Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations
NIH Basic Behavioral and Social Science Opportunity Network (OppNet; http://oppnet.nih.gov/) and its member institutes, centers and offices:

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Research Resources (NCRR)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Rare Diseases (ORD)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Mechanistic Pathways Linking Psychosocial Stress and Behavior (R01)

Activity Code

R01 Research Project Grant Award

Announcement Type

New

Related Notices

  • December 1, 2011 - See Notice NOT-HL-12-168. Notice of Change in Eligibility of Foreign Institutions.

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-037

Companion FOA

None

Number of Applications

See: Section III. 3. Additional Information on Eligibility.

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

93.837, 93.113, 93.121, 93.142, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.389, 93.393, 93.394, 93.395, 93.396, 93.399, 93.838, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.989

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by the NIH Basic Behavioral and Social Sciences Opportunity Network (OppNet) solicits Research Project grant (R01) applications from institutions and organizations that propose to investigate basic psychological, social, and environmental mechanisms and processes linking psychosocial stressors and behavior.  This FOA will facilitate investigation of multiple and potentially bidirectional pathways underlying the behavioral, environmental, and psychosocial link(s) between psychosocial stressors and behaviors that may ultimately impact biological function, health, and disease. Applicants are encouraged to use innovative and integrative designs to elucidate how psychological, social, and psychosocial environmental factors impact the processes by which stressors become coupled with and influenced by behaviors.  Applications examining moderating factors such as individual demographic (age, gender/sex, ethnicity) and psychological (vulnerabilities, resilience) differences, risk factors, timing of exposure to stressors, and environments are desirable.  This research will provide a deeper understanding of the psychological, environmental, and social processes that ultimately connect psychosocial stress and behaviors and consequently physiological processes, health, and disease.

Key Dates
Posted Date

September 22, 2011

Open Date (Earliest Submission Date)

November 19, 2011

Letter of Intent Due Date

November 19, 2011

Application Due Date(s)

December 19, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable 

Scientific Merit Review

March/April 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

October/December 2012

Expiration Date

December 20, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

This Funding Opportunity Announcement (FOA) issued by the NIH Basic Behavioral and Social Sciences Opportunity Network (OppNet) solicits Research Project Grant (R01) applications from institutions and organizations that propose to investigate basic psychological, social, and environmental mechanisms and processes linking psychosocial stressors and behavior.  Although psychosocial stressors influence a host of behaviors that may ultimately impact health outcomes, there is a paucity of data that has specified how these processes occur to impact behavior and, ultimately, health and disease.  This research will facilitate investigation of multiple and potentially bidirectional pathways underlying the link between psychosocial stressors and behaviors that may ultimately impact biological function, health, and disease.  Applicants are encouraged to use innovative approaches to design integrative studies elucidating how psychological, social, and psychosocial environmental factors impact the processes by which stressors are coupled with and influenced by various behaviors.  Applications examining moderating factors such as individual demographic (age, gender/sex, ethnicity) and psychological (vulnerabilities, resilience) differences, risk factors, early exposure, and environments are desirable.  This research will provide a deeper understanding of the psychological, environmental, and social processes that ultimately connect psychosocial stress to behaviors, physiological processes, health, and disease.

About OppNet  

OppNet is a trans-NIH initiative that funds activities that build the collective body of knowledge about the nature of behavior and social systems, and that deepen our understanding of basic mechanisms of behavioral and social processes.  All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet.  All OppNet initiatives invite investigators to propose innovative research that will advance a targeted domain of basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and life course-related research.  Applicants should understand that the NIH IC that made this FOA available to the public is not necessarily the NIH Institute or Center that ultimately will manage a funded OppNet project.  For more information about OppNet and all its funding opportunities, visit http://oppnet.nih.gov.

OppNet uses the NIH definition of basic behavioral and social science research (b-BSSR, http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx) to determine application responsiveness.  Consequently, OppNet strongly encourages prospective investigators to consult this definition, OppNet’s answers to frequently asked questions about b-BSSR (http://oppnet.nih.gov/about-faqs.asp), and answers to frequently asked questions regarding this specific RFA (use this segment and insert website, if applicable).  See this FOA’s Scientific Contacts section for individuals with expertise in the research subject matter and the OppNet initiative.

Background

Evidence from investigations of animal models and humans suggest that psychosocial stressors – including social (e.g., person-person, person-family, and person-peer group interactions), behavioral, environmental, and cognitive stressors - increase the risk of multiple health problems and all-cause mortality.  Current theory on stress-disease relationships places considerable emphasis on the biological and neural pathways through which stressors have their effects, but underemphasizes the behavioral processes involved. For example, a host of evidence has convincingly shown that bi-directional alterations in neural networks and peripheral systems can occur in response to psychosocial stressors.  Sustained psychosocial stress over days/weeks reduces neurons in the hippocampus and affects neurogenesis.  Research in rodents has shown that lack of maternal care affects epigenetic regulation resulting in faulty glucocorticoid receptor expression. Both chronic and acute psychosocial stressors in humans can increase sympathetic activity, impair vagal tone, alter HPA reactivity, lead to endothelial dysfunction, and increase proinflammatory processes. 

However, the data linking psychosocial stressors with health and disease endpoints are not universally consistent. Significant gaps remain in our understanding of the mechanistic pathways linking psychosocial stressors to behaviors that ultimately impact disease initiation and progression, calling into question whether additional stress-disease pathways are missing from existing models. Currently, very little empirical data on the specific and potentially bi-directional processes linking behaviors and stressors are currently available, but discovery of these factors may enhance our understanding of the stress-disease link.

Psychosocial stress influences a host of behaviors that may subsequently influence health and disease outcomes. For example, both acute and chronic stressors can impact executive function, thereby promoting impulsivity and poor choices for long-term healthful lifestyle.  Stress can promote and facilitate habitual behaviors over goal-directed choice behaviors, thereby perpetuating unhealthy practices.  Stress can induce anxiety states that can create vulnerabilities to self-medication and relapse to drug abuse and other health-damaging behaviors.  However, the specific mechanisms of how these processes occur to ultimately impact the stress-disease pathways is largely unstudied. In addition, there is a lack of understanding of how the impact of stressors on behaviors may be influenced by individual differences in vulnerabilities and resilience, environmental factors, individual differences, or early exposure to stressors and adversity.  A fully integrative model of a stress-health connection would incorporate multiple and potentially bidirectional and causal pathways between psychosocial stressors, behaviors, and individual differences in vulnerabilities and resilience to health-relevant biological endpoints, and this is the focus of the current Funding Opportunity Announcement.

Accumulating evidence supports the notion that exposure to psychosocial stressors early in life, such as lower socioeconomic status, abuse, diminished social support, and conflictual family and peer interactions, have formative effects on biological and psychological development of individuals.  For example, childhood adversity is linked to hormonal responses which in turn are risk factors for disease.  These stressors may be as severe as outright sexual or physical abuse, but may also include inconsistent nurturing, conflictual family interactions, and mild neglect.  Studies of the processes by which these multiple factors interact would help us to understand the etiology of resultant diseases.  While a variety of psychosocial, environmental, and biological factors associated with risk or resilience to psychosocial stress have been identified, it not known how and if the (potentially bi-directional) relationship between individual differences and exposure to early life stressors is translated to behavior changes.

The NIH has supported significant and innovative research investigating mechanisms driving behavioral responses to stress-related clinical disorders such as post-traumatic stress disorder and addictive behaviors; however there is much less known regarding the behavioral processes operating during psychosocial stressors among individuals without a stress-related disorder, and the resulting predisposing consequences to health outcomes.  Important questions surrounding stress-disease linkages concern (1) the mechanisms of embedding stress-associated behaviors; (2) understanding the processes by which distinct temporal windows of behavioral susceptibility to psychosocial stressors occur over the life course; and (3) the processes by which individual differences  impact the coupling of behavioral states with psychosocial stress.

This initiative aims to encourage studies seeking to elucidate the processes linking psychosocial stressors and behaviors, using comprehensive measures of psychosocial stress.  Psychosocial stressors have widespread consequences on both behavior and physiological function.  Yet the health consequences of stressors are variable due in part to the vulnerability/resilience of individuals to stress, and in part to whether the behavioral responses are adaptive or dysfunctional.  While some aspects of the impact of stress have been well recognized, significant gaps exist in our understanding of the mechanisms by which stress can alter behaviors and thereby impact health and disease.  Recent advances in both biological technologies and behavioral analysis now permit the possibility of connecting the behavioral response to the biological mechanisms underlying them.  Insight into genetic and epigenetic variability and a greater understanding of the individual’s resources will identify the vulnerability and resilience processes which determine behavioral consequences of stress.  Studies assessing functional connectivity during experimental stress exposure combined with brain-behavior studies (e.g., assessment of cognitive tasks, emotion regulation, etc) during stress can identify neural circuits that impact domains of function and connect cognitive processing (e.g., information processing, appraisal, etc) with behavioral reaction and emotional response.  Epigenetic modifications can connect the long term adaptation to adverse early life experiences and traumatic events to prolonged behavioral and biological response.  The underlying mechanisms linking genetic models of quantitative neurobiological traits and cognitive function with behavior should be determined in a variety of settings.  Behavioral processes related to psychosocial stress can be tested in a variety of model systems. Recent advances in technology and behavioral analysis may now permit significant advances in our understanding of the behavioral changes during and following stress.  Critical issues related to stress vulnerability/resilience and other key individual differences can now be addressed.

Scope and Specific Requirements

For this initiative, psychosocial stress is defined as the individual perception of having inadequate resources to cope with a perceived demand or threat.  Psychosocial stressors are considered to be social (e.g., person-person, person-family, and person-peer group interactions), behavioral, environmental, and cognitive demands that elicit individual perceptions of stress. Stress exposure is defined as the experience of being exposed to an external psychosocial stressor; exposure might occur during any stage of development.   Research focused on stressors of a non-psychosocial nature (including but not limited to oxidative and physical stressors) is not the focus of this initiative and applications examining non-psychosocial stress will be considered non-responsive to this FOA.

This initiative targets specific objectives essential for filling knowledge gaps in this area.  Investigations of the underlying processes and mechanisms linking psychosocial stress with behavioral changes, including an understanding of mechanisms of individual vulnerabilities and resilience, are needed. For example, studies are needed to develop robust behavioral phenotyping paradigms that can be used at various developmental phases to identify the processes by which individuals behaviorally respond to stressors at different life stages or during particularly vulnerable periods.  Such paradigms would include examination of moderating factors such as individual biological and psychological differences, sex/gender and age differences, risk factors, environmental and social environments.  Such studies will lead to a more process- and mechanistically-focused understanding of how psychosocial stress leads to health-relevant outcomes, and the impact of individual vulnerabilities and resilience to these effects. 

Any population, including clinical populations or model organisms, could potentially be the focus of a study of basic mechanisms and processes involved in stress-behavior linkages. However, the population should be appropriate to the research question and design, and the hypotheses under investigation should not be applicable only to a single disease or condition. The population and hypotheses selected must be able to shed light on basic processes linking psychosocial stress and behavior. Applications employing animal models should clearly define the relevance of the model used to the stress-behavior linkages being targeted and understanding human disease processes.

Examples of Research Topics

Appropriate topics that are relevant to this FOA include, but are not limited to those listed below:

Because this FOA targets basic research approaches to understanding processes linking behavior with psychosocial stress, areas of research that will NOT be considered responsive to the FOA include, but are not limited to:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

OppNet intends to commit approximately $2,000,000 in total costs (Direct Costs plus Facilities and Administrative (F&A) costs) in FY2012 to fund an estimated 2-4 grants in response to this FOA. The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

Award Budget

Budgets up to a maximum of $325,000 in direct costs per year (not including 3rd party Facilities and Administrative (F&A) costs) and a project duration of up to three years may be requested for a maximum of $975,000 in direct costs over a three-year project period per application.  Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Budgets must reflect the actual needs of the proposed project.

Award Project Period

 3 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Other

Foreign Institutions

[Updated language per NOT-HL-12-168]

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

(Old language)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.  

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

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:

The letter of intent should be sent to:

Catherine M. Stoney, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7936
Bethesda, MD 20892-7926
Telephone: 301-435-6670
Email: stoneyc@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by OppNet, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:  OppNet uses the NIH definition of basic behavioral and social science research (b_BSSR; 

http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx.)

Overall Impact

Reviewers will provide an overall impact/priority 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? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice are improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does the project identify a significant opportunity to advance knowledge about the nature of behavior and/or social systems and/or deepen our understanding of basic mechanisms of behavioral and social processes?  Does the project have the potential to inform biological, behavioral and/or translational sciences relevant to the Nation's health and well-being?  If animal studies are proposed, does the application articulate relevance to individual or social human behavior? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

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?   

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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?   

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority 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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Catherine M. Stoney, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, MSC 7936
Bethesda, MD  20892-7936
Telephone: 301-435-6670
Email:stoneyc@mail.nih.gov

Peer Review Contact(s)

Maribeth Champoux, Ph.D.
Scientific Review Officer MESH/F12B/BBBP-J
Center for Scientific Review, NIH
6701 Rockledge Drive Room 3170
MSC 7848
Bethesda MD 20892 (20817 for courier deliveries)
Telephone: 301 594-3163
Email: champoum@csr.nih.gov

Financial/Grants Management Contact(s)

Robert L. Tarwater
Prevention and Population Sciences Grants Management Branch
National Heart, Lung, and Blood Institute (NHLBI)
Two Rockledge Center, Room 7150
6701 Rockledge Drive, MSC 7926
Bethesda, MD  20892-7026
Telephone: 301-402-6090
Email: tarwater@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
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