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

Strengthening Adherence to Antiretroviral-Based HIV Treatment and Prevention (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-14-125

Companion Funding Opportunity

PA-14-126, 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, 93.856

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages research to understand and promote adherence to antiretroviral (ARV) regimens for HIV treatment and prevention. Studies addressing pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) are the foci of this FOA. The overarching emphasis is on the development of feasible interventions to improve and sustain PrEP or ART adherence which could be rapidly implemented in clinical, community, and policy environments to improve HIV treatment and prevention outcomes.

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

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.

Purpose

This Funding Opportunity Announcement (FOA) encourages research to understand and promote adherence to antiretroviral (ARV) regimens for HIV treatment and prevention. Studies addressing pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) are the foci of this FOA. The overarching emphasis is on the development of feasible interventions to improve and sustain PrEP or ART adherence which could be rapidly implemented in clinical, community, and policy environments to improve HIV treatment and prevention outcomes.

A well-articulated theoretical or conceptual framework is essential in all applications submitted under this announcement. Approaches based on basic behavioral and social scientific concepts such as cognition, emotion, motivation, communication, developmental approaches, social interaction, decision-making, behavioral economics, and structural models are invited. Any descriptive studies should be undertaken with the aim of informing the design or mechanisms of adherence interventions. Interventions should be appropriately tailored to relevant U.S. domestic and foreign populations, and may target individuals, providers, social networks, healthcare clinics, communities, or other groups.

In HIV treatment, ART adherence represents one element of the wider HIV care continuum. Research applications primarily addressing aspects of the HIV care continuum other than ART adherence, such as HIV diagnosis and care engagement, may consider the priorities identified in PA-14-130, and PA-14-132 "Accelerating Improvements in the HIV Care Continuum."

Background

Antiretroviral drugs have spurred numerous breakthroughs in HIV treatment and prevention. The advent of highly active combination ART was a profound turning point that has effectively transformed HIV disease from a fatal disease to a chronic manageable condition in settings where treatment is widely available. The estimated average life-expectancy for individuals who receive timely ART initiation and maintain long-term viral suppression now approaches that of individuals uninfected with HIV.

Antiretroviral drugs have driven a historic expansion of proven HIV prevention strategies in recent years. The landmark HPTN 052 trial determined that HIV transmission risk in serodiscordant couples decreased by 96% through early provision of ART to seropositive partners. A set of large-scale trials conducted with many thousands of participants throughout the world have proven oral and topical antiretroviral PrEP to be safe, well-tolerated, and efficacious for preventing HIV infection.

Achieving maximal benefit from antiretroviral-based HIV treatment and prevention requires excellent adherence. Adherence has been defined as the extent to which patients take medications as prescribed by their health care providers. Although adherence is frequently used as a synonym for medication dose-taking, the construct of adherence is multidimensional. The primary elements of medication adherence behavior are initiation (starting a recommended regimen), implementation (executing the prescribed regimen), and persistence (length of time before discontinuation). Patient implementation of ARV regimens is commonly assessed in terms of the percentage of prescribed doses taken, but it has also been examined in terms of dose-timing, patterns of dose-taking, and brief treatment interruptions.

The determinants of medication adherence behavior are considered multidimensional as well. The World Health Organization (WHO) has categorized medication adherence determinants into factors related to patients, drug regimens, medical conditions, health systems, and social/economic influences. These five domains present a range of opportunities for the development of discrete and combined interventions to support adherence.

Adherence research in HIV treatment and prevention must be addressed distinctly but can inform one another. Scientists and practitioners addressing ART adherence have made significant gains in recent years, but critical gaps remain in our knowledge and abilities for supporting ART adherence. Now that research breakthroughs have expanded the populations to whom ARV-based treatment and prevention is offered, research is additionally needed to create appropriate interventions that support adherence in these new paradigms (e.g., PrEP, treatment as prevention).

Research Scope

This FOA identifies research priorities intended to strengthen adherence to ARV-based HIV treatment and prevention. This review of priority areas is neither comprehensive nor restrictive; it is offered to stimulate critical thinking and innovative approaches on ARV adherence.

PrEP Adherence

Importance of PrEP adherence. The outcomes from major PrEP trials have individually and collectively demonstrated a strong dose-response relationship between greater adherence and reduced HIV transmission. Among trial participants receiving active drug, those evidencing adherence through drug concentration assays achieved notably greater prevention benefits than those who did not. Effective efforts to promote and sustain PrEP adherence should therefore help optimize its preventive impact.

PrEP is intended for use in key populations at high risk for HIV infection, and for time-limited use among particular individuals during intervals of risk. Key populations for further research on PrEP and PrEP adherence in US domestic and international settings include:

Adequacy of PrEP adherence. Inadequate study product adherence contributed to early discontinuation of certain PrEP trials. Although randomized placebo-controlled trials provide a different context for adherence compared to open-label use of a proven drug, trials indicating low to modest product adherence have raised questions about the potential adequacy of PrEP adherence under less-controlled conditions. Demonstration projects are underway to investigate PrEP uptake, adherence, and persistence in real-world use by key populations. Priority research in this area includes:

Assessment and monitoring of PrEP adherence. Apart from drug concentrations, PrEP lacks a ready biomarker associated with behavioral adherence that is analogous to viral load in HIV treatment. Prevention trial data have raised questions about the validity of adherence measures such as self-report and pill counts in trial settings. In the context of clinical care, feasible and valid approaches for monitoring PrEP adherence are needed to address clinical guidelines emphasizing regular adherence monitoring and to identify individuals needing additional support for adherence. There is an additional challenge of examining PrEP adherence concurrently with risk behavior, since PrEP will not have preventive utility unless its use appropriately encapsulates risk behavior. Priority research in this domain may include:

Determinants of PrEP adherence. Scant knowledge exists regarding PrEP use outside of the context of closely controlled, randomized double-blinded trials. Trial findings indicate a number of individual-level adherence determinants including age, alcohol use, and sexual activity. Perceived risk has been proposed as a driver of PrEP uptake and adherence, and relationship factors and social support may also have a role to play. Research designed to advance scientific understandings of determinants of open-label PrEP uptake, adherence, and persistence will be critical to developing effective adherence interventions that will strengthen its preventive impact. Related work includes:

Interventions for PrEP adherence. Proven interventions to promote and sustain adherence to PrEP are entirely lacking at this time. The strong relationship between PrEP adherence and PrEP efficacy means that efforts that promote and sustain PrEP adherence should help limit new infections among PrEP users. In an adherence sub-study nested within the Partners PrEP trial, electronically monitored adherence was nearly-perfect (~99%) under conditions where adherence counseling was provided to individuals evidencing <80% adherence during unannounced pill counts; at this exceptionally high adherence level no HIV infections were observed among individuals receiving active drug and 14 infections were found among those receiving placebo.

PrEP adherence interventions are likely to be delivered in conjunction with risk-reduction counseling, HIV testing, and other clinical monitoring accompanying PrEP. Among many possible approaches, the development of technologic approaches to monitor PrEP adherence and help deliver adherence support could be highly beneficial. Studies to develop and test PrEP adherence interventions will include, but are not limited to:

ART Adherence

Importance of ART adherence. Striving to achieve and maintain the highest possible level of ART adherence remains important for optimizing HIV treatment outcomes. Among many factors that can influence ART treatment success or failure, research has long identified adherence as a central determinant of viral suppression, improved CD4+ T-cell count, delayed progression to AIDS, and patient survival. Although the development of highly potent and boosted drug regimens may allow viral suppression despite imperfect ART adherence, adherence remains strongly predictive of viral suppression and long-term mortality even with contemporary antiretroviral regimens. There are indications that the relationship between ART adherence and risk of virologic failure may vary by drug class and can evolve in the context of durable viral suppression, and the significance of different forms of adherence behavior may vary over the course of treatment as a result.

Adequacy of ART adherence. Meta-analyses indicate that ART adherence remains sub-optimal in many patient groups and regions around the world. In the US, large patient samples evidence disparities in ARV initiation, adherence, and viral suppression along racial/ethnic, age, and gender lines. In sub-Saharan Africa, brief interruptions of ARV treatment adherence have been observed and predict the development viral failure.

Assessment and monitoring of ART adherence. There remains no gold standard for behavioral assessments of ARV adherence. Many assessment methods have been examined in the context of HIV treatment, including self-reports, pharmacy refill, announced and unannounced pill counts, and electronic drug monitoring. The validity and precision of these tools vary, and each contains advantages and disadvantages. Any assessment approach for ART adherence would be made more useful if it could be configured to systematically provide prospective or real-time monitoring of adherence behavior. Routine monitoring of ART adherence could empower patients through timely feedback, and could offer healthcare providers actionable information for the delivery of targeted adherence support interventions. Related studies may include:

Determinants of ART adherence. The conduct of formative research and the articulation of theoretical models are critical for designing effective adherence interventions. Theory-based and empirical studies have elaborated many important determinants of adherence to ART, particularly within general clinic populations in highly developed countries, and primarily at the level of patient- and regimen-related factors. Fewer studies have systematically investigated various social-contextual, healthcare system, and structural factors, despite evidence that ART adherence can be affected by factors such as care team composition, food insecurity, and experiences of discrimination and stigma. Further research to understand social and structural determinants of ART adherence in both domestic and international settings will be needed to inform the design and mechanisms of novel adherence interventions. Priority research in this domain may include:

Interventions for ART adherence. Regimen simplification has benefitted ART adherence but has not eliminated the challenge. Further studies are needed to expand available interventions to support ART adherence and enhance their efficacy. Research to date has generated a small but growing set of interventions with demonstrated efficacy in improving ART adherence. The US Centers for Disease Control and Prevention (CDC) maintains a list of rigorously-tested and evidence-based ART medication adherence interventions for dissemination here. Documented intervention effects to date have generally been modest and with greater impact on behavioral adherence than viral load. Key research gaps exist in the development and testing of interventions addressing youth living with HIV, interventions in resource-limited settings globally, and structural and systems-level interventions with broad impact on ARV treatment adherence.

ART adherence intervention trials should be mindful of rigor and should assess impact on both behavioral adherence and biological outcomes such as viral suppression. Related research will include, but is not limited to, the following:

Key populations and junctures to be targeted by ART interventions may include but are not limited to:

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
Revision

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 total project period may not exceed 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, 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

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)

Michael J. Stirratt, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3875
Email: stirrattm@mail.nih.gov

Vanessa Elharrar, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4787
Email: elharrarva@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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