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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/)

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

Announcement Type:
New

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAS-06-447

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

Key Dates
Release Date: June 6, 2006
Letters of Intent Receipt Date(s): August 14, 2006; August 17, 2007
Application Receipt or Submission Date(s): September 13, 2006; September 17, 2007
Peer Review Date(s): Nov/Dec 2006; Nov/Dec 2007
Council Review Date(s): January 2007; January 2008
Earliest Anticipated Start Date(s): April 1, 2007; April 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: September 18, 2006

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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application 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

Racial and ethnic minority (REM) communities bear a disproportionate share of health problems in the U.S. In the area of HIV prevention and treatment, REM populations 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 REM 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 under-representation of individuals from REM groups among HIV researchers, are the driving force behind this program announcement (PA).

The demographics of the HIV epidemic indicate that there is a disproportionate impact of HIV infection and transmission among REM groups, yet investigators from REM groups remain significantly under-represented among HIV investigators in the NIH portfolio. Compared to the general population of HIV-infected individuals, REM group members infected with HIV have not benefited equally from the unprecedented scientific advances in the diagnosis, pathogenesis and pathophysiology, prevention and treatment of HIV infection. This funding opportunity was developed in response to the (i) simultaneous over-representation of REM individuals among those with HIV/AIDS, yet the under-representation of individuals from REM groups as HIV/AIDS researchers; (ii) insufficient scientific information about HIV/AIDS disparities experienced by members of REM groups, and (iii) the paucity of HIV/AIDS mental health and alcohol abuse research produced by investigators from REM groups; and (iv) the limited number of REM individuals who are pursuing careers in HIV/AIDS mental health and/or alcohol abuse research. The National Institute of Mental Health (NIMH) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 from REM groups (i.e., African Americans, Hispanics, Native American/Alaska Natives, Asian/Pacific Islanders/Native Hawaiians and) and/or non-minority individuals, at these same levels, whose research focuses on HIV/AIDS disparities issues.

The specific purpose of this funding opportunity is: (i) to develop new and improved research mentorship programs for REM individuals, individuals with disability, or for non-minority individuals focused on HIV/AIDS disparities issues and/or (ii) to establish a network of senior mentors for REM mentees or for non-minorities focused on HIV/AIDS disparities issues. These programs may serve individuals at Minority Serving Institutions (i.e., Hispanic Service Institutions, Historically Black Colleges and Universities, Tribal Colleges and Universities) or Minority Predominant Institutions (greater than 50 percent racial and ethnic minority enrollment) or research-intensive institutions. 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 alcohol abuse aspects of HIV/AIDS on REM 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 REM groups (e.g., improve adherence, reduce CNS disease, etc.).

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 a critical barrier to research participation by REM investigators. Over the years, NIMH and NIAAA have taken a number of steps to increase the representation of REM investigators. Despite these efforts, the number of REM researchers who have obtained investigator-initiated research grants has been less than expected. Recently, more attention is being paid to ways to address mental health and HIV/AIDS outcome disparities among REM populations, to understand why persons from REM groups are at increased risk and to remedy the disproportionate impact. Similar actions for understanding the role of alcohol use, 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/fy2007/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. Investigators from REM 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 REM populations (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 REM 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 distant mentors 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 REM investigators, establishing minority-specific consortia or establishing a listserve for REM investigators 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 Minority Serving Institutions and research-intensive institutions and between Minority Serving Institutions and the communities they serve. Since this 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 PA is to develop new and improved research educational mentoring programs for two groups of scientists: (i) REM scientists (i.e., African Americans, American Indians/Alaska Natives, Asian/Pacific Islanders/Native Hawaiians and Hispanics) studying mental health, alcohol abuse or disparities issues of HIV/AIDS or (ii) non-minority scientists focused on HIV/AIDS disparities issues. 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. The proposed mentoring programs are intended to facilitate the entry of REM scientists to the HIV mental health research arena including research specific to alcohol abuse, or of non-minority scientists to the HIV/AIDS health disparities 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 programs focused on REM researchers.

Mentoring for REM investigators can address basic science, behavioral science and/or clinical science on mental health or alcohol abuse-related aspects of HIV/AIDS or HIV/AIDS disparities issues. Non-minority investigators are expected to focus only on health disparities HIV/AIDS research. 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 and NIAAA 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 targets individuals from REM groups and/or non-minority individuals whose research interests are focused on HIV/AIDS disparities issues.

2. Network of senior mentors in HIV/AIDS thematic research areas for individuals from REM groups and/or non-minority individuals interested in HIV/AIDS disparities issues.

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 under-represented 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 of racial/ethnic minority groups), health disparities, ethics and human subject protection, 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 conducting 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 areas such as assistance with career goals, research design and statistics, external funding proposal development, or visits to the laboratory or research site of mentor.

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), however, similar programs have not yet been developed in other CMHRA/NIMH priority research areas such as neuropsychiatry, neuropathogenesis and therapeutics, and we encourage development of mentoring programs in these content areas as well as expansion in prevention to translation and dissemination (see below for additional more specific content area examples).

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: process for matching of mentor with mentee; administrative coordination for collaborations among mentoring network; education, training and standardization of mentoring activities; and 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 racial/ethnic minority group investigators in HIV/AIDS or for non-minority HIV/AIDS-disparity focused investigators, but also will increase the number of competitive grant applications submitted to the NIH by these investigators, increase the overall participation of REM group researchers in NIH initiatives and programs, and foster the development of high-quality individual and collaborative HIV/AIDS mental health research on REM group populations.

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

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:

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Research Education (R25) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

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 IC(s) provide 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.

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 any of the following characteristics:

Foreign institutions are not eligible to apply.

Applications may include more than one institution to create a research education program through consortium agreements that includes 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.

It is anticipated that in most cases the programs created will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty would have active research projects in which students can gain relevant experiences. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (T32) or other federally funded training programs may apply for a research education grant, provided the proposed educational experiences are distinct from those training programs receiving NIH support and are not used to circumvent or bypass NRSA authorities or supplement NRSA supported research training programs.

1.B. Eligible Individuals

The Principal Investiqator/Program Director 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 Principal Investigator/Program Director must be actively engaged in mentoring, research and administration of research programs on the mental health and/or alcohol abuse of HIV/AIDS and must be capable of recruiting and retaining mentees from various underrepresented racial and ethnic groups, individuals with disability, and others who are interested in HIV/AIDS disparities research issues.

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

Responsiveness Criteria. The intent of this PA is to establish mentoring programs for under-represented racial and ethnic minorities or for non-minorities focused on HIV/AIDS disparities issues. These mentoring programs should be in the format of either an intensive institute or a network of established mentors and should address a thematic aspect of mental health HIV/AIDS research within an interdisciplinary or translational framework.

Applications that do not propose either a special institute or a network of mentors will not be reviewed.

Applications that do not propose a thematic approach to mental health HIV/AIDS research or an interdisciplinary/ translational framework will not be reviewed. Applications that do not have an evaluation and tracking plan will not be reviewed. Applications that do not have a section describing quantifiable milestones will not be reviewed.

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

Participant mentees: Doctoral and postdoctoral candidates and junior faculty level candidates from REM groups (i.e., African Americans, Hispanics, Native American/Alaska Natives, Asian/Pacific Islanders/Native Hawaiians and) who will conduct NIMH-AIDS or NIAAA-AIDS relevant research and/or non-minority individuals, at these same levels, whose research focuses on HIV/AIDS disparities issues.

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

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Allowable Costs

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the mentoring program proposed. 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 percent of time devoted to the program. All personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program may not exceed 25% of the total direct cost. If the application has personnel costs in excess of 25% of total direct costs, it will be deemed unresponsive and will not be reviewed. 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 are considered a regular part of an individual's academic duties, then mentoring and other interactions with students 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, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution.

Participant Costs: Because this is an educational and not a training mechanism, non-US citizens may participate in this program. However, requests for participation of non-US citizens under the auspices of this program announcement 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 or NIAAA mission, research education programs should be used primarily for the education of US 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-US citizens.

Participant Support Costs: Participants in the 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 an R25 program.

Because the R25 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 as an individual supported for 40 hours/week for a continuous 12-month period.

Evidence of institutional commitment to the 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, or at the actual F&A cost rate, whichever is less.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): August 14, 2006; August 17, 2007
Application Receipt Date(s): September 13, 2006; September 17, 2007
Peer Review Date(s): Nov/Dec 2006; Nov/Dec 2007
Council Review Date(s): January 2007; January 2008
Earliest Anticipated Start Date(s): April 1, 2007; 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 at the beginning of this document.

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: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIMH. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the PA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Applicants should follow the most current PHS 398 instructions. Additionally, applicants should include the additional items identified below.

Supplementary Application Instructions

1. Application face page: Item number 2 on this page must include the PA number and the title, Mentoring Programs to Diversify the Mental Health HIV/AIDS Research Workforce through Innovative Educational Initiatives (R25) .

2. Description, Performance Sites and Key Personnel (Form Page 2): Under Performance Sites include Consortium/ Contractual Arrangements, and a list of collaborating sites, if appropriate. If multiple sites are to be used, the applicant institution must be the primary site. A justification must be included if any other sites will be used. Key personnel must include the principal investigator, and may include essential faculty participating in the research education program, as well as any staff integral to the program.

3. Resources (Resources Format Page): Describe the research and mentoring environment, including a description of the facilities, research samples, participating departments, computer services, and any other resources to be used in the conduct of the proposed mentoring program, including related resources such as dormitories and food service. Describe how these facilities will be available for the program. Use continuation pages, if necessary.

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

5. Research Plan: Part D 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, 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 Program Director (and co-Program Director, if applicable) in mentoring, research and administration of the proposed research education programs; Provide evidence that the Program Director (and co-Program Director, if applicable) 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 or NIAAA staff, as appropriate, in didactic sessions on grants, grantsmanship, and grants review.

(c) Program Faculty/Mentors: Describe the characteristics and responsibilities of the faculty/mentors; provide evidence 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 P.I. biosketch in the application).

(d) Plan for Recruitment, Selection and Retention of Program Mentees: Provide details and a specific plan to recruit, select, and retain mentees from underrepresented racial and ethnic minority groups (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). The health disparity populations are the racial and ethnic minority groups in the NIH Health Disparities Strategic Plan, Fiscal Years 2004-2008, and delineated in Section 1707(g), Public Law 106-25. The racial and ethnic groups referred to includes Native Americans (including Alaska Natives, Eskimos and Aleuts); Asian Americans/Native Hawaiians and other Pacific Islanders; African Americans; and Hispanics. Describe an outreach plan to other institutions for the recruitment of racial and ethnic minority group members to the mentoring program. If appropriate, a plan must also be included for recruiting, selecting and retaining non-minority scientists who are focused on HIV/AIDS disparities issues. Peer reviewers will separately evaluate the recruitment, selection, and retention plan after the overall score has been determined. The review panel’s evaluation will be included in an administrative note in the summary statement. If the plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. NIMH staff, with guidance from the national advisory 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 of 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 encourage 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. If such training is not appropriate for the proposed research education program, then the principal investigator must provide a strong justification for its exclusion.

(f) 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 considered to be non-responsive. The inclusion of evaluation instruments in an appendix is encouraged.

(g) 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, presentation at scientific meetings, workshops, etc.

(h) 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 increase in the number of students admitted to research doctoral degree programs, acceptance to competitive postdoctoral positions or attaining faculty appointments, improvements in competitiveness for research scholarships, increased number of research publications, 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 submitted for this funding opportunity will be assigned to the NIMH and NIAAA on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/) will evaluate applications for scientific and technical merit.

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

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

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. The scientific review group will address and consider each of the following criteria 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 categories are not listed in any order of priority.

Scientific and Research Education Program: Innovativeness, Significance, Approach

Program Leadership and Principal Investigator

Program Faculty/Mentors

Program Infrastructure and Sponsoring Institution Commitment/Resources

Evaluation and Tracking Plan

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.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research education program. 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 for training in the responsible conduct of research 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 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.

Plan for Recruitment, Selection and Retention of Mentees:

The plan for recruitment, selection and retention of mentees 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 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.

2.C. Sharing Research Data

Not Applicable.

2.D. Sharing Research Resources

Not Applicable.

3. Anticipated Announcement and Award Dates

Anticipated award date for FY2006 is September, 2006; for FY2007 is July 1, 2007.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will be able to access his or her Review Results and Summary Statement (written critique) via the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

Termination of Award: When a grantee institution plans to terminate an award, 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.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PI. A change in any of these parameters requires prior approval by the responsible program officer. 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 Principal Investigator: If change of PI is necessary, support of the award is not automatic but may be continued with prior written approval by the awarding component, provided that the following conditions are met. The current PI or the grantee institution must submit a written request for the change, counter-signed by the appropriate institutional business official, to the responsible program officer describing the reasons for the change. The Biographical Sketch of the proposed 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 PI and that the new PI has the appropriate research and administrative expertise to lead the research education 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 notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (if the maximum three years are awarded) (http://grants.nih.gov/grants/funding/2590/2590.htm) 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, the number of applicants and participants (as well as their career level, gender, and racial/ethnic background), updates on the evaluation of the research education program and dissemination activities, and a list of any publications arising from the research education program. The annual progress report should also report on results/status of evaluation and tracking plan (see Section IV, 6f) and dissemination plan (see Section IV, 6g) as well as measurable results of milestones (see Section IV, 6h).

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH awarding component 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 at the end of the grant project period or upon relinquishment of an award. Note that an evaluation and tracking report is required as part of the Final Progress Report.

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: [email protected]

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: [email protected]

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

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

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: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) 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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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 new PHS Form 398; 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 (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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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