Extramural Loan Repayment for Individuals from Disadvantaged Backgrounds Conducting Clinical Research (93.308)

Program

93.308 Extramural Loan Repayment for Individuals from Disadvantaged Backgrounds Conducting Clinical Research

Federal Agency

Agency: Department of Health and Human Services
Office: National Institutes of Health

Authorization

Public Health Service Act; Title IV, Subtitle D, Part G, Section 487E, as amended; Public Law 106-554; 42 U.S.C. 288-5.

Program Number

93.308

Last Known Status

Active

Objectives

To encourage the recruitment and retention of qualified health professionals from disadvantaged backgrounds to conduct clinical research. Clinical research consists of 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 the 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 epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.

Types of Assistance

Direct Payments for Specified Use

Uses and Use Restrictions

To provide repayment of existing educational loan debt incurred by health professionals from disadvantaged backgrounds engaged in clinical research. Recipients must execute a written contract agreeing to engage in such research for a minimum of two years. The Secretary of the Department of Health and Human Services, or the Secretary's designee, may grant extension contracts for a one-year or two-year period after the completion of the initial two-year contract, provided that the participant applies for an extension, continues to engage in qualified research, and there is sufficient repayable debt remaining.

Eligibility Requirements

Applicant Eligibility

An applicant must: (1) be a United States citizen, national, or permanent resident; (2) have an M.D., Ph.D., Pharm.D., D.D.S., D.M.D., D.C., N.D., or equivalent doctoral degree from an accredited institution; (3) come from a disadvantaged background; (4) conduct research that is supported by a non-profit institution, foundation, professional society or U.S. government entity, (4) commit 50 percent or more of his/her time to clinical research; (5) have total qualifying educational debt greater than or equal to 20 percent of his/her institutional base salary at the time of award; (7) conduct research in accordance with applicable Federal, state and local law; (8) not be under any existing service obligations to Federal, State, or other entities, unless and until the existing service obligation is discharged or deferred during the period of program service; (9) not have Federal judgment liens against their property arising from a Federal debt from receiving Federal funds until all judgments have been paid in full or otherwise satisfied; (10) not be a full-time employee of a Federal government agency. Part-time Federal employees who engage in qualifying research as part of their non-Federal duties are eligible to apply for loan repayment if they meet all other eligibility requirements; and (11) have the institution provide an assurance that the applicant will be provided research support for two years, that the applicant will engage in qualified clinical research for 50 percent of his/her time, that the funding foundation, professional society, or institution is considered to be non-profit pursuant to Section 501 of the Internal Revenue Code or is a U.S. government entity, and certify the applicant's annual institutional base salary.

Beneficiary Eligibility

Qualified health professionals from a disadvantaged background who conduct clinical research and who possess substantial unpaid educational debt relative to income will benefit from this program.

Credentials/Documentation

An applicant must submit the following documentation electronically: (1) Applicant Information Statement; (2) Biosketch; (3) Personal Statement, which includes a discussion of career goals and academic objectives; (4) Description of Research Activities; (5) Contact Information of Three Recommenders; (6) Contact Information of Institution Official able to serve as the Institutional Contact; (7) On-line Certification; (8) Loan Information; (9) Notice of Grant/Award (or PHS 2271 for T32 recipients), if applying based on NIH support; and (10) Certification of Disadvantaged Background. The Research supervisor or mentor must electronically submit the following: (1) Recommendation; (2) Biosketch; (3) Assessment of the Research Activities Statement submitted by the applicant; (4) Description of the Research Environment; and (5) Training or Mentoring Plan. Recommenders must submit their recommendations electronically. Institutional Contacts must electronically submit a certification that: (1) 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; (2) assures that the applicant is or will be engaged in qualifying research for 50 percent of his/her time, i.e., not less than 20 hours per week; (3) certifies that the funding foundation, professional society, or institution is considered to be non-profit as provided under Section 501 of the Internal Revenue Code (26 U.S.C. 501) or is a U.S. government entity (Federal, state or local); and (4) provides the applicant's institutional base salary. This program is excluded from coverage under OMB Circular No. A-87.

Application and Award Process

Preapplication Coordination

Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.

Application Procedure

This program is excluded from coverage under OMB Circular No. A-102. This program is excluded from coverage under OMB Circular No. A-110. An application for participation in the program can be obtained from www.lrp.nih.gov and should be submitted to the NIH office, which is responsible for the receipt of applications, in such form and manner as the Secretary or the authorized designee may prescribe.

Award Procedure

All eligible and completed applications will be forwarded to the Special Emphasis Panel (SEP) for review. Awards will be made to those applications approved by the SEP, subject to the receipt of an appropriation and/or allocation of funds from the United States Congress, the NIH and/or NCMHD. All selections are subject to final approval by the Secretary or the authorized designee.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Range of Approval/Disapproval Time

> 180 Days. The approximate time for approval/disapproval is 6-8 months.

Appeals

Applicants may question the substantive or procedural aspects of the review of their application by communicating with NCMHD staff. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants2.nih.gov/grants/guide/notice-files/not97-232.html .

Renewals

After the completion of the initial two-year contract, participants may apply for a one-year or two-year extension provided the participant continues to engage in qualified clinical research and has outstanding repayable debt remaining. Applications submitted for an extension are reviewed and selected for funding on a competitive basis.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula.
This program has no matching requirements. This program has no statutory formula or matching requirements.
MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance

An initial contract provides assistance for a two-year period, and an extension contract provides assistance for a one-year or two-year period. Program payments will be made directly to lenders following each quarter of the participant's satisfactory service, unless otherwise agreed upon by the participant and Secretary or authorized designee. Method of awarding/releasing assistance: quarterly.

Post Assistance Requirements

Reports

Standard annual report from the NIH Division of Loan Repayment. Cash reports are not applicable. Participants must be periodically certified to have satisfactorily performed the duties of their positions. No expenditure reports are required. Participants must be periodically certified to have satisfactorily performed the duties of their positions.

Audits

Not Applicable.

Records

The NCMHD will retain applicant records for three years after rejection and participant records for six years after completion of final service obligation.

Program Accomplishments

Fiscal Year 2009: No Current Data Available Fiscal Year 2010: No Current Data Available Fiscal Year 2011: No Current Data Available

Financial Information

Account Identification

75-0897-0-1-552.

Obligations

(Direct Payments for Specified Use) FY 08 not reported.; FY 09 est $938,000; FY 10 est not reported.

Range and Average of Financial Assistance

The total dollar assistance for FY 09 for the 2-year contract period ranged from $4,775 up to $70,000 in loan repayments, and from ~$2,261 up to ~$33,138 in tax reimbursements. The average dollar assistance of awards made in FY 09 was ~$35,600 in loan repayments and ~$16,537 in tax reimbursements.

Regulations, Guidelines and Literature

Pertinent information is contained in Public Law 106-554; Section 487E of the Public Health Service Act (42 U.S.C. 288-5).

Related Programs

93.162 National Health Service Corps Loan Repayment Program; 93.209 Contraception and Infertility Research Loan Repayment Program; 93.923 Disadvantaged Health Professions Faculty Loan Repayment (FLRP) and Minority Faculty Fellowship Program (MFFP); 93.936 National Institutes of Health Acquired Immunodeficiency Syndrome Research Loan Repayment Program

Information Contacts

Regional or Local Office

None.

Headquarters Office

Francisco S. Sy, NIH/NCMHD, 6707 Democracy Blvd. Suite 800, Bethesda, Maryland 20892-5465 Phone: (301) 496-7074.

Web Site Address

http://www.ncmhd.nih.gov .

Examples of Funded Projects

Fiscal Year 2009: No Current Data Available Fiscal Year 2010: No Current Data Available Fiscal Year 2011: No Current Data Available

Criteria for Selecting Proposals

The major elements in evaluating applications/proposals include the assessment of the following: (1) personal statement; (2) proposed research project and its scientific merit (priority will be given to biomedical and behavioral researchers); (3) training plan and environment (which includes the research program, the facilities/environment, the mentor/advisor's training, the applicant's training); (4) loan debt ratio and any associated impediments that may affect the applicant's decision to pursue a research career; and (5) references.