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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