Schizophrenia and Related Disorders During Mid- to Late-Life (R01 Clinical Trial Optional) is sponsored by National Institute of Mental Health (NIMH). Encourages research on schizophrenia and related disorders in mid- to late-life, including prevention and treatment interventions.

PAR-25-039: Schizophrenia and related disorders during mid- to late-life (R01 Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Schizophrenia and related disorders during mid- to late-life (R01 Clinical Trial Optional) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Exploratory/Developmental Grants See Section III. 3.

Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications that will advance translational research to better understand the emergence, trajectory, and outcomes of schizophrenia and related psychotic disorders in mid- to late-life, and to identify targets for future development of prevention and treatment interventions.

This NOFO uses the R01 grant mechanism, while the companion NOFO ( PAR-25-040 ), uses the R21 mechanism. Investigators proposing high risk/high reward projects that lack preliminary data may be more appropriate for the R21 mechanism. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - 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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description The purpose of this Notice of Funding Opportunity (NOFO) is to accelerate research to better understand the emergence, trajectory, and outcome of schizophrenia and related psychotic disorders in mid- to late-life.

For the purposes of this NOFO, schizophrenia and related psychotic disorders include the nonaffective psychotic disorders (e.g., schizophrenia spectrum disorders, delusional and other nonorganic psychotic disorders) but also bipolar disorder with psychosis. Since on average, persons with schizophrenia and related psychotic disorders have a shorter lifespan, the mid- to late-life life period is defined as 35 years old and above.

Research that identifies mechanisms underlying the risk, emergence, and outcome of schizophrenia and related psychotic disorders during mid- to late-life is of special interest. Mechanisms include, but are not limited to biological, behavioral, psychosocial, and environmental.

Research to identify mechanisms for targets within an experimental therapeutics approach leading to intervention development or that identify ways to modify existing healthcare and community-based services to better support individuals with schizophrenia and related psychotic disorders in mid- to late-life is of special interest. This NOFO encourages applications from teams composed of a variety of researchers.

Teams may include but are not limited to members from the fields of neuroscience, engineering, gerontology, social work, pharmacology, psychiatry, and psychology with the expertise necessary to conduct rigorous research. Teams led by or including those with lived experience with psychosis are highly encouraged.

Schizophrenia and related psychotic disorders affect ~20 million people worldwide and are one of the top 15 leading causes of disability. Those living with schizophrenia and related psychotic disorders, on average, have a shorter lifespan and greater morbidity than the general population.

The majority of people living with schizophrenia and related psychotic disorders are in their mid- to late-life, including those first diagnosed and those aging with the illness. Individuals living with schizophrenia and related psychotic disorders in mid- to late-life have the highest amount of disability-adjusted life years compared to individuals with schizophrenia and related psychotic disorders of any other age group.

New prevention and intervention efforts specifically for this population are seriously needed. Further, research focused on people living with schizophrenia and related psychotic disorders, specifically in mid- to late-life period, is sparse, and the mechanisms underlying the emergence and trajectory of schizophrenia and related psychotic disorders during mid- to late-life remain poorly understood.

This NOFO is intended to support research designed to identify the neurobiological, behavioral, psychosocial, and environmental mechanisms underlying the onset, trajectory, and outcome of schizophrenia and related psychotic disorders in mid- to late-life, with consideration for the identification of novel targets for future development of prevention and intervention efforts.

Studies that leverage concepts, methods, and findings emerging from geroscience research on mechanisms of normative and pathological aging as predictors of risk, trajectory, and outcome of schizophrenia and related psychotic disorders in mid- to late-life are encouraged.

Research must target populations in the mid- to late-life age range or mid-late life stages, but relevant comparison populations may include those who are younger if scientifically justified. Research is encouraged that addresses minority health and NIH-designated populations that experience health disparities in schizophrenia and related psychotic disorders in mid- to late-life.

Research is also encouraged that adopts an intersectionality framework (i.e., a framework that addresses the multiple dimensions of individuals’ identity and social systems as they intersect with one another).

A Research Domain Criteria, ( RDoC ) approach encourages taking a dimensional perspective with respect to assessing psychopathology and concentrating on aspects of behavior and brain function that span a range from intact to gradations of impairment, independent of diagnosis.

Thus, in such an approach, recruitment and eligibility of study participants need not be determined on the basis of traditional diagnostic categories but should instead be based on criteria that result in a sample that is optimized to study the clinical phenomena of interest over their full range of variability.

Such an emphasis on understanding the full dimensionality of neurobehavioral functioning generally precludes simple, dichotomous designs comparing patients versus controls.

However, it is not inconsistent with the RDoC approach to additionally characterize transdiagnostic samples of participants, recruited to represent the clinical phenomena of interest across the full range of variability, into existing diagnostic criteria – this allows investigators to draw links from novel approaches of characterization and classification to existing diagnostic categories and extant research.

Under this NOFO, if study hypotheses and/or enrollment criteria are not based on existing diagnostic criteria (i.e., an RDoC or other dimensional construct is proposed to serve as the primary variable representing psychopathology), the study design and sampling plan must be designed in order to assure that an adequate number of individuals assessed as falling within the more severely impaired ranges of that dimension will be included in the study.

Research is encouraged that assesses symptoms relevant to schizophrenia and related psychotic disorders dimensionally, integrates across multiple levels of analysis (including but not limited to brain-level measurements), and employs cutting-edge methodology from fields such as neuroscience, neuroimaging, neurophysiology, lifespan psychology, and geroscience.

If the proposed research involves magnetic resonance (MR) neuroimaging, applicants are encouraged, but not limited, to use very high field (≥7 Tesla) multimodal MR applications to study dynamic brain processes in precise regions and circuits that could identify subtle pathophysiological mechanisms driving the risk, emergence, and outcome of schizophrenia and related psychotic disorders during mid- to late-life that are unlikely identifiable in vivo at lower MR field strengths.

A dynamic component is one that samples brain changes over time either in conjunction with a challenge (e.g., task-based, inducing or during different physiological/psychological states) or over multiple periods of time, such as with a longitudinal design and is encouraged.

Specific Areas of Interest Areas of interest include, but are not limited to: Improved understanding of phenomenology, etiology, and pathophysiology of first-episode psychosis that emerges during mid- to late-life. Studies identifying the underlying mechanisms and trajectories of psychotic symptoms, negative symptoms, cognition, social cognition, and functioning in schizophrenia and related psychotic disorders in mid- to late-life.

As a reminder mechanisms include, but are not limited to, biological, behavioral, psychosocial, and environmental. Studies identifying the underlying mechanisms for the increased risk of dementia among people with schizophrenia and related psychotic disorders.

Studies of accelerated biological aging mechanisms that may influence psychopathology, premature morbidity, and mortality among people with schizophrenia and related psychotic disorders. Studies of other biological and homeostatic processes such as metabolic, sleep/arousal, and neural plasticity that may impact risk, emergence, and outcome in schizophrenia and related psychotic disorders in mid- to late-life.

Studies on the impact of social determinants of health and on understudied populations, including women and minority health populations with schizophrenia and related psychotic disorders in mid- to late-life. Studies identifying mechanisms of resilience and recovery in schizophrenia and related psychotic disorders in mid- to late-life.

Identification and regulation of brain circuits and/or neurobiological, behavioral, or biological systems that may be targets for prevention and treatment development or mechanisms of pathophysiology in schizophrenia and related psychotic disorders in mid- to late-life.

Computational approaches to identify predictive and/or explanatory causal patterns of factors associated with emergence, worsening, improvement, and outcome in schizophrenia and related disorders in mid- to late-life. Novel methods of neural or behavioral recording and stimulation are encouraged.

This could include ultra-high field MR neuroimaging, novel electrodes, recording devices, passive sensing or digital phenotyping/dense behavioral trackers, and neurostimulation. However, this NOFO does not support the stand-alone development of novel technology. New methods should be incorporated into an underlying scientific question about schizophrenia and related psychotic disorders in mid- to late-life.

Applicants who propose to examine dimensional constructs that do not appear in the NIMH RDoC matrices but which are consistent with the central tenets of the RDoC initiative should cite substantial evidence for the validity of such constructs, and indicate strong theoretical support that the construct maps onto a specific biological system, such as a brain circuit or physiological pathway, though measurement of those brain circuits or physiological pathways as part of proposed research projects is not a requirement of this NOFO.

The companion R21 grant mechanism of this NOFO ( PAR-25-040 ) encourages shorter, higher-risk applications with little (or no) preliminary data. The following are non-responsive to this NOFO and will not be reviewed: Studies whose purpose is to evaluate safety, clinical efficacy, and effectiveness; See the NIMH Clinical Trials website for further details about submission of mechanistic clinical trials to NIMH.

Studies of mechanistic and translational research on the onset and worsening of psychotic disorders during the menopausal transition (see PAR-23-102 ). Studies that assess mechanisms at only a single level of observation and analysis (i.e., without combining multiple levels/methods such as genetic, cellular, brain circuit, physiological, behavioral, self-report).

Studies of psychosis in neurodegenerative diseases (i.e. participants that developed psychosis after a neurodegenerative disease diagnosis (e.g. Parkinson’s or Alzheimer’s disease). See PAR-23-207 . Studies that target population less than 35 years of age.

Brain-wide association studies (BWAS) that are data discovery without data reduction strategies and without clear hypotheses. Applications that do not include human subjects. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ).

The application’s PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. 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 Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Revision of RFA-MH-22-270 , PAR-24-023 and PAR-25-039 Renewal of RFA-MH-22-270 , PAR-24-023 and PAR-25-039 Resubmission of RFA-MH-22-27 0, PAR-24-023 and PAR-25-039 The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

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.

Eligible Individuals (Program Director/Principal Investigator) 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.

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 How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 How to Apply - 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy: Applications should not duplicate information provided in the attachment described in the PHS Human Subjects Clinical Trial Information form but may reference it to provide context as needed.

Factor 2. Rigor and Feasibilit y As part of the conceptual framework, indicate clear mechanistic hypotheses and provide adequate capacity to test and potentially refute the hypotheses. If using a dimensional construct, the study design and sampling plan must provide that an adequate number of individuals falling within the more severely impaired ranges of that dimension will be included in the study.

If taking an RDoC approach, describe assessment methods that converge on the construct from at least two levels of analysis (e.g., genes, molecules, cells, circuits, physiology, behavior, and self-report). Describe plans for assessing comorbid medical conditions and controlling or accounting for their potential confounding influence.

If applicable, describe scientific justification for the use of comparison populations that are not in mid- to late-life (i.e. younger than 35 years). Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-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 by NIMH 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 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) t he 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 .

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

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. 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 Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . 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 How to Apply-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. 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 Section 7. 9. 1 Selected Items of Cost.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply 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