Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, includingSupplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), except where instructed to do otherwise (in this FOA or in a Notice from the 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 the 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

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NIH Mentored Career Development Award (K01) is to provide salary and research support for a sustained period of protected time (3-5 years) for intensive, supervised research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding. After the first year of the award, award recipients must spend at least four months per year in-country conducting research at research sites or institutions in World Bank defined low- or middle-income countries (LMICs).

Persistent disparities in access to mental health care and inadequately distributed human resources for mental health contribute to unmet needs for mental health services in the United States. Similarly, low- and middle-income countries (LMICs) face special human resource challenges which exacerbate the mental health treatment gap. For example, the World Health Organization Africa Region has the fewest psychiatrists per capita with approximately four psychiatrists for every 10,000,000 people. In 2011, NIMH published the Grand Challenges in Global Mental Health (GCGMH), a set of global priorities that, if addressed, can help to reduce the burden of mental disorders around the world. One assumption underlying the GCGMH is the necessity of global cooperation in mental health research to solve problems. In this context, global mental health research contains three elements: (1) the problem bears relevance to many countries (i.e., high-, middle- and low-income) and may be influenced by determinants or solutions that transcend national borders; (2) the research activities aim to reduce disease burden and increase health equity; and (3) the research activities utilize collaborative, interdisciplinary approaches. In this regard, global mental health research is necessary for generating, implementing, and disseminating knowledge in the United States as well as abroad. In concert with robust mental health services research efforts domestically, collaborative global research activities permit innovations developed in wealthy countries to be adapted for use in lower income settings, and innovations in poor countries to be applied in wealthy countries. A new cadre of skilled investigators is needed to integrate the values of global cooperation for mental health research while developing rigorous methodological and study design skills.

For the purposes of this funding opportunity announcement (FOA), applications should focus on mental illness and mental disorders, specifically conditions and disorders of brain structure and function that affect cognition, social and emotional processing, and behavior and are leading causes of disease burden worldwide, estimated on the basis of disability adjusted life years (DALYs). For example, disorders of interest include, but are not limited to depression, schizophrenia, and bipolar disorder, but exclude conditions with vascular (e.g., Alzheimer's disease, dementia, epilepsy) or infectious etiology and alcohol and substance use disorders. The term "global" mental health encompasses mental health in any country of the world. A core focus in global mental health research is related to both reducing the overall burden of health conditions (i.e., effectiveness) and reducing, and, ultimately, eliminating health inequities within and between countries. In addition, the term "global" refers to global influences on health such as cross-national factors such as macroeconomic policies, adverse living conditions, or the socio-political landscape. The responsibility for improving global mental health transcends national borders, class, race, gender, ethnicity and culture; its promotion requires collective action based on global partnerships.

The NIMH invites K01 applications from advanced postdoctoral and/or newly independent research scientists (usually with a Ph.D., M.D., or equivalent degree and no more than six years of postdoctoral research experience at the time of application) in biomedical or behavioral sciences who are pursuing global mental health research careers in areas supported by the NIMH. Clinical training (i.e., internship, residency, and/or fellowship) is not considered a period of postdoctoral experience unless there is a research aspect of =50% effort in any year. This NIMH program will provide an intensive research training experience designed to enhance the participating scientist s ability to conduct global mental health research, particularly research that addresses disparities in access to mental health care in LMICs, care for chronic, noncommunicable diseases, and/or implementation science in LMIC contexts. These themes are consistent with goals C, E, and F of the GCGMH (i.e., improve treatments and expand access to care; build human resource capacity; and transform health system and policy responses). This FOA aims to augment the education and training of the scientific workforce to meet the nation’s biomedical, behavioral, and clinical research needs in global mental health research, a priority research area for the NIMH.

Specifically, this FOA seeks to:

(1) attract early career researchers to global mental health research by supporting their mentored research experience in the U.S. and in low- and middle-income countries;

(2) advance the career trajectories of exceptional, early career U.S. researchers in global mental health research; and

(3) stimulate more effective translation of the results of research on global mental health into public health practice.

Research topics might include, but are not limited to:

• Identification of effective treatment and prevention strategies to decrease the mental health treatment gap in LMICs;
• Implementation research for scale up of evidence-based models of task sharing in mental health care (The term task sharing is sometimes equated with task shifting, but may also be used to describe staff who take on additional tasks without dropping (i.e., shifting) their pre-existing tasks;
• Examination of integrated care approaches for integrating mental health into chronic disease care in LMICs;
• Development of innovative psychosocial and biomedical intervention models tailored to local contexts (e.g. kinds of providers, intervention settings);
• Testing novel models and methods to better implement effective mental health interventions in diverse systems of care.

Candidates are strongly encouraged to contact the Scientific/Research Contact for this FOA prior to preparing an application to discuss issues of eligibility, program relevance, and review the specific provisions of this award.

NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• Eligible Agencies of the Federal Government

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.

• 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor(s) and 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. Multiple PDs/PIs are not allowed.

By the time of 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 currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status.

Candidates for this award must have a research or health-professional doctoral degree or equivalent.

This funding opportunity may support individuals who propose to train in a new field.

Eligibility for the K01 is limited to individuals with no more than 6 years of postdoctoral research experience at the time of application. Clinical training (i.e., internship, residency, and/or fellowship) is not considered a period of postdoctoral experience unless there is a research component of =50% effort in any year. The NIMH will consider waiving this eligibility limitation on a case-by-case basis with strong justification. Potential applicants should contact the NIMH Scientific/Research Contact for this FOA with the rationale for the requested waiver at least seven weeks in advance of the application due date.

Former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), research training grants (D43), resource grants (R24), research education grants (R25), other career development awards (K awards), or the equivalent are not eligible. Former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Clinical Trial Planning Grant (R34), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible. PDs/PIs assigned to lead a research project as the PD/PI during the non-competing phase of a significant independent NIH research grant and who have not previously competed successfully as PD/PI are eligible. A candidate for the K01 may not concurrently apply for or have an award pending for any other NIH career development award. Individuals on institutional K awards (K12 or KL2) are not eligible.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

At the time of award, the candidate must have a full-time appointment at the applicant institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their career development and research training. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Before submitting the application, the candidate must identify a mentor(s) who will supervise the proposed career development and research experience. The mentor(s) should be an active investigator in the area of the proposed research, have a strong, well-established record of research, and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor(s) must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research and training. The candidate must work with the mentor(s) in preparing the application. Applicants are strongly encouraged to identify both U.S. based mentors and mentors from low- and middle-income countries. Applicants are strongly encouraged to identify no more than 4 mentors.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

LeShawndra N. Price, Ph.D.
Office for Research on Disparities & Global Mental Health
6001 Executive Boulevard, Rm. 6219B, MSC 9659
Bethesda, MD 20892-9659
Telephone: 301-443-2847
Email: [email protected]

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Candidate Information

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

Candidate s Background

• Describe the candidate's commitment to a global mental health research career.
• Describe the candidate's prior training, research efforts, and current research support and how they relate to the objectives and long-term career plans of the candidate.
• Explain how the career award will contribute to the candidate's career goals and further the candidate's global mental health research career.
• Provide evidence of the candidate's potential to develop into a successful independent global mental health researcher. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• For early career faculty candidates, provide an explanation as to how relief from non-research responsibilities will contribute to the development or expansion of the candidate's research program.

Career Goals and Objectives

• Describe a systematic career development plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur; (2) justifies the need for further career development to become an independent investigator; and (3) utilizes the relevant research and educational resources of U.S.-based and LMIC organizations.
• Describe the candidate's career goals and objectives under this award.
• The candidate must demonstrate that he/she is committed to developing an independent global mental health research career relevant to the mission of the NIMH. Candidates must clearly describe how the activities proposed in the application will enable them to progress to a research career as an independent scientist in global mental health.

Candidate s Plan for Career Development/Training Activities During Award Period

• Describe how the candidate will fulfill the requirement that he/she spend at least 4 months per year in-country conducting research at research sites or institutions in World Bank defined LMICs, after the first year of the award.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent research career
• Describe any new or enhanced research skills and knowledge the candidate will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue to build his/her research program as an independent global mental health scientist.
• Describe any courses, seminars, opportunities for interaction with other groups and scientists, and/or training in career skills (e.g., grant-writing and making effective presentations) in which the candidate will participate as part of the career development plan.

Training 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, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
• Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.
• Provide a description of the instruction the candidate will receive in the responsible conduct of research specifically in international contexts. Training might include innovative courses, workshops, instructional materials, etc., that address International Human Research Standards, Ethical Codes, and specific country guidelines.

Statements and Letters of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Statements by Mentor, Co-mentor(s), Consultants, Contributors

• Name a primary mentor(sponsor), who, together with the candidate, is responsible for the planning, directions and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program. The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• The application must include a statement from the primary mentor and any co-mentors providing: (1) information on his/her research qualifications and previous experience as a research supervisor; (2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the Candidate's scientific and professional independence will be promoted; and (3) a description of the elements of the planned research career development, including any formal course work. The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career.
• Each mentor and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any of the co-mentors is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. The research strategy may be related to the research activities of the mentor(s), but it should not be a duplication of the mentor's ongoing research efforts. The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements of support must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Any other opportunities for the candidate's professional growth should also be documented in these statements. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.

Mentoring Team (if applicable): Signed statements must be provided by each member of the proposed mentoring team. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Description of Institutional Environment

• Document a strong, well-established research and career development program related to the candidate's area of interest at the sponsoring institution, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support) must also be described in the facilities and other resources section of the application. The candidate, mentors, and institutions must describe a research career development program that will maximize the use of U.S. and low- and/or middle-income (LMIC) institutional environments, facilities, and resources.
• Describe the sponsoring institution’s scientific environment and the environment of any foreign institutions, including the resources and facilities that will be available to the candidate, and the history of conducting global mental health research.

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution and any international or foreign institutions must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. The sponsoring institution must provide the candidate with the appropriate facilities and other resources to carry out the proposed Research Plan.
• Provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Research Strategy

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• The Research Strategy should clearly indicate how the plan complements the career development plan toward achieving the candidate's career goals.
• After the first year of the award, award recipients must spend at least four months per year physically in-country conducting research at research sites or institutions in World Bank defined low- and middle-income countries (LMICs). Time planned to conduct research or participate in research activities in LMICs should be included in the application in a timeline for research activities. This timeline must meet the minimum in-country time requirements described above.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the NOT-OD-11-079). Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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.

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 Applying Electronically.

Important reminders:
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.

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 (SAM). 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 by the Center for Scientific Review and responsiveness by NIMH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers should provide their assessment of the likelihoodthat the proposed career development and research plan will enhance the candidate s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

Does the candidate have the potential to develop as an independent and productive global mental health researcher? Are the candidate's prior training and research experience appropriate for this award? Is the candidate’s academic, clinical (if applicable), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in global mental health research? Do the letters of reference address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent global mental health researcher?

Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring

What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence? Are the content, scope, phasing and duration of the career development plan appropriate when considered in the context of the candidate's prior training/research experience and the stated training and research objectives for achieving independence? Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

Is there evidence that the award will enable the candidate to devote full time (at least the required minimum percentage of full-time professional effort) to research and related duties by release from teaching, administration, clinical work, and other responsibilities? Does the career development plan include training activities that will facilitate translation of research findings to other low-resource settings (in low-, middle-, or high-income countries)?

Research Plan

Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan? Does the research plan adequately describe how the study population, health system, health policy, or clinical context contributes to the innovations of the proposed science? Will the results of the research advance the science of mental health services research and/or implementation research in the global context? Do the methods (i.e., recruitment, protocol development, data analysis) take into account potential barriers that are unique to the international research activities? If applicable, are there adequate plans for data safety and monitoring of clinical trials?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Are the mentor's research qualifications in the area of the proposed research appropriate? Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work, adequate? Is there evidence of the mentor s, consultant s, and collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of the mentor's current research productivity and peer-reviewed support? Is active/pending support for the proposed research project appropriate and adequate? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence? Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality? Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration? Do(es) the mentor(s) provide established expertise in global mental health generally, and specifically in the region/country of interest? Is there strong and appropriate mentorship/collaboration planned in the foreign country

Environment & Institutional Commitment to the Candidate

Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort (75% of the candidate's full-time professional effort) will be devoted directly to the research and career development activitiesdescribed in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?? Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities in the U.S. and the foreign site, including faculty capable of productive collaboration with the candidate, adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality? Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator? Is the proposed environment within the LMIC conducive to the candidate achieving the candidate's research goals? Are the letters of support from representatives of the U.S. and LMIC institutions strong?

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 six 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 six 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 Children

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 children 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 five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 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 fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS).

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. Does the candidate justify the need for three to five years of mentored research experience in order to become an independent global mental health researcher?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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:

• 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.
• Will receive a written critique.

Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Prior consultation with NIMH Staff is strongly encouraged.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

LeShawndra N. Price, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2847
Email: [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.