EmbraceHealth Research Consortia SOW - November 9 2026.pdf

RFP: 75N94027R00002 ATTACHMENT 1

IDIQ SOW 11-9-2026

STATEMENT OF WORK – IDIQ BASE

EMBRACEHEALTH CLINICAL RESEARCH NETWORK

I. BACKGROUND AND INTRODUCTION

The National Institute on Minority Health and Health Disparities (NIMHD) leads scientific research that takes a population health approach to improve health by identifying, understanding, preventing, and treating or intervening in diseases, disorders, or other conditions that are more common in specific populations compared with the general population. There is an urgent need to understand and address these adverse health differences, and NIMHD is dedicated to addressing critical research gaps by providing evidence for factors that contribute to disparities and identifying solutions to reduce them – with the overarching goal of improving American public health.

Advancing the NIMHD mission includes a comprehensive range of clinical and health services research initiatives as outlined in the priority areas below.

(1) Clinical Research and Treatment Delivery Within Healthcare Settings

Promotes and supports research to: (a) study clinical and pre-clinical presentations (phenotypes) and/or manifestations of health conditions; (b) reduce health disparities through the identification of novel tests, methods and strategies to prevent, screen, diagnose, treat, and/or manage health conditions, especially those associated with the highest morbidity and mortality, within the health care context; and (c) facilitate collaborations across healthcare settings to improve the quality and safety of care, care coordination, and clinically improved patient outcomes.

(2) Patient-Clinician and Patient-Health Care System Interactions

Promotes and supports research to: (a) explore in-depth how interactions between patients and clinicians or patients and health care systems (including non-clinical personnel) affect clinical outcomes and health care disparities, and interventions to improve them; and (b) explore and enhance patient-clinician and/or patient-health care system engagement and their roles in shared decision-making.

(3) Health Care Utilization and Outcomes

Promotes and supports research to: (a) identify patterns of healthcare availability, utilization, quality and their influence on health outcomes in a variety of settings including those outside of traditional healthcare settings/systems; and (b) identify/examine interventions to enhance the timeliness and quality of health services and procedures, and their subsequent effect on health disparities and clinically meaningful health outcomes.

(4) System-Level Health Services Research

Promotes and supports research to understand how health care settings factors, like care coordination, and integration influence health disparities and clinical outcomes.

The nation is witnessing rapidly evolving advances that address population-wide health challenges, and opportunities to re-think and re-design strategies to attain optimal health across the lifespan. However, the benefits of those advances are not yet fully manifested among some individuals, families, or communities. For instance, the prevalence of chronic conditions (more often coexisting than isolated) continues to increase across the nation, especially among children, as emphasized by the Make America Healthy Again (MAHA) Initiative, and the White House MAHA Report. Yet, individuals and communities from low socioeconomic backgrounds and resources, and specific Office of Management and Budget (OMB)-defined racial and/or ethnic categories, tend to have a high prevalence of chronic health conditions and/or a high risk of developing them. Moreover, the levels of awareness, treatment and control for some of the most prevalent chronic conditions tend to be significantly lower among individuals from the populations mentioned above. This translates into a higher risk of developing preventable, long-term health complications, and a shorter life expectancy.

Consistent with the NIH Director’s Priorities, NIMHD supports solutions-oriented health disparities research that is based on scientifically valid measurable health outcomes, and is rigorous, replicable and generalizable across the range of its projects and initiatives. NIMHD has funded a variety of clinical trials and other interventions, many of them embedded within the context of health care settings.

NIMHD has also ensured that its funded research reflects population and public health trends and addresses important research opportunities and gaps as they arise.

The scale and urgency of today’s population health challenges demand a research initiative capable of operating effectively in real-world care settings. This requires a research infrastructure embedded within health care systems, particularly those serving large numbers of low-resourced patients, where study findings can be rapidly translated into practice and benefit a broad range of communities. However, conducting biomedical research in these environments presents unique challenges and requires a collaborative, multidisciplinary infrastructure grounded in https://www.hhs.gov/maha/index.html chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.whitehouse.gov/wp-content/uploads/2025/05/MAHA-Report-The-White-House.pdf chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.whitehouse.gov/wp-content/uploads/2025/05/MAHA-Report-The-White-House.pdf systematic, rigorous practices. A well-established research infrastructure can accelerate the implementation of research activities and drive measurable improvements in health outcomes, clinical practice, and public health, particularly in response to emerging or urgent community health needs.

For this purpose, NIMHD requires a multi-site Clinical Research Network (EmbraceHealth CRN). The network will comprise of approximately five (5) Research Consortia (RCs) and a Coordinating Center (CC). This contract-based Initiative will enable NIMHD to efficiently acquire the expertise needed to design and execute solutions-oriented clinical research studies to improve health outcomes in clinically meaningful and measurable ways and reduce health disparities.

II. SCOPE, OBJECTIVES, AND RESEACH FRAMEWORK

A. Scope

The purpose of this multiple-award Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract is to establish and operate Research Consortia (RCs) within the EmbraceHealth CRN to design, develop, and conduct rigorous, hypothesis-driven clinical, behavioral, and health services research prioritizing solutions-oriented interventional studies, addressing chronic, acute, urgent, and emerging health needs of populations and communities experiencing health disparities throughout the United States and its territories.

Research activities will be responsive to the health needs and priorities of the populations and communities served by individual RCs, as well as encompass studies developed and implemented collaboratively across the network. The EmbraceHealth CRN will promote and encourage the development and implementation of innovative clinical and behavioral interventions and the appropriate application of data science, super intelligence (SI) methods, and emerging health technologies across the health care continuum.

RC activities include establishing and maintaining research infrastructure;

developing and implementing research protocols; collaborating with the network’s separate Research Coordinating Center (CC), NIMHD, and other RCs; and collecting, managing, analyzing, and disseminating research data and findings, as authorized under task orders issued during the five (5)-year multiple-award IDIQ ordering period.

B. Objectives

The overarching objectives of the EmbraceHealth CRN are to attain clinically meaningful and measurable improvements in health outcomes and reduce health disparities across the life course by advancing scientific knowledge and approaches that enhance timely screening and diagnosis, prevention, treatment, and optimal control of chronic, acute, urgent, and emerging health conditions in accordance with evidence-based clinical guidelines.

These objectives will be accomplished through the establishment and maintenance of an efficient and nimble research infrastructure that supports the generation of rigorous, actionable scientific evidence, the translation of research findings into clinical practice, and the scalability of effective interventions. The EmbraceHealth CRN will also leverage data science, super intelligence (SI) methods, and health technology, as appropriate, to conduct rigorous research studies embedded into healthcare settings that address emerging, urgent, acute, or chronic health needs and priorities of populations and communities experiencing health disparities.

C. Network Structure and Research Settings

The EmbraceHealth CRN will comprise multiple Research Consortia (RCs) and a Research Coordinating Center (CC) with the goal of achieving broad geographic representation across rural and urban areas of the U.S. and its territories. The Research Consortia will consist of collaborations or partnerships between organizations, including but not limited to academic institutions, health care settings, and other entities that provide ambulatory care, including family medicine, general internal medicine, general pediatrics, and medical subspecialties with a component of chronic ambulatory care.

To ensure successful recruitment and retention of study participants, scientific rigor of the research methodology, and appropriate interpretation of the study findings (including implementation outcomes), RCs are expected to serve patient populations with a scientifically meaningful proportion of individuals from populations experiencing health disparities. The sample size and characteristics of participants should allow sound analyses based on age, sex, and racial/ethnic groups in the proposed studies to be defined in future task orders.

Research Consortia will consist of collaborations or partnerships between academic institutions and health care settings that provide ambulatory care, including family medicine, general internal medicine, and general pediatrics, as well as medical subspecialties with a component of chronic ambulatory care. Existing partnerships among academic health centers that serve a high proportion of patients from low-income backgrounds or low-resourced communities, with public health insurance (Medicare, Medicaid, CHIP) or no insurance, community health care settings linked to safety net hospitals, and Federally Qualified Health Centers (FQHCs) are encouraged to respond to this Solicitation.

Offerors shall have established and will maintain a research consortium of partners with the organizational capacity, healthcare collaborations, and research infrastructure necessary to access and recruit a scientifically meaningful proportion of patients from populations and communities experiencing health disparities across participating healthcare settings, and successfully perform the proposed research projects Research participants may also be recruited from existing cohorts in the consortium, in alignment with the proposed research project questions, aims and design. Research consortia may span counties, cities, states, and territories.

Each consortium shall support research involving a broad range of patient populations, including different demographics, socioeconomic status, and age groups, and contribute to the EmbraceHealth CRN's goal of achieving geographic representation across urban, suburban, rural, and low-resourced communities and communities with limited availability of healthcare services throughout the 50 states and territories.

D. Research Activities and Approaches

Within the settings described above, EmbraceHealth CRN seeks to test and implement innovative clinical and behavioral interventions that are theoretically and scientifically supported and hypothesis driven. EmbraceHealth CRN RCs will test and implement clinical and behavioral interventions on chronic and acute conditions across age and sex groups that respond to the health needs of the local communities. These interventions will take place within the context of healthcare settings and will be designed to (1) achieve clinically meaningful health outcomes,

(2) evaluate measurable health outcomes using rigorous scientific methods, and (3) demonstrate feasibility, scalability, and reproducibility.

Interventions may encompass randomized clinical trials, randomized cluster trials, pragmatic trials, stepped-wedge cluster randomized clinical trial, comparative effectiveness research, implementation research, comparative implementation trials, hybrid effectiveness-implementation trial Type 1, hybrid Type 2 or Type 3 trials, adaptive trials, and factorial trials, among others.

Super intelligence and data science have advanced rapidly in health research and offer a powerful opportunity to accelerate progress toward reducing health disparities. As this field continues to evolve, the EmbraceHealth CRN data platform can provide a foundational resource for developing, validating, and applying innovative analytic approaches and algorithms that support prevention and diagnosis, comparative effectiveness research, risk prediction, and tailored clinical decision-making. These capabilities may help reduce the incidence of preventable complications and improve outcomes for populations experiencing health disparities. Accordingly, methods and analyses driven by data science are also envisioned activities of the EmbraceHealth CRN. As the EmbraceHealth CRN activities are solidified, future studies on emerging, urgent, chronic, and acute conditions and/or associated risk factors, biomarkers, genetics/omics, or epigenetics/omics could be implemented. In addition, data science and super intelligence (SI) research on causal inference, machine learning, longitudinal data, and implementation science could be further explored. The goal of these evolving research initiatives conducted through the EmbraceHealth CRN is not simply to predict who is at high-risk, but to estimate what interventions might work, for whom, under what circumstances, and at what point in a patient’s care trajectory.

Through the EmbraceHealth CRN, NIMHD seeks to identify and facilitate innovative research on reducing health disparities via technology-based studies, especially those that enhance patient self-reported data, interaction with clinicians and the health care system, and home-based biospecimen collection, remote monitoring, treatment and/or self-management.

EmbraceHealth CRN funded projects are envisioned to generate findings with the potential to inform formal implementation or revision of clinical practices, guide further research on implementation or scaling up, or generate new hypotheses for future studies.

E. Research Consortia and Coordinating Center Collaboration

The EmbraceHealth CRN Coordinating Center (CC) will serve as the central resource for coordination, technical assistance, data infrastructure, analytic support, and cross-site collaboration across the EmbraceHealth CRN RCs. Each RC will be expected to work collaboratively with the CC, NIMHD, and the other RCs to ensure that all the EmbraceHealth CRN activities are implemented in a consistent, rigorous, timely, and policy-compliant manner.

The EmbraceHealth CRN CC will support RCs in developing and strengthening the research infrastructure needed to conduct clinical studies in real-world health care settings.

RCs will be expected to collaborate with the CC on protocol finalization, study workflows, manuals of procedures, recruitment and retention strategies, data collection instruments, quality assurance and quality control procedures, and study implementation plans. The CC shall provide technical assistance to support study start-up, site readiness, implementation troubleshooting, performance monitoring, and adherence to consortium-wide standards based on clinical research best practices.

The EmbraceHealth CRN CC will provide biostatistical, methodological, informatics, and data science consultation to assist RCs with clinical study design, analytic planning, implementation, monitoring, and interpretation of findings. RCs will be expected to engage with the CC during study planning and execution to ensure that research questions, outcomes, measures, analytic approaches, and data submissions are aligned with EmbraceHealth CRN objectives and permit meaningful cross-site analyses.

The EmbraceHealth CRN CC will facilitate data management and data sharing across EmbraceHealth RCs, including coordination with National Institute of Health Science Collaborative for Health and Artificial intelligence Reduction of Errors (NIH SCHARE) a cloud-based research platform for secure storage and access to deposited data RCs will be expected to submit de-identified study data, electronic health record extracts, common data elements (CDEs), documentation, metadata, data dictionaries, and other required materials to the CC in accordance with approved timelines, formats, data use agreements, and NIH data sharing requirements, where applicable. RCs will also be expected to participate in data validation, harmonization, query resolution, and quality control activities led or coordinated by the CC.

The CC will facilitate the design and implementation of protocols across RCs, as applicable, for standard biospecimen collection, processing and storage, as well as refinement and finalization of these protocols.

The CC will provide logistical, technical, administrative, and coordination support to promote efficient network operations. This may include coordinating consortium governance activities, working groups, scientific meetings, training sessions, technical assistance calls, protocol-specific meetings, data harmonization discussions, and in-person and/or virtual meetings. RCs will be expected to designate appropriate personnel to participate in these activities; respond promptly to CC and NIMHD requests; provide required progress updates, deliverables, reports; and collaborate with other RCs on shared scientific, operational, and community-engagement activities.

Through this collaborative structure, the CC will help ensure that RC activities are scientifically rigorous, methodologically sound, operationally coordinated, and aligned with the overall goals of EmbraceHealth CRN. RCs will be expected to actively engage with the CC and consortium partners to support high-quality study implementation, timely data submission, cross-site learnings, dissemination of findings, and the generation and implementation of evidence-based practices that improve health outcomes and reduce health disparities.

https://www.nimhd.nih.gov/resources/schare

F. Health Conditions and Research Focus

NIMHD anticipates that research/interventions will be proposed within the context of chronic, acute, and/or urgent health conditions (associated treatment and/or clinical procedures) that are highly prevalent among populations that experience health disparities and are associated with significant morbidity and mortality across the life course. These conditions include, but are not limited to:

• Cardiovascular diseases (including coronary artery disease, cerebrovascular disease,) and risk factors

• Cardiometabolic diseases (including diabetes, prediabetes, overweight/obesity, hypertension, prehypertension, dyslipidemia) and risk factors

• Cancer

• Asthma and other chronic pulmonary conditions

• Sleep disorders

• Steatotic liver disease, hepatitis, and chronic liver disease

• Chronic kidney disease, and end-stage kidney disease

• Cognitive impairment/dementia

• Mental health conditions

• Substance use disorders

• HIV/AIDS and associated complications

• Pregnancy-related disorders and complications

• Acute and/or urgent health conditions

• Other conditions identified by the local community

Activities associated with such conditions will require multiple scientific and clinical experts in the health conditions of interest, research methodology, data science, biostatistics and other relevant research expertise, depending on the nature, scope, and objectives of the research activities.

The EmbraceHealth CRN CC will be expected to leverage the NIH SCHARE (NIH Science Collaborative for Health and Artificial intelligence Reduction of Errors) platform to establish and maintain a secure, centralized data hub containing de-identified data from clinical interventions contributed by each RC. The CC will support the CDEs, as appropriate and/or relevant to the RCs proposed projects, based on the electronic health record and study data required to support standardized data collection and harmonization, when such cross-RC analyses are agreed-upon and feasible. Examples of data include:

• Demographic data

• Medical history and physical examination

• Vital signs, body weight and height, blood pressure

• ICD-10 and CPT codes

• Diagnostic laboratory tests and other biomarkers

• Pathology/radiology/surgery reports

• Radiology/echo imaging

• Medication Profile

• Hospital and/or emergency department records

• Birth and/or death certificates or coroner’s reports

Findings derived from research projects funded through EmbraceHealth will be shared with the participating research and clinical partners, patients and communities, and help direct future NIH studies.

III. TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor will furnish all the necessary resources, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government under the terms of this Contract, as needed to fulfill the technical requirements outlined below and the specific requirements of task orders issued under this IDIQ contract.

The following task areas describe the types of activities that may be required under the IDIQ. The specific activities, performance requirements, deliverables, schedules, staffing expectations, and periods of performance will be established in individual task orders. The inclusion of an activity in this Statement of Work does not, by itself, require performance of that activity unless authorized under an applicable task order.

Task Area A: Core Research Operations and Research Infrastructure

Task Area A shall encompass all start-up and foundational activities required to prepare for the successful conduct of EmbraceHealth CRN studies.

1. Core Research Operations and Project Management

Establish and maintain core research operations, necessary to support the performance of awarded task orders. Finalize, implement and maintain, a Project Management Plan that identifies the organizational structure, staffing, roles and responsibilities, lines of authority, management of subcontractors and consultants, communication procedures, milestones, workflows, and processes for monitoring progress and addressing delays or performance issues.

2. Research Regulatory Compliance

The contractor shall ensure completion and ongoing maintenance of all required trainings and certifications. Clinical trials shall be conducted in accordance with FDA regulations and Good Clinical Practice (GCP) requirements, and human subjects research shall comply with regulatory and organizational review requirements as applicable.

The Contractor shall establish procedures for protecting participant safety, privacy, and confidentiality; obtaining and maintaining required research approvals; identifying, documenting, and reporting adverse events and serious adverse events, as applicable; and tracking required personnel training and certifications. Implementation of research regulatory and oversight activities; development, refinement, and implementation of standard operating procedures (SOPs); execution of memoranda of understanding (MOUs), data sharing protocols, data use agreements (DUAs), and other required agreements in collaboration with the CC and participating RCs; and establishment of appropriate governance and oversight structures.

3. Governance and Oversight

Establish or participate in appropriate governance and oversight structures.

These structures shall include, as applicable, a Data and Safety Monitoring Board (DSMB), a local Community Advisory Group, and others necessary to ensure scientific rigor, participant safety, regulatory compliance, transparency, and meaningful community input.

4. Research Infrastructure and Personnel

The Contractor shall provide expertise and a research infrastructure necessary to support and execute the research studies and consortium-wide activities, including scientific, technical and clinical experts and other qualified personnel necessary to support the research infrastructure and activities.

5. Protocol Development and Study Preparation

Participate in the development, refinement, and finalization of research study protocols and development of study workflows, recruitment and retention plans, data collection procedures, quality assurance and quality control processes, reporting mechanisms, and coordination with the CC and other RCs on cross-site research activities as applicable.

The Contractor shall support the development of scientifically rigorous study protocols that identify research questions or hypotheses, specific aims, study design, target populations, sampling approaches, primary and secondary outcomes, analytic methods, and procedures for evaluating intervention fidelity, feasibility, and scalability, as applicable to the research requirements.

Where required by the applicable task order, the study design and analytic plan shall address appropriate representation and assessment of outcomes among relevant population subgroups, including sex and racial or ethnic groups, consistent with the scientific objectives and applicable requirements.

6. Data Management Infrastructure

Establish and maintain the infrastructure and capabilities necessary to securely collect, extract, harmonize, manage, and transfer deidentified study data (including extracted and harmonized electronic health record data, CDEs, relevant training documents, and others) to the CC and the NIH SCHARE, and biospecimens to the CC or another biorepository identified by NIMHD, following secure data/biospecimen transfer standards and requirements.

The Contractor shall establish and maintain appropriate data management procedures and systems, including data entry, validation, quality control, cleaning, editing, dataset finalization, secure storage, and transfer. The Contractor shall maintain appropriate interfaces between participating healthcare systems, academic institutions, and designated research data systems, as required.

The Contractor shall develop and implement an applicable Data Management and Sharing Plan addressing the management, preservation, access, and sharing of research data in accordance with NIH requirements and approved study protocols.

Information systems used in contract performance shall comply with applicable federal information security, privacy, and contractual requirements, including FISMA-related requirements when applicable to the system and its use.

7. Biospecimen Infrastructure

Establish and maintain the capabilities necessary for biospecimen collection, processing, storage, and transfer to the CC or another biorepository identified by NIMHD, when required by the applicable task order and approved study protocol.

The Contractor shall maintain procedures for biospecimen identification, handling, tracking, quality control, storage conditions, and secure transfer, as applicable to the approved research protocol.

8. Community Engagement

Establish and maintain appropriate mechanisms for engaging participating communities, patients, and other relevant stakeholders in research activities, as applicable to the approved study protocols and consortium objectives.

The Contractor shall provide ongoing consultation and periodic updates to the NIMHD Contracting Officer's Representative (COR) regarding emerging health needs, changing community conditions, research priorities, and potential future research opportunities relevant to the populations and communities served.

The Contractor shall coordinate with the local Community Advisory Group and participating healthcare partners to support appropriate community input, culturally and contextually responsive recruitment strategies, and communication with study participants and communities.

Task Area B: Study Implementation, Close-Out, and Transition

Task Area B shall encompass all study implementation activities, including study close-out and transition of resources of EmbraceHealth CRN studies.

1. Study Implementation

a. Conduct approved research project authorized under awarded task orders in accordance with approved protocols, study implementation plans, and applicable research requirements.

b. The Contractor shall implement the approved research design, including sampling, randomization, intervention assignment, outcome measurement, and follow-up procedures, as applicable.

Implement applicable participant recruitment and enrollment, intervention delivery or implementation, retention, follow-up activities, clinical and research data collection, study monitoring, documentation, and adherence to approved protocols and SOPs.

c. The Contractor shall ensure timely and accurate collection of study data and transfer of required data/biospecimens to the NIH SCHARE, the CC or another biorepository identified by NIMHD, in accordance with approved data sharing protocols, DUAs, privacy and security requirements, and NIH policies.

2. Study Close-Out Activities

a. Prepare and submit required technical reports, study data, documentation, and other required deliverables, as specified in applicable task orders that include, but are not limited to, finalization and documentation of all informatics, technology, and data transfer SOPs; completion of data extraction, harmonization, validation, and transfer for all studies; resolution of data/biospecimen queries; final study monitoring and quality assurance activities; completion of required regulatory and administrative close-out procedures; and submission of final deliverables to NIMHD and the CC. Final deliverables shall include, as applicable, completed datasets, data dictionaries, documentation of data validation and quality control, final analyses, study findings, and records necessary to support required data sharing and research dissemination.

b. The Contractor shall ensure that study records, datasets, documentation, and analytic files are complete, accurate, and maintained or transferred in accordance with applicable policies and contractual requirements.

3. Transition of Study Activities and Resources

a. The Contractor shall perform activities necessary to ensure an orderly transition of study activities, data, documentation, materials, tools, workflows, and other resources to another entity, as directed by NIMHD, when applicable. The Contractor shall support continuity of operations by preparing transition plans, transferring relevant knowledge and documentation, assisting with data and resource migration, and coordinating with NIMHD, the CC, receiving entities, and other stakeholders to minimize disruption to ongoing or future research activities.

Note:

For all years, costs incurred to prepare and distribute analytic data sets and/or biological samples to approved outside investigators must be covered by the investigators and not the contract. Furthermore, when new exam procedures, assays or genotyping in ancillary studies reveal potentially clinically actionable conditions, the costs associated with participant notifications must come from the ancillary studies and not the contract.