Draft SOW - NIMHD DIR IDIQ Population Health Research Contract-10.30.2026.docx

National Institutes of Health National Institute on Minority Health and Health Disparities (NIMHD) Population Health and Clinical Research Draft Statement of Work

The National Institute on Minority Health and Health Disparities (NIMHD) conducts and supports research and training programs to advance knowledge and understanding of health disparities, identify mechanisms to improve minority health and reduce health disparities, and develop effective interventions in community and clinical settings.

NIMHD is the lead organization at the National Institutes of Health (NIH) for planning, reviewing, coordinating, and evaluating minority health and health disparities research activities. NIMHD also promotes workforce development, supports research capacity at less-resourced institutions that train students in research careers, serves populations experiencing health disparities, supports participation in clinical research, and promotes information dissemination through regular communications, public education outreach, and scientific presentations.

The President’s Executive Order (EO) 14212 Establishing the President’s Make America Healthy Again Commission aims to improve the health of Americans. As described in the EO, escalating burden of chronic diseases poses significant challenges in the United States. These conditions contribute to rising health costs, reduced workforce productivity, and stagnant life expectancies across the country, both in adults and children.

NIH defines a health disparity as a measurable difference in health that exists between specific population groups. This is a rigorously derived and data-driven determination operationalized by quantifiable metrics, rather than a statement of attribution. It is a scientific starting point that identifies where health outcomes diverge, not a predetermined conclusion about why. Scientific investigations to identify or understand the root causes are separate and distinct scientific questions, which are multifaceted and complex. NIH funded research is interested in those health disparities that are modifiable or actionable to improve the health of all population groups.

Health disparities may be observed in the risks, prevalence, or problems resulting from specific behaviors, as well as the incidence, prevalence, and mortality from conditions, diseases, and/or disorders.

To fulfill the NIH mission of seeking fundamental knowledge about the nature and behaviors of individuals as living systems, and the statutory purpose of NIMHD, as outlined in the Public Health Service Act (42 U.S.C. § 285t), to conduct research to understand and reduce health disparities, NIMHD Division of Intramural Research (DIR) conducts population health research to understand how health outcomes vary across populations, identify multilevel modifiable factors that drive these disparities, and develop, test, and evaluate clinical and population-based interventions to reduce these disparities.

This Statement of Work (SOW) outlines a requirement for Research and Development (R&D) social and behavioral sciences research services to support the NIMHD DIR in conducting population health and clinical research.

1.2 Purpose/Objectives

The purpose of this effort is to provide R&D social and behavioral sciences research services to support NIMHD DIR in conducting population health and clinical research to understand and reduce health disparities in the United States.

1.3 Scope

The scope of this contract encompasses the development, conduct, coordination, monitoring, analysis, and completion of population health and clinical research studies, including clinical trials and other research protocols. The Contractor shall provide necessary scientific, clinical, statistical, methodological, logistical, technical, administrative, data management as well as access to qualified research sites, investigators, laboratories, and other resources, as needed, to conduct and coordinate research studies to investigate health disparities across populations, identify modifiable risk and protective factors associated with these disparities, and develop and test interventions to reduce these disparities. Study designs may include, but are not limited to:

· Population-based cross-sectional surveys;

· Epidemiological studies (e.g., longitudinal cohort study, case-control studies);

· Clinical trials;

· Community-based intervention studies;

· Simulation modeling; and

· Qualitative research methods (e.g., direct observations, in-depth interviews, focus group discussions).

2.0 TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government to successfully perform the requirements stated below. Specifically, the Contractor shall, as required by individual task orders, perform the following technical requirements, including but not limited to:

1. Provide personnel, facilities, and other services necessary to maintain and coordinate multiple health disparities research studies funded through task orders under this Indefinite Delivery, Indefinite Quantity (IDIQ) contract.

2. Provide overall project management and coordination of activities performed under individual task orders, including development and maintenance of project plans, schedules, milestones, coordination of participating research sites and subcontractors, monitoring of performance, identification and resolution of project risks and issues, and preparation of progress reports as specified in the applicable task order.

3. Conduct research studies through qualified organizations, as specified in individual task orders, and receiving consent from the Contracting Officer’s Representative (COR) and Contracting Officer (CO). This includes (but is not limited to) implementation of protocols; population health and clinical research site monitoring; regulatory compliance assurance; and analyses of data from clinical, laboratory, population and epidemiologic studies.

4. Provide and manage participating population health research and clinical trial sites, investigators, laboratories, and other research resources necessary to conduct studies, directly or through qualified subcontractors.

The Contractor shall draft, negotiate, execute, administer, monitor, renew and/or modify as necessary, subject to subcontractor's satisfactory past performance, and with the consent of the CO, subcontracts with domestic population health studies, clinical research sites and laboratories, and provide support for these population health studies, clinical research site and laboratories. The Contractor shall assume responsibility for population health and clinical sites, including site readiness to start new research studies. This includes the establishment of new subcontract agreements for these sites (including laboratories), data management, and other operations and functions. As existing protocols close, the Contractor shall assume responsibility for any new protocols at these sites.

5. Recruit and retain numbers of potential research subjects sufficient for the timely completion of all protocols.

6. Provide United States based investigators in the United States with expertise in the population health and clinical care, to conduct protocols specified through individual task orders .

7. Provide professional and technical staff adequate to provide scientific and administrative coordination of multiple population health and clinical health disparities research studies. These staff shall include, but are not limited to, qualified medical, nursing, and neuropsychologic staff, study coordinators, personnel for participant identification, recruitment, study conduct, and retention, pharmacists, and laboratory technicians.

8. Ensure sites have access to populations of interest, laboratory facilities with the capability to perform clinical research specified in task orders.

9. Identify and engage community organizations, community leaders, health care providers, and other relevant stakeholders; establish and support community advisory boards, community coalitions, or other partnerships; conduct community needs and readiness assessments; and facilitate community participation in research planning, implementation, and dissemination of findings.

10. Develop and implement quantitative and qualitative data collection methods, including surveys, interviews, focus groups, direct observations, and other methods appropriate to the research protocol. The Contractor shall manage, analyze, and report data collected through these methods, as required by individual task orders.

11. Provide facilities and equipment adequate to conduct population health, inpatient and outpatient clinical research studies. Equipment purchases must be approved by the COR and CO.

12. Ensure that sites have (through lease or direct provision, if required) electronic information systems compliant with the Federal Information Security Modernization Act (FISMA), necessary specialized equipment (including hardware and software) for sites to electronically communicate with the Contractor, subcontractors, and NIMHD DIR as required, for processing and storage of biospecimens (e.g., ultralow temperature freezer, specialized shipping materials and training for shipment of biohazardous materials and dangerous goods, and for receipt, storage, monitoring, and dispensing of investigational drugs).

13. Obtain access for research protocol review and approval (or exemption) to a standing Institutional Review Board (IRB) and ensure that each institution conducting population health and clinical research studies has a current, approved Federal-Wide Assurance Number on file with the Office for Human Research Protections (OHRP).

14. Ensure that all the staff at each site participating in the design or conduct of population health and clinical research involving human subjects, complete and maintain education on the human research protections, as described in NIH Guide Notice OD-00-039 - REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS, release date June 5, 2000 (Revised August 25, 2000).

15. Ensure that when appropriate, population health and clinical research sites have a community advisory board (CAB) constituted with members of the local community that can provide community perspective and advice for science in the community where the population health and clinical research is located and that provides community input.

16. The Contractor shall provide services to ensure regulatory compliance for research activities including subcontracted sites' performance. More specifically:

a. Ensure site access to a communications system in compliance with U.S. Food and Drug Administration (FDA) requirements for the submission of Adverse Experience Reports (AERs) by Subcontractors to the Contractor for transmission as required to the COR as required. Monitor the accuracy of adverse experience reporting through regular summary reports for submission to the COR. Draft safety reports as required by the FDA for selected studies for COR Submission.

b. Develop, implement, and monitor plans for acquisition, distribution, dispensing, handling, administration, and accountability of study interventions (pharmaceutical and non-pharmaceutical), in compliance with applicable Federal, state, and local regulations.

c. Provide site monitoring for quality assurance of research conducted at all clinical and laboratory sites, as designated by the COR. Monitoring schedules shall be approved by and results reported to the COR with a copy to the CO and shall include assurance of compliance with FDA record keeping and reporting requirements (21 CFR 50 and 56; 21 CFR 312.50, Subpart D), accuracy and completeness of case report forms, source documentation, and other research records, and periodic record auditing and documentation by the staff of the subcontracted centers. Each site shall be visited a minimum of 2-3 times annually. Provide staff with laboratory expertise and assist in monitoring clinical trials site laboratory quality with the COR and NIMHD Quality Assurance (QA) programs.

d. Meet with the NIMHD program and contracting staff to review annual site performance and monitoring reports for participating population health and clinical research sites.

17. The Contractor shall provide population health, clinical and statistical analysis and reports. More specifically:

a. Provide scientific, technical, and administrative support for the development, implementation, and analysis of the specified research, including considerations of experimental design, sample size calculation, and interim and final primary and secondary analyses specified by study protocols, as requested by the COR.

b. Establish data elements to be recorded by the protocol research records, as requested by the COR and in conjunction with the protocol development team for each specific research project. Develop study forms for standardized collection of data items. Develop documentation and coding for computerization of data for retrieval, analysis, and reporting.

c. Provide for timely and accurate data collection and submission, data entry, data quality assurance, retrieval of source documentation, and generation of data and safety monitoring reports.

d. Provide training for staff of population health, clinical and laboratory sites in data management procedures.

e. Provide data input, editing, electronic data storage, database management, data retrieval, and statistical analysis using well-documented database management and statistical computer software programs.

f. Develop methodology, perform analyses, and provide results from meta-analyses of selected data sets derived from population health and clinical research studies that focus on health disparities.

g. Provide data analysis and results. More specifically:

· Perform statistical analyses of study data to test study hypotheses and evaluate potential confounding variables and/or covariates, as requested by the COR. Data analytic techniques needed include approaches to analyzing multiple measurements of biologic variables over time within participants and between participant groups, with consideration for normal changes in these variables with demographics.

· Provide for biweekly to monthly communication, as needed, of analytic progress and results through routine meetings (the majority to be virtually) with COR or designees and periodic generation of reports. The Project Manager shall attend all meetings. The Epidemiologist, Statistician, and Senior Systems Analyst shall attend these meetings on an as needed basis dependent upon the PI’s request.

· Provide programming and statistical support adequate for the timely generation of additional analyses requested by the COR.

h. Provide electronic data transmission between the Contractor, population health, clinical and laboratory sites, and NIMHD DIR using currently specified communications software and equipment.

i. Provide for electronic mail transmission between the Contractor, population health, clinical and laboratory sites, and NIMHD DIR using commercially available communications software and equipment.

j. Provide protocol development services and assistance.

18. The Contractor shall provide services for the implementation and monitoring of multiple population health and clinical research studies. More specifically:

a. Develop, initiate and coordinate implementation and oversight of protocols at all participating population health, clinical and laboratory sites designed by the COR and approved by the CO. Ensure compliance by sites with all requirements for protocol implementation, including IRB review and approval prior to protocol initiation, participant consent, and confidentiality requirements, and Federal bioresearch regulations and requirements for security and confidentiality of research records, and that each relevant population health and clinical research site staff member completes and maintains human research protection and Good Clinical Practice training, when appropriate.

b. Draft, negotiate, execute, administer, monitor, renew and/or modify as necessary with approval by CO a site-specific, protocol-specific budget for each protocol to be conducted by population health, clinical and laboratory sites, based on the anticipated number of participants to be enrolled.

c. Provide training for staff of clinical and laboratory centers in procedures for implementation and conduct of specific protocols. Retraining may be required to be performed as necessary.

d. Provide training in and ensure the fulfillment and maintenance of standards for Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP) across population health and clinical research sites and staff, whenever appropriate.

e. Ensure timely development and execution of material transfer agreements (MTAs) and data transfer agreements (DTAs) between the sponsor(s) and population health and clinical research sites.

19. The Contractor shall provide services for the development and review of research activities. More specifically:

a. For specific new protocol topics identified by the COR, identify a protocol development team consisting of Contractor staff, NIH staff, subcontractors, and/or consultants. Provide support for the planning and conduct of protocol development team meetings. Submit at the initial meeting a protocol development plan for COR review and approval, addressing regulatory issues, data collection forms development, drug distribution plan, protocol timeline, and participating sites. Develop a protocol document including background, objectives and endpoints, design, patient numbers, source, management, and selection, study agents or other interventions, clinical and laboratory monitoring, laboratory services, toxicity management, adverse experience reporting, evaluation of response, statistical considerations, data collection and monitoring, human subjects’ considerations, biohazard containment, and data and safety reviews. Review, edit, and rewrite draft protocols based on COR’s review. Prepare and maintain the necessary documentation for application submissions in compliance with FDA requirements. Upon completion of a final protocol, renegotiate subcontractor budgets with the approval of the CO and implement the new protocol at participating sites.

b. For ongoing protocols, provide, at the request of the COR, support for the planning and conduct of meetings of protocol committees and subcommittees, data and safety monitoring boards, and investigators.

c. Provide administrative, technical, and logistical support at the request of the COR and with approval of the CO as needed for interaction and collaboration of the Subcontractors with other institutes, agencies, and organizations conducting activities relevant to health disparities research.

d. Support the identification, development, implementation, and evaluation of interventions to improve health outcomes and reduce health disparities, including assessment of feasibility, acceptability, effectiveness, and potential impact.

20. Provide consultants with specialized expertise related to population health and clinical research especially related to health disparities, as requested by NIMHD DIR.

21. Plan, organize, and coordinate meetings involving internal and outside experts. This meeting will be an important venue to discuss important and complex scientific issues related to research protocols and emerging research priorities .

22. Provide support services for ongoing population health and clinical research studies, which include, but are not limited to, the following: site monitoring, subcontract management and invoicing, protocol management, oversight of data management and data analysis, study agent procurement, team meetings, regulatory compliance assurance, site activation and protocol registration, safety monitoring, committee management, data management services, oversight of central and site laboratories and pharmacies, protocol team support, FISMA compliance and IT security, laboratory equipment support, and training of site personnel, to support this effort.

23. Provide Core infrastructure support for ongoing population health and clinical research at the sites, including but not limited to the following: maintenance of IRB/EC regulatory reporting, subject recruitment and follow-up, Community Advisory Board (CAB) support for meetings, protocol updates and reporting, attendance and participation in site monitoring visits, attendance at the annual network meeting, invoicing and other report preparation.

24. Develop a draft and final transition plan, for resource protection and retention, and transfer of all data files to the government and/or subsequent Contractor at the end of the contract period or in the event the contract is terminated or expires. This would include all specimen collections, equipment and computerized data files. The plan must detail the transition to a possible successor Contractor of all contract-related tasks. These tasks shall be organized and catalogued in sufficient detail to support an orderly transition to ensure continuity of clinical trial study visits, data collection and transfer of data as necessary. The plan must include a summary of all ongoing contract activities including full disclosure on the use of the databases and data dictionaries for studies being conducted by the Contractor.

25. Propose a draft final transition plan for transferring all databases, data management systems, and files to the government and/or subsequent Contractor to the CO and COR. After discussion with the CO and COR, a final transition plan would be provided as specified in the task order. Upon approval of the CO, the Contractor must transfer all electronic databases, data management systems and files.

26. Provide all data files and software systems in electronic format and transferred in a secure manner that meets Federal Information Security Modernization Act (FISMA) guidelines.

27. As directed by the CO and COR, the Contractor shall begin working with a successor before the end of the contract performance period for the successful transfer necessary for study functions of all technical information, protocols, logistical components, and administrative actions that were developed using contract funds for all studies.