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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 11

11 RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARDS

11.1 General

This chapter includes general information about Kirschstein-NRSA individual fellowships and institutional research training grants. Separate but all inclusive sections are provided for each; therefore some information may appear duplicative but is provided separately so that nuances between individual fellowships and institutional training grants are covered. Many of the requirements of IIA also apply; this chapter of IIB includes appropriate cross-references to IIA when applicable.

11.1.1 Background

Section 487 of the PHS Act (42 U.S.C. 288) provides authority for NIH to award Kirschstein-NRSA individual fellowships to support predoctoral and postdoctoral training of individuals to undertake biomedical, behavioral, or clinical research at domestic and foreign, public and private institutions (profit and non-profit). Section 487(a)(1)(B) authorizes Kirschstein-NRSA institutional research training grants and limits institutional Kirschstein-NRSA support to training and research at domestic public and non-profit private entities. The legislation requires recipients to pay back to the Federal government their initial 12 months of Kirschstein-NRSA postdoctoral support by engaging in health-related biomedical, behavioral and/or clinical research, research training, health-related teaching, or any combination of these activities. (See Payback Requirements in this chapter.) The regulations at 42 CFR part 66 apply to these awards.

11.1.2 Nondiscrimination

The Kirschstein-NRSA program is conducted in compliance with applicable laws that provide that no person shall, on the grounds of race, color, national origin, handicap, or age, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity (or, on the basis of sex, with respect to any education program or activity) receiving Federal assistance. Applicant organizations are required to have appropriate Assurance of Compliance forms filed with HHS’s OCR before a grant may be made to that institution. The NIH awarding IC should be contacted if there are any questions concerning compliance. (See Public Policy Requirements and Objectives—Civil Rights in IIA for detailed requirements.)

11.2 Individual Fellowships

11.2.1 General

The Kirschstein-NRSA program helps ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical and behavioral research agenda. Fellowship activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission. Under this authority, NIH awards individual postdoctoral fellowships (F32) to promising applicants with the potential to become productive, independent investigators in fields related to the mission of the NIH ICs. Some specialized individual pre-doctoral fellowships (F31 and F30), Senior Fellowships (F33), and other unique fellowship programs also are provided under this authority. For individual predoctoral fellowships, NIH ICs have differing requirements; specific FOAs should be consulted for guidance.

Kirschstein-NRSA fellowships are awarded as a result of national competition for research training in specified health-related areas. All NIH ICs except FIC and NLM award Kirschstein-NRSA fellowships. FIC and NLM have unique funding authorities for fellowships that are not under the Kirschstein-NRSA authority.

11.2.2 Eligibility

11.2.2.1 Research Areas

Kirschstein-NRSA fellowships may be made for research training in areas that fall within the missions of the NIH ICs. Applications that do not address these areas will be returned. An increased emphasis has been placed on the research training of physicians. The HHS Secretary is required by law, in taking into account the overall national needs for biomedical research personnel, to give special consideration to physicians who agree to undertake a minimum of 2 consecutive years of biomedical, behavioral, or clinical research training. NIH recognizes the critical importance of training clinicians to become researchers and encourages them to apply. For those who have a doctoral-level health professional degree, the proposed training may be used to satisfy a portion of the degree requirements for a master's degree, a doctoral degree, or any other advanced research degree program.

11.2.2.2 Research Training Program

The Kirschstein-NRSA fellowship must be used to support a program of research training. It may not support studies leading to M.D., D.O., D.D.S., D.V.M., or other similar clinical, health professional degrees except when those studies are part of a formal combined research degree program such as the M.D./Ph.D. Similarly Kirschstein-NRSA fellowships may not support the clinical portion of residency training. Research fellows in clinical areas are expected to devote full time effort to the proposed research training and to confine clinical duties to those that are part of the research training.

11.2.2.3 Degree Requirements

Predoctoral Training. Individuals must have received, as of the activation date of their Kirschstein-NRSA pre-doctoral fellowship award, a baccalaureate degree and must be enrolled in and training at the postbaccalaureate level in a program leading to the award of a Doctor of Philosophy of Science (Ph.D. or Sc.D.) or a combined clinical degree and Ph.D. degree such as M.D./Ph.D.

Postdoctoral Training. Before a Kirschstein-NRSA postdoctoral fellowship award can be activated, individuals must have received a Ph.D., M.D., D.D.S, D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. Also acceptable is a statement by an AOR of the degree-granting institution that all degree requirements have been met. It is the responsibility of the sponsoring institution, not the NIH, to determine if a foreign degree is equivalent.

Senior Fellows. As of the beginning date of their award, senior fellows must have a doctoral degree (as specified in Postdoctoral training referenced above) and at least 7 subsequent years of relevant research and professional experience. The senior fellowship is awarded to provide opportunities for experienced scientists to make major changes in the direction of their research careers or to broaden their scientific backgrounds by acquiring new research capabilities. In addition, these awards will enable individuals who are beyond the new investigator stage to take time from regular professional responsibilities to enhance their capabilities to engage in health-related research. Senior fellowships are made for full-time research training. Health professionals may use some of their time in clinical duties as part of their research training. More information on the senior fellowship program can be found in the NIH Kirschstein-NRSA Senior Fellows (F33) program announcement available on the NIH Web site at http://grants.nih.gov/training/nrsa.htm - fellowships.

11.2.2.4 Citizenship

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence by the time of award. Noncitizen nationals are individuals, who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are people born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals who have been lawfully admitted for permanent residence must have a currently valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For example, if an individual has the proper validation on his/her passport, a notarized photocopy of the passport could suffice. Because there is a 6-month limitation on this validation, it is the responsibility of the sponsoring institution to follow up and ensure that the individual receives the I-551 before the 6-month expiration date.

An individual expecting to be admitted as a permanent resident by the earliest possible award date listed in the Kirschstein-NRSA individual fellowship program announcement may submit an application for a fellowship. The submission of documentation concerning permanent residency is not required as part of the initial application. Any fellowship applicant selected to receive an award must provide a notarized statement of admission for permanent residence prior to award.

Fellowship applicants who have been lawfully admitted for permanent residence, i.e., have a Permanent Resident Card or other legal verification of such status, should check the Permanent Resident box in the citizenship section on the PHS Fellowship Supplemental Form of the fellowship application. Fellowship applicants who have applied for and have not yet been granted admission as a permanent resident should check the box indicating Permanent Resident of U.S. Pending.

Individuals with a Conditional Permanent Residency Status may still apply for individual fellowships. However, in all cases when permanent residency status is involved, it is the responsibility of the sponsoring institution to assure the individual remains eligible for NRSA support for the period of time of any award.

Individuals with Asylum/Refugee status do not automatically hold a type of permanent residency status; they have the opportunity to apply for permanent residency status once they have been in the U.S. for a period of time. Therefore, individuals with Asylum/Refugee status should only submit an individual fellowship application once they have applied for permanent residency status.

When an application involving Permanent Residency is selected to receive an award, prior to any award being issued, a notarized statement will be required that documents that a licensed notary has seen the individual's valid Permanent Resident Card or other valid verification from the U.S. Immigration and Naturalization Service of legal admission to the U.S.

Individuals on temporary or student visas are not eligible to apply for Kirschstein-NRSA individual fellowships unless they have begun the process for becoming a permanent resident and expect to be admitted as a permanent resident by the earliest possible award date.

11.2.2.5 Sponsorship

General. Before submitting a Kirschstein-NRSA individual fellowship application, the fellowship applicant must identify a sponsoring institution and an individual who will serve as a sponsor (also called mentor or supervisor) and supervise the training and research experience. The sponsoring institution may be domestic or foreign, public or private (for-profit or non-profit), including the NIH intramural programs, other Federal laboratories, and units of State and local governments. The sponsoring institution is legally responsible for providing facilities for the applicant and financially responsible for the use and disposition of any funds awarded based on the application. The sponsor should be an active investigator in the area of the proposed research who will directly supervise the fellow's research. The sponsor must document in the application the training plan for the applicant as well as the availability of staff, research support, and facilities for high-quality research training. In most cases, postdoctoral fellowships support research training experiences in new settings in order to maximize acquisition of new skills and knowledge. Therefore, postdoctoral fellowship applicants proposing training at their doctoral institution must document thoroughly the opportunity for new training experiences designed to broaden their scientific backgrounds. In addition, the application should propose research experiences that will allow the fellow to acquire new knowledge and/or technical skills that will enhance his/her potential to become a productive, independent investigator.

Foreign Sponsorship. An individual may request support for training abroad. In such cases, the fellowship applicant is required to provide detailed justification for the foreign training, including the reasons why the facilities, the mentor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training may require additional administrative reviews and will be considered for funding only when the scientific advantages are clear.

11.2.2.6 NIH Employees & Other Federal Sponsorship (Federal Fellows)

Both civil service employees and PHS commissioned officers at NIH and other Federal laboratories are permitted to compete for predoctoral and postdoctoral fellowships. The proposed training should be primarily for career development rather than for the immediate research needs of NIH or the other Federal laboratory. When at an NIH laboratory, the employee's supervisor must disassociate himself/herself from the review and award process.

An individual at NIH or another Federal laboratory who is supported under an individual fellowship may not also hold an employee position with the Federal Government. Therefore, successful fellowship applicants for predoctoral or postdoctoral awards must either resign from NIH or the other Federal laboratory or take LWOP before activating the award. (There is no obligation or commitment by either the Federal agency or the fellow for future employment upon termination of the fellowship.)

Support provided for Federal fellows is similar to those at non-Federal sponsoring institutions; stipends, tuition (when applicable), and institutional allowance are provided. However, the administration and payment of these fellowships is unique. Specifics are noted in the applicable sections below.

11.2.2.7 Individuals on Active Military Duty

NIH does not restrict career military personnel from applying for Kirschstein-NRSA individual fellowship awards while on active military duty. At the time of application, the fellowship applicant's branch of the military service should submit a letter endorsing his/her application and indicating willingness to continue normal active duty pay and allowances during the period of the requested fellowship. If an award is made, the institutional allowance and necessary tuition and fees permitted on a postdoctoral program will be paid by NIH. However, stipends, health insurance, and travel allowances are not allowable charges to a Kirschstein-NRSA individual fellowship for career military personnel. Payment of concurrent benefits by NIH to active duty career military awardees is not allowed.

11.2.3 Application Requirements and Receipt Dates

11.2.3.1 Application

Each fellowship applicant must submit an application based on the application package provided as part of the FOA. Individual fellowship applications are submitted electronically through Grants.gov using an application package that combines form components from the SF424 (R&R) application with the PHS Fellowship Supplemental Form.

The major emphasis of the application should be the research training experience and broadening of scientific competence. The AOR of the sponsoring institution agrees to secure and retain, but need not submit to NIH, the assurance signatures of the fellowship applicant and sponsor. The assurance of the fellowship applicant includes certification that he or she has read the payback information and will meet any payback provisions required under the law as a condition for accepting the award.

Fellowship applicants and sponsoring institutions must comply with policies and procedures governing such requirements as civil rights; the protection of human subjects, including data and safety monitoring requirements; research misconduct; the humane care and use of live vertebrate animals; the inclusion of women, minorities and children in study populations; human embryonic stem cells; and recombinant DNA and human gene transfer research. (For a complete list of applicable requirements, see Exhibit 4, Public Policy Requirements, Objectives and Appropriation Mandates in IIA.)

11.2.3.2 eRA Commons Registration

All fellowship applicants and sponsoring institutions must be registered in the eRA Commons. The fellowship applicant must be assigned the "PI Role" in the eRA Commons. Only the PI Role will provide the fellowship applicant with the appropriate access in the eRA Commons to the application and review information. When a prospective fellowship applicant is submitting an application through a sponsoring institution that is different than their current institution, that individual must be affiliated with the sponsoring institution. Additional information on eRA Commons registration and affiliating individuals with different institutions can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.

11.2.3.3 Letters of Reference

As part of an application submission, at least three (but no more than five) letters of reference on behalf the fellowship applicant also must be submitted. Electronic submission of the fellowship application incorporates a separate, yet simultaneous electronic submission process for reference letters through the eRA Commons. Reference letters are submitted directly by the referee through the eRA Commons and not as part of the electronic application submitted through Grant.gov. Reference letters will be joined with the electronic application within the eRA system once an application completes the submission process. Applications that are missing the required letters may be delayed in the review process or not accepted. Applicants must carefully follow the instructions provided in Part I, Section 5.4 of the Individual Fellowship Application Guide found at: http://grants.nih.gov/grants/funding/424/index.htm. The Application Guide includes specific instructions to be sent to prospective referees.

11.2.3.4 Responsible Conduct of Research

All fellowship applicants must include a plan to obtain instruction in the responsible conduct of research. This section plan should document prior instruction in responsible conduct of research during the applicant's current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research. Such plans must address the five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained below. The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant's understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.

1. Format. Substantial face-to-face discussions between the fellow, other individuals in a similar training status and sponsors plus a combination of didactic and small-group discussions (e.g. case studies), are highly encouraged. While on-line courses can be a valuable supplement to instruction in responsible conduct of research, online instruction is not considered adequate as the sole means of instruction. A plan that employs only online coursework for instruction in responsible conduct of research will not be considered acceptable.
2. Subject Matter. While there are no specific curricular requirements for instruction in responsible conduct of research, the following topics have been incorporated into most acceptable plans for such instruction:
   1. conflict of interest – personal, professional, and financial
   2. policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
   3. sponsor/fellow responsibilities and relationships
   4. collaborative research including collaborations with industry
   5. peer review
   6. data acquisition and laboratory tools; data management, sharing and ownership
   7. research misconduct and policies for handling misconduct
   8. responsible authorship and publication
   9. the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
   
   While courses related to professional ethics, ethical issues in clinical research, or research involving vertebrate animals may form a part of instruction in responsible conduct of research, they generally are not sufficient to cover all aspects of responsible research conduct.
3. Faculty Participation. Sponsors and other appropriate faculty are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Informal instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. Sponsors may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors.
4. Duration of Instruction. Instruction should involve substantive contact hours between the fellow, sponsor and other appropriate faculty. Acceptable programs generally involve at least eight contact hours. A semester-long series of seminars/programs may be more effective than a single seminar or one-day workshop because it is expected that topics will then be considered in sufficient depth, learning will be better consolidated, and the subject matter will be synthesized within a broader conceptual framework.
5. Frequency of Instruction. Reflection on responsible conduct of research should recur throughout a scientist's career: at the undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels. Individual fellows are strongly encouraged to consider how to optimize instruction in responsible conduct of research for the particular career stage(s) of the individual(s) involved. Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years. It is highly encouraged that initial instruction during predoctoral training occurs as early as possible in graduate school. Senior fellows may fulfill the requirement for instruction in responsible conduct of research by participating as lecturers and discussion leaders. To meet the above requirements, instruction in responsible conduct of research may take place, in appropriate circumstances, in a year when the fellow award recipient is not actually supported by an NIH grant. This instruction must be documented in the submitted plan.

11.2.3.5 Concurrent applications

An individual may not have two or more competing Kirschstein-NRSA individual fellowship applications pending review concurrently. In addition, CSR will not accept for review any application that is essentially the same as one already reviewed.

11.2.3.6 Receipt Dates

Kirschstein-NRSA individual fellowship applications undergo a review process that takes 5 to 8 months. The annual schedule for application receipt, review, and award can be found in a specific Funding Opportunity Announcement and at http://grants.nih.gov/grants/funding/submissionschedule.htm.

11.2.4 Review

Each new and renewal application will be evaluated for scientific merit by an NIH SRG.

11.2.4.1 Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the fellowship will enhance the fellowship applicant's potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria (as applicable for the project proposed).

Individual Fellowship programs are training awards and not research awards. Major considerations in the review are the candidate's potential for a productive career, the candidate's need for the proposed training, and the degree to which the research training proposed, the sponsor, and the environment will satisfy those needs.

11.2.4.2 Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. The following review criteria are applicable primarily to F31 and F32 applications. For review criteria pertaining to other individual fellowship applications (e.g., F05, F30, F33), please refer to the specific FOA.

• Fellowship Applicant. Are the applicant's academic record and research experience of high quality? Does the applicant have the potential to develop as an independent and productive researcher in biomedical, behavioral or clinical science?
• Sponsor(s), Collaborator(s), and Consultant(s). Are the sponsor(s) research qualifications (including successful competition for research support) and track record of mentoring appropriate for the proposed fellowship? Are there (1) evidence of a match between the research interests of the applicant and the sponsor (including an understanding of the applicant's research training needs) and (2) a demonstrated ability and commitment of the sponsor to assist in meeting these needs? Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed research project?
• Research Training Plan. Is the proposed research plan of high scientific quality, and does it relate to the applicant's training plan? Is the training plan consistent with the candidate's stage of research development? Will the research training plan provide the applicant with individualized and supervised experiences that will develop research skills needed for his/her independent and productive research career?
• Training Potential. Does the proposed research training plan have the potential to provide the fellow with the requisite individualized and supervised experiences that will develop his/her research skills? Does the proposed research training have the potential to serve as a sound foundation that will lead the fellow to an independent and productive career?
• Institutional Environment and Commitment to Training. Are the research facilities, resources (e.g. equipment, laboratory space, computer time, subject populations), and training opportunities adequate and appropriate? Is the institutional environment for the scientific development of the applicant of high quality, and is there appropriate institutional commitment to fostering the fellows' training as an independent and productive researcher?

11.2.4.3 Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit but will not give separate scores for these items.

• Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
  
  For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
• Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
• Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
• Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
• Resubmission Applications. When reviewing a Resubmission application the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous SRG and changes made to the project.
• Renewal Applications. When reviewing a Renewal application the committee will consider the progress made in the last funding period.

11.2.4.4 Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

• Training in the Responsible Conduct of Research. Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration of Instruction, and Frequency of Instruction) as detailed in Application Requirements—Responsible Conduct of Research in this chapter. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.
• Select Agents Research. Reviewers will assess the information provided in this section of the application, including; 1) the select agent(s) to be used in the proposed research, 2) the registration status of all entities where select agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of select agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the select agent(s).
• Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
• Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research training.
• Foreign Sponsoring Institutions. For applications at foreign sponsoring institutions the reviewers will also assess whether the research training experience presents special opportunities for the fellowship applicant through the use of talent (e.g., mentor) resources, populations (if applicable), or training environment that are not readily available in the U.S. or augment existing U.S. talent and/or resources.

11.2.4.5 Secondary Level of Review

Kirschstein-NRSA individual fellowship applications receive a secondary level of review by IC staff. Criteria used in making award decisions include the SRG's recommendation concerning the overall merit of the application, the relevance of the application to the IC's research training priorities and program balance, and the availability of funds.

11.2.5 Notification of Action

Shortly after the initial review meeting, each fellowship applicant receives an e-mail indicating that the SRG recommendation/priority score is available in the eRA Commons. The fellowship applicant is also notified via an e-mail when the summary statement is available in the eRA Commons.

The PO may notify the fellowship applicant about the final review recommendation. All questions about initial review recommendations and funding possibilities should be directed to the designated IC PO, not to the SRO of the SRG. Name and contact information of the assigned PO is also available in the eRA Commons. If the application is under consideration for funding, NIH will request any additional necessary information from the applicant. After all program and administrative issues have been resolved, the NoA will be issued for those selected for funding.

11.2.6 Period of Support

No individual 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 Kirschstein-NRSA support from institutional research training grants and individual fellowships.

Any exception to the maximum period of support requires a waiver from the NIH awarding IC based on review of a justification from the individual and sponsoring institution. The AOR of the sponsoring institution must make the request in writing to the NIH awarding IC on behalf of the fellow, and must secure and retain, but need not submit to NIH, the fellow and sponsor’s signatures. The request must specify the amount of additional support for which approval is sought. Individuals seeking additional support beyond the third year of postdoctoral support are strongly advised to consult with their PO before submitting a waiver request.

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

• 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. An exception is contingent upon an assurance of the recipient’s good academic standing and justified.
• Interruptions (Break in Service). Requests for additional time also will be considered if an event unavoidably alters 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, which prevent a fellow 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 fellow an opportunity to use an exceptional training resource directly related to the approved research training program.

Requests for additional time that do not arise from either of the above-described circumstances will be considered only if they are accompanied by an exceptionally strong justification.

11.2.7 Full-Time and Part-Time Training

All fellows are required to pursue their research training full time. Full-time is generally defined as devoting at least 40 hours per week to research training activities or as specified by the sponsoring institution in accordance with its own policies.

Part-Time Training. While NRSA fellows are required to pursue training full-time, under certain circumstances, a written request may be submitted to the NIH awarding IC to permit less than full-time training.

Written requests for part-time training will be considered on a case by case basis and must be approved by the NIH awarding IC in advance of each budget period. The circumstances requiring part-time training might include medical conditions, disability, or personal or family situations such as a child or elder care. Part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or responsibilities associated with the fellow’s position at the sponsoring institution.

Each written request is submitted on behalf of the fellow by an AOR and must include documentation supporting the need for part-time training. The sponsoring institution must secure and retain, but need not submit to NIH, countersignatures of the fellow and sponsor prior to submission to NIH. The written request also must include an estimate of the expected duration of the period of part-time training and assurances that the fellow intends to return to full-time training when that becomes possible and intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in Kirschstein-NRSA support 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 Kirschstein-NRSA fellowship support.

NIH will issue a revised NoA with prorated stipend for the period of any approved part-time training. Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral fellows.

11.2.8 Initiation of Support

11.2.8.1 Process

The NIH IC will notify the fellowship applicant of the intention to make an award and confirm the plans for the start of fellowship support. The individual may activate the fellowship on or after the issue date of the NoA up to the latest activation date shown in the NoA (generally 6 months after the award issue date). This timing allows the individual to make arrangements, such as the completion of degree requirements, coordination with the sponsor, and, if necessary, a move to the sponsoring institution. The latest activation date may be extended in unusual circumstances. Written requests for extensions should be submitted to the NIH awarding IC, by the AOR of the sponsoring institution. The sponsoring institution must secure and retain, but need not submit to NIH, signatures of the fellowship applicant and sponsor before the request is submitted to NIH.

The Activation Notice must be submitted to the NIH awarding IC as of the day the individual begins training. A Payback Agreement also must be completed and submitted but only by postdoctoral fellows in their first 12 months of Kirschstein-NRSA postdoctoral support. See Reporting Requirements—Activation Notice and Reporting Requirements—Payback Agreement in this chapter. A stipend may not be paid until the forms are submitted and the fellow begins training. If necessary for payroll purposes, the Activation Notice and Payback Agreement may be submitted up to 30 days before the start date. However, any change in the planned activation start date must be reported immediately to the sponsoring institution’s business office and to the NIH awarding IC. If an award is conditioned upon completion of degree requirements, the fellow must submit, with the Activation Notice, proof of completion by the degree-granting institution.

Generally, individual fellowship support is approved for consecutive years of training. The initial award budget period is usually for 12 months. Subsequent periods of approved fellowship training are consecutive with the first year of support and are usually in 12-month increments (budget periods). Awards for less than 12 months will be prorated accordingly. If a fellow decides not to activate the award, or to terminate early, he or she must notify the institution’s business office, the sponsor, and the NIH awarding IC immediately, in writing. NIH will make any necessary adjustments in the stipend and other costs, including the institutional allowance.

11.2.8.2 Payment

Domestic. Non-Federal sponsoring institutions receive an award for the stipend, institutional allowance, and tuition and fees (when applicable). The institution directly pays the fellow and disburses all other awarded costs.

Federal Laboratories. Fellows training at Federal laboratories are paid stipends directly by the NIH awarding IC through NIH’s OFM. Reimbursement to the fellow for appropriate expenditures from the institutional allowance also is coordinated by the NIH awarding IC and paid through OFM. Note, if a fellow is training at a facility that is Government-owned but Contract operated, this is not considered a Federal laboratory. As with other grants to these types of facilities, the sponsoring institution would be the contractor.

Foreign. Fellows training at foreign sites receive stipends directly from NIH’s OFM. However, the institutional allowance is awarded to and disbursed by the sponsoring institution.

11.2.9 Allowable and Unallowable Costs

11.2.9.1 Pre-award Costs

Pre-award costs to an individual fellowship are limited. Stipends and tuition and fees may not be charged to a fellowship award until a fellow has actually activated and the appropriate paperwork submitted to the NIH. Therefore, these costs may never be charged as pre-award to an individual fellowship. There are rare occasions when costs associated with the institutional allowance may be allowable as pre-award costs. Sponsoring institutions should consult with the NIH awarding IC when considering a pre-award cost.

11.2.9.2 Stipends

A stipend is provided as a subsistence allowance for Kirschstein-NRSA fellows to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal government or the sponsoring institution. Stipends must be paid in accordance with stipend levels established by NIH, which are based on a 12-month full-time training appointment. In the event of early termination, the stipend will be prorated according to the amount of time spent in training. The sponsoring institution will submit a Termination Notice reflecting the early termination and the NIH awarding IC will issue a revised NoA to decrease approved funding. The sponsoring institution must base its calculations on the applicable stipend level provided by the NIH.

11.2.9.3 Stipend Levels

Stipend levels are updated periodically in conjunction with an NIH annual appropriation. When increases are approved, they are published in the NIH Guide for Grants and Contracts. Current levels are posted at http://grants.nih.gov/training/nrsa.htm. The NIH awarding IC will adjust fellowship awards on their anniversary dates to include the currently applicable stipend amount.

General information related to stipends follows:

• Predoctoral. One stipend level is used for all pre-doctoral candidates, regardless of the level of experience.
• Postdoctoral. The stipend level for the entire first year of support is determined by the number of full years of relevant postdoctoral experience when the award is issued. 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 fellow must be paid at that level for the entire grant year. The stipend for each additional year of Kirschstein-NRSA support is the next level in the stipend structure and does not change mid-year.
• Senior Fellows. The amount of the Kirschstein-NRSA stipend to be paid must be commensurate with the base salary or remuneration that the individual receiving the award would have been paid by the institution with which he or she has permanent affiliation on the issue date of the fellowship award. In no case shall the stipend award exceed the current Kirschstein-NRSA stipend limit set by NIH. The level of Kirschstein-NRSA support will take into account concurrent salary support provided by the institution and the policy of the sponsoring institution. NIH support does not provide fringe benefits for senior fellows.

11.2.9.4 Institutional Allowance

NIH awards an institutional allowance to help support the costs of training. The specific levels of allowance for predoctoral and postdoctoral support, including those for individuals training at Federal laboratories, for-profit organizations, or foreign institutions, are published in the NIH Guide for Grants and Contracts. They also are available on the NIH Web site at http://grants.nih.gov/training/nrsa.htm#fellowhsips.

The institutional allowance is a fixed amount. Expenditures under institutional allowances are not subject to NIH prior approval requirements, and the institution is not required to account for these expenditures on an actual cost basis. Allowable uses of the Institutional Allowance are described below.

Except for fellows at Federal training sites, consistent with NIH policy governing the type of expenditures appropriate for the institutional allowance, the sponsoring institution authorizes the expenditure of the institutional allowance on behalf of the fellow according to the institution’s policy. The institution is entitled to expend up to the full institutional allowance upon official activation of the award. However, if an individual fellow is not in a training status for more than 6 months of the award year, only one-half of that year’s institutional allowance may be charged to the grant. The NoA will be revised and the stipend and institutional allowance balances must be refunded to NIH.

For fellows at Federal training sites, the NIH awarding IC authorizes the expenditure of the allowance. Payment is made through NIH’s OFM.

The type of sponsoring institution dictates what costs may be charged to this category and how the funds are to be administered:

• Non-Federal Public and Private Non-Profit Institutions (Domestic and Foreign). The allowance is intended to defray expenses for the individual fellow such as research supplies, equipment, travel to scientific meetings, and health insurance and to otherwise offset, insofar as possible, appropriate administrative costs of training. Funds are paid directly to and administered by the sponsoring institution.
• Federal Laboratories. The allowance is intended to cover the costs of scientific meeting travel, health insurance, and books. Funds are administered by the NIH awarding IC and disbursed by OFM.
• For-Profit Institutions. The allowance is intended to cover the costs of scientific meeting travel, health insurance, and books. Funds are paid directly to the sponsoring institution for disbursement to the fellow.

The following are guidelines for the use of the institutional allowance:

• Travel. Payment for travel to scientific meetings is appropriate when it is necessary for the individual’s training and when the costs are incurred within the period of grant-supported training.
  
  For fellows at Federal laboratories, reimbursement of travel costs must be in accordance with applicable Federal travel regulations.
  
  Funds may not be expended to cover the costs of travel between the fellow’s place of residence and the domestic training institution, except that the sponsoring institution may authorize the cost of a one-way travel allowance in an individual case of extreme hardship.
• Health Insurance. A fellow’s health insurance is an allowable cost only if applied consistently to all individuals in a similar training status regardless of the source of support. Family health insurance is an allowable cost for fellows who have families and are eligible for family health insurance coverage at the sponsoring institution. Self-only health insurance is an allowable cost for fellows without families. Health insurance can include coverage for costs such as vision and/or dental care if consistent with organizational policy. Historically predoctoral fellowships included health insurance as part of the tuition and fees category. This is no longer the policy. For any fellowship (predoctoral and postdoctoral) that competed and was awarded in FY2007 and beyond, health insurance is awarded as part of the Institutional Allowance. Any fellowship that competed and was awarded prior to FY2007, health insurance will continue to be awarded as part of the Tuition and Fees category.
• Medical Liability and Other Special Insurance. Medical liability (malpractice) insurance or other special insurance is an allowable cost to NRSA grants only if nature of the research training requires such special insurance. For instance, medical liability would be allowable if the research training experience involves direct contact with patients or human subjects. In all cases, for the cost to be charged to the NRSA grant, it must be consistently required for all in a similar training status, regardless of the source of support. Special insurances that are routinely offered as optional employee benefits (such as disability insurance, life insurance, or workman’s compensation insurance), are not normally allowable charges (see separate section on Employee Benefits) unless the nature of the research training requires such special insurance.
• Extraordinary Costs. Additional funds may be requested by the institution when the training of a fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution or accommodations for fellows who are disabled, as defined by the Americans with Disabilities Act. The funds requested for extraordinary costs must be reasonable in relationship to the total dollars awarded under a fellowship and must be directly related to the approved research training project. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the institution in the application or as part of a special written request.

11.2.9.5 Tuition and Fees

Tuition and fees are provided under the following policy:

• For individual predoctoral fellowships (F30 and F31), an amount equal to 60% of the level requested by the sponsoring institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D., D.D.S.-Ph.D.), the amount provided will be up to $21,000 per year. Note the new policy moves health insurance into the Institutional Allowance budget category for predoctoral fellowships. This is now consistent with the treatment of this cost for postdoctoral fellowships
• For individual postdoctoral fellowships (F32) and individual senior fellowships (F33), an amount equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports postdoctoral individuals in formal degree-granting training, the amount provided will be up to $16,000 per year. For postdoctoral fellows, costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training. Health insurance is not included in this budget item because costs for it are to be charged as institutional allowance.

For fellowships that competed and were awarded before FY2007, tuition was awarded using a different formula. For predoctoral fellowships the tuition and fees category also included health insurance. When administering a fellowship that competed and was awarded prior to FY2007, consult the NIH awarding IC if there are questions concerning the awarding of tuition, fees, and health insurance.

11.2.9.6 Travel to Foreign Training Sites

For fellows at foreign training sites, in addition to the institutional allowance, awards may include a single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is the means of travel between the United States and a foreign country or between foreign countries. This requirement shall not be influenced by factors of cost, convenience, or personal travel preference. For additional information regarding foreign travel, see Cost Considerations—Allowability of Costs/Activities-Selected Items of Cost-Travel/Employees in IIA.

11.2.9.7 Employee Benefits

Since Kirschstein-NRSA fellowships are not provided as a condition of employment with either the Federal government or the sponsoring institution, institutions may not seek funds, or charge individual fellowship awards, for costs that normally would be associated with employee benefits (for example, FICA, workman’s compensation, life insurance, union dues, and unemployment insurance). Concerning union dues or other similar costs otherwise paid personally by the fellow; if a fellow requests the institution deduct such a cost from the stipend amount, the institution can provide the fellow such a service. However, in no case can such a deduction from the stipend be made automatically without the approval of the fellow.

11.2.9.8 Rebudgeting of Funds

Individual fellowship awards are formula based, generally restricted for the specific budget category of the award, and cannot be rebudgeted without prior written approval from the NIH awarding IC.

• Stipends must be expended using the stipend level provided in the award; no funds can be rebudgeted into the stipend category to accommodate a stipend level different from the established NIH level. When a fellowship terminates early, any unexpended stipends must be returned and cannot be rebudgeted into any other budget category.
• Institutional allowance is a fixed amount of money with a number of allowable costs. In the rare case where institutional allowance may be unexpended, it can only be rebudgeted into the tuition and fees category when tuition and fees have been awarded.
• When tuition and fees is awarded, it is generally restricted and cannot be rebudgeted without prior written approval from the NIH awarding IC.

11.2.10 Supplementation of Stipends, Compensation, and Other Income

11.2.10.1 Stipend Supplementation

Kirschstein-NRSA fellows receive stipends to defray living expenses. Stipends may be supplemented by an institution from non-Federal funds provided this supplementation is without any additional obligation for the fellow. An institution can determine the amount of stipend supplementation, if any, it will provide according to its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar 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. Under no circumstances may PHS funds be used for supplementation.

An individual may use Federal educational loan funds or VA benefits when permitted by those programs as described in Other Income: Educational Loans or GI Bill in this chapter.

11.2.10.2 Compensation

NIH recognizes that Kirschstein-NRSA fellows may seek part-time employment incidental to their training program to offset further their expenses. Funds characterized as compensation may be paid to fellows only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets the conditions for compensation of students as detailed in Cost Considerations—Selected Items of Cost—Salaries and Wages—Compensation of Students in IIA. In addition, compensation must be in accordance with organizational policies applied consistently 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, NIH expects 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 fellow’s planned training experience as approved in the Kirschstein-NRSA individual fellowship application.

Stipend Supplementation & Compensation. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow’s approved Kirschstein-NRSA training program. Fellowship sponsors must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.

11.2.10.3 Other Income: Concurrent Benefits

A Kirschstein-NRSA individual fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the Kirschstein-NRSA.

11.2.10.4 Other Income: 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.

11.2.10.5 Other Income: NIH Loan Repayment Program

Postdoctoral fellows may also be eligible to participate in the NIH Loan Repayment Program. Information on this program is available at http://www.lrp.nih.gov/.

11.2.10.6 Taxability of Stipends

Section 117 of the Internal Revenue Code (26 U.S.C. 117) applies to the tax treatment of scholarships and fellowships. In general, degree candidates may exclude from gross income (for tax purposes) any amount used for qualified tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. Non-degree 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 IRS and Treasury Department released regulations in January 2005 (Revenue Procedures 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. NIH’s understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards.

The taxability of stipends in no way alters the relationship between Kirschstein-NRSA fellows and sponsoring institutions. Kirschstein-NRSA stipends are not considered salaries. In addition, recipients of Kirschstein-NRSA individual fellowships are not considered to be in an employee-employer relationship with NIH or the sponsoring institution solely as a result of the Kirschstein-NRSA award. The 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.

11.2.10.7 Form 1099

Although stipends are not considered salaries, these funds are subject to Federal and, sometimes, State income tax. Such income may be reported by the sponsoring institution on IRS Form 1099, Statement of Miscellaneous Income. Normally, the business office of the sponsoring institution will be responsible for annually preparing and issuing IRS Form 1099 for fellows paid through the institution (fellows at domestic non-Federal institutions). Sponsoring institutions are not required to issue a Form 1099, but it is a useful form of documentation of funds received and it serves as a reminder to the fellow that some tax liability may exist. Fellows are reminded that, even if the sponsoring institution does not issue a Form 1099, they still are required to report Kirschstein-NRSA stipends. NIH will issue a Form 1099 for each fellow training at a Federal or foreign laboratory and receiving a stipend check from the NIH.

11.2.11 Reporting Requirements

The submission of the forms described in this subsection is critical to establishing and paying stipends and other costs and determining possible payback service. All of these forms are available in PDF-fillable and Word formats at http://grants.nih.gov/grants/forms.htm. The NIH awarding IC may provide copies of applicable forms with the NoA or reference this Web site in the NoA.

11.2.11.1 Activation Notice

Immediately upon the initiation of training, the individual must complete and sign the Ruth L. Kirschstein Individual Fellowship Activation Notice (Form PHS 416-5), obtain the signature of the AOR, and forward the notice along with the Payback Agreement (required only for postdoctoral fellows in their first 12 months of Kirschstein-NRSA support) to the NIH awarding IC.

For Kirschstein-NRSA fellows paid directly by NIH, the Activation Notice is required at the start of each award year. The form should not be submitted before the fellow actually begins training. Stipend checks are issued when both the Activation Notice and the Payback Agreement (required only for postdoctoral fellows in their first 12 months of Kirschstein-NRSA support) are received by the NIH awarding IC.

For fellows whose stipend is paid through the institution, the Activation Notice is required for the initial year only. The Activation Notice may be submitted up to 30 days before the individual begins training if necessary for payroll purposes. However, the institution must not release any funds until the individual has started training. Furthermore, if the individual does not begin research training on the day indicated, the institution must notify the NIH awarding IC immediately. Competing continuation awards must be activated on the day following the end of the last budget period of the previous award.

11.2.11.2 Payback Agreement

A Ruth L. Kirschstein National Research Service Award Payback Agreement (Form PHS 6031) that covers the initial 12 months of Kirschstein-NRSA postdoctoral support must be signed by each person who is to receive an individual postdoctoral fellowship. This form is not required if the individual has already received 12 months of postdoctoral Kirschstein-NRSA support under any Kirschstein-NRSA institutional research training grant or fellowship award. For details on Kirschstein-NRSA payback, see Payback Reporting Requirements in this chapter.

No Payback Agreement is required for predoctoral fellows.

11.2.11.3 Termination Notice

The Ruth L. Kirschstein National Research Service Award Termination Notice (Form PHS 416-7) (along with the Activation Notice and the NoA) is the basis for validating the total period of Kirschstein-NRSA support and establishing the amount of payback obligation for each Kirschstein-NRSA fellow. For individual fellowships, a reminder of this reporting requirement may be sent to the fellow by the NIH awarding IC before the scheduled termination date. For early terminations, the completed form will be required immediately upon receipt of notification from the fellow or an AOR. The termination notice must be submitted within 30 days of the termination date even if the fellow is not available for signature. In all cases, the information on the form must be verified by the sponsor and an institutional business official. The lack of timely and accurate information on this form could adversely affect data collected associated with aggregate NRSA support and the payback process. For additional information on early termination, see Changes in the Project below. Effective with Termination Notices submitted on/after January 1, 2011, all Termination Notices for individual fellowships are required to be submitted electronically using the eRA Commons xTrain application.

11.2.11.4 Consecutive Support

If a fellow switches from one Kirschstein-NRSA grant mechanism to another (e.g., from an institutional research training grant to an individual fellowship or from one NIH IC to another), the requirement for payback service incurred is deferred until the total period of Kirschstein-NRSA support is completed. All fellowship applications are reviewed to determine if previous Kirschstein-NRSA support has been provided.

11.2.11.5 Progress Reports

Annual progress reports must be submitted for non-competing continuation support in accordance with the instructions accompanying the Progress Report for Continuation Support (Form PHS 416-9). Progress report forms and instructions are available from the NIH Web site at http://grants.nih.gov/grants/forms.htm. Report form pages are available in PDF-fillable and Word formats. Inadequate or incomplete progress reports may be returned to the fellow for revision and may result in a delay of continued support. For Kirschstein-NRSA individual fellowship awards, the final progress report information is required as part of the Termination Notice.

11.2.11.6 Financial Reporting

An annual or final FFR to report expenditure information is not required for Kirschstein-NRSA individual fellowship awards. However, sponsoring institutions must still complete the quarterly reporting of Federal cash transactions using the FFR and submit that information directly to PMS.

11.2.12 Changes in the Project

Individual fellowship awards are made for training at a specific institution under the guidance of a particular sponsor. The approval of the NIH awarding IC is required for a transfer of the award to another institution, a change in sponsor, or a project change. As part of the approval process, if a fellow sponsored by a domestic non-Federal institution requests a transfer to another domestic non-Federal institution before the end of the current award year, the institutions are responsible for negotiating which will pay the stipend until the end of the current year. Disposition of the institutional allowance is also negotiable between the two sponsoring institutions. No Activation Notice is required from the new sponsoring institution.

Transfers involving Federal or foreign sponsoring institutions require unique administrative procedures and approvals. Because each transfer varies depending on individual circumstances, the sponsoring institution should contact the NIH awarding IC for specific guidance.

Any proposed change in the individual’s specified area of research training must be reviewed and approved in writing by the NIH awarding IC to ensure that the training continues to be within the scientific scope of the original peer-reviewed application.

When the sponsor plans to be absent for a continuous period of more than 3 months, an interim sponsor must be named by the institution and approved in writing by the NIH awarding IC.

11.2.13 Other Terms and Conditions

11.2.13.1 Leave

Vacations and Holidays. Kirschstein-NRSA fellows may receive the same vacations and holidays available to individuals in comparable training positions at the sponsoring institution. Fellows shall 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 and is not considered to be a vacation or holiday.

Sick Leave and Other Leave. Kirschstein-NRSA fellows 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 IC in response to a written request from an AOR. Sick leave may be used for medical conditions related to pregnancy and childbirth.

Parental Leave. Kirschstein-NRSA fellows may receive stipends for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or the birth of a child when individuals in comparable training positions at the sponsoring institution have access to this level of paid leave for this purpose. Either parent is eligible for parental leave. The use of parental leave requires approval by the sponsor.

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 60 calendar days of parental leave, must seek approval from the NIH awarding IC for an unpaid leave of absence. A request letter must be submitted by the AOR on behalf of the fellow and must advise the NIH awarding IC of the dates of the leave of absence. Upon approval of the request, the NIH awarding IC will issue a revised NoA extending the ending date of the current budget/project period by the appropriate number of days or months of unpaid leave time. Recipients are precluded from spending award funds during the leave of absence; although continued coverage of health insurance would be allowable if in accordance with policy of the sponsoring institution.

During a leave of absence, documentation to suspend the award and/or the accrual of service for calculating the payback obligation must be completed and retained by the sponsoring institution. When the fellowship is eventually terminated, the leave of absence must be clearly documented on the Termination Notice.

11.2.13.2 Termination

NIH may terminate a Kirschstein-NRSA individual fellowship before its scheduled expiration date if it determines that the recipient has materially failed to comply with the terms and conditions of the award or to carry out the purpose for which it was made. If an award is terminated for cause, NIH will notify the fellow in writing of the 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 sponsoring institution or the individual fellow. The NIH awarding IC must be notified immediately if a sponsoring institution wants to terminate an individual fellow or the fellow decides to terminate training before the scheduled expiration date.

If a fellow receives another NIH award, e.g., as a PD/PI on an R03, then the fellow is no longer eligible for the fellowship and the sponsoring institution should contact the awarding IC concerning early termination.

If a Kirschstein-NRSA fellowship is terminated early, the stipend must be prorated according to the amount of time spent in training, and the NoA will be revised downward. In addition, if the length of the final budget period was 6 months or less, the balance of any institutional allowance (at least one-half) must be refunded.

11.2.13.3 Publications and Sharing of Research Results

NIH supports the practical application and sharing of outcomes of funded research. Therefore, recipients of Kirschstein-NRSA fellowships should make the results and accomplishments of their activities available to the research community and to the public at large. The sponsoring institution should assist the fellow in such activities, including the further development of discoveries and inventions for furthering research and benefiting the public. No restrictions should be placed on the publication of results.

Kirschstein-NRSA fellows are encouraged to submit reports of their findings to the journals of their choice for publication. Responsibility for direction of the project should not be ascribed to NIH. However, NIH awarding IC support must be acknowledged by a footnote in language similar to the following: “This research 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 Appropriation Mandates—Acknowledgment of Federal Funding in IIA.

The Public Access Policy requirements described in Administrative Requirements—Availability of Research Results—NIH Public Access Policy in IIA apply to articles that are authored or co-authored by NRSA fellows and arose from NIH Support. Information on publications is included as part of the annual progress report.

11.2.13.4 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 approval of the NIH awarding IC. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce, translate, publish, and use and dispose of such materials, and to authorize others to do so for Federal government purposes.

11.2.13.5 Inventions and Patents

Fellowships funded primarily for educational purposes are not subject to invention reporting requirements nor does NIH have any rights to inventions under those awards (as specified in 37 CFR part 401.1(b)). Kirschstein-NRSA fellows training at NIH represent an exception to this policy. Those fellows are subject to the provisions of EO 10096 and NIH determines the disposition of rights to any invention conceived or first actually reduced to practice during the period of the fellowship.

11.2.13.6 Disposition of Professional Fees

Fees resulting from clinical practice, professional consultation, or other comparable activities performed pursuant to the purpose of the award must be assigned to the sponsoring institution for disposition in accordance with established organizational policy. 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, which, if permitted by organizational policy, may be retained by the fellow.

11.2.13.7 Public Policy Requirements and Objectives

All Public Policy Requirements, Objectives, and Other Appropriation Mandates discussed in IIA apply to Individual Kirschstein-NRSA fellowships when appropriate. Applicants must comply with policies and procedures governing such requirements as civil rights; the protection of human subjects, including data and safety monitoring requirements and inclusion policies for women, minorities and children; the humane care and use of live vertebrate animals; human embryonic stem cells; and/or recombinant DNA and human gene transfer research. See IIA for a complete list of applicable requirements.

It is the sponsoring institution’s responsibility to ensure that a fellow has received the proper training/education and is properly supervised particularly in the areas of human subjects research, vertebrate animal research, and occupational safety programs.

Additional information and any application requirements can be found in the Individual Fellowship Application Guide available at: http://grants.nih.gov/grants/funding/424/index.htm.

Information provided below is in addition to that provided in IIA where unique circumstances might exist for individual fellowships.

11.2.13.7.1 Human Subjects

Indefinite Involvement. If the sponsoring institution has an approved FWA 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 in 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.

If the applicant organization does not have a FWA registered with the OHRP, that registration process must be completed prior to IRB approval.

11.2.13.7.2 Vertebrate Animals

Indefinite Involvement. If the sponsoring institution 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, the institution should indicate “Yes,” to the involvement of Vertebrate Animals, 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 IC.

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 Individual Fellowship Application Guide or contact OLAW (see Part III).

11.2.13.8 Applicability of NIH Standard Terms of Award

Individual Fellowships are awarded under the NIH Standard Terms of Award however the provisions to extend the final budget period of a project period without additional funds and carryover of unobligated balances do not apply.

11.3 Institutional Research Training Grants

11.3.1 General

NIH will award Kirschstein-NRSA institutional research training grants (T32, TL2, T34, and T35) to eligible institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in specified areas of biomedical, behavioral, and clinical research. The purpose of the Kirschstein-NRSA program is to help ensure that a diverse and highly trained workforce is available in adequate numbers and in the appropriate research areas and fields to carry out the nation’s biomedical and behavioral research agenda. Training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH Mission. The Kirschstein-NRSA program supports predoctoral, postdoctoral, and short-term research training as well as limited specialized support at the prebaccalaureate level. All NIH ICs except FIC and NLM award Kirschstein-NRSA institutional research training grants. FIC and NLM have unique funding authorities for training grants that are separate from the Kirschstein-NRSA authority.

11.3.2 Eligibility

11.3.2.1 Applicant Eligibility

A domestic, non-profit public or private organization may apply for a grant to support a research training program in a specified area(s) of research. Support for predoctoral, postdoctoral, or a combination of trainees may be requested. (Specific program announcements should be consulted for IC guidelines.) Support for short-term training positions for students in health-professional degree programs also may be requested as indicated in Short-Term Research Training in this subsection. Each applicant institution must submit an application using the research training forms and instructions (see Application Requirements and Receipt Dates in this subsection).

11.3.2.2 Research Areas

Kirschstein-NRSA institutional research training grants may be made for research training in areas that fall within the missions of the NIH ICs. Applications that do not address these areas will be returned. An increased emphasis has been placed on the research training of physicians. The HHS Secretary is required by law, in taking into account the overall national needs for biomedical research personnel, to give special consideration to physicians who agree to undertake a minimum of 2 consecutive years of biomedical, behavioral, or clinical research training.

The applicant institution must have a strong research program in the areas proposed for research training and must have the staff and facilities required to carry out the proposed program.

Trainees appointed to the training program must have the opportunity to carry out supervised biomedical or behavioral research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career.

11.3.2.3 Training Program Director/Principal Investigator(s)

The Training PD/PI must be an individual with the skills, knowledge, and resources necessary to organize and implement a high-quality research training program at the recipient organization. The Training PD/PI at the recipient organization will be responsible for the selection and appointment of trainees to the Kirschstein-NRSA research training grant and for the overall direction, management, and administration of the training program, including program evaluation, and submission of all required forms in a timely manner. In selecting trainees, the PD/PI must make certain that individuals receiving support meet the eligibility requirements set forth in this subsection.

More than one Training PD/PI (or multiple PD/PIs), may be designated on the application for training programs that require a team approach and therefore, clearly do not fit the single-PD/PI model (e.g., interdisciplinary of multidisciplinary training). The decision to apply for a single PD/PI or multiple PD/PIs is the responsibility of the investigators and applicant organizations, and should be determined and justified by the goals of the training program. Applications for grants with multiple PD/PIs require additional information, including the structure and governance of the PD/PI leadership team. In addition, the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PD/PIs on a program share the authority and responsibility for leading and directing the training program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization for the proper conduct of the program, including the submission of required reports.

Applications reflecting multiple PD/PIs must provide a Leadership Plan. The emphasis in the Leadership Plan should be on how it will benefit the research training program and the trainees.

A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary. Because training programs are intended to be coherent, NIH will not allocate the budget or training positions between multiple PD/PIs. Only a single award will be issued. Multiple PD/PI training programs should include reasonable numbers of PD/PIs and each should individual should be included for a specific purpose. Multiple-PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases.

11.3.2.4 Research Training Program

A Kirschstein-NRSA institutional research training grant must be used to support a program of research training. It may not support studies leading to the M.D., D.D.S., D.V.M., or other clinical, health professional training except when those studies are a part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept Kirschstein-NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. However, clinicians are permitted and encouraged to engage in Kirschstein-NRSA-supported full-time, postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Research trainees are expected to devote full time to the proposed research training. Full-time is generally defined as devoting at least 40 hours per week to the program or as specified by the sponsoring institution in accordance with its own policies. In order to fulfill the full-time requirement, trainees who also are training as clinicians must confine clinical duties to those that are an integral part of the research training experience.

11.3.2.5 Degree Requirements

11.3.2.5.1 Predoctoral Training

Predoctoral research training is for individuals who have a baccalaureate degree and are enrolled in a doctoral program leading to either a Ph.D., a comparable research doctoral degree, or a combined clinical degree and Ph.D., such as M.D./Ph.D. Students enrolled in health-professional programs that are not part of a formal, combined program (i.e., M.D./Ph.D.), and who wish to postpone their professional studies to gain research experience, also may be appointed to a Kirschstein-NRSA institutional research training grant. Predoctoral research training must emphasize fundamental training in areas of basic biomedical and behavioral sciences.

11.3.2.5.2 Postdoctoral Training

Postdoctoral research training is for individuals who have received a Ph.D., M.D., D.D.S., D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. It is the responsibility of the grantee institution, not the NIH, to determine if a foreign degree is equivalent. Research training at the postdoctoral level must emphasize specialized training to meet national research priorities in the biomedical, behavioral, or clinical sciences.

Kirschstein-NRSA institutional research training grants are a desirable mechanism for the postdoctoral training of physicians and other health professionals who may have had extensive clinical training but limited research experience. For such individuals, the training may be a part of a research degree program. In all cases, health-professional postdoctoral trainees are to engage in at least 2 years of research, research training, or comparable experiences beginning at the time of appointment, since the duration of training has been shown to be strongly correlated with post-training research activity.

11.3.2.5.3 Short-Term Research Training

Short-term research training includes the following:

• Students in Health Professional Schools. NIH offers two short-term training programs: those that are part of a traditional institutional research training grant (T32) and those that exclusively support short-term trainees (T35). Short-term research training experiences of 2 to 3 months are available to students in health-professional schools under both mechanisms. All short-term training must be full time. Unless otherwise stated, the requirements that apply to institutional research training grants also apply to short-term research training. Current stipend levels are published in NIH Guide for Grants and Contracts.
• T32. T32 (Kirschstein NRSA-Institutional Research Training Grant) applications may include a request for short-term positions reserved specifically to provide full-time health-related research training experiences during the summer or other “off-quarter” periods. Such positions are limited to medical students, dental students, students in other health-professional programs, and graduate students in the physical or quantitative sciences. Short-term appointments under institutional research training grants are intended to provide health-professional students with opportunities to participate in biomedical or behavioral research in an effort to attract these individuals into research careers.

To be eligible for short-term predoctoral research training positions, students must be enrolled and in good standing and must have completed at least one quarter or semester in a program leading to a clinical doctorate or doctorate degree in a quantitative science, such as physics, mathematics, or engineering, before participating in the program. Individuals already matriculated in a formal research degree program in the health sciences, holding a research doctorate or master’s degree, or a combined professional and research doctorate normally are not eligible for short-term training positions. In schools of pharmacy, only candidates for the Pharm. D. degree are eligible for short-term positions.

Short-term positions should be requested in the application. Short-term research training positions should last at least 8, but no more than 12, weeks. Health-professional students and students in the quantitative sciences selected for appointment should be encouraged to obtain multiple periods of short-term, health-related research training during the years leading to their degrees. Such appointments may be consecutive or may be reserved for summers or other “off-quarter” periods.

Since some NIH ICs do not support short-term research training positions under the T32 or support them on a limited basis only, applicants are urged to contact the appropriate NIH IC before requesting short-term research training positions as part of a T32 application.

T35. Several NIH ICs provide short-term research using a separate training grant mechanism (T35). The program intent and student eligibility requirements are similar to those indicated for the T32. However, since this Kirschstein-NRSA funding mechanism is used by only a few NIH ICs; interested applicants are encouraged to contact specific ICs for details.

11.3.2.5.4 Pre-baccalaureate Training

NIH offers two distinct programs for pre-baccalaureate training under the auspices of the Kirschstein-NRSA undergraduate support mechanism (T34). Both programs are designed to support undergraduate students from institutions with a substantial minority enrollment.

NIGMS administers the MARC U*STAR program. This program is designed to support selected junior/senior undergraduate honors students at baccalaureate colleges and universities.

NIGMS recognizes that there are differences in organizational environments and missions. Therefore, the emphasis of this program is on the specific objectives and measurable goals that the applicant institution sets.

Information about the program is available in the applicable FOA.

NIMH administers the COR Program. The intent of this program is to provide focused undergraduate research and research training experiences in scientific disciplines related to mental health. An applicant institution (a 4-year college or university) must propose a 2-year COR Honors Undergraduate Program for which 6 to 10 highly talented third- and fourth-year undergraduate students will be selected. Students will be provided with mentored research training experiences designed to stimulate their entry into advanced research training programs leading to the doctoral-level or M.D. research career degrees. For more information on this program, applicants should review the applicable FOA.

11.3.2.6 Citizenship

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Noncitizen nationals are individuals who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are people born in outlying possessions of the United States(e.g., American Samoa and Swains Island). Individuals who have been lawfully admitted for permanent residence must have a currently valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For example, if an individual has the proper validation on his/her passport, a notarized photocopy of the passport could suffice. Because there is a 6-month limitation on this validation, it is the grantee’s responsibility to follow up and ensure that the individual received the I-551 prior to the 6-month expiration date.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status may be supported on Kirschstein-NRSA training grants; however, as with all types of Permanent Resident status it is the grantee’s responsibility to assure the individual remains eligible for NRSA support for the period of time of any appointment. Individuals with Asylum/Refugee status do not automatically hold a form of permanent residency status; they have the opportunity to apply for permanent residency status once they have been in the U.S. for a period of time. Therefore, individuals with Asylum/Refugee status may not be appointed to an Kirschstein-NRSA training grant until they have also secured permanent residency status. Individuals on temporary or student visas are not eligible for Kirschstein-NRSA support.

11.3.3 Application Requirements and Receipt Dates

11.3.3.1 Application

All applications for Kirschstein-NRSA institutional research training grants are submitted electronically through Grants.gov and use an application package that combines form components from the SF424 (R&R) application along with the PHS398 components. Application forms and instructions are provided as part of each FOA. Applicants should pay particular attention to the special instructions for institutional research training grants found in the SF424(R&R) Application Guide.

11.3.3.2 Receipt Dates

Several NIH ICs receive training grant applications three times each year; however, many ICs use only one or two receipt dates. Information on IC-specific receipt dates is available in the NIH Guide for Grants and Contracts in the NIH-wide T32 and T35 FOAs and FOAs issued by the individual NIH ICs or by contacting the appropriate NIH IC program official. For a list of the standard receipt dates and review cycle, see the http://grants.nih.gov/grants/funding/submissionschedule.htm. (Also see http://grants.nih.gov/training/nrsa.htm#inst.)

Applicants are encouraged to contact the appropriate NIH staff before preparing and submitting an application. Applications requesting funding of $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within the specific NIH ICs who has agreed to accept assignment of the application. This requirement is in place for all NIH ICs except those assigned to NIGMS, NICHD, NEI, NIDCR, or NINR; these ICs automatically accept all T32 applications regardless of the dollar amount, thus prior approval is not required. NIA waives this requirement for renewal and resubmission applications only. Applicants are strongly encouraged to contact the NIH IC if there are questions about the applicability of this policy

11.3.3.3 Special Program Considerations

The primary objective of the Kirschstein-NRSA program is to support graduate and postdoctoral research training to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s biomedical, behavioral and clinical research agenda.

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 PD/PIs 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 PD/PIs also should encourage and provide training in the skills necessary for postdoctoral trainees to apply for subsequent support through individual postdoctoral fellowships, mentored career development awards (K programs), or independent research project grants. 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 located n 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 also indicate whether both health professional trainees and trainees with research doctorates will be included in the training program.

Training PD/PIs also must develop methods for ongoing evaluation of the quality and effectiveness of the training program. This should include plans to obtain feedback from current and former trainees to help identify weaknesses in the program and provide suggestions for program improvements as well as plans for assessing trainee’s career development and progression, including publications, degree completion, and post-training positions. Evaluation results are to be included in competing continuation (renewal) applications and as part of the Final Progress Report.

Within the framework of the program’s longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting trainees from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. NIH’s requirements for diversity recruitment and retention are described below.

11.3.3.4 Recruitment and Retention Plan to Enhance Diversity

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individual currently underrepresented in the biomedical, behavioral, clinical, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

1. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/nsf07308/content.cfm?pub_id=3633&id=3). In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
2. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
3. Individuals from disadvantaged backgrounds who are defined as:
   1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS-Poverty Guidelines, Research and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
   2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
   Recruitment and retention plans related to a disadvantaged background (C.1 and C.2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

NRSA training programs require all applicants to submit a recruitment and retention plan to enhance diversity. New applications must include such a plan and may wish to include data in support of past accomplishments. Renewal applications also must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous the funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

• Students or postdoctorates who applied for admission or positions within the department(s)/program(s) relative to the research training grant;
• Students or postdoctorates who were offered admission to or a position within the department(s)/program(s);
• Students actually enrolled in the academic program relevant to the research training grant;
• Students or postdoctorates who were appointed to the research training grant.

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

Application without a diversity recruitment and retention plan will be considered incomplete and will not be reviewed.

A detailed account of experiences in recruiting individuals from underrepresented groups 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.

11.3.3.5 Training in the Responsible Conduct of Research

Every trainee supported by an NRSA training grant must receive instruction in the responsible conduct of research. All applications must include a plan to provide such instruction. The plan must address five components listed below. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.

1. Format. Substantial face-to-face discussions among the participating trainees; a combination of didactic and small-group discussions (e.g. case studies); and participation of research training faculty members in instruction in responsible conduct of research are highly encouraged. While on-line courses can be a valuable supplement to instruction in responsible conduct of research, online instruction is not considered adequate as the sole means of instruction. A plan that employs only online coursework for instruction in responsible conduct of research will not be considered acceptable, except in special instances of short-term training programs (see below), or unusual and well-justified circumstances.
2. Subject Matter. While there are no specific curricular requirements for instruction in responsible conduct of research, the following topics have been incorporated into most acceptable plans for such instruction:
   1. conflict of interest – personal, professional, and financial
   2. policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
   3. mentor/trainee responsibilities and relationships
   4. collaborative research including collaborations with industry
   5. peer review
   6. data acquisition and laboratory tools; management, sharing and ownership
   7. research misconduct and policies for handling misconduct
   8. responsible authorship and publication
   9. the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
   While courses related to professional ethics, ethical issues in clinical research, or research involving vertebrate animals may form a part of instruction in responsible conduct of research, they generally are not sufficient to cover all aspects of responsible research conduct.
3. Faculty Participation. Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Informal instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. Training faculty may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors. Rotation of training faculty as course directors, instructors, and/or discussion leaders may be a useful way to achieve the ideal of full faculty participation in formal responsible conduct of research courses over a period of time.
4. Duration of Instruction. Instruction should involve substantive contact hours between the trainees and the participating faculty. Acceptable programs generally involve at least eight contact hours. A semester-long series of seminars/programs may be more effective than a single seminar or one-day workshop because it is expected that topics will then be considered in sufficient depth, learning will be better consolidated, and the subject matter will be synthesized within a broader conceptual framework.
5. Frequency of Instruction. Reflection on responsible conduct of research should recur throughout a scientist’s career: at the undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels. Institutional training programs are strongly encouraged to consider how to optimize instruction in responsible conduct of research for the particular career stage(s) of the individual(s) involved. Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years. It is highly encouraged that initial instruction during predoctoral training occurs as early as possible in graduate school. Individuals at the early career investigator level must receive instruction in responsible conduct of research at least once during this career stage. To meet the above requirements, instruction in responsible conduct of research may take place, in appropriate circumstances, in a year when the trainee is not actually supported by an NIH grant. This instruction must be documented in the submitted plan.
   
   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.

11.3.4 Review

11.3.4.1 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.

11.3.4.2 Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research training program to exert a sustained, powerful influence on the research field(s) involved. The scored review criteria and additional review criteria (as applicable for the research training program proposed) will be considered when determining the overall impact.

11.3.4.3 Review Criteria

Reviewers will consider each of the review criteria below in the determination of the scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific merit.

• Training Program and Environment. Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical scientists? Do the objectives, design and direction of the proposed research program ensure effective training? Is the proposed program of training likely to ensure that trainees will be prepared for successful and productive scientific careers? Do the courses, where relevant, and research training experiences address state- of-the-art science relevant to the aims of the program? Does the program provide training in inter- or multi-disciplinary research and/or provide training in state of the art or novel methodologies and techniques? Is a significant level of institutional commitment to the program evident? For applications that request short-term research training positions, is this aspect of the program well designed and, where appropriate, integrated with other aspects of the training program; are the numbers of short-term positions appropriate; and does the program include features to encourage short-term trainees to consider careers in health-related research?
• Training Program Director/Principal Investigator. Does the Training PD/PI have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed research training program? Does the PD/PI plan to commit sufficient time to the program to ensure its success? Is sufficient administrative and research training support provided for the program? For applications designating multiple PD/PIs, is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the PD/PIs?
• Preceptor/Mentors. Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application? Do the preceptors/mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program? Do the preceptors/mentors have strong records of training pre- and/or postdoctorates?
• Trainees. Is a recruitment plan proposed with strategies to attract high quality trainees? Are there well-defined and justified selection criteria and retention strategies? Is a competitive applicant pool in sufficient numbers to warrant the proposed size and levels (predoctoral, postdoctoral and/or short-term) of the training program in evidence? For applications that request short-term research training positions, does the program have the potential or evidence to recruit high quality, short-term trainees? For renewal applications, how successful has the program been in attracting and retaining individuals from diverse populations, including populations underrepresented in science?
• Training Record. How successful are the trainees (or for new applications, other past students/fellows in similar training) in completing the program? How productive are trainees (or for new applications other past students/fellows) in terms of research accomplishments and publications? How successful are trainees (or other past students/fellows) in obtaining further training appointments, fellowships, and career development awards? How successful are the trainees in achieving productive scientific careers, as evidenced by successful competition for research grants, receipt of honors or awards, high-impact publications, receipt of patents, promotion to scientific leadership positions, and/or other such measures of success? Does the program have a rigorous evaluation plan to review the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees and monitoring trainees’ subsequent career development? For renewal applications, does the application describe the program’s accomplishments over the past funding period(s); are changes proposed that would improve/strengthen the training experience? For programs that provide research training to health-professional doctorates, is there a record of retaining health professionals in research training or other research activities for at least two years? For applications that request short-term research training positions, are plans presented to follow the careers of short-term trainees and to assess the effect of the training program on subsequent career choices? What is the success in attracting students back for multiple appointments? What is the effect of the short-term component on the overall training program?
• Individual Institutes and Centers may have additional specialized review criteria appropriate for their special initiatives and mission.

11.3.4.4 Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

• Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
  
  For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
• Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
• Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
• Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
• Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous SRG and changes made to the project.
• Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
• Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous SRG are adequate and whether substantial changes are clearly evident.

11.3.4.5 Additional Review Considerations

As applicable for the training program proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing the overall impact/priority score:

Recruitment and Retention Plan to Enhance Diversity. Peer reviewer will separately evaluate the recruitment and retention to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups.

The review panel’s evaluation will be included in an administrative note in the summary statement. If the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) 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.

Training in the Responsible Conduct of Research. Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency), taking into account the characteristics of institutional programs or the unique circumstances for short-term training programs. Plans and past record will be rated as acceptable or unacceptable.

Select Agents Research. When applicable, reviewers will assess the information provided in this section of the application, including 1) the select agent(s) to be used in the proposed research; 2) the registration status of all entities where select agent(s) will be used; 3) the procedures that will be used to monitor possession use and transfer of select agent(s); and, 4) plans for appropriate biosafety, biocontainment, and security of the select agent(s).

Budget and Period of Support. The reasonableness of the proposed budget and the requested period of support will be assessed in relation to the proposed research training program and the number of proposed trainees at the requested levels. The impact/priority score should not be affected by the evaluation of the budget.

For additional details, applicants also are encouraged to consult the application instructions, the NIH-wide T32 FOA, and specific IC FOAs.

11.3.4.6 National Advisory Council Review

Following initial peer 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 peer review group’s comments on the plan for recruitment and retention to enhance diversity and the plan for instruction in the responsible conduct of research.

11.3.5 Notification of Action

Shortly after the initial peer review meeting, the PD/PI will be sent an e-mail indicating that the SRG recommendation/priority score is available in the eRA Commons. The PD/PI is also notified via an e-mail when the summary statement is available in the eRA Commons. The PD/PI may be notified by the PO of the final review recommendation. Once all administrative and programmatic issues have been resolved, the NoA will be issued for applications selected for funding. Any questions concerning initial review recommendations and funding possibilities should be directed to the named PO, not to the SRO of the SRG. Name and contact information of the assigned PO is also available in the eRA Commons.

11.3.6 Period of Support

11.3.6.1 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, referred to as budget periods; support for additional non-competitive years depends on satisfactory progress, submission of all required trainee-related documents, and availability of funds.

11.3.6.2 Trainees

Trainees under Kirschstein-NRSA institutional research training grants generally are appointed for full-time 12-month continuous periods. An appointment or reappointment period may begin any time during a particular budget period but may not begin before the budget period start date of the grant year. An appointment or reappointment may not exceed 12 months without prior approval by the NIH awarding IC. All trainees are required to pursue their research training on a full-time basis. Full-time is generally defined as devoting at least 40 hours per week to the program or as specified by the grantee in accordance with its own policies. Unless the NIH awarding IC 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 IC and then usually only to complete an ongoing 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. While Kirschstein-NRSA trainees are required to pursue research training on a full-time basis, under certain circumstances, a written request may be submitted to the NIH awarding IC 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 IC before the applicable budget period. The circumstances requiring the part-time training might include medical conditions, disability, or 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, clinical training, or for other responsibilities associated with the trainee’s position at the organization. In each case, the written request must be signed by an AOR and must include documentation supporting the need for part-time training. Countersignatures of the trainee and program director must be secured and retained by the grantee, but need not be submitted to NIH prior to submission to NIH. 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 intends 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.

11.3.6.3 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 IC based on review of a justification from the individual and the grantee organization. The AOR must make the request in writing to the NIH awarding IC on behalf of the trainee. The endorsement of the trainee’s PD/PI certifying the need for additional support is retained by the grantee institution. The request must specify the amount and length of additional support for which approval is sought.

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

• 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.
• 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.

11.3.7 Initiation of Support

The NoA is issued to the grantee organization, generally 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 IC. A trainee appointment may not begin before the budget period start date.

At the time of the initial appointment and subsequent reappointment of trainees, the Training PD/PI must submit a Statement of Appointment for each trainee to the NIH awarding IC. 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 chapter 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.

11.3.8 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 NoA .

11.3.8.1 Pre-Award Costs

While some pre-award costs are allowable to a training grant, grantees should note that stipends and tuition and fees may not be charged to a grant until a trainee has been officially appointed and the appropriate paperwork submitted to the NIH. Therefore, these costs may not be charged as pre-award to an institutional training grant. There are rare occasions when costs associated with training related expenses and/or trainee travel may be allowable as pre-award costs. Grantee institutions should consult with the NIH awarding IC when considering a pre-award cost.

11.3.8.2 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 “salary” and 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:

• Prebaccalaureate. Two separate levels are provided for trainees: freshman/sophomore or junior/senior.
• Predoctoral. One stipend level is used for all predoctoral trainees, regardless of the level of experience.
• 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.

11.3.8.3 Trainee Tuition and Fees

Tuition and fees are allowable trainee costs only if such charges are applied consistently to all individuals in a similar training status at the organization, without regard to their source of support.

Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program and requires NIH awarding IC prior approval.

Tuition and fees are provided under the following policy:

• For Predoctoral Trainees. An amount equal to 60% of the level requested by the sponsoring institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D, D.D.S.-Ph.D.), the amount provided will be up to $21,000 per year.
• For Postdoctoral Trainees. An amount equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports postdoctoral individuals in formal degree-granting training, the amount provided will be up to $16,000 per year.

Historically tuition and fees was awarded using different formulas and included health insurance as part of that budget category; however this is no longer the policy. Health insurance is now awarded as part of the Training-Related Expenses category. When administering a training that competed and was awarded prior to FY2007 and is still active in that particular competitive segment, consult the NIH awarding IC if there are questions concerning the awarding of tuition, fees, and health insurance.

Tuition and fees are awarded as a lump sum that can be allocated (without the prior approval of the NIH awarding IC) based on recipient needs.

11.3.8.4 Training-Related Expenses

Funds are provided to defray costs such as staff salaries, consultant costs, equipment, research supplies, staff travel, trainee health insurance (self-only or family as applicable), 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. Many of the costs allowable under Training-Related Expenses may cover global costs for an institutional training program where the Kirschstein-NRSA support covers only some of the participating trainees. For these types of global costs, institutions should allocate the appropriate portion of such costs to the training grant. Institutions are reminded that this budget category is a finite amount of money available to cover a variety of allowable costs. Institutions should be particularly mindful to apply core cost principles of allocation and consistent treatment.

Health Insurance. Health Insurance (self-only or family) are allowable trainee related expenses only if such charges are applied consistently to all individuals 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. Historically health insurance was awarded as part of the tuition and fees category. This is no longer the policy. For any training grant that competed and was awarded in FY2006 and beyond, health insurance is awarded as part of the Training Related Expenses category.

Medical Liability and Other Special Insurance. Medical liability (malpractice) insurance or other special insurance is an allowable cost to NRSA grants only if nature of the research training requires such special insurance. For instance, medical liability would be allowable if the research training experience involves direct contact with patients or human subjects. In all cases, for the cost to be charged to the NRSA grant, it must be consistently required for all in a similar training status, regardless of the source of support. Special insurances that are routinely offered as optional employee benefits (such as disability insurance, life insurance, or workman’s compensation insurance), are not normally allowable charges (see separate section on Employee Benefits) unless the nature of the research training requires such special insurance.

Staff Salaries. Institutions are reminded that applicable cost principles apply. For institutions covered by OMB Circular A-21, training programs may qualify as a “major project” where administrative salaries are allowable as a training-related expense.

Speaker Fees. When speakers are part of program required for NSRA-supported trainees, a portion of such a cost could be charged as Training-related expenses.

Meals. As stated in IIA, the cost of meals may be allowable if they are provided in conjunction with a meeting where the primary purpose includes the dissemination of technical information. A portion of such a cost could be charged as Training-related expenses. See Cost Considerations—The Cost Principles in IIA for specific guidance on the need institutional policies on consistent treatment and reasonableness.

Extraordinary Costs. 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.

11.3.8.5 Trainee Travel Costs

If requested by the grantee, the NIH awarding IC 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. Trainees must be appointed to the training grants at time of the actual travel for this to be an allowable cost. 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 IC. Letters requesting such training may be submitted to the NIH awarding IC at any time during the appointment period.

11.3.8.6 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.

11.3.8.7 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, life insurance, union dues, and unemployment insurance). Concerning union dues or other similar costs otherwise paid personally by the trainee, if a trainee requests the institution deduct such a cost from the stipend amount, the institution can provide the trainee such a service. However, in no case can such a deduction from the stipend be made automatically without the approval of the trainee.

11.3.8.8 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 (when still awarded in the tuition and fees category), consortiums in excess of $25, 000, 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.

11.3.9 Rebudgeting of Funds

Funds may be rebudgeted only as follows:

• Trainee-Related Expenses. Rebudgeting of funds awarded in a lump sum for trainee-related expenses does not require NIH awarding IC prior approval.
• Trainee Costs. For rebudgeting purposes, trainee costs include funds awarded in the stipends or tuition/fees 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 IC. Unless otherwise restricted, rebudgeting into or within the stipends and tuition/fees is allowable without prior approval of the NIH awarding IC. Note during the transition period for the new tuition policy, health insurance is included as a trainee cost only when still awarded as part of the tuition and fees budget category. For those training programs awarded under the new policy, health insurance is included in the trainee-related expenses category; thus the rebudgeting policies of that category would apply.
• 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 IC.

11.3.10 Stipend Supplementation, Compensation, and Other Income

11.3.10.1 Stipend Supplementation

Grantees may supplement stipends from non-Federal funds provided the supplementation is without any additional obligation for 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 below. Under no circumstances may PHS funds be used for supplementation.

11.3.10.2 Compensation

NIH recognizes that student trainees 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 IIA. 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, NIH expects 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.

Stipend Supplementation & Compensation. 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 PD/PIs must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.

11.3.10.3 Other Income: 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.

11.3.10.4 Other Income: 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.

11.3.10.5 Other Income: NIH Loan Repayment Program

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/.

11.3.10.6 Taxability of Stipends

Section 117 of the Internal Revenue Code (26 U.S.C. 117) applies to the tax treatment of scholarships and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used for qualified 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 IRS and Treasury Department released regulations in January 2005 (Revenue Procedures 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. NIH’s understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards.

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.

11.3.10.7 Form 1099

Although stipends are not considered salaries, the funds are subject to Federal and, sometimes, State taxes. The grantee organization may report such funds 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 funding 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.

11.3.11 Carryover Authority

The NIH Standard Terms of Award apply to Kirschstein-NRSA institutional research training grants; however, in most cases, grantees must obtain awarding IC prior approval to carry over funds. Some NIH awarding ICs have also waived this prior approval requirement for training grants. The NoA for a Kirschstein-NRSA institutional research training grant will specify whether or not the grantee must obtain the prior approval of the awarding IC to carry over funds.

11.3.12 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 in IIA for policies that govern the disposition and reporting of program income.

11.3.13 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 MS Word formats at http://grants.nih.gov/grants/forms.htm.

11.3.13.1 Statement of Appointment (Form PHS 2271)

The grantee must submit a PHS 2271 to the NIH awarding IC before or at the start of each trainee’s appointment or reappointment. No 2271s can be submitted until after the NoA for the respective budget period has been issued. Effective with any PHS2271 submitted January 1, 2011 and beyond, grantees are required to submit the PHS 2271 data electronically using the eRA Commons xTrain application. More information on xTrain is available at http://era.nih.gov/services_for_applicants/other/xTrain.cfm.

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. A complete Social Security Number must be included on the Payback Agreement. The PD/PI 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 FFR.

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/PI to the NIH awarding IC on an amended PHS 2271 at the time of the change. Interim revisions for any appointment initially processed via xTrain, must also be submitted through xTrain.

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 IC 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.

11.3.13.2 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 Requirements in this chapter.

No Payback Agreement is required for predoctoral or prebaccalaureate trainees.

11.3.13.3 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/PI is responsible for submitting a Termination Notice for each trainee within 30 days of the end of the total period of support even if the trainee is not available for signature. In all cases, the information on the form must be verified by the program director and an institutional business official. The lack of timely and accurate information on this form could adversely affect data collected associated with aggregate NRSA support and the payback process. Effective with any Termination Notice submitted January 1, 2011 and beyond, grantees are required to submit the PHS 416-7 data electronically using the xTrain application. More information on xTrain is available at http://era.nih.gov/services_for_applicants/other/xTrain.cfm.

No Termination Notice is required for prebaccalaureate (T34) trainees.

11.3.13.4 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 Web site at http://grants.nih.gov/grants/forms.htm. Progress report form pages are available in PDF-fillable and MS Word 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 IC within 90 days after the end of grant support.

11.3.13.5 Federal Financial Report (FFR)

An annual FFR is required for all Kirschstein-NRSA institutional research training grant awards no later than 90 days after the end of the calendar quarter in which the budget period ended. 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 reported as unliquidated obligations. The same principal may apply to trainee health insurance when an institution can truly obligate the full amount of health insurance at the start of the appointment.

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 in IIA).

11.3.14 Closeout

The Closeout requirements included in IIA apply (see Administrative Requirements—Closeout—Final Reports). In addition, Termination Notices for all trainees are required.

11.3.15 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 IC.

If the PD/PI 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 IC. Any proposed change of PD/PI must be requested by the grantee organization and be approved in writing by the NIH awarding IC 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 IC 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.

11.3.16 Other Terms and Conditions

11.3.16.1 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 and is not considered to be a vacation or holiday.

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 IC in response to a written request from an AOR. Sick leave may be used for the medical conditions related to pregnancy and childbirth.

Parental Leave. Trainees may receive stipends for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or the birth of a child when individuals in comparable training positions at the grantee organization have access to this level of paid leave for this purpose. Either parent is eligible for parental leave. The use of parental leave must be approved by the Training PD/PI.

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 60 calendar days of parental leave, must seek approval from the NIH awarding IC for an unpaid leave of absence. Approval for a leave of absence must be requested in advance by an AOR on behalf of the trainee.

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 IC at the beginning of the leave. Upon resumption of Kirschstein-NRSA support, the reappointment must be documented on another Statement of Appointment form.

11.3.16.2 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 IC immediately. In such cases, NIH will issue a revised NoA to specify the changed period of support and to show prorated trainee stipends, depending on the amount of time spent in training.

11.3.16.3 Publications and Sharing of Research Results

NIH supports the practical application and sharing of outcomes of funded research. Therefore, PD/PIs 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 further development of discoveries and inventions for furthering research and benefiting the public. 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 Appropriation Mandates—Acknowledgment of Federal Funding in IIA.

The Public Access Policy requirements described in Administrative Requirements—Availability of Research Results—NIH Public Access Policy in IIA apply to articles that are authored or co-authored by NRSA trainees and arose from NIH Support. Information on trainee publications is included as part of the annual progress report.

11.3.16.4 Copyright

Except as otherwise provided in the NoA, 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 IC. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce, translate, publish, and use and dispose of such materials, and to authorize others to do so for Federal government purposes.

11.3.16.5 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 part 74.24(h) and in 37 CFR part 401.1(b)).

11.3.16.6 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 in IIA). 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.

11.3.16.7 Public Policy Requirements and Objectives

All Public Policy Requirements, Objectives, and Other Appropriation Mandates discussed in IIA apply to Kirschstein-NRSA Institutional programs when appropriate. Applicants must comply with policies and procedures governing such requirements as civil rights; the protection of human subjects, including data and safety monitoring requirements and inclusion policies for women, minorities and children; the humane care and use of live vertebrate animals; human embryonic stem cells; and/or recombinant DNA and human gene transfer research. See IIA for a complete list of applicable requirements.

Additional information and any application requirements can be found in the SF424 (R&R), Section 8. Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein-NRSA Applications.

Information provided below is in addition to that provided in IIA where unique circumstances might exist for institutional training programs.

11.3.16.7.1 Human Subjects

Indefinite Involvement. 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 in 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. The grantee institution must ensure that trainees have received the proper training/education in human subjects research.

11.3.16.7.2 Vertebrate Animals

Indefinite Involvement. 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, the organization should indicate "Yes," to the involvement of Vertebrate Animals and include the animal welfare Assurance of Compliance number. 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 IC.

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. The institution must ensure that trainees are enrolled in the institution’s animal welfare training and occupational health and safety programs for personnel who have contact with animals, as appropriate. It is also the institution’s responsibility to ensure that trainees are properly supervised when working with live vertebrate animals.

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 Application Guide or contact OLAW (see Part III).

11.4 Payback Requirements

11.4.1 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.

11.4.2 Implementation

The incurrence of a payback obligation for an NRSA recipient is solely dependent upon when NRSA support was received. This section reflects current Payback requirements for individuals supported on/after June 10, 1993. Payback requirements for individuals supported before June 10, 1993 are found on the Payback Service Center Home Page.

Predoctoral Recipients. For predoctoral trainees 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. However, the 13th and subsequent months of postdoctoral NRSA supported research training serves 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.

Short-Term Training. Any individual receiving support for predoctoral short-term training does not incur a payback obligation; however, postdoctoral short-term training does incur a payback obligation. Support for short-term training accrues, along with any subsequent NRSA 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.

11.4.3 Payback

Once a Termination Notice has been submitted and accepted, the NIH awarding IC 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 Payback Service Center (PSC). PSC personnel are NIH’s experts in Kirschstein-NRSA payback requirements. The PSC administers the payback activities of all of the NIH 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 then 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.

11.4.3.1 Service Payback

11.4.3.1.1 Definitions

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

• 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, will also satisfy the service payback obligation.
• 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.
• 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.

11.4.3.1.2 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.

11.4.3.1.3 Initiation of Payback Service

Service payback obligations for postdoctoral recipients may be discharged by

• receiving an equal number of months of postdoctoral Kirschstein-NRSA support beginning in the 13th month of such postdoctoral Kirschstein-NRSA support, or
• engaging in an equal number of months of health-related research, training, or teaching averaging more than 20 hours per week.

11.4.3.1.4 Source of Funding

There is no restriction on the source of funds supporting an individual’s service payback activity. An individual could be supported by a PHS grant or any non-Kirschstein-NRSA Federal or non-Federal source. Unpaid service also is permitted.

11.4.3.1.5 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 below).

11.4.3.2 Financial Payback

11.4.3.2.1 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 below), 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.

11.4.3.2.2 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 accrue 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 2007, OFM received an account reflecting January 31, 2005, as the termination date of NRSA support, the Federal government, lacking any documentation to the contrary, becomes entitled to financial payback effective February 1, 2005. The rate of interest applicable is determined based on the February 1, 2005, date, and the total NRSA obligation is required to be fulfilled by January 31, 2008.

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.

11.4.3.3 Extensions of Payback

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

11.4.3.3.1 Extensions of the 2-Year Period to Initiate Payback

An extension of the 2-year period to initiate payback may be requested in the Annual Payback Activities Certification form. Indication of valid plans to initiate payback soon after the 2-year grace period may be good reason to grant an extension.

11.4.3.3.2 Basis for Extensions or Break in Service

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

• An extension or break in service is necessary so the individual may complete his or her research or clinical training.
• An extension or break in service is necessary so the individual may participate in the NIH Loan Repayment Program.
• The individual is unable to complete the requirements within the specified period because of a temporary disability.
• 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, for example, completing residency training where clinical teaching or research are not an integral part of the 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 requested extension.

11.4.3.4 Waiver

11.4.3.4.1 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.

11.4.3.4.2 Waiver Criteria

Requests for waivers should be made in writing to the PSC and should include an explanation of the need for the waiver according to the following criteria:

• Compliance by an individual will be deemed impossible if the individual is permanently, and totally disabled.
• In determining whether compliance would involve substantial hardship to the individual and would be inequitable, the PSC will consider the individual's
  • financial resources and obligations at the time of request for a waiver and
  • estimated future financial resources and obligations.
• In rare cases, the following also may be considered:
  • Reasons for the individual’s failure to complete the requirements within the prescribed period, such as personal problems;
  • Extent to which the individual has engaged in payback activities;
  • Sufficiency of training to qualify the individual to perform such activities;
  • Lack of employment opportunities appropriate to the individual’s education and training;
  • Any other extenuating circumstances.

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

11.4.4 Certification of Payback Activities

11.4.4.1 Annual Payback Activities Certification (Form PHS 6031-1)

11.4.4.2 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 the PSC 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.

11.4.4.3 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 to NRSAPaybackCenter@mail.nih.gov.

11.4.4.4 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 Web site at http://grants.nih.gov/grants/forms.htm.

11.4.4.5 National Health Service Corps

A Kirschstein-NRSA recipient may have also been a National Health Service Corps (NHSC) scholar. Legislative changes effective October 26, 2002, eliminated the previously existing concurrent payback option. 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 Kirschstein-NRSA payback service.