Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
Title: Dental School Joint DDS or DMD/Masters Degree NRSA Research Training Program (T32)
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PAR-07-332
Catalog of Federal Domestic Assistance Number(s)
Release Date: March 16, 2007
Letters of Intent Receipt Date(s): August 25, 2007, 2008, 2009
Application Submission Date(s): September 25, 2007, 2008, 2009
Peer Review Date(s): February 2008, 2009, 2010
Council Review Date(s) : May 2008, 2009, 2010
Earliest Anticipated Start Date(s): June 1, 2008, 2009, 2010
Additional Information To Be Available Date (url Activation Date): Not Applicable
Expiration Date: September 26, 2009
Due Dates for E.O.
Additional Overview Content
This funding opportunity announcement (FOA) solicits applications from dental schools that propose to develop a joint DDS or DMD/Masters degree training program. The Masters degree must be in clinical/behavorial research, or in public health. The goal of this initiative is to make research training an integral component of the dental school environment and encourage more dental students to pursue academic research careers by providing an opportunity to gain research experience.
Table of Contents
I. Funding Opportunity Description
1. Research Objectives
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing
3. Other - Special Eligibility Criteria
IV. Application and Submission and Instructions
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
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
1. Research Training Objectives
Purpose of this FOA
The purpose of this Dental School Masters Degree NRSA Research Training Program FOA is to solicit grant applications from dental schools that propose to develop a joint DDS or DMD/Masters degree training program. The Masters degree must be in clinical/behavioral research or in public health (MPH). The goal of this initiative is to make research training an integral component of the dental school environment and encourage more dental students to pursue academic research careers by providing an opportunity to gain research experience.
This FOA will use the NIH Ruth L. Kirschstein National Research Service (T32) Award mechanism.
The National Research Service Award (NRSA) program has been used by the NIH as the primary means of supporting graduate and postdoctoral research training since enactment of the NRSA Legislation in 1974. This program uses a combination of institutional training grants and individual fellowships to ensure a continuing supply of well-trained scientists prepared to conduct cutting-edge health-related research. More information about NRSA programs is available at http://grants.nih.gov/training/nrsa.htm. Information on the career outcomes of predoctoral NRSA recipients is available at http://grants.nih.gov/training/career_progress/index.htm. The institutional research training grants described in this announcement provide support to training programs at U.S. dental schools. Institutional NRSA training grants are designed to allow the director of the program to select the trainees and to develop a curriculum of study and research experiences necessary to provide high quality research training. The grant offsets the cost of stipends and tuition support for the appointed trainees.
Background and Description
Over the years, a myriad of workshops, expert panels, and symposia have been conducted, and leaders in education and research have discussed the need for enhancing the dental education process to incorporate more opportunities for biomedical research, both to produce more dentist-scientists and to produce clinical dentists who understand the scientific foundations of clinical practice. Several recent reports have considered the rationale for and ways to strengthen the interaction between research and dental education. These reports include "Dental Education at the Crossroads - Challenges and Change" (Institute of Medicine, 1995), "Oral Health in America: A Report of the Surgeon General" (Department of Health and Human Services, 2000) and the "Future of Dentistry" (American Dental Association, 2001). Each of these documents reinforced the fundamental importance of research to oral health, the dental profession and dental education. Major recommendations of these reports were related to the creation and expansion of oral health knowledge, the importance of research and scholarship, and the interaction between research and education.
According to the American Dental Education Association, there were 250 vacant full-time dental school faculty positions in the 2004-5 academic year. Of these, 51 (20 percent) were classified as full-time research positions. At the same time, there is a shortage of new dentists who are entering careers in academic research.
The National Advisory Dental and Craniofacial Research Council (NADCRC) identified the twin challenges of stimulating academic dental biomedical and behavioral research and changing the culture of dental school education to value research in admissions and training.
Members of the Council recommended the development of programs to promote research training and enhance the academic curricula for a subset of interested and motivated dental students (further described in Herzberg MC, Griffith LG, Doyle MJ. Driving the future of dental research. J Dent Res. 2006 Jun;85(6):486-7 (http://jdr.iadrjournals.org/cgi/content/full/85/6/486). This FOA is in response to that recommendation.
The Dental School Masters Degree NRSA Research Training Program grants will be awarded to dental schools that engage a subset of students in each entering class in a five-year dual degree DDS/DMD Masters program, and that program will provide students with research experience either in a single full-time 12-month training period, or in multiple periods of full-time, short-term training distributed over the 5-year program period. Short-term research training positions should last at least 8, but no more than 12, weeks. Such appointments may be alternated with periods of clinical training within the dental curriculum, and must involve full-time research training, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.
The Masters degree program must be accredited, and must be integrated into the school and/or academic health center as a whole - the program must be designed to prepare trainees to engage in biomedical or behavioral research. The Masters degree must be a recognized terminal degree in the scientific field, such as an MS in clinical or behavioral research or a Masters of Public Health (MPH). MS degrees in basic sciences or those awarded for clinical specialty training are not fundable components of this program.
The proposed research training program may complement other ongoing research training and education programs occurring at the applicant institution, but the proposed educational experiences must be distinct from other institutional programs currently receiving federal support.
1. Mechanism of Support
This funding opportunity will use the NIH Ruth L. Kirschstein National Research Service (T32) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the non-modular budget format.
Through this FOA, NIDCR will provide funding support only for the time trainees spend in pursuit of the Masters degree. Tuition and stipend will not be paid for training leading to the clinical DDS or DMD degree. Support for an individual trainee is limited to twelve months.
2. Funds Available
All awards are subject to the
availability of funds. The estimated amount of funds available for support of projects awarded
as a result of this announcement is $1.5 million
total costs for fiscal year 2008. Future year amounts will depend on annual
Although the financial plans of the NIDCR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm). Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement (rev. 12/01/03), and the NRSA regulations, policies, guidelines, and conditions set forth in this document.
Applicants may request awards up to $250,000 in direct costs per year.
Funds under this program are allowable only for the Masters degree portion of the education. NIDCR will not provide funds for tuition, stipend and other costs associated with dental clinical education leading to the DDS or DMD degree. All costs for short-term training appointments are pro-rated based on annual allowances.
Predoctoral stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience and are based on a 12-month appointment period. The stipend is not provided as a condition of employment with either the Federal Government or the grantee institution nor is it to be considered a payment for services performed. Stipends will be based on the annual NIH stipend levels at the time of award. Stipend levels are adjusted periodically and current stipend levels are available on the NIH website at: http://grants.nih.gov/training/nrsa.htm. 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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html for specific information).
B. Tuition and Fees
The NIDCR will offset the combined cost of tuition and fees at the current rates as published at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html. The maximum amount payable for tuition support is at the predoctoral level. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the training grant.
C. Training Related Expenses (TRE)
Institutional costs of $4,200 a year per predoctoral trainee may be requested to defray the costs of health insurance and other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. The TRE amount is based on a full-time 12-month appointment period and must be pro-rated for 8-12 week programs. NRSA Training related expenses may be adjusted periodically in future fiscal years. Applicants may request compensation for up to 10% of a program director's direct salary and fringe benefits. This compensation is based on the total effort spent performing activities specifically related to implementing and conducting the proposed training program. No other institutional faculty or professional employees can be reimbursed through this award. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request training-related expenses above the standard rate.
D. Trainee Travel
Trainee travel to scientific meetings that the institution determines to be necessary for the individual's research training is an allowable trainee expense at $800 per trainee.
E. Facilities and Administrative Allowance
A facilities and administrative allowance based on 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment) may be requested.
F. Stipend Supplementation, Compensation, and Other Income
The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met. 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 PHS 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. Training Program Directors 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/archive/grants/policy/nihgps_2003/index.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.
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization meets the following criteria:
Foreign institutions are not eligible to apply for a T32 NRSA Institutional Training Grant.
Applicant institutions must have an active and well-funded research program in the proposed areas of training, either within the dental school or within the broader health science campus. Further, they must provide cross-disciplinary training opportunities through local collaborations with other professional or graduate schools at their institution or at other institutions in the local area. Because one goal of this program to make research training an integral component of the dental school environment, this FOA does not allow collaborative research training programs among different dental schools.
Dental schools with active NIDCR T32 grants or with NIDCR T32 applications pending are eligible to apply. However, an eligible institution (e.g., university) may submit only a single application per application cycle in response to this FOA. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH. Dental schools may submit both a Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Dental Research Training Program (PAR-05-101) and a Dental School Masters Degree NRSA Research Training Program during the same application cycle. If doing so, these should be submitted as separate applications.
1.B. Eligible Training Program Directors
Any individual with the skills, knowledge, and resources necessary to organize and implement the research training program is invited to work with his/her institution as the director of the research training program in order to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. The research training program director at the institution will be responsible for the selection and appointment of trainees to the NRSA research training grant and for the overall direction, management, and administration of the program, including the submission of all required forms in a timely manner. The PD will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., “Reporting.”)
should be an established investigator capable of providing both administrative
and scientific leadership to the development and implementation of the proposed
research training program.
2. Cost Sharing
Cost sharing is not required. The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.
This program is targeted at predoctoral dental students.
Trainees appointed to the Dental School Masters Degree NRSA Research Training Program must have the opportunity to carry out supervised clinical/behavioral and/or public health research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a career in oral, dental or craniofacial research. 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 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. Therefore, the Masters degree program must be designed as either a separate year devoted to research added into the dental school curriculum, or in multiple blocks of two-to-three months devoted full-time to short-term research training, distributed throughout the five years of dental school.
To be eligible for appointment to the Dental School Masters Degree NRSA Research Training Program, trainees must be enrolled in a formal, combined program that leads to the award of a D.D.S./D.M.D. and a Masters degree. The Masters degree must be a recognized terminal degree in the scientific field, such as an MS in clinical/behavioral research or a Masters of Public Health. Students enrolled in programs to earn MS degrees in basic sciences or for clinical specialty training are not eligible.
The Dental School Masters Degree NRSA Research Training Program may not be used to support studies leading to the D.D.S. or D.M.D. degree. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty
At the time of appointment to the training program, individuals selected for research training supported by NRSA institutional training grants must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence, i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of legal admission as a permanent resident. Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible for Kirschstein-NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.
Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, must be training at the post-baccalaureate level, and be enrolled in a program leading to a combined D.D.S./D.M.D. and a Masters degree. Trainees appointed to the training program must have the opportunity to carry out supervised research with the primary objective of encouraging more dental students to pursue academic research careers. The Master’s degree research training can be conducted in a continuous 12 month period or can be spread out over the five years of the combined degree program.
Dental students selected for short-term appointments must obtain multiple periods of full-time research training during the five years of dental school, and these training appointments must lead to a Masters degree in clinical or behavioral research or an MPH.
Short-term research training positions are defined as at least eight, but no more than 12, weeks. Such appointments may alternate with periods of clinical training within the dental curriculum, and must involve full-time research training, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.
Unless otherwise stated, the requirements that apply to institutional research training grants also apply to short-term research training. No trainee will receive more than a total of 12 months of support under this Program. The duration of the research training component of the dual degree program should be clearly stated in the application: either all one-year continuous appointments, all multiple short-term appointments, or a combination of both. Additional information may be required to clarify appointment periods prior to issuance of an award.
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. 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 PHS 398 research grant application instructions and forms. Applicants must use the T32 guidelines and the specific instructions for Institutional NRSA Applications, PHS 398, Section IV. http://grants.nih.gov/grants/funding/phs398/phs398.pdf.
Applications must have a Dun and Bradstreet (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/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
See Section VI.2 Administrative and National Policy Requirements for additional information.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Submission Dates and Times
See Section IV.3.A. for details.
Letters of Intent Receipt
Date(s): August 25, 2007,
Application Submission Date(s): September 25, 2007, 2008, 2009
Peer Review Date(s): February 2008, 2009, 2010
Council Review Date(s): May 2008, 2009, 2010
Earliest Anticipated Start Date(s): June 1, 2008, 2009, 2010
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Lynn Mertens King,
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AN 32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
3.B. Sending an Application to the NIH
Applications must be prepared using the application forms and instructions found in the PHS 398 instructions for preparing an Institutional NRSA application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and five copies of the appendix material must be sent to:
Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AN 32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are not allowable charges for either stipends or tuition on institutional training grants since stipends and tuition costs may not be charged to the grant before the trainee appointment is actually made. However, the policies governing the pre-award cost authority for the expenditure of the other funds provided in a training grant are those permitted in the NIH Grants Policy Statement as follows:
A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement .
The National Research Service Award (NRSA) policies apply to this program. Awards are contingent upon availability of funds. Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations.
Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.
Concurrent awards: An NRSA trainee appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.
Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.
The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws 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.
Service Payback: There is no service payback requirement for NRSA predoctoral trainees.
Research Training Program: Although support will be provided only for the Masters degree component, the application must describe how the dual-degree program is structured over the five-year dental school curriculum.
Applications should outline the timeline and schedule for the dual-degree program. Applications should describe the integrated training program for dual-degree students, including (A) didactic and experiential research components; (B) coordination among clinical, behavioral and other biomedical departments and the graduate school in the design and conduct of research programs; (C); the unique and innovative aspects of the program; and, (D) the plans to provide support for trainees in the event that continued funding from the NIDCR is not available. The application should describe the process by which the trainee's guided research activities will be selected, and should describe the plan for evaluating trainee experience and needs, and the plan to monitor trainee progress to accomplish desired program goals. The program should develop trainee skills in understanding research methodology, such as formulating a research problem, constructing hypotheses, developing a study design, critically analyzing data, and evaluating the results.
Trainees should be prepared to use their research experience to guide their future career paths. To facilitate this, programs should describe plans to provide all NRSA trainees with professional career development skills. This should include instruction and training in grant writing in order for trainees to apply successfully for further career development opportunities and independent research support.
The number of trainees proposed in the application must be justified by available mentorship and by the recruitment and training track record of the applicant institution.
Required Tables: The PHS 398 Instructions for Institutional NRSA Applications lists the inclusion of several tables. Only Tables 1-5 are required for applications for this FOA. Sample NRSA tables with links to PHS 398 instructions and blank table formats are available on the NIGMS website http://www.nigms.nih.gov/Training/Application/NRSATablesIntro.htm. Although applicants are not required to use these table formats, it is highly recommended.
Program Director: The Program Director must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program. The Program Director will be responsible for the selection and appointment of trainees to the program, and for the overall direction, management, administration, and evaluation of the program. Program Directors must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner.
Past Training Record: This should describe the past research training record of the Program Director, and participating faculty mentors. The information should describe the success of former trainees of the participating mentors in seeking further career development and in establishing productive scientific careers. Evidence can include further career advancement of former trainees such as the completion of additional masters or doctoral degree programs, or other postdoctoral training appointments and similar accomplishments; a record of successful competition for fellowship, career development or research grants; receipt of special honors or academic awards; a record of publications; filing of patents; subsequent positions (e.g., postdoctoral, academic, industrial, clinical); and any other accepted measures of success consistent with the nature and duration of the training period.
Trainee Appointments: All trainees are required to pursue their research training full time, defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Trainees may be appointed: 1) in a continuous 12-month appointment, or 2) in multiple, shorter term appointments totaling 12 months.
No individual trainee may receive more than a total of twelve months of support through the Dental School Masters Degree NRSA Research Training Program.
Institutional Commitment: Applicant institutions should show commitment to the program's goals, and provide assurances that the institution intends the program to be an integral part of its research and research-training endeavors. Evidence of Institutional commitment in support of the proposal includes letters from high-ranking institutional officials (e.g., Provost, President and/or Vice-President) that 1) describe how the proposed program will be an integral component of the institution's broader vision with respect to research, and 2) provide a commitment of 100 percent protected time for the trainees, equivalent to 40 hours per week.
Training Environment: The institution must demonstrate that it has a sufficiently funded research base, the infrastructure to support research, and the facilities and resources to support research relevant to dental, oral and craniofacial diseases and conditions. The applicant institution must have a strong and high-quality research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed training program. Applications must provide evidence that the applicant institution is able to provide programs tailored to meet the unique research and clinical development needs of each trainee, and ensure that the individuals complete the clinical and research programs with requisite competencies in both.
Advisory Committee: The application must describe the composition and role of an internal advisory committee in development of the program, assignment of mentors and projects, development of recruitment strategies, monitoring trainee progress and evaluation of progress.
Training Program Evaluation and Tracking: The application must describe a detailed 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 should include information on publications, grant applications and awards, and career trajectories of trainees who were supported by the program. The application should provide a prospective evaluation plan for process and outcome measures. Outcome measures may 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 report should be included annually as part of the Progress Report, in future competing continuation applications, and as part of the Final Progress Report.
Trainee Candidates Applicants must describe plans for recruiting trainees from both outside and inside their sponsoring institutions; qualifications for prospective trainees and criteria for selection. Demonstrated ability to recruit appropriate trainees will be a key factor in determining the number of training slots awarded.
Recruitment and Retention Plan to Enhance Diversity:
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.
Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see ). In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/indix.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.
Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:
For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.
Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. If the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council as needed, will determine whether amended plans and reports submitted after the initial review are acceptable.
This FOA 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. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.
Plan for Sharing
1. Criteria(Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
The role of peer review is to assess the extent to which the applicant is likely to develop and run a successful training program. Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCR in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The responsibility for award decisions resides solely with authorized program staff of the NIDCR. The following criteria will be used in making award decisions:
The goals of NIH-supported research training and career development programs are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research training plan will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assessing the application's overall merit, weighting them as appropriate for each application.
Overall Program Aims: Does the application address the need for a DDS/DMD/Masters degree training program in the dental school? If the aims of the application are achieved, how will they impact upon the shortage of well-trained oral, dental and craniofacial health investigators? What will be the effect of the proposed training program on studies, concepts, or methods that drive oral, dental and craniofacial health research?
Approach: Is the conceptual framework and design of the training program well developed, integrated, and appropriate to the goal of training dental, oral and craniofacial research scientists? Does the applicant acknowledge past barriers and potential problem areas and consider alternative strategies? Is the organization and timeline of the five-year dual-degree program described clearly, and will the structure lead to quality training in both the clinical and research degrees? Is the phasing and timeline of multiple short-term research appointments reasonable and appropriate (if applicable)?
Innovation: Is the program original and innovative? For example, does the program challenge existing training or career approaches, or address a critical barrier to progress in the training of oral, dental and craniofacial health researchers? Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies for research education that will lead to the recruitment and training of oral, dental and craniofacial health researchers? Does the program provide strong evidence that the addition of the T32 Program will provide research training that would not otherwise be possible?
Training Program Director: Does the Program Director possess the scientific background and administrative experience appropriate to coordinate and supervise a comprehensive and integrative dental and craniofacial health research training program? Does the Program Director have adequate time to commit to program administration? Will the Program Director have sufficient authority and credibility in the Institution to work across institutional boundaries (if applicable)?
Institutional Commitment: Is there evidence that the institution is committed to the goals of the program? Does the application include letters from high-ranking institutional officials (e.g., Provost, President and/or Vice-President) that describe how the proposed program will be an integral component of the institution's broader vision with respect to research? Does the institution provide a commitment of 100 percent protected time for the trainees, equivalent to 40 hours per week?
Training Environment: Does the environment in which the training program will be conducted contribute to the probability of success? Is there evidence of partnering with schools within the academic health center and/or other local universities? Is there evidence of ongoing clinical, behavioral and/or public health research, and availability of appropriate and relevant research support, equipment, facilities, and research resources?
Candidate Pool and Recruitment Plans: Do the plans have well-defined recruitment procedures, identify potential sources and appropriate numbers of high-quality candidates, and describe trainee selection criteria and retention strategies? Are these processes adequate to achieve a high-quality pool of trainees? Does the program seek to recruit trainees from outside the institution? Are there adequate plans to recruit women and members of underrepresented racial/ethnic minorities? Is the number of trainees proposed in the application justified by available mentorship, recruitment methodology and training track record of the applicant institution?
Past research training record: Is the past research training record of the Program Director, and designated mentors appropriate for this training program? How successful are former trainees in seeking further career development and in establishing productive scientific careers? Is there evidence of successful completion of programs, receipt of subsequent fellowships and/or career awards, further training appointments, and similar accomplishments? Is there evidence of a productive scientific career, such as a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, appointment to scientific positions, and any other measure of success consistent with the nature and duration of the training received. Do the mentors have a successful track record or training in similar research training programs?
Mentors: Is the caliber of faculty/mentors as researchers, including successful competition for research support in areas directly related to the proposed research training program appropriate for their role in the training program? Is there a sufficient number of experienced mentors with appropriate expertise and research funding available at the applicant institution to support the number of trainees being proposed in the application? Do the mentors have adequate time commitment for the duration of the program?
Advisory Committee: Does the application describe the composition and role of an advisory committee in development of the program, assignment of mentors and projects, development of recruitment strategies, monitoring and evaluating trainee progress?
Evaluation/Tracking: Does the proposed evaluation plan have sufficient detail to evaluate the performance of the Program as a whole (e.g., performance of mentors, extent of faculty participation), and to make changes that improve performance and outcomes? Are there adequate plans to track career outcomes of trainees, including subsequent training, positions held, papers published, grants and awards submitted/obtained, and other relevant information? Are the outcomes clearly identifiable and quantifiable?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed training-related research will be assessed (see the Research Plan, Section F on Human Subjects in the PHS Form 398, Kirschstein-NRSA).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the training-related project, the five items described under Section G of the PHS Form 398 (Kirschstein-NRSA) research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support will be assessed in relation to the proposed research training program and the number of proposed trainees at the requested levels. The priority score should not be affected by the evaluation of the budget.
Recruitment and Retention Plan to Enhance Diversity: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable. Plans will be judged as acceptable or unacceptable, and the result will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. The relevant NIH staff will judge the acceptability of the revised plan.
Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.
The plan will be discussed after the overall determination of merit, and the review panel’s evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable, and the result will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. The relevant NIDCR staff will judge the acceptability of the revised plan.
2.C. Sharing Research
2.D. Sharing Research
1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
For more information and detailed requirements, please refer to the NIH Grants Policy, particularly the section regarding the Institutional Research Training Grants of the Ruth L. Kirschstein National Research Service Awards .
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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm.
Special Administrative Requirements
1. Leave: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director.
A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals 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. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271).
2. Off-site training: Training in another institution may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such training does not exceed three months. For longer periods, prior written approval of NIDCR staff is required. To obtain prior approval, the Program Director must submit a letter to NIDCR Program Staff describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the off-site training is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such training, provided that it relates to the training program.
3. Carryover of Unobligated Balances: NIDCR requires prior written approval for carryover of funds from one budget period to the next. 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, the Program Director should contact the applicable IC’s Grants Management contact to determine the funding IC’s carryover policy.
4. Change of Institution: The Program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment following guidelines for termination as described above, and apply directly to the desired program.
5. Change of Training Program Director: If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIDCR prior approval, provided:
6. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NIDCR Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated by NIDCR Program Staff to ensure that the program remains within the scope of the original peer-reviewed application.
The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure 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. All of these forms are available on the NIH website at http://grants.nih.gov/grants/forms.htm#training.
Progress Reports: Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and annual financial statements as required in the NIH Grants Policy Statement. The NRSA program is not subject to SNAP.
The NRSA instructions for the non-competing grant progress report (starting on page 19, Form 2590) should be followed. Note that a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions.
An evaluation and tracking report as described in Section IV.6. of this announcement should be included annually as part of the Progress Report.
In addition to the required information, the following information should be included:
Financial Status Report (FSR): An annual FSR is required for all Kirschstein-NRSA institutional research training grant awards no later than 90 days after the close of each budget period. This report will document the financial status of the grant according to the official accounting records of the grantee organization. Trainee stipends and tuition are obligated for the full 12-month appointment from the budget period in which the appointment is initiated. Portions of stipends and tuition that extend beyond the budget period are carried over as unliquidated obligations. However, if the report covers the final budget period of the project period, it must have no unliquidated obligations and must indicate the exact balance of unobligated funds (see Administrative Requirements‚ Monitoring‚ Reporting‚ Financial Reports‚ and Administrative Requirements‚ Closeout‚ Final Reports.
Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This form must be completed at the beginning of the initial appointment and annually thereafter.
Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7, Rev. 10/05) 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.
Final Reports: A final progress report and Financial Status Report are required within 90 days after the end of the grant project period or upon relinquishment of an award.
Evaluation: In carrying out its stewardship of human resource-related programs, the NIDCR 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 contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the Program.
Publications and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, PDs and trainees should make the results and accomplishments of their Kirschstein-NRSA institutional training grant activities available to the research community and to the public at large. The grantee organization should assist trainees in these activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results.
Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. Responsibility for direction of the project should not be ascribed to NIH. However, NIH support must be acknowledged by a footnote in language similar to the following: This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number) from the NIDCR. In addition, Federal funding must be acknowledged as provided in Public Policy Requirements and Objectives, Availability of Information‚Acknowledgment of Federal Funding.
Copyrights: Except as otherwise provided in the conditions of the award, when a publication or similar copyrightable material is developed from work supported by NIH, the author is free to arrange for copyright without approval of the NIH awarding office. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce them, translate them, publish them, and use and dispose of them, and to authorize others to do so for Federal government purposes.
Inventions and Patents: All Kirschstein-NRSA institutional research training grants and other funding agreements awarded primarily for educational purposes are not subject to invention reporting requirements nor does NIH have any rights to inventions under those grants and agreements (as specified in 45¬†CFR 74.24(h) and in 37¬†CFR 401.1(b)).
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.
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 Contact:
Kevin S. Hardwick, DDS, MPH
Extramural Training Officer
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS25F
Bethesda, MD 20892
Telephone: (301) 594-2765
FAX: (301) 402-7033
2. Peer Review Contact:
Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AN 32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
3. Financial or Grants Management Contact:
Dede Rutberg, MBA
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN44J
Bethesda, Maryland 20892-6402
Telephone: (301) 594-4798
FAX: (301) 480-3562
Email: firstname.lastname@example.org or email@example.com
Required Federal Citations
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.
Kirschstein-NRSA institutional research training grants involving human subjects must comply with the requirements for their protection (see Public Policy Requirements and Objectives‚ Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services‚ Human Subjects). If the applicant organization has an approved FWA or other applicable assurance on file with OHRP but, at the time of application, plans for the involvement of human subjects are indefinite, the assurance number should be provided on the face page of the application. If an award is made, human subjects may not be involved until a certification of IRB approval or designation of exemption has been submitted.
In many instances, trainees supported by Kirschstein-NRSA institutional research training grants will be participating in research supported by research project grants for which the IRB review is already completed or an exemption is already designated. This review or exemption designation is sufficient, provided the research would not be substantially modified by the participation of a trainee. The appropriate grants must be identified along with their IRB review dates or exemption designation.
Monitoring Plan and Data
and Safety Monitoring Board:
Research involving clinical trials must include provisions to ensure the safety of participants and the validity and integrity of the data. A monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for monitoring and how adverse events will be reported to IRBs, NIH, and FDA. The frequency of monitoring will depend on potential risks, complexity, and the nature of the trial.
NIH specifically requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risks to the subject and, generally, for Phase III clinical trials. Although Phase I and Phase II clinical trials also may use DSMBs, smaller clinical trials may not require this type of oversight, and alternative monitoring plans may be appropriate.
PDs and trainees also should refer to the NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html, Public Policy Requirements and Objectives - Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services Data and Safety Monitoring in Subpart A, and the instructions in the PHS 398 application.
Sharing of Model
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/guide/notice-files/NOT-OD-04-042.html). 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/archive/archive/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 NIH policy that women and members of minority groups and their subpopulations 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 (see Public Policy Requirements and Objectives‚ Requirements for Inclusiveness in Research Design). This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October 2001, is available on the NIH website 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:
NIH policy requires that children (individuals under the age of 21) be included in all human subjects research conducted or supported by NIH, unless there are scientific and ethical reasons not to include them (see Public Policy Requirements and Objectives‚ Requirements for Inclusiveness in Research Design).
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 that is available at 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
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 (see 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.
Use of Animals in
Kirschstein-NRSA institutional research training grants involving use of vertebrate animals must comply with the requirements for their protection specified in Public Policy Requirements and Objectives‚ Requirements Affecting the Right and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services, Animal Welfare.
If the applicant organization has an approved Assurance of Compliance on file with OLAW but, at the time of application, its plans for the involvement of vertebrate animals are so indefinite that IACUC review and approval are not feasible, on the face page of the application, the organization should check Yes, include the animal welfare Assurance of Compliance number, and indicate Indefinite. If an award is made, vertebrate animals may not be involved until verification of the IACUC approval date has been submitted to the NIH awarding office.
In many instances, trainees supported by institutional research training grants will be participating in research supported by research project grants for which the IACUC review already is completed. This review is sufficient, provided the research would not be substantially modified by the participation of a trainee. The appropriate grants must be identified along with their IACUC review dates.
If the applicant organization does not have an approved Assurance of Compliance on file with OLAW or for additional information on vertebrate animals, refer to the PHS 398 or contact OLAW (see Part III).
Recombinant DNA Molecules
and Human Gene Transfer Research:
Institutions receiving Kirschstein-NRSA institutional research training grants involving use of recombinant DNA molecules must comply with the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules (see Public Policy Requirements and Objectives‚ Ethical and Safe Conduct in Science and Organizational Operations‚ NIH Guidelines for Research Involving Recombinant DNA Molecules and Human Gene Transfer Research). The NIH Guidelines, available from NIH's OBA (see Part III), should be consulted for complete requirements for the conduct of projects involving recombinant DNA techniques. The NIH Guidelines are available at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
Public Access to Research
Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards for Privacy of
Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. See http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html for appendix requirements.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of section 487 of the Public Health Service Act as amended (42 USC 288) and administered under Title 42 of the Code of Federal Regulations, Part 66.
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.
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