Full Text PA-95-085 RESEARCH ON ATHEROSCLEROSIS LESIONS USING HUMAN TISSUES COLLECTED IN PDAY/RFEHA NIH GUIDE, Volume 24, Number 31, August 25, 1995 PA NUMBER: PA-95-085 P.T. 34 Keywords: Cardiovascular Diseases Tissue Culture National Heart, Lung, and Blood Institute PURPOSE The Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute (NHLBI) announces a program to support research on atherosclerosis lesions utilizing human tissues collected in the Pathobiological Determinants of Atherosclerosis in Youth/Risk Factors in Early Human Atherogenesis (PDAY/RFEHA) program. These specimens are suitable for use to investigate cellular and molecular factors that may be implicated in the initiation and progression of atherosclerotic lesions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Research on Atherosclerosis Lesions Using Human Tissues Collected in PDAY/RFEHA, is related to the priority area of heart disease and stroke. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms include traditional research project grants (R01) and FIRST (R29) awards. Traditional research project grants (R01) provide support for up to five years. Applications for FIRST (R29) awards must request support for five years and are limited to $350,000 in direct costs over the entire project period. RESEARCH OBJECTIVES The NHLBI sponsored a multi-center study (PDAY/RFEHA) to document the natural history of atherosclerosis, its relationship to risk factors, and the pathobiology of lesion development in humans. From over 3,000 autopsy cases, there are samples collected from the thoracic and abdominal aortas, right and left anterior descending, and left circumflex coronary arteries in addition to samples of serum, liver, spleen, kidney, heart and adipose tissue. The samples collected are all from individuals who suffered sudden traumatic deaths ages 15 to 34, who had no indication of chronic disease. They are approximately 75 percent male, almost equally divided between black and white races, and are fairly evenly distributed among the four age cells of five years each from 15 to 34. Samples were collected by standardized techniques and the tissues have been prepared and stored in a variety of manners (i.e., frozen at -80x, OCT and glutaraldehyde-fixed). Most of these cases have demographic data on age, race, and sex. There are also risk factor data on smoking, hyperlipidemia, hypertension, diabetes, and obesity. Arteries have been evaluated for lesions (extent and stage of complexity) and correlated with available risk factors and demographic data. In addition, a number of genotypes related to apoproteins have been determined and correlated with the risk factors. More statistical analyses and correlations are currently under way to confirm that atherosclerosis starts at an early age, and that the recognized risk factors for coronary heart disease are associated with lesion development in the arteries of young subjects. However, because of the vast potential wealth of information that could be obtained, these tissues should provide a special opportunity to initiate studies on the origin and progression of the atherosclerotic lesion in humans. This program announcement provides the opportunity to perform state-of-the-art cellular and molecular biological research on PDAY/RFEHA specimens. Investigators are expected to utilize selected material from the PDAY/RFEHA samples for their proposed basic research projects. Thus, the type and quantity of tissue needed to perform the proposed research should be specified. The tissues are centrally housed at Louisiana State University Medical Center in New Orleans and will be provided to investigators (Jack Strong, M.D., Phone 504/568-6033). A Scientific Advisory Committee with representation from NHLBI, non-PDAY and PDAY Steering Committee will be convened to ensure that specimens will be provided according to Study Section recommendations. For other interested investigators, who already have non-NIH independent support, this committee will also assess the scientific merits and feasibility of their requests, which will not be reviewed by the NIH peer review system. In the event that an investigator requires extra samples, the Committee will be responsible for approving the request. 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 subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892, telephone 301/710-0267. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific and technical review, the applications will receive a second-level review by the appropriate national advisory council. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical or medical significance and originality of proposed research, o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issue or questions from potential applicants is welcome. Direct inquiries regarding programmatic issue to: Momtaz Wassef, Ph.D Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Two Rockledge Center, Suite 10193 6701 Rockledge Drive Bethesda, MD 20892-7956 Telephone: (301)435-0550 FAX: (301) 480-2858 Email: MOMTAZ_WASSEF@NIH.GOV Direct inquiries regarding fiscal matters to: William W. Darby Grants Operations Branch National Heart, Lung, and Blood Institute Two Rockledge Center Suite 7128 6701 Rockledge Drive Bethesda, MD 20892-7128 Telephone: (301)435-0177 FAX: (301)480-3310 Email: WILLIAM_DARBY@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants' policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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