Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)
National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Advancing Structural Level Interventions Through Enhanced Understanding of Social Determinants in HIV Prevention and Care (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PA-14-134

Companion Funding Opportunity

PA-14-133, R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242, 93.855, 93.856

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications that propose to understand and address social determinants associated with the prevention and treatment of HIV. This FOA describes two research endeavors that are unique and overlapping. The first is to characterize those social determinants that are most relevant to HIV prevention and treatment outcomes, particularly in their association with inequities in HIV risk or disease outcomes. The second is to develop and test structural interventions aimed at reducing the negative impact or maximizing positive aspects of social determinants.

The R21 mechanism is specifically intended to encourage new exploratory and developmental research projects. These studies should break new ground or extend previous discoveries toward new directions or applications. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel methodologies, tools, technologies, or interventions that could have an important impact on adherence research or practice. Unlike applications under the R01 mechanism, preliminary data are not required for R21 applications. Preliminary data may nonetheless be included if available.

Key Dates
Posted Date

February 28, 2014

Open Date (Earliest Submission Date)

April 7, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

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)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

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.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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.

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

This Funding Opportunity Announcement (FOA) encourages applications that propose to understand and address social determinants associated with the prevention and treatment of HIV. This FOA describes two research endeavors that are unique and overlapping. The first is to characterize those social determinants that are most relevant to HIV prevention and treatment outcomes, particularly in their association with inequities in HIV risk or disease outcomes. The second is to develop and test structural interventions aimed at reducing the negative impact or maximizing positive aspects of social determinants.

Background

Social determinants are an important, but under investigated contributing factor to risk and resilience for health. Social determinants can be defined as overlapping social and economic factors that influence health. Several agencies and entities, including the World Health Organization and the U.S. Centers for Disease Control and Prevention launched initiatives that emphasize the importance of addressing social determinants in order to reduce health disparities and achieve health equity (http://www.who.int/social_determinants/en/, http://www.cdc.gov/socialdeterminants/). The difference between addressing those social determinants that impact population health (e.g., lack of clean water in a village) and those that impact certain groups within a population (e.g., lack of housing) is an important distinction as the latter is connected to disparities in health outcomes. This FOA is focused on the latter as it focuses on those social determinants most strongly associated with disparities in HIV prevention and treatment outcomes.

Significant disparities in rates of HIV exist in and outside of the United States and there is mounting evidence of the disparities in HIV disease outcomes within certain subpopulations (e.g., men who have sex with men (MSM), women living in Africa). Addressing the psychosocial factors and individual risk behaviors associated with HIV transmission has been a significant focus of behavioral interventions for HIV prevention, and more recently, these approaches have been applied to HIV treatment related behaviors such as medication adherence. However, the focus on individual-level psychosocial factors alone fails to adequately account for the intersection of those factors with broad social factors (e.g., housing, neighborhood). The complex relationship between psychosocial factors and social conditions may explain why effective options to prevent and treat HIV have not yet been maximally effective in eliminating disparities in HIV rates and disease outcomes.

Linking factors together at different levels may also facilitate the development of multi-level structural interventions, more so than examining them independently. For example, several factors have been associated with risk for HIV acquisition among African women, including age, co-habitation status, history of violence, depression, employment status, and degree of education. There remains a gap in the knowledge as to the risk attributable to a factor or set of factors, the effectiveness of interventions to modify those factors and the cost required to bring those interventions to scale. Importantly, in order to devise effective interventions to address these various factors, the framework of the intervention must target those factors that are amenable to change.

The current gaps to fill can be characterized as: 1) a lack of broad understanding of the way in which social determinants interrelate and operate synergistically, and whether they can accrue to have a multiplicative effect on HIV prevention or treatment success, 2) a lack of understanding regarding the degree of attributable risk ascribed to different social factors in determining HIV infection, medication adherence, viral suppression or mortality, 3) a lack of understanding as to why some individuals, despite being exposed to some social conditions that are associated with HIV acquisition or negative care and treatment outcomes are not significantly negatively impacted.

Objectives

This FOA distinguishes the two broad areas of research, social determinants and structural interventions. Research on the factors that interrelate and underlie social determinants could include those at the individual (e.g., self-efficacy, coping), interpersonal (e.g., social capital, culture), systems/community (e.g., institutionalized racism, policies) levels. Research related to those factors that underlie social determinants would seek to understand how these multi-level factors operate individually and in combination to increase the vulnerability of certain groups with regard to HIV acquisition or care and treatment outcomes. The relationship between social determinants and syndemics observed in populations is particularly important given the evidence of the multiplicative impact of factors such as mental health and substance use on risk for HIV acquisition.

One definition of structural interventions refers to public health interventions that promote health and improve the risk environment by altering the structural context in which health is produced and reproduced. Thus, the second aspect of this FOA encourages applications that utilize a framework for understanding social determinants in the development of structural interventions to improve access to and uptake of effective HIV prevention and treatment tools (e.g., HIV testing, condoms, linkage to HIV care, ART). To accomplish this, a strong theoretical basis or operationalized framework is encouraged as part of the justification for the particular intervention being developed and/or tested.

Broadly, this FOA calls for basic social science and intervention research that aims to:

1) Identify multi-level factors (individual, familial, societal, economic and legislative) which underlie those social determinants that are associated with risk for HIV acquisition or negative HIV care and treatment outcomes at the individual or population levels. Research that focuses on modifiable factors beyond the individual-level is encouraged.

2) Identify individual and/or community-level mechanisms (e.g., coping, social networks) associated with desired HIV prevention or HIV disease outcomes despite exposure to negative social, economic and/or legal conditions. Research that operationalizes resilience as distinct from risk factors is particularly encouraged.

3) Design multi-level, structural interventions to intervene upon specified social determinants or sets of social determinants to minimize the negative effects of those social determinants; attempt to reduce the social and structural barriers that negatively impact HIV risk, care and treatment and go beyond influencing individual knowledge, attitudes, and beliefs. Evidence-based justification (e.g., modeling data) for the design of the structural intervention is encouraged prior to proposing to test its impact on HIV prevention, care and/or treatment outcomes.

There are several factors that have been identified in the literature that, if addressed, could improve the HIV outcomes in prevention and treatment. These include, but are not limited to:

1) Stigma and Discrimination:

Stigma and Discrimination have been associated with poor uptake of prevention and treatment services, delayed entry into HIV care and negative economic consequences in the form of employment and housing discrimination. In addition, HIV-associated stigma occurs concurrent to stigma associated with sexual behavior, gender identity, drug use, and as well as race and gender-based discrimination.

Potential Research Questions:

What enables some individuals to accept an HIV test, enter into care, and/or adhere to medications, despite stigma and discrimination? How do stigma and discrimination associated with HIV interact with stigma and discrimination associated with race, gender and/or sexual orientation? What is the impact of reduction of stigma and discrimination on HIV prevention, care and treatment outcomes?

2) Economic Factors:

Lack of employment, living in poverty, lack of health insurance coverage, food insecurity and other financial constraints have been associated with HIV risk behaviors, delayed entry into medical care, malnutrition, non-adherence to HIV medication and poor mental health.

Potential Research Questions: What factors mediate and/or moderate the association between economic factors and negative health outcomes? What economic strengthening approaches are effective to mitigate negative HIV associated health outcomes and what, if any, are the positive downstream effects?

3) Social Violence:

Social violence, physical and verbal abuse, childhood sexual abuse, domestic and/or intimate partner violence, neighborhood violence have all been associated with fears of negotiation during sex, delays in uptake of prevention and treatment, and unwillingness to disclose one's HIV status.

Potential Research Questions: What interventions are effective that target factors beyond individual knowledge, attitudes and beliefs to address the negative influence of social violence on HIV prevention, care and treatment outcomes? What factors are associated with resilience, at the individual and/or community level, in the context of violence and abuse and are those factors also associated with HIV prevention, care and treatment outcomes?

4) Legal Factors:

Incarceration, engagement in illegal activity, HIV-related criminalization, immigration status and deportation fears have been associated with lack of uptake and engagement in HIV prevention and care, increased HIV risk behavior in the form of needle sharing and transactional sex, and are related to social factors such as neighborhood violence and social network instability.

Potential Research Questions: What impact do legal or policy-level factors have on positive and negative HIV prevention, care and treatment outcomes? What are the relevant mediators and moderators of the potential relationships?

As a result of the broad scope of science called for in this FOA, it is expected that multi-disciplinary teams, including expertise outside of health and public health, would be assembled. Research teams could include expertise in legal studies, policy, urban planning, economics, statistical modeling, marketing, cultural, race and gender studies or other areas, as relevant to the set of social determinants of interest.

Within this FOA, research is encouraged to take a developmental perspective that addresses the substantial changes that occur across the lifespan (from infancy through older adulthood) that are associated with HIV prevention and care challenges. Factors can include individual-level factors, but with the goal of understanding their relationship to community and/or societal-level factors.

In addition, this FOA encourages modeling research that attempts to understand the interplay of social, economic, and legal factors to determine the individual and collective influence on HIV prevention, care and treatment outcomes. For understanding legal and policy-level factors, research that proposes to rigorously evaluate the impact of the initiation of laws or policies on individuals and communities through naturalistic, observational research paradigms is encouraged.

The R21 mechanism is specifically intended to encourage new exploratory and developmental research projects. These studies should break new ground or extend previous discoveries toward new directions or applications. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel methodologies, tools, technologies, or interventions that could have an important impact on adherence research or practice. Unlike applications under the R01 mechanism, preliminary data are not required for R21 applications. Preliminary data may nonetheless be included if available.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

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

The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 2 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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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.

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

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.

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.

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.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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 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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.



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, please note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? 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?

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/PI, 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 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?

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 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

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

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: https://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Gregory Greenwood, PhD, MPH
National Institute of Mental Health (NIMH)
Telephone: 240-669-5532
Email: gregory.greenwood@nih.gov

Ellen DeCarlo
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3096
Email: decarloe@niaid.nih.gov

Judi Miller
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4801
Email: jmillera@niaid.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 669-2988
Email: adevine@niaid.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.


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