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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, behavioral, and clinical 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.
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).
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, behavioral, or clinical research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career.
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 recipient 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.
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.
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, behavioral, and clinical sciences.
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 organization. It is the responsibility of the recipient 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.
Short-term research training includes the following:
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.
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.
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 recipient'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 recipient'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 a 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.
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.
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
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 in clinical departments that focus on research training for individuals with the M.D. or other health-professional degrees should consider developing ties to basic science departments, or, if consistent with the goals of the program, modifying the program to include individuals with research doctorates. In these cases, applications should describe the basic science department's contribution to the research training experience and 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 RPPR.
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 enhance diversity on a national or institutional basis. NIH's requirements for diversity recruitment and retention are described below.
Every facet of the United States scientific research enterprise-from basic laboratory research to clinical and translational research to policy formationâ€“requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to enhance the participation of individuals 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 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 basis.
Definition of Diversity Groups
The NIH is particularly interested in encouraging the recruitment of the following classes of candidates:
The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.
Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics.
Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines. (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at http://www.nsf.gov/statistics/wmpd/2013/sex.cfm, especially the table describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank (Table 9-23 of Special Report NSF 13-304 from 2013).)
Upon review of NSF data, and scientific discipline or field related data, NIH Institutes, Centers, and Offices may include women as eligible candidates in faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement. This option is not available for funding opportunities that do not directly provide structured opportunities for advancement (i.e., Diversity Supplement).
NRSA training programs require all applicants to submit a recruitment 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:
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 plan to enhance diversity will be considered incomplete and will not be reviewed.
The review panel's evaluation will be included in an administrative note in the summary statement. If the recruitment 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.
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.
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 the 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 to address any weaknesses in the current instructional 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. Plans and past record will be rated as acceptable or unacceptable. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. For additional instructions, see the specific FOA.
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, 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:
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 research and the extent of trainee and faculty participation also must be provided in the annual progress report submitted as a prerequisite to receiving non-competing continuation support.
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.
Reviewers will provide an overall impact 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.
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.
The FOA should be consulted for additional information describing each of the scored review criteria. Individual Institutes and Centers may have additional specialized review criteria appropriate for their special initiatives and mission.
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.
The FOA should be consulted for additional information describing each of the relevant addition review criteria.
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 score:
The FOA should be consulted for additional information describing each of the relevant addition review considerations.
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.
Shortly after the initial peer review meeting, the PD/PI will be sent an e-mail indicating that the SRG recommendation/impact 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.
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.
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 recipient 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 recipient 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 recipient, 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.
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 recipient 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 recipient 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:
Requests that arise from circumstances other than those described above will be considered only if they are accompanied by an exceptionally strong justification.
The NoA is issued to the recipient 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 recipient organization directly to the trainee.
Policies included in the applicable cost principles in 45 CFR 75, Subpart E and the NIHGPS govern the expenditure of all training grant funds, unless otherwise indicated in the NoA.
While some pre-award costs are allowable to a training grant, recipients 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. Recipient institutions should consult with the NIH awarding IC when considering a pre-award cost.
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 recipient 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 recipient 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:
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:
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.
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. 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 considered an ancillary activity to the training grant. 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.
If requested by the recipient, 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 recipient 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 recipient 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.
The recipient 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.
Because Kirschstein-NRSA awards are not provided as a condition of employment with either the Federal government or the recipient, 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.
Recipients, other than State, local, or Indian tribes (or ''federally recognized Indian tribes"), 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 tribe (or ''federally recognized Indian tribes") are eligible for full F&A cost reimbursement. For this policy, State universities or hospitals are not considered governmental agencies.
Funds may be rebudgeted only as follows:
Recipients 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.
NIH recognizes that student or postdoctoral trainees may seek part-time employment coincidental to their training program to further offset their expenses. Fellows and trainees may spend on average, an additional 25% of their time (e.g., 10 hours per week) in part time research, teaching, or clinical employment, so long as those activities do not interfere with, or lengthen, the duration of their NRSA training. 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-Fringe Benefits / IHE Tuition/Tuition Remission 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, laboratory assistance, or clinical duties 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.
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.
An individual may accept concurrent educational remuneration from the VA (GI Bill) and Federal educational loan funds. Such funds are not considered supplementation or compensation. In the case of the MARC-U*STAR program, funds from a Pell grant may be accepted as well.
Postdoctoral trainees also may be eligible to participate in the NIH Loan Repayment Program. Information about this program is available at http://www.lrp.nih.gov/.
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 recipient 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 recipient 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.
Although stipends are not considered salaries, the funds are subject to Federal and, sometimes, State taxes. The recipient organization may report such funds on IRS Form 1099, Statement of Miscellaneous Income. Normally, the business office of the recipient organization will be responsible for annually preparing and issuing the IRS Form 1099 for trainees. Recipient 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 recipient organization does not issue the Form 1099, trainees are required to report Kirschstein-NRSA stipends as income.
The NIH Standard Terms of Award apply to Kirschstein-NRSA institutional research training grants; however, in most cases, recipients 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 recipient must obtain the prior approval of the awarding IC to carry over funds.
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.
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.
The recipient 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, recipients 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.
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.
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. Recipients 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.
RPPRs must be submitted for non-competing continuation support in accordance with the RPPR instructions. Report forms and instructions are available from the NIH Web site at http://grants.nih.gov/grants/forms.htm. Guidance for training grants can be found in section 7.4 of the RPPR Instructions. Following completion or termination of a project period, the recipient must submit a Final RPPR to the NIH awarding IC within 120 days after the end of grant support.
The IDP provision described in Non-Competing Continuation Progress Reports applies to all trainees reported on a Statement of Appointment Form (PHS2271). This information should be provided using the instructions in Non-Competing Continuation Progress Reports.
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 recipient 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, tuition, and applicable F&A that extend beyond the budget period are reported as unliquidated obligations. The same principal may apply to trainee health insurance when an institution cannot 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, must indicate the exact balance of unobligated funds, and is due within 120 days of the period of performance end date (see Administrative Requirements-Monitoring-Reporting-Financial Reports and Administrative Requirements-Closeout-Final Reports in IIA).
The Closeout requirements included in IIA apply (see Administrative Requirements-Closeout-Final Reports). In addition, Termination Notices for all trainees are required.
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 recipient 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.
Note: The leave durations stated below apply to full-time trainees. Short-term trainee leave must be proportionally adjusted based depending on the duration of appointment.
In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may 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. 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 each child. Either parent is eligible for parental leave. Kirschstein-NRSA trainees and fellows must provide advanced notification to the grantee institution prior to taking parental leave. Notification of supervisors and others about plans to use leave must be consistent with the organization's policy and must be consistently applied regardless of the source of funds. A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here, i.e., more than 15 calendar days of sick leave or more than 60 calendar days of parental leave, must seek approval from the NIH awarding component 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. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines in the NIH Grants Policy Statement for further guidance regarding vacations and requested leave.
Vacations and Holidays. Trainees may receive the same vacations and holidays available to individuals in comparable training positions at the recipient 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 each child. Either parent is eligible for parental leave. Kirschstein-NRSA trainees and fellows must provide advanced notification to the grantee institution prior to taking parental leave. Notification of supervisors and others about plans to use leave must be consistent with the organization's policy and must be consistently applied regardless of the source of funds.
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.
NIH may terminate a Kirschstein-NRSA institutional research training grant before its normal completion 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 the award was made. If an award is terminated for cause, NIH will notify the recipient 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 recipient.
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.
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 recipient 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.
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.
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 75.322 and in 37 CFR 401.1(b)).
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 recipient 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.
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.
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 recipient institution must ensure that trainees have received the proper training/education in human subjects research.
Indefinite Involvement. If the applicant organization has an approved Animal Welfare Assurance 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 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 Animal Welfare Assurance on file with OLAW or for additional information on vertebrate animals, refer to the Application Guide or contact OLAW (see Part III).