TRAINING PROGRAMS IN DIABETES RESEARCH FOR PEDIATRIC ENDOCRINOLOGISTS
Release Date: October 18, 2001
RFA: RFA-DK-02-024
National Institute of Diabetes and Digestive and Kidney Diseases
(http://www.niddk.nih.gov)
American Diabetes Association
(http://www.diabetes.org/)
Juvenile Diabetes Research Foundation International
(http://www.jdf.org/)
Letter of Intent Receipt Date: February 26, 2002
Application Receipt Date: March 26, 2002
PURPOSE
To foster development of a diverse and highly trained workforce of pediatric
endocrinologists to assume leadership roles related to the Nation’s biomedical
and behavioral research efforts in the area of pediatric diabetes, the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in
cooperation with the American Diabetes Association (ADA) and the Juvenile
Diabetes Research Foundation International (JDRF), invites applications for
the establishment of joint programs for the research training and career
development of pediatric endocrinologists. The NIDDK will award complementary
Institutional research training (T32) and clinical scientist career
development program (K12) grants to eligible institutions to provide an
integrated program to prepare pediatricians, selected by the institution, for
careers in pediatric endocrinology research related to diabetes. In
combination, these awards will establish multilevel (postdoctoral fellow and
junior physician scientist) training and career development programs. This
initiative responds to the language in The Children’s Health Act of 2000
recommending support of the expansion of programs to train new investigators
in pediatrics.
Institutional research training grants (T32) are a desirable mechanism for the
postdoctoral training of physicians who may have extensive clinical training
but have limited research experience. It is anticipated that the appointed
trainees will be enrolled in a pediatric endocrinology fellowship program.
For such individuals, the training may be a part of a research degree program.
In most cases, postdoctoral trainees should engage in at least two years of
research, research training or comparable activities beginning at the time of
appointment since the duration of training has been shown to be strongly
correlated with post-training research activity.
Clinical scientist career development programs (K12) assist in the transition
of clinical investigators to an independent research career. These
institutional mentored research career development awards will provide up to
three years of supervised research experience that may combine didactic
studies with laboratory or patient oriented research.
In combination, the T32 and K12 programs will provide an opportunity for
continuous training from the clinical fellowship years to emergence as a fully
trained independent investigator. Moreover, the institutions receiving these
awards will be encouraged to interact with one another and to provide
opportunities for career development pathways involving more than one
institution.
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 Request for Applications (RFA),
Training Programs in Diabetes Research for Pediatric Endocrinologists, is
related one or more of the priority areas. Potential applicants may obtain a
copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.
APPLICANT ELIGIBILITY REQUIREMENTS
Only domestic, non-profit, private or public institutions may apply for grants
to support research training programs. Foreign institutions are not eligible
for this program. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators. The
applicant institution must have a strong research program in the area of
pediatric endocrinology and diabetes. In addition, the applicant institution
must have the requisite research facilities, mentors, personnel and support
for the proposed program. The research training program director at the
institution will be responsible for the selection and appointment of the
trainees and for the overall direction, management and administration of the
program. It is expected that the research training program director will be a
pediatric endocrinologist with a strong record in biomedical research and
mentoring. If the program director is not a pediatric diabetologist, a senior
investigator with expertise in pediatric diabetes research must be included as
a part of the leadership in the training program. Trainees appointed to the
training program must have the opportunity to carry out supervised basic or
clinical biomedical or behavioral research with the primary objective of
developing or extending their research skills and knowledge in preparation for
an independent research career in pediatric diabetes. The applicant
institution must have access to a training environment with ongoing basic and
clinical research in diabetes.
To be eligible for consideration under this RFA, each applicant institution
must submit a package of two separate applications [one complete application
for research fellowship training (T32) and a second complete application for
the training and career development of physician scientists (K12)]. The
program director for each application should be the same individual and the
two complete applications must be submitted with separate face pages including
the appropriate signatures by the institution’s business official. Those
applicant institutions that already have an established, on-going NIH-funded
fellowship-training grant (T32) or its equivalent in place with a focus on
training in pediatric diabetes research must indicate how they would modify
the existing grant, if the new T32/K12 grants were funded. As with all
features of this program, potential applicants are strongly advised to contact
the NIDDK staff listed under INQUIRIES if they have any questions regarding
eligibility.
TRAINEE ELIGIBILITY REQUIREMENTS
All trainees (T32 and K12 appointees) must be U.S. citizens, noncitizen
nationals, or legal permanent residents (i.e. in possession of the Alien
Registration Receipt Card, I-551, or other legal verification of such status).
Noncitizen nationals are generally persons born in possessions of the United
States (e.g. American Samoa and Swains Island). Individuals on temporary or
student visas are not eligible. For purposes of this RFA only, only
candidates who possess an M.D. or equivalent degree (e.g. D.O.) from an
accredited domestic or foreign institution and who have completed their
postgraduate clinical training in an American Board of Pediatrics-approved
pediatric residency program will be eligible for appointment as trainees to
the T32 training program. It is expected that T32 trainees will be enrolled
in a pediatric endocrinology fellowship program. National Research Service
Award (NRSA)-supported training is limited to three years without a waiver
issued by the awarding unit.
NRSA trainees are required to pursue their research training on a full-time
basis, devoting at least 40 hours per week to the program. Within the 40
hours per week training period, research trainees who are also training as
clinicians must devote their time to the proposed research training and must
confine clinical duties to those that are an integral part of the research
training experience. Postdoctoral NRSA trainees must sign a payback agreement
form (PHS Form 6031) in the first 12 months of support. One month of
obligation is incurred for each month of support. The 13th and subsequent
months of NRSA support do not incur further obligation and are considered
acceptable payback service for the prior 12 months of support.
Physician scientist trainees appointed to the K12 career development program
must have completed their pediatric endocrinology fellowship training. We
anticipate that all physician scientist trainees appointed to the K12 training
program will be either board-certified or board eligible by the completion of
their training. These candidates may spend up to three years in the K12
training program, but are strongly encouraged to apply for either an
individual Mentored Clinical Scientist Award (K08,
http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html) or an individual
Mentored Patient-Oriented Research Career Development Award (K23,
http://grants.nih.gov/grants/guide/pa-files/PA-00-004.html) after 1-2 years of
support through the K12 training program. The physician scientist may receive
up to a total of 6 years of combined support through the K12 and K08/K23 grant
mechanisms. The candidates must devote a minimum of 75 percent of full-time
professional effort conducting research and research career development.
Individuals ineligible for appointment to the K12 training program include
current and former principal investigators on NIH research project (R01),
FIRST Awards (R29), comparable career development awards (e.g. K01, K08, K23),
sub-projects of program project (P01) or center grants (P50), and the
equivalent. Former principal investigators of NIH Small Grants (R03) or
Exploratory/Developmental Grants (R21) remain eligible. Current and former
recipients of Clinical Associate Physicians Award (CAP) support may apply for
the K12 program provided they have had no more than 3 years of CAP support by
the time of the K12 appointment. The combined total of CAP plus K12 support
must not exceed 6 years.
Appointment of women and minority groups underrepresented nationally in the
biomedical and behavioral sciences is strongly encouraged.
MECHANISM OF SUPPORT
This RFA will combine two National Institutes of Health (NIH) award
mechanisms, the NRSA Institutional Training Grant (T32) and the Mentored
Clinical Scientist Development Program Award (K12).
The provisions of the T32 mechanism are detailed in the NIH announcement for
NRSA Institutional Training Grants, published in the NIH Guide for Grants and
Contracts, June 1, 2000, and are available at:
http://grants.nih.gov/grants/guide/pa-files/PA-00-103.html. All provisions of
the T32 award described in the announcement apply to grants made under this
initiative, except as noted in this RFA. Only postdoctoral level training
will be supported under this RFA. The applicant institutions may request up
to three slots in the T32 training grant and up to three slots in the K12
career development program. However, no more than a total of five slots may
be requested in a combined T32/K12 program.
Institutional NRSA (T32) and K12 research training programs may be funded for
periods up to five years and are renewable. Awards within an approved
competitive segment normally are made in 12-month increments, with support for
additional years based upon satisfactory progress and the continued
availability of funds.
Trainee appointments are normally made in 12-month increments. No trainee may
be appointed for less than nine months during the initial period of
appointment, except with prior approval of the NIDDK. No individual trainee
may receive more than three years of aggregate NRSA support at the
postdoctoral level, including any combination of support from institutional
training grants and individual fellowship awards. Any extension of the total
duration of trainee support requires prior approval by NIDDK.
Applicants from institutions which have a Diabetes Endocrinology Research
Center (DERC), Diabetes Research and Training Center (DRTC) or General
Clinical Research Center (GCRC) may wish to identify these centers as a
resource for conducting the proposed research. In such a case, a letter of
agreement from either the principal investigator or GCRC program director
should be included with the application.
If the NIDDK determines that there is a sufficient continuing program need,
and if funds are available, it is expected that a new request for competing
continuation and new applications will be announced in five years. The total
project period for applications submitted in response to this RFA should is
five years. The anticipated award date is September 30, 2002.
FUNDS AVAILABLE
The NIDDK intends to commit approximately $1.5 million in FY 2002 to fund
three new T32 and three new K12 grants in response to this RFA. The JDRF and
ADA may provide supplemental funding to support additional training or career
awards. Applicants may request a project period of up to five years.
Applicants may request funds to support up to 3 individuals each year under
each mechanism, however, actual funding will be provided for a maximum of 5
individuals per year 3 under one mechanism and 2 under the other. Because the
nature and scope of the research proposed may vary, it is anticipated that the
size of each award will also vary. Although the financial plans of the NIDDK
provide support for this program, 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.
RESEARCH OBJECTIVES
Pediatric diabetes, including type 1 diabetes, type 2 diabetes (formerly
almost exclusively a disease of adults which is now being reported with
increasing frequency in children), and other rarer formers of diabetes in
youth, subjects children to the risk of devastating complications over time,
including accelerated cardiovascular disease, kidney failure, blindness,
neuropathy, and amputation. Management of diabetes in children is
particularly arduous, with suboptimal glycemic control increasing the risk of
long term complications and intensive therapy to optimize glucose levels
associated with substantial risk of hypoglycemia. Effective therapy for
pediatric diabetes requires an exceptional level of effort from the children,
their families, and their health care providers. These extraordinary clinical
care demands make it particularly challenging for pediatric endocrinologists
involved in diabetes care to pursue research careers. Although there has been
considerable recent progress in understanding the etiology and pathogenesis of
pediatric diabetes and in developing improved therapies, we still cannot
prevent or cure these disorders. Thus, it is imperative to enhance the
diabetes research training and career development of pediatric
endocrinologists to create the cadre of skilled investigators needed to build
upon the foundation of current basic and clinical knowledge and to develop new
approaches to the treatment, prevention and cure of pediatric diabetes.
The NIDDK, JDRF, and ADA intend to provide support for programs of research
training and career development in pediatric diabetes at institutions that
have environments, mentors and programs that will make them particularly
effective in enhancing the number of independent investigators contributing to
research in pediatric diabetes. For this purpose the following attributes of
applicant institutions and programs are desirable:
A. Environment: The institution must have a substantial and well-established
program of basic and clinical research funded through peer reviewed grants
from the NIH, JDRF, ADA or other organizations. The institution must also
have a highly qualified faculty with expertise in clinical and basic research
relevant to pediatric diabetes to serve as sponsors/mentors. The institution
must also be able to demonstrate a commitment to and track record of success
in the development of the trainees as productive, independent diabetes
investigators. The program director, sponsors/mentors, and institution must
be able to describe an in-depth, multidisciplinary research training program
that will utilize the relevant research and educational resources.
B. Training Program: The awards will provide up to five consecutive 12-month
awards. Both the didactic and research phases of an award period must be
designed to develop the necessary knowledge and skills in research relevant to
pediatric diabetes and to the career goals of the trainees.
Because of the focus on progression to independence as a researcher, trainees
should have a period of research training and career development consistent
with his or her previous research and clinical experience. For example, a
trainee with limited experience in a given field of research may find a phased
developmental program lasting three to five years that includes a designated
period of didactic training followed by a period of closely supervised
research experience the most efficient means of attaining independence. A
trainee with previous research experience and training may not require
extensive additional didactic preparation and a shorter program that focuses
on an intensive, supervised patient-oriented or basic research experience may
be appropriate. All programs must be tailored to meet the individual needs of
the trainees, ensuring that they will gain the skills and knowledge necessary
to carry out high quality research. The trainee and the sponsor/mentor are
jointly responsible for the preparation of the individual training plan. The
sponsor/mentor and trainee may form an advisory committee to assist with the
development of a program of study or to monitor the trainee"s progress through
the career development program. The didactic and research components of both
phases must develop new knowledge and research skills in scientific areas
relevant to the career goals of the trainee.
Applicants should describe how instruction in informed consent and other
aspects of human subjects protection, biostatistics, clinical trial design,
and methodologies related to basic research, etc. will be provided. Plans
must be presented for the means by which individual trainee needs and goals
will be developed and addressed. Plans for ongoing program evaluation and
mechanisms to improve course content, mentoring and supervised research
experiences must be included in the application.
C. Mentors: Trainees appointed to the training programs must name a primary
sponsor (or mentor), who together with the appointee is responsible for the
planning, direction, and execution of the research training program. The
mentor should be recognized as an accomplished investigator in the proposed
research area and have a track record of success in training independent
investigators. The mentor should have sufficient independent research support
to cover the costs of the proposed research project in excess of the allowable
costs of this award. Trainees may also nominate co-mentors as appropriate to
the goals of the program. Where feasible, women, minority individuals and
individuals with disabilities should be involved as mentors to serve as role
models.
Plans must be presented in the application for the means by which qualified
mentors will be selected to guide each trainee.
D. Curriculum Development: The program director should provide details on how
a curriculum centered on pediatric diabetes research will be developed. It is
expected that both basic and clinical aspects of diabetes research will be
incorporated. Moreover, more general themes such as human subjects
protection, research ethics, clinical trial methodologies, biostatistics,
genetics, cellular and molecular biology, and genomics, proteomics,
bioinformatics, and other state-of-the-art laboratory technologies may be
incorporated. Those institutions with an NIH K30 Clinical Research Curriculum
Award are encouraged to use this program as a resource. GCRCs, DERCs, and
DRTCs may also serve as resources for instruction in specific research
methodologies.
E. Special Program Considerations: It is anticipated that institutions
receiving these awards will develop cooperative programs to enhance the
training of pediatric diabetes researchers. Applicants should include
proposals for how this could be accomplished, such as joint meetings at which
trainees would present their results to each other and the mentors from
multiple institutions or other joint activities.
Applicants may wish to propose and request funds for related training
activities designed to increase the future pool of investigators in pediatric
diabetes and to enhance future recruitment of trainees to the institution.
This could include programs such as research stipends for undergraduates or
medical students wishing to spend a summer doing research relevant to
pediatric diabetes, and development of special curricula or didactic programs
focused on pediatric diabetes or other programs to encourage premedical or
medical students to elect careers in pediatric diabetes research.
ALLOWABLE COSTS
NRSA Postdoctoral Stipends
National Research Service Awards provide funds, in the form of stipends, to
physician trainees. A stipend is provided as a subsistence allowance to help
trainees defray living expenses during the research training experience. It
is not provided as a condition of employment with either the Federal
Government or the awardee institution. Stipends must be paid to all trainees
at the levels approved by the Secretary of the Department of Health and Human
Services. Stipend levels are adjusted from time-to-time and current stipend
levels are available on the NIH website at:
http://grants.nih.gov/training/nrsa.htm.
The current annual stipend for postdoctoral trainees is determined by the
number of FULL years of relevant postdoctoral experience at the time of
appointment. Relevant experience may include research experience (including
industrial), teaching, internship, residency, clinical duties, or other time
spent in full-time studies in a health-related field following the date of the
qualifying doctoral degree. Stipend levels for fiscal years 2002 and beyond
may change. Consult the NIH website above for the future announcements of
stipend levels. Postdoctoral stipends for awards made with fiscal year 2001
funds are as follows:
Years of Relevant Experience Annual Amount
Less than 1 $28,260
Greater than or equal to 1 but less than 2 $29,832
Greater than or equal to 2 but less than 3 $35,196
Greater than or equal to 3 but less than 4 $36,996
Greater than or equal to 4 but less than 5 $38,772
Greater than or equal to 5 but less than 6 $40,560
Greater than or equal to 6 but less than 7 $42,348
Greater than or equal to 7 $44,412
No departure from the established stipend schedule may be negotiated by the
institution with the trainee. For postdoctoral trainees, the stipend for each
additional full year of research training support is the next level in the
stipend structure and does not change in the middle of an appointment. The
grantee institution is allowed to provide funds to an individual in addition
to the stipends paid by the NIH. Such additional amounts may be either 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 following 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.
NRSA Stipend Supplementation
The grantee institution may provide supplementation or additional support to
offset the cost of living. Supplementation does not require any additional
effort from the trainee. Federal funds may not be used for supplementation
unless specifically authorized under the terms of both the program from which
such supplemental funds are to be received and the program whose funds are to
be supplemented. Under no circumstances may DHHS funds be used for
supplementation.
NRSA 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 research that constitutes the research training experience.
NRSA Tax Liability
Internal Revenue Code Section 117 applies to the tax treatment of all
scholarships and fellowships. Under that section, non-degree candidates are
required to report as gross income any monies paid on their behalf for
stipends, or any course tuition and fees required for attendance. Degree
candidates may exclude from gross income (for tax purposes) any amount used
for tuition and related expenses such as fees, books, supplies, and equipment
required for courses of instruction at a qualified educational organization.
The 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
employee-employer relationship with the NIH or the awardee institution. It is
therefore, inappropriate and unallowable for institutions to charge costs
associated with employment (such as FICA, workman"s compensation, or
unemployment insurance) to the training grant. 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. The NIH takes no position on
the status of a particular taxpayer, and it does not have the authority to
dispense tax advice. Individuals should consult their local IRS office about
the applicability of the law to their situation and for information on their
tax obligations.
NRSA Tuition, Fees and Health Insurance
The NIH will offset the combined cost of tuition, fees, and health insurance
(either self-only or family as appropriate) at the following rate: 100 percent
of all costs up to $3,000 and 60 percent of costs above $3,000. Costs
associated with tuition, fees, and health insurance are allowable only if they
are required for all individuals in a similar research training status at the
institution regardless of the source of support. A full description of the
tuition policy is contained within the NRSA Policy Guidelines on the NIH
website at: http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm.
NRSA Other Trainee Costs
Trainee travel, including attendance at scientific meetings that the
institution determines to be necessary to the individual"s research training,
is an allowable trainee expense. Trainee travel costs of $1,000 a year per
NRSA postdoctoral trainee may be requested. 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 compliment 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.
NRSA Training Related Expenses
Institutional costs of $3,500 a year per postdoctoral trainee may be
requested to defray the costs of other research training related expenses,
such as staff salaries, consultant costs, equipment, research supplies, and
staff travel.
K12 Salary Support for Appointees
The NIDDK will provide salary and fringe benefits for the career award (K12)
appointee. At least 75 percent of the appointee"s full-time professional
effort must be devoted to the research goals of this award. The remainder may
be devoted to clinical, teaching, or other research pursuits consistent with
the objectives of the award. Both the didactic and the research phases of an
award period must be designed to develop the necessary knowledge and research
skills in scientific areas relevant to the career goals of the candidate. The
total salary requested must be based on a full-time, 12-month staff
appointment. It must be consistent both with the established salary structure
at the institution and with salaries actually provided by the institution from
its own funds to other staff members of equivalent qualifications, rank, and
responsibilities in the department concerned. If full-time, 12-month salaries
are not currently paid to comparable staff members, the salary proposed must
be appropriately related to the existing salary structure.
At the present time, NIDDK has a salary limit of $75,000 per year (plus fringe
benefits) for all physician scientists appointed to K12 training programs.
The institution may supplement the NIH salary contribution up to a level that
is consistent with the institution"s salary scale, however, supplementation
may not be from Federal funds unless specifically authorized by the Federal
program from which such funds are derived. Because the salary amount provided
by this award is based on the full-time institutional salary, no other PHS
funds may be used for salary supplementation. Institutional supplementation
of salary must not require extra duties or responsibilities that would
interfere with the purpose of the K12.
K12 Research and Development Support for Appointees
The amount of research and development support is currently $25,000 per year
for each physician scientist appointed to the K12 training program. These
funds may be used for the following expenses: (a) tuition, fees, and books
related to career development, (b) research expenses, such as supplies,
equipment and technical personnel, (c) travel to research meetings or
training, (d) statistical and computational services including personnel and
computer time. All expenses must be directly related to the proposed research
career development program.
K12 Other Income of Appointees:
Fees resulting from clinical practice, professional consultation, or other
comparable activities required by the research and research-related activities
of this award may not be retained by the career award recipient. Such fees
must be assigned to the grantee institution for disposition by any of the
following methods:
o The funds may be expended by the grantee institution in accordance with the
NIH policy on supplementation of career award salaries and to provide fringe
benefits in proportion to such supplementation. Such salary supplementation
and fringe benefit payments must be within the established policies of the
grantee institution.
o The funds may be used for health-related research purposes.
o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks
should be made payable to the Department of Health and Human Services, NIH and
forwarded to the Director, Office of Financial Management, NIH, Bethesda,
Maryland 20892. Checks must identify the relevant award account and reason
for the payment.
o K12 appointees may retain royalties and fees for activities such as
scholarly writing, service on advisory groups, or honoraria from other
institutions for lectures or seminars, provided these activities remain
incidental and provided that the retention of such pay is consistent with the
policies and practices of the grantee institution.
Usually, funds budgeted in an NIH supported research or research training
grant for the salaries or fringe benefits of individuals, but freed as a
result of a career award, may not be rebudgeted. The awarding component will
give consideration to approval for the use of released funds only under
unusual circumstances. Any proposed retention of funds released as a result
of a career development award (K12) must receive prior written approval of the
NIH awarding component.
K12 Salary Support for Program Directors
Salary for the program director will be provided for levels of effort up to 10
percent. The program director may request salary support up to 10% effort on
the K12 grant application. No salary support may be requested on the T32
grant application. The actual salary provided by the award is based on the
program director’s full-time, 12-month institutional salary and the level of
effort requested up to the maximum legislated salary rate in effect at the
time of award. For example, in fiscal year 2001, the maximum allowable annual
salary is $161,200 for a full-time position. Therefore, in FY 2001, the
maximum annual base salary that will be provided for an award recipient at 10
percent effort is $16,120. In all cases, the salary requested must be
consistent both with the established salary structure at the institution and
with salaries actually provided by the institution from its own funds to other
staff members of equivalent qualifications, rank, and responsibilities in the
department concerned. If full-time, 12-month salaries are not currently paid
to comparable staff members, the salary proposed must be appropriately related
to the existing salary structure. The award will also provide fringe benefits
on the calculated base salary at the established institutional rate.
Salary support is being provided to allow the K12 program director to develop
and oversee a comprehensive training program in pediatric diabetes. The
training program should include didactic and research opportunities in both
basic and clinical sciences. The program director is expected to develop a
curriculum that is tailored to the specific needs of the trainees. This
curriculum should encompass a broad overview of topics related to both
clinical and basic concepts related to diabetes. If the applicant institution
has an NIH K30 Clinical Research Curriculum Award, the program director is
encouraged to use the K30 program as a resource for the training program.
The institution may supplement the NIH contribution to the salary of the
program director up to a level that is consistent with the institution"s
salary scale. Institutional supplementation of salary must not require extra
duties or responsibilities that would interfere with the purpose of the award.
In addition, recipients of this award may derive additional compensation for
effort associated with other Federal sources or awards provided the total
salary derived from all Federal sources does not exceed the maximum legislated
salary rate and the total percent effort does not exceed 100 percent.
NRSA/K12 Annual Meeting of Program Directors and Trainees
Applicant institutions should request additional travel funds to attend a
joint NIDDK/ADA/JDRF annual meeting. Travel costs (up to $1,000 per
individual), should be requested for the program director, trainees, and
mentors. In addition, travel funds to attend one scientific meeting annually
may be requested for each of the training grant/program appointees. Except
for travel funds to attend the joint NIDDK/ADA/JDRF annual meeting, which will
be restricted to this purpose, travel funds are not available for the program
director, mentors or training faculty.
NRSA/K12 Special Programs
As described above, applicants may request funds for related research
activities designed to increase the future pool of investigators in pediatric
diabetes and to enhance future recruitment of trainees to the institution.
This could include providing research salaries for undergraduates or medical
students wishing to spend a summer conducting research within the scope of
existing, funded NIH research grants relevant to pediatric diabetes.
NRSA/K12 Facilities and Administrative Costs
A facilities and administrative allowance (indirect cost allowance) based on
eight percent of total allowable direct costs (this excludes amounts for
tuition, fees, health insurance, and equipment) may be requested. See NRSA
Policy Guidelines on the NIH Website at:
http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm.
NRSA PAYBACK PROVISIONS
As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a
service payback obligation only during their first 12 months of postdoctoral
support. Additionally, the NIH Revitalization Act of 1993 specifies that the
second and subsequent years of postdoctoral NRSA training will serve to pay
back a postdoctoral service payback obligation. Accordingly, the following
guidelines apply:
o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support
must sign the payback agreement form (PHS form 6031) before initiating an
appointment. Postdoctoral trainees in their first 12 months of support will
incur a period of service payback obligation equal to the period of support.
o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral
support are not required to sign the payback agreement form and will not incur
a service payback obligation for this period of support.
o The 13th and subsequent months of postdoctoral NRSA support are considered
acceptable payback service for prior postdoctoral support. For example,
postdoctoral trainees who continue under that award for two years have
fulfilled the obligation incurred during the first 12 months of support by the
end of the second year. Service payback obligations can also be paid back by
conducting health-related research or teaching averaging more than 20 hours
per week of a full work year after terminating NRSA support.
o Recipients with service obligations must begin to provide acceptable payback
service on a continuous basis within two years of termination of NRSA support.
The period for undertaking payback service may be delayed for such reasons as
temporary disability, completion of residency requirements, or completion of
the requirements for a graduate degree. Requests for an extension must be
made in writing to the NIH, specifying the need for additional time and the
length of the required extension.
o Recipients of NRSA support are responsible for informing the NIH of changes
in status or address.
o For individuals who fail to fulfill their obligation through service, the
United States is entitled to recover the total amount of NRSA funds paid to
the individual for the obligated period plus interest at a rate determined by
the Secretary of the Treasury. Financial payback must be completed within
three years beginning on the date the United States becomes entitled to
recover such amount.
o Under certain conditions, the Secretary, U.S. Department of Health and Human
Services (or those delegated this authority) may extend the period for
starting service or repayment, permit breaks in service, or in rare cases in
which service or financial repayment would constitute an extreme hardship, may
waive or suspend the payback obligation of an individual.
o Officials at the awardee institution have the responsibility of explaining
the terms of the payback requirements to all prospective training candidates
before appointment to the training grant. Additionally, all trainees recruited
into the training program must be provided with information related to the
career options that might be available when they complete the program. The
relationship of the positions available and the training provided must also be
discussed along with the applicability of these positions to any outstanding
service payback obligation.
NRSA Trainee Reporting Requirements
The institution must submit a completed Statement of Appointment (PHS Form
2271) for each NRSA trainee appointed or reappointed to the training grant at
the beginning of the appointment period. Additionally, a completed Payback
Agreement (PHS Form 6031) must be submitted for each trainee in his or her
first twelve months of postdoctoral support. Within 30 days of the end of the
total support period for each trainee, the institution must submit a
Termination Notice (PHS Form 416-7). Failure to submit the required forms in
a timely, complete, and accurate manner may result in an expenditure
disallowance or a delay in any continuation funding for the award.
LEAVE
NRSA Trainees
In general, trainees may receive stipends during the normal periods of
vacation and holidays observed by individuals in comparable training positions
at the grantee institution. For the purpose of these awards, however, the
period between the spring and fall semesters is considered to be an active
time of research and research training and is not considered to be a vacation
or holiday. Trainees may receive stipends for up to 15 calendar days of sick
leave per year. Sick leave may be used for the medical conditions related to
pregnancy and childbirth. Trainees may also receive stipends for up to 30
calendar days of parental leave per year for the adoption or the birth of a
child when those in comparable training positions at the grantee institution
have access to paid leave for this purpose and the use of parental leave is
approved by the program director.
A period of terminal leave is not permitted and payment may not be made from
grant funds for leave not taken. Individuals requiring periods of time away
from their research training experience longer than specified here must seek
approval from the NIH awarding component for an unpaid leave of absence. At
the beginning of a leave of absence, the trainee must submit a Termination
Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee
must be formally reappointed to the grant by submitting an updated Statement
of Appointment (PHS Form 2271). Trainees within the first 12 months of
postdoctoral support must also submit a Payback Agreement (PHS Form 6031) upon
return from a leave of absence.
K12 Appointees
Leave to another institution, including a foreign laboratory, may be permitted
if the proposed experience is directly related to the purpose of the award.
Only local, institutional approval is required if such leave does not exceed 3
months. For longer periods, prior written approval of the NIDDK is required.
To obtain prior approval, the award recipient must submit a letter to the
NIDDK describing the plan, countersigned by the training program director, the
primary research mentor and the appropriate institutional official. A copy of
a letter or other evidence from the institution where the leave is to be taken
must be submitted to assure that satisfactory arrangements have been made.
Support from the career award will continue during such leave.
Leave without award support may not exceed 12 months. Such leave requires the
prior written approval of the NIDDK and will be granted only in unusual
situations. Support from other sources is permissible during the period of
leave. Such leave does not reduce the total number of months of program
support for which an individual is eligible.
Under unusual and pressing circumstances, a K12 appointee may submit a written
request to the awarding component, requesting a reduction in professional
effort below 75 percent. Such requests will be considered on a case-by-case
basis during the award period. In no case, will it be permissible to work at
a rate of less than 50 percent effort. The nature of the circumstances
requiring reduced effort might include medical conditions, disability, or
pressing personal or family situations such as child or elder care.
Permission to reduce the level of effort will not be approved to accommodate
other sources of funding, job opportunities, clinical practice, or clinical
training. In each situation, the grantee institution must submit
documentation supporting the need for reduced effort along with assurance of a
continuing commitment to the scientific development of the appointee.
Further, the appointee must submit assurance of his or her intention to return
to full-time professional effort (at least 75 percent) as soon as possible.
During the period of reduced effort, the salary and other costs supported by
the award will be reduced accordingly.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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 biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.
It is the policy of NIH 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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. Reviewers are cautioned that their anonymity may be compromised when
they directly access an Internet site.
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 RFA 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.
LETTER OF INTENT
Prospective applicants are asked to submit, by February 26, 2002, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title
of the RFA in response to which the application may be submitted.
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 NIDDK staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in
applying for these grants. This version of the PHS 398 is available in an
interactive, searchable format. It contains additional special instructions
for preparing Institutional National Research Service Award (T32)
applications. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.
Application Instructions
Applicants must observe the 25-page limit on the narrative section.
Applicants may request up to five years of support through the T32/K12
mechanisms. The applicant should justify the number of full-time postdoctoral
training positions requested (e.g. 2-3 NRSA postdoctoral fellows, 2-3 K12
appointees, 5 trainees maximum per combined program). Tuition, fees, health
insurance, and trainee travel, and other expenses are to be included in
"training related expenses." The program director for each of the two
applications (i.e. T32 and K12) should be the same individual and the two full
applications must be submitted with separate face pages including the
appropriate signatures from the institution’s business official. No applicant
institution may submit only a T32 application in response to this RFA.
Submission Instructions
The RFA label available in the PHS 398 (rev. 05/01) application form must be
stapled to the bottom of the face page of the application and must display the
RFA number DK-02-024. A sample RFA label is available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is
in the pdf format. 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.
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 must be
sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Applications must be received by March 26, 2002. If an application is
received after this date, it will be returned to the applicant without review.
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. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
for responsiveness to this RFA by the NIDDK. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIDDK in accordance with the review criteria stated below. As part of the
initial merit review, all applications will receive a written critique and
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, and receive a second level
review by the National Diabetes and Digestive and Kidney Diseases Advisory
Council.
Review Criteria
T32 Applications:
o Past research training record of both the program and the designated
preceptors 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 individual
fellowships, career awards, further training appointments, and similar
accomplishments. Evidence of a productive scientific career can include a
record of successful competition for research grants, receipt of special
honors, 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 Objectives, design, and direction of the research training program(s).
o Caliber of preceptors as researchers with expertise in both basic and
clinical research related to pediatric diabetes, including successful
competition for research support.
o The institutional training environment, including the level of
institutional commitment, quality of the facilities, availability of
appropriate courses, and availability of research support, including access to
and training in new molecular biology technology.
o Recruitment and selection plans for clinical trainees and the availability
of high quality candidates with the potential to develop as independent
investigators.
o Record of the research training program in retaining health-professional
postdoctoral trainees for at least two 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. Established investigators from basic
science departments may be included as mentors to provide expertise and
resources provided that the emphasis remains on research that is relevant to
pediatric diabetes and consistent with the goals of the program. Applications
should describe the basic science department"s contribution to the research
training experience.
o Institutional commitment to the objectives, design, and direction of a
research training program responsive to this RFA.
o For renewal (competing continuation) applications, or subsequent new
applications from an institution with a previously funded training grant,
success of the trainees in producing research publications and in obtaining
independent, competitively funded support for pediatric research.
K12 Applications:
o The experience and success of the Program Director in managing career
development programs.
o The plans for selection, recruitment and retention of clinical candidates
with the potential to develop as independent investigators, and the likelihood
that the career development plan will contribute substantially to the
scientific development and independence of the prospective candidates.
Efforts to develop novel mechanisms for recruiting candidates for new project
development awards from women and minority groups under-represented in
pediatric diabetes research.
o Appropriateness of the content, the phasing, and the proposed duration of
the career development plan for achieving scientific independence for the
prospective candidates.
o Usefulness of the research plans as a vehicle for developing the research
skills as described in the career development plan, as well as the scientific
and technical merit of the research questions, design and methodology.
o Appropriateness of the faculty mentor"s research qualifications in the
area(s) of pediatric diabetes research, and the previous experience of the
faculty mentors in fostering the development of researchers.
o Quality of the environment for scientific and professional development, and
the applicant institution"s commitment to the appropriate balance of research
and clinical responsibilities.
o Quality of the proposed training in the responsible conduct of research.
o For renewal (competing continuation) applications, or subsequent new
applications from an institution with a previously funded career development
program, success of the junior investigators in producing research
publications and in obtaining independent, competitively funded support for
pediatric diabetes research.
Additional Review Criteria for all Applications:
Recruitment Plan for Underrepresented Minorities: After the overall
educational and scientific merit of an application has been assessed, peer
reviewers will examine and evaluate the minority recruitment plan. The
findings of the panel will be included in an administrative note in the
summary statement. If the minority recruitment plan or if the record of
recruitment and retention of minorities is judged to be unacceptable, funding
will be withheld until a revised plan that addresses the deficiencies is
received. Staff within the NIDDK, with guidance from the National Diabetes
and Digestive and Kidney Diseases Advisory Council, will determine whether
amended plans and reports submitted after the initial review are acceptable.
Training in the Responsible Conduct of Research: The applicant’s plans for
providing experience in the responsible conduct of research will be assessed
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 scientific,
educational and administrative merit, so that the quality 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
considered for funding until the applicant provides a revised, acceptable
plan. NIDDK staff
will judge the acceptability of the revised plan.
Following initial review, applications are reviewed by the National Diabetes
and Digestive and Kidney Diseases Advisory Council. The council will
consider, in addition to the assessment of the scientific and educational
merit of the research training grant application, the scientific review
group"s comments on the recruitment of individuals from under-represented
minority groups into the research training program and the plan for
instruction in the responsible conduct of research.
SCHEDULE
Letter of Intent Receipt Date: February 26, 2002
Application Receipt Date: March 26, 2002
Peer Review Date: June/July 2002
Council Review: September, 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Responsiveness to the purpose of this announcement,
o Quality of the proposed training program(s), as determined by peer review,
o Availability of funds,
o Programmatic priorities,
o Geographic distribution.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome. Consultation with
NIDDK staff is strongly encouraged, especially during the planning phase of
the application process.
Direct inquiries regarding programmatic issues to:
James F. Hyde, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 603 MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-7692
FAX: (301) 480-3503
E-mail: jh486z@nih.gov
Direct inquiries regarding fiscal matters to:
Donald Ellis
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 709B MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8849
FAX: (301) 594-9523
E-mail: de30z@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.847. Awards are under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under NIH grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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