Extramural Clinical Research Loan Repayment Program for Clinical Researchers from Disadvantaged Backgrounds (LRP-IDB)

Notice Number: NOT-OD-12-124

Update: The following update relating to this announcement has been issued:

• July 16, 2013 - See Replacement Notice NOT-OD-13-082.

Catalog of Federal Domestic Assistance Number
93.308

Release Date: July 20, 2012

National Institutes of Health (NIH)

Application Period
Annually: from September 1 through November 15, at 8:00 PM EST.

Purpose

This Notice replaces NOT-OD-11-089, and provides program specific information for Extramural Loan Repayment Program for Individuals from Disadvantaged Backgrounds (LRP-IDB). The overall purpose of the extramural LRP is the recruitment and retention of highly qualified health professionals as research investigators to careers in clinical research. Additional detailed Information about each LRP is provided at http://www.lrp.nih.gov/about_the_programs/index.aspx. The NIH invites qualified health professionals who contractually agree to engage in NIH mission-relevant research for at least two years, and who agree to engage in such research for at least 20 hours per week based on a 40-hour work week, to apply for participation in the extramural LRP. Extramural LRPs provide for the repayment of educational loan debt of up to $35,000 annually for qualified health professionals performing research within the mission of NIH and supported by domestic, non-profit, or government entities. LRP applications will be accepted annually from September 1 through November 15, 8:00 p.m. EST. Applications must be submitted electronically using the NIH Loan Repayment Program Website, www.lrp.nih.gov.

LRP-IDB Program Objective

The objective of the LRP-IDB is the recruitment and retention of highly qualified health professionals from disadvantaged backgrounds to clinical research careers. The emphasis on clinical research and individuals from disadvantaged backgrounds highlights the need for the involvement of a cadre of competent health professionals in 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 epidemiological or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.

An individual from a disadvantaged background is defined as one who comes from a family with an annual income below a level based on low-income thresholds according to family size published by the U.S. Bureau of the Census, adjusted annually for the changes in the Consumer Price Index, and adjusted by the Secretary of the U.S. Department of Health and Human Services (Secretary) for use in all health professions programs. The Secretary periodically publishes these income levels in the Federal Register. An applicant must certify his/her disadvantaged status under the above definition by submitting: (a) a written statement from the individual’s former health professions school(s) that indicates that he/she qualified for Federal disadvantaged assistance during attendance; or (b) documentation that he/she received any of the following financial aid: Health Professions Student Loans (HPSL) or Loans for Disadvantaged Student Program; or (c) documentation that he/she received scholarships from the U.S. Department of Health and Human Services (DHHS) under the Scholarship for Individuals with Exceptional Financial Need.

Eligible Applicants

Eligibility criteria with regard to participation in the extramural LRPs include the following:

• Applicants must be U.S. citizens, U.S. nationals, or permanent resident of the U.S.
• Applicants for LRP-IDB must have a M.D., Ph.D., Dr.P.H., D.N.P., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., O.D. or equivalent doctoral degree from an accredited institution.
• Applicants must have total qualifying educational debt equal to or in excess of 20 percent of their institutional base salary at the time of award which will be between July and September annually). Institutional base salary is the annual amount the organization pays for the individual’s appointment, whether the time is spent on research, teaching, patient care, or other activities. Institutional base salary excludes any income that an applicant may earn outside of the duties of the organization. Institutional base salary may not include or comprise any income (salary or wages) earned as a Federal employee.
• Applicants must conduct qualifying research (as defined above) supported by a domestic non-profit foundation (e.g., universities), 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).
• Applicants must engage in research that averages at least 20 hours per week during each quarterly service period. That is, during each contract quarter, participants must conduct the required research for a minimum of 240 hours (based on a 12-week quarter) or 260 hours (based on a 13-week quarter).
• Part-time federal employees (4/8ths or less) working 20 hours per week or less who are (a) not conducting research as a Federal employee, and (b) whose funding source is from a domestic non-profit source as defined in Paragraph 4 of this section, are eligible to apply for loan repayment if they meet all other eligibility requirements.
• 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) for the entire contract period.
• Applicants will not be excluded from consideration on the basis of age, race, culture, religion, gender, sexual orientation, disability, or other non-merit factors.
• No individual may submit more than one LRP application to the NIH in any fiscal year. Individuals who have applied previously for the LRP, but did not receive an award, are eligible to submit a new application if they meet all of the above eligibility criteria.
• Recipients of a 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://grants1.nih.gov/training/payback.htm). Concurrent payment of LRP and NRSA service obligations is prohibited.

The following individuals are ineligible for participation in the extramural LRPs:

• Persons who are not U.S. citizens, nationals, or permanent residents.
• 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.
• 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 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
• National Research Service Award (NRSA) Program
• Individuals who are employed by the federal government with work schedules of more than 20 hours per week.
• Current recipients of NIH Intramural Research Training Awards (IRTA) or Cancer Research Training (CRTA).
• 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).
• 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.

Funds Available

The NIMHD intends to commit approximately $1.7 million annually to fund LRP-IDB contracts.

Where to Obtain Additional Information
Please see the LRP website at http://www.lrp.nih.gov, send an email to [email protected], or call the Division of Loan Repayment Information Center toll free at (866) 849-4047. Applicants are strongly encouraged to pay attention to Institute or Center (IC) specific funding priorities, and also to discuss their career interests with an IC scientific liaison (contact), using this link: LRP Contacts Website. LRP applications for Clinical Research for Individuals from Disadvantaged Backgrounds are exclusively assigned to the National Institute for Minority Health and Health Disparities (NIMHD).

All applicants are encouraged to view this webinar for application tips and guidance.

Annual Receipt, Peer Review, and Review Schedule
Upon receipt, applications for both initial and renewal awards will be reviewed for eligibility and completeness. Incomplete or ineligible applications will not be considered. Applications that are complete and eligible will be forwarded for peer review.

• Annual Application Receipt Date: September 1 through November 15, 8:00 p.m. EST
• Annual Peer Review Date: February May
• Annual Anticipated Award Date: July September

Application Materials (New and Renewal Applicants)

The following information is furnished by applicants or others on behalf of applicants (forms are completed electronically using the LRP Website: www.lrp.nih.gov), and must be submitted annually from September 1, through November 15, 8:00 p.m. EST.

Applicants electronically transmit the following to the NIH Division of Loan Repayment:

• Applicant information
• NIH Biosketch
• Personal statement, which includes a discussion of career goals and research interests
• Funding Information: source of your research funding
• On-line certification
• Citizenship Verification
• 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. For Renewal: Description of Research Accomplishments
• Identification of three recommenders (one of whom is identified as research supervisor or mentor)
• Identification of institutional contact
• 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

Research supervisors or mentors electronically transmit the following to the NIH Division of Loan Repayment:

• Recommendation
• Biosketch
• Assessment of the research activities statement submitted by the applicant
• 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
• 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 Division of Loan Repayment.
Information is obtained from Individuals who can comment on the research skills and the abilities of the applicant. This includes the applicants research supervisor or most recent mentor who rates the applicant with respect to the following:

• Previous training and experience to prepare for a research career
• Commitment to a career as a clinical researcher
• Potential for a successful career in clinical research
• Applicant’s research related strengths and weaknesses
• Overall recommendation

Institutional contacts electronically transmit a certification to the NIH Division of Loan Repayment that:

• Assures the applicant will be provided the necessary time and resources to engage in the research project for the period of the Loan Repayment Program contract (two years for new and one or two years for renewal)
• Assures the applicant is or will be engaged in qualifying research for an average of 20 hours per week (a total of 240 hours spent on research during a 12-week quarter, or a total of 260 hours spent on research during a 13-week quarter)
• Certifies the sponsoring entity is a domestic non-profit institution (exempt from tax under 26 USC 501)
• Confirms the applicant’s institutional base salary

Renewal Applications

Loan repayment recipients who wish to extend their loan repayment should reapply the year before the current contract ends. 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 clinical investigator. An explanation of research accomplishments during the initial award period is required. Progress toward development as an independent clinical 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.

Applicants are strongly encouraged to discuss their career interests with an NIH Institute or Center scientific liaison provided at this site: LRP Contacts Website.

Evaluation Criteria

Applications for the extramural LRP are evaluated against the following criteria as related to the likelihood that the applicant will continue in a career focused on research in one of the above five program areas:

Applicant s potential to pursue a career in research, including:

• Appropriateness of the applicant’s previous training and experience to prepare for a research career
• Appropriateness of the proposed research activities during the LRP contract period to foster a career in clinical research.
• Commitment to a clinical research career, as reflected by the personal statement of long-term career goals and plan to achieve those goals
• Strength of the letters of recommendations attesting to the applicant’s potential for a successful career in clinical research

Quality of the overall environment to prepare the applicant for a research career, including:

• Quality and availability of appropriate scientific mentors and colleagues to help achieve or enhance the applicant’s research independence, including the mentors record in mentoring researchers, funding history and research productivity.
• Quality and appropriateness of institutional resources and facilities.

For renewal applications (also known as type 2 applications), progress under the previous project period is an additional evaluation criterion:

• Assessment of the renewal applicant’s research accomplishments during the previous LRP support period; and
• Assessment of the renewal applicant’s development as an independent investigator. Renewal applications need to be submitted one year before the current contract ends.

Program Administration Details

Under the LRP, 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. Failure to fulfill the terms of the LRP contract will result in termination of the LRP, or could be considered a breach of contract. The penalty for a breach of contract is $7,500 for every month of unfulfilled service or a minimum of $31,000, whichever is higher.

LRP service obligation and NRSA service payback cannot overlap, and permission to defer NRSA payback must be obtained prior to receipt of LRP funding.

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.

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:

• Health Education Assistance Loan (HEAL)
• Health Professions Student Loan (HPSL)
• Loans for Disadvantaged Students (LDS)
• Nursing Student Loan Program (NSL)

2. Loans guaranteed by the U.S. Department of Education:

• Direct Subsidized Stafford Loan
• Direct Unsubsidized Stafford Loan
• Direct Consolidation Loan
• Perkins Loan
• FFEL Subsidized Stafford Loan
• FFEL Unsubsidized Stafford Loan
• FFEL Consolidation Loan
• PLUS Loans disbursed to graduate and professional students on or after July 1, 2006. Note: PLUS loans to parents do not qualify

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

5. Private ("Alternative") Educational Loans:

• MEDLOANS
• Private (non-guaranteed) Consolidation Loans

The following loans are NOT repayable under this program:

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:

• Armed Forces (Army, Navy, or Air Force) Health Professions Scholarship Program
• Indian Health Service (IHS) Scholarship Program
• National Institutes of Health Undergraduate Scholarship Program (UGSP)
• National Research Service Award (NRSA) Program
• Physicians Shortage Area Scholarship Program (Federal or State)
• Primary Care Loan (PCL) Program
• 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 to parents (PLUS Loans disbursed to graduate and professional students on or after July 1, 2006 quality for repayment)

8. Loans that have been paid in full

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 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 LWOP or a break in service. Penalties and/or fees assessed to participants failing to maintain current payment status may not be considered for reimbursement.

LRP payments are NOT retroactive. Loan repayment will commence after a loan repayment contract has been executed, expected to be no earlier than July through September annually.

Required Federal Citations

Awards are made pursuant to the Minority Health and Health Disparities Research and Education Act of 2000 (Public Law 106-525) that added Section 485G of the Public Health Service Act (42 USC 287c-33). The Federal Debt Collections Procedures Act of 1990, contained in Public Law 101-647, requires that an individual who 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 U.S.C. 3201).