TRAINING PROGRAMS IN DIABETES RESEARCH FOR PEDIATRIC ENDOCRINOLOGISTS Release Date: October 18, 2001 RFA: RFA-DK-02-024 National Institute of Diabetes and Digestive and Kidney Diseases ( American Diabetes Association ( Juvenile Diabetes Research Foundation International ( Letter of Intent Receipt Date: February 26, 2002 Application Receipt Date: March 26, 2002 PURPOSE To foster development of a diverse and highly trained workforce of pediatric endocrinologists to assume leadership roles related to the Nation’s biomedical and behavioral research efforts in the area of pediatric diabetes, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in cooperation with the American Diabetes Association (ADA) and the Juvenile Diabetes Research Foundation International (JDRF), invites applications for the establishment of joint programs for the research training and career development of pediatric endocrinologists. The NIDDK will award complementary Institutional research training (T32) and clinical scientist career development program (K12) grants to eligible institutions to provide an integrated program to prepare pediatricians, selected by the institution, for careers in pediatric endocrinology research related to diabetes. In combination, these awards will establish multilevel (postdoctoral fellow and junior physician scientist) training and career development programs. This initiative responds to the language in The Children’s Health Act of 2000 recommending support of the expansion of programs to train new investigators in pediatrics. Institutional research training grants (T32) are a desirable mechanism for the postdoctoral training of physicians who may have extensive clinical training but have limited research experience. It is anticipated that the appointed trainees will be enrolled in a pediatric endocrinology fellowship program. For such individuals, the training may be a part of a research degree program. In most cases, postdoctoral trainees should engage in at least two years of research, research training or comparable activities beginning at the time of appointment since the duration of training has been shown to be strongly correlated with post-training research activity. Clinical scientist career development programs (K12) assist in the transition of clinical investigators to an independent research career. These institutional mentored research career development awards will provide up to three years of supervised research experience that may combine didactic studies with laboratory or patient oriented research. In combination, the T32 and K12 programs will provide an opportunity for continuous training from the clinical fellowship years to emergence as a fully trained independent investigator. Moreover, the institutions receiving these awards will be encouraged to interact with one another and to provide opportunities for career development pathways involving more than one institution. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Training Programs in Diabetes Research for Pediatric Endocrinologists, is related one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at APPLICANT ELIGIBILITY REQUIREMENTS Only domestic, non-profit, private or public institutions may apply for grants to support research training programs. Foreign institutions are not eligible for this program. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. The applicant institution must have a strong research program in the area of pediatric endocrinology and diabetes. In addition, the applicant institution must have the requisite research facilities, mentors, personnel and support for the proposed program. The research training program director at the institution will be responsible for the selection and appointment of the trainees and for the overall direction, management and administration of the program. It is expected that the research training program director will be a pediatric endocrinologist with a strong record in biomedical research and mentoring. If the program director is not a pediatric diabetologist, a senior investigator with expertise in pediatric diabetes research must be included as a part of the leadership in the training program. Trainees appointed to the training program must have the opportunity to carry out supervised basic or clinical biomedical or behavioral research with the primary objective of developing or extending their research skills and knowledge in preparation for an independent research career in pediatric diabetes. The applicant institution must have access to a training environment with ongoing basic and clinical research in diabetes. To be eligible for consideration under this RFA, each applicant institution must submit a package of two separate applications [one complete application for research fellowship training (T32) and a second complete application for the training and career development of physician scientists (K12)]. The program director for each application should be the same individual and the two complete applications must be submitted with separate face pages including the appropriate signatures by the institution’s business official. Those applicant institutions that already have an established, on-going NIH-funded fellowship-training grant (T32) or its equivalent in place with a focus on training in pediatric diabetes research must indicate how they would modify the existing grant, if the new T32/K12 grants were funded. As with all features of this program, potential applicants are strongly advised to contact the NIDDK staff listed under INQUIRIES if they have any questions regarding eligibility. TRAINEE ELIGIBILITY REQUIREMENTS All trainees (T32 and K12 appointees) must be U.S. citizens, noncitizen nationals, or legal permanent residents (i.e. in possession of the Alien Registration Receipt Card, I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in possessions of the United States (e.g. American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. For purposes of this RFA only, only candidates who possess an M.D. or equivalent degree (e.g. D.O.) from an accredited domestic or foreign institution and who have completed their postgraduate clinical training in an American Board of Pediatrics-approved pediatric residency program will be eligible for appointment as trainees to the T32 training program. It is expected that T32 trainees will be enrolled in a pediatric endocrinology fellowship program. National Research Service Award (NRSA)-supported training is limited to three years without a waiver issued by the awarding unit. NRSA trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. Postdoctoral NRSA trainees must sign a payback agreement form (PHS Form 6031) in the first 12 months of support. One month of obligation is incurred for each month of support. The 13th and subsequent months of NRSA support do not incur further obligation and are considered acceptable payback service for the prior 12 months of support. Physician scientist trainees appointed to the K12 career development program must have completed their pediatric endocrinology fellowship training. We anticipate that all physician scientist trainees appointed to the K12 training program will be either board-certified or board eligible by the completion of their training. These candidates may spend up to three years in the K12 training program, but are strongly encouraged to apply for either an individual Mentored Clinical Scientist Award (K08, or an individual Mentored Patient-Oriented Research Career Development Award (K23, after 1-2 years of support through the K12 training program. The physician scientist may receive up to a total of 6 years of combined support through the K12 and K08/K23 grant mechanisms. The candidates must devote a minimum of 75 percent of full-time professional effort conducting research and research career development. Individuals ineligible for appointment to the K12 training program include current and former principal investigators on NIH research project (R01), FIRST Awards (R29), comparable career development awards (e.g. K01, K08, K23), sub-projects of program project (P01) or center grants (P50), and the equivalent. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible. Current and former recipients of Clinical Associate Physicians Award (CAP) support may apply for the K12 program provided they have had no more than 3 years of CAP support by the time of the K12 appointment. The combined total of CAP plus K12 support must not exceed 6 years. Appointment of women and minority groups underrepresented nationally in the biomedical and behavioral sciences is strongly encouraged. MECHANISM OF SUPPORT This RFA will combine two National Institutes of Health (NIH) award mechanisms, the NRSA Institutional Training Grant (T32) and the Mentored Clinical Scientist Development Program Award (K12). The provisions of the T32 mechanism are detailed in the NIH announcement for NRSA Institutional Training Grants, published in the NIH Guide for Grants and Contracts, June 1, 2000, and are available at: All provisions of the T32 award described in the announcement apply to grants made under this initiative, except as noted in this RFA. Only postdoctoral level training will be supported under this RFA. The applicant institutions may request up to three slots in the T32 training grant and up to three slots in the K12 career development program. However, no more than a total of five slots may be requested in a combined T32/K12 program. Institutional NRSA (T32) and K12 research training programs may be funded for periods up to five years and are renewable. Awards within an approved competitive segment normally are made in 12-month increments, with support for additional years based upon satisfactory progress and the continued availability of funds. Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than nine months during the initial period of appointment, except with prior approval of the NIDDK. No individual trainee may receive more than three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Any extension of the total duration of trainee support requires prior approval by NIDDK. Applicants from institutions which have a Diabetes Endocrinology Research Center (DERC), Diabetes Research and Training Center (DRTC) or General Clinical Research Center (GCRC) may wish to identify these centers as a resource for conducting the proposed research. In such a case, a letter of agreement from either the principal investigator or GCRC program director should be included with the application. If the NIDDK determines that there is a sufficient continuing program need, and if funds are available, it is expected that a new request for competing continuation and new applications will be announced in five years. The total project period for applications submitted in response to this RFA should is five years. The anticipated award date is September 30, 2002. FUNDS AVAILABLE The NIDDK intends to commit approximately $1.5 million in FY 2002 to fund three new T32 and three new K12 grants in response to this RFA. The JDRF and ADA may provide supplemental funding to support additional training or career awards. Applicants may request a project period of up to five years. Applicants may request funds to support up to 3 individuals each year under each mechanism, however, actual funding will be provided for a maximum of 5 individuals per year 3 under one mechanism and 2 under the other. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Pediatric diabetes, including type 1 diabetes, type 2 diabetes (formerly almost exclusively a disease of adults which is now being reported with increasing frequency in children), and other rarer formers of diabetes in youth, subjects children to the risk of devastating complications over time, including accelerated cardiovascular disease, kidney failure, blindness, neuropathy, and amputation. Management of diabetes in children is particularly arduous, with suboptimal glycemic control increasing the risk of long term complications and intensive therapy to optimize glucose levels associated with substantial risk of hypoglycemia. Effective therapy for pediatric diabetes requires an exceptional level of effort from the children, their families, and their health care providers. These extraordinary clinical care demands make it particularly challenging for pediatric endocrinologists involved in diabetes care to pursue research careers. Although there has been considerable recent progress in understanding the etiology and pathogenesis of pediatric diabetes and in developing improved therapies, we still cannot prevent or cure these disorders. Thus, it is imperative to enhance the diabetes research training and career development of pediatric endocrinologists to create the cadre of skilled investigators needed to build upon the foundation of current basic and clinical knowledge and to develop new approaches to the treatment, prevention and cure of pediatric diabetes. The NIDDK, JDRF, and ADA intend to provide support for programs of research training and career development in pediatric diabetes at institutions that have environments, mentors and programs that will make them particularly effective in enhancing the number of independent investigators contributing to research in pediatric diabetes. For this purpose the following attributes of applicant institutions and programs are desirable: A. Environment: The institution must have a substantial and well-established program of basic and clinical research funded through peer reviewed grants from the NIH, JDRF, ADA or other organizations. The institution must also have a highly qualified faculty with expertise in clinical and basic research relevant to pediatric diabetes to serve as sponsors/mentors. The institution must also be able to demonstrate a commitment to and track record of success in the development of the trainees as productive, independent diabetes investigators. The program director, sponsors/mentors, and institution must be able to describe an in-depth, multidisciplinary research training program that will utilize the relevant research and educational resources. B. Training Program: The awards will provide up to five consecutive 12-month awards. Both the didactic and research phases of an award period must be designed to develop the necessary knowledge and skills in research relevant to pediatric diabetes and to the career goals of the trainees. Because of the focus on progression to independence as a researcher, trainees should have a period of research training and career development consistent with his or her previous research and clinical experience. For example, a trainee with limited experience in a given field of research may find a phased developmental program lasting three to five years that includes a designated period of didactic training followed by a period of closely supervised research experience the most efficient means of attaining independence. A trainee with previous research experience and training may not require extensive additional didactic preparation and a shorter program that focuses on an intensive, supervised patient-oriented or basic research experience may be appropriate. All programs must be tailored to meet the individual needs of the trainees, ensuring that they will gain the skills and knowledge necessary to carry out high quality research. The trainee and the sponsor/mentor are jointly responsible for the preparation of the individual training plan. The sponsor/mentor and trainee may form an advisory committee to assist with the development of a program of study or to monitor the trainee"s progress through the career development program. The didactic and research components of both phases must develop new knowledge and research skills in scientific areas relevant to the career goals of the trainee. Applicants should describe how instruction in informed consent and other aspects of human subjects protection, biostatistics, clinical trial design, and methodologies related to basic research, etc. will be provided. Plans must be presented for the means by which individual trainee needs and goals will be developed and addressed. Plans for ongoing program evaluation and mechanisms to improve course content, mentoring and supervised research experiences must be included in the application. C. Mentors: Trainees appointed to the training programs must name a primary sponsor (or mentor), who together with the appointee is responsible for the planning, direction, and execution of the research training program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Trainees may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models. Plans must be presented in the application for the means by which qualified mentors will be selected to guide each trainee. D. Curriculum Development: The program director should provide details on how a curriculum centered on pediatric diabetes research will be developed. It is expected that both basic and clinical aspects of diabetes research will be incorporated. Moreover, more general themes such as human subjects protection, research ethics, clinical trial methodologies, biostatistics, genetics, cellular and molecular biology, and genomics, proteomics, bioinformatics, and other state-of-the-art laboratory technologies may be incorporated. Those institutions with an NIH K30 Clinical Research Curriculum Award are encouraged to use this program as a resource. GCRCs, DERCs, and DRTCs may also serve as resources for instruction in specific research methodologies. E. Special Program Considerations: It is anticipated that institutions receiving these awards will develop cooperative programs to enhance the training of pediatric diabetes researchers. Applicants should include proposals for how this could be accomplished, such as joint meetings at which trainees would present their results to each other and the mentors from multiple institutions or other joint activities. Applicants may wish to propose and request funds for related training activities designed to increase the future pool of investigators in pediatric diabetes and to enhance future recruitment of trainees to the institution. This could include programs such as research stipends for undergraduates or medical students wishing to spend a summer doing research relevant to pediatric diabetes, and development of special curricula or didactic programs focused on pediatric diabetes or other programs to encourage premedical or medical students to elect careers in pediatric diabetes research. ALLOWABLE COSTS NRSA Postdoctoral Stipends National Research Service Awards provide funds, in the form of stipends, to physician trainees. A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Stipend levels are adjusted from time-to-time and current stipend levels are available on the NIH website at: The current annual stipend for postdoctoral trainees 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, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field following the date of the qualifying doctoral degree. Stipend levels for fiscal years 2002 and beyond may change. Consult the NIH website above for the future announcements of stipend levels. Postdoctoral stipends for awards made with fiscal year 2001 funds are as follows: Years of Relevant Experience Annual Amount Less than 1 $28,260 Greater than or equal to 1 but less than 2 $29,832 Greater than or equal to 2 but less than 3 $35,196 Greater than or equal to 3 but less than 4 $36,996 Greater than or equal to 4 but less than 5 $38,772 Greater than or equal to 5 but less than 6 $40,560 Greater than or equal to 6 but less than 7 $42,348 Greater than or equal to 7 $44,412 No departure from the established stipend schedule may be negotiated by the institution with the trainee. For postdoctoral trainees, the stipend for each additional full year of research training support is the next level in the stipend structure and does not change in the middle of an appointment. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the following conditions described below are met. 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 NRSA training program. NRSA Stipend Supplementation The grantee institution may provide supplementation or additional support to offset the cost of living. Supplementation does not require any additional effort from the trainee. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may DHHS funds be used for supplementation. NRSA Compensation An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that constitutes the research training experience. NRSA Tax Liability Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. Under that section, 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. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between NRSA trainees and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employee-employer relationship with the NIH or the awardee institution. It is therefore, inappropriate and unallowable for institutions to charge costs associated with employment (such as FICA, workman"s compensation, or unemployment insurance) to the training grant. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. The NIH takes no position on the status of 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. NRSA Tuition, Fees and Health Insurance The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition, fees, and health insurance are allowable only if they are required for all individuals in a similar research training status at the institution regardless of the source of support. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at: NRSA Other Trainee Costs Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual"s research training, is an allowable trainee expense. Trainee travel costs of $1,000 a year per NRSA postdoctoral trainee may be requested. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and compliment those offered at the parent institution, and the relationship of the proposed experience to the trainee"s career stage and goals. This type of research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised. NRSA Training Related Expenses Institutional costs of $3,500 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. K12 Salary Support for Appointees The NIDDK will provide salary and fringe benefits for the career award (K12) appointee. At least 75 percent of the appointee"s full-time professional effort must be devoted to the research goals of this award. The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. At the present time, NIDDK has a salary limit of $75,000 per year (plus fringe benefits) for all physician scientists appointed to K12 training programs. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution"s salary scale, however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full-time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K12. K12 Research and Development Support for Appointees The amount of research and development support is currently $25,000 per year for each physician scientist appointed to the K12 training program. These funds may be used for the following expenses: (a) tuition, fees, and books related to career development, (b) research expenses, such as supplies, equipment and technical personnel, (c) travel to research meetings or training, (d) statistical and computational services including personnel and computer time. All expenses must be directly related to the proposed research career development program. K12 Other Income of Appointees: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: o The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. o The funds may be used for health-related research purposes. o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. o K12 appointees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career development award (K12) must receive prior written approval of the NIH awarding component. K12 Salary Support for Program Directors Salary for the program director will be provided for levels of effort up to 10 percent. The program director may request salary support up to 10% effort on the K12 grant application. No salary support may be requested on the T32 grant application. The actual salary provided by the award is based on the program director’s full-time, 12-month institutional salary and the level of effort requested up to the maximum legislated salary rate in effect at the time of award. For example, in fiscal year 2001, the maximum allowable annual salary is $161,200 for a full-time position. Therefore, in FY 2001, the maximum annual base salary that will be provided for an award recipient at 10 percent effort is $16,120. In all cases, the salary requested must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The award will also provide fringe benefits on the calculated base salary at the established institutional rate. Salary support is being provided to allow the K12 program director to develop and oversee a comprehensive training program in pediatric diabetes. The training program should include didactic and research opportunities in both basic and clinical sciences. The program director is expected to develop a curriculum that is tailored to the specific needs of the trainees. This curriculum should encompass a broad overview of topics related to both clinical and basic concepts related to diabetes. If the applicant institution has an NIH K30 Clinical Research Curriculum Award, the program director is encouraged to use the K30 program as a resource for the training program. The institution may supplement the NIH contribution to the salary of the program director up to a level that is consistent with the institution"s salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. In addition, recipients of this award may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100 percent. NRSA/K12 Annual Meeting of Program Directors and Trainees Applicant institutions should request additional travel funds to attend a joint NIDDK/ADA/JDRF annual meeting. Travel costs (up to $1,000 per individual), should be requested for the program director, trainees, and mentors. In addition, travel funds to attend one scientific meeting annually may be requested for each of the training grant/program appointees. Except for travel funds to attend the joint NIDDK/ADA/JDRF annual meeting, which will be restricted to this purpose, travel funds are not available for the program director, mentors or training faculty. NRSA/K12 Special Programs As described above, applicants may request funds for related research activities designed to increase the future pool of investigators in pediatric diabetes and to enhance future recruitment of trainees to the institution. This could include providing research salaries for undergraduates or medical students wishing to spend a summer conducting research within the scope of existing, funded NIH research grants relevant to pediatric diabetes. NRSA/K12 Facilities and Administrative Costs A facilities and administrative allowance (indirect cost allowance) based on eight percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Website at: NRSA PAYBACK PROVISIONS As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign the payback agreement form (PHS form 6031) before initiating an appointment. Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support. o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payback agreement form and will not incur a service payback obligation for this period of support. o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. For example, postdoctoral trainees who continue under that award for two years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year. Service payback obligations can also be paid back by conducting health-related research or teaching averaging more than 20 hours per week of a full work year after terminating NRSA support. o Recipients with service obligations must begin to provide acceptable payback service on a continuous basis within two years of termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the NIH, specifying the need for additional time and the length of the required extension. o Recipients of NRSA support are responsible for informing the NIH of changes in status or address. o For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. o Under certain conditions, the Secretary, U.S. Department of Health and Human Services (or those delegated this authority) may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. o Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program. The relationship of the positions available and the training provided must also be discussed along with the applicability of these positions to any outstanding service payback obligation. NRSA Trainee Reporting Requirements The institution must submit a completed Statement of Appointment (PHS Form 2271) for each NRSA trainee appointed or reappointed to the training grant at the beginning of the appointment period. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in his or her first twelve months of postdoctoral support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. LEAVE NRSA Trainees In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the grantee 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. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). Trainees within the first 12 months of postdoctoral support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence. K12 Appointees Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIDDK is required. To obtain prior approval, the award recipient must submit a letter to the NIDDK describing the plan, countersigned by the training program director, the primary research mentor and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIDDK and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Under unusual and pressing circumstances, a K12 appointee may submit a written request to the awarding component, requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case, will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the appointee. Further, the appointee must submit assurance of his or her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines are available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit, by February 26, 2002, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. It contains additional special instructions for preparing Institutional National Research Service Award (T32) applications. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: Application Instructions Applicants must observe the 25-page limit on the narrative section. Applicants may request up to five years of support through the T32/K12 mechanisms. The applicant should justify the number of full-time postdoctoral training positions requested (e.g. 2-3 NRSA postdoctoral fellows, 2-3 K12 appointees, 5 trainees maximum per combined program). Tuition, fees, health insurance, and trainee travel, and other expenses are to be included in "training related expenses." The program director for each of the two applications (i.e. T32 and K12) should be the same individual and the two full applications must be submitted with separate face pages including the appropriate signatures from the institution’s business official. No applicant institution may submit only a T32 application in response to this RFA. Submission Instructions The RFA label available in the PHS 398 (rev. 05/01) application form must be stapled to the bottom of the face page of the application and must display the RFA number DK-02-024. A sample RFA label is available at Please note this is in the pdf format. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Applications must be received by March 26, 2002. If an application is received after this date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness to this RFA by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria T32 Applications: o Past research training record of both the program and the designated preceptors as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers. Evidence of further career development can include receipt of individual fellowships, career awards, further training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. o Objectives, design, and direction of the research training program(s). o Caliber of preceptors as researchers with expertise in both basic and clinical research related to pediatric diabetes, including successful competition for research support. o The institutional training environment, including the level of institutional commitment, quality of the facilities, availability of appropriate courses, and availability of research support, including access to and training in new molecular biology technology. o Recruitment and selection plans for clinical trainees and the availability of high quality candidates with the potential to develop as independent investigators. o Record of the research training program in retaining health-professional postdoctoral trainees for at least two years in research training or other research activities. o When appropriate, the concomitant research training of health-professional postdoctorates (i.e., individuals with the M.D., D.O., D.D.S., etc.) with basic science postdoctorates (i.e., individuals with a Ph.D., etc.) or linkages with basic science departments. Established investigators from basic science departments may be included as mentors to provide expertise and resources provided that the emphasis remains on research that is relevant to pediatric diabetes and consistent with the goals of the program. Applications should describe the basic science department"s contribution to the research training experience. o Institutional commitment to the objectives, design, and direction of a research training program responsive to this RFA. o For renewal (competing continuation) applications, or subsequent new applications from an institution with a previously funded training grant, success of the trainees in producing research publications and in obtaining independent, competitively funded support for pediatric research. K12 Applications: o The experience and success of the Program Director in managing career development programs. o The plans for selection, recruitment and retention of clinical candidates with the potential to develop as independent investigators, and the likelihood that the career development plan will contribute substantially to the scientific development and independence of the prospective candidates. Efforts to develop novel mechanisms for recruiting candidates for new project development awards from women and minority groups under-represented in pediatric diabetes research. o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates. o Usefulness of the research plans as a vehicle for developing the research skills as described in the career development plan, as well as the scientific and technical merit of the research questions, design and methodology. o Appropriateness of the faculty mentor"s research qualifications in the area(s) of pediatric diabetes research, and the previous experience of the faculty mentors in fostering the development of researchers. o Quality of the environment for scientific and professional development, and the applicant institution"s commitment to the appropriate balance of research and clinical responsibilities. o Quality of the proposed training in the responsible conduct of research. o For renewal (competing continuation) applications, or subsequent new applications from an institution with a previously funded career development program, success of the junior investigators in producing research publications and in obtaining independent, competitively funded support for pediatric diabetes research. Additional Review Criteria for all Applications: Recruitment Plan for Underrepresented Minorities: After the overall educational and scientific merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan. The findings of the panel will be included in an administrative note in the summary statement. If the minority recruitment plan or if the record of recruitment and retention of minorities is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NIDDK, with guidance from the National Diabetes and Digestive and Kidney Diseases Advisory Council, will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: The applicant’s plans for providing experience in the responsible conduct of research will be assessed on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of scientific, educational and administrative merit, so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be considered for funding until the applicant provides a revised, acceptable plan. NIDDK staff will judge the acceptability of the revised plan. Following initial review, applications are reviewed by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The council will consider, in addition to the assessment of the scientific and educational merit of the research training grant application, the scientific review group"s comments on the recruitment of individuals from under-represented minority groups into the research training program and the plan for instruction in the responsible conduct of research. SCHEDULE Letter of Intent Receipt Date: February 26, 2002 Application Receipt Date: March 26, 2002 Peer Review Date: June/July 2002 Council Review: September, 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Responsiveness to the purpose of this announcement, o Quality of the proposed training program(s), as determined by peer review, o Availability of funds, o Programmatic priorities, o Geographic distribution. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Consultation with NIDDK staff is strongly encouraged, especially during the planning phase of the application process. Direct inquiries regarding programmatic issues to: James F. Hyde, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 603 MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-7692 FAX: (301) 480-3503 E-mail: Direct inquiries regarding fiscal matters to: Donald Ellis Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 709B MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8849 FAX: (301) 594-9523 E-mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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