Part 1. Overview Information

Key Dates

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.

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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This Notice of Funding Opportunity (NOFO) is intended to stimulate and support research that will use behavioral measures and computational methods to define novel clinical signatures that can be used for individual-level prediction and clinical decision making in mental disorders. A multi-component approach is proposed in which grantees will (1) identify and/or develop behavioral tasks (and other types of measures, as appropriate) that are optimized for measurement of individual differences in individuals with or at risk of developing mental disorders; (2) collect the data from novel clinical cohorts and/or identify existing datasets that include behavioral data and other data that are typically available in the clinical record; (3) derive novel clinical signatures that incorporate behavioral measures and information derived from the clinical record, and are informative for clinical purposes; and (4) partner with a Data Coordinating Center (DCC) as described in funding opportunity RFA-MH-23-106 which will coordinate the harmonization of methods, aggregation of data, analysis of combined data, and creation of a data infrastructure to support data sharing with the scientific community. Applicants may propose new cohorts from one or more populations targeted to specific clinical groupings (e.g., mood/anxiety disorders, disorders of behavior regulation, psychosis) and/or care delivery settings, may leverage data from existing clinical research cohorts that have appropriate data structures, or may use a combination of approaches with new and existing data.

Background

Current approaches for diagnosing mental disorders lead to a great deal of heterogeneity within diagnostic groups and do not provide a sufficiently precise characterization of individual patients to maximally inform clinical decision-making. Using machine learning and other data-driven approaches to integrate data from behavioral assessment(s) with clinically available data has the potential to generate more precise and objective clinical phenotypes. Consistent with the Research Domain Criteria framework, the National Institute of Mental Health (NIMH) seeks to support studies that will enable data-driven algorithms to generate clinical phenotypes that can optimize evaluation at the level of the individual and which are informative for clinical purposes (e.g., predicting prognosis, enhancing clinical monitoring, and selecting effective treatments and doses). Novel clinical phenotypes, derived from individual participant-level measurements, could foster more informative classification schemes, improve clinical practice, and lead to the identification of specific pathology-related mechanisms.

Research Objectives

Identifying and Deploying Measures of Individual Differences

Proposed research projects should focus on integrating data collected via behavioral tasks and measures with data available via clinical records (such as diagnostic codes, demographic data, treatment history, clinician notes, and symptom ratings). Behavioral measures are the focus of this initiative because they are relatively inexpensive to administer, may be delivered remotely and repeatedly, and allow manipulation of task and stimulus characteristics. In addition, performance on some behavioral tasks can prompt hypotheses regarding specific neural circuits and mechanisms related to phenotypes. Behavioral tasks and measures may include computerized tasks administered via web- or device-based platforms and/or passive collection of behavioral data (including speech, mobility, and sleep patterns) via mobile or wearable devices. Behavioral measurements should be selected with scalability in mind, including their potential to be implemented in routine clinical practice.

Behavioral tasks that have been shown to reliably detect differences between groups (e.g., a clinical group versus healthy controls) may not have appropriate psychometric properties to distinguish between individuals for the purposes of informing individual-level predictions. Many tasks have been developed to demonstrate a particular mechanism, and reliability is demonstrated by replication of results across multiple studies (e.g., the differences in accuracy and reaction times between go and no-go trials in an impulse-control task). Precisely because the tasks were developed to replicate consistently the findings across subjects, there may be insufficient variability among individuals or over repeated assessments to be sensitive to individual differences. In addition, there may be measures that have been primarily used in studies of group differences for which insufficient data exist to allow interpretation of individual-level performance (i.e., a lack of normative data against which to compare individual performance). Research activities focused on optimization of existing measures, development of novel measures, and/or collection of normative data for the purpose of identifying novel clinical signatures at the level of the individual would be appropriate under this NOFO. It is also highly encouraged to use or to develop behavioral tasks that yield data that are amenable to analysis using computational methods such as artificial intelligence, machine learning, or Bayesian techniques allowing iterative testing of predicted values associated with various task parameters.

Deriving Novel Clinical Signatures

For the purpose of this NOFO, a clinical signature is considered to be a clinical phenotype comprised of a combination of features derived from behavioral data and the clinical record that can be assessed at the level of the individual and is prospectively associated with a specific clinical and/or functional trajectory, differential response to specific treatment types or dose, and/or biological or psychological mechanisms.

To derive these signatures, analyses should focus on determining the extent to which incrementally adding behavioral data to information that is typically available in the clinical record improves clinically relevant prediction at the level of the individual. For example, it would be possible to quantify the degree to which performance on a reward-related task, when added to predictors derived from the clinical record (such as diagnostic codes, patterns of clinical encounters, and prescription history), improves the prediction of response to a specific treatment. Identification of these signatures could pave the way for the deployment of integrative, tailored assessment tools in treatment settings.

Data types other than behavioral data and clinical records data, such as EEG, MRI, blood-based measures, or genomics, could be used in conjunction with behavioral data to further refine or disambiguate novel clinical phenotypes. For example, early phases of classification might be based on behavioral measures and data from the clinical record; a subsequent phase in a subset of individuals might incorporate a biological measure, such that a novel clinical signature can be derived via integration of data types. These other data types may also be useful for investigating mechanisms that further inform the novel phenotypes. However, the primary goal of this initiative is to develop highly accessible tools, so the use of costly, resource-intensive methods should be considered judiciously.

Both new and existing datasets may be appropriate for the purposes of this NOFO. All proposed datasets should include:

• data from individuals with mental disorders or at risk of developing mental disorders,
• behavioral data from either task-based and/or naturalistic/passive assessments,
• clinical records data,
• sufficiently large sample size to allow for detection of robust novel phenotypes that can be identified on an individual basis.

A major goal of this NOFO concerns the development of data structures that are designed from the outset to enable machine learning and related algorithms. Accordingly, databases from cohorts used under this NOFO must incorporate structures that comply with the FAIR data principles (ensuring that data are Findable, Accessible, Interoperable, and Reusable). Applicants proposing the use of extant databases must provide evidence that the data structures are fully consistent with FAIR.

Clinical signatures will likely vary according to clinical population features such as age, prevalence of co-occurring illnesses, rates of health insurance, and environmental factors such as poverty and availability of healthcare services. Efforts to deploy measures of individual differences and derive clinical signatures should take into consideration the population(s) with which the eventual clinical tool(s) will be used and the setting(s) in which services are delivered. The proposed research should also describe strategies to recruit and retain research participants, with clear plans to monitor for and mitigate potential biases and attrition in data acquisition and analyses.

Research Team Expertise

The project PD/PI (or multi-PDs/PIs) must be experienced in the successful establishment, coordination, and management of research projects. Projects require multidisciplinary teams with expertise in the following domains: clinical practice in mental health; behavioral assessment; phenotype development and validation; data practices; participant recruitment and retention; and ethical considerations. In line with the Notice of NIH's Interest in Diversity (NOT-OD-20-031), teams should strive for the inclusion of scientists and trainees from diverse backgrounds, including those from underrepresented groups and life experiences to bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Research teams should likewise have the experience needed to focus on advancing the likelihood that underserved or NIH-designated populations that experience health disparities participate in and benefit from health research, and enhancing public trust.

Partnership with the IMPACT Data Coordinating Center

The companion NOFO (RFA-MH-23-106) invites applications for an IMPACT Data Coordinating Center (DCC) to support the work of the projects to be funded under this NOFO. The DCC will be responsible for facilitating the coordination and communication among the IMPACT-MH projects, leveraging opportunities for harmonization of methods and measures, building data infrastructure and pipelines, conducting analyses of aggregated datasets, and partnering with U01 sites to monitor and mitigate potential biases in collected data and analytic approaches. The DCC will also transfer data collected by the IMPACT-MH sites to the NIMH Data Archive (NDA) in accordance with NIMH data sharing policy (NOT-MH-23-100).

By responding to this NOFO, applicants agree to cooperate with all proposed IMPACT-MH DCC activities, including:

• Participating as a member of the IMPACT-MH DCC Steering Committee and attending annual virtual meetings and at least quarterly phone calls
• Sharing with the DCC detailed information about planned data collection methods, measures, and procedures
• Adopting, where appropriate, common measures identified through the IMPACT-MH DCC harmonization process described below
• Sharing de-identified subject-level data with the IMPACT-MH DCC throughout the course of the project.

Data Harmonization and Monitoring. The DCC will coordinate this cross-project harmonization. Data analyses specific to the aims of the awards funded under this NOFO will be the responsibility of the U01 recipients, and analysis of combined datasets will be the responsibility of the DCC (in collaboration with the IMPACT-MH Steering Committee). When two or more funded U01 projects propose to measure the same information (e.g., the same cognitive construct, symptom ratings for the same psychopathology, or even the same demographic information), applicants will be asked to use identical measurement tools and collection procedures whenever feasible and should otherwise establish a means to aggregate across similar measures. To maximize the scientific value of the data generated by projects funded under this NOFO, applicants should follow the guidelines set out in the NIH Data Management and Sharing Policy. This involves focusing on FAIR principles as well as addressing biases that may be intrinsic to the data. These biases, described by NIH’s Office of Data Science Strategy (https://datascience.nih.gov/artificial-intelligence/initiatives/ethics-bias-and-transparency-for-people-and-machines), can include bias in measurement accuracy, selection bias of the cohort, and biases introduced through missing data, among others. Applications should include plans to assess their data for these biases and a description of techniques that will be used to address them. U01 projects will coordinate with the DCC to ensure that data is collected and stored in an appropriate format so that it will be able to be used in future studies and to build clinical decision-making tools.

Best practices for data collection will be coordinated through the partnership with the DCC to ensure the longevity and usability of the data. However, each project team should have a local data expert who can monitor the data collection specific to the funded project and act as the liaison to the DCC.

Enhancing Diverse Perspectives

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in and benefit from research, and enhancing public trust. See Notice of NIH's Interest in Diversity (NOT-OD-20-031).

To support the best science, NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include, but are not limited to:

• Transdisciplinary research projects and collaborations among investigators from different fields.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Guidance Regarding Clinical Trials

Clinical studies that address the research objectives outlined in this NOFO are encouraged across all areas of mental health, with the exception of clinical trials focused on developing a new intervention and clinical trials to test treatment efficacy and effectiveness. Applicants proposing such projects should consult https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas. Grants for treatment development trials and efficacy and effectiveness trials are supported under other funding opportunities and will not be considered responsive to this NOFO. Further information on support of clinical trials at NIMH can be found at: http://www.nimh.nih.gov/funding/clinical-trials-for-researchers/index.shtml.

NIH defines a clinical trial as, "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015)

Under this NOFO, NIMH will accept applications that propose studies that meet the definition of a clinical trial if the prospective assignment to intervention and assessment of outcomes serves the purpose of deriving or validating a novel clinical signature.

Examples of Research Interest

The following are examples of the types of studies that would be considered responsive to the NOFO. These are meant to be illustrative only and are not intended to be exclusive or exhaustive.

• Studies that deliver an intervention with established clinical efficacy and use data from the electronic health record in combination with data from behavioral tasks to develop algorithms to predict treatment response that can be applied at the level of the individual.
• Studies that focus on behavioral tasks in order to increase within-subjects reliability and/or to optimize tasks for computational models, followed by collecting data to test clinical signatures.
• A large observational cohort study in at-risk individuals who might not necessarily be seeking mental health care but otherwise have a clinical record that might yield data whose trajectories are predictive of eventuating in a mental disorder.
• Studies that focus on validating a clinical signature across different settings/populations using more than one data collection site.
• Studies which focus on using existing data to test hypotheses regarding clinical signatures and then collecting new data to validate them.
• Studies to collect data in a new cohort to identify dimensional phenotypes via machine-learning algorithms (e.g., related but differentiable constructs of reward responsiveness, reward learning, and reward valuation) and then validate the predictive clinical signatures using multiple out-of-sample data splits.

Applications Not Responsive to this NOFO

Applications proposing the following will be considered non-responsive to this NOFO and will not be reviewed:

• Applications that do not incorporate both behavioral measure(s) and clinical records data to derive or validate a clinical phenotype
• Applications focused on developing a new intervention and clinical trials to test treatment efficacy and effectiveness.
• Applications aimed primarily at elucidating mechanism
• Applications proposing animal research
• Applications that do not include adherence to FAIR data principles
• Applications proposing the use of extant databases that do not provide evidence that the data structures are (or can be made) fully consistent with FAIR
• Applications that do not address the inclusion of individuals from groups that are underrepresented in biomedical research
• Applications that lack a PEDP

Technical Assistance

NIMH strongly encourages applicants to consult with NIMH program staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to discuss the goals of the NOFO, clarify NIMH policies and guidelines, and identify whether the proposed project is consistent with NIMH priorities.

In addition to any individual consultation with program staff, a web-based Technical Assistance Meeting will be held for potential applicants to this NOFO and RFA-MH-23-106 on Tuesday, May 2, 2023, from 2:00 pm - 3:00 pm ET, when NIMH staff will be available to answer general questions related to these funding announcements. Prospective applicants can participate in the meeting by joining Zoom Meeting ID: 161 090 9065 and are encouraged to submit their questions or comments in advance to [email protected]. Participation in the teleconference is neither required nor necessary for a successful application. A recording of the teleconference will be available at https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/resources/rdoc-resources-webinar-series.

The NIMH 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.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

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 Governments

• 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. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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).

Section IV. Application and Submission Information

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 NOFO. 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 notice of funding opportunity 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:

Email: [email protected]

Page Limitations

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 NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants should budget appropriately for costs related to data management and sharing and can refer to NOT-OD-21-015 for an outline of allowable costs.

The proposed budget should account for costs of the behavioral assessment tools, including costs of any proprietary measures to be employed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: All of the following are required:

Significance:

Explain why the proposed approach to integrating behavioral measures for novel clinical phenotypes is optimal to achieve the scientific objectives of the NOFO.

Describe the anticipated clinical utility of the novel clinical signatures.

Investigators:

Highlight the multi-disciplinary experience of the team members in the following areas:

• practicing clinical knowledge of the area(s) of psychopathology under study
• behavioral measurement and experimental design
• advanced statistical and computational approaches for deriving or validating phenotypes, and data science best practices to ensure that data are amenable to future AI/ML techniques
• recruitment and retention of individuals in the study population(s) of interest; community-based partnerships are encouraged
• ethical considerations inherent to precision assessments, including privacy.
  

Innovation:

Describe plans to employ unique or novel methodologies to (a) assess behavior in a way that promotes robust, scalable measurements with the capacity to measure individual-level differences and (b) incorporate behavioral measures and clinical records data to identify or validate clinical phenotypes relevant to clinical decision-making.

Explain how the research team plans to use current best practices to recruit, assess, and retain participants and partner with the DCC to promote state-of-the-art data and resource sharing.

Approach:

Identifying and deploying measures of individual differences

Describe the following:

• How the proposed behavioral measure(s) allow for characterization of individual-level differences. The description should address psychometric properties, including reliability and variability within and across subjects, with emphasis on prediction rather than inference.
• The scalability of the behavioral measure(s), including capacity for remote administration, issues related to clinician and patient burden, and monetary cost.
• For projects proposing new data collection: discuss potential pitfalls in the ability to collect behavioral data in a bias-free manner in the relevant population(s) of interest, and proposed strategies to detect and remedy any barriers to the acquisition of equitable, representative data.
• For projects proposing the use of existing data, provide detail and evidence that the dataset is appropriate to answer the proposed scientific question. Describe how the proposed dataset is adequate to achieve the goals of the NOFO, particularly with respect to sample size, data types, attention to bias, and format of the data for use with computational methods.

Derivation of clinical signatures

Describe the following:

• The analytic methods that will be used to integrate behavioral measures, clinical data, and any other selected modalities of data for the purpose of developing clinical signatures. Address the methods to test the incremental changes in predictive power achieved with the addition of new data types. When the project involves validation of a clinical signature, applicants should describe plans to demonstrate validity.
• Plans to assess the generalizability or specificity of the clinical signatures with respect to the population(s) of interest and test setting. For example, discuss whether the proposed study cohort is expected to have characteristics that will make findings more or less generalizable to other segments of the U.S. population. If applicable, discuss any features of the test setting that might promote or limit translation to other settings. Note that the goal is not universal generalizability but a clear articulation of expected use cases.
• Describe the plan for maintaining high standards for data completeness and integrity, including establishing data quality metrics and data submission procedures to ensure appropriate quality control. Include plans to address FAIR data principles and strategies to detect and mitigate potential biases. In projects proposing existing data sets, be sure to include a description of how the data already comply with FAIR standards.

Partnership with the DCC

Outline a strategy for maintaining an effective partnership with the DCC on key tasks, include the following activities:

• Designating a member of the project team, with appropriate specialization in data curation and harmonization, to serve as liaison to the DCC.
• Committing to close coordination with the DCC, to include attendance at a kick-off meeting, regular (minimum quarterly) calls, and an annual all-hands meeting; meetings will be held virtually.
• Sharing project information with the DCC to support the process of identifying opportunities for harmonization. This information includes but is not limited to: project aims and activities, study protocols including the details of data collection methods and measurement parameters, data processing pipelines, and analysis tools.
• For projects proposing new data collection: participating in the DCC-led harmonization process for measures and methods. Document the willingness and pragmatic considerations for adjusting the planned study protocol to maximize use of shared measures and methods across U01 projects.

Outline clear procedures for submitting de-identified, subject-level data to the DCC, to foster additional computational analyses at the DCC and to support uploading and sharing data with the NDA, to provide an accessible data resource available to the extramural research community.

Project management plan

Provide a Management Plan that describes the following:

• How the PD(s)/PI(s) will manage the proposed project. Who will oversee the day-to-day activities (e.g., a project manager if not a PD/PI)
• How the management will support achievement of the proposed goals
• How collaborations or subcontracts, if proposed, will be managed

Milestones

Present a detailed set of milestones and a timeline covering all aspects of the proposed project, including annual milestones with metrics that will document progress towards the achievement of the ultimate goals.

Environment:

Describe features of the research environment and any relevant community partnerships that promote recruitment and retention of the study population(s) of interest, with attention to fostering mutually beneficial partnerships. Describe how the research environment will promote the careful use of new and/or existing data and appropriate analyses to ensure that potential biases are identified and addressed.

Provide evidence of the ability of the site(s) to (1) enroll the proposed numbers of participants; (2) collect behavioral data in a robust and timely fashion; (3) coordinate with the DCC to ensure that data are acquired in a manner consistent with FAIR principles and amenable to computational techniques; (4) conduct the local analyses required to identify or validate clinical signatures consistent with the aims of the U01 project, and (5) share data on an agreed-upon basis with the DCC to promote further computational exploration.

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIMH, 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 NOFO 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 preparing and transferring data to the DCC for submission to the NDA. The NDA web site provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Estimation Tool 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 NOFO 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. For more guidance on submitting data to NDA refer to the NDA web site https://nda.nih.gov/contribute/contribute-data.html. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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.

PHS Assignment Request Form

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

4. Submission Dates and Times

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.

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 expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Sharing for Applicants and Awardees.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 NIMH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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.

Section V. Application Review Information

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.

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).

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.

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.

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.

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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

• 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.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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:

• Federal wide 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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 NOFO.

• 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 providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/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 religious nondiscrimination laws and 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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Define the details of the project within the guidelines of this NOFO.
• Assume responsibility and accountability to the applicant organization and to NIH for performance and proper conduct of all research in accordance with the Terms and Conditions of Award.
• Accept close coordination, cooperation, and participation of NIH program staff in the scientific, technical, and administrative management of the grant.
• Provide milestones for the grant to NIH program staff as requested (usually at the onset of the award and annually thereafter, but also at other times as requested).
• Provide periodic progress reports summarizing IMPACT-MH project activities and achievement of project milestones to NIMH staff as requested.
• Serve as a member of the Steering Committee and fulfill related duties outlined below in Areas of Joint Responsibility; inform the NIMH Program Official of all major interactions with other members of the Steering Committee.
• Adhere to NIMH policies regarding intellectual property and other policies that might be established during the course of this project activity. Awardees will retain custody of and have primary rights to the software developed under the U24 awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
• Share all novel subject-level data generated by the IMPACT-MH project with the IMPACT-MH DCC. The DCC will be responsible for uploading the data to the NIMH Data Archive (see NDA;?https://data-archive.nimh.nih.gov/). All data will be deposited into NDA bi-annually.
• Appropriately acknowledge NIMH support in publications or oral presentations of work done under this agreement, including the assigned cooperative agreement award number.
• Share data and resources according to the data release and resource sharing policies developed for and by this project as appropriate and consistent with achieving the goals of the project.
• Fully disclose algorithms and software source code as necessary to the IMPACT-MH projects and DCC for the purpose of scientific evaluation.
• Not disclose confidential information obtained from the IMPACT-MH projects.
• Submit data for quality assessment and/or validation in any manner specified by the Steering Committee and/or the NIMH program staff to ensure scientific rigor.
• Accept and implement the common guidelines and procedures approved by the Steering Committee and NIMH.
• Provide updates at least annually on implementation of the PEDP.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• An NIMH Program Officer will be named on the award notice. The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award, including programmatic monitoring and assistance in the coordination of the overall project and implementation of the Data Management and Sharing plans, and will be named in the award notice. The Program Officer may attend Steering Committee meetings as a non-voting participant.
• One or more extramural NIH program staff member(s) will be assigned as the Project Scientist(s) for this award. The same person may serve as the Project Scientist for multiple IMPACT-MH awards. The Project Scientist(s) will interact scientifically with the PDs/PIs and other named personnel of that award, as a partner in the research, including providing technical assistance, advice, and coordination for IMPACT-MH and its component parts. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the IMPACT-MH Steering Committee and that NIH staff will be given the opportunity to offer input to this process. One NIH Project Scientist will participate as a member of the Steering Committee and will have one vote.
• The NIH Project Scientist will facilitate interactions between the IMPACT-MH DCC, the Steering Committee and awardees of RFA-MH-23-105.
• The role of the NIH Project Scientist is to assist, participate in deliberations, and facilitate discussion, but not to direct activities. This level of staff involvement does not alter the awardee’s dominant role and prime authority in conducting the activities of the IMPACT-MH U01. The NIMH Project Scientist may cooperate with the awardee as author or co-author of resulting publications in accordance with publication policies developed by the Steering Committee. Publications involving NIMH staff must follow NIH and NIMH publication policies.

Areas of Joint Responsibility include:

A Steering Committee will be established to assist in ensuring that the IMPACT-MH DCC provides the necessary support for IMPACT-MH projects and to monitor progress over time. The Steering Committee will be composed of the DCC PD(s)/PI(s); the NIMH Project Scientist(s); PD(s)/PI(s) of all of the funded IMPACT-MH projects; and additional members with expertise in the overall goals of the IMPACT-MH initiative. Experts in learning health care, measurement-based treatment, health information technology, health informatics, computational modeling, bioethics, and other areas may also be included, as appropriate.

Steering Committee members will meet periodically, but not less than twice per year, to plan research activities, review study progress, and establish priorities, policies, and procedures. Each member will have one vote on any decision to be made by the Steering Committee with respect to study policies and procedures.?The NIMH Project Scientist will be a voting member of the Steering Committee. Adoption of policies and procedures will require a majority vote.?

NIMH Program Officials may attend Steering Committee meetings as non-voting participants.

The IMPACT-MH Steering Committee will have involvement in any DCC planned analyses that utilize data collected at IMPACT-MH project to ensure that data are used and interpreted according to the intent with which they were collected.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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 NOFOs 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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: https://www.era.nih.gov/need-help (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]

Jenni Pacheco, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3645
Email: [email protected]

Nicholas 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]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 2 CFR Part 200.