NOT-OD-03-057: EXTRAMURAL LOAN REPAYMENT PROGRAM FOR CLINICAL RESEARCHERS

Department of Health
and Human Services (HHS)

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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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