NIDDK SHORT-TERM EDUCATION PROGRAM FOR MINORITY STUDENTS (R25) RELEASE DATE: March 19, 2003 RFA: DK-03-014 (This RFA has been modified, see RFA-DK-06-008) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847 (DEM), 93.848 (DDN), and 93.849 (KUH) NIDDK LETTER OF INTENT RECEIPT DATE: April 16, 2003 APPLICATION RECEIPT DATE: May 14, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Eligible Program Directors o Trainee Eligibility Requirements o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Short-Term Education Program for Minority Students is designed to provide short-term research education for underrepresented minority high school and/or undergraduate students to expose them to research in the areas of diabetes, endocrinology, metabolism, nutrition, obesity, and digestive, liver, urologic, kidney, and hematologic diseases. By providing an early research experience it is hoped that many of these students will pursue a career in biomedical research. Underrepresented minority and ethnic groups include Blacks, Hispanics/Latinos, American Indians, Alaska Natives, and Pacific Islanders, and other racial and ethnic groups determined by the institution to be underrepresented in the health-related sciences. The grant provides support for two to three consecutive months of research training in the laboratories of experienced investigators as well as the opportunity to participate in research forums, guest lectures, student presentations, special courses, and social activities. The awards are intended for any institution that has access to highly motivated minority high school and/or undergraduate students. The institution may design a program specifically for high school students, undergraduate students, or both. RESEARCH OBJECTIVES There is a need for programs designed to increase the number of minority students in the pipeline for biomedical research careers. The scientific community is interested in attracting qualified minority students into research careers, but few minority students opt for science degrees and research careers, and fewer minority graduates of health professional schools pursue research careers. The shortage of qualified minority investigators in academic research positions exacerbates the situation since this means there are few visible role models for students. One way to address this problem is to expose minority students to research opportunities early in their education and to provide them with research training opportunities to develop both their research capabilities and their interest in pursuing a career in research. The NIDDK Short-Term Education Program for Minority Students is intended to offer research-education opportunities for minority students in an effort to encourage them to pursue a research career in an area of science relevant to the interests of the NIDDK. NIDDK supports research in the areas of diabetes, endocrinology, metabolism, nutrition, obesity, and digestive, liver, urologic, kidney, and hematologic diseases and recognizes the need for a diverse workforce, representative of the population, to pursue this research. MECHANISM OF SUPPORT This RFA will use the Educational Research Project Grant (R25) award mechanism. Responsibility for the planning, direction, and execution of the proposed education project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and availability of funds. The anticipated award date is September 30, 2003. This RFA uses just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIDDK intends to commit $200,000 in FY 2003 to fund 3-5 grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $40,000 per year. Although the financial plans of the NIDDK provides 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. It is not known, at this time, if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign Only one application per health professional school may be submitted in response to this solicitation. Although an institution may have more than one NIDDK Short-Term Education Program for Minority Students, they may not be in the same school. The applicant institution must have the available research facilities, personnel, and support for the program in the areas of diabetes, endocrinology, metabolism, nutrition, obesity, and digestive, liver, urologic, kidney, and hematologic diseases. Minority institutions with adequate staff and resources in these areas are encouraged to apply. These grants will support short-term research education experiences for a duration of two to three consecutive months for minority high school and/or undergraduate students. The grantee institution will determine which racial and ethnic groups are underrepresented in biomedical or behavioral research and will be responsible for the selection and appointment of trainees. ELIGIBLE PROGRAM DIRECTORS Any individual with the skills, knowledge, and resources necessary to initiate and carry out the proposed education program is invited to work with their colleagues and their institution to develop an application for support. Individuals from racial/ethnic minority groups, women, and persons with disabilities are encouraged to apply as Principal Investigators. TRAINEE ELIGIBILITY REQUIREMENTS High school students (who will have completed the 10th grade) and undergraduate students who will have completed at least one year at an accredited school or university (including baccalaureate schools of nursing) at the time their research experience would begin, and who are in good academic standing at their school, are eligible to participate 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 to them through their regular course of studies. Trainees appointed to this program must be U.S. citizens, non-citizen nationals, or legal permanent residents (i.e., in possession of the Alien Registration Receipt Card or other legal verification of such status). Non- citizen 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 may be from the applicant institution or from other institutions, schools, colleges, or universities where such training experiences are not available. The only requirement for student selection is that the trainees fulfill the eligibility requirements stated above. SPECIAL REQUIREMENTS Provisions of the Award Institutions may request support for at least 3, but not more than 10 trainees, per budget period, based on a full-time three-month appointment. A trainee must be appointed for a minimum of 8 weeks, and up to a maximum of twelve weeks during a single budget period. Institutions are encouraged to appoint a trainee for more than one budget period, i.e., two or more successive summer research experiences. 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 sequence. It is expected that most programs will be designed to provide a summer research experience, but other innovative program designs and time schedules will be considered. The requested number of short-term trainees must be justified in the application. Funds may be requested for: o Stipends - The grantee institution must set the stipend level of the students appointed to the program and must justify the stipend level in the budget section of the application. o Education-related Expenses - Up to $183 per month per trainee may be requested yearly; and 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 $1000 per year per trainee to cover the cost of travel to support an educational experience away from the grantee institution or to a scientific meeting. In cases of extreme hardship, a one-way travel allowance will be provided for travel between the trainee's residence and the education institution. Travel requests will be subject to the Initial Review Group (IRG) and NIDDK review. Applicants may share travel costs among trainees so that the $1000 allotted for a local trainee may be reprogrammed to trainees needing higher cost reimbursement. Training in the Responsible Conduct of Research: The application must include a description of plans to provide instruction in the responsible conduct of research (RCR). The Public Health Service policy on RCR (http://ori.hhs.gov/policies/RCR_Policy.shtml#rcr) describes nine core instructional areas that comprise RCR: data acquisition, management, sharing, and ownership; mentor/trainee responsibilities; publication practices and responsible authorship; peer review; collaborative science; human subjects; research involving animals; research misconduct; and conflict of interest and commitment. Plans for RCR training must describe the proposed subject matter, format, frequency and duration of instruction. No award will be made if an application lacks this component. See the NIH website http://www.nih.gov/sigs/bioethics for resources and information on this topic. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: Lawrence Agodoa, M.D. Director, Office of Minority Health Research Coordination National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd, Room 653 Bethesda, MD 20892-5454 Telephone: (301) 594-1932 FAX: (301) 594-9358 E-mail: la21j@nih.gov o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 FAX: (301) 480-3505 E-mail: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Mr. George Tucker Deputy Chief Grants Management Officer National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 718 Bethesda, MD 20892 Telephone: (301) 594-8853 FAX: (301) 480-3504 Email: Tuckerg@extra.niddk.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o a descriptive title of the proposed program o the name, address, and telephone number of the Principal Investigator o the names of other key personnel o participating institutions o number and title of this RFA. 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 by April 16, 2003 to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 Bethesda, MD 20892-5452 (Courier use Zip 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 E-mail: fc15y@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. In addition, the RFA title (NIDDK Short-term Education Program for Minority Students) and the number RFA-DK-03-014 must be typed on line 2 of the face page of the application form, and the Yes box marked. 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 RFA label is also available at https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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, 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 and all appendices must be sent to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 Bethesda, MD 20892-5452 (Courier use Zip 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 E-mail: fc15y@nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness 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 Review Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o receive a written critique o undergo a process in which all applications will be discussed and assigned a priority score, o receive a second level review by the National Diabetes, and Digestive and Kidney Diseases Advisory Council. Review Considerations The application should provide a summary of the training program including its objectives, the types of research activities available, the faculty who will participate, the schools, universities, and/or geographic area to be included in recruitment efforts, a mentoring plan, and any special activities or experiences to be provided to the trainees. It should also describe the administrative structure of the program and the distribution of responsibilities within it, plans for recruiting, selecting, and assigning trainees to research activities, duration of training and months in which it will occur, description of a typical student program including percent time to be spent in various activities, and additional support or services to be provided by the applicant institution. All applications must include a description of formal or informal activities or instruction related to the responsible conduct of research that will be incorporated into the proposed research education program. REVIEW CRITERIA The following criteria will be considered when assessing the merits of the proposed NIDDK Short-Term Education Program for Minority Students. o Design of the proposed education program; o Qualifications, dedication, and previous training record of the program director and participating faculty, particularly with regard to prior experience with high school and undergraduate students; o Adequacy of facilities, environment, and resources for the proposed research training; o Recruitment and selection plans for trainees, and the availability of high quality candidates; o Methods for retaining promising students in the program and methods for tracking students; o Commitment of the institution and participating faculty to the goals of the education program; and o Procedures for evaluation of the effectiveness of the program and the impact of the program on the students involved. Training in the Responsible Conduct of Research: o Quality of the proposed training in responsible conduct of research ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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). 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. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: April 16, 2003 Application Receipt Date: May 14, 2003 Peer Review Date: July/August 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific and training merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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 (https://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 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. 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 RFA 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. 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) 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 https://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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