Path: utzoo!utgpu!news-server.csri.toronto.edu!rpi!uwm.edu!bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 15, pt. 3, 12 April 1991 Message-ID: Date: 12 Apr 91 05:25:56 GMT Sender: kristoff@genbank.bio.net Lines: 1552 $$XID RFA CA9114 CA-91-14 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: CA-91-14 P.T. 34; K.W. 0715035, 0745020, 0745027, 0745035 PUBLIC HEALTH APPROACHES TO BREAST AND CERVIX SCREENING National Cancer Institute Letter of Intent Receipt Date: June 7, 1991 Application Receipt Date: August 2, 1991 I. INTRODUCTION The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites grant applications from a consortium of public health agencies or institutions to develop, implement, and evaluate programs designed to increase breast and cervical cancer screening of older, low income, low education, and minority women. Priority will be given to applications specifically designed to include evaluation of breast and cervical screening utilization of women over the age of 65 and those targeting populations residing in rural areas. Among Hispanic women, priority will be given to applications targeting Puerto Rican and Cuban populations to provide more comprehensive information on Hispanic populations. The NCI currently funds projects targeting Hispanic women of Mexican descent. The Request for Applications (RFA) method of grant application solicitation is used to encourage projects of special importance to the National Cancer Program, and awards are made in accordance with the policies of the National Institutes of Health (NIH) grant-in-aid and applicable Public Health Service (PHS) policies. This RFA is limited to applicants from within the U.S. The 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 is related to the priority area of Cancer. This project proposes to demonstrate how a consortium of community agencies can develop and evaluate strategies to increase the availability, accessibility, awareness, and utilization of breast and cervical cancer screening regimens, including mammography, clinical breast examination, breast self- examination, and Pap smears by low income, low education, and minority women over 40 years of age. Health agencies are expected to provide or arrange for funding for screening procedures. The intent of this RFA is to invite applications from official health agencies or institutions, such as health departments, community health centers, or public hospitals, in collaboration with other community agencies or institutions capable of addressing early detection of breast and cervical cancers in the target population. The lead agency must demonstrate experience with disease control and must indicate how coordination of agencies will be conducted. II. BACKGROUND INFORMATION The Cancer Control Program, NCI, is located within the Division of Cancer Prevention and Control. This program is authorized under the National Cancer Act and calls for cooperation with health agencies in the prevention, control, and eradication of cancer. Cancer control is defined as the reduction of cancer incidence, morbidity, and mortality through an orderly sequence of research on interventions and their impact in defined populations to the broad, systematic application of the research results. Activities supported under this RFA will involve the application of valid interventions. Research Rationale Each year 41,000 women die of breast cancer and 4,500 die from cancer of the cervix. The women most likely to die are the least likely to have been screened. Among women 40 years of age and older, those of lower income, less education, and members of minority groups are less likely to have been screened for cancer. Socioeconomic factors appear to play an important role in cancer survival as well. Cancer mortality rates are higher for patients of low socioeconomic status (SES) than for those of higher brackets. Data suggest that much of the difference in survival rates is due to late diagnosis of cancer among lower SES patients. Clearly, there is a need to develop effective screening programs for lower SES and minority segments of the population. NCI's Early Detection Guidelines indicate: "That beginning at age 40, all women should be encouraged to have a mammogram every one to two years until age 50 after which it should become annual." "That all women who are, or have been sexually active, or have reached 18 years, have an annual Pap test and pelvic examination. After a woman has had three or more consecutive satisfactory normal examinations, the Pap test may be performed less frequently at the discretion of her physician." National data indicate that subgroups of women (e.g., older women, minority women, and women lower in socioeconomic status) at risk for breast cancer or cervical cancer do not receive preventive services to detect these conditions early. The lack of preventive care does not appear to be due to a lack of physician contact, however. Rather, these data suggest failure to integrate routine preventive care with other services being provided to unscreened segments of the population, and/or behavioral barriers in unscreened populations that prevent them from utilizing screening, even if it is available. Public agencies or institutions, such as health departments, community health centers, outpatient clinics, and public hospitals frequently serve as providers of health care for lower SES populations, or have the responsibility for ensuring that health services are available to them through other channels in the community. However, many of these agencies have not been actively developing and evaluating strategies to increase the availability, accessibility, awareness, and utilization of mammography and Pap smears by women over 40 years of age. Although not identical, the overlap in risk status for breast and cervical cancers based on age provides strong justification for linking efforts in these two areas. This research, therefore, is intended to stimulate public health and community agencies to demonstrate approaches to increasing the use of mammography and cervical cytology among these unscreened women. III. RESEARCH GOALS AND SCOPE Objectives The goal of this project is to develop, implement, and evaluate programs designed to increase breast and cervical cancer screening of older, low income, low education, and minority women. The primary objectives of this research are to demonstrate how a consortium of community agencies can: 1) Characterize utilization patterns for breast and cervical screening in the target population through baseline surveys. These data will establish frequency of screening, as well as assess barriers to utilization. 2) Design and pilot test interventions to recruit women in need of breast and cervical cancer screening regimens that can o be integrated with other health services used by these women o affect the behavior of non-health agency clients. 3) Evaluate the effectiveness of specific interventions to reach the target population for breast and cervical cancer screening. 4) Ensure compliance with follow-up recommendations for women with anything but completely normal mammograms (i.e., indeterminate or suspicious findings) and smears (i.e., further action recommended). 5) Establish a mechanism to describe prospectively the screening behavior of the targeted women in view of current NCI recommendations, i.e., establish whether or not women are coming back at recommended intervals for screening. Project Description This research will stimulate the development and evaluation of strategies to increase and sustain the utilization of screening mammograms and Pap smears in the least likely to be screened women 40 years of age and older and in geographically defined population areas. This approach will permit extrapolation of research results to other communities nationwide. Exceptions to the geographic focus may be proposed, if generalizations can be made from the applicant's defined population to the larger community. Census and/or survey data should permit the characterization of both the female population of a defined service area and its sources of health care. Moreover, the applicant's choice of communities and consortium members should provide opportunities to test a variety of promotional strategies. Of particular interest is the effectiveness of approaches that utilize contacts with women who are already receiving care in public health clinics, or other public facilities, for problems unrelated to cancer screening ("inreach"), compared to strategies to encourage women in the community who are at risk to come in for screening examinations ("outreach"). Both approaches to the problem must be proposed and tested. Investigators must be able to enumerate unscreened women in the population. They must propose a feasible and technically sound means for measuring the effect of their proposed inreach and outreach interventions. A variety of experimental and quasi- experimental designs may be employed in testing interventions, including the use of control communities, clinics, or health centers. An adequate design must be employed to reliably demonstrate the effectiveness of interventions in reaching the target population. An assessment of current utilization patterns must be conducted before any intervention is undertaken. An evaluation of the effectiveness of the intervention must be undertaken by the applicant per se or by one or more subcontractors. During the baseline period, before any intervention is undertaken, survey or medical audit data should permit an assessment of current usage patterns for mammography and cervical cytology within the target population. If self- report of mammography and Pap smear utilization is to be an outcome measure of the proposed interventions, investigators must propose methods of assessing the validity of this measure for the target population. Investigators also should consider developing methods that have the potential to improve the accuracy of self- reported measures. Applicants must provide a detailed description of how they propose to monitor the effectiveness of the interventions over time, including follow-up, in terms of the number of women scheduled for repeat exams at recommended intervals. It can be assumed for the purposes of application that NCI funds for the intervention activity will expire in three years. However, the evaluation effort should be budgeted for an additional year -- four years altogether. However, investigators should briefly outline mechanisms of how, through continuation of the project beyond the four-year period, they will be able to prospectively study maintenance of screening behavior. NCI will encourage investigators to study this important aspect of behavior through a competitive renewal process. Sample size calculations for the purpose of the evaluation must take into account the need for data on the behavior and attitudes of appropriate subgroups within the target population. NCI expects that the baseline and post-baseline evaluations of utilization patterns will include assessments of barriers to the use of mammography and cervical cytology as well as expediting factors. Thus, the applicant must address the measurement of process variables that link the interventions to behavioral change or nonchange among specific groups of women and their health care providers. To control for behavioral change that occurs independent of the intervention strategies, applicants must address the issue of control communities or subcommmunities. Control groups may be proposed as an integral part of the experimental design or simply as a means of evaluating the impact of a particular intervention strategy. In developing the interventions, researchers must identify and consider barriers to the utilization of mammograms and Pap smears among the target population, as well as mechanisms needed to overcome them. It is anticipated that interventions will be designed for the women as well as their health care providers or the existing health care system. Investigators will be required to document that they have access to and can recruit a population of unscreened women 40 years of age and older who are of low SES or minority status. Priority will be given to proposals specifically designed to include evaluation of breast and cervical screening utilization among women 65 years and over and proposals targeting women residing in rural areas. Among Hispanic women, proposals addressing Puerto Rican and Cuban populations also will be given priority. Additionally, applicants will have to provide or arrange for the necessary screening and follow-up services. A feasible plan to integrate interventions into the usual practice of the health care facility also will be required. For cases with any but normal screening results, investigators will be required to provide a specific plan for implementing procedures that will ensure compliance with appropriate follow-up recommendations. This must include how and where women will be referred for necessary treatment and follow-up, as well as mechanisms to pay for the procedures. With respect to quality and safety issues, all clinical, laboratory, and radiologic procedures performed in relation to the grant-supported interventions must meet state-of-science levels. Agencies already incorporating physical examination and/or breast self-examination in their breast health programs will be expected to continue to do so. Where feasible, these features must be incorporated into newly developed programs. The discussion in the application must include a series of quality assurance criteria and certify that facilities involved in the project meet the current state and Federal requirements for mammography and cervical cytology. In addition, applicants must include an implementation plan for quality assurance. This research will be accomplished by official health agencies or institutions, such as health departments, community health centers, or public hospitals, in collaboration with other community agencies or institutions capable of addressing early detection of breast and cervical cancers in the target population. The lead agency must demonstrate experience with disease control and must indicate how coordination of agencies will be conducted. In many communities, the lead agency is likely to be the health department or a community health center, although other public agencies could fill this role. Consortia will be comprised of a variety of organizations that will vary according to site. If it is feasible, these agencies should collaborate with research institutions or research efforts, such as the Community Clinical Oncology Program (CCOP), cancer centers, and SEER registries in the population proposed, especially when addressing professional education as a means to increase utilization of screening procedures. The lead agency does not necessarily have to be the direct provider of screening services and may cooperate/contract with private practices or hospitals for these services. It is not the intention of this research to offset the cost of screening procedures. However, in order for the results of this research to be of benefit to other communities, applicants must document that they will be able to provide these procedures in significant numbers at low cost. Investigators must explain mechanisms to be used for payment of screening and follow-up procedures, such as self-insurance, Medicaid or Medicare, and describe approaches that will be used to pay for women who do not have any coverage. Investigators must maximize all sources of third-party payment, including Medicare or Medicaid, private insurance payments, and self-insurance. Reimbursement must be used to offset appropriate expenses. Applicants must describe methods by which low-income and uninsured women will be provided the full range of services. To ensure a sustained reduction in breast and cervical cancer mortality, utilization of effective screening technologies must be sustained within the population. High priority will be given to research designs that ensure continuation of the intervention beyond the funded period. IV. MECHANISM OF SUPPORT Support of this program will be through a National Institutes of Health (NIH) grant-in-aid (RO1). Applicants will be responsible for the planning, direction, and execution of the proposed project. Allowable direct costs for the intervention will not include funds to pay for mammograms and Pap smears. However, expenses incurred in developing and promoting the utilization of these services, such as baseline and follow-up surveys, design of materials, and public and professional education are considered allowable costs. Except as otherwise stated in this 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. This RFA is a one-time solicitation. Future competing renewal applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, if the NCI determines that there is a sufficient continuing program need, a request for renewal applications will be announced. Only recipients of awards under this RFA will be eligible to apply. Approximately $5,400,000 in total costs for four years ($1,200,000 for year one and for year four, $1,500,000 for year two and for year three) will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that three to four awards will be made dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed four years. The earliest feasible start date for the initial awards will be April 1992. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. V. SPECIAL REQUIREMENTS It is expected that awardees will participate in a series of collaborative meetings at NCI and that some components of the evaluation protocols will be common to all areas. Although independence and originality are encouraged in the approaches of the various investigators, they are expected to share ideas, experiences, and information in attempting to reach their common goal. Funds must be budgeted to permit travel of senior staff to Bethesda, Maryland, twice a year over the course of the grant. Funds awarded for travel to these meetings will be restricted for this purpose only. Failure to participate in these meetings may adversely affect NCI evaluation of the project's progress when the non-competing continuation application for the following year is reviewed. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS The following is the NIH and ADAMHA policy regarding the inclusion of women and minorities in study populations. Applications that are responsive to this RFA will, by definition, meet the requirement for inclusion of women. The inclusion of minorities must be addressed in application submitted responding to this RFA. NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 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. VI. ELIGIBILITY REQUIREMENTS Grants-in-aid may be awarded to profit and nonprofit organizations and institutions, and governments and their agencies within the United States. However, it should be noted that this RFA is primarily targeted at a consortium approach, involving public agencies or institutions, such as health departments, community and migrant health centers or public hospitals with established linkages to the target population (e.g., the health department or community health center may have experience with providing or contracting for the health services, a regional agency on aging may have established networks with elderly women, and a voluntary organization may have experience with providing public education campaigns). This approach seeks to address the problem in a coordinated fashion while taking advantage of the public agency's role as noncompetitive collaborator, stimulator, convenor, and facilitator of existing resources to increase mammography and Pap smear utilization in women least likely to be screened. The lead agency must demonstrate experience with disease control, but does not necessarily have to be the direct provider of the screening services. In many communities, the lead agency is likely to be a health department, although other public agencies could fill this role. Among the team of applicants or consortium, one institution must be proposed as the lead institution to serve as the applicant and assume responsibility for the conduct of the award. VII. REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURE Upon receipt, applications will be examined by the 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 that are judged non-responsive will be returned to the applicant but may be submitted as investigator-initiated research grants at the next receipt date. Questions concerning the responsiveness of proposed research to the RFA should be directed to program staff (see Section X). If 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 noncompetitive 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. REVIEW CRITERIA The applications will be evaluated on the basis of the following criteria: 1. Extent to which proposed research will meet the project goal of developing, implementing, and evaluating the effectiveness of interventions designed to increase breast and cervical cancer screening of older, low income, low education, or minority women. 2. Scientific merit of the research approach, design, and methodology, including appropriateness of the proposed plans and methods to characterize utilization of screening and evaluate the effectiveness of both inreach and outreach strategies to screen the target population at recommended intervals over time. 3. Appropriateness of quality assurance procedures for mammography and cervical cytology. 4. Appropriateness and feasibility of ensuring adequate follow-up procedures for positive screenees. 5. Documented access and ability to recruit participation of the target population. 6. Evidence that the applicant will be able to provide screening procedures in significant numbers at low cost, as well as evidence that the applicant will maximize all sources of third- party payment, including Medicare or Medicaid, private insurance payments, self-insurance, and other grants. Applicants must also describe methods by which low-income and uninsured women will be provided the full range of services. 7. Availability of resources to conduct proposed interventions. 8. Research experience and competence of the Principal Investigator and staff and adequacy of time (effort) that they will devote to proposed project. 9. Relevant experience within the consortium in conducting chronic disease control programs. 10. Documented support for the project from participating community agencies, including previous relationship and relevant experience in conducting other collaborative efforts with the lead agency, as well as a clear delineation of each agency's responsibilities with regard to the project. 11. Feasibility of approach to work, including how tasks are to be carried out by different community agencies, project management, and anticipated problems and proposed solutions. 12. Extent to which study design will ensure continuation of the intervention beyond the funded period. 13. Extent to which relationships have been, or will be, developed with existing cancer centers, CCOPs, and SEER registries in the proposed study area. 14. Originality of approach to the research, i.e., does not duplicate past or current breast and cervical cancer intervention research funded by the NCI or any other institution. 15. Provision for the protection of human subjects. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. VIII. 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 Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, Maryland 20892 (301) 496-7441; and from the NCI Program Director named below. State Health Departments may submit applications on either Form PHS 398 (revised 10/88) or PHS 5161-1. If the PHS 5161-1 is used, it is requested that the budget pages from PHS 398 (pages 4 and 5) be used. In addition, separate detailed budgets must be provided for contracts/coalitions as described in PHS 398 (revised 10/88). The RFA label available in the 10/88 revision of application form PHS 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. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies, in one package to the 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 Room 848, Westwood Building 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by August 2, 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 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. IX. LETTER OF INTENT Prospective applicants are asked to submit, by June 7, 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. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent must be sent to: Helen I. Meissner, Sc.M., C.H.E.S. Program Director Public Health Applications Research Branch National Cancer Institute EPN, Room 239G Bethesda, MD 20892 Telephone: (301) 496-0273 X. INQUIRIES Written and 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 the program director at the above address. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. Grants management inquiries should be directed to: Marian F. Focke Grants Management Specialist Grants Administration Branch EPS, Room 242 Grants Administration Branch National Cancer Institute 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 46 This program is described in the Catalog of Federal Domestic Assistance No. 93.399. Awards are under authorization of the Public Health Services Act, Title IV, Part A and administered under PHS grant 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. $$XID RFA MH9114 MH-91-14 P1O1 ***************************************** MENTAL HEALTH CLINICAL TRAINING GRANTS: INDIVIDUAL FACULTY SCHOLAR AWARDS National Institute of Mental Health REQUEST FOR APPLICATIONS P.T. 44; K.W. 0720005, 0715129, 0414000, 0785185, 0730050 RFA: MH-91-14 Catalog of Federal Domestic Assistance 93.244 Under the authority of Section 303, Public Health Act, U.S.C. 242a and regulations at 42 CFR Part 64, the National Institute of Mental Health will accept applications in response to this request under the single receipt date of June 12, 1991. Darrel A. Regier, M.D., M.P.H. Director Division of Clinical Research Alan I. Leshner, Ph.D. Acting Director National Institute of Mental Health PURPOSE There is a marked disparity between the need for treatment of persons with major mental disorders and the availability of appropriately trained mental health professionals to assess, provide, and supervise the treatment. For this reason, the National Institute of Mental Health (NIMH) supports the Individual Faculty Scholar Awards program to develop a cadre of academically based faculty scholars who will guide the training of professionals in the core mental health disciplines (psychiatry, social work, psychology, psychiatric nursing, and marriage and family therapy) and who will play major leadership roles in the continued development of their professions. TRAINING OBJECTIVES It is anticipated that these faculty scholar awards will help ensure the successful preparation, development, and advancement of the academic careers of the awardees of this program. By funding a new group of faculty scholars, well-grounded and experienced in modern mental health diagnostic, treatment, and rehabilitation techniques, research methodologies and findings, and the delivery of care within community-based systems, the program will serve to strengthen the scope and quality of the preparation of future direct providers of mental health services. The training and experience of the faculty scholars should be well integrated and include clinical, academic, and research activities. This program is designed for an individual faculty nominee who holds, or has been assured of, a full-time, non-tenured faculty position, at least at the assistant professor level, that he or she will continue, or assume, after the period of the award. The training may take place at the scholar's home institution and/or other institutions that possess the necessary expertise in the designated priority area. Candidates whose home institutions do not offer highly developed programs in the designated priority areas should consider educational plans that incorporate substantial periods of training at other institutions where the required advanced preparation can be obtained. Each faculty scholar will be expected to improve and participate in the appropriate clinical training program of the institution with which he or she is affiliated upon completion of the award and to serve as an expert resource person in the priority area at that institution and elsewhere. The program prepared for the nominee must contain a mix of clinical education, research training, and other experiences appropriate to meet the career development goals established for him or her. Individual Faculty Scholar Awards are intended to support the preparation of those seeking careers combining research and clinical practice exclusively. Information regarding NIMH programs of support for advanced training for careers exclusively in research or clinical training may be obtained from other NIMH and ADAMHA announcements and/or the NIMH staff listed below. Concentration in one of the four specified priority areas must be the predominant feature of a faculty scholar nominee's development program. PRIORITY AREAS Schizophrenic Disorders Schizophrenia is one of the most severe and disabling of the chronic major mental disorders. The clinical course commonly includes repeated psychotic episodes with chronic impairment of social and occupational functioning. Despite ongoing research efforts, the etiology (or etiologies) of schizophrenia remains largely unknown. The treatments available for schizophrenia are important in relieving some of the suffering for many of the people affected. Antipsychotic medications have proven to be crucial in decreasing the severity of positive symptoms of schizophrenia such as hallucinations, delusions, and incoherent speech, but they do not consistently relieve all the symptoms of the disorder. Many patients continue to suffer from the deficit or negative symptoms of schizophrenia, e.g., lack of goal-directed behavior, and verbal paucity; and from disordered personal relationships, e.g., inability to establish and maintain social relationships, social isolation, and withdrawal. However, aspects of schizophrenic disorganization have been successfully treated with integrated psychoeducation, behavioral, and family approaches if combined with maintenance medications. Overall, it is estimated that up to 25 percent of those afflicted with schizophrenia will never recover their ability to function independently. An additional 50 percent or more will experience some form of disability in an intermittent course of the illness throughout their lives. NIMH has designated schizophrenia as one of its foremost research priorities. In so doing, NIMH recognized the enormous public health challenge posed by schizophrenia, acknowledged the immense and chronic burden borne by people with this disorder and by their families, and made a commitment to advance rapidly the state of knowledge and clinical training relative to this major mental illness. Faculty who are expert clinicians and researchers are needed to train additional mental health professionals to provide services for those affected by this illness. Mood, Anxiety, and Personality Disorders Mood, anxiety, and personality disorders rank among the most serious and pervasive public health problems in the United States. Depressive disorders affect one in twenty American adults in any one-month period, and the figures for anxiety are even higher. Most persons with depression also have an anxiety disorder. Depressive disorders are the most frequent antecedent of suicide, and the suicide rate increases among people with several psychiatric disorders. Personality disorders are thought to be pervasive and debilitating, but less is known about this class of mental illness. The personal and economic cost to the patients with these disorders, to their families, and to the Nation is estimated to be greater than such ailments as arthritis, ulcers, diabetes, and hypertension. Although effective psychotherapeutic and pharmacological treatments exist, research shows that most depressed and anxious persons are undiagnosed, often untreated, and frequently treated inappropriately. Improved service provider training is needed and possible. Faculty with clinical and research expertise in these disorders are needed to train service providers and researchers. Severe Mental Disorders of Children and Adolescents Because the mental disorders of childhood and adolescence are among the most devastating and least understood disorders of humankind, the NIMH has embarked on a "National Plan for Research on Child and Adolescent Mental Disorders," a major program designed to expand greatly its research activities on child and adolescent mental disorders. At least 7.5 million children and adolescents in the U.S. under 18 years old suffer some sort of mental disorder or developmental impairment (about 12 percent of our children). Because of a combination of factors, including a lack of awareness on the part of some investigators of the critical needs and opportunities in this area, as well as a relative lack of qualified clinicians and investigators, the progress in mental health research and treatment for child and adolescent disorders has not kept pace with related research in adults. Major efforts are needed to increase understanding of the causes and determinants of child and adolescent psychopathology, determine the effectiveness of biologic, psychotherapeutic, and social treatments, develop more effective service delivery systems, and enlarge our cadre of qualified, committed researchers and clinicians. >From a clinical perspective, the child and adolescent disorders are often devastating in their compromising of the child's personal, cognitive, and social development as well as the impact on family and society. The direct costs to society are enormous because of the financial outlays required to support the intensive care needed by those children who suffer from the most devastating illnesses such as pervasive developmental disorders, autism, and childhood psychoses. The disruptive behavior disorders are a particular burden on society as they are frequently associated with tragic consequences such as delinquency, substance abuse, family disruptions, lack of educational attainment, and the corresponding failure to achieve the social and occupational accomplishments that could otherwise be expected. There is increasing awareness of the morbidity associated with the mood disorders/anxiety disorders and their protracted course, co-morbidity, and resistance to therapeutic intervention. Pediatric AIDS and homelessness of children and adolescents are increasing mental health problems. The critical shortage of mental health professionals trained to diagnose, treat, and rehabilitate children and adolescents with severe mental disorders requires focused clinical and research training programs. Mental Disorders of the Aging Risk factors for mental disorders multiply through old age along such dimensions as physical limitation, social disruption, and psychological loss. Many surveys have shown increases in the prevalence of symptoms of depression, in Alzheimer's disease and other dementing disorders, and in behavioral problems such as sleeplessness, agitation, and confusion that are disruptive to established patterns of family and community life. Furthermore, the duration of schizophrenia and other chronic mental disorders of adulthood can be lifelong; and except for the potential risk of suicide, life expectancy is generally thought to be unaffected by the presence of a mental disorder, assuming there is adequate care of the mentally ill older person. The death rate for suicide, however, increases by age, with those over age 55 accounting for 32 percent of all completed suicides. An estimated 80 percent of those age 65 and older in nursing homes have some degree of mental impairment, with Alzheimer's disease being the most common condition. Faculty leadership to establish research and training programs in geriatric mental health is extremely limited; growth in this area represents a significant priority in NIMH. In addition to these four priority areas, scholars are encouraged to focus on specific subgroups that continue to be underserved. The problem of co-morbidity (i.e., the mentally disordered who are also substance abusers) is recognized as a challenge since 32 percent of persons with mood disorders and 47 percent of persons with schizophrenia also have an addictive disorder. Other subgroups include minority and rural populations. Another area of interest is the development of strong ties between academic mental health training institutions and public mental health facilities. These systems offer a rich opportunity for enhanced services in the public sector. Thus, NIMH strongly encourages faculty scholar applications that demonstrate collaborative linkages between academic centers and those public mental health service settings where the seriously mentally ill receive treatment. ELIGIBILITY On behalf of a qualified nominee, applications may be submitted by an academic department or professional school in a U.S. college, university, or nonprofit mental health training institution. Qualifications of the applicant department by discipline are: o a department of psychiatry in a college or university school of medicine, a division of child psychiatry, or a free-standing mental health institution with an approved university-affiliated psychiatric residency or an approved university-affiliated child psychiatry residency o a university-based department or school of professional psychology or university-affiliated internship program with appropriate accreditation for training in clinical, counseling, or school psychology o an accredited college or university school of nursing that offers training through a graduate program in psychiatric nursing o an accredited school of social work offering graduate education o a college or university-based accredited graduate program in marriage and family therapy Nominees must meet the following minimal qualifications: o psychiatry - completion of general psychiatry residency training or, in child psychiatry, completion of child and adolescent fellowship training, and the appropriate Board certification or Board eligibility o psychology - completion of a Ph.D. or a Psy.D. degree from an APA-accredited graduate psychology program, and a year of clinical internship o nursing - completion of a doctoral degree, preceded by a master's degree in psychiatric mental health nursing, or a doctoral degree in psychiatric mental health nursing o social work - completion of a doctoral degree in social work or a doctoral degree in a related discipline preceded by a master's degree in social work o marriage and family therapy - completion of a doctoral degree in marriage and family therapy or a related field Nominees must be U.S. citizens or have been lawfully admitted to the United States for permanent residence. Nominees must have a full-time academic appointment or be assured of such an appointment upon completion of this award. Women and minority candidates are particularly encouraged to apply. Faculty Scholar nominees are typically expected to be at a point in their careers no more than five years after completion of medical residency or doctoral education, because the emphasis here is on new faculty scholars. Under exceptional circumstances, more senior candidates may apply, in which case the nominees and sponsoring institutions must present a very strong rationale for excepting nominees from the earlier stated requirement. While other justifications are conceivable, a principal one would be a nominee's intention, supported by firm evidence, to make a major career change to focus on an NIMH priority area. Tenured associate and full professors are not eligible to apply under this RFA. SPECIAL APPLICATION CHARACTERISTICS The following outline must be used to prepare a description of the training program in the narrative portion of the application: Nominee Instead of the Biographical Sketch, the nominee should submit a comprehensive curriculum vitae to precede the narrative proposal. In addition, the nominee should indicate his or her strengths and weaknesses in the designated priority area and provide a statement of goals for clinical and research training for the period of award and nominee's subsequent career. A clear, strong commitment to a career in the identified priority area should be demonstrated in the application. A record of research and other scholarly pursuits appropriate to the nominee's professional level, especially in the priority area, will greatly strengthen an application, as will demonstrated potential for enhanced future scholarly contributions and leadership in the profession. The nominee's background, beyond the foregoing, should also show evidence of superior clinical and teaching capabilities and research interests. Program Plan The nominee must submit a proposed program of development, the goal of which will be a successful career as clinician/teacher/researcher and faculty scholar in an academic setting. The nominee must describe areas of additional experience that will be required to meet the stated educational goals. He or she may include such activities as participation in formal academic courses, consultation with experts in the priority area, visits to other academic centers with recognized educational and research expertise in the priority area, and other training efforts appropriate to the nominee's developmental goals. A letter from institutions other than the sponsoring institution agreeing to participate in the program must be included. In addition, the nominee must outline as precisely as possible the clinical, academic, and research experiences that will comprise the training program. A research project is required of each nominee, who must submit a research design in sufficient detail for a review committee to judge its scientific merit. Attention must be given by nominees to considerations of inclusion of women and minorities, informed consent, confidentiality, subject rights and welfare, and subject risks. (Grants under this RFA are subject to the regulations of 45 CFR 46, Protection of Human Subjects.) The nominee must also outline an area of concentration within the priority area, e.g., schizophrenia, that he or she proposes to develop as a special area of expertise with regard to clinical, academic, and research activities. Such a focus could be concentrated on a specific disorder (e.g., diagnosis and treatment of manic depressive disorders); a modality focus (psychopharmacology, psychotherapy); a conceptual focus (health and behavior, prevention); or a community health care system focus (community-based services, including psychosocial rehabilitation, mental health administration, consultation-liaison, and crisis care). The nominee must furnish his or her perceptions of how the benefits of the proposed training plan will be expressed in the nominee's later career as a faculty scholar. The proposed training plan, to which a faculty scholar is required to devote full-time, i.e., 40 hours per week, must represent a clear departure from the nominee's usual work activities at the home institution. Supervision/Sponsorship The overall supervision and sponsorship of the nominee will be the responsibility (direct or delegated) of the dean, department chairperson, or other qualified faculty member of the sponsoring institution. A description of the role of the sponsor (supervisor) in relation to the nominee's clinical, academic, and research activities and goals during the period of the award must be included. If supervision is to be delegated to someone other than the sponsor, the relationship of the sponsor to the supervisor must be described, including how the sponsor proposes to oversee the faculty scholar's development. Comments must also be supplied with regard to the sponsor's perception of the future promise and current strengths and weaknesses of the nominee relative to a successful academic career, along with plans for addressing the perceived areas of weakness. Supervision provided by a sponsoring institution must be contributed by the latter and not charged to the grant. Supervisory costs to be incurred by cooperating institutions participating in the training plan may be requested as part of the grant budget. Applicant Institution The application must provide general information about the applicant institution, including its current educational, clinical service, and research programs and emphasizing those in the nominee's designated priority area. The availability of established faculty as potential academic role models for the training program at the applicant and other institutions must be described. Additional resources, such as established clinical, academic, and/or research centers or unique clinical service programs, directed to the priority areas must be included. Assurances must be provided that ample time will be made available for the faculty candidate to develop as an independent clinical educator and scholar; the applicant institution must assure that the nominee will be released from activities not directly related to his or her development as a faculty scholar. Documentation must be included regarding continuation of the appointment of the nominee beyond the period of the grant award, and it must be clear what professional opportunities will be made available for the nominee to fulfill his or her faculty scholar career objectives. It must be shown that the nominee will not be performing basic faculty tasks and roles and that his or her faculty scholar training program does not repeat the nominee's regular work assignment. EVALUATION Each application must include an evaluation component. The evaluation component must include, at a minimum, a statement regarding the process variables that will be used to determine the progress of the faculty scholar through a proposed program and the outcome variables to assess the impact of the training program on the scholar and the institution. An evaluation plan of high quality is an essential element of the faculty scholar proposals. TERMS AND CONDITIONS OF SUPPORT Grants will be awarded directly to academic institutions on behalf of specific nominees and are not transferable from one institution or individual to another. The applicant is the institution, although the nominee must participate in preparing the application. Grants must be administered in accordance with the PHS Grants Policy Statement DHHS Publication No. (OASH) 90- 50,000 (Rev) October 1, 1990. Period of Support The period of support for an individual receiving the NIMH Faculty Scholar Award is one to three years. Plans for each year of the award, including detailed budgets, must be fully presented in this application. However, support for the second and third year of an award is contingent upon the availability of funds and also upon the receipt of an annual continuation application that provides a summary of progress to date, plans for the next year, and the sponsor's appraisal of the awardee's progress. Continuation applications are due four months before the end of the current budget period; application forms will be sent routinely to the individual awardee. Individual Faculty Scholar Awards may not be renewed beyond the initial one- to three-year period of an award. Salary Support Salary support is based on a full-time, 12-month appointment, consistent with the established salary structure at the institution. The institution must provide information specifying how the proposed salary was derived. Federal contribution to salary support is geared to the institution's base as follows: Base Institute Salary NIMH Contribution Up to $45,000 100 percent of the Institutional Salary $45,001 - $60,000 $45,000 $60,001 and above 75 percent of the Base Institutional Salary up to a Maximum of $75,000 Institutional supplementation of the Federal contribution must be from non-Federal funds and may not require extra duties or responsibilities that would interfere with the purpose of the award, i.e., full-time commitment to career development activities. Fringe Benefits Fringe benefits are paid out of grant funds in the same proportion as the salary contribution. In addition, practices related to partial payments of fringe benefits shall be consistent with institution policies and not be altered for these awards. Professional Development Support Costs for professional development support may be provided when fully justified as essential for career enhancement. Funds for this purpose, up to $25,000 per year, will be provided. These funds may be used to pay for secretarial or technical support, tuition, fees, travel, per diem, and supervision for study at centers other than the grantee institution. Relocation costs from a place of residence to the applicant institution are not allowable. Indirect Costs Indirect costs will be reimbursed at 8 percent of total allowable direct costs or actual indirect costs, whichever is less. Payback Any graduate or postgraduate trainee, including a Faculty Scholar awardee, in psychology, psychiatry, nursing, social work, or marriage and family therapy who receives support in an established training program designed to be for a period of 180 days or more under an NIMH clinical training grant must pay back through a period of obligated service equal to the length of support. The period of support need not be continuous. Any support received for any period of time under previous NIMH clinical training grants, if the stipend was awarded on or after September 1, 1981, will count toward this total. The conditions of the obligated service requirement are set forth in the 42 Code of Federal Regulations Part 64a. No trainee or Faculty Scholar awardee may receive a stipend or other allowance from the grant until he or she has signed and submitted both a payback agreement form and a Statement of Appointment Form (PHS 2271), and a certification of Non-delinquency on Federal Debt. Further information on payback requirements and fiscal and administrative matters is available from: Mr. Stephen Hudak Chief, Grants Management Section Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-26 Rockville, MD 20857 Telephone: (301) 443-4456 APPLICATION PROCEDURES Application kits (PHS 398, rev. 10/88) are available from the Education and Training Branch, Division of Clinical Research, NIMH (see the final section of this announcement). The name of the nominee should be placed in line 3a of the first page of the application. The type of grant, e.g., Faculty Scholar (Psychiatry, Psychology, Nursing, Social Work, or Marriage and Family Therapy) Award in priority area (e.g., Schizophrenic Disorders) should be identified on line 2 of the first page of the application. Prospective applicants are encouraged to consult NIMH staff on eligibility and assistance in developing applications. The address and phone numbers for staff consultation are listed in the final section of this document. Applications must be complete and contain all information needed for initial and National Advisory Mental Health Council review. No addenda will be accepted later, unless specifically requested by the Executive Secretary of the review committee. No site visits will be made. The narrative section of the application may not exceed 20 single-spaced typewritten pages. Applications exceeding this limitation will be returned. Appendices containing such information as detailed resumes and letters of support may be attached, but the appendices may not be used to expand the narrative section; extensive appendices are strongly discouraged. The applicant should include a project abstract that should not exceed one-half of a single-spaced typewritten page. The original and five (5) copies of the application must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Complete line 2 of the application by typing in the RFA number and title. The RFA label (found in the 10/88 revision of application form PHS 398) must be affixed to the bottom of the face page of the original copy of the application. Failure to use this label could result in delayed processing of your application such that it will not reach the review committee in time for review. Because of the very short time available for initial and Council review, it is requested that an additional copy of the application marked NIMH CLINICAL TRAINING should be sent directly to: NIMH Division of Extramural Activities Parklawn Building, Room 9C-23 5600 Fishers Lane Rockville, MD 20857 Attention: Edna Hardy-Hill REVIEW OF APPLICATIONS A dual review system is used to ensure expert, objective review of the quality of applications. Initial peer review for educational and technical merit is by Initial Review Groups comprised of non-Federal mental health authorities. Final review is by the National Advisory Mental Health Council whose review may be based on policy as well as educational and technical merit. Each grant application is evaluated on its own merits. The following general review criteria are used: o background and potential of the nominee as a clinical educator, researcher, and national leader in the designated priority area o clarity, depth, and appropriateness of the goals of the proposed training program relative to the purposes of this announcement o appropriateness and feasibility of the content, methods, and organization of the training plan o appropriate assurances that the nominee will have the time available to ensure development as a clinical educator, investigator, and emerging leader in the priority area selected o appropriateness and strength of the evaluation plan o viability of the research design o commitment of the sponsor, supervisor, and institution to the development of the nominee o competence of the faculty sponsor, supervisors, and consultants in the proposed areas of training o one or more subgroups addressed within the priority area o commitment of the nominee, sponsor, supervisor, and institution to public-academic linkages o suitability of the clinical, educational, and research facilities and environments, including community-based programs, for carrying out the proposed activities o adequacy of the budget projections and other resources for carrying out the project activities o if the faculty scholar is to receive training at another institution, assurance of the cooperation of the other institution and competence of the faculty in the proposed area of training o potential of the nominee for a successful academic career along with the capacity to provide faculty leadership upon completion of award RECEIPT AND REVIEW SCHEDULE National Advisory Receipt of Initial Mental Health Earliest Application Review Council Review Start Date June 12, 1991 July September September 1991 Applications received after the deadline specified above will be returned to the applicant. AWARD CRITERIA It is anticipated that in fiscal year 1991 up to six new Individual Faculty Scholar Awards (TO1) will be made. The maximum total cost per award is estimated to be $117,000 per year. A disciplinary school or department in a single institution may submit multiple faculty scholar applications as long as each focuses on a different priority area. In considering multiple requests, however, applicants should be aware that NIMH funding decisions are based, at least in part, on disciplinary and geographic distribution considerations. Awards will be limited to one per professional school or academic department for each priority area. The responsibility for award decisions on applications recommended for approval by the National Advisory Mental Health Council lies solely with authorized NIMH program staff. The following basic criteria will be used in making award decisions: o quality of the overall application as determined during the review process o quality of public-academic linkages provision o where appropriate, balance among disciplines, geographic locations, and priority areas o availability of funds STAFF CONSULTATION Application kits and staff consultation on all aspects of clinical training in the core mental health disciplines in relation to schizophrenic disorders, mood disorders, and severe mental disorders of children and adolescents, with the exception of specific research issues bearing upon these populations, are available from General Information Lemuel B. Clark, M.D., Chief Education and Training Branch (301) 443-5850 Social Work and Marriage Neilson F. Smith, D.S.W., Chief and Family Therapy Social Work Education Program (301) 443-5850 Psychiatry Melvyn R. Haas, M.D., Chief Psychiatry Education Program (301) 443-2120 Psychology Paul Wohlford, Ph.D., Chief Psychology Education Program (301) 443-5850 Psychiatry Nursing Carol Bush, Ph.D., R.N., Chief Psychiatric Nursing Education Program (301) 443-5850 The mailing address for all of the above is: Education and Training Branch Division of Clinical Research National Institute of Mental Health 5600 Fishers Lane, Room 7C02 Rockville, MD 20857 For those wishing staff consultation on research issues, such as NIMH-supported research grants in schizophrenic disorders, mood disorders, and severe mental disorders of children and adolescents, or information regarding training support specifically for research careers in these areas, the following may be contacted: Schizophrenia Alice Lowery Schizophrenia Research Branch Room 10C-06 (301) 443-3524 Mood, Anxiety, and Barry Wolfe, Ph.D. Personality Disorders Mood, Anxiety, and Personality Disorders Research Branch Room 10C-24 (301) 443-3568 Children and Adolescents Eleanor Dibble, D.S.W. Child and Adolescent Disorders Research Branch Room 10-104 (301) 443-5944 Staff consultation on both general clinical training matters and specific research issues in relation to mental disorders of the aging is available from: Enid Light, Ph.D. Mental Disorders of the Aging Research Branch Room 11C-03 (301) 443-1185 The mailing address for the above four staff is: Division of Clinical Research, NIMH 5600 Fishers Lane Rockville, MD 20857 This announcement is not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through DHHS regulations at 45 CFR Part 100.