Intervention Research to Improve Native American Health (R01 Clinical Trial Optional)

National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health
Disparities (NIMHD)
Office of Behavioral and Social Sciences Research (OBSSR)
National Institute of Nursing Research (NINR)
National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

Intervention Research to Improve Native
American Health (R01 Clinical Trial Optional)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-14-260

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-17-496

Companion Funding Opportunity

PAR-17-464, R21 Exploratory/Developmental Grant

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393,  93.273,  93.113, 93.242, 93.307; 93.279, 93.361, 93.121

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA)
is to encourage exploratory developmental research to improve Native American
(NA) health. Such research can include: conducting secondary analysis of
existing data (such as databases that the Tribal Epidemiology Centers have
collected); merge various sources of data to answer critical research questions;
conduct pilot and feasibility studies; and/or assess and validate measures
that are being developed and/or adapted for use in NA communities.

For the purposes of this FOA, the term ‘Native Americans’
includes the following populations: Alaska Native, American Indian, and
Native Hawaiian. The term ‘Native Hawaiian’ means any individual whose
ancestors were natives, prior to 1778, belonging to the area that now
comprises the State of Hawaii.

Studies should: be culturally appropriate and result in
promoting the adoption of healthy lifestyles; improve behaviors and social
conditions and/or improve environmental conditions related to chronic
disease; prevent or reduce the consumption of tobacco, alcohol, and other
drugs; improve mental health outcomes; reduce risk of HIV infection; improve
treatment adherence and/or health-care systems adopting standards of care to
improve overall quality of life.

Key Dates

Posted Date

September 29, 2017

Open Date (Earliest Submission Date)

April 14, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

May 14, 2018; May 14, 2019; May 14, 2020, by 5:00 PM local
time of applicant organization. All
types
of non-AIDS applications
allowed for this funding opportunity
announcement are due on these dates.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2018; October 2019; October 2020

Advisory Council Review

January 2019; January 2020; January 2021

Earliest Start Date

April 2019; April 2020; April 2021

Expiration Date

May 15, 2020

Due Dates for E.O. 12372

Not Applicable

It is critical that applicants follow 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 the 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 1. Overview Information
    Part 2. Full Text of the Announcement

    Section
    I. Funding Opportunity Description

    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission
    Information

    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Purpose

    The purpose of this funding opportunity announcement (FOA)
    is to develop, adapt, and test the effectiveness of interventions to improve
    health outcomes in Native Americans (NA) populations. Interventions proposed should:
    be culturally appropriate and promote the adoption of healthy lifestyles;
    improve behaviors and social conditions and/or improve environmental conditions
    related to chronic disease; prevent or reduce the consumption of tobacco,
    alcohol, and other drugs; improve mental health outcomes; reduce risk of HIV
    infection; develop, test, and disseminate treatment interventions; and improve
    treatment adherence and/or health-care systems adopting standards of care to
    improve overall quality of life. The intervention should be designed so that it
    can be sustained within the entire community with existing resources, and, if
    successful, disseminated and/or implemented in other NA communities. The
    long-term goal of this FOA is to reduce morbidity and mortality in NA
    communities.

    Tribes, communities, and organizations that do not have
    research experience are strongly encouraged to develop collaborations with
    research organizations.

    This FOA will utilize the Research Project Grant (R01)
    mechanism, and is suitable for projects where proof-of-principle of the
    proposed technology or methodology has already been established and supportive
    preliminary data are available.

    This FOA runs in parallel with an FOA of similar scientific
    scope, PAR-17-464, which utilizes the Exploratory/Developmental Grant (R21)
    mechanism.

    Background

    For the purposes of this funding opportunity announcement, Native
    Americans include the following populations: Alaska Native (AN), American
    Indian (AI), and Native Hawaiian (NH). The term ‘Native Hawaiian’ means any
    individual any of whose ancestors were natives, prior to 1778, of the area
    which now comprises the State of Hawaii. 

    Investigators are encouraged to view the following website: Intervention
    Research to Improve Native American Health (IRINAH)
    and are encouraged to
    contact the relevant Scientific/Research Contact listed in Section
    VII. Agency Contacts
     before application submission. This website will
    have information related to Technical Assistance Workshops that are planned for
    this FOA.

    Cultural
    Factors

    NAs have a concept of health that is often broader than the
    definition of absence of disease. All four elements of life — physical,
    emotional, mental, and spiritual– are intricately woven together and interact
    to support a strong and healthy person. In this holistic perspective, illness
    results from imbalance.

    Visiting the health-care system is often not the first
    recourse to those AI/ANs who identify strongly with their Tribal culture. They
    may initially go to a traditional healer or medicine man. Traditional native
    cultures often integrate several factors, such as an imbalance in the elements
    of life, as contributing to diseases such as cancer. AI/AN cultural norms
    regarding modesty, introversion, pragmatism, and fatalism can be barriers to
    screening, secondary prevention and treatment programs. However, high levels of
    traditionalism are significantly associated with disease protective behaviors
    and are inversely associated with disease risk factors, such as smoking and
    obesity. To be effective, interventions must demonstrate the immediate and
    long-term value of prevention and its importance to the balance of health.

    Individual
    Factors

    Increasing rates of chronic conditions in AI/AN populations
    are likely the result of a combination of factors, as discussed above. Adopting
    unhealthy lifestyles at the expense of healthy, culturally appropriate
    lifestyles are possibly the most important (i.e., physical activity and healthy
    eating patterns).

    Unhealthy diets have had a significant impact on the health
    and disease progression and survivorship among AI/ANs. The Federal government
    food commodities program, introduced about 60 years ago to combat starvation on
    reservations, had the unintended consequence of introducing some unhealthy
    dietary changes. For example, fry bread was one of the foods that resulted from
    the commodities given to reservation-residing NAs. Traditional diets, by
    contrast, are very healthy, based on seasonal foods, and consist largely of
    vegetables (corn, climbing beans, squash), lean game meats (bison, deer,
    turkey, fish), and gathered foods (wild rice, nuts, berries). The traditional
    life promoted active lifestyles, such as hunting, canoeing, athletics, and
    traditional dancing. Currently, there is also limited access to traditional
    healthy foods and diets.

    Tobacco is a sacred plant in many native cultures, and
    tobacco is used in prayer and in other customs. Mass-produced cigarettes, along
    with the introduction of habitual use of tobacco, have led to the current
    permissive attitudes towards smoking among AI/AN populations. This contrasts
    with traditional Native cultures in which smoking cigarettes is called abusing
    tobacco, and is considered taboo.

    Interventions

    Relatively few intervention studies on primary and secondary
    prevention as well as treatment have been conducted among Native Americans. However,
    there is an extreme dearth of research in some areas such as palliative care
    and cancer survivorship. Development and implementation of interventions within
    the health-care delivery systems in majority NA population areas are also very
    limited, and the research in this area is not on par with those in mainstream
    health systems.

    Physical activity and diet: Environmental change has been
    the most frequent intervention approach for physical activity interventions in
    AI/AN populations. Youth were targeted in over half of the interventions, with
    over a quarter implemented in schools. Research suggests that a very small
    percentage of interventions with evaluation components reported significant
    changes in health and fitness measures. Significant gaps include: 1) a paucity
    of programs focusing on urban AI/AN; and 2) lack of culturally acceptable and
    scientifically sound evaluation methods that can be implemented by local
    personnel to assess the health and social consequences of the interventions.
    Gaps in knowledge and areas for future research include: 1) enhancing the
    cultural and social relevance of the interventions; 2) integrating the
    interventions into the family and tribal/community infrastructure; and 3)
    developing sustainable programs.

    Cessation of tobacco abuse: At present, no Native-oriented
    program for trans-tribal cessation of tobacco abuse has been developed and
    proven efficacious. Research demonstrates that overall cessation rates for AI
    are very poor. However, higher smoking cessation rates for Native populations
    have been observed in Canada and Alaska Natives.

    Systemic changes in health-care delivery: There have been
    several emerging studies about access and utilization of care and the facility
    to complete treatments. Many of the differences in health outcomes can be
    attributed to patient-provider communication and access to and utilization of
    care (including transportation challenges).

    Numerous patient characteristics have been identified as
    contributors to disparities, including demographic (e.g., race), physiologic
    (e.g., immune status), health literacy and culture including beliefs, values,
    trust, and preferences. Other factors, such as socioeconomic status (SES), also
    have an impact on these issues. Patients with low SES are less likely to
    receive appropriate treatment services, and they often have worse outcomes and
    higher mortality than otherwise similar patients of higher SES. Several
    geographic, financial, and bureaucratic barriers are faced by AI/AN
    populations, resulting in lower access to specialty medical care for the early
    diagnosis and treatment of cancer.

    It is important to develop and implement prevention and
    treatment interventions that are directed at the individual, familial, and
    health-care delivery system levels to reduce the burden of cancer and improve
    overall quality of life.

    Developing
    Culturally Appropriate Studies

    The research plan should be consistent with community
    attitudes. The following describes elements of the research and
    experimental approaches that are being sought to achieve the following Specific
    Research Objectives:

    1.
    Community-based Participatory Research (CBPR).
     Given the
    long history and deep involvement of the family and the tribe in individual
    decisions on health and ultimately disease outcomes, projects to serve the NA
    communities should incorporate a community-based participatory research (CBPR)
    approach to adapt, develop, and test interventions, in which the
    tribes/communities are equal partners with academic/research institutions.
    Interventions should focus on community/cultural strengths and resiliencies.

    The CBPR endeavor should adopt an intervention approach that
    seeks to target both individual behaviors and seeks to intervene at the social
    and institutional levels (e.g., familial, and tribal levels, respectively).
    These studies can design and implement community-based participatory prevention
    strategies to promote aggregate-level health by changing social and community
    environments (e.g., regulation of smoking in public places, institutional
    policies, access to safe/cleaner water, food, air, and soil). These
    interventions should be culturally sensitive, consistent with community values,
    and responsive to health literacy demands; they may include traditional health,
    medical, and/or cultural practices. It is recommended that an ecological
    approach to the design be considered, so that these interventions can be
    sustained over a long period of time.

    Tribal-level approval and buy-in from the NA community are
    also critical to the implementation of these interventions. Thus, for the
    initial phase of the application researchers may choose to incorporate a
    mixed-model approach, with an initial qualitative data phase for intervention
    development, using talking circles, interviews, focus groups, and surveys.

    2.
    Interventions.
     Interventions should be designed to engage
    the participants and be of sufficient intensity to affect change, because
    sustained behavior change is needed to reduce risk of disease, morbidity, and
    mortality. Moreover, despite the efficacy of some treatments, such as
    combination HIV-related therapies, many people living with HIV in the U.S. and
    worldwide do not benefit from treatment because they are poorly engaged in
    medical care, and research is needed to promote factors contributing to
    engagement. Interventions should be directed both at the individual and
    familial/institutional/structural levels simultaneously. The proposed intervention
    in addition to behavior change should also incorporate
    familial/community/institutional changes so that these interventions can be
    sustained over time. However, the interventions should not be so intensive or
    time-consuming that they would exceed the resources of the
    participants/community to participate.

    The interventions to be tested must be consistent with
    community values and may include traditional health, medical, and/or cultural
    practices. Proposed interventions proposed should account for community
    resilience in the health promotion and disease prevention projects. The term
    community resilience is often defined as the sustained ability to utilize
    available resources to respond to, cope, withstand and recover from with
    unexpected shocks or adverse situations. Resilient communities are those with a
    particular capacity to cope and respond to these adverse conditions. As a
    result, if ethics are not consciously considered at the inception of
    community-driven data projects, steps taken to increase community resilience
    and eliminate health inequities could in fact create more vulnerability and
    thus do harm.

    It will be important for studies to consider the development
    of intervention manuals for primary and secondary prevention that can be
    disseminated if proven effective, to other NA communities.

    The interventions should be delivered by individuals (e.g.,
    behavioral professionals, community health workers, counselors, nutritionists,
    nurse practitioners, physician assistants, traditional healers) drawn from the
    community to the greatest extent possible.

    3.
    Standardization and Coordination
    . Although the studies
    supported by this initiative will not use a common study protocol, whenever
    possible, investigators are expected to meet after the awards are made and
    should, to the extent possible, collaborate and report in a standardized manner
    when they are measuring key common variables, such as social and environmental
    determinants of health, access to care, diet, physical activity, height and
    weight, oral disease status, and smoking status and rates. Investigators may
    also use different methods of measuring similar outcome variables when
    justified. Investigators may also collaborate in the development of formative
    assessment measures, such as survey instruments and focus group guidelines.

    Investigators are encouraged to collaborate for data
    archiving, such as selecting a single archive and archiving format, if that is
    acceptable to community collaborators. Locations of semi-annual meetings will vary
    depending on sites funded through the initiative. The meetings will provide a
    venue for presenting scientific findings from each of the funded studies and
    are intended to facilitate synergistic interactions among the projects within
    the evolving community of scientists. The investigators may form committees
    that would meet periodically by conference calls as needed. PDs/PIs will be
    expected to participate in these conference calls for planning purposes at
    monthly or other appropriate intervals. Other investigators should set time
    aside as needed to participate in cross-cutting “research interest groups” and
    other collaborative activities as a way of advancing transdisciplinary science
    in NA communities.

    4.
    Outcome Measures
    . Potential
    outcome measures include, but are not limited to:

  • Increased availability of healthy foods;
  • Increased development of community-based programs, such as
    community physical activity programs;
  • Improved clinical practices that are culturally relevant and
    appropriate;
  • Verified screening rates;
  • Biochemical verification for smoking status;
  • Nutrient biomarkers as measures of dietary intake (e.g., urinary
    sodium as a measure of dietary sodium intake, urinary potassium as a measure of
    fruit and vegetable intake);
  • Body mass index or body weight for diet and physical activity;
  • Delayed initiation of drug and alcohol use or decreased frequency
    of use;
  • Reduction in high risk drinking and alcohol use;
  • Reduction in alcohol and drug use among women of childbearing
    age;
  • Improvement in HIV-related biological markers (CD4, VL); 
  • Reduction in HIV-related risk behaviors and in AIDS-associated
    co-morbidities;
  • Increase in pro-social behaviors;
  • Reductions in deaths due to suicide and/or number of persons who
    report a major depressive episode;
  • Increased use of mental health services;
  • Increased access to specialized mental health services through
    mobile devices, or telemedicine;
  • Decreased body burden of key environmental agents of interest;
  • Improved access to and use of sustainable preventive, telehealth,
    and self-care strategies for oral health.

Adherence to recommendations, such as engaging in physical
activity, diet, smoking cessation, moderate drinking, screening, oral disease
preventive self-care, as well as improved quality of life, are of interest as
indicators of success of the program(s). In addition to specifying the primary
outcome, applicants should propose and justify secondary outcomes and measures.
Although an extensive cost analysis is beyond the scope of this initiative,
applicants should collect and consider limited analyses of cost data.

Specific Research Objectives and Scope

Each institute has specific areas of research interest.

National
Cancer Institute (NCI)

Native American populations have the lowest 5-year cancer
survival rate and highest percentage of disseminated and ill-defined cancers of
any subpopulation in the U.S. Poorer cancer survival rates have been attributed
to many factors, among them inadequate access to health care, geographic
isolation, later stage of detection, underutilization of treatment, poverty,
and social and cultural barriers.

The National Cancer Institute (NCI) is interested in
applications that focus on both individual and community interventions relating
to primary and secondary cancer prevention and treatment. It is important that
researchers consider the context in which people live (place, built
environment, etc.) and develop interventions that can improve overall health
and result in improved health outcomes as they relate to health care delivery, cancer,
and cancer survivorship; improve treatment adherence and/or health-care systems
in adopting standard of care treatment to improve overall quality of life.

National
Institute on Alcoholism and Alcohol Abuse (NIAAA)

According to the CDC, from 2001 to 2005, alcohol attributed
deaths accounted for 11.7% of Native American deaths. At present, little is
known about how empirically-supported alcohol prevention, intervention and
clinical treatment interventions operate within Native American populations,
and how they can be modified to address their societal and cultural needs. Additionally,
little is known about how Native Americans may utilize already existing
recovery-based support systems. Given this background, the National Institute
on Alcoholism and Alcohol Abuse (NIAAA) is interested in prevention and
clinical interventions as well as research that seeks to understand processes
of recovery among Native Americans.

  • Intervention research of interest is as follows, but not limited
    to the following areas:
  • Interventions to reduce high risk drinking and alcohol use;
  • Interventions to promote moderate drinking or abstention;
  • Interventions to postpone onset of drinking among youth; and
  • Interventions to prevent any alcohol use among pregnant women
  • Test the relative effectiveness of comprehensive, multicomponent,
    community-based environmental interventions to reduce underage and binge
    drinking and related harmful behaviors among youth and young adults, in rural
    and urban areas;
  • Research to culturally adapt existing behavioral treatments among
    Native Americans in order to reduce heavy and problematic drinking;
  • Identify precipitants of relapse, and evaluate interventions to
    address these risk factors in the course of recovery;
  • Develop and test interventions that integrate clients, families,
    communities and other local support institutions into the prevention, treatment
    and recovery process;
  • Identify, develop, and test models and methods that can enhance
    the diffusion, implementation, and adoption of evidence-based alcohol-related
    treatment practices across the full spectrum of services for at-risk, harmful,
    and dependent Native American drinkers.

National
Institute on Drug Abuse (NIDA)

NIDA is interested in culturally appropriate applications
focused on substance use among Native adolescents and adults. Applications may
use a range of approaches to assess substance abuse and related factors,
including but not limited to piloting or testing novel prevention, screening,
and treatment interventions; harmonizing and analyzing existing datasets to
address intervention or etiological questions. Applications may also focus on a
range of topics such as etiological factors; intervention; examining patterns
of health service utilization; examining treatment work force factors; and studying
adaptation, implementation, and dissemination of existing evidence-based
prevention or treatment interventions to increase uptake. Specific areas of
interest include, but are not limited to:

  • Research pertaining to any aspect of opiate use disorder (OUD),
    including data on the nature of the problem and related factors on and/or off
    reservations; examining the efficacy of prevention and treatment interventions
    (including models that that integrate treatment with healthcare); examining the
    impacts of increased availability of naloxone and approaches to disseminate
    naloxone widely; utilization of, and/or identification of factors associated
    with uptake of, medication assisted treatment (MAT) to treat opiate use
    disorder (OUD); characterization of workforce and/or community factors and
    barriers related to the treatment of OUD; a focus on pregnant women and
    exposure to opioids
  • Research to test interventions developed through theory-based
    approaches to support healing, resilience, and substance abuse in Native youth
    with risk factors for drug use, such as suicidal ideation and other mental
    health conditions
  • Research to test evidence-based prevention or treatment
    intervention approaches developed for a specific Native or non-Native
    population across multiple tribes, reservations, or regions
  • Studies that examine SU prevention and treatment targeting AI/AN
    adolescents and young adults
  • Development, implementation, or analysis of trauma-informed
    interventions to address SUD
  • Research to examine the impact of environmental, programmatic,
    and policy changes on initiation and/or escalation of drug use in youth and
    adolescents
  • Therapist/provider training and fidelity interventions to ensure
    faithful administration of treatment interventions
  • Research that uses innovative technologies to develop or improve
    treatment interventions
  • Research on the essential components of treatment intervention
    (putative treatment targets) to focus on personalization and optimization
  • Research that addresses prescription drug abuse or effective pain
    management in AI/AN populations
  • Studies that include justice-involved AI/AN populations. Data
    from SAMHSA’s Treatment Episode Data Set (TEDS) show that nearly half of all
    substance abuse treatment referrals in AI/AN populations come from the criminal
    justice system. 
  • Studies that take a multi-generational perspective, for example
    addressing maternal-child effects of OUD

National
Institute on Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested
in applications relevant to preventive and treatment interventions in Native
American communities in both non-AIDS and AIDS research areas.

Examples of specific areas of interest for NIMH are included
below, but not limited to: 

a) Non-AIDS-related Research Areas

  • Develop and test new preventive and treatment strategies and
    novel implementation approaches to support sustained use of science-based
    interventions;
  • Optimize and test science-based interventions that preempt,
    prevent and treat mental disorders, including interventions to reduce suicide,
    consistent with research priorities noted by the National Action Alliance for
    Suicide Prevention’s Research Prioritization Task Force;
  • Develop empirically informed culturally appropriate interventions
    for increasing engagement in mental health services and linkage to care across
    Tribes and geographical regions;
  • Test strategies to increase use of evidence-based mental health
    care for individuals in hard-to-reach communities, including mobile and IT
    interventions; 
  • Explore which factors promote resilience and prevent mental
    disorders in at the individual level to develop preventive intervention
    targets;
  • Test innovative, empirically guided strategies for integrated
    primary health care and mental health care in order to improve access,
    engagement, and continuity, equity, and value of mental health services while
    simultaneously addressing commonly occurring medical comorbidities

b) AIDS-related Research Areas

  • Develop and test interventions to address the prevention, care,
    and treatment needs for sexual and gender minorities, two spirit people, and
    other individuals vulnerable to HIV from indigenous communities;
  • Develop and test interventions based on the mechanisms that are
    driving new infections and poor health outcomes among those living with HIV
    (e.g., factors like stigma, mental health, social/sexual networks, access to
    and quality of health care, experiences of trauma);
  • Develop novel multilevel preventive interventions, combination
    biomedical-behavioral approaches, and/or interventions targeting comorbidities
    to advance HIV prevention and care within those Tribal communities most
    impacted by HIV;
  • Explore operations research to focus on barriers, facilitating
    factors, and outcomes of scaling-up HIV prevention and care interventions with
    known efficacy; and improve uptake and effectiveness of efficacious
    interventions, particularly for individuals in hard-to-reach remote
    communities.

Applications that involve developing or testing preventive-,
therapeutic-, or services- interventions are expected to comply with NIMH’s
mechanism-based, experimental therapeutics approach as outlined in NIMH’s Clinical Trials Funding Opportunity
Announcements
. Under this approach, trials must be designed to
explicitly test whether the intervention engages the proximal
target(s)/mechanism(s) presumed to underlie the intervention effects. Both
non-AIDS and AIDS, that applications propose adaptations to existing
interventions should provide an empirical rationale for the need for and focus
of the adaptation, consistent with NAMHC Workgroup Report recommendations on intervention
adaptation (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/fromdiscoverytocure.pdf).
Potential applicants are strongly encouraged to consult with relevant Institute
Scientific/Research Staff as far as possible in advance of any application to
discuss the match to current Institute priorities.

National
Institute of Environmental Health Sciences (NIEHS)

The National Institute of Environmental Health Sciences
(NIEHS) is interested in interventions aimed to reduce the impact of
environmental exposures on diseases and disorders among NA populations. In
addition to testing the efficacy of interventions on exposure reduction,
applicants also are encouraged to examine the effects on interim preclinical
markers of disease when possible. Applications may include, but are not limited
to, projects focused on:

  • Development and testing of culturally-appropriate health
    promotion strategies and interventions designed to educate tribal leaders and
    tribal members about historical and emerging environmental hazards;
  • Evaluation of existing environmental risk messages for their
    efficacy at changing behavior or policies (Implementation Research);
  • Development and testing of interventions that encourage behavior
    change to reduce or eliminate exposure;
  • Development and testing of existing low cost, sustainable methods
    that address indoor air pollution; or that provide safe alternatives to contaminated
    drinking water and food and/or remediation of contaminated water, air and/or
    soil;
  • Testing the impacts of policy-level decisions and interventions
    which are likely to influence environmental exposure levels and associated
    health outcomes.

National
Institute on Minority Health and Health Disparities (NIMHD)

NIMHD leads scientific research to improve minority health
and reduce health disparities, to realize an America in which all populations
will have an equal opportunity to live long, healthy, and productive lives. To
accomplish this, NIMHD raises national awareness about the prevalence and
impact of health disparities and disseminates effective individual-,
community-, and population-level interventions to reduce and encourage
elimination of health disparities. NIMHD is interested in projects including,
but not limited to, the following:

  • Interventions derived from local culture in strategies, process, implementation,
    and evaluation.
  • Projects that directly address methodological issues inherent in research
    in small populations such as those in many native communities.
  • Culturally-leveraged community based interventions focused on
    existing practices that support strengths and resilience factors that may be
    applicable and useful in other communities.
  • Projects that document efficacy and monetize traditional healing
    interventions for coverage by insurance.
  • Projects that develop innovative approaches to the provision of
    non-stigmatizing and resilience supportive prevention and treatment
    interventions.

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.

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 total project period may not
exceed 5 years.

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

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)

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)
  • 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

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 allowed only when the
ancestral catchment area(s) of tribe(s) cross(es) national boundaries.

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) (formerly CCR) – 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.
  • NATO
    Commercial and Government Entity (NCAGE) Code
    – Foreign organizations must
    obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • eRA Commons – Applicants
    must have an active DUNS number and SAM registration in order to complete the
    eRA Commons registration. Organizations can register with the eRA Commons as
    they are working through their SAM or Grants.gov registration. 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.

Involvement of Native American researchers and other
appropriate professionals is encouraged.

2. Cost Sharing

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

Number of Applications

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will not
accept:

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms 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.

It is critical that applicants follow the Research (R) Instructions
in the
SF424
(R&R) Application Guide
, including Supplemental
Grant Application Instructions
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.

For information on Application Submission and Receipt, visit Frequently
Asked Questions – Application Guide, Electronic Submission of Grant
Applications
.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information
, prospective applicants are asked to submit a letter of intent
that includes the following information:

  • 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:

Shobha Srinivasan, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6936
Fax: 240-276-7908
Email: ss688k@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:

Research
Strategy:
Applicants should address the following topics as
they pertain to the research project proposed:

A. Pilot
Data:
 Given that many NA communities are small and many
members are dispersed across the US, it is not a requirement to provide pilot
data from the community under study. However, PD/PI(s) and collaborator(s) are
encouraged to provide such data if they are available. Or else applicant(s) are
encouraged to provide data on similar interventions that have been conducted in
comparable (sub) populations or settings. Some of the sources or citations may
not published. Similarly, it may not be possible to generalize results from
these studies to other (sub) populations. However, applicant(s) should discuss the
above factors in the application.

B.
Recruitment of Individuals and Communities
: Applicants can propose
to include one or more NA communities to achieve the necessary sample size or
otherwise enhance the scientific value of the study sample. Applicants must
provide evidence of community support and of their ability to recruit
participants in each community involved in the study, to implement measurement
and intervention protocols in the target population, to provide appropriate
oversight, and to maintain high rates of retention throughout the intervention
and follow-up period.

Individuals recruited as part of a pre-existing
non-intervention study may be proposed for inclusion in the proposed study.
However, applicants must provide evidence that recruitment from an existing
cohort will not unduly interfere with the goals of the existing study or that
the cohort is no longer being studied. In addition, the application should
include a justification for including such participants for the proposed
protocol.

C. Study
Design:
 Applicants should choose rigorous study designs to
test the effectiveness or efficacy of the proposed intervention. While
randomized designs are ideal for reducing threats to internal validity, other
research designs will be given consideration. The research approach is an
important review criterion and investigators are encouraged to select a
research design that will provide convincing evidence regarding the research
questions. Thus application must address concerns related to the quality of the
research such as outcome variables and anticipated magnitude of change,
psychometrics for planned measures, expected attrition, power estimation, and
statistical analyses planned. Applicants should also provide plans for
assessing fidelity of implementation and other relevant process measures.
Applicants are advised to consult with a methodologist and/or statistician when
proposing a design with regard to its appropriateness for testing the proposed
intervention, level of rigor, handling of missing data, and with regard to the
data points needed for the planned analyses.

It is imperative that applicants describe and justify the
nature of any comparison/control group, that is, whether the comparison group
will receive, for example, usual care, information only, minimal treatment, or
delayed intervention. Applicants should consult with collaborating communities
to discuss the appropriateness of the selected approach to the comparison
group, as tribal leaders and community members may believe that comparison
group members should receive something more than usual care.

Awardees will have primary responsibility for collecting,
editing, storing, and analyzing their data. Awardees should oversee testing of
their interventions and adherence to their protocols, and assure that
appropriate quality control procedures are in place. Each awardee will be
responsible for training and certification of personnel.

D.
Collaborations:
Collaborators should address issues of ownership,
control, and storage of data and biological samples in the application.
However, NIH recognizes that communities may wish to retain ownership or
control of data and biological samples. After award, partners should negotiate
a formal and written data and biological sample agreement. This written
agreement, once signed by all parties, should be submitted to NIH after award.

E.
Community-based Participatory Research (CBPR):
 The
community-researcher partnership should be documented in the grant application
under Research Strategy to demonstrate the community’s involvement in
development, design, testing, and dissemination of the study, including
establishing a Community Advisory Board. If this approach is used, the
application should provide sufficient description of the intervention approach
and its implementation for reviewers to assess its significance, innovation,
and potential for public health impact.

F.
Community Support:
 Applications are expected to include
evidence of: 1) strong scientific capabilities; and 2) community involvement
and support.

Applications that represent collaborations between a tribe
or community and a research organization should describe the scientific,
logistic, and organizational responsibilities of each of the collaborators for
each aspect of the proposed project. The application should also describe the
history of the partners in collaborating on prior research projects, or other
mutually beneficial activities, the mutual understanding and cooperation among
the partners, procedures for resolving disagreements, and the relative
contributions to the previous projects.

G.
Standardization and Coordination
: When applicable,
Investigators should indicate in their application their willingness to
collaborate on the development and use of standardized measurement protocols,
and coordination of formative assessment and possibly of intervention
approaches.

Letters
of Support:
 If the applicant(s) is working with
tribes/Tribal governments then Tribal/community resolutions of support, or
equivalent documents, must accompany the application.

  • Applications that represent a partnership between a tribe or
    community and a research organization must include a resolution from the tribal
    or community government or equivalent document, specifying that the community
    or tribe agrees to participate as a partner in the project and will strongly
    support the project for its entire duration.
  • Applications that include more than one tribe or community must
    include a resolution of support, or equivalent document from each participating
    tribe and community.
  • If the application includes a consortium of tribes or
    communities, applicants must provide a resolution of support from each tribe or
    community of the consortium.
  • Applicants including participants from an extant study must
    submit, prior to the review, a letter from the PD/PI or steering committee of
    the parent study approving their participation. 
  • If the applicant is a tribally sanctioned non-profit tribal
    organization, specific tribal resolution(s) of support will not be required if
    the current tribal resolution(s) under which the organization operates
    encompasses activities proposed in the application. A copy of the current
    operational resolution(s) must be submitted with the application.
  • Each NA organization that participates in the project must also
    submit such a letter of support.
  • If tribes seek ownership or control of all data and all
    biological samples, then universities and other partners should be prepared to
    negotiate data sharing and biological sample sharing agreements as appropriate
    and provide letters of agreement/partnership.
  • In recognizing that Tribal governments are legal sovereign
    nations, potential partners should be informed that tribes may seek ownership
    or control of all data and all biological samples; therefore, universities and
    other partners should be prepared to negotiate data sharing and biological
    sample sharing agreements with tribes/Tribal government(s) as appropriate. If
    such an agreement is in place the applicant(s) should provide the letter of
    such an agreement with the application. Letters of Support should also
    explicitly stipulate that Tribes agree to respond expeditiously to requests for
    approval of the protocol, protocol modifications, approval of abstracts for
    presentation to scientific meetings, and approval of manuscripts for submission
    for publication in scientific journals. The time required for approving each of
    these (protocol, abstracts, manuscripts): 1) must be proposed and stated within
    the resolution of support, 2) may differ for each of these activities, 3) may
    be modified by study investigators only in consultation with the
    tribal/community leadership, and 4) should identify an individual or entity
    within the tribe or community to whom a request for waiver of the time
    requirement can be directed if circumstances arise. PD/PI(s) and
    tribes/communities are expected to publish scientific papers, present at
    scientific conferences/associations/meetings; and may also be expected to
    develop fact sheets/materials for dissemination to the tribe/community.
  • Because the application represents collaboration(s) between
    tribe(s)/community(ies) and research organization(s), the letters of support
    should also describe the scientific, logistic, and organizational
    responsibilities of each of the collaborators for each aspect of the proposed
    project. The letter(s) of support should also describe the history of the
    partners in collaborating on prior research projects, or other mutually
    beneficial activities, the mutual understanding and cooperation among the
    partners, and the relative contributions to the previous projects.
  • All applications, regardless of the amount of direct costs
    requested for any one year, should address a Data Sharing Plan.

Appendix:

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical
research, and/or clinical trials 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 a Delayed
Onset Study
record.

Protection of Human Subjects: A Data and Safety
Monitoring Plan (DSMP) may be required or projects that are proposing to pilot
test interventions. If a DSMP is needed, the PD(s)/PI(s) of each study will
establish a DSMP to monitor data and oversee participant safety in each study
supported by this initiative.

Applicants should not appoint DSMP members in advance of the
peer review, or even inquire about the interest of possible DSMP members, to
facilitate peer review. 

Study
Record: PHS Human Subjects and Clinical Trials Information

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

Delayed
Onset Study

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.

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 Applying
Electronically
. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues
. 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.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Only the review criteria described below will be considered
in the review process. As part of the
NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

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 there a
strong scientific premise for the project? 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 proposing clinical trials

For all CT FOAs, add the following questions, after
the standard questions for the Significance criterion.

Are the scientific rationale and need for a clinical
trial to test the proposed hypothesis or intervention well supported by
preliminary data, clinical and/or preclinical studies, or information in the
literature or knowledge of biological mechanisms? For trials focusing on
clinical or public health endpoints, is this clinical trial necessary for
testing the safety, efficacy or effectiveness of an intervention that could
lead to a change in clinical practice, community behaviors or health care
policy? For trials focusing on mechanistic, behavioral, physiological, biochemical,
or other biomedical endpoints, is this trial needed to advance scientific
understanding?

Specific to this FOA: Does the project
address issues that are critical to Native American communities/tribes? Will
the project advance the science and improve the lives for Native American
communities/tribes? Does the project address issues related to sustainability
and/or implications for implementing and/or disseminating the intervention, if
successful, to other Native American communities/tribes?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or 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 proposing clinical trials

For all CT FOAs, add the following questions, after
the standard questions for the Investigator(s) review criterion.

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?

In
addition, for applications proposing clinical trials

For all CT FOAs, add the following questions, after
the standard questions for the Innovation review criterion.

Does the design/research plan include innovative
elements, as appropriate, that enhance its sensitivity, potential for
information or potential to advance scientific knowledge or clinical practice?

Specific
for this FOA:
Does the application provide novel or innovative
insights into improving the health of the Native American community/tribe? Are
the issues addressed in the application of priority and importance to the
Native American community/tribe?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the 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?

In
addition, for applications proposing clinical trials

For all CT FOAs, add the following questions, after
the standard questions for the Approach review criterion.

Does the application adequately address the
following, if applicable:

Study
Design

Is the study design justified and appropriate to
address primary and secondary outcome variable(s)/endpoints that will be clear,
informative and relevant to the hypothesis being tested? Is the scientific
rationale/premise of the study based on previously well-designed preclinical
and/or clinical research? Given the methods used to assign participants and
deliver interventions, is the study design adequately powered to answer the
research question(s), test the proposed hypothesis/hypotheses, and provide
interpretable results? Is the trial appropriately designed to conduct the
research efficiently? Are the study populations (size, gender, age, demographic
group), proposed intervention arms/dose, and duration of the trial, appropriate
and well justified?

Are potential ethical issues adequately addressed? Is
the process for obtaining informed consent or assent appropriate? Is the
eligible population available? Are the plans for recruitment outreach,
enrollment, retention, handling dropouts, missed visits, and losses to
follow-up appropriate to ensure robust data collection? Are the planned
recruitment timelines feasible and is the plan to monitor accrual adequate? Has
the need for randomization (or not), masking (if appropriate), controls, and
inclusion/exclusion criteria been addressed? Are differences addressed, if applicable,
in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and
monitor adherence to, the trial protocol and data collection or distribution
guidelines appropriate? Is there a plan to obtain required study agent(s)? Does
the application propose to use existing available resources, as applicable?

Data
Management and Statistical Analysis

Are planned analyses and statistical approach
appropriate for the proposed study design and methods used to assign
participants and deliver interventions? Are the procedures for data management
and quality control of data adequate at clinical site(s) or at center
laboratories, as applicable? Have the methods for standardization of procedures
for data management to assess the effect of the intervention and quality
control been addressed? Is there a plan to complete data analysis within the
proposed period of the award?

Specific to this FOA: Is there evidence
that the Native American community/tribe(s) have been appropriately involved in
the study design and overall approach for the research proposed? 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 children, justified in terms of the
scientific goals and research strategy proposed?

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?

In
addition, for applications proposing clinical trials

For all CT FOAs, add the following questions, after
the standard questions for the Environment review criterion.

If proposed, are the administrative, data
coordinating, enrollment and laboratory/testing centers, appropriate for the
trial proposed?

Does the application adequately address the
capability and ability to conduct the trial at the proposed site(s) or centers?
Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the
application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the
ability of the individual site or center to: (1) enroll the proposed numbers;
(2) adhere to the protocol; (3) collect and transmit data in an accurate and
timely fashion; and, (4) operate within the proposed organizational structure?

Specific to this FOA: Does the project
provide evidence of Native American community/tribal support, as appropriate?

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.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six 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 six 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 Children 

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 children 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

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

Revisions

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.

Applications from Foreign Organizations

Not Applicable.

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 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:

  • 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.
  • Will receive a written critique.

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.

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
.

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 grantee’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.

Additionally, ICs may specify any special reporting
requirements for the proposed clinical trial to be included under IC-specific
terms and conditions in the NoA.  For example: If the proposed clinical trial
has elevated risks, ICs may require closer programmatic monitoring and it may
be necessary to require the awardee to provide more frequent information and
data as a term of the award (e.g., to clarify issues, address and evaluate
concerns, provide documentation). All additional communications and information
related to programmatic monitoring must be documented and incorporated into the
official project file.  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 of all trials
whether required under the law or not. For more information, see
http://grants.nih.gov/ClinicalTrials_fdaaa/ 

Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that the application as well as 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).

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, Grantees, 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 law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. 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. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

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
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, 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)

Grants.gov
Customer Support
(Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Shobha Srinivasan, Ph.D. 
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: ss688k@nih.gov

Judith A. Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: Jarroyo@mail.nih.gov

Aria Davis Crump, Sc.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: acrump@nida.nih.gov

Andrea Horvath Marques, M.D., Ph.D., M.P.H.
National Institutes of Mental Health (NIMH)
Telephone: 301-443-2847 
Email: andrea.horvathmarques@nih.gov

Symma Finn, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: finns@niehs.nih.gov

Dorothy Castille, Ph.D.
National Institute on Minority Health and Health Disparities
(NIMHD)
Telephone: 301-594-9411
Email: dorothy.castille@nih.gov

Mary Roary, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-2154
Email: Mary.roary@nih.gov

Darien Weatherspoon, D.D.S., M.P.H.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5394
Email: darien.weatherspoon@nih.gov

Peer Review Contact(s)

Martha L. Hare, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-451-8504
Email: harem@mail.nih.gov

Financial/Grants Management Contact(s)

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282 
Email: perryc@mail.nih.gov

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 302-443-4704
Email: jfox@mail.nih.gov

Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-774-3803
Email: mconnell@nida.nih.gov

Rebecca Claycamp, M.S., CRA
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: rclaycam@mail.nih.gov

Molly Puente, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: puentem@mail.nih.gov

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

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: Freundlichr@mail.nih.gov

April L. Harrison
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4628
Email: harrisona@mail.nih.gov

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.