PAR-00-051: NEI CLINICAL STUDY PLANNING GRANT (R21)

Department of Health
and Human Services (HHS)

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NEI CLINICAL STUDY PLANNING GRANT (R21) Release Date: January 27, 2000 PA NUMBER: PAR-00-051 (This PA has been reissued, see PAR-05-115) 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 the "National Eye Institute Clinical Trial Planning Grant", which was last revised in September, 1989. The National Eye Institute (NEI) supports large-scale clinical research projects, including randomized clinical trials and epidemiologic studies. At the time of submission, applications requesting support for these activities are expected to provide detailed information regarding the study"s rationale, design, analytic techniques, protocols and procedures, facilities and environment, organizational structure, and collaborative arrangements. This information is best conveyed in a well-documented Manual of Procedures (MOP), the development of which represents a costly and time-consuming activity. The Clinical Study Planning Grant, providing up to $100,000 annual Direct Costs for up to two years, is an NEI support mechanism designed to facilitate activities central to the refinement of the study"s protocol and procedures and the development of a detailed MOP. 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 Study Planning Grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) R21 Exploratory/Development Grant award mechanism. 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 two years, and the annual Direct Costs may not exceed $100,000 per year. 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 http://grants.nih.gov/grants/funding/modular/modular.htm . RESEARCH OBJECTIVES The Clinical Study Planning Grant provides support for the development of a comprehensive research protocol for a large-scale clinical trial or epidemiologic study. This grant provides early peer review of the proposed clinical study in terms of its rationale, design, organizational structure and implementation plan. The planning grant is used to support the development of a detailed MOP and can include preliminary studies to refine study procedures or to document recruitment potential. Prospective applicants should note that funding of a Clinical Study Planning Grant does not guarantee or imply funding for any subsequent competitive application for the support of a full-scale study. 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: http://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: http://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 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 301/435-0714, 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- 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 http://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: http://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. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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 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 be discussed and assigned a priority score. All applications also receive a second level review by the National Advisory Eye Council. Review Criteria Applications will be evaluated in accordance with standard NIH peer review criteria and procedures. Special emphasis will be placed on the rationale of the proposed study in terms of relevance, importance, timeliness, and generalizability. Other factors to be considered in assessing the merit of the application will include: Significance: Relationship of the proposed project with the NEI"s published priorities as set forth in "Vision Research--A National Plan: 1999-2003". Approach: Appropriateness and rigor of the proposed study design, in particular the selection of primary and secondary outcomes of interest, discussion of statistical issues, enumeration of possible study limitations or biases and plans for dealing with them, detailed description of and timetable for activities to take place during the planning grant period. Innovation: Discussion of novel or creative aspects of the proposed project’s focus, design or implementation, including plans for recruiting and retaining eligible study participants. Investigator: Expertise, leadership, and experience of the proposed investigative team in conducting collaborative clinical research. Environment: Methods of communication to promote interaction among proposed investigative team members, organizational resources, e.g. level of effort, use of equipment and financial support, available to the investigative team to augment NEI funds in developing a detailed, clinical study protocol. 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 concerning this PA 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. Collaborative Clinical 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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