Mental Health Research Dissertation Grant to Enhance Workforce Diversity

Mental Health Research Dissertation Grant to Enhance Workforce Diversity is sponsored by National Institutes of Health (NIH) / National Institute of Mental Health (NIMH). This program aims to enhance the diversity of the mental health research workforce by providing dissertation awards in all research areas within the strategic priorities of the NIMH to individuals from backgrounds underrepresented in biomedical, behavioral, clinical and social s…

Expired PAR-21-325: Mental Health Research Dissertation Grant to Enhance Workforce Diversity (R36 Independent Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. 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 Mental Health Research Dissertation Grant to Enhance Workforce Diversity (R36 Independent Clinical Trial Not Allowed) Notices of Special Interest associated with this funding opportunity May 25, 2022 - This PAR has been reissued as PAR-22-172 March 29, 2022 - Notice of Intent to Reissue PAR-21-325.

See Notice NOT-MH-22-201 . March 29, 2022 - Notice of Early Expiration of PAR-21-325. See Notice NOT-MH-22-200 .

October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients.

See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to enhance the diversity of the mental health research workforce by providing dissertation awards in all research areas within the strategic priorities of the NIMH to individuals from groups underrepresented in biomedical, behavioral, clinical and social sciences research.

This FOA provides support to complete a mental health-related doctoral research project and includes funds not readily available in NRSA predoctoral (F31) awards, which limit support to stipends, tuition and fees, and institutional allowance. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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.

New Date May 8, 2022 per issuance of NOT-MH-22-200 . (Original Expiration Date: September 08, 2024 ) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. 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. Funding Opportunity Description This Funding Opportunity Announcement (FOA) seeks to enhance the diversity of scientist by providing funding support to complete the dissertation of their research careers, which falls at a particularly critical juncture in doctoral training, and a period during which institutional support may decline or terminate altogether.

This FOA provides support to complete mental health-related dissertation research and includes funds not readily available in NRSA predoctoral (F31) awards, which limit support to stipends, tuition and fees, and institutional allowance. The NIH has an interest in diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce (see NOT-OD-20-031 ).

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Despite tremendous advancements in scientific research, information as well as educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences.

NIMH is committed to recruiting and retaining in its research workforce talented individuals from the diverse fabric of U.S. society. In 2008, a workgroup of the National Advisory Mental Health Council issued a report, " Investing in the Future ," highlighting the need for enhancing the diversity of the mental health research workforce.

Enhancing workforce diversity has meant creating opportunity, especially opportunity for people from underrepresented groups who bring different perspectives and who may solve problems in new ways. By promoting programs to enhance workforce diversity, the NIMH aims to enlist the full spectrum of perspectives and knowledge to accomplish the mission of the NIMH. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Resubmission from PAR-18-894 and PAR-21-325 Revision from PAR-18-894 and PAR-21-325 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Not Allowed: Only accepting applications that do not propose clinical trials, clinical feasibility studies, or ancillary clinical trials.

Note: Candidates may propose a research experience in a clinical trial led by a mentor or co- mentor. 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.

This FOA allows for budget requests to cover, per year, a salary consistent with the current fiscal year National Research Service Award (NRSA) predoctoral stipend level ( https://grants. nih. gov/training/nrsa.

htm#policy ) and up to $15,000 for additional expenses such as fringe benefits in accordance with institutional policies including health insurance for self and family members, travel to scientific meetings, and dissertation research costs. One hundred percent effort is required for disseration research activities and associated didactics.

With the exception of costs associated with the dissertation (i.e., dissertation credits), no funds may be used to pay tuition or fees. Other specific costs not allowed on dissertation research grants are equipment, alterations/renovations, space rental, contracting or consortium costs, dissertation defense or deposit fees, membership fees, and faculty or consultant effort.

This listing is not exhaustive, and the applicant institution should contact NIMH staff regarding any other cost item being considered. For more information on allowable and unallowable costs, see https://grants. nih.

gov/grants/policy/policy. htm . The total award project period may not exceed twenty-four months but must be no less than 12 months.

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

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (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 In addition, eligible institutions must have a doctoral degree-granting program in the candidate's area of study.

The applicant institution must be the institution at which the PD/PI is pursuing doctoral studies. The research training should occur in a strong research environment that has appropriate human and technical resources for the proposed research and is demonstrably committed to high-quality research training in the research area proposed by the PD/PI. 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 not allowed. 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.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

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. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but 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 DUNS number and 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 his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Eligible PDs/PIs include predoctoral students at the dissertation stage of training.

The applicant must have an approved dissertation proposal (at the time of award), show evidence of high academic performance in the field of study and a commitment to a career as an independent research scientist, an independent physician-scientist or other clinician-scientist (dual-degree training) This FOA is available to predoctoral students from groups underrepresented in biomedical research who are in good standing in accredited research doctoral programs in the United States (including Puerto Rico and other U.S. territories or possessions; see Section III for additional information regarding eligibility for this program).

The PD/PI must have a baccalaureate degree and be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, PsyD, ScD), a formally combined MD/PhD program, or other combined professional/clinical and research doctoral (e.g., DDS/PhD) in the biomedical, behavioral, or clinical sciences.

The NIH is particularly interested in encouraging the recruitment and retention of the following groups of individuals: A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www. nsf.

gov/statistics/showpub. cfm? TopID=2&SubID=27 ), and the report Women, Minorities, and Persons with Disabilities in Science and Engineering ).

The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see NOT-OD-15-089 . B.

Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended . See NSF data at: http://www. nsf.

gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10. pdf . C.

Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria: 1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act 2. Were or currently are in the foster care system, as defined by the Administration for Children and Families 3.

Were eligible for the Federal Free and Reduced Lunch Program for two or more years 4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces. ed.

gov/pubs2018/2018009. pdf ) 5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.

ed. gov/programs/fpg/eligibility. html ) 6.

Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www. fns. usda.

gov/wic/wic-eligibility-requirements ) 7. Grew up in one of the following areas: a) U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer ,or b) Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zipcodes are included in the file).

Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition. Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces. ed.

gov/programs/coe/indicator_tva. asp ), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.

ed. gov/ ; https://nces. ed.

gov/programs/coe/indicator_tva. asp ; and https://www2. ed.

gov/rschstat/research/pubs/advancing-diversity-inclusion. pdf . Multiple PD/PIs are not allowed.

By the time of the award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a valid Permanent Resident Card USCIS Form I-551 or other legal verification of such status). This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 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.

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 NOT-OD-11-101 ). At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

Other Attachments: Instruction in the Responsible Conduct of Research: All applications must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR).

The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the instruction; 4) Duration of Instruction - the number of contact hours of instruction; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years.

Document any prior instruction during the applicant’s current career stage, including the inclusive dates instruction was last completed. See also NOT-OD-10-019 . The attachment is limited to one page.

Applications lacking a Plan for Instruction in the Responsible Conduct of Research, or containing an attachment more than one page long, are noncompliant and will not be reviewed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. Biographical Sketches: Biographical Sketches must be provided for the PD/PI and the dissertation project advisor.

Follow the recommended format of the SF424 (R&R) Application Guide at https://grants. nih. gov/grants/funding/424/index.

htm . The PD/PI's Biographical Sketch must include information on Scholastic Performance as described in the SF424 (R&R) Application Guide for predoctoral applicants/candidates. The advisor's Biographical Sketch should document the experience, resources, and time available to supervise and mentor the PD/PI so that he/she will complete the dissertation in a timely manner.

All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Explain how completion of the project will help the PD/PI to advance his/her research career goals. Explain the importance of the problem or critical barrier to progress that the proposed project addresses.

Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, describe the relationship of the proposed research project to the clinical trial. All letters must be combined into a single pdf file.

Letter of Certification: The faculty advisor, dissertation committee chair, or university official directly responsible for supervising the dissertation research must submit a signed letter on institutional letterhead certifying that the PD/PI meets the eligibility criteria for the award.

Advisor and Reference Letters: The faculty advisor and at least one other member of the dissertation committee must submit letters, each no longer than 2 pages, that assess (a) the doctoral candidate’s progress to date; and (b) the candidate’s commitment to mental health-related research and her/his prospect of becoming an independent investigator in this area.

The reference letters should address the institutional supports and resources available to foster the completion of the dissertation project. 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. Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov. 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide .

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

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Use of Common Data Elements in NIH-funded Research Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.

Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.

NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" ( http://cde. nih.

gov/ ) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.

Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. NIMH has released expectations for collecting common data elements when an application involves human research participants. Details can be found at NOT-MH-20-067 and the NIMH webpage on Data Sharing for Applicants and Awardees .

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy. Section V.

Application Review Information 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.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Significance should be evaluated within the context of a doctoral dissertation: to what extent will successful completion of the project help the PD/PI to advance his/her research career goals?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary