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.
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
This Funding Opportunity Announcement (FOA) encourages research project grant applications to leverage large-scale, real-world data from electronic health records (EHRs) from a variety of systems (e.g., the Department of Defense, Department of Veterans Affairs (VA), Centers for Medicare and Medicaid Services administrative claims as well as public or private health care systems and networks) to understand impact of treatments and services for mental and neurological disorders and to identify promising new mental health and neurological disorders research directions. There is particular interest in leveraging EHRs and administrative data to 1) understand and improve the treatment of post traumatic psychopathology including posttraumatic stress disorder, depression, traumatic brain injury (TBI), and risk for suicide and 2) characterize post trauma multi-symptom recovery trajectory patterns of TBI that may include posttraumatic stress disorder, depression, cognitive impairment, pain, substance abuse disorder, and risk for suicide.
Given the prevalence of PTSD, depression, TBI, and suicidality among Service Members and Veterans, the NIMH, the NINDS and the VA Office of Research & Development (ORD) are particularly interested in health record examinations that may reveal new approaches to treatment of post-traumatic mental health and TBI sequelae. Both PTSD and TBI may be experienced by Service Members and Veterans and are prevalent in the general population as conditions that could develop after life-threatening trauma. PTSD and TBI presentations are heterogeneous and overlap with several problems associated with exposure to trauma. People exposed to trauma also may experience other severe neurological, psychological, behavioral, medical, and social dysfunction, including TBI, depression, anxiety, cognitive impairment, pain, substance abuse, and suicidality. There is also a growing awareness that post-traumatic psychopathology is linked to other serious health conditions (e.g., hypertension, smoking, heart disease).
This FOA aligns with a 2012 White House Executive Order directing the Departments of Defense (DoD), Veterans Affairs (VA), and Health and Human Services (HHS) to develop a National Research Action Plan (NRAP) on PTSD, other mental health conditions, and TBI, specifically through better use of EHRs to gain insight into the risk and mitigation of PTSD, TBI, and related injuries.
The healthcare landscape in the United States is constantly changing, creating new challenges for the delivery of high quality treatments and services to children, youth, adults, and older adults with unmet or under-met mental health needs. Epidemiological findings suggest that approximately one half of the United States population meets lifetime criteria for a mental disorder, and approximately one quarter of the population meets criteria in any given year. However, only one half of people with any mental health disorder and only two thirds of people with a serious mental health disorder received mental health services in the previous year. Of those that find their way into mental health care, many fall out of care and/or do not receive guideline concordant treatment. Disparities in population status (e.g., members of racial, ethnic, sexual, and gender minority communities), a fragmented healthcare system, provider shortages, healthcare affordability, and other factors moderate these findings. Research is needed to improve access, continuity, quality, equity, efficiency, and value of mental health services, and to bring effective strategies to scale to maximize public health impact.
In the past 40 years, major advances have been made, including the inception of the diagnosis of PTSD. There is now strong evidence to support the use of psychotherapies and the systematic rollout of Prolonged Exposure and Cognitive Processing Therapy throughout the Veterans Affairs Healthcare System has improved access for veterans receiving care within that system. Although no medications have been specifically developed for treatment of PTSD, two medications repurposed from other mental health disorders have been approved by the US Food and Drug Administration for PTSD treatment. Despite these advances, many individuals suffering from PTSD do not receive minimally adequate care. Similarly, recent evidence in TBI suggests that nearly half of patients presenting at Emergency Departments for TBI do not seek follow-up care 3 months post-injury despite recent evidence that a significant portion of mild TBI patients continue to report symptoms up to a year post-injury. Even among patients who have access to and receive the best evidence-based care for their diagnosis, far too many people will not respond adequately. Health care providers do not have guidance to suggest which patients will best respond to available treatments and often take polypharmacy approaches that include off-label approaches to try to address patients’ complaints.
Efforts are underway across the federal sponsors of research to improve existing evidence-based treatments and to develop new pharmacological, psychosocial and device-based interventions e.g., VA PTSD Psychopharmacology Initiative (PPI), NIMH Clinical Trials Funding Opportunity Announcements: First in Human, Exploratory Experimental Therapeutics, Confirmatory Efficacy, and Effectiveness. However, these and other initiatives will require substantial time and the yield is uncertain. The urgent clinical and public health needs associated with exposure to trauma including post-traumatic psychopathology and TBI broadly requires guidance in the short term for practicing clinicians. The use of large-scale, real-world data in EHRs may inform care in the near term.
The sponsors of this FOA recognize that while imperfect, data captured in large health care systems and information exchanges/networks which link together multiple electronic record systems have the potential for new insights. Health care systems such as the VA and DoD as well as integrated public or private health care systems and networks are believed to be valuable resources for rapidly understanding both the false positive and false negative results of failed clinical trials as many of the same medications are routinely prescribed. Health record examination may also inform which patients successfully adhere to or do not complete evidence-based treatments, highlighting the importance of complete treatment course or reasons why failures occur as pathways to promote better healthcare. Further, identifying clinical and functional impacts of current on- and off- label treatment practices is also a priority. Data from large EHR systems can also provide longitudinal health information valuable for understanding and characterizing post-traumatic disease course beyond what is currently known about the general trajectories of illness recovery (e.g., the role of pain in the development of illness). These longer-term outcomes have utility for classifying outcome trajectories based on treatment of post-trauma symptoms and clusters of symptoms. Understanding the role of care in altering post-trauma symptom trajectory as well as novel mediators and moderators can be used to develop prognostic risk models, inform treatment strategies, and be used for patient stratification in future clinical trials.
Electronic Health Records queried under this FOA should be used to address urgent clinical and public health needs, especially those associated with post-traumatic psychopathology and TBI, but also for other mental disorders that could be better interrogated using EHR data. Data and measures selected are expected to reflect the care of the population and support the possibilities of hypothesized relationships between care and outcomes of interest. This work is expected to advance understanding of which patients may most benefit from available on and off-label treatments, including psychotherapies, pharmacotherapies, and devices. As this work hinges on the data available in the EHR and other records, inherent opportunities, as well as the limitations, that should be addressed in the application.
The goals of this FOA include, but are not limited to the following:
Inform the development of novel treatments, improve efficiency, and enhance clinical impact of existing treatments
Examine services delivery to improve the quality and outcomes of care
Research on innovative service delivery models to reduce or eliminate known health disparities related to race, ethnicity, geography, sexual and gender minority status, socioeconomic status
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
All instructions in the SF424 (R&R) Application Guide must be followed.
Background and Overview: This section should include a general introduction to the study topic area, including relevant literature reviews to support the subsequent design strategies. Applicants should clearly state the specific goals being addressed with the proposed research. Additionally, this section should be used to describe:
Innovation: This section should describe:
Approach: The section should include information on the availability, access, opportunities, and limitations of EHRs as well as any proposed methodological advances to improve the use of EHR . This section should describe:
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. This timeline might include, for example, data acquisition, transformation, integration, and application of various statistical approaches, and interpretation. These milestones should be tailored to the unique scope of each project and written concretely enough to evaluate exactly what will have been achieved during the course of the project. The application should describe the potential implications of how the proposed research might extend beyond the purview of existing federal- and private-supported research. Investigators should describe how results will be used to inform future phases of research and development. Future work to follow from funded projects likely would include validation of novel treatments and therapeutic targets and experiments to refine and optimize services toward improved outcomes of care.
The following modifications also apply:
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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.
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.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 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?
Does the applicant describe the availability, access, opportunities and limitations of EHRs as well as any proposed methodological advances to improve the use of EHR? Are methods for data procurement, harmonization across systems for research use (if applicable) described? Are approaches to quality assurance/quality control, processing, and analysis described? Are rigor and transparency for data selection and variable inclusion described?
Does the applicant provide a timeline and milestones as part of the Research Strategy and a distinct section, entitled “Milestones”, that briefly proposes operationally-defined indicators of progress at critical junctures?
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?
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?
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.
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.
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.
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).
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.
Following the completion of the review process, VA will consider any applications that meet VA funding eligibility criteria.
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.
Awards considered for VA funding will be subject to VA ORD rules and regulations governing the support of scientific research and development projects. For specific information see VHA Handbook 1204.01 available at www.hsrd.research.va.gov/funding/budget-limitations.pdf
If the application is under consideration for VA funding, the VA will request "just-in-time" information from the applicant. For details, applicants may refer to the VAHSRD website http://www.hsrd.research.va.gov/funding/ .
For VA awardees, the HSRD will provide notification of approval to the principal investigator's VA Medical Center.
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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Farris Tuma, ScD
National Institute of Mental Health
Patrick Bellgowan, PhD
National Institute of Neurological Disorders and Stroke
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke
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