FELLOWSHIP AND CAREER AWARDS IN SICKLE CELL DISEASE RESEARCH NIH GUIDE, Volume 23, Number 9, March 4, 1994 PAR NUMBER: PAR-94-042 P.T. 22 Keywords: Blood Diseases National Heart, Lung, and Blood Institute PURPOSE The objective of this program announcement is to encourage the submission of applications for Fellowship and Clinical Investigator Development Awards in Sickle Cell Disease research in order to support the training and professional development of individuals who can serve the expanding research, teaching, and clinical requirements in the area of sickle cell disease. This program announcement emphasizes the need for increased research training and career development in this area and encourages individuals at varying levels of experience to submit applications for support by using three existing research training and career development mechanisms that are sponsored by the NHLBI. 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, Fellowship and Clinical Investigator Development Awards in Sickle Cell Disease Research, is related to the priority areas of clinical prevention services, chronic disabling conditions, and maternal and infant health. Potential applicants may obtain a copy of "Health People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Only domestic institutions are eligible for K awards. At the time of application for a fellowship or K award, individuals must be either citizens or noncitizen nationals of the United States or have been lawfully admitted to the United States for permanent residence. An individual lawfully admitted for permanent residence must submit with the application a notarized statement indicating possession of the alien Registration Receipt Card (1-151 or 1-551). Individuals on temporary or student visas are not eligible.MECHANISM OF SUPPORT The mechanisms of support available for this program announcement are the NRSA Individual Fellowship (F32), NRSA Senior Fellowship (F33) and the Clinical Investigator Development Award (CIDA) (K08). The three support mechanisms for Fellowship and Clinical Investigator Development Awards in Sickle Cell Disease provide a wide range of training and career development opportunities to obtain research experience in sickle cell disease. A brief description of these mechanisms is listed below. NSRA Individual Fellowship Award (F32) Provides support for individuals at the postdoctoral level who wish to gain experience in biomedical and behavioral research related to sickle cell disease. Upon completion of this training, individuals are encouraged to consider other mechanisms to support further research experience. NRSA for Senior Fellows (F33) Provides support to experienced scientists who have at least seven years of relevant postdoctoral research or professional experience and wish to make major changes in the direction of their scientific careers, or enhance and enlarge their capabilities to conduct biomedical and behavioral research on problems related to sickle cell disease. Clinical Investigator Development Award (K08) Provides support to physicians with varying levels of research experience to prepare them for research careers as independent investigators. Candidates" development programs are based on scholastic background, previous research experience, past achievements, and identified skills needed to become an independent scientist. The objective is to develop clinical investigators whose basic and clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems in sickle cell disease. Detailed guidelines for each of the support mechanisms can be obtained from most institutional offices of sponsored research, the Office of Grants Information, Division of Research Grants, National Institutes of Health, telephone (301) 435-0714, and Dr. Fann Harding, Division of Blood Diseases and Resources, telephone (301) 496-1817. RESEARCH OBJECTIVES Background Sickle cell anemia is a major health problem characterized by recurrent episodes of pain called "crises," a chronic anemia related to accelerated destruction of red blood cells, increased susceptibility to certain infections, and acute and chronic damage to various organs. This blood disorder results from the presence of genes for sickle hemoglobin inherited from both parents. In the United States, sickle cell anemia is predominantly, but not exclusively, found in persons of African ancestry. The prevalence of sickle cell anemia within this group is about 1 in 500 at birth, affecting more than 50,000 individuals in this country. This disorder is also found in Greeks, Southern Italians, Eti-Turks, Arabs, Egyptians, Southern Iranians and Asiatic Indians at incidence rates often equal to or greater than that found in African-Americans. In addition, sickle cell hemoglobin also occurs in combination with other abnormal hemoglobins and thalassemia, bringing the total number of individuals affected with various forms of sickle cell disease to over 70,000 in the United States. Thus, sickle cell anemia and related hemoglobinopathies are among the most common genetic blood disorders seen in this country. During the past two decades, there has been a quantum leap in basic and clinical research leading to significant advances at the molecular and cellular levels. This progress embraces a number of important research areas, including the molecular structure of the sickle hemoglobin fiber, kinetics of polymerization, adherence of sickle cells to vascular endothelium, alterations in blood flow, regulation, and control of globin gene expression, development of animal models, abnormalities of the red cell membrane, and identification of genetic modifiers. At the clinical level, there appears to be a new era of therapeutic optimism, especially with agents that increase fetal hemoglobin, which are now undergoing clinical trials. Patients are living longer and more productive lives. Mortality from infection, the major cause of early death in infants and young children, has been significantly reduced with early identification of newborns with sickle cell disease and adding prophylactic penicillin to the management regimen. In spite of this progress to date, an effective therapy remains elusive. These major advances in basic and clinical understanding of sickle cell disease provide an unprecedented opportunity for further improvements in patient management. In addition, the enormous health and economic impact of sickle cell disease, estimated to be more than $705 million per year, argues strongly for increased attention to this disorder. A particular emphasis is placed on training due to the paucity of qualified investigators to carry out basic and clinical research as well as patient care in sickle cell disease. This need was reaffirmed by the NHLBI Sickle Cell Task Force convened to investigate the significant decline noted in investigator-initiated research in sickle cell disease. Although the Task Force was unable to ascribe the decline to any single factor, it made several recommendations to remedy this problem. These recommendations included the initiation of strategies to augment the availability of training and career development programs devoted to sickle cell disease. This Program Announcement is a direct response to that recommendation. The "Sickle Cell Task Force Report on Investigator-Initiated Research" was published in May, 1993. Areas of Interest The integration of a broad range of disciplines is required to further elucidate the basic pathophysiology of the disease and achieve the goals of treatment, prevention, and management. Thus, sickle cell disease is an especially exciting research area, encompassing a wide spectrum of scientific interactions with important behavioral and humanistic components. Potential research areas include cell biology, biochemistry, genetics, molecular biology, physiology, and psychology. Individual programs that offer research training and career development opportunities in all areas related to sickle cell disease are encouraged. The past training of candidates applying for these programs may have been in the basic sciences or in the clinical disciplines. If candidates do not possess skills in research design and biostatistics, the applicant should consider including these areas in his/her training or career development plan. Candidates submitting applications in response to this program announcement should focus on topics exemplified by those listed below. These topics are examples only and should not be viewed as inclusive. Applicants are encouraged to consider other related topics and innovative approaches. o Basic research projects that lead to a better understanding of the pathophysiology and clinical manifestations of sickle cell disease. o Basic and applied research projects that lead to the development of effective therapeutic approaches for the treatment of sickle cell disease. o Clinical research projects that will improve the identification of patients at risk for severe disease and the development of methods and therapies to prevent sequelae. o Studies that deal with the psychosocial and behavioral aspects of sickle cell disease. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study, special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications for NRSA Individual Fellowships (F32) and Senior Fellowships (F33) are to be submitted on the grant application form PHS 416-1 (rev. 10/91) and will be accepted at the standard application deadlines as indicated in the application kit. Applications for Clinical Investigator Development Awards (K08) are to be submitted on PHS 398 (rev. 9/91) 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, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 435-0714. The title and number of the program announcement must be typed in Section 2a on the face page of the application. The completed original application, for a Clinical Investigator Development Award, and three legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications for NRSA Fellowships will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH. Applications for Clinical Investigator Development Awards, assigned to the NHLBI, will be reviewed by the appropriate initial review group managed by the Division of Extramural Affairs, NHLBI. All reviews will be conducted in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. The review criteria are set forth in the guidelines for each support mechanism. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the ICD. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review. o Availability of funds o Program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Fann Harding, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5A08 Bethesda, MD 20892 Telephone: (301) 496-1817 For fiscal and administrative matters, contact: Ms. Jane R. Davis Blood Division Grants Management Section National Heart, Lung, and Blood Institute Westwood Building, Room 4A15 Bethesda, MD 20892 Telephone: (301) 594-7436 AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute are identified in the Catalog of Federal Domestic Assistance, number 93.839. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency review. .

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