and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
National Institute of Nursing Research (NINR) ( http://ninr.nih.gov/ )
Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS) http://www.nigms.nih.gov
Title: Predoctoral Training at the Interface of the Behavioral and Biomedical Sciences (T32)
Announcement Type
New
Updates: The following updates relating to this announcement have been issued:
Program Announcement (PA) Number: PAR-06-503
Catalog of Federal Domestic Assistance Number(s)
93.121,
93.172, 93.859
Key Dates
Release Date: July 31, 2006
Letters of Intent Submission
Date(s): August 25, 2007; August 25, 2008
Application Submission Date(s):
September 25, 2007; September 25, 2008
Peer Review Date(s): March 2007;
March 2008; March 2009
Council Review Date(s): May 2007;
May 2008; May 2009
Earliest Anticipated Start
Date(s): July 1, 2007; July 1, 2008; July 1, 2009
Expiration Date: September 26, 2008
Due Dates
for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
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
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
A. Submission, Review and Anticipated Start Dates
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental
Review
5. Funding Restrictions
6. Other Submission
Requirements
Section V. Application Review Information
1. Criteria
2.
Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3.
Anticipated Announcement and award Dates
Section VI. Award Administration Information
1.
Award Notices
2. Administrative and
National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research
Contact(s)
2. Peer Review
Contact(s)
3. Financial/ Grants
Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Training Objectives
The National Institute of General Medical Sciences (NIGMS) announces a new predoctoral NRSA institutional research training grant program to train scientists at the interface of the behavioral and biomedical sciences. The goal of the program is to develop basic behavioral scientists with rigorous broad-based training in the biomedical sciences who are available to assume leadership roles related to the Nation’s biomedical, clinical and behavioral research needs. These programs must include equal participation of both biomedical AND behavioral faculty and leadership, and must provide an interdisciplinary research training experience and curriculum for predoctoral trainees that integrates both behavioral and biomedical perspectives, approaches and methodologies. The primary focus is on providing this training to students with previous behavioral training, and/or who are enrolled in behavioral sciences graduate departments. However, programs can be enriched by including some students with basic biomedical backgrounds and providing cross-training in the behavioral sciences. A definition of behavioral sciences research for NIH can be found at: http://obssr.od.nih.gov/Content/About_OBSSR/BSSR_Definition/.
NIGMS has unique training and program goals and initiatives and it is therefore critical that all applicants consult with the contact at the Institute for current information about program priorities and policies before preparing an application (see Section VII). This action is of utmost importance because applications with marginal or no relevance to NIGMS and this announcement may not be accepted for review or possible funding.
Purpose and Background Information
Behavioral factors are important contributors to health and disease and often interact with biological factors to influence health. In recent years, numerous reports from the NIH and the National Academy of Sciences have concluded that basic behavioral research is critical to the mission of NIH and to understanding the links of molecular, genetic and neural processes with health and disease outcomes [see Report of the Working Group of the NIH Advisory Committee to the Director on Research Opportunities in the Basic Behavioral and Social Sciences; National Research Council(2005) Advancing the Nation’s Health Needs].
These reports identify the need for training future scientists in basic behavioral science that is not targeted to a specific developmental stage or disease, but which is fundamental to a range of diseases and health conditions. Many of the disease or developmental stage-targeted Institutes and Centers (ICs) at NIH currently support behavioral research training in areas specific to the IC’s mission, and inquiries for training grants in targeted areas should be directed to the specific ICs. This program announcement is to support basic behavioral research training that is broad-based, and that transcends the missions of many of the NIH ICs.
Current pressing health problems are increasingly viewed as influenced by complex systems that call for a new approach that integrates advances in behavioral sciences with those of biomedical sciences. Recent initiatives from the NIH Roadmap, for example, encourage interdisciplinary research training to meet future public health needs [http://nihroadmap.nih.gov/interdisciplinary/].
This new institutional NRSA training grant program is designed to integrate training in basic behavioral research with similar rigorous training in biological and the biomedical sciences. As in all of its existing predoctoral training grant programs, the NIGMS promotes interdisciplinary research training designed to provide trainees with broad access to research opportunities across disciplinary and departmental lines. Collaborative involvement of faculty members who are from several different academic units and who conduct research programs in differing disciplines is essential. This program Predoctoral Training at the Interface of the Behavioral and Biomedical Sciences is designed to provide an interdisciplinary research training experience and curriculum for predoctoral trainees that integrates both behavioral and biomedical perspectives, approaches and methodologies. Further information about NIGMS training grant programs and general guidelines for NIGMS predoctoral institutional training grants can be found at http://www.nigms.nih.gov/Training/InstPredoc/PredocTrainingDescription.htm#special.
The overall goal of the NIH NRSA training programs is to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s biomedical and behavioral research agenda. The NRSA program has been the primary means of supporting graduate and postdoctoral research training program since enactment of the NRSA legislation in 1974. More information about NRSA programs may be found at http://grants.nih.gov/training/nrsa.htm.
NIH institutional NRSA research training programs are designed to allow the Program Director to select the trainees and develop a curriculum of study and research experiences necessary to provide high quality research training. The grant offsets the cost of stipends, tuition, fees, applicable health insurance and training related support for the appointed trainees in accordance with the approved NIH NRSA predoctoral support levels.
Special Program Objectives and Considerations
Applicants for this new predoctoral NRSA institutional training grant program need to describe an interdisciplinary program that integrates training in the conceptual models, methods and approaches of both behavioral and biomedical sciences. This should be a joint effort between the faculty and leadership of departments from both sides of this interface which could include, but is not limited to, departments of psychology, anthropology, behavior, demography, and economics on the behavioral side, and departments of biology, physiology, cellular and/or molecular biology, pharmacology, neuroscience, biochemistry, biophysics, immunology, genetics, and biomedical engineering on the biomedical side. One of the main challenges in this training program is to bridge scientific cultural differences between disciplines. The requirements of this announcement are intended to be sufficiently flexible to allow applicant institutions to tailor their proposed training program to take advantage of the resources available to them and the areas of strength at their institutions.
To promote these goals, NIGMS asks all applicants to address the following items and challenges:
In addition, applicants should refer to the
NIGMS-specific guidelines for predoctoral institutional training grant
applications published on the NIGMS webpage at: http://www.nigms.nih.gov/Training/InstPredoc/PredocTrainingDescription.htm#special . This site includes
instructions for preparing an application to NIGMS including:
1. Six items that must be addressed in a section
entitled Special Requirements to be inserted at the end of Section 8.A.
Background of the PHS 398 application:
2. Suggested formats (tables) for organizing the requested data
3. Additional suggestions for NIGMS training grant applications to enhance the training experience. If relevant, descriptions of these activities in the training grant application would be appropriate:
1. Mechanism(s) of Support
This funding opportunity
will use the Ruth L. Kirschstein National Research Service Award (NRSA) T32
award mechanism. Predoctoral institutional training grant funds are intended to
support trainee stipends; partially cover tuition, fees, and health insurance;
and provide modest sums for equipment, supplies, and travel to scientific
meetings. Predoctoral trainees may receive up to five years of support under
the NRSA provisions. However, the normal period of support for trainees on
NIGMS institutional predoctoral training grants is between one and three years,
and is typically offered in the early years of training to provide students
with flexibility to select courses, laboratory rotations, and mentors.
Awards may be made for periods up to 5 years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years based on satisfactory progress, the submission of all required forms, and the continued availability of funds. Information on the policies governing the institutional predoctoral training grant awards, including notification, tenure, trainee eligibility, and other provisions, may be found on the NIH home page at http://grants.nih.gov/training/extramural.htm.
As an applicant, you will be solely responsible for planning, directing, and
executing the proposed research training program.
This funding opportunity uses the non-modular budget format described in the
PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds Available
NIGMS anticipates awarding 5 to 10 training grants starting in July 2007. Because the nature and scope of the proposed research training programs will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NIGMS provides 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 cost policies and the NRSA Guidelines (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.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 DHHS Cost Principles, the NIH Grants Policy Statement (rev. 12/01/2003), the NRSA regulations, policies, and guidelines, and conditions set forth in this document.
Allowable Costs:
A. Stipends:
Stipends are provided as a subsistence allowance for trainee to help defray living expenses during the research training experience. The stipend is not 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 . The total stipend must be based on a 12-month appointment. 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 annually 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-06-026.html for specific information).
B. Tuition, Fees, and Health Insurance
The NIH will offset the combined costs of tuition, fees and health insurance (either self-only or family as appropriate) at the rate in place at the time of award. Currently NIH provides 100% of all costs up to $3,000 and 60% of costs in excess of $3,000 per trainee. 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 is in the NIH Grants Policy Statement and on the NIH website at: http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm.
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. NIGMS currently provides an annual amount of $300 per trainee for travel.
D. Trainee Related Expenses (TRE)
The applicant institution may request the NIH standard NRSA Training Related Expenses of $2,200 annually for each predoctoral trainee to help defray other research training expenses, such as staff salaries, consultant costs, research supplies, and faculty/staff travel directly related to the research training program (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-026.html for additional information).
E. Facilities and Administrative Allowance
A facilities and administrative allowance based on 8% of modified total direct costs (exclusive of tuition and fees, health insurance, 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.
Stipend Supplementation: 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: 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.
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. Postdoctoral trainees in their first and third years of training may also be eligible to participate in the NIH Extramural Loan Repayment Program.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application if your organization has any of the following characteristics:
Only domestic, non-profit, private or public institutions may apply for grants to support the Institutional NRSA research training programs. Foreign institutions are not eligible to apply. 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 on site to conduct the proposed research training program.
An
eligible institution (e.g., a university) may submit only a single application
in response to this funding opportunity. For the purposes of this PA,
components of a large or multi-component organization that are sufficiently
independent to constitute, in effect, separate organizations are considered
separate institutions. For example, the multiple campuses of the University of California system are considered separate institutions. However, the medical
school, engineering school, dental school, etc., of a university, even if on
different campuses, constitute a single institution. Multiple applications from
different divisions, faculties, schools, centers, etc., at the same institution
will not be reviewed.
1.B.
Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
The Program Director should be an established researcher with a successful past training record, and available resources to conduct the proposed research training program at the institution. Successful programs should have a Program Director with acknowledged accomplishments in research and training at the behavior-biomedical interface, or a program director and co-director who together provide appropriate experience from both sides of the interface. The Program Director will be responsible for the selection and appointment of trainees to the NRSA training grant and for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner.
2. Cost Sharing or Matching
Cost sharing is not
required
3. Other-Special Eligibility Criteria
Training Program
The intent of this PA is to establish training programs that are broad-based, multi-departmental and interdisciplinary, rather than focused upon a specific disease or developmental stage. The application should include evidence that the training program meets these objectives. Trainees appointed to the research training program must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career at the behavior-biomedical research interface. Programs must provide an interdisciplinary research training experience and curriculum for predoctoral trainess that integrates both behavioral and biomedical perspectives, approaches and methodologies. Training programs must include coursework, laboratory rotations and programmatic activities that reinforce training at this interface. 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 40 hours per week 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. Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at the postbaccalaureate level and be enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program.
Trainee positions on NRSA institutional grants may not be used for study 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 degree program, such as the M.D./Ph.D. 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 or subspecialty.
Trainee Citizenship
Individuals appointed to 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.
Mentors
Successful programs should provide co-mentoring of trainees by faculty from both the behavioral and biomedical sciences.
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. The institution should provide evidence that it is committed to integrating this training program into the academic programs of the institution. The application must include statements from the appropriate administrators and/or deans outlining how the proposed training program contributes to the broader vision of the institution with respect to faculty recruitment, curriculum development, and other relevant existing NIH training grants.
Section IV. Application and Submission Information
1.
Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo,,
Telephone (301) 710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms (http://grants.nih.gov/grants/funding/phs398/phs398.pdf.)
Applicants must use the T32 guidelines and the specific instructions for
Institutional NRSA Applications, PHS 398, Section IV, which begins on page 54.
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.
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.
In addition, applicants should refer to the NIGMS-specific guidelines for predoctoral institutional training grant applications published on the NIGMS webpage at: http://www.nigms.nih.gov/Training/InstPredoc/PredocTrainingDescription.htm#special
This site includes instructions for preparing an application to NIGMS including six items that must be addressed (in a section entitled Special Requirements to be inserted at the end of Section 8.A. Background of the PHS 398 application) and suggested formats (sample tables) for organizing the requested data. Applicants should refer to the information on page 6 of this PA which lists the 6 items.
3. Submission Dates and Times
Applications must be submitted on or before the application receipt/submission dates described below (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Submission Date(s): August 25, 2007; August 25, 2008
Application
Submission Date(s): September 25, 2007; September 25, 2008.
Peer
Review Date(s): March 2007; March 2008; March 2009
Council
Review Date(s): May 2007; May 2008; May 2009
Earliest
Anticipated Start Date(s): July 1, 2007; July 1, 2008; July 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 at the beginning of this document.
The letter of intent should be sent to:
Alison
Cole , Ph.D.
Deputy Assistant Director for Research Training
National Institute of General Medical Sciences
45 Center Drive , Room 2AS-49K, MSC 6200
Bethesda , MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application and the specific NRSA
institutional grant application instructions that begin on page 54 of the PHS
398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Submit a signed, typewritten original of the
application, including the checklist, and five 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).
3.C.
Application Processing
Applications must be submitted on or before the
application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt applications will be evaluated for completeness by CSR.
Incomplete applications will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous critique.
Information on the
status of an application should be checked by the Program Director in the eRA
Commons at: https://commons.era.nih.gov/commons/ .
4. Intergovernmental Review
This initiative is not subject
to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are not allowable
charges for either stipends or tuition on institutional training grants since
stipends and tuition costs may not be charged to the grant before the trainee
appointment is actually made. However, the policies governing the pre-award
cost authority for the expenditure of the other funds provided in a training
grant are those permitted in the NIH Grants Policy Statement as follows:
A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
continuation award if such costs are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
The National Research Service Award (NRSA) policies apply to this program. Awards are contingent upon availability of funds. Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations. Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.
Concurrent awards: An NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.
Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.
The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws 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
NIGMS does not require applicants requesting $500,000 (direct costs) or more per year to
obtain advance agreement from IC staff that the IC will accept your application
for consideration for award. However, NIGMS strongly encourages applicants for
this funding opportunity to contact staff listed in Section VII as early as
possible (i.e. as you are developing plans for the training grant application) to
answer questions
Special Program Requirements:
Research Training Program: These programs must provide an interdisciplinary research training experience and curriculum for predoctoral trainees that integrates both behavioral and biomedical perspectives, approaches and methodologies. These training programs must include coursework, laboratory rotations and programmatic activities that reinforce training at this interface. Significant participation by faculty and leadership from both behavioral and biomedical science departments is required, as is co-mentoring of trainees by faculty from both components.
The program should provide didactic training as well as laboratory research experience. This should include a plan for determining trainee experience and needs, and monitoring progress to accomplish desired goals. The program should develop trainee skills in understanding research, applying their critical abilities to conduct research, identify problems in the process of conducting research, raise questions and propose solutions to resolving problems. Trainees should be prepared to utilize their research findings as they pursue future training and scientific investigation. Trainees should have adequate quantitative backgrounds relevant to the proposed training; if matriculants to the program do not have adequate quantitative training, the application should describe how this training will be provided by the program. The program should provide all NRSA trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. .
Program Director: The Program Director must possess the scientific background, leadership skills 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 approved research training 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.
Past Training Record: This should describe the past research training record of the program, the Program Director, and designated preceptors/mentors. The information should describe the success of former trainees of the designated preceptors/mentors in seeking further career development and in establishing productive scientific careers. Evidence can include successful completion of programs, further career advancement of former trainees such as receipt of fellowships, career awards, further training appointments and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other 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. 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 NIH awarding unit, or when trainees are appointed to approved, short-term training positions.
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 NIGMS based on a review of the written justification from the individual trainee, and endorsed by the Program Director, and the sponsoring grantee institution. Trainees seeking additional support are strongly advised to consult with the NIH awarding office.
Trainees supported by NRSA funds are not considered to be in an employer-employee relationship with NIH or the institution at which they are pursuing research training.
Research Environment/resources: 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 program.
Institutional Commitment: The applicant institution should include information that documents a commitment to the proposed research training program’s goals, and provide assurance that the institution intends the program to be an integral part of its research and research training endeavor. The application should include a description of support (financial or otherwise) to be provided to the program, which could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director and participating faculty, support for additional trainees in the program, or any other creative ways to improve and enhance the growth of the research training program. The application must include statements from the appropriate administrators and/or deans outlining how the proposed training program contributes to the broader vision of the institution with respect to faculty recruitment, curriculum development, and other relevant existing NIH training grants.
Evaluation and Tracking Component: The application must describe a strong evaluation and tracking component that will review and determine the effectiveness of all aspects of the program. This should include a system for tracking trainees for a 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 career trajectory 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.
Recruitment Plan: Applicants must submit a recruitment plan that includes a scheme for recruiting trainees from both outside and inside their sponsoring institutions. The application should describe any recruitment and outreach 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.
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 http://www.nsf.gov/sbe/srs/women/start.htm) In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.
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 NIGMS, with guidance from the National General Medical Sciences Advisory Council, will determine whether amended plans and reports submitted after the initial review are acceptable.
This Program Announcement 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.
Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students appointed to the program.
Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.
Plan for Sharing Research Data
Not applicable.
Sharing Research Resources
Not applicable.
Section V. Application Review Information
1. Criteria
Not applicable.
2.
Review and Selection Process
Applications submitted for this funding opportunity will be assigned to
the NIGMS on the basis of established PHS referral guidelines. Upon receipt,
applications will be reviewed for completeness by the Center for Scientific
Review. Incomplete applications will not be reviewed. Applications that are
complete will be evaluated for scientific and technical merit by an appropriate
scientific review group convened by NIGMS in accordance with the standard NIH
peer review procedures (http://www.csr.nih.gov/refrev.htm)
stated below.
As part of the initial merit review, all applications:
The following will be considered in making funding decisions:
The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the proposed research training program and then consider whether the requested number of trainee positions is appropriate for the program.
The research training applications for this funding opportunity will be evaluated using the following criteria:
Training Program:
Training Program Director and Administrative Structure:
Preceptors/Mentors:
Past Training Record:
Institutional Training Environment, Commitment, and Resources:
Trainee Recruitment, Selection, and Retention Plan:
Evaluation and Tracking Plan:
As detailed earlier in this announcement and as described on the NIGMS webpage (http://www.nigms.nih.gov/Training/InstPredoc/PredocTrainingDescription.htm#special), applications for this research training opportunity must address six specific items in a section entitled Special NIGMS Requirements to be inserted at the end of Section 8.A. Background of the PHS 398 application. From this section reviewers will specifically evaluate:
1. Does the application adequately describe the mission and objectives of the program to be supported by the training grant and whether it fulfills the objectives of this funding opportunity?
2. Does the application describe how the proposed training grant fits into the institution’s overall graduate training programs and how it is unique from other existing predoctoral training programs?
3. Does the application describe collaborative and interdisciplinary features of the proposed training program?
4. Does the application describe any innovative features or activities that will be provided for trainees?
5. Do the prospective trainees have adequate quantitative backgrounds relevant to the proposed training to pursue cutting-edge behavioral/biomedical research? Does the training program have adequate means to ensure that students have appropriate quantitative graduate training?
6. Does the training program provide opportunities for exposure to topics related to human health, physiology, and disease?
2.A.
Additional Review Criteria:
In addition to
the above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support will be assessed in
relation to the proposed research training program. 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 NIGMS, with guidance from the National General Medical Sciences Advisory Council, will determine whether amended plans submitted after the 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, 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. NIGMS program staff will judge the acceptability of the revised plan.
Following initial review, the National General Medical Sciences Advisory Council also reviews applications. This advisory group will consider the assessment of the scientific and educational merit of the research training grant application as well as the initial review group’s comments on the recruitment of individuals from underrepresented minority groups and the plan for instruction in the responsible conduct of research.
2.C.
Sharing Research Data
Not applicable.
2.D. Sharing Research
Resources
Not applicable
3. Anticipated Announcement and Award Dates
Not applicable.
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the
application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official (designated in item 12 on the
Application Face Page). If a grantee is not email enabled, a hard copy of the
NoA will be mailed to the business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy
Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
Special
Administrative Requirements associated with NRSA programs:
Leave Policies: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-06-468.html for further guidance regarding vacations and requested leave.
Part-time Training: Under unusual and pressing personal circumstances, a Program Director may submit a written request to the awarding component to change a trainee appointment to less than full-time. Such requests will be considered on a case-by-case basis and must be approved by the awarding Institute in advance for each budget period. The nature of the circumstances requiring part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee’s position at the institution. In each case, the Program Director must submit a written request countersigned by the trainee and an appropriate institutional business official that includes documentation supporting the need for part-time training The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the trainee intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the research training program. In no case will it be permissible for the trainee to be engaged in NRSA supported research training for less than 50% effort. Individuals who must reduce their commitment to less than 50% effort must take a leave-of-absence from NRSA training grant support. The stipend will be pro-rated in the grant award during the period of any approved part-time training.
Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval by NIGMS. 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 NIGMS Grants Management Specialist to determine the NIGMS carryover policy.
Termination of Award: When a grantee institution plans to terminate an award, the NIGMS must be notified in writing as soon as possible.
Change of Institution: 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), located at http://grants.nih.gov/grants/forms.htm.
Change of Training Program Director: If change of a Training Program Director (TPD) is necessary, support of the award is not automatic but may be continued with prior written approval by the NIGMS, provided that the following conditions are met. The current TPD or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to NIGMS program staff describing the reasons for the change. The Biographical Sketch of the proposed TPD, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new TPD and that the new TPD has the appropriate research and administrative expertise to lead the training program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.
Change of program: A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. Any change requires prior approval by program staff of the NIH funding component. If the new program does not satisfy this requirement, the award will be terminated.
All NIH Grant and cooperative agreement awards include the NIH Grants Policy
Statement as part of the notice of grant award. For these terms of award, see
the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant
Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.
3. Reporting
Awardees
will be required to submit the PHS Non-Competing Grant Progress Report, Form
2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and annual financial statements as required in the NIH Grants Policy Statement.
This 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.
Additional information that should be included in the annual progress report in concert with the PHS 2590 instructions:
A brief introductory description of the program objectives;
Information describing which, if any, faculty and/or mentors have left the program and which, if any, new individuals have been added; for new faculty and/or mentors involved in the program, biographical sketches should be included in the application.
A detailed account of experiences in recruiting individuals from under-represented groups during the previous funding period must be included. Information must document both successful and unsuccessful recruitment strategies, including aggregated information on the distribution of:
Information on the distribution of predoctoral trainees in each of these categories should include the SUM totals for ALL under-represented groups (A, plus, B, plus, C) defined in Section IV.6 and specific information about the numbers or predoctoral trainees in each of the under-represented groups (A, B, C). Individual should be counted only once, in either group A, B, or C, not in multiple groups even though they may qualify as a member of more than one group.
Any recommended changes to improve the program (e.g., new mentors, changes in courses, recruitment strategies, etc.)
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 Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. No funds may be provided until such documents are submitted and accepted by the funding Institute.
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 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.
Inventions and Publications: 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 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.
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:
Alison E. Cole, Ph.D.
Deputy
Assistant Director for Research Training
National
Institute of General Medical Sciences
45 Center
Drive,
Room 2AS.49K
Bethesda, MD 20892-6200
Telephone:
(301) 594-3827
FAX: (301) 480-2802
Email: [email protected]
2. Peer Review Contacts:
Helen R. Sunshine, Ph.D
Office
of Scientific Review
National
Institute of General Medical Sciences
45
Center Drive, Room 3AN.12F
Bethesda, MD 20892-6200
Telephone:
(301) 594-5520
FAX: (301) 480-8506
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Lisa Moeller
Grants
Management Branch
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.50C, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-3914
FAX: (301) 480-2554
E-mail: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
Investigators submitting
an NIH application seeking $500,000 or more in direct costs in any single year
are expected to include a plan for data sharing or state why this is not
possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public funding.
The inclusion of a model organism sharing plan is not subject to a cost
threshold in any year and is expected to be included in all applications where
the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require for
all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children
as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on
the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH
Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author’s final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author’s final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors Manual(http://publicaccess.nih.gov/publicaccess_Manual.htm
Access
to Research Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Standards for Privacy
of Individually Identifiable Health Information:
The Department of Health
and Human Services (DHHS) issued final modification to the "Standards for
Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996
that governs the protection of individually identifiable health information,
and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html
URLs in NIH Grant
Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. 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 PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
(Be sure to cite any additional appropriate authorizations, regulations
or policies below)
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the authorization
of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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