborn cohort study.

In addition to direct assessment, mothers were asked (see Table  1 ) about the child’s skills and development as well as about the child’s health. The questions on the child’s skills and development cover items on cognition (e.g., means-end task and object categorization), communicative gesture (e.g., to draw someone’s attention, negation/headshaking), gross and fine motor skills (e.g., climbing up steps, stacking of toy blocks) as well as language (e.g., size of productive vocabulary, comprehension of short instructions). A short version of the Infant Behavior Questionnaire (IBQ-R, Gartstein and Rothbart 2003 ) was used to assess facets of the child’s temperament, specifically orienting/regulatory capacity (items like “if you sing or speak to <target child’s name>, how often does she/he calm down instantly?”) and negative affectivity (items like “when <target child’s name> can’t have what she/he wants, how often does she/he get angry?”) (Bayer et al. 2015 ). In wave 3, a German language checklist and, for bilingual children, an additional Turkish or Russian language checklist (versions of the well-known MacArthur Communicative Development Inventory (CDI); Fenson et al. 1993 ) was introduced.

Measuring learning environments: aims, challenges, and solutions

Likewise, measuring learning environments that impact child development is an important challenge for longitudinal large-scale educational studies. As suggested by bioecological theories (Bronfenbrenner and Morris 2006 ), it is not enough to just focus on the home-learning environment; the use and features of non-parental care and other learning environments like parent–child programs, which 55 % of the children in the newborn cohort study experience in their first year of life, should also be assessed. Moreover, it is not sufficient to only measure quantitative structural characteristics, since domain-general and domain-specific qualitative aspects have been shown to be especially important (e.g., Anders et al. 2012 ; Sylva et al. 2006 ); however, indispensable direct observational measurements are hard to obtain in large-scale studies. It is important to note that the meaningfulness of the specific features/aspects assessed for characterizing the different learning environments and the constraints of the measurements have a large impact on the validity of subsequent analyses and conclusions.

General framework of the NEPS

To deal with these issues coherently across cohorts, the measurement of important characteristics of learning environments draws on a general framework which subdivides three different dimensions: Structural quality , which refers to relatively persistent general conditions; orientational quality , like values, norms, and attitudes of an actor; and process quality , which refers to the interaction of the individual with her/his learning environment (Bäumer et al. 2011 ).

Selection and measurement of indicators

For the assessment of the process quality of the home-learning environment as the central learning environment in the very early years, the NEPS newborn cohort study relies on both interviews/questionnaires and direct observations (see below).

In addition, as approx. 24 % of the children of the newborns’ cohort sample were using supplementary non-parental care settings in wave 2, the dimensions specified above were also surveyed in these child care settings using self-administered drop-off questionnaires for center-based ECEC as well as for child minders. Because the NEPS has to rely on survey data, the validity of the quality of non-parental care settings gained from the questionnaire is tested by conducting a sub-study, which compares observational methods with the questionnaire used in the NEPS study. The questionnaire covers structural characteristics as well as process characteristics (see Table  2 for examples).

Besides external day care, the newborn cohort study of the NEPS places a strong emphasis on the home-learning environment—especially in very early childhood—as it is of central importance for later development (NICHD 1998 ). Large-scale longitudinal studies mostly focus on the structural aspects of the home-learning environment to account for variability in infants’ and toddlers’ cognitive and social skills (Halle et al. 2009 ; Hillemeier et al. 2009 ). However, process variables account for additional variance in both social and cognitive child outcomes and may even mediate the effect of structural characteristics (Flöter et al. 2013 ; NICHD 1998 ). Therefore, the assessment of the home-learning environment is not only limited to measuring structural aspects like sociodemographics, but also includes orientations (see Table  3 ); in particular, special emphasis is given to the assessment of processes . Mothers are asked about issues, such as joint activities and their language use at home and the quality of these interactions is also assessed by means of videotaping mother–child interactions during the first three assessment waves (see Table  3 ; “ Assessment of mother–child interaction: direct measurement of the home-learning environment and of the child’s characteristics in mother-child interaction ” section).

Assessment of mother–child interaction: direct measurement of the home-learning environment and of the child’s characteristics in mother–child interaction

On the one hand, the assessment of mother–child interactions as a dyadic process allows a deeper look into maternal interaction behavior as a crucial characteristic of the home-learning environment; on the other hand, it captures additional information about the relevant characteristics of the child.

The quality of maternal interaction behavior has been shown to impact a child’s language (Nozadi et al. 2013 ; Tamis-LeMonda et al. 2001 ), cognitive (NICHD 1998 ; Pearson et al. 2011 ), and socio-emotional development (Bigelow et al. 2010 ; Meins et al. 2001 ). High-quality maternal interaction behavior in very early childhood is mostly described as interaction behavior that provides the child with emotional support in terms of sensitivity, which is defined as a prompt, warm, and contingent reaction to the child’s needs and signals (Ainsworth et al. 1974 ). But stimulating interaction behavior in the sense of scaffolding behavior (Wood 1989 ) is also regarded as high-quality maternal behavior, even in early childhood.

However, maternal interaction behavior cannot be considered separately from the child’s behavior, as interaction is a dyadic process in which both partners’ behavior refers to each other in a reciprocal way. It is well acknowledged that children play an active role in the dyadic interaction process from the very beginning, initiating interactions (van den Bloom and Hoeksma 1994 ) and influencing their occurrence and appearance (Lloyd and Masur 2014 ). Additionally, the child’s temperament (e.g., fear, excitement, protesting, and crying) can become effective in an interaction (Mayer 2013 ).

Accordingly, the NEPS newborn cohort study assesses maternal as well as filial interaction behavior via observation. The mother–child interactions are videotaped in the family home and are rated afterward by trained coders. The interaction itself takes place in a semi-standardized play situation in which the mother and the child play with a standardized toy set (Sommer et al. 2016 ). The play situation is adapted to the different age-related requirements: In the first wave, the mother–child interaction is videotaped for 5 min in which toys from the NEPS toy set are provided. In waves 2 and 3, the mother and child are observed while carrying out a three-bag procedure in which the mother and child played for 10 min with toys from three different bags in a set order (NICHD 2005 ).

Maternal as well as filial interaction behavior is assessed using a macro analytic rating system whereby various interactional characteristics are evaluated on five-point-rating scales with qualitatively specified graduations ([EKIE]; Sommer and Mann 2015 ). The assessment of maternal behavior covers emotional supportive interaction behavior (like sensitivity to distress and non-distress, positive regard for the child, emotionality) and stimulating interaction behavior, including a common rating for language and play stimulation in the first two waves and differentiating language and mathematical stimulation in wave 3 when children were 2 years of age (see Table  3 ). The mother’s intrusiveness, detachment, and negative regard of the child were also rated. The coding of the child’s behavior and emotions focuses on the child’s mood, activity level, social interest in the mother, and sustained attention to objects.

Some selected results

NEPS data are disseminated among the scientific community for analysis and provide an important basis for substantive longitudinal and comparative research. In particular, the various measurements of child characteristics and the detailed measures of the home-learning environment, including the observation of mother–child interactions, enable in-depth analyses to be conducted. In the first section, the results on the reliability and validity of these direct measures and information on the underlying constructs are given, while the second section contains an analysis of early social disparities in the mother’s behavior and child’s development. In addition to using the data from the newborn cohort study (wave 1), Footnote 2 we also draw on the data obtained from the “ViVA project,” Footnote 3 which aims to validate the NEPS measures as one of its objectives.

Reliability and validity of measures of mother–child interaction

Assessing interactions in a large-scale assessment is challenging with regard to validity and reliability of the measurements and ratings. In the NEPS newborn cohort study, these challenges were solved quite successfully: Weighted inter-rater reliability ranged from 84 to 100 % and the ecologic validity of the observed maternal interaction behavior seems to be high, as the data from the ViVA project show that interaction behavior assessed in the semi-structured play situation is comparable to maternal interaction behavior in other situations, i.e., natural feeding and diapering situations (Friedman test comparing differences between interaction situations: χ 2  = 0.74, p  = 0.69; Intra-Class-Correlations of maternal interaction behavior in different situations: ICC  = 0.68, p  < 0.001; n  = 23–30; Vogel et al. 2015 ).

Assessing the quality of the mother’s interaction behavior is a core construct of the home-learning environment in the first waves of the newborn cohort study and focuses on socio-emotional aspects as well as on stimulation. Although the assessed indicators address different aspects of maternal interaction behavior, some of them are related to each other (see Table  4 ). It is worth noting that aspects, like intrusiveness, detachment, or negative regard, are not simply the negative end of the more or less pronounced positive dimensions.

From a theoretical point of view, high-quality interaction behavior includes both sensitivity and stimulation behavior. To test the assumption that a rather broad composite indicator of quality of interaction behavior is not only theoretically but also empirically meaningful, a confirmatory factor analysis was conducted (see Fig.  1 ). Items in the socio-emotional domain ( sensitivity to non - distress , Footnote 4 positive regard , and emotionality ) as well as stimulation loaded substantially on quality of interaction behavior (all standardized coefficients above 0.45). Positive regard (0.69) and stimulation (0.77) contributed the most to this factor. Internal consistency was high (Cronbach's α = 0.80).

Results from confirmatory factor analysis for the latent variable Q uality of interaction behavior (Linberg et al. 2016 ). N  = 2190; Chi 2 (2) = 16.05, p  < .000; RMSEA  = 0.06; CFI  = .99; based on all German-speaking mother–child interactions in wave 1

One should note, however, that this broad measure of the quality of interaction behavior is only slightly, albeit significantly, related to other aspects of the home-learning environment which were assessed via the parents interview: This includes issues, like the overall amount of joint activities with the child ( r  = 0.13, p  < 0.000) and special activities (joint picture book reading, r  = 0.13, p  < 0.000; joint construction play, r  = 0.07, p  < 0.000; and talking to the child, r  = 0.07, p  < 0.000).

Reliability and validity of measures of early child characteristics

Given the sample size and household setting, the available data on child characteristics provide a rather detailed insight into the early stages of development, especially with respect to early cognitive capacities and child temperament, which are both measured by multiple indicators. As expected, the first results revealed that these multiple assessment approaches refer to different facets of early child development.

The mother’s report on the child’s temperament deals with the reactions of the child to stressful situations and her/his susceptibility to calming related behavior. In line with previous evidence, this is hardly related to the indicators of child’s temperament, which were assessed in a fairly relaxed mother–child interaction situation ( r  = 0.05, p  < 0.05; Freund and Weinert 2015 ). At the same time, there is evidence supporting the validity and reliability of these measurements. In the ViVA validation study, the information from the questionnaire has been shown to represent the complete subscales of the IBQ-R from which the items were selected ( r  = 0.51 for negative affectivity/0.70 for orienting/regulatory capacity, p  < 0.01; Bayer et al. 2015 ). In addition, it is correlated with the children’s reactions to stress-inducing maternal behavior in a still-face-paradigm where the mother is instructed not to react to her child’s signals ( r  = 0.34–0.43, p  < 0.05; Freund and Weinert 2015 ).

Likewise this can be shown for the assessments of early cognitive capacities/competencies. In the ViVA study, the items on sensorimotor development (assessment of developmental status) were highly correlated with the complete cognition and motor subscales of the Bayley Scales, respectively ( r  = 0.48–0.63, p  < 0.01; Attig et al. 2015 ). Hence the data on sensorimotor development as well as the data on basic information processing abilities (habituation–dishabituation paradigm; 85 % of the videos codable; non-completion of child <1 %; inter-coder reliability in wave 1: κ = 0.91) both rely on scientifically well-established and successfully applied assessments. Nevertheless, they are hardly correlated with each other and thus seem to cover different aspects of early development ( r  = 0.06/0.14, p  < 0.05; Weinert et al. 2016 ).

Although the findings always have to be considered within the context in which the assessments were made (e.g., short version/time), the validity of the various measurements of child characteristics and maternal interaction behavior seems to be apparent.

Early roots of social disparities in child development

The data of the NEPS newborn cohort study allow for an analysis of early social disparities with respect to both early child characteristics and their mother’s interaction behavior. Analyses of data from the first assessment wave when children were 6–8 months of age are in accordance with a bioecological model of child development (Weinert et al. 2016 ). As hypothesized, the mother’s interaction behavior in the video-taped mother–child interaction situation varied significantly according to her educational background. With regard to the broad concept of quality of interaction behavior described above, the mother’s education accounted—even in these early phases of child development—for 4 % ( p  < 0.001) of the variance within the German subgroup of participants. However, as expected we did not find substantial disparities in child characteristics in early childhood, like basic information processing abilities (habituation–dishabituation paradigm), developmental status (sensorimotor scale), or socio-emotional child characteristics coded during mother–child interaction. Interestingly, some early roots of social disparities were observed in child’s characteristics, such as sustained attention to objects and activity level in mother–child interaction. Notably, as predicted, mother–child interaction turned out to be a mutual endeavor: Interactional characteristics of the child (especially the child’s mood, her/his social interest, and continuing sustained attention to objects) and the child’s temperament (orienting/regulatory capacity) accounted for 29 % ( p  < 0.001) of the differences in the overall quality of the mother’s interaction behavior, over and above the control variables (age, sex) and socio-economic conditions (equivalized family income, education of mother, living in partnership) (Weinert et al. 2016 ). Of course, it is still an open question whether the differences observed between children result from former or actual differences in the mother’s behavior or whether the differences in child characteristics and behavior are effective in eliciting their mother’s behavior. In fact, the interrelation between mother and child behavior may vary according to other factors, e.g., additional protective or risk factors (Freund et al. 2016 ). Future findings from the NEPS cohort study of newborns will contribute to explaining how social disparities (suspected at age two and beyond) emerge, how they change over time, which mechanisms contribute to their emergence, and how they impact future development and education.

Prospects and conclusions

Insights and conclusions from longitudinal studies and analyses on the conditions which influence early developmental progress, the emergence of disparities, and their impacts are relevant to educational facilities and social policy and thus to the individual child as well as to society. The present paper focused on the first waves of a large-scale German cohort study of newborns. The various measures will help to better understand the stabilities, changes, and effects of qualitative and quantitative characteristics that early learning environments and other influential conditions have. They also illustrate how the very early outcomes of infant development act as a basis for future development. The child’s development will be measured by testing the development of mathematical, language, and early natural science competencies. Domain-general cognitive abilities will also be assessed (i.e., non-verbal categorization, delay of gratification, verbal memory, and executive functions) along with indicators of socio-emotional development (subscales of the Strength and Difficulties Questionnaire (SDQ), Goodman 1997 ), temperament (subscales of the Children’s Behavior Questionnaire (CBQ), Rothbart et al. 2001 ), and personality (BigFive; short version of the Five Factor Questionnaire for Children (FFFK); Asendorpf and van Aken 2003 ). Learning environments will be measured by interviews and questionnaires which draw on the general framework described above and will be supplemented with assessments of different facets of parenting style. To ensure standardization and reduce administration errors, all tests are carried out on tablet computers in child-oriented, playful settings.

It is worth noting that the kindergarten cohort of the NEPS, which started in 2010, also assessed comparable measures from age five onward. Here a sample of about 3000 children (institutional sample from 279 ECEC centers and 720 groups) was included. Despite differences between cohort designs (e.g., individual vs. institutional sample; child assessments at the children’s home vs. in preschool; playful test administration with vs. without tablet computers; CAPI vs. CATI interviews of the parents) the two cohort studies allow for comparisons while at the same time being characterized by partially complementary strengths and weaknesses (e.g., more elaborate information on home-learning environment vs. on institutional characteristics; extensive assessment of early roots vs. extensive assessment of further development). Among other things, this allows for an in-depth analysis of the interrelation between variations as well as an analysis of the constancies and changes in learning environments and child development, and it also relays important information concerning relevant aspects of early education and how it impacts development, educational career, and future prospects.

A better understanding of the relevant factors and conditions influencing early child development and learning together with their impact on children’s future development, educational success, and well-being is of special importance for ECEC policy. Longitudinal studies are needed because they allow analyses of the mechanism and processes of change in these decisive variables. While in cross-sectional studies causal effects cannot be inferred, longitudinal studies—especially those that enable complex group-specific growth-curve modeling and the modeling of intra-individual change—combined with experimental and quasi-experimental comparisons not only contribute significantly to gaining deeper insights into developmental and educational processes and the conditions influencing them but can also answer important questions relevant to ECEC policy such as how does early compared to late entry to institutional care impact later development in various cognitive and non-cognitive domains? Is early institutional care especially valuable (and to what extent) for different subgroups of children/families (e.g., disadvantaged families, children/families with specific risk factors, children with a migration background, refugees, multilingual children, e.g., children learning German as an (early) second or third language)? What are the determinants of the quality of home-learning environment and its effects on child development and education? What are specific risk (or protective) factors and is it possible to compensate for (or to draw on) them?

Obviously, even longitudinal studies will not deliver straightforward conclusions for ECEC policy. However, they provide an important and essential basis for evidence-based policy by informing about relevant conditions of early child education and how they impact later development (e.g., successful future development, educational drawbacks or opportunities in the social, socio-emotional, and cognitive domain). In fact, it has been suggested that high-quality early education is of special importance from a psychological, an educational, a sociological, and an economic perspective and thus is of significant relevance not only to the individual but also to society as a whole (Heckman 2013 ; Sylva et al. 2011 ). NEPS data are especially helpful when it comes to gaining a better understanding of the development of competencies and decisive conditions over the life course—the samples are carefully drawn, the validity of data is high, and longitudinal data are available in a user-friendly form for analyses and even for international comparisons.

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Authors’ contributions

SW conceptualized and drafted the overall manuscript, sequence alignment, and revisions. In addition she cooperatively conceived the design and assessments of the studies, in particular the assessment of early child competencies, and the analyses of social disparities. AL especially drafted the part on the learning environments and the assessment of mother-child interaction; she conducted the data analyses on mother-child interaction and supported the analyses on ecologic validity of mother-child-interaction. MA contributed to the description of the overall design and did the analyses on early roots of social disparities. She is also involved in the conceptualization and coordination of data assessment of the infant cohort study. TL drafted the part on regulations in Germany and contributed to the description of the assessment of learning environments. He is also involved in the conceptualization of the assessment of this data. JDF did the analyses on the reliability and validity of measures of early child characteristics; he drafted this part and cooperatively planned and conducted the validation study. All authors were involved in the sequence alignment and revisions, and approved the final manuscript. All authors read and approved the final manuscript.

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Weinert, S., Linberg, A., Attig, M. et al. Analyzing early child development, influential conditions, and future impacts: prospects of a German newborn cohort study. ICEP 10 , 7 (2016). https://doi.org/10.1186/s40723-016-0022-6

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DOI : https://doi.org/10.1186/s40723-016-0022-6

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Theories of Child Development and Their Impact on Early Childhood Education and Care

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Developmental theorists use their research to generate philosophies on children’s development. They organize and interpret data based on a scheme to develop their theory. A theory refers to a systematic statement of principles related to observed phenomena and their relationship to each other. A theory of child development looks at the children's growth and behavior and interprets it. It suggests elements in the child's genetic makeup and the environmental conditions that influence development and behavior and how these elements are related. Many developmental theories offer insights about how the performance of individuals is stimulated, sustained, directed, and encouraged. Psychologists have established several developmental theories. Many different competing theories exist, some dealing with only limited domains of development, and are continuously revised. This article describes the developmental theories and their founders who have had the greatest influence on the fields of child development, early childhood education, and care. The following sections discuss some influences on the individuals’ development, such as theories, theorists, theoretical conceptions, and specific principles. It focuses on five theories that have had the most impact: maturationist, constructivist, behavioral, psychoanalytic, and ecological. Each theory offers interpretations on the meaning of children's development and behavior. Although the theories are clustered collectively into schools of thought, they differ within each school.

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Saracho, O.N. Theories of Child Development and Their Impact on Early Childhood Education and Care. Early Childhood Educ J 51 , 15–30 (2023). https://doi.org/10.1007/s10643-021-01271-5

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Accepted : 22 September 2021

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DOI : https://doi.org/10.1007/s10643-021-01271-5

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Early childhood development: an imperative for action and measurement at scale

Linda richter.

1 Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa

Maureen Black

2 RTI International, Research Triangle Park, North Carolina, USA

3 Early Childhood Development, Unicef USA, New York City, New York, USA

Bernadette Daelmans

4 Department of Maternal, Newborn, Child and Adolescent Health, WHO, Geneva, Switzerland

Chris Desmond

5 DST-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa

Amanda Devercelli

6 Early Childhood Development, World Bank Group, Washington, District of Columbia, USA

7 Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland

Günther Fink

8 Household Economics and Health Systems, Swiss Tropical and Public Health Institute, Basel, Switzerland

9 Global Health and Population, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA

Jody Heymann

10 Fielding School of Public Health and WORLD Policy Analysis Center, University of California, Los Angeles, California, USA

Joan Lombardi

11 Early Opportunities, Washington, District of Columbia, USA

Chunling Lu

12 Division of Global Health, Brigham and Women's Hospital and Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA

Sara Naicker

Emily vargas-barón.

13 RISE Institute, Washington, District of Columbia, USA

Experiences during early childhood shape biological and psychological structures and functions in ways that affect health, well-being and productivity throughout the life course. The science of early childhood and its long-term consequences have generated political momentum to improve early childhood development and elevated action to country, regional and global levels. These advances have made it urgent that a framework, measurement tools and indicators to monitor progress globally and in countries are developed and sustained. We review progress in three areas of measurement contributing to these goals: the development of an index to allow country comparisons of young children’s development that can easily be incorporated into ongoing national surveys; improvements in population-level assessments of young children at risk of poor early development; and the production of country profiles of determinants, drivers and coverage for early childhood development and services using currently available data in 91 countries. While advances in these three areas are encouraging, more investment is needed to standardise measurement tools, regularly collect country data at the population level, and improve country capacity to collect, interpret and use data relevant to monitoring progress in early childhood development.

Summary box

• New knowledge of the extent to which experiences during early childhood shape health, well-being and productivity throughout the life course has prompted action to improve early childhood development at the country, regional and global levels.
• Advances have been made in three areas of measurement needed to achieve these goals: population-level child assessments, population proxies of children at risk of poor childhood development, and country and regional profiles of drivers and supports for early childhood development.
• Regular, country-comparable, population-level measurements of childhood development, as well as threats to development and available supports and services, are needed to drive progress and accountability in efforts to improve early childhood development.

Introduction

Scientific findings from diverse disciplines are in agreement that critical elements of lifelong health, well-being and productivity are shaped during the first 2–3 years of life, 1 beginning with parental health and well-being. 2 The experiences and exposures of young children during this time-bound period of neuroplasticity shape the development of both biological and psychological structures and functions across the life course.

Adversities during pregnancy and early childhood, due to undernutrition, stress, poverty, violence, chronic illnesses and exposure to toxins, among others, can disrupt brain development, with consequences that endure throughout life and into future generations. 3 4 Children whose early development is compromised have fewer personal and social skills and less capacity to benefit from schooling. These deficits limit their work opportunities and earnings as adults. 5 A corollary of early susceptibility to adversity includes responsiveness to opportunities during these early years. As a result, interventions during the first 3 years of life are more effective and less costly than later efforts to compensate for early adversities and to promote human development. 6

It is estimated that, in 2010, at least 249 million (43%) children under the age of 5 years in low-income and middle-income countries (LMICs) were at risk of poor early childhood development (ECD) as a consequence of being stunted or living in extreme poverty. 7 This loss of potential is costly for individuals and societies. The average percentage loss of adult income per year is estimated at 26%, increasing the likelihood of persistent poverty for these children, families and societies. 5 Assuming 125 million children are born each year with a global average of poor infant growth, 8 the estimated annual global income loss is US$177 billion. 9 These impacts have serious consequences on economic growth. Recent World Bank estimates suggest that the average country’s per capital gross domestic product would be 7% higher than it is now had stunting been eliminated when today’s workers were children. 10 At the global level, human capital accounts for as much as two-thirds of the wealth differences between countries. ECD is the foundation of human capital. 11

Supported by a growing body of evidence and increasing global interest in this field, ECD is included in the 2015 United Nations Sustainable Development Goals (SDGs). Target 4.2 is ‘improved access to quality early childhood development, care and pre-primary education’. Progress towards achieving this target is measured by indicator 4.2.1, ‘the proportion of children under 5 years of age who are developmentally on track in health, learning and psychosocial well-being, by sex’. ECD is closely linked to other SDGs as well, for example, eradicate poverty (1), end hunger and improve nutrition (2), ensure healthy lives (3), achieve gender equality (5), reduce inequality in and among countries (10), and promote peaceful societies (16), and it is implied in several more. 5

The United Nations Global Strategy for Women’s, Children’s and Adolescents’ Health, 2016–2030 synthesises the 17 SDGs in three strategies: survive, thrive and transform. Survive refers to sustained and increased reductions in preventable deaths of women, newborns, children and adolescents, as well as stillbirths; thrive refers to children receiving the nurturing care necessary to reach their developmental potential; and transform refers to comprehensive changes in policies, programmes and services for women, children and adolescents to achieve their potential. 12

ECD has also become an important component of other global agendas, including Scaling Up Nutrition, the Global Partnership for Education, the Global Financing Facility for Every Woman Every Child, the Every Woman Every Child movement, the work plans of the WHO, Unicef and the World Bank Group, the G20, 13 international funding agencies, and philanthropic foundations. 7

These multifaceted findings have generated political momentum to improve ECD as a critical phase in the life course, making it urgent to develop measurement tools and indicators to monitor progress globally and in countries. Advances in measurement are needed to support efforts to motivate and track political and financial commitments, and to monitor implementation and impact. This means that we must be able to determine how many and which children are thriving, and on track in health, learning and psychosocial well-being.

Measurement of children’s progress in childhood is acknowledged to be challenging because development is by nature dynamic and children have varying individual trajectories. Well-validated instruments of individual development are complex and require extensive training and expertise. These challenges are amplified in efforts to make measurements across populations of children. Taking these limitations into account, we review progress in three areas of measurement that are contributing data to the current political momentum for ECD and efforts to monitor implementation and impact. Progress is being made to construct a feasible country-comparable measure of young children’s development that could be incorporated into national surveys, to improve proxies of population levels of young children at risk of poor early development, and to generate country profiles of determinants, drivers and coverage for early childhood development and services, using currently available data.

A new initiative to construct a population measure of ECD

A direct measure of the development of children 0–5 years that could be administered globally and used both within and across countries is urgently needed. Efforts have been made since the 1980s to develop a globally applicable measure of ECD, with the major challenges being individual and cultural variations in the onset of early skills. 14

Currently, the Early Child Development Index (ECDI) is included as the indicator of SDG goal 4, target 4.2. It is a composite index, first introduced in Unicef’s fourth Multiple Indicator Cluster Survey (MICS) in 2010. It is derived from 10 caregiver-reported questions designed for children aged 36–59 months to assess four domains of development: literacy-numeracy, learning/cognition, physical development and socioemotional development. Some items are acknowledged to be unsuitable for assessing development, 15 and efforts are under way to revise the index, as well as to include items applicable to children younger than 3 years of age.

Three research efforts have collaborated to create the Global Scale for Early Development (GSED): the Infant and Young Child Development from the WHO, 16 the Caregiver-Reported Early Development Instrument from the Harvard Graduate School of Education, 17 and the Developmental Score from the Global Child Development Group at the University of the West Indies. 18 The goals of the GSED are to develop two instruments for measuring ECD (0–3 years) globally: a population-based instrument and a programme evaluation instrument, as described in table 1 .

Global Scale for Early Development: population and programme measures

The GSED takes advantage of large-scale and cohort studies from many countries and is harmonising efforts to generate population-based and programmatic evaluation measures of the development of children aged 0–3 years old that can be used globally ( table 2 ). The scale will be available for country testing in 2019. The aim is to have the population-based measure incorporated into national surveys, including Unicef’s MICS and the US Agency for International Development’s Demographic and Health Surveys (DHS), to produce globally comparable monitoring data. Efforts are also under way to harmonise the revision of ECDI and the development of GSED to align on child outcome measurement from birth to 59 months of age.

Development and validation of the Global Scale for Early Development

CREDI, Caregiver-Reported Early Development Instrument; D-score, Developmental Score; IYCD, Infant and Young Child Development.

A country-comparable proxy for population levels of risk of poor childhood development

Information about children’s risk for poor development is important, as is identifying areas for intervention. To track these, a proxy measure of population levels of young children at risk of suboptimal development has been calculated.

Stunting and poverty were used in the first published estimation in 2007 of the global prevalence of risk to children’s development. The initial choice of indicators was based on evidence that they both predict poor cognitive development and school performance. 19 20 Additional advantages are that their definitions are standardised and many countries have data on both indicators. 21

Lu et al 21 updated the earlier values to 2010, using the 2006 WHO growth standards and World Bank poverty rates (US$1.25 per person per day), leading to an estimate of 249 million children or 43% of all children under 5 years of age in LMICs being at risk of poor childhood development. The accuracy and comparability of the later estimates benefited greatly from major advances in both data availability and estimation methods. 21

To estimate the long-term consequences of poor ECD, studies focus on estimating the impact on subsequent schooling and labour market participation and wages. The current estimate, that the average percentage of annual adult income lost as a result of stunting and extreme poverty in early childhood is about 26%, is supported by follow-up adult data from early life interventions. Two programmes have found wage increases between 25% in Jamaica attributed to a psychosocial intervention 22 and 46% in Guatemala attributed to a protein supplement. 23

In order to improve the estimate of risk, efforts are under way to include additional risks experienced in ECD known to affect health and well-being across the life course. For example, adding low maternal schooling and exposure to harsh punishment to stunting and extreme poverty, for 15 countries with available data from MICS in 2010/2011, increased the number of children estimated to be at risk of poor childhood development substantially. 5

Country profiles of ECD

Population-based measures of early child development and proxies of children at risk give an indication of prevalence, and indicators of disparity can be derived according to gender, urban–rural location and socioeconomic status. However, they do not include drivers, determinants nor coverage of interventions that could improve childhood development.

The Countdown to 2015 for Maternal, Newborn and Child Survival , established in 2005, set a precedent by creating mechanisms to portray multidimensional aspects of progress towards improving maternal and child health, and is testimony of its value. 24 Countdown to 2030 , which tracks maternal, child and adolescent health and nutrition goals, has expanded to address the broader SDG agenda, including ECD, health in humanitarian settings and conflict, and adolescent health and well-being. 25 26 It includes coverage and equity of essential interventions, as well as indicators of determinants and the enabling environment provided by policies.

This approach has been applied to ECD using the Nurturing Care Framework, 27 launched at the 71st World Health Assembly. The concept of nurturing care was introduced in the 2017 Lancet Series Advancing Early Child Development: From Science to Scale . Nurturing Care Framework comprises conditions for early development: good health and nutrition; protection from environmental and personal harm; affectionate and encouraging responses to young children’s communications; and opportunities for young children to learn through exploration and interpersonal interactions. 7

These early experiences are nested in caregiver–child and family relationships. In turn, parents, families and other caregivers require support from a facilitating environment of policies, services and communities. Policies, services and programmes can protect women’s health and well-being, safeguard pregnancy and birth, and enable families and caregivers to promote and protect young children’s development. 6

The Nurturing Care Framework has been used to produce ECD profiles for 91 LMICs. 28 Countries were selected either to ensure alignment of ECD with Countdown to 2030 , or because more than 30% of children are estimated to be at risk of poor ECD in 2010, using the methods described in Lu et al 21 and Black et al . 7

These country profiles, which consist of currently available data from LMICs, are laid out to represent the Nurturing Care Framework. The profiles consist of the following sections:

• Selected demographic indicators of the country relevant to early child development: total population, annual births, children under 5 years of age and under-5 mortality.
• Threats to ECD, including maternal mortality, young motherhood, low birth weight, preterm births, child poverty, under-5 stunting, harsh punishment and inadequate supervision.
• The prevalence of young children at risk of poor child development disaggregated by gender and rural–urban residence, and lifetime costs of growth deficit in early childhood in US dollars.
• The facilitating policy environment for caregivers and children, as indexed by relevant conventions and national policies.
• Support and services to promote ECD in the five areas of nurturing care: early learning, health, nutrition, responsive caregiving, and security and safety.

Most of the existing data are published in Unicef’s annual State of the World’s Children. Convention and policy data come from, among others, the United Nations Treaty Collections and the International Labour Organization.

Figure 1 shows an example of the country profiles, with the country name replace by ‘Country Profiles’.

An example of an early childhood development (ECD) country profile. CRC, convention on the rights of the child.

In a forthcoming paper, Lu and Richter (2019) describe in detail the updated estimates of children at risk of poor childhood development using the newly released poverty line of US$1.9 per person per day to estimate that, in 2015, 233 million children or 40.5% of children under 5 years of age were at risk of poor childhood development. Figures 2 and 3 show the estimates of risk for poor ECD across a decade, from 2005 to 2010 and 2015, and using the 2010 data variations between children at risk living in rural and urban areas. Gender is not illustrated here because, in most countries, the differences are small and not statistically significant.

Decline in the number of countries with high proportions of young children at risk of poor development between 2005 and 2015.

Differences in risk of poor development among urban and rural children in 63 countries (most recent years with available data).

Figure 2 shows that, between 2005 and 2010, countries with two-thirds of young children at risk (>67%) declined in both central Europe and South-East Asia. There was little change in countries with high proportions of young children at risk in sub-Saharan Africa during this period, and by 2015 countries with the highest proportion of children at risk were in Central and Southern Africa.

Estimates on the prevalence of children at risk of poor development in urban and rural areas were derived using DHS, MICS and country data for 63 countries with available data in most recent years ( figure 3 ). The differences are strikingly high, with more rural children at risk than their urban counterparts in 50 countries (differences of more than 20%). Almost all countries with 40% point differences were in sub-Saharan Africa. 28

There are additional indicators that ideally should be included in a monitoring framework, but currently lack comparable country data. Data are usually unavailable because reliable, valid instruments feasible for multicountry administration are still in development, or the instruments are not yet included in representative surveys. In particular, there are as yet no global population-based indicators for assessing responsive caregiving. Suggestions have been made that data should be collected on whether information about ECD and caregiver–child interaction is publicly disseminated, whether home visits or groups are provided for parents at high risk of experiencing difficulties providing their children with nurturing care, and whether affordable good quality child day care is available for families who need it. 29 National data on laws and policies that support responsive caregiving are also insufficient, for example, wages and other forms of income to enable families to provide for their young children. 30

Additional data gaps concern risks arising from poor parental mental health, 31 low maternal schooling, and maternal tobacco and alcohol use, among others, prevalence of childhood developmental delays and disabilities, 32 and maltreatment and institutionalisation of young children. 33 There is also no comparable information on government budget allocation to ECD or household expenditure on ECD services care, among others.

Multidisciplinary scientific evidence and political momentum are focusing on ECD as a critical phase in enhancing health and well-being across the life course. Additional measurements and indicators for monitoring and evaluation are urgently needed to support expansions in implementation and investment, and to report progress. New data will stimulate global, regional and national action, and in turn motivate for more areas of ECD to be covered in national surveys.

The Nurturing Care Framework provides a platform for three important areas of work. First, very significant progress is being made through the revision of the ECDI and the development of the GSED, a short caregiver-reported population measure of ECD that could feasibly be included in DHS, MICS and other nationally representative household surveys. The GSED will enable ECD to be tracked at population levels, and for programmes and services to be monitored and evaluated in comparable ways.

Second, a country-comparable proxy of the risk of poor ECD developed from 2004 data and updated with 2010 data has been extended to 2015, enabling comparisons to be made globally, regionally and by country across the last decade. Plans are in place to update these estimates regularly, and to add new risks as data for more countries become available.

Third, using these estimates, data included in Countdown to 2030 , and additional data from MICS and policy databases, initial profiles have been constructed for 91 LMICs. The profiles are organised according to the ecological model of the Nurturing Care Framework with policies, services and programmes supporting families and caregivers to provide good health and nutrition, security and safety, opportunities for early learning, and responsive caregiving for young children to thrive. The further development of these profiles is overseen by a multiagency committee as part of Countdown to 2030 and are freely available ( http://www.ecdan.org/countries.html and https://nurturing-care.org/?page_id=703 ). Unicef will update the country data annually and the profiles will be reproduced every 2 years.

However, as indicated earlier, substantial gaps in national and global data on topics of concern to ECD remain. The current global estimation on burden of risks, for example, does not include known risk factors other than stunting and extreme poverty, as a result of which the existing burden calculation is considerably underestimated. 5 The limited information on ECD investments at the country and global levels is exacerbated by the lack of appreciation of what constitute essential and continuous services, standard indicators for measuring ECD interventions and policies, as well as systematically collected data. Country capacity needs to be strengthened and ECD costing modules integrated into existing household income or expenditure surveys, and routinely collected from specific types of programmes. Clear definitions are needed to track donor contributions to ECD, and efforts should be made to address data issues, including collecting data from emerging donor countries (eg, China), foundations and international non-governmental organisations that are playing an increasing role in financing ECD, as has been called for by the G20. 33 National policies, strategic plans and laws which support ECD through nurturing care should be tracked for this intersectoral area.

To improve measurements of risks, intervention coverage, policies, financial commitments and impact on young children’s development, more investment is needed to regularly collect and disseminate data at the national and subnational levels. Analytical gaps at the country and global levels exist, especially with respect to equity analyses by household wealth, maternal education and rural–urban location, as well as by gender and child age within 0–5 years.

In conclusion, progress has been extremely positive, but too slow and too fragmented for the bold global agenda of ECD and the Nurturing Care Framework. The alliance with Countdown to 2030 is helpful as there is much to be learnt from the initiative’s experience under the Millennium Development Goals (MDGs), as well as collaboration with the SDGs. The country profiles boldly portray what we currently know about ECD in some of the most at-risk conditions and will prove a valuable tool for advocacy and implementation, including to improve measurement. Successful implementation and impact are dependent on accountability supported by regularly updated reliable and valid information.

Acknowledgments

Robert Inglis (Jive Media Africa, Pietermaritzburg, South Africa) and Frank Sokolic (EduAction, Durban, South Africa) for assistance with the country profiles and maps.

Handling editor: Seye Abimbola

Contributors: All authors meet the conditions for authorship: substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data; drafting the work or revising it critically for important intellectual content; final approval of the version published; and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Funding: This study has been funded by Conrad N Hilton Foundation and the Bill and Melinda Gates Foundation.

Competing interests: None declared.

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Provenance and peer review: Not commissioned; externally peer reviewed.

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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.

[1] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[2] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[3] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk ; Kimmelman, J., Hyun, I., Benvenisty, N.  et al.  Policy: Global standards for stem-cell research.  Nature   533 , 311–313 (2016). https://doi.org/10.1038/533311a

[4] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk

[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:

Sandel M. J. (2004). Embryo ethics--the moral logic of stem-cell research.  The New England journal of medicine ,  351 (3), 207–209. https://doi.org/10.1056/NEJMp048145 ; George, R. P., & Lee, P. (2020, September 26). Acorns and Embryos . The New Atlantis. https://www.thenewatlantis.com/publications/acorns-and-embryos ; Sagan, A., & Singer, P. (2007). The moral status of stem cells. Metaphilosophy , 38 (2/3), 264–284. http://www.jstor.org/stable/24439776 ; McHugh P. R. (2004). Zygote and "clonote"--the ethical use of embryonic stem cells.  The New England journal of medicine ,  351 (3), 209–211. https://doi.org/10.1056/NEJMp048147 ; Kurjak, A., & Tripalo, A. (2004). The facts and doubts about beginning of the human life and personality.  Bosnian journal of basic medical sciences ,  4 (1), 5–14. https://doi.org/10.17305/bjbms.2004.3453

[6] Vazin, T., & Freed, W. J. (2010). Human embryonic stem cells: derivation, culture, and differentiation: a review.  Restorative neurology and neuroscience ,  28 (4), 589–603. https://doi.org/10.3233/RNN-2010-0543

[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

[25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech.

[26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine , 12 (6), 647–656. https://doi.org/10.2217/rme-2017-0035

[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

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[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

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[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

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

[79] International Society for Stem Cell Research. (2024). Standards in stem cell research . International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research

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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)

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