PA-01-120: NIDDK SHORT-TERM TRAINING FOR MEDICAL STUDENTS (T35)

Department of Health
and Human Services (HHS)

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This Program Announcement expires on February 1, 2004. NIDDK SHORT-TERM TRAINING FOR MEDICAL STUDENTS (T35) Release Date: July 26, 2001 PA NUMBER: PA-01-120 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) Application Receipt Date: January 10, 2002 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for its ongoing Short-Term Training for Medical Students program. This trans-NIDDK program provides short-term research support for medical students, and students in other health professional schools, to expose them to career opportunities in research related to diabetes, obesity, endocrine disorders, metabolic diseases, nutritional disorders, digestive diseases, liver disease, kidney diseases, urologic diseases, and hematologic disorders. These Institutional National Research Service Award (NRSA) grants (T35) provide training experiences of eight to twelve consecutive weeks under the supervision of experienced researchers and exposes students to the possibility of pursuing a biomedical or behavioral research career. In addition to the research experience, institutions are encouraged to provide seminars, research forums, guest lecturers, student presentations, special courses, or travel to a scientific meeting of interest to the student. 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 Program Announcement (PA), NIDDK Short-term Training for Medical Students, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. 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 the available research facilities, personnel, and support for the program in the areas of diabetes, endocrinology, metabolic disorders, digestive diseases, nutrition, obesity, kidney, urology, or hematologic diseases. These grants will support short-term research training experiences of consecutive two to three months duration, generally between the first and second years of medical school. Trainees must have successfully completed at least one semester at a school of medicine, optometry, osteopathy, dentistry, veterinary medicine, pharmacy, or public health prior to participating in the program. Institutions must adhere strictly to these requirements when selecting trainees. These grants are intended to introduce students to research that would not otherwise be available through their regular course of studies. The research period must not be a requirement for the degree being earned nor may the research period be used for credit towards the degree being earned. Trainees must be U.S. citizens, noncitizen nationals, or legal permanent residents (i.e., in possession of the Alien Registration Receipt Card, I-155, or other legal verification of such status). Noncitizen nationals are generally persons born in possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas and individuals holding Ph.D., M.D., D.V.M., or equivalent doctoral degrees in the health sciences are not eligible. Trainees appointed to the program need not be from the applicant institution, but may be students from other institutions as long as they fulfill the eligibility requirements listed above. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) National Research Service Award (NRSA) Short-Term Training grant (T35) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. DURATION OF PROGRAM ANNOUNCEMENT This PA will remain active for three years, until February, 2004, at which time applications may no longer be submitted in response to this announcement. The NIDDK only accepts T35 applications once a year, for the January 10 receipt date. RESEARCH OBJECTIVES The NIDDK Short-Term Research Training program is intended to: o expose medical students, early in their training, to the excitement and challenges of a research career, o encourage medical students to seriously consider pursuing either a basic, behavioral, or clinical research career in the areas of research that are important to the NIDDK, o provide valuable experience and references for students who hope to obtain further research training and funding in the future, and o increase the pool of physician scientists engaged in biomedical or behavioral research in those areas necessary to continue the mission of the NIDDK. SPECIAL REQUIREMENTS Provisions of the Award Institutions may request support for at least 6, but not more than 35 trainees per budget period, based on a full-time, three month appointment. A trainee must be appointed for a minimum of two months and a maximum of three months during a budget period. Institutions are encouraged to appoint a trainee for more than one budget period, if scheduling allows, i.e. for two or more consecutive summers. A student may be appointed, in special circumstances, to more than one 3-month period during a budget period, provided prior approval is obtained from the staff of the NIDDK. All research training must be full-time during the specific training period. It is expected that most programs will provide a summer research training program, but other innovative program designs and time schedules will be considered. The requested number of short-term trainees must be justified in the application based on the number of students enrolled in the medical or health professional school, the magnitude and focus of the research supported at the applicant institution, particularly its relevance to the areas of research supported by the NIDDK, the interest of the investigators to serve as training faculty, and role models, and the level of interest of the students. Students should be able to pursue basic, behavioral, and/or clinical research projects in the broad areas of diabetes, obesity, endocrinology, metabolic diseases, digestive and hepatobiliary diseases, nutrition, and kidney, urologic, and hematologic disorders. Funds may be requested for: o Stipends The current stipend level for trainees is $1375 per month. The stipend level actually awarded will be that in effect for predoctoral trainees at the time the award is issued. Stipends may be supplemented from non-Federal funds. o Training-related Expenses up to $167 per month per trainee may be requested yearly. This may be used for faculty, laboratory, and secretarial assistance, supplies and equipment, consultant costs, and tuition and fees. o Travel Expenses The institution may request up to $1,000 per year per trainee to cover the cost of travel to a relevant scientific meeting. The meeting should typically be one held in the same budget period as that in which the training occurs. A Statement of Appointment form (PHS 2271, rev. 4/98) must be submitted at the start of each trainee appointment and reappointment. This form is available at the following URL address: http://grants.nih.gov/training/phs2271.pdf. Trainees supported under this program are not required to sign an NRSA Payback Agreement or submit an NRSA Termination Notice. Every NRSA trainee supported by an institutional training grant must receive instruction in the Responsible Conduct of Research. (For more information on this provision, see the current announcement for NRSA Intuitional Research training grants [T32] published in the NIH Guide for Grants and Contracts [PA-00-103, Release Date: June 1, 2000] or at the following URL address: http://grants.nih.gov/grants/guide/pa-files/PA-00-103.html. 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 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: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this PA 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. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines for this mechanism as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Submit the signed, original, single-sided application, including the Checklist, along with five signed photocopies and, if necessary, five collated sets of appendix materials 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) The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 Applications will be assigned on the basis of established Public Health Service referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures will evaluate applications for scientific and technical merit. 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 applications under review, will be discussed, assigned a priority score, and receive a second-level review by the appropriate national advisory council or board. Review Criteria The following criteria will be considered when evaluating the applications: o the objectives and design of the research training program, o the qualifications of the program director and the participating preceptors as basic and clinical researchers, including publications and successful competition for research support, o past training record of both the program director and the designated preceptors, o the institutional training environment, including the institutional commitment to training students in basic and clinical research, quality of the facilities, availability of appropriate courses and seminars, and the availability of research support, o the proposed plans for advertisement, selection, and assignment of trainees to preceptors, o the availability of high quality trainees, and o the institution’s plan for measuring the effectiveness of the training program, including the productivity of the trainees (e.g. publications, abstracts, presentations), the impact of the program on the institution, and the impact of the program on the career choices, opportunities, and further research activities of the trainees. Additional Review Considerations The review groups will also comment on each application’s plan for attracting individuals from underrepresented minority groups into the research training program and for training in the responsible conduct of research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the National Institute of Diabetes and Digestive and Kidney Diseases. The following will be considered in making funding decisions: o Quality of the proposed training program as determined by peer review, o Availability of funds, o Program priority, i.e. how focused on NIDDK research areas is the proposed training, o Geographic distribution. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Judith Podskalny, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 667 MSC 5450 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 FAX: (301) 480-8300 E-mail: jp53s@nih.gov Direct inquiries regarding fiscal matters to: Donald Ellis Division of Extramural Activities Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 709A MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8849 FAX: (301) 480-3504 E-mail: de30Z@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.848, and 93.849. 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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