NIH EXTRAMURAL LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS

RELEASE DATE:  October 10, 2002

NOTICE:  NOT-OD-03-004

National Institutes of Health

APPLICATION RECEIPT DATE:  5 PM EST, November 30, 2002

THIS NOTICE CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS NOTICE

The National Institutes of Health (NIH) announces the 2003 Extramural 
Loan Repayment Program for Clinical Researchers (LRP-CR). The LRP-CR 
provides for the repayment of educational loan debt of qualified health 
professionals who agree to conduct clinical research for two years.  
The program provides for the repayment of up to $35,000 of the 
principal and interest of the educational loans.  The program covers 
the Federal taxes on the loan repayments which are considered taxable 
income to program participants.  

The 2003 LRP-CR differs from the 2002 program in that the awards are no 
longer restricted to NIH grantees, as described below in the 
eligibility criteria. 

PROGRAM OBJECTIVES

The objective of the Program is the recruitment and retention of highly 
qualified health professionals to careers as clinical investigators.   

Clinical research is defined as follows: "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."

The NIH invites qualified health professionals who meet program 
eligibility requirements to apply for participation in the NIH Loan 
Repayment Program for Clinical Researchers.

FUNDS AVAILABLE

The NIH intends to commit approximately $40,800,000 in Fiscal Year 2003 
to fund 790 Clinical Research LRP awards. 

ELIGIBLE APPLICANTS

Specific eligibility criteria for the LRP-CR include the following:

Applicants must be United States citizens, nationals, or 
permanent residents.
 
Applicants must have an M.D., Ph.D., Pharm.D., D.O., D.D.S., 
D.M.D., D.P.M., D.C., N.D., or equivalent doctoral degree from an 
accredited institution.
 
Applicants must be supported by a non-profit institution, 
foundation, professional society or U.S. government entity 
(Federal, state, or local) and commit 50% or more of their time, 
or not less than 20 hours per week, to clinical research.  

Applicants must have total qualifying educational debt that is 
greater than or equal to 20 percent of their institutional base 
salary at the time of award, expected to be between June 1 and 
August 1, 2003.  Institutional base 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 be comprised of any 
income (salary or wages) earned as a Federal employee.  

The applicant's institution must provide assurance to the NIH 
that the applicant will be provided clinical research support for 
two years, that the applicant will engage in qualified clinical 
research for 50% or more of his/her time, or not less than 20 
hours per week, and that the institution is non-profit.  The 
institution also certifies the applicant's institutional 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.  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 the above eligibility criteria. 

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.
 
Individuals with existing service obligations to Federal, State 
or other entities will not be considered for an award unless the 
existing service is discharged or deferred for the duration of 
the Loan Repayment contract. 

A current recipient of postdoctoral National Research Service Award 
support from an individual postdoctoral fellowship (F32) or an 
institutional research training grant (T32) will not be eligible for 
loan repayment during the second year of NRSA support without a formal 
deferral of the NRSA service repayment (see 
http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html).  
Concurrent repayment of service obligations is prohibited.  
Participation in an NIH LRP is only permissible by first satisfying the 
NRSA service obligation, which is satisfied either by completing the 
second year of NRSA support or by requesting a deferral of the NRSA 
service repayment.  For more information on terms and conditions for 
specific types of grants, grantees, and activities, see Subpart B, Part 
II of the NIH Grants Policy Statement 
(http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_5.htm#_Toc504812118).

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 an outside entity for at least 20 hours per week are eligible 
to apply for loan repayment if they meet all other eligibility 
requirements.   

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

ELIGIBLE INSTITUTIONS

Applicants must conduct qualifying research supported by a non-profit 
foundation, non-profit professional society or other non-profit 
institution or a U.S. government entity (Federal, state, or local).  A 
foundation, professional society 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 USC 501).
 
WHERE TO SEND INQUIRIES

For questions on the LRP-CR program, please see the LRP website at  
www.lrp.nih.gov, send an email to lrp@nih.gov or telephone the LRP 
helpline at (866) 849-4047.  

Direct your remaining questions regarding scientific matters to the 
relevant NIH program contact listed on the LRP website at 
http://www.lrp.nih.gov/contact/index.htm.
  
SUBMITTING AN APPLICATION

All potential applicants are encouraged to read the eligibility 
requirements, benefits, and application procedures for the LRP-CR 
program located at the LRP website at www.lrp.nih.gov.  

Applications are collected electronically and must be submitted via the 
LRP Website at www.lrp.nih.gov by November 30, 2002 at 5 PM EST.

RECEIPT AND PEER REVIEW PROCESS

Complete applications must be received by the receipt date and time 
listed in the heading of this Notice.    

Upon receipt, applications will be reviewed for eligibility and 
completeness by the Office of Loan Repayment, NIH.  Incomplete or 
ineligible applications will not be considered.  Applications that are 
complete and eligible will be referred to the appropriate NIH Institute 
for peer review by the NIH Center for Scientific Review (CSR).  In 
evaluating the application, reviewers will be directed to consider 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.

The following information is furnished by the applicant or others on 
behalf of the applicant (forms are completed electronically at the NIH 
LRP Web-site, 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 in the research project 
description provided by the applicant.  
5.  Identification of Three Recommenders (One of whom is identified 
as 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 
2271 for T32 recipients)

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.  This document is completed by the research supervisor 
or mentor and is submitted for all applicants (except for 
applicants with an NIH R01 equivalent grant).  
6.  Biosketch of a laboratory staff member if involved in 
training or mentoring the applicant.

The other recommenders electronically transmit recommendations to the 
NIH Office of Loan Repayment.  

Institutional Contacts electronically transmit the following to the 
NIH Office of Loan Repayment:

1.  A certification 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 that 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; (c) certifies 
that the institution is non-profit (exempt from tax under 26 USC 
501), and (d) provides the applicant's institutional base salary.    

RECEIPT AND REVIEW SCHEDULE

Application Receipt Date:     November 30, 2002, 5 PM  EST
Peer Review Date:             March-May, 2003
Anticipated Start Date:       June-August, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Merit (as determined by peer review)
o  Availability of funds

REQUIRED FEDERAL CITATIONS

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).  The Federal Debt Collections 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.
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.


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