Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
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)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
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 Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to accelerate development, testing and implementation of evidence-based interventions that are culturally and linguistically appropriate for NIH-designated populations that experience health disparities (HDPs) in the United States to mitigate disparities in provision of care and treatment decisions, reduce susceptibility to chronic pain and improve patient outcomes. Expected outcomes of this initiative include evidence-based interventions that mitigate: 1) the effects of bias, stigma and discrimination at multiple levels, and/or 2) socioeconomic, environmental and other barriers to quality pain assessment, treatment and management. Studies that address multiple socioecological domains and levels of influence (e.g. organizational/institutional, community/neighborhood, societal) to advance health equity and mitigate health disparities in pain management are of higher priority. Studies must address research topics within the mission and research interests of participating NIH Institutes and Centers.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| December 09, 2021 | Not Applicable | Not Applicable | March 2022 | May 2022 | July 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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 Funding Opportunity Announcement.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
The purpose of this FOA is to solicit applications to accelerate development, testing and implementation of evidence-based interventions that are culturally and linguistically appropriate for NIH-designated populations that experience health disparities (HDPs) in the United States to mitigate disparities in provision of care and treatment decisions, reduce susceptibility to chronic pain and improve patient outcomes. Expected outcomes of this initiative include evidence-based strategies that mitigate: 1) the effects of bias, stigma and discrimination at multiple levels, and/or 2) socioeconomic, environmental and other barriers to quality pain assessment, treatment and management. Incorporation of strategies to ensure successful HDP patient engagement and bolster inclusion to enhance better pain management outcomes are also desired. Studies that address multiple socioecological domains and levels of influence (e.g. organizational/institutional, community/neighborhood, societal) to advance health equity and mitigate health disparities in pain management are of higher priority. A framework describing multi-domain, multilevel factors that may influence health disparities is available at https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html. Studies must address research topics within the mission and research interests of participating NIH Institutes and Centers.
Awards made under this FOA will support a milestone-driven planning phase (R61) for 1 to 2 years, with possible transition to an implementation phase (R33) of up to 4 years. The maximum period of combined R61 and R33 phases is 5 years. Only R61 projects that meet the scientific milestones and feasibility requirements will transition to the R33 phase. The R61/R33 application must be submitted as a single application, following the instructions described in this FOA.
This FOA may NOT be used for applications that propose testing of interventions to establish initial efficacy of drugs, devices or biologics for approval by the Food and Drug Administration (FDA).
Background
This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed the development and implementation of 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.
Disparities in pain care are well-documented and likely stem from a combination of biopsychosocial factors, biases, financial inequality, and limited access to resources, including healthcare. HDPs experience poorer pain management compared to Whites due to social determinants of health (SDOH), race-based discrimination, and systems characteristics.
Pain reporting is inherently subjective and, correspondingly, pain assessment can also be subjective and vulnerable to conscious or unconscious bias. Decisions about pain treatment may reflect provider biases in pain assessment, or patient biases including treatment preference. For example, studies show that Blacks/African Americans (AAs) are less likely than White Americans (WA) to receive analgesic medication, including opioids, for pain. Blacks/AA were found to be less frequently screened for the presence and severity of pain, less likely to receive opioids under the age of 65 irrespective of reporting moderate to high levels of pain, and more likely to receive opioids after the age of 65 with a pain intensity rating of 0 when compared to WAs. Latinx patients with long-bone fractures presenting to the Emergency Department (ED) were only half as likely as non-Latinx White patients to receive opioid analgesia despite no differences in physician ability to assess pain in both patient groups and similar expectations for analgesia in both groups. Blacks/AAs were significantly more likely to receive no analgesics whatsoever and are substantially more vulnerable to involuntary opioid tapers among non-aberrant and stable chronic pain patients. Several studies also indicate that Blacks/AAs, Indigenous and People of Color are less likely to receive advanced diagnostic imaging compared to White patients and less likely to be treated through non-pharmacological rehabilitative approaches such as physical therapy or surgery. There are wide disparities in provision of care and treatment decisions resulting in undertreatment, overtreatment with opioids increasing risk of addiction and overdose, and lack of non-pharmacological options leading to increased pain-related suffering in HDPs necessitating evidence-based approaches to mitigate the effects of bias on pain management.
Socioeconomic and other environmental challenges, together with other SDOH, also compound pain and limit access to adequate pain management. Conditions of poverty, isolation from health care services, inadequate accommodation, poor access to health care professionals and limited access to support increase the likelihood of inadequately managed pain. Poverty is commonly linked to social marginalization and is associated with disparities in provision and receipt of pain management. Pharmacy/medication deserts have been noted in HDP neighborhoods together with insufficient analgesic supplies and lack of access to pharmacy services such as discount generic drug programs. HDP patients not only deal with challenges related to obtaining prescriptions for adequate analgesia but also face difficulties associated with being able to fill prescriptions. In addition to economic barriers, health literacy and language barriers also present challenges in accessing pain treatment for HDPs and can lead to miscommunication further eroding trust and influencing treatment decisions as well as medication adherence. Patients express that they are not listened to, not taken seriously, marginalized, stigmatized, subjected to racism, discrimination, and more. As a result, HDPs often express unwillingness to access existing facilities and/or are less likely to have access to specialized care for persistent pain because of discrimination and bias. This can lead patients to pursue nonregulated services or rely on themselves for pain mitigation. Patients concerned about injustices in the treatment they receive are vulnerable to greater emotional distress, prolonged work disability, invalidating or stigmatizing reactions of others, and poor rehabilitation pain outcomes. Taken together, the cumulative effects of social disadvantage and/or chronic stress associated with HDP status may contribute to the development or exacerbation of chronic pain. Development and implementation of culturally and linguistically appropriate interventions for pain prevention and management with attention to intersecting contexts of social and environmental factors together with other SDOH that determine the experience and expression of pain are sorely needed.
Pain management in HDPs is further complicated by the high prevalence of comorbid conditions. For example, diabetes, high blood pressure, and heart disease are significantly linked to high-impact chronic pain and have higher prevalence in racial/ethnic minority populations. Chronic pain often occurs within the context of comorbid conditions that may impact pain and modify the effectiveness of interventions necessitating consideration of these bidirectional relationships.
During a February 2021 workshop on achieving equity within the NIH HEAL Initiative, speakers discussed how increasing the diversity of research participants will improve communities that have been left behind by research advances and how this is critically important given the increased pursuit of precision medicine and interventions that are specifically tailored for individual patients. The session emphasized how meaningful and inclusive diversity among participants requires trust with the communities that have been underrepresented in research. To build that trust, researchers must sincerely engage with those communities, incorporate community feedback into the research process and follow through on commitments. In summary, patient engagement, trust-building and diversity are all interconnected prerequisites for developing evidence-based interventions that could mitigate disparities.
Research Objectives
Applications to this FOA must propose a research plan designed to develop, test and implement evidence-based interventions to mitigate or eliminate health disparities in persons with acute and/or chronic pain. Interventions must directly address the cause or source of the disparity/ies and not solely focus on helping HDPs cope with them. As such, this FOA encourages studies that address multiple socioecological domains and levels of influence (e.g. organizational/institutional, community/neighborhood, societal) to advance health equity and mitigate health disparities in pain management. Consideration of models that hierarchically connect information at different levels of NIMHD's research frameworkand differentiate between individual and structural factors are encouraged. Research designs should also include assessment of mechanisms through which the intervention mitigates/eliminates health disparities and how these changes result in improvement in pain management outcomes. Additionally, consideration of potential for long-term sustainability and scalability of proposed interventions is expected.
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. Projects that include populations that identify across more than one group are encouraged. Applications are expected to demonstrate an existing health disparity or health disparities in acute and/or chronic pain in the population of interest and outline a detailed plan for an evidence-based intervention to mitigate or eliminate the disparity(disparities) to improve pain and pain-related outcomes. Potential outcomes may reflect health status, disability, quality of life, mortality and morbidity, health behaviors, and access to, utilization of, or quality of health care.
Applications are expected to include collaborations with relevant organizations or groups or stakeholders, such as patients with lived experience, health service providers and systems, academic institutions, state and local public health agencies, Federally Qualified Health Centers (FQHCs), patient or consumer advocacy groups, community-based organizations, and faith-based organizations. Congruently, projects must include a detailed recruitment and retention plan with robust HDP patient and stakeholder engagement (e.g. community groups, patients, caregivers, a broad array of health care providers, researchers, educators) and bolster inclusion.
Research teams must include appropriate expertise in the fields of acute and/or chronic pain, pain management as well as health disparities research. Multidisciplinary research teams that bring together ideas, theories, methods and approaches from different scientific and clinical disciplines to address underlying social, cultural, clinical, environmental or biological factors responsible for disparities in pain management are encouraged.
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 homogenous 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 populations that experience health disparities (HDPs) participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH’s Interest in Diversity NOT-OD-20-031 for more details.
Specific Areas of Research Interest
The scope of this initiative includes but is not limited to interventions designed to address:
Examples of interventions and settings include but are not limited to:
The interventions listed above are only examples, are not listed in priority order, and are not intended to be all-inclusive.
Applications submitted in response to this FOA are strongly encouraged to: 1) include multi-level interventions with systemic implementation strategies that are scalable and conducive to long-term sustainability and can be rapidly implemented by healthcare systems, 2) incorporate efficiencies and utilize existing resources (e.g., NCATS CTSAs and the Trial Innovation Network including the Recruitment Innovation Center, practice-based research networks, electronic health records, administrative databases, and/or patient registries) to increase the efficiency of participant enrollment, retention and data collection, 3) consider subpopulation analysis to determine which interventions work best for specific population groups (e.g. Hispanic or Latino subpopulations, Pacific Islander subpopulations), including medically underserved and under-represented groups with the intent to focus on reduction of health disparities, and 4) assess social determinants of health using measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org) or other widely adopted measures, as appropriate.
Please note that exclusion of non-English speaking participants without compelling scientific justification is discouraged and appropriate translation services should be provided in the research plan and the budget.
Applications Not Responsive to the FOA include:
Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.
Phases of Award
Utilization of milestones is a key characteristic of this FOA. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Plans must be guided by milestones that will be reached by the end of the R61 phase. Milestones are to be performance-based to achieve completion of the study on time and on budget. The individual milestones must be well-defined, quantifiable, and measurable. A summary of the milestones will undergo an administrative review by the administering NIH Institute/Center (I/C) to ascertain if each milestone proposed was or was not met. Only R61 projects that have met milestones will be deemed eligible to transition to the R33 phase.
The R61 Phase
The primary objective of the R61 phase supported under this FOA is to perform the formative work necessary to prepare for a successful R33 phase. This may include adaptation and tailoring of interventions for the proposed R33, stakeholder interviews, focus groups, tests of feasibility and acceptability. Applicants are expected to provide a detailed description of the intervention(s) they propose to study. Applicants are also expected to provide detailed descriptions of the measures and a strong rationale for choosing such measures.
Examples of R61 milestones include, but are not limited to:
Funding for and transition to the R33 phase is 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).
Please note: To transition from the R61 phase to the R33 phase, grantees will submit a transition request 3 months prior to the proposed transition date. Successful achievement of milestones must be documented prior to submission of the transition package.
The R33 Phase
The primary objective of the R33 phase is the execution of the research study refined during the R61 phase. The R33 phase will execute the evidence-based intervention at full scale and demonstrate a reduction in health disparities resulting in improved outcomes (e.g., reduced pain, reduction in opioid use, improved quality of life) for the population of interest. Applicants should address how this intervention can be implemented, scaled-up and/or sustained.
PI Meeting Attendance
The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.
Common Data Elements (CDEs)
The HEAL Clinical Pain Common Data Element (CDE) Initiative provides an unprecedented opportunity for the pain research community to access quality and meaningful data across pain conditions, diverse populations, and multiple interventions. The HEAL CDE initiative aims to facilitate cross-study comparisons, improve interpretability of findings for patient-reported outcomes, and improves the ability to compare results across trials to quantify the impact of interventions. For studies involving human subjects, projects will be required to use the HEAL Clinical Pain Core CDEs which include measures within 9 pain domains and are specific to either adult or pediatric populations and acute or chronic pain conditions. The domains include pain intensity, pain interference, physical functioning/quality of life, sleep, pain catastrophizing, depression, anxiety, treatment satisfaction, and a substance use screener (HEAL CDE Program). Studies that use additional pain screening tools must select from a comprehensive set coded through HEAL or submit their tools for coding to comply with HEAL pain data harmonization. Any outcome measures specific to clinical pain should be validated measures appropriate for the pain condition.
Information Relevant to Specific Institutes/Centers/Offices:
In addition to the above description of the scientific objectives, resources communicating scientific interests of selected NIH Institutes, Centers and Offices (ICOs) are summarized below. Applicants are encouraged to contact the Scientific/Research contact of the intended I/C to ensure that the aims of the proposed project are consistent with ICO mission.
National Institute of Neurological Disorders and Stroke (NINDS)
NINDS commits to reducing the disproportionate burden of neurological diseases experienced by underserved groups of society, including racial and ethnic minoritized, rural, and socioeconomically disadvantaged populations, by funding a spectrum of research from basic science through clinical studies and training the next generation of health equity investigators (https://www.ninds.nih.gov/Current-Research/Focus-Tools-Topics/Health-Disparities-Research).
NINDS is particularly interested in:
A letter of intent and communication with NINDS program staff prior to submission of an application are strongly encouraged. Applicants proposing to develop interventions are expected to proactively identify a theory or model that applies to the intervention proposed and the critical variables expected to result in change. Applications are required to use an appropriate experimental design to test the proposed theory, identify the essential components of complex interventions, and/or elucidate the mechanism(s) by which an intervention exerts its effects. For the development of behavioral interventions, applicants are encouraged to articulate their research aims and a proposed framework.
National Center for Advancing Translational Sciences (NCATS)
NCATS mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of diseases and conditions. NCATS is interested in attainment of health equity in pain management for HDPs by getting more treatments to more patients more quickly through the use of translational science https://ncats.nih.gov/translation/spectrum. NCATS is interested in studies that accelerate development, testing and implementation of innovations that reduce, remove or bypass system-wide bottlenecks to attainment of health equity in pain management for HDPs. Multi-level innovations that catalyze translational efficiency and the development and delivery of interventions to mitigate or eliminate disparities in provision of care and treatment decisions, reduce susceptibility to chronic pain and improve HDP outcomes are encouraged. Applications from the Clinical and Translational Science Award (CTSA) Program hub institutions that leverage CTSA resources including: existing partnerships/collaborations across institutions, stakeholders, and communities to address health disparities; the Trial Innovation Network including the Recruitment Innovation Center; and, the National Center for Data to Health (CD2H). Additionally, applications proposing collaborations between two or more CTSA Program hub institutions, that cannot be accomplished by a single hub, that extends the regional/national reach of the proposed intervention such that it has the potential to reach more patients more quickly are encouraged.
National Institute on Minority Health and Health Disparities (NIMHD)
is interested in supporting research and interventions that consider determinants from more than one domain or level of influence (see NIMHD Research Framework). Intervention design should be based on theories from minority health and health disparities science. Research must focus on one or more minority or health populations (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations). Applications may include but are not limited to multi-disciplinary etiologic and intervention research projects in community settings that advance the understanding of the mechanisms, pathways, and processes related to health promoting behaviors (e.g., adherence to treatments, health seeking behaviors for pain care), preventive screening recommendations for medication or other medical treatment regimens, and/or chronic disease self-management strategies. Research may propose using available secondary data, health system data and/or collection of primary data.
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Dental and Craniofacial Research (NIDCR) is interested in supporting multi-level interventions to address disparities in chronic temporomandibular disorder (TMD)-associated pain assessment, treatment, and management. Subpopulation analyses are highly encouraged to better delineate the specific populations that experience disparities related to TMD pain assessment, treatment, and management (see National Academies of Sciences, Engineering, and Medicine Consensus Study Report, Temporomandibular Disorders: Priorities for Research and Care. National Academies Press (US); 2020 Mar 12; Chapter 3), as well as to determine which interventions work best for specific population groups.
National Center for Complementary and Integrative Health (NCCIH)
The National Center for Complementary and Integrative Health (NCCIH) is interested in supporting studies that develop, test, and implement culturally and linguistically appropriate complementary and integrative health approaches to mitigate and/or eliminate health disparities in persons with acute or chronic pain. Complementary health approaches include a broad range of practices and interventions that are not typically part of conventional medical care. Complementary approaches include those with their primary therapeutic input, which may be dietary therapeutic inputs, or considered natural products (e.g., botanicals, probiotics/microbials, naturally derived peptides, dietary supplements, and special diets) as well as physical and/or psychological therapeutic inputs, often called mind and body approaches (e.g., acupuncture, yoga, tai chi, qi gong, meditation, hypnosis, music therapy, art therapy, spinal or chiropractic manipulation, and massage). Integrative approaches bring conventional and complementary approaches together in a coordinated way.
National Cancer Institute (NCI)
NCI is interested in supporting intervention research in the following areas that include, but are not limited to:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in applications that address factors that contribute to disparities in pain assessment, treatment, and management in the NIAMS mission-relevant disease areas. Research in community health care settings is particularly encouraged. Note, applications focusing on chronic low back pain (cLBP) will be expected to align with the Back Pain Consortium (BACPAC) Research Program definition of cLBP and collect the BACPAC minimum data set as appropriate. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
A clinically significant proportion of people with chronic pain conditions drink alcohol or have Alcohol Use Disorder (AUD). Binge alcohol doses have analgesic effects leading to attempted pain self-medication with alcohol, but long-term excessive drinking contributes to worse pain outcomes. In the context of the current FOA, NIAAA is interested in the influence of alcohol drinking status on pain conditions presenting in HDPs, how baseline drinking status contributes to pain intervention efficacy and how alcohol drinking is altered by successful or unsuccessful amelioration of pain conditions in HDPs.
National Institute of Nursing Research (NINR)
The National Institute of Nursing Research (NINR) supports research that uses nursing’s holistic perspective to improve individual and population health outcomes and advance health equity across the clinical and community settings where nurses practice. NINR encourages research that integrates factors at multiple levels including social determinants to identify their role in health, health improvement, and health disparities with the goal of improving the health of individuals, families, and populations.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Required: Only accepting applications that propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
NIH intends to fund an estimate of 4 to 8 awards, corresponding to a total of $4,500,000 per year for fiscal years 2022/2023 and a total of $9,000,000 per year for fiscal years 2024, 2025 and 2026.
The number of awards is contingent upon NIH appropriations and submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project. It is strongly recommended that applicants not request a budget of more than $500,000 in direct costs per year for the R61 phase and $1,000,000 in direct costs per year for the R33 phase.
The scope of the project should determine the project period for each phase. The maximum period of the combined R61 and R33 phases is 5 years, with 1 to 2 years for the R61 phase and up to 4 years for the R33 phase.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Cheryse A. Sankar, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-318-2889
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims:
In the single page attachment allowed for the specific aims, applicants should include clearly marked headers for R61 Specific Aims and R33 Specific Aims with brief descriptions of key hypotheses.
Research Strategy:
The Research Strategy should be organized in a manner that will facilitate peer review. The body of the application should present an overview of the state of the science, current status and relevance of the trial, a discussion of the specific protocol, the approach to data collection, analysis, and dissemination as well as consideration of long-term sustainability and scalability of the proposed interventions. The application should contain separate Approach sections for the R61 and R33 phases.
Separate Significance and Innovation sections may be included, but they could also be combined into a single section within the R61 section as appropriate. It is not necessary to repeat any information or details in the R33 section that are described in the R61 section.
The following criteria should be addressed:
Significance: The significance of the proposed study and importance of the question should be clearly stated. If available, the application should provide rigorous preliminary data to support the study rationale. It is particularly important that there be a discussion of how the trial will test the proposed hypotheses. The application should make clear the need for and timeliness of the study with emphasis on how the results will address an evidence gap and therefore advance our knowledge of theory and practice in this area. A discussion of the costs and benefits of the study should be included for evaluation of the trial's significance. The applicant is expected to address the following questions: (1) Will the results provide implementable evidence-based strategies that mitigate a) the effects of bias, stigma and discrimination at multiple levels and/or b) socioeconomic, environmental and other barriers to quality pain assessment, treatment and management? (2) How will the results advance health equity in pain management?
Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
Approach: The research approach section should include a description of the supporting data, clinical trial experience, the experimental approach, and reference the Timeline and Milestone Plan.
Supporting Data: Studies that led to the proposed project should be presented. Data from studies that show the need for and feasibility of the trial should also be presented. While an R61/R33 grant application need not have preliminary data, extensive background material or preliminary information, they should be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Additional supporting data from other research should be included so that the approach chosen is clearly justified and adequately framed. The application should adequately frame and justify the initial planning/feasibility phase (R61), transition to the R33 phase and overall project. Applications should address the rationale for choosing the planned intervention. This may include public health impact if subsequent efficacy trials are conducted and positive; ethical dimensions; and/or patient perspectives on acceptability of the proposed intervention. Characteristics of any preliminary research results provided in support of the proposed project, whether conducted by the applicant or others, should be described in the application.
Experimental Approach: The proposed experimental approach should include an appropriate study design and the rationale for the design chosen. The following elements should be included as part of the PHS Human Subjects/Clinical Trials Information forms as indicated or within the research strategy, but not in both sections. The experimental approach description should include:
Letters of Support: Letters of support from relevant organizations, groups, stakeholders (e.g. health service providers and/or systems, clinicians or clinical department chairs, etc) whose support are necessary to the successful conduct of the trial should be provided, if available.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
HEAL Data Sharing
NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), (all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem.
To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:
The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.
Awardees conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).
Awardees conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Section 2 - Study Population Characteristics
2.5 Recruitment and Retention Plan
Describe the following: 1) the planned recruitment methods including use of contact lists, databases or other pre-screening resources, advertisements, outreach, media / social media and referral networks or groups; 2) if there are known participant or study-related barriers to accrual or participation (based on literature or prior experience), please list these barriers and describe plans to address them to optimize success; 3) contingency plans for participant accrual if enrollment significantly lags behind accrual benchmarks; 4) participant retention and adherence strategies; 5) possible competition from other trials for study participants; ; 6) culturally and linguistically appropriate strategies for outreach, recruitment and retention of NIH-designated HDPs; and 7) stakeholder engagement that will play a critical role in recruitment and retention.
2.7 Study Timeline
A milestone plan must describe the key milestones that need to be met throughout the lifecycle of the project to ensure its success; the processes that will be used to reach the milestones. Include a table or graph of the overall study timeline. This is expected to be a visual representation (such as a Gantt Chart) of milestone plan and key project management activities. All applicants must use the following definition of a milestone in their application: a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be relevant, achievable, and measurable. The research plan should include anticipated challenges to meeting milestones and propose potential mitigation or corrective actions strategies. Milestones should address overall recruitment and retention goals. The Terms and Conditions for an award under this FOA will include a milestone plan that is mutually agreed upon by the investigators and NIH.
Milestones of particular interest that should be described in the application may include, but are not limited to, the following:
Investigators and NIH will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the grant, if awarded. During the award phase, achievement of each milestone will need to be communicated to the NIH Program Officer listed on the Notice of Award. Award continuation, even during the period recommended for support, is conditional upon satisfactory progress. If, at any time, recruitment falls significantly below projections, or milestones mutually agreed upon by the PD/PI and the NIH, are not met, the NIH may consider ending support and negotiating an orderly phase-out of the award. The NIH retains, as an option, periodic external peer review of progress. NIH staff will closely monitor progress at all trial stages including milestones, accrual, and safety.
Please note: To transition from the R61 phase to the R33 phase, grantees will submit a transition request 3 months prior to the proposed transition date. Successful achievement of milestones must be documented prior to submission of the transition package.
Section 3 - Protection and Monitoring Plans
3.3 Data and Safety Monitoring Plan
All applications are expected to include a detailed data and safety monitoring plan. Applicants should refer to NIH’s policy on data and safety monitoring (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html).
Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-Related Attachments
Clinical Trial Experience.
Applicants must provide a detailed table listing the characteristics of trials that demonstrate experience in trial conduct and/or coordination in the last 5 years. The table must be provided as an attachment called "Clinical Trial Experience.pdf", appended with 1, 2, 3, etc. as needed, and must not exceed 3 pages. Applications that do not include this attachment or exceed the page limit will not be peer reviewed.
The table columns should include:
Column A: clinical trial title
Column B: applicant's role in the trial
Column C: a brief description of the trial design
Column D: planned enrollment
Column E: actual enrollment
Column F: number of sites
Column G: whether the trial(s) were completed on schedule or not
Column H: publication reference(s)
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R61/R33 phased innovation grant supports highly innovative studies as well as a rapid translation of such insights into clinically relevant optimization strategies. While highly innovative work often inherently carries a substantial scientific risk (i.e., the original hypothesis may not be proven), this risk can be substantially mitigated by properly designed milestones that would help determine whether at the end of the R61 phase the study is ready to move forward to the R33 phase. A well-planned R33 phase is only meaningful if the R61 phase is both innovative and well-designed. An R61/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they should be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the level of innovation, the potential to significantly optimize the proposed intervention, and the rigor of the proposed experimental designs. Reviewers will assign a single impact score for the entire application, which includes the R61 phase, the proposed R61-to-R33 transition milestones, and the R33 phase.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific to this FOA:
Is there adequate evidence of a significant health disparity that impacts pain and/or pain-related outcomes in the health disparity population of interest?
How well does the project address the source of the disparity/ies, assess the impact of the proposed intervention on pain and/or pain-related outcomes, and increase health equity in pain management for HDPs?
If the evidence-based intervention were successful, would there be significant and clinically meaningful changes to HDP pain-related patient outcomes? Does the project include consideration for long-term sustainability and scalability?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this FOA:
Does the team of research investigators demonstrate expertise in both health disparities research AND pain research? hat evidence is provided to ensure that the investigators' clinical facilities will employ the appropriate personnel to recruit subjects and design/implement the clinical protocol? Does the investigative team have a track record of publishing the results of previously completed research?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Specific to this FOA:
Doesin pain management? Does the proposed research have the potential to advance the field even if the proposed study design, methods, and intervention are not innovative?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this FOA:
Does the application include a data management and sharing plan that is inline with the HEAL initiative Public Access and Data Sharing policy? Does the plan describe data types, file formats, submission timelines, and standards used in collecting or processing the data?
Does the research design include assessment of mechanisms through which the proposed intervention mitigates/eliminates health disparities and how these changes result in improvement in pain management outcomes? Are models that hierarchically connect information at different levels (e.g. NIMHD's research framework) and differentiate between individual and structural factors considered? Have investigators proposed methods to mitigate bias, error, and confounding? How well are the outcome measures, duration of intervention and follow up, appropriateness of inclusion/exclusion criteria, and sample size justified and explained? Are collaborations with relevant organizations, groups, and/or stakeholders included? How well does the Recruitment and Retention plan provide evidence that the accrual goals can be reached within the application? Does it incorporate HDP patient/stakeholder engagement and inclusion strategies? Is it culturally and linguistically appropriate for the proposed HDP population/s? How appropriate is the plan to monitor accrual? Are there plans for adverse events to be appropriately captured and monitored? For the R61 phase will the proposed adaptions and tailoring provide the formative work to allow for a successful R33 phase? For the R33 phase will the chosen study design be appropriate for the stated goals of the project?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Specific to this FOA:
Does the application document the availability of the requisite eligible participant pool in proposed recruitment site(s)? Is there documentation of the commitment of any subcontractors and consultants, as well as service agreements for personnel and facilities?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
R61 to R33 Milestones
Do the milestones define clear assessment(s) that will justify the transition to the R33 phase? Are the proposed milestones relevant, achievable, and measurable? Does the research plan include anticipated challenges to meeting milestones and propose potential mitigation or corrective actions strategies? Do milestones address overall recruitment and retention goals?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Cheryse A. Sankar, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-318-2889
Email: [email protected]
Leslie K Derr, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: (301) 594-8174
E-mail: [email protected]
Dave Thomas, Ph.D.
Office of Research on Women's Health (ORWH)
Phone: 301-435-1313
Email: [email protected]
Hiroko Iida, DDS, MPH
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-7404
E-mail: [email protected]
Yolanda F Vallejo, Ph.D.
National Center For Advancing Translational Sciences (NCATS)
Phone: (301) 451-1751
E-mail: [email protected]
Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-5899
Email: [email protected]
Priscah Mujuru, Dr.PH, MPH, RN
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-9765
E-mail: [email protected]
Alexis Bakos, Ph.D., M.P.H., R.N.
National Cancer Institute (NCI)
Telephone: 301-921-5970
Email: [email protected]
National Institute of Mental Health (NIMH)
Alexander M. Talkovsky, Ph.D.
Telephone: 301-827-7614
Email: [email protected]
Mark Egli
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-594-6382
E-mail: [email protected]
Inna Belfer, MD, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-435-1573
Email: [email protected]
Ziya Kirkali, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-7718
E-mail: [email protected]
Jeri L. Miller, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-6152
Email: [email protected]
Houmam H Araj
National Eye Institute (NEI)
Phone: (301) 435-8166
E-mail: [email protected]
Center for Scientific Review (CSR)
Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: [email protected]
Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]
Matthew Thomas Zeback
National Center For Advancing Translational Sciences (NCATS)
Phone: (301) 451-8309
E-mail: [email protected]
Paolo Arguinzoni-Urrutia
National Institute on Aging (NIA)
Phone: 301-827-5985
Email: [email protected]
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]
Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]
Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: [email protected]
Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]
Pamela Love
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 435-6198
E-mail: [email protected]
Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]
Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.