Part I Overview Information 


Department of Health and Human Services

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

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

Title:   National Institute of Mental Health (NIMH) Career Opportunities in Research (COR) Honors Undergraduate Research Training Grant (T34)

Announcement Type
This is a reissue of PAR-01-008, which was previously released October 31, 2000. 

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 the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. 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).

Program Announcement (PA) Number: PAR-08-093

Catalog of Federal Domestic Assistance Number:
93.282

Key Dates
Release Date:  February 8, 2008
Application Receipt or Submission Date(s): May 12 annually
Peer Review Date(s): October-November annually
Council Review Date(s): January annually
Earliest Anticipated Start Date: April 1 annually
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: (Now Expired December 24, 2009 per NOT-MH-10-008), Original: May 13, 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 Training 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. Resource Sharing Plan(s)
    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 Training Objectives

The objective of the National Institute of Mental Health Career Opportunities in Research (NIMH COR) Honors Undergraduate Research Training Grant (T34) program is to provide pre-baccalaureate research training opportunities for individuals from diverse backgrounds who are interested in pursuing mental health research careers and to prepare these individuals to pursue Ph.D. and M.D./Ph.D. degrees in research areas relevant to the mission of the NIMH.

Purpose and Background Information

The purpose of this pre-baccalaureate NRSA research training program is to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s mental health research agenda.  Diverse populations refer to: individuals from a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical, neuroscience, behavioral, or clinical research; individuals with disabilities; and individuals from disadvantaged backgrounds.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce.  The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

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

A.  Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27)  In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

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

C.  Individuals from disadvantaged backgrounds who are defined as:

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

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.  Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Research training activities can be in basic biomedical, neuroscience, behavioral, or clinical sciences, including health services research or any other discipline relevant to the NIMH mission.  Applicants should refer to NIMH-specific program areas of research interest and contact information as found in the NIMH Division web pages at: http://www.nimh.nih.gov/about/organization/nimh-extramural-research-programs.shtml

The NIMH COR research training programs are designed to permit the applicant institution to select trainees and develop a curriculum of study and research experiences necessary to provide high quality research training.  The program provides support for the trainees, who are appointed for the last two years of their undergraduate education, typically called the junior and senior years, to enable them to be fully engaged in the training experience.  The program also provides support to enable the institution to improve its educational and research outcomes by strengthening the mental health-related science curriculum.  The proposed research training program should provide NIMH COR students with unique research training experiences designed to improve their qualifications for entry into and completion of a graduate research training program that leads to a Ph.D. or M.D./Ph.D. in research relevant to the NIMH mission. 

Undergraduate curricula typically preparatory for graduate research training in relevant areas of study include, but are not limited to, biology, psychology, neurobiology, neuroscience, psychobiology, experimental psychology, cognitive science, social work, sociology, epidemiology, and genetics, as well as quantitative disciplines such as mathematics, physics, chemistry, engineering, statistics, and computer sciences.  More importantly, a strong foundation in scientific research methods, critical thinking, and writing are necessary to prepare students for the rigor of graduate research training.  Therefore, NIMH COR programs must offer curricula to introduce trainees to critical analysis and experimental design and statistical methodology used in basic and/or clinical mental health research.  To develop a research workforce capable of optimally pursuing rapidly expanding scientific advances, NIMH will place higher priority on training programs that provide trainees with both multidisciplinary and translational research experience. 

The program should be viewed as a four- or five-year institutional training activity even though financial support to individual trainees is limited to 24 months or the final two undergraduate years.  The grant offsets the cost of stipends and tuition support (which includes fees) for the appointed trainees in accordance with the approved NIH support levels (see Section II, “Allowable Costs”).

Program Directors are responsible for ongoing evaluation of the quality of the training program.  It is expected that plans will be developed to obtain feedback from former trainees to enhance the programmatic outcomes, achieve the goals, and suggest program improvements.  All applications must describe an evaluation plan for the proposed activities and a tracking plan for trainees in order to assess program activities/outcomes and to determine the effectiveness of all aspects of the proposed program.  Measures may include trainees’ completion of the NIMH COR program; entry into a mental health relevant doctoral-level research program; completion of a graduate degree; or obtaining a research position on a private or public grant.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the Undergraduate National Research Service Award (NRSA) Institutional Grant (T34) award mechanism.  Awards may be made for periods up to 5 years and are renewable.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed research training program.
 
This funding opportunity 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, following the Instructions for preparing an NRSA application.

2. Funds Available

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

Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines (http://odoerdb2-1.od.nih.gov/gmac/nihgps_2003/NIHGPS_Part10.htm#_Toc54600187). Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement (rev. 12/01/03), and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Allowable Costs:

A. Stipends: 

Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience and are based on a 12-month appointment period.  The stipend is not provided as a condition of employment with either the Federal Government or the grantee institution nor is it to be considered a payment for services performed.  Stipends will be based on the annual NIH stipend levels at the time of award.  The fiscal year (FY) 2007 annual stipend level for a pre-baccalaureate trainee (junior or senior) is $10,956 (or $913 per month). Stipends may be adjusted only at the time of appointment or reappointment and may not be changed in the middle of an appointment period.  For appointments of less than a full year, the stipend will be based on a monthly or daily pro-ration of the annual amount.  No departure from the established stipend schedule may be negotiated by the institution with the trainee.  The maximum period of support a trainee may receive from the grant is 2 years (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html  for specific information).

B. Tuition and Fees

The NIMH will offset the combined costs of tuition and fees at the rate in place at the time of the award.  For institutional training grants, an amount per trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided. Costs associated with this category are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support.  A full description of the NIH tuition policy can be found in the following link to the NIH Guide: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html

C. Trainee Travel

Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable expense.  Additionally, travel to a research training site away from the institution is expected and support may be requested.  NIMH COR programs may request per diem funds to help defray the cost of summer housing at an extramural research training site, as well as funds for travel to the extramural site.  An institution may request per diem costs equal to the time spent at the extramural site, as well as up to $500 for travel to and from the training site.  NIMH COR-supported institutions that are long distances from the training site, such as in Puerto Rico or Hawaii, may request up to $750 travel expense per trainee, if justified. 

All trainees are expected to attend the annual NIMH COR Colloquium; costs are estimated at $1200 per trainee for this meeting (5 days and 4 nights). College juniors are expected to participate in a summer research laboratory experience away from their home institution and seniors are expected to participate in a national scientific meeting.  If additional travel support is needed for a trainee, trainee related expense funds may be used and/or support may be competitively sought via other mechanisms.

D. Trainee Related Expenses (TRE)

The applicant institution may request the NIMH standard NRSA Training Related Expenses for each pre-baccalaureate (junior or senior) to help defray other research training expenses such as staff salaries, health insurance (self-only or family, as appropriate), consultant costs, equipment, research supplies, and faculty/staff  travel directly related to the research training program. Funds are provided as a lump sum on the basis of the predetermined amount per pre-baccalaureate trainee approved for support. 

Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request training related expenses above the standard level set by NIMH.  Requests for additional costs must be explained in detail and justified in the application.  Consultation with NIMH program staff in advance of such requests is advised.  A full description of the NIH policy can be found in the following link to the NIH Guide: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html

E. Facilities and Administrative Allowance

The facilities and administrative (F&A) allowance for the NIMH COR T34 mechanism is 8% of modified total direct costs, exclusive of tuition, fees, and equipment.

F. Stipend Supplementation, Compensation, and Other Income

A full description of the NIH policy regarding NRSA supplementation and compensation can be found in the NIH Grants Policy Statement at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm.

Educational Loans or G.I. Bill:  An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill).  Such funds are not considered supplementation or compensation. 

Acceptance of funds from a PELL grant is allowable as well.

Unallowable Costs

NRSA funds may not be used to provide stipends for non-trainees, including students who may be designated as pre-trainees, nor may funds be used to support more than the awarded number of trainees.  Salaries or other benefits in lieu of salaries for trainees or potential trainee participation are not permitted.  Recruitment activities are not allowable costs nor are costs for faculty to conduct research or to develop in research.  Faculty may not be paid on an overtime or overload basis.  Use of a consultant who is also a faculty member of the applicant institution is not permitted.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions
 
Eligible organizations include domestic, non-profit, private or public educational institutions that offer the baccalaureate degree in a subject related to mental health research and have a substantial enrollment of students of diversity.   Students of diversity include: 1) individuals from racial and ethnic groups shown by the NSF reports to be underrepresented in the scientific workforce (http://www.nsf.gov/statistics/wmpd/); 2) individuals with disabilities, which are defined as those with a physical or mental impairment that substantially limits one or more major life activities; and 3) individuals from disadvantaged backgrounds defined as individuals from a family with an annual income below established  low-income thresholds based on family size, and individuals from a social, cultural, or educational environment that inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.   For more details see Part II, Section I.1.

The applicant institution must have the requisite staff and facilities on site to conduct the proposed research training program.

Foreign institutions are not eligible to apply. 

1.B. Eligible Individuals

Program Director

Any full-time faculty member with the skills, knowledge, and resources necessary to carry out the proposed research training program is invited to work with their institution to develop an application for support.  Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

The Program Director should be an established biomedical, neuroscience, behavioral, or clinical science researcher with a successful research and training record and available resources to conduct the proposed research training program at the institution.  The Program Director will be responsible for overseeing the selection and appointment of eligible trainees to the NIMH COR Honors Undergraduate Research Training program grant, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner.

2. Cost Sharing or Matching

Cost sharing is not required.

3. Other-Special Eligibility Criteria

Training Program

Trainees appointed to the NIMH COR research training program must have the opportunity to carry out supervised biomedical, neuroscience, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge as well as their academic preparedness for enrollment in and completion of graduate Ph.D. or MD/Ph.D. programs leading to a future career in mental health research.  Trainees must be full-time students as specified by the sponsoring institution in accordance with its own policies.

Pre-baccalaureate Trainees

Students appointed to the NIMH COR research training program must be students matriculated full-time at the applicant institution in the sciences relevant to NIMH’s research mission.  Only U.S. citizens, non-citizen nationals or those who have been lawfully admitted to the US for permanent residence are eligible for these traineeships.  The primary objective of this program is to increase the number of competitively trained students of diversity who enroll in and complete Ph.D. programs. 

The NIMH COR is an undergraduate Honors Program.  Therefore, trainees must be students majoring in an appropriate discipline, who have attained the junior or senior year class standing in a program leading to a baccalaureate degree and must have at least a 3.00 grade point average (on a scale of 4.00) by the beginning date of their NRSA appointment.

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: 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 current PHS 398 research grant application instructions and forms (http://grants.nih.gov/grants/funding/phs398/phs398.pdf.)  Applicants must use the T34 instructions in this FOA and the specific instructions for Institutional NRSA Applications Preparing an NRSA Application, found in the PHS 398 (titled “Instructions for Preparing an NRSA Application) .  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 the face page of the PHS 398 form.

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

3. Submission Dates and Times

See Section IV.3.A for details.
 
3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Submission Date(s):  A letter of intent is not required for this funding opportunity. 
Application Submission Date(s): May 12 annually
Peer Review Date(s): October/November annually
Council Review Date(s): January annually
Earliest Anticipated Start Date(s): April 1, annually 

3.B. Sending an Application to the NIH
 
Applications must be prepared using the most recent version of the PHS 398 research grant application forms and the specific NRSA institutional grant application instructions of the PHS 398.  The Table of Contents must be submitted using the Kirschstein-NRSA Substitute Form Page.  A categorical budget for the initial budget period of Training Related Expenses must be submitted using the Kirschstein-NRSA Substitute Form Page, and the budget for the entire proposed period of support must be submitted using the Kirschstein-NRSA Substitute Form Page.  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 must be sent to:

Shuang-Bao Hu, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6156, MSC 9608
Bethesda, MD 20892-9608
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5160
FAX: (301) 480-3402
Email: shuangbaohu@mail.nih.gov

3.C. Application Processing
 
Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Program Director 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 not allowable charges for either stipends or tuition on institutional training grants since stipends and tuition costs may not be charged to the grant before the trainee appointment is actually made. However, the policies governing the pre-award cost authority for the expenditure of the other funds provided in a training grant are those permitted in the NIH Grants Policy Statement as follows:

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation 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 or competing continuation 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.

The National Research Service Award (NRSA) policies apply to this program.  Awards are contingent upon availability of funds.  Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations.

Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

Concurrent awards:  An NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts on the tax liability of all individuals supported under the NRSA program.  Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance.  Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study.  Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience.  NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice.  The interpretation and implementation of the tax laws is the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Service Payback:   No service payback is required for participation in the NIMH COR research training grant.

6. Other Submission Requirements

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the training program;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Special Requirements

Research Training Program: 

The research training program is expected to provide didactic training in addition to a mentored research experience.   A contemporary curriculum with a strong foundation in research methodology is necessary to prepare students for the rigor of graduate research experiences that are interdisciplinary, multidisciplinary and translational.  The proposed training program should provide at least eight (8) NIMH COR students with unique research training experiences designed to improve their qualifications for entry into and completion of a graduate program leading to Ph.D. or M.D./Ph.D. in a research area relevant to the NIMH mission and a mental health-related research career.

The undergraduate curriculum typically preparatory for graduate research training in relevant areas of mental health study include, but are not limited to, biology, psychology, and neuroscience as well as disciplines such as mathematics, physics, chemistry, statistics, and computer sciences.  NIMH COR programs must also offer coursework to introduce trainees to critical analysis, writing and oral presentation, and experimental design and statistical methodology used in the basic and/or clinical mental health research setting.  The curriculum should incorporate a broad range of courses that utilize the strengths of the institutional resources.  Mandatory course(s) are required in research design and statistical methodology and in the responsible conduct of research.  There should also be a seminar or colloquia series in current mental health research areas with visits by prominent mental health researchers and opportunities for trainee presentation.   

The mentored research experience, laboratory and/or clinical, will also be required and it is expected that trainees will study, conduct, and write about research in an area relevant to mental health research.  Such a research experience would include a summer research experience with an NIMH supported investigator or with an investigator in the NIMH intramural research program.  Other sites for the research experience may be considered based on the research topic and relevance to the NIMH research interests.

If proposed, a description of the membership and role of a Program Advisory Committee in helping to develop and/or manage the program should be included.

Institutional Setting and Characteristics:   This section should describe the nature and extent of the participation of students from diverse groups at the institution.  Institutional data must include:

Program Director:  The Program Director must possess the scientific background, leadership, and research training experience as well as the administrative skills to coordinate, supervise, and direct the proposed research training program.  The Program Director along with an advisory team of NIMH COR mentors and university administrators will be responsible for the selection and appointment of trainees to the approved research training program, for the development and implementation of any proposed curricular changes, as well as the institutional activities to be used to strengthen the pool of potential trainees.  In addition, the Program Director will be responsible for the overall direction, management, administration, and evaluation of the program.  Program Directors must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner.

Past Training Record:  This section should describe the last five-year research training record of the applicant institution in sending its baccalaureates on to Ph.D. and/or MD/Ph.D. programs in the biomedical neuroscience, behavioral, and/or clinical science research areas related to mental health.  A renewal application will also describe the past research training record of the NIMH COR program in developing the educational outcomes of potential trainees and trainees.  That is, the report must describe the success of former trainees in seeking further career development in mental health related sciences.  It must specifically identify graduate programs, dates of entry and dates of completion.  For former trainees currently in graduate programs, contact information must be provided.   An example of how the information can be organized so it is easily interpreted by reviewers can be found in the following sample table.

Sample Table:                             

NIMH COR PROGRAM  CUMULATIVE  REPORT

Outcomes

   

Progress Report

Current

Non-Competing  Continuation

Reporting Period

YR1

YR2

YR3

YR4

YR5

2008-2009

Number of trainees slots awarded:

           

Number of trainees appointed:  Junior

           

Number of trainees appointed:  Senior

           

Number of trainees graduating with BS or BA:

           

Number of trainees enrolled in Ph.D programs:

           

Number of trainees enrolled in MD/Ph.D programs:

           

Number of trainees enrolled in MD programs:

           

Number of trainees enrolled in MS programs:

           

Number of trainees in post-bacc programs:

           

Number of trainees in other professional degree programs:

           

Number of trainees in teaching positions:

           

Number of publications by NIMH COR trainees:

           

For example, YR1 could be 2008, and YR2 could be 2009, etc.  Whether or not an institution chooses to use this table is the choice of the Program Director, but the information requested must be provided with the application.     

Trainee Appointments: Appointments are made in 12 month increments with an anticipated total appointment of 24 consecutive months.  No trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval from NIMH.  Appointments are normally made for the last two years of undergraduate education, commonly called the junior and senior years.  Trainees should not be appointed unless they plan to complete two years of training.  No individual trainee may receive more than two years of aggregate NRSA support at the pre-baccalaureate level.  All trainees are required to pursue their research training on a full-time basis, including required coursework and workshops, as specified by the applicant institution in accordance with its own policies.  Trainees are expected to spend at least one summer engaged in a research internship at an appropriate site (e.g. in the laboratory of an NIMH- funded investigator, with an NIMH intramural investigator, or with an investigator who is conducting relevant NIMH research).  

Research Environment/Resources:  The applicant institution must have on-site, or through a formal partnership with another university, a strong and high-quality research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program.  This section should include: 1) a description of the research infrastructure (i.e. facilities, laboratories, participating departments, computer services and other resources to be used in the program); 2) if applicable, a description of other NIH-supported programs at the institution that have similar objectives related to diversity in biomedical, neuroscience, clinical, or behavioral science research training and how the NIMH COR program will interact with, complement, enhance, or extend the scope of the other NIH-supported training;  and 3) if applicable, a description of plans for collaborating with other institutions and laboratories for the purposes of exchange, consolidation, and sharing of resources including faculty, equipment and facilities (letters of agreement should be included with the application).

Institutional Commitment:  The applicant institution should include information that documents a commitment to the proposed research training program’s goals, and provide assurance that the institution intends the program to be an integral part of its research and research training endeavor.  The application should include a description of support (financial or otherwise) to be provided to the program, which could include support for curriculum implementation, support for additional trainees in the program, space, shared laboratory facilities and equipment, release time for the Program Director and participating faculty, or any other creative ways to improve and enhance the growth of the research training program.  While cost sharing is not required, the applicant institution should show that funds for program activities, including financial support for trainees, are not merely being substituted for institutional resources.     

Evaluation and Tracking Component:  The application must describe a strong evaluation and tracking component that will review and determine the effectiveness of all aspects of the program.  This should include a system for tracking trainees for a 15-year period following their completion of the program to determine success or failure of the program in launching competitive research careers in mental health. The follow-up tracking would include information on the career trajectory of trainees who were supported by the program.  The application must provide a prospective evaluation plan for process and outcome measures.  Outcome measures are expected to be described (for all supported activities) relative to baseline data.  The evaluation and tracking report must be included annually as part of the Progress Report.  Competing renewal applications must describe the program accomplishments to date, following the application instructions In Section IV of the PHS 398 application (4/2006 rev.)  and include the evaluation and outcome measures report described in Section IV.6 (past training record) of this announcement.    

Recruitment Plan:  Applicants must submit a recruitment plan for recruiting trainees from both outside and inside their sponsoring institutions.  The application should describe the recruitment and outreach plan to support the diversity of the applicant pool, leading to the required diversity of enrolled students.

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

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

As this aim of this program is to train students of diversity, see the review criteria section for evaluation of the plans to recruit, select and retain such trainees and for renewal applications, the record of recruitment, selection, and retention of trainees. 

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

Training in the Responsible Conduct of Research:  Every NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research.  For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 23, Number 23, June 17, 1994: http://grants1.nih.gov/grants/guide/notice-files/not94-200.html ).  Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research.  Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.  

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

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

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

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)

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 NIMH.

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

As part of the initial merit review, all applications:

The following will be considered in making funding decisions:

The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application.  Reviewers will first determine the quality of the proposed research training program and then consider whether the requested number of trainee positions is appropriate for the program.

The NIMH COR research training applications are evaluated using the following criteria:

Training Program:  Are the objectives, design and direction of the proposed research training program appropriate?  Does the proposed program provide an appropriate foundation (didactics, programmatic activities, and research experience) for subsequent graduate training in a research area relevant to the NIMH mission?  Does the training program incorporate inter- and multi-disciplinary and state-of-the-art research training opportunities?  Are innovative approaches to research training utilized?

Training Program Director:  Does the Program Director have the scientific research background, training expertise, and administrative experience necessary to lead the proposed research training program?  Does the Program Director plan to commit adequate time to the program?

Preceptors/Mentors: Is there appropriate expertise available in the scientific community at the institution?  What is the caliber of the preceptors as researchers, including the overall quality of their research, their publication record and their successful competition for research support in areas directly related to the proposed training program?  What is the record of preceptors as mentors, especially as mentors of undergraduate students?

Training Record:  This criterion evaluates the past research training record of both the program (if a competing renewal) and the designated preceptors.  What is the success of former trainees in seeking further career development and establishing productive NIMH-related scientific careers?  Evidence of further career development can include matriculation into a Ph.D. or M.D.-Ph.D. program, successful completion of the Ph.D or M.D.-Ph.D., receipt of fellowships or career awards, additional training appointments and similar accomplishments.  Evidence  of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received.  What is the track record of the preceptors in directing undergraduate training or the potential of those preceptors lacking a track record?

Institutional Training Environment, Commitment, and Resources:  Is the quality of the research environment appropriate for the proposed research training program?  Is the level of institutional commitment appropriate?  Is the quality of available facilities, and resources for education and research  suitable? 

Trainee Recruitment, Selection, and Retention Plan:  Are the quality and size of the applicant pool appropriate?  Are the plans and procedures for the recruitment, selection, and retention of diverse individuals appointed to the training program well defined and appropriate? 

For competing renewal applications:  Have these plans been maintained/modified to address past successes or concerns with recruiting, selection, and retention?

Evaluation and Tracking Plan:  Is the evaluation plan adequate and sufficiently detailed to track career outcomes of trainees and determine if the program is successful in launching research careers in mental health? Does it include a system for tracking participants following program completion, such as publications, grant applications and awards, and career trajectory of supported trainees?

2.A. Additional Review Criteria:

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 will be assessed in relation to the proposed research training program and the number of proposed trainees. 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 plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel’s evaluation of the plan will not be a factor in the determination of the priority score.  Plans will be judged as acceptable or unacceptable, and the result 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.  The relevant NIMH staff will judge the acceptability of the revised plan.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 Program Director will be able to access the written critique called a Summary Statement via the eRA Commons.

If the application is under consideration for funding, NIMH 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).

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.

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.
 
2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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).

Special Administrative Requirements associated with NRSA programs:

Leave Policies:  In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday.  Trainees may receive stipends for up to 15 calendar days of sick leave per year.  Sick leave may be used for the medical conditions related to pregnancy and childbirth.  Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director.  A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence.  Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm for further guidance regarding vacations and requested leave. 

Part-time Training:  While NRSA trainees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under unusual and pressing personal circumstances, a Program Director may submit a written request to the awarding component to change a trainee appointment to less than full-time.  Such requests will be considered on a case-by-case basis and must be approved by the awarding Institute in advance for each budget period.  The nature of the circumstances requiring part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee’s position at the institution.  In each case, the Program Director must submit a written request countersigned by the trainee and an appropriate institutional business official that includes documentation supporting the need for part-time training.  The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the trainee intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the research training program.  In no case will it be permissible for the trainee to be engaged in NRSA supported research training for less than 50% effort.  Individuals who must reduce their commitment to less than 50% effort must take a leave-of-absence from NRSA training grant support.  The stipend will be pro-rated in the grant award during the period of any approved part-time training. 

Carryover of Unobligated Balances: NIMH requires prior written approval to consider carryover of funds from one budget period to the next.  Such requests must include compelling justification including the status of trainee appointments to the program.  If not stated on the Notice of Award, the Program Director should contact the NIMH Grants Management contact to determine the funding carryover policy.

Termination of Award:  When a grantee institution plans to terminate an award, the NIMH component must be notified in writing as soon as possible

Change of Institution: Awards are made to a specific institution for a specific research training program and the training program may not be transferred from one institution to another.  Trainees seeking to change institutions must terminate their current appointment using the Termination Notice (form PHS 416-7, Rev. 10/05), located at http://grants.nih.gov/grants/forms.htm#training.

Change of Training Program Director: If change of a Training Program Director (TPD) is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met.  The current TPD or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to program and grants management staff at the NIH funding component describing the reasons for the change.  The Biographical Sketch of the proposed TPD, 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 program will remain unchanged under the direction of the new TPD and that the new TPD has the appropriate research training and administrative expertise to lead the training program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Change of Program:   A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  Any change requires prior approval by program staff of the NIMH. If the new program does not satisfy this requirement, the award will be terminated.  

Service Payback Provisions:  Not applicable

3. Reporting  

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and annual financial statements as required in the NIH Grants Policy Statement.  The NRSA program is not subject to SNAP.

The NRSA instructions for the non-competing grant progress report (Form PHS 2590) should be followed. Note that a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program.  Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions.

An evaluation and tracking report as described in Section IV.6. of this announcement should be included annually as part of the Progress Report. 

Additional information that should be included in the annual progress report in concert with the PHS 2590 instructions:

Additional Reporting Requirements: 

Financial Status Report (FSR):  An annual FSR is required and must be submitted within 90 days of the end of each budget period.  Continuation support will not be provided until the required form is submitted and accepted.

Trainee Reporting Requirements:  Recipients of Kirschstein-NRSA support are responsible for informing the NIH of changes in status or address.  The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant.  This form must be completed at the beginning of the initial appointment and annually thereafter.  No funds may be provided until such documents are submitted and accepted by the funding Institute.

Evaluation:  In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program.  Accordingly, trainees are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

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 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:

Mark Chavez, Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7101, MSC 9632
Bethesda, MD 20892-9632
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8942
Email: mchavez1@mail.nih.gov

2.  Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9609
Bethesda, MD  20892-9609
Telephone:  (301) 443-3534
FAX:  (301) 443-4720
Email:  armstrda@mail.nih.gov

3. Financial or Grants Management Contacts:

Joy Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Email: knipplej@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 institutional review board (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.

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

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

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

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.

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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.  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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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