Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Howard Hughes Medical Institute (HHMI) (http://www.hhmi.org

Components of Participating Organizations
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)

Title: NIBIB Interfaces Initiative for Interdisciplinary Graduate Research Training (T32)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-EB-08-003

Catalog of Federal Domestic Assistance Number(s)
93.286

Key Dates
Release Date:  March 19, 2008
Letters of Intent Receipt Date: May 19, 2008.
Application Receipt Date: June 17, 2008
Peer Review Date: October-November 2008 
Council Review Date: January 2009  
Earliest Anticipated Start Date: April 1, 2009
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: June 18, 2008

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, 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 and Information

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

Purpose

The importance of interdisciplinary research for the advancement of biomedical science is widely recognized in the scientific community. It has become increasingly clear that approaches to science are becoming more integrative and that scientific advances are being made at the interfaces of traditional disciplines. This requires a cooperative effort among a new workforce, typically in the form of investigators from diverse research backgrounds working collectively across traditional disciplinary boundaries to answer complex scientific questions. In the past, this need has been addressed by forming multi-disciplinary teams that bring experts from diverse disciplines to address collectively a common complex problem from multiple perspectives. More recently, a different approach, where two or more disciplines have been melded to create a new interdisciplinary science, has been used to tackle these more complex problems. Interdisciplinary research, like multi-disciplinary research, brings together different disciplines to address a particular issue. Unlike multi-disciplinary research, interdisciplinary research integrates and combines the contributing disciplines in new ways that produce a new conceptual framework.  Bioengineering, bioinformatics, biophysics, neuroscience, and regenerative medicine are some examples of existing interdisciplinary sciences. Integrating different disciplines in this way holds the promise of opening up unimagined scientific avenues of inquiry, and in the process, may form whole new disciplines. Importantly, interdisciplinary research does not merely result in new technical approaches, but new intellectual approaches; that is, new ways to conceptualize and think about a research problem. In order to increase the number of interdisciplinary researchers capable of working at the intersection of the biomedical sciences, physical sciences, and engineering, interdisciplinary approaches need to be applied to research training as well.

Background

In 2005, the Howard Hughes Medical Institute (HHMI) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) launched a new partnership to develop and sustain interdisciplinary research training programs. The primary goal of this initiative was to take advantage of the strengths of the two organizations to facilitate the development of new training opportunities in emerging interdisciplinary research environments.

Phase I of this partnership, issued in January, 2005 and described in an earlier HHMI program announcement (see http://www.hhmi.org/grants/pdf/comp_annc/2005_nibib_program.pdf), used HHMI funds to create new interdisciplinary research training programs to integrate the biomedical sciences, physical sciences, and engineering. The objective of Phase I was to assist institutions to achieve specific core program goals in the following areas:

1) Program Leadership,

2) Curriculum and Educational Resources,

3) Faculty,

4) Graduate Students,

5) Program Administration, and

6) Program Assessment.

This previous initiative was intended to encourage interdisciplinary research training by removing institutional barriers among the biomedical sciences, physical sciences, and engineering; developing interdisciplinary coursework, laboratory research, and community-building activities; and disseminating program practices that support interdisciplinary training at domestic institutions of higher education. Phase II of the partnership, to be funded by this RFA, is intended to continue these constructive developments and to provide support to sustain recently established interdisciplinary training programs through their critical early years.

Program Objective

The goals of NIH-supported research training programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs. The goal of this funding opportunity is to foster the development of recently established interdisciplinary training programs that, by integrating the biomedical sciences, physical sciences, and engineering, will produce a scientific workforce capable of integrative research that crosses traditional disciplinary boundaries.

NIBIB recognizes that multi-disciplinary collaborations may be a necessary step in the evolution of interdisciplinary training, and the NIBIB currently offers traditional opportunities and mechanisms to support multi-disciplinary training. However, for the purposes of this RFA, applications that propose training in multi-disciplinary approaches as a precursor to interdisciplinary training or facilitate communication among different disciplines and promote, but do not achieve a seamless integration of different disciplines in the proposed project period, will be considered non-responsive and will not be reviewed. Although previous participation in Phase I is not required in order to apply to this RFA, all applicants are therefore strongly encouraged to contact and discuss their plans with NIBIB program staff before developing an application (see Section VII. Agency Contacts).

Special Program Objectives and Considerations

Research Training programs eligible for funding through this funding opportunity must integrate the biomedical sciences with physical sciences and/or engineering. These fields may include, but are not limited to, biology, chemistry, engineering, materials science, mathematics, computational science, medicine and physics. The intent of this RFA is to target and provide support for recently established interdisciplinary training programs in emerging areas at the intersection of the biomedical sciences, physical sciences, and engineering.

Interdisciplinary training programs must be structured to train students from the biomedical sciences, physical sciences, and/or engineering in an integrated program. Trainees are expected to participate in a formal multi-year curriculum that provides cohesive, integrated and novel approaches to interdisciplinary research, including the theories, techniques, methodologies, and application strategies of emerging interdisciplinary research environments. Trainees appointed to the training program must receive supervised education and research training that is interdisciplinary in nature. The primary objective of this program must be to promote the recruitment, training, advancement, and retention of new investigators in interdisciplinary science. These programs should support a variety of new and innovative didactic and research experiences designed to provide pre-doctoral students with the knowledge and research experience necessary to develop interdisciplinary solutions to complex health problems. 

Training Program Director(s) (PDs) should limit appointments to individuals who are committed to a career in research and who plan to remain on the training grant for a cumulative minimum of 2 years. Attention should also be given to recruiting trainees from racial and/or ethnic groups underrepresented in the biomedical sciences, individual with disabilities, and individuals from disadvantaged backgrounds. PDs should encourage and provide training in the skills necessary for trainees to apply for subsequent support through individual fellowship and mentored career development award programs as well as independent research project grants. PDs are encouraged to develop methods for ongoing evaluation of the quality of the training program and to develop plans to obtain feedback from former trainees to help identify weaknesses in the program and provide suggestions for program improvements.  All applications must describe an evaluation and tracking plan that will review and determine the effectiveness of all aspects of the program.

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 Ruth L. Kirschstein NRSA Institutional Research Training (T32) award mechanism(s). 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).  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 institutional research training (T32) grant application.

Applicants to this RFA are only required to submit the first five training data tables requested of applicants to the Ruth L. Kirschstein NRSA Institutional Research Training (T32) grant mechanism. 

If applicable, the qualifications of recent and/or current Pre-doctoral applicant trainees may either be presented in Tables 8A and/or 9A respectively or discussed in narrative form.

2. Funds Available

NIBIB has set aside $3- 4M to fund between 10-12 interdisciplinary research training programs under this initiative. Applicants may not request more than $500,000 in direct costs or more than 10 slots for any grant year. Because the nature and scope of the proposed interdisciplinary research training programs will vary from application to application, it is anticipated that the size of each award will also vary. The number of awards and the actual amount awarded are therefore contingent upon the receipt of a sufficient number of meritorious applications and will depend upon the number, quality, and costs of the applications received.  

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.

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. This 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 pre-doctoral NRSA stipend level at the time of award. The annual stipend level for a pre-doctoral trainee for fiscal year (FY) 2008 is $20,772. 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 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html for specific information).

B. Tuition and Fees: The NIH will offset the combined costs of tuition and fees at the rate in place at the time of the award. The rate currently provides an amount per predoctoral trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year. 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, see: http://grants1.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 trainee expense. In addition, the NIBIB requires that applicants include funds to allow Training Program Director(s) (PDs) and two to four trainees to attend the biennial NIBIB Training Grantee Meeting, held in even-numbered years in the Washington DC/Bethesda, MD area. Note that funds for PDs should be included under Training Related Expenses (TRE) while funds for trainees to attend the meeting should be requested as trainee travel.

Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution, except that the grantee organization may authorize a one-way travel allowance in an individual case of extreme hardship. Additionally, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent organization must be justified considering the type of opportunities available for training, the manner in which these opportunities differ from, and complement those, offered at the parent institution, and the relationship of the proposed training experience to the trainee’s career stage and goals. This type of travel and research training requires prior approval from the NIBIB. Letters requesting such training may be submitted to the NIBIB at any time during the award period. 

D. Training-Related Expenses: The applicant institution may request the NIH standard NRSA Training-Related Expenses ($4,200 annually for each predoctoral trainee in FY 2008) to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty directly related to the research training program (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html for additional information). Funds are provided as a lump sum on the basis of the predetermined amount per predoctoral 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.  Requests for additional costs must be explained in detail and justified in the application.  Consultation with NIBIB staff in advance of such requests is strongly advised.

E. Facilities and Administrative Allowance: A facilities and administrative allowance (indirect cost allowance) based on 8% of total modified direct costs (exclusive of tuition and fees, health insurance, and equipment) may be requested.

F. Stipend Supplementation, Compensation, and Other Income:

Stipend Supplementation: The grantee institution is allowed to provide funds to an individual in addition to the stipends paid in the form of stipend supplementation or in the form of compensation.  Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program. Grantees may supplement stipends from non-Federal funds provided the supplementation is without obligation to the trainee. An organization can determine what amount of stipend supplementation, if any, will be provided according to its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar training status regardless of the source of funds.  Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived. An individual may use Federal educational loan funds or VA benefits when permitted by those programs.  Under no circumstances may DHHS funds be used for supplementation.

Compensation: Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets all of the conditions and policies in the NIH Grants Policy Statement. Additionally, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship.  An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training such as teaching or serving as a research assistant.  A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant.  However, compensated services should occur on a limited, part-time basis apart from the normal full-time research training activities. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application. PDs must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program. 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. 

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Eligible institutions are expected to have addressed and achieved the program objectives of the Phase I HHMI-NIBIB Interfaces Initiative program announcement (see the HHMI website at http://www.hhmi.org/grants/pdf/comp_annc/2005_nibib_program.pdf). This initiative was intended to encourage interdisciplinary research training by removing institutional barriers among the biomedical sciences, physical sciences, and engineering; developing effective interdisciplinary coursework, laboratory research, and community-building activities; and identifying and disseminating program practices that support interdisciplinary training at domestic institutions of higher education.  Phase II of the partnership, to be funded by this RFA, is intended to continue these constructive changes and to provide support to sustain recently established interdisciplinary training programs through their critical early years. We anticipate that grantee institutions funded in Phase I of this initiative will apply to this funding opportunity and these applications are highly encouraged. However, previous participation in Phase I is not required in order to apply to this RFA. Any domestic institution that can demonstrate it has addressed and achieved the program goals of Phase I is eligible and welcome to apply. Previous participation in Phase I is not required in order to apply to this RFA.

This funding opportunity allows the participation of multiple sites.  When multiple sites are involved, the applicant institution must be the primary site (and identified as the lead), and the application must include a “resource format page” for each site (partnering institutions) as described in the PHS 398 application. The applicant institution whether applying as a single entity or representing a multi-institutional consortium, may submit only one application in response to this funding opportunity. For the purposes of this RFA, components of a large or multi-component organization that are sufficiently independent to constitute, in effect, separate organizations are considered separate institutions and thus may submit separate applications. For example, the multiple campuses of the University of California system are considered separate institutions.  However, the medical school, engineering school, or dental school, etc., of a university, even if on different campuses, constitute a single institution.

Institutions with currently active federally funded research training grants (e.g., an NIH T32 or an NSF IGERT award) in interdisciplinary research or one that includes a significant interdisciplinary component are eligible to apply only if the new application is significantly and substantively different than the current program(s). Applicants must address in their application any real or apparent overlap with existing sources of support for interdisciplinary training.

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.

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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual 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.

Applicants submitting a multi-PD application must provide a Leadership Plan. The emphasis in this leadership plan should be on how it will benefit the training program and the trainees. A single Contact PD must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD when necessary. Because training programs are intended to be coherent, a single award will be made and NIH will not allocate the budget or training positions between multiple PDs. Multiple-PD applications should include reasonable numbers of PDs and each should be included for a specific purpose. Multiple-PD applications should not include all mentors of the training grant as PDs, except in unusual cases.

The Training Program Director(s) (PDs) for each award will be responsible for the overall direction, management, and administration of the proposed interdisciplinary training program, including planning, directing and executing the program, selecting and appointing program trainees, evaluating the success of the program, and submitting all required forms in a timely manner. This individual should be an established researcher with acknowledged accomplishments in interdisciplinary research and training, capable of providing both administrative and scientific leadership to the development and implementation of the proposed program, and have the necessary institutional resources to conduct the proposed program.

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

Resubmission applications will not be allowed under this FOA.  Previously unfunded T32 applications must be submitted as new and must not include an Introduction addressing the previous peer review critiques.  The reviewers will not receive a copy of the previous summary statement.

Renewal applications will not be allowed under this FOA. 

Responsiveness Criteria

The intent of this RFA is to support recently established interdisciplinary training programs that integrate the biomedical sciences with physical sciences and/or engineering. Training programs will only be considered responsive if they have taken substantive steps to encourage and facilitate interdisciplinary research training. These may include, but are not limited to, the removal of institutional barriers among the biomedical sciences, physical sciences, and engineering; the development and implementation of interdisciplinary coursework, laboratory research, and community-building activities; and the evaluation and dissemination of ‘best practices’ that best support interdisciplinary training at domestic institutions of higher education.

Activities that facilitate communication among different disciplines and promote, but do not completely achieve integration of different disciplines in the proposed project period, or propose training in multi-disciplinary approaches as a precursor to interdisciplinary training, will be considered non-responsive and will not be reviewed.

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

Research Training Program

Trainees appointed to the research training program must have the opportunity to carry out supervised research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career. Trainees must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research activities, consonant with the NRSA guidelines. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

An NRSA institutional training grant must be used to support a program of full-time research training. It may not be used to support studies leading to the M.D., D.D.S., or other clinical, health- professional training except when those studies are part of a formal combined research program, such as the M.D./Ph.D.  

Trainee Citizenship

At the time of appointment to the training program, individuals financially supported by the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment. Foreign trainees, while they can be affiliated with the training program, ie., take part in all program activities, may not be financially supported by the training program.

Pre-doctoral Trainees

Pre-doctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA research training appointment, must be training at a post-baccalaureate level, and be enrolled in a research doctoral degree program leading to the Ph.D. (or equivalent) degree.

Section IV. Application and Submission Information


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 most current PHS 398 research grant application instructions and forms. Applicants must use the T32 guidelines and the specific instructions for Institutional NRSA Applications, PHS 398. Applicants to this RFA are only required to submit the first five training data tables requested of applicants to the Ruth L. Kirschstein NRSA Institutional Research Training (T32) grant mechanism. 

The Data Tables are to be numbered exactly as shown below and are to be gathered at the end of the application, but placed before the checklist. The following Data Tables are mandatory for this FOA.

Table 1 Membership of Participating Departments/Programs

Table 2  Participating Faculty Members

Table 3 Institutional Training Grant Support Available to Participating Faculty Members, Departments, or Programs

Table 4 Grant and Contract Support of the Participating Faculty Members

Table 5  Pre- and Postdoctoral Trainees of Participating Faculty Members

If applicable, the qualifications of recent and/or current Pre-doctoral applicant trainees may either be presented in Tables 8A and/or 9A respectively or discussed in narrative form.

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

The title and number of this funding opportunity must be typed on lines 1 and 2 of the face page of the application form and the YES box must be checked.

The NIBIB recognizes that applicants will be able to respond in different ways to the opportunity presented by this RFA. Applicants are therefore strongly encouraged to contact NIBIB program staff early in the application process and they should have a thorough understanding of the intent and expectations of this RFA before developing an application. A website (http://www.nibib.nih.gov/Training/Predoctoral) will be used to post additional information about this initiative including answers to frequently asked questions and instructions on how to register for and participate in a pre-submission teleconference. This teleconference will be conducted on Thursday, May 1, 2008, from 12:30 pm to 3:30 pm [EST]. During the teleconference, the NIBIB staff will explain the goals and objectives of the RFA and answer questions. All prospective applicants are invited to participate in the teleconference. The results of the teleconference, either in the form of minutes and/or responses to the questions asked, will be available on the above website.

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
Letter of Intent Receipt Date: May 19, 2008
Application Receipt Date: June 17, 2008
Peer Review Date: October – November, 2008
Council Review Date: January 2009.
Earliest Anticipated Start Date: April 1, 2009

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:

Richard Baird, Ph.D.
Director, Division of Interdisciplinary Training
National Institute of Biomedical Imaging and Bioengineering
Democracy II, Suite 200
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 496-7671
Email: bairdri@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions http://grants.nih.gov/grants/funding/phs398/phs398.html for preparing a research grant application and the specific NRSA institutional grant application instructions in the PHS 398. 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:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
Democracy II, Suite 920
6707 Democracy Boulevard
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Telephone: (301) 496-8633
Email: georged@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, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at 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.)

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.

The 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.

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 Ruth L. Kirschstein NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Ruth L. Kirschstein NRSA 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 are 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.

6. Other Submission Requirements and Information

Special Requirements

The primary goal of this funding opportunity is to support the development of recently established interdisciplinary research training programs that train students to conduct research at the interface among the biomedical sciences, physical sciences, and engineering. Trainees are expected to participate in a formal, integrated, multi-year curriculum that provides novel and cohesive approaches to interdisciplinary research, including theories, techniques, and applications of that research. The product of the training program should be independent interdisciplinary scientists who are adept in not just combining, but integrating multiple approaches, theories and principles as part of their research interests, goals, and career paths. 

Applicants should address, and reviewers will evaluate, the following areas in their applications:

Institutional History and Impact:

Applicants should describe the institutional history and impact of their interdisciplinary research training programs, focusing on the institutional and academic activities that have taken place over the three to five years leading up to the current proposal. This narrative should clearly describe the events leading up to the implementation of the proposed interdisciplinary training program, including the degree of interaction, collaboration, and interdisciplinary training among the participating departments, schools, and/or institutions before the establishment of the training program; the specific institutional and academic events and activities that led up to the establishment of the training program; and the current interactions among these organizational elements since the implementation of the training program. They should also document specific examples of institutional change, including interdisciplinary faculty recruitment and collaborative interdisciplinary research, which would not have otherwise occurred without the training program.

Since the proposed interdisciplinary training programs are expected to be less mature than traditional T32 training programs, the review criteria will focus on the potential of the training program rather than its long-term training record. Applicants should, however, describe the participation of the Training Program Director(s) (PDs) and/or faculty mentors in the proposed interdisciplinary training program, other interdisciplinary programs, and/or disciplinary feeder programs that would be expected to contribute to the success of the training program. Applicants should also discuss the short-term training record of the training program. This should include the quality and background of any trainees selected by or currently in the interdisciplinary training program as well as their short-term accomplishments since joining the training program. This evidence should focus on the interdisciplinary nature of their research rotations and research projects, completion of interdisciplinary program and departmental requirements, and any other measure of success consistent with the nature and duration of the training received.

Research Training program:

The proposed interdisciplinary research training program should provide broad-based, integrated training across traditional academic departments, multiple schools, and/or institutions; encourage institutional access to core facilities; and reduce departmental and institutional barriers to interdisciplinary training. All programs are encouraged to have a strong administrative structure, including both internal and external advisory committees and to provide detailed information regarding the number and expertise of persons who will serve on these committees (Nota bene: members of the external advisory committee should not be identified, named or recruited before award).

Applicants should also provide information on existing training programs in the areas(s) proposed for training and discuss, if appropriate, how these programs will interact with the proposed interdisciplinary training program. Training programs should include formalized interactions of participating departments and programs that will foster the development of interdisciplinary scientists. It is expected that trainees will take integrated coursework, laboratory research, and other community-building activities appropriate for trainees from different scientific backgrounds and will receive hands-on training in interdisciplinary research appropriate to their previous research experience. Applicants should identify and describe specific coursework and attendance requirements expected of program trainees. Curriculum and degree requirements should avoid extending time to degree; a plan for tailoring degree requirements and a description of milestones for accomplishing the plan should be included.

There should be specific plans to develop a sense of program cohesiveness across departmental boundaries and trainee interactions should be of sufficient quantity and quality to ensure that the students and associated faculty develop a sense for the identity of their interdisciplinary field. These community and team-building activities for fostering program cohesiveness may include, but are not restricted to, journal clubs, seminar series, and retreats. In addition, programs are encouraged to include activities that are likely to improve leadership and teambuilding skills and help trainees to establish and maintain their own interdisciplinary research programs. These activities may include grantsmanship workshops and mock grant reviews; job interviews, negotiation, and professional “survival-skills” coursework; and laboratory management skills. More senior trainees should be encouraged to assist in the mentoring of more junior trainees.

Training Program Director(s): 

Training Program Director(s) (PDs) must possess the scientific background, leadership, and administrative capabilities required to coordinate, supervise, and direct the proposed interdisciplinary training program.  PDs will be responsible for the overall direction, management, administration, and evaluation of the program as well as the selection and appointment of trainees. PDs, although not required to have current grant funding, should have a strong administrative and/or scientific background in one or more of the areas covered by the training program. The application should describe the qualities possessed by the PDs that make them uniquely qualified for this position.

Faculty Mentors:

The research projects of trainees must be supervised by appropriate faculty mentors.  Each trainee is expected to have a mentoring team that includes at least two faculty co-mentors, from different disciplines, that combine to form the backbone of the interdisciplinary training team. Faculty mentors should be funded investigators in appropriate research areas and evidence of ongoing research funding during the requested award period must be provided. The application should describe the qualifications of proposed faculty mentors for interdisciplinary training 

Institutional Environment, Resources, and Commitment: 

The applicant institution(s) must have strong and high-quality research programs in the area(s) proposed for research training and have the requisite staff and facilities to carry out the proposed interdisciplinary training program. The scientific environment is expected to be strongly collaborative with many interdepartmental interactions and opportunities to engage in interdisciplinary research. This may be evidenced by team development and teaching of coursework, collaborative research projects, joint service on dissertation committees, and co-authored publications.

Institution(s) should include information that documents a commitment to the goals of the training program’s goals and provide assurance that they intend the program to be an integral part of their overall research and training mission. The application should also include a description (and confirming letters from appropriate institutional officials) of all support to be provided to the program, including dedicated research and/or teaching space, shared laboratory facilities and equipment, administrative salary support, funds for curriculum development and teaching release time, and support for additional program trainees.  Institution(s) should also discuss their plans to sustain the training program beyond the end of any support that may be received from this RFA.

Trainee Recruitment, Selection and Retention Plans:

Applicants must submit a recruitment plan for recruiting trainees from both inside and outside their sponsoring institution(s) as well as a selection plan outlining the criteria they will use to select from the pool of potential trainees. The application should also describe an outreach and recruitment plan to increase the depth and diversity of the applicant pool including those underrepresented in the current scientific research workforce in the area of the proposed research training (see Recruitment and Retention Plan to Enhance Diversity).

Trainee Appointments:  

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution(s) in accordance with their own policies.  Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIBIB.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level, including any combination of support from institutional training and individual fellowship awards. Any exception to the maximum period of support requires a waiver from the NIBIB based on a review of the written justification from the individual trainee and endorsed by the PDs and the sponsoring grantee institution(s). Trainees seeking additional support are strongly advised to consult with the NIBIB program staff.

Evaluation and Tracking Plan: 

Applicants 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 10-year period following their completion of the program to determine success or failure of the program. The follow up tracking would include information on program publications, grant proposals, and awards, and the career trajectory of all trainees who were supported by the program. The application should also provide a prospective evaluation plan for process and outcome measures. Process measures should include the methods that will keep the interdisciplinary team focused and coordinated; outcome measures should include relevant positions obtained, current activities related to research, publication record, and the success rate of applying for and obtaining Federal and non-Federal research grant support. The evaluation and tracking plan should include measures to evaluate the short-term and long-term effectiveness of each training component, identify program strengths, and correct weaker program areas. An evaluation and tracking report should be included annually as part of the Progress Report, in future renewal applications, and as part of the Final Progress Report. If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

Dissemination Plan:

Applicants must describe a plan for disseminating successful program elements of their training programs to the extramural science community. These include noteworthy innovations or compelling approaches for reducing departmental and institutional barriers to interdisciplinary training, developing interdisciplinary course materials, and increasing the number of interdisciplinary faculty mentors. If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

Recruitment and Retention Plan to Enhance Diversity:

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

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

A.  Individuals from racial and ethnic groups that have been shown by the National Science Foundation (NSF) 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(s) 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:

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement.  If the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  NIBIB staff will determine whether amended plans and reports are acceptable before an award is made.

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

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 21, Number 43, November 27, 1992, see http://grants1.nih.gov/grants/guide/notice-files/not92-236.html. Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research for every year of trainee participation. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.  

Research Plan Page Limitations

The research plan, sections 2-5, is limited to 25 pages. 

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

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

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIBIB 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 following will be considered in making funding decisions:

The merit of the proposed interdisciplinary training program will be evaluated by peer review of the following elements:

Only the review criteria described below will be considered in the review process. 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 interdisciplinary training program and then consider whether the requested number of trainee positions is appropriate for the training program.

Institutional History and Impact:

Research Training Program: 

Training Program Director(s): 

Faculty Mentors: 

Trainee Recruitment, Selection and Retention: 

Institutional Environment, Resources, and Commitment: 

Evaluation and Tracking Plan:

Dissemination Plan: 

2.A. Additional Review Criteria:

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

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 on Human Subjects in the PHS 398 instructions).

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 on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Diversity Recruitment and Retention: 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 diversity the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

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

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

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. The acceptability of the plans will be described in an administrative note in 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 NIBIB program staff will judge the acceptability of the revised plan.

2. C. Resource Sharing Plan(s)   

The following resource sharing policies do not apply to this FOA:

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 Training PD(s)/PI(s) 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.

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 Notice of Award 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 PDs.  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, PDs 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 PDs 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.  Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral trainees. 

Termination of Award: PDs must consult with NIH staff when termination of the program is being considered. When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. 

Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval of the NIBIB. When required, such requests must include compelling justification including the status of trainee appointments to the program. If not stated on the Notice of Award, PDs should contact the NIBIB’s Grant Management contact to determine the NIBIB’s carryover policy.

Termination of Award:  When a grantee institution plans to terminate an award, the NIBIB 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(s): If a change of PDs is necessary, support of the award is not automatic but may be continued with prior written approval by the NIBIB, provided that the following conditions are met. The current PDs or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to the NIBIB program and grants management staff describing the reasons for the change. The biographical sketch of the proposed new PDs, 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 PDs and that the new PDs have the appropriate interdisciplinary training and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Change of Program: A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated to ensure that the program remains within the scope of the original peer-reviewed application. If the new program does not satisfy this requirement, the award will be terminated.

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.

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.

The NRSA instructions for the Non-Competing Grant Progress Report (Form 2590) should be followed. Note that a substitute budget page and a summary of trainees 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 well as a dissemination plan, as described in Section VI.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:  The institution must submit a completed Statement of Appointment (PHS 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 this document is submitted to and accepted by the NIBIB.

Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7) to the NIH. Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Evaluation and Tracking Results: 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, recipients 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 contacts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program. 

Publication and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, trainees should make the results and accomplishments of their Ruth L. Kirschstein NRSA research training activities available to the research community and to the public at large.  The grantee organization should assist trainees in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public. No restrictions should be placed on the publication of results in a timely manner.

Trainees are encouraged to submit reports of their findings for publication in the journals of their choice. For each publication that results from a trainee’s research, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by the National Institutes of Health under Ruth L. Kirschstein NRSA (number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.” In addition, federal funding must be acknowledged as provided in “Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.”

Inventions:  Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants. 

Copyrights:  Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

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 , as well as a dissemination report, is required as part of the Final Progress Report.

Human Embryonic Stem Cells (hESC):  Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

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:

Richard Baird, Ph.D.
Director, Division of Interdisciplinary Training
National Institute of Biomedical Imaging and Bioengineering
Democracy II, Suite 200
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 496-7671
Email: bairdri@mail.nih.gov

2. Peer Review Contacts:

David George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
Democracy II, Suite 920
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 496-9474
Email: georged@nih.gov

3. Financial or Grants Management Contacts:

Florence Turska
Office of Grants Management
National Institute of Biomedical Imaging and Bioengineering
Democracy II, Suite 900
6707 Democracy Boulevard

Bethesda, MD 20892
Telephone: (301) 496-9314
Email: turskaf@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. 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/.

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-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 (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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 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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