Artificial intelligence (AI) has emerged as one of the most powerful forces shaping clinical and translational sciences. There are real opportunities as well as significant challenges and potential threats, which become very real upon implementation. At Translational Science 2026 in Milwaukee, Wisconsin, the Regulatory Sciences and Clinical Research Professional Taskforce Special Interest Groups (SIGs) jointly discussed opportunities, challenges, and threats associated with AI in clinical and translational sciences through the lived experiences of the SIGs’ members. Common uses, concerns, questions, and gaps were surfaced in the discussions and are presented in this manuscript, along with possible paths forward.

Crisis planning based on stated treatment preferences should not be judged by trials that never verified delivery infrastructure. Lessons from UK joint crisis plans and advance choice documents (ACDs) suggest outcomes depend on facilitation, accessibility, specificity and exception governance. Japan should test ACDs as measurable crisis-care infrastructure, not paperwork.

Learning Health Systems (LHSs) enable data-driven improvement in clinical care. However, research processes that generate this evidence remain fragmented, limiting systematic learning across study portfolios and contributing to persistent translational inefficiencies. We introduce the Learning Research System (LRS) as a sociotechnical extension of the LHS that leverages LHS infrastructure to render research operations measurable, reusable, and governable across studies, positioning research as an object of continuous learning. Using targeted literature synthesis and supplementary searches, we traced the emergence of the LRS from foundational LHS scholarship and developed five core capabilities as proposed maturity indicators: cross-study measurement, reuse of cohorts and analytic assets, portfolio-level governance, feedback-enabled workflow optimization, and integration of research outputs into clinical and operational improvement. We illustrate the distinction between LHS and LRS roles across the NCATS Translational Science Spectrum. Finally, we applied the capabilities to a formative case at the University of Nebraska Medical Center through an institutional environmental scan, mapping them as indicators of emerging LRS maturity from an existing LHS. The LRS provides a framework for evaluating research-process learning, reducing fragmentation across translational stages, and addressing selected translational discontinuities, such as early-stage “valley of death” barriers between discovery and human studies.

There is growing emphasis on the importance of active partner engagement in research and the design, planning, and implementation of new programs. Indeed, the science of engagement is gaining is receiving more attention from researchers, being formally included in research studies more often, and increasingly being required by funders. Financial costs and economic implications are well-known drivers of successful adoption, implementation, and sustainment of evidence-based programs; however, partner engagement costs are often excluded from economic evaluations even when elements of engagement may be relevant to sustainment and replication. Resource constraints in both research and practice highlight the need to better understand engagement costs to ensure that scarce resources are put towards the richest engagement activities. As part of the Rapid and Rigorous Patient-Centered Program (R2P2) in Colorado, we designed an approach to systematically document and analyze partner engagement costs across four prototype projects. We describe this approach, summarize needed adaptations, share an interactive data collection template, synthesize the relevant engagement costs during implementation, replication, and sustainment, and discuss lessons learned. Our experiences in R2P2 in costing initial engagement activities across four diverse projects offer direction for future research and practice that balances high-quality partner engagement with efficiency in addressing resource constraints facing researchers and practitioners.

Cognitive impairment affects over 75% of young people with first-episode psychosis (FEP), yet cognitive rehabilitation is rarely available within public mental health services in sub-Saharan Africa. This implementation gap reflects both limited intervention availability and insufficient planning for local service realities. This article describes the participatory development of a Theory of Change (ToC) for the CognIFiEd study, a task-shifted Compensatory Cognitive Training intervention for young adults with FEP across three tertiary psychiatric hospitals in South-West Nigeria. Guided by WHO ExpandNet, RE-AIM, the Consolidated Framework for Implementation Research and established ToC methods, 25 stakeholders, including young people with lived experience, caregivers, clinicians, facilitators, administrators, policymakers and implementation scientists, co-produced and validated an implementation logic model through five workshops. The ToC identifies four core inputs: trained non-specialist facilitators, culturally adapted manuals, low-technology SMS and print reinforcement systems, and stakeholder engagement structures. These support weekly group sessions, caregiver psychoeducation, digital reinforcement, supervision and outpatient integration. Immediate outputs include cognitive strategy use, retention, social reintegration and caregiver skill development, while proximal outcomes include neurocognition, functional capacity, self-efficacy and caregiver strain. The model also specifies assumptions, LMIC-specific barriers, mitigation pathways and an accountability ceiling for distinguishing pilot outcomes from longer-term system impacts.

The Deep South has the highest prevalence of obesity, diabetes, and hypertension in the United States, with marked disparities by race, socioeconomic status, and rurality. Addressing these disparities requires not only effective interventions, but also a translational science workforce equipped to design, implement, and scale solutions in real-world settings. The Forge AHEAD Center was established to improve cardiometabolic health outcomes across the Deep South by advancing both research and scientific workforce development. As a central component of this mission, the Center has developed the “Pilot Plus” model, an integrated framework that combines pilot funding with structured training in translational science, multidisciplinary team-based mentorship, and embedded community engagement. Early-stage investigators are supported through coordinated access to methodological expertise, including dissemination and implantation science and assessment of social determinants of health, while community stakeholders are incorporated into the research process. By aligning funding, training, and infrastructure within a single program, the Pilot Plus model addresses fragmentation in traditional research development approaches and expands access to critical resources across institutions. This model provides an adaptable framework for strengthening translational research capacity and developing a cadre of demographically varied investigators prepared to advance health outcomes in regions with a high burden of chronic disease

In Nigeria, religious leaders are de facto mental health gatekeepers, yet their explanatory models and attitudes remain poorly characterised at the population level. This cross-sectional study maps causal beliefs and attitudes among 207 Christian and Muslim religious leaders in Lagos using validated, culturally adapted instruments, forming the attitudinal and typological component of the CLERIC research programme. An integrated conceptual model posits that explanatory models structure causal attributions, which constitute the cognitive foundation of stigma-related attitudes clustering into typologies with direct implementation implications. Spiritual causation was most strongly endorsed (M = 11.9, SD = 2.3) but coexisted with psychosocial and biological attributions in pluralistic frameworks. Stronger spiritual beliefs linked to more restrictive attitudes (r = .41); biological beliefs predicted more supportive orientations (r = .35). Latent class analysis identified three optimal typologies (AIC = 2,847.3, BIC = 2,912.8, entropy = 0.82): spiritually oriented–high restrictiveness (38.2%), pluralistic–high benevolence (35.7%) and biologically oriented–low restrictiveness (26.1%). Education and prior mental health training were the strongest independent modifiable predictors of supportive orientation. These typologies challenge monolithic views of religious leaders and provide a stratified, evidence-based framework for designing tailored faith–health integration strategies beyond universalist engagement models in Nigeria and comparable low- and middle-income countries contexts.

Despite substantial investment in clinical and translational research, only a small proportion of evidence-based interventions are adopted and sustained in routine practice, contributing to persistent delays between discovery and population benefit. Dissemination and implementation (D&I) science is a critical discipline for addressing this gap, and the NIH Clinical and Translational Science Award (CTSA) program (established 2006) has been strategically positioned as a national infrastructure to advance D&I capacity. We conducted a national environmental scan of publicly available websites and documents from all 66 CTSA hubs (May–July 2025), using a structured extraction tool to capture D&I-specific activities across seven domains: institution and community partnerships, formal D&I organizational structures within the CTSA, consultation services, collaborative programming, training opportunities, educational offerings, and pilot funding mechanisms. Findings reveal substantial heterogeneity in D&I science activities across CTSA hubs; 45% had a formal D&I unit, 54% offered D&I consultation services, and 37% provided collaborative programming. Structured workforce development was limited: 12% offered D&I-focused training grants, 15% offered structured educational programs, and 15% provided D&I-specific pilot funding. Consultation models varied widely in scope, access, and evaluation practices. These findings demonstrate uneven development of D&I science infrastructure across CTSAs and highlight opportunities to strengthen capacity nationally.

Tobacco use causes over 8 million deaths annually, with low- and middle-income countries (LMICs) bearing most of the burden. In Botswana, tobacco use prevalence rose from 17.6% in 2017 to 22.2% in 2024. Despite this, tobacco control infrastructure remains limited. Tobacco Control Resource Centers (TCRCs) have been established to consolidate provider training, research, and dissemination of tobacco control resources. The World Health Organization (WHO) Centre for Tobacco Control in Africa (CTCA), a regional TCRC, has a cross-country mandate that could be further strengthened through complementary, country-specific support. We applied the Community Engagement Studio (CES) methodology to co-design of a Botswana-based TCRC-assessing acceptability, priorities, potential challenges, and implementation strategies. In July 2025, 12 stakeholders from the Botswana Smoking Abstinence Reinforcement Trial (BSMART), a NIH-funded study aimed at integrating smoking cessation interventions in HIV clinics, participated in a 2-hour CES. Stakeholders endorsed the need for a national TCRC, prioritizing provider training, dissemination, and cessation services. Sustainable financing emerged as a key challenge, prompting proposals for diversified funding models. We successfully conducted a CES to guide the co-design of a Botswana-based TCRC, illustrating the acceptability of a national TCRC and how CES can be leveraged to strengthen tobacco control infrastructure in Botswana.

Clinical and Translational Science Award (CTSA) hubs must advance implementation science via innovative approaches to understand and develop strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines. This special communication describes adaption of the I-Corps™@NCATS training program, a Lean Start-Up approach developed to advance commercialization of academic innovation, as a mechanism for building implementation science capacity at the Institute for Translational Medicine, a Chicago-based multi-institutional CTSA hub. Results from seven training cohorts (2021–2025) are presented (43 teams, 157 participants). In this five-week experiential program, teams conducted “customer discovery” interviews with stakeholders (mean = 23.8/team, SD = 5.6) to rapidly assess fit-to-context of their innovation and adoption requirements. Likelihood of recommending the program to a colleague was high (8.9, SD = 1.5; 1–10 scale, where “10” = “extremely likely”). Important adaptations were providing non-commercial use cases; defining “customers” in terms of stakeholders and partners; reframing commercial business model goals in terms of designing-for-dissemination-and-sustainability; and showing how the value proposition hypothesis is analogous to a research hypothesis being tested and validated with “customer discovery” data. Findings support that the modified I-Corps@NCATS training program provides flexible translational science skill-building to advance implementation science capacity among clinical and translational researchers.

Depression is underrecognized in primary care, which is a barrier to treatment. For the last decade, Zimbabwe has invested in increasing access to depression treatment within primary healthcare. This study describes depression recognition by nurses and referral to treatment in four primary care clinics in Zimbabwe. Research staff screened 200 patients after they attended a primary care visit at a study clinic. They assessed depression using the PHQ-9 and assessed depression and/or anxiety using the Shona Symptoms Questionnaire (SSQ-14). Medical records were examined for depression and/or anxiety diagnoses. Positive depression and anxiety screens were compared with nurse documentation. 69.5% of participants were women and 56.5% were living with HIV. 6.0% had a PHQ-9 score ≥11, indicative of depression, and 22.0% had an SSQ score ≥9, indicative of depression and/or anxiety. None of the patients who screened positive for probable depression and/or anxiety were recognized by nurses. Nurses who saw the patients in the sample were surveyed. Most had not received formal training on mental health in primary care (mhGAP) prior to patient data collection. Despite efforts to expand depression treatment in Zimbabwe, individuals with probable depression were unrecognized by nurses, though nurses offered some care for other mental health conditions.

To address challenges in the real-world implementation of digital health for mental healthcare in Nigeria, this study conducted a process evaluation of five World Health Organization-recommended digital tools within a state-wide primary health care program in Lagos. Employing a convergent mixed-methods design across five facilities, we measured implementation fidelity through observation and platform analytics, and assessed stakeholder perceptions via validated surveys and interviews. The findings revealed a sharp divergence in success. Administrative tools that streamlined workflows, such as drug stock notification and automated client reminders, achieved high fidelity (>90% adherence). In contrast, clinical tools that altered provider–patient interactions, including a decision support app and a client helpline, demonstrated low fidelity (<66% adherence). Qualitative analysis attributed this gap to the successful tools’ seamless workflow integration versus the clinical tools’ disruption of practice and introduction of perceived professional and liability risks. The study concludes that digital health adoption is determined less by technological sophistication than by its integration into human systems. Scaling these innovations effectively requires prioritizing tools that align with existing workflows and developing a supportive policy ecosystem to address the professional concerns of frontline health workers.

Older adults have long been considered critical actors in developing and implementing age-friendly community (AFC) initiatives. However, there has been limited empirical research on the ways they advance AFC implementation, especially in terms of their participation through AFC leadership roles (e.g. committee chairs, work group members). This study addresses this critical gap by exploring the functions that older adults exhibit in AFC implementation in the United States – namely, the underlying purposes and processes operating through their implementation actions. As one of the few studies exploring AFC implementation processes from the direct perspectives of older adults, this study conducted qualitative interviews with 23 older adult leaders of AFC initiatives across four states. Through reflexive thematic analysis, we identified two overarching thematic categories regarding the functions of their efforts towards AFC change. First, older adults advance AFC programme processes by guiding (e.g. determining priority areas) and carrying out (e.g. handling day-to-day programme logistics) the work. Second, older adults strengthen network capacity through connecting people and organizations to advance AFC implementation and spreading ageing-inclusive mindsets and practices among community actors. The findings support the view of older adults’ participation in AFC implementation as a multidimensional phenomenon wherein they employ multiple co-occurring functions that fluctuate dynamically across organizational roles, activities and tenure with the initiative. This study highlights the importance of continued research on the people enacting age-friendly efforts in their communities to better understand the ways that AFC efforts can catalyze local leaders – including older adults themselves – towards impact on ageing.

Implementation science plays a crucial role in effectively translating scientific knowledge into sustainable, evidence-based health practices. This perspective article focuses on some Latin American experiences, highlighting the limitations of applying methodologies developed in the Global North to settings marked by structural inequalities, economic constraints and cultural diversity. The included experiences examine a range of programs, such as the national Breastfeeding and Feeding Strategy, the evaluation of the Triple P-Positive Parenting Program in Chile and the community component of Mental Health Gap Action Programme in Colombia. Other contributions explore professional training initiatives and offer critical reflections on frameworks, such as the Consolidated Framework for Implementation Research and the Reach, Effectiveness, Adoption, Implementation and Maintenance. The reflections call for strengthening local capacities, fostering meaningful South–South and South–North collaborations, and advancing a context-sensitive, equity-oriented approach to implementation science that supports the development of more adaptive, effective and just health systems.

Adolescent mental health problems are prevalent in low- and middle-income countries, like Kenya, where access to care remains severely limited. Task-shifted, school-based interventions offer solutions but often lack structured protocols for managing risk, such as suicidality or abuse. The Shamiri Risk Management Protocol (Shamiri-RMP) was developed to address this gap through a tiered system for screening, classifying and responding to risk within a stepped-care mental health model. We conducted a mixed-methods implementation study across 149 public high schools in Kenya. Caseworker fidelity and risk classification accuracy were evaluated through a review of 222 student cases. The Consolidated Framework for Implementation Research guided the qualitative analysis of caseworker surveys to identify implementation barriers and facilitators. Of 76,855 students enrolled in the broader Shamiri program, 977 (1.27%) were referred for risk assessment, and 222 (0.28%) were enrolled in the Shamiri-RMP. Among them, 42.71% were low-risk, 35.68% moderate-risk and 21.61% high-risk. Risk reductions occurred in 60.47% of high-risk cases, 56.34% of moderate-risk cases and 51.76% of low-risk cases. Implementation facilitators included supervisory support (50.88% of caseworkers) and protocol clarity (80.70%), while barriers included referral gaps (5.26%) and confidentiality concerns (54.39%). Findings support the feasibility and scalability of the Shamiri-RMP in low-resource school settings.