kristoff@GENBANK.BIO.NET (Dave Kristofferson) (03/16/91)
$$XID RFA CA9112 CA-91-12 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: CA-91-12 P.T. 34; K.W. 0715035, 0411005, 0715120, 0785055, 0785140, 0785210, 0745062 CLINICAL INVESTIGATOR AWARD FOR RESEARCH ON SPECIAL POPULATIONS National Cancer Institute Letter of Intent Receipt Date: April 5, 1991 Application Receipt Date: May 17, 1991 I. PURPOSE AND BACKGROUND The Comprehensive Minority Biomedical Research Program, Division of Extramural Activities, National Cancer Institute (NCI) announces the availability of Clinical Investigator Awards for Research on Special Populations. This program is intended to: o Encourage newly trained clinicians to develop research interests and skills in the basic and applied sciences relevant to cancers and risks for cancers that have a high prevalence or incidence in special populations that may be underserved by limited access to current knowledge and medical care. o Increase the pool of cancer physician-investigators in medical oncology, epidemiology, nutrition, behavioral medicine, surgical oncology, preventive oncology and diagnostic and therapeutic radiology who are committed to investigation of the unique problems facing special populations. o Provide the opportunity for clinically trained physicians with a commitment to research to develop into independent biomedical research investigators. The term "special populations" refers to those population segments that may experience or are known to experience high cancer rates and are underserved in terms of: cancer prevention and control programs (e.g., smoking or health screening programs); diagnostic and treatment modalities; study for special risk factors or underlying biological differences; and who may have limited access to regular medical care. This definition is taken to include: African Americans, Alaska Natives, American Indians, Asian Americans, Pacific Islanders, Hispanics, the elderly, and low-income groups. HEALTHY PEOPLE FOR THE YEAR 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/RFA, "Clinical Investigator Award for Research on Special Populations (K08)", is related to the priority area of cancer research. Potential applicants may obtain a copy of Healthy 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, D.C. 20402-9325 (Telephone 202-783-3238). II. GOALS AND SCOPE The award will enable candidates to undertake from three to five years of special study and supervised research experience tailored to individual needs with a sponsor (or sponsors) competent to provide research guidance. This award is intended to cover the transition between postdoctoral experience and a career in independent investigation, and to acquaint the candidate with the often unique challenges and circumstances involved in designing research protocols directed toward improving the health of groups comprising a significant and often disproportional percentage of individuals at risk from high cancer morbidity and mortality rates. This award differs from the NIH Research Career Development Award (RCDA) in that it seeks to develop research ability in individuals with a clinical background early in the candidate's career rather than to promote the further development of research skills of individuals already demonstrating significant research achievement. A major purpose of this award is to increase the number of cancer-oriented research physicians in the United States with research interests and experience focused specifically on the unique needs of special populations and the broad array of issues at the biological, behavioral, social, economic and medical levels that render such populations at increased risk for cancer and for mortality from cancer. III. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health grant-in-aid (K08). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this Request for Applications (RFA), awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Applicants may request three to five years of support. Awards are non-renewable and non-transferable from one awardee to another. Funding beyond the first year of the grant is contingent on satisfactory progress during the preceding year. Future program interest in this initiative will be announced through the NIH program announcement mechanism. It is anticipated that the experience and results achieved by the awardee from this special grants program, in the majority of cases, will provide the basis for successful competition in the regular research support programs of the NCI. Up to $300,000 has been set-aside in FY 1991 to fund meritorious applications received in response to this competition. Depending on the merit and distribution of applications received, approximately 1 to 3 Clinical Investigators will be funded with a start date of September 30, 1991. Meritorious applications received for this competition that cannot be funded at that time may be held over for possible funding in Fiscal Year 1991. IV. PROVISIONS FOR THE AWARD The Clinical Investigator Award for Research on Special Populations will be funded for a minimum of three and a maximum of five years. All funds must be used to support the original awardee. Support is based on a full-time, twelve-month appointment. The awardee will be provided salary support of up to $50,000 each year, plus fringe benefits. The actual salary must be consistent with the established salary structure of the institution for persons of equivalent qualifications, experience, and rank. Up to a total of $10,000 annually will be provided in years 01 and 02 and up to $20,000 annually in succeeding years for supplies, equipment, travel, and other expenses that are necessary for pursuit of the awardee's research program. An appropriate sponsor must assume responsibility and provide guidance for the development of the candidate's research program, and for maintaining the focus of the award and the awardee's time commitments on special populations. Institutions may apply for awards on behalf of named individuals meeting the criteria for this award. Evidence of the commitment of the institution and sponsors to the candidate's research and career development is to be included in the applications. Access to sufficient numbers of patients and subjects meeting the above cited definition of "special populations" must be documented. The grant will be made annually to the awardee's parent institution for each of the annual budget periods. Costs allowed include: o Awardee's Salary - A maximum of $50,000 per year for full-time support; in addition, fringe benefits will be provided. Institutional supplementation is permitted. o Research Support - A maximum of $10,000 annually for years 01 and 02 and $20,000 annually for succeeding years for the categories listed below: Equipment: specialized research equipment essential to the proposed program (the available facilities should include most of the necessary equipment); Supplies: consumable supplies essential to the proposed program; Travel: domestic travel essential to the proposed program; Tuition for Training Courses: if essential to the awardee's individual research development program; and Other: publication costs, patient costs, and other expenses necessary for the research program. o Indirect Costs - The indirect cost rate may not exceed 8 percent of the total allowable direct costs. The grantee institution's share of the fringe benefits may be paid as a direct cost (if not treated as an indirect cost) on that portion of the salary provided by the Clinical Investigator Award. V. ELIGIBILITY o The award is designed to provide intensive, supervised research experience on the above designated topics for physicians. Although the award is primarily for those holding the M.D. degree, applications will be accepted from M.D.'s and D.O.'s already holding the Ph.D. or an equivalent research degree if special circumstances can be shown, such as a Ph.D. in unrelated field or an intervening period of clinical training since the completion of the Ph.D. These applications will be considered on a case by case basis. If the candidate has less than three or more than seven years of postdoctoral experience at the time of application, a strong justification for an exception must be included in the application and must be clearly indicated as such. Candidates should have completed their clinical training, should have documented competence in clinical activities, and should show research experience in the chosen area of interest. Candidates must provide evidence of a serious intent for research and academic careers, and for an interest in medical issues associated with special populations. o Applicants for this Clinical Investigator Award may not submit a concurrent application for an NIH Research Career Development Award, Academic Award, or First Independent Research Support and Transition Award or a research project grant. However, an Awardee of this program may apply subsequently for a research project grant. o The grantee institution must be a domestic nonprofit research institution, school, or comparable institution with strong, well-established research and training programs, adequate numbers of highly trained faculty in clinical and basic science departments, and commitment to providing guidance to new medical scientists in the development of independent research careers. o Candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and potential for a research career. o Candidates must have one or more sponsors or advisors who are recognized as accomplished investigators in the research proposed at the applicant's institution. o NIH and ADAMHA policy is that applicants for clinical research grants, cooperative agreements, and contracts 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, because of the emphasis of this award, such populations must be included if human subjects are to be employed in the proposed research. 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. 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 (American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. Applicants must include a description of the composition of the proposed study population in terms of gender and racial/ethnic group and a rationale for its choice. 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 should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized on Section 2, E, Human Subjects. Applications must employ a study design with gender and/or minority representation (by age distribution, risk factors, incidence/prevalence, or other) appropriate to the scientific objectives of the disease, disorder, or condition, or condition being studied. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women with regard to the hypothesis under investigation, applicants should include an evaluation of gender and minority group differences in the proposed study. o Awardees and their sponsors will be required to submit a non-competing continuation report at the end of each year of support. This report is to contain specific information concerning progress, accomplishments and plans for the next year. o Candidates must agree to inform the NCI annually for ten years subsequent to completion of the award about academic status, publications, and research grants or contracts received. o Candidates for an award must be citizens or non-citizen nationals of the United States or its possessions and territories or must have been lawfully admitted to the United States for permanent residence at the time of application. Applications not meeting the above criteria will be returned without review. VI. REVIEW PROCEDURES AND CRITERIA A. PROCEDURES Upon receipt, applications will be reviewed initially by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications which are judged non-responsive will be returned to the applicant. Questions concerning the relevance of proposed research to the RFA should be directed to program staff as described in the INQUIRIES section. In cases where the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those applications that are clearly not competitive. The NCI will remove from competition those applications judged to be non-competitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. B. REVIEW CRITERIA o The candidate's potential for a career in independent research. o The candidate's commitment to a research career. o The overall merit of the candidate's plan for research and the development of research skills. o The quality of the candidate's clinical training and experience. o The institution's ability to provide quality facilities, resources, and opportunities necessary to the candidate's research development. o Presence of highly trained faculty in clinical and basic science departments relative to the area of study. o The ability and plans of the sponsor (or sponsors) who will provide the candidate with the guidance necessary for career development in research. o The candidate's conformance to the eligibility requirements. The review group will recommend an appropriate budget for each approved application. VII. METHOD OF APPLYING The research grant application form PHS 398 (revised 10/88) must be used in applying for these grants. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institute of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892; and from the NCI Program Director below. The RFA label available in the 10/88 revision of application form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2 of the face page of the application form. In Section 2 of the application under the heading "Research Plan" note the following: Candidates must provide a description of the proposed research and career development plan for the period of the award. The candidate must be prepared to commit full-time effort to the objectives of this award. It is required that a minimum of 75 percent effort be devoted to the research program. The remaining 25 percent may be divided among other activities such as teaching and clinical training pursuits only if they are consonant with the program goals, i.e., the awardee's development into an independent biomedical research investigator. The reasons for a commitment to research in the problems facing special populations with respect to cancer must be indicated. The sponsor must provide: o His/her concept of a development and research plan for the awardee. o His/her curriculum vitae (updated) with complete bibliography and research support. o A letter indicating his/her evaluation of the proposed awardee and his/her willingness to provide guidance and support. Evidence of the commitment of the institution to the candidate's research and development must be provided. Adequate access to populations comprised of one or more of the groups targeted by this award must be demonstrated. Submit a signed, typewritten original of the application, including Checklist, and four (4) signed, exact photocopies, in one package to DRG at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, send two (2) additional copies of the application to: REFERRAL OFFICER Division of Extramural Activities National Cancer Institute Westwood Building, Room 848 5333 Westbard Avenue Bethesda, MD 20892 If the applicant has an approved assurance covering the research (multiple project assurance for human subjects/full assurance of compliance for animal subjects), the applicant should provide with the application, certification of institutional review board (IRB) approval if humans are involved and verification of the institutional animal care and use committee (IACUC) approval if animals are involved. These reviews and approvals should occur PRIOR TO SUBMISSION of the applications for award and the certifications and verifications should be SUBMITTED WITH the applications. Failure to provide required certifications and verifications within applications could result in deferral or rejection. If animals or humans will be subjects of the research at PERFORMANCE SITES OTHER THAN THE APPLICANT ORGANIZATION, the applicants must identify, within the application, the assurance status of each participant. Failure to provide this information within applications could result in deferral or rejection. Applications must be received by May 17, 1991. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA which is essentially identical to one that has already been 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. VIII. LETTER OF INTENT Prospective applicants are asked to submit, by April 5, 1991, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. The letter of intent is of great benefit to the NCI in planning and implementing the review process although the letter is not required, is not binding, and does not enter into the review of subsequent applications. The letter of intent should be sent to the NCI Program Director: Dr. Lemuel Evans Division of Extramural Activities Comprehensive Minority Biomedical Program National Cancer Institute NIH, Building 31, Room 10A04 Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 402-0062 IX. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to Dr. Lemuel Evans at the above address. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. For information regarding budgetary/administrative issues related to this RFA, please contact: Mr. Leo Buscher, Jr. Chief, Grants Administration Branch National Cancer Institute National Institutes of Health Executive Plaza South, Room 216 Bethesda, MD 20892 Telephone: (301) 496-7753 This program is described in the Catalog of Federal Domestic Assistance No. 93-398, Cancer Research Manpower. Awards are under the authority of 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 grant policies and Federal Regulations 42 CFR Part 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. $$XID RFA AI9108 AI-91-08 P1O1 ***************************************** RESEARCH UNITS ON PELVIC INFLAMMATORY DISEASE AND ITS SEQUELAE RFA: AI-91-08 P.T. 34; K.W. 0715026, 1002004, 1002027, 0710070 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 15, 1991 Application Receipt Date: October 21, 1991 The Sexually Transmitted Disease (STD) Branch of the Division of Microbiology and Infectious Disease (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites grant applications for program project grants to be initiated in FY 1992 that focus on pelvic inflammatory disease (PID) and its sequelae. In recognition of the severe impact of PID on the health of women, the Institute wishes to expand research in this area and to place greater emphasis on investigations that are likely to lead to reduction of the incidence and severity of long-term sequelae such as infertility, ectopic pregnancy and chronic pelvic pain syndrome. The Research Units on PID and its Sequelae will provide a strong, interdisciplinary approach to PID research which will draw upon expertise in clinical, epidemiological, behavioral, and basic sciences. Although a broad range of PID research issues will be addressed, research in the following three areas is particularly enthusiastically encouraged: 1) Long-term sequelae - Characterization of the molecular, microbiological, immunological, and behavioral determinants of the development of long-term sequelae of PID and use of animal models to evaluate interventions to reduce these sequelae; 2) Atypical PID - Development of methods to detect atypical PID, and definition of the epidemiology of this portion of the PID spectrum; 3) Diagnostic Approaches - Development and assessment of non-invasive methods to diagnose symptomatic PID. 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 RFA, Research Units on Pelvic Inflammatory Disease and its Sequelae, is related to the priority area of Sexually Transmitted Diseases. Potential applicants may obtain a copy of "Healthy 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, D.C. 20402-9325 (telephone 202-783-3238). BACKGROUND INFORMATION In the United States, PID-related sexually transmitted diseases (STDs) have remained refractory to control efforts. * Annually, approximately 2 million new cases of gonorrhea occur at an estimated cost of almost $1 billion; 25 percent of these cases are in teenagers. In addition, four new types of antibiotic resistance have emerged in the last decade. * The annual incidence of chlamydial infection is approximately 4 million cases at a comprehensive cost estimated to exceed $2.18 billion. Control of chlamydial infection is complicated by the frequency of asymptomatic disease, the cost and technical difficulty of available diagnostic tests, and the absence of effective, single dose therapy. As a result, in 1990 PID continues to be the single most serious and most costly common STD affecting American women. * Each year, between 10 and 40 percent of women with untreated gonococcal and chlamydial infections develop PID. * It is estimated that in the United States, 10 to 15 percent of women of reproductive age have had a least one episode of PID, and that annually between 750,000 and 1,000,000 new cases are added to this figure. * PID frequently results in severe, irreversible sequelae. Due to scarring following PID, approximately 17-25 percent of women become infertile, 15-18 percent develop debilitating chronic pelvic pain, and 20-25 percent present with recurrent PID. In addition, a woman who has had PID is 6-10 times more likely to have a potentially fatal ectopic pregnancy than a woman who has never had upper genital tract infection. These complications are particularly devastating because approximately 70 percent of women who develop PID are less than 25 years old and 75 percent have not yet had a child. * Serologic data from infertility and ectopic pregnancy patients suggest that atypical PID may be responsible for a substantial proportion of both conditions. "Silent" salpingitis and subsequent tubal scarring probably account for the majority of tubal infertility and a significant proportion of ectopic pregnancies. * The long-term, devastating consequences of PID disproportionately affect minority women. Although non-white women comprise only 17 percent of the total female population of the United States, they represent 33 percent of consultations for PID. Ectopic pregnancies, 50 percent of which are caused by previous PID, are the principal cause of pregnancy-related mortality among black women in the United States. Furthermore, minority teenagers with ectopic pregnancies are almost six times as likely to die as their Caucasian counterparts. * The highest annual PID incidence among sexually active women is in the adolescent group. Sexually active 15-19 year old females have approximately a one in eight risk of developing PID. * PID has an enormous personal and economic impact at the time of the acute episode and again when sequelae of PID (infertility, ectopic pregnancy and chronic pelvic pain) manifest. It is estimated that in the United States, PID and its sequelae will cost more than $4.2 billion in 1990. If the incidence of PID remains constant, at the current rate of inflation, projected comprehensive costs of PID for the year 2000 will be almost $10 billion. RESEARCH OBJECTIVES AND SCOPE Research Objectives The goal of this program is to encourage investigators to undertake research that will provide the microbiological, immunological, clinical, epidemiological and behavioral information needed for the eventual control of PID and its long-term sequelae. In addition to other important research issues, data that are needed to design and conduct intervention trials to reduce the incidence and severity of sequelae of PID are of high priority. It should be understood that such a trial is not a component of this solicitation nor has the NIAID developed specific plans for such a trial at this time. However, one of the major purposes of this RFA is to stimulate exceptionally high quality, multi-disciplinary research on those aspects of the epidemiology, pathogenesis and detection of PID, which are likely to be critical in the design of such trials. Programmatic Parameters In addition to the importance of utilizing a multi-disciplinary approach, specific programmatic requirements and constraints are as follows: * Structure of Program Projects: Each program project must consist of at least three individual subprojects which are synergistically inter-related. Each subproject should have clearly described research objectives and each should be headed by a project leader, with a research staff and a separately identifiable budget. It is the primary responsibility of the project leader to clearly state the objectives and approaches of the project, to plan and conduct the research stipulated in the proposal and to ensure that the results obtained are analyzed and published in a timely manner. The Program Director of the Research Unit will be responsible for the overall direction and administration of the total program project. It is the Program Director's responsibility to promote effective coordination and strong interaction among the research staff of individual subprojects, directed towards resolving the problems of PID and its sequelae. The concept of a team effort is an especially important one; the strength of the team approach can have a major impact on the review of these applications. * Clinical Facility: In order to bridge the basic research and clinical arenas, the PID program project must offer a strong clinical facility with accessible patient populations that are appropriate to answering PID research questions. Adolescents and inner city minority groups are examples of populations which should be considered for special attention in the context of these program project grants. * Exposure of Pre- and Postdoctoral Candidates: Efforts should be made within the setting of the program project to advance learning experiences in PID research and to make medical students, house staff and postdoctoral candidates more aware of the research opportunities in PID at both the clinical and basic science levels. A selected program of training that also involves student stipends, however, will not be considered part of this program. Formal training programs at either the clinical or basic sciences level that include stipends for these students are supported by other funding mechanisms at the NIH, such as the National Research Service Awards/Institutional Training Grants (T32s) and do not, therefore, fall within the purview of this program request. Research Scope A broad range of research questions is potentially relevant to the goal of this program. Specific research issues of high priority include but are not limited to the following: Microbiology and Pathogenesis * Definition of the chronological and molecular relationships among lower tract infection, tubal infection, and subsequent scarring. * Elucidation of the structure and function of bacterial and host factors which play a role in the pathogenesis of long-term sequelae of PID. It may be particularly productive in these studies to compare women with localized cervicitis and with clinical salpingitis stratified by pathogen and to evaluate host determinants in a multi-dimensional fashion including innate genetic determinants, immune responses, behavioral factors, sperm factors, myometrial contractions, poor reproductive history, and endocrinologic factors. * Further development and use of animal models to better define the relationship between lower and upper genital tract infection. Relevant questions include the immunologic mechanisms that promote both protective and pathogenic responses to C. trachomatis infection and the effects of immunomodulators and oral contraceptives on ascending chlamydial infection. * Characterization of the full etiological spectrum of both symptomatic and atypical PID. Definition of the relative role of STD and non-STD pathogens in the development of PID and it sequelae will be important to the development of effective control efforts. Epidemiology/Behavioral Research * Further elucidation of the descriptive epidemiology of PID with particular emphasis on atypical infections. Cervicitis patients without lower abdominal pain and women with menorrhagia are two populations in which the latter issue may be explored. * The definition of the role of specific behavioral risk factors and risk markers in the development of PID and its sequelae. Factors requiring additional study include douching, intercourse during menses, contraceptive practices, and provider behaviors. It may be useful to design research approaches that attempt to distinguish among factors affecting risk of lower tract infection, risk of spread to the upper tract, and risk of long-term sequelae. * Assessment of the role of the male in the development of PID and its sequelae. Issues include whether the stage of infection and/or the inoculum size in the male alters the risk of upper tract infection in female partners. Detection and Diagnosis * Design and evaluation of diagnostic algorithms based on epidemiologic, clinical, and simple laboratory data. These studies should use well-defined standards such as laparoscopy, or laparoscopy and endometrial biopsy to provide standardized assessments. * Development and evaluation of diagnostic criteria for atypical or "silent" PID. Use of broad inclusion criteria and data on women initially misdiagnosed with other diseases may be helpful in these studies. * Development and assessment of non-invasive methods to diagnose PID and to identify individuals at high risk of developing sequelae. Examples of relevant approaches might include vaginal probe ultrasonography, and organism or host-specific markers. MECHANISM OF SUPPORT Successful applicants funded under this RFA will be supported through program project grants (PO1). This type of funding mechanism is utilized when it is desired to encourage multi-disciplinary investigator-initiated research on a broad range of problems which are linked by a common theme. This solicitation represents a single competition with a specified deadline for receipt of applications. Although there are no present plans to reissue this request for applications at any future time, NIAID may invite competitive renewal applications upon expiration of the initial funding period, contingent on the availability of funds for this purpose. NIAID anticipates making three program project grant awards as a result of this RFA. FOR A PROGRAM PROJECT TO BE CONSIDERED FOR FUNDING, IT MUST CONTAIN AT LEAST THREE APPROVED, INTER-RELATED RESEARCH PROJECTS. Program project grants are awarded to an institution on behalf of a program director for the support of a broadly based, multi-disciplinary, long-term research program that has a specific major objective or basic theme. A program project generally involves the organized efforts of relatively large groups of investigators, whose members conduct research projects that focus on various components of the overall program objective. The grant can provide support for the projects and for certain shared basic resources (cores) which will facilitate the total research effort. Each project supported under a program project grant is expected to contribute to the common theme of the program; the individual projects must be scientifically meritorious in their own right, and must also demonstrate an essential element of unity, interdependence, and synergy. Level and Duration of Support NIAID anticipates making three program project grant awards as a result of this RFA. The final number of awards to be made is dependent upon the availability of funds. The initial year's direct and indirect costs should not exceed $800,000 for each award. Awards will be made for a project period of up to four years. The earliest possible award date is July 1, 1992. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress during the preceding years and upon availability of funds. If a Request for Applications (RFA) is not issued about a year prior to termination of the grant, the program director must contact NIAID program staff if there is intention to submit a competing renewal application. It is NIAID policy to accept a program project application only with prior contact with and approval of the program officer. Allowable Costs Award funds may be utilized to support the following research-related activities: * Scientific and Professional Personnel Costs: The requested percentage of an individual's salary may not exceed the percentage of effort devoted specifically to activities associated with the PID program project grant. Information substantiating this level of effort must be included in the application. * Administrative Costs: This category includes the costs necessary for the central administration and fiscal management of the program project, such as salaries of the Chief Administrator and secretarial support. Those costs may not duplicate or replace costs included in the institution's indirect cost base. * Shared Research Resources (Cores): The PID program project grant may include funds for equipment, supplies and services to expand and/or maintain clinical, laboratory, biostatistical, and behavioral facilities which are shared by research staff from at least two research projects. In addition to the above categories, budget requests within each project may include research-related costs for supplies, patient involvement and medical care, funds for limited investigator travel, and costs of publication. An applicant whose institution has an NIH-supported General Clinical Research Centers (GCRC) must first attempt to utilize such a Center for relevant categories of patient care before requesting budgets for such costs. Because the program project cannot provide funds for new construction, adequate physical facilities must be available to meet the primary needs of the project. ELIGIBILITY - ONLY DOMESTIC INSTITUTIONS ARE ELIGIBLE TO APPLY. MINIMUM REQUIREMENTS FOR APPLICATION Before preparing an application, the applicant should read the information brochure which accompanies each RFA: Program Project and Center Grants, NIAID. Instructions outlined in the brochure for the formatting of the application should be followed carefully. Failure to follow the instructions may result in unnecessary delays in the review process. Particular attention should be given to the following areas when responding to the application instructions found in the brochure. * The detailed description of each research project should demonstrate how it contributes to the attainment of the program project objectives. Furthermore, in addressing the Organization and Administrative structure of the program project grant, the mutually reinforcing inter-relationships among the investigators should be clearly described. This section must include an organizational chart showing the name, the organization and the scientific discipline of the Principal Investigator, the Project Leaders, and the key personnel for the projects and cores. * In describing the clinical and laboratory facilities available to conduct each project, specific information should be included on the institution's present PID patient load and projections for patient involvement and patient follow-up in clinical investigations as well as on the availability of appropriate biohazard facilities and safety procedures. * SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES - For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. By the nature of this program, subjects will consist largely of women. Applicants are urged to give added attention, where feasible and appropriate, to the inclusion of minorities in study populations for PID program project grants. If minorities are not included or adequately represented in the study populations for clinical studies, a specific justification for this exclusion or inadequate representation must be provided. Applications without such documentation will not be accepted for review. 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 should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors 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 (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, 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, prevention (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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. 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. * Included in information under the "Other Support" section must be an explicit written plan which explains how applicant Principal Investigators who also hold Principal Investigator status on grants unrelated to the PID program project application (particularly on Center, Training or other program project grants) will be able to successfully and fully meet the responsibilities demanded by both endeavors. * The application must include a signed letter of agreement from each collaborator and/or consultant to the program indicating 1) willingness to participate in the program, and 2) the exact nature of the participation. Applicants from institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the applications. REVIEW PROCEDURES AND PEER REVIEW CRITERIA Review Procedures Applications that are judged to be non-responsive to this RFA will be screened out by NIAID staff upon receipt and returned to the applicant without further consideration. Those applications that are complete and responsive to the RFA may be subjected to triage review by a NIAID peer review group to determine their scientific merit relative to the other applications received in response to the RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award, and will notify the applicant and the institutional business office. Those applications considered to be competitive for award will be reviewed for scientific and technical merit on or about November 1991 by a committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council in May 1992. The earliest award date is July 1, 1992. Peer Review Criteria It is again emphasized that prospective applicants should carefully read the information brochure "PROGRAM PROJECT AND CENTER GRANTS, NIAID" which accompanies each RFA. The brochure describes program projects and other large, multi-disciplinary grants; outlines review criteria for such programs; and includes other important information that will aid in formatting the application. The review criteria outlined in the brochure are the review criteria to be used by the peer review group in the evaluation of applications received in response to this RFA. Specifically, proposals will be evaluated for scientific merit including the originality, uniqueness and technical excellence of the research projects. Programmatic relevance, overall responsiveness to the research objectives stated within this RFA and the degree of synergy of the projects will, of course, also be considered. In addition to the review criteria stated above, proposals must satisfy the previously mentioned specific programmatic requirements which are summarized below. These requirements appear in greater detail in Section III - "RESEARCH OBJECTIVES AND SCOPE" and applicants are urged to review this section. Requirements * A minimum of three projects which are linked synergistically to a common research focus or theme. * A multi-disciplinary approach to the research issues. * A clinical facility with appropriate patient populations. Applicants are also strongly encouraged but not required to address issues in: i) Development of long-term sequelae; ii) Characterization of atypical PID; iii) Improved and less invasive diagnosis. Descriptive behavioral research and inclusion of minority/adolescent populations are also encouraged as part of this RFA. METHOD OF APPLYING Letter of Intent Prospective applicants are asked to submit, by April 15, 1991, a short letter of intent that includes a descriptive title and the names and affiliations of proposed key investigators for each of the proposed research projects. The letter of intent is requested to provide an indication of the number and scope of applications to be reviewed. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent should be sent to: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Program and Project Review Branch National Institute of Allergy and Infectious Diseases National Institutes of Health Westwood Building, Room 3A10 Bethesda, MD 20892 Telephone: (301) 496-8208 Format of Applications Applications must be submitted on form PHS 398 (rev. 10/88), the application form for research grants. To assure the identification of your application with this RFA, the application must have "RFA AI-91-08, Research Units on Pelvic Inflammatory Disease and its Sequelae" typed on item 2 of the face page of the application. Application kits are available at most institutional business offices, and may be obtained from: Office of Grants Inquiries Division of Research Grants Westwood Building, Room 449 5333 Westbard Avenue Bethesda, MD 20892 Application Procedure A signed, typewritten original of the application, including the checklist, and four (4) signed, exact, single-sided copies should be sent or delivered, in one package, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** TWO ADDITIONAL COPIES MUST ALSO BE SENT DIRECTLY TO DR. OLIVIA PREBLE AT THE ADDRESS GIVEN ABOVE. THE RFA LABEL AVAILABLE IN THE 10/88 REVISION OF APPLICATION FORM 398 MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE. FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED PROCESSING OF YOUR APPLICATION SO THAT IT MAY NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW. Consequences of Late Applications To ensure their review, applications must be received by both DRG and Dr. Olivia Preble by October 21, 1991. Applications received after October 21, 1991, will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. INQUIRIES Investigators seeking information relevant to this RFA should contact: Dr. Judith Wasserheit Chief, Sexually Transmitted Diseases Branch Westwood Building, Room 749 National Institute of Allergy and Infectious Diseases National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 402-0443 Questions regarding review procedures should be addressed to Dr. Preble, at the address given above. Questions regarding fiscal matters should be addressed to: Mr. Todd Ball Grants Management Branch Division of Extramural Activities NIAID, NIH Westwood Building, Room 726 Bethesda, MD 20892 Telephone: (301) 496-7075 Support is authorized by the Public Health Service Act, Public Law 78-410, as amended. The Catalog of Federal Domestic Assistance citation is Sec. 93.856, Microbiology and Infectious Diseases Research. Awards will be administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review of Executive Order 12372 or Health System Agency review.