INTERDISCIPLINARY HEALTH RESEARCH TRAINING: BEHAVIOR, ENVIRONMENT AND 
BIOLOGY

RELEASE DATE:  November 17, 2003

RFA Number:  RFA-RM-04-010  (reissued as RFA-RM-05-010)  
                            (formerly RFA-MH-04-007, see NOT-OD-04-008)

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

This RFA is developed as an NIH Roadmap initiative 
(http://nihroadmap.nih.gov/). All NIH Institutes and Centers participate 
in Roadmap initiatives. The RFA will be administered by the National 
Institute of Mental Health (NIMH) on behalf of the NIH.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.282

LETTER OF INTENT RECEIPT DATE:  February 11, 2004
APPLICATION RECEIPT DATE:  March 11, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Program Objectives
o  Specific Objectives
o  Mechanism of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Program Directors
o  Special Requirements
o  Allowable Costs
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS RFA

The Institutes, Centers and Offices of the National Institutes of 
Health invite applications for Interdisciplinary Health Research 
Training: Behavior, Environment and Biology.  This institutional, 
postdoctoral National Research Training Award (NRSA) will support the 
establishment of programs that provide formal coursework and research 
training in a new interdisciplinary field to individuals holding 
advanced degrees in a different discipline.  These training programs 
are required to include a behavioral or social science discipline, and 
we are especially interested in programs that integrate the behavioral 
and/or social sciences with the more traditional biomedical sciences.  
We encourage the development of programs that accept postdoctoral 
trainees with varied research backgrounds, provide multiple tracks of 
research training that enhance each trainee’s development of new, 
interdisciplinary knowledge and skills, while supporting opportunities 
for trainee interaction and research integration across the research 
tracks.

The overall goal of NRSA training programs is to ensure that highly 
trained scientists will be available in adequate numbers and in 
appropriate scientific areas to carry out the Nation’s biomedical and 
behavioral health research agenda.  Many of our most pressing health 
problems involve disease processes that are influenced by biological, 
behavioral, and social environment factors.  The purpose of this NRSA 
program is to help ensure the development of a cadre of scientists with 
the requisite skills and knowledge to integrate multiple scientific 
approaches and to work in interdisciplinary research teams to solve 
these complex health problems.

PROGRAM OBJECTIVES

The National Institutes of Health (NIH) are engaged in a series of 
activities collectively known as the “NIH Roadmap” whose goal, in 
keeping with the NIH mission of uncovering new knowledge about the 
prevention, detection, diagnosis, and treatment of disease and 
disability, is to accelerate both the pace of discovery in these key 
areas and the translation of therapies from bench to bedside.  In the 
course of developing the NIH Roadmap, it has become clear that 
increasingly, scientific advances are being made at the interfaces of 
traditional disciplines, and that approaches to science are becoming 
more integrative.  This requires a cooperative effort, typically in the 
form of investigators from diverse research backgrounds working 
collectively across traditional disciplinary boundaries to answer 
scientific questions and achieve specific endpoints.  This also 
requires a workforce capable of crossing disciplinary boundaries and 
leading and participating in integrative and team approaches to complex 
health problems.  Building research teams for the future has therefore 
emerged as one of the major themes in Roadmap implementation.  
(Additional information about the NIH Roadmap can be found on the NIH 
website at http://nihroadmap.nih.gov/index.asp.)

NIH is particularly interested in developing a new interdisciplinary 
research workforce.  An interdisciplinary approach is distinguished 
from a multidisciplinary approach in that a multidisciplinary approach 
brings experts from diverse disciplines to address collectively a 
common complex problem, each from his or her unique perspective.  By 
contrast, an interdisciplinary approach is what results from the 
melding of two or more disciplines to create a new (interdisciplinary) 
science.  Biophysics, biostatistics, bioinformatics, bioengineering, 
social neuroscience, biodemography, behavioral economics and 
psychoneuroimmunology are just some examples of existing 
interdisciplinary sciences.  NIH recognizes the value and enormous 
contributions that existing interdisciplinary approaches have made and 
are making to our understanding of health, disease, and disability.  
However, the Roadmap is focused on developing new interdisciplinary 
approaches and therefore the necessary interdisciplinary workforce.  

NIH is proposing a series of initiatives that aim to provide 
investigators with the training to effectively lead and engage in 
integrative and team approaches to complex biomedical problems.  These 
initiatives fall into three categories: programs for long-term 
interdisciplinary research training; short-term courses and research 
experiences; and curriculum development.  Collectively, the initiatives 
provide opportunities for integration of disciplines at all stages of 
investigators’ careers, facilitate communication among the disciplines, 
and ensure the development of necessary infrastructure to accomplish 
the building the workforce for the research teams for the future.  
Common features of the proposed initiatives include having: 
comprehensive integrative approaches to solving complex health 
problems; developing and implementing new curricula that integrate 
disparate disciplines; activities that promote cohesiveness among 
training program participants at all levels (faculty-student, student-
student, and faculty-faculty); inclusion of training in the personal 
and professional skills necessary to lead and participate in 
multidisciplinary teams; outreach to the under-represented minority 
community to ensure their participation; monitoring of student progress 
and outcome; and self-evaluation of the training program.  

NIH recognizes that multidisciplinary approaches may be a necessary 
step in the evolution of interdisciplinary research training, and 
currently offers many opportunities and mechanisms to support 
multidisciplinary research training.  Thus, for the purposes of the 
Roadmap’s interdisciplinary research training RFAs (including this 
RFA), activities that facilitate communication among different 
disciplines, promote but perhaps do not completely achieve integration 
of different disciplines in the proposed project period, or propose 
training in multidisciplinary approaches as a precursor to 
interdisciplinary research training, are acceptable if they include a 
detailed plan with appropriate milestones for achieving the Roadmap 
goal of developing interdisciplinary research training.  

SPECIFIC OBJECTIVES

Numerous reports from the NIH and the National Academies of Science 
have concluded that in order to successfully advance our understanding 
of health and disease, researchers will need to integrate multiple 
disciplinary perspectives, methodologies and levels of analysis.  
Common to these reports is a recommendation to increase 
interdisciplinary research training. (See list of reference reports and 
associated URLs below.)

Interdisciplinary research and training are not new concepts.  There 
are many instances of the integration of disciplines in trying to meet 
scientific challenges, and of programs that provide interdisciplinary 
research training.  However, what each of the recent reports indicates 
is lacking, and therefore is needed, is research training that 
integrates three primary areas of science -- biology, behavior, and the 
social environment. Examples of research areas that might benefit from 
such an interdisciplinary approach include, but are not limited to, the 
following:

o  The mechanisms by which interactions between genetics and the 
environment influence molecular, cellular, and organismal function, 
thus impacting physiology and health 

o  Elucidation of the biological mechanisms by which racial, ethnic, 
socioeconomic and gender inequality affects physiology (at all levels) 
and thus, health outcomes

o  The study of mental disorders by approaches that integrate 
neuroscience, genetics, behavioral science, computational 
science/modeling, and clinical sciences, using both animal models of 
these disorders and human populations, to understand the confluence of 
genetic, biological, behavioral and environmental factors involved in 
the etiology, treatment and prevention of these disorders

o  Cognitive rehabilitation, which can be addressed by merging 
cognitive neuroscience, physical and occupational therapy, and clinical 
neurology

o  Management of the multiple conditions of senescence: clinical 
symptoms (cardiovascular, neurological, and endocrine changes; frailty, 
cancer) in light of age-associated changes in psychological and social 
factors

o  Treatment of drug addition based on the translation of basic 
behavioral science, cognitive and affective and social neuroscience 
research into novel behavioral therapies

o  Understanding the roles of biological, social and psychological 
factors in the etiology and maintenance of conditions with pain as a 
primary symptom

o  The regulation of energy balance, as determined by genetics, neural 
and endocrine function, and behavioral, societal and cultural factors

o  The influence of social interactions on health and disease

In order to work collaboratively to tackle these complex health-related 
problems, researchers will need training in the conceptual models and 
methods of disciplines that address these different areas of influence.  
Moreover, progress in integrating these scientific fields requires 
quantitative capabilities to link across multiple levels of analysis 
(molecular, genetic, cellular, physiological, cultural, social, 
community, population) and improved modeling to allow for prediction of 
outcomes – multi-directionally and among all intermediate steps between 
the molecular and population levels.

For this NRSA we envision programs that will provide formal coursework 
and research training in a new discipline for individuals holding 
advanced degrees in a first field. The postdoctoral fellows and the 
program faculty are expected to represent multiple disciplines so that 
the trainees’ benefits will accrue not simply from instruction in 
another field, but from a rich, integrative research environment 
created by established investigators working collaboratively in an 
interdisciplinary fashion. One of the program disciplines must be in 
the behavioral or social sciences and we are especially interested in 
programs that integrate the behavioral and/or social sciences with more 
traditional, biomedical disciplines (e.g., genetics, molecular biology, 
cell biology, physiology, immunology, biochemistry, neuroscience, 
genomics, etc.). A definition of behavioral and social sciences 
research for the NIH can be found at 
http://obssr.od.nih.gov/funding/definition.html.

For example, a program centered on gene-social environment interactions 
could be designed to accept trainees with genetics, cell and molecular 
biology, social psychology and computational science backgrounds.  
Individuals would receive training in fields different from their own 
and the program as a whole would provide opportunities for all trainees 
to engage in integrative research seminars and broad discussion of 
gene-environment interactions and health.  These individuals would 
emerge from such a program poised to work collaboratively to model the 
influence of the social environment on gene expression, cellular 
function and ultimately, physiology and health. Another example might 
be a program that trained a gerontologist in epidemiology, an 
epidemiologist in cognitive neuroscience and a cognitive neuroscientist 
in gerontology, economists and demographers in behavior genetics and or 
neuroscience, to facilitate the design of epidemiological surveys of 
the elderly to include measures of age-related changes in brain 
function and cognition and the impact of changing cognition on decision 
making in the areas of health and finances.  A program focused on the 
health effects of stress might provide training in the neural and 
endocrine regulation of the stress response, the interactions between 
stress and the immune system, and the impact of the social environment 
on stress and immune system function.  Trainees emerging from such a 
program will be competent to lead an interdisciplinary research team 
working on the mechanisms by which psychosocial interventions prevent 
the immunosuppression that often results from chronic stress. A program 
focused on obesity and type II diabetes might train individuals from 
various disciplinary backgrounds in metabolic endocrinology and energy 
balance, the genetics of obesity, and the role of psychosocial factors 
in the development and treatment of obesity and diabetes.  Trainees 
completing such a program would be suited to function in highly 
interdisciplinary teams to take advantage of the integrated knowledge 
and approaches from multiple disciplines in developing more effective 
obesity and diabetes prevention and treatment strategies.

Reference reports:

Institute of Medicine (2000) Bridging the Disciplines in the Brain, 
Behavioral and Clinical Sciences.  Committee on Building Bridges in the 
Brain, Behavioral and Clinical Sciences.  TC Pellmar and L Eisenberg, 
eds.  Division of Neuroscience and Behavioral Health. Washington, DC: 
National Academy Press. 
http://books.nap.edu/books/0309070783/html/index.html

Institute of Medicine (2001) Exploring the Biological Contributions to 
Human Health: Does Sex Matter? Committee on Understanding the Biology 
of Sex and Gender Differences. TM Wizemann and M-L Pardue, Eds. Board 
on Health Sciences Policy. Washington, DC: National Academy Press. 
http://books.nap.edu/books/0309072816/html/index.html

Institute of Medicine (2001) Health and Behavior: The Interplay of 
Biological, Behavioral, and Societal Influences.  Committee on Health 
and Behavior: Research, Practice and Policy, Board on Neuroscience and 
Behavioral Health.  Washington, DC: National Academy Press.
 http://books.nap.edu/books/0309070309/html/index.html

National Institute of Mental Health (1999) Bridging Science and 
Service. http://www.nimh.nih.gov/research/bridge.pdf

National Institute of Mental Health (2000) Translating behavioral 
science into action. http://www.nimh.nih.gov/council/bswreport.pdf 

National Research Council (2000) Addressing the Nation’s Changing Needs 
for Biomedical and Behavioral Scientists. Committee on National Needs 
for Biomedical and Behavioral Scientists. Washington, DC: National 
Academy Press. http://www.nap.edu/books/0309069815/html/

National Research Council (2001) New Horizons in Health: An Integrative 
Approach.  Committee on Future Directions for Behavioral and Social 
Sciences Research at the National Institutes of Health. BH Singer and 
CD Ryff, Eds. Commission on Behavioral and Social Sciences and 
Education. Washington, DC: National Academy Press.
http://books.nap.edu/books/0309072964/html/index.html

National Research Council (1997) Between Zeus and the Salmon: The 
Biodemography of Longevity. Committee on Population. K.W. Wachter and 
C.E. Finch, Eds. Commission on Behavioral and Social Sciences and 
Education. Washington, DC: National Academy Press.
http://books.nap.edu/catalog/5740.html

National Research Council (2001) Cells and Surveys: Should Biological 
Measures Be Included in Social Science Research? Committee on 
Population. C.E. Finch, J.W. Vaupel, and K. Kinsella, Eds. Commission 
on Behavioral and Social Sciences and Education. Washington, DC: 
National Academy Press. http://books.nap.edu/catalog/9995.html

MECHANISM OF SUPPORT

This RFA will use the Ruth L. Kirschstein National Research Service 
Award (NRSA) Institutional Research Training Grants (T32) mechanism.  
This award will only support postdoctoral trainees.  The applicant will 
be solely responsible for planning, directing and executing the 
proposed project.  The earliest anticipated start date for award of 
grants under this RFA is September 30, 2004.  Applications that are not 
funded in the competition described in this RFA may be resubmitted as 
NEW investigator-initiated applications using the standard receipt 
dates for NEW applications described in the instructions to the PHS 398 
application.

This RFA uses just-in-time concepts.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE

The National Institutes of Health intend to commit approximately $2.1 
million in fiscal year 2004 to fund approximately 6-8 training programs 
with 4-5 training slots/program in response to this RFA.  The total 
project period for an application submitted in response to this RFA may 
not exceed 5 years.  Because the nature and scope of proposed program 
may vary, it is anticipated that the size of each award will vary.  
Awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of applications of 
outstanding scientific and technical merit.  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 
beyond the initial year are determined by the success as described in 
the annual progress report, the timely submission of all required 
forms, and the availability of funds.  This RFA may be re-issued in the 
future if it is determined that such interdisciplinary research 
training remains relevant to the mission of each Institute.

ELIGIBILE INSTITUTIONS

Because training program applications in response to this RFA have 
special eligibility requirements, application formats, and review 
criteria, it is critical that prospective applicants consult with the 
program staff listed under INQUIRIES. Prospective applicants should 
also consult the NRSA Guidelines 
(http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm) and the 
omnibus NIH NRSA Institutional Research Training Grants Program 
announcement 
(http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html). 

Applications may be submitted by domestic, non-profit organizations, 
public and private, such as universities, colleges, medical schools, or 
from comparable institutions of higher education that have strong, 
well-established research and training programs. Foreign institutions 
are not eligible for NRSA institutional research training grants. The 
applicant institution must have adequate numbers of highly trained 
faculty researchers in the biomedical, behavioral, social and/or 
computational sciences. The environment must stimulate and allow for 
interactions among the involved disciplines and support cross-
disciplinary research opportunities.  Proposals from multiple 
institutions working collaboratively are encouraged.

INDIVIDUALS ELIGIBLE TO BECOME PROGRAM DIRECTORS

The Program Director must be an established researcher with 
acknowledged accomplishments in interdisciplinary research and 
training, and be capable of providing both administrative and 
scientific leadership to the program. Individuals from racial and 
ethnic minority groups as well as individuals with disabilities are 
always encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

Trainees:  Individuals selected to participate in these training 
programs must be citizens or non-citizen nationals of the United 
States, or have been lawfully admitted to the United States for 
permanent residence and have in their possession an Alien Registration 
Receipt Card (I-151 or I-551) or other legal verification of admission 
for permanent residence at the time of appointment to the training 
program.  Non-citizen nationals are persons born in lands that are not 
States but are under U.S. sovereignty, jurisdiction, or administration 
(e.g., American Samoa).  Individuals on temporary or student visas are 
not eligible for NRSA support.

Postdoctoral trainees must have received, as of the beginning date of 
the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral 
degree from an accredited domestic or foreign institution.  Other 
eligible doctoral degrees include, but are not limited to, the 
following: D.M.D., D.C., D.O., D.V.M., O.D., Dr.P.H., D.S.W., D.P.M., 
Sc.D., D.Eng., Pharm.D., Psy.D., D.N.Sc., or N.D. (Doctor of 
Naturopathy).

Individuals currently supported by other Federal funds are not eligible 
for trainee support from these programs at the same time.  Further, 
NRSA fellowships are not given for study leading to a M.D., D.O., 
D.D.S., or other similar professional clinical degree, or master’s 
clinical degree.

Similarly, trainees may not accept NRSA support for studies that are 
part of residency training leading to clinical certification in a 
medical specialty or subspecialty.  However, funds provided by this 
award may be used to support full or partial completion of a Master’s 
degree or certificate program in a health-related research field (e.g., 
M.S., M.P.H.).  Additional information may be obtained in the NRSA 
Guidelines at: 
http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm. 

Trainees are customarily appointed for full-time, 12-month continuous 
periods.  All trainees are required to pursue their research training 
on a full-time basis, at a minimum of 40 hours per week.  The amount of 
the stipend and tuition (defined for the purposes of NRSA as the 
cumulative amount of tuition, all fees, and health insurance) for each 
full appointment period must be obligated from funds available at the 
time the individual begins training.  See 
http://grants.nih.gov/grants/guide/notice-files/not96-020.html for 
additional details on allowable stipend/tuition fees.

By law, an individual trainee may receive no more than 5 years of NRSA 
support in the aggregate at the predoctoral level, and no more than 3 
years of NRSA support in the aggregate at the postdoctoral level.  
Exceptions to this limitation require a waiver from the director of the 
funding institute based on a review of the justification provided by 
the awardee, and must be submitted for prior written approval.

Payback Requirements:  Pursuant to the NIH Revitalization Act of 1993, 
postdoctoral trainees receiving NRSA support incur a service payback 
obligation only during their first 12 months of postdoctoral support.  
The second and subsequent years of postdoctoral NRSA training will 
serve to pay back a postdoctoral service payback obligation.  
Therefore, the payback agreement must be signed and submitted with the 
appointment form for only the initial year of support.

Recruitment:  The primary objective of the NRSA program is to prepare 
qualified individuals for careers that have a significant impact on the 
Nation's research agenda.  Within the framework of the program's 
longstanding commitment to excellence and projected need for 
investigators in particular areas of research, attention must be given 
to recruiting individuals from racial or ethnic groups underrepresented 
in the biomedical and behavioral sciences.  The following groups have 
been identified as underrepresented in biomedical and behavioral 
research nationally: African Americans, Hispanic Americans, Native 
Americans, Alaskan Natives, and Pacific Islanders. Use of the term 
"minority" in this announcement will refer to these groups.

Duration of training and the transition of trainees to individual 
support mechanisms:  Studies have shown that the length of the 
appointment to a training grant for postdoctoral trainees with health-
professional degrees strongly correlates with subsequent application 
for and receipt of independent NIH research support.  Training grant 
Program Directors, therefore, should limit appointments to individuals 
who are committed to a career in research and plan to remain on the 
training grant or in a non-NRSA research experience for a cumulative 
minimum of 2 years.  It has also been shown that transition to 
independent support is related to career success.  Therefore, Program 
Directors should encourage postdoctoral trainees to apply for the 
individual postdoctoral fellowships (F32) or mentored career 
development awards (K awards).  During the review of training grant 
applications, peer reviewers will examine the training record to 
determine the average duration of training appointments for health-
professional postdoctoral trainees and whether there is a record of 
transition to individual support mechanisms.

Past studies have shown that health professional trainees, who train in 
combined programs with postdoctoral researchers with an intensive 
research background, are more likely to apply for and receive research 
grant support.  Programs located in clinical departments that focus on 
research training for individuals with the M.D. or other health-
professional degrees should consider developing ties to basic science 
departments or modifying their program to include individuals with 
research doctorates when this approach is consistent with the goals of 
the program.  Applications should describe the basic science 
department's contribution to the research training experience and also 
indicate whether both health professional trainees and trainees with 
research doctorates will be included in the training program.

Evaluation: Program Directors are encouraged to develop methods for 
ongoing evaluation of the quality of the training program.  Although 
the T32 application process requires extensive career tracking 
information, it is often useful to obtain more proximal feedback from 
trainees.  For example, Program Directors are encouraged to develop 
plans to obtain feedback from current and former trainees to help 
identify weaknesses in the training program and to provide 
suggestions for program improvements.

Annual Meeting: Program Directors are required to attend an annual, 1-
day meeting with other Program Directors and NIH staff in the 
Washington, DC area.  Funds to cover the costs of travel to this 
meeting should be requested in the budget.

Conditions of Award:  Grants must be administered in accordance with 
the revised NIH Grants Policy Statement (NIHGPS, available at: 
http://grants.nih.gov/grants/policy/nihgps_2001).  The provisions of 
the revised NIHGPS are effective for all funded NIH grants and 
cooperative agreements with budget periods beginning on or after March 
1, 2001.

The applicant organization must submit a Statement of Appointment form 
(PHS 2271) along with the signed Payback Agreement, at the time a 
postdoctoral trainee is appointed.  No funds may be provided until such 
documents are submitted and accepted by the funding institute.  At the 
end of the total support period for each individual trainee, the 
applicant must submit a Termination Notice (PHS 416-7) to NIH.  Failure 
to submit the required forms in a timely manner may result in an 
expenditure disallowance or a delay in any future funding of the grant.

Awardees may use some of their time in course studies and clinical 
duties if such work is closely related to and necessary for the 
research training experience.  No appointment for less than 12 months 
may be made without prior approval of the NIH program staff.

Trainees supported by academic institutions should refer to the NIH 
NRSA guidelines at: 
http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance 
regarding vacations and requested leave. 

ALLOWABLE COSTS

o  Annual Stipends

The annual stipend for postdoctoral trainees is dependent on the number 
of full years of relevant experience at the time of the initial 
appointment.  Applicants should consult with institute program staff 
for the latest stipend level.  Alternatively, applicants may obtain 
information about current stipend levels and other policy documents 
from the URL for "Ruth L. Kirschstein National Research Service Award 
Research Training Grants and Fellowships" at: 
http://grants.nih.gov/training/nrsa.htm.

The stipend is provided as a subsistence allowance for trainees to help 
defray living expenses during the research training experience.  The 
stipend is not a payment for services performed.  Trainees are not 
considered to be employees of the PHS or their sponsoring organization.  

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 
99-514, impacts on the tax liability of all individuals supported under 
the NRSA program.  Under that section, degree candidates (e.g., 
predocs) 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.  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.

The taxability of stipends, however, in no way alters the relationship 
between NRSA trainees, and institutions.  NRSA stipends are not 
considered salaries.  In addition, trainees supported under the NRSA 
are not considered to be in an employer-employee relationship with NIH 
or the institution in which they are pursuing research training.  
Therefore, it is inappropriate and unallowable for institutions to seek 
funds for or to charge institutional research training grant awards for 
costs that would normally be associated with employee benefits (e.g., 
FICA, workman's compensation, and unemployment insurance).

It must be emphasized that the interpretation and implementation of the 
tax laws are the domain of the Internal Revenue Service (IRS) and the 
courts.  PHS takes no position on what the status may be for a 
particular taxpayer, and it does not have the authority to dispense 
advice to trainees or institutions about their tax liability.  
Individuals should consult their local IRS office about the 
applicability of the law to their situation and for information on 
their tax obligations.

o Tuition

Applicant organizations can request funds for tuition, which includes 
all fees and health insurance.  Such costs will be provided according 
to existing NIH policies on Ruth L. Kirschstein Research Training 
Opportunities - National Research Service Award Research Training 
Grants and Fellowships, at the following website: 
http://grants.nih.gov/training/nrsa.htm.

o  Travel

Applicants may also request funds for certain types of training-related 
travel for trainees, (e.g., to attend professional meetings and other 
meetings directly related to their training).  Annual levels are 
anticipated to be up to $1,000 per postdoctoral fellow.  The National 
Heart, Lung and Blood Institute allows annual travel expenses of up to 
$1400 per fellow. In addition, support for travel to a research 
training experience away from the institution may be permitted. 
Research training experiences away from the parent institution must be 
justified considering the type of opportunities for training available, 
the manner in which these opportunities differ from and complement 
those offered at the parent institution, and the relationship of the 
proposed experience to the trainee's career stage and goals.  This type 
of research training requires prior approval from the NIH.  Letters 
requesting such training may be submitted to the NIH awarding component 
at any time during the award period.  Under exceptional circumstances, 
which can include providing accommodations for a trainee with 
disabilities, it is possible to request institutional costs above the 
standard rate.  Requests for additional trainee costs must be explained 
in detail and carefully justified in the application.  Consultation 
with NIH program staff in advance of such requests is strongly advised. 
Additionally, as noted above, funds to support travel of the Program 
Director to the annual meeting in the Washington, DC area should be 
requested.

o  Training-Related-Expenses

The applicant organization may also request funds for other Training-
Related Expenses (TRE) such as personnel directing the program, 
consultants, project specific supplies, travel, reproduction and 
printing costs, rental equipment, minor equipment items, and other 
items that are directly related to the recruitment, selection, 
placement, monitoring and retention of the students.  Funds for such 
other training-related expenses are intended to provide the applicant 
with only partial support for the costs of the proposed research 
training and for meeting the costs of the trainees’ research projects.  
Ordinarily, under NRSA Awards, up to $3,850 per postdoctoral trainee is 
provided on an annual basis for the other training-related expenses 
that are deemed essential to carry out the training program for the 
NRSA awardees appointed under the grant.  

However, for the purpose of these Interdisciplinary Research Training 
programs, the Training-Related-Expenses may exceed $3,850 per trainee 
by allowing up to five percent of the Program Director’s salary plus 
fringe benefits, per year, plus up to $5,000 annually for 
administrative costs associated specifically with the interdisciplinary 
nature of the proposed training program (e.g., coordination among 
multiple institutions).  All budget items within the TRE category must 
be explained in detail and be fully justified at the level requested.  
The type and amount of fiscal or in-kind costs to be contributed by the 
grantee organization should be identified and discussed in detail.  
Grantees are expected to be familiar with and comply with applicable 
cost policies, and the NRSA Guidelines.

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. 03/01/01), the NRSA regulations and guidelines, 
and conditions set forth in this document.

o  Facilities and Administrative (F&A) Costs:  These costs are limited 
to 8 percent of allowable direct costs (excludes all tuition costs, 
health fees, and equipment).  

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: Supplementation or additional support to 
offset the cost of living may be provided by the grantee institution. 
Supplementation does not require additional effort from the trainee.  
DHHS funds may not be used for supplementation under any circumstances.    
Additionally, no funds from other Federal agencies may be used for 
supplementation unless specifically authorized by the NIH and the other 
Federal Agency.    

Compensation:  An institution may provide additional funds to a trainee 
in the form of compensation (as salary and/or tuition remission) for 
services 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 research training 
activities, which require a minimum of 40 hours per week. In addition, 
compensation may not be paid from a research grant supporting the 
research training experience. 

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.

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

Other important information items regarding terms and conditions are 
located in the NRSA Guidelines 
(http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm) and in the 
revised NIH Grants Policy Statement 
http://grants.nih.gov/grants/policy/nihgps_2001/index.htm).

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

Nancy L Desmond, Ph.D.
National Institute of Mental Health
Division of Neuroscience & Basic Behavioral Science
6001 Executive Blvd., Room 7197, MSC 9645
Bethesda, MD  20892-9645 (USPS)
Rockville, MD  20852 (FedEx, UPS, etc.)
Telephone: (301) 443-3563
FAX: (301) 443-1731
E-mail: ndesmond@nih.gov

Direct inquiries about peer review issues to:

Michael Kozak, Ph.D.
Review Chief
National Institute of Mental Health
6001 Executive Blvd Rm 6138
Bethesda, Maryland 20892-9605
Rockville, Maryland 20852 (overnight)
Telephone: (301) 443-6471
Fax: (301) 334-4270
E-mail: mkozak@mail.nih.gov

Direct inquiries about financial or grants management matters to:

Rebecca D. Claycamp, CRA
Chief Grants Management Officer
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, Maryland 20892-9605
Rockville, Maryland 20852 (overnight)
Telephone: (301) 443-2811
Fax: (301) 443-6885
E-mail: rc253d@nih.gov 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Program Director
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NIH program 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:

Nancy L Desmond, Ph.D.
National Institute of Mental Health
Division of Neuroscience & Basic Behavioral Science
6001 Executive Blvd., Room 7197, MSC 9645
Bethesda, MD  20892-9645 (USPS)
Rockville, MD  20852 (FedEx, UPS, etc.)
Telephone: (301) 443-3563
FAX: (301) 443-1731
E-mail: ndesmond@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 is 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.

SUPPLEMENTARY INSTRUCTIONS 
 
The following information should be provided IN ADDITION to that 
specified by the PHS 398 instructions.

Background: Provide a rationale and overall conceptual framework for 
the interdisciplinary research training program. Indicate how the 
proposed program is innovative and distinct from, yet integrated with 
existing training programs. Describe how training in behavioral or 
social science disciplines might be integrated with biomedical science 
training (if applicable). 

Program Direction: Describe the Program Director’s accomplishments and 
leadership in interdisciplinary research and training. Describe the 
administrative structures that allow and encourage interdisciplinary 
and/or cross-departmental research opportunities and how these will 
affect training opportunities for the fellows.

Program Faculty: Describe each faculty member’s interdisciplinary 
research and training accomplishments and the extent to which 
participating faculty members cooperate and collaborate in pursuing 
interdisciplinary research relevant to the program.  Inclusion of 
investigators from the behavioral or social sciences is required. A 
definition of behavioral and social sciences research for the NIH can 
be found at http://obssr.od.nih.gov/funding/definition.html.

Proposed Training: Describe the proposed interdisciplinary training 
program. Describe the course work and research experiences. For 
programs with multiple tracks, provide course work and research 
experiences for each track, as well as opportunities and experiences 
for trainee interaction and research integration that span the whole 
program. Describe formal endpoint(s), if any, to be achieved by the 
trainees (e.g., Master’s degree, certificate).  Provide the proposed 
distribution of trainees by original discipline (e.g., genetics, 
biochemistry, physiology, cell biology, molecular biology, psychology, 
sociology, epidemiology, mathematics). Describe plans for provision of 
training in the personal and professional skills necessary to lead and 
participate in multidisciplinary teams.

NIH Roadmap Goal:  For programs that facilitate communication among 
different disciplines, promote but perhaps do not completely achieve 
integration of different disciplines in the proposed project period, or 
propose training in multidisciplinary approaches as a precursor to 
interdisciplinary research training, include a detailed plan with 
appropriate milestones for achieving the NIH Roadmap goal of developing 
interdisciplinary research training.  

Program Evaluation:  Provide plans for monitoring trainee progress and 
overall program evaluation. Describe the measures (e.g., publications, 
grant proposals and awards, career trajectory of trainees) that will be 
used to assess the success or failure of the program. Include in the 
evaluation plan an assessment of the program’s impact on the culture 
for doing interdisciplinary research at the participating 
institution(s).  Input for evaluating the program should be obtained 
from faculty and trainees.

Institutional Support:  Describe support (financial or otherwise) that 
the institution(s) will provide for the proposed training program.  
This could include, for example, space, shared laboratory facilities 
and equipment, funds for curriculum development, release time for the 
Program Director or participating faculty, support for additional 
trainees in the program, or any other creative mechanisms to improve 
the climate for the establishment and growth of the training program.

Trainee Recruitment:  The NIH remains committed to increasing the 
participation of individuals from underrepresented minority groups in 
biomedical and behavioral research.  As first announced in 1989, all 
competing applications for institutional NRSA research training grants 
must include a specific plan to recruit and retain underrepresented 
minorities in the training program.  Additional information on this 
requirement was published in the NIH Guide for Grants and Contracts, 
Volume 22, Number 25, July 16, 1993 (see 
http://grants.nih.gov/grants/guide/notice-files/not93-188.html).

Applications requesting $500,000 or more in direct costs for any year 
must include a cover letter identifying the NIH staff member within one 
of NIH institutes or centers who has agreed to accept assignment of the 
application.   Applicants requesting more than $500,000 must carry out 
the following steps: 1) Contact the IC program staff at least 6 weeks 
before submitting the application, i.e., as you are developing plans 
for the program; 2) Obtain agreement from the IC staff that the IC will 
accept your application for consideration for award; 3) Identify, in a 
cover letter sent with the application, the staff member and IC who 
agreed to accept assignment of the application.  

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

Jean G. Noronha, Ph.D. 
Referral Liaison 
Division of Extramural Activities 
National Institute of Mental Health 
6001 Executive Blvd., Room 6147, MSC 9609 
Bethesda, MD  20892-9609 
(for courier service use:  Rockville, MD  20852) 
phone: 301-443-3367 
fax: 301-443-4720 
e-mail: jnoronha@mail.nih.gov 

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed. However, when a 
previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to 
an RFA, it is to be prepared as a NEW application. That is, the 
application for the RFA must not include an Introduction describing the 
changes and improvements made, and the text must not be marked to 
indicate the changes from the previous unfunded version of the 
application.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the relevant Institute(s), Offices or Center(s).  
Incomplete applications will not be reviewed. 

If the application is not responsive to the RFA, NIH staff may contact 
the applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific, technical, and educational merit by an 
appropriate peer review group in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

o  Undergo a process in which only those applications deemed to have 
the highest scientific merit, generally the top half of the 
applications under review, will be discussed, assigned a priority score
o  Receive a written critique
o  Receive a second level review by the appropriate National Advisory 
Council or Board.

Notification

Shortly after the review meeting, each applicant will be sent 
notification of the Initial Review Group’s recommendation and the name 
and phone number of the NIH official responsible for the application. 
When the NIH official receives the summary statement of the review, 
prepared by the Scientific Review Administrator after the review 
meeting, a copy will be forwarded to the applicant. Following Council 
or Board review the NIH program officer will notify each applicant of 
the final disposition of the application.

REVIEW CRITERIA

Major considerations in the review are the breadth, depth, and quality 
of the plan for implementing the interdisciplinary training program; 
qualifications, capability, and experience of the Program Director, 
faculty and participating institution(s) to implement the plan; plans 
for recruiting, selecting, and monitoring trainee progress; and 
adequacy of the facilities and resources.  Detailed review criteria are 
listed below:

BACKGROUND 

o  Clarity of the program’s objectives, rationale, and overall 
conceptual framework
o  Adequacy in meeting the RFA’s intent to prepare candidates who can 
design and implement research that integrates research in behavioral or 
social science disciplines with research in other health- or biomedical  
disciplines
o  Evidence of institutional commitment to training and development of 
independent researchers
o  Evidence that the proposed program is innovative and distinct, yet 
integrated with other training programs at the institution, such as K30 
or T32 programs

PROGRAM DIRECTION

o  Qualifications of the Program Director to lead the interdisciplinary 
research and training program, including his/her research training 
record, as determined by the success of former trainees in seeking 
further career development and in establishing productive scientific 
careers.  Evidence of further career development can include receipt of 
fellowships or career awards, subsequent training appointments, and 
similar accomplishments.  Evidence of a productive scientific career 
can include a record of successful competition for research grants, 
receipt of special honors or awards, a record of publications, receipt 
of patents, promotion to scientific positions, and any other measure of 
success consistent with the nature and duration of the training 
received.
o  Appropriateness of the Program Director’s time devoted to 
administering the program
o  Adequacy of the administrative structures that allow and encourage 
interdisciplinary, cross-departmental and/or cross-institutional (if 
applicable) research and training opportunities

PROGRAM FACULTY

o Evidence of a multi- and interdisciplinary program faculty and their 
involvement in teaching and research activities (programs are required 
to include a behavioral or social science discipline)
o  Evidence of the availability and commitment of faculty mentors now 
and for the duration of the program
o  Quality of the training faculty in interdisciplinary research 
relevant to the program, as evidenced by, for example, publications, 
scientific accomplishments, experience in conducting funded 
interdisciplinary research, and success in placing former trainees in 
interdisciplinary research positions
o  Quality of mentoring as indicated by the faculty training record 
(see explanation of training record, under “Program Direction” above)
o  Evidence of cooperation and collaboration among program faculty in 
pursuing interdisciplinary research and training relevant to the 
program

PROPOSED TRAINING

o  Adequacy of the nature and duration of proposed course work and 
research experiences for each research training track
o  Adequacy of the proposed research training tracks given program 
faculty expertise and size
o  Adequacy of the proposed plans for interdisciplinary research 
seminars and experiences that allow for trainee interaction and 
research integration across the whole program
o  Adequacy of the proposed number and distribution of trainees by 
degree and original discipline
o  Quality of plans to monitor progress of the trainees, of the program 
as a whole, and of the program’s impact on the culture for performance 
of interdisciplinary research at the participating institution(s)
o  Adequacy of the proposed plans for instruction in the responsible 
conduct of research (see below)
o  Adequacy of training in the personal and professional skills 
necessary to lead and participate in multidisciplinary teams
o  Adequacy of specific plan to track progress toward achievement of 
the NIH Roadmap goal of developing interdisciplinary research training  

RECRUITMENT, SELECTION, AND RETENTION OF TRAINEE CANDIDATES

o  Adequacy of the plans for recruiting qualified candidates from on-
site programs, as well as strategies for recruiting regionally and/or 
nationally
o  Adequacy of the criteria and administrative procedures for selecting 
qualified candidates
o  Adequacy of plans for recruiting and retaining candidates from 
underrepresented minority groups.  This assessment will include 
consideration of the racial and ethnic diversity of the trainee pool, 
but will also take into account the described recruitment and retention 
efforts as well as the availability of individuals from 
underrepresented groups within the relevant pool of applicants.
o  If appropriate, record of the research training program in retaining 
health-professional postdoctoral trainees for at least 2 years in 
research training or other research activities;
o  When appropriate, the concomitant research training of health-
professional postdoctorates (i.e., individuals with the M.D., D.O., 
D.D.S., etc.) with basic science postdoctorates (i.e., individuals with 
a Ph.D., etc.) or linkages with basic science departments.

BUDGET

Appropriateness and justification for all items in the proposed budget; 
compelling justification for training-related-expenses in excess of 
$3,850 per postdoctoral trainee to support up to five percent of the 
Program Director’s salary (plus fringe benefits) and administrative 
costs associated with the unique, interdisciplinary nature of the 
training program.

FACILITIES AND RESOURCES

o  Availability of facilities and resources for supporting and 
conducting interdisciplinary research and training
o  Extent of institutional support for trainees and the program

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, 
http://grants.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 or the responsible 
conduct of research.  Applications without plans for instruction in the 
responsible conduct of research will be considered incomplete and will 
be returned to the applicant without review. 

o 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 or postdoctorates appointed to 
the program.
o Plans must address the subject matter of the instruction, the format 
of the instruction, the degree of faculty participation, trainee 
attendance, and the frequency of instruction.
o The rationale for the proposed plan of instruction must be provided.
o Program reports on the type of instruction provided, topics covered, 
and other relevant information, such as attendance by trainees and 
faculty participation, must be included in future competing 
continuation and noncompeting applications. The NIH encourages 
institutions to provide instruction in the responsible conduct of 
research to all graduate students, postdoctorates, and research staff 
regardless of their source of support.

NIH initial review groups will assess the applicant's plans 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, so 
that the review panel's evaluation of the plan will not be a factor in 
the determination of the priority score.  Plans will be judged as 
acceptable or unacceptable.  The acceptability of the plan 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.  Staff within the NIH awarding component will judge the 
acceptability of the revised plan. 

Following initial review, the appropriate NIH institute or center 
council, board, or other advisory group also reviews applications.  
These advisory groups 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.

USE OF HUMAN SUBJECTS IN RESEARCH

If appropriate, the involvement of human subjects and protections from 
research risk relating to their participation in the proposed research 
will be assessed. Moreover, 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 reviewed.  Plans for the recruitment and retention of subjects will 
also be evaluated. (See Inclusion Criteria in the sections on Federal 
Citations, below).

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 398 research grant application 
instructions (rev. 5/2001) will be assessed. 
 
RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: February 11, 2004
Application Receipt Date:  March 11, 2004
Peer Review Date: June/July, 2004
Council or Board Review: September, 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Applications are selected for funding primarily on the basis of 
scientific and educational merit and sound administrative organization. 
However, other factors are considered, such as: availability of funds, 
research program priorities, the balance among types of research 
training and career development supported by the IC’s, the 
acceptability of the plan for minority recruitment, and the 
acceptability of the plan for instruction in the responsible conduct of 
research. The NIH appreciates the value of complementary funding from 
other public and private sources, including foundations and industrial 
concerns, for activities that will complement and expand those 
supported by the NIH.

REQUIRED FEDERAL CITATIONS 

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 SAFETY AND 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).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

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 proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, 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 (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. 

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 public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.   Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 487 f 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.the plan for 
instruction in the responsible conduct of research.

USE OF HUMAN SUBJECTS IN RESEARCH

If appropriate, the involvement of human subjects and protections from 
research risk relating to their participation in the proposed research 
will be assessed. Moreover, 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 reviewed.  Plans for the recruitment and retention of subjects will 
also be evaluated. (See Inclusion Criteria in the sections on Federal 
Citations, below).

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 398 research grant application 
instructions (rev. 5/2001) will be assessed. 
 
RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: February 11, 2004
Application Receipt Date:  March 11, 2004
Peer Review Date: June/July, 2004
Council or Board Review: September, 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Applications are selected for funding primarily on the basis of 
scientific and educational merit and sound administrative organization. 
However, other factors are considered, such as: availability of funds, 
research program priorities, the balance among types of research 
training and career development supported by the IC’s, the 
acceptability of the plan for minority recruitment, and the 
acceptability of the plan for instruction in the responsible conduct of 
research. The NIH appreciates the value of complementary funding from 
other public and private sources, including foundations and industrial 
concerns, for activities that will complement and expand those 
supported by the NIH.

REQUIRED FEDERAL CITATIONS 

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 SAFETY AND 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).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

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 proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, 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 (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. 

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 public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.   Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 487 f 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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