Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: NIMH Research Education Programs for HIV/AIDS Research (R25)

Announcement Type

This is a reissue of the AIDS-related portion of PAR-08-079.

Update: The following update relating to this announcement has been issued:

• August 28, 2012 - This PAR has been expired and reissued as PAR-12-273.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Program Announcement (PA) Number: PAR-11-002

Notice: Applications submitted in response to the Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

A compatible version of Adobe Reader is required for download. For assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport.

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release/Posted Date: October 4, 2010
Opening Date: December 7, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): 30 days before the submission date
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
AIDS Application Submission/Receipt Date(s): January 7 annually
Peer Review Date(s): March annually
Council Review Date(s): May annually
Earliest Anticipated Start Date(s): July 1 annually
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration/Closing Date: (Now Expired August 29, 2012 per issuance of PAR-12-273), Originally January 8, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This funding opportunity announcement (FOA) issued by the National Institute of Mental Health encourages Research Education Grant (R25) applications from Institutions/Organizations that propose creative and innovative research education programs to facilitate the development of a cadre of investigators in appropriate scientific areas to fulfill the mental health relevant objectives as defined by the Office of Aids Research (OAR) Annual Strategic Plan. The NIMH expects all programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, individuals from disadvantaged backgrounds, and women.
• Mechanism of Support. This FOA will use the NIH Research Education (R25) award mechanism. Research education programs may not be transferred from one institution to another, unless strongly justified (see Section VI.2).
• Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism, numbers, quality, duration, and costs of the applications received.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed five years. The direct costs are limited to $250,000 annually. All personnel costs (including administrative and clerical costs, as well as salaries of the PD/PI and other investigators/faculty) associated with directing, coordinating, and administering the program should be justified and reasonable. Personnel costs cannot exceed 35% of the requested direct costs annually.
• Application Research Strategy Length. The R25 application Research Education Program Plan (uploaded using the Research Strategy section) of the PHS398 Research Plan Component (SF424 Application Guide, Section 5.5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research education program are invited to work with their institution/ 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.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Renewal applications are allowed for this research education program.
• Special Dates: This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
• General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Education Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Education Objectives

This FOA issued by NIMH encourages Research Education Grant (R25) applications from Institutions/Organizations that propose creative and innovative research education programs to facilitate the development of a cadre of investigators in appropriate scientific areas to fulfill the mental health-relevant objectives as defined in the Office of AIDS Research (OAR) Annual Strategic Plan. The NIH Research Education (R25) grant mechanism is a flexible and specialized mechanism designed to foster the development of biomedical, behavioral, and clinical researchers through creative and innovative research education programs. The overall goal of this FOA is to support research education programs that provide research mentoring experiences and whose ultimate aim is to increase the number of highly trained scientists in various scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs that are relevant to the mission of the NIMH AIDS research program. The NIH expects all programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women.

The NIMH expects applicant institutions to propose their own creative and innovative research education programs. While not limited to the categories and examples provided below, the NIMH is particularly interested in R25 applications that propose to support the development of innovative programs with a strong mentoring component, relevant to the mission of the NIMH AIDS research program (see below section on Program Scope ), and that fulfill one or more of the objectives below:

• Continue and/or expand current R25 programs, originally funded under PAS-06-447 and PAR-07-386, to develop educational/research experiences that enhance public health, interdisciplinary and translational approaches to the mental health-related aspects of HIV/AIDS;
• Expand the pool of investigators who participate in a program of didactic/academic and research-based components to increase critical mass for sustained and full participation in HIV mental health research;
• Support new specialized, intensive institute mentoring programs (see below for details) or new national mentoring network programs, either in areas of critical importance or in underserved HIV-vulnerable populations;
• Recruit faculty members from across the country for the proposed mentoring programs that are intended to attract pre-doctoral students, medical residents, postdoctoral fellows or junior faculty. A multidisciplinary mentoring program (in domestic or international settings) should be proposed in an HIV/AIDS field that has thematic concentration such as disparities, prevention, implementation, neuropsychiatry, therapeutics or NeuroAIDS.

Program Scope

Preparing a new generation of basic and clinical research scientists requires research education and career development experiences in highly inter-disciplinary and collaborative HIV/AIDS research settings that are integrated with a specialized curriculum. These experiences will require access to multiple scientific disciplines and methodologies, the involvement of mentors from more than one discipline, and the opportunity for individually tailored research education programs. Due to the likely breadth of the science involved, these experiences will frequently require facilitation and coordination across departments, schools, centers, and institutions; and dedicated time of interdisciplinary faculty. In today’s research climate, having junior and senior faculty with different, but complementary expertise (crossing basic, clinical and services disciplines) serve as co-mentors would be potentially advantageous. Such co-mentoring could provide guidance on cutting-edge as well as established research to help ensure research success. Such co-mentoring would also be likely to facilitate interdisciplinary and translational approaches to HIV/AIDS research.

Successful mentoring and capacity development requires a sustained commitment and ongoing effort and must be done in the context of infrastructure development and partnering between institutions as well as between institutions and the communities they serve. Since this FOA does not provide such infrastructure support, it will be important for existing institutional infrastructure and resources to be identified and linked to these programs to carry out mentoring effectively.

Examples of creative or innovative programs include:

• Special Institutes : institute -based research education programs combine didactics and research opportunities with mentoring. An institute is comprised of an Academic Program Component; a Research Program Component; A Local Mentoring Network; and an Evaluation Plan (see below for further details);
• National research mentoring networks: national network-based research education programs that will provide a resource of mentors and will enhance the professional development of the participating individuals, sustain their career trajectory through research independence, and lead to scientific advances addressing the mental health of those affected by HIV/AIDS.

Essential Program Features: Special Institute

The major intent of this program type is to establish long-term mentoring that will enable participants to develop a research program and obtain NIH funding. A multidisciplinary mentoring program should be developed in an HIV/AIDS field that has thematic concentration such as prevention, disparities, neuropsychiatry, therapeutics or neuroAIDS (see CMHRA programs at http://www.nimh.nih.gov/about/organization/dar//center-for-mental-health-research-on-aids/index.shtml). Mentoring activities should be the cornerstone of this program to promote research career development in the field. These mentoring activities should be embedded in both academic and research educational activities that include the four components listed below.

(1) Academic program component. The academic program component might include seminars or didactic instruction to provide an introduction to a particular field of research relevant to HIV/AIDS. This should include information relevant to state of the art research methods, recent developments and research findings, particularly those relevant to underrepresented and underserved groups. Didactic instruction should provide the background and basis of individual and/or small group seminars on research planning to help elaborate and clarify new research questions and develop a preliminary research plan. Regardless of the theme selected, cross-cutting topic areas such as networking/career development/survival, and grantsmanship should be addressed.

(2) Research program component. The research program component should involve research career development-related networking activities and mentoring (in-person, telephonic or online) in the context of the mentee’s original research studies (including preliminary pilot work). Research should involve preliminary pilot studies and conduct of the research itself as well as the subsequent development of research grant applications for NIH submission. Pilot research projects are limited to $20,000 for up to two years, as detailed in Section II.2 Participant Costs. All pilot research proposals will be administratively reviewed by NIMH and approved prior to the release of funds designated for pilot research projects.

(3) Local mentoring network. A critical mass of faculty/research mentors with ongoing funded research projects is necessary to implement the proposed specialized, intensive institute academic and research program components. This network should describe the following three tasks: (i) the process for matching of mentor with mentee; (ii) the education and training proposed as well as the standardization of mentoring activities; and (iii) the regularly occurring workshops/meetings whose purpose is to pair mentor(s) with mentees so that they may work together on the design of research projects and development of research applications for NIMH grant submission.

(4) Evaluation. An evaluation plan to assess program process and outcomes should be developed with baseline data, milestones and performance measure targets for each stated aim. The evaluation plan is also expected to collect the relevant data and report progress to the NIMH, according to the annual reporting requirements for federal grants. A formal plan for evaluating the research education mentoring program must address how the major goals and objectives of the project will be achieved as well as the degree of portability and generalizability of the program to other settings. An external evaluation team should be identified to carry out this plan. The application must describe a prospective evaluation plan for monitoring mentee progress (i.e., short-2 year and long-5 year effectiveness of mentoring program).

Essential Program Features: National research mentoring networks

The major intent of a national research mentoring network is to build a qualified pool of HIV/AIDS research scientists who will serve as a central resource of mentors to facilitate the transition of mentees to the next level of career development. Mentoring networks may propose to include only mentees from a single career stage or may propose to bridge several career stages from post baccalaureate through the transition to research independence and a tenured, or equivalent, academic faculty position. Applicants should provide a rationale for the proposed career stage(s) of the mentees who will participate in the mentoring network. An applicant organization may wish to partner with scientific professional organizations or other partnering organizations to develop a national mentoring network. The national mentoring network should include the five components listed below.

(1) Mentor-Mentee matching process. Applicants must clearly define and justify the mentoring approach that is proposed for the types and levels of mentees that will be targeted. This would require matching and tailoring mentors to mentees based on interests, needs, personality, and other relevant characteristics.

(2) Administrative coordination. A process for administrative coordination should be described to provide a resource for overall management, coordination and supervision of the national mentoring program. This should ensure satisfactory ongoing management of an integrated mentoring program across several sites with fiscal accountability and evidence of a strong collaborative environment for the program.

(3) Mentor training and standardization of mentoring activities. Since applicant institutions are free to choose different delivery modes (e.g., online, peer-based, team-based), it will be important to ensure a process for specific mentorship training, both in general and program-specific activities. After training of mentors is established, standardized mentee outcomes should be used to assess the success of mentoring activities.

(4) Workshops/meetings During these workshops, concept papers should be critiqued, major trends in HIV/AIDS research discussed, and opportunities provided to network with mentors, experts and federal program officials. These workshops should also provide a forum for appropriate didactic instruction, plenaries by senior investigators and presentations by mentees.

(5) Evaluation. An evaluation plan to assess program process and outcomes should be developed with baseline data, milestones and performance measure targets for each stated aim. The evaluation plan is also expected to collect the relevant data and report progress to the NIMH according to the annual reporting requirements for federal grants.

Other than the above-mentioned key features or components, all programs are expected to incorporate training opportunities that will help individuals move a step forward towards productive careers as HIV research scientists. These opportunities might include individualized long-term mentoring; networking interactions; protected research time; experience in grant writing, preparing presentations, and writing research papers for publication; reviewing manuscripts; participating in mock grant application reviews; having access to state of the art methodology; and traveling to scientific meetings.

Although NIMH/DAR interest is largely in the above R25 program types, we recognize that a number of other educational tools (formats) may be appropriate. It is recommended that if other tools are proposed, consideration should be given to how these formats enhance outcomes from the specialized intensive institute programs or the national research mentoring networks. Any format, however, must also include a mentoring component (i.e. the Institute program and/or the national research mentoring network component). Alternative formats that might be proposed include but are not limited to the following:

• State-of-the-art courses focusing on topics relevant to the NIMH/DAR mission
• Seminar series or yearly symposia focusing on topics relevant to the NIMH/DAR mission
• Innovative activities during medical school and/or residency that encourage development of research-oriented physician-scientists with research interests in topic areas relevant to the NIMH/DAR mission

The proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research-training program (T32), and cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms. The R25 mechanism cannot be used to support the research of participants conducting 12-month, full-time biomedical research.

Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by innovation, scholarship and responsiveness to the priorities and/or changing needs of the NIMH in meeting its objectives. Applicants are strongly encouraged to contact NIMH program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Research Education Grant (R25) award mechanism. The Project Director/Principal Investigator (PD/PI) (or multiple PD(s)/PI(s) if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed research education program.

This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.

Research education grant support is renewable. It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a renewal application. Only one resubmission of a previously reviewed research education grant application may be submitted. See NOT-OD-09-003 and NOT-OD-09-016.

2. Funds Available

Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIMH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this FOA may not exceed 5 years. Although the size of award may vary with the scope of the research education program proposed, applications must stay within the following budgetary guidelines: total direct costs are limited to $250,000 annually, and personnel costs may not exceed 35% of the direct costs in any year of the project period.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution, nor can they be used to circumvent or supplement funds provided to individuals supported by Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Personnel: These requested expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Individuals (PD/PIs) designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds). Personnel costs may not exceed 35% of the direct costs in any year of the project period.

Other Program-Related Expenses: These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget. Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution.

Participant Costs: Participants are those individuals who benefit from the proposed research education program. In some instances, participants may be paid if specifically required for the proposed research education program and sufficiently justified. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program. For example, Undergraduate Students are allowed to receive salary and fringe benefits consistent with the institutional salary policies for employees in similar positions. Institutional rates for undergraduate salary should be no more than $10.00 per hour plus fringe benefits, only when such benefits are provided to other employees in similar positions. Graduate students, including health professional students, may receive compensation in accordance with the NIH policy for graduate student compensation (see: NOT-OD-02-017). Amounts for all participants must conform to the established, consistently applied salary and wage policies of the institution and reflect the percentage of time/effort devoted to the program.

Participants in the research education program may receive partial costs of meals unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, and other education-related expenses.

Expenses for foreign travel must be exceptionally well justified.

Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens. Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participants are not allowable. A full-time participant is defined for the research education program as an individual supported for 40 hours/week for a continuous, 12-month period or as specified by the sponsoring institution in accordance with its own policies.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (exclusive of tuition, fees, and equipment).

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• 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
• 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)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• Eligible Agencies of the Federal Government

Foreign institutions are not eligible to apply in response to this FOA.

Justification for a foreign component: If the research education project includes a foreign component, the application must provide a justification including the special resources or characteristics of the project necessitating a foreign component, the availability (or lack thereof) of this resource in the United States and the need for additional research education projects in this area. For a definition of a substantial foreign component, see Definitions section of PHS 398, Part III: Policies, Assurances, Definitions, and Other Information.

In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.

If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program. The need for and use of multiple sites must be justified.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research education program as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program.

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required (See Section VI.3. Reporting )

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the research education program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Sponsoring Institution. The sponsoring institution must assure support for the proposed research education program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. The application must have a strong research program in the area(s) proposed for research education and should include a letter explaining the institutional commitment to the proposed research education program.

Participants. NIMH R25 grants support the development and implementation of educational activities targeting individuals at the career stage of graduate/medical students, medical residents, and/or postdoctoral scholars. It is allowable for individuals who are beyond the postdoctoral stage to participate in short courses and workshops; however, support for part-time research training experiences across an academic year is not allowed for individuals who are beyond postdoctoral training. While non-U.S. citizens may participate in research education programs, research education programs should be used primarily for the education of U.S. citizens.

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals. Renewal applications are allowed for this research education program.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see Section IV.3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered http://www.grants.gov/applicants/get_registered.jsp

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SF 424 Research & Related Budget

Optional Components
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs. When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan. For applications designating multiple PDs/PIs, a new section of the Research Plan, entitled Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the Research Plan should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the program or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution: When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions: If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program. The need for and use of multiple sites must be justified.

Funding for the other institutions(s) must be requested via a subcontract to be administered by the primary institution. When submitting a detailed budget, the primary institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: December 7, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): 30 days before the submission date
AIDS Application Due Date(s): January 7 annually
Peer Review Date(s): March annually
Council Review Date(s): May annually
Earliest Anticipated Start Date(s): July 1 annually

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research education program.
• Name, address, and telephone number of the PD(s)/PI(s).
• Names of other key personnel.
• Participating institutions.
• Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it is strongly recommended since the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

David M. Stoff, Ph.D.
Division of AIDS Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-4625
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction (limited to 3 pages) addressing the critique from the previous review.

4. Intergovernmental Review

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS 398 Research Plan Component Sections

Page limitations must be followed as outlined in the SF424 (R&R) Application Guide.

• The Introduction for a resubmission application is limited to three pages.
• The Introduction for a revision application is limited to one page.
• Specific Aims (Item 2) is limited to 1 page.
• The Research Education Program Plan must be uploaded using the Research Strategy section (Item 3 of the Research Plan). This section may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.

All application instructions outlined in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm) are to be followed, with the following requirements for R25 applications:

• Research Education Program Plan (Item 3). The Research Education Program Plan must be uploaded using the Research Strategy section, and must include the following components:
• Proposed Research Education Program (Component of Item 3). While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program. The information should include a description of the education and/or career levels of the planned participants. The application should provide programmatic detail on the specific activities proposed (e.g., courses, curricula, seminars, workshops) that are appropriate to the design of the program, either special institute or monitoring network, and rational for choosing that approach. The application should also describe expected processes for: (a) conducting and monitoring participant progress during the research education program, (b) planning research and educational activities, and (c) matching mentors to participants, and (d) coordinating among existing training or research activities available at the site (where appropriate). Organizations participating in joint applications should demonstrably be involved in the planning, implementation, and assessment of the program. If an advisory committee is proposed, describe the function, structure, and composition of this committee and the frequency of meetings.
• Institutional Environment and Commitment (Component of Item 3). Describe the institutional environment, including facilities and educational resources that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached at line item 14 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.
• Program Director/Principal Investigator (Component of Item 3). For multiple PD/PI Leadership Plan, see instructions for the Multiple PD/PI Leadership Plan section of the Research Plan. Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of the NIMH, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional commitment and support for the proposed program.
• Program Faculty/Staff (Component of Item 3). Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NIMH when research is an integral part of the research education program.
• Program Participants (Component of Item 3). Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc. Describe the criteria that will be used to select individuals who will participate in the program.
• Diversity Recruitment and Retention Plan (Component of Item 3). Provide a detailed diversity recruitment and retention plan for the research education program. Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. To accomplish this, include a table that for each academic year indicates the total number of individuals who applied, the number accepted, the number who matriculated, and the total number of individuals participating in the program. This table should also list specifically for underrepresented racial and ethnic individuals the number who applied, the number accepted, and the number who matriculated; and for individuals with disabilities and individuals from disadvantaged backgrounds, the table should list the number participating in the program each year. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI should indicate that this requirement is not applicable.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to 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.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. 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 http://aspe.hhs.gov/poverty/index.shtml. 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 are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic 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.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIMH, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Applications without a diversity recruitment and retention plan will be considered incomplete and may be delayed in the review process or not reviewed. An award cannot be made if an application lacks this component.

• Training in the Responsible Conduct of Research (Component of Item 3): Every participant supported by this Research Education grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or not reviewed. An award cannot be made if an application lacks this component. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

• Evaluation Plan (Component of Item 3): Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. A plan must be provided for program evaluation. Benchmarks should be specified and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements.
• Dissemination Plan (Component of Item 3): A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc.
• Select Agent Research (Item 11): If participating faculty proposed in the Research Education program are conducting or plan to conduct research involving select agents in which participant are involved, follow the instructions in SF424, Section 5.5, and include the appropriate information.
• Resource Sharing Plan(s) (Item 15): NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042).

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

(d) Research education programs: These programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

The initial review group will comment on the appropriateness of the proposed software dissemination plan. Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. The adequacy of the resources sharing plan and any related data sharing plans (if applicable) will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

• Appendix (Item 16): Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

SF 424 Research & Related Other Project Information

• Item 9 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

SF 424 Research & Related Senior/Key Person Profile

Key Personnel must include the PD/PI (or multiple PDs/PIs) as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.

Research & Related Budget

Complete for each budget period requested.

A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI (or multiple PDs/PIs) must be included here.

B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.

C. Equipment: self-explanatory.

D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program.

E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program. Refer to Section II.2 for allowable participant support costs.

F. Other Direct Costs: itemize as appropriate and allowed for the research education program.

K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify. Note that the total funds requested in Sections A + B may not exceed 35% of the total direct costs in any year of the project period.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Review Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned an overall impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the National Advisory Mental Health Council.

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs. The goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions.

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research education program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

Scored Review Criteria

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

Significance: Does the proposed research education program address an important problem or critical question in research education or other critical issues as outlined in this funding opportunity announcement (FOA)? How will implementation of the proposed program advance the objectives of this FOA? If the aims of the education program are achieved, will they achieve the intended purpose of this FOA?

Investigator(s): Are the PD/PIs, collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program? If Early Stage Investigator or New Investigator, does the PD/PI have appropriate experience to lead the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project/program and the expertise of each of the PDs/PIs? Is the commitment adequate to develop and implement the research education program in a way that meets the scientific and educational requirements of the institution and the field? Is there evidence (at the individual and institutional levels) of the capacity to develop and implement a research education program with a strong mentoring component that is based on sound research concepts and educational principles?

Innovation: Is the proposed research education program characterized by innovation and scholarship? Does the proposed program challenge and seek to shift current research education paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area? Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program. If short courses and/or workshops are proposed, do they provide state-of-the-art educational opportunities?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? Does the program include the required components for a either a special institute or a mentoring program and are the program features adequately constructed? Are the planned activities consonant with the proposed objectives, are they appropriate to the background and ability of the participants activities, and will they enhance academic preparation and research competitiveness of the participants thereby promoting their entry into HIV mental health research fields? Are there specific plans to facilitate efficient and effective communication among local and national network members, both mentors and participants, and to achieve a balance between network security and appropriate access to and dissemination of information beyond the network? lf activities are targeting research-oriented physician-scientists during medical school and/or residency, are they structured to facilitate the development of scientific expertise in areas relevant to mission of the NIMH? Are benchmarks, plans, and procedures to capture, analyze and report program outcome measures adequately specified and described? Are evaluation instruments adequately described and justified?

Environment: Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success? Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Are there adequate plans to ensure coordination among other training or career development programs while ensuring that the proposed program is distinct from other extant programs? Are satisfactory plans included for allowing faculty time, educational resources, computer time and/or plans to accommodate lodging and subsistence for participants/mentees in the program as needed?

Additional Review Criteria

As applicable for the program t proposed, reviewers will consider the following additional items in the determination of scientific merit, but will not give separate scores for these items.

Partnerships and Collaborations: Are there adequate plans for ensuring effective communication and coordination among the investigators participating in the R25 application? Are the nature and extent of the partnerships explained? Is there appropriate evidence of commitment by the key partners to the planning and pilot implementation of the proposed mentoring network? Where partnerships are proposed, are there plans to monitor their effectiveness? Will duplication be avoided?

Mentors: Are the mentors appropriately qualified, experienced, productive, and well suited to carry out the proposed program in scientific/education areas and topics important to the mission of the NIMH on HIV/AIDS? Do they have active research support in relevant areas? Is the past training record of program faculty mentors adequate to foster the development of independent investigators for productive research careers? How available and accessible, based on other support and other commitments, are faculty mentors to provide intensive supervision, direction, guidance and advice to the mentees? Do the program faculty/mentors adequately demonstrate their commitment to the mentees? What is the merit of the plans for providing mentees with a strong mentoring experience? Are there strong plans for effective program administration and coordination among faculty/mentors and with any partnering organizations?

Mentees: Are plans in place that suggest the feasibility of recruiting sufficient numbers of qualified prot g s at the desired career stage(s) who have research interests aligned with the mission of the DAR? Are the criteria for prot g s, including eligibility, recruitment, retention, and expectations for their participation sufficiently detailed, appropriate and rigorous to support the proposed mentoring program?

Milestones: Are appropriate milestones provided for the design, implementation and evaluation of the prototype mentoring network? Is the evaluation plan appropriately designed to assess the significance of the proposed project and the feasibility of full implementation of the mentoring network?

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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), 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 program. .

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. In addition, the committee will consider the following:

• Has the research education program successfully achieved its stated objectives during the prior project period?
• Has the research education program successfully recruited a diverse pool of participants (if applicable)? Has the PD/PI effectively shaped the recruitment plan in response to recruitment outcomes?
• Has the program been innovative in the past and does it continue to demonstrate innovation?
• Has the program documented a strong need for continued support?

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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.

Diversity Recruitment and Retention Plan: Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. Plans and past record (if a renewal application) will be rated as ACCEPTABLE or UNACCEPTABLE.

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency) taking into account the characteristics of the proposed Research Education program. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

Applications from Foreign Organizations: When applicable, 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 Agents Research: When applicable, 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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html); and 4) Research education programs: If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the appropriateness of the proposed software dissemination plan.

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 education program and the number of proposed participants.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed Education Program to program priorities.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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 NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the Institute to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any allowable costs incurred 90 days before the beginning (or start) date of the Notice of Award (NoA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

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

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The research education program may not be transferred from one institution to another unless strongly justified.

Consultation with the Institute program staff is strongly encouraged when a change of institution is being considered. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the Institute may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the NIMH for review:

• An official letter (with an official institutional signature) addressing the need and circumstances for the requested transfer, and that the aims and objectives of the program to be conducted at the new institution are within the scope of the original peer-reviewed program.
• A relinquishing statement from the original institution and a transfer application by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review.
• All conditions of the award are met at the new institution, including institutional environment and commitment to the program.
• The period of support requested is no more than the time remaining within the existing award.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

3. Reporting

Awards made in response to this FOA are not subject to the streamlined non-competing application process (SNAP).

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

The Progress Report should provide information on the development and implementation of the proposed research education program, modifications to the research education program as originally proposed, updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program. To facilitate and standardize reporting, programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 additional instructions for preparing a Progress Report for an institutional training grant.

Evaluation: 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. Accordingly, award participants are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Education Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated. Evaluation results should be included as part of the Final Progress Report.

Statement of Appointment: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed for eight weeks or more. This form must be submitted to the awarding IC at or before the start of each participant’s appointment or reappointment If registered in the NIH eRA Commons, grantees are encouraged to submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.gov/commons/. An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) to the NIH for each participant appointed for eight weeks or more. If registered in the NIH eRA Commons, grantees are encouraged to submit the PHS 416-7 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.gov/commons/.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

David M. Stoff, Ph.D.
Division of AIDS Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6219, MSC 9619
Rockville, MD 20892
Telephone: (301) 443-4525
Email: [email protected]

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
FAX: (301) 443-4720
Email: [email protected]

3. Financial or Grants Management Contacts:

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.