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 Increase Diversity (R36)

Activity Code

R36 Dissertation Award

Announcement Type

Reissue of PAR-09-132

Related Notices

  • April 8, 2015 - This PA has been reissued as PAR-15-181.
  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • September 6, 2013 - See Notice NOT-MH-13-021. Notice to Clarify the Placement of the Transcript in Applications Submitted.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • November 16, 2012 - See Notice NOT-MH-13-005. Notice to Clarify Eligibility Requirements.

Funding Opportunity Announcement (FOA) Number

PAR-12-103

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242

FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), is to increase the diversity of the mental health research workforce by providing dissertation awards in all areas of research within the strategic priorities of the NIMH to individuals from diverse backgrounds underrepresented in mental health research to support the completion of the doctoral research project.

Key Dates
Posted Date

February 14, 2012

Open Date (Earliest Submission Date)

February 14, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

April 23, 2012, August 22, 2012, December 21, 2012, April 22, 2013, August 22, 2013, December 23, 2013, April 22, 2014, August 22, 2014, December 22, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

January 8, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The goal of this Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), is to increase the diversity of the mental health research workforce by providing awards to support the completion of the doctoral research project and dissertation for individuals from diverse backgrounds underrepresented in mental health research. Recent national data on U.S. citizen/permanent resident recipients of the doctorate demonstrate a continuing need to enhance diversity in the disciplines from which current and future mental health researchers are anticipated, e.g., the neurosciences, genetics, and clinical psychology (Doctorate Recipients from U.S. Universities; http://www.nsf.gov/statistics/sed/ ). Of those earning a neuroscience doctorate, <1% were Native American, 3.9% were Black/African American, and 5.6% were Hispanic/Latino. Of those earning a doctorate in genetics, <1% were Native American, 5.3% were Black/African American, and 3.9% were Hispanic/Latino. Similarly, among those earning a doctorate in clinical psychology, <1% were Native American, 5.6% were Black/African American and 7.7% were Hispanic/Latino.

The Mental Health Dissertation Research Grant to Increase Diversity allows for budget requests to cover full-time salary support and modest research funds for up to two years, but no less than 12 months, for eligible students to facilitate completion of their doctoral research project and dissertation in a research area relevant to the NIMH mission and strategic research priorities (http://www.nimh.nih.gov/research-priorities/strategic-objectives/index.shtml). These awards are available to predoctoral students who are enrolled in good standing at accredited domestic or foreign institutions and who have an approved dissertation proposal at the time of the award. Applicants must have the goal of becoming successful researchers in areas of biomedical or behavioral science relevant to the mission of the NIMH.

The NIMH, as part of the NIH, recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. A workgroup of the National Advisory Mental Health Council issued a report (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/investing-in-the-future.pdf) in 2008 that highlighted the need for increasing the diversity of the mental health research workforce. For a detailed description of diversity categories see Eligible Individuals below.

The NIMH encourages applications for dissertation research support across all research areas supported by NIMH. The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. In support of this mission, the NIMH encourages research and research training that addresses the strategic research priority areas (http://www.nimh.nih.gov/research-priorities/strategic-objectives/index.shtml) within the four objectives of the NIMH Strategic Plan:

Programmatic Evaluation

This FOA targets the timely awarding of the doctoral degree. In the Final Progress Report the PD/PI must provide information on the status of his/her dissertation research project, the actual or anticipated dissertation defense date, the actual or anticipated graduation date, and post-doctoral career plans (e.g., if he/she has accepted a job or post-doctoral research position, and if so, what it is.) Within five years of publication of this FOA, NIMH will assess the program’s overall outcomes and gauge its effectiveness in enhancing diversity of the mental health research workforce. The overall evaluation of the Mental Health Research Dissertation Grant (R36) program will be based on metrics that will include, but are not limited to, the following:

Upon the completion of this evaluation, the NIMH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

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.

Award Budget

Total allowable costs per year are the current fiscal year National Research Service Award (NRSA) predoctoral stipend level (http://grants.nih.gov/training/nrsa.htm#policy) and up to $15,000 for additional expenses such as fringe benefits (including health insurance for self and family members), travel to scientific meetings, and research costs of the dissertation in accordance with institutional policies.

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/advisor mentor supervision. This listing is not exhaustive, and the applicant institution should contact NIMH staff regarding any other cost item being considered.

F&A costs are limited to 8% of the modified total direct costs for this program.

Award Project Period

The total award project period may not exceed two years, 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 in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

In addition, eligible institutions must have an accredited, 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.

Both domestic and foreign sponsoring institutions must have staff and facilities available on site to provide a suitable environment for performing high-quality research. The research-training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the research area proposed by the PD/PI. The sponsoring institution may be private (for-profit or not-for-profit) or public, and must be a doctoral-granting institution.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

Eligible PD/PI include predoctoral students at the dissertation stage of training with the skills, knowledge, and resources necessary to carry out the proposed research.

Multiple PD/PI 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).

Diversity:

The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

For the purpose of this announcement, institutions are encouraged to identify applicants who come from backgrounds underrepresented in mental health research who will increase diversity on a national or institutional basis. As indicated in Section I, the NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

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 most recent report on 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: African Americans, Hispanic Americans, American Indians, 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 convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Potential applicants are encouraged to contact the appropriate Scientific/Research Contact listed in Section VII to gain more information on the relevance of their proposed application topic to NIMH's mission and strategic research priorities.

Eligibility related to predoctoral and dissertation-eligible status:

Individuals are eligible to apply for this award provided that they:

Level of Effort: It is expected that the doctoral candidate will devote 12 person months to the dissertation. Any level of effort that is less than full time must be fully justified, and the candidate's salary must be prorated accordingly.

Note that individuals supported under Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms, including F30 and F31 predoctoral fellowships and predoctoral trainees on NIH institutional research training awards, are eligible to apply for a dissertation award. Such candidates may not receive concurrent support from a NRSA fellowship or traineeship and an R36 Dissertation Award.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

Preliminary data are not required but may be included if available.

Letter of Certification. The faculty advisor, dissertation committee chair, or university official directly responsible for supervising the dissertation research must submit a letter certifying that the applicant meets the eligibility criteria for this award. As only one .pdf file is allowed for the Letter of Support item in the PHS Research Plan Component, combine this letter with Letters of Support (below) into one file.

Letters of Support. The faculty advisor and at least one other member of the dissertation committee must submit letters, each no longer than 2 pages, that address (a) their assessment of the doctoral candidate’s progress to date; (b) the candidate’s commitment to mental health-related research and her/his prospect of becoming an independent investigator in this area; and (c) the institutional commitment to ensuring completion of the dissertation in a timely manner.

Senior/Key Person Profile Component

Biographical Sketches. Biographical Sketches must be provided as attachments for each Senior/Key Person. Follow the recommended format in the SF424 (R&R) Application Guide. For the doctoral candidate, the Biographical Sketch should contain a personal statement that serves as a scientific autobiography, indicating the candidate's career goals, describing his/her interest in mental health/mental disorders-related research relevant to the dissertation project, and describing his/her intended career trajectory.

Other Project Information Component

Instruction in the Responsible Conduct of Research. A detailed plan for the Instruction in the Responsible Conduct of Research must be included (see NOT-OD-10-019). Applications without plans for training in the responsible conduct of research will be considered incomplete and may be returned without review. No award will be made if an application lacks this component. For additional information, see the US DHHS Office of Extramural Research, NIH on Training in the Responsible Conduct of Research (http://grants1.nih.gov/training/responsibleconduct.htm) or the USDHHS Office of Research Integrity (http://ori.dhhs.gov/). The description of the plan for the Instruction in the Responsible Conduct of Research is limited to one page and must be placed in the Other Attachments section of the Other Project Information Component, not in the Appendix.

Transcripts. The application must include a transcript of the student's record to date in the doctoral program of which the dissertation is a part. The transcript must be placed in the Other Attachments section of the Other Project Information Component, not in the Appendix.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 SF 424(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 Central Contractor Registration (CCR). 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, NIH. Applications that are incomplete will not be reviewed.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

The purpose of this program is to facilitate completion of a doctoral research project and dissertation in a research area relevant to the NIMH mission and research priorities, as articulated in the NIMH Strategic Plan. Because the Research Plan component is restricted to 6 pages, a dissertation research grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, rather than methodological details and preliminary data. Appropriate justification for the proposed work may be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required.

Overall impact should be evaluated within the context of a doctoral dissertation. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to make a contribution to the field, and the extent to which it exemplifies the current state-of-the-art of the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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: how will the successful completion of the aims help the applicant to advance his/her career goals?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the student show promise as a research investigator in areas relevant to the application, as evidenced in his/her Biographical Sketch and reference letters? Are the faculty advisor/dissertation chair and other doctoral committee members appropriately qualified to provide guidance as needed, that is do they have sufficient experience and resources to provide the necessary supervision and mentoring? Have the faculty advisor/dissertation chair and any other participating members of the committee indicated that they will allocate sufficient time to guide and support the PD/PI so that he/she will complete the dissertation in a timely manner?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Innovation should be considered within the context of the doctoral dissertation: Is the level of innovation appropriate for the PD/PI’s career stage?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

For all projects, not just those involving clinical research: Does the project reflect the student’s grasp of scientific principles and adequate knowledge of other research related to the proposed research question?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there sufficient institutional support to foster completion of the project in a timely manner, as evidenced by the letters of support?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

Additional Review Considerations

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/priority score.

Instruction in the Responsible Conduct of Research

Taking into account the circumstances of the PD/PI, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups? Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety? Does the plan adequately describe the role of the sponsor/mentor or other faculty involvement in the student s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction 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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

Not Applicable

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIMH,,in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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 .

In the Final Progress Report, the PD/PI must provide information on the status of his/her dissertation research project, the actual or anticipated dissertation defense date, the actual or anticipated graduation date, and post-doctoral career plans (e.g., if he/she has accepted a job or post-doctoral research position, and if so, the position title and the employer).

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.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Please see: http://www.nimh.nih.gov/funding/training/contacts-for-research-training-and-career-development-programs.shtml

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3534
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Rebecca Claycamp, MS, CRA
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2811
Email: rclaycam@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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.


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