Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Neurological Disorders and Stroke (NINDS)
National Cancer Institute (NCI)
Reissue of PAR-17-234
October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.
August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
None
93.307, 93.837, 93.838, 93.839, 93.233, 93.840, 93.866, 93.273, 93.853, 93.393, 93.394, 93.395, 93.396, 93.399
The purpose of this Funding Opportunity Announcement (FOA) is to promote research to understand the underlying mechanisms of sleep deficiencies among U.S. populations that experience health disparities and how sleep deficiencies may lead to disparities in health outcomes.
April 03, 2020
July 14, 2020, July 14, 2021, July 14, 2022
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
November 2020, November 2021, November 2022
January 2021, January 2022, January 2023
April 2021, April 2022, April 2023
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.
?The purpose of this initiative is to promote research to understand the underlying mechanisms contributing to sleep deficiencies among U.S. racial/ethnic minority populations and other populations that experience health disparities and how sleep deficiencies may lead to disparities in health outcomes. For the purposes of this initiative, sleep deficiencies are defined as insufficient or long sleep duration, poor sleep efficiency, quality, timing, regularity and sleep/circadian disorders. In addition, research on sleep health as a risk and/or protective factor for disparities in health outcomes is of interest for this initiative.
Sleep is an important determinant of overall health and a prerequisite for individuals to achieve their full potential for health and well-being across the lifespan. Inadequate sleep leads to poorer perceived health and poorer cognitive, emotional, and social functioning. Healthy sleep is just as important for health as a healthy diet and adequate physical activity. In addition, healthy sleep may be understood as a protective factor for overall quality of health and from a variety of adverse health outcomes. For example, healthy sleep for children exposed to childhood adversity is associated with improved social functioning, emotional regulation, cognition, and academic performance.
In the U.S., 30-40% of adults and 65-80% of adolescents report sleep deficiencies annually. Racial and ethnic minority populations and socioeconomically disadvantaged populations have the highest prevalence of sleep deficiency. According to Centers for Disease Control (CDC) survey data, the prevalence of age-adjusted 7 hours of recommended sleep is lower for racial and ethnic minority populations, particularly for Native Hawaiians and Other Pacific Islanders, African American/Blacks, and American Indians and Alaska Natives compared with Whites, Latinos, and Asians. The prevalence of sleep deficiency was also higher for unemployed respondents compared to those who were employed, and for those with high school diplomas only compared to those with college degrees. Furthermore, there is geographic clustering of people who experience sleep deficiencies. The highest prevalence of sleep deficiencies in the U.S. was observed in the southeastern and Appalachian regions, and the lowest prevalence was observed in the Great Plains states. The distribution of sleep deficiencies overlaps with the same geographic regions and same populations as those most impacted by conditions with known health disparities.?
Sleep deficiencies have been associated with a variety of poor health outcomes. Shorter sleep duration is associated with hypertension, stroke, diabetes, liver disease, cancer, and obesity. Studies have shown that short sleepers are more likely to be obese than those reporting =7 hours of sleep. Adverse mental health conditions such as depression are also associated with sleep deficiencies. These associations with sleep and health are complex and may be bidirectional. Sleep deficiencies impact sleep and circadian-related mechanisms, such as learning and memory consolidation, emotional regulation, energy conservation, metabolism, immune function, and cardiovascular regulation, and can mediate or modify different health outcomes. Few studies have investigated the mechanisms and pathways that result in sleep deficiencies in racial/ethnic minority populations.
Sleep deficiencies may also be influenced by sociocultural and physical/built environmental factors. Features of the physical and built environment such as artificial light, noise, poor air quality, walkability and housing conditions, and access to natural amenities (e.g., green space) have been shown to affect sleep. In addition to the physical environment, sociocultural factors like family dynamics, safety, and social cohesion have been shown to influence sleep and sleep disorders among adults and children. While a few studies have reported association of sleep deficiencies with higher levels of discrimination and chronic and major life stressors, there is a paucity of research investigating the underlying factors and potential causal mechanisms associated with sleep disparities in racial/ethnic minority and low-socioeconomic status (SES) populations.
Racial/ethnic minorities are more likely than Whites to have persistent, severe, and under-diagnosed sleep disorders. Some cultural differences have been noted for the way in which sleep deficiencies are reported by persons from different populations, thus the level of disparity for sleep is speculated to be underestimated.
Strikingly, sleep deficiencies appear to share many of the same determinants and causal pathways observed for health outcomes with well-known disparities. Few studies have investigated whether similar mechanisms and pathways that result in health disparities for other health outcomes can explain the disparities in sleep deficiencies. Further, understanding what is contributing to disparities in sleep deficiencies may identify common causal health disparity pathways and/or sleep and circadian-related mechanisms that contribute to many well-known health disparities.
Therefore, more research is needed to explore these pathways especially how social determinants of health and other factors that may cause sleep deficiencies and health disparities.
Research Objectives
The overall objective of this initiative is to support research to understand the causal pathways of how social, cultural, and environmental factors contribute to 1) healthy sleep including quality of sleep, 2) sleep deficiencies, and 3) how sleep deficiencies may lead to disparities in health outcomes among U.S. racial/ethnic minorities and other populations that experience health disparities.
Health disparities have been shown to be caused by multiple and overlapping contributing factors (i.e., biological, behavioral, physical/built environment, sociocultural environment and health care system) acting at multiple levels of influence (i.e., individual, interpersonal, community and societal). Social determinants, the conditions in which people are born, grow, live, work and age, are known to drive health disparities. Therefore, this initiative seeks applications that use a socioecological framework to explain how multi-level determinants result in sleep disparities or healthy sleep. (See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health multiple domains and levels). Successful projects will include a conceptual model and multidisciplinary research to understand the interplay of multiple factors and mechanisms to explain sleep disparities. Successful projects will include a conceptual model that integrates health disparity causal pathways with sleep and circadian-related mechanisms to explain sleep disparities.
Studies for this initiative may include multi-disciplinary translational, behavioral, or epidemiological, or health services projects. In addition, projects can involve primary and/or secondary data collection and analysis. Because the goal of this initiative is to better understand the mechanisms of documented sleep disparities, studies whose sole purpose is to assess the incidence/prevalence of sleep deficiencies in specific populations or sub-populations are not a priority for this FOA
Projects must include a focus on one or more NIH-designated populations that experience health disparities in the United States, which include racial and ethnic minorities (Blacks or African Americans, Hispanics/Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders), low socioeconomic status, sexual and gender minorities and underserved rural populations. Comparisons between populations as well as examining only one minority population are appropriate for funding inthis initiative. Projects should consider unique barriers to participation in research that people in vulnerable/underserved groups may have.
Outcomes of interest include sleep, health outcomes, including multimorbidity, and social consequences such as quality of life, interpersonal and social functioning, and academic and job performance. Investigating sleep as either a risk and/or protective factor is of interest.
Projects are encouraged to involve research collaborations with relevant stakeholders, such as community organizations, clinicians, public health organizations, consumer advocacy groups, and faith-based organizations. As appropriate for the research questions posed, inclusion of key community members in the conceptualization, planning and implementation of the research is encouraged (but not required) to generate better-informed hypotheses and enhance the translation of the research results into practice.
Specific Areas of Research Interest
Research topics of specific interest include but are not limited to:
Investigating how sleep deficiencies influence risk of chronic disease prevalence, morbidity and mortality in populations that experience health disparities.
Understanding how sleep attitudes, behaviors, and practices, including self-management strategies contribute to sleep deficiencies and or healthy sleep among racial/ethnic minorities and other populations that experience health disparities.
Investigating the mechanisms through which sociocultural and environmental determinants of health contribute to disparities in circadian rhythm disruption, differences in underlying circadian physiology, and how circadian disruptions directly affect various health outcomes among racial/ethnic minorities and other populations that experience health disparities.
Understanding whether and how racism and discrimination contribute to sleep disparities, as well as mechanisms on how this influences biological systems and pathogenesis that leads to health disparities.
Investigating the role of healthy sleep as a protective and resilience factor among populations that experience health disparities.
Examine the influence of healthy sleep or sleep deficiencies on quality of life, social functioning, emotional regulation, and academic and job performance among racial/ethnic minorities and other populations that experience health disparities.
Examination of identification, diagnosis, and treatment/management of sleep deficiencies among health disparity populations by clinicians and other healthcare professionals and whether these contribute to disparities in sleep deficiencies.
In addition, different Institutes and Centers at NIH are interested to support research in the following specific areas:
The National Heart, Lung, and Blood Institute (NHLBI) is particularly interested in mechanistic studies that:
Potential applicants are strongly encouraged to discuss their anticipated research plans with the NHLBI Scientific/Research contact listed in this announcement well in advance of the anticipated submission date. NHLBI will not fund epidemiological or population-based studies under this funding opportunity announcement.
The National Institute on Aging (NIA) is particularly interested in:
The National Institute on Aging (NIA) promotes genetic, biological, clinical, behavioral, social, and economic research related to aging and life course health, including research on Alzheimer’s disease. A strategic priority of NIA is the understanding of health differences and development of strategies to improve the health status of older adults in diverse populations. NIA encourages comparisons between racial/ethnic groups versus other race/ethnic groups, and research on factors affecting health and longevity, such as cultural affiliation, socioeconomic and geographic inequality, gender differences, discrimination, and stress, among minority groups. NIA interests in this area include, but are not limited to, the following:
Social, cultural and behavioral factors over the life course, such as early life adversity, education, employment, health behaviors (e.g., substance use and physical exercise/inactivity), and cultural beliefs, that may influence sleep, and explain the link between the sleep and accelerated aging and cognition.
Behavioral and social research on the impacts of later life transitions (which can include, but are not limited to retirement, bereavement, divorce, re-partnering, caregiving, children exiting/reentering the home, residential change) on changes in sleep among health disparity populations.
Research aimed at understanding and modifying organizational or individual behaviors that contribute to sleep disparities, including organizational and individual interventions in workplaces, health care and residential contexts.
Research aimed at understanding how neurobiological and/or genetic and other risk factors contribute to sleep disparities in older adults from health disparities populations and how sleep disorders and aging interact to increase risk for neurodegenerative diseases in diverse populations.
Studies focused on disparities in early diagnosis of sleep and neurodegenerative disorders and how the disparities in diagnosis impact outcomes and opportunities for intervention.
Studies to understand relationships between sleep deficiencies and health disparities with regard to development or progression of disabilities, multi-morbidity, polypharmacy, geriatric syndromes, chronic pain, delirium, and institutionalization.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is particularly interested in:
Alcohol has a profound influence on sleep patterns. Alcohol consumption and effects vary among various racial and ethnic minorities. Clearly more research is needed to explore links between alcohol consumption and sleep deficiencies resulting in health disparities among racial and ethnic minorities.
Some research topics include but are not limited to:
The National Institute of Neurological Disorders and Stroke (NINDS) is particularly interested in:
Sleep is important to a number of brain functions, including how neurons communicate and the removal of toxins in the brain that build up while awake. Conversely, sleep loss is prevalent in neurological disorders. Chronic lack of sleep, or poor sleep quality, increases the risk and morbidity of many neurological conditions. It is increasingly recognized that sleep disturbances (often overlooked, but modifiable) can worsen symptoms and induce complications, in addition to interfering with treatments of brain disorders.
The National Institute of Neurological Disorders and Stroke supports basic, clinical, translational, and outcomes research focused on identifying, monitoring, and targeting biologic, environmental, social, and healthcare system factors that lead to or are associated with sleep disparities and neurological diseases across the lifespan. Some priority disease areas include stroke and other cerebrovascular diseases, epilepsy, migraine, nervous system infections, spinal cord injury, headache, Parkinson's disease and other neurodegenerative disorders, brain trauma, neurodevelopmental disorders, and the neurological consequences of HIV/AIDS
Investigators are strongly encouraged to discuss their research plans with NINDS Scientific/Research contacts prior to submitting their application. Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center, will not be considered through this program.
The National Cancer Institute (NCI) is particularly interested in:
NCI is interested in understanding the mechanisms underlying how sleep deficiency or sleep disruption among minority and health disparity cancer populations may contribute to the cancer therapeutic outcomes such as progress free survival or overall survival through effect on therapeutic efficacy, side-effect and quality of life.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Dr. Rina Das
National Institute on Minority Health and health Disparities (NIMHD
Telephone: 301-496-3996
Email: [email protected]
All instructions in the SF424 (R&R) Application Guide must be followed.
Describe how the project will contribute to the understanding of causal pathways and mechanisms that explain sleep disparities or and/or sleep and circadian-related mechanisms that contribute to minority health and health disparities. Describe how the research focuses on health disparities among U.S. racial/ethnic minority, low socioeconomic status, underserved rural or sexual gender minority populations.
Describe how the composition of the research team has the appropriate breadth and inclusiveness of expertise and disciplines (such as for social science, health disparities or sleep research expertise)..
Describe how the project uses a multidisciplinary approach and integrates health disparity causal pathways with sleep and circadian-related mechanisms to understand the complex factors that underlie sleep disparities or healthy sleep among racial/ethnic minority and other populations that experience health disparities.
If there are foreign component(s), describe how the proposed activities at foreign sites will contribute to the knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States.
The following modifications also apply:
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.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
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.
NIMHD will not approve applications requesting $500,000 or above indirect costs annually.
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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, specific to this FOA, to what extent willthe project contribute to the understanding of the etiology and/or mechanisms that influence sleep deficiencies or sleep health and its health consequences in U.S. populations that experience health disparities? How well does the research address health disparities among U.S. racial/ethnic minorities, low socioeconomic status, or sexual gender minorities or underserved rural populations?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, specific to this FOA, does the composition of the research team have appropriate breadth and inclusiveness of expertise and disciplines (such as social science, public health, health disparities and/or sleep research expertise)?
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?
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?
In addition, specific to this FOA, to what extent does the project propose approaches to integrate health disparity causal pathways and sleep and circadian-related mechanisms in a meaningful and appropriate way for research on minority health and/or health disparities of sleep deficiencies and or sleep health?
If there are foreign component(s), how well will the proposed activities at foreign sites contribute to knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States?
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?
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?
For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Not Applicable.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: Data Sharing Plan.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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.
Information regarding the disposition of applications is available 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.
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 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.
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 agreementsare 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.
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:[email protected](preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:[email protected]
Rina Das, Ph.D.
National Institute on Minority health and health Disparities (NIMHD)
Telephone: 301-496-3996
Email: [email protected]
Nancy Jones, Ph.D.
National Institute on Minority health and health Disparities (NIMHD)
Telephone: 301-594-8945
Email: [email protected]
Marishka Brown, Ph.D.
National Center on Sleep Disorders Research
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0199
Email: [email protected]
Miroslaw (Mack) Mackiewicz, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-594-7636
E-mail: [email protected]
Frank Bandiera, Ph.D.
National Institute on Aging (NIA)
Division of Behavioral and Social Research
Telephone: 301-496-3131
E-mail: [email protected]
Judy Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism National Institutes of Health (NIAAA)
Telephone: 301-402-0717
Email: [email protected]
Janet (Yejun) He, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: [email protected]
Richard T. Benson, M.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-9071
Email: [email protected]v?
Dan Xi, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6143
Email: [email protected]
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]
Anthony Agresti
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: [email protected]
?Eva Lawson-Lipchin
National Institute on Aging (NIA)
Telephone: 301-435-2020
Email: [email protected]
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Shane Woodward
National Cancer Institute (NCI)Telephone: 240-276-6303
Email: [email protected]