Research (OER)
9000 Rockville Pike
Bethesda, Maryland 20892
and Human Services (HHS)
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EXTRAMURAL LOAN REPAYMENT PROGRAM FOR CLINICAL RESEARCHERS
RELEASE DATE: August 23, 2004
NOTICE: NOT-OD-04-060
National Institutes of Health (NIH)
APPLICATION PERIOD: September 1, 2004, through 5 PM EST, December 15, 2004
THIS NOTICE ADDRESSES THE FOLLOWING TOPICS:
o Purpose of this Notice
o Where to Obtain Additional Information
o Program Objectives
o Funds Available
o Award Criteria
o Eligible Applicants
o Receipt, Peer Review, and Review Schedule
o Application Materials (New and Renewal Applications)
o Renewal Applications
o Program Administration and Details
o Required Federal Citations
PURPOSE OF THIS NOTICE
The National Institutes of Health (NIH) announces the availability of
educational loan repayment under the NIH Extramural Loan Repayment Program
for Clinical Researchers (LRP-CR). The Loan Repayment Program for Clinical
Researchers provides for the repayment of up to $35,000 of the principal and
interest of the extant educational loans of such health professionals for
each year of obligated service. Payments equal to 39 percent of total loan
repayments are issued to the Internal Revenue Service on behalf of program
participants to offset Federal tax liabilities incurred.
The purpose of the Loan Repayment Program for Clinical Researchers is the
recruitment and retention of highly qualified health professionals as
clinical investigators. Through this notice, the NIH invites qualified
health professionals who contractually agree to engage in clinical research
for at least two years, and who agree to engage in such research for at least
50 percent of their time, i.e., not less than 20 hours per week, to apply for
participation in the NIH Loan Repayment Program for Clinical Researchers.
LRP-CR applications will be accepted September 1 through December 15, 2004.
They must be submitted via the NIH Loan Repayment Website, http://www.lrp.nih.gov.
WHERE TO OBTAIN ADDITIONAL INFORMATION
For questions on the LRP-CR program, please see the LRP website at
http://www.lrp.nih.gov, send an email to lrp@nih.gov, or call the LRP
helpline at (866) 849-4047.
Direct your remaining questions regarding your research project to the
relevant NIH scientific program contact listed on the LRP website at
http://www.lrp.nih.gov/contact/index.htm.
PROGRAM OBJECTIVES
The objective of the program is to recruit and retain highly qualified health
professionals as clinical investigators.
NIH defines clinical research as “patient-oriented clinical research
conducted with human subjects, or research on the causes and consequences of
disease in human populations involving material of human origin (such as
tissue specimens and cognitive phenomena) for which an investigator or
colleague directly interacts with human subjects in an outpatient or
inpatient setting to clarify a problem in human physiology, pathophysiology
or disease, or epidemiological or behavioral studies, outcomes research or
health services research, or developing new technologies, therapeutic
interventions, or clinical trials."
FUNDS AVAILABLE
The NIH intends to commit $43 million in Fiscal Year 2005 to fund
approximately 750 LRP-CR individuals.
AWARD CRITERIA
Applications for the LRP-CR are evaluated against the following components as
they relate to the likelihood that the applicant will continue in a clinical
research career:
a. Potential of the applicant to pursue a career in clinical research.
o Appropriateness of the applicant’s previous training and experience to
prepare him/her for a clinical research career.
o Suitability of the applicant’s proposed clinical research activities in
the two-year loan repayment period to foster a research career.
o Assessment of the applicant’s commitment to a research career as
reflected by the personal statement of long-term career goals and the plan
outlined to achieve those goals.
o Strength of recommendations attesting to the applicant’s potential for
a research career.
b. Quality of the overall environment to prepare the applicant for a
clinical research career.
o Availability of appropriate scientific colleagues to achieve and/or
enhance the applicant’s research independence.
o Quality and appropriateness of institutional resources and facilities.
Renewal applications are competitive and are evaluated using the same
criteria as new applications plus two additional criteria - an assessment of
research accomplishments and development of an individual as an independent
investigator.
ELIGIBLE APPLICANTS
Specific eligibility criteria with regard to participation in the Loan
Repayment Program for Clinical Researchers include the following:
1. Applicants must be a U.S. citizen, U.S. national, or permanent resident
of the United States;
2. Applicants must have a M.D., Ph.D., Pharm. D., Psy.D., D.O., D.D.S.,
D.M.D., D.P.M., D.C., N.D., or equivalent doctoral degree from an accredited
institution;
3. Applicants must have total qualifying educational loan debt equal to or
in excess of 20 percent of their institutional base salary on the date of
program eligibility (the effective date that a loan repayment contract has
been executed by the Secretary of Health and Human Services or designee),
expected to be between July 1 and September 1, 2005. Institutional base
salary is the annual amount that the organization pays for the participant’s
appointment, whether the time is spent in research, teaching, patient care,
or other activities. Institutional base salary excludes any income that a
participant may earn outside the duties of the organization. Institutional
base salary may not include or comprise any income (salary or wages) earned
as a Federal employee;
4. Applicants must conduct qualifying research supported by a domestic non-
profit foundation, non-profit professional association, or other non-profit
institution, or a U.S. or other government agency (Federal, State, or local).
A domestic foundation, professional association, or institution is considered
to be non-profit if exempt from Federal tax under the provisions of Section
501 of the Internal Revenue Code (26 U.S.C. 501);
5. Applicants must engage in qualified clinical research. Clinical research
is defined as patient-oriented clinical research conducted with human
subjects or research on the causes and consequences of disease in human
populations involving material of human origin (such as tissue specimens and
cognitive phenomena) for which an investigator or colleague directly
interacts with human subjects in an outpatient or inpatient setting to
clarify a problem in human physiology, pathophysiology or disease, or
epidemiologic or behavioral studies, outcomes research or health services
research, or developing new technologies, therapeutic interventions, or
clinical trials;
6. Applicants must engage in qualified clinical research for at least 50
percent of their time, i.e., not less than 20 hours per week based on a 40
hour week;
7. Full-time employees of Federal Government agencies are ineligible to
apply for LRP benefits. Part-time Federal employees who engage in qualifying
research as part of their non-Federal duties for at least 20 hours per week,
and whose funding source is from a domestic non-profit source as defined in
number 4 of this section, are eligible to apply for loan repayment if they
meet all other eligibility requirements;
8. Applicants must agree to conduct research for which funding is not
prohibited by Federal law, regulation, or HHS/NIH policy. Recipients who
receive LRP awards must conduct their research in accordance with applicable
Federal, State and local law (e.g., applicable human subject protection
regulations);
9. Applicants will not be excluded from consideration under the Loan
Repayment Program for Clinical Researchers on the basis of age, race,
culture, religion, gender, sexual orientation, disability, or other non-merit
factors; and
10. No individual may submit more than one LRP application to the NIH in any
fiscal year. Individuals who have applied previously for the LRP-CR but did
not receive an award are eligible to submit a new application if they meet
all of the above eligibility criteria.
The following individuals are ineligible for participation in the Loan
Repayment Program for Clinical Researchers:
1. Persons who are not United States citizens, nationals, or permanent
residents;
2. Any individual who has a Federal judgment lien against his/her property
arising from a Federal debt is barred from receiving Federal funds until the
judgment is paid in full or satisfied;
3. Any individual who owes an obligation of health professional service to
the Federal Government, a State, or other entity, unless deferrals or
extensions are granted for the length of their Extramural Loan Repayment
Program service obligation. The following are examples of programs with
service obligations that disqualify an applicant from consideration, unless a
deferral for the length of participation in the Loan Repayment Program for
Clinical Researchers is obtained:
Armed Forces (Army, Navy, or Air Force) Professions
Scholarship Program,
Exceptional Financial Need (EFN) Scholarship Program,
Financial Assistance for Disadvantaged Health
Professions Students (FADHPS),
Indian Health Service (IHS) Scholarship Program,
National Health Service Corps (NHSC) Scholarship Program,
National Institutes of Health Undergraduate Scholarship Program
(UGSP),
Physicians Shortage Area Scholarship Program,
Primary Care Loan (PCL) Program,
Public Health Service (PHS) Scholarship Program, and
National Research Service Award (NRSA) Program;
4. Full-time employees of Federal Government agencies. Part-time Federal
employees who engage in qualifying research supported by a domestic non-
profit institution, as part of their non-Federal duties, for an outside
entity for at least 20 hours per week, based on a 40 hour week, are eligible
to apply for the LRP-CR if they meet all other eligibility requirements;
5. Current recipients of NIH Intramural Research Training Awards (IRTA) or
Cancer Research Training Awards (CRTA);
6. Individuals conducting research for which funding is precluded by Federal
law, regulations or HHS/NIH policy, or that does not comply with applicable
Federal, State, and local law regarding the conduct of the research (e.g.,
applicable human subject protection regulations); and
7. Individuals with ineligible loans, which include loans that have been
consolidated with a loan of another individual (including spouses or
children), or loans that are not educational, such as home equity loans.
RECEIPT, PEER REVIEW, AND REVIEW SCHEDULE
Upon receipt, applications for both initial and renewal awards will be
reviewed for eligibility and completeness by the NIH Loan Repayment Program.
Incomplete or ineligible applications will not be considered. Applications
that are complete and eligible will be forwarded to the NIH Center for
Scientific Review (CSR), which will assign the application to an NIH
Institute or Center for peer review.
Application Receipt Date: December 15, 2004, 5 P.M. EST
Peer Review Date: March-May, 2005
Anticipated Award Date: June-August, 2005
APPLICATION MATERIALS (New and Renewal Applicants)
The following information is furnished by applicants or others on behalf of
applicants (forms are completed electronically at the NIH LRP Web-site,
http://www.lrp.nih.gov), and must be submitted from September 1, 2004, through
December 15, 2004 at 5 PM EST:
Applicants electronically transmit the following to the NIH Office of Loan
Repayment:
1. Applicant information statement.
2. Biosketch.
3. Personal statement, which includes a discussion of career goals and
academic objectives.
4. Description of research activities, which describes the current or
proposed research project including the specific responsibilities
and role of the applicant in conducting the research. The research
supervisor or mentor will be asked to concur.
5. Identification of three recommenders (including research supervisor
or mentor).
6. Identification of institutional contact.
7. On-line certification.
8. Loan information, including current account statement(s), and
promissory note(s) or disclosure statement(s), obtained from lending
institution(s), submitted via facsimile to 866-849-4046.
9. If applying based on NIH support, Notice of Grant/Award (or PHS Form
2271 for Ruth L. Kirschstein NRSA training fellowships).
Research supervisors or mentors electronically transmit the following to the
NIH Office of Loan Repayment:
1. Recommendation.
2. Biosketch.
3. Assessment of the research activities statement submitted by the
applicant.
4. Description of the research environment, which provides detailed
information about the lab where the applicant is or will be
conducting research, including funding, lab space, and major areas
under investigation.
5. Training or mentoring plan, which includes a detailed discussion of
the training or mentoring plan, including a discussion of the
research methods and scientific techniques to be taught.
Recommenders electronically transmit recommendation forms to the NIH Office
of Loan Repayment.
Institutional contacts electronically transmit a certification to the NIH
Office of Loan Repayment that:
(a) assures the applicant will be provided the necessary time and
resources to engage in the research project for two years from the
date a Loan Repayment Program contract is executed;
(b) assures the applicant is or will be engaged in qualifying research
for 50 percent of their work effort or not less than 20 hours per
week based upon a 40 hour week;
(c) certifies the sponsoring entity is a domestic non-profit
institution (exempt from tax under 26 USC 501); and
(d) identifies the applicant’s institutional base salary.
RENEWAL APPLICATIONS
Recipients who wish to extend their NIH loan repayment should reapply during
the 2005 application cycle if their initial LRP contract began in 2003.
LRP renewal contracts are available for one- and two-year periods and are
based upon the same criteria as the initial application plus two additional
criteria - an assessment of research accomplishments and development of an
individual as an independent investigator. An explanation of research
accomplishments during the initial award period is required. Progress toward
development as an independent investigator is a major factor in awarding
renewal of loan repayment support. Renewal LRP awards are competitive and
submission of a renewal application does not assure the award of loan
repayment.
PROGRAM ADMINISTRATION AND DETAILS
Under the Loan Repayment Program for Clinical Researchers, the NIH will repay
a portion of the extant qualified educational loan debt incurred to pay for
the researcher’s undergraduate, graduate, and/or health professional school
educational expenses. Individuals must have total qualified educational debt
that equals or exceeds 20 percent of their institutional base salary on the
date of program eligibility. This is called the debt threshold. The formula
used to calculate the potential annual loan repayment amount is total
educational debt less the participant obligation (an amount equal to 10
percent of institutional base salary), which yields the total repayable debt;
the total repayable debt is divided by 25 percent, which yields the potential
annual repayment amount (up to $35,000). Participants are encouraged to pay
the participant obligation during the contract period.
Following is an example of loan repayment calculations: An applicant has a
loan debt of $100,000 and a university compensation of $40,000. Since the
loan debt exceeds the debt threshold (20 percent of university compensation =
$8,000), the applicant has sufficient debt for loan repayment consideration.
The participant obligation is 10 percent of the institutional base salary, in
this case $4,000. Thus, repayment of the $4,000 debt is the applicant’s
responsibility. The remaining amount, in this example $96,000 (total
repayable debt) will be considered for repayment on a graduated basis. In
this case, the maximum to be repaid in the initial two-year contract is
$48,000 or $24,000 per year, plus tax reimbursement benefits.
The total repayable debt will be paid at the rate of one-quarter per year,
subject to a statutory limit of $35,000 per year, for each year of obligated
service. Individuals are required to initially engage in 2 years of
qualified clinical research.
The NIH will repay lenders for the extant principal, interest, and related
expenses (such as the required insurance premiums on the unpaid balances of
some loans) of educational loans from a U.S. government entity, academic
institution, or a commercial or other chartered U.S. lending institution,
such as banks, credit unions, savings and loan associations, not-for-profit
organizations, insurance companies, and other financial or credit
institutions which are subject to examination and supervision in their
capacity as lending institutions by an agency of the United States or of the
State in which the lender has its principal place of business, obtained by
participants for the following:
(1) Undergraduate, graduate, and health professional school tuition
expenses;
(2) Other reasonable educational expenses required by the school(s)
attended, including fees, books, supplies, educational equipment and
materials, and laboratory expenses; and
(3) Reasonable living expenses, including the cost of room and board,
transportation and commuting costs, and other living expenses as determined
by the Secretary.
Repayments are made directly to lenders, following receipt of (1) the
Principal Investigator, Program Director, or Research Supervisor's
verification of completion of the prior period of research, and (2) lender
verification of the crediting of prior loan repayments, including the
resulting account balances and current account status. The NIH will repay
loans in the following order, unless the Secretary determines that
significant savings would result from a different order of priority:
(1) Loans guaranteed by the U.S. Department of Health and Human
Services:
o Health Education Assistance Loan (HEAL);
o Health Professions Student Loan (HPSL);
o Loans for Disadvantaged Students (LDS); and
o Nursing Student Loan Program (NSL);
(2) Loans guaranteed by the U.S. Department of Education:
o Direct Subsidized Stafford Loan;
o Direct Unsubsidized Stafford Loan;
o Direct Consolidation Loan;
o Perkins Loan;
o FFEL Subsidized Stafford Loan;
o FFEL Unsubsidized Stafford Loan; and
o FFEL Consolidation Loan;
(3) Loans made or guaranteed by a State, the District of
Columbia, the Commonwealth of Puerto Rico, or a territory
or possession of the United States;
(4) Loans made by academic institutions; and
(5) Private ("Alternative") Educational Loans:
o MEDLOANS; and
o Private (non-guaranteed) Consolidation Loans.
The following loans are NOT repayable under the Loan Repayment Program for
Clinical Researchers:
(1) Loans not obtained from a U.S. or other government entity,
academic institution, or a commercial or other chartered U.S. lending
institution such as loans from friends, relatives, or other individuals, and
non-educational loans, such as home equity loans;
(2) Loans for which contemporaneous documentation (current account
statement, and promissory note or lender disclosure statement) is not
available;
(3) Loans that have been consolidated with loans of other
individuals, such as a spouse or child;
(4) Loans or portions of loans obtained for educational or living
expenses, which exceed a reasonable level, as determined by the standard
school budget for the year in which the loan was made, and are not determined
by the LRP to be reasonable based on additional contemporaneous documentation
provided by the applicant;
(5) Loans, financial debts, or service obligations incurred under the
following programs, or other programs that incur a service obligation that
converts to a loan on failure to satisfy the service obligation:
o Armed Forces (Army, Navy, or Air Force) Health Professions
Scholarship Program;
o Indian Health Service (IHS) Scholarship Program;
o National Institutes of Health Undergraduate Scholarship
Program (UGSP);
o National Research Service Award (NRSA) Program;
o Physicians Shortage Area Scholarship Program (Federal or
State);
o Primary Care Loan (PCL) Program; and
o Public Health Service (PHS) and National Health Service Corps
(NHSC) Scholarship Program;
(6) Delinquent loans, loans in default, or loans not current in their
payment schedule;
(7) PLUS Loans;
(8) Loans that have been paid in full; and
(9) Loans obtained after the execution of the NIH Loan Repayment
Program Contract (e.g., promissory note signed after the LRP contract has
been awarded) (this provision does not apply to qualifying loan
consolidations).
Before the commencement of loan repayment, or during lapses in loan
repayments, due to NIH administrative complications, Leave Without Pay
(LWOP), or a break in service, LRP participants are wholly responsible for
making payments or other arrangements that maintain loans current, such that
increases in either principal or interest do not occur. The LRP contract
period will not be modified or extended as a result of Leave Without Pay
(LWOP) or a break in service. Penalties assessed participants as a result of
NIH administrative complications to maintain a current payment status may not
be considered for reimbursement.
LRP payments are NOT retroactive. Loan repayment for Fiscal Year 2005 will
commence after a loan repayment contract has been executed, which is expected
to be no earlier than July 2005.
CITATIONS OF FEDERAL AUTHORITY
Awards are made pursuant to the Public Health Improvement Act of November
2000 (Public Law 106-505), also known as the Clinical Research Enhancement
Act, which added Section 487F of the Public Health Service (PHS) Act (42
U.S.C. 288-5a) [So in law. There are two sections 487F. Section 205 of
Public Law 106-505 (114 Stat. 2329), inserted section 487F after section
487E. Previously, section 1002(b) of Public Law 106-310 (114 Stat. 1129),
which relates to a Pediatric Research Loan Repayment Program, inserted
section 487F after section 487E.] The Federal Debt Collection Procedures Act
of 1990, contained in Public Law 101-647, requires that an individual that
has a judgment lien against his/her property for a debt to the United States
shall not be eligible to receive funds directly from the Federal government
in any program, except funds to which the debtor is entitled as a
beneficiary, until the judgment is paid in full or otherwise satisfied (28
USC 3201). The Catalog of Federal Domestic Assistance number for the LRP for
Clinical Researchers is 93.280.
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Office of Extramural Research (OER) |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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Department of Health and Human Services (HHS) |
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