National Institutes of Health (NIH)
R21 Exploratory/Developmental Research Grant
July 20, 2023 - This RFA has been reissued as PAR-23-239
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
The purpose of this FOA is to encourage research that addresses the link between social disconnection in late-life and late-life suicidal thoughts and behaviors. Of specific interest is research that identifies mechanisms by which social disconnection confers risk for, and social integration protects against, suicidal thoughts and behaviors in late life. Mechanisms to be considered exist at multiple levels of analysis, including but not limited to neurobiological, behavioral, and environmental.
This FOA solicits R21 applications, while the companion announcement RFA-MH-22-135 solicits R01 applications. High risk/high payoff projects that lack preliminary data may be most appropriate for this R21 mechanism, while applications with preliminary data should apply to the R01 mechanism, RFA-MH-22-135.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| March 15, 2022 | March 15, 2022 | Not Applicable | July 2022 | October 2022 | December 2022 |
| October 15, 2022 | October 15, 2022 | Not Applicable | March 2023 | May 2023 | July 2023 |
All applications are due 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.
No late applications will be accepted for this Funding Opportunity Announcement.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
The purpose of this FOA is to stimulate research to understand the link between social disconnection including both objective social isolation as well as perceived social isolation (otherwise known as loneliness) and suicidal thoughts and behaviors in late-life. For the purposes of this FOA, social disconnection can be characterized by structural components (e.g., objectively few social relationships or infrequent social contact, whether driven by individual choice or societal forces), functional components (e.g., low or insufficient levels of social support and feelings of being excluded), and qualitative components (e.g., perceptions that relationships are of poor quality or are dissatisfying).
Of specific interest is research that identifies mechanisms by which social disconnection confers risk for, and social integration protects against, suicidal thoughts and behaviors in late life. Putative mechanisms exist at multiple levels of analysis, including but not limited to neurobiological, behavioral, and environmental. Investigators are encouraged but not required to consider units of analysis within the Research Domain Criteria (RDoC).
Of particular interest is research that identifies neurobiological, behavioral, psychosocial, or environmental mechanisms that can be targets within an experimental therapeutics approach (e.g., the NIH Stage Model) intervention development or that can point to ways to modify existing healthcare and community-based services to better provide support for individuals in late-life in the midst of a suicidal crisis.
Of particular interest is research that identifies neurobiological, behavioral, or environmental mechanisms that can be targets within an experimental therapeutics approach intervention development or that can point to ways to modify existing healthcare and community-based services to better provide support for individuals in late-life in the midst of a suicidal crisis.
Background
In late adulthood, suicide rates are higher than in any other age group and have risen over 40% in the past ten years (National Center for Health Statistics). Late life suicide attempts are also the most likely to be fatal. Older adults are also disproportionately likely to be socially disconnected.In addition to exiting the workforce (i.e., through retirement or layoffs) and experiencing high rates of bereavement, many also endure functional limitations and reduced mobility which limit in-person social interactions, suffer visual and hearing impairments which make digitally-mediated social interaction difficult or impossible, and experience deficits in core cognitive domains which degrade overall social functioning. Indeed, nearly a quarter of Americans over the age of 65 living in community settings are socially disconnected. Objective social isolation i.e., the objective state of having few social relationships or infrequent contact with others is associated with as much as a 3-fold greater risk of suicide in middle and late life. Perceived social isolation, or loneliness i.e., a subjective feeling of being isolated that typically occurs when there is a discrepancy between one’s perceived and desired social relationships doubles the odds of experiencing suicidal thoughts in late life. Overall, social disconnection is reported to be one of the primary motivators of self-harm in older adults.
Suicide prevention and intervention efforts that target the aging US population a population most vulnerable to suicide are urgently needed. Yet the evidence base for interventions that leverage social connection to prevent or treat late-life suicidal thoughts and behaviors must be further developed, beginning with mechanistic research that identifies potential intervention targets. At present, the evidence remains insubstantial regarding mechanisms which link social disconnection and late-life suicidal thoughts and behaviors. How does social disconnection put individuals at risk for suicidal thoughts and behaviors in late life? How does social integration protect against or ameliorate late-life suicide risk? How do suicidal thoughts and behaviors disrupt opportunities for social connection in late life that protect against suicide attempts? Important questions also remain regarding how individual factors such as sex and gender, race and ethnicity, socioeconomic status and cultural norms around death and dying and how they interact with environmental and structural factors such as urban vs rural setting, and community resources and supports to either confer or prevent risk. In addition, how the intersection of both individual and community/structural factors moderate the association between social disconnection and suicide risk in late life. Mechanisms by which healthcare and community-based services can be improved to support older adults experiencing a suicidal crisis are an additional area where further research is needed.
Research Objectives
This FOA is intended to support research designed to identify the neurobiological, behavioral, and social mechanisms underlying social isolation and social disconnection with consideration for the identification of novel targets for future development of prevention and intervention efforts. Studies that leverage concepts, methods, and findings emerging from research on mechanisms in social isolation, social disconnection, and both as predictors of risk/resilience are encouraged.
Clinical research should target populations that would be at risk for suicidal thoughts and/or behaviors or intentional self-harm to examine mechanisms relevant to both social disconnection and suicidal thoughts and behaviors to examine mechanisms relevant to both social disconnection and suicidality. Applications submitted to this FOA that are designated as clinical trials must be mechanistic clinical trials, as defined in NOT-MH-19-006. Clinical trials that propose to influence a clinical outcome, test safety or feasibility of an intervention, demonstrate the clinical efficacy or effectiveness of an intervention, or analyze the effect size of an intervention on clinical outcomes are ineligible for this FOA.
Research is encouraged that addresses issues of health equity and health disparities in late life social connection and suicide, particularly work that adopts the NIA Health Disparities Research Framework. Research is also encouraged that adopts an intersectionality framework (i.e., a framework that addresses the multiple dimensions of individuals identity and social systems as they intersect with one another).
Research is encouraged that assesses symptoms relevant to mental disorder, and well-being, and suicide dimensionally, integrates across multiple levels of analysis (including but not limited to brain-level measurements), and employs cutting-edge methodology from fields such as cognitive and affective neuroscience, neuroimaging, neurophysiology, neuroendocrinology, lifespan psychology, and geroscience.
An RDoC approach encourages taking a dimensional perspective with respect to assessing human functioning psychopathology and concentrating on aspects of behavior and brain function that span a range from intact to gradations of impairment, independent of diagnosis. Thus, in such an approach, recruitment and eligibility of study participants need not be determined on the basis of traditional diagnostic categories, but should instead be based on criteria that result in a sample that is optimized to study the clinical phenomena of interest over their full range of variability. Such an emphasis on understanding the full dimensionality of neurobehavioral functioning generally precludes simple, dichotomous designs comparing patients versus controls. However, it is not inconsistent with the RDoC approach to additionally characterize transdiagnostic samples of participants, recruited to represent the clinical phenomena of interest across the full range of variability, into existing diagnostic criteria. this allows investigators to draw links from novel approaches of characterization and classification to existing diagnostic categories and extant research. Under this FOA, if study hypotheses and/or enrollment criteria are not based on existing diagnostic criteria (i.e., an RDoC or other dimensional construct is proposed to serve as the primary variable representing psychopathology), the study design and sampling plan must be such as to assure that an adequate number of individuals assessed as falling within the more severely impaired ranges of that dimension will be included in the study. Varied research paradigms may be useful for pursuing the goals outlined above. Use of NIMH's Research Domain Criteria (RDoC) framework, or of RDoC-compatible approaches, in assessing component aspects of health, well-being, psychopathology and/or related domains of brain function dimensionally is not required but encouraged. If taking an RDoC approach, projects should employ assessment methods that converge on the construct from at least two levels of analysis. RDoC units of analysis (potential levels of measurement) include genes, molecules, cells, circuits, physiology, behavior, and self-report.
If the proposed research involves neuroimaging methods, applicants are encouraged to incorporate the use of protocols from the Human Connectome Project, assuming that the research addresses constructs that have been previously examined in the Human Connectome Project and that such protocols are available to the investigator.
Applicants are also strongly encouraged to review the Notice on enhancing the reproducibility of NIH-supported research through rigor and transparency (NOT-OD-15-103) and to incorporate appropriate features into the proposed research plans. NIMH has published guidelines for reporting elements of rigor in experimental design in applications (NOT-MH-14-004), and examples of critical elements for a well-designed study are summarized on the NIMH website.
Specific Areas of Interest
National Institute of Mental Health
Areas of interest include, but are not limited to:
- Improved understanding of the neurobiological and behavioral mechanisms underlying social isolation and social disconnection as it relates to suicidal behavior among older adults.
- Identification of social disconnection factors that increase risk of suicide in late life and/or the modality or lethality of suicidal behavior. Comparisons between the following dimensions of social connection are encouraged:
- Functional dimension of social connection (e.g., the functions provided or perceived to be provided by social connections such as social support, means restriction, loneliness)
- Structural dimension of social connection (e.g., social- and societal-level variables related to social connectedness such as relationship status, living arrangement, the natural and built environments (e.g., urbanicity/rural status), structural discrimination (including racism, sexism, ageism, and heterosexism), job loss/retirement, social capital, policy, healthcare delivery system, access, and quality, stigma)
- Qualitative dimension of social connection (e.g., perceptions of positive and negative aspects of social connectedness such as relationship satisfaction, relationship strain, conflict)
- How biological, genetic, psychosocial, and environmental factors, including but not limited to mental health history, age, race, ethnicity, zip code, socioeconomic status, gender identity, disability, and marital status, impact social connectedness and risk for late-life suicide. Studies examining how the impact of social disconnection on suicide risk varies across populations of older adults, including in sexual, gender, racial, and ethnic minorities, and as a function of environmental contexts, such as community-dwelling versus assisted living status are encouraged.
- Research is encouraged that addresses issues of health equity and health disparities in late life social connection and suicide, particularly work that adopts the NIA Health Disparities Research Framework. Research is also encouraged that adopts an intersectionality framework (i.e., a framework that addresses the multiple dimensions of individuals identity and social systems as they intersect with one another).
- Identification of brain circuits and/or neurobiological systems that may be modified by social connections and are mechanisms of pathophysiology or can be targets for the development of treatments that can prevent suicidal behavior among older adults.
- Studies that examine the role of structural barriers to social connection across different older adult communities that may predispose to enhancing risk of suicide.
- Studies that examine the intersectionality of both structural and societal barriers to connection and their impact on vulnerable elders.
- Studies that construct and validate assessments for social isolation and social disconnection in primary care and emergency departments and develops clearly defined taxonomies of social disconnection to enhance communication among members of integrative care teams who provide care to patients considering suicide in late life
- Computational approaches to identify predictive and/or explanatory causal patterns of factors associated with social isolation and suicidal behavior.
- Explore how mechanisms in social disengagement trajectories may be affected by older adult community service outreach efforts (e.g., nutrition support programs; home healthcare, etc.).
- Mechanisms by which social connections may be modified to prevent suicidal thoughts and behaviors.
Applicants who propose to examine dimensional constructs that do not appear in the NIMH RDoC matrices but which are consistent with the central tenets of the RDoC initiative should cite substantial evidence for the validity of such constructs, and indicate strong theoretical support that the construct maps onto a specific biological system, such as a brain circuit or physiological pathway, thought to be involved in aspects of suicidality, though measurement of those brain circuits or physiological pathways as part of proposed research projects is not a requirement of this FOA).
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 PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.
National Institute on Aging
-
The National Institute on Aging (NIA) will only accept research that examines social disconnection and suicide risk in the context of Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD), including Mild Cognitive Impairment, or caregiving for people living with AD/ADRD. The aforementioned topic areas are also of interest to NIA insofar as they relate to AD/ADRD and/or align with the AD/ADRD Research Implementation Milestones. Additional research topics of interest to NIA include, but are not limited to:
NIA encourages the use of a mechanism-focused approach for identifying intervention targets (e.g., Stage 0), as promoted by the NIH Science of Behavior Change and the NIH Stage Model. NIA encourages secondary analysis projects that leverage existing cohorts and datasets, including but not limited to those listed in NOT-AG-21-020. Projects addressing priorities outlined within the NIA Health Disparities Research Framework are encouraged.
- The potential harms of screening for cognitive impairment in older adults, including how receiving preclinical diagnostic information or a dementia diagnosis impacts suicidal thoughts and behaviors as a function of social connectedness, both for the person receiving the diagnosis and/or for the person’s presumptive caregiver(s)
- The effects of worsening cognitive decline on social connections and risk for suicidal thoughts or lethality of suicidal behaviors
- How suicidal thoughts and behaviors may be modified by interventions designed to increase social connections in people living with AD/ADRD or their caregivers
- How the social connectedness of a person living with AD/ADRD to other members of their community and/or to their healthcare providers and/or palliative care specialists influences decisions to pursue planned death or physician-assisted suicide
- How interpersonal factors within a caregiving dyad are related to suicidal thoughts and behaviors
- The extent to which emotional contagion in social networks contributes to the spread of suicidal thoughts and behaviors for people living with AD/ADRD and their caregivers
- The effects of AD/ADRD neuropathology on suicidal behavior in the context of social isolation and disconnection
- How health disparities in the diagnosis, management, and burden of AD/ADRD affect risk for suicidal behavior in the context of social isolation and disconnection.
- How differences in AD/ADRD neuropathology across individuals from different racial and ethnic minority groups and ancestries affect suicidal behavior in the context of social isolation and disconnection
- How the trajectory of neurobiological or clinical changes driving social disconnection in patients with AD/ADRD relates to risk for suicidal thoughts and behaviors, and how differences between AD and other AD-related dementias, such as Frontotemporal dementia and Lewy-body dementia, affect social connectedness and risk for suicidal behavior
- How social disconnection exacerbates established risk factors for suicidal behaviors, such as substance abuse and chronic pain, in people living with AD/ADRD and/or their caregivers
- Methods to assess perceptions of social connectedness and suicidal ideation in people living with AD/ADRD
The companion R01 grant mechanism of this FOA (RFA-MH-22-135) encourages longer term applications with preliminary data.
The following research activities are non-responsive to this FOA, and will not be reviewed (All applications-both NIMH and NIA):
- Studies whose purpose is to evaluate safety; clinical efficacy, effectiveness, and management; and/or development or implementation of new interventions. See the NIMH Clinical Trials website and NOT-MH-19-006 for further details about submission of mechanistic clinical trials to NIMH.
- Studies that are descriptive and do not address mechanism
- Studies that assess mechanisms of social disconnection and late-life suicidal thoughts and behaviors at only a single level of observation and analysis (i.e., without combining multiple levels/methods such as genetic, cellular, brain circuit, physiological, behavioral, self-report)
- Studies that address only social disconnection in late life (in the absence of measuring risk for or experience of suicidal thoughts or behaviors) or that address only late-life suicide (in the absence of assessing social factors)
- Nonhuman animal studies
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Resubmission
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.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
NIMH intends to commit a total of $4,000,000 in FY 2023 to fund 6-8 awards for this FOA and the companion FOA, RFA-MH-22-135, listed in Part 1.
NIA intends to commit a total of $2,000,000 in FY 2023 to fund 4-6 awards for this FOA and the companion FOA, RFA-MH-22-135, listed in Part 1.
The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
The scope of the proposed project should determine the project period. The maximum project period is 2 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (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.
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.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
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.
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.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
1. Requesting an Application Package
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.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) 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.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:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Applicants should include the following sections as part of the Research Strategy. Applications should not duplicate information provided in the attachment described in the PHS Human Subjects Clinical Trial Information form but may reference it to provide context as needed.
Significance
- Discuss the likelihood that the project will contribute to improving the understanding of the link between both social connectedness/disconnection and suicidality.
Investigators
- Provide evidence that the investigative team has adequate expertise in studying both social connectedness/disconnection and suicidality. For projects that propose to enroll human participants, detail how investigators are appropriately prepared to address clinical, ethical, and safety considerations necessary when conducting research with participants at elevated risk for suicide.
Approach
- If taking an RDoC approach, describe assessment methods that converge on the construct from at least two levels of analysis (e.g., genes, molecules, cells, circuits, physiology, behavior, and self-report).
- As part of the conceptual framework, indicate clear mechanistic hypotheses and have adequate capacity to test and potentially refute the hypotheses.
- If using a dimensional construct, the study design and sampling plan must assure that an adequate number of individuals falling within the more severely impaired ranges of that dimension will be included in the study.
- Describe plans for assessing comorbid medical conditions and controlling or accounting for their potential confounding influence.
- For mechanistic clinical trials, discuss how the study design addresses whether the intervention engages the mechanism(s) presumed to underlie the intervention effects. Explain plans for assessing target engagement/mechanisms. Detail how the data analysis will determine whether intervention-induced changes in target(s) are associated with intended outcomes. Applications should clearly state the rationale for the selection of suicide-related constructs and corresponding assessment instruments, the time periods assessed, and the schedule for assessments. For studies enrolling human subjects, address the provisions for clinical management when suicidal behavior is reported.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
In keeping with NIH's goals to enhance transparency of reporting and enable reproducible and translatable discovery research, applicants are expected to make all data, analytical methods and outputs, and research tools available to the broad scientific community prior to publication. Data is defined as the final data on which a publication is based, usually presented in summary form in a publication. These may include image libraries, video, and audio recordings, or other derivatives of data that are relevant to the research being reported. In general, sufficient materials should be made available to allow replication and/or productive secondary analysis of the data. Thus, it is expected that raw data or minimally processed data would be shared.
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan
To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this FOA are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-19-033). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA are expected to use these technologies to submit data to NDA.
To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA web site provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. The NDA Data Sharing Plan is available for review on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.
Applications to the NIA should include a data sharing plan that addresses NIA Guidance on Sharing Data and other Resources and, for applications that propose to enroll human subjects, should comply with expectations outlined in NOT-AG-21-029.
Applicants to either institute are encouraged to include appropriate support for annotation and curation of the molecular and clinical data types used and/or generated on the project to maximize the usability of the data by the broader research community for various types of meta-analyses and systems biology research.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
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.
Delayed Onset Study
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.
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.
3. Unique Entity Identifier and System for Award Management (SAM)
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.
5. Intergovernmental Review (E.O. 12372)
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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
NIMH has released expectations for collecting common data elements when an application involves human research participants. Details can be found at NOT-MH-20-067 and the NIMH webpage on Data Sharing for Applicants and Awardees.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
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.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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? 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?
If the aims are successfully completed, how likely is it that the project will contribute to improving the understanding of the relationship between social disconnection and suicide in late life?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
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?
Is there evidence that the investigative team has adequate expertise in studying both social connectedness/disconnection and suicidality? For projects that propose to enroll human participants, are the investigators appropriately prepared to address clinical, ethical, and safety considerations necessary when conducting research with participants at elevated risk for suicide?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
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?
- If taking an RDoC approach, to what degree does the project employ assessment methods that converge on the construct of interest across a spectrum of functioning?
- How well does the project address potential issues of statistical power and other design issues that may arise when working with populations at elevated risk for suicide and/or a low-base rate event such as suicide? To what extent does the project address risk for sampling bias and/or biased reports of suicidal ideation or behavior?
- To what degress does the project propose clear, mechanistic hypotheses and have the capacity to test and potentially refute the hypotheses? How well do the projects clearly justify the experimental design and methods proposed, including the rationale comparison condition(s) (as applicable), the data collection plan, and the analytic strategy that will be used to interpret the results?
- Are adequate plans described for addressing comorbid medical conditions or other confounding factors and for controlling or accounting for their confounding influence?
- For mechanistic clinical trials, does the study design address whether the intervention engages the mechanism(s) presumed to underlie the intervention effects? Are plans for assessing target engagement/mechanisms well-justified? Will data analysis determine whether intervention-induced changes in target(s) are associated with intended outcomes?
- How well does the application clearly state the rationale for the selection of suicide-related constructs and corresponding assessment instruments, the time periods assessed, and the schedule for assessments? For studies enrolling human subjects, please evaluate how well the application addresses provisions for clinical management when suicidal behavior is reported.
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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.
Vertebrate Animals
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.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
Not Applicable
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) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
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.
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 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.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 recipient's business official.
Recipients 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.
The NIMH has published policies and guidance for investigators regarding human research protection, data and safety monitoring, Independent Safety Monitors and Data and Safety Monitoring Boards, reportable events, and participant recruitment monitoring (NOT-MH-19-027). The application’s PHS Human Subjects and Clinical Trials Information should reflect the manner in which these policies will be implemented for each study record. These plans will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. The NIMH will expect clinical trials to be conducted in accordance with these policies including, but not limited to: timely registration to ClinicalTrials.gov, submission of review determinations from the clinical trial’s data and safety monitoring entity (at least annually), timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
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. 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.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.
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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
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 instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Jovier Evans, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6328
Email: [email protected]
Liz Necka, Ph.D.
National Institute on Aging (NIA)
Phone: 301-480-6947
Email: [email protected]
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]
Maurice Koo
National Institute on Aging (NIA)
Phone: 301-827-6372
Email: [email protected]
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.
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 Part 75.
and Human Services (HHS)
