Extramural Loan Repayment for Individuals from Disadvantaged Backgrounds Conducting Clinical Research
Published on AidPage by IDILOGIC
on Jun 24, 2005
Purpose of this program:
The purpose of the Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds is 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.
Possible 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.
Who is eligible to apply...
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.
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.
Note:This is a brief description of the credentials or documentation required prior to, or along with, an application for assistance.
About this section:
This section indicates who can apply to the Federal government for assistance and the criteria the potential applicant must satisfy.
For example, individuals may be eligible for research grants, and the criteria to be satisfied may be that they have a professional or scientific degree,
3 years of research experience, and be a citizen of the United States. Universities, medical schools, hospitals, or State and local governments may also be eligible.
Where State governments are eligible, the type of State agency will be indicated (State welfare agency or State agency on aging) and the criteria that they
Certain federal programs (e.g., the Pell Grant program which provides grants to students) involve intermediate levels of application processing, i.e., applications
are transmitted through colleges or universities that are neither the direct applicant nor the ultimate beneficiary. For these programs,
the criteria that the intermediaries must satisfy are also indicated, along with intermediaries who are not eligible.
How to apply...
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.
Note: Each program will indicate whether applications are to be submitted to the Federal headquarters, regional or local office, or to a State or local government office.
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.
Note: Grant payments may be made by a letter of credit, advance by Treasury check, or reimbursement by Treasury check.
Awards may be made by the headquarters office directly to the applicant, an agency field office, a regional office,
or by an authorized county office. The assistance may pass through the initial applicant for further distribution by
intermediate level applicants to groups or individuals in the private sector.
Deadlines and process...
Contact the National Center on Minority Health and Health Disparities listed below for application deadlines or visit the website located at www.lrp.nih.gov.
When available, this section indicates the deadlines for applications to the funding agency which will
be stated in terms of the date(s) or between what dates the application should be received.
When not available, applicants should contact the funding agency for deadline information.
Range of Approval/Disapproval Time
The approximate time for approval/disapproval is 6-8 months.
Not applicable. This program is excluded from coverage under E.O. 12372.
This section indicates whether any prior coordination or approval is required with governmental or nongovernmental units
prior to the submission of a formal application to the federal funding agency.
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.
In some cases, there are no provisions for appeal. Where applicable, this section discusses appeal procedures or allowable rework time for resubmission
of applications to be processed by the funding agency. Appeal procedures vary with individual programs and are either listed in this section or
applicants are referred to appeal procedures documented in the relevant Code of Federal Regulations (CFR).
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.
In some instances, renewal procedures may be the same as for the application procedure, e.g., for projects of a non-continuing nature renewals will be treated as new, competing applications; for projects of an ongoing nature, renewals may be given annually.
Who can benefit...
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.
About this section:
This section lists the ultimate beneficiaries of a program, the criteria they must satisfy and who specifically is not eligible. The applicant and beneficiary will generally be the same for programs that provide assistance directly from a Federal agency. However, financial assistance that passes through State or local governments will have different applicants and beneficiaries since the assistance is transmitted to private sector beneficiaries who are not obligated to request or apply for the assistance.
What types of assistance...
The funding, for fixed or known periods, of specific projects. Project grants can include fellowships, scholarships, research grants, training grants, traineeships, experimental and demonstration grants, evaluation grants, planning grants, technical assistance grants, survey grants, and construction grants.
How much financial aid...
Range and Average of Financial Assistance
The total dollar assistance for FY 02 for the 2-year contract period ranged from $5,362 up to $70,000 in loan repayments, and from $2,933 up to $27,300 in tax reimbursements. The average dollar assistance of awards made in FY 02 was $49,266 in loan repayments and $17,422 in tax reimbursements.
This section lists the representative range (smallest to largest) of the amount of financial assistance available. These figures are based upon funds awarded in the past fiscal year and the current fiscal year to date. Also indicated is an approximate average amount of awards which were made in the past and current fiscal years.
(Grants) FY 03 $2,020,000; FY 04 est $2,056,000; and FY 05 est $2,409,000.
The dollar amounts listed in this section represent obligations for the past fiscal year (PY), estimates for the current fiscal year (CY), and estimates for the budget fiscal year (BY) as reported by the Federal agencies. Obligations for non-financial assistance programs indicate the administrative expenses involved in the operation of a program.
Note: This 11-digit budget account identification code represents the account which funds a particular program.
This code should be consistent with the code given for the program area as specified in Appendix III of the Budget of the United States Government.
Examples of funded projects...
HIV-specific T-helper and CTL responses in viral vertically infected children; Evaluations of immunologic correlates of human papiloma virus infection and disease progression; Treatment in children with congenital heart disease; Oral disease and prevention amongst urban elderly populations; Psoriasis phenotype and atopic dermatitis; Genetic epidemiology and pathophysiological mechanisms of dyspepsia; Antiresorptive therapy for osteopenia associated with chronically immobilized children and adults with neuromuscular disease; Examining for the presence of local hypoxia in chondrosarcoma as a potential mechanism; Cognitive remediation program for childhood cancer survivors.
About this section
This section indicates the different types of projects which have been funded in the past. Only projects funded under Project Grants or Direct Payments for Specified Use should be listed here. The examples give potential applicants an idea of the types of projects that may be accepted for funding. The agency should list at least five examples of the most recently funded projects.
For fiscal year 2002, NCMHD received 72 applications and made 41 awards. It is anticipated that NCMHD will make 42 awards for fiscal year 2003 and 44 awards for fiscal year 2004.
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.
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.
Formula and Matching Requirements
This program has no statutory formula or matching requirements.
A formula may be based on population, per capita income, and other statistical factors. Applicants are informed whether there are any matching requirements to be met when participating in the cost of a project. In general, the matching share represents that portion of the project costs not borne by the Federal government. Attachment F of OMB Circular No. A-102 (Office of Management and Budget) sets forth the criteria and procedures for the evaluation of matching share requirements which may be cash or in-kind contributions made by State and local governments or other agencies, institutions, private organizations, or individuals to satisfy matching requirements of Federal grants or loans.
Cash contributions represent the grantees' cash outlay, including the outlay of money contributed to the grantee by other public agencies, institutions, private organizations, or individuals. When authorized by Federal regulation, Federal funds received from other grants may be considered as the grantees' cash contribution.
In-kind contributions represent the value of noncash contributions provided by the grantee, other public agencies and institutions, private organizations or individuals. In-kind contributions may consist of charges for real property and equipment, and value of goods and services directly benefiting and specifically identifiable to the grant program. When authorized by Federal legislation, property purchased with Federal funds may be considered as grantees' in-kind contribution.
Maintenance of effort (MOE) is a requirement contained in certain legislation, regulations, or administrative policies stating that a grantee must maintain a specified level of financial effort in a specific area in order to receive Federal grant funds, and that the Federal grant funds may be used only to supplement, not supplant, the level of grantee funds.
Post assistance requirements...
Participants must be periodically certified to have satisfactorily performed the duties of their positions.
This section indicates whether program reports, expenditure reports, cash reports or performance monitoring are required by the Federal funding agency, and specifies at what time intervals (monthly, annually, etc.) this must be accomplished.
Not applicable. This program has no statutory audit requirements.
This section discusses audits required by the Federal agency.
The procedures and requirements for State and local governments and nonprofit entities are set forth in OMB Circular No. A-133.
These requirements pertain to awards made within the respective State's fiscal year - not the Federal fiscal year,
as some State and local governments may use the calendar year or other variation of time span designated as the fiscal year period,
rather than that commonly known as the Federal fiscal year (from October 1st through September 30th).
The NCMHD will retain applicant records for three years after rejection and participant records for six years after completion of final service obligation.
This section indicates the record retention requirements and the type of records the Federal agency may require.
Not included are the normally imposed requirements of the General Accounting Office.
For programs falling under the purview of OMB Circular No. A-102, record retention is set forth in Attachment C.
For other programs, record retention is governed by the funding agency's requirements.
Public Health Service Act; Title IV, Subtitle D, Part G, Section 487E, as amended; Public Law 106-554; 42 U.S.C. 288-5.
This section lists the legal authority upon which a program is based (acts, amendments to acts, Public Law numbers, titles, sections, Statute Codes, citations to the U.S. Code, Executive Orders, Presidential Reorganization Plans, and Memoranda from an agency head).
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).