EXTRAMURAL LOAN REPAYMENT PROGRAM FOR CLINICAL RESEARCHERS

RELEASE DATE:  August 21, 2003

NOTICE:  NOT-OD-03-057 

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

APPLICATION PERIOD:  September 1, 2003, through 5 PM EST, December 31, 2003

THIS NOTICE ADDRESSES THE FOLLOWING TOPICS:

o Purpose of this Notice
o Program Objectives
o Funds Available
o Eligible Applicants
o Eligible Institutions
o Where to Send Inquiries
o Submitting a New Application
o Receipt and Peer Review Process
o Application Materials
o Submitting a Renewal Application
o Receipt and Peer Review Process
o Application Materials
o Receipt, Review and Award Schedule for New and Renewal Applications
o Award Criteria for New and Renewal Applications
o Required Federal Citations

PURPOSE OF THIS NOTICE

The National Institutes of Health (NIH) announces the 2004 Extramural Loan 
Repayment Program for Clinical Researchers (LRP-CR).  The LRP-CR provides for 
the repayment of educational loan debt of up to $35,000 annually for 
qualified health professionals conducting clinical research for domestic non-
profit or government entities.  In addition, NIH will cover up to 39 percent 
of the Federal tax liability resulting from loan repayment, and may also 
provide reimbursement for state and local tax liabilities.  Participants 
contract to conduct research for 50 percent of their time, or not less than 
20 hours per week based upon a 40 hour week, for a two-year period.  

LRP-CR applications will be accepted September 1 through December 31, 2003. 

They must be submitted via the NIH Loan Repayment Website, 
http://www.lrp.nih.gov.

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 $38 million in Fiscal Year 2004 to fund 700 LRP-CR 
participants. 

AWARD CRITERIA 

For both new and renewal applications, awards will be based upon merit 
scoring by peer review committees and the availability of funds.

ELIGIBLE APPLICANTS

Eligibility criteria for the LRP-CR include the following:

Applicants must be United States citizens, nationals, or permanent residents.
 
Applicants must have a Ph.D., M.D., D.O., D.D.S., D.M.D., D.P.M., Pharm.D., 
D.C., N.D., or equivalent doctoral degree from an accredited institution.

Applicants must be supported by a domestic non-profit institution (tax exempt 
under 26 USC 501) or a Federal or domestic state or local government entity 
and devote at least 50% of their time (not less than 20 hours per week based 
upon a 40 hour week) to clinical research.

Applicants must have total qualifying educational debt equal to at least 20 
percent of their institutional base salary at the time of award (projected to 
be between June 1 and August 1, 2004).  An individual's institutional base 
salary is the annual compensation that the applicant's organization pays for 
the individual's appointment, whether that individual's time is spent on 
research, teaching, patient care, or other activities.  Base salary excludes 
any income that an individual may be permitted to earn outside of the duties 
to the applicant organization. It cannot include any income earned as a 
Federal employee.  

The applicant's sponsoring entity must certify the applicant will receive 
clinical research support for two years, the applicant will engage in 
qualified clinical research for 50% or more of his/her working hours (not 
less than 20 hours per week based upon a 40 hour week), and its non-profit 
status.  The institution must also provide the applicant's base salary.  

Applicants must agree to conduct research for which funding is not prohibited 
by Federal law, regulations, or DHHS/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).

No individual may submit more than one LRP application to the NIH in any 
fiscal year.  Unsuccessful LRP-CR applicants may reapply in subsequent fiscal 
years. 

Any individual with a Federal judgment lien arising from a Federal debt 
cannot receive program funds until the judgment is satisfied. Similarly, 
individuals with existing service obligations to Federal, state, or other 
government entities remain ineligible until the service is discharged or 
deferred during the LRP contract period. 

Recipients of postdoctoral Ruth L. Kirschstein National Research Service 
Award (NRSA) support from an individual postdoctoral fellowship (F32) or an 
institutional research training grant (T32) will be eligible for loan 
repayment during the second year of NRSA support if a formal extension of the 
NRSA service payback is granted (see 
http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html).  
Concurrent repayment of LRP and NRSA service obligations is prohibited.  

Full-time employees of Federal government agencies are ineligible to apply 
for NIH loan repayment.  Part-time Federal employees – employed by a Federal 
agency 20 hours or less per week – are eligible to apply if they meet all 
other eligibility requirements, including commitment of at least 20 hours per 
week based upon a 40 hour week in qualifying research for which they are not 
compensated as a Federal employee.  

Applicants will not be excluded from consideration on the basis of age, race, 
culture, religion, gender, sexual orientation, disability, or other non-merit 
factors. 

WHERE TO SEND INQUIRIES

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.
  
APPLICANTS' USE OF THE NIH-LRP WEBSITE

All applications must be submitted via the LRP Website at 
http://www.lrp.nih.gov from September 1, 2003, through December 31, 2003 
at 5 PM EST.

All applicants and renewal applicants are encouraged to review the 
eligibility requirements, application procedures, and other participation 
conditions for the LRP-CR program located at the LRP website at 
http://www.lrp.nih.gov.  

RECEIPT AND PEER REVIEW (New and Renewal Applicants):

Upon receipt, applications for both initial awards and renewals 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.  

In evaluating applications, reviewers will be directed to consider the 
following criteria:

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.  
o The applicant's stated commitment to a research career.
o Recommendations attesting to the applicant's potential for a research 
career.

b.  Quality of the applicant's overall research environment:
o Availability of appropriate scientific colleagues to achieve and enhance 
the applicant's research independence.
o Quality and appropriateness of institutional resources and facilities.

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):

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 2004 application cycle if their initial LRP contract began in 2002.  

LRP renewal contracts are available for one- and two-year periods and are 
based upon the same criteria as the initial contract.  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.  Submission of a renewal 
application does not assure the award of loan repayment.  

RECEIPT AND REVIEW SCHEDULE

Application Receipt Date:  September 1, 2003-December 31, 2003, 5 P.M. EST
Peer Review Date:          March-May, 2004
Anticipated Award Date:    June-September, 2004

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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