NIDDK SHORT-TERM TRAINING FOR MEDICAL STUDENTS (T35) RELEASE DATE: April 7, 2004 PA NUMBER: PAR-04-090 EXPIRATION DATE: February 1, 2007, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.848, 93.849 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites new and competing continuation applications for its ongoing Short- Term Training for Medical Students program. This trans-NIDDK program provides short-term research support for medical students, or students in 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 support for training experiences of eight to twelve consecutive weeks under the supervision of experienced researchers. This exposure to an active research environment may encourage students to pursue 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. RESEARCH OBJECTIVES The NIDDK Short-Term Research Training program is intended to o expose medical, or other health professional, students, early in their training, to the excitement and challenges of a research career; o encourage 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. 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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed training program. The total project period for an application submitted in response to this PA may not exceed five years. ELIGIBLE INSTITUTIONS Only domestic, non-profit, private or public institutions may apply for grants to support research training programs. The applicant institution must have a strong research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to organize and implement a high quality research training program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, disadvantaged backgrounds, or individuals with disabilities are always encouraged to apply for NIH programs. The research training program director at the institution will be responsible for the selection and appointment of students to the training grant and for the overall direction, management, and administration of the program. SPECIAL REQUIREMENTS 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 citizens or non-citizen nationals of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Judith Podskalny, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 667 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 FAX: (301) 480-8300 E-mail: jp53s@nih.gov o Direct your questions about peer review issues to: Francisco Calvo, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 FAX: (301) 480-8300 E-mail: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Denise Payne National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 733 Bethesda, MD 20892-5456 Telephone: (301) 594-8845 FAX: (301) 480-3504 E-mail: dp43b@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. SUPPLEMENTARY INSTRUCTIONS 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 specified 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 FY04 stipend level for trainees is $1731 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, however, under no circumstances may the conditions of the supplementation interfere with, detract from or prolong the participant’s NRSA supported training program. o Training-related Expenses up to $183 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; however, they must 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- 02-109; Release Date: Nay 16, 2002] or at the following URL address: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines for Institutional National Research Service Awards January 10, May 10, and September 10. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: 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 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The 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 a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which all submitted applications will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. 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. The review group 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. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research training. 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; and o Geographic distribution. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 93.847, 93.848, and 93.849 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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