Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NIH Basic Behavioral and Social Science Opportunity Network (OPPNET)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute on Minority Health and Health Disparities (NIMHD)

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)

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Dyadic Interpersonal Processes and Biopsychosocial Outcomes (R01 - Basic Experimental Studies with Humans)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-21-280
Companion Funding Opportunity
PAR-21-281 , R01 Research Project
Assistance Listing Number(s)
93.399, 93.313, 93.866, 93.279, 93.242, 93.121, 93.307, 93.273, 93.865
Funding Opportunity Purpose

This funding opportunity announcement (FOA) invites basic and/or methodological research projects that illuminate and/or measure independent and interdependent health-related effects within dyads across relationships and settings. For the purpose of this FOA, a dyad is a unit of two individuals whose interactions and influences on one another are nested within larger social contexts and networks. Dyads are social relationships that extend beyond the individual and have strong bidirectional influences on physical and mental health. For the purpose of this FOA, independent effects are those effects that affect each member of the dyad individually (i.e., by nature of being part of the dyad), whereas interdependent effects are those that affect one member of the dyad contingent upon the other member of the dyad (i.e., not only because the individual is part of a dyad but also because being part of the dyad has an effect on the other individual within the dyad as well).

Key Dates

Posted Date
July 09, 2021
Open Date (Earliest Submission Date)
February 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
March 05, 2022 March 05, 2022 * May 07, 2022 * July 2022 October 2022 December 2022
March 05, 2023 March 05, 2023 * May 07, 2023 * July 2023 October 2023 December 2023

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
May 08, 2022
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

This funding opportunity announcement (FOA) invites basic and/or methodological research projects that illuminate and/or measure independent and interdependent health-related effects within dyads across relationships and settings. For the purpose of this FOA, a dyad is a unit of two individuals whose interactions and influences on one another are nested within larger social contexts and networks. Dyads are social relationships that extend beyond the individual and have strong bidirectional influences on physical and mental health. For the purpose of this FOA, independent effects are those effects that affect each member of the dyad individually (i.e., by nature of being part of the dyad), whereas interdependent effects are those that affect one member of the dyad contingent upon the other member of the dyad (i.e., not only because the individual is part of a dyad but also because being part of the dyad has an effect on the other individual within the dyad as well).

All applications submitted through this FOA must propose basic science experimental studies with humans, also referred to in NOT-OD-21-088 as “prospective basic science studies involving human participants.” These studies meet the NIH definition of basic research and also fall within the NIH definition of a clinical trial. Observational studies involving humans should submit under the companion Clinical Trials Not Allowed version of this FOA.

NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind” (32 CFR 272.3).

NIH defines a clinical trial as, "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes" (NOT-OD-15-015).

Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of this FOA, “specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an experimental manipulation or intervention where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may submit under this FOA.

Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate FOA for the type of study.

Background

Humans are a social species who form, maintain, and rely upon social entities that extend beyond the individual self. Such social intercourse has strong bidirectional influences on physical and mental health. This FOA focuses on the dyad, a unit of two individuals whose interactions and influences on one another are nested within larger social contexts and networks.

Examples of dyads include and, are not limited to:

  • Dyadic relationships that occur/endure over the lifecourse or other extended periods of time
    • E.g., romantic partners, siblings, close friends, colleagues, mentors
  • Care-givers and -receivers within existing relationships (aka “informal caregivers” and “care-partners”)
    • E.g., parent-child with Attention Deficit Hyperactivity Disorder(ADHD), adult with elder parent with Alzheimer's Disease and Related Dementias (ADRD)
  • Clinician and patient/client/consumer
  • Two members of a clinical team
  • Pairs of individuals who regularly engage in behaviors that have implications for health and/or wellbeing (E.g., Gym partners, running companions; alcohol, tobacco, or other substance-use (ATOD) buddies; other peers)
  • Pairs of individuals who interact in settings in which there are disparate levels of influence
    • E.g.,employee-employer, individual-observer, individual-law enforcer, student-teacher

Research across multiple disciplines has demonstrated that dyadic relationships not only influence the health and wellbeing of people within a dyad, but also that health-related outcomes at the dyadic level can be influenced by environmental, institutional, social, and/or other structural factors over the lifecourse. NIH-relevant (e.g. health relevant) factors influenced by dyadic relationships or interactions include and are not limited to, perception of risk; emotional experiences (e.g. fear); medical treatments; financial decision-making; and initiation, maintenance, and/or change in health-related behaviors.

Much research on dyads, behaviors, and health outcomes to date has relied on self-reported data, including data reported by a sole individual to describe both dyad members. Although past studies of dyads also have used lab-based methods, including observation with behavioral coding, paradigms for controlled interaction, and/or psychophysiological measures, twentieth-century technology and resources constrained more holistic and real-world data collection. Advances in current technology permit the development and collection of behavioral, environmental, interpersonal, social, and biospecimen data in myriad ways and settings to illuminate biopsychosocial processes within dyads and their longer-term implications for health and well-being.

The R01 mechanism, common to all NIH ICOs participating in this FOA, was chosen expressly to empower investigators to propose innovative scopes of work with correspondingly appropriate budgets. Regardless of the number of project-years proposed, investigators should budget each year for travel to an annual meeting of grantees on or near the NIH Campus in Bethesda, MD, to share research methods and findings. Awardees will be encouraged to work together on some shared scientific opportunities at the annual meeting and across the award period.

This funding opportunity invites basic and/or methodological research projects that measure and illuminate independent and interdependent effects within dyads across types of relationships and settings. Research projects between 2-5 years with correspondingly resourced budgets are recommended for submission. Proposed research projects are expected to address at least one of two broad research questions:

  1. How do interpersonal, dyadic-level processes influence health, illness, recovery, treatment, and/or overall wellbeing of one or both members of a dyad? (The following sample sub-questions are not exhaustive. Researchers are encouraged to read IC-specific targets of interest that appear later in this FOA.)
  • How, where and when do people form dyads to make health-related decisions?
  • What impacts do sex and gender have on one or both members of a dyad?
    • "Sex" refers to biological differences between females and males, including chromosomes, sex organs, and endogenous hormonal profiles. "Gender" refers to socially constructed and enacted roles and behaviors which occur in historical and cultural contexts and vary across societies and over time.
    • Individuals act in many ways that fulfill the gender expectations of their society. With continuous interaction between sex and gender, both biology and the expression of gender inform biopsychosocial processes that influence health, illness, treatment, recovery, and overall well-being (see, e.g., NOT-OD-15-102)
  • How do human dyads negotiate and set health-related goals?
  • How do specific qualities of dyadic relationships and communication settings impact interpersonal processes and functions such as individual/shared decision-making, beliefs, behavior, attitudes, emotions, stress responses, etc.?
    • Relationship qualities
    • In-person vs. online or written settings
  • How do similarities or differences between members of a dyad (such as age, sex, gender[-identity], sexual identity/orientation, race, ethnicity) influence health-related dyadic processes?
  • How do health-promotion, disease-treatment, or chronic-condition management contexts influence dyadic behaviors?
  • What biological processes support the formation and maintenance of different types of dyadic relationships?
    • E.g., Similar neural responses, synchronized pupil dilation
  • How do dyadic relationships moderate heritability of genetic risks by mitigating or exacerbating the risks of other environmental factors over time?
    • E.g., Parent-child dyad and child’s genetic risks for learning disabilities
  • How do electronic media (e.g., smartphone-delivered interventions, medical-system web portals, smartphone, or smart-app-delivered messages) impact on dyadic relationships and influences?
  1. How do processes at community and/or structural levels influence the dyadic interactions associated with health, illness, and well-being? (The following sample sub-questions are not exhaustive. Researchers are encouraged to read IC-specific targets of interest that appear later in this FOA.)
  • Which community, institutional, and/or structural factors or processes shape the dyadic interactions that influence health-related behaviors and outcomes?
  • How do historical or contemporary societal or cultural role expectations and power dynamics associated with race, gender[-identity], and/or sex influence dyadic interactions?
  • How do factors specific to healthcare influence provider-patient interactions/ communication? These factors could include and not be limited to, a healthcare provider’s profession/title, training, communication style, health care system. et cetera.
    • What influences do structural/institutional healthcare settings have on dyadic, health-related outcomes?
  • What factors within professional-level dyads facilitate or impede implementation of best care practices and/or positive health outcomes?

About OppNet

OppNet is a trans-NIH initiative that funds research activities that build the collective body of knowledge on the nature of behaviors and social systems and deepen our understanding of basic social-behavioral mechanisms and processes. All OppNet initiatives invite investigators to propose research projects that will advance basic social and behavioral sciences and produce knowledge and/or tools with potential relevance to multiple domains of health research. All NIH Institutes and Centers that fund research and Program Coordination Offices within the NIH Office of the Director (ICOs) collectively manage OppNet's scientific direction yet may not participate in every OppNet FOA. Consequently, applicants should review the list of ICOs in this FOA's Components of Participating Organizations. For more information about OppNet, visit https://oppnet.nih.gov.

OppNet strives to ensure that proposed projects focus primarily on basic social, behavioral, and biopsychosocial sciences. Though OppNet defers from imposing a definition on the field, OppNet uses the following statement to guide the concepts it develops toward funding opportunity announcements: basic behavioral and social sciences research (bBSSR) furthers our understanding of fundamental mechanisms and patterns of behavioral and social functioning, relevant to the Nation's health and wellbeing, and as they interact with each other, with biology, and with the environment. OppNet acknowledges that disease-, risk-, and wellness-contexts can provide opportunities to study basic behavioral or social processes, basic biobehavioral or biosocial interrelationships, or methodology and measurement relevant to bBSSR.

Research Objectives

OppNet recognizes that basic research in the behavioral and social sciences can be conducted in a broad variety of settings, including general population and clinical samples. It also can be embedded within studies that include disease (or risk-factor) outcomes, as long as the focus of the study is on basic behavioral or social processes, basic biobehavioral or biosocial interrelationships, or methodology and measurement relevant to BSS research. Applications submitted cannot include any specific aims that propose to measure clinical efficacy or effectiveness of any intervention. Investigators who wish to conduct studies with clinical endpoints as the primary outcomes should consider other NIH FOAs. The ICs participating in this FOA have specific interests and priorities listed below. OppNet strongly encourages researchers to contact IC-based Scientific/Research officials well in advance of submitting applications.

National Institute on Aging (NIA)

The National Institute on Aging (NIA) supports mechanism-based basic research under this FOA, including, but not limited to, the following:

  • The role of dyadic interactions in shared decision making across the lifespan and particularly across key life transitions
  • The role of interpersonal expectations (e.g., for instrumental/emotional support, for shared values, etc.) within dyads on physical, emotional, and cognitive resilience, well-being, and health in aging
  • The role of the dyad in promoting health behavior change and adherence to health-promoting behaviors, medical regimens, and lifestyles
  • How dyadic relationships contribute to health equity/inequity across health disparities populations (https://www.nia.nih.gov/research/osp/framework) in mid- and late-life
  • How dyadic interactions drive changes in central and peripheral physiology, with potential effects on health, function, well-being, and social connections
  • How dual-brain interactions (e.g. temporal dynamics, synchronization, coordination of neural activity) change in mid- and late-life
  • How features and dynamics of informal-caregiver and care-recipient relationships impact health and well-being for both members of the dyad
  • How differences (e.g., across birth cohort, geography, culture, etc.) in caregiving expectations influence dyadic interactions, with potential consequences for health and well-being
  • How structural and systemic inequities in access to healthcare (e.g., based on geography, policy, stigma, etc.) and other social determinants of health modify the impact of the dyad on mid- and late-life health and well-being
  • The role of technological advances in communication (e.g., telehealth, video chat) in supporting or undermining dyadic processes in mid- and late-life
  • The impact that institutions and cultures/communities have on mid-life dyads, and on trajectories of aging, cognitive and emotional function, and health

NIA is especially interested in dyadic-based research projects that align with the Alzheimer's Disease-Related Dementias (AD/ADRD) Research Implementation Milestones (https://www.nia.nih.gov/research/milestones). Mechanistic-based research that identifies or evaluates potential targets for behavior change interventions (Stage 0 of the NIH Stage Model; https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development), to be developed within the NIH Science of Behavior Change framework (https://commonfund.nih.gov/behaviorchange), is supported under this FOA.

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

NICHD seeks basic social, behavioral, and/or methodological research applications on dyads and health that align with the NICHD mission to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The NICHD's broad and diverse research portfolio includes research related to conception and pregnancy; normal and abnormal development in childhood; childhood trauma and critical illness; the transition from adolescence to adulthood; reproductive health; rehabilitation; intellectual, developmental, and physical disabilities; and population dynamics across the lifespan. Throughout its strategic priorities, NICHD encourages research that integrates cross-cutting topics: health disparities, disease prevention, infectious disease, nutrition, and global health.

Areas of particular interest to NICHD include, but are not limited to:

  • How parental-infant dyadic-level processes influence the composition and function of human milk, perinatal/infant outcomes, or maternal morbidity or mortality
  • How caregiver-child dyadic-level processes influence the nutritional or weight status of either member of the dyad and/or child growth and pubertal maturation
  • How dyadic-level processes, such as parent-child and peer-peer dyads, influence children's and adolescents' use of technology and digital media, and how those processes mediate the positive and negative relationships between distance learning or social media interactions and associated health outcomes (e.g., self-regulation, stress modulation, sleep disruption)
  • How parent-child (or other caregiver-child) dyadic relationships impact health literacy, shared medical decision-making, health care utilization, and health outcomes in dyads in which one or both members have limited English proficiency (LEP)
  • How the dyadic relationship between a critically ill child (or the parent of that child) and the child's health care provider affects patient care, health outcomes, and/or clinical decision making
  • How dyadic-level processes influence health in dyads in which one member is an individual with intellectual or developmental disabilities (IDD) or a physical disability (e.g., when either a parent or a child is an individual with IDD)
  • How dyads make decisions about and negotiate use (or non-use) of contraception and/or HIV/STI prevention, including the individual and relationship characteristics that influence those decisions
  • How exposure to trauma affects the dyadic relationship between a parent/caregiver and child or between intimate partners

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of the NIMHD is to lead scientific research to improve minority health and reduce health disparities. NIMHD supports the study of many aspects of minority health and health disparities— from biological and population sciences to clinical, behavioral, and translational research, as well as research on health care services, health systems and workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interrelation of these causes. Projects must include a focus on one or more of the following NIH-designated populations that experience health disparities in the United States: African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, less privileged socioeconomic groups, underserved rural populations, and sexual and gender minorities (SGMs). Comparison groups/populations may also be included as appropriate for the research questions posed. NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information).

NIMHD will not support animal studies under this FOA.

For the purposes of this FOA, we seek to understand the interrelation between dyad-level relationships and minority health and health disparities, including but not limited to research projects focused on the following:

  • Impact of dyad-level relationships on health behaviors and health outcomes in populations that experience health and health care disparities
  • Mechanisms by which racial, ethnic and sexual and gender minority dyad relationships influence resiliency and coping mechanisms to mitigate health risk factors
  • Impact of interpersonal, structural/systemic racism and discrimination and microaggressions on dyad-level relationships and health disparities
  • Impact of neighborhood/place, poverty, and stigma on dyad-level relationships
  • Impact of diverse cultures and the sociocultural environment on dyad-level relationships
  • Dyad-level intervention targets to improve health outcomes for populations that experience health disparities

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) supports research to discover the causes of mental illness and develop more effective and safer treatments. NIMH additionally supports mental health research in HIV through its Division of AIDS Research. NIMH strongly encourages applicants to consult with NIMH Program Officials when developing plans for an application. This early contact will provide an opportunity to clarify NIMH policies and guidelines, identify whether the proposed project is consistent with NIMH program priorities, and determine which available FOA would best support the proposed research. NIMH is interested in studies of interpersonal processes as they relate to the etiology, development, characterization, identification, and treatment of mental illness. NIMH encourages applicants to consider these goals when developing proposed studies that address the two broad research questions provided in the Background section above. NIMH is particularly interested in research that focuses on operationally-defined, empirically-supported functional domains or symptom(s) of mental disorders as opposed to broad diagnostic categories in which not all subjects may share the same underlying disease process. NIMH Research Domain Criteria (RDoC) constructs, such as those in the Social Processes domain, may inform mechanism-based hypotheses, the selection of measures, and criteria for enrolling participants who are experiencing (or at elevated risk of developing) disruptions in mental health. RDoC constructs are of interest for this Notice, but other, non-RDoC constructs may be suitable as well, especially if they maximize the probability that participants share the same mechanism of disorder.

Examples of such topics include but are not limited to:

  • Studies involving transgenerational dyads (e.g., parent-child) that address mental health or HIV related outcomes.
  • Individual differences in the effectiveness of paralinguistic communication, coordinated activity or synchronized behavior and/or brain function between individuals, including developmental processes related to such differences, for example:
    • Cross-subject real-time oscillatory or hemodynamic synchrony during dyadic communication or coordination.
    • Processes supporting turn-taking behavior.
    • Process supporting joint attention and/or the formation of common ground.
    • Vocal, facial, and gestural mimicry.
  • Ecologically valid studies of RDoC constructs (e.g., social communication, negative and positive valence systems, language, and attention) within a dyadic framework and the role of such processes in mental illness.
  • The relationships between dyadic interactions and functional outcomes in mental illness or HIV across the lifespan.
  • Elucidating whether and how thought processes associated with mental illness or psychopathology in one member of a dyad impacts the mental health of the other, for example via social contagion.
  • Determining neurobiological mechanisms by which dyadic interactions affect individual mental health.
  • Development of ecologically valid experimental paradigms by which to study the impact of dyadic relationships on mental health or HIV.
  • Mechanism-based research to identify characteristics of dyadic relationships that enhance or diminish risk for HIV or mental illness, and in particular, suicidal thoughts and behaviors.
  • Neural mechanisms and the utility of paralinguistic communication as a potential behavioral marker that can be exploited in mental health relevant mobile applications.
  • Dyadic interpersonal studies that examine the role of engagement in the intervention process.
  • Dyadic studies that illuminate the therapeutic process and/or mental health service utilization:
    • E.g. The development of dyadic metrics to measure therapeutic efficacy.
    • E.g. The use of paralinguistic audio-visual signals in detecting and classifying mental disorders and optimizing treatment.
  • Computational modeling empirically observed coordinated behavior from data obtained in dyadic human experiments and theoretical model development for quantifying dyadic human interactions
  • Mechanism-based research to better understand pathways between dyadic processes, intersectional stigma, and HIV treatment and prevention engagement and outcomes.
  • Innovative basic behavioral research on dyadic processes in couples which may influence use of HIV prevention strategies or risk of HIV acquisition.
  • Innovative basic behavioral research on dyadic processes that occur between people living with HIV or people placed at risk for HIV and their health care providers which may influence HIV prevention, care engagement, adherence, or clinical outcomes.

Finally, NIMH encourages applications that are focused on interpersonal processes, and which assess mental health dimensionally, integrate multiple levels of analysis (e.g., brain-based measures, physiology, behavior, self-report), and employ advanced methodology from fields such as social, cognitive, and affective neuroscience, communication science, clinical and experimental psychology, neuroimaging, and developmental or lifespan psychology.

The following areas are beyond NIMH’s scope of interest for this FOA:

  • Studies focusing on interpersonal processes among professional-level healthcare providers that are not related to mental health outcomes or HIV outcomes.
  • How interpersonal processes accelerate or affect burnout among healthcare professionals that do not measure mental health outcomes.
  • Studies on attachment in infant-parent communication.

National Institute of Dental and Craniofacial Research (NIDCR)

The NIDCR will prioritize applications that propose mechanistic research on dyadic processes relevant to dental, oral, or craniofacial health. Specific topics may include:

  • Dyadic processes that may contribute to the development or amelioration of dental fear or anxiety
  • Fundamental processes involved in interpersonal communication or other relationship dynamics (e.g., trust, power differentials, stigma, etc.) that may influence the provision of dental care and/or patient-provider interactions
  • Interpersonal processes that may advance understanding of best practices for formal or informal caregiving related to oral health

National Cancer Institute (NCI)

The NCI supports research into understanding mechanisms through which dyadic processes influence cancer prevention and control outcomes, including:

  • Health behaviors and decisions integral to effective cancer prevention and control, and for which relationships are an important determinant, including energy balance (diet, exercise, sedentariness); alcohol consumption; smoking/tobacco initiation and cessation; and sun safety;
  • Cancer screening and genetic/ genomic testing;
  • Cancer-related health communication (e.g., among patient-provider, patient-caregiver)
  • Adherence to cancer treatment regimens;
  • Decisions regarding treatments in contexts of clinical equipoise;
  • Cancer care delivery outcomes;
  • Aging-related consequences of cancer and cancer treatment on symptoms and symptom management (e.g., cognitive impairment, cancer pain);
  • Caregiver outcomes;
  • Inequities in cancer prevention and control outcomes.

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
Resubmission

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?

Required:Basic Experimental Studies with Humans: Only accepting applications that propose clinical trial(s) that also meet the definition of basic research.

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

  • Eligible Agencies of the Federal Government
  • 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
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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) ̵#8211; 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.

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.  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 NOT-OD-11-101)

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.

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.

Data Sharing Guidance for Applications Submitted to the National Institute of Mental Health (NIMH)

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-19-033). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. The NDA Data Sharing Plan is available for review on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.”

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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, NIH. Applications that are incomplete or non-compliant 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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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.

For this particular announcement, note the following:

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.

Significance

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?

Investigator(s)

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?

Innovation

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?

Approach

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?

Environment

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?

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.

Study Timeline


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)?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

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.

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

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.

Select Agent Research

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).

Resource Sharing Plans

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).

Authentication of Key Biological and/or Chemical 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.

Budget and Period of Support

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 Scienctific 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. 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.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

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 awardee 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).

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. More information is provided at Award Conditions and Information for NIH Grants.

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 “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, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions 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)

The Office of Behavioral and Social Sciences Research (OBSSR) facilitates OppNet on behalf of NIH but cannot accept assignment of applications or manage awards that are funded. Please contact one of the IC-based officials below for inquiries regarding the suitability of the proposed project for this FOA and the IC's research portfolio.

William Elwood, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-402-0116
Email: william.elwood@nih.gov

Ronna Popkin, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-5121
Email: ronna.popkin@nih.gov

Elizabeth Anne Barr, Ph.D.
Office Of Research On Women's Health (ORWH)
Phone: 301-402-7895
E-mail: elizabeth.barr@nih.gov

Mary Kautz, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: (301) 443-3206
Email: kautzm@nida.nih.gov

Rebecca Ferrer, Ph.D.

National Cancer Institute (NCI)

Phone: 240-276-6914

Email: ferrerra@mail.nih.gov 

Nadra Tyus
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301.402.1366
E-mail: nadra.tyus@nih.gov

Michael Sayre
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301 435-0962
E-mail: sayrem@mail.nih.gov

Laura Elizabeth Kwako
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-451-8507
E-mail: laura.kwako@nih.gov

The Office of Behavioral and Social Sciences Research (OBSSR) facilitates OppNet on behalf of NIH but cannot accept assignment of applications or manage awards that are funded. Please communicate with IC-based contacts for inquiries regarding the suitability of the proposed project for this FOA and the IC's research portfolio.

William N Elwood, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Phone: 301-402-0116
E-mail: elwoodwi@mail.nih.gov

David I. Leitman, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:301-827-6131 
Email: david.leitman@nih.gov Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov Liz Necka, Ph. D.
National Institute on Aging (NIA)
Phone: 301-480-6947 
Email: Liz.Necka@nih.gov

Elise Rice, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-4814
E-mail: elise.rice@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)

Replace this text with Staff Contact Name

Institute or Center full name (IC abbreviation)
Telephone: 301-NNN-NNNN
Email: xxxx@mail.nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nih.gov

Priscilla Grant
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov John Bladen 
National Institute on Aging (NIA)
Phone: 301-402-7730
Email: bladenj@nia.nih.gov

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@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.


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