HEAL Initiative: NIH-DOD-VA Pain Management Collaboratory – Pragmatic and/or Implementation Science Demonstration Projects ((UG3/UH3) Clinical Trial Required)

HEAL Initiative: NIH-DOD-VA Pain Management Collaboratory – Pragmatic and/or Implementation Science Demonstration Projects ((UG3/UH3) Clinical Trial Required) is sponsored by National Institutes of Health (NIH). This NOFO solicits UG3/UH3 phased cooperative agreement research applications to conduct efficient, large-scale pragmatic clinical trials and/or implementation science demonstration projects within the infrastructure of the NIH-DOD-VA Pain Management Collaboratory on nonopioid a…

Expired RFA-AT-24-011: HEAL Initiative: NIH-DOD-VA Pain Management Collaboratory Pragmatic and/or Implementation Science Demonstration Projects ((UG3/UH3) Clinical Trial Required) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Center for Complementary and Integrative Health ( NCCIH ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Funding Opportunity Title HEAL Initiative: NIH-DOD-VA Pain Management Collaboratory – Pragmatic and/or Implementation Science Demonstration Projects ((UG3/UH3) Clinical Trial Required) UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III.

3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this NOFO is to solicit UG3/UH3 phased cooperative agreement research applications to conduct efficient, large-scale pragmatic clinical trials and/or implementation science demonstration projects within the infrastructure of the NIH-DOD-VA Pain Management Collaboratory (PMC) on nonopioid approaches to management of pain and other comorbid conditions, including complementary and integrative approaches used alone and in combination with standard care (e.g., mindfulness meditation combined with standard pharmaceutical treatment), and improving prevention and treatment for opioid misuse and addiction in U.S. Veterans, military personnel, and their families.

Supporting the trials, the PMC has established a coordinating center that provides national leadership and technical expertise for all aspects of health care system (HCS)-focused research including assistance to UG3/UH3 grant recipients. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description The NIH HEAL Initiative: This notice of funding opportunity (NOFO) is part of the Helping to End Addiction Long-term ® Initiative, or NIH HEAL Initiative ® to speed scientific solutions to the national opioid public health crisis.

The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the initiative is available at https://heal. nih.

gov/ . Since 2001, more than 2. 77 million U.S. troops have been deployed for Operation Enduring Freedom in Afghanistan and Operation Iraqi Freedom and Operation New Dawn in Iraq.

The all-volunteer military experienced multiple redeployments to the war zone and extensive use of the reserve components of the military and National Guard, that also involved the deployment of women and parents of young children. Many of these deployed service members sustained severe injuries that in previous wars would have resulted in death.

Significant and continuing improvements in outer tactical vests (body armor) and helmets have saved lives. However, despite these improvements, many service members returning from these operations and from other military operations experienced pain, traumatic brain injuries (TBIs), symptoms of post-traumatic stress disorder (PTSD), suicidal thoughts or behaviors, substance abuse, and/or related comorbidities.

Studies report nearly 45 percent of active-duty service members and 50 percent of Veterans experience pain on a regular basis, and there is significant overlap among chronic pain, PTSD, and persistent post-concussive symptoms. There is an ongoing challenge with pain among military and Veteran populations and an incomplete evidence base for effective pain management.

Opioid medications continue to be prescribed for the treatment of chronic pain despite the association of chronic opioid use with the potential for misuse, and they often fail to adequately control pain. As a result, there continues to be a need for additional nonopioid approaches to complement or replace opioid-based strategies for pain management and to reduce the needs and risks associated with excessive reliance on opioids.

In June 2011, the Institute of Medicine (IOM) released a Consensus Report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research . The report notes that chronic pain affects an estimated 116 million American adults— more than the total affected by heart disease, cancer, and diabetes combined. Pain also costs the nation up to $635 billion each year in medical treatment and lost productivity.

The report notes that ideally, most patients with severe persistent pain would obtain pain care from an interdisciplinary team using an integrated approach that would target multiple dimensions of the chronic pain experience including disease management, reduction in pain severity, and improved functioning, emotional well-being, and health-related quality of life.

The NIH, the U.S. Department of Defense (DOD), and the U.S. Department of Veterans Affairs (VA) have been working individually and collaboratively to develop and improve pain management approaches for military personnel, Veterans, and their families.

In 2014, NCCIH partnered with the National Institute on Drug Abuse (NIDA) and the VA to fund 13 grants to research military and Veteran health with a focus on nonopioid approaches to pain and related conditions.

This important partnership was expanded in 2017 to include the DOD and additional components of NIH [National Institute on Alcohol Abuse and Alcoholism (NIAAA), Eucine Kenney Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), and Office of Research on Women's Health (ORWH)] to initiate the NIH-DOD-VA Pain Management Collaboratory (PMC).

The PMC r supported 11 research projects focused on the development and testing of nonopioid approaches to pain management ( RFA-AT-17-001 ) along with a coordinating center ( RFA-AT-17-002 ) to support the program. A twelfth research project was funded in FY22 and a thirteenth in FY23 ( RFA-AT-22-006 ).

Military and Veteran health care systems (HCS) and other HCS that provide services to military personnel, Veterans, and their families are the paradigmatic research platforms for this program. Research conducted in partnership with eligible VA and DOD health care providers is essential for obtaining meaningful and relevant research results in real world health care delivery systems serving veterans and military service members.

Team-based integrative care is increasingly recognized as a fundamental effective aspect of HCS. Team-based care is defined as an interprofessional, multidisciplinary team approach to patient-centered care coordinated across a variety of systems.

The National Academy of Medicine (formerly known as the Institute of Medicine) predicts team-based care models will significantly reduce health care costs, saving an estimated $240 billion annually in national health care expenditures.

Despite the recognized and compelling need for research to identify and implement effective complementary nonopioid approaches for management of pain and comorbid conditions in military and Veteran populations, many challenges exist. Ethical and regulatory issues must be addressed to perform research in health care delivery settings.

Health care providers focus on providing the best treatment, based on current knowledge, whereas research typically focuses on studying which treatments work best in a precisely defined population. Further, multiple challenges remain in identifying the best strategies to successfully integrate evidence-based interventions within specific health care settings.

For example, research studies frequently use study endpoints that are not part of routine patient care and results may suggest adoption of interventions that are challenging to deliver. . Bridging the gap between research and practice is an important step in the direction of providing increased effective treatment options to patients.

The purpose of this NOFO is to solicit UG3/UH3 phased cooperative agreement research applications to conduct efficient, large-scale pragmatic clinical trials and/or implementation science demonstration projects within the infrastructure of the PMC that focus on nonopioid approaches to management of pain and other comorbid conditions, including complementary and integrative approaches used alone or in combination with standard care (e.g., mindfulness meditation combined with standard pharmaceutical treatment), and improving prevention and treatment for opioid misuse and addiction in U.S. military personnel, Veterans, and their families.

The PMC has established a coordinating center that provides national leadership and technical expertise for all aspects of HCS-focused research including assistance to UG3/UH3 grant recipients.

Applications submitted under this NOFO are expected to: Support the design and execution of additional high-impact demonstration projects that will conduct pragmatic clinical trials focusing on effectiveness research, implementation research, or hybrid effectiveness-implementation research on nonopioid approaches for the management of pain and comorbidities with patients in health care delivery systems that provide care to veterans, military personnel, and their families.

Make available data, tools, best practices, and resources that will facilitate a research partnership with health care delivery systems that provide care to veterans, military personnel, and/or their families. Research projects funded through this NOFO will be expected to work with the Pain Management Collaboratory Coordinating Center (PMC3) and the other funded PMC projects.

This includes participation in PMC3 work groups, working with PMC3 on detailed plans for site implementation, determining resource needs, testing data extraction methods, developing plans for all aspects of ethical and regulatory oversight/protection of human subjects, and integrating data using common data elements (CDEs) within the NIH HEAL Initiative CDE repository to increase the overall impact of findings.

Awards made under this NOFO will initially support a 1-year milestone-driven research planning phase (UG3), with possible transition to a pragmatic trial and/or implementation science demonstration project research execution phase (UH3; 2–4 years). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase following administrative review by the respective funding agency.

The UG3/UH3 application must be submitted as a single application, following the instructions described in this NOFO. All demonstration projects should address a research question important to the health of U.S. Veterans, military personnel, and their families that is focused on nonopioid approaches to the management of pain and, if applicable, co-occurring conditions.

The demonstration project may provide a definitive test of the underlying question to assess intervention effectiveness or carry out implementation research (or hybrid effectiveness-implementation research).

Applications that include effectiveness research aims should be guided by the Pragmatic-Explanatory Continuum Indicator Summary 2 tool (PRECIS-2) and use more pragmatic approaches rather than explanatory ones when appropriate to address the proposed hypothesis (PRECIS-2 is described in https://www. bmj. com/content/350/bmj.

h2147 ). We define pragmatic trials as trials primarily designed to determine the effects of an intervention under the usual conditions in which it will be applied, in contrast with explanatory trials, which are primarily designed to determine the effects of an intervention under ideal circumstances. Efficacy research involves strict limitations on who may participate to minimize error, bias, and confounding.

The emphasis on internal validity enhances confidence in interpreting positive results as indicating a causal relationship between the intervention(s) and outcome(s).

Effectiveness research is designed to test interventions of known efficacy in real-world settings with an emphasis on external validity, that is, whether the results can be applied to a definable group of patients in a particular clinical setting in routine practice (i.e., generalizability).

In effectiveness research, limitations on who may participate are minimized in order to maximize the likelihood that study participants and the population intended to benefit from the interventions are similar.

Dissemination research is the scientific study of targeted distribution of information and intervention materials to a specific public health or clinical practice audience, while implementation science is the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve patient outcomes and benefit population health.

For the purposes of this NOFO, only effectiveness research, implementation science, and hybrid effectiveness-implementation trials will be responsive. Dissemination may be included as an aim, but applications that only propose dissemination research will be considered nonresponsive.

The research question(s) proposed should be of major public health importance, focusing on nonopioid approaches to the management of pain and comorbid conditions in Veterans, military personnel, and one that will engage partnership with health care delivery systems providing services to this population.

Although trials will likely be conducted in the VA and DOD health care systems, it is expected that many of the findings will be generalizable to practices across the broader health care community.

The NIH HEAL Initiative prioritizes speeding scientific solutions to stem the national opioid public health crisis, and developing nonopioid approaches to pain management and co-occurring conditions remains integral to improving prevention and treatment of opioid misuse and addiction.

The unique challenges to service member and Veteran health represent an opportunity to conduct pragmatic clinical trial research to identify what approaches to pain management are effective when delivered in the VA and DOD health care settings. Of special interest are effectiveness trials of approaches that have not yet been evaluated for effectiveness in the VA and/or DOD health care settings.

Applicants are strongly encouraged to review the PMC website to avoid submitting a trial that overlaps significantly with other ongoing or completed PMC trials.

For example, investigators should avoid overlap with approaches being evaluated in ongoing PMC trials, including remotely delivered cognitive behavioral therapy, remotely delivered mindfulness, chiropractic care dose optimization, a Screening, Brief Intervention, and Referral to Treatment for Pain Management (SBIRT) approach, percutaneous peripheral nerve stimulation, and several multi-modal coordinated care pathways.

Prior to submitting to this NOFO, applicants are encouraged to speak with the NCCIH scientific/research contact person. The NIH RePORTER website at https://reporter. nih.

gov , the DOD Defense Technical Information Center website at https://discover. dtic. mil , and the Patient-Centered Outcomes Research Institute website at https://www.

pcori. org/ should also be reviewed to avoid submitting a trial that overlaps significantly with other ongoing or completed trials testing methods to manage pain in U.S. Veterans, military personnel, and their families.

In addition, integrated models of multicomponent care that are delivered in different settings (e.g., pain care that could include collaborative care, care management, care delivered through tele-care, peer coaches, or informal caregivers) will be of higher programmatic priority.

Research projects should be performed within large HCS that use electronic health records (EHRs) to leverage data collection that occurs in health care delivery rather than requiring independent research data collection. The HCS partnerships must be able to facilitate access to all data sources relevant to the project, which may include inpatient, outpatient, clinical laboratory, and pharmacy data.

Applicants, who may be from academic institutions or other organizations, must have demonstrated success in conducting clinical research in partnerships with HCS serving military or Veterans. Interdisciplinary teams should include necessary expertise to conduct the trial such as military researchers on military-focused applications and VA researchers on Veteran-focused applications.

Applicants should involve appropriate HCS personnel when conducting the pragmatic clinical trial. .

Applicants must document the commitment of the health care organization to the project and must include letters of support from the HCS partners that relate their commitment to the proposed research and outline how the project fits with organizational priorities For this NOFO, multisite clinical trials are defined as trials that enroll from at least three recruitment sites that are geographically distinct and non-overlapping with respect to the population of patients engaging with services and are likely to be compliant with NIH policy on the inclusion of women and minorities as subjects in clinical research, as well as individuals across the lifespan ( https://grants.

nih. gov/policy/inclusion/women-and-minorities. htm and https://grants.

nih. gov/policy/inclusion/lifespan. htm ),.

Two sites will be permitted if there is a strong justification for how fewer sites can still achieve generalizability and and be sufficient for valid analysis of the data. Multiple sites are necessary in efficacy trials to increase generalizability of findings and ensure appropriate size and diversity of eligible participants.

For projects proposing effectiveness aims: Outcomes should include assessing pain and pain reduction, pain interference, ability to function in daily life, quality of life, and medication usage/reduction/discontinuation. Additional outcomes may focus on assessing conditions co-occurring with high frequency in this population.

There is also interest in obtaining objective sensor-based measures that provide data on people’s daily activities to gain a better understanding of the relationship between ratings of pain and functional changes.

When testing effectiveness, projects are encouraged to enroll participants based on broad eligibility criteria to maximize generalizability, with minimum exclusions based on risk, age, health literacy, comorbidities, or expected adherence. Studies should enroll from the target populations the interventions are intended to benefit, namely Veterans, active-duty service members, and their beneficiaries.

It is important that women are represented according to their proportion of the population being studied, preferably overrepresented, and that studies include a comparative analysis of differential effects between men and women. Projects aimed at evaluating team-based care models should determine overall effectiveness of team-based care compared to conventional, non-team-based primary care.

Secondary outcomes may assess differential benefits contributed by unique components of the team-based care package. In some cases, a stepped-wedge design may be the only practical way to generate the appropriate data.

Nevertheless, considering the practical, ethical, and analytical challenges as outlined by the PMC , stepped-wedge designs should be avoided when another rigorous study design is feasible and will answer the study question. If proposed, a strong justification for a stepped-wedge design should be provided, including why an alternative design is not superior.

For projects proposing implementation science aims: Outcomes of implementation trials should focus on rigorous assessment of the strategies designed to increase uptake and adoption of evidence-based nonopioid pain interventions. Investigators are encouraged to incorporate theories, models, and/or frameworks appropriate for implementation research when considering study hypotheses, measures, and outcomes.

When designing an application, applicants are also encouraged to use the extant literature on barriers to and facilitators of the implementation of practices to manage pain and to consider the multilevel context and environment in which the proposed research will be conducted.

Research Planning Phase and Research Execution Phase These projects will be funded as phased awards with a 1-year research planning phase (UG3) and a 2–4-year research execution phase (UH3). The UH3 budget will undergo reassessment during the UG3 planning phase. Activities in both phases will depend on the specific study (e.g., type of intervention, randomization strategy, and proposed outcome measures).

During the UG3 or research planning phase, activities should generally include, but are not limited to: Identify project staff who will participate in work groups of the PMC (see Additional Information below), which will develop and update policies and practices to be implemented across PMC projects.

Work with the PMC to comply with approved policies and practices for electronic data access extraction and sharing and develop quality control methods and tools.

This could include developing and validating all electronic data methods and tools within the HCS needed for the demonstration project (e.g., EHRs, electronic methods for patient identification and outcomes assessment, biospecimens, images, genomic data, family history, and data abstraction, and survey instruments) and complete quality control testing at all sites.

Assess adequacy and finalize clinically relevant outcome measures, which may include adding measures that are common across demonstration projects. Identify additional implementation sites, if needed, in consultation with NIH, the DOD, the VA, and the PMC3. Review analytic plans and power calculations with the biostatistics/design workgroup to optimize design and methods.

Develop detailed plans for site implementation, including determining need and role of site staff; method of participant identification, recruitment, and acquisition; randomization (as applicable); and administration/implementation of the intervention, if applicable.

Address all ethical, human subject safety, and oversight issues for the demonstration project, including development of informed consent documents or opt-out consent, if applicable, and finalizing single institutional review board (IRB) review for trial oversight, in accordance with the Revised Common Rule, and other requirements needed for implementing a study in a Veteran or military facility.

Address all potential regulatory elements of the proposed trial (if applicable). Develop a detailed budget for conducting and completing the demonstration project, including preparation of a final study report. Develop detailed plans for data coordination and quality control, as these activities will not be provided by the PMC3.

The objective of the 2–4-year UH3 research execution phase is to conduct the effectiveness and/or implementation research within the PMC, in accordance with activities planned in the UG3 planning phase. UH3 activities will depend upon the study, but in general the following goals should be achieved: Each demonstration project is expected to implement all aspects of the proposed trial as finalized during the UG3 research planning phase.

Each project is expected to provide a complete assessment of all issues related to patient, clinician, and site identification and EHR tools used in these steps. Each project is expected to provide definitive information about the execution of the intervention at all sites. Each project is to provide detailed and definitive testing of the validity of methods used for monitoring fidelity and outcome assessment.

Each project is to provide all data coordination, cleaning, and analysis during the implementation of the trial. Each project is expected to provide periodic reports to a Data and Safety Monitoring Board, which may require closed reports including unmasked data prepared by an independent statistician.

Applicants who propose effectiveness aims should address one or more critical research questions to improve pain management for U.S. Veterans and military personnel.

The following list provides examples of some potential research that addresses the effectiveness of evidence-based approaches delivered in the VA and DOD health care settings: Evaluation of evidence-based, nonopioid pain management/prevention approaches that also address common co-occurring conditions in Veterans and service members such as PTSD, TBI, and suicidal thoughts or behaviors Evaluation of evidence-based, integrative interventions that improve pain and comorbidity outcomes in populations that experience health inequities, such as individuals who are socioeconomically disadvantaged, from medically underserved rural areas, and/or from racial and ethnic minority groups and/or sexual and gender minority groups who receive care in the VA and DOD HCS Studies focusing on testing the timing, optimum components, and overall benefit of an individualized integrated package of nonopioid interventions such as mind-body therapies and other complementary health approaches Evaluation of team-based, coordinated health care versus provider-driven models of health care delivery particularly in settings in which military personnel or Veterans normally receive care Assessing approaches to address chronic overlapping pain conditions (COPCs), a set of painful chronic conditions with a high degree of co-occurrence and thought to have shared etiology) alone or while also addressing conditions comorbid with COPC in women Veterans and service members Evaluation of nonopioid pain management/prevention strategies for Veterans and service members with current opioid use/misuse Evaluating tailored approaches to address chronic pain in women Veterans who have experienced military sexual trauma Evaluating nonopioid pain management/prevention for chronic pelvic pain in women Veterans Studies to determine overall effectiveness of team-based care compared to conventional, non-team-based, primary care.

Studies that include secondary outcomes to assess differential health benefits contributed by unique components of a team-based care package and the cost-effectiveness of the care package as a whole and of each component within the package compared to each other.

Studies to identify mediators and/or moderators of positive outcomes associated with team-based care compared to conventional, non-team-based primary care (e.g., more efficient delivery of services, improved physician-patient communication and relationships, better treatment adherence, higher patient satisfaction).

Assessment of the effectiveness of complementary and integrative pain management strategies to facilitate health restoration Assessment of integrative pain management approaches and strategies to be implemented in outpatient transitions of care from the DOD to the VA Applicants who propose implementation science should address one or more critical research questions for implementing evidence-based pain management interventions for U.S. military personnel and Veterans.

The following list provides examples of some of the potential research questions that might be addressed by such trials: Studies to test the effect of system-level innovations to improve implementation of established guidelines for nonopioid approaches to management of pain and comorbid conditions Studies of the implementation of multiple evidence-based pain management practices within community or clinical settings to meet the needs of Veterans and U.S. military personnel in systems of care that serve Veterans and service members Studies of the local adaptation of evidence-based practices in the context of implementation Studies testing the effectiveness and cost-effectiveness of dissemination or implementation strategies for pain management to reduce health disparities and improve quality of care among rural, minority, low literacy and numeracy, and other underserved populations Studies on reducing or stopping (“de-implementing”) the use of clinical and community pain management practices that are ineffective, unproven, low value, or harmful Studies of influences on the creation, packaging, transmission, and reception of evidence-based nonopioid pain management interventions Studies that identify and test theories, models, and frameworks for dissemination and implementation (D&I) processes will be of higher programmatic priority.

Milestones and UG3/UH3 Transition Projects should include well-defined milestones for the research planning phase (UG3) and annual milestones for the research execution phase (UH3).

It is understood that the proposed milestones for the UH3 phase will be revised as activities in the UG3 phase progress In the event of an award, the program director/principal investigator (PD/PI) and NIH staff will negotiate a final list of milestones for each year of support prior to releasing an award .

Prior to the completion of the UG3 research planning phase, the applicant will be required to submit a detailed transition request for the UH3 demonstration project research execution phase at least 60 days before the anticipated transition date. UH3 transition requests will undergo an administrative review by the respective funding agency to determine whether the demonstration project will be awarded the research execution phase (UH3).

Prospective applicants should note that initial funding of the UG3/UH3 cooperative agreement does not guarantee support of the UH3 demonstration project research execution phase. Successful completion of all UG3 milestones also does not guarantee transition to nor full support of the UH3 phase.

Applicants should understand that transition to the UH3 phase of the project will occur only if an administrative review process concludes that the UG3 planning milestones have been successfully met and that the UH3 phase can proceed with confidence of success, continued relevance to the funding agency, and availability of funds.

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information and, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences.

Please refer to Notice of NIH’'s Interest in Diversity NOT-OD-20-031 for more details. Engaging People with Lived Experience and Other Collaborators: People with lived experience (e.g., patients, patient advocates, caregivers, families, community leaders) have important insights that can improve meaningful outcomes, uptake of research findings, and health equity across the continuum of research from basic through implementation studies.

The perspectives of other relevant collaborators (e.g., health service providers, payors, public health agencies, community-based organizations, biotech, pharma) can further improve research impact. The NIH HEAL initiative strongly encourages applicants to specify their plan for meaningful engagement of people with lived experience and other collaborators in the research process.

Meaningful engagement will vary with the focus of the research but should at minimum ensure that researchers are connecting with relevant collaborators and incorporating their perspectives throughout the conception, implementation, and dissemination of the research. Meaningful engagement should address what the researchers will learn and how the people with lived experience and/or collaborators will benefit from the partnership.

To promote health equity, as is relevant for the research proposed, it is recommended that at least two people with lived experience from populations who experience health disparities should be meaningfully engaged in these efforts (see NIH’s Notice of Interest in Diversity for more information: NOT-OD-20-031 ). See this resource for more information in engaging people with lived experience: https://aspe. hhs.

gov/lived-experience ). Governance: The awards funded under this NOFO will be cooperative agreements (see Section VI. 2 Cooperative Agreement Terms and Conditions of Award).

Participation in the work groups established by the PMC3 is a core collaborative activity of this program. The work groups provide a forum for discussion of challenges and solutions across projects; harmonized and standardized