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 a non-competitive funding opportunity intended to fund a single award. The NIMH is announcing its intent to issue a single source award to Brigham and Women's Hospital to support a CT-DPACC for the Clinical Trial Network to be established under RFA-MH-24-150. The CT-DPACC will provide executive management, direction, and overall coordination, including data processing and analyses of data from one or more 12 16 week Proof of Principle (PoP) trials utilizing Phase 2 ready compound(s) that will be conducted by the CHR Clinical Trial Network. The Clinical Trial Network will be responsible for conducting at least one PoP trial with the possibility of conducting a second subsequent trial depending on the availability and selection of another suitable pharmacologic agent and the success of the first PoP trial in meeting its predetermined goals and milestones. The CHR Clinical Trial Network uses the validated biomarkers, digital measures, clinical outcome measures, and algorithms previously assessed in the AMP SCZ observational study (RFA-MH-20-341).

To support the acquisition of new data via establishment of multi-site CHR cohort(s), the CT-DPACC will (a) coordinate and monitor the CHR network data collected by each of the clinical trial sites within the CHR Clinical Trial Network and transferred directly to the CT-DPACC; (b) assume responsibility for quality assurance and reliability of assessments; (c) ensure uniform standards for adverse event reporting, safety and protocol deviation monitoring; (d) develop data analysis, presentation, and reporting tools to facilitate analyses of clinical, digital, and biomarker data generated by the Clinical Trial Network; (e) provide data management, processing and archiving; (f) support Investigational New Drug (IND) regulatory submission, provide regulatory reporting and safety monitoring preferably including a contract research organization (CRO); and (g) manage the dissemination of CT-DPACC resources.

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

Background

Clinical heterogeneity within the CHR population presents a substantial challenge for intervention development for this population with unmet medical needs. Approaches for addressing this heterogeneity to enable future intervention trials require the development of tools to address: (a) defining a core set of clinical and functional outcomes beyond onset of psychosis to include affective, cognitive, and negative symptom domains and functional outcomes; (b) prospective stratification of CHR individuals into more homogeneous risk subtypes to predict the likelihood of clinical outcomes; and (c) testing of interventions that target hypothesized underlying mechanisms for emerging psychosis, mood disorders, and functional disability.

The companion initiative, RFA-MH-24-150, solicits Clinical Trial Network grant applications for studies that use multi-modal biomarkers, cognitive, digital, and clinical outcome measures characterized in the AMP SCZ observational study and selected compound(s) that has a known mechanism of action that addresses a hypothesis linked to pathophysiology in CHR. This NOFO is a limited competition that focuses on the continued development and maintenance of the established quality assurance and quality control (QA/QC) and data processing pipelines, and data analytic strategies developed under RFA-MH-20-341. The CT-DPACC is also expected to implement innovative changes based on prior experience during the observational study and apply these learnings to the PoP trial(s).

Research Objectives

Management, direction, and coordination for a multi-site Clinical Trial Network

The CT-DPACC will provide the organizational framework for the management, direction, and overall coordination of the multi-site Clinical Trial Network for at least one PoP trial, with the possibility of conducting a second, subsequent trial depending on availability and selection of another suitable pharmacologic agent and success of the first PoP trial. The project period for the entire CT-DPACC project may last up to five years, but could be less than 5 years if a second trial is not undertaken.

The CT-DPACC team must include: (a) a director (or co-directors) from a recipient organization awarded under RFA-MH-20-341 and one or more associate directors (who are not necessarily from the original award) to ensure that the wide scope of activities is seamlessly coordinated; (b) individuals with bioinformatics and data processing expertise appropriate to establish and implement the procedures for collecting, processing, and analyzing specialized biomarker and digital data types, including multi-modal data analysis; and (c) individuals with expertise monitoring clinical trials and assisting with regulatory filings and reporting, preferably including CRO within the CT-DPACC team.

Activities related to these objectives include the following:

1. Coordinate and monitor CHR network data collection and transfers across multiple CHR research sites within the Clinical Trial Network

The CT-DPACC will establish and implement harmonized research methods across the multi-site Clinical Trial Network. Specifically, the CT-DPACC will: (a) establish standardized methods for data collection, data transfer, QA/QC, and data aggregation; (b) train project site staff in data collection methods and implement fidelity monitoring and performance improvement activities across network research sites; (c) coordinate the integration of data collection methods across research sites; (d) utilize AMP SCZ established informatics infrastructure and pipelines necessary to gather, process and upload de-identified, patient-level data collected across all research sites to the NIMH Data Archive (NDA); (e) conduct ongoing monitoring and periodic reporting of the rate of subject recruitment and retention, demographic characteristics, and trends in cumulative data collection; and (f) prioritize and coordinate network-based data analyses and publications of scientific findings in conjunction with NIMH and an NIMH CHR Steering Committee (SC), and with feedback from the AMP SCZ SC. The PD/PI (or Multi-PDs/PIs) of the CT-DPACC must be experienced in the coordination and management of multi-site clinical studies, including success in meeting milestones and timelines. In addition, to ensure the investigators have appropriate experience, they are encouraged to work with a CRO.

2. Assume responsibility for quality assurance and reliability of assessments

The CT-DPACC will optionally use previously established servers and standard operating procedures (SOPs) for the AMP SCZ observational study data to provide rapid QA/QC data checks and data cleaning in a centralized location. CT-DPACC must access and inspect data from each site recruiting study participants for comprehensive QA/QC of raw data and uninterrupted data transfer to the CT-DPACC and then to the NDA.

3. Ensure uniform standards for adverse event reporting, safety, and protocol deviation monitoring

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). Applications should reflect the policies and guidance in this notice. Applications should describe how the CT-DPACC will ensure that appropriate ethical and human subjects protections are in place and supervise the reporting of and responses to adverse events to NIMH, the Institutional Review Board of record, a Data and Safety Monitoring Board (DSMB), and the FDA. The data and safety monitoring plan must be established (and approved by the NIMH) prior to the Clinical Trial Network initiating study recruitment. 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.

4. Develop data analysis, presentation, and reporting tools to facilitate analyses of clinical, digital, and biomarker data generated by the Clinical Trial Network

The CT-DPACC will be responsible for the development and implementation of an informatics infrastructure, analytic methods, and data visualization tools that: (i) leverage multi-modal information collected from CHR network participants; (ii) explore variations in patient characteristics; and (iii) visualize individual research site performance across all network research sites.

These activities will be planned in consultation with the CHR Clinical Trial Network, the NIMH CHR steering committee (SC) and NIMH. The CT-DPACC will develop a procedure for selecting and prioritizing analyses to be performed and planning for publications.

To promote scientific investigation across the network of research sites, the CT-DPACC will serve as the main locus of computational expertise for the research network and will develop an informatics infrastructure that should include a secure interface that allows network investigators to access aggregated de-identified patient-level data, conduct distributed analyses, and collaboratively build, edit, and run data workflows. The CT-DPACC will also be responsible for developing, in consultation with the NIMH CHR SC, a metadata repository for the network with access controls that are independent of the data itself.

5. Provide data management, processing, and archiving

Applications in response to this limited competition NOFO are encouraged to engage thought leaders in bioinformatics and multi-site clinical studies. The CT-DPACC will make the data Findable, Accessible, Interoperable, and Reusable (FAIR) to enable secondary analyses by the scientific community.

The CT-DPACC will develop, implement, and maintain a data management system similar to that used in the AMP SCZ observational trial, which incorporates best practices in bioinformatics for multi-site clinical trials including:

• Leveraging and implementing data infrastructure and pipelines used in the AMP SCZ observational study to gather, combine, store, and manipulate de-identified data types;
• Privacy procedures and security processes for safely storing and accessing de-identified data from participants enrolled Clinical Trial Network sites;
• Data dictionaries, data capture systems, validation tools, and quality metrics to ensure data completeness and integrity;
• A process for receiving data from the network sites in near real-time and for rapid completion of centralized quality checks and data cleaning, and uploading of the data to the NDA;
• Processes and pipelines for data processing prior to archiving data in NDA;
• Deployment of data analytic tools accessible to researchers, and linked to NDA;
• Methods for providing technical assistance and support to research site investigators.

The CT-DPACC will be responsible for depositing participant-level data (raw, processed, and analyzed data) collected under this award in the NDA. All network data will be deposited into NDA and made available to qualified investigators through data access agreements at the completion of the PoP trial data analysis plan. The CT-DPACC and the Clinical Trial Network sites will use the NIMH Global Unique Identifier (GUID) infrastructure to create unique identifiers that protect the anonymity of individual-level patient data. CT-DPACC will work with NDA staff to export the relevant GUID tools to all research sites so that they can generate GUIDs for all study participants.

6. Support IND regulatory submission, provide regulatory reporting and safety monitoring

The CT-DPACC will support IND application sponsors by helping to prepare the application and by submitting to the FDA, NIMH and DSMB a safety report indicating if there are any adverse experiences associated with the use of the compound(s) that is both serious and unexpected or any findings that suggest a significant risk for human subjects. Also, the CT-DPACC is responsible for submitting a follow-up safety report if any relevant additional information obtained by the sponsor that pertains to a previously submitted IND safety report needs to be updated.

The Clinical Trial Network is responsible for registering the study in ClinicalTrials.gov and the CT-DPACC will collaborate with the Clinical Trial Network to support annual updates on reportable events, progress reports, and annual submission of review determinations from the clinical trial’s data and safety monitoring. To ensure the investigators have appropriate experience they are encouraged to work with a CRO.

7. Manage the dissemination of CT-DPACC resources

Applications must describe plans for adding information from the PoP trial to an already established AMP SCZ website and maintaining the website that conveys the aims and activities of the CT-DPACC and the Clinical Trial Network. The PoP section of the website must describe the PoP protocol (including details about the data collection methods and tools), provide updates about data uploads to NDA, data processing pipelines, data analysis tools, and links to the project’s publications. The website will direct users to the workflows to analyze the data. Applicants are encouraged to propose maintaining all relevant workflows and documentation in a single location.

Technical Assistance

Applicants are strongly encouraged to consult with NIMH staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to clarify NIMH policies and guidelines and identify whether the proposed project is consistent with the purpose of this NOFO.

Prospective applicants are encouraged to submit their questions or comments in advance to [email protected]. Emails should include "RFA-MH-24-151 Consultation" in the subject line.

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

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

Only the Brigham and Women's Hospital may apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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 registration; 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.

Only the PI/PDs associated with the award issued under RFA-MH-20-341 to Brigham and Women's Hospital are eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

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

Only one application is allowed.

Only a single award will be issued to Brigham and Women's Hospital under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

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]

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.

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.

In the biosketches, detail PD/PI (or Multi-PDs/PIs) of the CT-DPACC experience in the coordination and management of multi-site clinical studies, including success in meeting milestones and timelines.

The experience of each PD/PI and all Key Personnel must be carefully documented, and roles and responsibilities must be well-defined. The biosketch should detail the required information.

R&R Budget

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

R&R Subaward 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, with the following additional instructions:

Research Strategy:

Significance:

Explain why the proposed approach to analysis of aggregated CHR data and management and coordination of the Clinical Trial Network are optimal to achieve the scientific objectives of the CT-DPACC.

Investigators:

A CT-DPACC should include a multidisciplinary team and the application should reflect the team's background in hands-on involvement in the steps needed for data acquisition, processing, aggregation and analyses of multi-modal biomarker, digital, and clinical data, as well as study coordination (including establishing study protocols and maintaining reliability of procedures), and data management, analysis and dissemination.

Describe the study team members experience and expertise in the following areas:

• bioinformatics and large-scale multi-site longitudinal studies, including cloud computing and data science;
• establishment of criteria that define subjects, at the individual level, who meet criteria for assessments of biomarker prediction/outcomes;
• an understanding of the criteria needed for application of biomarker and/or clinical algorithms; and
• clinical trial monitoring.

Innovation:

Describe the novel organizational concepts and management strategies the CT-DPACC will use in coordinating the Clinical Trial Network. Describe how the concepts and strategies related to managing a PoP trial are novel.

Describe plans to employ unique or novel methodologies that will enhance the analysis of the PoP data. Explain how the CT-DPACC plans to use current best practices in clinical trial monitoring.

Provide a detailed plan to deploy analytic tools appropriate for analyses of the proposed CHR biomarker, digital, cognitive, and clinical data types in the context of a 12-16 week double-blind PoP trial with three arms, placebo, low dose, and high dose of an investigational compound(s). Describe how the proposed analytic strategy will be useful to assess the ability of one or more, or a composite of measures to detect a potential change in signal associated with a compound.

Approach:

Describe an overall strategy, organizational structure, and management/operational plan to accomplish the goals of the Clinical Trial Network. The research approach should include strategies to ensure a robust and unbiased scientific approach across the network and include discussion of potential problems, alternative strategies, and benchmarks for success. The description of the proposed strategy should adequately establish feasibility and a plan to manage the risks associated with the activities of the network. An appropriate plan for workflow and a well-established timeline and project milestones should be included.

Propose an organizational structure to ensure that leadership of the CT-DPACC has the capacity to coordinate its diverse activities. This organizational structure includes a director (or co-directors) and one or more associate directors.

Propose a detailed management/operational plan for the rapid aggregation and transfer of data from the network sites, conducting quality control on that data, and then transmitting the cleaned, raw, and processed data to NDA.

Provide a detailed plan for developing and carrying out the various administrative and project management activities, including standardization of study protocols, training of staff, site monitoring, clinical trial monitoring, establishment of data processing pipelines, coordination of analyses, and production of regulatory and other reports.

Propose a data management system that includes the data infrastructure and pipelines necessary to gather, combine, store, and manipulate de-identified biomarker, digital, cognitive, and clinical data as well as combined/multi-modal data from multiple network sites in a timely manner.

Describe how the CT-DPACC will coordinate with the Clinical Trial Network leadership, NIMH and NIMH CHR SC to develop a procedure for shared decision-making, selecting and prioritizing analyses to be performed, planning for reports (including progress toward milestones) and publications.

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 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 NOFO are expected to use these technologies to submit data to the 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 website 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 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 Data Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

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.

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.

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 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 , 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 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

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed CT-DPACC address the needs of the research Clinical Trial Network that it will coordinate? Is the scope of activities proposed for the CT-DPAAC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research Clinical Trial Network?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the CT-DPACC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing multicenter collaborative clinical research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the CT-DPACC? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research Clinical Trial Network the CT-DPACC will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research Clinical Trial Network the CT-DPACC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Clinical Trial Network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Clinical Trial Network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Clinical Trial Network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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?

Specific to this NOFO:

Evaluate the reasonableness of the strategy for the acquisition, processing, and analyses of network biomarker and clinical CHR data and uploading of the raw and derived data to the NDA?

Environment

Will the institutional environment in which the CT-DPACC will operate contribute to the probability of success in facilitating the research Clinical Trial Network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the CT-DPACC proposed? Will the CT-DPACC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.

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 Animals 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

Not Applicable

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

Not Applicable.

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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] 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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds 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.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 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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 condition of receiving the grant, to administer 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. 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.

• 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 Parts 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 award 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 responsibilities as described below:

• Provide scientific and administrative leadership and coordination of the project at the recipient and sub-recipient institutions and among collaborators.
• Oversee and perform the scientific activities within the guidelines of this NOFO.
• Accept close coordination, cooperation, and participation of NIMH program staff in the scientific, technical, and administrative management of the grant.
• Provide milestones and cost for the grant to the NIMH program staff as requested (usually at the outset of the award and annually thereafter, but also at other times as requested by the program staff).
• Provide periodic progress reports summarizing CT-DPACC, Clinical Trial Network activities, and achievement of project milestones to NIMH staff as requested.
• Serve as a voting member of the NIMH CHR SC and fulfill related duties outlined below in Areas of Joint Responsibility.
• Coordinate NIMH CHR SC meetings at least once every two weeks and one yearly in-person meeting. The PD/PIs will be responsible for preparing and disseminating concise proceedings or minutes to the meeting attendees and should budget travel funds for the annual in-person meeting.
• Coordinate and collaborate with Clinical Trial Network investigators who are generating relevant CHR biomarker and clinical datasets.
• Demonstrate capability of acquiring different types of biomarker data from collaborators and the Clinical Trial Networks.
• 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 rapid and broad sharing goals of the program, and consistent with the approved Data Management and Sharing Plan under the NIH Data Management and Sharing Policy (DMS Policy).
• Adhere to NIMH policies regarding intellectual property and other policies that might be established during the course of this activity.
• This research project is being funded by NIMH under auspices of AMP SCZ. All AMP projects operate under the broad principle of delivering pre-competitive advancements to the research and medical fields and enabling the broadest possible access and use of AMP research discoveries. As part of the AMP, research supported by this NOFO is expected to generate raw and processed data. NIMH considers these data as pre-competitive and urges Recipients of funding under this NOFO to avoid making intellectual property (IP) claims derived directly from these data. These data would require a considerable amount of work to be performed beyond the initial data production to demonstrate utility. It is expected that these pre-competitive data, and conclusions derived therefrom, will remain freely available, without requirement for licensing, consistent with achieving the goals of this program. With respect to downstream discoveries, the NIH also supports and recognizes the importance of the subsequent development of IP (e.g., patenting) on those downstream discoveries, especially in therapeutics, which will be necessary to support full investment in products to benefit the public.
• Accept and implement the common guidelines and procedures approved by the AMP SCZ SC and NIMH.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIH Project Scientist(s) will:

• Provide relevant scientific expertise to the CT-DPACC and Clinical Trial Network.
• Participate as a voting member of the NIMH CHR SC, attend NIMH CHR SC meetings, and assist in developing operating guidelines, quality control procedures, data processing pipelines, as well as the selection and provision of data analytic tools.
• Participate with other NIMH CHR SC members in the group process of setting research priorities (key questions) for aggregation and harmonization of data by the Clinical Trial Network and for analyses of CHR biomarker and clinical data, annual milestones for the project, and periodic adjustments of research protocols or approaches as warranted.
• Participate with other NIMH CHR SC members in the group process of setting research priorities for acquisition of data by the Clinical Trial Network and for analyses of CHR biomarker and clinical data, annual milestones for the project, and periodic adjustments of research protocols or approaches as warranted.
• Assist with coordination of CT-DPACC activities with the development of evolving tools and technologies in data science, database management, and analysis, with the scientific mission and evolving goals of the NIMH, and with other U.S. efforts that focus on sharing research resources for CHR biomarkers, digital measures, and clinical outcome measures.
• Assist in promoting and encouraging the sharing of unique research resources for studies of CHR biomarkers by the scientific community at large.
• Assist in developing timetables for the timely, open, and free sharing of data and research resources received and produced by the network and CT-DPACC to the scientific community.
• Participate in NIMH CHR SC activities, including conference calls, working groups and special committees.
• Participate in the project update meetings and conference calls with the PD(s)/PI(s) on a weekly or monthly basis, as dictated by the needs of the project.
• Participate in the decision making for all activities, which will require consensus of the NIMH CHR SC. One or more NIH Project Scientists will participate as a member of the NIMH CHR SC and will have a combined total of one vote.

The NIH Program Officer will:

• Be responsible for the normal scientific and programmatic stewardship of the award, including programmatic monitoring of the overall project and will be named in the award notice.
• Be responsible for negotiating, monitoring, and implementing the Data Management and Sharing Plan and the milestones to ensure that the goals of the project are being met.
• Monitor the conduct and progress of the project to ensure milestones are accomplished in accordance with the timeline.
• Approve modifications to the research plan and/or study protocol(s), in consultation with the NIMH CHR SC, based on emerging data and/or other issues that impact progress of the project.
• Reserve the right to obtain periodic external peer review and recommend reviewers for an assessment of progress and achievement of milestones and deliverables.
• Monitor performance and compliance with NIH procedures.
• Participate in NIMH CHR SC meetings, working groups and/or special committees as a non-voting participant and serve as an administrative liaison.
• Approve modifications to the research plan and/or study protocol(s), in consultation with the NIMH CHR SC, AMP SCZ Operations Working Group and AMP SCZ Steering Committee based on emerging data and/or other issues that impact progress of the project.
• Reserve the right to obtain periodic external peer review and recommend reviewers for an assessment of progress and achievement of milestones and deliverables.
• Monitor performance and compliance with NIH procedures.
• Negotiate the selection of existing cohorts for aggregation and harmonization of biomarker, clinical, and functional outcome measures with the awardee based on research priorities and associated cost.
• Negotiate the data types and frequency of new data collection by the Clinical Trial Network, quality control, and cost goals with the awardees, including options to modify protocols for data collection when certain objectives of this NOFO are not being met or as scientific goals evolve.

Areas of Joint Responsibility include:

NIMH CHR SC. The NIMH CHR SC will serve as the operational governing board for CT-DPACC and the Clinical Trial Network. The NIMH CHR SC will include: the PD(s)/PI(s) of CT-DPACC and Clinical Trial Network, Project Manager of CT-DPACC, NIMH Project Scientist(s), NIMH Program Officers and members of the NIMH Executive Committee.

The NIMH CHR SC will:

• Coordinate the activities of the CT-DPACC and Clinical Trial Network as well as the distribution of data, algorithms, and other resources to the wider scientific community.
• Facilitate the development of uniform procedures for CHR data acquisition, data quality, and nomenclature and annotation conventions for data depositions to the NDA.
• Advise on research priorities, optimal research designs, and project milestones.
• Discuss scientific progress and make recommendations regarding the enhancement of research activities and the facilitation of free and open sharing of resources.
• Participate in AMP SCZ working groups to develop a protocol for the PoP trial(s) based on the compound(s) made available to the AMP SCZ consortium and, as needed, to address the scientific goals of this program. The workgroups should include representatives from the CT-DPACC and Clinical Trial Network, NIMH Project Scientists, NIMH Program Officers, and AMP SCZ public and private partners. Participate in reviewing scientific progress of the project, Clinical Trial Network recruitment, and development of standard operating procedures.
• Vote to elect the initial chair, who will be responsible for developing meeting agendas and chairing meetings. Every six months a new chair will resume these responsibilities. The chair must be a PD/PI of the awards.
• Meet once a week by teleconference/zoom.
• Plan to hold an annual in-person investigators meeting that includes NIMH CHR SC members. External Working Group members should also be included as appropriate. Further meetings can be convened on an ad hoc basis around specific issues. The CT-DPACC PD(s)/PI(s) will provide funds for travel for themselves and for external advisors to attend the annual in-person meeting.
• Hold teleconferences to address operational issues on a weekly or monthly basis, or as dictated by the needs of the project.
• Establish workgroups or subcommittees for specific tasks as the NIMH CHR SC deems appropriate. The workgroups or subcommittees will make recommendations to the AMP SCZ Operations Working Group. Then the Operations Working Group will move the agreed upon recommendations to the AMP SCZ Steering Committee, composed of public and private partners, for final vote and decision.
• Prioritize and coordinate publications of scientific findings.
• If a vote is needed, each Committee member will have one vote, except for the Project Scientists, who collectively will have one vote.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award 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 AMP SCZ SC 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. The recipient organization should be represented by at least one of the three members. 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.

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 should reflect the manner in which these policies will be implemented in support of the proposed Clinical Trial Network. 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, timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.

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 $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 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 Conditions 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]

Jonathan Pevsner, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-728-5618
Email: [email protected]

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
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.