NEI CLINICAL VISION RESEARCH DEVELOPMENT AWARD (R21) Release Date: January 27, 2000 PA NUMBER: PAR-00-050 National Eye Institute THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE This Program Announcement (PA) replaces "Clinical Vision Research Development Award", which was originally published in the National Institutes of Health (NIH) Guide for Grants and Contracts, Vol. 16, No. 23, July 10, 1987, and last revised in May, 1998. The Clinical Vision Research Development Award is an NEI support mechanism designed to provide up to $100,000 in annual direct costs for up to five years to assist institutions in developing the expertise of staff and acquiring resources necessary to enhance their clinical vision research programs. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. 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. Foreign institutions are not eligible for NEI Clinical Vision Research Development Awards. Institutions having current or past NEI Core Grant for Vision Research (P30) support for a biostatistics module are not eligible to apply. On the application receipt date, the prospective Principal Investigators and at least one other participating investigator must have a clinical research grant, contract, or cooperative agreement award actively funded by the NEI. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This PA will use the NIH R21 Exploratory/Development Grant award mechanism to provide up to $100,000 annual direct costs. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. This award cannot be renewed. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at https://grants.nih.gov/grants/funding/modular/modular.htm . RESEARCH OBJECTIVES Background The NEI supports a large number of clinical research projects, including single center and multicenter randomized clinical trials, epidemiologic studies, genetic epidemiologic studies, and health services research projects. The intent of these projects is to advance the understanding, prevention, or clinical management of visual system disorders. A number of experienced investigators and research groups are needed to provide leadership in the design and implementation of such clinical vision research projects. Therefore, the NEI wishes to help institutions with NEI-funded investigators augment staff expertise and acquire the resources necessary to enhance their clinical vision research programs. This award is intended to strengthen interactions among clinicians, biostatisticians, epidemiologists, statistical geneticists, and other clinical trial specialists to facilitate the design and conduct of clinical research projects, such as the development of coordinating center capabilities. Prospective applicants should note that institutions holding or planning to submit an NEI Core Grant for Vision Research (P30) award application could request support for the above-mentioned activities by including a biostatistics module. Applicants should consider the relevance of their proposed research to NEI programs and priorities as described in "Vision Research--A National Plan: 1999-2003", which is available at http://www.nei.nih.gov 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not94-100.html . INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html . Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov . BUDGET INSTRUCTIONS Modular Grant applications will request Direct Costs in $25,000 modules, up to a Total Direct Cost request of $100,000 per year. The Total Direct Costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE- In item 2 check "Yes" and enter the PA number and "NEI Clinical Vision Research Development Award". Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) Costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative Page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the Total Direct Costs requested for each year. This is not a Form Page. o Personnel - List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs (Direct plus F&A Costs) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and their role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. o Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years; - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A Costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submit a signed, typewritten original of the application, including the Checklist, and four signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW 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, one additional copy of the application should be sent to: Andrew P. Mariani, Ph.D. Chief, Scientific Review Branch National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda MD 20892-7164 REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NEI in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and will be discussed and assigned a priority score. All applications also receive a second level review by the National Advisory Eye Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Relationship of the proposed program area in which to develop a clinical research capability with the NEI's published priorities as set forth in "Vision Research--A National Plan: 1999-2003" (2) Approach: Description of the initial problem(s) proposed for study and an outline of long-range plans for continuing the studies after termination of the requested support; identification of any potential difficulties that may arise in carrying out these plans and proposed strategies for remedial action (3) Innovation: Documentation of the need for, uniqueness of, and probable impact of, developing an enhanced clinical vision research capability; possible future directions for clinical vision research by the applicant group (4) Investigator: Professional background and training of key personnel, with special reference to research interests (current and/or planned), experience, and administrative capability; identification, even if tentative, of the specific person or category of person to be sought and this person's training and background; specific, detailed plans for the role this individual will play in the development of an enhanced clinical vision research capability; evidence of a "critical mass" of potential investigators who can reasonably be expected to contribute to the development of a clinical vision research capability (5) Environment: Opportunities for the proposed individual(s) to formally or informally interact with colleagues in Schools of Public Health, Departments of Biostatistics, etc.; existence of the requisite research facilities and other resources; evidence of institutional personnel, space, and resources for developing a clinical vision research program; institutional commitment to the continuation of the program beyond the period of NEI support In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Mary Frances Cotch, Ph.D.; Donald F. Everett, M.A.; or Natalie Kurinij, Ph.D.: Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5983 FAX: (301) 402-0528 Email: mfcotch@nei.nih.gov, deverett@nei.nih.gov, kurinij@nei.nih.gov Direct inquiries regarding fiscal matters to: William W. Darby Grants Management Officer Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5884 FAX: (301- 496-9997 Email: wwd@nei.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.867. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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, a 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.
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