Part I Overview Information


Department of Health and Human Services

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

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

Title:  Seeding National Mentoring Networks to Enhance Diversity of the Mental Health Research Workforce (U24)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-MH-10-050

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: November 13, 2009
Letters of Intent Receipt Date(s): December 30, 2009; August 30, 2010
Application Receipt Date(s): January 29, 2010; September 29, 2010
Peer Review Date(s): April/May 2010, February/March 2011
Council Review Date(s): August 2010, May 2011
Earliest Anticipated Start Date: September 2010, July 2011
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: September 30, 2010

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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Dispute Resolution
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

Purpose

This FOA, issued by the National Institute of Mental Health, solicits Resource-Related Research Project Cooperative Agreement (U24) applications from institutions/organizations that propose to conceptualize, plan and pilot an innovative prototype of a national infrastructure for mentoring individuals from diverse groups who are conducting research relevant to the mission of the NIMH.  It is expected that the resulting infrastructure will be capable of sustaining an effective and vibrant national mentoring network.  Each mentoring network will be expected to have a focused scientific theme that is highly germane to the mission and strategic priorities of the NIMH including the Center for Mental Health Research on AIDS.  The NIMH expects that each mentoring network will recruit outstanding researchers as mentors for individuals (protégés) at various career stages beginning no earlier in the career path than the post-baccalaureate level.  These networks are envisioned to enhance the professional development of the participating individuals, sustain their career trajectory through research independence, and lead to scientific advances that will help transform the understanding and treatment of mental illness and HIV/AIDS.

Background

Workforce Diversity.  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:

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals from groups currently underrepresented in the biomedical, clinical, behavioral, and social sciences at a national level.

For the purposes of this funding announcement, individuals from diverse backgrounds include:

A.  Individuals from underrepresented 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);

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

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.

Recent data highlight challenges to increasing the diversity of the biomedical research workforce.  For example, in 1986, 3.7% of the U.S. citizen recipients of life sciences doctorates self-identified as American Indian, Black or Hispanic; in 2006, 9.3% self-identified as American Indian, Black or Hispanic (see Table 8, 2006 Survey of Earned Doctorates at http://www.norc.org/SED.htm).  In all science fields, only 1.2% of doctorate recipients in 2006 self-identified as disabled (Table F-15, National Science Foundation, Women, Minorities, and Persons with Disabilities in Science and Engineering: 2009, NSF 09-305 at http://www.nsf.gov/statistics/wmpd/).

The NIMH has a long-standing commitment to increasing the diversity of its research workforce. This commitment is exemplified by the research training and career development programs supported by the Institute and by the reports and associated recommendations issued by two workgroups of the National Advisory Mental Health Council (NAMHC) (National Advisory Mental Health Council Workgroup on Racial/Ethnic Diversity in Research Training and Health Disparities Research. An Investment in America’s Future: Racial/Ethnic Diversity in Mental Health Research Careers. Washington, DC, 2001.  National Advisory Mental Health Council Workgroup on Research Training. Investing in the Future. Washington, DC 2008; available at http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/index.shtml).

The NIMH research workforce is increasingly multidisciplinary and thus it can be reasonably expected to draw from those receiving training in a variety of scientific disciplines. Exemplars of these disciplines are those U.S. citizens receiving doctorates in neuroscience, human and animal genetics, clinical psychology and social work.  In 2006, the percentage of U.S. citizens receiving doctorates in these four disciplines who identified as American Indian and Alaska Native, Black, Hispanic, Native Hawaiian or Other Pacific Islander, or of multiple races was 11.7% in human and animal genetics, 14.9% in neuroscience, 17.9% in clinical psychology, and 27.8% in social work  (see Appendix Table A-2 (revised June 2008), 2006 Survey of Earned Doctorates at http://www.norc.org/SED.htm).  These data provide some baseline information for future efforts to enhance the diversity of the NIMH research workforce.

Mentoring: An Important Component of a Scientist’s Development.  While there is no universally accepted definition of scientific mentoring, it is widely recognized as an important element for career development, and the absence of effective mentoring is often cited as a critical barrier to career success (e.g., Shavers et al. J Natl Med Assoc 2005 97(8) 1063-1077; Eby et al. J Vocat Behav 2008 72(2) 254-267). In 2008, the NAMHC Workgroup on Research Training recommended that the NIMH develop a program for well-qualified individuals from diverse backgrounds so that they may receive appropriate mentoring.  This program is expected to help increase the number of individuals in the training pipeline and retain them in the research workforce.  In the long term, this program will help ensure that a diverse research workforce is available and equipped with the skills, tools, and interdisciplinary perspectives needed to solve the pressing research agenda of the Institute.  Moreover, the scope of such programs is expected to be relatively broad because a diverse set of skills is needed to achieve career success.  As a result, mentoring programs are expected to propose a set of goals rather than a single goal, e.g., to develop a national mentoring network for grantsmanship and successful competition for an NIMH R01 award.

Access to a national network of skilled mentors who are outstanding researchers is envisioned to assist protégés in various ways with their specific goals depending upon the career stage of each protégé.  For example, a national mentoring network could provide an additional perspective on a research stumbling block or on effectively balancing professional and personal demands. A national mentoring network could facilitate leadership development, learning to mentor others, and successful transitions from one career stage to another, e.g. from graduate school to postdoctoral training or from postdoctoral training to a tenure-track faculty position.  Finally, a national mentoring network could help protégés identify potential collaborators and could facilitate establishing interdisciplinary or translational collaborations.  However, it is expected that an over-arching goal of any mentoring network is to facilitate the professional success of protégés as independent researchers and members of the research community.

Just as there is no universally accepted definition of scientific mentoring, there is no single model for successful mentoring.  Therefore, applicants should propose a program of content, resources and interactive opportunities in a specific scientific content area as the framework for the proposed mentoring network. The rationale for the mentoring model and the scientific content area chosen, as well as the relationship of the scientific content area to the mission and Strategic Plan of the NIMH (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) or the NIH AIDS Strategic Plan (http://www.oar.nih.gov/strategicplan/fy2010/index.asp) should be described in the application. The chosen content area should be of sufficient breadth to provide reasonable assurance of the ability to recruit a sufficient and high-quality pool of potential protégés annually and to ensure a critical mass of mentors and protégés who participate in the mentoring network.

It is expected that an innovative combination of didactic interactions, one-on-one, and small group discussions are likely components of any proposed mentoring network. Both formal and informal interactions between mentors and protégés are expected.  Applicants are encouraged to take advantage of contemporary communication strategies, e.g. social networking, as appropriate for the goals of their network. Applicants are also encouraged to describe a framework for, and the components of, their proposed mentoring network that are well-reasoned, appropriately grounded in experience and pedagogical theory, and can be justified based on the long-term goals for the proposed mentoring network. A rationale for the proposed structure and content should be provided in the application.

While mentoring is undoubtedly beneficial for interested individuals as early as high school and college, this funding opportunity is limited to applications proposing to develop and pilot mentoring networks for individuals (protégés) no earlier than the post-baccalaureate stage of the research pipeline and no later than tenure-track (or equivalent) academic faculty position.  Mentoring networks may propose to include only individuals from a single career stage or may propose to bridge several career stages from post baccalaureate through the transition to research independence and a tenured, or equivalent, academic faculty position.  For example, a network may propose to mentor postdoctoral scholars and assistant professors.  Regardless, applicants should provide a rationale for the proposed career stage(s) of the protégés who will participate in the mentoring network.

It is expected that applicants will propose innovative strategies to recruit a pool of potential protégés to participate in the mentoring network.  One source of potential protégés is individuals supported on NIMH-funded institutional and individual research training and mentored career development award programs.  These programs support individuals from diverse backgrounds, and the NIMH encourages applicants to take this pool of eligible and potential protégés into consideration when developing an application in response to this RFA. However, this is not the only potential pool of protégés, and it is expected that applicants will propose strategies to recruit individuals who are not already in the NIMH funding pipeline.

An applicant organization may wish to partner with other organizations to begin to develop a national mentoring network.  As noted in the recommendations of the NAMHC Workgroup on Research Training (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/investing-in-the-future.pdf), national scientific professional organizations may be effective partners in efforts to establish national mentoring networks.

Responsive applications will be distinguished by an innovative plan to accomplish the following, minimal objectives during the two-year, U24 project period:

It is expected that the prototype network will be planned in year 1 and piloted in year 2 of the project period.

This FOA is intended to encourage the development of new national mentoring networks in research areas central to the mission and strategic priorities of the NIMH including HIV/AIDS. As a result, it is not an appropriate vehicle for support of existing national mentoring networks; applications to support existing national mentoring networks will be deemed non-responsive and will not be  reviewed.

This funding opportunity is intended to seed mentoring networks across the scientific spectrum of the NIMH research mission including HIV/AIDS.  In order to provide sustained, competitive funding for national mentoring networks the NIMH expects to issue a subsequent funding opportunity announcement to provide an opportunity to compete for continued support of mentoring networks for individuals from diverse backgrounds to achieve a long-term vision of an integrated collective of mentoring networks.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the Resource-Related Research Projects-Cooperative Agreements (U24) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts.  It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The estimated amount of funds available for support of 10-12 projects awarded as a result of this announcement is $3.8 million. Direct costs are limited to $300,000 over a two-year project period with no more than $225,000 in direct costs allowed in any one year.  Future year amounts will depend on annual appropriations.

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.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

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

The PD/PI must be actively engaged in research that is relevant to the mission of the NIMH and must have a successful track record mentoring protégés.  Given the skills, knowledge, and resources necessary to conceptualize and pilot a mentoring network, multiple PDs/PIs (see below) may be appropriate. If multiple PDs/PIs are designated on the application, then a minimum of one of these individuals must be actively engaged in research relevant to the mission of the NIMH.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, 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 grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering 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 PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the 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

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions.  Applicants may submit a resubmission application in response to the second receipt date of this FOA, but such an application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016.

Renewals.  Renewal applications are not permitted in response to this FOA.

Responsiveness Criteria.  Applications must follow the supplementary instructions provided in Section IV.6.  Applications must have a section describing quantifiable milestones.

Protégés.  This funding opportunity is limited to applications proposing to develop and pilot mentoring networks for individuals no earlier in the pipeline than the post-baccalaureate stage; applications proposing mentoring networks that include individuals earlier than this career stage will be considered non-responsive and will be not be reviewed.  Applications must include an inclusive plan to recruit and retain, as protégés, individuals from all diverse backgrounds as defined in Section I. of this funding opportunity.  An application that proposes a plan to recruit and retain individuals from a subset of diverse backgrounds will be considered incomplete and will be not be reviewed.

Sponsoring Institution/Organization. The sponsoring institution/organization must provide evidence of commitment to and support of the proposed program, e.g., by providing resources such as facilities, staff and faculty time, and computer services necessary for the development of the proposed program.

Section IV. Application and Submission Information


1. Address to Request Application Information

The most current 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: GrantsInfo@nih.gov.

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

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

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

If budget allocation is planned, the distribution of resources to specific components of the 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.

Additional information is available in the PHS 398 grant application instructions.

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): December 30, 2009, August 30, 2010
Application Receipt Date(s): January 29, 2010; September 29, 2010
Peer Review Date(s): April-May 2010, February-March 2011
Council Review Date(s): August 2010, May 2011
Earliest Anticipated Start Date(s) September 2010, July 2011

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:

Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7197, MSC 9645
Bethesda, MD 20892-9645
Telephone: (301) 443-3107
FAX: (301) 443-4186
Email: ndesmond@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms 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 Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6147, MSC 9609  
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 443-3367
Email: jnoronha@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

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, the NIH will accept a resubmission application, but such application must include an introduction addressing the critique from the previous review.

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 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: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new 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

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A “Award Administration Information.”

Research Plan Component Sections

The Research Strategy section of the U24 application may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.

Supplementary Application Instructions

Applicants should use the following guidance in addition to the instructions accompanying the PHS 398 form. Applications that do not conform to these specific instructions will be returned.

Biographical Sketch. Include any mentoring awards and honors in the Biographical Sketch.  For all Key Personnel, provide the following information on each individual’s mentoring track record:  the names of the mentoring networks (and inclusive dates of participation) in which the individual has participated and/or currently participates and his/her role; the total number of individuals at the predoctoral, postdoctoral, and early career level mentored to date; and the details on the most recent 10 protégés (protégé’s name, degree(s), career stage and inclusive dates when the protégé was mentored, and the protégé’s current position and institutional affiliation.

Specific Aims.  (1 page) In addition to the instructions accompanying the PHS398 form describe the overall goals and specific measurable objectives that the applicant institution intends to accomplish through the proposed program.

Research Strategy (12 pages)

Significance.  In addition to the instructions accompanying the PHS 398 form, explain how the proposed project will lead to an infrastructure that has the potential to sustain an effective and vibrant national mentoring network for protégés from diverse backgrounds within a scientific area that is germane to the mission of the NIMH including the Center for Mental Health Research on AIDS (if appropriate) and the Institute’s strategic priorities. 

Innovation. In addition to the instructions accompanying the PHS 398 form, describe how the network will utilize novel communication formats to enhance and encourage interactions among participants.

Approach.  In addition to other unique elements appropriate for any particular application, include the following specific components.

1. Objective and rationale for the proposed mentoring network. Provide a conceptual overview of the proposed network including the rationale for and educational principles underlying its design and content. Describe the vision for the proposed mentoring network and how it will leverage existing resources and programs. Describe plans for how the proposed network will partner with and complement other efforts, including NIMH-supported institutional and individual training and career development programs. Provide programmatic detail on the structure of the network including its format(s), planned content areas, and tools (as applicable) as well as the rationale for the proposed components. Describe the criteria and process by which mentors and protégés will be matched and how mentor-protégé relationships will be monitored and assessed.

2. Administrative structure including PDs/PIs and advisory committee (if applicable). Describe the PDs/PIs’ commitment to developing and implementing the proposed network. Provide evidence that the PDs/PIs and their team (if applicable) are actively engaged in research and mentoring in research areas relevant to the mission of the NIMH and that they have the requisite skills to organize and coordinate and administer a mentoring network that is based on sound educational principles.

3. Mentors.  Describe the anticipated number of mentors who will participate in the mentoring network and their desired qualifications. Do not name specific individuals but rather provide descriptive detail. Describe the planned recruitment process for mentors as well as eligibility, selection, evaluation, and removal criteria. Describe the responsibilities of mentors.

4. Protégés. Describe the pool from which protégés will be selected (including its anticipated size and qualifications) and criteria for protégé eligibility and selection. Describe planned methods for reviewing the progress of protégés and for identifying and addressing any problems.  Describe strategies that will be used to advertise the mentoring network to this pool, recruitment strategies, and retention strategies.

5. Timeline. Provide a timeline for development and pilot implementation including anticipated, concrete milestones. Outline an evaluation plan to assess the signigicance and feasibility of full implementation of the montoring network

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

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

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

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

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

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

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

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Mental Health and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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

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

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

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  To what extent will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the strategic priorities of the NIMH? To what extent does the planned mentoring network show potential to help increase the diversity of the NIMH research workforce?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the PI’s time commitment sufficient to achieve the goals? Have collaborations been established or consultants identified to provide the appropriate depth and breadth of expertise required for the project? Does the leadership team collectively have appropriate scientific, administrative and mentoring expertise/track record to develop and pilot the proposed national mentoring network?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application propose an innovative approach to mentoring individuals from diverse backgrounds on a national basis?  Does the overall strategy take advantage of contemporary communication methods and other innovative tools? Does the program duplicate, or overlap with, existing mentoring activities currently supported at the applicant institution or available elsewhere? Adaptations of existing mentoring network programs may be considered innovative under special circumstances, e.g. the addition of unique components.

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the overall strategy based on sound pedagogical principles, appropriate consideration of the career stage(s) of the protégés, and appropriate consideration of the challenges inherent in creating a distributed infrastructure whether it be physical and/or virtual?  Is the scientific theme for the mentoring network well-defined, well justified and likely to contribute to the development of a successful mentoring network?

Mentors.  Are plans in place that suggest the feasibility of recruiting sufficient numbers of experienced mentors with appropriate research and mentoring expertise to support the number and career level of the protégés proposed in the application? Are the criteria for mentors, including eligibility, recruitment, retention, and expectations for their participation sufficiently detailed, appropriate and rigorous to support the proposed mentoring program?

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

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

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Partnerships and Collaborations. Are there adequate plans for ensuring effective communication and coordination among the PDs/PIs, NIH project scientists, and other members of the leadership team?  Do the investigators state their willingness to collaborate extensively and share information fully? Are the nature and extent of the partnerships explained? Is there appropriate evidence of commitment by the key partners to the planning and pilot implementation of the proposed mentoring network? Where partnerships are proposed, are there plans to monitor their effectiveness? Will duplication be avoided?

Additional Review Criteria

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

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

Additional Review Considerations

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

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

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

The following will be considered in making funding decisions:

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 eRA Commons.

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of 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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility to define objectives and approaches and to plan and conduct the proposed research. She/he will assume responsibility and accountability to the applicant organization and to the NIMH for performance and proper conduct of all supported research, including the NIH intramural component, if applicable, in accordance with the Terms and Conditions of Award. The Principal Investigator will be a member of the leadership team.

Intramural research scientists participating as part of the leadership team have the same rights and responsibilities as others with that role.  

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIMH support including the assigned cooperative agreement award number. 

2. A.2. NIH Responsibilities

An NIH Project Scientist  will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The Project Scientist interacts scientifically with the leadership team and may provide appropriate assistance, including assisting in research planning, suggesting possible content and tools within the scope of the program’s objectives and activities, presenting experimental findings from published sources, participating in the design of the mentoring network, participating in recruitment and evaluation activities, participating in the analysis of results, and advising in management and technical performance.  The Project Scientist will be a member of the leadership team.  In all cases, the role of NIMH will be to assist and facilitate and not to direct activities. 

The NIMH Project Scientist can recommend that information concerning NIMH-funded training and career development programs be made available to the leadership team.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

A leadership team composed of the PD(s)/PI(s), NIH Project Scientist(s), and NIH Program Official will be established in each program to assist in monitoring and developing the content and direction of the program.  The leadership team members will meet periodically to review progress, establish priorities, and plan and design activities.  The frequency of meetings, not fewer than two per year, will be determined by the PD/PI who will be responsible for scheduling and for preparing concise minutes which will be delivered to the leadership team members within 30 days of the meeting. Virtual meetings are appropriate.

The principal end-products are expected to include: 1) an effective administrative structure for a national mentoring network; 2) effective strategies for recruiting qualified mentors and protégés to the network and for their retention as members of the network; and 3) development of appropriate content and tools, as applicable.

2.A.4. Dispute Resolution  

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report is expected to describe the development and efforts to pilot the proposed mentoring network, modifications from the originally proposed conceptualization, details about the applicant pool and mentor pool for the pilot phase planned for year 2, and the success of efforts to meet the targeted milestones during year 1 of the award.  

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or 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:

Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7197, MSC 9645
Bethesda, MD 20892-9645
Telephone: (301) 443-3107
Email: ndesmond@nih.gov

For AIDS-related applications only:

David M. Stoff, Ph.D.
Division of AIDS and Health and Behavioral Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-4625
Email: dstoff@mail.nih.gov

2. Peer Review Contact(s):

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
Email: armstrda@mail.nih.gov

3. Financial/Grants Management Contact(s):

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6120, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
Email: siscor@mail.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 (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.

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

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 public 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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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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