From owner-sci-resources@net.bio.net Sun Oct 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: M J Geisow Newsgroups: bionet.sci-resources Subject: General Request for information from agencies and individuals Date: 2 Oct 1995 15:29:30 -0700 Organization: UnipalmPIPEX server (post doesn't reflect views of UnipalmPIPEX) Lines: 8 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <44lslq$bbp@soap.news> NNTP-Posting-Host: net.bio.net I am organising chairman for a major EU Structural Biology conference in France (March 1996). I would like to hear from anyone about sources of travel funds world wide that I can pass on to applicants through our WWW site: http://www.cryst.bbk.sc.uk/CEC/pope5.html Mike Geisow UK LINK Protein Engineering Programme Co-ordinator From owner-sci-resources@net.bio.net Mon Oct 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 17 September 1995 Date: 2 Oct 1995 17:03:57 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 113 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <44puld$mv0@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): STIS Filename: notice95.txt Document Type: Press Release Title: HURRICANES PAST, PRESENT, AND FUTURE File size (bytes): NEW PERSPECTIVES STIS Filename: pr9558.txt (NSF) Title: NSF AWARDS $9 MILLION UNDER HUMAN CAPITAL INITIATIVE File size (bytes): 3735 STIS Filename: pr9559.txt Title: NEW FOUNDATION SUPPORT RESEARCH COLLABORATIONS-US&STATES FORMER SU File size (bytes): STIS Filename: pr9560.txt Title: THE INTERNET GROWS UP File size (bytes): DOMAIN NAME SERVICES NO LONGER SUBSIDIZED BY TAXPAYERS STIS Filename: pr9561.txt (NSF) ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Graduate Fellowships Title: NSF 95-121 NSF Graduate Fellowship Program File size (bytes): 34351 STIS Filename: nsf95121.txt Also available: nsf95121.wp5 nsf95121.doc Document Type: Press Release Title: NSF AWARDS $9 MILLION UNDER HUMAN CAPITAL INITIATIVE File size (bytes): 3735 STIS Filename: pr9559.txt Title: NSF AWARDS $9 MILLION UNDER HUMAN CAPITAL INITIATIVE File size (bytes): 3735 STIS Filename: pr9559.txt Title: NSF AWARDS $9 MILLION UNDER HUMAN CAPITAL INITIATIVE File size (bytes): 3735 STIS Filename: pr9559.txt Title: NSF AWARDS $9 MILLION UNDER HUMAN CAPITAL INITIATIVE File size (bytes): 3735 STIS Filename: pr9559.txt Title: NSF AWARDS $9 MILLION UNDER HUMAN CAPITAL INITIATIVE File size (bytes): 3735 STIS Filename: pr9559.txt Title: NSF AWARDS $9 MILLION UNDER HUMAN CAPITAL INITIATIVE File size (bytes): 3735 STIS Filename: pr9559.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 44507 STIS Filename: sesvac.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac.txt, the text of your message should be as follows: get sesvac.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac.txt, you would enter: ftp> get sesvac.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Oct 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-96-001 - V24(34) 09/29/95 Date: 2 Oct 1995 17:09:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1139 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <44pv0b$n9i@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AG96001 AG-96-001 P1O1 *************************************** TRIAL OF A COGNITIVE INTERVENTION FOR OLDER ADULTS NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFA: AG-96-001 P.T. 34, CC; K.W. 0710010, 0414005, 0755015 National Institute on Aging National Institute of Nursing Research Letter of Intent Receipt Date: January 15, 1996 Application Receipt Date: March 20, 1996 PURPOSE This Request for Applications (RFA) seeks applications to pursue a cooperative field trial of a cognitive or related perceptual intervention to maintain and promote independent functioning among older adults. This RFA targets older adults who are at increased risk for loss of independence through hospitalization, need for formal care, or other major restrictions in quality of life. A number of recent findings have indicated some promise of preventing or postponing declines in critical activities of daily living through intervention to improve cognitive or related perceptual abilities and skills. However, differences in the outcome measures examined, the kind of intervention chosen, and the samples tested indicate that it is not possible to generalize from individual findings to reach consensus on the success or failure of these techniques. The objective of this project is to stimulate researchers to develop a cooperative trial investigating whether a common cognitive intervention conducted by several sites simultaneously can improve functioning or postpone decline in different samples of subjects, varying in racial, ethnic, gender, socioeconomic, and cognitive characteristics. The common protocol will then allow a consensus assessment of the success of this approach with respect to the likelihood of preventing or postponing the loss of independence, need for formal care, or other major restrictions in quality of life. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priorities. This RFA, Trial of a cognitive Intervention for Older Adults, addresses several priority areas including chronic disabling conditions, physical activity and fitness, and unintentional injuries as they relate to older people. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The support mechanism for these awards will be the cooperative agreement (U01), an assistance mechanism in which substantial NIH scientific involvement with the awardee is anticipated during performance of the activity, as outlined in the award. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study to be funded under the cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." Five years of support should be requested. At that time, depending on the results of the exploratory trial, a second RFA may be issued to pursue a full-scale trial of the intervention. FUNDS AVAILABLE Field Sites It is estimated that $1,380,000 in total costs will be available in the first year for start-up costs associated with the field sites. Funds available for the field sites in the second and subsequent years are expected to increase to $2,700,000 in total costs. These funds are expected to support five to seven sites at an average cost of $450,000 in total costs. Site-specific protocols will be allowed, but will have a maximum of $50,000 in total costs each per year. The purpose of the maximum amount is to protect the integrity of funding for the common protocol. Coordinating Center In the first year, up to $80,000 will be available for start-up costs associated with the coordinating center. In the second year up to $200,000 is expected to be available. In the third year these funds are expected to increase to $400,000 and in the fourth and fifth years the available funds are expected to be $600,000. All estimates are expressed as total costs. These funds will support one coordinating center. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NIA and the NINR, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds for this purpose. RESEARCH OBJECTIVES Background The long-term goal of this initiative is to reduce the increasing public health problems of need for formal care, hospitalization, and substantial loss of independence in the Nation's growing number of older persons. Persons over the age of 65 account for almost half of all days of care in short stay hospitals and constitute the majority of residents of nursing homes. Interventions that can postpone or prevent hospitalization or formal care, therefore, have much to contribute both to public health and to the quality of life among older people. The immediate goal of this initiative is to examine the effects of perceptual and cognitive interventions on more proximal outcome measures that are associated strongly with hospitalization and need for formal care. The impetus for this trial comes from (a) the recent success of a number of different cognitive, or related perceptual, intervention techniques at enhancing some aspects of ability or functioning; (b) the increasing evidence that cognitive factors are associated with key public health outcomes such as hospitalization and death; and (c) the increasing need to find preventative techniques that successfully maintain the quality of life of the older population. Studies reporting success with laboratory-based interventions include: Interventions to increase scores on intellectual abilities (e.g., Baltes & Willis, 1982; Labouvie-Vief & Gonda, 1976; Hayslip, 1989; Hayslip, Maloy, & Kohl, 1995; Willis, 1987); techniques to improve speed of reaction (Baron & Mattila, 1989); training to boost functional perceptual abilities (Ball, Beard, Roenker, Miller, & Griggs, 1988) and training on various aspects of memory (Greenberg & Powers, 1987; Yesavage, 1985). Several studies have also identified a relation between the abilities and skills being intervened on and performance on everyday activities of critical importance to independent functioning (Leirer, Morrow, Pariante, & Sheikh, 1988; Owsley, Ball, Sloane, Roenker, & Bruni, 1991; Ball, Owsley, Sloane, Roenker, & Bruni, 1993). Recent research has confirmed earlier findings of an association between decline in cognitive functioning and measures of hospitalization, need for formal care, and mortality. Analyzing data >From the Longitudinal Study on Aging, Wolinsky and Johnson (1991) found that a factor they call advanced activities of daily living (advanced ADL) was uniquely associated with bed-disability days, hospital contact and mortality. The advanced ADL measure was constructed to focus on cognitive capacity and included measures of telephone communication and planning for the future. Several studies using a range of measures of cognitive impairment have established associations with quality of life of family members and risk of institutionalization (e.g., Branch & Jette, 1982). More recently, Kelman, Thomas, and Kennedy (1994) have identified an association between both mild and severe cognitive impairment and mortality in community-dwelling elderly. Swan, Carmelli, and LaRue (1995) reported that performance on the digit-symbol substitution test was associated with five-year mortality in their sample of older men. The association remained after adjustment for age, education, baseline serum cholesterol, and blood pressure. The association was of the same order as that of a subgroup of subjects with a history of cancer. The above promising findings demonstrate the success of cognitive interventions at improving performance in activities of daily living, and illustrate the now clear links between decline in cognitive function and subsequent hospitalization, need for formal care, and mortality. Nevertheless, no clear consensus exists on the likelihood of success of cognitive interventions at reducing the public health problems of hospitalization and need for formal care in the older population. Differences in the outcome measures examined, the interventions tested, and the samples recruited have made generalizations across different findings impossible. This trial seeks to address these problems by testing a planned intervention on defined samples using common outcome measures. Therefore, the trial will explore whether site-specific variations or specific sample characteristics limit the applicability of the findings. Study Design The scientific goal of the trial is to test the efficacy, using field measures of functioning, of a cognitive or related perceptual, motivational and attitudinal intervention that has previously been found to be successful at improving functioning under laboratory or small-scale field conditions. The focus should be on older adults who are identified to be at risk of loss of independence from causes to which the variables under study contribute. The particular protocol to be developed must provide tests of theories linking changes in degree of independence, to increases or decreases in intellectual and perceptual strategies and processes. Therefore, in order to retain the advantage of a multisite field trial, yet capitalize on the interventions already found to be successful in laboratory studies (see below), the trial should focus on a class of outcome measures that are basic to living independently, have a strong cognitive component, and whose decline has been associated with loss of independence. These significant everyday tasks include, but are not limited to: communicating via the telephone, remembering key events and activities (e.g., remembering to eat, remembering to take medication), and financial planning and management. The intended subject populations must be living largely independent of formal care at the point of entry into the study. Improvement, or postponement of decline, in the activities of daily living (telephone communication, financial management, etc.) should be the primary outcome variable. The final protocol will be designed to allow maximum power on tests of the intervention on this class of variables. Investigators are also encouraged to develop tests for secondary outcome variables, such as hospitalization, need for formal or informal assistance, disability, morbidity, or mortality. However, power calculations should be based on the primary indicator (or indicators) of outcome. The common intervention should involve training of basic abilities or skills, or training on factors expected to boost such basic abilities or skills. Thus, the study should not intervene directly on the outcome variables. The study should include intermediate examinations of maintenance of training effects on the basic abilities and skills. Failure to show maintenance of these effects may be considered a reason to stop the trial. These tests do not substitute for final analyses of the effects of the intervention on the primary outcome variables. Such a test should be planned to be conducted at a time beyond the initial intervention determined by power calculations on differences in the expected relative rate of decline among experimental comparison groups. Particular sites may also propose studies that are planned as site- specific. These studies should be planned to complement or extend the multisite protocol. For example, they may address issues of the specificity of transfer. They may compare the efficacy of training versus cuing (or other environmental support) as a means of maintaining or increasing competence in critical everyday tasks. They may compare the efficacy of intervening on basic abilities alone versus on outcome variables alone, or in combination with training on basic abilities. Such separate hypotheses must be integrated with the planned cooperative project in such a way that their investigation does not compromise the integrity of the cooperative trial across sites. Each application (except for the coordinating center) should propose one intervention as its candidate for the cooperative trial as a whole. The intervention should be designed to improve performance on outcomes that: (a) rely on intact cognitive functioning; and (b) are critical for maintaining independence. These outcomes include but are not limited to: telephone communication, financial management and planning, and remembering key events or instructions. Subsequently, a common protocol will be developed by the steering committee combining the best features of the proposed protocols; this intervention will be used by all field sites. The outcome measures must be justified by: (a) an analysis showing the degree to which the intervened abilities or skills are related to the outcome being measured; (b) their association with direct measures of loss of independence or disability, morbidity or mortality (e.g., hospitalization, need for formal care, bed- disability days); and (c) their estimated sensitivity to tests of the effect of the proposed intervention. Applications must address the issue of the likelihood of transfer of training from the cognitive abilities and skills examined to the primary outcomes proposed. Several recent studies have found that although training is successful at boosting cognitive abilities, transfer to other skills is limited (e.g., Dittman-Kohli, Lachman, Kliegl, & Baltes, 1991, Neely & Backman, 1995). Applications must offer a theoretical rationale as to why transfer would be expected. If the proposed outcome assessment is limited to self- or proxy- report of functioning, the particular self-report or proxy-report surveys used must previously have been validated against relevant outcomes. Simulations may be used as manipulation checks or to provide additional measurement of the outcome. However, the primary outcome measures upon which the intervention is evaluated must be a clearly delimited set, justified by the criteria described above. The intervention that is adopted for this trial as a whole will be conducted cooperatively by all field sites participating in the trial. Therefore, in order to ensure uniform administration across sites, investigators must propose standardization criteria for assessing baseline and follow-up performance on the outcome measures as well as standardization criteria for implementing the intervention. The initiative will examine an intervention designed to prevent, or reduce the risk of, future loss of independence rather than rehabilitate older adults who are already dependent. Therefore, subject groups should be selected who are at recognizable risk of loss of independence but who are living independently at the point of entry into the study. Relevant risk factors can include demographic and social, as well as cognitive factors. Applications may propose screening and eligibility criteria to identify target subjects. The criteria should be expected to eliminate both those who are at little risk of loss of independence over the term of the study and those who, because of a prevailing disease or medical condition (e.g., Alzheimer's disease), would be poor candidates for intervention. However, costs of screening must be carefully controlled to accommodate the overall budget for the study. Investigators may wish to consider collaborating with sites in which there are studies ongoing that use well described samples whose cognitive abilities are already known. Such collaboration may substantially reduce the costs of screening. This initiative is focused on an assessment of the intervention at a substantial interval after treatment. Therefore, proposed designs must be able to accommodate attrition as well as test the efficacy of the treatment on those subjects who adhere to instructions throughout the testing period. Potential applicants should be familiar with appropriate methodological approaches to minimizing attrition, should indicate the expected amount of attrition, and should justify the approach to minimizing attrition that they propose to adopt. Because this field trial is preliminary, power calculations on the primary outcome measures should be based on the number of subjects expected to complete the study, rather than the total number recruited into the study. However, attrition rates substantially higher than expected will be considered a reason to stop the study. Moreover, because the initiative focuses on a delayed assessment, the design for the multisite trial should include intermediate tests of maintenance of the intervention on the targeted basic abilities. The design may also include strategies to ensure maintenance of the intervention's effects, including booster training sessions. SPECIAL REQUIREMENTS A coordinated multisite protocol is dictated by the need to have a planned intervention examined on a defined sample using a common set of outcome measures. The terms and conditions section describes the elements and organization required to assure that a common protocol can be agreed upon, and that recruitment and operating procedures are standardized across intervention sites. Multiple intervention sites will conduct the common protocol. A coordinating center will interact with the intervention sites to ensure the smooth conduct of the trial and to organize data collection and analysis. A steering committee will be the main decision-making body for the trial. An advisory panel, chosen by the steering committee, will provide advice to the committee on the performance of particular sites and on the progress of the trial. These intervention sites may also run site-specific studies designed to complement the multisite protocol. Such studies will not be part of the multisite protocol. The following terms and conditions will be incorporated into the award notice. Terms and Conditions of Award The following special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92 and other HHS, PHS and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U01). Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the collaborative aspects will be shared among the awardees and the NIA/NINR scientific coordinators. 1. Organizational Components Intervention Sites An intervention site is one of several institutions that will receive awards for conducting the multisite protocol under this RFA. The Principal Investigator at each applicant intervention site is encouraged to form a multidisciplinary team, including a senior staff member or consultant who has expertise in clinical trials. Each intervention site will be responsible for recruiting subjects, collecting data using the common protocol, and submitting data to the coordinating center. Intervention site may conduct site specific studies. Coordinating Center The coordinating center will interact with the intervention sites, an advisory panel, and the NIA/NINR scientific coordinators on a variety of topics ranging from seeking and compiling information, to providing technical assistance, to conducting cross-site analyses. In consultation with other organizational components, the coordinating center will have the primary responsibility for instrument development and testing activities (e.g., compiling the listing of proposed common measures; reviewing the literature and assessing the advantages and disadvantages of different measures for common study variables; conducting psychometric analyses on the common data set; and making recommendations at the end of the study about the most parsimonious set of measures to be archived). Moreover, the coordinating center will be responsible for tracking recruitment and retention across the different sites, and advising the sites on strategies for enhancing recruitment/retention, especially in minority populations. The coordinating center will also ensure that data collection is standardized, and will manage and analyze the common data set. This work will also include setting up data collection systems at the different intervention sites and visiting the sites to set up these data systems. The coordinating center will also provide certain support functions. It will develop a cross-project manual of procedures, maintain a directory of intervention sites' staff, arrange all conference calls and meetings, and facilitate information exchange among the sites and NIH, and with the general research community. Steering Committee A steering committee, composed of one principal investigators from each field site, the principal investigator at the coordinating center, and the NIA/NINR scientific coordinators, will be the main governing body of the study. The steering committee will elect a chair from among the principal investigators. The steering committee may also establish subcommittees to oversee major operational components of the study. One vote will be given to each principal investigator and to the NIH. The steering committee will meet at least every six months. The steering committee will have overall responsibility for the multisite intervention and will review, for inclusion in the protocol, proposals from its members for any modifications designed to facilitate any aspect of recruitment, design, or analysis. The steering committee will specify the common data set to be collected, using the information in this RFA as a guide. With the advice of coordinating center staff, it will specify procedures and frequency of data submission to the coordinating center. It will specify rules concerning access to data generated >From the multisite protocol. The steering committee will establish a publications subcommittee to advise on publication and presentation of data collected through the multisite protocol. The chair of the steering committee will also serve as the chair of the publications subcommittee. The publications subcommittee will review all proposed presentations and publications using data from the common protocol. The subcommittee will be responsible for setting standards and guidelines for presenting and publishing data from the common protocol. The subcommittee will also advise on public information dissemination activities regarding the common data set. These requirements are not intended to jeopardize individual investigators' rights to their own data, but are intended to facilitate data sharing and collaborative work. Advisory Panel An advisory panel will be selected by the steering committee to serve in an advisory capacity to the study and all its organizational components. The functions of this panel include reviewing the multisite intervention protocol and making suggestions to the awardees and the NIA/NINR scientific coordinators; monitoring individual site performance, using material provided by the coordinating center and through site inspections; advising the steering committee on design and protocol changes requested by individual investigators; reviewing site-specific protocols and advising on disagreements regarding site-specific studies; and advising the awardees and NIA/NINR scientific coordinators regarding analyses and publications arising from the multisite protocol. The panel will also serve as a data and safety monitoring board for the multisite protocol. In that capacity panel members will monitor the protocol at individual sites for possible adverse effects associated with the design and for variations from prevailing NIH policy on treatment of human subjects. The panel will consist of at least six experts in relevant behavioral, clinical, statistical, and bioethical fields and will convene at least once a year. The experts must be independent of all components of all sites participating in the multisite protocol and be free from conflicts of interest with awardees. A chair will be elected by members of the advisory panel with input from the NIA/NINR scientific coordinators. The chair of the steering committee, the principal investigator of the coordinating center, and the NIA/NINR scientific coordinators will all participate as non-voting members during each panel meeting. Interim conference calls and other correspondence may be necessary between meetings. Two panel members will visit each of the field sites and the coordinating center twice during the course of the multisite protocol. The members will report back to the full advisory panel on the site's compliance with data collection and record keeping procedures and with safety and ethical issues concerning human subjects. 2. Responsibilities Awardee Rights and Responsibilities Awardees individually propose a research design for the common protocol and collectively decide on the design for the common protocol. They are responsible for data analysis. Through the steering committee, they are responsible for changes in the direction of the project and the scope of activities at particular sites. Through a publications committee, they are responsible for preparing publications from the multisite protocol. The individual awardees are responsible for recruitment and retention at their own sites. The coordinating center awardee is responsible for developing and updating a manual of operations and for quality control at the different field sites. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. NIH Staff Responsibilities The NIH scientific coordinators will have substantial scientific/programmatic involvement during conduct of the activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. Such assistance is intended to facilitate, not to direct, the design, implementation and analysis of the trial. Awardees agree to accept assistance from the NIA/NINR scientific coordinators in: o providing technical assistance for developing the common protocol for the multisite intervention, and for formulation or consideration of refinements and adjustments to the study objectives, design and protocol; o monitoring of performance issues involved in recruitment, follow- up, quality control, adherence to protocol, and attainment of study objectives; o assistance in analysis and reporting of the multisite intervention study results; o assistance in identifying subject-matter and financial experts to help the steering committee; o assistance in locating potential replacements for key personnel involved in the project. The NIA/NINR scientific coordinators may also provide advice on statistical requirements. In instances where the NIA/NINR scientific coordinators has had significant input into study design and analysis, and in accordance with publication guidelines developed by the publications committee, and with NIH policies regarding staff co-authorship of publications resulting from extramural awards, he/she may cooperate with awardees as a co- author in preparing manuscripts that report results from these studies. As part of these duties, the NIA/NINR scientific coordinators will meet at least three times with other steering committee members in the first year of the award, and at least twice a year in subsequent years. The scientific coordinator will also meet at least once a year with advisory panel members. Collaborative Responsibilities Development and monitoring of common protocol. The awardees, with the assistance of such other experts as are deemed necessary by the steering committee, shall develop, within six months of the official start date of the awards, a single common protocol for multisite testing of the intervention, drawing upon the best aspects of the applicants' proposals. The protocol will be reviewed by an advisory panel that is chosen by the steering committee. The advisory panel will recommend changes to the steering committee not later than three months after receiving it. The steering committee will then decide on the final form of the protocol. Awardees will be required to accept and implement the common protocol and procedures approved by the steering committee. Following implementation of the protocol, the steering committee will meet at least twice a year, once may be by teleconference, to consider progress at individual sites, progress in the multisite protocol as a whole, and any modifications to the protocol either at individual sites or across all sites. The steering committee will consider advice from the advisory panel as well as input from steering committee members in making decisions regarding the common protocol. Site-specific studies. Individual awardee investigators who conduct site-specific studies in conjunction with the overall trial must submit any proposed study, or modification to a study, to the steering committee regardless of whether the study or modification is considered to affect the management or implementation of the common intervention protocol. Before approving a single-site protocol, the steering committee will determine whether the proposal complements or extends the overall project, and whether it interferes with the common protocol. The $50,000 maximum funds for a site-specific study may be reduced by the steering committee. Arbitration Process Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIH may be brought to arbitration. An arbitration panel will be composed of three members - one selected by the steering committee (the NIH representative will not vote) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIH, and the third member selected by the prior two selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 15, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of the key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Jared B. Jobe Behavioral and Social Research National Institute on Aging Gateway Building, Room 533 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, Bethesda, MD 20892-7762, telephone 301/435-0714, girg@drgpo.drg.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. With the exception of coordinating center applications (see below), instructions in the PHS-398 form should be followed as if the application were a regular (R01) research grant request. Additional Information The information below is requested in addition to the requirements in the PHS 398 package. With the exception of the budget information, all additional information described below should be presented as part of the research plan, which is limited to no more than 25 pages. 1. Choice of Outcome Variables As part of the proposed common intervention each application must propose primary outcome variables that are: (a) measures of activities of daily living; and (b) have a strong cognitive or perceptual component. In particular, applications must offer empirically supported models of the relation between the outcome variables and the cognitive or perceptual abilities and skills being trained. Estimates of the effects of the intervention on these outcome variables must yield sufficient power so that a multisite trial with the budget structure and amount shown under FUNDS AVAILABLE can provide an adequate test of the hypotheses on these outcome variables. 2. Multisite and Single-site Interventions Any intervention proposed by an applicant as the common protocol must be justified by prior published work. These studies must be directly related to the proposed intervention and allow estimates of the likely size of effect of the intervention on samples to be recruited through this trial. Such prior publications are not necessary for interventions proposed as single-site studies. As with a conventional grant, however, theoretical rationale, supporting literature, and some supporting pilot data are an advantage. 3. Sample Population The application must specify the desired sample characteristics (e.g., age, sex, ethnic status, health-status) and size of the multisite sample required to test the proposed multisite intervention. The application must also specify characteristics of the sample to be recruited at the local site. The application must specify the particular recruiting strategies to be used to attract target subjects and any special outreach procedures that will be used to ensure retention of diverse subject groups in the common protocol. If the applicant is proposing collaboration with other investigators who have already recruited well-defined samples to ongoing studies, the letter of collaboration from the principal investigator of such studies must specify the numbers of subjects available for the study and their demographic profile. 4. Screening Instruments Any screening instruments that are proposed for the cooperative trial must be justified both in terms of reliability of measurement and validity in relation to the target subject populations. Estimates of the proportion of subjects who would be excluded through these instruments, and the costs of recruiting replacement subjects should be clearly indicated. 5. Data Analysis The data analysis section should describe both the specific analyses to be performed on site-specific studies, and the analytic plan that yields the power estimates on which the proposed multisite intervention is based. A limited set of primary outcome variables must be identified in the analysis plan. 6. Cooperation The applicant must indicate a willingness to work cooperatively with the NIA/NINR scientific coordinators, the data coordinating center, fellow principal investigators, and the advisory panel in pursuing the research project. 7. Organizational Structure An organizational structure for the intervention site should be described in the application, designating lines of responsibility and authority. 8. Budgeting The applicants should prepare a detailed budget for the first twelve months of the project at the applicant's institution (including sub- contracts). The applicants should assume that data collection does not begin until the tenth month of the project. During the first nine months, funds should be budgeted for the principal investigator, and two other investigators to travel to three steering committee meetings in Bethesda. Funds should also be budgeted for one meeting a year subsequent to that in Bethesda. Applicants should also prepare a budget for the investigator's site-specific costs in all years of the cooperative agreement. Finally, the applicant should prepare a budget for all years of the proposed cooperative intervention across all sites. The budget should reflect all costs of the multisite trial across all sites. Investigators are not required to identify all sites in their application. Costs should be projected using direct costs at the applicant site as the base. Applicants should use a 50 percent indirect cost rate to estimate total costs at sites other than those identified in the application. Acceptance of funding under this RFA implies agreeing to be a participant site for the multisite field trial. 9. Advisory Panel Candidates should not be contacted or recruited to serve on the advisory panel or be named prior to the onset of the project. However, applicants are encouraged to specify areas of expertise appropriate for representation on the panel. Advisory panel members will be reimbursed for necessary travel and attendance at advisory board meetings, but will not receive consultant fees for input to individual projects. Travel funds for members of the panel are to be included as a line item in the coordinating center budget. Special Instructions for Coordinating Center Applications Two completely different applications, with different principal investigators, must be submitted if an institution seeks selection both as an intervention site and as the coordinating center. The coordinating center will provide expertise in multisite field trial design, in the data management and communication associated with such trials, and with multivariate statistical techniques required for analysis and reporting of the results. It is essential that applicants show such expertise among the personnel selected for the coordinating center. Completion of PHS 398 The data coordinating center applications should use the form PHS 398 (rev.5/95). However, the following procedures should be applied in completing it. 1. Human Subjects The data coordinating center is not responsible for Institutional Review Board review of human subject protocols. That is the duty of the individual sites. 2. Budget Both the detailed budget for the first year and the full budget for all years should reflect only costs specific to the data coordinating center. The first year budget should assume that data collection begins in the tenth month of the award. The budget should include projected costs of travel by the advisory panel to the individual field sites and to Bethesda. The budget should include funds for one annual visit to Bethesda by the advisory panel (assume six members of the committee), and funds for two site-visits to each of the field sites by two panel members across the five years of the trial. 3. Research Plan This section should reflect plans for data management (including entering, editing, and storing of data); plans for data archiving; plans for establishing an effective communication network among the different project sites; plans for producing forms, protocols, and a manual of operations for the multisite trial; plans for receiving information from the sites on a regular basis; and plans for integrating that information and providing summaries to the sites, the NIA/NINR scientific coordinators, and the advisory panel. The section should also discuss strategies for enhancing recruitment and retention of subjects at intervention sites, especially among minority populations. This section should also discuss succinctly the alternative benefits of different approaches to data analysis. (The data coordinating center will provide a key role in the design of the multi-phase trial at the start of the project. The center will provide key expertise on how best to integrate the data from the different sites, on the costs to data quality of individual site variation in project design, and on the advantages and disadvantages of different methods of pooling data. These and other relevant issues must be discussed in the application.) All applicants, including coordinating center applicants, must submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. Michael Oxman Scientific Review Office National Institute on Aging Gateway Building, Room 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Applications must be received by March 15, 1996. If an application is received after that date it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NIA/NINR. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the national advisory councils of NIA and NINR. Review Criteria: Field Sites Both the proposed multisite intervention and single-site studies will be evaluated for: o scientific significance and originality of the proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to conduct the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in perceptual and cognitive functioning and aging; o availability of the resources necessary to conduct the proposed research; o appropriateness of the proposed budget; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The proposed multisite intervention will be evaluated for the following additional criteria: o a demonstrated need for the intervention in the proposed target population; o evidence that the intervention has worked in prior small-scale or laboratory studies; o a theoretical rationale that links the targeted basic abilities to the primary outcome measures proposed; o a recruitment strategy that shows how appropriate numbers of suitable subjects can be recruited for the intervention and retained in the study. The recruitment strategy must include a description of procedures to ensure adequate recruitment and retention of women and minority subjects; o evidence of prior experience with multisite clinical or field trial studies; o the time commitment of the principal investigator should be sufficient both to ensure personal supervision of the day-to-day running of that field site and to ensure time to work cooperatively with the coordinating center, principal investigators of other field sites, the advisory panel, and the NIA/NINR program administrators; o demonstrated willingness of the principal investigator and staff to work collaboratively with the coordinating center, the other principal investigators, the advisory panel and the NIA program administrator. Review Criteria: Coordinating Center: o adequacy of the proposed operating procedures for the management of the multisite intervention; o adequacy of the proposed plans for data management and archiving, and for communication among field sites and the coordinating center; o appropriate discussion of alternative procedures for data analysis; o leadership ability, relevant experience in appropriate areas, and scientific stature of the principal investigator. The time commitment of the principal investigator must be sufficient both to supervise the coordinating center staff and to liaise with principal investigators of field sites, the advisory panel, and the NIA/NINR program administrators; o qualifications and experience of other staff of the coordinating center, and their investment of time in the project. It is important that some coordinating staff show prior experience in data analytic and project-coordinating aspects of the management of a multisite field trial; o Commitment from the host institution to the coordinating center's activity and availability of appropriate facilities for the activities proposed; o The appropriateness of the budget. AWARD CRITERIA Awards will be made on the basis of the availability of funds with consideration being given to the compatibility of the different projects funded and the overall representation of women and minorities across the sites selected. Primary weight will be given to results obtained through the NIH peer review mechanism. Schedule Letter of Intent Receipt Date: January 15, 1996 Application Receipt Date: March 15, 1996 Review by Advisory Councils: September, 1996 Anticipated Award Date: September 30, 1996 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Jared B. Jobe Behavioral and Social Research National Institute on Aging Gateway Building, Room 533 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: Jared_Jobe@nih.gov Dr. J. Taylor Harden Extramural Programs National Institute of Nursing Research Natcher Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: THarden@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Mr. David Reiter Grants and Contracts Management National Institute on Aging Gateway Building, Room 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-1472 Email: David_Reiter@nih.gov Bibliography Ball, K., Beard, B.L., Roenker, D.L., Miller, R.L., & Griggs, D.S. (1988). Age and visual search: Expanding the useful field of view. Journal of the Optical Society of America, 5, 2210-2219. Ball, K., Owsley, C., Sloane, M.E., Roenker, D.L., & Bruni, J.R. (1993). Visual attention problems as a predictor of vehicle crashes in older drivers. Investigative Ophthalmology and Visual Science, 34, 3110-3123. Baltes, P.B., & Willis, S.L. (1982). Plasticity and enhancement of intellectual functioning in old age: Penn State's Adult Enrichment Project (ADEPT). In F. I. M. Craik & S. Trehub (Eds.) Aging and Cognitive Processes (pp. 353-390). New York: Plenum Press. Baron, A., & Mattila, W. R. (1989). Response slowing of older adults: Effects of time limit contingencies on single and dual task performances. Psychology and Aging, 4, 66-72. Branch, L. G., & Jette, A. M. (1982). A prospective study of long- term care institutionalization among the aged. American Journal of Public Health, 72, 1373-1379. Dittman-Kohli, F., Lachman, M. E., Kliegl, R., & Baltes, P. B. (1991). Effects of cognitive training and testing on intellectual efficacy beliefs in elderly adults. Journal of Gerontology: Psychological Sciences, 46, P162-164. Greenberg, C., & Powers, S. M. (1987). Memory improvement among adult learners. Educational Gerontology, 12, 385-394. Hayslip, B., Jr., (1989). Alternative mechanisms for improvements in fluid ability performance in older adults. Psychology and Aging, 4, 122-124. Hayslip, B. Jr., Maloy, R. M., & Kohl, R. (1995). Long-term efficacy of fluid ability interventions with older adults. Journal of Gerontology: Psychological Sciences, 50B, P141-149 Kelman, H. R., Thomas, C. Kennedy, G. J., & Cheng, J. (1994). Cognitive impairment and mortality in older community residents. American Journal of Public Health, 84, 1255-1260. Labouvie-Vief, G., & Gonda, J. N. (1976). Cognitive strategy training and intellectual performance in the elderly. Journal of Gerontology, 31, 372-382. Leirer, V. O., Morrow, D. G., Pariante, G. M., & Sheikh, J. I. (1988). Elders' nonadherence, its assessment, and computer assisted instruction for medication recall training. Journal of the American Geriatrics Society, 36, 877-884. Neely, A. S., & Backman, L. (1995). Effects of multifactorial training in old age: Generalizability across tasks and individuals. Journal of Gerontology: Psychological Sciences, 50B, P134-140. Owsley, C., Ball, K., Sloane, M. E., Roenker, D. L., & Bruni, J. R. (1991). Visual/cognitive correlates of vehicle accidents in older drivers. Psychology and Aging, 6, 403-415. Swan, G. E., Carmelli, D., & LaRue, A. (1995). Performance on the digit-symbol substitution test and 5-year mortality in the Western Collaborative Group Study. American Journal of Epidemiology, 141, 32-40. Willis, S. L. (1987). Cognitive training and everyday competence. In K.W. Schaie (Ed.), Annual Review of Gerontology and Geriatrics, 7, New York: Springer. Wolinsky, F. R., & Johnson, R. J. (1991). The use of health services by older adults. Journal of Gerontology: Social Sciences, 46, S345- S357. Yesavage, J. A. (1985). Nonpharmacologic treatments for memory losses with normal aging. American Journal of Psychiatry, 142, 600-605. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A Section 301 (42 USC 241) and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Parts 74 and 92. Special Terms of Awards applying to projects funded in response to this RFA are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administrative regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH grant administration policies. Awardees will maintain custody of, and primary rights to, their data developed under their awards, subject to Government rights of access, consistent with current HHS, PHS, and NIH policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Oct 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 34, pt. 1of1, 29 September 1995 Date: 2 Oct 1995 17:09:39 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 524 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <44pv03$n98@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950929 V24N34 P1O1 ************************************ X-comment: RFAs described: AG-96-001, CA-95-021, DC-96-002, DK-96-006 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/95.09.29 NIH GUIDE - Vol. 24, No. 34 - September 29, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDING OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** BIOLOGICAL TESTING FACILITY (RFP NICHD-CD-96-01) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 03/20/96 ************************************************* TRIAL OF A COGNITIVE INTERVENTION FOR OLDER ADULTS (RFA AG-96-001) National Institute on Aging National Institute of Nursing Research INDEX: AGING; NURSING RESEARCH $$INDEX R3 02/14/96 ************************************************* SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN GASTROINTESTINAL CANCER (RFA CA-95-021) National Cancer Institute INDEX: CANCER $$INDEX R4 04/11/96 ************************************************* CLINICAL TRIALS COOPERATIVE GROUPS (RFA DC-96-002) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX R5 07/17/96 ************************************************* SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS (RFA DK-96-006) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDING OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 34, September 29, 1995 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Alan L. Landay, Ph.D., Rush-Presbyterian--St. Luke~s Medical Center: Based on an investigation conducted by the institution, ORI found that Alan L. Landay, Ph.D., Associate Professor, Department of Immunology/Microbiology, engaged in scientific misconduct involving two instances of plagiarism in publications related to two Public Health Service (PHS) grants. Dr. Landay has entered into a Voluntary Settlement Agreement with ORI in which he has accepted ORI~s finding and, for the two (2) year period beginning August 8, 1995, has voluntarily agreed to: (1) exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) certify in every PHS research application or report that all contributors to the application or report are properly cited or otherwise acknowledged. The certification by the Respondent must be endorsed by an institutional official. A copy of the endorsed certification is to be sent to ORI by the institution. ORI acknowledges that Dr. Landay cooperated with the institutional investigation and the ORI review, accepted responsibility for his actions, and appropriately corrected the scientific literature. The two published papers (Coon, J.S., Landay, A.L., & Weinstein, R.S. "Advances in flow cytometry for diagnostic pathology." Laboratory Investigations 57:453-479, 1987; and Landay, A., Hennings, C., Forman, M., & Raynor, R. "Whole blood method for simultaneous detection of surface and cytoplasmic antigens by flow cytometry." Cytometry 14:433-440, 1993) that contained plagiarized text have been corrected (Landay, A. Correspondence. Laboratory Investigations 70:134, 1994; and Landay, A., Jennings, C., Forman, M., & Raynor, R. Correction. Cytometry 14:698, 1993). INQUIRIES Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NICHD-CD-96-01 ******************************************* BIOLOGICAL TESTING FACILITY NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFP AVAILABLE: NICHD-CD-96-01 P.T. 34; K.W. 0780005, 0755010, 0740022 National Institute of Child Health and Human Development The Contraceptive Development Branch of the Center for Population Research, NICHD, is seeking an organization to operate and maintain a biological testing facility. The program is designed to permit the rapid evaluation of new compositions of matter, drug formulations, delivery systems, and devices. Such evaluation requires the availability of a broad spectrum of biological tests, assays, and analytical procedures. These include antifertility tests in male and female animals, bioassays, mechanism of action studies, radioimmunoassays of steroid and protein hormones, radioreceptorassays, pharmacokinetic studies, and drug safety evaluation. At a minimum, the offeror must have in-house capabilities and technical staff to undertake the tests, assays, and evaluation studies identified in the statement of work, have adequate facilities for undertaking these studies including housing for rats, rabbits, and rhesus monkeys in individual cages, have and maintain AAALAC accreditation, which must be approved by the Office for Protection >From Research Risks (OPRR), NIH for the contract period, have individuals who can be assigned to the contract full-time (100 percent effort) and have experience in conducting studies under GLP guidelines and be ready to perform such studies under the contract. All responsible sources may submit an offer that will be considered by the Agency. It is anticipated that one cost-reimbursement incrementally funded type contract will be awarded under the Request for Proposals (RFP) for a period of five years, beginning June 1, 1996. The RFP represents a recompetition of Contract NO1-HD-1-3130 for the "Operation and Maintenance of a Biological Testing Facility" being performed by Bioqual, Inc., Rockville, Maryland. INQUIRIES This is not an RFP. RFP No. NICHD-CD-96-01 will be issued on or about October 4, 1995. Proposals will be due approximately 60 days thereafter. Copies of the RFP may be obtained by sending a written request to: Paul J. Duska Contracts Management Branch National Institute of Child Health and Human Development Executive Building, Suite 7A-07 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 FAX: (301) 402-3676 $$R1 END ************************************************************ $$R2 BEGIN AG-96-001 FULL-TEXT ************************************** TRIAL OF A COGNITIVE INTERVENTION FOR OLDER ADULTS NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFA AVAILABLE: AG-96-001 P.T. 34, CC; K.W. 0710010, 0414005, 0755015 National Institute on Aging National Institute of Nursing Research Letter of Intent Receipt Date: January 15, 1996 Application Receipt Date: March 20, 1996 PURPOSE This Request for Applications (RFA) seeks applications to pursue a cooperative field trial of a cognitive or related perceptual intervention to maintain and promote independent functioning among older adults who are at increased risk of loss of independence through hospitalization, need for formal care, or other major restriction in quality of life. A number of recent findings have indicated some promise of preventing or postponing declines in critical activities of daily living through intervention to improve cognitive or related perceptual abilities and skills. However, differences in the outcome measures examined, the kind of intervention chosen, and the samples tested indicate that it is not possible to generalize from individual findings to reach consensus on the success or failure of these techniques. The objective of this project is to stimulate researchers to develop a cooperative trial investigating whether a common cognitive intervention conducted by several sites simultaneously can improve functioning or postpone decline in different samples of subjects, varying in racial, ethnic, gender, socioeconomic, and cognitive characteristics. The common protocol will then allow a consensus assessment of the success of this approach with respect to the likelihood of preventing or postponing the loss of independence. It is estimated that $1,380,000 will be available to fund five to seven cooperative agreement (U01) awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priorities. This RFA, Trial of a Cognitive Intervention for Older Adults, addresses several priority areas including chronic disabling conditions, physical activity and fitness, and unintentional injuries as they relate to older people. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Jared B. Jobe Behavioral and Social Research National Institute on Aging Gateway Building, Room 533 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: Jared_Jobe@nih.gov Dr. J. Taylor Harden Extramural Programs National Institute of Nursing Research Natcher Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: THarden@ep.ninr.nih.gov $$R2 END ************************************************************ $$R3 BEGIN CA-95-021 FULL-TEXT ************************************** SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN GASTROINTESTINAL CANCER NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFA AVAILABLE: CA-95-021 P.T. 34; K.W. 0715035, 0715085 National Cancer Institute Letter of Intent Receipt Date: December 4, 1995 Application Receipt Date: February 14, 1996 PURPOSE The Organ Systems Coordinating Branch of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC) at the National Cancer Institute (NCI) invites applications for center grants (P50) for Specialized Programs of Research Excellence (SPORE) that address Gastrointestinal (GI) Cancers of highest incidence and mortality, i.e., colorectal and/or pancreatic cancers. The intent of this initiative is to recompete the SPORE in GI Cancer and to expand the program with the addition of at least one new SPORE through open recompetition. Awards will be made to those institutions at which the highest quality balanced translational research approaches on the prevention, etiology, screening, diagnosis, and treatment of colorectal and/or pancreatic cancers can be conducted. Because basic research in pancreatic cancer has lagged behind that of the other major solid tumors, greater leeway is given for basic research studies on pancreatic cancer. However, such studies must have translational potential or significance. SPOREs are at institutions that have made or will make a strong institutional commitment to the organization and conduct of these programs. SPORE applicants will be judged on their current and potential ability to translate basic research findings into innovative research settings involving patients and populations. Each SPORE is encouraged to conduct rehabilitation and quality-of- life research. Each SPORE must provide career development opportunities for new and established investigators who wish to pursue active research careers in translational GI cancer research; develop and maintain human GI cancer tissue resources that will benefit translational research; develop extended collaborations in critical areas of research need with laboratory scientists and clinical scientists within the institution and in other institutions; and participate with other SPORES on a regular basis to share positive and negative information, assess scientific progress in the field, identify new research opportunities, and promote inter-SPORE collaborations to resolve areas of scientific controversy. Each SPORE and the "network" of SPOREs is expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality to human GI cancer. Each SPORE should support a mix of basic and clinical researchers whose formal interactive and collaborative research efforts will result in new approaches for early detection, diagnosis, therapy, prevention, and control. The SPORE mechanism is not intended to support basic research to the exclusion of clinical research or vice versa. The NCI anticipates making one and possibly two awards, and anticipates setting aside $3 million total for the initial year's funding. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Specialized Programs of Research Excellence (SPORE) in Gastrointestinal Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). INQUIRIES The RFA which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Andrew Chiarodo, Ph.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Suite 512 Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 Email: chiaroda@dcbdcep1.nci.nih.gov $$R3 END ************************************************************ $$R4 BEGIN DC-96-002 FULL-TEXT ************************************** CLINICAL TRIALS COOPERATIVE GROUPS NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFA AVAILABLE: DC-96-002 P.T. 34; K.W. 0715050, 0715055, 0755015 National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: November 1, 1995 Application Receipt Date: April 11, 1996 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications from organizations, institutions, or groups of institutions that have the capability and resources to organize multicenter cooperative clinical trials of the efficacy of treatment for diseases and disorders of human communication. These consortia, referred to as Cooperative Groups, will plan, implement, conduct, analyze and disseminate results of clinical studies on the treatment or management of diseases and disorders of hearing, balance, smell, taste, voice, speech or language, or any combination thereof. The goal of these studies will be to evaluate: 1) innovative therapeutic approaches; 2) established but controversial therapeutic approaches; or 3) modifications in existing therapeutic approaches to diseases and disorders affecting the processes involved in human communication. The administrative and funding mechanism to be used to support this program will be the Cooperative Agreement (U01), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $2,000,000. In Fiscal Year 1997, the NIDCD plans to award up to two Clinical Trials Cooperative Groups. It is anticipated that the size of awards will vary depending on the number of participating institutions and the number of potential study participants. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), "Clinical Trials Cooperative Groups," is related to the priority area of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001- 00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Amy M. Donahue, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400C 6120 EXECUTIVE BOULEVARD MSC 7180 BETHESDA MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 EMAIL: Amy_Donahue@nih.gov $$R4 END ************************************************************ $$R5 BEGIN DK-96-006 FULL-TEXT ************************************** SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFA AVAILABLE: DK-96-006 P.T. 04; K.W. 0715085, 0710030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 19, 1996 Application Receipt Date: July 17, 1996 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) anticipates funding one Silvio O. Conte Digestive Diseases Core Center (P30) grant application submitted in response to this RFA, and will commit up to $800,000 total costs in FY 1997 for this purpose. The receipt of one competing continuation application is anticipated. This application will be in competition with other applications received in response to this Request for Applications (RFA). Silvio O. Conte Digestive Diseases Core Centers provide shared resources, termed cores, to enhance and expand research into a specific area of digestive disease research. Core facilities are intended to enhance the efficiency of research and foster collaborations at institutions with strong existing bases of research relevant to digestive diseases. In addition to biomedical research cores, Centers provide support for pilot and feasibility studies and enrichment activities. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Silvio O. Conte Digestive Diseases Research Core Centers, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and Email from the program contact listed below. Judith M. Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AN12E 45 Center Dr MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: podskalnyj@ep.niddk.nih.gov $$R5 END ************************************************************ From owner-sci-resources@net.bio.net Mon Oct 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 1 October 1995 Date: 2 Oct 1995 17:04:15 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 187 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <44pulv$mvr@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: NSF 95-149 DUE NEWS File size (bytes): STIS Filename: nsf95149.txt Document Type: News Title: PRESIDENT NAMES EIGHT TO RECEIVE NATIONAL MEDAL OF SCIENCE File size (bytes): STIS Filename: mos1995.txt Title: CU-BOULDER PROFESSOR TOM CECH WINS NATIONAL MEDAL OF SCIENCE File size (bytes): STIS Filename: moscech.txt Title: UNIVERSITY OF WASHINGTON PHYSICIST TO RECEIVE NATION'S HIGHEST SCIENTIFIC HONOR File size (bytes): STIS Filename: mosdehme.txt Title: FACT SHEET What is the National Medal of Science? File size (bytes): STIS Filename: mosfacts.txt Title: CALTECH PLANETARY SCIENTIST RECEIVES NATIONAL MEDAL OF SCIENCE File size (bytes): STIS Filename: mosgldre.txt Title: HERMANN HAUS OF MIT TO RECEIVE MEDAL OF SCIENCE FROM PRESIDENT CLINTON File size (bytes): STIS Filename: moshaus.txt Title: NAVAL RESEARCH LABORATORY SCIENTIST TO RECEIVE NATIONAL MEDAL OF SCIENCE File size (bytes): STIS Filename: moskarle.txt Title: NYU MATHEMATICIAN LOUIS NIRENBERG TO BE AWARDED NATIONAL MEDAL OF SCIENCE BY PRESIDENT CLINTON File size (bytes): STIS Filename: mosniren.txt Title: MIT BIOLOGIST ALEXANDER RICH TO RECEIVE MEDAL OF SCIENCE FROM PRESIDENT CLINTON File size (bytes): STIS Filename: mosrich.txt Title: STANFORD SCIENTIST RECEIVES NATIONAL MEDAL OF SCIENCE File size (bytes): STIS Filename: mosshepa.txt Title: TIP 50922 Media Tipsheet September 22, 1995 File size (bytes): STIS Filename: tip50922.txt Document Type: Press Release Title: UNDERGROUND EXPLOSIONS SHED NEW LIGHT ON THE INNER EARTH File size (bytes): STIS Filename: pr9563.txt Document Type: Program Guideline Title: NSF 95-111 Grant Opportunities for Academic Liaison with Industry File size (bytes): STIS Filename: nsf95111.txt Title: NSF 95-139 IMPORTANT PROGRAM AND DEADLINE INFORMATION DIVISION OF MATHEMATICAL SCIENCES File size (bytes): STIS Filename: nsf95139.txt Title: NSF 95-139 IMPORTANT PROGRAM AND DEADLINE INFORMATION DIVISION OF MATHEMATICAL SCIENCES File size (bytes): STIS Filename: nsf95139.txt Title: NSF 95-155 - Research Opportunity File size (bytes): Cooperative Studies Of The Earth's Deep Interior (CSEDI) STIS Filename: nsf95155.txt (NSF) Document Type: Recruit Title: Selective Placement Talent Bank for Persons with Disabilities File size (bytes): STIS Filename: v961d.txt Title: Staff Scientist for Oversight File size (bytes): STIS Filename: vex9531.txt Title: Program Assistant (Office Automation) File size (bytes): STIS Filename: vgs95124.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Grant Conditions Title: FDP-AFO AIR FORCE OFFICE OF SCIENTIFIC RESEARCH (AFOSR) Specific Requirements File size (bytes): 10480 STIS Filename: fdpafo.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112277 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 105592 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 95-112 - Grant Opportunities for Academic Liaison with Industry File size (bytes): 16244 STIS Filename: nsf95112.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 40479 STIS Filename: sesvac.txt Document Type: STIS Title: Document Types on STIS File size (bytes): 1939 STIS Filename: stistype.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve stistype.txt, the text of your message should be as follows: get stistype.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stistype.txt, you would enter: ftp> get stistype.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Oct 02 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-021 - V24(34) 09/29/95 Date: 2 Oct 1995 17:09:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 887 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <44pv0k$na1@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95021 CA-95-021 P1O1 *************************************** SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN GASTROINTESTINAL CANCER NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFA: CA-95-021 P.T. 34; K.W. 0715035, 0715085 National Cancer Institute Letter of Intent Receipt Date: December 4, 1995 Application Receipt Date: February 14, 1996 PURPOSE The Organ Systems Coordinating Branch of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC) at the National Cancer Institute (NCI) invites grant applications (P50) for Specialized Programs of Research Excellence (SPORE) that address Gastrointestinal (GI) Cancers of highest incidence and mortality, i.e., colorectal and/or pancreatic cancers. The intent of this initiative is to recompete the SPORE in GI Cancer and to expand the program with the addition of at least one new SPORE through open recompetition by making awards to those institutions that can conduct the highest quality balanced translational research approaches on the prevention, etiology, screening, diagnosis, and treatment of colorectal and/or pancreatic cancers. Because basic research in pancreatic cancer has lagged behind that of the other major solid tumors, greater leeway is given for basic research studies on pancreatic cancer. However, such studies must have translational potential or significance. SPOREs are at institutions that have made or will make a strong institutional commitment to the organization and conduct of these programs. SPORE applicants will be judged on their current and potential ability to translate basic research findings into innovative research settings involving patients and populations. Each SPORE is encouraged to conduct rehabilitation and quality-of- life research. Each SPORE must provide career development opportunities for new and established investigators who wish to pursue active research careers in translational GI cancer research; develop and maintain human GI cancer tissue resources that will benefit translational research; develop extended collaborations in critical areas of research need with laboratory scientists and clinical scientists within the institution and in other institutions; and participate with other SPORES on a regular basis to share positive and negative information, assess scientific progress in the field, identify new research opportunities, and promote inter-SPORE collaborations to resolve areas of scientific controversy. Each SPORE and the "network" of SPOREs is expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality to human GI cancer. Each SPORE should support a mix of basic and clinical researchers whose formal interactive and collaborative research efforts will result in new approaches for early detection, diagnosis, therapy, and prevention and control. The SPORE mechanism is not intended to support basic research to the exclusion of clinical research or vice versa. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Specialized Programs of Research Excellence (SPORE) in Gastrointestinal Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. To be considered, applicant organizations must have (1) a minimum of three independent investigators who are successful in obtaining peer-reviewed research support directly related to GI cancer, and who together represent experience in both laboratory and clinical research, or in the alternate, a minimum of three independent investigators, each having published articles that significantly address GI cancer in peer- reviewed research journals, and who as a group represent experience in both laboratory and clinical research; (2) access to a patient care and service facility that serves GI cancer patients and, if the facility is not part of the parent institution, a statement that assures access to GI cancer patients for clinical research; the statement must be signed by the responsible officials of the applicant institution and the consortial care facility; (3) although applications must be submitted from one institution, they may include subcontracted collaborative scientific arrangements with scientists >From other institutions as long as these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the parent institution receiving the award. Support will not be provided for applications with research activities focused exclusively on basic research, clinical research or trials, or epidemiological research. NCI staff (See INQUIRIES below) should be consulted if there are questions regarding any of the above requirements or exclusions. MECHANISM OF SUPPORT Support of this program will be through the P50 Specialized Center Grant (P50) mechanism. This mechanism supports any part of the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem. These grants differ from program project grants in that they are more complex and flexible in terms of the types of activities that can be supported. In addition to support for multidisciplinary research projects, support is also provided for career development, pilot research projects, specialized resources, and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed SPORE program. Awards will be administered under the Public Health Service Grants Policy Statement. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI anticipates making one and possibly two awards. Applicants applying for competitive renewals may request up to five years of support. New applicants or applicants that have received P20 SPORE feasibility awards in the past may request up to three years of support. The NCI anticipates setting aside $3 million total for the initial year's funding. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. NCI policy for SPORE grants establishes the following limits to the requested budgets: All new and competing renewal P50 SPORE applications may request up to a maximum annual direct cost of $1.5 million and maximum annual total cost of $2.5 million per individual SPORE. In complying with the direct cost cap of $1.5 million, the indirect costs related to subcontracts to other institutions or organizations will not apply toward the direct cost cap, but the total dollar request may not exceed $2.5 million. Future year increases are limited to four percent, but may not exceed this cap. Funding for successful P50 renewal applications will be for up to five years. Initial funding for new P50 SPOREs will be for no more than three years. Recognizing that the initial three year funding period for new SPOREs may be too short for multiple substantive scientific accomplishments, any future recompetition for this group will be evaluated on scientific accomplishment and on interim progress in pursuit of SPORE organizational, collaborative and research objectives. This would include, for example, progress toward planning, developing and implementing new innovative translational research programs, progress toward developing the careers of new scientists, progress toward procuring and distributing tissue specimens, progress toward developing substantive collaborative interactions. RESEARCH OBJECTIVES Background Gastrointestinal cancers pose major public health problems in this country. In 1995, there are an estimated 100,000 cases of colon cancer and 38,000 cases of rectal cancer with 47,500 and 7,800 deaths respectively. Although there have been recent advances in adjuvant therapy, there have been no major breakthroughs in the treatment of colorectal cancers. Animal studies have provided important insights into the etiology of colon cancer, but there have been no major advances in the prevention of this disease. Pancreatic cancer remains a significant and intransigent problem. The incidence of this cancer (24,000 cases in 1994) approaches the mortality rate (25,000 deaths). Average survival time from time of diagnosis is less than a year. There have been no advances in understanding the causes of this disease, in detecting or diagnosing it early, and there is no effective treatment. Although there have been recent advances in the biology of this disease, pancreatic cancer remains an intransigent cancer. In recent years, the scientific information base for gastrointestinal cancers has expanded significantly. Similarly, there has been increasing interest and opportunity in pancreatic research. This was documented at a workshop on pancreatic cancer convened by the NCI in 1994. The proceedings and research recommendations from this workshop are published in the International Journal of Pancreatology, Volume 16, nos. 2-3, October/November 1994. Application of this scientific base to clinical and preventive activities has not been commensurate with this expansion. Specialized Programs of Research Excellence provide focal points for sustaining and maintaining state- of-the-art research that will contribute to improved detection, diagnosis, treatment and prevention of GI cancer. SPORES will not only be expected to conduct a wide spectrum of research activities, but also to contribute significantly to the development of specialized research resources, career development of new investigators, and the expansion of the research base through collaborative research with scientists and clinicians in other institutions locally and nationwide. The research supported through this program must have translational significance. It will require interdependence between basic and clinical investigators in both the planning and implementation of research and would emphasize clinical application of basic research findings with patients and populations. Translational research also applies clinical findings to advance basic research that ultimately may lead to hypothesis-driven clinical trials or prevention and control interventions. It should be noted that clinical research that is not based on nor derived from laboratory findings is not considered translational for purposes of this RFA. Objectives The goal of this RFA is to expand the current GI Cancer SPORE program with the addition of at least one new SPORE. Each SPORE assembles critical masses of laboratory and clinical scientists to work together on GI cancer and to focus on innovative translation of basic findings into research settings involving patients and populations. The ultimate objective is to reduce incidence and mortality, and to increase and improve survival to the disease. The essential characteristics of a SPORE include (1) a strong scientific program that will have a clear impact on the human disease, (2) a strong innovative developmental or pilot research program that can respond quickly to new research opportunities, (3) a strong career development program to develop and expand the scientific cadre of investigators dedicated to translational research on human GI cancer, (4) a human GI cancer tissue procurement resource, and other resources specifically dedicated to translational research objectives, and (5) a willingness and commitment to work with other SPOREs and scientists in order to maximize research progress. The special features of SPORE grants provide opportunities for investigators with mutual or complementary interests to engage in multidisciplinary research that will impact on prevention, diagnosis, or treatment of human GI cancer, as well as rehabilitation or quality of life. Individual research projects must be highly interactive and must be conceived, planned, and implemented through the multidisciplinary interactions of independent laboratory and clinical scientists. Such interactions should demonstrate the potential for accelerating the translation of research findings into practical benefits for patients and populations. A distinguishing feature of a SPORE P50 grant is the highly dependent nature of the research objectives upon intra- and inter- project interactions. Thus, each project may, but ordinarily would not, be expected to stand on its own in the absence of interactions with other research projects. Developmental research funds provide support for highly innovative pilot projects that take maximum advantage of new research opportunities. This provides a flexible means for responding quickly to new research opportunities. Career development of new and established investigators will generate a cadre of scientists who could leave the SPORE with research experience to develop independent GI cancer research programs that emphasize translational research objectives. In order to facilitate achievement of SPORE program goals, each SPORE must develop resources specialized for GI cancer research activities. This must include human GI cancer tissue collection for research activities of the SPORE and for use by scientists who are concentrating on translational research within and outside the parent institution. The development of additional resources specialized for GI cancer research is also encouraged. Interactions among SPOREs is an important objective of this initiative. This may be in the form of research collaborations, exchange of scientists on a visiting basis, exchange of resources and materials, and other innovative ways. A requirement for all SPOREs is an annual meeting coordinated by the Organ Systems Coordinating Branch of the NCI. The purpose of the meeting is to share scientific information, assess scientific progress, identify new research opportunities, and establish priorities that will accelerate the translation of basic research findings to applied settings in patients and populations. SPECIAL REQUIREMENTS Each SPORE must include the following elements: 1. A strong institutional commitment. An institution receiving this award should incorporate the SPORE high within its institutional priorities. The institution should demonstrate a strong commitment to the program's stability and success. The application must provide a plan which addresses how the institutional commitment will be established and sustained, how it will maintain accountability for promoting scientific progress, and how the SPORE research effort will be given a high priority within the institution relative to other research efforts. This institutional commitment may be in the form of commitments to recruit scientific talent, provision of discretionary resources to the SPORE director, faculty appointments for SPORE investigators, assignment of research space, cost sharing of resources, or other ways to be proposed by the applicant. 2. A qualified principal investigator. A leader should be selected as principal investigator who can oversee and conduct planning activities, provide direction to the SPORE and ensure a translational research emphasis. 3. A substantive GI cancer patient population. Each SPORE should be recognized as a leading program in the treatment of GI cancer. The grant application must demonstrate and document access to a patient population which can participate in and can benefit from the innovative clinical and population research activities of the SPORE. 4. Research projects. Each SPORE application must include at least three approved research projects, which together represent reasonably diverse experimental approaches. Each research project must be headed by basic and clinical co- investigators. It is not necessary that both co- investigators commit equal effort to the project, but it should be evident from this collaboration that translational research objectives will be accelerated. The research must be oriented toward the most critically needed areas of GI cancer research, and toward translational activities which address new innovative possibilities in GI cancer research. As indicated above, each project must involve multidisciplinary laboratory and clinical interaction in the conception, planning, design and implementation of research. Projects should be interactive with each other whenever possible. This program will not support basic research that is without translational potential or significance nor will it support clinical studies that are not "translated" from basic research. Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. Funds should be budgeted for these activities and should appear as a separate budget page in the application. They should not duplicate internal review and monitoring systems that are already in place at the institution. For any treatment protocols supported directly or indirectly by the SPORE, copies of Informed Consent forms, Early Stopping rules and procedures to detect and monitor Adverse Drug Reactions (ADR) must be provided in the application, or in the case of future protocols, to the NCI program director. Collaborative arrangements within the SPORE, within the parent institution and with other institutions are encouraged. Collaborations with scientists outside the immediate SPORE should be documented with appropriate letters of commitment as applicable. Collaborations with other institutions may involve subcontracting arrangements but an award will be made to one institution only; that institution is expected to demonstrate the full institutional commitment noted in 1. above. It is expected that all SPOREs will have a balanced approach to GI cancer that encompasses the areas of prevention, etiology, screening, diagnosis and treatment. This balanced approach may be either through research being conducted in their institution, or through collaborative associations they have developed or plan to develop with other SPOREs or with other investigators in the biomedical research community. 5. Developmental Research Funds. Each SPORE should continually allocate a significant proportion of its budget and effort to pilot projects that explore innovative ideas. It is important that SPOREs use developmental funds to stimulate projects that take maximum advantage of new research opportunities. Pilot projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE environment. The SPORE application should propose an institutional review process that selects pilot projects for funding which represent the most innovative ideas and which are likely to have the greatest impact on reducing GI cancer incidence and mortality, and increasing and improving survival and quality-of-life of GI cancer patients. These funds are intended to remain flexible and to support feasibility and pilot studies of a limited duration, e.g., two years or less, rather than the duration of the entire grant period. The expectation is that successful feasibility studies will become fully developed projects within the SPORE, or funded through other forms of research support, e.g., R29, R01. 6. Specialized Resources. The SPORE must have a dedicated activity to human gastrointestinal cancer tissue collection. This resource must benefit the specific research activities of the SPORE as well as the research activities of other scientists within and outside of the parent institution who are concentrating on translational research issues. The SPORE must be willing to participate in any national prioritization for distribution of tissues through NCI supported tissue networks. A plan must be proposed for prioritizing distribution of tissues to SPORE scientists and others based on the most innovative ideas in translational gastrointestinal cancer research. This plan should be flexible enough to accommodate and complement broader national priorities as they are developed. The development of other resources of special significance to translational research in these cancers is also encouraged. For example, human samples of normal and neoplastic tissues are not easily available. A registry that could organize material from many institutions in a form optimal for laboratory investigation would be invaluable. If the SPORE is part of an NCI-designated Cancer Center, the development of resources should not duplicate resources already provided by the center on an existing Cancer Center Support Grant (P30). The applicant should show that the P50 will become an effective, integrated research arm of the cancer center when it is supported by a P30 grant. 7. Career Development. The SPORE should demonstrate a consistent commitment to career development. A sufficient portion of the budget should be dedicated to the salaries and research activities of investigators who wish to pursue careers in translational research on GI cancer and who would acquire the necessary research experience to develop independent GI cancer translational research programs within or outside of the parent institution. These may be new investigators or established investigators who wish to change research directions. Candidates should be scientists who have demonstrated outstanding research potential but who need additional time in a productive scientific environment to establish an independent GI cancer research program. Candidates are expected to devote full time to research. Any deviation will require prior NCI approval. Recruitment should encourage the participation of qualified women and minorities where possible. To this end, each applicant should include a clear policy and plans for recruiting minorities and women. The SPORE application should propose the number of slots available, the criteria for eligibility and for selection of candidates, and describe the selection process. Also, the application should indicate prospective mentors who are already in place at the proposed SPORE, briefly describe their research programs, and describe complementary activities that contribute to the environment for career development (e.g., existing training grants, other career development mechanisms and relevant programs). 8. Annual Meeting of SPORE. GI Cancer SPOREs will be expected to participate in an annual meeting with the Organ Systems Coordinating Branch of the NCI to share positive and negative results with other SPOREs, share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations that will maximize the impact of the research on reducing incidence and mortality, and improving survival. Travel funds for the Principal Investigator and selected Project Investigators may be budgeted for this purpose. This may include Project Investigators from other institutions who are actively collaborating with SPORE investigators. In addition, travel funds should be budgeted for the SPORE Director to attend an annual SPORE Directors' administrative and planning meeting at the NCI. This Directors' meeting is in addition to the annual SPORE Investigators' meeting. A SPORE application can originate from an institution with or without an existing NCI Cancer Center Support Grant or P30 core grant. However, if a P30 grant already exists: a) the Principal Investigator of the SPORE should be a senior leader in the cancer center; b) the P30 Center Director may be the Principal Investigator of the P50 SPORE, but this is not necessary; c) lines of authority should be indicated clearly such that the SPORE is an integral part of the Cancer Center and does not interfere with the P30 chain of authority; d) a letter of commitment which delineates organizational relationships and lines of authority is required; the letter must be signed by the proposed Principal Investigator of the SPORE, the Cancer Center Director and the appropriate institutional official; e) the SPORE must be an integrated major programmatic element in the cancer center; however, there must also be a separate and distinctive institutional commitment to the SPORE as opposed to the NCI- designated Cancer Center; f) the development of resources in the SPORE should not duplicate resources already provided by the existing P30 grant; however, SPORE resources can be used to augment existing center resources to orient these resources more effectively to SPORE research objectives if this is a more efficient and more cost effective alternative; g) the applicant should describe how the P50 SPORE will interact synergistically and effectively with the existing P30 programs in order to maximize SPORE research objectives and contribute to cancer center research objectives. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 4, 1995, a letter of intent that includes the name and address of the principal investigator and other key personnel, any collaborating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Furthermore, NCI staff can discuss the most recent policies of the NCI relative to funding issues, potential problems in meeting program requirements or clarification of the peer review process before the final application is submitted. The letter of intent is to be sent to: Andrew Chiarodo, Ph.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Suite 512 6130 Executive Boulevard MSC 7386 Bethesda, MD 20892-7386 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8528 FAX: (301) 402-0181 APPLICATION PROCEDURES The research grant application form PHS 398 (Rev.5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the application form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title "SPORE in Gastrointestinal Cancer" must be typed on line 2 of the face page of the application form. Complete applications are due by February 14, 1996. Applications must meet all eligibility requirements as described above and must address all programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA. Applications received after this date will not be accepted. Also, the Division of Research Grants (DRG) will not accept any application in response to this RFA, any part of which is the same as one currently being considered by any other review group or NIH awarding unit. Specific instructions for preparing a SPORE grant application are available from NCI program staff listed under INQUIRIES. These instructions should be used in preparing the application. Submit a signed typewritten original of the application, including the Checklist, and three signed exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA MD 20892-7710 BETHESDA MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities, National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (if hand-delivered or delivery service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received in response to this RFA. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed initially by the Division of Research Grants for completeness. Applications that are incomplete or have not addressed all of the required elements noted above under SPECIAL REQUIREMENTS, or do not meet the ELIGIBILITY REQUIREMENTS as noted above, will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements stated in the RFA is an NCI program staff function; this will be done stringently and will be based primarily on the clear orientation of the application to human GI cancer, translational research objectives, and an absence of duplication between the proposed research and currently supported research. Applications judged to be non- responsive to this RFA will be returned without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit and for special SPORE characteristics and requirements by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Applications judged to be competitive will be discussed and be assigned a priority score. The second level of review will be provided by the National Cancer Advisory Board. B. Review Criteria The major factors to be considered in the evaluation of all applications are given below. Additional factors are noted in a separate section below for applications from P50 SPOREs applying for competitive renewal. 1. The Institutional Commitment a) adequacy of facilities, equipment and space to promote translational research objectives; b) adequacy of institutional procedures and plans for monitoring, evaluating and assuming accountability for the general success of the SPORE; adequacy of the institutional infrastructure for assessing progress and needs; c) adequacy of recruitment objectives and plans to strengthen the scientific capabilities of the SPORE; d) presence of other tangible commitments, i.e., discretionary resources, to the SPORE, e.g., dollars and space. 2. Overall Program Organization and Capability a) the scientific qualifications and demonstrated scientific and administrative leadership capabilities of the SPORE Principal Investigator; adequacy of the time commitment of the Principal Investigator; b) the depth and breadth of the proposed research activities and plans to effectively pursue translational research objectives; c) the adequacy of access to patients and to a population for conducting current and projected therapeutic, prevention and control research; d) the adequacy of the procedures, processes, and plans for promoting interactions; e) if applicable, the adequacy of plans for synergistic and effective interactions with existing P30 programs. 3. Individual Research Projects a) qualifications and demonstrated competence of the investigators to conduct the proposed research; the adequacy of the time commitment of all key laboratory and clinical researchers associated with the project; b) clear evidence of significant multidisciplinary basic and clinical interactions in the conception, design and proposed implementation of the project; c) degree to which the project addresses an issue of substantive importance for reducing incidence and mortality or for increasing survival in human GI cancer; d) the scientific merit and adequacy of experimental design of the project; e) in clinical research components, clear evidence of full protection of human subjects, and appropriate mechanisms for the rigorous management and verification of research data; f) the adequacy of quality assurance and audit processes, and related budget for research involving clinical trials; g) the originality, novelty, and innovativeness of the experimental design and relevance to the overall goals and objectives of the SPORE; h) the degree to which the project is interactive with other projects in the SPORE conceptually, experimentally, and translationally; i) appropriateness of the budget to achieve research objectives. 4. Developmental Funds a) adequacy of the proposed process for continuously reviewing and funding pilot projects for their quality, innovativeness and potential impact on reducing incidence and mortality, and/or improving survival to GI cancer; b) quality, innovativeness and potential impact of proposed pilot projects; c) degree to which developmental funds will be used to stimulate pilot projects with multidisciplinary interactions and/or collaborative interactions with other scientists within or outside of the parent institution; d) appropriateness of the proposed budget relative to the proposed pilot projects and potential of the program to generate innovative pilot projects on a consistent basis. 5. Career Development a) the adequacy of the process for selecting candidates for career development who demonstrate potential for independent research careers or who are established investigators and are changing the direction of their research careers; b) adequacy of the policies to seek out and include qualified minorities and women in the career development program; c) adequacy of the individuals available in the program to serve as possible mentors of career development candidates; the current availability and adequacy of projects for career development candidates; d) complementary activities that contribute to the environment for career development; e) capacity of the overall program to absorb career development candidates and prepare them for independent GI cancer research careers; f) appropriateness of the budget relative to the proposed plans for sustaining a strong activity in career development. 6. Shared Resources a) adequacy of the proposed plans to develop, maintain and distribute a fresh/frozen human GI cancer tissue resource with pathological and clinical data; b) willingness to participate in any national prioritization for distribution of tissues through NCI- supported tissue networks; c) confirmation that the plan does not duplicate resources already available within the institution (e.g. as part of a Cancer Center Support Grant or P30) or through readily available national resources; d) adequacy of the justification for other specialized resources essential for the conduct of SPORE research; e) adequacy of qualifications of proposed managers of resources to conduct high quality, reliable resource operations; f) appropriateness of the requested budgets to conduct each resource operation. 7. Interactions with other SPOREs a) adequacy of plans to promote and maintain communication and integration with other SPOREs; b) willingness to interact with other SPOREs and with the NCI in sharing information, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. The above criteria apply to all new and competing applications. Additional factors to be considered in the evaluation of competing renewal applications from current P50 SPORE grantees, will be: 1. Research Projects a) progress in establishing a high quality research effort and scientific productivity in translational research over the previous funding period; b) degree to which applied researchers (e.g., clinical researchers, prevention and control researchers) are interacting with basic investigators in the planning, design, and implementation of research projects; c) collaborative efforts that have been established within and outside the SPORE institution; d) results (positive or negative) from each research project; e) degree to which each project is interacting with other projects; f) translational potential or significance of each individual research project; 2. Developmental Projects a) progress in the effective use of developmental funds to explore new research opportunities and/or stimulate the field; b) quality, innovativeness, and potential or actual impact of funded pilot projects; c) positive and/or negative results for each developmental project; d) how the SPORE has set priorities in the use of developmental funds; e) impact of developmental projects in stimulating new full translational research projects within the SPORE, or through other support mechanisms; f) impact of developmental projects in stimulating new multidisciplinary or collaborative interactions within or outside the SPORE. 3. Shared Resources a) effectiveness and efficiency of previously funded resources in meeting the specific translational research needs of the scientific projects in the S