NIDDK MEDICAL STUDENT RESEARCH SCHOLARS (MSRS) PROGRAM Release Date: July 25, 2001 RFA: RFA-DK-02-003 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) Letter of Intent Receipt Date: November 20, 2001 Application Receipt Date: December 11, 2001 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases Medical Student Research Scholars Program invites applications for a National Research Service Award (NRSA) Program developed to address the shortage of minority investigators trained in biomedical research. This NIDDK program provides the opportunity for members of underrepresented minority groups who have completed at least two years of medical school and are currently enrolled, to gain research experience by contributing to or completing a research project in conjunction with one of the NIDDK-sponsored research centers. The NIDDK Medical Student Scholars Program supports research training in diabetes, endocrinology and metabolic diseases, kidney and urologic diseases, liver and digestive diseases, hematologic diseases, and nutrition and obesity research in order to increase the trainees awareness of disease research and to encourage them to enter research careers in areas especially identified with racial and ethnic health disparities. This RFA solicits applications for T32 grants from institutions that have NIDDK-funded centers to increase the number of research training opportunities available to minority medical students. The Medical Students Research Scholars Program is designed to maximize the effectiveness of the research experience for the medical student by requiring students to pursue a research project at an institution where NIDDK supports one or more centers. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NIDDK Medical Student Research Scholars Program, addresses one or more of the HP2010 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 any domestic institution at which the NIDDK supports one or more P30, P50, or P60 Centers. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Program Directors and/or to be included as training faculty. Because T32 applications in response to this RFA have special eligibility requirements, application formats, and review criteria, it is critical that prospective applicants consult with the program staff listed under INQUIRIES. Prospective applicants should also consult the National Research Service Awards Guidelines (http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm) and the omnibus NIH National Research Service Award Institutional Research Training Grants Program announcement (http://grants.nih.gov/grants/guide/pa-files/PA-00-103.html). Institutional Eligibility Requirements Applicant institutions must currently have at least one NIDDK-funded research Center. A complete list of NIDDK Centers is available at http://www.niddk.nih.gov/fund/other/centers.htm The Program Director of the T32 at the applicant institution will be responsible for the recruitment, selection and appointment of medical students, as well as coordination of the program with the DK-Centers and their members. The latter will serve as training faculty in most cases. It is expected that the core facilities supported by NIDDK-funded Centers at the applicant institution will be made available to the students supported by the MSRS program. Trainee Eligibility Requirements Individuals selected to participate in the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid alien registration receipt card I-551) at the time of appointment. Individuals on temporary or student visas are not eligible. For the purposes of this RFA, underrepresented minorities are defined as individuals belonging to a particular ethnic or racial group that has been determined by the applicant institution to be underrepresented in behavioral or biomedical research. The NIDDK particularly encourages institutions to identify and encourage individuals from racial and ethnic groups that have been shown to be underrepresented in health-related research nationally. These groups include African Americans, Latinos/Hispanics, American Indians, Alaskan Natives, Native Hawaiians, and Pacific Islanders. Trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. A minimum of 9 months of stipend at the current NRSA predoctoral level will be provided for each trainee. Students must postpone their medical school studies while appointed to the program. In most cases, trainees will be enrolled at the applicant institution. Other arrangements and recruitment strategies are encouraged, however. For example, if a student, whose primary residence is in the city where an MSRS program exists, is enrolled in medical school at another location, but wishes to pursue training at the MSRS program site, he/she should be able to do so without incurring additional moving and living expenses not covered by the T32. These students must meet all the other criteria for support, including permission of their medical school Dean. CENTERS The NIDDK supports P30, P50, and P60 Centers at 28 locations. To ensure that the medical students supported by the MSRS program are exposed to the highest quality research using the most up-to-date equipment and cutting edge technologies, the NIDDK wishes to encourage the use of already funded, ongoing core facilities at the applicant institution. The training faculty recruited for the program should have access to these core facilities and most often will be members of one or more NIDDK-funded Centers. In addition, the trainees should be exposed to all of the enrichment activities organized and funded by the Center(s). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Institutional National Research Service Award (NRSA) grant (T32) mechanism. Responsibility for the planning, direction, and execution of the proposed training program will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. This is a one-time solicitation. NIDDK may re-issue the RFA in the future if the response is great and the program is well received by minority medical students. FUNDS AVAILABLE The NIDDK will commit approximately $270,000 in FY 2002 to fund 3 to 5 new training grants in response to this RFA. Applicants may request up to 3 predoctoral slots per year for each of 5 years. Funds will be provided on an annual basis, contingent upon success as described in the annual progress report in the continuation application, the timely submission of required forms, and the availability of funds. 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 meritorious applications. RESEARCH TRAINING OBJECTIVES Background Available data indicate that there is a serious shortage of racial and ethnic minority physicians. There is an even greater shortage of health researchers from these groups. These physicians from racial/ethnic minority communities provide an invaluable service to patients who are minorities, poor, and are Medicaid beneficiaries. It is essential that there be adequate numbers of physician researchers trained to focus on problems related to health disparities and bring incisive research to these areas. The NIDDK supports research in many areas with racial and ethnic health disparities, including diabetes, endocrinology and metabolic diseases, kidney and urologic diseases, liver and digestive diseases, hematologic diseases, and nutrition and obesity research. The Medical Students Research Scholars Program (MSRSP) is intended to provide research training for a cadre of minority investigators with appropriate expertise in these important areas of health disparities. This program is designed to attract students in the early stages of their medical careers, provide research training and mentoring with outstanding investigators actively engaged in biomedical research, and encourage the students to continue in a research career path once their medical school and clinical training has been completed. It is critical for this program to be successful that the members of the training faculty, the administration of the medical school, and the training program director work together to identify, recruit, and encourage those minority medical students demonstrating an interest in a research career to participate in the program. This will include outreach efforts, with the assistance of the staff of the recently created Office of Minority Health Research Coordination (OMHRC), NIDDK, to interested students at minority serving institutions where currently there are no NIDDK-funded Centers. SPECIAL REQUIREMENTS The Program Director of the MSRS program ideally will be a member of one of the NIDDK-funded Centers at the applicant institution. He/she should have a strong commitment to the mentoring and career development of minority researchers and be in a position to coordinate and facilitate the use of core facilities by the trainees. The training faculty, who also will most likely be Center members, must provide a nurturing, supportive environment for the trainees and make available their expertise, time, and laboratory facilities. Non-center members who will be given access to Center core facilities, if otherwise qualified to serve as training faculty, may also be appropriate training faculty. Students should be encouraged to pursue a research project not only in an area of research in which they are interested, but also with a mentor with whom they are comfortable. Therefore, plans for recruitment of students, assignment to a mentor, and developing a research project must be well described in the application. In addition, clear support from both the Dean of the medical school at the applicant institution and from the Directors of the participating NIDDK-funded Centers must be evident. Each medical student appointed to the program must be in good standing in the medical school and have written permission from the Dean to take a one year leave of absence from their medical school curriculum for the purposes of pursing this research training. Both the student and the Dean must also provide confirmation that the student will continue with his/her medical school studies following the training period. Because this program is intended to recruit only minority students, the numbers of enrolled medical students eligible for the program at the applicant institution must be provided, as well as any plans for recruiting students from neighboring medical schools, from minority serving medical schools, or nationally. Provisions of the Award Stipends. Each trainee must be appointed to the T32 for a minimum of 9 months and will receive the predoctoral stipend in effect at the time the award is issued, prorated to the months of appointment. No departure from the established stipend may be negotiated with the trainee, but supplementation by the grantee institution is allowable. Payback. Predoctoral trainees incur no payback obligation and therefore do not need to fill out or submit a payback agreement. Trainee Related Expenses: Institutional costs of $2,000 a year per predoctoral trainee may be requested to defray the costs of research training related expenses such as staff salaries, consultant costs, use of Core services, and research supplies. Travel. If appropriate, and well justified, travel expenses up to $1,000 per trainee may be requested for participation in an appropriate scientific meeting. Travel must be completed within one year following the end date of the trainee appointment. Facilities and Administrative Costs. A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs may be requested. Reporting Requirements The institution must submit a completed Statement of Appointment (PHS 2271) form for each trainee appointed to the program at the beginning of the training period. 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. 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 also may 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 RFA (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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the name, address, and telephone number of the Program Director (i.e., the Principal Investigator of the grant), the participating DK-funded Centers at the applicant institution, and the number and title of this RFA: DK-02-003, NIDDK Medical Student Research Scholars Program. 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 or emailed to Dr. Francisco O. Calvo, Chief, Review Branch at the address listed under APPLICATION PROCEDURES by November 20, 2001. 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. Refer to the section of the PHS 398 entitled Institutional National Research Service Award for this particular application submission. 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. The RFA label available in the PHS 398 (rev. 5/01) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 (2) additional copies of the application must be sent to: Dr. Francisco O. Calvo Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 MSC 5452 Bethesda, MD 20892-5452 Telephone (301) 594 8885 FAX: (301) 480-3505 Email: fc15y@nih.gov Applications must be received by December 11, 2001. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and 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 NIDDK National Advisory Council. Review Criteria The following criteria will be considered in evaluating applications received in response to this RFA: o Design of the proposed training program, including the use of DK-funded Centers and their members, staff, facilities, and enrichment activities, and an indication of the type of projects in which a student could be engaged for a one-year period, o Qualifications and previous training record of the Program Director and all participating training faculty, including participation in other ongoing training programs, o Adequacy of facilities, environment, resources, and institutional commitment for the training program, o Identification of the pool of potential trainees and the adequacy of the plans for recruitment, selection, and mentoring of the trainees, o Appropriateness of the methods for monitoring trainee progress, reporting on trainee activities, and tracking trainees once they return to their medical school studies, o Development of appropriate assessment tools to evaluate success of the program in recruiting trainees, selecting the appropriate trainees, matching trainees with a mentor(s) and appropriate project, and in positively influencing their future career choices. Training in the Responsible Conduct of Research Every predoctoral and postdoctoral trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. It is anticipated that all the applicant institutions already have such a program in place that could be adapted for this purpose or in which the MSRS trainees could participate. Schedule Letter of Intent Receipt Date: November 20, 2001 Application Receipt Date: December 11, 2001 Peer Review Date: Feb/Mar 2002 Council Review: May 2002 Earliest Anticipated Start Date: May 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o the merit of the training program as determined by peer review, o availability of funds, o programmatic priorities and balance, o geographic distribution. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Lawrence Y. Agodoa Director, OMHRC National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 653 MSC 5454 Bethesda, MD 20892-5454 Telephone: (301) 594-9652 FAX: 301 594 9652 Email: la21j@nih.gov Direct inquiries regarding review issues to: Dr. Francisco O. Calvo Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 MSC 5452 Bethesda, MD 20892-5452 Telephone (301) 594 8885 FAX: (301) 480-3505 Email: fc15y@nih.gov Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Chief, Grants Management Officer Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 731 MSC 5456 Two Democracy Plaza MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8854 FAX: 301 480-3504 Email: dm44x@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 made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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 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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