and Human Services (HHS)
EXPIRED
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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) 710-0267, Email: [email protected].
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: [email protected]
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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