Co-Producing Principles of Engagement to Improve the Inclusion of Black Women in UK Maternity and Neonatal Research: A Qualitative Study

Co-Producing Principles of Engagement to Improve the Inclusion of Black Women in UK Maternity and Neonatal Research: A Qualitative Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Co-Producing Principles of Engagement to Improve the Inclusion of Black Women in UK Maternity and Neonatal Research: A Qualitative Study Georgia Clancy, Shireen Patel, Bhuvan Majmudar, Catherine Henshall, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9418759/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 6 You are reading this latest preprint version Abstract Background: Black women in the United Kingdom persistently experience poor health outcomes in pregnancy and childbirth compared to white women. These healthcare inequities have multiple causalities, and are rooted in intersecting structural, systemic, institutional and sociocultural factors. This is exemplified by the underrepresentation of Black women in healthcare research. Mistrust in research, shaped by historical exploitation and contemporary discrimination, alongside organisational barriers within research delivery, continues to limit equitable research participation. Aim: To critically explore how maternity and neonatal research opportunities are offered, understood, and experienced by Black women and research delivery teams, and to co-produce Principles of Engagement (PoE) to support more inclusive research practices. Methods: An exploratory qualitative design was employed, informed by the Double Diamond framework. In the discover phase, seven online focus groups were conducted with Black women and community representatives (n=26), as well as research midwives (n=24). Data was analysed using reflexive thematic analysis to define key themes. These findings, alongside patient and public involvement and engagement (PPIE) input, and evidence from a recent systematic review, informed the develop phase, generating draft Principles of Engagement. In the deliver phase, these principles were iteratively refined, discussed, and rated through three online consensus workshops with stakeholders (n=20). Results: Four interrelated themes were generated from the focus groups: (1) Trust as a precondition for ethical participation; (2) Making research inclusive and accessible; (3) Power, agency and relational decision-making; and (4) Motivation and value of participation. During subsequent consensus workshops, eight Principles of Engagement were generated; all eight principles were rated as 100% important in the final consensus round. Conclusion: Research engagement was found to be socially negotiated and structurally shaped rather than a solely individual choice. Inclusive intent alone was often insufficient without resourced structural support and relational accountability. Our findings have been translated into novel, co-produced and system-ready principles of engagement which aim to advance equity in UK maternity and neonatal research. Embedding these principles in research practice has the potential to improve trust between clinicians and Black women, widen research participation and improve the fairness, transparency, and relevance of maternity research. Black women maternal health healthcare research participation barriers health equity recruitment strategies focus groups consensus building Background Persistent health inequalities affecting Black women highlight the urgent need for maternity and health services research that meaningfully reflect their experiences, priorities, and needs. In the United Kingdom, Black women are currently 2.3 times more likely to die from pregnancy-related causes than white women and experience higher rates of preterm birth and stillbirth ( 1 , 2 ). These disparities stem, in part, from intersecting sociocultural, structural and institutional factors, which result in unequal access to services ( 3 ). For example, Black women’s engagement with healthcare is influenced by intergenerational knowledge, community norms, and poor prior healthcare experiences ( 4 – 6 ). In the UK, around 65% of Black people report ethnicity-based discrimination from healthcare professionals ( 7 ). These experiences affect health outcomes, and decrease trust and willingness to engage with healthcare research ( 8 ). Improving healthcare equity requires the meaningful inclusion of ethnic minority groups in healthcare research to ensure that the research outcomes are applicable across diverse populations ( 9 ). Genetic, environmental, social, and cultural factors influence how individuals respond to both pharmacological and non-pharmacological interventions, meaning that research conducted with homogenous populations risks producing biased evidence and perpetuating inequitable outcomes ( 10 , 11 ). Despite this, Black women remain substantially underrepresented in healthcare research compared to other ethnic groups across national population demographics ( 12 – 14 ). Mistrust in healthcare research among Black communities is well documented and is rooted in histories of exploitation including the Tuskegee Syphilis Study, the nonconsensual use of Henrietta Lacks’ cells, and reproductive coercion ( 15 – 18 ), which continue to shape collective memory and perception of risk ( 8 ). Black women commonly report concerns about unequal treatment, culturally insensitive communication, limited transparency, and poor relationships with research teams during the research process ( 19 – 22 ). Across ethnic minority groups, commonly reported barriers to research participation include mistrust, poor relationships with healthcare professionals, financial and logistical burdens, language barriers and competing caregiving responsibilities ( 8 , 21 , 23 ). Improving inclusion in healthcare research requires moving beyond deficit based accounts to models that recognise participation decisions as negotiated within relationships shaped by trust, power, communication and perceived value ( 24 ). Within this context, healthcare professionals in research delivery roles – such as research nurses and midwives – serve as key intermediaries in introducing and facilitating research participation and are central to addressing these barriers. However, while many research nurses and midwives are committed to inclusive practice, they report limited training, resources and organisational support to engage confidently and sensitively with Black women ( 25 ). This is compounded by a lack of evidence on specific barriers to research experienced by Black women, particularly in maternity settings where reproductive injustice, heightened vulnerability and complex decision making intersect with persisting inequalities in outcomes for Black women. This empirical study builds on a recent systematic review( 8 ) of barriers and facilitators to Black women’s participation in healthcare research which identified mistrust, poor interpersonal experiences, and low health/research literacy as key barriers, and highlighted community engagement, cultural competence and transparent communication as facilitators. Using a co-design approach informed by the Double Diamond framework( 26 ), this paper sought to extend and critically examine these systematic review findings by exploring how maternity and neonatal research opportunities are offered, understood, and experienced by Black women and research delivery teams. Through an initial exploratory phase using focus groups, PPIE and collaborative refinement, the study aimed to both deepen understanding of engagement processes and translate these insights into practice. A second aim was to co-develop Principles of Engagement through consensus workshops, providing actionable guidance to support more inclusive, meaningful, and equitable research practices. Methods Ethical Approval Ethical approval was granted by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of Nottingham in October 2024 (Ref: 284-0924). The COnsolidated criteria for Reporting Qualitative research (COREQ) guided the reporting of this study (27) (Supplementary file 1). Participants We aimed for a diverse sample to gain a broad range of experiences from Black women and research delivery teams. Participants were purposively sampled to include, first-, second- and third-generation Black women, differing ethnicities, educational, and employment statuses. Representatives of Black women were deemed eligible if they were aged 18 years or over, able to provide informed consent, and met at least one of the following criteria: identified as a Black woman of childbearing age (including dual heritage); had personal experience of pregnancy during or after 2010; identified as being a father/birthing partner of a Black woman; a leader, support worker or volunteer within a Black community organisation, including faith-based groups. Research delivery team members were eligible if they had worked in maternity or neonatal healthcare research within the past three years, had held a clinical research delivery role during this period, and were able to provide informed consent. Potential participants were notified about the study through a flyer shared through multiple recruitment channels; professional local and national networks of the study team and study advisory group (consisting of senior professionals and academics), the project’s community partner Egality Health (a community engagement agency which supports access to research), professional mailing lists, social media, and snowball sampling. If interested, potential participants contacted the study team via email for more information. They were then provided with a digital copy of the participant information sheet to read in their own time, invited to ask questions and given a choice of focus group dates and times. If participants wished to proceed, they were sent a link to an online consent form and brief demographic questionnaire to complete prior to the focus group. Participants were provided with online shopping vouchers in appreciation of their time and contribution to the study, as well as costs incurred for taking part (e.g. data allowance). Participants who took part in the focus groups were invited to also take part in the consensus workshops, in addition to other senior professionals, researchers and representatives of relevant community organisations. Patient and Public Involvement and Engagement (PPIE) The study design, focus group topic guides and plan for the consensus workshops were developed with input from Egality Health and our PPIE group of 11 Black mothers. Reflexive discussions were held throughout data collection and analysis, and themes were iteratively reviewed with the wider team, including PPIE contributors, to challenge assumptions and strengthen interpretations. The study team recognise that positionalities shape the analytic process and therefore aimed to centre participants’ voices through extensive PPIE work and strived to remain attentive to power imbalances by always introducing themselves, sharing their interest in the project and being open to participants’ questions and views throughout. Study design and data collection The study was conceptually guided by the Double Diamond design framework(26), which was operationalised as a reflexive, equity‑oriented approach to co‑production. The framework supported structured movement from experiential exploration to the generation of system‑ready outputs, while maintaining attention to power, relational ethics, and accountability throughout. In the Discover phase, four focus groups with Black women and three focus groups with research delivery teams were used to surface lived, relational, and institutional experiences of research engagement within maternity and neonatal settings. This phase explored how research opportunities were encountered, understood, and negotiated, allowing participants to articulate concerns, motivations, and tensions without premature problem‑framing or solution‑seeking. The focus groups were conducted between May-August 2025 and took place on Microsoft Teams. Focus groups lasted approximately 60 minutes and participants only took part in one focus group each. Discussions were recorded and transcribed via Microsoft Teams, with transcripts subsequently checked for accuracy and anonymised by the study team. A semi-structured focus group topic guide (Supplementary file 2) was developed based on literature searches and discussions amongst the study team, as well as PPIE members. The topic guide consisted of core questions for both Black women and research delivery teams, as well as specific questions for each group relating to their experiences of conducting or considering taking part in research. The Define phase focused on sense‑making and problem clarification. Insights from the focus groups were analysed using reflexive thematic analysis and integrated with findings from a prior systematic review(8), enabling the identification of shared patterns, key challenges, and priorities shaping inclusion and exclusion in research. This phase moved beyond describing barriers to reframing engagement as socially negotiated and structurally conditioned. During the Develop phase, these analytically derived priorities were translated into draft Principles of Engagement through iterative co‑production with PPIE contributors and stakeholders. Emphasis was placed on ensuring that emerging principles were ethically grounded and practically meaningful across different contexts. The Deliver phase centred on validation, refinement, and legitimation of the Principles of Engagement through three structured consensus workshops (60-90 minutes each). Prior to the first workshop, participants received the draft Principles of Engagement (Supplementary file 3) and completed an initial, individual rating using a 9-point Likert scale (1 = not at all important; 9 = extremely important) via Microsoft Forms. During the workshops, stakeholders collaboratively discussed, refined, and rated each principle supporting collective ownership and ensuring that the final principles reflected shared priorities and actionable commitments rather than individual or institutional perspectives. The consensus workshops were recorded and transcribed in Microsoft Teams to enable the study team to review stakeholder contributions and ensure that subsequent iterations reflected the group’s priorities. The aim was to formulate a final set of Principles of Engagement to guide research delivery teams to better recruit and retain Black women into maternal and neonatal healthcare research. In line with co-production approaches, an interim version of the Principles of Engagement was also sent to two participants (one Black woman and one research midwife) for an additional ‘sense-checking’ stage to ensure that changes aligned with their perspectives. Their feedback informed minor revisions before the third and final round of voting from the full consensus group. Together, these stages enabled the progression from lived experience to co‑produced, consensus‑endorsed principles to support more inclusive maternity and neonatal research practice. Data analysis Focus group transcripts were imported into NVivo12 and analysed by GC following Braun and Clarke’s (28) six-phase approach to reflexive thematic analysis: (i) becoming familiar with the data, (ii) generating initial codes, (iii) searching for themes, (iv) reviewing themes, (v) defining themes, (vi) writing up findings. To begin with, the women’s and research delivery team’s transcripts were coded separately, inductively and largely descriptively, with themes developed by identifying concepts that cut across codes and participant groups. Similarities across the themes generated for each participant group meant that the two datasets were eventually combined to formulate the final themes. This iterative process was facilitated by regular discussion, review, and refinement during team meetings (GC, SH, SP). Data saturation was reached after the fourth focus group and subsequent focus groups added clarification and elaboration to the research findings. During the consensus workshops, agreement on the concepts for inclusion in the final Principles of Engagements was determined via anonymous voting within the group. The threshold for consensus was set at >70% agreement between members present based on ratings of 7, 8 or 9 in the 9-point Likert scale (1 = not at all important; 9 = extremely important) used and stated as a priori. Author positionality The study team recognises that our identities and professional roles shape the design, conduct, and interpretation of this study. The focus groups with research delivery teams were facilitated by GC and CH, who identify as White British; CH is also a mother and a healthcare professional with a background in clinical research delivery. Focus groups with Black women and community representatives were facilitated by GC, SH (White British) and SP (British Indian Muslim). These positionalities provided insight into research delivery contexts but also meant that the team were removed from the lived experiences of Black women. All authors identify as female, hold PhDs and work within UK academic and healthcare research institutions, with an interest maternal health and health inequalities. They therefore hold positions of relative privilege within the systems being examined. This may have influenced the questions we prioritised and how we interpreted participants’ accounts. Results Across the focus groups and consensus workshops a total of 57 participants took part in the study. Focus groups Seven online focus groups were conducted: four with Black women (n=29, 10.3% drop out rate from consent); and three with research midwives (n=28, 13.8% drop out rate). Drop out was typically due to participants being unable to make focus group date/times. Full demographic characteristics for focus groups participants are in Table 1[1]. Table 1. Focus group participants. Characteristic Black women and their Representatives Research Midwives (n=26) % (n=24) % Participant group: Representative of women Women Research midwife 1 25 3.8 96.2 - - 24 - - 100 Gender: Female 26 100 24 100 Age (years): Mean 36.8 - 40 - Ethnicity: Black African Black British Black Caribbean Mixed – Black and White African Mixed/Multiple ethnic background Other (please specify): Black British-Caribbean Latin American White English/Welsh/Scottish/Northern Irish/British Irish White European White Other 15 3 4 1 - 1 1 - - - 57.7 11.5 15.2 3.8 - 3.8 3.8 - - - - 1 - - 2 - - 17 3 1 - 4.2 - - 8.3 - - 65.4 11.5 4.2 Country of birth: Bolivia Germany Italy Nigeria Spain Sudan Trinidad United Kingdom Zimbabwe Prefer not to say 1 - - 6 - 5 1 8 1 4 3.8 - - 23.1 - 19.2 3.8 30.8 3.8 15.4 - 1 1 - 1 - - 21 - - - 4.2 4.2 - 4.2 - - 84 - - First language: English Arabic German Italian Ndebele Igbo Spanish Yoruba 14 7 - - 2 1 1 1 53.8 26.9 - - 7.7 3.8 3.8 3.8 21 - 1 1 - - 1 - 84 - 4.2 4.2 - - 4.2 - Children: No I don’t have a child/children but I am pregnant Yes I have a child/children 1 25 3.8 96.2 n/a n/a Marital status: Married Single 20 6 76.9 23.1 n/a n/a Highest qualification: O-level/GCSE A-level First degree Higher degree Other higher qualification No qualifications Other Prefer not to say 2 2 7 8 3 1 - 3 7.7 7.7 26.9 30.7 11.5 3.8 - 11.5 - - 14 7 2 - 1 - - - 58.3 29.2 8.3 - 4.2 - Religion: Christian Jewish Muslim No religion/belief Prefer not to say Spiritual 14 - 8 2 1 1 53.8 - 30.8 7.7 3.8 3.8 13 1 1 1 - - 54.2 4.2 4.2 4.2 - - Disability: Yes No Prefer not to say 1 24 1 3.8 92.3 3.8 1 22 1 4.2 91.7 4.2 Main occupation: Prefer not to say Homemaker Unemployed Modern professional occupations Clerical and intermediate occupations Senior managers or administrators Semi-routine manual and service occupations Middle or Junior managers Traditional professional occupations Other 3 3 3 4 1 4 1 2 2 3 - 11.5 11.5 11.5 15.4 3.8 15.4 3.8 7.7 7.7 11.5 - n/a n/a Have you ever taken part in a research study as a participant? Yes No Prefer not to say 10 10 6 38.5 38.5 23.1 n/a n/a NHS salary band: Band 6 Band 7 Other n/a n/a 18 5 1 75 20.8 4.2 How many years have you worked in research delivery? Less than 1 year 1-2 years 3-5 years 6-9 years 10 years or more n/a n/a 3 4 9 5 3 11.5 16.7 37.5 20.8 11.5 Twenty-five Black women, and one community representative of Black women, took part in one of four focus groups, with a mean age of 36.8 years. All women described their ethnicity as Black or Mixed Black and White, with the most common ethnicity being Black African (57.7%). The community representative of Black women identified as a Latin American woman and worked for a charitable organisation which supports Black women asylum seekers/refugees in the UK. Most women were born outside of the UK (53.8%) and would be considered first-generation immigrants, whilst 30.8% were second-generation immigrants born in the UK. Fifty-four percent spoke English as their first language. One woman was currently pregnant with her first child, and the others (96.2%) already had a child/children. Across the remaining three focus groups, all 24 research delivery team members worked as research midwives and identified as female, with a mean age of 40 years. Most were White English/Welsh/Scottish/Northern Irish/British Irish (65.4%), born in the UK (84%) and spoke English as a first language (84%). Twelve percent had been working in research delivery settings for less than 1 year, 16.7% 1-2 years, 37.5% for 3-5 years, 20.8% for 6-9 years, and 11.5% for 10 years or more. The focus group findings presented here correspond to the Discover and Define phases of the Double Diamond framework (26). Together, these phases capture the exploration of lived and professional experiences of research engagement (Discover) and their analytic synthesis into shared patterns and priorities (Define), which subsequently informed the co‑development of the Principles of Engagement. Four interrelated themes were identified across Black women (BW), research midwives (RM), and a community representative (CR): (i) trust as a precondition for ethical research participation; (ii) making research inclusive and accessible; (iii) power, agency, and relational decision‑making; and (iv) motivation and value of participation. Points of convergence and divergence between participant groups are highlighted within each theme. Theme 1: Trust as a Precondition for Ethical Research Participation Trust was identified as the foundational condition underpinning Black women’s research participation. Research midwife participants demonstrated an awareness of historical and contemporary sources of mistrust among Black communities, often shaped by wider experiences of discrimination and unequal treatment within healthcare. As one midwife reflected, “the historic basis around that is completely understandable given the level of mistrust that there has been […] into research in the last 100 years or so” (RM-9). This could be especially true for first-generation immigrants as “they've come over often quite close to when they've then fallen pregnant. So, the overall trust in just the NHS is not there” (RM-11). Similarly, women described how memories of exploitation informed their decision-making, particularly where studies involved clinical procedures or biological samples: “Black communities have sometimes been the target of unethical research and I think that has traumatised the community […] they need that trust and they want to be convinced that […] we’re not being used but this is to benefit us” (BW-1); “I wouldn’t trust it if it was wanting to take blood samples […] I don’t know where it’s going and that would kind of put me off” (BW-25). Trust was influenced by the perceived credibility of those sharing information. Black women highlighted that when recruitment invitations were circulated through trusted intermediaries – such as Black led community organisations, faith groups, online networks and personal contacts – it felt more reassuring and legitimate: “We feel like they [community groups] […] exist to support us as Black women, Black people. So, I would just have a lot more trust in them than coming from the [healthcare] professionals” (BW-7). Similarly, one research midwife described a church event where a matron spoke to her community and “gave that extra validation […] a lot of women signed up […] I think it improved their confidence in research because she was a known person” (RM-15). In contrast, studies appearing “randomly on social media” were likely to be ignored (BW-8). Midwives also recognised that trust depended on how women were approached and emphasised that building rapport and demonstrating transparency were important prerequisites to introducing research: “you don’t just go in there and say, oh I’m the research midwife, do you want to take part […] you have to chat with that woman first” (RM-12). Black women echoed the importance of researcher behaviour, noting that interactions which felt overly cautious could be interpreted as avoidance: “I think sometimes they don’t even try […] they don’t actually even tell you about these things because yeah, they just don’t want to say the wrong thing” (BW-4). Representation within research teams also influenced trust, with some women describing feeling immediately more at ease when they perceived concordance with the researcher: If someone comes in the room that looks like me, instantly I’m put at ease and I feel like you can identify with me on some level […] you're more likely to have my best interests at heart than somebody that doesn't look like me. And being able to understand the some of the cultural nuances. (BW-7) However, women and midwives also cautioned against assuming that racial or cultural concordance guaranteed trust: I don't think that women are more receptive to joining because I'm Black and then also like similarly I wouldn't myself just join something because somebody the person that's telling me about this is black. But, that being said, I do find that if you speak another language or you speak the same language as someone else […] that is helpful. (RM-14). Similarly, “I'm conscious about, you know, me being white and I constantly ask about these things and they say, well, I don't care so much about how you look, but how you make me feel” (RM-5). Women also highlighted that the gender of the researcher could be important, particularly for sensitive topics: “I prefer to work with women. I think we share the same thought[s] and I will be open to talk to the women rather than just talk to men […] whether it's like an Asian, African or white women, or old or young, it doesn't matter” (BW-15). Theme 2: Making Research Inclusive and Accessible Black women and research midwives described how poor recruitment practices and materials could undermine inclusivity, regardless of the research teams’ intentions. As participants noted, limited funding meant that “we’re not allowed to use interpretation services because of the cost” (RM-22) and “if the literature isn’t translated, it’s an exclusion” (RM-12). Even when interpreters were available, midwives expressed ethical concerns about accuracy and whether women had provided “truly informed consent” (RM-9), with translated materials often culturally misaligned and still written in a way that is “sensitive to an English white person rather than […] a person of colour” (RM-6). For Black female participants, medical and/or research jargon emerged as a significant obstacle: “I’m really open to participating in research as long as the information [is] clearly stated and they’re easy for anybody to understand” (BW-5). However, target-driven environments with a focus in recruitment efficiency and total numbers recruited, compounded these challenges, with lengthy recruitment discussions between research delivery team members and potential participants often perceived as inefficient or hard to justify. This deterred some research delivery staff from having these discussions in the first instance: “it’s quite hard to document […] why have you taken so long with that one particular person?” (RM-20). Black women described a sense of exclusion from healthcare settings, which shaped their willingness to engage with research: “If you want to get more Black mums, you have to say it […] it definitely has to be more intentional, that you make it clear that we're welcome, because we're so used to not being welcomed” (BW-4). Research midwives discussed a strong commitment to culturally sensitive practice and reflexivity, whilst resisting assumptions of homogeneity: “Africa is a massive continent […] I’m not gonna get it right 100% of the time, but going in there being aware of different cultural barriers […] and treating each person as an individual” (RM-3). Some midwives described building cultural competence through reflective practice and accountability, recognising the need to “ask questions and try to learn […] because we know […] we’re not doing well and […] need to be accountable for [the diversity of] our recruits” (RM-24). Both participant groups highlighted that delivering research information during clinical appointments, hospital inpatient stays, or immediately postpartum could compromise women’s ability to make informed choices around research participation: “there’s a lot going on […] I don’t know if you’re in the right frame of mind to consent to anything” (BW-4). Midwives acknowledged that postnatal exhaustion and time-limited study windows constrained informed decision-making. They also stated that women of Black ethnicity often wanted information in advance so they had time to consider it and speak with family members about it “a good two weeks beforehand to really read all of the PIS [participant information sheet] in much more detail. Speak to any community […] speak to their husbands,” (RM-7), whilst shorter timelines were perceived to be more acceptable to white British women. Practical caregiving responsibilities also intersected with access and Black women valued online research opportunities for reducing these burdens: “doing things online just allows them to be sociable but not having to think about […] transport […] it’s very convenient for me” (BW-2). Theme 3: Power, Agency, and Relational Decision-Making Agency in research participation was consistently described by participants as negotiated, situational, and relational rather than purely individual. Research midwife participants frequently described ethical dilemmas arising from the influence of partners, families and community norms. As one midwife noted, “sometimes the mother is just mute […] they look at their husband and it’s like, no, you can’t do that” (RM-6). These dynamics were often framed in relation to migration status, with first-generation women perceived as more likely to seek permission from partners or communities. However, midwives acknowledged that decision-making could be genuinely collective rather than coercive: “it’s more of a family discussion and a community discussion about them taking part or not” (RM-24). Navigating these dynamics placed staff in ethically complex positions, balancing cultural respect with individual consent. Women’s accounts offered a more nuanced understanding of agency, emphasising that this was not necessarily experienced as a loss of autonomy, but rather collaborative decision-making: So people from Africa, Middle East, so yeah you have to ask your partner or husband [...] in the UK I must ask you know because of the culture, the system you know, like he’s been living the UK for a long, long, long time so to make me feel safe, you know. (BW-14) If it's something that creates doubt and I'm not unsure of, that's when I will definitely go to friends, family, husband in order to do that. But something […] as simple as this where I know I can share my experience I've got no, I know I don't feel that there's any sort of hidden agenda towards it then yeah, it’s not a problem. (BW-11) Both groups highlighted the role of knowledge and familiarity with the healthcare system in shaping agency. Midwives perceived first-generation women as being “on a back foot […] not clear on what is available or choices” (RM-22). Similarly, it was emphasised that ensuring participants “know what their rights are within research” was key (CR-1). As one participant noted, “people think if I commit to this, then I must get to the end of it, which is not what it says” (BW-1). Clear communication of rights was highlighted as central to ethical empowerment. Theme 4: Motivation and Value of Participation Black women identified that a strong motivator to research participation was the belief that their experiences are often overlooked and research is a route to visibility, recognition, and influence. As one Black woman expressed, “I do like taking part […] because I think Black voices need to be heard […] I don't know if it's making a change or a difference, but it, you know, I do feel like it's something good to do” (BW-4). Others believed that their participation would lead to valuable improvements, noting “I know my feedback will be used to improve outcomes” (BW-1). Personal relevance was also highlighted as being key, with participants recognising that they were drawn to the current study because of its focus on Black maternal health was something they could contribute to and was worth engaging with: “the relevance of the research, that it was related to Black maternal health and obviously I am a mum […] so I felt like I could share some experiences” (BW-7). In many cases, the chance to reflect on and process their own maternity journeys also acted as a motivator for participants: “when you put that out there and you hear yourself, sometimes you rethink how much that has been affecting you” (CR-1). Research midwife participants emphasised the importance of affirming women’s autonomy and respecting their decision to say no without giving a reason: “respecting that, letting them have the control back in their care and you know, giving it a positive impression that she can decline” (RM-3). Feedback and evidence of how previous research had led to tangible change was also a critical motivator for Black women, particularly when findings were shared through trusted community channels; “so these changes were made as a result of Black women taking part in this research […] if something else comes up like that, then OK, I know that change can happen” (BW-7). Financial incentives, such as vouchers, were acknowledged as helpful but secondary to the perceived purpose and impact of the research. Translating themes into draft Principles of Engagement Building on the Discover and Define phases, the Develop phase focused on translating analytic insights into provisional Principles of Engagement. The four thematic areas provided a shared conceptual foundation from which engagement-related priorities were articulated and reformulated as principle statements. This phase involved iterative sense‑making with PPIE contributors and the wider study team to ensure that emerging principles remained grounded in participants’ accounts, while also being framed in ways that were practically applicable across system‑level, research/trial‑level, and research delivery contexts. Rather than generating principles as abstract ideals, this stage emphasised clarity of intent, feasibility, and accountability, resulting in a set of draft Principles of Engagement that reflected both experiential evidence and collective judgement. Seven draft principles were subsequently drafted taken forward for refinement and validation during the consensus workshops. Consensus workshops The Deliver phase focused on refining, validating, and legitimising the draft Principles of Engagement through consensus workshops. Building on priorities articulated during the Develop phase, the draft Principles of Engagement (Supplementary file 3) provided a concrete starting point for structured discussion during the workshops, enabling stakeholders to interrogate their clarity, relevance, and practical applicability across maternity and neonatal research contexts. In the consensus workshops (n=20), 95% of participants identified as female and 5% male. 50% of participants identified as Black, 35% white, 5% Asian and 5% Latin American. In terms of the key stakeholder groups involved; 30% of participants represented lay Black women, 30% represented research delivery teams, 25% represented relevant community organisations and 15% were senior professionals from the study advisory group. Members of the study team (SSH, GC, SP) facilitated but did not vote in the consensus workshops. The full results of the votes for each principle across the three workshops can be found in Supplementary file 4 and a summary of the results is in Table 2. The final, refined Principles are in Box 1. There was strong initial agreement on the importance of seven the draft Principles of Engagement, with growing alignment and shared understanding as stakeholders engaged in iterative discussions and refinement of the principles across the three workshops (see Table 2). Principles relating to trust, clear communication, acknowledgement of mistrust and valuing women’s contributions reached 100% importance by the second vote. A re-occurring discussion for each principle was that of accountability, and that to implement and realise the potential of each principle, a combined and collaborative effort between the wider system level, trial/research teams, and research delivery teams was required. During workshop one, the idea of promoting transparent and accountable research practice was discussed, highlighting structural accountability as essential to building and sustaining trust. This was later added as a new principle during the refinement process before the final vote. In the final vote, all eight refined Principles of Engagement were rated as 100% important, indicating full consensus. Table 2. Summary of consensus workshop votes First vote (n=18) (draft PoE, consensus workshop 1) 1. Build Trust Through Relationships and Respect 2. Strive for Cultural Sensitivity 3. Communicate Clearly 4. Empower Safe and Autonomous Decision-Making 5. Be Flexible and Creative in Recruitment 6. Acknowledge and Address Mistrust 7. Value Women’s Contributions - Result 84% important 90% important 94% important 95% important 84% important 95% important 95% important - Second vote (n=18) (draft PoE, consensus workshops 2 & 3) 1. Build Trust Through Relationships and Respect 2. Strive for Cultural Sensitivity 3. Communicate Clearly 4. Empower Safe and Autonomous Decision-Making 5. Be Flexible and Creative in Recruitment 6. Acknowledge and Address Mistrust 7. Value Women’s Contributions - Result 100% important 93.75 % important 100% important 88.2% important 92.85% important 100% important 100% important - Third vote (n=18) (refined PoE, conducted via MS Forms after the workshops) 1. Build Trust Through Relationships and Respect 2. Strive for Cultural Sensitivity 3. Communicate Clearly with Black Women 4. Empower Informed Choice and Decision-Making 5. Be Flexible and Creative in Recruitment 6. Actively Acknowledge and Address Mistrust 7. Openly Value Women’s Contributions to Healthcare Research 8. Promote Transparent and Accountable Research Practice Result 100% important 100% important 100% important 100% important 100% important 100% important 100% important 100% important Box 1. Refined principles of Engagement Definitions: System level – structures, policies, organisations, and processes that shape care for many people at once. For example, research funding bodies (e.g. NIHR), Universities or NHS England and NHS Trusts. It is focussed on strategic change with a ‘top-down’ approach. Trial/research team – academics or researchers based within a research organisation (e.g. University, Clinical Trials Unit) who are responsible for overseeing all stages of the research study and supporting the research delivery teams at healthcare sites. Research nurses and midwives – registered nurses or midwives who work in health and clinical research, helping to design, run, and deliver research studies involving patients or communities. They are often the face of research for service users, responsible for recruitment and delivering safe, high-quality care. Build Trust Through Relationships and Respect System level : Be visible in communities before research starts to build credibility and cultural understanding. Partner with trusted organisations to raise awareness of research and co-create research priorities to inform funding calls. Trial/research team : Work through existing relationships with trusted NHS (e.g. known midwives/obstetricians) and non-NHS (e.g. community groups, doulas, antenatal classes) networks to plan, design and conduct research sensitively and collaboratively. Research nurses and midwives : Create a positive and safe environment for Black women, this can be achieved by considering the timing, tone and setting of the research conversation. Strive for Cultural Sensitivity System level : Support research midwives/nurses to have access to, and time to engage with, formal training in inclusive research practices, ethical practices and cultural awareness. Trial/research team : Include a research midwife/nurse and a Black women representative on research teams, potentially as a co-applicant, and on the trial (or study) steering committee (TSC). Research nurses and midwives : Aim not to treat Black women as a homogenous group; respect individual identities and cultural experiences, be mindful of verbal and non-verbal communications. Communicate Clearly System level : Address language barriers proactively by equipping researchers with appropriate inclusion frameworks and strategies. Allocate adequate funding to develop materials/approaches that are accessible and appropriate for the local population. Interpreter services should be accurate and culturally informed . Trial/research team : Provide clear, concise recruitment information which avoids jargon and is tailored to the intended audience. Clearly highlight the target group in any recruitment materials (e.g. where appropriate, Black women should be specifically mentioned and/or pictured in recruitment materials). Where possible, share materials in advance to allow time for reflection. Research nurses and midwives : Inform Black women that research studies are actively being undertaken within their care setting and that they might be invited to take part during their maternity journey. This should be done as early as possible and can be shared via correspondence, posters, online or in-person. Empower Informed Choice and Decision-Making System level : Strengthen health and research literacy, through community-based programs, that empower women to make informed choices without pressure or coercion. Acknowledge differences in experiences, prior knowledge and pre-conceptions between first- and second-generation women. Trial/research team : Clearly explain the risks/burdens (including time and resources) and benefits of taking part during discussions and in participant information sheets. Research nurses and midwives : Recognise and respect the role that partners, the wider family, friends, and community may play in decision-making. Where possible, offer time, flexibility and clear follow-up options which allow women to return after discussion with others. Be Flexible and Creative in Recruitment System level : Recognise and support the time and resources needed for researchers to engage meaningfully with community organisations and PPI, e.g. within research inclusion statements and budgets. Trial/research team : Developing recruitment strategies requires time, resources, and planning. Consider developing roles and responsibilities at the protocol development stage regarding inclusive research practices. Research nurses and midwives : Tailor recruitment strategies to meet women where they are—physically, emotionally, and culturally. Identify and map local trusted community organisations as a resource to share with the trial/research team. Consider convenience and logistical barriers and offer flexible participation options. Actively Acknowledge and Address Mistrust System level : Require researchers to report specific actions taken to address historical and structural inequities (e.g. active acknowledgement, working with community partners). Funders and oversight bodies should prioritise and resource studies that demonstrate culturally responsive engagement and concrete plans to build trust with underrepresented communities. Trial/research team : Over time, develop examples and testimonials (written and video) to illustrate participant experiences and show how research leads to real-world positive change. Research nurses and midwives : Be clear and transparent about the purpose, risks, benefits and rights of participants taking part in research. Avoid assuming prior knowledge and address any fears and concerns. Develop myth-busting documents (e.g. data misuse, confidentiality) and share with the research team. Openly Value Women’s Contributions to Healthcare Research System level : Funding bodies should advise researchers, and review grant applications, with a focus on how the dissemination of results and knowledge mobilisation will continue after the funding period. Highlight that dissemination funds can be used to engage non-academic audiences, as well as produce academic outputs beyond the originally budgeted timeframe. Trial/research team : Emphasise the important role of Black women in shaping research, offer appropriate incentives that reflect participants’ time and effort, and ensure that they have opportunities to stay informed about research results and impact (e.g. via newsletters, social media and dissemination events). Consider EDI (equality, diversity and inclusivity) nurse/midwife roles to support this. Research nurses and midwives : Recognise participation as a meaningful contribution to improving care to avoid an impression of tokenism. Highlighting the range of financial and non-financial benefits they may gain from taking part. 8. Promote Transparent and Accountable Research Practice System level : Support reporting of recruitment based on key demographics of interest in the study (e.g. ethnicity). Encourage flexibility in the number of contact points to enable teams to build trust and engage underrepresented or marginalised groups. Trial/research team : Plan recruitment strategies based on the time and effort required from research delivery teams to effectively engage Black women, rather than focussing solely on numerical targets. Research nurses and midwives : Support and empower your team to recruit inclusively – share best-practice, track, and celebrate individual achievements in inclusive engagement. [1] In line with data minimization principles, only data deemed relevant and necessary to the study was collected from each group and as such both groups did not answer all the same demographic questions. This is indicated with ‘n/a’ (not applicable) in the table. Discussion This study addressed two interlinked aims: (1) to critically explore how maternity and neonatal research opportunities are offered, understood, and experienced by Black women and research delivery teams; and (2) to co‑develop Principles of Engagement to support more inclusive, meaningful, and equitable research practice. Guided by the Double Diamond framework (26), the study moved from exploration of lived and professional experiences to the co‑production of actionable outputs, enabling analytic depth to be translated into system‑relevant guidance. Findings from the Discover and Define phases revealed four interrelated themes – trust; inclusion and accessibility; power and decision‑making; and perceived value – which together advance understanding of research engagement as a socially negotiated and structurally shaped process rather than a solely individual choice. These themes illuminate how research invitations are embedded within relationships, histories of mistrust, organisational constraints, and perceptions of benefit, thereby directly addressing the first aim of the study. Importantly, the findings demonstrate that inclusive intent alone is insufficient in the absence of resourced structural support (e.g. time, interpretation, flexibility) and relational accountability within research delivery. Through subsequent Develop and Deliver phases, these insights were translated and collectively refined into eight stakeholder‑endorsed Principles of Engagement, addressing the second aim by providing concrete, co‑produced guidance for implementation across system‑, research/trial‑, and research delivery‑level contexts. Our findings corroborate evidence that historical and structural drivers, including racism in healthcare and research, continue to shape mistrust and perceived risk among Black communities. Participants framed mistrust as historically and socially embedded, shaped by structural racism, exploitative research practices and persistent inequities in healthcare (8, 16, 29, 30). Collective memories of unethical research and reproductive injustice continued to inform perceptions of risk. Research midwives acknowledged the legitimacy of this mistrust, aligning with calls for research ethics to explicitly recognise historical harms and structural power imbalances when engaging racially minoritised communities (31-33). In line with community engaged scholarship, trusted intermediaries – including Black-led organisations, faith groups and known clinicians – were identified as important legitimising mechanisms, enhanced perceived legitimacy and enabled more meaningful invitations to participate (24, 34). While evidence on racial/ethnic concordance is mixed (22, 35), this study added important nuance: women valued concordance when it signalled cultural understanding, but relational competence (timing, tone and transparency) mattered more than concordance alone. Findings identified that inclusion could be constrained through organisational structures and systemic barriers such as staffing pressures, poorly translated materials and restricted interpreter access, reflecting evidence that institutional resource allocation can reproduce inequities in research access (36). Women emphasised the need for explicit, culturally aligned communication and plain-language explanations, reinforcing the importance of health and research literacy (8, 37). Timing was also critical with advance information and flexible consent and participation pathways preferable for meaningful research decision-making (38, 39). Agency was described as relational rather than purely individual, with women seeking support rather than permission from partners or communities, consistent with relational autonomy research (40). Finally, motivation to participate was strengthened when research felt relevant and important, with visible results; findings that support the case for ongoing dissemination and knowledge mobilisation beyond study closure (41, 42). Implications for policy and practice These findings highlight the need for structural rather than individualised approaches to improving equity in research engagement for Black women in maternity care. Building trust must be treated as a routine and resourced component of research delivery, rather than an intangible by‑product of good practice. This includes protected time for rapport building, transparent discussion of risks, benefits and rights, and early partnership with trusted community organisations. The Principles of Engagement provide a mechanism for translating these expectations into clear actions. Accounts of restricted interpreter use due to cost exposes a modifiable structural barrier. Equitable participation is contingent on high‑quality translation, culturally aligned materials and access to professional interpretation, all of which require ring‑fenced funding and contractually specified standards from healthcare organisations and research funders. Consent processes also need to reflect real-world context and timing. Routine provision of pre‑appointment information and flexible remote follow‑up for consent could strengthen autonomy and reduce the burden of decision-making. This is particularly important in perinatal care, where clinical encounters can be busy and emotionally demanding. Improving research literacy and establishing meaningful feedback loops to participants are also imperative. Embedding research literacy initiatives within maternity pathways and ensuring post‑study feedback to participating communities aligns with NHS commitments to transparency and public partnership. Finally, participants emphasised the importance of joined‑up accountability across the research ecosystem. Transparent reporting and coordinated responsibilities across funders, universities, NHS trusts and research delivery teams are essential for equity. The inclusion of system‑level actions within the Principles of Engagement – particularly principle 8, ‘promoting transparent and accountable research practice’ – responds directly to this need. Commissioners and funders should require equity‑focused recruitment plans, monitor their delivery, and support mechanisms to incentivise inclusive practice across research design and delivery teams. Strengths, limitations and future research A key strength of this study is the inclusion of diverse perspectives from Black women, spanning first‑ and second‑generation immigrants, a range of ethnicities, languages, occupations and educational backgrounds, together with insights from research midwives. This breadth enabled a relational analysis of how research invitations were offered, received and negotiated in real-world maternity care settings. The high response rate further demonstrates the feasibility of engaging Black women in maternity and neonatal research. However, it is important to note that the Black women who took part may have already been open to research participation and therefore the views of those more wary of research may not have been fully captured. The co-design approach is a key strength as lived experiences shaped the entire research process, from discovery to delivery .(26) Qualitative findings were systematically translated through PPIE discussions and consensus workshops with key stakeholders into an actionable Principles of Engagement framework, ensuring co-production, stakeholder endorsement, and iterative refinement. This triangulation supported thematic saturation and enhanced the credibility and practical relevance of the Principles of Engagement. Indeed, a further strength is the use of the Double Diamond structured design framework(26), which supported transparent progression from exploratory qualitative data to co-produced, consensus-driven outputs. As with most qualitative research, the aim is transferability rather than generalisability. The modest focus group sample size may be viewed as a limitation; however, saturation was considered achieved and the subsequent consensus process provided additional perspectives and validation. Finally, the work is grounded in the UK NHS maternity and research context, which strengthens policy relevance but may limit applicability in settings with different healthcare structures, although the principles are still likely to inform inclusive research practices elsewhere. The development and validation of the Principles reflected the views of those who took part and therefore might not represent the views of wider stakeholders. Nonetheless, using a 70% priori consensus approach ensured methodical rigour and reflected the results of a large systematic review,(8) focus groups and PPIE consultations. It would be beneficial for future research to validate these results with a wider stakeholder group. For example, longitudinal studies could examine how trust evolves across repeated research encounters and how intersectional factors (e.g., migration status, language, deprivation) mediate engagement. The Principles above also primarily aim to support the recruitment of Black women into research studies. However further research could more explicitly consider retention to explore how the principles can be adapted and applied at key participant-research team touch points to support sustained participation. Implementing and evaluating the Principles of Engagement in maternity and neonatal research (feasibility, acceptability, and impact on recruitment, retention and participant experience), and developing/testing of research‑literacy resources co‑designed with Black women and research delivery teams is a key priority. To support this, the research team are currently undertaking implementation work with research delivery teams, researchers/trialists and system-level/service leaders to further build on the Deliver phase of the Double Diamond design process(26). Conclusion Through the Double Diamond framework, PPIE co-design and a consensus-building approach, this study has translated findings from a systematic review and focus groups to create the first co‑produced, system‑ready Principles of Engagement. These Principles are specifically designed to improve equity in the recruitment and engagement of Black women in maternity and neonatal research. The Principles move beyond documenting barriers to providing actionable, accountable guidance for organisations, researchers, and research delivery teams. Embedding them in practice has the potential to strengthen trust, widen participation in research, and improve the relevance and fairness of evidence informing UK maternity care. Abbreviations BW Black women CR Community representative NHS National Health Service NIHR National Institute for Health and Care Research PoE Principles of Engagement PPIE Patient and public involvement and engagement RM Research midwives TSC Trial Steering Committee UK United Kingdom Declarations Ethics approval and consent to participate Ethical approval was granted by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of Nottingham in October 2024 (Ref: 284-0924). Informed consent was collected via an online form. Consent for publication All participants explicitly gave consent for their anonymised data to be used in publications. Clinical trial number: Clinical trial number not applicable. Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding This project was funded by the National Institute for Health and Care Research (NIHR:206842). The funder had no role in the design, collection, analysis, interpretation of data, nor in the writing of the report or decision to publish. The researchers are independent from funders and had full access to the data. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Author contributions SSH, CH, GC, SP and BM participated in the concept and design of the work. GC, CH, SP and SSH facilitated data collection. GC led data analysis and interpretation with support from SSH and SP. GC drafted the original manuscript and developed this with SSH. All authors have read, commented on and approved the final manuscript. Acknowledgements We would like to thank the women, community representatives, research midwives, senior healthcare professionals and academics who took part and supported this project. References MBRRACE-UK. Saving Lives, Improving Mothers’ Care. 2024. MBRRACE-UK. MBRRACE-UK perinatal mortality surveillance: UK perinatal deaths of babies born in 2023. 2025. Kalinowski J, Kaur K, Newsome-Garcia V, Langford A, Kalejaiye A, Vieira D, et al. Stress interventions and hypertension in Black women. Womens Health (Lond). 2021;17:17455065211009751. Bigatti SM, Weathers T, Hayes L, Daggy J. Challenges Experienced by Black Women with Breast Cancer During Active Treatment: Relationship to Treatment Adherence. J Racial Ethn Health Disparities. 2024;11(1):516-27. Boitano TKL, Ketch P, Maier JG, Nguyen CT, Huh WK, Michael Straughn J, et al. Increased disparities associated with black women and abnormal cervical cancer screening follow-up. Gynecol Oncol Rep. 2022;42:101041. Sage SK, Hawkins-Taylor C, Crockett RA, Sr., Balls-Berry JE. "Girl, just pray …": Factors That Influence Breast and Cervical Cancer Screening Among Black Women in Rochester, MN. J Natl Med Assoc. 2020;112(5):454-67. Black Equity Organisation. State of Black Britain Report: Discrimination still prevalent. 2022. Hall SS, Clancy G, Patel S, Thorpe N, Majmudar B, Merriman C, et al. A Systematic Review and Meta-Synthesis to Explore the Barriers and Facilitators to Black Women’s Participation in Healthcare Research. PREPRINT (Version 1) available at Research Square. 2026. Oh SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, et al. Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. PLoS Med. 2015;12(12):e1001918. Burchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, et al. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med. 2003;348(12):1170-5. George S, Duran N, Norris K. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am J Public Health. 2014;104(2):e16-31. Luebbert R, Perez A. Barriers to Clinical Research Participation Among African Americans. J Transcult Nurs. 2016;27(5):456-63. Camidge DR, Park H, Smoyer KE, Jacobs I, Lee LJ, Askerova Z, et al. Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials. Future Oncol. 2021;17(24):3271-80. Xiao H, Vaidya R, Liu F, Chang X, Xia X, Unger JM. Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials: A Systematic Review and Meta-analysis. JAMA Intern Med. 2023;183(1):50-60. Buseh AG, Stevens PE, Millon-Underwood S, Townsend L, Kelber ST. Community leaders' perspectives on engaging African Americans in biobanks and other human genetics initiatives. Journal of Community Genetics. 2013;4:483-94. Scharf DP, Mathews KJ, Jackson P, Hofsuemmer J, Martin E, Edwards D. More than Tuskegee: Understanding mistrust about research participation. Journal of Health Care for the Poor and Underserved. 2010;21:879-97. Skloot R. The Immortal Life of Henrietta Lacks: Macmillan; 2010. Washington HA. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present: Knopf Doubleday Publishing Group; 2008. Brown KK, Thomas SP, Brothers RM, Liao Y. "Lord Knows What's Being Done with My Blood!": Black Women's Perceptions of Biospecimen Donation for Clinical Research in the United States. J Racial Ethn Health Disparities. 2025;12(3):1856-65. Fairley R, Lillard JW, Jr., Berk A, Cornew S, Gaspero J, Gillespie J, et al. Increasing Clinical Trial Participation of Black Women Diagnosed with Breast Cancer. J Racial Ethn Health Disparities. 2024;11(3):1701-17. Le D, Ozbeki H, Salazar S, Berl M, Turner MM, Price OA. Improving African American women's engagement in clinical research: A systematic review of barriers to participation in clinical trials. J Natl Med Assoc. 2022;114(3):324-39. Mindlis I, Livert D, Federman AD, Wisnivesky JP, Revenson TA. Racial/ethnic concordance between patients and researchers as a predictor of study attrition. Social Science & Medicine. 2020;255:113009. Lovell H, Silverio SA, Story L, Skelton E, Matthew J. Factors which influence ethnic minority women's participation in maternity research: A systematic review of quantitative and qualitative studies. PLOS One. 2023;18(2):e0282088. Wallerstein N, Duran B, Oetzel JG, Minkler M. Community-Based Participatory Research for Health: Advancing Social and Health Equity: Wiley; 2017. Legor KA, Hayman LL, Foust JB, Blazey ML. Clinical research nurses' perceptions of the unique needs of people of color for successful recruitment to cancer clinical trials. Contemp Clin Trials. 2023;128:107161. Design Council. The Double Diamond: A universally accepted depiction of the design process. 2026 [Available from: https://www.designcouncil.org.uk/our-resources/the-double-diamond/. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International journal for quality in health care. 2007;19(6):349-57. Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qualitative Research in Sport, Exercise and Health. 2019;11(4):589-97. Corbie-Smith G, Thomas SB, St. George DMM. Distrust, Race, and Research. Archives of Internal Medicine. 2002;162(21):2458-63. Smirnoff M, Wilets I, Ragin DF, Adams R, Holohan J, Rhodes R, et al. A paradigm for understanding trust and mistrust in medical research: The Community VOICES study. AJOB Empirical Bioethics. 2018;9(1):39-47. Bowen FR, Epps F, Lowe J, Guilamo-Ramos V. Restoring trust in research among historically underrepresented communities: A call to action for antiracism research in nursing. Nursing Outlook. 2022;70(5):700-9. Curtis E, Jones R, Tipene-Leach D, Walker C, Loring B, Paine SJ, et al. Why cultural safety rather than cultural competency is required to achieve health equity: a literature review and recommended definition. Int J Equity Health. 2019;18(1):174. Reber L, Griggs Z, Patel MJ, Ruiz E, Tamirisa S, Huan E, et al. “Misled, misinformed, under-informed”: Socio-ecological determinants for rebuilding trust in clinical research. Ethics, Medicine and Public Health. 2025;33:101142. Jagosh J, Bush PL, Salsberg J, Macaulay AC, Greenhalgh T, Wong G, et al. A realist evaluation of community-based participatory research: partnership synergy, trust building and related ripple effects. BMC Public Health. 2015;15(1):725. Moore C, Coates E, Watson A, de Heer R, McLeod A, Prudhomme A. "It's Important to Work with People that Look Like Me": Black Patients' Preferences for Patient-Provider Race Concordance. J Racial Ethn Health Disparities. 2023;10(5):2552-64. Bonevski B, Randell M, Paul C, Chapman K, Twyman L, Bryant J, et al. Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Medical Research Methodology. 2014;14(1):42. Nutbeam D. The evolving concept of health literacy. Soc Sci Med. 2008;67(12):2072-8. Gedela K, Wong R, Balendra S, Chita S, Jones H, Golombek R, et al. Embedding equity, diversity and inclusion processes within clinical trials and health and social care research. BMJ Open. 2025;15(3):e091807. van der Zande ISE, van der Graaf R, Hooft L, van Delden JJM. Facilitators and barriers to pregnant women’s participation in research: A systematic review. Women and Birth. 2018;31(5):350-61. Dove ES, Kelly SE, Lucivero F, Machirori M, Dheensa S, Prainsack B. Beyond individualism: Is there a place for relational autonomy in clinical practice and research? Clin Ethics. 2017;12(3):150-65. Riessman CK. Narrative Methods for the Human Sciences: SAGE Publications; 2007. Gwizdala KL, Pugh EA, Carter L, Carmichael OT, Newton RL. Impact of COVID-19 Pandemic on Research Participation among Older African Americans. Alzheimer Disease and Associated Disorders. 2022;36:350-3. Additional Declarations No competing interests reported. Supplementary Files Supplementaryfile1.COREQTemplate.docx Supplementaryfile2.FocusGroupTopicGuides.docx Supplementaryfile3.Draftprinciplesofengagement.docx Supplementaryfile4.Resultsofconsensusworkshops.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 06 May, 2026 Reviewers invited by journal 29 Apr, 2026 Editor invited by journal 22 Apr, 2026 Editor assigned by journal 21 Apr, 2026 Submission checks completed at journal 21 Apr, 2026 First submitted to journal 14 Apr, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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04:29:27","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":27303,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfile1.COREQTemplate.docx","url":"https://assets-eu.researchsquare.com/files/rs-9418759/v1/5d23e63f100f5104627041d9.docx"},{"id":108753892,"identity":"cf2a3943-5fa2-43fe-9a65-c6df9d16334e","added_by":"auto","created_at":"2026-05-08 04:29:27","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":24163,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfile2.FocusGroupTopicGuides.docx","url":"https://assets-eu.researchsquare.com/files/rs-9418759/v1/b54c60229a8bc97e28f724b3.docx"},{"id":108753893,"identity":"79b8848c-8d2b-4a93-a98f-601bd0c0888f","added_by":"auto","created_at":"2026-05-08 04:29:27","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":22971,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfile3.Draftprinciplesofengagement.docx","url":"https://assets-eu.researchsquare.com/files/rs-9418759/v1/6bf727bc1f0701a0e9daf87f.docx"},{"id":108753895,"identity":"5fa18455-a92e-44f4-bb48-6f9ea033d9f6","added_by":"auto","created_at":"2026-05-08 04:29:27","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":32463,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfile4.Resultsofconsensusworkshops.docx","url":"https://assets-eu.researchsquare.com/files/rs-9418759/v1/7dda83e7bf70348b2bd1399d.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Co-Producing Principles of Engagement to Improve the Inclusion of Black Women in UK Maternity and Neonatal Research: A Qualitative Study","fulltext":[{"header":"Background","content":"\u003cp\u003ePersistent health inequalities affecting Black women highlight the urgent need for maternity and health services research that meaningfully reflect their experiences, priorities, and needs. In the United Kingdom, Black women are currently 2.3 times more likely to die from pregnancy-related causes than white women and experience higher rates of preterm birth and stillbirth (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). These disparities stem, in part, from intersecting sociocultural, structural and institutional factors, which result in unequal access to services (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). For example, Black women\u0026rsquo;s engagement with healthcare is influenced by intergenerational knowledge, community norms, and poor prior healthcare experiences (\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). In the UK, around 65% of Black people report ethnicity-based discrimination from healthcare professionals (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). These experiences affect health outcomes, and decrease trust and willingness to engage with healthcare research (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eImproving healthcare equity requires the meaningful inclusion of ethnic minority groups in healthcare research to ensure that the research outcomes are applicable across diverse populations (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Genetic, environmental, social, and cultural factors influence how individuals respond to both pharmacological and non-pharmacological interventions, meaning that research conducted with homogenous populations risks producing biased evidence and perpetuating inequitable outcomes (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Despite this, Black women remain substantially underrepresented in healthcare research compared to other ethnic groups across national population demographics (\u003cspan additionalcitationids=\"CR13\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eMistrust in healthcare research among Black communities is well documented and is rooted in histories of exploitation including the Tuskegee Syphilis Study, the nonconsensual use of Henrietta Lacks\u0026rsquo; cells, and reproductive coercion (\u003cspan additionalcitationids=\"CR16 CR17\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), which continue to shape collective memory and perception of risk (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Black women commonly report concerns about unequal treatment, culturally insensitive communication, limited transparency, and poor relationships with research teams during the research process (\u003cspan additionalcitationids=\"CR20 CR21\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAcross ethnic minority groups, commonly reported barriers to research participation include mistrust, poor relationships with healthcare professionals, financial and logistical burdens, language barriers and competing caregiving responsibilities (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). Improving inclusion in healthcare research requires moving beyond deficit based accounts to models that recognise participation decisions as negotiated within relationships shaped by trust, power, communication and perceived value (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Within this context, healthcare professionals in research delivery roles \u0026ndash; such as research nurses and midwives \u0026ndash; serve as key intermediaries in introducing and facilitating research participation and are central to addressing these barriers. However, while many research nurses and midwives are committed to inclusive practice, they report limited training, resources and organisational support to engage confidently and sensitively with Black women (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). This is compounded by a lack of evidence on specific barriers to research experienced by Black women, particularly in maternity settings where reproductive injustice, heightened vulnerability and complex decision making intersect with persisting inequalities in outcomes for Black women.\u003c/p\u003e \u003cp\u003eThis empirical study builds on a recent systematic review(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) of barriers and facilitators to Black women\u0026rsquo;s participation in healthcare research which identified mistrust, poor interpersonal experiences, and low health/research literacy as key barriers, and highlighted community engagement, cultural competence and transparent communication as facilitators.\u003c/p\u003e \u003cp\u003eUsing a co-design approach informed by the Double Diamond framework(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), this paper sought to extend and critically examine these systematic review findings by exploring how maternity and neonatal research opportunities are offered, understood, and experienced by Black women and research delivery teams. Through an initial exploratory phase using focus groups, PPIE and collaborative refinement, the study aimed to both deepen understanding of engagement processes and translate these insights into practice. A second aim was to co-develop Principles of Engagement through consensus workshops, providing actionable guidance to support more inclusive, meaningful, and equitable research practices.\u003c/p\u003e"},{"header":"Methods","content":"\u003ch3\u003eEthical Approval\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eEthical approval was granted by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of Nottingham in October 2024 (Ref: 284-0924). The COnsolidated criteria for Reporting Qualitative research (COREQ) guided the reporting of this study (27) (Supplementary file 1).\u003c/p\u003e\n\u003ch3\u003eParticipants\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eWe aimed for a diverse sample to gain a broad range of experiences from Black women and research delivery teams. Participants were purposively sampled to include, first-, second- and third-generation Black women, differing ethnicities, educational, and employment statuses. Representatives of Black women were deemed eligible if they were aged 18 years or over, able to provide informed consent, and met at least one of the following criteria: identified as a Black woman of childbearing age (including dual heritage); had personal experience of pregnancy during or after 2010; identified as being a father/birthing partner of a Black woman; a leader, support worker or volunteer within a Black community organisation, including faith-based groups.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResearch delivery team members were eligible if they had worked in maternity or neonatal healthcare research within the past three years, had held a clinical research delivery role during this period, and were able to provide informed consent.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePotential participants were notified about the study through a flyer shared through multiple recruitment channels; professional local and national networks of the study team and study advisory group (consisting of senior professionals and academics), the project’s community partner Egality Health (a community engagement agency which supports access to research), professional mailing lists, social media, and \u0026nbsp; snowball sampling.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIf interested, potential participants contacted the study team via email for more information. They were then provided with a digital copy of the participant information sheet to read in their own time, invited to ask questions and given a choice of focus group dates and times. If participants wished to proceed, they were sent a link to an online consent form and brief demographic questionnaire to complete prior to the focus group. Participants were provided with online shopping vouchers in appreciation of their time and contribution to the study, as well as costs incurred for taking part (e.g. data allowance). Participants who took part in the focus groups were invited to also take part in the consensus workshops, in addition to other senior professionals, researchers and representatives of relevant community organisations.\u003c/p\u003e\n\u003ch3\u003ePatient and Public Involvement and Engagement (PPIE)\u003c/h3\u003e\n\u003cp\u003eThe study design, focus group topic guides and plan for the consensus workshops were developed with input from Egality Health and our PPIE group of 11 Black mothers. Reflexive discussions were held throughout data collection and analysis, and themes were iteratively reviewed with the wider team, including PPIE contributors, to challenge assumptions and strengthen interpretations. The study team recognise that positionalities shape the analytic process and therefore aimed to centre participants’ voices through extensive PPIE work and strived to remain attentive to power imbalances by always introducing themselves, sharing their interest in the project and being open to participants’ questions and views throughout.\u003c/p\u003e\n\u003ch3\u003eStudy design and data collection\u003c/h3\u003e\n\u003cp\u003eThe study was conceptually guided by the Double Diamond design framework(26), which was operationalised as a reflexive, equity‑oriented approach to co‑production. The framework supported structured movement from experiential exploration to the generation of system‑ready outputs, while maintaining attention to power, relational ethics, and accountability throughout.\u003c/p\u003e\n\u003cp\u003eIn the \u003cstrong\u003eDiscover\u003c/strong\u003e phase, four focus groups with Black women and three focus groups with research delivery teams were used to surface lived, relational, and institutional experiences of research engagement within maternity and neonatal settings. This phase explored how research opportunities were encountered, understood, and negotiated, allowing participants to articulate concerns, motivations, and tensions without premature problem‑framing or solution‑seeking. The focus groups were conducted between May-August 2025 and took place on Microsoft Teams. Focus groups lasted approximately 60 minutes and participants only took part in one focus group each. Discussions were recorded and transcribed via Microsoft Teams, with transcripts subsequently checked for accuracy and anonymised by the study team. A semi-structured focus group topic guide (Supplementary file 2) was developed based on literature searches and discussions amongst the study team, as well as PPIE members. The topic guide consisted of core questions for both Black women and research delivery teams, as well as specific questions for each group relating to their experiences of conducting or considering taking part in research.\u003c/p\u003e\n\u003cp\u003eThe \u003cstrong\u003eDefine\u003c/strong\u003e phase focused on sense‑making and problem clarification. Insights from the focus groups were analysed using reflexive thematic analysis and integrated with findings from a prior systematic review(8), enabling the identification of shared patterns, key challenges, and priorities shaping inclusion and exclusion in research. This phase moved beyond describing barriers to reframing engagement as socially negotiated and structurally conditioned.\u003c/p\u003e\n\u003cp\u003eDuring the \u003cstrong\u003eDevelop\u003c/strong\u003e phase, these analytically derived priorities were translated into draft Principles of Engagement through iterative co‑production with PPIE contributors and stakeholders. Emphasis was placed on ensuring that emerging principles were ethically grounded and practically meaningful across different contexts.\u003c/p\u003e\n\u003cp\u003eThe \u003cstrong\u003eDeliver\u003c/strong\u003e phase centred on validation, refinement, and legitimation of the Principles of Engagement through three structured consensus workshops (60-90 minutes each). Prior to the first workshop, participants received the draft Principles of Engagement (Supplementary file 3) and completed an initial, individual rating using a 9-point Likert scale (1 = not at all important; 9 = extremely important) via Microsoft Forms. During the workshops, stakeholders collaboratively discussed, refined, and rated each principle supporting collective ownership and ensuring that the final principles reflected shared priorities and actionable commitments rather than individual or institutional perspectives. The consensus workshops were recorded and transcribed in Microsoft Teams to enable the study team to review stakeholder contributions and ensure that subsequent iterations reflected the group’s priorities. The aim was to formulate a final set of Principles of Engagement to guide research delivery teams to better recruit and retain Black women into maternal and neonatal healthcare research.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn line with co-production approaches, an interim version of the Principles of Engagement was also sent to two participants (one Black woman and one research midwife) for an additional ‘sense-checking’ stage to ensure that changes aligned with their perspectives. Their feedback informed minor revisions before the third and final round of voting from the full consensus group. Together, these stages enabled the progression from lived experience to co‑produced, consensus‑endorsed principles to support more inclusive maternity and neonatal research practice.\u003c/p\u003e\n\u003ch3\u003eData analysis\u003c/h3\u003e\n\u003cp\u003eFocus group transcripts were imported into NVivo12 and analysed by GC following Braun and Clarke’s (28) six-phase approach to reflexive thematic analysis: (i) becoming familiar with the data, (ii) generating initial codes, (iii) searching for themes, (iv) reviewing themes, (v) defining themes, (vi) writing up findings. To begin with, the women’s and research delivery team’s transcripts were coded separately, inductively and largely descriptively, with themes developed by identifying concepts that cut across codes and participant groups. Similarities across the themes generated for each participant group meant that the two datasets were eventually combined to formulate the final themes. This iterative process was facilitated by regular discussion, review, and refinement during team meetings (GC, SH, SP). Data saturation was reached after the fourth focus group and subsequent focus groups added clarification and elaboration to the research findings.\u003c/p\u003e\n\u003cp\u003eDuring the consensus workshops, agreement on the concepts for inclusion in the final Principles of Engagements was determined via anonymous voting within the group. The threshold for consensus was set at \u0026gt;70% agreement between members present based on ratings of 7, 8 or 9 in the\u0026nbsp;9-point Likert scale (1 = not at all important; 9 = extremely important) used and stated as a priori.\u003c/p\u003e\n\u003ch3\u003eAuthor positionality\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe study team recognises that our identities and professional roles shape the design, conduct, and interpretation of this study. The focus groups with research delivery teams were facilitated by GC and CH, who identify as White British; CH is also a mother and a healthcare professional with a background in clinical research delivery. Focus groups with Black women and community representatives were facilitated by GC, SH (White British) and SP (British Indian Muslim). These positionalities provided insight into research delivery contexts but also meant that the team were removed from the lived experiences of Black women. All authors identify as female, hold PhDs and work within UK academic and healthcare research institutions, with an interest maternal health and health inequalities. They therefore hold positions of relative privilege within the systems being examined. This may have influenced the questions we prioritised and how we interpreted participants’ accounts.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eAcross the focus groups and consensus workshops a total of 57 participants took part in the study.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eFocus groups\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eSeven online focus groups were conducted: four with Black women (n=29, 10.3% drop out rate from consent); and three with research midwives (n=28, 13.8% drop out rate). Drop out was typically due to participants being unable to make focus group date/times. Full demographic characteristics for focus groups participants are in Table 1[1].\u003c/p\u003e\n\u003cp\u003eTable 1. Focus group participants.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCharacteristic\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBlack women and their Representatives\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResearch Midwives\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e(n=26)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e(n=24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eParticipant group:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eRepresentative of women\u003c/p\u003e\n \u003cp\u003eWomen\u003c/p\u003e\n \u003cp\u003eResearch midwife\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e96.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e100\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGender:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e100\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e100\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge (years):\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eMean\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e36.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEthnicity:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eBlack African\u003c/p\u003e\n \u003cp\u003eBlack British\u003c/p\u003e\n \u003cp\u003eBlack Caribbean\u003c/p\u003e\n \u003cp\u003eMixed \u0026ndash; Black and White African\u003c/p\u003e\n \u003cp\u003eMixed/Multiple ethnic background\u003c/p\u003e\n \u003cp\u003eOther (please specify):\u003c/p\u003e\n \u003cp\u003eBlack British-Caribbean\u003c/p\u003e\n \u003cp\u003eLatin American\u003c/p\u003e\n \u003cp\u003eWhite English/Welsh/Scottish/Northern Irish/British Irish\u003c/p\u003e\n \u003cp\u003eWhite European\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eWhite Other\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e15\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e57.7\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e15.2\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e8.3\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e65.4\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCountry of birth:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eBolivia\u003c/p\u003e\n \u003cp\u003eGermany\u003c/p\u003e\n \u003cp\u003eItaly\u003c/p\u003e\n \u003cp\u003eNigeria\u003c/p\u003e\n \u003cp\u003eSpain\u003c/p\u003e\n \u003cp\u003eSudan\u003c/p\u003e\n \u003cp\u003eTrinidad\u003c/p\u003e\n \u003cp\u003eUnited Kingdom\u003c/p\u003e\n \u003cp\u003eZimbabwe\u003c/p\u003e\n \u003cp\u003ePrefer not to say\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e23.1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e19.2\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e30.8\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e15.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e21\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e84\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFirst language:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eEnglish\u003c/p\u003e\n \u003cp\u003eArabic\u003c/p\u003e\n \u003cp\u003eGerman\u003c/p\u003e\n \u003cp\u003eItalian\u003c/p\u003e\n \u003cp\u003eNdebele\u003c/p\u003e\n \u003cp\u003eIgbo\u003c/p\u003e\n \u003cp\u003eSpanish\u003c/p\u003e\n \u003cp\u003eYoruba\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e53.8\u003c/p\u003e\n \u003cp\u003e26.9\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e7.7\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e21\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e84\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eChildren:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eNo I don\u0026rsquo;t have a child/children but I am pregnant\u003c/p\u003e\n \u003cp\u003eYes I have a child/children\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e96.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMarital status:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eMarried\u003c/p\u003e\n \u003cp\u003eSingle\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e76.9\u003c/p\u003e\n \u003cp\u003e23.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eHighest qualification:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eO-level/GCSE\u003c/p\u003e\n \u003cp\u003eA-level\u003c/p\u003e\n \u003cp\u003eFirst degree\u003c/p\u003e\n \u003cp\u003eHigher degree\u003c/p\u003e\n \u003cp\u003eOther higher qualification\u003c/p\u003e\n \u003cp\u003eNo qualifications\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003cp\u003ePrefer not to say\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e7.7\u003c/p\u003e\n \u003cp\u003e7.7\u003c/p\u003e\n \u003cp\u003e26.9\u003c/p\u003e\n \u003cp\u003e30.7\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e58.3\u003c/p\u003e\n \u003cp\u003e29.2\u003c/p\u003e\n \u003cp\u003e8.3\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eReligion:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eChristian\u003c/p\u003e\n \u003cp\u003eJewish\u003c/p\u003e\n \u003cp\u003eMuslim\u003c/p\u003e\n \u003cp\u003eNo religion/belief\u003c/p\u003e\n \u003cp\u003ePrefer not to say\u003c/p\u003e\n \u003cp\u003eSpiritual\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e53.8\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e30.8\u003c/p\u003e\n \u003cp\u003e7.7\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e54.2\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDisability:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003cp\u003ePrefer not to say\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e92.3\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e22\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003cp\u003e91.7\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMain occupation:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003ePrefer not to say\u003c/p\u003e\n \u003cp\u003eHomemaker\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eUnemployed\u003c/p\u003e\n \u003cp\u003eModern professional occupations\u003c/p\u003e\n \u003cp\u003eClerical and intermediate occupations\u003c/p\u003e\n \u003cp\u003eSenior managers or administrators\u003c/p\u003e\n \u003cp\u003eSemi-routine manual and service occupations\u003c/p\u003e\n \u003cp\u003eMiddle or Junior managers\u003c/p\u003e\n \u003cp\u003eTraditional professional occupations\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e15.4\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e15.4\u003c/p\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003cp\u003e7.7\u003c/p\u003e\n \u003cp\u003e7.7\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eHave you ever taken part in a research study as a participant?\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003cp\u003ePrefer not to say\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e38.5\u003c/p\u003e\n \u003cp\u003e38.5\u003c/p\u003e\n \u003cp\u003e23.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNHS salary band:\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eBand 6\u003c/p\u003e\n \u003cp\u003eBand 7\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e75\u003c/p\u003e\n \u003cp\u003e20.8\u003c/p\u003e\n \u003cp\u003e4.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eHow many years have you worked in research delivery?\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eLess than 1 year\u003c/p\u003e\n \u003cp\u003e1-2 years\u003c/p\u003e\n \u003cp\u003e3-5 years\u003c/p\u003e\n \u003cp\u003e6-9 years\u003c/p\u003e\n \u003cp\u003e10 years or more\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003en/a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003cp\u003e16.7\u003c/p\u003e\n \u003cp\u003e37.5\u003c/p\u003e\n \u003cp\u003e20.8\u003c/p\u003e\n \u003cp\u003e11.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTwenty-five Black women, and one community representative of Black women, took part in one of four focus groups, with a mean age of 36.8 years. All women described their ethnicity as Black or Mixed Black and White, with the most common ethnicity being Black African (57.7%). The community representative of Black women identified as a Latin American woman and worked for a charitable organisation which supports Black women asylum seekers/refugees in the UK. Most women were born outside of the UK (53.8%) and would \u0026nbsp;be considered first-generation immigrants, whilst 30.8% were second-generation immigrants born in the UK. Fifty-four percent spoke English as their first language. One woman was currently pregnant with her first child, and the others (96.2%) already had a child/children.\u003c/p\u003e\n\u003cp\u003eAcross the remaining three focus groups, all 24 research delivery team members worked as research midwives and identified as female, with a mean age of 40 years. Most were White English/Welsh/Scottish/Northern Irish/British Irish (65.4%), born in the UK (84%) and spoke English as a first language (84%). Twelve percent had been working in research delivery settings for less than 1 year, 16.7% 1-2 years, 37.5% for 3-5 years, 20.8% for 6-9 years, and 11.5% for 10 years or more.\u003c/p\u003e\n\u003cp\u003eThe focus group findings presented here correspond to the \u003cstrong\u003eDiscover\u003c/strong\u003e and \u003cstrong\u003eDefine\u003c/strong\u003e phases of the Double Diamond framework (26). Together, these phases capture the exploration of lived and professional experiences of research engagement (Discover) and their analytic synthesis into shared patterns and priorities (Define), which subsequently informed the co‑development of the Principles of Engagement. Four interrelated themes were identified across Black women (BW), research midwives (RM), and a community representative (CR): (i) trust as a precondition for ethical research participation; (ii) making research inclusive and accessible; (iii) power, agency, and relational decision‑making; and (iv) motivation and value of participation. Points of convergence and divergence between participant groups are highlighted within each theme.\u003c/p\u003e\n\u003ch4\u003eTheme 1: Trust as a Precondition for Ethical Research Participation\u003c/h4\u003e\n\u003cp\u003eTrust was identified as the foundational condition underpinning Black women\u0026rsquo;s research participation. Research midwife participants demonstrated an awareness of historical and contemporary sources of mistrust among Black communities, often shaped by wider experiences of discrimination and unequal treatment within healthcare. As one midwife reflected, \u0026ldquo;the historic basis around that is completely understandable given the level of mistrust that there has been [\u0026hellip;] into research in the last 100 years or so\u0026rdquo; (RM-9). This could be especially true for first-generation immigrants as \u0026ldquo;they\u0026apos;ve come over often quite close to when they\u0026apos;ve then fallen pregnant. So, the overall trust in just the NHS is not there\u0026rdquo; (RM-11).\u003c/p\u003e\n\u003cp\u003eSimilarly, women described how memories of exploitation informed their decision-making, particularly where studies involved clinical procedures or biological samples: \u0026ldquo;Black communities have sometimes been the target of unethical research and I think that has traumatised the community [\u0026hellip;] they need that trust and they want to be convinced that [\u0026hellip;] we\u0026rsquo;re not being used but this is to benefit us\u0026rdquo; (BW-1); \u0026ldquo;I wouldn\u0026rsquo;t trust it if it was wanting to take blood samples [\u0026hellip;] I don\u0026rsquo;t know where it\u0026rsquo;s going and that would kind of put me off\u0026rdquo; (BW-25).\u003c/p\u003e\n\u003cp\u003eTrust was influenced by the perceived credibility of those sharing information. Black women highlighted that when recruitment invitations were circulated through trusted intermediaries \u0026ndash; such as Black led community organisations, faith groups, online networks and personal contacts \u0026ndash; it felt more reassuring and legitimate: \u0026ldquo;We feel like they [community groups] [\u0026hellip;] exist to support us as Black women, Black people. So, I would just have a lot more trust in them than coming from the [healthcare] professionals\u0026rdquo; (BW-7). Similarly, one research midwife described a church event where a matron spoke to her community and \u0026ldquo;gave that extra validation [\u0026hellip;] a lot of women signed up [\u0026hellip;] I think it improved their confidence in research because she was a known person\u0026rdquo; (RM-15). In contrast, studies appearing \u0026ldquo;randomly on social media\u0026rdquo; were likely to be ignored (BW-8).\u003c/p\u003e\n\u003cp\u003eMidwives also recognised that trust depended on how women were approached and emphasised that building rapport and demonstrating transparency were important prerequisites to introducing research: \u0026ldquo;you don\u0026rsquo;t just go in there and say, oh I\u0026rsquo;m the research midwife, do you want to take part [\u0026hellip;] you have to chat with that woman first\u0026rdquo; (RM-12). Black women echoed the importance of researcher behaviour, noting that interactions which felt overly cautious could be interpreted as avoidance: \u0026ldquo;I think sometimes they don\u0026rsquo;t even try [\u0026hellip;] they don\u0026rsquo;t actually even tell you about these things because yeah, they just don\u0026rsquo;t want to say the wrong thing\u0026rdquo; (BW-4).\u003c/p\u003e\n\u003cp\u003eRepresentation within research teams also influenced trust, with some women describing feeling immediately more at ease when they perceived concordance with the researcher:\u003c/p\u003e\n\u003cp\u003eIf someone comes in the room that looks like me, instantly I\u0026rsquo;m put at ease and I feel like you can identify with me on some level [\u0026hellip;] you\u0026apos;re more likely to have my best interests at heart than somebody that doesn\u0026apos;t look like me. And being able to understand the some of the cultural nuances. (BW-7)\u003c/p\u003e\n\u003cp\u003eHowever, women and midwives also cautioned against assuming that racial or cultural concordance guaranteed trust:\u003c/p\u003e\n\u003cp\u003eI don\u0026apos;t think that women are more receptive to joining because I\u0026apos;m Black and then also like similarly I wouldn\u0026apos;t myself just join something because somebody the person that\u0026apos;s telling me about this is black. But, that being said, I do find that if you speak another language or you speak the same language as someone else [\u0026hellip;] that is helpful. (RM-14).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSimilarly, \u0026ldquo;I\u0026apos;m conscious about, you know, me being white and I constantly ask about these things and they say, well, I don\u0026apos;t care so much about how you look, but how you make me feel\u0026rdquo; (RM-5). Women also highlighted that the gender of the researcher could be important, particularly for sensitive topics: \u0026ldquo;I prefer to work with women. I think we share the same thought[s] and I will be open to talk to the women rather than just talk to men [\u0026hellip;] whether it\u0026apos;s like an Asian, African or white women, or old or young, it doesn\u0026apos;t matter\u0026rdquo; (BW-15).\u003c/p\u003e\n\u003ch4\u003eTheme 2: Making Research Inclusive and Accessible\u003c/h4\u003e\n\u003cp\u003eBlack women and research midwives described how poor recruitment practices and materials could undermine inclusivity, regardless of the research teams\u0026rsquo; intentions. As participants noted, limited funding meant that \u0026ldquo;we\u0026rsquo;re not allowed to use interpretation services because of the cost\u0026rdquo; (RM-22) and \u0026ldquo;if the literature isn\u0026rsquo;t translated, it\u0026rsquo;s an exclusion\u0026rdquo; (RM-12). Even when interpreters were available, midwives expressed ethical concerns about accuracy and whether women had provided \u0026ldquo;truly informed consent\u0026rdquo; (RM-9), with translated materials often culturally misaligned and still written in a way that is \u0026ldquo;sensitive to an English white person rather than [\u0026hellip;] a person of colour\u0026rdquo; (RM-6).\u003c/p\u003e\n\u003cp\u003eFor Black female participants, medical and/or research jargon emerged as a significant obstacle: \u0026ldquo;I\u0026rsquo;m really open to participating in research as long as the information [is] clearly stated and they\u0026rsquo;re easy for anybody to understand\u0026rdquo; (BW-5). However, target-driven environments with a focus in recruitment efficiency and total numbers recruited, compounded these challenges, with lengthy recruitment discussions between research delivery team members and potential participants often perceived as inefficient or hard to justify. This deterred some research delivery staff from having these discussions in the first instance: \u0026ldquo;it\u0026rsquo;s quite hard to document [\u0026hellip;] why have you taken so long with that one particular person?\u0026rdquo; (RM-20).\u003c/p\u003e\n\u003cp\u003eBlack women described a sense of exclusion from healthcare settings, which shaped their willingness to engage with research: \u0026ldquo;If you want to get more Black mums, you have to say it [\u0026hellip;] it definitely has to be more intentional, that you make it clear that we\u0026apos;re welcome, because we\u0026apos;re so used to not being welcomed\u0026rdquo; (BW-4).\u003c/p\u003e\n\u003cp\u003eResearch midwives discussed a strong commitment to culturally sensitive practice and reflexivity, whilst resisting assumptions of homogeneity: \u0026ldquo;Africa is a massive continent [\u0026hellip;] I\u0026rsquo;m not gonna get it right 100% of the time, but going in there being aware of different cultural barriers [\u0026hellip;] and treating each person as an individual\u0026rdquo; (RM-3). Some midwives described building cultural competence through reflective practice and accountability, recognising the need to \u0026ldquo;ask questions and try to learn [\u0026hellip;] because we know [\u0026hellip;] we\u0026rsquo;re not doing well and [\u0026hellip;] need to be accountable for [the diversity of] our recruits\u0026rdquo; (RM-24).\u003c/p\u003e\n\u003cp\u003eBoth participant groups highlighted that delivering research information during clinical appointments, hospital inpatient stays, or immediately postpartum could compromise women\u0026rsquo;s ability to make informed choices around research participation: \u0026ldquo;there\u0026rsquo;s a lot going on [\u0026hellip;] I don\u0026rsquo;t know if you\u0026rsquo;re in the right frame of mind to consent to anything\u0026rdquo; (BW-4). Midwives acknowledged that postnatal exhaustion and time-limited study windows constrained informed decision-making. They also stated that women of Black ethnicity often wanted information in advance so they had time to consider it and speak with family members about it \u0026ldquo;a good two weeks beforehand to really read all of the PIS [participant information sheet] in much more detail. Speak to any community [\u0026hellip;] speak to their husbands,\u0026rdquo; (RM-7), whilst shorter timelines were perceived to be more acceptable to white British women.\u003c/p\u003e\n\u003cp\u003ePractical caregiving responsibilities also intersected with access and Black women valued online research opportunities for reducing these burdens: \u0026ldquo;doing things online just allows them to be sociable but not having to think about [\u0026hellip;] transport [\u0026hellip;] it\u0026rsquo;s very convenient for me\u0026rdquo; (BW-2).\u003c/p\u003e\n\u003ch4\u003eTheme 3: Power, Agency, and Relational Decision-Making\u003c/h4\u003e\n\u003cp\u003eAgency in research participation was consistently described by participants as negotiated, situational, and relational rather than purely individual. Research midwife participants frequently described ethical dilemmas arising from the influence of partners, families and community norms. As one midwife noted, \u0026ldquo;sometimes the mother is just mute [\u0026hellip;] they look at their husband and it\u0026rsquo;s like, no, you can\u0026rsquo;t do that\u0026rdquo; (RM-6). These dynamics were often framed in relation to migration status, with first-generation women perceived as more likely to seek permission from partners or communities. However, midwives acknowledged that decision-making could be genuinely collective rather than coercive: \u0026ldquo;it\u0026rsquo;s more of a family discussion and a community discussion about them taking part or not\u0026rdquo; (RM-24). Navigating these dynamics placed staff in ethically complex positions, balancing cultural respect with individual consent. Women\u0026rsquo;s accounts offered a more nuanced understanding of agency, emphasising that this was not necessarily experienced as a loss of autonomy, but rather collaborative decision-making:\u003c/p\u003e\n\u003cp\u003eSo people from Africa, Middle East, so yeah you have to ask your partner or husband [...] in the UK I must ask you know because of the culture, the system you know, like he\u0026rsquo;s been living the UK for a long, long, long time so to make me feel safe, you know. (BW-14)\u003c/p\u003e\n\u003cp\u003eIf it\u0026apos;s something that creates doubt and I\u0026apos;m not unsure of, that\u0026apos;s when I will definitely go to friends, family, husband in order to do that. But something [\u0026hellip;] as simple as this where I know I can share my experience I\u0026apos;ve got no, I know I don\u0026apos;t feel that there\u0026apos;s any sort of hidden agenda towards it then yeah, it\u0026rsquo;s not a problem. (BW-11)\u003c/p\u003e\n\u003cp\u003eBoth groups highlighted the role of knowledge and familiarity with the healthcare system in shaping agency. Midwives perceived first-generation women as being \u0026ldquo;on a back foot [\u0026hellip;] not clear on what is available or choices\u0026rdquo; (RM-22). Similarly, it was emphasised that ensuring participants \u0026ldquo;know what their rights are within research\u0026rdquo; was key (CR-1). As one participant noted, \u0026ldquo;people think if I commit to this, then I must get to the end of it, which is not what it says\u0026rdquo; (BW-1). Clear communication of rights was highlighted as central to ethical empowerment.\u003c/p\u003e\n\u003ch4\u003eTheme 4: Motivation and Value of Participation\u003c/h4\u003e\n\u003cp\u003eBlack women identified that a strong motivator to research participation was the belief that their experiences are often overlooked and research is a route to visibility, recognition, and influence. As one Black woman expressed, \u0026ldquo;I do like taking part [\u0026hellip;] because I think Black voices need to be heard [\u0026hellip;] I don\u0026apos;t know if it\u0026apos;s making a change or a difference, but it, you know, I do feel like it\u0026apos;s something good to do\u0026rdquo; (BW-4). Others believed that their participation would lead to valuable improvements, noting \u0026ldquo;I know my feedback will be used to improve outcomes\u0026rdquo; (BW-1).\u003c/p\u003e\n\u003cp\u003ePersonal relevance was also highlighted as being key, with participants recognising that they were drawn to the current study because of its focus on Black maternal health was something they could contribute to and was worth engaging with: \u0026ldquo;the relevance of the research, that it was related to Black maternal health and obviously I am a mum [\u0026hellip;] so I felt like I could share some experiences\u0026rdquo; (BW-7). In many cases, the chance to reflect on and process their own maternity journeys also acted as a motivator for participants: \u0026ldquo;when you put that out there and you hear yourself, sometimes you rethink how much that has been affecting you\u0026rdquo; (CR-1).\u003c/p\u003e\n\u003cp\u003eResearch midwife participants emphasised the importance of affirming women\u0026rsquo;s autonomy and respecting their decision to say no without giving a reason: \u0026ldquo;respecting that, letting them have the control back in their care and you know, giving it a positive impression that she can decline\u0026rdquo; (RM-3).\u003c/p\u003e\n\u003cp\u003eFeedback and evidence of how previous research had led to tangible change was also a critical motivator for Black women, particularly when findings were shared through trusted community channels; \u0026ldquo;so these changes were made as a result of Black women taking part in this research [\u0026hellip;] if something else comes up like that, then OK, I know that change can happen\u0026rdquo; (BW-7). Financial incentives, such as vouchers, were acknowledged as helpful but secondary to the perceived purpose and impact of the research.\u003c/p\u003e\n\u003ch3\u003eTranslating themes into draft Principles of Engagement\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eBuilding on the \u003cstrong\u003eDiscover\u003c/strong\u003e and \u003cstrong\u003eDefine\u003c/strong\u003e phases, the \u003cstrong\u003eDevelop\u003c/strong\u003e phase focused on translating analytic insights into provisional Principles of Engagement. The four thematic areas provided a shared conceptual foundation from which engagement-related priorities were articulated and reformulated as principle statements. This phase involved iterative sense‑making with PPIE contributors and the wider study team to ensure that emerging principles remained grounded in participants\u0026rsquo; accounts, while also being framed in ways that were practically applicable across system‑level, research/trial‑level, and research delivery contexts. Rather than generating principles as abstract ideals, this stage emphasised clarity of intent, feasibility, and accountability, resulting in a set of draft Principles of Engagement that reflected both experiential evidence and collective judgement. Seven draft principles were subsequently drafted taken forward for refinement and validation during the consensus workshops.\u003c/p\u003e\n\u003ch3\u003eConsensus workshops\u003c/h3\u003e\n\u003cp\u003eThe \u003cstrong\u003eDeliver\u003c/strong\u003e phase focused on refining, validating, and legitimising the draft Principles of Engagement through consensus workshops. Building on priorities articulated during the \u003cstrong\u003eDevelop\u003c/strong\u003e phase, the draft Principles of Engagement (Supplementary file 3) provided a concrete starting point for structured discussion during the workshops, enabling stakeholders to interrogate their clarity, relevance, and practical applicability across maternity and neonatal research contexts.\u003c/p\u003e\n\u003cp\u003eIn the consensus workshops (n=20), 95% of participants identified as female and 5% male. 50% of participants identified as Black,\u0026nbsp;35% white, 5% Asian and 5% Latin American. In terms of the key stakeholder groups involved; 30% of participants represented lay Black women, 30% represented research delivery teams, 25% represented relevant community organisations and 15% were senior professionals from the study advisory group. Members of the study team (SSH, GC, SP) facilitated but did not vote in the consensus workshops.\u003c/p\u003e\n\u003cp\u003eThe full results of the votes for each principle across the three workshops can be found in Supplementary file 4 and a summary of the results is in Table 2. The final, refined Principles are in Box 1.\u003c/p\u003e\n\u003cp\u003eThere was strong initial agreement on the importance of seven the draft Principles of Engagement, with growing alignment and shared understanding as stakeholders engaged in iterative discussions and refinement of the principles across the three workshops (see Table 2). Principles relating to trust, clear communication, acknowledgement of mistrust and valuing women\u0026rsquo;s contributions reached 100% importance by the second vote.\u003c/p\u003e\n\u003cp\u003eA re-occurring discussion for each principle was that of accountability, and that to implement and realise the potential of each principle, a combined and collaborative effort between the wider system level, trial/research teams, and research delivery teams was required. During workshop one, the idea of promoting transparent and accountable research practice was discussed, highlighting structural accountability as essential to building and sustaining trust. This was later added as a new principle during the refinement process before the final vote. In the final vote, all eight refined Principles of Engagement were rated as 100% important, indicating full consensus.\u003c/p\u003e\n\u003cp\u003eTable 2. Summary of consensus workshop votes\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"9\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFirst vote (n=18) (draft PoE, consensus workshop 1)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1. Build Trust Through Relationships and Respect\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2. Strive for Cultural Sensitivity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3. Communicate Clearly\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4. Empower Safe and Autonomous Decision-Making\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5. Be Flexible and Creative in Recruitment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6. Acknowledge and Address Mistrust\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7. Value Women\u0026rsquo;s Contributions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eResult\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e84% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e90% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e94% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e95% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e84% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e95% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e95% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"9\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecond vote (n=18) (draft PoE, consensus workshops 2 \u0026amp; 3)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1. Build Trust Through Relationships and Respect\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2. Strive for Cultural Sensitivity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3. Communicate Clearly\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4. Empower Safe and Autonomous Decision-Making\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5. Be Flexible and Creative in Recruitment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6. Acknowledge and Address Mistrust\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7. Value Women\u0026rsquo;s Contributions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eResult\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e93.75 % important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e88.2% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e92.85% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"9\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eThird vote (n=18) (refined PoE, conducted via MS Forms after the workshops)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1. Build Trust Through Relationships and Respect\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2. Strive for Cultural Sensitivity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3. Communicate Clearly with Black Women\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4. Empower Informed Choice and Decision-Making\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5. Be Flexible and Creative in Recruitment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6. Actively Acknowledge and Address Mistrust\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7. Openly Value Women\u0026rsquo;s Contributions to Healthcare Research\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e8. Promote Transparent and Accountable Research Practice\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eResult\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100% important\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eBox 1. Refined principles of Engagement\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDefinitions:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSystem level\u003c/strong\u003e \u0026ndash; structures, policies, organisations, and processes that shape care for \u003cem\u003emany\u003c/em\u003e people at once. For example, research funding bodies (e.g. NIHR), Universities or NHS England and NHS Trusts. It is focussed on strategic change with a \u0026lsquo;top-down\u0026rsquo; approach.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial/research team\u003c/strong\u003e \u0026ndash; academics or researchers based within a research organisation (e.g. University, Clinical Trials Unit) who are responsible for overseeing all stages of the research study and supporting the research delivery teams at healthcare sites.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResearch nurses and midwives\u0026nbsp;\u003c/strong\u003e\u0026ndash; registered nurses or midwives who work in health and clinical research, helping to design, run, and deliver research studies involving patients or communities. They are often the face of research for service users, responsible for recruitment and delivering safe, high-quality care.\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003e\u003cstrong\u003eBuild Trust Through Relationships and Respect\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e: Be visible in communities before research starts to build credibility and cultural understanding. Partner with trusted organisations to raise awareness of research and co-create research priorities to inform funding calls.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Work through existing relationships with trusted NHS (e.g. known midwives/obstetricians) and non-NHS (e.g. community groups, doulas, antenatal classes) networks to plan, design and conduct research sensitively and collaboratively.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Create a positive and safe environment for Black women, this can be achieved by considering the timing, tone and setting of the research conversation.\u003c/li\u003e\n\u003c/ul\u003e\n\u003col start=\"2\"\u003e\n \u003cli\u003e\u003cstrong\u003eStrive for Cultural Sensitivity\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e: Support research midwives/nurses to have access to, and time to engage with, formal training in inclusive research practices, ethical practices and cultural awareness.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Include a research midwife/nurse and a Black women representative on research teams, potentially as a co-applicant, and on the trial (or study) steering committee (TSC).\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Aim not to treat Black women as a homogenous group; respect individual identities and cultural experiences, be mindful of verbal and non-verbal communications.\u003c/li\u003e\n\u003c/ul\u003e\n\u003col start=\"3\"\u003e\n \u003cli\u003e\u003cstrong\u003eCommunicate Clearly\u0026nbsp;\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e: Address language barriers proactively by equipping researchers with appropriate inclusion frameworks and strategies. Allocate adequate funding to develop materials/approaches that are accessible and appropriate for the local population.\u003cem\u003e\u0026nbsp;\u003c/em\u003eInterpreter services should be accurate and culturally informed\u003cem\u003e.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Provide clear, concise recruitment information which avoids jargon and is tailored to the intended audience. Clearly highlight the target group in any recruitment materials (e.g. where appropriate, Black women should be specifically mentioned and/or pictured in recruitment materials). Where possible, share materials in advance to allow time for reflection.\u0026nbsp;\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Inform Black women that research studies are actively being undertaken within their care setting and that they might be invited to take part during their maternity journey. This should be done as early as possible and can be shared via correspondence, posters, online or in-person.\u003c/li\u003e\n\u003c/ul\u003e\n\u003col start=\"4\"\u003e\n \u003cli\u003e\u003cstrong\u003eEmpower Informed Choice and Decision-Making\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e: Strengthen health and research literacy, through community-based programs, that empower women to make informed choices without pressure or coercion. Acknowledge differences in experiences, prior knowledge and pre-conceptions between first- and second-generation women.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Clearly explain the risks/burdens (including time and resources) and benefits of taking part during discussions and in participant information sheets.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Recognise and respect the role that partners, the wider family, friends, and community may play in decision-making. Where possible, offer time, flexibility and clear follow-up options which allow women to return after discussion with others.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003col start=\"5\"\u003e\n \u003cli\u003e\u003cstrong\u003eBe Flexible and Creative in Recruitment\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e:\u003cem\u003e\u0026nbsp;\u003c/em\u003eRecognise and support the time and resources needed for researchers to engage meaningfully with community organisations and PPI, e.g. within research inclusion statements and budgets.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Developing recruitment strategies requires time, resources, and planning. Consider developing roles and responsibilities at the protocol development stage regarding inclusive research practices.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Tailor recruitment strategies to meet women where they are\u0026mdash;physically, emotionally, and culturally. Identify and map local trusted community organisations as a resource to share with the trial/research team. Consider convenience and logistical barriers and offer flexible participation options.\u003c/li\u003e\n\u003c/ul\u003e\n\u003col start=\"6\"\u003e\n \u003cli\u003e\u003cstrong\u003eActively Acknowledge and Address Mistrust\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e: Require researchers to report specific actions taken to address historical and structural inequities (e.g. active acknowledgement, working with community partners). Funders and oversight bodies should prioritise and resource studies that demonstrate culturally responsive engagement and concrete plans to build trust with underrepresented communities.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Over time, develop examples and testimonials (written and video) to illustrate participant experiences and show how research leads to real-world positive change.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Be clear and transparent about the purpose, risks, benefits and rights of participants taking part in research. Avoid assuming prior knowledge and address any fears and concerns. Develop myth-busting documents (e.g. data misuse, confidentiality) and share with the research team.\u003c/li\u003e\n\u003c/ul\u003e\n\u003col start=\"7\"\u003e\n \u003cli\u003e\u003cstrong\u003eOpenly Value Women\u0026rsquo;s Contributions to Healthcare Research\u0026nbsp;\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e: Funding bodies should advise researchers, and review grant applications, with a focus on how the dissemination of results and knowledge mobilisation will continue after the funding period. Highlight that dissemination funds can be used to engage non-academic audiences, as well as produce academic outputs beyond the originally budgeted timeframe.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Emphasise the important role of Black women in shaping research, offer appropriate incentives that reflect participants\u0026rsquo; time and effort, and ensure that they have opportunities to stay informed about research results and impact (e.g. via newsletters, social media and dissemination events). Consider EDI (equality, diversity and inclusivity) nurse/midwife roles to support this.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Recognise participation as a meaningful contribution to improving care to avoid an impression of tokenism. Highlighting the range of financial and non-financial benefits they may gain from taking part.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e8. Promote Transparent and Accountable Research Practice\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eSystem level\u003c/em\u003e\u003c/strong\u003e: Support reporting of recruitment based on key demographics of interest in the study (e.g. ethnicity). Encourage flexibility in the number of contact points to enable teams to build trust and engage underrepresented or marginalised groups.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003e\u003cem\u003eTrial/research team\u003c/em\u003e\u003c/strong\u003e: Plan recruitment strategies based on the time and effort required from research delivery teams to effectively engage Black women, rather than focussing solely on numerical targets.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eResearch nurses and midwives\u003c/em\u003e\u003c/strong\u003e: Support and empower your team to recruit inclusively \u0026ndash; share best-practice, track, and celebrate individual achievements in inclusive engagement.\u003c/p\u003e\n\u003cp\u003e[1] In line with data minimization principles, only data deemed relevant and necessary to the study was collected from each group and as such both groups did not answer all the same demographic questions. This is indicated with \u0026lsquo;n/a\u0026rsquo; (not applicable) in the table.\u003c/p\u003e"},{"header":"Discussion ","content":"\u003cp\u003eThis study addressed two interlinked aims: (1) to critically explore how maternity and neonatal research opportunities are offered, understood, and experienced by Black women and research delivery teams; and (2) to co‑develop Principles of Engagement to support more inclusive, meaningful, and equitable research practice. Guided by the Double Diamond framework\u0026nbsp;(26), the study moved from exploration of lived and professional experiences to the co‑production of actionable outputs, enabling analytic depth to be translated into system‑relevant guidance.\u003c/p\u003e\n\u003cp\u003eFindings from the \u003cstrong\u003eDiscover\u003c/strong\u003e and \u003cstrong\u003eDefine\u003c/strong\u003e phases revealed four interrelated themes – trust; inclusion and accessibility; power and decision‑making; and perceived value – which together advance understanding of research engagement as a socially negotiated and structurally shaped process rather than a solely individual choice. These themes illuminate how research invitations are embedded within relationships, histories of mistrust, organisational constraints, and perceptions of benefit, thereby directly addressing the first aim of the study. Importantly, the findings demonstrate that inclusive intent alone is insufficient in the absence of resourced structural support (e.g. time, interpretation, flexibility) and relational accountability within research delivery. Through subsequent \u003cstrong\u003eDevelop\u003c/strong\u003e and \u003cstrong\u003eDeliver\u003c/strong\u003e phases, these insights were translated and collectively refined into eight stakeholder‑endorsed Principles of Engagement, addressing the second aim by providing concrete, co‑produced guidance for implementation across system‑, research/trial‑, and research delivery‑level contexts.\u003c/p\u003e\n\u003cp\u003eOur findings corroborate evidence that historical and structural drivers, including racism in healthcare and research, continue to shape mistrust and perceived risk among Black communities. Participants framed mistrust as historically and socially embedded, shaped by structural racism, exploitative research practices and persistent inequities in healthcare (8, 16, 29, 30). Collective memories of unethical research and reproductive injustice continued to inform perceptions of risk. Research midwives acknowledged the legitimacy of this mistrust, aligning with calls for research ethics to explicitly recognise historical harms and structural power imbalances when engaging racially minoritised communities (31-33). In line with community engaged scholarship, trusted intermediaries – including Black-led organisations, faith groups and known clinicians – were identified as important legitimising mechanisms,\u0026nbsp;enhanced perceived legitimacy and enabled more meaningful invitations to participate (24, 34). While evidence on racial/ethnic concordance is mixed\u0026nbsp;(22, 35), this study added important nuance:\u0026nbsp;women valued concordance when it signalled cultural understanding, but relational competence (timing, tone and transparency) mattered more than concordance alone.\u003c/p\u003e\n\u003cp\u003eFindings identified that inclusion could be constrained through organisational structures and systemic barriers such as staffing pressures, poorly translated materials and restricted interpreter access, reflecting evidence that institutional resource allocation can reproduce inequities in research access (36). Women emphasised the need for explicit, culturally aligned communication and plain-language explanations, reinforcing the importance of health and research literacy (8, 37). Timing was also critical with advance information and flexible consent and participation pathways preferable for meaningful research decision-making \u0026nbsp;(38, 39).\u003c/p\u003e\n\u003cp\u003eAgency was described as relational rather than purely individual, with women seeking support rather than permission from partners or communities, consistent with relational autonomy research (40).\u0026nbsp;Finally, motivation to participate was strengthened when research felt relevant and important, with visible results; findings that support the case for ongoing dissemination and knowledge mobilisation beyond study closure\u0026nbsp;(41, 42).\u003c/p\u003e\n\u003ch3\u003eImplications for policy and practice\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThese findings highlight the need for structural rather than individualised approaches to improving equity in research engagement for Black women in maternity care. Building trust must be treated as a routine and resourced component of research delivery, rather than an intangible by‑product of good practice. This includes protected time for rapport building, transparent discussion of risks, benefits and rights, and early partnership with trusted community organisations. The Principles of Engagement provide a mechanism for translating these expectations into clear actions.\u003c/p\u003e\n\u003cp\u003eAccounts of restricted interpreter use due to cost exposes a modifiable structural barrier. Equitable participation is contingent on high‑quality translation, culturally aligned materials and access to professional interpretation, all of which require ring‑fenced funding and contractually specified standards from healthcare organisations and research funders.\u003c/p\u003e\n\u003cp\u003eConsent processes also need to reflect real-world context and timing. Routine provision of pre‑appointment information and flexible remote follow‑up for consent could strengthen autonomy and reduce the burden of decision-making. This is particularly important in perinatal care, where clinical encounters can be busy and emotionally demanding.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eImproving research literacy and establishing meaningful feedback loops to participants are also imperative. Embedding research literacy initiatives within maternity pathways and ensuring post‑study feedback to participating communities aligns with NHS commitments to transparency and public partnership.\u003c/p\u003e\n\u003cp\u003eFinally, participants emphasised the importance of joined‑up accountability across the research ecosystem. Transparent reporting and coordinated responsibilities across funders, universities, NHS trusts and research delivery teams are essential for equity. The inclusion of system‑level actions within the Principles of Engagement – particularly principle 8, ‘promoting transparent and accountable research practice’ – responds directly to this need. Commissioners and funders should require equity‑focused recruitment plans, monitor their delivery, and support mechanisms to incentivise inclusive practice across research design and delivery teams.\u003c/p\u003e\n\u003ch3\u003eStrengths, limitations and future research\u003c/h3\u003e\n\u003cp\u003eA key strength of this study is the inclusion of diverse perspectives from Black women, spanning first‑ and second‑generation immigrants, a range of ethnicities, languages, occupations and educational backgrounds, together with insights from research midwives. This breadth enabled a relational analysis of how research invitations were offered, received and negotiated in real-world maternity care settings. The high response rate further demonstrates the feasibility of engaging Black women in maternity and neonatal research. However, it is important to note that the Black women who took part may have already been open to research participation and therefore the views of those more wary of research may not have been fully captured.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe co-design approach is a key strength as lived experiences shaped the entire research process, from \u003cstrong\u003ediscovery\u003c/strong\u003e to \u003cstrong\u003edelivery\u003c/strong\u003e.(26) Qualitative findings were systematically translated through PPIE discussions and consensus workshops with key stakeholders into an actionable Principles of Engagement framework, ensuring co-production, stakeholder endorsement, and iterative refinement. This triangulation supported thematic saturation and enhanced the credibility and practical relevance of the Principles of Engagement. Indeed, a further strength is the use of the Double Diamond structured design framework(26), which supported transparent progression from exploratory qualitative data to co-produced, consensus-driven outputs. As with most qualitative research, the aim is transferability rather than generalisability. The modest focus group sample size may be viewed as a limitation; however, saturation was considered achieved and the subsequent consensus process provided additional perspectives and validation. Finally, the work is grounded in the UK NHS maternity and research context, which strengthens policy relevance but may limit applicability in settings with different healthcare structures, although the principles are still likely to \u0026nbsp;inform inclusive research practices elsewhere.\u003c/p\u003e\n\u003cp\u003eThe development and validation of the Principles reflected the views of those who took part and therefore might not represent the views of wider stakeholders. Nonetheless, using a 70% priori consensus approach ensured \u0026nbsp;methodical rigour and reflected the results of a large systematic review,(8) focus groups and PPIE consultations. It would be beneficial for future research to validate these results with a wider stakeholder group. For example, longitudinal studies could examine how trust evolves across repeated research encounters and how intersectional factors (e.g., migration status, language, deprivation) mediate engagement. The Principles above also primarily aim to support the \u003cem\u003erecruitment\u003c/em\u003e of Black women into research studies. However further research could more explicitly consider \u003cem\u003eretention\u003c/em\u003e to explore how the principles can be adapted and applied at key participant-research team touch points to support sustained participation.\u003c/p\u003e\n\u003cp\u003eImplementing and evaluating the Principles of Engagement in maternity and neonatal research (feasibility, acceptability, and impact on recruitment, retention and participant experience), and developing/testing of research‑literacy resources co‑designed with Black women and research delivery teams is a key priority. To support this, the research team are currently undertaking implementation work with research delivery teams, researchers/trialists and system-level/service leaders to further build on the Deliver phase of the Double Diamond design process(26).\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThrough the Double Diamond framework, PPIE co-design and a consensus-building approach, this study has translated findings from a systematic review and focus groups to create the first co‑produced, system‑ready Principles of Engagement. These Principles are specifically designed to improve equity in the recruitment and engagement of Black women in maternity and neonatal research. The Principles move beyond documenting barriers to providing actionable, accountable guidance for organisations, researchers, and research delivery teams. Embedding them in practice has the potential to strengthen trust, widen participation in research, and improve the relevance and fairness of evidence informing UK maternity care.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBW\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBlack women\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCommunity representative\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNHS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Health Service\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNIHR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Institute for Health and Care Research\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePoE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePrinciples of Engagement\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePPIE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePatient and public involvement and engagement\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eResearch midwives\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTSC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTrial Steering Committee\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eUK\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eUnited Kingdom\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003ch3\u003eEthics approval and consent to participate\u003c/h3\u003e\n\u003cp\u003eEthical approval was granted by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of Nottingham in October 2024 (Ref: 284-0924). Informed consent was collected via an online form.\u003c/p\u003e\n\u003ch3\u003eConsent for publication\u003c/h3\u003e\n\u003cp\u003eAll participants explicitly gave consent for their anonymised data to be used in publications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eClinical trial number:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eClinical trial number not applicable.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eAvailability of data and materials\u003c/h3\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003ch3\u003eCompeting interests\u003c/h3\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003ch3\u003eFunding\u003c/h3\u003e\n\u003cp\u003eThis project was funded by the National Institute for Health and Care Research (NIHR:206842). The funder had no role in the design, collection, analysis, interpretation of data, nor in the writing of the report or decision to publish. The researchers are independent from funders and had full access to the data. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.\u003c/p\u003e\n\u003ch3\u003eAuthor contributions\u003c/h3\u003e\n\u003cp\u003eSSH, CH, GC, SP and BM participated in the concept and design of the work. GC, CH, SP and SSH facilitated data collection. GC led data analysis and interpretation with support from SSH and SP. GC drafted the original manuscript and developed this with SSH. All authors have read, commented on and approved the final manuscript.\u003c/p\u003e\n\u003ch3\u003eAcknowledgements\u003c/h3\u003e\n\u003cp\u003eWe would like to thank the women, community representatives, research midwives, senior healthcare professionals and\u0026nbsp;academics who took part and supported this project.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eMBRRACE-UK. Saving Lives, Improving Mothers\u0026rsquo; Care. 2024.\u003c/li\u003e\n \u003cli\u003eMBRRACE-UK. MBRRACE-UK perinatal mortality surveillance: UK perinatal deaths of babies born in 2023. 2025.\u003c/li\u003e\n \u003cli\u003eKalinowski J, Kaur K, Newsome-Garcia V, Langford A, Kalejaiye A, Vieira D, et al. Stress interventions and hypertension in Black women. Womens Health (Lond). 2021;17:17455065211009751.\u003c/li\u003e\n \u003cli\u003eBigatti SM, Weathers T, Hayes L, Daggy J. Challenges Experienced by Black Women with Breast Cancer During Active Treatment: Relationship to Treatment Adherence. J Racial Ethn Health Disparities. 2024;11(1):516-27.\u003c/li\u003e\n \u003cli\u003eBoitano TKL, Ketch P, Maier JG, Nguyen CT, Huh WK, Michael Straughn J, et al. Increased disparities associated with black women and abnormal cervical cancer screening follow-up. Gynecol Oncol Rep. 2022;42:101041.\u003c/li\u003e\n \u003cli\u003eSage SK, Hawkins-Taylor C, Crockett RA, Sr., Balls-Berry JE. \u0026quot;Girl, just pray \u0026hellip;\u0026quot;: Factors That Influence Breast and Cervical Cancer Screening Among Black Women in Rochester, MN. J Natl Med Assoc. 2020;112(5):454-67.\u003c/li\u003e\n \u003cli\u003eBlack Equity Organisation. State of Black Britain Report: Discrimination still prevalent. 2022.\u003c/li\u003e\n \u003cli\u003eHall SS, Clancy G, Patel S, Thorpe N, Majmudar B, Merriman C, et al. A Systematic Review and Meta-Synthesis to Explore the Barriers and Facilitators to Black Women\u0026rsquo;s Participation in Healthcare Research. PREPRINT (Version 1) available at Research Square. 2026.\u003c/li\u003e\n \u003cli\u003eOh SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, et al. Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. PLoS Med. 2015;12(12):e1001918.\u003c/li\u003e\n \u003cli\u003eBurchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, et al. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med. 2003;348(12):1170-5.\u003c/li\u003e\n \u003cli\u003eGeorge S, Duran N, Norris K. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am J Public Health. 2014;104(2):e16-31.\u003c/li\u003e\n \u003cli\u003eLuebbert R, Perez A. Barriers to Clinical Research Participation Among African Americans. J Transcult Nurs. 2016;27(5):456-63.\u003c/li\u003e\n \u003cli\u003eCamidge DR, Park H, Smoyer KE, Jacobs I, Lee LJ, Askerova Z, et al. Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials. Future Oncol. 2021;17(24):3271-80.\u003c/li\u003e\n \u003cli\u003eXiao H, Vaidya R, Liu F, Chang X, Xia X, Unger JM. Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials: A Systematic Review and Meta-analysis. JAMA Intern Med. 2023;183(1):50-60.\u003c/li\u003e\n \u003cli\u003eBuseh AG, Stevens PE, Millon-Underwood S, Townsend L, Kelber ST. Community leaders\u0026apos; perspectives on engaging African Americans in biobanks and other human genetics initiatives. Journal of Community Genetics. 2013;4:483-94.\u003c/li\u003e\n \u003cli\u003eScharf DP, Mathews KJ, Jackson P, Hofsuemmer J, Martin E, Edwards D. More than Tuskegee: Understanding mistrust about research participation. Journal of Health Care for the Poor and Underserved. 2010;21:879-97.\u003c/li\u003e\n \u003cli\u003eSkloot R. The Immortal Life of Henrietta Lacks: Macmillan; 2010.\u003c/li\u003e\n \u003cli\u003eWashington HA. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present: Knopf Doubleday Publishing Group; 2008.\u003c/li\u003e\n \u003cli\u003eBrown KK, Thomas SP, Brothers RM, Liao Y. \u0026quot;Lord Knows What\u0026apos;s Being Done with My Blood!\u0026quot;: Black Women\u0026apos;s Perceptions of Biospecimen Donation for Clinical Research in the United States. J Racial Ethn Health Disparities. 2025;12(3):1856-65.\u003c/li\u003e\n \u003cli\u003eFairley R, Lillard JW, Jr., Berk A, Cornew S, Gaspero J, Gillespie J, et al. Increasing Clinical Trial Participation of Black Women Diagnosed with Breast Cancer. J Racial Ethn Health Disparities. 2024;11(3):1701-17.\u003c/li\u003e\n \u003cli\u003eLe D, Ozbeki H, Salazar S, Berl M, Turner MM, Price OA. Improving African American women\u0026apos;s engagement in clinical research: A systematic review of barriers to participation in clinical trials. J Natl Med Assoc. 2022;114(3):324-39.\u003c/li\u003e\n \u003cli\u003eMindlis I, Livert D, Federman AD, Wisnivesky JP, Revenson TA. Racial/ethnic concordance between patients and researchers as a predictor of study attrition. Social Science \u0026amp; Medicine. 2020;255:113009.\u003c/li\u003e\n \u003cli\u003eLovell H, Silverio SA, Story L, Skelton E, Matthew J. Factors which influence ethnic minority women\u0026apos;s participation in maternity research: A systematic review of quantitative and qualitative studies. PLOS One. 2023;18(2):e0282088.\u003c/li\u003e\n \u003cli\u003eWallerstein N, Duran B, Oetzel JG, Minkler M. Community-Based Participatory Research for Health: Advancing Social and Health Equity: Wiley; 2017.\u003c/li\u003e\n \u003cli\u003eLegor KA, Hayman LL, Foust JB, Blazey ML. Clinical research nurses\u0026apos; perceptions of the unique needs of people of color for successful recruitment to cancer clinical trials. Contemp Clin Trials. 2023;128:107161.\u003c/li\u003e\n \u003cli\u003eDesign Council. The Double Diamond: A universally accepted depiction of the design process. 2026 [Available from: https://www.designcouncil.org.uk/our-resources/the-double-diamond/.\u003c/li\u003e\n \u003cli\u003eTong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International journal for quality in health care. 2007;19(6):349-57.\u003c/li\u003e\n \u003cli\u003eBraun V, Clarke V. Reflecting on reflexive thematic analysis. Qualitative Research in Sport, Exercise and Health. 2019;11(4):589-97.\u003c/li\u003e\n \u003cli\u003eCorbie-Smith G, Thomas SB, St. George DMM. Distrust, Race, and Research. Archives of Internal Medicine. 2002;162(21):2458-63.\u003c/li\u003e\n \u003cli\u003eSmirnoff M, Wilets I, Ragin DF, Adams R, Holohan J, Rhodes R, et al. A paradigm for understanding trust and mistrust in medical research: The Community VOICES study. AJOB Empirical Bioethics. 2018;9(1):39-47.\u003c/li\u003e\n \u003cli\u003eBowen FR, Epps F, Lowe J, Guilamo-Ramos V. Restoring trust in research among historically underrepresented communities: A call to action for antiracism research in nursing. Nursing Outlook. 2022;70(5):700-9.\u003c/li\u003e\n \u003cli\u003eCurtis E, Jones R, Tipene-Leach D, Walker C, Loring B, Paine SJ, et al. Why cultural safety rather than cultural competency is required to achieve health equity: a literature review and recommended definition. Int J Equity Health. 2019;18(1):174.\u003c/li\u003e\n \u003cli\u003eReber L, Griggs Z, Patel MJ, Ruiz E, Tamirisa S, Huan E, et al. \u0026ldquo;Misled, misinformed, under-informed\u0026rdquo;: Socio-ecological determinants for rebuilding trust in clinical research. Ethics, Medicine and Public Health. 2025;33:101142.\u003c/li\u003e\n \u003cli\u003eJagosh J, Bush PL, Salsberg J, Macaulay AC, Greenhalgh T, Wong G, et al. A realist evaluation of community-based participatory research: partnership synergy, trust building and related ripple effects. BMC Public Health. 2015;15(1):725.\u003c/li\u003e\n \u003cli\u003eMoore C, Coates E, Watson A, de Heer R, McLeod A, Prudhomme A. \u0026quot;It\u0026apos;s Important to Work with People that Look Like Me\u0026quot;: Black Patients\u0026apos; Preferences for Patient-Provider Race Concordance. J Racial Ethn Health Disparities. 2023;10(5):2552-64.\u003c/li\u003e\n \u003cli\u003eBonevski B, Randell M, Paul C, Chapman K, Twyman L, Bryant J, et al. Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Medical Research Methodology. 2014;14(1):42.\u003c/li\u003e\n \u003cli\u003eNutbeam D. The evolving concept of health literacy. Soc Sci Med. 2008;67(12):2072-8.\u003c/li\u003e\n \u003cli\u003eGedela K, Wong R, Balendra S, Chita S, Jones H, Golombek R, et al. Embedding equity, diversity and inclusion processes within clinical trials and health and social care research. BMJ Open. 2025;15(3):e091807.\u003c/li\u003e\n \u003cli\u003evan der Zande ISE, van der Graaf R, Hooft L, van Delden JJM. Facilitators and barriers to pregnant women\u0026rsquo;s participation in research: A systematic review. Women and Birth. 2018;31(5):350-61.\u003c/li\u003e\n \u003cli\u003eDove ES, Kelly SE, Lucivero F, Machirori M, Dheensa S, Prainsack B. Beyond individualism: Is there a place for relational autonomy in clinical practice and research? Clin Ethics. 2017;12(3):150-65.\u003c/li\u003e\n \u003cli\u003eRiessman CK. Narrative Methods for the Human Sciences: SAGE Publications; 2007.\u003c/li\u003e\n \u003cli\u003eGwizdala KL, Pugh EA, Carter L, Carmichael OT, Newton RL. Impact of COVID-19 Pandemic on Research Participation among Older African Americans. Alzheimer Disease and Associated Disorders. 2022;36:350-3.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-research-methodology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmrm","sideBox":"Learn more about [BMC Medical Research Methodology](http://bmcmedresmethodol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmrm/default.aspx","title":"BMC Medical Research Methodology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Black women, maternal health, healthcare research, participation barriers, health equity, recruitment strategies, focus groups, consensus building","lastPublishedDoi":"10.21203/rs.3.rs-9418759/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9418759/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eBlack women in the United Kingdom persistently experience poor health outcomes in pregnancy and childbirth compared to white women. These healthcare inequities have multiple causalities, and are rooted in intersecting structural, systemic, institutional and sociocultural factors. This is exemplified by the underrepresentation of Black women in healthcare research. Mistrust in research, shaped by historical exploitation and contemporary discrimination, alongside organisational barriers within research delivery, continues to limit equitable research participation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAim: \u003c/strong\u003eTo critically explore how maternity and neonatal research opportunities are offered, understood, and experienced by Black women and research delivery teams, and to co-produce Principles of Engagement (PoE) to support more inclusive research practices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eAn exploratory qualitative design was employed, informed by the Double Diamond framework. In the \u003cem\u003ediscover\u003c/em\u003e phase, seven online focus groups were conducted with Black women and community representatives (n=26), as well as research midwives (n=24). Data was analysed using reflexive thematic analysis to \u003cem\u003edefine\u003c/em\u003ekey themes. These findings, alongside patient and public involvement and engagement (PPIE) input, and evidence from a recent systematic review, informed the \u003cem\u003edevelop\u003c/em\u003e phase, generating draft Principles of Engagement. In the \u003cem\u003edeliver\u003c/em\u003ephase, these principles were iteratively refined, discussed, and rated through three online consensus workshops with stakeholders (n=20).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eFour interrelated themes were generated from the focus groups: (1) Trust as a precondition for ethical participation; (2) Making research inclusive and accessible; (3) Power, agency and relational decision-making; and (4) Motivation and value of participation. During subsequent consensus workshops, eight Principles of Engagement were generated; all eight principles were rated as 100% important in the final consensus round.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eResearch engagement was found to be socially negotiated and structurally shaped rather than a solely individual choice. Inclusive intent alone was often insufficient without resourced structural support and relational accountability. Our findings have been translated into novel, co-produced and system-ready principles of engagement which aim to advance equity in UK maternity and neonatal research. Embedding these principles in research practice has the potential to improve trust between clinicians and Black women, widen research participation and improve the fairness, transparency, and relevance of maternity research.\u003c/p\u003e","manuscriptTitle":"Co-Producing Principles of Engagement to Improve the Inclusion of Black Women in UK Maternity and Neonatal Research: A Qualitative Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-05-08 04:29:21","doi":"10.21203/rs.3.rs-9418759/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"179631599854583609556512045278288948990","date":"2026-05-06T15:32:36+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-29T13:27:01+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-04-22T10:57:12+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-21T07:43:02+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-21T07:42:07+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Medical Research Methodology","date":"2026-04-14T18:10:52+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-research-methodology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmrm","sideBox":"Learn more about [BMC Medical Research Methodology](http://bmcmedresmethodol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmrm/default.aspx","title":"BMC Medical Research Methodology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8ae8299e-51cd-4f8a-882d-39975f5c9bbc","owner":[],"postedDate":"May 8th, 2026","published":true,"recentEditorialEvents":[{"type":"reviewerAgreed","content":"179631599854583609556512045278288948990","date":"2026-05-06T15:32:36+00:00","index":33,"fulltext":""},{"type":"reviewersInvited","content":"16","date":"2026-04-29T13:27:01+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-08T04:29:21+00:00","versionOfRecord":[],"versionCreatedAt":"2026-05-08 04:29:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9418759","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9418759","identity":"rs-9418759","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}