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/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)

Title: Mentoring Programs to Diversify the Mental Health and Substance Abuse HIV/AIDS Research Workforce through Innovative Educational Initiatives (R25)

Announcement Type
This is a reissue of PAS-06-447, which was previously released June 6, 2006.

NOTICE: Applications submitted in response to this 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 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-386

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.273

Key Dates
Release/Posted Date: June 29, 2007
Opening Date: July 17, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 17, 2007
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).
Application Submission/Receipt Date(s): September 17, 2007
Peer Review Date(s): November/December 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008
Expiration Date: September 18, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
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 Objectives

Individuals from racial and ethnic communities bear a disproportionate share of health problems in the U.S. In the area of HIV prevention and treatment, these communities carry a disproportionate risk of HIV infection. In 2002, the AIDS diagnosis rate among African-Americans was almost 11 times the rate among Caucasians. African-American women had almost a nine-times greater rate of AIDS diagnosis than Caucasians (Centers for Disease Control and Prevention-Division of HIV/AIDS Prevention 2003). HIV surveillance indicates that 69% of new infections are in individuals from underrepresented racial and ethnic groups (Centers for Disease Control and Prevention. HIV Prevention Strategic Plan through 2005. Atlanta: CDC, 2000), although these communities make up less than 25% of the U.S. population. In 2000, the AIDS incidence among Hispanics was 22.5 per 100,000, more than three-times greater than the rate for Caucasians (Centers for Disease Control and Prevention-Division of HIV/AIDS Prevention 2002:1). These disparities, together with the underrepresentation of individuals from racial and ethnic groups among HIV researchers, are the driving force behind this FOA.

The demographics of the HIV epidemic indicate that there is a disproportionate impact of HIV infection and transmission among racial and ethnic groups, yet investigators from racial and ethnic groups remain significantly underrepresented among HIV investigators in the NIH portfolio. Compared to the general population of HIV-infected, individuals from underrepresented racial and ethnic groups infected with HIV have not benefited equally from the unprecedented scientific advances in the diagnosis, pathogenesis and pathophysiology, prevention and treatment of HIV infection. Recently, more attention is being paid to ways to address mental health HIV/AIDS outcome disparities among underrepresented racial and ethnic populations, to understand why persons from these groups are at increased risk and to remedy the disproportionate impact. Similar actions for understanding the role of substance abuse and dependence in the prevention and treatment of HIV/AIDS for these communities are in progress. The most pertinent and recent strategic plan for action in this regard is the NIH Office of AIDS Research (OAR) Fiscal Year 2007 Plan and Priorities of HIV Research Relating to Racial and Ethnic Minorities (http://www.nih.gov/od/oar/public/pubs/fy2008/VIII_RacialEthnic.pdf) It is clear from this report that the reasons for this disproportionate impact, as well as the high rates of HIV transmission, are complex and represent a confluence of social, economic, and historical factors.

This funding opportunity was developed in response to the (i) simultaneous over-representation of individuals from racial and ethnic groups among those with HIV/AIDS, yet the underrepresentation of individuals from racial and ethnic groups as HIV/AIDS researchers; (ii) insufficient scientific information about HIV/AIDS disparities experienced by members of underrepresented racial and ethnic groups; (iii) the paucity of HIV/AIDS mental health and substance abuse research by investigators from communities disproportionately affected by HIV/AIDS; and (iv) the limited number of individuals from underrepresented racial and ethnic groups who are pursuing careers in HIV/AIDS mental health and/or substance abuse research. The National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA) seek to encourage applications to improve the capacity for high quality HIV research by developing mentoring programs for doctoral and postdoctoral candidates and junior faculty level candidates belonging to underrepresented racial and ethnic groups (i.e., African Americans, Hispanics, Native American/Alaska Natives, Asian/Pacific Islanders/Native Hawaiians).

The specific purpose of this funding opportunity is: (i) to develop new and improved research mentorship programs for eligible participants (i.e., individuals from underrepresented racial and ethnic groups , individuals with disability, individuals from disadvantaged backgrounds and/or (ii) to establish a network of senior mentors for eligible participants. These programs are intended for institutions that have a substantial enrollment, as defined by the institution, of students drawn from groups that are underrepresented in the nation s biomedical and behavioral science research fields. Targeting underrepresented groups is based on the severe underrepresentation of racial and ethnic groups in fields of science. For example, in 2001, individuals from underrepresented racial and ethnic groups earned only 5.6 percent of all doctorates in the biological sciences and 9.2% of doctorates in the social and behavioral sciences (NSF/NIH/NEH/USDA/NASA, 2001 Survey of Earned Doctorates).

It is expected that the research generated by investigators who participate in these research educational/mentoring programs will describe, explain and remedy the disproportionate impact of mental health-related and/or substance abuse aspects of HIV/AIDS on individuals from underrepresented racial and ethnic populations. Accordingly, mentoring programs will be supported to establish and conduct research educational activities in areas that relate to the mental health or CNS aspects of HIV infection (e.g., prevention, disparities, neuropsychiatry, neuropathogenesis, treatment, and services). Similarly, in those mentoring programs that focus on alcohol abuse and dependence in the context of HIV prevention and treatment, it is expected that this research education experience will more fully integrate the understanding of alcohol’s role in the prevention and treatment of HIV among individuals from racial and ethnic groups (e.g., improve adherence, reduce CNS disease, etc.). Likewise, mentoring programs that focus on drug abuse aspects of HIV/AIDS (e.g., role of drug abuse in HIV acquisition/transmission and disease progression; HIV prevention, including drug abuse treatment as a preventive intervention; HIV/AIDS treatment, including adherence issues and drug interactions; and consequences of HIV/AIDS and drug abuse, including neuroAIDS) should address health/disparities and/or individuals from underrepresented racial and ethnic populations.

THE NEED FOR HIV MENTORING PROGRAMS

Mentorship is arguably the most intense and critical form of leadership associated with training in any field. It is one of the most frequently cited components of a successful research career. The absence of mentoring and research collaboration have been identified as critical barriers to research participation by investigators from communities disproportionately affected by HIV/AIDS. Over the years, NIMH, NIAAA and NIDA have taken a number of steps to increase the representation of investigators from communities disproportionately affected by HIV/AIDS. Despite these efforts, the number of underrepresented racial and ethnic researchers who have obtained investigator-initiated research grants has been less than expected. Investigators from underrepresented racial and ethnic groups have unique qualifications for doing research with their respective communities, yet they often face various impediments to obtaining funding for research and must overcome particular challenges to conducting research with populations of individuals from underrepresented racial and ethnic groups (Shavers et al. 2005, Journal of the National Medical Association, 97: 12063-1077). Creating opportunities for mentorship/collaboration may reduce the barriers to successful competition for research funding by investigators from underrepresented racial and ethnic groups.

The availability of dedicated mentors and role models is essential for developing the future cadre of scientists in HIV/AIDS research. Mentoring is a skill for which academic researchers rarely receive any formalized education or training. Educating and training faculty to be mentors and program directors to be more effective is also essential. In today’s research climate which often calls upon methods from different related disciplines, having junior and senior faculty serve as co-mentors and/or having co-mentors with different, but complementary, expertise (crossing basic, clinical and services disciplines) would present the potential advantage that cutting-edge work could be combined with established work to help ensure research success. Such co-mentoring would also be likely to facilitate interdisciplinary and translational approaches to HIV/AIDS research.

There is also a need to define the ideal mentor and mentee, their respective roles, and to determine the characteristics that make the best mentor-mentee match. The lack of substantive incentive for senior investigators to mentor junior minority investigators is problematic in that many mentors may have competing interests and/or responsibilities. Mentoring programs should consider creating a cadre of mentors at a distance to assist mentees in departments that do not have a critical mass of research activity. Strategies for mentoring might include developing and implementing structured mentor-mentee interactions, creating a network of senior mentors and establishing a database of senior investigators interested in mentoring investigators from underrepresented racial and ethnic groups, establishing specific consortia or a listserve for investigators from underrepresented racial and ethnic groups and a telementoring program (e.g., mentoring via phone, computer or other telecommuting techniques) to allow new investigators to identify and access senior investigators with knowledge and interest in their specific research area.

Successful mentoring and capacity development requires a sustained commitment and ongoing effort (in terms of financial resources and faculty/institutional support) 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 funding opportunity 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.

RESEARCH EDUCATION PROGRAM OBJECTIVES AND DESCRIPTION

The principal objective of this FOA is to develop new and improved research educational mentoring programs for scientists from underrepresented racial and ethnic groups (i.e., African Americans, American Indians/Alaska Natives, Asian/Pacific Islanders/Native Hawaiians and Hispanics) or for individuals with disabilities or from disadvantaged backgrounds studying HIV/AIDS issues relevant to the HIV/AIDS missions of the sponsoring institutes. Faculty members may be recruited from across the country for the proposed mentoring programs that are intended to attract predoctoral (PhD, MD, MD/PhD) students, medical residents, postdoctoral fellows or junior faculty at the early career development level to NIMH-AIDS relevant research or to NIAAA-AIDS relevant research or to NIDA-AIDS relevant research. The proposed mentoring programs are intended to facilitate the entry of scientists from underrepresented racial and ethnic groups into the HIV mental health/substance abuse research arena. Applicants are expected to propose unique, innovative, curriculum-based research education programs that focus on the scientific areas of interest to the Center for Mental Health Research on AIDS (CMHRA) at NIMH (see http://www.nimh.nih.gov/dahbr/9a-as.cfm) or to NIAAA (see http://pubs.niaaa.nih.gov/publications%5CDEPRStrategicPlan%5CBriefingBook2.htm) or to the NIDA AIDS Research Program (see http://www.nida.nih.gov/about/organization/arp/).

Mentoring of investigators from underrepresented racial and ethnic groups can address basic science, behavioral science and/or clinical science on mental health, substance abuse or alcohol abuse-related aspects of HIV/AIDS or HIV/AIDS disparities issues. It is expected that the major form that these research educational programs will generally take is intensive, mentor-based research education programs with concentrated career development components.

While the NIMH, NIAAA, and NIDA expect applicant institutions to propose their own creative and innovative programs, the two types of programs below are the highest priority. Applicants may propose either type of program or may incorporate key features of both programs in the same proposal.

1. Special institute for collaborative and intensive, mentor-based HIV/AIDS-thematic research program that enhances the diversity of the scientific workforce.

2. Network of senior mentors in HIV/AIDS thematic research areas for the individuals in the research educational programs .

Suggested guidelines for these programs are described below.

1. Special Institute: The major intent of this program type should be to establish long-term mentoring that will enable participants to develop a research program and obtain NIH funding. A multidisciplinary mentoring program should be chosen 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/dahbr/9a-as.cfm). 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 components (further described below).

The academic component of the program might be in the form of seminars or didactic instruction and should provide an introduction to the basics of the HIV field chosen, its methods, new developments and research examples from studies, particularly those relevant to underrepresented groups. If prevention is the selected theme, then the academic component could include didactics on topics such as observational studies, randomized controlled trials, recruiting/retaining/conducting research in communities (especially in communities disproportionately affected by HIV/AIDS), health disparities, ethics and human subject protection, and the latest analytical innovations. Regardless of the theme selected, cross-cutting topic areas, such as networking/career development/survival, and grantsmanship should be addressed. Didactic instruction should form the background and basis of individual and/or small group seminars on research planning and other areas that help to elaborate and clarify the research question, conceptualize the problem and develop a preliminary studies plan. The research educational 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 proposal’s for NIH submission. Activities that occur in the context of the educational mentoring program might include topics such as assistance with career goals, research design and statistics, external funding proposal development, or visits to the laboratory or research site of the mentor.

While there are some ongoing NIMH-supported special institute type programs for mentoring in HIV prevention research (Marin, B. and Diaz, R., Public Health Reports, May-June 2002, 117: 218-230), similar programs have not yet been developed in other CMHRA/NIMH priority research areas such as neuropsychiatry, neuropathogenesis and therapeutics. We encourage development of mentoring programs in these content areas as well as expansion in prevention to translation and dissemination (see below for additional examples of specific content areas).

2. Mentoring Network: The major intent of a mentoring network program is to build a qualified pool and cadre of HIV/AIDS scientists who will serve as a central resource to facilitate the transition of mentees to the next level of career development. The mentoring network should be chosen in an HIV/AIDS field that has thematic concentration such as prevention, disparities, neuropsychiatry, therapeutics or neuroAIDS. It should also be multidisciplinary, within any given thematic area, thereby ensuring state of the art research approaches and translation among basic, behavioral, clinical and services research arenas.

The mentoring network should have at least four components: (i) process for matching of mentor with mentee; (ii) administrative coordination for collaborations within mentoring network; (iii) education, training and standardization of mentoring activities; and (iv) regularly occurring workshops/meetings to pair mentor(s) with mentees for the design of research projects and development of research proposals for NIH grant submission. 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. It is expected that these mentoring networks will not only build a supportive research network for emerging HIV/AIDS, investigators from underrepresented racial and ethnic groups, but also will increase the number of competitive grant applications submitted to the NIH by these investigators, increase the overall participation of researchers from underrepresented racial and ethnic groups in NIH initiatives and programs, and foster the development of high-quality individual and collaborative HIV/AIDS mental health and/or substance abuse research..

Examples of content areas for potential mentoring programs include, but are not limited to educational/research experiences:

The mentoring programs should incorporate certain key features or components of programs that help individuals move a step forward toward productive careers as HIV research scientists. Any combination of the features/components below, or others, may be proposed for this purpose:

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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses just-in-time concepts. 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 for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments ) of a previously reviewed research education grant application may be submitted. See NOT-OD-03-041, May 7, 2003.

2. Funds Available

The NIMH anticipates awarding up to $750,000 (Direct Costs) in FY 2008, the NIAAA anticipates awarding up $375,000 (Direct Costs) in FY 2008, and the NIDA anticipates awarding up to $500,000 (Direct Costs) in FY 2008 through this announcement. It is anticipated that three to five awards will be made in FY 2008. The direct cost of an individual award may not exceed $250,000 annually, with a project period of up to three years. Awards are expected to begin April 2008.

Because the nature and scope of the proposed research 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, NIAAA and NIDA provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has a substantial enrollment (as defined by the institution) of students drawn from groups that are underrepresented in the nation’s biomedical and behavioral science research fields. It is required that your organization have a substantial pool of students who meet the below eligibility requirement (see Section 1.B.).

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

Applications may include more than one institution to create a research education program through consortium agreements that include all of the disciplines, research environments, students, and faculty needed to accomplish the proposed educational objectives. However, only one of the participating institutions can be the recipient and primary site of the award. If multiple sites are to be used, the applicant institution must be the primary site.

An institution may submit more than one application in order to support programs in different areas of scientific emphasis.

In many cases, it is anticipated that the proposed research education program will complement other 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 individuals supported by Ruth L. Kirschstein NRSA T and F research training mechanisms.

1.B. Eligible Individuals

The Program Director/Principal Investigator/ (PD/PI) must possess the skills, knowledge, and resources necessary to carry out the proposed research education program and should have a regular full-time appointment at the applicant institution. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The PD/PI must be actively engaged in mentoring, research and administration of research programs on the mental health and/or substance abuse of HIV/AIDS and must be capable of recruiting and retaining a qualified pool of eligible mentees. The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., Reporting. )

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does 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 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, 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 PD/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 project, 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

Cost sharing is not required. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applications must target mentees from underrepresented racial and ethnic groups (or individuals with disabilities or individuals from disadvantaged backgrounds).

Applications must propose either a special institute or a network of mentors.

Applications must propose a thematic approach to mental health or substance abuse HIV/AIDS research or an interdisciplinary/ translational framework. Applications must have an evaluation and tracking plan. Applications must have a section describing quantifiable milestones.

Applications must follow the supplementary instructions provided in Section IV.6.

Participants (mentees): Participants may include doctoral and postdoctoral candidates and junior faculty level candidates who will conduct HIV/AIDS research in communities disproportionately affected by HIV/AIDS.

This program is intended to provide support for doctoral or postdoctoral or junior faculty level candidates. For the purpose of this announcement, institutions are encouraged to identify individuals who will increase diversity on a national or institutional basis. The strength of an institution's description and justification for the appointment of an identified candidate will be judged along with all other aspects of the proposed experience (see review criteria in Section V.1.). The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates: (a) Individuals from underrepresented racial and ethnic groups, (b) Individuals with disabilities, and (c) Individuals from disadvantaged backgrounds (see Section IV.6. Other Submission Requirements).Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Program Faculty/Mentors: Participating faculty/mentors must be actively engaged in mentoring, research or other scholarly activities related to the mental health or the CNS aspects of HIV/AIDS, or in other HIV-related disciplines relevant to the proposed research education program.

Sponsoring Institution/Organization: The sponsoring institution/organization must provide evidence of commitment to and support of the proposed program, e.g., providing adequate facilities, staff and faculty time, computer services, and educational resources necessary for the program. This commitment may also include plans to accommodate lodging and subsistence for participants in the program as needed. The sponsoring institution/organization must also be willing to collaborate with other sites that may be involved in the 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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

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 Started

2) Organizational/Institutional Registration in the eRA Commons

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

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

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and 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: GrantsInfo@nih.gov.

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 (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Multiple PD/PI Special Instructions

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 in item 15 of 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 (Section 14 of the Research Plan Component in the SF424 (R&R)), 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 project should be described, including 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 project 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 (See also: NOT-OD-07-017).

Research Education Program

While the proposed research education program may complement other, 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.

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 the degree of success or failure. 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 outcome measures that would determine the success of the research education program in achieving its objectives.

A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, etc

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.

Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. 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 mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.

Other Program-Related Expenses: 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. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.

Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

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 NIMH, NIAAA or NIDA missions, 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.

Participants in the research education program may receive a subsistence allowance, including partial costs of meals and lodging unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, other education-related, and travel expenses. Expenses for foreign travel must be exceptionally well justified. Funds will not be provided for fringe benefits or health insurance for participants in any research education program. 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.

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged.

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).

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  June 29, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 17, 2007
Application Submission/Receipt Date(s): September 17, 2007
Peer Review Date(s): November/December 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date: April 1, 2008

3.A.1. Letter of Intent

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

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

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.
Center for Mental Health Research on AIDS
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Blvd, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-4625
FAX: (301) 443-9719
Email: dstoff@mail.nih.gov

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.

In order to expedite the review, applicants are requested to notify the National Institute of Mental Health Referral Office by email (NIMHReferral@mail.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation.

Once an application package has been successfully submitted through Grants.gov, any 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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 award if such costs: are necessary to conduct the project, and 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 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

The NIH requires the PD/PI 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. 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

APPENDIX MATERIALS

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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

Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.

SPECIAL REQUIREMENTS

Recruitment and Retention Plan to Enhance Diversity:

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences 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 candidates:

A.  Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27)  In addition, it is recognized that underrepresentation can vary from setting to setting and 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 candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans:  Health Professional 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 undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council as needed, will determine whether amended plans and reports submitted after the initial review are acceptable.

This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity.   If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form. Applications that do not conform to the specific instructions detailed below will be returned.

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.

2. 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.

3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI (and multiple PD/PI if applicable) as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc.,) who are integral to the proposed research education program) participating in the research education program. The biographical sketch for each key personnel, including consultant(s) and potential research mentors, should include information on his/her teaching and/or research achievements, current grant support, and past student training record.

4. 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 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. The allowable categories of participant support costs are summarized in Section IV.2 for this FOA.

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.

5.   PHS 398 Research Plan Attachments:

Research education program applications for the Summer Institute typically include academic/didactic and research components as well as regularly occurring workshops addressing progress and plans. Research education program applications for the Mentoring Network include components for matching (mentee with mentor), administrative coordination and collaborations, training/standardization and regularly occurring workshops addressing progress and plans. These programs should be organized to reflect the institutional scope of the proposed program, and it should be presented as an integrated set of developmental activities that enhance academic excellence and promote timely progression of students to the next academic/career step.

There are five parts to the Research Plan. Part 1 refers to PHS 398 section on Introduction and is required only for resubmissions (previously known as revisions). Parts 2-5 correspond to PHS 398 sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods.

The page limit for the Research Plan (corresponding to PHS 398 sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods) is 25 pages, including tables, figures, diagrams, and charts.

Details of the information required to be included in a research education grant application in each of these sections in the Research Plan are presented below.

Specific Aims (Part 2): In this section, the application must describe (1) the overall goals and specific measurable objectives (including anticipated milestones) that the institution expects to accomplish through mentoring of individuals from underrepresented racial and ethnic groups or by creating a central mentoring network and (2) how these objectives contribute to the NIMH/CMHRA mission (http://www.nimh.nih.gov/dahbr/9a-as.cfm).

Background and Significance (Part 3): Include the following specific items in this section:

1) Institutional Setting and Current Status of Preparation for HIV-Related Academic Programs: Briefly describe the mission of the institution and its academic components. Provide evidence of the institution's commitment to diversity, particularly in the hiring of faculty from groups underrepresented in HIV/mental health fields. Describe current academic programs and their success in preparing underrepresented groups for careers in HIV-related sciences. Discuss any perceived impediments to preparation for HIV research careers at the institution to the success of students in biomedical sciences in general, and of underrepresented groups in particular. Cite literature on which you base your rationale for incorporating particular features into the program.

2) Mentee Enrollment: Document the depth and quality of the applicant pool from underrepresented racial and ethnic groups. Provide baseline data for potential mentees, over the past three years, including numbers of mentees from underrepresented racial and ethnic minority groups, individuals with disability or disadvantaged backgrounds or others who are interested in HIV/AIDS educational research programs.

3) Vision and Anticipated Value of the Research Education Program: Discuss the potential impact of the proposed Summer Institute Mentoring Program or Mentor Network Program on the mentees preparation toward careers in HIV mental health research. Describe the institution’s vision of the research education program and how it will be integrated into any existing academic programs. Describe how the research education program will partner with and complement other externally funded initiatives, including NIH-funded T32 training programs, for undergraduate/graduate student training. Describe options available to the institution for embracing and incorporating, beyond the scope of the R25 grant, any particularly effective curricular, training, programmatic, etc., elements that may be developed within the research education program.

Part 4 of this section (Preliminary Studies/Progress Report) should be re-titled Preliminary Data and Activities and included if applicable. This section should contain information on steps that led to the proposed research education program, including collaborations to date.

Part 5 of this section (Research Design and Methods) should be re-titled "Scientific and Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

(a) Proposed Scientific and Research Education Program: Describe the appropriate HIV/AIDS research area selected (see Section I) including a justification for the area selected. Describe the didactic and research education program, each component of the program, and each activity within each component. Describe plans for providing mentees with appropriate mentoring experiences. Describe plans to provide education to mentees regarding the responsible conduct of research. Although we do not require specific program features or components for program development, implementation and direction, all programs are encouraged to consider program features and components identified in Section I.1, based on strengths and resources of the institution and Program Director. If the application proposes a structured summer intensive mentoring program, it is expected that at least two major components will be described in detail and labeled accordingly (Academic/ Didactic Instruction and Mentoring; Research and Mentoring). If the application proposes a mentoring network, it is expected that the following components will be described in detail and labeled accordingly (Mentor-Mentee Matching; Coordination and Integration of Mentor Network; Mentor Training; Workshop Activities).

(b) Program Leadership: Describe qualifications of Principal Investigator(s)/Program Director(s) (or multiple PDs/PIs if applicable) in mentoring, research and administration of the proposed research education programs. Document that the PD/PI is actively engaged in mentoring and in research and can organize and administer the program. Describe plans for effective program administration and coordination among faculty/mentors. Provide evidence of institutional commitment and support for the proposed program. Include a statement that the applicant is willing to collaborate with NIMH/CMHRA, NIAAA or NIDA staff, as appropriate, in didactic sessions on grantsmanship, and peer review.

(c) Program Faculty/Mentors: Describe the characteristics and responsibilities of the faculty/mentors. Document that participating faculty/mentors are actively engaged in mentoring, research or other scholarly activities related to the mental health, CNS or alcohol abuse aspects of HIV/AIDS or other disciplines relevant to the proposed program. Indicate the exact role of each faculty/mentor in the mentoring. Provide a letter of cooperation from each faculty/mentor who has agreed to participate in the program as well as a biosketch (the biosketches of program faculty should follow the PI biosketch in the application).

(d) Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the research education program. Include, in a table, the total numbers of individuals recruited from the three categories of participants defined below.

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 http://www.nsf.gov/sbe/srs/women/start.htm). 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.

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. The review panel’s evaluation will be included in an administrative note in the summary statement. 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.

(e) Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.

(f) Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.

(g) Evaluation and Tracking Plan: 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 both a prospective evaluation plan and tracking plan for monitoring mentee progress (i.e., short-2 year and long-5 year effectiveness of mentoring program). Applications that do not have an evaluation and tracking plan will be returned without review The inclusion of evaluation instruments in an appendix is encouraged.

(h) Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, etc.

(i) Milestones: A specific section labeled Milestones must be included as the last section of the Research Plan. Milestones that are related to the impact of the program on the mentees should be well described, quantifiable, and scientifically justified. Applicants should write milestones assuming that a scientifically literate non-expert will use them to evaluate the progress that has been achieved. Milestones should not be simply a restatement of the specific aims. Some examples of measurable milestones might be (1) an increase in the number of students admitted to research doctoral degree programs; (2) acceptance of students to competitive postdoctoral positions or attaining faculty appointments; (3) improvements in competitiveness for research scholarships, increased number of research publications; (4) NIH grant submissions and funding.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Not applicable

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

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NIMH in accordance with the review criteria stated below.

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

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:

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. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research education program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. These criteria are not listed in any order of priority.

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).

Significance: Does the proposed research education program address scientific/education areas and/or topics important to the mission of the NIMH, NIAAA or NIDA on HIV/AIDS? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the NIMH, NIAAA or NIDA? Is the proposed research education-mentoring program likely to increase the numbers of researchers from underrepresented racial and ethnic groups moving to the next academic stage in pursuit of a HIV/AIDS research career?

Approach: Are the conceptual approach and methodology adequately developed, well integrated, well reasoned and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  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? Are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? Does the overall educational-mentoring program proposed include at least the two required components for a special institute (i.e., academic, research educational) or at least the four required components for a network (i.e., mentor-mentee matching, administrative coordination, training/standardization, workshops/meetings) and are the program features adequately constructed? Are the planned activities consonant with the proposed objectives and are they appropriate to the background and ability of the participants? Will the planned activities enhance the academic preparation and research competitiveness of the targeted population(s) and thereby promote their entry into HIV mental health research fields? 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?

Innovation: Is the research education program original and innovative? For example, does the program challenge existing approaches to research education, address an innovative hypothesis concerning inadequacies in current research education methods or critical barriers to advances in career development for underrepresented racial and ethnic groups? Is the research education program innovative conceptually and/or in implementation for scientific areas pertinent to the HIV/AIDS missions of NIMH, NIAAA and/or NIDA? Does the program develop or employ novel concepts, approaches, methodologies, tools or technologies for competitively preparing individuals from underrepresented groups or health disparities researchers to successfully compete for research grants in HIV mental health research fields? Does this program duplicate, or overlap with, existing research education, training and /or career development activities currently supported at the applicant institution? 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.

Investigators: Are the investigators appropriately trained and well suited to supervise the program? Is the Program appropriate to the experience level of the PD/PI, if applicable? Is there evidence of the Principal Investigator’s excellence in research and academic activities and the quality and breadth of prior HIV/AIDS training experience in mental health and/or alcohol abuse? Is the commitment adequate to develop and implement the mentoring 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 mentoring program that is based on sound research concepts and educational principles? Is the level of effort that will be devoted to direction and leadership adequate for a successful program? What is the quality of plans for effective program administration and coordination among faculty/mentors and with any partnering organizations? What is the quality of the pool of faculty 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 and/or NIAAA on HIV/AIDS, especially in health disparities issues? 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 make provisions, based on faculty letters, for providing mentees with appropriate mentoring experiences? What is the merit of the plans for providing mentees with mentoring experience?

Environment: Are facilities and related resources for the proposed program adequate and is there evidence that these facilities will be available to and will contribute to the success of the program? Will the proposed mentoring program benefit from unique features of the scientific environment or employ useful collaborative arrangements? What is the quality of the host institutions , collaborating partners and faculty/mentors participation in the mentoring project? Is the scope and nature of collaborations among participating programs adequate? Is there adequate institutional support for the proposed program from the Program Director’s chair, dean, or other appropriate supervisor?

Is there evidence of the commitment of the sponsoring institution to the program? 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? If multiple sites are to be used, is the justification for the educational experiences at these sites appropriate? Are the plans for coordination and communication among the multiple sites of high quality?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Evaluation Plan and Tracking Plan: Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program’s evaluation? Are methods adequate for monitoring and tracking mentees progress and for reaching milestones in the program? Is there an external evaluation team and what is the potential quality of the external review? Does the program have an adequate plan for evaluating its degree of portability and generalizability?.

Dissemination Plan: Is the dissemination plan strong and of high quality?

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research education program will be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Recruitment and Retention Plan to Enhance Diversity: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences 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. 

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups.  The review panel’s evaluation will be included in an administrative note in the summary statement.  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 NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

Not Applicable

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.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt 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.

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 NIMH to the grantee business official.

2. Administrative and National Policy Requirements

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 NIMH 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 NIMH 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:

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.

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.

3. Reporting

Awards made in response to this FOA are not subject to 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.

Progress Report: The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), 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.

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 recipients are hereby notified that they may be contacted during and 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 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.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.

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.
Center for Mental Health Research on AIDS
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Blvd, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-4625
FAX: (301) 443-9719
Email: dstoff@mail.nih.gov

Kendall Bryant, Ph.D.
Division of Epidemiology & Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2069
Rockville MD 20852-7003
Telephone: (301) 402-9389
FAX: (301) 443-8614
Email: kbryant@mail.nih.gov

Lynda Erinoff, Ph.D.
AIDS Research Program
National Institute on Drug Abuse
6001 Executive Blvd., Room 5274, MSC 9581
Bethesda, MD 20892-9581
Telephone: (301) 402-1972
Fax: (301) 594-5610
Email: le30q@nih.gov

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: armstrda@mail.nih.gov

3. Financial or Grants Management Contacts:

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd., Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: siscor@mail.nih.gov

Judy S. Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Rockville, MD 20852-1705 (for express/courier service)
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: jfox@mail.nih.gov

Pamela G. Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: pfleming@nida.nih.gov

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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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.

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.

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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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.

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