Objective 4.1: Improve the design, delivery, and outcomes of HHS programs by prioritizing science, evidence, and inclusion

HHS works on strategies to improve the design, delivery, and outcomes of HHS programs by prioritizing science, evidence, and inclusion.  The Department leverages stakeholder engagement, communication, and collaboration to build and implement evidence-based interventions and approaches for stronger health, public health, and human services outcomes.

Objectives represent the changes, outcomes and impact the HHS Strategic Plan is trying to achieve.  This objective is informed by data and evidence, including the information below.

• Original research may take decades to become routine practice for public health professionals, clinicians, communicators, and the public, especially if the research is not widely disseminated.  (Source: Sharing Health Literacy Research)  Researchers produce many evidence-based practices and interventions that can improve outcomes if successfully implemented.  (Source: Key Concepts for Knowledge Translation and Implementation)
• Implementation science is the study of methods to promote the integration of research findings and evidence into policy and practices to improve health.  (Source: Implementation science news, resources and funding for global health researchers)  Implementation science helps us answer questions such as: Why do some research based practices easily transfer from one place to another? What are the supports necessary to promote successful adoption, implementation, and scaling up?  How can we combine multiple interventions effectively to be more cost efficient and less duplicative?  (Source: Investing in What Works)

Contributing OpDivs and StaffDivs

All OpDivs and StaffDivs contribute to achievement of this objective.

HHS OpDivs and StaffDivs engage and work with a broad range of partners and stakeholders to implement the strategies and achieve this Objective.  They include: the Animal Cell Culture, Clinical Trials Transformation Initiative (CTTI), CURE ID App, FNIH Biomarkers Consortium (FNIH), Models of Infectious Disease Agent Study (MIDAS), Reagan-Udall Foundation, and US-Canada Regulatory Cooperation Council (RCC).

Strategies

Leverage stakeholder engagement, communication, and collaboration to build and implement evidence-based interventions for stronger healthcare, public health, and human services outcomes

• Promote an evidence-based and equity-focused approach to the design, redesign, implementation, and quality of HHS programs, to inform decision making, improve oversight, and strengthen data integrity and program fidelity.
• Improve communication and collaboration across HHS and across other federal agencies to bring together research and evaluation to better inform the translation of evidence throughout the Department.
• Promote sharing of lessons learned between grantees, from grantees to HHS staff, and where applicable, to the broader community.
• Build participation into research agendas by engaging stakeholders, including those with lived experience and citizen scientists, in the design and revision of evaluation and data collection systems and advancing equity amongst researchers and those communities targeted or underrepresented by research efforts.
• Ensure research institutions have the capacity, technology, and infrastructure, including access to tools, technologies, and training, needed to conduct cutting edge-research.
• Improve communication and access to community members to facilitate transparent flow of information and education regarding HHS programs.

Performance Goals

The HHS Annual Performance Plan provides information on the Department’s measures of progress towards achieving the goals and objectives described in the HHS Strategic Plan for FY 2022–2026.  Below are the related performance measures for this Objective.

• By 2026, enhance understanding of how five health information technologies can be applied effectively to improve minority health or to reduce health disparities
• Increase the percentage of Community-Based Child Abuse Prevention (CBCAP) total funding that supports evidence-based and evidence-informed child abuse prevention programs and practices

Learn More About HHS Work in this Objective

• Artificial Intelligence (AI) and Machine Learning (ML) in Software as a Medical Device Action Plan: As part of the AI/ML Action Plan, the FDA is highlighting its intention to develop an update to the proposed regulatory framework presented in the AI/ML-based SaMD discussion paper, including through the issuance of a draft guidance on the predetermined change control plan.  FDA is continuing to increase capacity to develop standards for AI technologies, regulatory science research and building internal capacity.
• Center for Biologics Evaluation and Research (CBER) Advanced Technologies Team (CATT): The CATT was established to promote dialogue, education, and input among CBER staff and between CBER and prospective innovators/developers of advanced manufacturing technologies.
• Collaborative Communities: Addressing Health Care Challenges Together: At the FDA, the Center for Devices and Radiological Health (CDRH) believes collaborative communities can contribute to improvements in areas affecting patients and healthcare in the United States.
• Community Engagement Alliance (CEAL): Treatments and vaccines must be safe and effective for everyone.  Diversity in medical science is essential, and NIH is committed to removing barriers, building trust, and ensuring that participants in any clinical trial represent all the people who will use the drug or vaccine being studied.
• COVID-19 Interdisciplinary Toxicology Studies: FDA's National Center for Toxicological Research (NCTR) initiated COVID-19 research in March 2020, with the goal of developing an approach to rapidly indicate the effectiveness of COVID-19 therapeutic treatments.  NCTR currently has more than 30 scientific COVID-related studies that are in progress or development.
• Digital Health Center of Excellence and Related Work: The goal of the Digital Health Center of Excellence is to empower stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.
• Human Microbiome and Antimicrobial Resistance Interdisciplinary Toxicology Studies: NCTR is conducting research in collaboration with CVM to: (1) Evaluate the impact of antimicrobial agents, food contaminants, food additives, nanomaterials, and FDA-regulated products on the microbiome; (2) Determine antimicrobial resistance and virulence mechanisms of foodborne and other pathogens; (3) Develop tools to assess the sequences of plasmids, which can transmit antimicrobial resistance, virulence and other genes between bacteria.
• Implementing a Parenting Curriculum Using Implementation Science: Research has shown that preschool programs can positively impact parenting when they go beyond simply providing parenting information.  Parents and children receive even greater benefits when programs offer parents experiences that model positive interactions and provide opportunities to practice with feedback.  A parenting curriculum can provide information and opportunities to practice skills that parents in your program may welcome.
• Knowledge Translation Program: Helps to ensure that knowledge generated by grantees is used or adopted by its intended users, especially persons with disabilities and their families.
• NIGMS' Institutional Development Award (IDeA) Program: The Institutional Development Award (IDeA) is a congressionally mandated program that builds research capacity in states that historically have had low levels of NIH funding.  It supports competitive basic, clinical, and translational research, faculty development, and infrastructure improvements.  The program aims to strengthen an institution’s ability to support biomedical research, enhance the competitiveness of investigators in securing research funding, and enable clinical and translational research that addresses the needs of medically underserved communities.
• Perinatal and Maternal Health Interdisciplinary Toxicology Studies: Maternal and perinatal research has been a cornerstone of NCTR research for 30+ years and throughout that time NCTR has worked collaboratively with FDA product centers (e.g., CDER), external partners (e.g., Mayo Clinic), and academic institutions (e.g., University of Arkansas for Medical Sciences).
• Prevention Research Centers (PRCS): PRCs are a network of 26 academic research centers in the United States that study how people and their communities can avoid or counter the risks for chronic illnesses.  PRCs work to identify public health problems and to develop, test, and evaluate public health interventions that can be applied widely, particularly in underserved communities.
• Preparedness and Response Applied Research: The Public Health Emergency Preparedness and Response (PHEPR) Applied Research Program leads the CDC Center for Preparedness and Response initiatives to strengthen and expand the evidence base for preparedness and response and translate science into evidence-based practices to improve federal, state, tribal, local and territorial (STLT) preparedness and response to all-hazards emergencies.
• SAMHSA Evidence-Based Practices Resource Center: SAMHSA is committed to improving prevention, treatment, and recovery support services for mental and substance use disorders.  The Evidence-Based Practices Resource Center provides communities, clinicians, policymakers and others with the information and tools to incorporate evidence-based practices into their communities or clinical settings.