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)

Funding Opportunity Title

New Computational Methods for Understanding the Functional Role of DNA Variants that are Associated with Mental Disorders (Collaborative R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-391

Companion Funding Opportunity

PAR-13-392, 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

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support the development of advanced computational, bioinformatic and statistical tools to determine the functional relevance of genetic variants associated with mental disorders of complex etiologies identified through genome-wide association or sequencing studies. The overarching goal of this initiative is to support the development of innovative computational methods that facilitate the elucidation of the functionality of genetic variants associated with mental illness, taking into account the added complexities and nuances of brain diseases, and to ultimately inform the identification and validation of potential targets for novel treatment development. This FOA should be used when two or more sites are needed to complete the study. For a linked set of collaborative R01s, each site must have its own Program Director/Principal Investigator and the set of linked applications provide a mechanism for cross-site coordination, quality control, database management, statistical analysis, and reporting.

Key Dates
Posted Date

November 13, 2013

Open Date (Earliest Submission Date)

January 5, 2014

Letter of Intent Due Date(s)

At least one month prior to the application due date

Application Due Date(s)

Standard 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.


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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


Background and Rationale

More than 1,000 published Genome-wide association studies (GWAS) have collectively reported significant associations of ~4,000 single-nucleotide polymorphisms (SNPs) for more than 200 traits/diseases. The challenge is to move SNP associations to biological insights and then to translate these insights, ultimately towards achieving better clinical treatments and outcomes. This ambitious goal requires an inclusive and effective strategy to solve the molecular basis by which these variants confer disease susceptibility. To date, many significant genetic signals associated with mental illness have been found with variants located both in non-coding and protein coding regions of the genome. One of the many challenges in the "post-GWAS" era is to understand the regulatory principles of risk variants in gene desert regions and the mechanisms underlying the risk conferred by these loci.  While large efforts, such as ENCODE and psychENCODE (http://www.genome.gov/10005107, and http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-14-020.html), to identify and characterize functional elements throughout the genome are ongoing, signals in non-coding regions pose a particular conceptual and analytical challenge; lack of sophisticated, scalable computational methods to decipher the allelic architecture of risk conferring genes and their biology, still remains a major constraint in the field of psychiatric genomics.

Next generation sequencing has transformed the field of human genetics by revealing the ubiquity of DNA sequence variants. Interpretation of these numerous variants in both healthy individuals and those with Mendelian and complex diseases will require novel strategies. Human geneticists, sequencing candidate genes and whole genomes, have found an unexpected plethora of loss-of-function and gain-of-function mutations as well as copy number variants. Genome-wide association studies of mental illness have identified many variants associated with small effects. In addition, non-coding regions, gene regulatory regions, as well as genetic background will undoubtedly prove to be important in determining mental health outcomes. Existing human DNA sequence data sets provide important research opportunities to determine which variants, among the many identified, underlie the genetic basis of mental disorders. This requires a fundamental shift in both the conceptual and technical approaches currently used by human geneticists. Now that researchers have reliably identified a large number of risk loci for severe mental illness, we need to employ computational tools to help us prioritize these loci for further functional characterization and ultimately, translation to novel treatment targets.

The long-term goal of the research to be supported by this initiative is to develop principles and computational tools for evaluating the functional relevance of both common and rare variants that have validated associations with mental disorders in order to maximize efficiency for identifying viable targets for new therapeutic development. Several genome-wide studies conducted to date in psychiatric disorders, have implicated involvement of multiple genetic loci. Currently, once genomic data are generated, there are few strategies available for determining which variations at a genetic locus have biological importance. In addition, there is a need to define the mechanisms by which variations at many loci work in concert to produce a particular phenotype. At the level of an individual, the broad range of epistasis, pleiotropic, penetrance and expressivity of the genetic variants has created opportunities to integrate genomic information with systems biology and clinical phenotype in innovative ways.  Relevant phenotypes may go beyond a dichotomous clinical diagnosis to include constructs such as those described by the Research Domain Criteria (RDoC) project (http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml).

Scientific Scope of Research Program

This FOA invites applications to develop and apply novel statistical and computational methods to delineate functional attributes of the genetic variants identified through whole genome association and sequencing studies of severe mental illness.  It is expected that the proposed studies use existing human genomic and phenotypic data from well-phenotyped cohorts with highly heritable mental illnesses.  In addition, the proposed projects should pay particular attention to the unique nuances and challenges that are involved with studying brain diseases.

The data types used could include whole-genome sequence data, targeted genome sequence data, GWAS genotype and phenotype data, gene-gene or gene-environment interactions, patterns of variation within and among populations and species, and various functional data types such as RNA expression, DNA methylation, transcription-factor binding sites, chromatin structure, protein interactions, and biochemical pathways, so long as they are of direct relevance to mental illness. Applicants will need to explain what datasets they will use and how they will obtain them. Relevant data may be obtained from public resources such as the NIMH Repository (www.nimhgenetics.org), NDAR (http://ndar.nih.gov/), brain atlases (www.brain-map.org), the Human Connectome (www.humanconnectomeproject.org), dbGap (www.ncbi.nlm.nih.gov/gap), 1000 Genomes (www.1000genomes.org), GTEx (http://commonfund.nih.gov/GTEx), ENCODE (http://genome.ucsc.edu/ENCODE/), Roadmap Epigenomics (www.roadmapepigenomics.org), LINCS (www.lincsproject.org), and GEO (www.ncbi.nlm.nih.gov/geo.

Examples of research topics that would be areas of interest include, but are not limited to, the following:

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Renewal
Resubmission
Revision

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

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.

The NIMH intends to commit approximately $3,000,000 (total costs) in FY 2015 for this FOA and the companion announcement.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The total project period may not exceed 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

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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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:

Thomas Lehner, Ph.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 7190, MSC 9643
Bethesda, MD  20892-9643
Telephone:  (301) 443-9869
Email: tlehner@mail.nih.gov

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, with the following additional instructions:

Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative R01s, the titles for each R01 in the set must have the following format:  a “1/N” indicator + Identical title (e.g., “1/6-Multisite Comparison of Drug A vs. Drug B for Treatment of Disorder X”, where the 1/6 means this is site 1 of 6 sites in the set.  The other sites will be labeled 2/6, 3/6, etc.)  Titles may not exceed 80 characters in length, including the tag, e.g., 1/6, at the beginning of the title.

Cover Letter Attachment: The Cover Letter is one pdf file only.  Therefore, it must include the information requested below on the collaborative sites, as well as, where required, the Institute approval information on applications that are at or exceed a $500,000 direct cost budget in any year (see Section IV.6).  The following collaborative information is required in the Cover Letter:  a listing of all the applications that are a part of the set of collaborative R01s being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., “1/6”), and 3) the Applicant Institution.  Each site should submit an identical listing.

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, with the following additional instructions:

Facilities and Other Resources: Applicants are advised that this section should address not only physical resources, but also the intellectual and collaborative resources for executing the project.

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, with the following additional instructions:

Specific Aims: The collaborative mechanisms currently require an Overview section that is part of the specific aims. This Overview section should be identical for all applications that are linked together for the collaborative R01. The requirements of the Overview are as follows:

The overview should provide an overall rationale for applying as a collaborative study; the role of each site; the approach to project management; and elements unique to any of the sites.

This information is required in order to address the sixth review criterion, Collaboration.

Research Strategy: The application from each site must contain a Research Strategy that clearly describes those aspects of the project that are common to all sites of the collaboration. All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site." In this subsection PDs/PIs should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, (etc).

Applications must describe a feasible mechanism for scientific integration of research procedures, overall managerial and administrative responsibilities, and cross-site comparability of training to assure reliability and quality control.  The PDs/PIs may or may not wish to designate a Steering Committee or other decision making body, or identify one individual as the contact person for the group as a whole, for purposes of NIMH correspondence. Plans for ensuring access to data by all sites, analytic resources, publication and authorship rights, the possibility of public use research materials and data, or other means of distributing research materials to the wider scientific community, and a means of arbitrating disagreements on publication and other issues should be included in the application.

Any site that contracts out some portions of this work should list this fact under "Elements Unique to This Site," and provide a full description of the nature, purpose and oversight of this contractual arrangement.

Letters of Support: Please provide signed letters of support confirming access to existing data resources.

Human Subjects: All applicants using human data should carefully explain how they got the data, whether this is human subjects research, whether someone in their research group has the individual identifiers for the data (in which case this is human subjects research), and whether the data are anonymous or publicly available (in which case this is not human subjects research).  This explanation is required whether or not NIH rules define the research as involving human subjects.

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:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The NIMH is committed to the principle of rapid release of data, experimental protocols, models, and software to the scientific community.  Applicants are expected to provide a plan to release to the research community the methods, algorithms, software, data, and evaluations of the methods in a timely fashion through an informatics platform. 

Applicants may propose to use or develop datasets that are not publicly shared at the start of the project as long as they describe their plan for sharing these datasets by the end of the first year of the award.  If data sharing is not possible on this timeline, applicant should provide an explanation of why sharing is not possible.

Plan for Sharing Software:  A software dissemination plan, with appropriate timelines, is expected to be included in the Resource Sharing Plans to meet the goals of this program.  There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate dissemination plans based on their likely impact.  A dissemination plan guided by the following principles is thought to promote the largest impact:

1.  The software should be freely available to biomedical researchers and educators in the non-profit sector, such as education institutions, research institutions, and government laboratories.

2.  The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators.  The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, and incorporation of the software or pieces of it into other software packages.

3.  To preserve utility to the community, the software should be transferable such that another individual or team can continue development if the original investigators are unwilling or unable to do so.

4.  Applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources that are contributed by others. This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. 

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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) OR $500,000 or more in direct costs for the COMBINED budgets across the linked applications, in any year (excluding consortium F&A costs) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide. For collaborative sets where the combined budgets are at or above $500,000, each application should include their letter of approval from the NIMH in the Cover Letter component, even if an individual application budget is below $500,000.

Additional Information about Linked Applications

Applications must be submitted as a linked group or set of R01s, usually one R01 per participating PD/PI.  For each set of linked collaborative R01 applications, it is expected that each application will be coordinated and interlocked with the others as each application will contribute an essential component to the overall study.  However, there are likely to be elements unique to some sites (e.g., data coordination, fidelity assessment, statistical analyses).  Based on the particular science proposed and the determined need for substantial involvement by NIMH staff, NIMH may convert a linked set of collaborative R01s into cooperative agreement U01s, following peer review.

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


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.

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? Do the methods proposed have the potential to provide new transformative insights into the functional implications of genetic risks associated with severe mental illness?  Is the plan for dissemination of new software sufficient to progress the 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?  Do the PD(s)/PI(s) and other key personnel have adequate expertise in computational statistical methodologies as well as expertise and understanding of the complexities of psychiatric genomics?   

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?  Is the application proposing the development of novel statistical/computational approaches or innovative ways to expand on existing methods to deciphering the functional role of genetic variants associated with mental illness? If successful, will the proposed project delineate functional attributes of the genetic variants identified through whole genome association and sequencing studies of severe mental illness?  

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? Are proposed new methods being applied to existing human genomic and phenotypic data from well-phenotyped cohorts with highly heritable mental illnesses?

 
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.

Collaboration

Does the Research Plan justify the need for a collaborative multi-site project using this FOA? Are sufficient and feasible mechanisms in place to ensure collaboration across sites to achieve scientific integration of research procedures, overall managerial and administrative responsibilities, appropriate quality control and reliability assurance, and planning for data management, analysis and reporting of results?  Are there adequate plans for shared decision making among PDs/PIs with regard to personnel, clinical decisions, changes in study protocol, and authorship?

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

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

Revisions

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

Additional Review Considerations

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

Applications from Foreign Organizations

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 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 National Advisory Mental Health Council. 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.

Program staff may negotiate modifications of software sharing plans with the PD/PI before making recommendations on funding an application.  Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.  The final versions of any accepted software sharing plans will become a condition of the award.

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.  The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report.

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 Commons Help Desk (Questions regarding 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)

Web ticketing system: https://public.era.nih.gov/commonshelp
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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Anjené M. Addington, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6653
Email: anjene.addington@nih.gov

Peer Review Contact(s)

Ross Shonat, Ph.D.
Center for Scientific Review (CSR)
Telephone:  301-435-2786
Email:  Ross.Shonat@nih.gov

Financial/Grants Management Contact(s)

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@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.


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