Vol. 18, No. 10, March 24, 1989 NOTICES NIH/FDA REGIONAL WORKSHOPS - PROTECTION OF HUMAN SUBJECTS ..(84/214)......... 1 National Institutes of Health Food and Drug Administration Index: NATIONAL INSTITUTES OF HEALTH, FOOD AND DRUG ADMINISTRATION DATED ANNOUNCEMENTS (RFPs AND RFAs) PRODUCTION OF POLYCLONAL ANTIBODIES DIRECTED AGAINST RAT PITUITARY HORMONES (RFP) ...................................(220/248)........ 2 National Institute of Diabetes, and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES OPERATION OF A HAEMOPHILUS INFLUENZAE TYPE B REFERENCE LABORATORY (RFP) ...........................................(251/285)........ 3 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES COORDINATING CENTER FOR COLLABORATIVE STUDIES ON THE GENETICS OF ALCOHOLISM (RFA) ........................................(288/312)........ 3 National Institute on Alcohol Abuse and Alcoholism Index: ALCOHOL ABUSE, ALCOHOLISM EXTRAMURAL RESEARCH GROUPS FOR COLLABORATIVE STUDIES ON THE GENETICS OF ALCOHOLISM (RFA) ...............................(321/346)........ 4 National Institute on Alcohol Abuse and Alcoholism Index: ALCOHOL ABUSE, ALCOHOLISM MEASURING THE IMPACT OF ALCOHOL WARNING LABELS (RFA) .......(349/504)........ 4 National Institute on Alcohol Abuse and Alcoholism Index: ALCOHOL ABUSE, ALCOHOLISM AVOIDABLE MORTALITY FROM CANCERS IN NATIVE AMERICAN POPULATIONS (RFA) ....... 6 National Cancer Institute (507/568, 964/1853) Index: CANCER PRIMARY PREVENTION: SMOKING/SMOKELESS TOBACCO USE AND DIETARY CHANGE IN NATIVE AMERICAN POPULATIONS (RFA) ........(571/618, 1856/2759)..... 7 National Cancer Institute Index: CANCER ONGOING PROGRAM ANNOUNCEMENTS HUMAN FACTORS RESEARCH ON OLDER PEOPLE ..................(624/911)........... 7 National Institute on Aging Index: AGING NOTICES NIH/FDA REGIONAL WORKSHOPS - PROTECTION OF HUMAN SUBJECTS P.T. 42; K.W. 0783005, 0783010 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in biomedical and behavioral research. The workshops are open to everyone with an interest in research. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. The current schedule includes: o Dates: April 6-7, 1989 Location: Cincinnati, Ohio Title of Workshop: "Regulations, Ethics, and Compassion" Contact: Mrs. Emogene deMaagd Assistant to Associate Dean for AHEC/CONMED University of Cincinnati 140 Health Professions Bldg. Cincinnati, Ohio 45267 Telephone: (513) 558-5259 o Date: April 13-14, 1989 Location: Honolulu, Hawaii Title of Workshop: "Protecting the Rights of Human Subjects in Research: A Shared Responsibility" Contact: Ms. Vicki Shambaugh Director, Research and Development 846 South Hotel St. (#303) Honolulu, Hawaii 96813-2512 Telephone: (808) 524-4411 o Dates: May 4-5, 1989 Location: Omaha, Nebraska Title of Workshop: "Current Ethical Issues in the Protection of Vulnerable Human Subjects in Clinical, Behavioral, and Sociological Research" Contact: Ms. Marge Adey Center for Continuing Education University of Nebraska Medical Center 42nd and Dewey Avenue Omaha, Nebraska 68105-1065 Telephone: (402) 559-4152 o Dates: June 1-2, 1989 Location: Indianapolis, Indiana Title of Workshop: "Protection from Research Risks: Whom Are We Protecting?" Vol. 18, No. 10, March 24, 1989 - Page 1 Contact: Mrs. Roxanne Loomis Research Risk Coordinator Indiana University 355 Lansing Street Administration Building (Rm. 126) Indianapolis, Indiana 46202 Telephone: (317) 274-8289 o Dates: June 15-16, 1989 Location: Philadelphia, Pennsylvania Title of Workshop: "NIH/FDA Regional Workshop on the Protection of Human Subjects" Contact: Mrs. Ruth Clark Assistant Director for Regulatory Affairs University of Pennsylvania The Office of Research Administration 133 South 36th St. (Suite 300) Philadelphia, Pennsylvania 19104 Telephone: (215) 898-2614 o Dates: July 10-11, 1989 Location: Syracuse, New York Title of Workshop: "Research Involving Human Subjects" Contact: Ms. Linda Weaver Senior Administrator Syracuse University College of Arts and Science 329 Hall of Languages Syracuse, New York 13244-1170 Telephone: (315) 443-2202 Additional workshops will be announced later. For further information regarding human subjects education programs contact: Darlene Marie Ross Education Program Coordinator Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B62 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: (301) 496-8101 DATED ANNOUNCEMENTS (RFPs AND RFAs) PRODUCTION OF POLYCLONAL ANTIBODIES DIRECTED AGAINST RAT PITUITARY HORMONES RFP AVAILABLE: RFP-NIH-NIDDK-89-3 P.T. 34; K.W. 0780005, 0760025, 0760070 National Institute of Diabetes, and Digestive and Kidney Diseases The National Institute of Diabetes, and Digestive and Kidney Diseases has a requirement for the Production of Polyclonal Antibodies Directed Against Rat Pituitary Hormones. The RFP will be available on or about March 27, 1989, and responses will be due approximately 45 days thereafter. The Institute expects to award one contract from this solicitation. To receive a copy of this RFP, please supply this office with two self-addressed mailing labels. Requests for copies of the RFP should be sent to the following address: Vol. 18, No. 10, March 24, 1989 - Page 2 Robert Webber Contract Specialist Contracts Management Branch National Institute of Diabetes, and Digestive and Kidney Diseases Westwood Building, Room 602 Bethesda, Maryland 20892 This advertisement does not commit the Government to make an award. OPERATION OF A HAEMOPHILUS INFLUENZAE TYPE B REFERENCE LABORATORY RFP AVAILABLE: RFP-NIH-NIAID-MIDP-90-l7 P.T. 34; K.W. 0780005, 0755010 National Institute of Allergy and Infectious Diseases The Microbiology and Infectious Diseases Program of the National Institute of Allergy and Infectious Diseases has a requirement for the operation of a Haemophilus influenzae type b reference laboratory. The successful offeror should have the capabilities and facilities to: (1) operate a serologic reference laboratory for performance of assays of Haemophilus influenzae type by capsular polysaccharide antibodies; and (2) provide radiolabeled and reagent-grade PRP antigen to other investigators for performance of radioimmunoassays. This NIAID-sponsored project will take approximately four years to complete. One cost-reimbursement type contract is anticipated. RFP-NIH-NIAID-MIDP-90-17 will be issued on or about April 6, 1989, with a closing date for receipt of proposals tentatively set for May 22, 1989. To receive a copy of the RFP please supply this office with two (2) self-addressed mailing labels. All responsible sources may submit a proposal which will be considered by NIAID. Request for the RFP shall be directed to: Mr. William C. Roberts National Institute of Allergy and Infectious Diseases National Institutes of Health Westwood Building, Room 707 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-2508 This advertisement does not commit the Government to award a contract. COORDINATING CENTER FOR COLLABORATIVE STUDIES ON THE GENETICS OF ALCOHOLISM RFA: 89-AA-01A P.T. 04; K.W. 0404003, 1002019, 0745020, 0760003 National Institute on Alcohol Abuse and Alcoholism New Application Receipt Date: April 24, 1989 The National Institute on Alcohol Abuse and Alcoholism has changed the receipt date for Request for Applications 89-AA-01A, Coordinating Center for Collaborative Studies on the Genetics of Alcoholism from April 3, 1989, to April 24, 1989, to allow additional time to complete the preparation of applications. For further information, see NIH Guide, Volume 17, December 23, 1988, page 5 or contact: W. Sue Badman Shafer, Ph.D. Acting Director, Division of Basic Research, NIAAA 14 C 10 Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-2530 Vol. 18, No. 10, March 24, 1989 - Page 3 EXTRAMURAL RESEARCH GROUPS FOR COLLABORATIVE STUDIES ON THE GENETICS OF ALCOHOLISM RFA: 89-AA-01B P.T. 34; K.W. 0404003, 1002019, 0760002 National Institute on Alcohol Abuse and Alcoholism New Application Receipt Date: April 24, 1989 The National Institute on Alcohol Abuse and Alcoholism has changed the receipt date for Request for Applications 89-AA-01B, Extramural Research Groups for Collaborative Studies on the Genetics of Alcoholism from April 3, 1989, to April 24, 1989, to allow additional time to complete the preparation of applications. For further information, see NIH Guide, Volume 17, December 23, 1988, page 6 or contact: W. Sue Badman Shafer, Ph.D. Acting Director, Division of Basic Research, NIAAA 14 C 10 Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-2530 MEASURING THE IMPACT OF ALCOHOL WARNING LABELS RFA AVAILABLE: AA-89-06 P.T. 34; K.W. 0404003, 0411005, 0404000 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: July 17, 1989 To increase awareness of possible hazards associated with alcohol consumption, all alcoholic beverages manufactured, imported, or bottled for sale or distribution in the United States, after November 18, 1989, are required by law to bear the following statement on the sealed containers in which they are offered for sale to the general public: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2) Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems. National Institute on Alcohol Abuse and Alcoholism (NIAAA) requests applications for research on the impact of warning labels on the knowledge, attitudes, behavior, and alcohol-related morbidity and mortality of relevant American populations. The statutory authorities for anticipated awards are sections 301 and 510 of the Public Health Service Act (42 USC 241 and 290bb). BACKGROUND STUDIES AND RESEARCH DIRECTIONS Although health warning labels have been used on alcoholic beverages in other countries, the literature reveals no studies of their impact. Research on labeling of other substances, such as foods or cigarettes, shows behavior change in the desired direction. To attribute this directly to warning labels, however, is precarious because of the many other countermeasures being applied in close conjunction. It becomes difficult to measure causality and to distinguish independent and interactive effects. Further, the effectiveness of labeling seems to vary with characteristics of the message (e.g., length and complexity) and the audience (e.g., reading and educational levels). Research on mass communication and marketing also have implications for the effective use of alcohol labels. Media interventions appear to be particularly effective when combined with interpersonal communication or community mobilization efforts. In addition, theory and research methods in such disciplines as psychology, sociology and anthropology are germane to alcohol warning label research. NIAAA is most interested in determining the impact of warning labels on drinking behavior and its adverse health consequences. The endpoints should include process outcomes that serve as mediating variables in the cognition-action chain. Also of interest is whether and in what manner warning labels might affect the "cultural position" of alcohol in American Vol. 18, No. 10, March 24, 1989 - Page 4 society--how society perceives, defines, responds to, and controls alcohol use and abuse. Investigators are encouraged to examine the independent effects of warning labels and interactions with other concurrent prevention efforts such as counteradvertising. Researchers should attempt to measure shorter- and longer-term consequences of the labeling intervention, paying particular attention to possible systematic and unpredictable variations in impact. Longitudinal designs that employ time-series analyses would be relevant. If policy makers change the form and content of warning labels over time, the intervention might be viewed as a continuing process with multiple components and effects. It is important to determine how different subgroups will react to warning labels, especially those at high risk for the specific problems that the warning labels address. Studies might additionally focus on groups who are not themselves at high risk, but who are in a key position to help those who are. Another research opportunity concerns the relative impact of different types of warning labels. Variations in content, form, and readability might be studied to determine which messages have the greatest impact on various target populations. Funds under this RFA will not be available in time to support the collection of baseline data prior to the implementation of warning labels in November 1989. Thus, the gathering of baseline data is not a requirement for applications submitted under this RFA. Applicants are encouraged, however, to obtain baseline data in other ways, e.g., by securing seed monies to conduct pilot studies or by identifying relevant information from existing data sets. MECHANISM OF SUPPORT It is estimated $600,000 will be available to make awards for the first year of funding, including direct and indirect costs. If more applications are worthy of support, funds can be made available from the larger R01 pool. Awards will be made as soon as possible after final review in the fall of 1989. REVIEW PROCEDURES AND CRITERIA The standard scientific and technical merit review procedures of the Alcohol, Drug Abuse, and Mental Health Administration will be followed for applications responding to this RFA. Criteria to be used in the merit review include: 1. Relevance of the research to the central focus of the RFA: measuring the impact of alcohol warning labels in increasing awareness of the health hazards of alcohol abuse and in reducing deleterious behavior; 2. Responsiveness of the research approach to possible changes over time in the effects of the warning labels and in the labels themselves; 3. Evidence that the investigators are familiar with the state-of-the-art and existing knowledge gaps in their proposed area of research; 4. Degree of scientific rigor in the design and implementation of the study; 5. Adequacy of the methods used to collect and analyze data; 6. Qualifications and research experience of the principal investigator and other key research personnel; 7. Evidence of availability of facilities, resources, collaborative arrangements, and subjects appropriate to the goals of the research; 8. Adequacy of procedures to protect human subjects; 9. Appropriateness of budget estimates for the proposed research activities. Applicants are urged to include females and ethnic and racial minorities in study populations and at sufficient numbers to generalize the results. If females and minorities are excluded, a clear rationale should be provided. APPLICATION PROCEDURES The standard research grant application form PHS 398 (revised 9/86) must be used to apply for these awards. When applying, type the name of this RFA, "Measuring the Impact of Alcohol Warning Labels, RFA AA-89-06," on page 1, item 2, of PHS 398. State and local government agencies should use form PHS 5161-1 (revised 11/88), and insert the name and number of this RFA on line 9 under Name of Federal Agency. The RFA label in the kit must be affixed to the bottom of the original face page and be duplicated on all copies. Application kits containing the necessary forms and instructions (PHS 398) may be obtained from institutional business offices or offices of sponsored research at most universities, colleges, medical schools, and other major Vol. 18, No. 10, March 24, 1989 - Page 5 research facilities. Application forms may also be obtained from the National Clearinghouse for Alcohol and Drug Information, Reference Department, P.O. Box 2345, Rockville, Maryland 20852 (telephone: 301-468-2600). The signed original and four permanent, legible copies (original and two copies if using form PHS 5161-1) of the complete application and any appendices should be submitted to: Division of Research Grants, NIH Westwood Building, Room 240, Bethesda, Maryland 20892**. In addition, it is requested that the applicant send two copies directly to: Office of Scientific Affairs, NIAAA Parklawn Building, Room 16-C-20 Rockville, Maryland 20857 Telephone: (301) 443-4375 For a copy of the complete RFA and preapplication consultation contact: Dr. Mary Ganikos Prevention Research Branch, NIAAA 5600 Fishers Lane Parklawn Building, Room 16C-03 Rockville, Maryland 20857 Telephone: (301) 443-1677 AVOIDABLE MORTALITY FROM CANCERS IN NATIVE AMERICAN POPULATIONS RFA AVAILABLE: 89-CA-10 P.T. 34, FE; K.W. 0715035, 0745027, 0404000 National Cancer Institute Letter of Intent Receipt Date: May 1, 1989 Application Receipt Date: August 3, 1989 The Special Populations Studies Branch of the Division of Cancer Prevention and Control, National Cancer Institute (NCI) announces the availability of a Request for Applications (RFA) on the above subject. Note that awards will not be made to foreign institutions. The Division of Cancer Prevention and Control (DCPC) invites cooperative agreement applications for investigators to participate, with the assistance of the National Cancer Institute (NCI), in studies to determine the effectiveness of cancer control and prevention intervention strategies in Native American Populations. The subjects for the studies will be Native Hawaiians, Alaskan Natives and American Indians and the research will involve studies which address the effectiveness and efficacy of cancer control and prevention intervention strategies to increase appropriate use of screening procedures to reduce cancer rates and or risks among Native Americans. Interventions in Avoidable Mortality are characterized by methods which will circumvent or reduce barriers to cancer prevention and control services. Such barriers include but are not limited to: (1) Behavioral/Cultural Barriers, i.e., language differences, social psychological considerations, particular cultural beliefs which may affect accessing cancer control services, lack of knowledge and understanding of cancer prevention and control opportunities; and (2) Health System/Structural Barriers, i.e., availability of cancer control services, financial limitations, and transportation barriers. The assistance mechanism used to support these studies will be the cooperative agreement, which is similar to the traditional NIH research grant but which differs from a research grant principally in the extent and nature of NCI staff involvement with investigators. Two elements are critical for obtaining support for a study. Respondents must demonstrate the ability to: 1) access and obtain the participation of the Native American population in which the cancer intervention study will be conducted, and 2) develop and evaluate a culturally compatible intervention in the target population. Intervention Studies will encompass the definition of a Phase Three Cancer Control Study: Controlled Intervention Study. Interested institutions may request copies of the RFA. Approximately $1,200,000 in total costs per year for 5 years will be committed to specifically fund applications which are submitted in response to the RFA. Requests for copies of the RFA should be addressed to: Vol. 18, No. 10, March 24, 1989 - Page 6 Gregory M. Christenson, Ph.D. Special Populations Studies Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 9000 Rockville Pike Bethesda, Maryland 20897 Telephone: (301) 496-8589 PRIMARY PREVENTION: SMOKING/SMOKELESS TOBACCO USE AND DIETARY CHANGE IN NATIVE AMERICAN POPULATIONS RFA AVAILABLE: 89-CA-11 P.T. 34, FE; K.W. 0715035, 0745027, 0404019, 0404000 National Cancer Institute Letter of Intent Receipt Date: May 1, 1989 Application Receipt Date: August 3, 1989 The Special Populations Studies Branch of the Division of Cancer Prevention and Control, National Cancer Institute (NCI), announces the availability of a Request for Applications (RFA) on the above subject. Note that awards will not be made to foreign institutions. The Division of Cancer Prevention and Control (DCPC) invites cooperative agreement applications for investigators to participate, with the assistance of the NCI, in studies to determine the effectiveness of cancer control and prevention intervention strategies in Native American populations. The subjects for the studies will be Native Hawaiians, Alaskan Natives and American Indians and the research will involve studies which address the effectiveness and efficacy of smoking/smokeless tobacco prevention and cessation or dietary change intervention strategies. The assistance mechanism used to support these studies will be the cooperative agreement, which is similar to the traditional NIH research grant. It differs from a research grant principally in the extent and nature of NCI staff involvement with investigators. Two elements are critical for obtaining support for a study. Respondents must demonstrate the ability to: 1) access and obtain the participation of the Native American population in which the cancer intervention study will be conducted, and 2) develop and evaluate a culturally compatible intervention in the target population. Intervention Studies will encompass the definition of a Phase Three Cancer Control Study: Controlled Intervention Study. Interested institutions may request copies of the RFA. Approximately $1,100,000 in total costs per year for 5 years will be committed to specifically fund applications which are submitted in response to the RFA. Requests for copies of the RFA should be addressed to: Gregory M. Christenson , Ph.D. Special Populations Studies Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 9000 Rockville Pike Bethesda, Maryland 20897 Telephone: (301) 496-8589 ONGOING PROGRAM ANNOUNCEMENTS HUMAN FACTORS RESEARCH ON OLDER PEOPLE P.T. 34, CC; K.W. 0710010, 0404000, 0710030 National Institute on Aging I. Introduction The National Institute on Aging (NIA) seeks applications for research and research training that focus on human factors research on older adults. The announcement is part of the broad program of the Institute which was established by law for the "conduct and support of biomedical, social, and behavioral research and training related to the aging process and the diseases and other special problems and needs of the aged." It supplements NIA's broad announcement on HEALTH AND EFFECTIVE FUNCTIONING IN THE MIDDLE AND LATER Vol. 18, No. 10, March 24, 1989 - Page 7 YEARS. (See NIH Guide for Grants and Contracts, Vol. 12, No. 6, June 17, 1983.) It is issued by the Behavioral and Social Research Program in collaboration with the other NIA programs on Neuroscience and Neuropsychology of Aging and on Biomedical Research and Clinical Medicine. II. Background NIA seeks biomedical, behavioral and social applications with a human factors emphasis; that is, applications that relate the skills, capacities, and functioning of older adults to the activities in which they engage and the environments that they encounter. Such a human factors approach to the study of aging should generate a knowledge base that permits optimizing environments, tasks and equipment for older people and identifies interventions designed to improve functioning and enhance quality of life. Two emerging trends are driving the need for human factors research on older people. The first trend is societal. Because the older population is expanding just as the proportion of younger adults is decreasing, older people are becoming an increasingly large segment of the likely users of new and rapidly changing technologies. For example, there are more older drivers than ever before. Older adults are more and more frequent users of recreation and leisure facilities. Additionally, as cohorts of young adults become too small to meet the demands for workers, the century-long trend towards earlier retirement may be reversed: It already is to the economic advantage of many employers and employees to establish working conditions maximally suited to the experience of older workers. In health care, economic and social pressures are increasingly generating the need to investigate new technologies that can aid in the prevention of disability as well as in its amelioration. Such technologies increasingly must be administered at home by the patient or other family members. The second trend is individual and reflects recent research findings. It is already clear that even basic perceptual processes in older adults are improved by altering the environmental conditions of reinforcement. Simple changes in task structure improve performance on memory tasks and can eliminate previously existing age differences. Such results imply that human factors research techniques that focus on the person-environment interaction hold considerable promise for enhancing the functioning of older adults. Therefore, NIA encourages researchers to use the techniques of human factors to address the needs of this population. One central problem for this research area is that the older population is heterogeneous and the environments that they encounter are diverse. Therefore, since it is unlikely that any one set of results will apply to all older people, researchers are encouraged to focus on major subgroups, and on given domains of experience. Likely subgroups include healthy adults living independently, nursing home residents and Alzheimer's patients. Likely domains include home, workplace, leisure activities, transportation, communication, health care and rehabilitation. Background reading on human factors can be found in the Handbook of Human Factors Engineering, (1987), ed., G. Salvendy, New York, Wiley. Research needs on human factors and aging are discussed in the report issued by the National Research Council, Committee on Human Factors, Human Factors Research Issues for an Aging Population (1989) and in the earlier report by the Committee on Vision, Work, Aging and Vision (1987). Both reports are available from the National Research Council, National Academy of Sciences, 2101 Constitution Ave., NW, Washington, DC, 20418. III. Specific Objectives NIA seeks applications that: (a) build upon the principles obtained from prior research that established that older adults' functioning is sensitive to changes in environment; and (b) use these principles to explore and specify how environments may be modified appropriately. Such applications will likely address the following three related questions. (1) How and why, in given environments, do older and younger adults differ in their activities? (2) What are the most appropriate measures of the functional capacities of older and younger adults in relation to particular tasks and environments? (3) How does modifying the older person-environment interaction alter functional capacity? Applications may combine these topics to develop a comprehensive, theoretically guided approach to a particular problem. Interdisciplinary collaboration among human factors researchers and other scientists from the biomedical and behavioral research community is especially encouraged. NIA also seeks research training applications that combine the areas of research on aging and human factors to produce investigators skilled in both specialties. Vol. 18, No. 10, March 24, 1989 - Page 8 (1) Activities of Older and Younger Adults In order to identify those changes to the older person-environment interaction that will have the most impact it is necessary to identify where older and younger adults' activities differ and the reasons for such differences. It is known, for example, that older adults drive substantially less than younger and middle-aged adults. This self-imposed restriction might be removed by better lighting and signs on the highways. However, this intervention would be premature until it is shown that existing lighting and signs contribute to the restriction. In domains, other than driving, less is known about how adults modify their activities as they grow older. For example, the ability to prepare one's own meals is an important aspect of independent functioning that reduces the need for costly care or service delivery. Cross-sectional survey data indicate that many frail older women report difficulty preparing meals. Without observing this activity in detail and specifying major problem areas it is impossible to be certain that a particular intervention strategy is appropriate. A redesigned work area, lighter weight equipment, or simpler operating procedures for appliances, all may help frail older women to prepare meals. However, without prior supporting observation such interventions may prove to be costly errors. Careful description of older and younger adults' activities, then, can do much to establish the base for successful intervention. Researchers should be aware, however, that a purely descriptive study usually will be inappropriate. Instead such applications should be presented in the context of identifying possible intervention strategies. (2) Measures of Functional Capacity Functional capacity refers here to the limits on performance set by an individual's capacities as they fit particular environments and tasks e.g., musculoskeletal flexibility and strength in relation to reaching for heavy objects, or memory performance in relation to adherence to medication schedules. An important part of such functional capacity includes physical health status and its relation to functioning in different kinds of tasks and environments. Change in functional capacity is the goal of any strategy that involves modifying the environment. Applications targeting functional capacity could focus on detailed analyses of performance in certain tasks. Such microanalysis will help to reveal the mechanisms that underlie age differences and may be used to predict how performance will be affected by changes in task structure. Also, analyses that reveal the skills required can be used, together with performance assessments of older humans, to predict those tasks that older adults will find problematic. Measures of reaction time, sensory acuity, accuracy of tracking and pursuit movements, musculoskeletal range of motion and other measures can be integrated into an overall model of older human operators that shows not only the mean performance of particular groups of older adults in given tasks, but also the range of variation expected with changes in health status or declines in sensory systems. Such a model could then be used in environmental design or for intervention programs. (3) Modifying the Older Person-Environment Interaction The primary aim of this announcement is to encourage research that seeks to improve the functioning of older adults through modifying the person-environment interaction. Research on how and why the activities of older and younger adults differ and on the functional capacities of older adults is an important adjunct to that research goal. However, the primary intent is to encourage research that seeks strategies to modify the older person-environment interaction. Such research must be based on integrative theoretical principles that permit detailed predictions, and the results should generalize beyond the specific task or equipment that is investigated. Thus, for example, it is not sufficient to evaluate a particular machine to determine its suitability for use by older people. Instead the research must address the principles that determine when a class of machine will be well suited to older individuals and when it will not. Some applications, focused on aspects of older adults that are task relevant, may test modifications that suit the capacities of older people. Other applications may focus on methods of training older adults in particular skills. Such research on skill learning should again be based on an integrative theory. Showing that a particular training approach is effective Vol. 18, No. 10, March 24, 1989 - Page 9 on one occasion is not sufficient. Instead the research should investigate why the training approach is effective. (4) Need for Research Training NIA encourages institutional applications for research training from interdisciplinary groups that have considerable research experience both in human factors research and aspects of research on aging. Institutional training applications for predoctoral support leading to biomedical and behavioral doctorates with human factors and aging specialties are especially encouraged. There is also a need for postdoctoral training and fellowship applications that allow individuals trained in one of the specialties to gain knowledge and experience of the other specialty. V. Methodology Research applications should be designed to yield findings that generalize beyond the particular setting in which older adults are tested. Applications will therefore benefit from developing a conceptual model of the relevant person-environment interaction and designing studies to evaluate or extend this model. In this way the resulting knowledge base can be applied to new situations as they arise. Researchers may choose different approaches to examine the diverse areas of research described in this announcement. Appropriate methodologies include, but are not limited to, task analysis, critical incident analysis, accident analysis, or simulation of task components. VI. Review Criteria and Application Procedures Research project grant (RO1) and FIRST (R29) applications, fellowships (F32, F33), and research career development awards (KO4) will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. All other applications will be reviewed by an appropriate institute review group. Secondary review will be by the corresponding National Advisory Council. Applications compete on the basis of scientific merit with all other applications. Researchers considering an application in response to this announcement are encouraged to discuss their project, and the range of grant mechanisms available, with staff in advance of formal submission. Investigators should be aware that NIH urges applicants for grants to give added attention (where feasible and appropriate) to the inclusion of minorities in study populations. If minorities are not included in a given study, a clear rationale for their exclusion should be provided. Merely including an arbitrary number of minority group participants in a given study is insufficient to guarantee generalization of results. Applicants should use the regular research project and program project grant application form (PHS 398, Rev. 9/86), available at the applicant's institutional Application Control Office or from the Office of Grants Inquiries, Division of Research grants, NIH (see address below). In order to expedite the application form's routing within NIH, please (1) check the box #2 on the face sheet of the application indicating that your proposal is in response to this announcement and print (next to the checked box) HUMAN FACTORS RESEARCH ON OLDER PEOPLE. In assigning applications to NIA or other Institutes, accepted referral guidelines will be followed. Mail the completed application (with 6 copies) to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** Telephone: (301) 496-7441 Receipt dates for the Research Project Grant, the Research Program Project Grant and the First Independent Research Support and Transition Award applications are February 1, June 1, and October 1; those for the National Research Service Awards applications are January 10, May 10, and September 10. Correspondence and inquiries (please indicate Human Factors Research in your inquiry) should be directed to: Vol. 18, No. 10, March 24, 1989 - Page 10 Dr. Robin Barr Behavioral and Social Research National Institute on Aging Building 31, Room 5C32 Bethesda, Maryland 20892 Telephone: (301) 496-3136 or Dr. Richard Weindruch Biomedical Research and Clinical Medicine National Institute on Aging Building 31, Room 5C25 Bethesda, Maryland 20892 Telephone: (301) 496-9350 or Dr. Leonard Jakubczak Neurosciences and Neuropsychology of Aging National Institute on Aging Building 31, Room 5C35 Bethesda, Maryland 20892 Telephone: (301) 496-9350 This program is described in the Catalog of Federal Domestic Assistance No. 13.866, Aging Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to Health Systems Agency review. **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 Vol. 18, No. 10, March 24, 1989 - Page 11 FULL TEXT OF RFAs FOR ONLINE ACCESS REQUEST FOR RESEARCH COOPERATIVE AGREEMENT APPLICATIONS: RFA NUMBER: 89-CA-10 RFA TITLE: AVOIDABLE MORTALITY FROM CANCER IN NATIVE AMERICAN POPULATIONS P.T. 34, FE; K.W. 0715035, 0745027, 0404000 NATIONAL CANCER INSTITUTE Letter of Intent Receipt Date: 05/01/89 Application Receipt Date: 08/03/89 I. PURPOSE The Division of Cancer Prevention and Control (DCPC) invites cooperative agreement applications for investigators to participate, with the assistance of the National Cancer Institute (NCI), in studies to determine the effectiveness of cancer control and prevention intervention strategies in Native American Populations. The subjects for the studies will be Native Hawaiians, Alaskan Natives and American Indians and the research will involve studies which address the effectiveness and efficacy of cancer control and prevention intervention strategies. The assistance mechanism used to support these studies will be the cooperative agreement, which is similar to the traditional NIH research grant. It differs from a research grant principally in the extent and nature of NCI staff involvement with investigators. II. DISCIPLINES AND EXPERTISE The disciplines and expertise that are appropriate for this research program include a broad knowledge of cancer control science and cancer epidemiology, and may include but are not limited to disciplines and expertise in health intervention, anthropology, nutrition, and behavioral science. The research team should include members with experience in the conduct of epidemiologic or related studies of cancer and/or its associated risk factors and, preferably, in the conduct of health related projects within the Native Hawaiian, Alaskan Native, and American Indian population. Special consideration should be given to team members with demonstrated access to as well as knowledge of and sensitivity to the cultural nuances of the specified study population. The study team must include persons with demonstrated skills in data base management and statistical analysis. _______________________________________ This program is described in the Catalog of Federal Domestic Assistance No. 13.399. Awards are under the authorization of the Public Health Service Act, Title IV, Part A 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. III. BACKGROUND The recommendations of the Secretary of Health and Human Services's Task Force on Black and Minority Health establishing the future research agenda for HHS strongly supported investigations into the effectiveness of Health System Intervention and Preventive Services strategies for minorities including the Native American populations (defined as Native Hawaiians, Alaska Natives, and American Indians) (1). Additionally, The National Cancer Institute (NCI) established (1981) a set of principles for cancer control science which are designed to reduce the incidence, morbidity and mortality of cancers through an orderly sequence of research on interventions and their effect in defined human populations.(2) The Special Populations Studies Branch (SPSB) within the Cancer Control Science Program in the Division of Cancer Prevention and Control was established in l986. The program goals of the SPSB are designed to address NCI's year 2000 goals to reduce and eliminate the differentials in cancer incidence, mortality and survival between minority/special populations and the general population. The terms "special populations" refer to those population segments which may experience or are known to experience high cancer rates and are under served in terms of cancer prevention and control programs e.g. avoidable mortality, smoking or screening programs. Special populations include Blacks, Hispanics, Native Americans (Native Hawaiians, Alaska Natives, and American Indians), Asian Americans, the aging, blue-collar groups, and low- income groups. IV. SCIENTIFIC BACKGROUND Cancer has become an increasingly important health problem for Native American populations. (1) Native Americans have unique cancer rate patterns which include excessive incidence and mortality and poor survival from a number of cancers. Additionally, high or increasing tobacco use (cigarette and smokeless), high dietary fat intake, and numerous barriers to cancer control services exist for these target groups. A. Native Hawaiian The Native Hawaiian population when compared to the general population has: o excessive cancer incidence for esophagus, stomach, lung, breast, cervix uteri, corpus uteri, and ovary; o excessive cancer mortality from all sites combined, breast, cervix uteri, corpus uteri, ovary, esophagus, lung, pancreas, stomach, and leukemia; o survival rates poorer for all sites combined, breast, corpus uteri, prostate, bladder, and leukemia; B. American Indians In comparison to the general population American Indians have: o excessive cancer incidence for stomach, cervix uteri, liver, gallbladder, and kidney; o excessive cancer mortality for cervix uteri, and gallbladder; o survival rates poorer for all sites combined, digestive system, colon/rectum, lung, breast, prostate, and leukemia; C. Alaska Natives Existing data indicate that Alaska Natives are at high risk for nasopharyngeal, gallbladder, cervix, and kidney cancer in females. Elevated risk in males appear for nasopharynx and liver cancers. All three Native American populations are over represented in the lower socioeconomic categories. The lack of financial resources for large numbers of Native Americans affects quality, access, utilization and delivery of health services, including cancer control services, e.g. cancer screening. Low income status has been associated with educational attainment, employment status and occupational category, tobacco use and dietary practices, all of which are related to cancer risk profiles. Factors associated with cancer risk in Native Americans include low cancer knowledge, attitude, and practice test scores; delay in seeking cancer diagnosis or treatment; and higher cancer stage at diagnosis. The etiology, manifestations and natural history of cancer among Native Americans is not well known. Studies are frequently conducted on individual tribes and not repeated, therefore, data on temporal trends in cancer prevalence and incidence in American Natives are limited. Several possible explanations exist for differences in apparent cancer rates and for potential differences in cancer risk factor distributions among Native Americans. Native Americans have undergone rapid cultural changes during this century with many changes taking place during the last 40 to 50 years. Prior to 1940, over 90 per cent of Indians lived on reservations set aside by the Federal Government and, in many cases, constituted a "country within a country" with customs, diet and living conditions that differed dramatically from those of the surrounding white population (3). By the 1980 census, however, almost two thirds of the 1.4 million persons identifying themselves as Indians lived off reservations, tribal trust lands or other Indian lands. Over 50 per cent lived in metropolitan areas and 10 per cent reported living on or near reservations that were in or contiguous to metropolitan areas. Poverty remains widespread and the low socioeconomic status of the majority of Native Americans contributes to the patterns of disease seen in this subgroup of the population. Currently, the amount of cultural and genetic admixture of American Indians with the remaining U.S. population varies substantially and corresponds generally to the geographic location of tribal groups. Far more integration has taken place in some areas and native populations than in others.(4) These changes may account for part of the apparent tribal (and geographic) variation in reported cancer rates. A frequently overlooked but potentially important distinction is the heterogeneity of the Native American Indian. Tribal groups now living within U.S. borders originated from several distinct migrations from Asia into North America over a 40,000 year period. Distinct subgroups of Indians of different origin can be identified both by linguistic analyses and by determination of genetic markers.(5) Some Southwestern tribes are thought to have originated from early migrations and to have returned to the U.S. after initially migrating to Central America while other tribes now residing in the Northern United States are thought to be descendant from later migrations which entered the U.S. from the North. Differences between tribes of American Indians on the main land are further highlighted when the differences of Native Hawaiians and Alaska Natives are included. Multiple factors may contribute to current risk factor levels in Native Americans. Variations may exist among tribal groups, secondary to genetic admixture and to both the degree and duration of acculturation and in relation to attained socioeconomic status. It is important to recognize that generalization about risk factors for cancer in Native Americans are inappropriate and that available data only apply to groups with similar origins and history. V. RESEARCH OBJECTIVES AND SCOPE Controlled studies are necessary to assess the efficacy and effectiveness of cancer prevention and control intervention strategies in Native American populations and to determine the levels and distributions of recognized barriers to service and recognized cancer risk factors. The objective of this RFA is to obtain estimates of the efficacy and effectiveness of culturally sensitive interventions for cancer prevention and control. Overview This study of Avoidable Cancer Mortality in Native Americans is envisioned as taking place in four or five different geographic regions of the United States (Geographic regions may or may not be represented by groups from either or both Alaska and Hawaii. Whether Alaska and/or Hawaii are or are not represented every attempt will be made to provide regional representation within the "lower 48" States.) to enable assessment of cancer control and prevention intervention strategies in Indians from different linguistic (migratory origin) groups. Intervention strategies may differ between Native Americans living in urban areas and those remaining on reservations. The definition of the population at risk and the availability of the population for testing the intervention pose difficulties for studies in Native Americans residing outside of reservations. However, it is thought that creative methodologies could be used to include urban groups; therefore, both Urban and reservation groups are eligible for study under this RFA. For any study in Native Americans to succeed an active collaboration between investigators and the selected tribal groups and local health care providers is essential. Therefore, in their applications, investigators must provide detailed evidence of their ability to obtain cooperation and information from both the selected tribal groups and the agencies which have information regarding Indian health and deaths such as the relevant tribal health services, the local Indian Health Service and the Bureau of Indian Affairs. The study is seen as having three phases: A Planning Phase (Phase I); 2) An intervention and evaluation plan implementation phase, (Phase II); and 3) Data analysis and report preparation phase (Phase III). For planning purposes one possible outline for the study is presented below. This cooperative agreements is designed to enhance cooperation between investigators and NCI. The role of NCI will be that of the provider of technical assistance; however, in order to assess applicant ability to conduct research projects under the conditions of this cooperative agreement, applicants must demonstrate their understanding of the research process and their responsiblilities as a partner in the cooperative agreement. As such, investigators will be responsible for selecting sites and recruiting participants for this study. Each applicant should propose the study design she or he believes most appropriate for this project. This might include a description of the characteristics of the population to be selected. Evidence should be presented indicating the likelihood of recruiting study participants. This should include data on the likelihood of subject availability for long term follow-up. Evidence should be presented indicating the feasibility of achieving significant participation rates in this group. Applicants should discuss the advantages and disadvantages of their proposed approaches to the intervention and describe their plan for obtaining collaboration for the study. Applicants should discuss any factors which they believe should exclude a participant from the study. Applicants should discuss: a) what data should be collected, b) how, when, where and by whom the data are to be collected, and c) the procedures for assuring timeliness, completeness and accuracy of the data. Phase II should be discussed in light of the evidence of barriers to service and evidence of cancer associated risk factors. Core intervention knowledge, attitude and practice data might include interview data. A limited physical examination concentrating on evidence of cancer prevention or control practice and risk factor assessment could also be appropriate. Study Organization The Steering Committee will be the main oversight body of the study and will be composed of the Principal Investigators of the Study Group and the NCI Program Director. Each member will have one vote. The Committee will meet 6 to 8 times during the first 12 months and approximately twice yearly thereafter. All major scientific decisions will be determined by vote of the Steering Committee. All investigators selected will need to be able and willing to implement the core data collection method and strategy collaboratively decided upon by the Steering Committee during Phase I. Additionally, the investigators must be able to implement the intervention strategy specifically designed for their study population. An organizational meeting of the steering committee will be convened early in Phase I by the NCI Program Director. A Chairperson, other than the NCI representative, will be selected during Phase I by a vote of the members. Subcommittees of the Steering Committee, such as Quality Control and Publications Subcommittees, and subcommittees devoted to specific aspects of study design and execution will be convened as necessary. The NCI will have a representative, the Program Director, on each Subcommittee. Local external advisory groups may be set up by individual investigators. Objectives for Phase I Phase I will be the design of the study and should take approximately 12 months. Meetings of a Steering Committee, to be composed of the Principal Investigators and the NCI Program Director, will be held approximately 8 times during this first 12 months. The primary issues to be resolved by the Steering Committee during this phase include design of the over-all study and determination of continued awardee eligibility criteria for participation in Phases II. This phase will have the following objectives: 1. To develop a common protocol using standardized methods to collect cancer control and prevention knowledge, attitude, practice and services data in the selected communities. 2. To develop a common protocol for a core set of intervention activities to be implemented and evaluated at each study site. 3. To develop an over-all evaluation strategy and plan for this intervention study. Investigators will decide during the planning phase whether to conduct the parts of the study sequentially or simultaneously in order to maximize efficiency. Additional objectives for this phase are to develop data forms and a Manual of Operations for the study; to recruit and train key staff in procedures for designing, implementing and evaluating the study. Near the conclusion of this phase, a two to three day training session will be held at a central location. Objectives for Phase II The goal of Phase II is to conduct the intervention studies and collect the data needed to evaluate the effectiveness and efficacy of the interventions. Phase II will consist of two components, 1) implementing the study design including the evaluation plan and the intervention strategy; 2) carrying out the evaluation plan. It is envisioned that all participating groups will implement as part of the project a common standardized protocol developed by the Steering Committee during Phase I. Phase II should take approximately three years to complete. It appears probable that the Steering Committee will need to meet approximately every six months to review progress during the phase II period. Additional communication will be by telephone conference call (approximately monthly). Objectives for Phase III Phase III will be a period for data analysis, manuscript preparation and close out activities. Reduced support will be continued for a limited period to complete final data entry and respond to edit queries. It is anticipated that a description of the main results will be prepared by the investigators and submitted for publication in the scientific literature. Continued participation by as many investigators as possible during this phase is desirable. NCI will support the preparation of written materials with consultation on data analyses, statistical methods, editorial tasks and coordination of meetings. It is anticipated that at least two meetings of the Principal Investigators and NCI staff as well as periodic conference calls will be necessary during this period. VI. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement. The Cooperative Agreement is an assistance mechanism in which NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in Section VII. 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) 82-50,000, revised January 1, l987. This RFA is a one-time solicitation. Generally future unsolicited competing continuation applications will compete as research project applications with all other investigator initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competing continuation cooperative agreement applications for review. Approximately $1,200,000 in total costs per year for 5 years will be committed to specifically fund applications which are submitted in response to the RFA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to this RFA should not exceed five years. The earliest feasible start date for the initial awards will be 03/01/90. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Each applicant should submit an adequately justified budget for each 12 month segment for a total of five years of support. Estimates of staffing needs, including the Principal Investigator and other professional and support staff, need to be included for each phase. The planning period may include up to 8 round trips to a central meeting place plus time and effort of key personnel required to participate in the planning. Staff representing each functional category requiring training might need to be available for a training meeting, held at a central location (Bethesda, MD should be used for cost estimation), before the end of Phase I, for approximately 2 days. VII. Terms of Cooperation Under the cooperative agreement, a partnership will exist between the recipient of the award and the NCI. The role of the NCI will be to provide technical assistance to the awardees. The following terms and conditions pertaining to the scope and nature of the interaction between the NCI and the investigators will be incorporated in the Notice of Award. These agreements will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Terms of Award: Nature of Participation of NCI Staff" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; HHS grant administration regulations at 45 CFR 74; other HHS, PHS, and NIH grant administration policy statements and other NCI administrative terms of award. The terms will be as follows: Responsibilities of the Awardees 1. Coordination Among Investigators Coordination among investigators is required. Shortly after the awards are made, the Principal Investigators and their key personnel, assisted by the NCI Program Director, will develop common data elements, evaluation instruments, and procedures where appropriate. 2. Project Implemention All investigators selected will need to be able and willing to implement the core data collection method and strategy collaboratively decided upon by the steering committee during Phase I. Additionally, the investigators must be able to implement the intervention strategy specifically designed for their study population. 3. Meetings Principal investigators should include in their budgets eight trips to NCI for up to three persons in the first year of the project and two per year there after. These meetings will be for the purpose of convening the steering committee. The NCI Program Director will call the first meeting shortly after awards are made. Subsequent meeting will be scheduled by the Steering Committee during this first session. It is anticipated that common data elements, instruments, and procedures will be agreed upon, thereby enabling comparisons across cooperative agreements. 4. Data Management NCI staff and Principal Investigators (steering committee) will periodically review data management procedures and will have access to all data. Each Principal Investigator will be responsible for supplying computerized data, ready for analysis, to the steering committee for assignment to a sub-committee for data analysis. This sub-committee will consist of, at minimum, one member from each awardee and the NCI Program Director. Analyses will be joint efforts of the data coordination sub-committee, Principal Investigators, and NCI. 5. Reporting Requirements In conjunction with the required annual progress reports, additional information in written report format will be required. A summary report of the project activities up to implementation of the intervention as well as a final report will be required in a format to be supplied after awards are made. 6. Publications Publications of data finding and procedures by each awardee are encouraged. Collaborative publications among grantees, and NCI are anticipated. Inclusion of NCI staff as a co-author will occur if NCI's participation in the analysis warrants such. Plans for joint publication will be outlined no later than the fourth year of the cooperative agreements. Copies of all publications and major presentations are to be provided to the NCI Program Director. Responsibilities of NCI Staff 1. Monitoring There may be periodic on-site monitoring of each project by the NCI Program Director and/or NCI staff designees. Such visits may include discussions with the research team, observation of the interventions, monitoring the data quality control system, fiscal review, etc. These reviews may result in a recommendation for continuation of support, suspension or termination of support previously provided, the withholding of support recommended for future budget periods, or adjustments to recommended levels of support for future years. 2. Personnel The NCI Program Director retains the right to approve all key personnel changes during the project period. Key personnel are the Principal Investigator and the principal project staff responsible for designing and implementing the intervention. 3. Award Continuation Process As part of the annual review process, the NCI Program Director will review the conduct of each study, using information obtained form site visits and the annual progress report, to determine if sufficient progress has been achieved to justify continued funding. As described under "Monitoring" above, adjustments to support may be made based on the review. Decisions for continued funding will be based on overall progress as well as the criteria listed below: o accrual and retention of the number of Native Americans participants adequate to attain the desired statistical power of the project; o cooperation with NCI and fellow awardees (e.g., attending the Steering Committee meetings; implementing group decisions; complying with reporting requirements, etc.); o maintenance of high professional quality in the research and implementation aspects of the project which will allow comparisons across cooperative agreements where common data items exist. Arbitration Procedures These "Terms of Cooperation" require that the NCI Program Director make certain decisions, e.g., concerning continuation of an award based on successful performance of the awardees during Phase I of the cooperative agreement. Disagreements arising pursuant to these approvals will be arbitrated by a panel composed of one award recipient designee, one NCI designee, and a third designee, with expertise in the relevant area, chosen by the other two. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR, Part 50, Subpart D and HHS regulations at 45 CFR, Part 16. VIII. SPECIAL REQUIREMENTS 1. The research team, composed of the Principal Investigator and her or his Co-Investigators for each project, should represent experience in health intervention programs and the conduct of studies which use interdisciplinary researchers who have collaborated with community agencies or groups. The applicant should include in the application a succinct discussion of previous relevant investigational efforts. 2. The applicant must demonstrate that the research team will be able to access the target population and that they have an understanding of and are sensitive to the target population. Where specific language barriers are important the respondent must provide a plan for addressing these barriers. 3. Since evidence exists of geographic variation in cancer rates among Native Americans, NCI staff will take into account demographic and geographic distribution of peer reveiwed and approved applications in the final selection process in order to obtain an assesment of cancer rates and risk factor levels among Native Americans from different geographic locations and linguistic groups. IX. ELIGIBILITY REQUIREMENTS Applicants may be universities, tribal health boards, public health departments, voluntary organizations, health clinics, tribal councils, IHS hospitals and service units, tribal health facilities, etc., or combinations thereof. Teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution to serve as the applicant and assume the responsibility for the conduct of the project. Note that awards will not be made to foreign institutions. X. SPECIAL INSTRUCTIONS FOR PREPARATION OF COOPERATIVE AGREEMENT APPLICATIONS General instructions for the preparation of the cooperative agreement application are contained in the Grant Application Form PHS 398 (revised 9/86). Because the Terms of Cooperation discussed in Section VII above will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Applicants should provide a complete description of how they would propose to conduct the study if selected for funding. Their proposed study design should be completely explained as if it were the design which would eventually be decided on for implementation by the steering committee. Particular attention should be given to the review criteria described under item XI of this RFA. Plans should describe how the applicant will comply with the NCI program staff involvement as well as how all the responsibilities of awardees will be fulfilled. XI. REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURE 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 but may be submitted by the applicant as investigator initiated regular research grants at the next receipt date. 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 which are clearly not competitive for award. The NCI will remove from competition those applications judged to be noncompetitive and return them to the applicant. 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 Applicants are encouraged to submit and describe their own ideas on how best to meet the goals of this announcement. Applications will be judged primarily on the availability of a suitable Native American population for study, evidence of ability to establish collaboration with the tribal groups and other agencies involved in health care of the selected populations, the originality and scientific merit of the application submitted, the discussion of considerations relevant to this RFA, experience of the investigators, capability to perform the work proposed, and a demonstrated willingness to work together with other project staff, and NCI staff. Criteria for review of the applications follow: 1. Ability to identify a Native American population for study and to recruit participants for the intervention and evaluation phase including: o description of the age and sex composition of the population at risk o documentation of the availability of adequate records of medical care and causes of death for the selected population o evidence to indicate the likelihood of acceptable intervention/participation rates (Phase II) o the geographic location and linguistic grouping of the selected tribal group o demonstrated agreement of target group to participate in the study 2. Scientific merit of the study including: o proposed study design o methods of assessment of cancer death rates and incidence and prevalence o methods to assess risk factors for cancer o originality of approach 3. Qualifications, experience and commitment of key personnel including: o scientific and administrative abilities of the Principal Investigator and other team members o experience of the investigators and other key personnel in the conduct of cancer prevention and control intervention studies o experience of members in working with Native Americans o demonstrated evidence of staff understanding of and sensitivity to the cultural and language barriers in the native population o ability of key personnel to devote adequate time for the effective conduct of the study o willingness to work in cooperation with other intervention projects and the NCI in the manner summarized in the RFA, including implementation of the common protocol selected 4. Ability to implement the data collection procedures. 5. A description of facilities and resources available and/or needed. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. XII. LETTER OF INTENT Prospective applicants are asked to submit, by 05/01/89, 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, the NCI would like to emphasize the benefits to the applicant of having a principal investigator submit a letter of intent. First, it allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. In telephone followup with prospective applicants, program staff may provide assistance as well as ascertain whether the prospective applicant has misunderstood the requirements and objectives of the RFA or opted for an inappropriate funding mechanism, NCI staff will be able to inform the applicant. This letter of intent should be sent to: Gregory M. Christenson, Ph.D. Special Populations Studies Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 9000 Rockville Pike Bethesda, Maryland 20892-4200 Telephone: (301) 496-8589 XIII. 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, clarifying scientific content and objectives of an application, size and focus of a research program, organization of an application, and appropriate use of consultants are encouraged and should be directed to Gregory M. Christenson at the above address. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. XIV. METHOD OF APPLYING The regular research grant application form PHS-398 (revised 9/86) must be used in applying for cooperative agreement 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; or from the NCI Program Director named in section XVI above. The RFA label available in the 9/86 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 title of the RFA and the number should be typed on line 2 of the face page on 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 Westwood Building, Room 240 National Institutes of Health 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 828, Westwood Building 5333 Westbard Avenue Bethesda, Maryland 20892 Applications must be received by 08/04/89. If an application is received after that date, it will returned to the applicant. Also, the DRG will not accept any application in response to this announcement that is the same as one currently being considered by any other review group or NIH awarding unit. REFERENCES 1. Report of the Secretary's Task Force on Black and Minority Health. Vol. III: Cancer U.S. Department of Health and Human Services, Washington, D.C., U.S. Government Printing Office, January, l986. 2. NCI Monograph. Cancer Control Objectives for the Nation: l985-2000. (eds) Greenwald, P. and Sondik, E. Division of Cancer Prevention and Control. NIH Pub No 86- 2880, Number 2, l986. 3. DHHS. Proceedings of the National Conference of High Blood Pressure Control in Native American Communities. NIH Publication No. 79-1960. April l977. 4. U.S. Department of Health, Education, and Welfare. The Indian Health Trends and Services. U.S. Government Printing Office. Washington, D.C. l978. HSA 78-12009. 5. Williams RC, Steinberg AG, Gershowitz H, Bennett PH, Knowler WC, Pettitt DJ, Butler W, Baird R, Dowda-Rea L, Burch TA. GM allotypes in Native Americans: evidence for three distinct migrations across the Bering land bridge. Am J Phys Anthropology l985, Jan; 66 (1): 9-19. REQUEST FOR RESEARCH COOPERATIVE AGREEMENT APPLICATIONS: RFA NUMBER: 89-CA-11 RFA TITLE: PRIMARY PREVENTION: SMOKING/SMOKELESS TOBACCO USE AND DIETARY CHANGE IN NATIVE AMERICAN POPULATIONS P.T. 34, FE; K.W. 0715035, 0745027, 0404019, 0404000 NATIONAL CANCER INSTITUTE Letter of Intent Receipt Date: 05/01/89 Application Receipt Date: 08/03/89 I. PURPOSE The Division of Cancer Prevention and Control (DCPC) invites cooperative agreement applications for investigators to participate, with the assistance of the National Cancer Institute (NCI), in studies to determine the effectiveness of cancer control and prevention intervention strategies in Native American Populations. The subjects for the studies will be Native Hawaiians, Alaskan Natives and American Indians and the research will involve studies which address the effectiveness and efficacy of smoking/smokeless tobacco prevention and cessation or dietary change intervention strategies. The assistance mechanism used to support these studies will be the cooperative agreement, which is similar to the traditional NIH research grant. It differs from a research grant principally in the extent and nature of NCI staff involvement with investigators. II. DISCIPLINES AND EXPERTISE The disciplines and expertise that are appropriate for this research program include a broad knowledge of cancer control science and cancer epidemiology, and may include but are not limited to disciplines and expertise in health intervention, anthropology, nutrition, and behavioral science. The research team should include members with experience in the conduct of epidemiologic or related studies of cancer and/or its associated risk factors and, preferably, in the conduct of health related projects within the Native Hawaiian, Alaskan Native, and American Indian population. Special consideration should be given to team members with demonstrated access to as well as knowledge of and sensitivity to the cultural nuances of the specified study population. The study team must include persons with demonstrated skills in data base management and statistical analysis. _______________________________________ This program is described in the Catalog of Federal Domestic Assistance No. 13.399. Awards are under the authorization of the Public Health Service Act, Title IV, Part A 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. III. BACKGROUND The recommendations of the Secretary of Health and Human Services's Task Force on Black and Minority Health establishing the future research agenda for HHS strongly supported investigations into the effectiveness of Health System Intervention and Preventive Services strategies for minorities including the Native American populations (defined as Native Hawaiians, Alaska Natives, and American Indians) (1). Additionally, The National Cancer Institute (NCI) established (1981) a set of principles for cancer control science which are designed to reduce the incidence, morbidity and mortality of cancers through an orderly sequence of research on interventions and their effect in defined human populations.(2) The Special Populations Studies Branch (SPSB) within the Cancer Control Science Program in the Division of Cancer Prevention and Control was established in l986. The program goals of the SPSB are designed to address NCI's year 2000 goals to reduce and eliminate the differentials in cancer incidence, mortality and survival between minority/special populations and the general population. The terms "special populations" refer to those population segments which may experience or are known to experience high cancer rates and are under served in terms of cancer prevention and control programs e.g. avoidable mortality, smoking, dietary change or screening programs. Special populations include Blacks, Hispanics, Native Americans (Native Hawaiians, Alaska Natives, and American Indians), Asian Americans, the aging, blue-collar groups, and low-income groups. IV. SCIENTIFIC BACKGROUND Cancer has become an increasingly important health problem for Native American populations. (1) Native Americans have unique cancer rate patterns which include excessive incidence and mortality and poor survival from a number of cancers. Additionally, high or increasing tobacco use (cigarette and smokeless), high dietary fat intake, and numerous barriers to cancer control services exist for these target groups. A. Native Hawaiian The Native Hawaiian population when compared to the general population has: o excessive cancer incidence for esophagus, stomach, lung, breast, cervix uteri, corpus uteri, and ovary; o excessive cancer mortality from all sites combined, breast, cervix uteri, corpus uteri, ovary, esophagus, lung, pancreas, stomach, and leukemia; o survival rates poorer for all sites combined, breast, corpus uteri, prostate, bladder, and leukemia; B. American Indians In comparison to the general population American Indians have: o excessive cancer incidence for stomach, cervix uteri, liver, gallbladder, and kidney; o excessive cancer mortality for cervix uteri, and gallbladder; o survival rates poorer for all sites combined, digestive system, colon/rectum, lung, breast, prostate, and leukemia; C. Alaska Natives Existing data indicate that Alaska Natives are at high risk for nasopharyngeal, gallbladder, cervix, and kidney cancer in females. Elevated risk in males appear for nasopharynx and liver cancers. All three Native American populations are over represented in the lower socioeconomic categories. The lack of financial resources for large numbers of Native Americans affects quality, access, utilization and delivery of health services, including cancer control services, e.g. cancer screening. Low income status has been associated with educational attainment, employment status and occupational category, tobacco use and dietary practices, all of which are related to cancer risk profiles. Factors associated with cancer risk in Native Americans include low cancer knowledge, attitude, and practice test scores; delay in seeking cancer diagnosis or treatment; and higher cancer stage at diagnosis. The etiology, manifestations and natural history of cancer among Native Americans is not well known. Studies are frequently conducted on individual tribes and not repeated, therefore, data on temporal trends in cancer prevalence and incidence in American Natives are limited. Several possible explanations exist for differences in apparent cancer rates and for potential differences in cancer risk factor distributions among Native Americans. Native Americans have undergone rapid cultural changes during this century with many changes taking place during the last 40 to 50 years. Prior to 1940, over 90 per cent of Indians lived on reservations set aside by the Federal Government and, in many cases, constituted a "country within a country" with customs, diet and living conditions that differed dramatically from those of the surrounding white population (3). By the 1980 census, however, almost two thirds of the 1.4 million persons identifying themselves as Indians lived off reservations, tribal trust lands or other Indian lands. Over 50 per cent lived in metropolitan areas and 10 per cent reported living on or near reservations that were in or contiguous to metropolitan areas. Poverty remains widespread and the low socioeconomic status of the majority of Native Americans contributes to the patterns of disease seen in this subgroup of the population. Currently, the amount of cultural and genetic admixture of American Indians with the remaining U.S. population varies substantially and corresponds generally to the geographic location of tribal groups. Far more integration has taken place in some areas and native populations than in others.(4) These changes may account for part of the apparent tribal (and geographic) variation in reported cancer rates. A frequently overlooked but potentially important distinction is the heterogeneity of the Native American Indian. Tribal groups now living within U.S. borders originated from several distinct migrations from Asia into North America over a 40,000 year period. Distinct subgroups of Indians of different origin can be identified both by linguistic analyses and by determination of genetic markers.(5) Some Southwestern tribes are thought to have originated from early migrations and to have returned to the U.S. after initially migrating to Central America while other tribes now residing in the Northern United States are thought to be descendant from later migrations which entered the U.S. from the North. Differences between tribes of American Indians on the main land are further highlighted when the differences of Native Hawaiians and Alaska Natives are included. Multiple factors may contribute to current risk factor levels in Native Americans. Variations may exist among tribal groups, secondary to genetic admixture and to both the degree and duration of acculturation and in relation to attained socioeconomic status. It is important to recognize that generalization about risk factors for cancer in Native Americans are inappropriate and that available data only apply to groups with similar origins and history. V. RESEARCH OBJECTIVES AND SCOPE Controlled studies are necessary to assess the efficacy and effectiveness of smoking/smokeless tobacco prevention and cessation programs, or dietary change intervention strategies in Native American populations and to determine the levels and distributions of recognized risk behaviors and barriers to service and recognized cancer risk factors. The objective of this RFA is to obtain estimates of the efficacy and effectiveness of culturally sensitive interventions for smoking/smokeless tobacco prevention and cessation, or dietary change for cancer prevention. Overview This study of Primary Prevention in Native Americans is envisioned as taking place in different geographic regions of the United States (Geographic regions may or may not be represented by groups from either or both Alaska and Hawaii. Whether Alaska and/or Hawaii are or are not represented every attempt will be made to provide regional representation within the "lower 48" States.) to enable assessment of intervention strategies in Indians from different linguistic (migratory origin) groups. Intervention strategies may differ between Native Americans living in urban areas and those remaining on reservations. The definition of the population at risk and the availability of the population for testing the intervention pose difficulties for studies in Native Americans residing outside of reservations. However, it is thought that creative methodologies could be used to include urban groups; therefore, both Urban and reservation groups are eligible for study under this RFA. For any study in Native Americans to succeed an active collaboration between investigators and the selected tribal groups and local health care providers is essential. Therefore, in their applications, investigators must provide detailed evidence of their ability to obtain cooperation and information from both the selected tribal groups and the agencies which have information regarding Indian health and deaths such as the relevant tribal health services, the local Indian Health Service and the Bureau of Indian Affairs. The study is seen as having three phases: A Planning Phase (Phase I); 2) An intervention and evaluation plan implementation phase, (Phase II); and 3) Data analysis and report preparation phase (Phase III). For planning purposes one possible outline for the study is presented below. This cooperative agreements is designed to enhance cooperation between investigators and NCI. The role of NCI will be that of the provider of technical assistance; however, in order to assess applicant ability to conduct research projects under the conditions of this cooperative agreement, applicants must demonstrate their understanding of the research process and their responsiblilities as a partner in the cooperative agreement. As such, investigators will be responsible for selecting sites and recruiting participants for this study. Each applicant should propose the study design she or he believes most appropriate for this project. This might include a description of the characteristics of the population to be selected. Evidence should be presented indicating the likelihood of recruiting study participants. This should include data on the likelihood of subject availability for long term follow-up. Evidence should be presented indicating the feasibility of achieving significant participation rates in this group. Applicants should discuss the advantages and disadvantages of their proposed approaches to the intervention and describe their plan for obtaining collaboration for the study. Applicants should discuss any factors which they believe should exclude a participant from the study. Applicants should discuss: a) what data should be collected, b) how, when, where and by whom the data are to be collected, and c) the procedures for assuring timeliness, completeness and accuracy of the data. Phase II should be discussed in light of the evidence of barriers to service and evidence of cancer associated risk factors. Core intervention knowledge, attitude and practice data might include interview data. A limited physical examination concentrating on evidence of tobacco use or diet change and risk factor assessment could also be appropriate. Study Organization The Steering Committee will be the main oversight body of the study and will be composed of the Principal Investigators of the Study Group and the NCI Program Director. Each member will have one vote. The Committee will meet 6 to 8 times during the first 12 months and approximately twice yearly thereafter. All major scientific decisions will be determined by vote of the Steering Committee. All investigators selected will need to be able and willing to implement the core data collection method and strategy collaboratively decided upon by the Steering Committee during Phase I. Additionally, the investigators must be able to implement the intervention strategy specifically designed for their study population. An organizational meeting of the steering committee will be convened early in Phase I by the NCI Program Director. A Chairperson, other than the NCI representative, will be selected during Phase I by a vote of the members. Subcommittees of the Steering Committee, such as Quality Control and Publications Subcommittees, and subcommittees devoted to specific aspects of study design and execution will be convened as necessary. The NCI will have a representative, the Program Director, on each Subcommittee. Local external advisory groups may be set up by individual investigators. Objectives for Phase I Phase I will be the design of the study and should take approximately 12 months. Meetings of a Steering Committee, to be composed of the Principal Investigators and the NCI Program Director, will be held approximately 8 times during this first 12 months. The primary issues to be resolved by the Steering Committee during this phase include design of the over-all study and determination of continued awardee eligibility criteria for participation in Phases II. This phase will have the following objectives: 1. To develop a common protocol (one for smoking/smokeless tobacco and a separate one for dietary change) using standardized methods to collect cancer control and prevention knowledge, attitude, practice and services data in the selected communities (this protocol will differ for dietary change and smoking projects). 2. To develop a common protocol (one for smoking/smokeless tobacco and a separate on for dietary change) for a core set of intervention activities (Differ for smoking and dietary change) to be implemented and evaluated at each study site. 3. To develop an over-all evaluation strategy and plan for the intervention study(ies). Investigators will decide during the planning phase whether to conduct the parts of the study sequentially or simultaneously in order to maximize efficiency. Additional objectives for this phase are to develop data forms and a Manual of Operations for the study; to recruit and train key staff in procedures for designing, implementing and evaluating the study. Near the conclusion of this phase, a two to three day training session will be held at a central location. Objectives for Phase II The goal of Phase II is to conduct the intervention studies and collect the data needed to evaluate the effectiveness and efficacy of the interventions. Phase II will consist of two components, 1) implementing the study design including the evaluation plan and the intervention strategy; 2) carrying out the evaluation plan. It is envisioned that all participating groups will implement as part of the project a common standardized protocol developed by the Steering Committee during Phase I. Phase II should take approximately three years to complete. It appears probable that the Steering Committee will need to meet approximately every six months to review progress during the phase II period. Additional communication will be by telephone conference call (approximately monthly). Objectives for Phase III Phase III will be a period for data analysis, manuscript preparation and close out activities. Reduced support will be continued for a limited period to complete final data entry and respond to edit queries. It is anticipated that a description of the main results will be prepared by the investigators and submitted for publication in the scientific literature. Continued participation by as many investigators as possible during this phase is desirable. NCI will support the preparation of written materials with consultation on data analyses, statistical methods, editorial tasks and coordination of meetings. It is anticipated that at least two meetings of the Principal Investigators and NCI staff as well as periodic conference calls will be necessary during this period. VI. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement. The Cooperative Agreement is an assistance mechanism in which NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement will be to provide technical assistance when requested and required and is described in Section VII. 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) 82-50,000, revised January 1, l987. This RFA is a one-time solicitation. Generally future unsolicited competing continuation applications will compete as research project applications with all other investigator initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competing continuation cooperative agreement applications for review. Approximately $1,100,000 in total costs per year for 5 years will be committed to specifically fund applications which are submitted in response to the RFA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to this RFA should not exceed five years. The earliest feasible start date for the initial awards will be 03/01/90. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Each applicant should submit an adequately justified budget for each 12 month segment for a total of five years of support. Estimates of staffing needs, including the Principal Investigator and other professional and support staff, need to be included for each phase. The planning period may include up to 8 round trips to a central meeting place plus time and effort of key personnel required to participate in the planning. Staff representing each functional category requiring training might need to be available for a training meeting, held at a central location (Bethesda, MD should be used for cost estimation), before the end of Phase I, for approximately 2 days. VII. Terms of Cooperation Under the cooperative agreement, a partnership will exist between the recipient of the award and the NCI. The role of the NCI will be to provide technical assistance to the awardees. The following terms and conditions pertaining to the scope and nature of the interaction between the NCI and the investigators will be incorporated in the Notice of Award. These agreements will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Terms of Award: Nature of Participation of NCI Staff" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; HHS grant administration regulations at 45 CFR 74; other HHS, PHS, and NIH grant administration policy statements and other NCI administrative terms of award. Responsibilities of the Awardees 1. Coordination Among Investigators Coordination among investigators is required. Shortly after the awards are made, the Principal Investigators and their key personnel, with technical assistance from the NCI Program Director, will develop common data elements, evaluation instruments, and procedures where appropriate. 2. Project Implemention All investigators selected will need to be able and willing to implement the core data collection method and strategy collaboratively decided upon by the steering committee during Phase I. Additionally, the investigators must be able to implement the intervention strategy specifically designed for their study population. 3. Meetings Principal investigators should include in their budgets eight trips to NCI for up to three persons in the first year of the project and two per year there after. The first of these meetings, to be held shortly after funding of the agreements, will be called by the NCI Program Director. Subsequent meetings will be planned during the first meeting and scheduled by the Steering Committee. These meetings will be for the purpose of convening the steering committee. It is anticipated that common data elements, instruments, and procedures will be agreed upon, thereby enabling comparisons across cooperative agreements. 4. Data Management Principal Investigators and the NCI Program Director (steering committee) will periodically review data management procedures and will have access to all data. Each Principal Investigator will be responsible for supplying computerized data, ready for analysis, to the steering committee for assignment to a sub-committee for data analysis. This sub-committee will include, at minimum, one member from each awardee and the NCI Program Director. Analyses will be joint efforts of the data coordination sub-committee, Principal Investigators, and NCI. 5. Reporting Requirements In conjunction with the required annual progress reports, additional information will be required in periodic written reports to the NCI Program Director. A summary report of the project activities up to implementation of the intervention as well as a final report will be required in a format to be supplied after awards are made. 6. Publications Publications of data finding and procedures by each awardee are encouraged. Collaborative publications among grantees, and NCI are anticipated. Inclusion of NCI personnel as a co-author will occur if NCI's participation in the analysis warrants such. Plans for joint publication will be outlined no later than the fourth year of the cooperative agreements. Copies of all publications and major presentations are to be provided to the NCI Program Director. Responsibilities of NCI Staff 1. Monitoring There may be periodic on-site monitoring of each project by the NCI Program Director and/or NCI staff designees. Such visits may include discussions with the research team, observation of the interventions, monitoring the data quality control system, fiscal review, etc. These reviews may result in a recommendation for continuation of support, suspension or termination of support previously provided, the withholding of support recommended for future budget periods, or adjustments to recommended levels of support for future years. 2. Personnel The NCI Program Director retains the right to approve all key personnel changes during the project period. Key personnel are the Principal Investigator and the principal project staff responsible for designing and implementing the intervention. 3. Continuation Award Process As part of the annual review process, the NCI Program Director will review the conduct of each study, using information obtained from site visits and the annual progress report to determine if sufficient progress has been achieved to justify continued funding. As described under "Monitoring" above, adjustments to support may be made based on the program review. Decisions for continued funding will be based on overall progress as well as the criteria listed below: o accrual and retention of the number of Native Americans participants adequate to attain the desired statistical power of the project; o cooperation with NCI and fellow awardees (e.g., attending the steering committee meetings; implementing group decisions; complying with reporting requirements, etc.); o maintenance of high professional quality in the research and implementation aspects of the project which will allow comparisons across cooperative agreements where common data items exist. Arbitration Procedures These "Terms of Cooperation" require that the NCI Program Director make certain decisions, e.g., concerning continuation of an award based on successful performance of the awardees during Phase I of the cooperative agreement. Disagreements arising pursuant to these approvals will be arbitrated by a panel composed of one award recipient designee, one NCI designee, and a third designee, with expertise in the relevant area, chosen by the other two. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR, Part 50, Subpart D and HHS regulations at 45 CFR, Part l6. VIII. SPECIAL REQUIREMENTS 1. The research team, composed of the Principal Investigator and her or his Co-Investigators for each project, should represent experience in health intervention programs and the conduct of studies which use interdisciplinary researchers who have collaborated with community agencies or groups. The applicant should include in the application a succinct discussion of previous relevant investigational efforts. 2. The applicant must demonstrate that the research team will be able to access the target population and that they have an understanding of and are sensitive to the target population. Where specific language barriers are important the respondent must provide a plan for addressing these barriers. 3. Since evidence exists of geographic variation in cancer rates among Native Americans, NCI staff will take into account demographic and geographic distribution of peer reviewed and approved applications in the final selection process in order to obtain an assessment of cancer rates and risk factor levels among Native Americans from different geographic locations and linguistic groups. IX. ELIGIBILITY REQUIREMENTS Applicants may be universities, tribal health boards, public health departments, voluntary organizations, health clinics, tribal councils, IHS hospitals and service units, tribal health facilities, etc., or combinations thereof. Teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution to serve as the applicant and assume the responsibility for the conduct of the project. Note that awards will not be made to foreign institutions. X. SPECIAL INSTRUCTIONS FOR PREPARATION OF COOPERATIVE AGREEMENT APPLICATIONS General instructions for the preparation of the cooperative agreement application are contained in the Grant Application Form PHS 398 (revised 9/86). Because the Terms of Cooperation discussed in Section VII above will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Applicants should provide a complete description of how they would propose to conduct the study if selected for funding. Their proposed study design should be completely explained as if it were the design which would eventually be decided on for implementation by the steering committee. Particular attention should be given to the review criteria described under item XI of this RFA. Plans should describe how the applicant will comply with the NCI program staff involvement as well as how all the responsibilities of awardees will be fulfilled. XI. REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURE 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, but may be submitted by the applicant as investigator initiated regular research grants at the next receipt date. 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 which are clearly not competitive for award. The NCI will remove from competition those applications judged to be noncompetitive and will return them to the applicant. 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 Applicants are encouraged to submit and describe their own ideas on how best to meet the goals of this announcement. Applications will be judged primarily on the availability of a suitable Native American population for study, evidence of ability to establish collaboration with the tribal groups and other agencies involved in health care of the selected populations, the originality and scientific merit of the application submitted, the discussion of considerations relevant to this RFA, experience of the investigators, capability to perform the work proposed, and a demonstrated willingness to work together with other project staff, and NCI staff. Criteria for review of the applications follow: 1. Ability to identify a Native American population for study and to recruit participants for the intervention and evaluation phase including: o description of the age and sex composition of the population at risk o documentation of the availability of adequate records of medical care and causes of death for the selected population o evidence to indicate the likelihood of acceptable/intervention participation rates (Phase II) o the geographic location and linguistic grouping of the selected tribal group o demonstrated agreement of target group to participate in the study 2. Scientific merit of the study including: o proposed study design o methods of assessment of cancer death rates and incidence and prevalence o methods to assess risk factors for cancer o originality of approach 3. Qualifications, experience and commitment of key personnel including: o scientific and administrative abilities of the Principal Investigator and other team members o experience of the investigators and other key personnel in the conduct of cancer prevention and control intervention studies o experience of members in working with Native Americans o demonstrated evidence of staff understanding of and sensitivity to the cultural and language barriers in the native population o ability of key personnel to devote adequate time for the effective conduct of the study o willingness to work in cooperation with other intervention projects and the NCI in the manner summarized in the RFA, including implementation of the common protocol selected 4. Ability to implement the data collection procedures. 5. A description of facilities and resources available and/or needed. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. XII. LETTER OF INTENT Prospective applicants are asked to submit, by 05/01/89, 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, the NCI would like to emphasize the benefits to the applicant of having a principal investigator submit a letter of intent. First, it allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. In telephone followup with prospective applicants, program staff may provide assistance as well as ascertain whether the prospective applicant has misunderstood the requirements and objectives of the RFA or opted for an inappropriate funding mechanism. This letter of intent should be sent to: Gregory M. Christenson, Ph.D. Special Populations Studies Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 9000 Rockville Pike Bethesda, Maryland 20892-4200 Telephone: (301) 496-8589 XIII. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries to clarify scientific content and objectives of an application, size and focus of a research program, organization of an application, and appropriate use of consultants, and about whether or not specific proposed research would be responsive are encouraged and should be directed to Gregory M. Christenson at the above address. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. XIV. METHOD OF APPLYING The regular research grant application form PHS-398 (revised 9/86) must be used in applying for cooperative agreement awards. 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; or from the NCI Program Director named in section XVI above. The RFA label available in the 9/86 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 title of the RFA and number should be typed on line 2 of the face page on 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 Westwood Building, Room 240 National Institutes of Health 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 828, Westwood Building 5333 Westbard Avenue Bethesda, Maryland 20892 Applications must be received by 08/03/89. If an application is received after that date, it will returned to the applicant. Also, the DRG will not accept any application in response to this announcement that is the same as one currently being considered by any other review group or NIH awarding unit. REFERENCES 1. Report of the Secretary's Task Force on Black and Minority Health. Vol. III: Cancer U.S. Department of Health and Human Services, Washington, D.C., U.S. Government Printing Office, January, l986. 2. NCI Monograph. Cancer Control Objectives for the Nation: l985-2000. (eds) Greenwald, P. and Sondik, E. Division of Cancer Prevention and Control. NIH Pub No 86- 2880, Number 2, l986. 3. DHHS. Proceedings of the National Conference of High Blood Pressure Control in Native American Communities. NIH Publication No. 79-1960. April l977. 4. U.S. Department of Health, Education, and Welfare. The Indian Health Trends and Services. U.S. Government Printing Office. Washington, D.C. l978. HSA 78-12009. 5. Williams RC, Steinberg AG, Gershowitz H, Bennett PH, Knowler WC, Pettitt DJ, Butler W, Baird R, Dowda-Rea L, Burch TA. GM allotypes in Native Americans: evidence for three distinct migrations across the Bering land bridge. Am J Phys Anthropology l985, Jan; 66 (1): 9-19.