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ARCHIVED - NIH Grants Policy Statement (10/03)


NIH Grants Policy Statement
(12/03)

Part II: Terms and Conditions of NIH Grant Awards
Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities -- File 3 of 5


Special Program Considerations

The primary objective of the Kirschstein-NRSA program is to prepare qualified individuals for careers that have a significant impact on the Nation’s research agenda. Within the framework of the program’s longstanding commitment to excellence and projected need for investigators in certain areas of research, institutions must attempt to recruit individuals from racial or ethnic groups underrepresented in the biomedical and behavioral sciences. The following groups are ones that nationally are underrepresented in biomedical and behavioral research: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. NIH’s requirements for minority recruitment and retention are described in “Review—Minority Recruitment Plan” in this subsection.

NIH also considers the duration of training and the transition of trainees to other support mechanisms. Studies have shown that the length of the research training grant appointment of postdoctoral trainees with health-professional degrees strongly correlates to subsequent application for and success in receiving independent NIH research support. Therefore, training PDs should appoint only those individuals who are committed to a career in research and plan to remain on the training grant or in a non-Kirschstein-NRSA research experience for a minimum of 2 years in the aggregate. It also has been shown that transition to independent support is related to career success. Therefore, training PDs also should encourage postdoctoral trainees to apply for Kirschstein-NRSA individual postdoctoral fellowships (F32) or mentored career development awards (K awards). When reviewing Kirschstein-NRSA institutional research training grant applications, peer reviewers will examine the training record to determine the average duration of training appointments for health-professional postdoctoral trainees and whether there is a history of transition to individual support mechanisms.

Studies also have shown that health professional trainees that train in combined programs with postdoctoral researchers with intensive research experience are more likely to apply for and receive research grant support. Programs in clinical departments that focus on research training for individuals with the M.D. or other health-professional degrees should consider developing ties to basic science departments or, if consistent with the goals of the program, modifying the program to include individuals with research doctorates. In these cases, applications should describe the basic science department’s contribution to the research training experience and indicate whether both health professional trainees and trainees with research doctorates will be included in the training program.

Training PDs also are encouraged to develop methods for ongoing evaluation of the quality of the training program. Although the T32 application process requires extensive career-tracking information, it often is useful to obtain more timely feedback. NIH encourages PDs to develop plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvement. Applicant institutions are encouraged to include a description of these plans in competing applications.

Review

Overall

Each initial and competing continuation application will be evaluated for scientific merit by an NIH peer review group. Kirschstein-NRSA institutional research training grant applications also must be reviewed by the National Advisory Council or Board of the IC whose activities relate to the proposed research training.

Applications for Kirschstein-NRSA institutional research training grants will be evaluated using criteria such as the following:

l      Past research training record of both the program and the designated preceptors.

l      Objectives, design, and direction of the research training program.

l      Caliber of preceptors as researchers, including successful competition for research support.

l      Quality of the organizational training environment for NRSA-supported trainees and relationship of the NRSA program to the broader training program, if appropriate. This includes the level of organizational commitment, quality of the facilities, availability of appropriate courses, and the availability of research support.

l      Quality of the applicant pool and the selection of individuals for appointment to the training program, including an assessment of the racial and ethnic diversity of the trainee pool. The assessment will take into account described recruitment and retention and the availability of individuals from underrepresented groups within the relevant pool of applicants.

l      Record of the research training program in retaining health-professional postdoctoral trainees for at least 2 years.

In addition, when applicable, the concomitant training of health-professional postdoctorates (e.g., individuals with the M.D., D.O. or D.D.S. degree) with basic science postdoctorates (e.g., individuals with a Ph.D. or Sc.D. degree) or linkages with basic science departments will receive special consideration.

Applicants also are encouraged to consult the PHS 398 application instructions, the NIH T32 PA, and specific IC PAs for additional details.

Short-Term Research Training Positions

In addition to the overall programmatic criteria, applications that request short-term research training positions in conjunction with full-time positions will be assessed using specific criteria. The NIH T32 PA and/or specific IC PAs should be consulted for details.

Minority Recruitment Plan

The Kirschstein-NRSA institutional research training grant program must provide for the recruitment and retention of individuals from underrepresented minority groups including, but not limited to, African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. All competing applications for Kirschstein-NRSA institutional research training grants must include a specific plan to recruit minorities.

Competing continuation applications for Kirschstein-NRSA institutional research training grants also must include a detailed section on the outcomes of the minority recruitment plan proposed in the previous competing application. Information on successful and unsuccessful recruitment strategies must be included. The application also must include information on the racial/ethnic distribution of the following:

l      Students or postdoctorates who applied for admission or positions within the department under the Kirschstein-NRSA institutional research training grant

l      Students or postdoctorates who were offered admission to or a position within the department

l      Students enrolled in the academic program related to the research training grant

l      Students or postdoctorates appointed to the research training grant.

For trainees who were enrolled in the academic program, the application should include information about the duration of research training and whether those trainees have finished their training in good standing.

The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included in the priority score. In addition, peer reviewers will evaluate the minority recruitment plan and accomplishments (for competing continuation applications) after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of minorities and whether the experience in recruitment during the previous competitive segment has been incorporated into the formulation of the plan for the next competitive segment.

If an application is received without a minority recruitment plan, or without a report on the previous competitive segment, the application will be considered incomplete and may be returned to the applicant without review.

The findings of the review group will be included in an administrative note in the summary statement. If the minority recruitment plan of the application is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NIH IC, with guidance from its National Advisory Council or Board, will determine whether amended plans and reports submitted after the initial review are acceptable.

Information on the recruitment and retention of underrepresented minority trainees during the previous budget period also must be provided in the non-competing progress report submitted as a prerequisite to receiving non-competing continuation support.

Training in the Responsible Conduct of Research

All Kirschstein-NRSA institutional research training grant applications must include a description of the formal and informal activities related to instruction in the responsible conduct of research planned for the proposed research training program. In addition, NIH encourages institutions to provide instruction in the responsible conduct of research to all individuals in a training program or department, regardless of the source of support.

Every prebaccalaureate, predoctoral, and postdoctoral Kirschstein-NRSA trainee must receive instruction in the responsible conduct of research. Applications must describe a program to provide formal or informal instruction in research integrity and/or the responsible conduct of research, as follows:

l      Although NIH does not establish specific curricula or formal requirements, all programs are strongly encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it also is beneficial to discuss the mutual responsibilities of the institution and the trainees participating in the program.

l      Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance requirements, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.

l      Information on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation applications.

Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.

NIH SRGs will assess the applicant’s plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. The acceptability of the revised plan will be judged by staff members in the NIH IC.

Following initial review, applications undergo a second-level review by the appropriate NIH IC’s National Advisory Council or Board. In addition to the assessment of the scientific and educational merit of the research training grant application, these advisory groups will consider the initial review group’s comments on the plan for instruction in the responsible conduct of research.

Information on the nature of the instruction in the responsible conduct of science and the extent of trainee and faculty participation also must be provided in the progress report submitted as a prerequisite to receiving non-competing continuation support.

Notification of Action

Shortly after the initial review meeting, the PD will be sent a mailer that includes the SRG recommendation/priority score and the name and telephone number of a PO in the assigned NIH IC. The NIH IC automatically forwards a copy of the summary statement to the PD as soon as possible after receiving it from the SRG. The PD will be notified by the PO of the final review recommendation. An NGA will be issued for applications selected for funding. Any questions about initial review recommendations and funding possibilities should be directed to the named PO, not to the SRA of the SRG.

Period of Support

Training Grants

Kirschstein-NRSA institutional research training grants may be made for competitive segments of up to 5 years and are renewable. Awards within an approved competitive segment normally are made in 12-month increments; support for additional non-competitive years depends on satisfactory progress and availability of funds.

Trainees

Trainees under Kirschstein-NRSA institutional research training grants generally are appointed for full-time 12-month continuous periods. An appointment or reappointment may not exceed 12 months without prior approval by the NIH awarding office. All trainees are required to pursue their research training full time, normally defined as 40 hours per week or as specified by the grantee in accordance with its own policies. Unless the NIH awarding office furnishes other instructions, the amount of the stipend, tuition, and fees for each full period of appointment must be obligated by the grantee from funds available when the individual begins training.

With the exception of specifically designated short-term research training positions, no trainee may be appointed under a regular Kirschstein-NRSA institutional research training grant for less than 9 months except with the prior written approval of the NIH awarding office and then usually only to complete a planned program of training. An initial appointment of less than 9 months may be allowed as long as an assurance is included that the individual will be immediately reappointed in the subsequent year so that the cumulative continuous training period is at least 9 months.

Part-time training. Under unusual and pressing personal circumstances, a PD may submit a written request to the NIH awarding office to change a trainee appointment to less than full time. Such requests will be considered case-by-case and must be approved by the awarding office before the applicable budget period. The circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as a child or elder care. Part-time training will not be approved to accommodate use of other sources of funding, job opportunities, clinical practice, or clinical training, or for other responsibilities associated with the trainee’s position at the organization. In each case, the written request must be countersigned by the trainee and an AOO and must include documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training and assurances that the trainee intends to return to full-time training when that becomes possible and to complete the research training program.

The stipend may be prorated in the grant award during the period of any approved part-time training. Part-time training also may affect the rate of accrual or repayment of the service obligation for postdoctoral trainees. In no case will it be permissible for the trainee to be engaged in Kirschstein-NRSA-supported research for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from a Kirschstein-NRSA training grant.

Kirschstein-NRSA Limitations

No individual trainee may receive more than 5 years of aggregate Kirschstein-NRSA support at the predoctoral level and 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from Kirschstein-NRSA institutional research training grants and individual fellowships.

Any exception to the maximum period of support requires a waiver from the NIH awarding office based on review of a justification from the individual and the grantee organization. The trainee must make the request in writing to the NIH awarding office. The trainee’s PD and an AOO must endorse the request certifying the need for additional support. The request must specify the amount of additional support for which approval is sought.

Some generally recognized categories under which NIH may grant exceptions include the following:

l      Physicians/clinicians. Individuals requiring additional time to complete training, either as participants in a combined M.D./Ph.D. program or as clinicians (e.g., physicians, dentists, veterinarians) who are completing postdoctoral research training, may anticipate favorable consideration of a request for waiver of the time limitation. This action is contingent upon an assurance of the trainee’s good academic standing and justified need for the exception to this policy.

l      Interruptions (break in service). Requests for additional time also will be considered if an event unavoidably has altered the planned course of the research training, if the interruption has significantly detracted from the nature or quality of the planned research training, and if a short extension would permit completion of the training as planned. Such events include sudden loss of the preceptor’s services or an accident, illness, or other personal situation that prevents a trainee from effectively pursuing research training for a significant period of time. Requests for extension of support also will be considered if a short additional period would provide the trainee an opportunity to use an exceptional training resource directly related to the approved research training program.

Requests that arise from circumstances other than those described above will be considered only if they are accompanied by an exceptionally strong justification.

Initiation of Support

An NGA is issued to the grantee organization, normally for a budget period of 12 months. A trainee may be appointed any time during the budget period for an appointment period of 9 to 12 months, without prior approval by the NIH awarding office.

At the time of the initial appointment and subsequent reappointment, the training PD must submit a Statement of Appointment to the NIH awarding office. In addition, a signed Payback Agreement must be submitted for each postdoctoral trainee who is in his/her first 12 months of Kirschstein-NRSA postdoctoral support. See “Reporting Requirements—Statement of Appointment (Form PHS 2271)” and “Reporting Requirements—Payback Agreement (Form PHS 6031)” in this subsection for specific information on required forms. The Statement of Appointment includes biographical data on the trainee and the stipend level for the period of appointment. The stipend is paid by the grantee organization directly to the trainee.

Allowable and Unallowable Costs

Policies included in the applicable cost principles and the NIHGPS govern the expenditure of all training grant funds, unless otherwise indicated in the NGA.

Stipends

Trainees generally are supported for 12-month full-time training appointments for which they receive a stipend as a subsistence allowance to help defray living expenses during the research training experience. The stipend is not provided as a condition of employment with either the Federal government or the grantee organization. Stipends must be paid in accordance with established stipend levels. No departure from the standard stipend provided by NIH under the grant may be negotiated by the grantee organization with the trainee. NIH stipend amounts may be adjusted only at the time of appointment or reappointment. For appointments of less than 12 months, the stipend will be prorated.

Stipend levels are updated almost every fiscal year. When increases are approved, they are published in NIH Guide for Grants and Contracts. Current levels also are posted at http://grants.nih.gov/training/nrsa.htm.

Stipend levels are as follows:

l      Prebaccalaureate. Two separate levels are provided for trainees: freshman/
sophomore or junior/senior.

l      Predoctoral. One stipend level is used for all predoctoral trainees, regardless of the level of experience.

l      Postdoctoral. The stipend level for the entire first year of support is determined by the number of full years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching assistantship, internship, residency, clinical duties, or other time spent in a health-related field beyond that of the qualifying doctoral degree. Once the appropriate stipend level has been determined, the trainee must be paid at that level for the entire period of appointment. The stipend for each additional year of Kirschstein-NRSA support is the next level in the stipend structure and does not change mid-year.

Training-Related Expenses

Funds are provided to defray costs such as staff salaries, consultant costs, equipment, research supplies, staff travel, and other expenses directly related to the training program. Funds are requested and awarded as a lump sum on the basis of the predetermined amount per predoctoral and postdoctoral trainee approved for support. Levels are published in the NIH Guide for Grants and Contracts. Interested applicants should consult the program announcement regarding the specific level for programs such as the short-term training program, the MARC U*STAR program, or the COR program.

Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request organizational costs above the standard level. Requests for additional costs must be explained in detail and justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised.

Trainee Tuition, Fees, and Health Insurance

Tuition, fees, and health insurance (self-only or family) are allowable trainee costs only if such charges are applied consistently to all people in a similar training status at the organization, without regard to their source of support. Health insurance can include coverage for costs such as vision and/or dental care if consistent with organizational policy.

Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program and requires NIH awarding office prior approval. For all Kirschstein-NRSA institutional research training grant awards, this budget category (tuition, fees, and health insurance) is calculated at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Tuition, fees, and health insurance are awarded as a lump sum that can be allocated (without the prior approval of the NIH awarding office) based on recipient needs.

Trainee Travel Costs

If requested by the grantee, the NIH awarding office may provide grant funds to cover the costs of trainee travel, including attendance at scientific meetings, which the organization determines is necessary to the individual’s training. Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution, except that the grantee organization may authorize a one-way travel allowance in an individual case of extreme hardship.

In addition, support for travel to a research training experience away from the grantee organization may be permitted. Research training experiences away from the parent organization must be justified on the basis of the type of opportunities for training available, the opportunities offered that are different from those at the parent organization, and the relationship of the proposed experience to the trainee’s career stage and career goals. This type of research training requires prior approval of the NIH awarding office. Letters requesting such training may be submitted to the NIH awarding office at any time during the appointment period.

Short-Term Training Costs

The grantee may receive up to one-twelfth of the annual amount designated for training-related expenses each month to offset the costs of tuition, fees, travel, supplies, and other expenses for each short-term, health-professional research training position.

Employee Benefits

Because Kirschstein-NRSA awards are not provided as a condition of employment with either the Federal government or the grantee, it is inappropriate and unallowable for organizations to seek funds, or to charge Kirschstein-NRSA institutional research training grants, for costs that normally would be associated with employee benefits (for example, FICA, workers compensation, and unemployment insurance).

Facilities and Administrative Costs

Grantees, other than State, local, or Indian tribal governments, will receive F&A costs at 8 percent of modified total direct costs (exclusive of tuition and fees, health insurance, and expenditures for equipment) rather than on the basis of a negotiated rate agreement. State, local, and Indian tribal government agencies are eligible for full F&A cost reimbursement. For this policy, State universities or hospitals are not considered governmental agencies.

Rebudgeting of Funds

Funds may be rebudgeted only as follows:

l      Trainee-related expenses. Rebudgeting of funds awarded in a lump sum for trainee-related expenses does not require NIH awarding office prior approval.

l      Trainee costs. For rebudgeting purposes, trainee costs include funds awarded in the stipends or tuition/fees and health insurance budget categories. These costs may not be used for other purposes except under unusual circumstances and then only with the prior approval of the NIH awarding office. Unless otherwise restricted, rebudgeting into or within the stipends and tuition, fees, and health insurance categories is allowable without prior approval of the NIH awarding office.

l      Trainee travel. For rebudgeting purposes, trainee travel is not considered a trainee cost and, therefore, may be rebudgeted into any other budget category without prior approval of the NIH awarding office.

Stipend Supplementation, Compensation, and Other Income

Stipend Supplementation

Grantees may supplement stipends from non-Federal funds provided the supplementation is without obligation to the trainee. An organization can determine what amount of stipend supplementation, if any, will be provided according to its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar training status regardless of the source of funds. Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived. An individual may use Federal educational loan funds or VA benefits when permitted by those programs as described in “Educational Loans or GI Bill” in this subsection. Under no circumstances may PHS funds be used for supplementation.

Student Compensation

NIH recognizes that trainees as students may seek part-time employment coincidental to their training program to further offset their expenses. Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets the conditions of the compensation of students as detailed in “Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Salaries and Wages—Compensation of Students.” In addition, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship. Under these conditions, the funds provided as compensation (salary, fringe benefits, and/or tuition remission) for services rendered, such as teaching or laboratory assistance, are not considered stipend supplementation; they are allowable charges to Federal grants, including PHS research grants. However, it is expected that compensation from research grants will be for limited part-time employment apart from the normal full-time training activities.

Compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the Kirschstein-NRSA institutional research training grant application. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee’s approved Kirschstein-NRSA training program. Training PDs must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.

Concurrent Benefits

An individual may not receive support under a Kirschstein-NRSA institutional research training grant concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the Kirschstein-NRSA award.

Educational Loans or GI Bill

An individual may accept concurrent educational remuneration from the VA (GI Bill) and Federal educational loan funds. Such funds are not considered supplementation or compensation. In the case of the MARC-U*STAR program, funds from a PELL grant may be accepted as well. Postdoctoral trainees also may be eligible to participate in the NIH Loan Repayment Program. Information about this program is available at http://www.lrp.nih.gov/.

Taxability of Stipends

Section 117 of the Internal Revenue Code applies to the tax treatment of scholarships and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used for course tuition and related expenses, such as fees, books, supplies, and equipment, required for courses of instruction at a qualified educational organization. Nondegree candidates are required to report as gross income any monies paid on their behalf for stipends or any course tuition and fees required for attendance.

The taxability of stipends in no way alters the relationship between Kirschstein-NRSA trainees and grantee organizations. Kirschstein-NRSA stipends are not considered salaries. In addition, trainees supported under Kirschstein-NRSA institutional research training grants are not considered to be in an employee-employer relationship with NIH or the grantee organization solely as a result of the Kirschstein-NRSA support. Interpretation and implementation of the tax laws are the domain of the IRS and the courts. NIH takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations.

Form 1099

Although stipends are not considered salaries, the income still is subject to Federal and, sometimes, State taxes. The grantee organization may report such income on IRS Form 1099, Statement of Miscellaneous Income. Normally, the business office of the grantee organization will be responsible for annually preparing and issuing the IRS Form 1099 for trainees. Grantee organizations are not required to issue the Form 1099, but it is a useful form of documentation of income received and it serves as a reminder to the trainee that some tax liability may exist. Even if the grantee organization does not issue the Form 1099, trainees are required to report Kirschstein-NRSA stipends as income.

Carryover Authority

Kirschstein-NRSA institutional research training grants are included in expanded authorities (except for carryover of unobligated balances). In most cases, grantees must obtain awarding office prior approval to carry over funds; however, some NIH awarding offices have waived this requirement for training grants as well. The NGA for a Kirschstein-NRSA institutional research training grant will specify whether or not the grantee must obtain the prior approval of the awarding office to carry over funds.

Program Income

Applicants for NIH research grants, including Kirschstein-NRSA institutional research training grants, are required to include in their grant applications an estimate of the amount and source of program income expected to be generated as a result of the project for which support is being sought. See “Administrative Requirements—Management Systems and Procedures—Program Income” for policies that govern the disposition and reporting of program income.

Reporting Requirements

The submission of the forms described in this subsection is critical to establishing the payment of stipends and other costs and determining possible payback service. Failure to submit the required forms in a timely manner may result in an expenditure disallowance or a delay in any continuation funding. All of these forms are available in pdf-fillable and rtf formats at http://grants.nih.gov/grants/forms.htm. The NIH awarding office also may provide copies of applicable forms along with the NGA or reference this website in the award.

Statement of Appointment (Form PHS 2271)

The grantee must submit a PHS 2271 to the NIH awarding office before or at the start of each trainee’s appointment or reappointment. If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data electronically using the X-TRAIN application. More information on X-TRAIN is available at https://commons.era.gov/commons/.

No stipend or other allowance may be paid until the appointment form has been submitted. If the support covers the individual’s initial 12 months of postdoctoral support, a signed Payback Agreement also must be submitted. The information on the Statement of Appointment (and the Termination Notice as discussed below) is the basis for determining the length or amount of an individual’s payback requirement. An accurate Social Security Number should be included on the Statement of Appointment and all other documents. The PD and the organizations’ financial officials should coordinate the information reported on the Statement of Appointment. It should be treated as a financial document for obligating funds (stipends), which later are reflected on the Termination Notice and as part of the total costs in the FSR.

Interim revisions. Any changes or corrections involving a trainee appointment under a Kirschstein-NRSA institutional research training grant, such as name, permanent mailing address, period of training, or stipend support, must be reported by the training PD to the NIH awarding office on an amended PHS 2271 at the time of the change.

Consecutive support. If a trainee switches from one Kirschstein-NRSA mechanism to another (e.g., from an individual fellowship to a training grant) or from one NIH awarding office to another, the requirement for payback service incurred is deferred until the total period of Kirschstein-NRSA support is completed. All Statement of Appointment forms are reviewed to determine if previous Kirschstein-NRSA support has been provided.

Payback Agreement (Form PHS 6031)

A Payback Agreement that covers the initial 12 months of Kirschstein-NRSA postdoctoral support must be signed by each postdoctoral trainee. If the individual has already received 12 months of postdoctoral support under any Kirschstein-NRSA training grant or fellowship award, this form is not required. For details on Kirschstein-NRSA payback, see “Payback Reporting Requirements” in this section.

No Payback Agreement is required for predoctoral or prebaccalaureate trainees.

Termination Notice (Form PHS 416-7)

The Termination Notice (along with the PHS 2271 Statement of Appointment form) is the basis for validating the total period of Kirschstein-NRSA support and establishing the amount of payback obligation, if any, for each Kirschstein-NRSA trainee. The PD is responsible for submitting a Termination Notice for each trainee within 30 days of the end of the total period of support. The lack of timely and accurate information on this form could adversely affect the payback process.

Progress Reports

Progress reports must be submitted for non-competing continuation support in accordance with the instructions accompanying the progress report forms (PHS 2590). Progress report forms and instructions are available from the NIH website at http://grants.nih.gov/grants/forms.htm. Progress report form pages are available in pdf-fillable and rtf formats. Incomplete or inadequate progress reports may be returned for revision and may result in a delay of continued support. Following completion or termination of a project period, the grantee must submit a final progress report to the NIH awarding office within 90 days after the end of grant support.

Financial Status Report

An annual FSR is required for all Kirschstein-NRSA institutional research training grant awards no later than 90 days after the close of each budget period. This report will document the financial status of the grant according to the official accounting records of the grantee organization. Trainee stipends and tuition are obligated for the full 12-month appointment from the budget period in which the appointment is initiated. Portions of stipends and tuition that extend beyond the budget period are carried over as unliquidated obligations. However, if the report covers the final budget period of the project period, it must have no unliquidated obligations and must indicate the exact balance of unobligated funds (see “Administrative Requirements—Monitoring—Reporting—Financial Reports” and “Administrative Requirements—Closeout—Final Reports”).

Changes in the Project

Changes in the program objectives as they relate to the area of research training for which the grant was approved require prior approval of the NIH awarding office.

If the PD is expected to be absent more than 3 months, plans for the conduct of the program during his or her absence must be approved in writing by the NIH awarding office. Any proposed change of PD must be requested by the grantee organization and be approved in writing by the NIH awarding office following review of the nominee’s qualifications and re-evaluation of the project in light of the proposed change.

Kirschstein-NRSA institutional research training grants may not be transferred from one domestic organization to another except under the most unusual circumstances. Such a change generally will be approved by the NIH awarding office only if all of the major benefits attributable to the original grant can be transferred and there is no negative impact on trainees active in the program.

Other Terms and Conditions

Leave

Vacations and holidays. Trainees may receive the same vacations and holidays available to individuals in comparable training positions at the grantee organization. Trainees will continue to receive stipends during vacations and holidays. At academic institutions, the time between semesters or academic quarters generally is considered an active part of the training period.

Sick leave and other leave. Trainees may continue to receive stipends for up to 15 calendar days of sick leave per year. Under exceptional circumstances, this period may be extended by the NIH awarding office in response to a written request from the training PD countersigned by an AOO. Sick leave may be used for the medical conditions related to pregnancy and childbirth.

Parental leave. Trainees may receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee organization have access to paid leave for this purpose. Either parent is eligible for parental leave. The use of parental leave must be approved by the training PD.

Terminal leave. A period of terminal leave is not permitted, and payment may not be made from grant funds for leave not taken.

Unpaid leave. Individuals requiring extended periods of time away from their research training experience, that is, more than 15 calendar days of sick leave or more than 30 calendar days of parental leave, must seek approval from the NIH awarding office for an unpaid leave of absence. Approval for a leave of absence must be requested in advance by the training PD and be countersigned by an AOO.

During a leave of absence, documentation to suspend the period of appointment must be completed by submitting an amended Statement of Appointment and a Termination Notice. These forms should be submitted to the NIH awarding office at the beginning of the leave. Upon resumption of Kirschstein-NRSA support, the reappointment must be documented on another Statement of Appointment form.

Termination

NIH may terminate a Kirschstein-NRSA institutional research training grant before its normal expiration date if it determines that the grantee has materially failed to comply with the terms and conditions of the award or to carry out the purpose for which the award was made. If an award is terminated for cause, NIH will notify the grantee organization in writing of this determination, the reasons for the determination, the effective date, and the right to appeal the decision. NIH also may terminate an award at the request of the grantee.

An organization that wants to terminate a training grant before the scheduled termination date must notify the NIH awarding office immediately. In such cases, NIH will issue a revised NGA to specify the changed period of support and to show prorated trainee stipends, depending on the amount of time spent in training.

Publications and Sharing of Research Results

NIH supports the practical application and sharing of outcomes of funded research. Therefore, PDs and trainees should make the results and accomplishments of their Kirschstein-NRSA institutional training grant activities available to the research community and to the public at large. The grantee organization should assist trainees in these activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. Responsibility for direction of the project should not be ascribed to NIH. However, NIH IC support must be acknowledged by a footnote in language similar to the following: “This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number) from the (name of NIH IC).” In addition, Federal funding must be acknowledged as provided in “Public Policy Requirements and Objectives—Availability of Information—Acknowledgment of Federal Funding.”

Copyright

Except as otherwise provided in the conditions of the award, when a publication or similar copyrightable material is developed from work supported by NIH, the author is free to arrange for copyright without the approval of the NIH awarding office. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce them, translate them, publish them, and use and dispose of them, and to authorize others to do so for Federal government purposes.

Inventions and Patents

All Kirschstein-NRSA institutional research training grants and other funding agreements awarded primarily for educational purposes are not subject to invention reporting requirements nor does NIH have any rights to inventions under those grants and agreements (as specified in 45 CFR 74.24(h) and in 37 CFR 401.1(b)).

Public Access to Research Data

As specified in 45 CFR 74.36(d), the public must be given access to research data (through FOIA) under specified circumstances. NIH guidance is available at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Disposition of Professional Fees

Fees resulting from clinical practice, professional consultation, or other comparable activities performed pursuant to the purpose of the award may not be retained by the trainee. Such fees must be assigned to the grantee organization for disposition in accordance with NIH policy on program income (see “Administrative Requirements—Management Systems and Procedures—Program Income”). The term “professional fees” does not apply to honoraria, fees for scholarly writing, delivery of occasional outside lectures, or service in an advisory capacity to public or private non-profit organizations. If permitted by organizational policy, these fees may be retained by the trainee.

Public Policy Requirements and Objectives

Human Subjects

Kirschstein-NRSA institutional research training grants involving human subjects must comply with the requirements for their protection (see “Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Human Subjects”). If the applicant organization has an approved FWA or other applicable assurance on file with OHRP but, at the time of application, plans for the involvement of human subjects are indefinite, the assurance number should be provided on the face page of the application. If an award is made, human subjects may not be involved until a certification of IRB approval or designation of exemption has been submitted.

In many instances, trainees supported by Kirschstein-NRSA institutional research training grants will be participating in research supported by research project grants for which the IRB review is already completed or an exemption is already designated. This review or exemption designation is sufficient, provided the research would not be substantially modified by the participation of a trainee. The appropriate grants must be identified along with their IRB review dates or exemption designation.

For additional information on human subjects requirements, refer to the PHS 398 or contact OHRP (see Part III for contact information).

Monitoring Plan and Data and Safety Monitoring Board

Research involving clinical trials must include provisions to ensure the safety of participants and the validity and integrity of the data. A monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for monitoring and how adverse events will be reported to IRBs, NIH, and FDA. The frequency of monitoring will depend on potential risks, complexity, and the nature of the trial.

NIH specifically requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risks to the subject and, generally, for Phase III clinical trials. Although Phase I and Phase II clinical trials also may use DSMBs, smaller clinical trials may not require this type of oversight, and alternative monitoring plans may be appropriate.

PDs and trainees also should refer to the NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html, “Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Data and Safety Monitoring” in Subpart A, and the instructions in the PHS 398 application.

Inclusion of Women and Minorities in Clinical Research

It is NIH policy that women and members of minority groups and their subpopulations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research (see “Public Policy Requirements and Objectives—Requirements for Inclusiveness in Research Design”). This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October 2001, is available on the NIH website at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.

Inclusion of Children as Participants in Research Involving Human Subjects

NIH maintains a policy that children (individuals under the age of 21) must be included in all human subjects research conducted or supported by NIH, unless there are scientific and ethical reasons not to include them (see “Public Policy Requirements and Objectives—Inclusiveness in Research Design”). NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects is available on the NIH website at http://grants.nih.gov/grants/funding/children/children.htm.

Human Embryonic Stem Cell Research

Criteria for Federal funding of research on hESC can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the trainee to provide the official NIH identifiers for the hESC lines to be used in the proposed research (see “Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations—NIH Guidelines for Research Using Human Embryonic Stem Cells”). Applications that do not provide this information will be returned without review.

Vertebrate Animals

Kirschstein-NRSA institutional research training grants involving use of vertebrate animals must comply with the requirements for their protection (see “Public Policy Requirements and Objectives—Animal Welfare”).

If the applicant organization has an approved Assurance of Compliance on file with OLAW but, at the time of application, its plans for the involvement of vertebrate animals are so indefinite that IACUC review and approval are not feasible, on the face page of the application, the organization should check “Yes,” include the animal welfare Assurance of Compliance number, and indicate “Indefinite.” If an award is made, vertebrate animals may not be involved until verification of the IACUC approval date has been submitted to the NIH awarding office.

In many instances, trainees supported by institutional research training grants will be participating in research supported by research project grants for which the IACUC review already is completed. This review is sufficient, provided the research would not be substantially modified by the participation of a trainee. The appropriate grants must be identified along with their IACUC review dates.

If the applicant organization does not have an approved Assurance of Compliance on file with OLAW or for additional information on vertebrate animals, refer to the PHS 398 or contact OLAW (see Part III).

Recombinant DNA Molecules and Human Gene Transfer Research

Institutions receiving Kirschstein-NRSA institutional research training grants involving use of recombinant DNA molecules must comply with the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules (see “Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations—NIH Guidelines for Research Involving Recombinant DNA Molecules and Human Gene Transfer Research”). The NIH Guidelines, available from NIH’s OBA (see Part III), should be consulted for complete requirements for the conduct of projects involving recombinant DNA techniques. The NIH Guidelines are available at http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm.

Payback Reporting Requirements

General

The Kirschstein-NRSA legislation requires some recipients of support (fellows or trainees) to pay back the Federal government by engaging in health-related biomedical or behavioral research, including the direct administration or review of health-related research, health-related teaching, or any combination of these activities. See “Payback—Service Payback—Definitions” in this subsection for complete coverage of requirements.

The National Institutes of Health Revitalization Act of 1993, signed into law on June 10, 1993, included provisions in Section 1602 that substantially modified the service payback requirement for individuals supported by NRSA fellowships and research training grants.

An individual who was appointed to a research training grant or who had a fellowship award activated before June 10, 1993, is subject to the service payback provisions in effect at the time of the appointment or award.

Implementation

The incurrence of a payback obligation for an NRSA recipient is solely dependent upon when NRSA support was received.

Before August 13, 1981

Before August 13, 1981 (enactment of the Omnibus Reconciliation Act), a payback obligation existed for all prebaccalaureate, predoctoral, and postdoctoral support received.

Effective August 13, 1981

Effective August 13, 1981, a 12-month legislative allowance waiving payback obligation for the first 12 months of support was enacted for all predoctoral and postdoctoral trainees and fellows. This legislation provided that all trainees and fellows who were not in delinquent status on that date receive the allowance (this was retroactive to the beginning of the NRSA program). Individuals in delinquent status continued to have a payback obligation for all support received. This legislative change also eliminated the payback obligation for prebaccalaureate recipients.

Historically, short-term trainees supported by the T35 mechanism (NRSA short-term training) incurred no payback obligation. However, for short-term trainees supported within a T32 program, the periods of support accrued and ultimately counted toward the total NRSA support.

Effective June 10, 1993 (NIH Revitalization Act)

Predoctoral recipients. For predoctoral trainees beginning appointments and for predoctoral fellows activating awards on or after June 10, 1993, no payback obligation is incurred. Thus a Payback Agreement Form (PHS 6031) is not required.

Postdoctoral recipients. For individuals receiving postdoctoral support under individual fellowships or institutional research training grants, a payback obligation is incurred for the first 12 months of Kirschstein-NRSA support with the 13th and subsequent months of postdoctoral support serving to pay back this obligation month by month. A Payback Agreement (PHS 6031) is required but only for the initial 12-month postdoctoral support period.

The requirements established by the Revitalization Act also provide that the 13th and subsequent months of postdoctoral Kirschstein-NRSA-supported research training will be used to discharge any prior postdoctoral Kirschstein-NRSA service payback obligation. See “Payback—Service Payback—Initiation of Payback Service” in this subsection for other requirements of the Act.

Short-Term Training

Any individual receiving support for predoctoral short-term training does not incur a payback obligation. Postdoctoral short-term training incurs a payback obligation. Any support accrues along with any subsequent postdoctoral support until the first 12 months is established. At that point, the 13th and subsequent months of support serve to offset the obligation month by month. If subsequent postdoctoral support is not received, the individual has an obligation to pay back in the traditional manner.

Payback

Once a Termination Notice has been submitted and accepted, the NIH awarding office determines if a payback obligation exists. When a trainee or fellow must pay back, the Termination Notice and related documents are forwarded to the NIH Kirschstein-NRSA PSC. PSC personnel are NIH’s experts in Kirschstein-NRSA payback requirements. The PSC currently administers the payback activities of almost all of the NIH ICs and soon is expected to have this responsibility for all ICs. The authorities related to payback normally delegated to the IC are delegated to the Chief, Kirschstein-NRSA PSC. The PSC retains all records until an obligation is satisfied and transfers closed records to the Federal Records Center.

Most Kirschstein-NRSA recipients eventually fulfill their payback obligation by engaging in activities that are determined to be acceptable service. Some recipients fulfill their obligation via financial payback. On rare occasions, the payback obligation is waived.

As indicated in “Payback Reporting Requirements—Implementation” in this subsection, the amount of a payback obligation incurred is solely dependent on the total period of support and the laws in effect when the Kirschstein-NRSA support was received.

Service Payback

Definitions

For fulfilling the Kirschstein-NRSA service payback obligation, the following definitions apply:

l      Research. Research is defined as an activity that involves designing experiments, developing protocols, and collecting and interpreting data. In addition, review of original research or administration of original research that includes providing scientific direction and guidance to research may be acceptable if a doctoral degree and relevant research experience is required for individuals filling such positions. Such research can be conducted in an academic, government, commercial, or other environment in either a foreign or domestic setting. In addition, when consistent with the cumulative amount, type, and frequency of research or research training experiences, functions that involve analytic or other technical activities conducted in direct support of research, as defined above, also will satisfy the service payback obligation.

l      Teaching. Teaching is an instructional activity that takes place in an organized educational or other instructional environment. Activities classified as teaching are generally carried out in a formal didactic setting, but other activities will be considered if they are consistent with the certifying institution’s policy on the definition of teaching responsibilities. Such teaching can be conducted at universities, professional schools, research institutes, teaching hospitals, primary schools, secondary schools, or colleges. When calculating hours of teaching per week, it is permissible to include 3 hours of preparation time for each hour of direct instruction. Acceptable teaching activities must have a biomedical or health-related relevance.

l      Health-related activities. This incorporates a broad range of activities related to the description, diagnosis, prevention, or treatment of disease from the most basic biomedical or behavioral research to the most applied or clinical research. Activities in fields other than those usually considered to be directly related to human disease, such as agriculture, environmental sciences, biotechnology, and bioengineering, also will be considered health-related.

Time Commitment

All acceptable activities must be undertaken for periods that average at least 20 hours per week. Total employment in such activities averaging less than 20 hours per week cannot be counted toward fulfilling the obligation except in cases of disability or other pressing personal or family circumstances, such as child care or elder care responsibilities. It is not permissible for individuals otherwise engaged in full-time employment to engage in service payback activities at effort levels below 20 hours per week.

If less than 20 hours commitment per week is permitted, the total period of service obligation will be prorated. For example, an individual who owes 12 months of service and can devote only 10 hours per week to service payback activities due to a disability will be required to engage in such service for 24 months. These exceptions are rare and must receive prior approval from the PSC.

Initiation of Payback Service

Initiation of payback service depends on when awards were made:

l      Support received before NIH Revitalization Act. For predoctoral NRSA recipients who incurred a payback obligation from support received prior to June 10, 1993, payback service must be performed, or financial repayment made, following completion of NRSA support. No amount or type of activity before or during the period of NRSA support will satisfy the NRSA service payback obligation. However, payback service may be initiated immediately after termination of NRSA support if the research or teaching activities meet the criteria cited in “Payback Reporting Requirements—Payback—Service Payback—Definitions.”

For postdoctoral NRSA recipients who incurred a payback obligation from support received prior to June 10, 1993, continued postdoctoral NRSA support can be used to satisfy any previous postdoctoral payback obligation. However, continued postdoctoral NRSA support cannot be used to payback any obligation remaining from predoctoral support received before June 10, 1993.

l      Support received after NIH Revitalization Act. Beginning with awards made under the authority of the NIH Revitalization Act (appointments on or after June 10, 1993), service payback obligations for postdoctoral recipients may be discharged by

Ø      receiving an equal number of months of postdoctoral Kirschstein-NRSA support beginning in the 13th month of such postdoctoral Kirschstein-NRSA support, or

Ø      engaging in an equal number of months of health-related research, training, or teaching averaging more than 20 hours per week.

Trainees and fellows beginning appointments for the 13th and subsequent months of postdoctoral Kirschstein-NRSA support on or after June 10, 1993, will be engaging in service that also satisfies any postdoctoral NRSA service payback obligation incurred before June 10, 1993. Post-award service in non-Kirschstein-NRSA supported health-related research, training, or teaching is creditable toward any predoctoral or postdoctoral Kirschstein-NRSA service payback obligation.

Source of Funding

There is no restriction on the source of funds supporting an individual’s service payback activity except that predoctoral payback activities must not be supported by Kirschstein-NRSA funds. An individual could be supported by a PHS grant or any non-Kirschstein-NRSA Federal or non-Federal source. Unpaid service also is permitted.

Timing of Service Obligation

An individual must begin to undertake the payback service requirement within 2 years after the termination date of the individual’s Kirschstein-NRSA support unless an extension of time to begin payback has been approved by the PSC (see “Payback—Extensions of Payback—Extensions of the 2-Year Period to Initiate Payback”).

Financial Payback

Policy and Principal Calculation

If an individual does not perform payback service, the Federal government shall be entitled to recover certain costs. The amount the United States is entitled to recover depends on when support was received. Calculation formulas take into account the total amount paid the individual (see “Interest and Interest Rate Calculation” in this subsection), less any obligation already fulfilled through service or legislative allowance when applicable. The total paid an individual under an institutional research training grant or individual fellowship award at a domestic, non-Federal sponsoring institution is considered to be the stipend only. The total paid an individual under a fellowship award at a foreign sponsoring institution includes the payment for the round-trip travel costs. The total paid an individual under a fellowship award at a Federal sponsoring institution includes any money expended from the institutional allowance provided for such purposes as health insurance, travel, tuition, and fees.

Interest and Interest Rate Calculation

NIH computes interest on the principal amount beginning on the date the United States became entitled to recover stipends. The interest rate is the rate fixed by the Secretary of the Treasury after considering prevailing consumer rates of interest. Accordingly, interest may be accruing on any Kirschstein-NRSA obligation if the 2-year grace period has passed, if deferment has expired, or if service has terminated before completion of the payback obligation. The Department of the Treasury certifies Kirschstein-NRSA interest rates quarterly. Interest is computed on a 360 day-a-year basis and is applied through the date of receipt. Any outstanding amount will continue to bear interest at the initial rate set by the Secretary of the Treasury until financial payback is complete.

The date that sets the applicable rate of interest depends on the type of Kirschstein-NRSA account received for collection. If financial payback is voluntary, the signature date of the notification of voluntary payback is the date that determines the interest rate as well as the initiation of the 3-year repayment period. If financial payback is involuntary, the date that sets the interest rate and the 3-year repayment period is the date of expiration of the 2-year period following the termination of Kirschstein-NRSA support. For example, if during June 1998, OFM received an account reflecting January 31, 1996, as the termination date of NRSA support, the Federal government, lacking any documentation to the contrary, becomes entitled to financial payback effective February 1, 1998. The rate of interest applicable is determined based on the February 1, 1998, date, and the total NRSA obligation is required to be fulfilled by January 31, 2001.

The amount to be recovered financially, as determined from the Termination Notice plus applicable interest, shall be paid to the United States within the 3-year period following such date.

Extensions of Payback

The authorizing legislation and the implementing regulations (42 CFR Part 66) permit exceptions to certain requirements under the Act.

Extensions of the 2-Year Period to Initiate Payback

Frequently, an Annual Payback Activities Certification is returned requesting an extension of the 2-year period to initiate payback. Indication of valid plans to initiate payback soon after the 2-year grace period may be good reason to grant an extension.

Basis for Extensions or Break in Service

The Payback Service Center may extend the period for undertaking payback service or permit breaks in continuous service. These determinations are based on the following criteria:

l      An extension or break in service is necessary so the individual may complete his or her research or clinical training.

l      An extension or break in service is necessary so the individual may participate in the NIH Loan Repayment Program.

l      The individual is unable to complete the requirements within the specified period because of a temporary disability.

l      Completion by the individual of the requirement within the specified period would involve substantial hardship to the individual, and failure to extend the period would be against equity and good conscience.

Reasons for an extension or break in service include such things as completing residency training, where clinical teaching or research are not an integral part of their training, or seeking employment that would fulfill the payback requirements.

Requests must be made in writing (separate letter or APAC) to the PSC, specifying the need for additional time and the length of the required extension.

Waiver

Policy

The authorizing legislation and the implementing regulation (42 CFR Part 66) permit exceptions to certain requirements under the Act. NIH may waive, in whole or in part, the payback obligation, upon determination that compliance by the individual is impossible or would involve substantial hardship, and enforcement of the individual’s obligation would be against equity and good conscience.

Waiver Criteria

Requests for waivers should be made in writing to the PSC and should explain the need for the waiver according to the following criteria:

l      Compliance by an individual will be deemed impossible if the individual is permanently and totally disabled.

l      In determining whether compliance would involve substantial hardship to the individual and would be inequitable, the PSC will consider the individual’s

Ø      financial resources and obligations at the time of request for a waiver and

Ø      estimated future financial resources and obligations.

In rare cases, the following also might be considered:

Ø      Reasons for the individual’s failure to complete the requirements within the prescribed period, such as personal problems

Ø      Extent to which the individual has engaged in payback activities

Ø      Sufficiency of training to qualify the individual to perform such activities

Ø      Lack of employment opportunities appropriate to the individual’s education and training

l      Any other extenuating circumstances.

Any obligation of any individual toward payback will be canceled upon death of the individual.

Certification of Payback Activities

Annual Payback Activities Certification (Form PHS 6031-1)

Annual Certification

Payback service is certified through the use of the Kirschstein-NRSA APAC (PHS 6031-1). Individuals with an outstanding payback obligation must complete an APAC annually until their payback obligation is fulfilled.

If an individual has a payback obligation, an APAC is sent by NIH approximately one year after the completion of Kirschstein-NRSA support. Payback service may be initiated within the first 12 months of termination even though trainees and fellows have up to 24 months to initiate payback. There is no penalty to those individuals who do not initiate payback within the first 12 months; however, it is critical that they complete an APAC form to ensure contact is maintained and addresses are current.

The individual will report on the APAC the activity in which he or she was engaged for the preceding 12 months, within the specified reporting period. These forms are to be returned within 30 days of the reporting period end date to the address specified on the mailing label included with the form.

The PSC reviews the forms, determines acceptability of reported activities, and then informs the former trainee or fellow of his or her status. This process will continue annually until the individual’s total payback obligation is satisfied.

Change of Address

Any change in the mailing address of a Kirschstein-NRSA recipient must be reported promptly to the PSC until the service obligation is fully discharged. Notification of changes can be made by letter, telephone, fax, or e-mail.

Breaks in Kirschstein-NRSA Support

Sometimes a trainee/fellow will have a period of non-Kirschstein-NRSA support between two Kirschstein-NRSA awards. An appropriate activity performed during this period of time may count for payback purposes toward the first Kirschstein-NRSA award. If the nonsupport period is 6 months or longer, the individual receives an APAC form through the regular mechanism. However, if the break is less than 6 months, an APAC will not be mailed automatically. If acceptable payback service was performed during the break, the individual may complete an APAC, which can be obtained from the NIH website at http://grants.nih.gov/grants/forms.htm.

National Health Service Corps

Occasionally, a Kirschstein-NRSA recipient may have been a NHSC scholar. Before October 26, 2002, legislation provided authority for holders of both awards to pay back the obligation of the two sources of support concurrently. Therefore, activities that qualified as Kirschstein-NRSA payback also served as payback for the NHSC obligation. However, no Kirschstein-NRSA legislative allowance is credited toward NHSC service The PSC monitors both obligations until they are both satisfactorily completed.

Effective October 26, 2002, the legislation was changed to eliminate concurrent payback. As a result, Kirschstein-NRSA recipients that also are NHSC scholars now are required to fulfill their NHSC service commitment through direct clinical service to the underserved in accordance with NHSC policy. Any Kirschstein-NRSA payback must be fulfilled separately through acceptable payback service.


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