NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (T32) RELEASE DATE: March 6, 2002 RFA: HL-02-024 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) LETTER OF INTENT RECEIPT DATE: May 20, 2002 APPLICATION RECEIPT DATE: June 19, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o 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 NHLBI Minority Institutional Research Training Program is a National Research Service Award Program intended to support training of graduate and health professional students and individuals in postdoctoral training at minority schools having the potential to develop meritorious training programs in cardiovascular, pulmonary, hematologic, and sleep disorders. Graduate and health professional students and individuals in postdoctoral training in minority schools need further opportunities to develop biomedical and behavioral research skills. The NHLBI Minority Institutional Research Training Program is designed to attract students in their developmental stages, to increase their awareness of cardiovascular, pulmonary, hematologic, and sleep disorders research, and to encourage them to pursue research career opportunities in these areas. RESEARCH OBJECTIVES Although the number of underrepresented minority individuals (Blacks, Hispanics, Native Americans) pursuing advanced degrees in the biomedical and behavioral sciences increased over the past 20 years, their representation in these fields remains below their representation in the U.S. population (National Research Council, Survey of Earned Doctorates, 2000). There are existing programs at the NIH that are designed to increase the number of minorities in biomedical and behavioral research. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and the Research Supplements for Underrepresented Minorities Program. Even though these programs appear successful in meeting their specific objectives and career development goals, more needs to be done to attract minorities to biomedical and behavioral research careers. The NHLBI Minority Institutional Research Training Program makes research training grant awards in cardiovascular, pulmonary, hematologic, and sleep disorders research to minority schools to enable qualified graduate and health professional students and individuals in postdoctoral training to participate in research programs. It is expected to attract students in their developmental stages, increase their awareness of these diseases, and to encourage them to pursue career opportunities in research related to the mission of the National Heart, Lung, and Blood Institute (NHLBI). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Institutional National Research Service Award (NSRA) mechanism (T32). 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 five years. Funds will be provided on an annual basis to develop and maintain a stable research training experience for qualified students. Successful applicants may compete for a second or subsequent awards of up to five years" duration upon completion of the initial grant period. 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 April 1, 2003. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is expected to be $250,000 in Fiscal Year 2003 (October 1, 2002-September 30, 2003). The actual amount may vary, depending on the response to the RFA and availability of funds. Two new awards are anticipated. Facilities and Administrative Costs will be awarded based on 8% of total direct costs exclusive of tuition, and fees. ELIGIBILITY REQUIREMENTS A. Minority School The Institution must be a domestic college or university with student enrollment drawn substantially from minority ethnic groups (including Blacks, Hispanics, American Indians, Alaska Natives, and Pacific Islanders). It must have the ongoing staff and facilities required for the proposed program. The program director at the minority school will be responsible for the selection and appointment of students and the overall direction of the program. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as program directors. B. Research Center The minority institution must identify and collaborate with a research center (medical school or comparable institution) that has strong, well-established cardiovascular, pulmonary, hematologic, or sleep disorders research and research training programs. Cooperation and collaboration between institutions is needed to provide each trainee with a mentor who is recognized as an accomplished investigator in cardiovascular, pulmonary, hematologic or sleep disorders research and who will assist the advisor at the minority institution with the trainee"s development and research plan. Plans for summer training as well as academic year training should be developed by the student and advisor at the trainee"s home institution in collaboration with the mentor at the research center. It is expected that both advisor and mentor will guide the trainee through the initial training period and continue this interaction throughout the award. The development of strong mentoring relationships is essential to the success of the trainees and the program. The minority institution will identify and complete arrangements with an established cardiovascular, pulmonary, hematologic, or sleep disorders research center(s) before submitting an application. Arrangements between the participating institutions for the recruitment of trainees and joint selection of trainers for the provision of training, and for ongoing cooperation and collaboration between the institutions in the implementation of the program, should be clearly outlined in the application. C. Trainees Individuals appointed to the training grant must be citizens of the United States, non-citizen nationals, or lawfully admitted to the United States for permanent residence (i.e. in possession of a currently valid Alien Registration Receipt Card) at the time of appointment, and be enrolled at the minority institution. Trainees must be training at the post-baccalaureate level (i.e., predoctoral or postdoctoral level) in a relevant biomedical or behavioral science and have made a strong commitment to complete a doctoral degree or equivalent in a biomedical or behavioral science. The NHLBI Minority Institutional Research Training Program may not support course work leading to a health professional degree. Research trainees who have or are pursuing clinical degrees must confine clinical duties to those which are a part of the research training experience. Students are expected to pursue their research training on a full-time basis devoting at least 40 hours per week as specified by the sponsoring institution in accordance with its own policies. Students are expected to meet the degree requirements at their home institution. SPECIAL REQUIREMENTS Provisions Of The Award o The trainees may be appointed for 9 - 12 months at any time during the course of the budget period. Students must be enrolled on a full-time basis. A strong interest in a cardiovascular, pulmonary, hematologic, or sleep disorder research career must be evident. Short-term training positions for health professional students are allowed under this program. Predoctoral trainees appointed to the grant may receive support for up to five years. Postdoctoral trainees appointed to the grant may receive support for up to three years. o A written commitment to the training plan signed by the intended faculty mentors at the research center, the department(s) involved and countersigned by both institutional officials, must be part of the application. The trainee and his or her faculty advisor at the minority institution will jointly select a faculty mentor at the research center. o Procedures for annual evaluation of the program should include plans to measure the impact of the program on the individual students and plans to measure the trainees= progress. The evaluation procedures should also describe plans to monitor the future career course of individual trainees, to evaluate the effectiveness of the overall program, and assess the impact of the training program on the institution. It should also include plans for assessing the effectiveness of the mentoring relationship and the training plan. Funds may be requested for: A. Stipends - The current stipend level for graduate and health professional student trainees at all levels of experience is $18,156 per year. Current stipend levels for postdoctoral trainees are as follows: Years of Experience Per Annum Stipend 0 $31,092 1 $32,820 2 $38,712 3 $40,692 4 $42,648 5 $44,616 6 $46,584 7 or more $48,852 B. Tuition, Fees, and Health Insurance - The combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) will be offset at the following rate: 100% of all costs up to $3,000 and 60% of costs above $3,000 per trainee. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the training grant. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at: https://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm C. Trainee Travel Costs - The institution may request funds to cover the costs of trainees= travel, including attendance at scientific meetings, that are necessary to the individual"s training. The maximum allowable per student per year is $1,400. D. Training-related Expenses - Institutional costs of $2,200 a year per predoctoral trainee and $3,850 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. E. Facilities and Administrative Costs - The Notice of Grant Award will provide facilities and administrative costs based on 8% of total direct costs, exclusive of tuition, and fees. F. Short-Term Training - Applicants who wish to include a request for short- term research training positions should identify short-term positions separately within the "stipends" and "training related expenses" categories on the budget page. Under "stipends," short-term positions should be listed in the "other" category. Tuition, fees, health insurance, and trainee travel, and other expenses are to be included in "training related expenses." Within each section of the program plan, a separate description of the short-term training should be included. The applicant should address the relationship of the proposed short-term training to the regular research training and provide assurance that the short-term program will not detract from the regular program. Applicants must observe the 25-page limit on the narrative section. Payback Agreement - As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Predoctoral trainees are not required to sign the payback agreement and do not incur a service payback obligation. o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign the payback agreement form (PHS form 6031) before initiating an appointment. Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support. o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payback agreement form and will not incur a service payback obligation. o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. For example, postdoctoral trainees who continue under that award for 2 years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year. Simple guidelines for completing the payback requirement are available at http://www.nhlbi.nih.gov/funding/policies/t32/payback.htm. Service payback obligations can also be paid back by conducting health-related research or teaching averaging more than 20 hours per week of a full work year after terminating NRSA support. o Recipients with service obligations must begin to provide service on a continuous basis within two years of termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the NIH specifying the need for additional time and the length of the required extension. o Recipients of NRSA support are responsible for informing the NIH of changes in status or address. o For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. o Under certain conditions, the Secretary, U.S. Department of Health and Human Services (or those delegated this authority) may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. o Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program. The relationship of the positions available and the training provided must also be discussed along with the applicability of these positions to any outstanding service payback obligation. 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: programmatic, review and financial or grants management issues: o Direct your questions about programmatic issues to: Sandra Colombini Hatch, M.D. Division of Lung Diseases (responding for all NHLBI programmatic Divisions) National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, MSC 7952 Bethesda, Maryland 20892-7952 Telephone (301) 435-0222 FAX: (301) 480-3557 Email: HatchS@nhlbi.nih.gov o Direct your questions about review issues to: Anne Clark, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Two Rockledge Center, Room 7178 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Bethesda, MD 20817 (for express mail) Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: clarka@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Beckie Chamberlin Grants Management Specialist National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7152, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0172 FAX: (301) 480-3310 Email: chamberr@nhlbi.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 research o Name, address, and telephone number of the Principal Investigator o 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 NHLBI staff to estimate the potential review workload and plan for the review. The letter of intent is to be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES by May 20, 2002. 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. 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 (NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM) and number (HL-02- 024) 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/labels.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 additional copies of the application and all five collated sets of the appendix material must be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received by June 19, 2002. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. 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 a Special Emphasis Panel in the Division of Extramural Affairs, NHLBI, 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 only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Heart, Lung, and Blood Advisory Council. REVIEW CRITERIA The following criteria will be considered in the evaluation of the proposed NHLBI Minority Institutional Research Training Program: o Design of the proposed training program, o Qualifications, dedication, and previous training record of the program director and all participating faculty, particularly with regard to prior experience with similar programs, o Adequacy of facilities, environment, and resources for the proposed research training, both at the minority institution and the collaborating research center, o Adequacy of the cooperative arrangements between the minority institution and the collaborating research center, 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 relevant faculty and the two institutions to the goals of the training program, and o Procedures for evaluation of the effectiveness of the program and impact of the program on the trainees 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: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o 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: May 20, 2002 Application Receipt Date: June 19, 2002 Peer Review Date: October/November 2002 Council Review: February 2003 Earliest Anticipated Start Date: April 1, 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 AMENDMENT "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. 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 No. 93.233, 93.837, 93.838, and 93.839 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 66. 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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