Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

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.

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Patient-Clinician Relationship: Improving Health Outcomes in Populations that Experience Health Care Disparities (R01 Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-22-064
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.307, 93.846, 93.173, 93.313
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support innovative multi-disciplinary and multi-level (e.g., patient, clinician, interpersonal, health care system, community) research designed to understand how optimizing patient-clinician communication and relationship affects health care outcomes in patients from populations with health care disparities. In addition, this initiative will support research to (1) gain an understanding of how the Patient-Clinician Relationship (PCR) in the primary care and chronic disease care settings affects clinical and non-clinical health outcomes in populations that experience health disparities, and (2) identify best practices and interventions that build and improve PCR leading to better health outcomes and increased health equity.

Key Dates

Posted Date
November 16, 2021
Open Date (Earliest Submission Date)
January 05, 2022
Letter of Intent Due Date(s)

Not applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
February 05, 2022 * March 05, 2022 * Not Applicable July 2022 October 2022 December 2022
June 05, 2022 * July 05, 2022 * Not Applicable November 2022 January 2023 April 2023
October 05, 2022 * November 05, 2022 * Not Applicable March 2023 May 2023 July 2023
February 05, 2023 * March 05, 2023 * Not Applicable July 2023 October 2023 December 2023
June 05, 2023 * July 05, 2023 * Not Applicable November 2023 January 2024 April 2024
October 05, 2023 * November 05, 2023 * Not Applicable March 2024 May 2024 July 2024
February 05, 2024 * March 05, 2024 * Not Applicable July 2024 October 2024 December 2024
June 05, 2024 * July 05, 2024 * Not Applicable November 2024 January 2025 April 2025
October 05, 2024 * November 05, 2024 * Not Applicable March 2025 May 2025 July 2025

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.

Expiration Date
January 08, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Key Definitions

The terms patient-clinician communication and patient-clinician relationship are often interchanged in the scientific literature. Communication implies a time- or context-specific interaction and exchange of information, while in a relationship there is an implicit commitment and deeper understanding of one another. For the purpose of this funding opportunity announcement (FOA), we integrate both concepts into patient-clinician relationship (PCR), except in a few scenarios in which communication is specifically highlighted.

The term “populations that experience health/health care disparities” refers to the NIH-designated U.S. health disparity populations 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 (https://www.nimhd.nih.gov/about/overview/).

The term “multi-level” refers to the multi-dimensional framework of determinants relevant to understand and address minority health and health disparities. This concept is further described under the NIMHD Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework/).

The term “clinician” refers to health care professional who is directly involved in the care of patients, including diagnosis and therapy of health conditions, and assessment of evolving health care needs. For the purpose of this FOA, clinicians include medical or osteopathic doctors, dentists, clinical psychologists, nurses, nurse practitioners, physician assistants, podiatrists, pharmacists, nutritionists, occupational/physical therapists, speech/language therapists, social workers in health care, and other licensed health care professionals engaged in direct patient care.

Background

Patient-clinician interactions and modes of communication have fundamentally changed with technological advances, managed health care systems, and the COVID-19 pandemic. The optimal balance of technology, efficiency, and human connection within health care systems is being reconsidered. Balancing and recalibration efforts need to include a health equity lens perspective (e.g, moving from mere improvement to attaining recommended optimal therapeutic, control and continuity of care goals) that goes beyond focusing on individualized care and recognizes that interpersonal dynamics during clinical care exist within broader cultural, societal and structural contexts.

The NIMHD Minority Health and Health Disparities Research Framework showcases a continually evolving conceptualization of factors relevant to the understanding of minority health and health disparities. It addresses the complex and multifaceted nature of research in this area and identifies key areas for research in health disparities. The patient-clinician communication and relationship (PCR) is a crucial research element at the intersection of the health care system and interpersonal level of influence, and importantly, is nested within the broader NIMHD multi-level/multi-factor research framework. Moreover, strengthening the stability of the patient-clinician relationship was highlighted in the 2003 Institute of Medicine (IOM) report Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, as one of the recommendations to eliminate health disparities.

Good communication between clinicians and patients is associated with higher quality of health care as demonstrated by better medical outcomes, patient safety, adherence to recommended or prescribed treatment(s), and satisfaction, and clinician satisfaction and efficiency. Nonverbal communication in particular plays a critical role in fostering trusting PCR. Effective communication enables patient activation and a proactive approach to health care.

Various factors influence the development and strengthening of the PCR. Within a traditional health care encounter, the PCR is developed and strengthened in a progressive manner, and evolves through multiple phases. The establishment of the relationship occurs at the beginning of the first patient-clinician encounter when rapport is built, concerns are elicited, and a plan is set. The relationship is further developed as the clinician obtains the full patient history and conducts a physical exam. This is followed by communication of a potential diagnosis (or differential diagnoses), next steps regarding additional diagnostic tests and/or the immediate and/or long-term management of the concern. Preventive services and lifestyle factors are also critical components of a comprehensive visit especially in the primary care setting. At this key stage, the relationship is further built through shared decision making, patient education and the clinician’s commitment to be accessible for problem solving. The PCR continues evolving as continuity of care is established, which may involve the patient alone, the patient’s family, and/or the patient’s caregivers.

While good communication strengthens the PCR, clinician-, patient-, and system-level factors may influence its effectiveness. Factors that influence the PCR at the clinician level include individual factors (e.g., communication skills, conscious and unconscious bias, cultural proficiency, personal/cultural beliefs, expertise in the patient’s condition) and system level factors [e.g., health insurance policies, health care system policies, health care systems and resources (including subspecialty care), non-clinical staff interactions with patients, communication within the health care system different components, societal-level health care and non-health care policies, health care coordination and organization, implementation of recommended guidelines of care, and other factors mediating decision making]. Similarly, at the patient level, there are individual factors [e.g., English language proficiency, health and/or digital technology literacy, personal/cultural beliefs and norms of communication, historical trauma, mistrust of the health care system], and system/societal level factors [e.g., communication between the patient and the health care system, health insurance policy/coverage, family/employment responsibilities, ability to afford co-pay, workplace policies, transportation, housing/built environment] that affect the PCR.

Positive relationships between patients and their clinicians develop as part of routine medical care and can have a therapeutic benefit. A systematic review of randomized clinical trials conducted through 2012 documents a modest positive association between interventions to improve the PCR and health outcomes (e.g., blood pressure control and pain scores). A more recent systematic review of studies performed through 2017 examined the association of patient-clinician interpersonal interventions with health care quality measures (clinical outcomes; patient experiences; costs; provider experiences) and provides insight into prior research trends. The most common interpersonal interventions focused on clinician (as opposed to patient or bi-directional) general communication skills and techniques (e.g., verbal and nonverbal skills), and patient-centered care strategies. Most studies included multiple interventions and did not address just one intervention. Most studies also included patient experience as a measured outcome while about half of the studies included a health outcome. In either systematic review, studies were not specifically focused on populations with health disparities or on the reduction of health disparities.

It is fundamental to underline that PCRs involve interactions between the patient and the clinician as well as their lived experiences, and perceptions within both patients and the health care system. In addition, there are shared patient-clinician factors such as internalized social identities, and their intersectionality. Patient-clinician concordance in identities (e.g., racial/ethnic/sex or gender/cultural/religious or spiritual), language and socioeconomic status (SES) may have a positive effect on the PCR and eventually on health outcomes.

Conversely, inherent differences in various facets/modalities of communication exist for patients from populations that experience health disparities and are observed early during their interactions with health care systems. For these patients, communication with clinicians tends to be of lower quality (e.g., communication gaps, misunderstandings) for some populations that experience health care disparities per subjective self-report and objective coded audio/visual tapes of clinical encounters. Clinicians tend to be more verbally dominant and behave less affectively (e.g., less likely to build rapport, be friendly, or show concern) when interacting with patients from racial/ethnic minority populations compared to non-Hispanic White patients. Poor communication between clinicians and racial/ethnic minority patients has been characterized by implicit physician bias, less patient-centered communication, less discussion of treatment goals and options, less informal conversation about non-medical issues, and more disengaged non-verbal behavior. This is associated with lower satisfaction with care and poorer outcomes for chronic diseases and pain management. Additional factors to consider include cultural proficiency and humility among clinicians and within health care systems, clinicians’ and other health care system’s staff’s empathy, location of health care settings (e.g., rural or urban, distance and physical access), and the interaction of health care systems with the local and nearby communities, including their perceived quality. Patients’ factors also play a role in quality or success of the PCR, and some of them include patients’ health and/or digital literacy, English language proficiency, socioeconomic status, health/health care beliefs, cultural norms, and biases.

Other factors, like institutional racism and discrimination, also influence the nature and quality of the PCR, and in turn contribute to health disparities. In addition, individuals’ experiences may be shaped by the different levels of influence highlighted in NIMHD research framework. For instance, the same person may experience internalized racism (intrapersonal level), bias and discrimination (interpersonal level), have different experiences at work, place of worship, and the grocery store (interpersonal, community levels), experience or participate in hate crimes (community, societal levels), and/or experience the impact of structural inequalities such as educational opportunities and built environment. Lastly, the realities and perceptions of structural inequality and hierarchical power differentials must be considered in the PCR within the context of the care of patients from populations that experience health/health care disparities.

Patient-centered care emerged in 2001 as one of six aims (safe, effective, timely, efficient, patient-centered care, equitable) in improving the health care delivery in the United States. It is defined as “providing care that is respectful of and responsive to individual patient preferences, needs and values and ensuring that patient values guide all clinical decisions.” Despite 20 years of work toward this effort, progress is slow with respect to the populations that experience health care disparities. Implementation is incomplete with impediments including but not limited to consideration of social determinants of health, and inadequate trust and respect within the PCR and with respect to patients’ interactions with health care systems.

Research Objectives

This FOA aims at supporting innovative multi-disciplinary and multi-level (e.g., patient, clinician, interpersonal, health care system, community) research designed to (1) understand how optimizing PCR through systemic, environmental, biological, and behavioral domains affects health care outcomes in patients from populations that experience health disparities, and (2) identify multi-level best practices and interventions that improve PCR leading to improved health outcomes. A fundamental goal of this FOA is to identify and understand best practices where building a sustainable PCR is central to the health care of patients from populations that experience health disparities.

This initiative will support research in outpatient and inpatient health care settings serving populations (including children and adults) that experience health disparities. Outpatient settings include primary care, specialty clinics and specialty care settings such as dialysis or chemotherapy centers. Research within the context of transitional care (e.g., hospital to home, rehabilitation), palliative care, end-of-life care, and long-term care, where patients interact with clinicians on a regular basis, is also of interest. Studies may involve in-person and/or telemedicine patient-clinician encounters.

Proposed projects are expected to test the effect of various strategies on (1) quality of care measures (beyond clinical encounter satisfaction), such as return to follow-up care, medication safety and adverse events, (2) assessment of communication styles and design of training programs to improve patient-clinician communication, and (3) outcomes and experiences that will inform actions that can be taken -especially best practices and training programs- to improve the performance of the health care workforce in this area.

This initiative is not solely focused on clinical health outcomes. Research on intermediary measures (e.g., patient trust, self-efficacy, empowerment, and safety), clinician’s job satisfaction, and cultural competence are also of interest. Projects should complement the NIMHD Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework/) and portfolio focusing on areas ready for further study and that are high yield targets for intervention. Applications that plan to collect primary data from patients, clinicians and other persons are strongly encouraged to use the measures on social determinats of health in the PhenX tool kit (https://www.phenxtoolkit.org/).

Research Methodology

The research types anticipated include mixed-methods; retrospective-prospective analyses; intervention studies; and matching and mismatching designs such as those that assess individual preferences. To develop a comprehensive understanding of PCR, required objective measurements can be complemented by subjective secondary measurements. It is expected that lessons learned from these studies will lead to mechanistic understanding of key drivers and barriers of PCR. Lessons learned will also include best practices, sustainability, and cost effectiveness.

Areas of Research Interest

Areas of specific interest to NIMHD include but are not limited to the following:

  • Evaluation of the effectiveness and sustainability of methods or interventions (for example, patient-clinician or patient—health care system communication modalities, organizational changes) designed to maintain the PCR when caring for patients from populations that experience health/health care disparities. Outcome measures are not limited to clinical outcomes, but the use of multi-level and/or intermediary outcome measures is encouraged.
  • Evaluation of the multi-level benefits of interventions geared towards PCR building and communication. Benefits can be in the form of health outcomes, community health benefits, clinician/patient satisfaction, or outcomes related to the structural systemic factors impacting the PCR, for example.
  • Evaluation of current models or best practices of PCR and their effectiveness in preventing the short- and long-term complications of chronic diseases. These may include analyses of experiences of these populations within the context of care for a specific chronic disease or for coexisting multiple chronic conditions by the same clinician or group of clinicians.
  • Interventions geared toward developing a sustainable and effective PCR for patients with multiple chronic conditions who require long term and/or frequent visits with their clinicians.
  • Studies that assess the effect of patient-clinician communication modalities (e.g., in-person, phone, video, patient electronic portals, texting, or other digital-based interactions) on disease prevention and treatment. These assessments should include multi-level outcomes and not just clinical or patient-level outcomes.
  • Evaluation of current approaches and interventions to develop effective, ethical, and sustainable communication both in general and in scenarios in which patients are unable to make decisions and a family member or other individual is the legally authorized representative
  • Studies that examine, test and/or evaluate the role of the family in the communication/relationship between the patient (individual) and the clinician, or as a unit receiving medical care and interacting with the clinician, and its effect on health outcomes.
  • Examination of the multidirectional role of racism, discrimination, and explicit and implicit biases between patients and clinicians or patients and health care systems in PCR across different populations that experience health/health care disparities, strategies to address them, and the impact of those strategies on health/health care disparities or health outcomes.
  • Examination of the multidirectional role of racism, discrimination, and implicit and explicit biases (from both patients and clinicians), as well as empathy, trust, and positive emotions in PCR especially in scenarios in which clinicians are members of populations that experience health disparities. Studies that investigate strategies that address patients’ and clinicians’ biases, and the impact of those strategies on health disparities or health outcomes are of interest.
  • Examination of the role of structural racism and discrimination at the health care system level experienced by clinicians from populations with health disparities and its effect on PCR, patient health outcomes and/or health/health care disparities, and strategies or interventions to address it.
  • Studies that examine and compare the role of sociocultural determinants of health (including health literacy, cultural norms and values, health beliefs) in effective shared decision making and patient agency across different populations that experience health care disparities
  • Studies that examine, test, and evaluate the role of religiosity and spirituality in PCR building, effective shared decision making and patient agency across different populations that experience health care disparities
  • Examination of the role of the clinician as a healer, expert consultant, or as a clinical investigator in the PCR and its effect on the recruitment of patients from populations that experience health disparities into clinical research. The intersection of the ethics of medical care and the ethics of biomedical research in this PCR scenario is of interest.
  • Studies that examine the impact of patients’ interactions with health care systems on PCR. For example, how do these interactions affect the length, depth and frequency of the patient-clinician communication, and the trust, length, and continuity of the patient-clinician relationship?
    • Address multi-level factors that impact PCR in the care of patients from medically underserved immigrant populations with limited English proficiency.
    • Describe the life-course of the PCR. For example, how the quality of experiences with the health care system impact future relationships with clinicians.
    • Examine the impact of health care/health insurance policies, changes in health insurance carrier, or health insurance coverage on PCR (e.g., temporary interruption or permanent disruption), continuity of care and health outcomes.
  • Studies that evaluate the effects of telehealth communication on the PCR.
    • Current best practices of patient-clinician telehealth communication and whether these represent facilitators or barriers to PCR addressing health/health care disparities
    • Telemedicine delivery systems or protocols that represent viable, sustainable, and effective approaches to providing care particularly for patients in low SES or living in remote, isolated, or rural communities, including Tribal communities, and identify best approaches to help speed its adoption.
    • Telemedicine delivery systems or protocols that enhance effective care by integrating clinician to clinician remote consultation and its effect on the PCR.
    • The impact of telemedicine on trans-cultural and trans-generational patient-clinician communication and strategies to address any negative impact on health or continuity of care
  • Examination of the role of the health care delivery setting on the PCR by evaluating the potential impact of structural, systemic, and interpersonal factors on clinical outcomes.
    • Identify optimal strategies by health care settings (e.g., academic outpatient clinics, federally qualified health centers, other community clinics, school-based health centers, group practices) for effective PCR building for patients and/or families.
    • Examine similarities and differences in PCR building in primary care and sub-specialty-based chronic disease management clinics that serve populations with health/ health care disparities.
    • Examine the impact of the dynamics, structure, composition, roles, and communication of the health care team (e.g., physicians, nurse practitioners, physician assistants, nurses, allied health professionals, community health workers) on the PCR, and strategies to facilitate it or improve it.
    • Examine when, where and how is effective patient-clinician relationship building most likely to occur.
    • Examine the impact of the communication within the health care system on the PCR, and strategies to address any negative impact on health or continuity of care.
    • Examine the role of clinician and administrative workforce diversity and its impact on the PCR through multi-level outcome measures.
  • Evaluate the communication challenges brought about by the COVID-19 pandemic, particularly in primary care and behavioral health care settings, and strategies to mitigate their impact.

Other Participating Institutes/Centers/Offices Areas of Research Interest

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 the use of innovative approaches to optimize patient-clinician communication and relationship, on individual, community or healthcare system levels, to reduce and encourage elimination of health disparities in patients with multiple chronic condition within the NIAMS mission relevant diseases. Research areas include rheumatology, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. Clinical trial applications will only be supported by NIAMS if submitted to a NIAMS clinical trial-specific FOAs. A current list of active NIAMS clinical trials FOAs is available at https://www.niams.nih.gov/grants-funding/conducting-clinical-research/grants. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

National Institute on Deafness and Other Communication Disorders (NIDCD)

The National Institute on Deafness and Other Communication Disorders (NIDCD) welcomes responsive applications involving populations with communication disorders including those affecting hearing, balance, taste, smell, voice, speech, and language. Populations of interest include both pediatric and adult.

Office for Research on Women's Health (ORWH)

The Office for Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that research on women’s health is supported at the NIH and within the larger scientific community. There is growing evidence that structural determinants of health (e.g. racism) influence health outcomes for women, including women receiving care for chronic conditions. Members of the clinical care team have the power to shift care practices to emphasize quality and affirmation as the standard, and incorporate the lens of equity, cultural humility, and interpersonal safety across health institutions. For this funding opportunity, ORWH is interested in supporting applications proposing to design, implement and evaluate clinician and unit-/practice-level trainings, seeking to improve patient-clinician communication, enhance safety and trust, and increase adherence to clinical recommendations in the care of women. Studies exploring multiple aspects of the clinical encounter (e.g. clinician communication style, approach to shared decision-making) are of particular interest. For additional guidance on areas of interest to the ORWH, please refer to the 2019-2023 Trans-NIH Strategic Plan for the Health of Women on the ORWH website (https://www.nih.gov/women/strategicplan).

The following types of projects will be considered not responsive to this FOA, and as such, will not be reviewed:

  • Studies without a focus on addressing PCR in one or more NIH-designated populations that experience health disparities.
  • Projects that do not examine the impact of PCR on health/health care disparities.
  • Studies proposing analyses or interventions at only one level or domain of influence (based on the NIMHD Research Framework)
  • Projects exclusively proposing qualitative methods.
  • Studies that exclusively describe the prevalence or use of modalities of patient-clinician communication among populations that experience health disparities.
  • Studies focused exclusively on clinician communication (verbal, non-verbal, written).
  • Studies focused on communication or relationship between patients and lay health personnel, or on education delivered by lay health personnel inside or outside of a health care setting.
  • Projects performed or with components outside of the U.S. and its territories.

Applicants are strongly encouraged to reach out to the relevant scientific contact(s) to discuss whether their applications align with the scope of this announcement.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal
Resubmission
Revision

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.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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. 

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Eligible Individuals (Program Director/Principal Investigator)

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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities (NOT-OD-22-019).

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

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:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

At any time prior to submission, prospective applicants may submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Larissa Aviles-Santa, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-6924
Email: avilessantal@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. A rationale for not having a formal plan should be addressed.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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.

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.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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.

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

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.

In addition, for applications involving clinical trials: 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.

Overall Impact

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).

Scored Review Criteria

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?

In addition, for applications involving clinical trials

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?
 

 

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?

In addition, for applications involving clinical trials

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?
 

 

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?

In addition, for applications involving clinical trials

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?

 

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?

In addition, for applications involving clinical trials
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?
 

 

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?

In addition, for applications involving clinical trials

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?
 

Additional Review Criteria

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.

 

Specific to applications involving clinical trials

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)?

 

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.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

For Renewals, the committee will consider the progress made in the last funding period.

 

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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 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.

 

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 comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

 

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.

2. Review and Selection Process

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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).

2. Administrative and National Policy Requirements

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Larissa Aviles-Santa, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-6924
Email: avilessantal@nih.gov

Xincheng (Ted) Zheng, MD, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-4953
E-mail: zhengx4@mail.nih.gov

Howard J. Hoffman
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: 301-402-1843
E-mail: hoffmanh@ms.nidcd.nih.gov

Damiya Eve Whitaker
Office Of Research On Women's Health (ORWH)
Phone: 240-276-6170
E-mail: damiya.whitaker@nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov


 

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Christopher Myers
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: (301) 435-0713
E-mail: myersc@nih.gov


 

Section VIII. Other Information

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.

Authority and Regulations

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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.