None

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

The National Institute of Neurological Disorders and Stroke (NINDS), with other NIH Institutes and Centers (ICs), intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research that will advance health equity in pain and comorbidities. The FOA will support research to develop, test, and implement novel, culturally-appropriate pain interventions and/or adapt, test and evaluate efficacy and effectiveness of existing pain interventions, in populations that disproportionately experience negative health outcomes. Desired outcomes of these interventions include reduction of pain and pain-related symptoms, and improvement in overall health outcomes, including function and quality of life. Interventions that target populations that experience health disparities with chronic pain in addition to at least one comorbid condition (OUD, mental health disorders and/or chronic health conditions) are of the highest priority.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations among established health disparity experts, pain researchers, health care providers, patients, and relevant organizations, groups or stakeholders. It will also allow potential applicants sufficient time to develop projects responsive to the bi-phasic FOA.

The FOA is expected to be published in Early 2022 with an expected due date in Winter 2022.

The FOA will utilize the R61/R33 Exploratory/Developmental Phased Award (Clinical Trial Required) activity code to issue a milestone-driven planning phase (R61) award for 1 to 2 years, with possible transition to an implementation phase (R33) award of up to 4 years. The maximum period of combined R61 and R33 phases is 5 years. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Transition between the two phases of award will be administratively reviewed and will be determined by successful completion of quantifiable transition milestones that should be clearly specified in the application and negotiated with NIH prior to an award. Only R61 projects that meet NIH-approved scientific milestones and feasibility requirements will transition to the R33 phase. Funding for and transition to the R33 phase will be contingent on the following: 1) meeting the milestones articulated in the R61 phase, 2) the availability of funds, 3) continued relevance/impact of the research to the NIH and ICO missions, and 4) NIH and regulatory approval of the planned R33 activities (e.g., study documents, IRB).

Research Initiative Details

In April 2018, the National Institutes of Health (NIH) launched the Helping to End Addiction Long-term^SMInitiative or HEAL Initiative^SM, an aggressive, trans-agency effort to speed scientific solutions to stem 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 HEAL Initiative is available at: https://heal.nih.gov/.

Populations that experience health disparities (HDPs), including racial and ethnic groups and socioeconomically disadvantaged populations too often have higher rates of chronic pain and comorbid conditions, receive poorer pain care, and experience overall worse health outcomes resulting in decreased quality of life and shorter lifespan. Wide disparities in access to appropriate pain care may result in undertreatment of pain, leading to unnecessary suffering, or overreliance on opioids that carry an increased risk of addiction and overdose.

Due to the low representation of HDPs within clinical trials, many interventions for pain have not been tested rigorously in populations that experience health disparities. Thus, cultural and community-based adaptation and rigorous testing of existing evidence-based interventions for HDPs with acute and/or chronic pain are needed.

Pain management in HDPs is further complicated by the high prevalence of comorbid conditions. Chronic pain often occurs within the context of comorbid conditions that may impact pain and modify the effectiveness of interventions necessitating consideration of the relationships between the comorbid conditions and pain. . Multimorbidity (coexistence of two or more chronic health conditions) is more common in disadvantaged and older populations. Evidence-based interventions that target biological, psychological, and social factors that contribute to co-occurrence and exacerbation of chronic pain and comorbidities in HDPs are needed.

A number of causal factors influence pain and comorbid condition outcomes. Identifying putative intervention targets through an experimental medicine approach may be a valuable approach to further address the overlap of chronic pain and other comorbid chronic conditions.

Social determinants of health (SDOH) are major driving factors for health disparities in racial/ethnic and socioeconomically disadvantaged populations. There is a need to develop novel, SDOH-driven interventions that target chronic pain and comorbid conditions in HDPs.

Single treatments and single interventions are not likely to have lasting and sustainable changes in mitigating or eliminating health disparities in pain care. Rather, whole system changes from the top down are likely to have the greatest impact at a population-level. Multidisciplinary care offers the best solution for sustainable and lasting care that would improve the overall trajectory of health. HDPs are not as likely to receive multidisciplinary pain care that focuses on whole person health due to structural and systemic factors. Evidence-based interventions that improve multidisciplinary care for HDPs at disproportionate risk of pain and comorbidities is needed.

Effective evidence-based interventions are needed for HDPs that suffer disproportionately from pain and other comorbid conditions including OUD, mental health disorders and other prevalent chronic health conditions. These interventions should take into account the lived experience of these individuals as a more patient-centered, interpersonal approach can improve pain outcomes and satisfaction with treatment.

The scope of this initiative includes but is not limited to:

• Adapting and testing existing evidence-based interventions for chronic pain to culturally-tailored interventions for specific HDPs
• Developing and testing culturally-tailored interventions that target biological, psychological and social stressors that exacerbate chronic pain and comorbidities in HDPs
• Developing interventions that target common causal factors between comorbid pain and other chronic conditions
• Developing and testing novel SDOH-driven, culturally-tailored interventions that target chronic pain and comorbid conditions
• Improving multidisciplinary care for populations at disproportionate risk of pain and comorbidities

Projects must include a focus on one or more NIH-designated populations that experience health disparities, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

Applications are expected to include extensive stakeholder engagement including collaborations with relevant organizations, groups and/or persons with lived experience.

Collaborative investigations combining expertise of established health disparity researchers and pain researchers are strongly encouraged. In addition to scientific diversity, applicants should incorporate diversity in their team development plan. Please refer to Notice of NIH’s Interest in Diversity NOT-OD-20-031 for more details.

TBD