NIH Grants Policy Statement
(12/03)
Part II: Terms and Conditions of NIH Grant Awards
Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities -- File 3 of 5
The primary objective of the Kirschstein-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 certain areas
of research, institutions must attempt to recruit individuals from racial or
ethnic groups underrepresented in the biomedical and behavioral sciences. The
following groups are ones that nationally are underrepresented in biomedical
and behavioral research: African Americans, Hispanic Americans, Native
Americans, Alaskan Natives, and Pacific Islanders. NIH’s requirements for
minority recruitment and retention are described in “Review—Minority Recruitment Plan” in
this subsection.
NIH also considers the duration of training and the
transition of trainees to other support mechanisms. Studies have shown that the
length of the research training grant appointment of postdoctoral trainees with
health-professional degrees strongly correlates to subsequent application for
and success in receiving independent NIH research support. Therefore, training
PDs should appoint only those individuals who are committed to a career in
research and plan to remain on the training grant or in a non-Kirschstein-NRSA
research experience for a minimum of 2 years in the aggregate. It also has been
shown that transition to independent support is related to career success.
Therefore, training PDs also should encourage postdoctoral trainees to apply
for Kirschstein-NRSA individual postdoctoral fellowships (F32) or mentored
career development awards (K awards). When reviewing Kirschstein-NRSA
institutional research 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 history of
transition to individual support mechanisms.
Studies also have shown that health professional trainees
that train in combined programs with postdoctoral researchers with intensive
research experience are more likely to apply for and receive research grant
support. Programs 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, if consistent with the goals
of the program, modifying the program to include individuals with research
doctorates. In these cases, applications should describe the basic science
department’s contribution to the research training experience and indicate
whether both health professional trainees and trainees with research doctorates
will be included in the training program.
Training PDs also 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 often is
useful to obtain more timely feedback. NIH encourages PDs 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 improvement.
Applicant institutions are encouraged to include a description of these plans
in competing applications.
Each initial and competing continuation application will be
evaluated for scientific merit by an NIH peer review group. Kirschstein-NRSA
institutional research training grant applications also must be reviewed by the
National Advisory Council or Board of the IC whose activities relate to the
proposed research training.
Applications for Kirschstein-NRSA institutional research
training grants will be evaluated using criteria such as the following:
l Past
research training record of both the program and the designated preceptors.
l Objectives,
design, and direction of the research training program.
l Caliber
of preceptors as researchers, including successful competition for research
support.
l Quality
of the organizational training environment for NRSA-supported trainees and
relationship of the NRSA program to the broader training program, if
appropriate. This includes the level of organizational commitment, quality of
the facilities, availability of appropriate courses, and the availability of
research support.
l Quality
of the applicant pool and the selection of individuals for appointment to the
training program, including an assessment of the racial and ethnic diversity of
the trainee pool. The assessment will take into account described recruitment
and retention and the availability of individuals from underrepresented groups
within the relevant pool of applicants.
l Record
of the research training program in retaining health-professional postdoctoral
trainees for at least 2 years.
In addition, when applicable, the concomitant training of
health-professional postdoctorates (e.g., individuals with the M.D., D.O. or
D.D.S. degree) with basic science postdoctorates (e.g., individuals with a
Ph.D. or Sc.D. degree) or linkages with basic science departments will receive
special consideration.
Applicants also are encouraged to consult the PHS 398
application instructions, the NIH T32 PA, and specific IC PAs for additional
details.
In addition to the overall programmatic criteria,
applications that request short-term research training positions in conjunction
with full-time positions will be assessed using specific criteria. The NIH T32
PA and/or specific IC PAs should be consulted for details.
Minority Recruitment Plan
The Kirschstein-NRSA institutional research training grant
program must provide for the recruitment and retention of individuals from
underrepresented minority groups including, but not limited to, African
Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific
Islanders. All competing applications for Kirschstein-NRSA institutional
research training grants must include a specific plan to recruit minorities.
Competing continuation
applications for Kirschstein-NRSA institutional research training grants also
must include a detailed section on the outcomes of the minority recruitment
plan proposed in the previous competing application. Information on successful
and unsuccessful recruitment strategies must be included. The application also
must include information on the racial/ethnic distribution of the following:
l Students
or postdoctorates who applied for admission or positions within the department
under the Kirschstein-NRSA institutional research training grant
l Students
or postdoctorates who were offered admission to or a position within the
department
l Students
enrolled in the academic program related to the research training grant
l Students
or postdoctorates appointed to the research training grant.
For trainees who were enrolled in the academic program, the
application should include information about the duration of research training
and whether those trainees have finished their training in good standing.
The success of efforts to recruit and retain minority
trainees is a factor in the assessment of the quality of the trainee pool and
thus will be included in the priority score. In addition, peer reviewers will
evaluate the minority recruitment plan and accomplishments (for competing
continuation applications) after the overall score has been determined.
Reviewers will examine the strategies to be used in the recruitment of
minorities and whether the experience in recruitment during the previous
competitive segment has been incorporated into the formulation of the plan for
the next competitive segment.
If an application is received without a minority recruitment
plan, or without a report on the previous competitive segment, the application
will be considered incomplete and may be returned to the applicant without
review.
The findings of the review group will be included in an
administrative note in the summary statement. If the minority recruitment plan
of the application is judged to be unacceptable, funding will be withheld until
a revised plan that addresses the deficiencies is received. Staff within the
NIH IC, with guidance from its National Advisory Council or Board, will
determine whether amended plans and reports submitted after the initial review
are acceptable.
Information on the recruitment and retention of
underrepresented minority trainees during the previous budget period also must
be provided in the non-competing progress report submitted as a prerequisite to
receiving non-competing continuation support.
All Kirschstein-NRSA institutional research training grant
applications must include a description of the formal and informal activities
related to instruction in the responsible conduct of research planned for the
proposed research training program. In addition, NIH encourages institutions to
provide instruction in the responsible conduct of research to all individuals
in a training program or department, regardless of the source of support.
Every prebaccalaureate,
predoctoral, and postdoctoral Kirschstein-NRSA trainee must receive instruction
in the responsible conduct of research. Applications must describe a program to
provide formal or informal instruction in research integrity and/or the
responsible conduct of research, as follows:
l Although
NIH does not establish specific curricula or formal requirements, all programs
are strongly 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
also is beneficial to discuss the mutual responsibilities of the institution
and the trainees participating in the program.
l Plans
must address the subject matter of the instruction, the format of the
instruction, the degree of faculty participation, trainee attendance
requirements, and the frequency of instruction. The rationale for the proposed
plan of instruction must be provided.
l Information
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 applications.
Applications without plans for instruction in the
responsible conduct of research will be considered incomplete and may be
returned to the applicant without review.
NIH SRGs will assess the applicant’s plans on the basis of
the appropriateness of topics, format, amount and nature of faculty
participation, and frequency and duration of instruction. The plan will be
discussed after the overall determination of 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 funded until the applicant provides a revised, acceptable plan. The
acceptability of the revised plan will be judged by staff members in the NIH
IC.
Following initial review, applications undergo a
second-level review by the appropriate NIH IC’s National Advisory Council or
Board. In addition to the assessment of the scientific and educational merit of
the research training grant application, these advisory groups will consider
the initial review group’s comments on the plan for instruction in the
responsible conduct of research.
Information on the nature of the instruction in the
responsible conduct of science and the extent of trainee and faculty
participation also must be provided in the progress report submitted as a
prerequisite to receiving non-competing continuation support.
Shortly after the initial review meeting, the PD will be
sent a mailer that includes the SRG recommendation/priority score and the name
and telephone number of a PO in the assigned NIH IC. The NIH IC automatically
forwards a copy of the summary statement to the PD as soon as possible after
receiving it from the SRG. The PD will be notified by the PO of the final
review recommendation. An NGA will be issued for applications selected for
funding. Any questions about initial review recommendations and funding
possibilities should be directed to the named PO, not to the SRA of the SRG.
Kirschstein-NRSA institutional research training grants may
be made for competitive segments of up to 5 years and are renewable. Awards
within an approved competitive segment normally are made in 12-month
increments; support for additional non-competitive years depends on
satisfactory progress and availability of funds.
Trainees under
Kirschstein-NRSA institutional research training grants generally are appointed
for full-time 12-month continuous periods. An appointment or reappointment may
not exceed 12 months without prior approval by the NIH awarding office. All
trainees are required to pursue their research training full time, normally
defined as 40 hours per week or as specified by the grantee in accordance with
its own policies. Unless the NIH awarding office furnishes other instructions,
the amount of the stipend, tuition, and fees for each full period of
appointment must be obligated by the grantee from funds available when the
individual begins training.
With the exception of specifically designated short-term
research training positions, no trainee may be appointed under a regular
Kirschstein-NRSA institutional research training grant for less than 9 months
except with the prior written approval of the NIH awarding office and then
usually only to complete a planned program of training. An initial appointment
of less than 9 months may be allowed as long as an assurance is included that
the individual will be immediately reappointed in the subsequent year so that
the cumulative continuous training period is at least 9 months.
Part-time training. Under unusual and pressing
personal circumstances, a PD may submit a written request to the NIH awarding
office to change a trainee appointment to less than full time. Such requests
will be considered case-by-case and must be approved by the awarding office
before the applicable budget period. The circumstances requiring the part-time
training might include medical conditions, disability, or pressing personal or
family situations such as a child or elder care. Part-time training will not be
approved to accommodate use of other sources of funding, job opportunities,
clinical practice, or clinical training, or for other responsibilities
associated with the trainee’s position at the organization. In each case, the
written request must be countersigned by the trainee and an AOO and must
include documentation supporting the need for part-time training. The written
request also must include an estimate of the expected duration of the period of
part-time training and assurances that the trainee intends to return to
full-time training when that becomes possible and to complete the research
training program.
The stipend may be prorated in the grant award during the
period of any approved part-time training. Part-time training also may affect
the rate of accrual or repayment of the service obligation for postdoctoral
trainees. In no case will it be permissible for the trainee to be engaged in
Kirschstein-NRSA-supported research for less than 50 percent effort.
Individuals who must reduce their commitment to less than 50 percent effort
must take a leave-of-absence from a Kirschstein-NRSA training grant.
No individual trainee may receive more than 5 years of
aggregate Kirschstein-NRSA support at the predoctoral level and 3 years of
aggregate Kirschstein-NRSA support at the postdoctoral level, including any
combination of support from Kirschstein-NRSA institutional research training
grants and individual fellowships.
Any exception to the maximum period of support requires a
waiver from the NIH awarding office based on review of a justification from the
individual and the grantee organization. The trainee must make the
request in writing to the NIH awarding office. The trainee’s PD and an AOO must
endorse the request certifying the need for additional support. The request
must specify the amount of additional support for which approval is sought.
Some generally recognized categories under which NIH may
grant exceptions include the following:
l Physicians/clinicians.
Individuals requiring additional time to complete training, either as
participants in a combined M.D./Ph.D. program or as clinicians (e.g.,
physicians, dentists, veterinarians) who are completing postdoctoral research
training, may anticipate favorable consideration of a request for waiver of the
time limitation. This action is contingent upon an assurance of the trainee’s
good academic standing and justified need for the exception to this policy.
l Interruptions
(break in service). Requests for additional time also will be
considered if an event unavoidably has altered the planned course of the
research training, if the interruption has significantly detracted from the
nature or quality of the planned research training, and if a short extension
would permit completion of the training as planned. Such events include sudden
loss of the preceptor’s services or an accident, illness, or other personal
situation that prevents a trainee from effectively pursuing research training
for a significant period of time. Requests for extension of support also will
be considered if a short additional period would provide the trainee an
opportunity to use an exceptional training resource directly related to the
approved research training program.
Requests that arise from circumstances other than those
described above will be considered only if they are accompanied by an
exceptionally strong justification.
An NGA is issued to the grantee organization, normally for a
budget period of 12 months. A trainee may be appointed any time during the
budget period for an appointment period of 9 to 12 months, without prior
approval by the NIH awarding office.
At the time of the initial appointment and subsequent
reappointment, the training PD must submit a Statement of Appointment to the
NIH awarding office. In addition, a signed Payback Agreement must be submitted
for each postdoctoral trainee who is in his/her first 12 months of
Kirschstein-NRSA postdoctoral support. See “Reporting
Requirements—Statement of Appointment (Form PHS 2271)” and “Reporting Requirements—Payback Agreement (Form
PHS 6031)” in this subsection for specific information on required forms.
The Statement of Appointment includes biographical data on the trainee and the
stipend level for the period of appointment. The stipend is paid by the grantee
organization directly to the trainee.
Allowable
and Unallowable Costs
Policies included in the applicable cost principles and the
NIHGPS govern the expenditure of all training grant funds, unless otherwise
indicated in the NGA.
Stipends
Trainees generally are supported for 12-month full-time
training appointments for which they receive a stipend as a subsistence
allowance to help defray living expenses during the research training
experience. The stipend is not provided as a condition of employment with
either the Federal government or the grantee organization. Stipends must be paid
in accordance with established stipend levels. No departure from the standard
stipend provided by NIH under the grant may be negotiated by the grantee
organization with the trainee. NIH stipend amounts may be adjusted only at the
time of appointment or reappointment. For appointments of less than 12 months,
the stipend will be prorated.
Stipend levels are updated almost every fiscal year. When
increases are approved, they are published in NIH Guide for Grants and
Contracts. Current levels also are posted at http://grants.nih.gov/training/nrsa.htm.
Stipend levels are as
follows:
l Prebaccalaureate.
Two separate levels are provided for trainees: freshman/
sophomore or junior/senior.
l Predoctoral.
One stipend level is used for all predoctoral trainees, regardless of the level
of experience.
l Postdoctoral.
The stipend level for the entire first year of support 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 assistantship, internship, residency, clinical duties, or other time
spent in a health-related field beyond that of the qualifying doctoral degree.
Once the appropriate stipend level has been determined, the trainee must be
paid at that level for the entire period of appointment. The stipend for each
additional year of Kirschstein-NRSA support is the next level in the stipend
structure and does not change mid-year.
Training-Related Expenses
Funds are provided to defray costs such as staff salaries,
consultant costs, equipment, research supplies, staff travel, and other
expenses directly related to the training program. Funds are requested and
awarded as a lump sum on the basis of the predetermined amount per predoctoral
and postdoctoral trainee approved for support. Levels are published in the NIH
Guide for Grants and Contracts. Interested applicants should consult the
program announcement regarding the specific level for programs such as the
short-term training program, the MARC U*STAR program, or the COR program.
Under exceptional circumstances, which can include
accommodating the disabilities of a trainee, it is possible to request
organizational costs above the standard level. Requests for additional costs
must be explained in detail and justified in the application. Consultation with
NIH program staff in advance of such requests is strongly advised.
Trainee Tuition, Fees, and
Health Insurance
Tuition, fees, and health insurance (self-only or family)
are allowable trainee costs only if such charges are applied consistently to
all people in a similar training status at the organization, without regard to
their source of support. Health insurance can include coverage for costs such
as vision and/or dental care if consistent with organizational policy.
Tuition at the postdoctoral level is limited to that
required for specific courses in support of the approved training program and
requires NIH awarding office prior approval. For all Kirschstein-NRSA
institutional research training grant awards, this budget category (tuition,
fees, and health insurance) is calculated at the following rate: 100 percent of
all costs up to $3,000 and 60 percent of costs above $3,000. Tuition, fees, and
health insurance are awarded as a lump sum that can be allocated (without the
prior approval of the NIH awarding office) based on recipient needs.
Trainee Travel Costs
If requested by the grantee, the NIH awarding office may
provide grant funds to cover the costs of trainee travel, including attendance
at scientific meetings, which the organization determines is necessary to the
individual’s training. Funds may not be expended to cover the costs of travel
between the trainee’s place of residence and the training institution, except
that the grantee organization may authorize a one-way travel allowance in an
individual case of extreme hardship.
In addition, support for travel to a research training
experience away from the grantee organization may be permitted. Research
training experiences away from the parent organization must be justified on the
basis of the type of opportunities for training available, the opportunities
offered that are different from those at the parent organization, and the relationship
of the proposed experience to the trainee’s career stage and career goals. This
type of research training requires prior approval of the NIH awarding office.
Letters requesting such training may be submitted to the NIH awarding office at
any time during the appointment period.
Short-Term Training Costs
The grantee may receive up to one-twelfth of the annual
amount designated for training-related expenses each month to offset the costs
of tuition, fees, travel, supplies, and other expenses for each short-term,
health-professional research training position.
Employee Benefits
Because Kirschstein-NRSA awards are not provided as a
condition of employment with either the Federal government or the grantee, it
is inappropriate and unallowable for organizations to seek funds, or to charge
Kirschstein-NRSA institutional research training grants, for costs that
normally would be associated with employee benefits (for example, FICA, workers
compensation, and unemployment insurance).
Grantees, other than State, local, or Indian tribal
governments, will receive F&A costs at 8 percent of modified total direct
costs (exclusive of tuition and fees, health insurance, and expenditures for
equipment) rather than on the basis of a negotiated rate agreement. State,
local, and Indian tribal government agencies are eligible for full F&A cost
reimbursement. For this policy, State universities or hospitals are not
considered governmental agencies.
Rebudgeting of
Funds
Funds may be rebudgeted only
as follows:
l Trainee-related
expenses. Rebudgeting of funds awarded in a lump sum for trainee-related
expenses does not require NIH awarding office prior approval.
l Trainee
costs. For rebudgeting purposes, trainee costs include funds awarded in the
stipends or tuition/fees and health insurance budget categories. These costs
may not be used for other purposes except under unusual circumstances and then
only with the prior approval of the NIH awarding office. Unless otherwise
restricted, rebudgeting into or within the stipends and tuition, fees, and
health insurance categories is allowable without prior approval of the NIH
awarding office.
l Trainee
travel. For rebudgeting purposes, trainee travel is not considered a
trainee cost and, therefore, may be rebudgeted into any other budget category
without prior approval of the NIH awarding office.
Grantees may supplement stipends from non-Federal funds
provided the supplementation is without obligation to the trainee. An
organization can determine what amount of stipend supplementation, if any, will
be provided according to its own formally established policies governing
stipend support. These policies must be consistently applied to all individuals
in a similar training status regardless of the source of funds. Federal funds
may not be used for stipend supplementation unless specifically authorized
under the terms of the program from which funds are derived. An individual may
use Federal educational loan funds or VA benefits when permitted by those
programs as described in “Educational Loans
or GI Bill” in this subsection. Under no circumstances may PHS funds be
used for supplementation.
Student Compensation
NIH recognizes that trainees as students may seek part-time
employment coincidental to their training program to further offset their
expenses. Funds characterized as compensation may be paid to trainees only when
there is an employer-employee relationship, the payments are for services
rendered, and the situation otherwise meets the conditions of the compensation
of students as detailed in “Cost
Considerations—Allowability of Costs/Activities—Selected Items of Cost—Salaries
and Wages—Compensation of Students.” In addition, compensation must be in
accordance with organizational policies consistently applied to both federally
and non-federally supported activities and must be supported by acceptable
accounting records that reflect the employer-employee relationship. Under these
conditions, the funds provided as compensation (salary, fringe benefits, and/or
tuition remission) for services rendered, such as teaching or laboratory
assistance, are not considered stipend supplementation; they are allowable
charges to Federal grants, including PHS research grants. However, it is
expected that compensation from research grants will be for limited part-time
employment apart from the normal full-time training activities.
Compensation may not be paid from a research grant that
supports the same research that is part of the trainee’s planned training
experience as approved in the Kirschstein-NRSA institutional research training
grant application. 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 Kirschstein-NRSA training
program. Training PDs must approve all instances of employment on research
grants to verify that the circumstances will not detract from or prolong the
approved training program.
Concurrent Benefits
An individual may not receive support under a
Kirschstein-NRSA institutional research training grant concurrently with another
federally sponsored fellowship or similar Federal award that provides a stipend
or otherwise duplicates provisions of the Kirschstein-NRSA award.
Educational
Loans or GI Bill
An individual may accept concurrent educational remuneration
from the VA (GI Bill) and Federal educational loan funds. Such funds are not
considered supplementation or compensation. In the case of the MARC-U*STAR
program, funds from a PELL grant may be accepted as well. Postdoctoral trainees
also may be eligible to participate in the NIH Loan Repayment Program.
Information about this program is available at http://www.lrp.nih.gov/.
Taxability of Stipends
Section 117 of the Internal Revenue Code applies to the tax
treatment of scholarships and fellowships. Degree candidates may exclude from
gross income (for tax purposes) any amount used for course tuition and related
expenses, such as fees, books, supplies, and equipment, required for courses of
instruction at a qualified educational organization. Nondegree 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.
The taxability of stipends in no way alters the relationship
between Kirschstein-NRSA trainees and grantee organizations. Kirschstein-NRSA
stipends are not considered salaries. In addition, trainees supported under
Kirschstein-NRSA institutional research training grants are not considered to
be in an employee-employer relationship with NIH or the grantee organization
solely as a result of the Kirschstein-NRSA support. Interpretation and
implementation of the tax laws are the domain of the IRS and the courts. NIH
takes no position on what the status may be for 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.
Form 1099
Although stipends are not considered salaries, the income
still is subject to Federal and, sometimes, State taxes. The grantee
organization may report such income on IRS Form 1099, Statement of
Miscellaneous Income. Normally, the business office of the grantee organization
will be responsible for annually preparing and issuing the IRS Form 1099 for
trainees. Grantee organizations are not required to issue the Form 1099, but it
is a useful form of documentation of income received and it serves as a
reminder to the trainee that some tax liability may exist. Even if the grantee
organization does not issue the Form 1099, trainees are required to report
Kirschstein-NRSA stipends as income.
Kirschstein-NRSA institutional research training grants are
included in expanded authorities (except for carryover of unobligated
balances). In most cases, grantees must obtain awarding office prior approval
to carry over funds; however, some NIH awarding offices have waived this
requirement for training grants as well. The NGA for a Kirschstein-NRSA institutional
research training grant will specify whether or not the grantee must obtain the
prior approval of the awarding office to carry over funds.
Applicants for NIH research grants, including
Kirschstein-NRSA institutional research training grants, are required to
include in their grant applications an estimate of the amount and source of
program income expected to be generated as a result of the project for which
support is being sought. See “Administrative
Requirements—Management Systems and Procedures—Program Income” for policies
that govern the disposition and reporting of program income.
The submission of the forms described in this subsection is
critical to establishing the payment of stipends and other costs and
determining possible payback service. Failure to submit the required forms in a
timely manner may result in an expenditure disallowance or a delay in any
continuation funding. All
of these forms are available in pdf-fillable and rtf formats at http://grants.nih.gov/grants/forms.htm. The NIH awarding
office also may provide copies of applicable forms along with the NGA or
reference this website in the award.
Statement of Appointment (Form PHS 2271)
The grantee must submit a PHS 2271 to the NIH awarding
office before or at the start of each trainee’s appointment or reappointment.
If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data
electronically using the X-TRAIN application. More information on X-TRAIN is
available at https://commons.era.gov/commons/.
No stipend or other allowance may be paid until the
appointment form has been submitted. If the support covers the individual’s
initial 12 months of postdoctoral support, a signed Payback Agreement also must
be submitted. The information on the Statement of Appointment (and the Termination Notice as discussed below) is
the basis for determining the length or amount of an individual’s payback
requirement. An accurate Social Security Number should be included on the
Statement of Appointment and all other documents. The PD and the organizations’
financial officials should coordinate the information reported on the Statement
of Appointment. It should be treated as a financial document for obligating
funds (stipends), which later are reflected on the Termination Notice and as
part of the total costs in the FSR.
Interim revisions. Any changes or corrections
involving a trainee appointment under a Kirschstein-NRSA institutional research
training grant, such as name, permanent mailing address, period of training, or
stipend support, must be reported by the training PD to the NIH awarding office
on an amended PHS 2271 at the time of the change.
Consecutive support. If a trainee switches from one
Kirschstein-NRSA mechanism to another (e.g., from an individual fellowship to a
training grant) or from one NIH awarding office to another, the requirement for
payback service incurred is deferred until the total period of Kirschstein-NRSA
support is completed. All Statement of Appointment forms are reviewed to
determine if previous Kirschstein-NRSA support has been provided.
Payback Agreement (Form PHS 6031)
A Payback Agreement that covers the initial 12 months of
Kirschstein-NRSA postdoctoral support must be signed by each postdoctoral
trainee. If the individual has already received 12 months of postdoctoral
support under any Kirschstein-NRSA training grant or fellowship award, this
form is not required. For details on Kirschstein-NRSA payback, see “Payback Reporting Requirements” in
this section.
No Payback Agreement is required for predoctoral or
prebaccalaureate trainees.
Termination Notice (Form PHS 416-7)
The Termination Notice (along with the PHS 2271 Statement of
Appointment form) is the basis for validating the total period of
Kirschstein-NRSA support and establishing the amount of payback obligation, if
any, for each Kirschstein-NRSA trainee. The PD is responsible for submitting a
Termination Notice for each trainee within 30 days of the end of the total
period of support. The lack of timely and accurate information on this form
could adversely affect the payback process.
Progress reports must be submitted for non-competing
continuation support in accordance with the instructions accompanying the
progress report forms (PHS 2590). Progress report forms and instructions are
available from the NIH website at http://grants.nih.gov/grants/forms.htm. Progress report form
pages are available in pdf-fillable and rtf formats. Incomplete or inadequate
progress reports may be returned for revision and may result in a delay of
continued support. Following completion or termination of a project period, the
grantee must submit a final progress report to the NIH awarding office within
90 days after the end of grant support.
An annual FSR is required for all Kirschstein-NRSA
institutional research training grant awards no later than 90 days after the
close of each budget period. This report will document the financial status of
the grant according to the official accounting records of the grantee
organization. Trainee stipends and tuition are obligated for the full 12-month
appointment from the budget period in which the appointment is initiated.
Portions of stipends and tuition that extend beyond the budget period are
carried over as unliquidated obligations. However, if the report covers the
final budget period of the project period, it must have no unliquidated
obligations and must indicate the exact balance of unobligated funds (see “Administrative
Requirements—Monitoring—Reporting—Financial Reports” and “Administrative Requirements—Closeout—Final Reports”).
Changes in the program objectives as they relate to the area
of research training for which the grant was approved require prior approval of
the NIH awarding office.
If the PD is expected to be absent more than 3 months, plans
for the conduct of the program during his or her absence must be approved in
writing by the NIH awarding office. Any proposed change of PD must be requested
by the grantee organization and be approved in writing by the NIH awarding
office following review of the nominee’s qualifications and re-evaluation of
the project in light of the proposed change.
Kirschstein-NRSA institutional research training grants may
not be transferred from one domestic organization to another except under the
most unusual circumstances. Such a change generally will be approved by the NIH
awarding office only if all of the major benefits attributable to the original
grant can be transferred and there is no negative impact on trainees active in
the program.
Leave
Vacations and holidays. Trainees may receive
the same vacations and holidays available to individuals in comparable training
positions at the grantee organization. Trainees will continue to receive
stipends during vacations and holidays. At academic institutions, the time
between semesters or academic quarters generally is considered an active part
of the training period.
Sick leave and other leave. Trainees may continue to
receive stipends for up to 15 calendar days of sick leave per year. Under
exceptional circumstances, this period may be extended by the NIH awarding
office in response to a written request from the training PD countersigned by
an AOO. Sick leave may be used for the medical conditions related to pregnancy
and childbirth.
Parental leave. Trainees may 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
organization have access to paid leave for this purpose. Either parent is
eligible for parental leave. The use of parental leave must be approved by the
training PD.
Terminal leave. A period of terminal leave is not
permitted, and payment may not be made from grant funds for leave not taken.
Unpaid leave. Individuals requiring extended periods
of time away from their research training experience, that is, more than 15
calendar days of sick leave or more than 30 calendar days of parental leave,
must seek approval from the NIH awarding office for an unpaid leave of absence.
Approval for a leave of absence must be requested in advance by the training PD
and be countersigned by an AOO.
During a leave of absence, documentation to suspend the
period of appointment must be completed by submitting an amended Statement of
Appointment and a Termination Notice. These forms should be submitted to the
NIH awarding office at the beginning of the leave. Upon resumption of
Kirschstein-NRSA support, the reappointment must be documented on another
Statement of Appointment form.
NIH may terminate a Kirschstein-NRSA institutional research
training grant before its normal expiration date if it determines that the
grantee has materially failed to comply with the terms and conditions of the
award or to carry out the purpose for which the award was made. If an award is
terminated for cause, NIH will notify the grantee organization in writing of
this determination, the reasons for the determination, the effective date, and
the right to appeal the decision. NIH also may terminate an award at the
request of the grantee.
An organization that wants to terminate a training grant
before the scheduled termination date must notify the NIH awarding office
immediately. In such cases, NIH will issue a revised NGA to specify the changed
period of support and to show prorated trainee stipends, depending on the amount
of time spent in training.
Publications and Sharing
of Research Results
NIH supports the practical application and sharing of
outcomes of funded research. Therefore, PDs and trainees should make the
results and accomplishments of their Kirschstein-NRSA institutional training
grant activities available to the research community and to the public at
large. The grantee organization should assist trainees in these activities,
including the potential commercialization of inventions. No restrictions should
be placed on the publication of results.
Trainees are encouraged to submit reports of their findings
for publication to the journals of their choice. Responsibility for direction
of the project should not be ascribed to NIH. However, NIH IC support must be
acknowledged by a footnote in language similar to the following: “This
investigation was supported by the National Institutes of Health under Ruth L.
Kirschstein National Research Service Award (number) from the (name of NIH
IC).” In addition, Federal funding must be acknowledged as provided in “Public Policy Requirements and
Objectives—Availability of Information—Acknowledgment of Federal Funding.”
Except as otherwise provided in the conditions of the award,
when a publication or similar copyrightable material is developed from work
supported by NIH, the author is free to arrange for copyright without the
approval of the NIH awarding office. Any such copyrighted materials shall be
subject to a royalty-free, nonexclusive, and irrevocable license to the Federal
government to reproduce them, translate them, publish them, and use and dispose
of them, and to authorize others to do so for Federal government purposes.
All Kirschstein-NRSA institutional research training grants
and other funding agreements awarded primarily for educational purposes are not
subject to invention reporting requirements nor does NIH have any rights to
inventions under those grants and agreements (as specified in 45 CFR
74.24(h) and in 37 CFR 401.1(b)).
Public Access to Research Data
As specified in 45 CFR 74.36(d), the public must be
given access to research data (through FOIA) under specified circumstances. NIH
guidance is available at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Fees resulting from clinical practice, professional
consultation, or other comparable activities performed pursuant to the purpose
of the award may not be retained by the trainee. Such fees must be assigned to
the grantee organization for disposition in accordance with NIH policy on
program income (see “Administrative
Requirements—Management Systems and Procedures—Program Income”). The term
“professional fees” does not apply to honoraria, fees for scholarly writing,
delivery of occasional outside lectures, or service in an advisory capacity to
public or private non-profit organizations. If permitted by organizational
policy, these fees may be retained by the trainee.
Kirschstein-NRSA institutional research training grants
involving human subjects must comply with the requirements for their protection
(see “Public Policy Requirements and
Objectives—Requirements Affecting the Rights and Welfare of Individuals as
Research Subjects, Patients, or Recipients of Services—Human Subjects”). If
the applicant organization has an approved FWA or other applicable assurance on
file with OHRP but, at the time of application, plans for the involvement of
human subjects are indefinite, the assurance number should be provided on the
face page of the application. If an award is made, human subjects may not be
involved until a certification of IRB approval or designation of exemption has
been submitted.
In many instances, trainees supported by Kirschstein-NRSA
institutional research training grants will be participating in research
supported by research project grants for which the IRB review is already
completed or an exemption is already designated. This review or exemption
designation is sufficient, provided the research would not be substantially
modified by the participation of a trainee. The appropriate grants must be
identified along with their IRB review dates or exemption designation.
For additional information on human subjects requirements,
refer to the PHS
398 or contact OHRP (see Part III for contact information).
Monitoring Plan and Data and Safety
Monitoring Board
Research involving clinical trials must include provisions
to ensure the safety of participants and the validity and integrity of the
data. A monitoring plan establishes the overall framework for data and safety
monitoring. It should describe the entity that will be responsible for
monitoring and how adverse events will be reported to IRBs, NIH, and FDA. The
frequency of monitoring will depend on potential risks, complexity, and the
nature of the trial.
NIH specifically requires the establishment of DSMBs for
multi-site clinical trials involving interventions that entail potential risks
to the subject and, generally, for Phase III clinical trials. Although Phase I
and Phase II clinical trials also may use DSMBs, smaller clinical trials may
not require this type of oversight, and alternative monitoring plans may be appropriate.
PDs and trainees also should refer to the NIH Policy for
Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html,
“Public Policy Requirements and
Objectives—Requirements Affecting the Rights and Welfare of Individuals as
Research Subjects, Patients, or Recipients of Services—Data and Safety
Monitoring” in Subpart A, and the instructions in the PHS 398
application.
Inclusion of Women and Minorities
in Clinical Research
It is NIH policy that women and members of minority groups
and their subpopulations must be included in all NIH-supported clinical
research projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research (see “Public Policy Requirements and
Objectives—Requirements for Inclusiveness in Research Design”). This policy
results from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43). NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research, Amended, October 2001, is available on the NIH website
at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
Inclusion of Children as
Participants in Research Involving Human Subjects
NIH maintains a policy that children (individuals under the
age of 21) must be included in all human subjects research conducted or
supported by NIH, unless there are scientific and ethical reasons not to
include them (see “Public Policy
Requirements and Objectives—Inclusiveness in Research Design”). NIH
Policy and Guidelines on the Inclusion of Children as Participants in Research
Involving Human Subjects is available on the NIH website at http://grants.nih.gov/grants/funding/children/children.htm.
Human Embryonic Stem Cell Research
Criteria for Federal funding of research on hESC 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 trainee to provide the official NIH identifiers
for the hESC lines to be used in the proposed research (see “Public Policy Requirements and Objectives—Ethical
and Safe Conduct in Science and Organizational Operations—NIH Guidelines for
Research Using Human Embryonic Stem Cells”). Applications that do not
provide this information will be returned without review.
Kirschstein-NRSA institutional research training grants involving
use of vertebrate animals must comply with the requirements for their
protection (see “Public Policy Requirements and
Objectives—Animal Welfare”).
If the applicant organization has an approved Assurance of
Compliance on file with OLAW but, at the time of application, its plans for the
involvement of vertebrate animals are so indefinite that IACUC review and
approval are not feasible, on the face page of the application, the
organization should check “Yes,” include the animal welfare Assurance of
Compliance number, and indicate “Indefinite.” If an award is made, vertebrate
animals may not be involved until verification of the IACUC approval date has
been submitted to the NIH awarding office.
In many instances, trainees supported by institutional
research training grants will be participating in research supported by
research project grants for which the IACUC review already is completed. This
review is sufficient, provided the research would not be substantially modified
by the participation of a trainee. The appropriate grants must be identified
along with their IACUC review dates.
If the applicant organization does not have an approved
Assurance of Compliance on file with OLAW or for additional information on vertebrate
animals, refer to the PHS 398 or contact OLAW (see Part III).
Recombinant
DNA Molecules and Human Gene Transfer Research
Institutions receiving Kirschstein-NRSA institutional
research training grants involving use of recombinant DNA molecules must comply
with the requirements of the NIH Guidelines for Research Involving
Recombinant DNA Molecules (see “Public
Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational
Operations—NIH Guidelines for Research Involving Recombinant DNA Molecules and
Human Gene Transfer Research”). The NIH Guidelines, available from NIH’s
OBA (see Part III), should be consulted for complete
requirements for the conduct of projects involving recombinant DNA techniques.
The NIH Guidelines are available at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
Payback Reporting Requirements
The Kirschstein-NRSA legislation requires some recipients of
support (fellows or trainees) to pay back the Federal government by engaging in
health-related biomedical or behavioral research, including the direct
administration or review of health-related research, health-related teaching,
or any combination of these activities. See “Payback—Service
Payback—Definitions” in this subsection for complete coverage of
requirements.
The National Institutes of Health Revitalization Act of
1993, signed into law on June 10, 1993, included provisions in Section 1602
that substantially modified the service payback requirement for individuals
supported by NRSA fellowships and research training grants.
An individual who was appointed to a research training grant
or who had a fellowship award activated before June 10, 1993, is subject to the
service payback provisions in effect at the time of the appointment or award.
Implementation
The incurrence of a payback obligation for an NRSA recipient
is solely dependent upon when NRSA support was received.
Before August 13, 1981 (enactment of the Omnibus
Reconciliation Act), a payback obligation existed for all prebaccalaureate,
predoctoral, and postdoctoral support received.
Effective August 13, 1981, a 12-month legislative allowance
waiving payback obligation for the first 12 months of support was enacted for
all predoctoral and postdoctoral trainees and fellows. This legislation provided
that all trainees and fellows who were not in delinquent status on that date
receive the allowance (this was retroactive to the beginning of the NRSA
program). Individuals in delinquent status continued to have a payback
obligation for all support received. This legislative change also eliminated
the payback obligation for prebaccalaureate recipients.
Historically, short-term trainees supported by the T35
mechanism (NRSA short-term training) incurred no payback obligation. However,
for short-term trainees supported within a T32 program, the periods of support
accrued and ultimately counted toward the total NRSA support.
Predoctoral recipients. For predoctoral trainees
beginning appointments and for predoctoral fellows activating awards on or
after June 10, 1993, no payback obligation is incurred. Thus a Payback
Agreement Form (PHS 6031) is not required.
Postdoctoral recipients. For individuals receiving
postdoctoral support under individual fellowships or institutional research
training grants, a payback obligation is incurred for the first 12 months of
Kirschstein-NRSA support with the 13th and subsequent months of postdoctoral
support serving to pay back this obligation month by month. A Payback Agreement
(PHS 6031) is required but only for the initial 12-month postdoctoral support
period.
The requirements established by the Revitalization Act also
provide that the 13th and subsequent months of postdoctoral
Kirschstein-NRSA-supported research training will be used to discharge any
prior postdoctoral Kirschstein-NRSA service payback obligation. See “Payback—Service Payback—Initiation of
Payback Service” in this subsection for other requirements of the Act.
Any individual receiving support for predoctoral short-term
training does not incur a payback obligation. Postdoctoral short-term training
incurs a payback obligation. Any support accrues along with any subsequent
postdoctoral support until the first 12 months is established. At that point,
the 13th and subsequent months of support serve to offset the obligation month
by month. If subsequent postdoctoral support is not received, the individual
has an obligation to pay back in the traditional manner.
Once a Termination Notice has been submitted and accepted,
the NIH awarding office determines if a payback obligation exists. When a
trainee or fellow must pay back, the Termination Notice and related documents
are forwarded to the NIH Kirschstein-NRSA PSC. PSC personnel are NIH’s experts
in Kirschstein-NRSA payback requirements. The PSC currently administers the
payback activities of almost all of the NIH ICs and soon is expected to have
this responsibility for all ICs. The authorities related to payback normally
delegated to the IC are delegated to the Chief, Kirschstein-NRSA PSC. The PSC
retains all records until an obligation is satisfied and transfers closed
records to the Federal Records Center.
Most Kirschstein-NRSA recipients eventually fulfill their
payback obligation by engaging in activities that are determined to be
acceptable service. Some recipients fulfill their obligation via financial
payback. On rare occasions, the payback obligation is waived.
As indicated in “Payback
Reporting Requirements—Implementation” in this subsection, the amount of a
payback obligation incurred is solely dependent on the total period of support
and the laws in effect when the Kirschstein-NRSA support was received.
Definitions
For fulfilling the Kirschstein-NRSA service payback
obligation, the following definitions apply:
l
Research. Research is defined as an activity
that involves designing experiments, developing protocols, and collecting and interpreting
data. In addition, review of original research or administration of original
research that includes providing scientific direction and guidance to research
may be acceptable if a doctoral degree and relevant research experience is
required for individuals filling such positions. Such research can be conducted
in an academic, government, commercial, or other environment in either a
foreign or domestic setting. In addition, when consistent with the cumulative
amount, type, and frequency of research or research training experiences,
functions that involve analytic or other technical activities conducted in
direct support of research, as defined above, also will satisfy the service
payback obligation.
l
Teaching. Teaching is an instructional activity
that takes place in an organized educational or other instructional
environment. Activities classified as teaching are generally carried out in a
formal didactic setting, but other activities will be considered if they are
consistent with the certifying institution’s policy on the definition of
teaching responsibilities. Such teaching can be conducted at universities,
professional schools, research institutes, teaching hospitals, primary schools,
secondary schools, or colleges. When calculating hours of teaching per week, it
is permissible to include 3 hours of preparation time for each hour of direct
instruction. Acceptable teaching activities must have a biomedical or
health-related relevance.
l
Health-related activities. This incorporates a
broad range of activities related to the description, diagnosis, prevention, or
treatment of disease from the most basic biomedical or behavioral research to
the most applied or clinical research. Activities in fields other than those
usually considered to be directly related to human disease, such as
agriculture, environmental sciences, biotechnology, and bioengineering, also
will be considered health-related.
All acceptable activities must be undertaken for periods
that average at least 20 hours per week. Total employment in such activities
averaging less than 20 hours per week cannot be counted toward fulfilling the
obligation except in cases of disability or other pressing personal or family
circumstances, such as child care or elder care responsibilities. It is not
permissible for individuals otherwise engaged in full-time employment to engage
in service payback activities at effort levels below 20 hours per week.
If less than 20 hours commitment per week is permitted, the
total period of service obligation will be prorated. For example, an individual
who owes 12 months of service and can devote only 10 hours per week to service
payback activities due to a disability will be required to engage in such
service for 24 months. These exceptions are rare and must receive prior
approval from the PSC.
Initiation of Payback Service
Initiation of payback service depends on when awards were
made:
l Support
received before NIH Revitalization Act. For predoctoral NRSA
recipients who incurred a payback obligation from support received prior to
June 10, 1993, payback service must be performed, or financial repayment made,
following completion of NRSA support. No amount or type of activity before or
during the period of NRSA support will satisfy the NRSA service payback obligation.
However, payback service may be initiated immediately after termination of NRSA
support if the research or teaching activities meet the criteria cited in “Payback Reporting Requirements—Payback—Service
Payback—Definitions.”
For postdoctoral NRSA recipients
who incurred a payback obligation from support received prior to June 10, 1993,
continued postdoctoral NRSA support can be used to satisfy any previous
postdoctoral payback obligation. However, continued postdoctoral NRSA support
cannot be used to payback any obligation remaining from
predoctoral support received before June 10, 1993.
l Support
received after NIH Revitalization Act. Beginning with awards
made under the authority of the NIH Revitalization Act (appointments on or
after June 10, 1993), service payback obligations for postdoctoral recipients
may be discharged by
Ø
receiving an equal number of months of postdoctoral
Kirschstein-NRSA support beginning in the 13th month of such postdoctoral
Kirschstein-NRSA support, or
Ø
engaging in an equal number of months of health-related research,
training, or teaching averaging more than 20 hours per week.
Trainees and fellows beginning
appointments for the 13th and subsequent months of postdoctoral
Kirschstein-NRSA support on or after June 10, 1993, will be engaging in service
that also satisfies any postdoctoral NRSA service payback obligation incurred
before June 10, 1993. Post-award service in non-Kirschstein-NRSA supported
health-related research, training, or teaching is creditable toward any
predoctoral or postdoctoral Kirschstein-NRSA service payback obligation.
There is no restriction on the source of funds supporting an
individual’s service payback activity except that predoctoral payback activities
must not be supported by Kirschstein-NRSA funds. An individual could be
supported by a PHS grant or any non-Kirschstein-NRSA Federal or non-Federal
source. Unpaid service also is permitted.
An individual must begin to undertake the payback service
requirement within 2 years after the termination date of the individual’s
Kirschstein-NRSA support unless an extension of time to begin payback has been
approved by the PSC (see “Payback—Extensions
of Payback—Extensions of the 2-Year Period to Initiate Payback”).
If an individual does not perform payback service, the
Federal government shall be entitled to recover certain costs. The amount the
United States is entitled to recover depends on when support was received.
Calculation formulas take into account the total amount paid the individual
(see “Interest and Interest
Rate Calculation” in this subsection), less any obligation already
fulfilled through service or legislative allowance when applicable. The total
paid an individual under an institutional research training grant or individual
fellowship award at a domestic, non-Federal sponsoring institution is
considered to be the stipend only. The total paid an individual under a
fellowship award at a foreign sponsoring institution includes the payment for
the round-trip travel costs. The total paid an individual under a fellowship
award at a Federal sponsoring institution includes any money expended from the
institutional allowance provided for such purposes as health insurance, travel,
tuition, and fees.
NIH computes interest on the principal amount beginning on
the date the United States became entitled to recover stipends. The interest
rate is the rate fixed by the Secretary of the Treasury after considering
prevailing consumer rates of interest. Accordingly, interest may be accruing on
any Kirschstein-NRSA obligation if the 2-year grace period has passed, if
deferment has expired, or if service has terminated before completion of the
payback obligation. The Department of the Treasury certifies Kirschstein-NRSA
interest rates quarterly. Interest is computed on a 360 day-a-year basis and is
applied through the date of receipt. Any outstanding amount will continue to
bear interest at the initial rate set by the Secretary of the Treasury until
financial payback is complete.
The date that sets the applicable rate of interest depends
on the type of Kirschstein-NRSA account received for collection. If financial
payback is voluntary, the signature date of the notification of voluntary
payback is the date that determines the interest rate as well as the initiation
of the 3-year repayment period. If financial payback is involuntary, the date
that sets the interest rate and the 3-year repayment period is the date of
expiration of the 2-year period following the termination of Kirschstein-NRSA support.
For example, if during June 1998, OFM received an account reflecting January
31, 1996, as the termination date of NRSA support, the Federal government,
lacking any documentation to the contrary, becomes entitled to financial
payback effective February 1, 1998. The rate of interest applicable is
determined based on the February 1, 1998, date, and the total NRSA obligation
is required to be fulfilled by January 31, 2001.
The amount to be recovered financially, as determined from
the Termination Notice plus applicable interest, shall be paid to the United
States within the 3-year period following such date.
The authorizing legislation and the implementing regulations
(42 CFR Part 66) permit exceptions to certain requirements under the Act.
Frequently, an Annual Payback Activities Certification is
returned requesting an extension of the 2-year period to initiate payback.
Indication of valid plans to initiate payback soon after the 2-year grace
period may be good reason to grant an extension.
The Payback Service Center
may extend the period for undertaking payback service or permit breaks in
continuous service. These determinations are based on the following criteria:
l An
extension or break in service is necessary so the individual may complete his
or her research or clinical training.
l An
extension or break in service is necessary so the individual may participate in
the NIH Loan Repayment Program.
l The
individual is unable to complete the requirements within the specified period
because of a temporary disability.
l Completion
by the individual of the requirement within the specified period would involve
substantial hardship to the individual, and failure to extend the period would
be against equity and good conscience.
Reasons for an extension or break in service include such
things as completing residency training, where clinical teaching or research
are not an integral part of their training, or seeking employment that would
fulfill the payback requirements.
Requests must be made in writing (separate letter or APAC)
to the PSC, specifying the need for additional time and the length of the
required extension.
The authorizing legislation and the implementing regulation
(42 CFR Part 66) permit exceptions to certain requirements under the Act.
NIH may waive, in whole or in part, the payback obligation, upon determination
that compliance by the individual is impossible or would involve substantial
hardship, and enforcement of the individual’s obligation would be against
equity and good conscience.
Requests for waivers should
be made in writing to the PSC and should explain the need for the waiver
according to the following criteria:
l Compliance
by an individual will be deemed impossible if the individual is permanently and
totally disabled.
l
In determining whether compliance would involve substantial
hardship to the individual and would be inequitable, the PSC will consider the individual’s
Ø
financial resources and obligations at the time of request for a
waiver and
Ø
estimated future financial resources and obligations.
In rare cases,
the following also might be considered:
Ø
Reasons for the individual’s failure to complete the requirements
within the prescribed period, such as personal problems
Ø
Extent to which the individual has engaged in payback activities
Ø
Sufficiency of training to qualify the individual to perform such
activities
Ø
Lack of employment opportunities appropriate to the individual’s
education and training
l Any
other extenuating circumstances.
Any obligation of any individual toward payback will be
canceled upon death of the individual.
Annual Certification
Payback service is certified through the use of the
Kirschstein-NRSA APAC (PHS 6031-1). Individuals with an outstanding payback
obligation must complete an APAC annually until their payback obligation is
fulfilled.
If an individual has a payback obligation, an APAC is sent
by NIH approximately one year after the completion of Kirschstein-NRSA support.
Payback service may be initiated within the first 12 months of termination even
though trainees and fellows have up to 24 months to initiate payback. There is
no penalty to those individuals who do not initiate payback within the first 12
months; however, it is critical that they complete an APAC form to ensure
contact is maintained and addresses are current.
The individual will report on the APAC the activity in which
he or she was engaged for the preceding 12 months, within the specified
reporting period. These forms are to be returned within 30 days of the
reporting period end date to the address specified on the mailing label included
with the form.
The PSC reviews the forms, determines acceptability of
reported activities, and then informs the former trainee or fellow of his or
her status. This process will continue annually until the individual’s total
payback obligation is satisfied.
Any change in the mailing address of a Kirschstein-NRSA
recipient must be reported promptly to the PSC until the service obligation is
fully discharged. Notification of changes can be made by letter, telephone,
fax, or e-mail.
Sometimes a trainee/fellow will have a period of
non-Kirschstein-NRSA support between two Kirschstein-NRSA awards. An
appropriate activity performed during this period of time may count for payback
purposes toward the first Kirschstein-NRSA award. If the nonsupport period is 6
months or longer, the individual receives an APAC form through the regular
mechanism. However, if the break is less than 6 months, an APAC will not be
mailed automatically. If acceptable payback service was performed during the
break, the individual may complete an APAC, which can be obtained from the NIH
website at http://grants.nih.gov/grants/forms.htm.
Occasionally, a Kirschstein-NRSA recipient may have been a
NHSC scholar. Before October 26, 2002, legislation provided authority for
holders of both awards to pay back the obligation of the two sources of support
concurrently. Therefore, activities that qualified as Kirschstein-NRSA payback
also served as payback for the NHSC obligation. However, no Kirschstein-NRSA
legislative allowance is credited toward NHSC service The PSC monitors both
obligations until they are both satisfactorily completed.
Effective October 26, 2002, the legislation was changed to
eliminate concurrent payback. As a result, Kirschstein-NRSA recipients that
also are NHSC scholars now are required to fulfill their NHSC service
commitment through direct clinical service to the underserved in accordance
with NHSC policy. Any Kirschstein-NRSA payback must be fulfilled separately
through acceptable payback service.
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