Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Mental Health (NIMH)
Reissue of RFA-MH-18-400
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
RFA-MH-20-305, R01 Research Project Grant
93.242
This Funding Opportunity Announcement (FOA) seeks to leverage data from existing basic, clinical, and intervention research on suicide risk and behaviors as well as social media and healthcare records data, by encouraging the integration of existing data sets for novel secondary analyses aimed at identifying potential biological, experiential, and other predictors, moderators, and mitigators of suicide risk. The use of dimensional variables and inclusion of multiple levels of analyses are particularly encouraged. A secondary goal of this FOA is to support innovative projects that will generate foundational work for research studies on suicide-related behaviors that inform a Research Domain Criteria (RDoC) approach in this area. Projects supported by this FOA will help address gaps identified in the 2014 Prioritized Research Agenda for Suicide Prevention. Applicants seeking to support efforts focused on linking pertinent data from healthcare system records (e.g., suicide attempt events) to mortality data so that a more accurate understanding of the risk factors for, and the burden of, suicide among those seen in structured healthcare settings can be discerned should apply to the companion NIMH Funding Announcement, RFA-MH-20-305 .
November 20, 2019
January 10, 2020
February 10, 2020
No late applications will be accepted for this Funding Opportunity Announcement
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
June 2020
August 2020
December 2020
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.
Background
In 2017 there were more than 47,000 suicide deaths in the United States. This staggering loss of life more than doubles the number of homicide deaths in the U.S. in the reporting period. The annual suicide rate in the U.S. has continued to climb over the past several decades and suicide is the 10th leading causes of death in the U.S. Compounding the impact of mortality, the rate of suicide attempts is many times higher than the rate of suicide death and the economic impact of suicidal behaviors has been estimated to exceed more than $50 billion annually in the U.S. Yet, as sobering and alarming as these statistics are, the low base rate occurrence and heterogeneous path for suicidal behaviors present significant challenges to clinicians attempting to detect and address such behaviors and researchers striving to better understand the trajectories of suicidal behavior. What has become clear, however, is that suicidal ideation, non-fatal and fatal attempts, often occur in the context of underlying mental health and substance use disorders.
The transdiagnostic path of suicidal ideation, attempts, and death vary across the lifespan, and are differentially influenced by factors such as gender, age, culture, and other experiential moderators. Given this heterogeneity, there are likely multiple behavioral and biological factors that interact with situational variables to confer elevated risk for suicide thoughts and behaviors (i.e., ideation, attempt, and death). Thus, by using a multifactorial and dimensional approach it may be possible to parse suicide behavior into component elements and identify smaller sets of variables that interact with each other to potentiate risk or protection. These variables may also then lend themselves to scrutiny by rigorous research analyses. Recent efforts in developing powerful computational tools have shown great promise in identifying subgroups of individuals with elevated predicted suicide risk or protection and have the potential for advancing personalized medicine goals. Leveraging computational approaches offers opportunities to better tailor interventions by identifying groups who could benefit from specific existing interventions or novel interventions.
In a continuing effort to engage experts focused on discovering and understanding the variety of behaviors and markers of suicidal behavior, the NIMH convened a workshop entitled “Mechanisms Underlying Suicide Risk: Integrating RDoC to Inform Novel and Personalized Intervention Research.” One theme distilled from this meeting was the need to leverage opportunities with existing datasets that when combined, could provide more power to detect various risk or protective trajectories. Aggregating data across multiple existing studies to bolster the ability to detect signals of suicidal behavior could prove fruitful. An expert panel reviewing suicide prevention approaches recommended probing existing data from preventive intervention trials, where intervention effects on suicide outcomes (e.g., ideation, attempts, deaths) could be examined along with intended targets that are also suicide risk factors (e.g., aggression, substance use, depression). Integrating existing prevention datasets could potentially be used to determine whether preventive interventions delivered earlier in life (prenatal through adolescence) have effects proximally and/or distally on suicidal ideation and behaviors, including long-term and/or cross-over effects (unanticipated beneficial effects). It would also allow for examining the impact of interventions on subpopulations (e.g., racial/ethnic minorities, sexual gender minorities). Yet another approach might be to systematically evaluate (typically large) existing healthcare data and social media that have previously not been closely examined for signals of suicidal behaviors. Efforts in this area might then serve as an incubator for novel prospective studies and could inform future Research Domain Criteria (RDoC) and computational psychiatry approaches for understanding suicidal behaviors. Responses solicited to a recent Request for Information from the NIMH (NOT-MH-16-027) support converging interest in pooling existing datasets and mining existing healthcare data as an important initial step to enhance signal detection and enable appropriately powered multi-factorial analyses.
Purpose/Research Objectives:
Given these many existing, untapped data resources, the purpose of this Funding Opportunity Announcement (FOA) is to provide an opportunity for investigators to integrate and analyze datasets in a cost-efficient manner, to yield novel findings, to identify key scientific gaps, and to inform future research investments focused on identifying predictors of suicidal behaviors and quantifying risk. Better understanding of mechanisms and trajectories associated with suicide risk and behaviors can also facilitate the development of novel interventions and the refinement of preventive and therapeutic interventions that can be used to effectively reduce suicide risk. Data from these projects also offer the potential to inform understanding of how the measures of suicidal behavior in current studies and datasets might link to, or inform NIMH’s RDoC efforts. Understanding the mechanisms and trajectories of these behaviors has the potential to influence novel prevention and intervention development.
NIMH Specific Areas of Research Interest:
Projects proposed under this announcement could involve, but are not limited to the integration and analyses of datasets from:
Potential research approaches and questions include, but are not limited to:
Scale and Scope of Studies Covered Under this Announcement
This FOA is intended to support the integration and analysis of datasets in a cost-efficient manner, to yield novel findings, to identify key scientific gaps, and to inform future research investments focused on identifying predictors of suicidal behaviors and quantifying risk. Better understanding of mechanisms and trajectories associated with suicide risk and behaviors can also facilitate the development of novel interventions and the refinement of preventive and/or therapeutic interventions that can be used to effectively reduce suicide risk. Data from these projects also offer potential to inform understanding of how the measures of suicidal behavior in current studies and datasets might link to, or inform NIMH’s RDoC efforts.
Applications that address questions using these combined/large datasets are particularly encouraged to include: 1) the identification of composite suicide risk and protective factors; 2) moderators and mediators of risk for suicidal behavior; and 3) identification of subgroups of populations (e.g., age, gender, racial/ethnic, cultural and sexual orientation differences) as they pertain to suicidal behaviors.
The National Library of Medicine has a website that lists NIH Data Sharing Repositories (https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html), where data dictionaries of shared studies can be reviewed for suicidal ideation and behavior measures. The NIMH Data Archive offers tools, such as Global Unique Identifiers (GUIDs) to address participant privacy, and allow data to be anonymized and shared (https://data-archive.nimh.nih.gov/ndct/s/nda/tools.html). The NIMH Data Archive is also willing to work with awardees to provide a private cloud-based storage site that will facilitate the proposed work. Applicants who are interested in exploring this possibility should contact the NIMH Data Archive help desk ([email protected]). Sharing of datasets for broad research use is strongly encouraged, when appropriate. Inter-university Consortium for Political and Social Research (ICPSR) maintains a data archive of more than 250,000 files of research in the social and behavioral sciences, and can potentially be used as a resource for finding relevant data.
NIMH encourages the use of state-of-the art computational approaches. For applications that propose data harmonization and analytic/computational approaches for which there is limited feasibility information, a sound rationale should support why the proposed approach is the most appropriate and likely to generate an exceptionally high impact if successful.
NIMH encourages harmonization of databases where data can be publicly shared. When possible , investigators funded under this FOA are encouraged to share data via the NIMH Data Archive (https://data-archive.nimh.nih.gov/ndct/about ). The NIMH Data Archive is willing to work with applicants to determine what data can be shared (e.g., electronic medical record data; National Death Index acquired data). The NIMH Data Archive can also provide a private cloud-based storage site that will facilitate the proposed work. Applicants who are interested in exploring this possibility should contact the NIMH Data Archive help desk ([email protected]).
Protection of Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.
Potential applicants are strongly encouraged to consult with NIH staff as early as possible when developing plans for an application (see Scientific/Research Contacts, Section VII). This early contact will provide an opportunity to clarify NIH policies and guidelines and help to identify whether the proposed project is consistent with NIMH program priorities and the goals.
Non-responsive Applications
Applications that do not focus on primary variables of relevance to understanding suicidal behavior will be deemed non-responsive and will not be reviewed. Likewise, applications that are not strongly focused on identifying novel factors or composite approaches to better understand suicidal behaviors will be deemed non-responsive and will not be reviewed. This FOA is intended to support re-analysis of existing data: collection of new data is not allowed for this FOA, and applications will be deemed non-responsive if new data collection is proposed. The FOA is intended to support analysis of integrated data sets: applications that propose analysis of data from a single study/trial or parallel analyses of separate studies/trials are not considered responsive.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NIMH intends to commit $3 million in FY 2021 to fund 4-6 meritorious applications.
Application budgets are limited to $500,000 in direct costs (not including consortium F&A) in any project year, and need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 4 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy: Research supported through this FOA should focus on theory-based novel, transformative approaches that leverage and aggregate existing datasets to advance our understanding of suicidal behaviors.
Significance
Investigators
Innovation
Approach
For applications that involve integration of prevention and/or treatment data sets:
Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes operationally-defined indicators of progress at critical junctures. The milestones should be tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the course of the project. When multiple datasets are proposed to be aggregated, there should be a clearly documented commitment by the data owners and the informed consent documents should permit such aggregation. If the application includes leveraging healthcare data or social media data, there should be included appropriate permissions for using these data for research purposes. There should be specific proof-of-concept test(s) that indicate how the proposed approaches will be tested and validated, along with alternative strategies should an effort fail to perform as expected .
Letters of Support: When multiple datasets are proposed to be aggregated, a clearly documented commitment by the data owners must be provided in the application and documentation that the informed consent documents permit such aggregation. Likewise, if the application includes leveraging healthcare data or social media data, appropriate permissions for using these data for research purposes must be included.
The following modifications also apply:
Sharing Data via the NIMH Data Archive: To advance research through widespread data sharing among researchers, investigators funded under this FOA are encouraged to share human subjects data via the NIMH Data Archive (NDA) (NOT-MH-19-033, Notice of Data Sharing Policy for the National Institute of Mental Health). Established by the NIMH, and supported by other NIH Institutes, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, results, tools, and supporting documentation.
Where possible, investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://nda.nih.gov/contribute/sharing-regimen.html. A resource sharing plan, formulated in accordance with these NDA Data Sharing Terms and Conditions, should be included in the grant application. The NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technologies. Investigators funded under this FOA should use these technologies to submit and share their research data and results at the appropriate times. The NDA Cost Estimation Tool is a customizable Excel worksheet that can be used to calculate an estimate of the resources needed to submit and share data with the NDA. This resource estimate should be submitted as part of the application budget (http://nda.nih.gov/contribute_cost_estimation.html).
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Timeline and Milestones: Are these milestones tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the course of the project? When multiple datasets are proposed to be aggregated, is there a clearly documented commitment by the data owners and do the informed consent documents permit such aggregation? If the application includes leveraging healthcare data or social media data, are the appropriate permissions for using these data for research purposes included? Are there specific proof-of-concept test(s) that indicate how the proposed approaches will be tested and validated, along with alternative strategies should an effort fail to perform as expected? Does the application consider where additional research might arise from the proposed project? Does the application specifically consider how it might inform potential future research avenues that could germinate from the proposed project?
For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable.
Not applicable.
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.
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.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
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General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
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Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Eve E. Reider, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-1496
Email: [email protected]
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]