PAR-00-007: NIDCD CLINICAL TRIAL PLANNING GRANT

Department of Health
and Human Services (HHS)

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NIDCD CLINICAL TRIAL PLANNING GRANT Release Date: October 20, 1999 PA NUMBER: PAR-00-007 National Institute on Deafness and Other Communication Disorders 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 The National Institute on Deafness and Other Communication Disorders (NIDCD) is committed to fostering the development, and funding, of meritorious applications seeking to improve health by supporting well-executed clinical trials in its mission areas of hearing, balance, smell, taste, voice, speech and language. Investigators who submit applications for large-scale clinical trials for consideration by the NIDCD (see the NIDCD Investigator-Initiated Clinical Trials Program Announcement) are expected to provide detailed information regarding the study rationale, design, protocols and procedures, analytical techniques, facilities and environment, administrative procedures, and collaborative arrangements. Much of this information is best presented in a complete Manual of Procedures/Operations (MOP) submitted as part of the application. It is recognized that the development of a MOP is a time- consuming and expensive activity. The NIDCD Clinical Trial Planning Grant is intended to help support this and other related activities necessary to develop clinical trials. The Planning Grant also allows for peer review of the rationale for, and design of, clinical trials of interventions aimed at preventing or treating diseases and disorders of hearing, balance, smell, taste, voice, speech and language. 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, NIDCD CLINICAL TRIAL PLANNING GRANT, addresses aspects of 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), or 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 organizations are not eligible to apply. Domestic applications may include international components; however, the domestic components must constitute the majority of the application. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism of support will be the NIDCD Clinical Trial Planning Grant (R21), which will provide up to $75,000 in direct costs for one year. The award cannot be renewed. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining procedures of 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 objective of the NIDCD Clinical Trial Planning Grant is to address preliminary design and methodological issues for specific clinical trials intended to evaluate interventions for the treatment or prevention of diseases and disorders of hearing, balance, smell, taste, voice, speech and language. The NIDCD Clinical Trial Planning Grant supports the development of specific elements essential to the conduct of a successful clinical trial, particularly those involving multiple centers. Examples of these elements include adequate plans for recruitment of patients, experimental design and protocols, data management, analytical techniques, facilities, administrative procedures, and collaborative arrangements. Detailed information regarding the rationale of the clinical trial, based on adequate, preclinical science and preliminary clinical research, must be developed prior to submission and included in the application for a Clinical Trial Planning Grant. The purpose of the planning grant is not to obtain preliminary data or to conduct studies to support the rationale for the clinical trial. The expected product of the Clinical Trial Planning Grant is a detailed clinical trial research plan including a complete manual of operations and procedures (MOP). 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 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 28, 1994, available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN 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 subject 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 children as subjects should read the "NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS," which were published in the NIH Guide for Grants and Contracts, Volume 27, No. 8, March 6, 1998, and are available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. APPLICATION PROCEDURES 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 301/435- 0714, email GrantsInfo@nih.gov and at the following URL address http://grants.nih.gov/grants/forms.htm. As with most applications to NIH, the research plan is limited to 25 pages. All information for review of the NIDCD Clinical Trial Planning Grant application must be included in the body of the application; appendices will not be considered during the review for this mechanism. The completed original application and three legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) In order to facilitate the review of applications assigned to the NIDCD, the applicant should, at the same time, mail or deliver TWO copies of the application to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, 400C, MSC-7180 6120 Executive Boulevard Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) 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. SPECIFIC INSTRUCTIONS: On the face page, item 2, mark "YES" and enter the title and number of this Program Announcement (NIDCD Clinical Trial Planning Grant). The body of the application must contain the following four elements: the rationale for the clinical trial; a full description of the experimental design of the clinical trial; plans for patient recruitment and retention; and, a description of the leadership and proposed organization of the clinical trial. For details of these four elements, see the REVIEW CONSIDERATIONS section. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules; applications responding to this PA cannot exceed a total direct cost request of $75,000. 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 $75,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the one-year budget period. Items 8a and 8b should also be completed indicating the same Direct and Total Costs. 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 this 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 the year. This is not a Form page. o Under 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. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for the year, 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 the 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 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 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 one-year budget period. 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. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. An appropriate clinical trials peer review committee, convened by the NIDCD in accordance with the standard NIH peer review procedures, will evaluate applications that are complete for scientific and technical merit. As part of the initial 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 Deafness and Other Communication Disorders Advisory Council. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the following criteria will be addressed and considered in the assignment of the overall scientific merit rating. (1) Rationale. The background and significance of the application must address the rationale for the future clinical trial (CT) including: o a clear statement of the question that a CT would address; o information adequate to determine the significance and timeliness of, as well as the need to perform, the CT; o the biological mechanisms and clinical data that support conducting a CT; o impact on health care; o reasons for selection of intervention and mode of delivery, including specific details such as dose or a particular procedure; o competitive therapies including both clinical and economic advantages and disadvantages of each; and o the ethical issues surrounding the CT and the disease/condition under study. (2) Study Design. The application for a planning grant must include a full description of the experimental design of the CT, including such elements as the following: o translation of the clinical question into a statistical hypothesis; o endpoint(s) and data to be collected including relevance to the clinical and statistical hypothesis being tested; o sample size and duration of the CT; o randomization, masking (if appropriate), and inclusion/exclusion criteria; o strengths and weaknesses of the proposed methods and possible alternatives; o ancillary therapies; o plans to standardize and monitor adherence to the clinical protocol in each center; and o methods for standardization of procedures for data management and quality control. While the criteria listed above apply to all clinical trials, there are specific issues of particular relevance to multi-center trials which must also be addressed, such as standardization/quality control of, and adherence to, the clinical protocol and data collection or distribution guidelines, and the use of a data coordinating center. (3) Plans for Patient Recruitment/Retention. The application must include an assessment of the following items: o availability of the requisite eligible patient pool; o availability of children, women and minority individuals as trial participants and specific recruitment and retention plans for their inclusion; and o plans for recruitment outreach and, as appropriate, follow-up procedures to ensure collection of data at stated intervals. (4) Investigators. The application must include a clear statement of the leadership and proposed organization of the CT, including: o identification of a principal investigator, and, for multi-center trials, a core of potential center investigators and staffing for a coordinating center; o professional training and experience of the CT organizers in such areas as the clinical problem under study, administration of complex projects, and study design; o inclusion of statisticians, data managers and study coordinators; o plans to add or drop centers; o essential committee structure appropriate to the complexity of the trial (e.g., Planning, Steering, Executive committees); and o for multi-center trials, the organizational structure of the trial, especially the organizational relationships among the enrollment centers and between the coordinating center and the enrollment centers. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. Quality of the proposed project as determined by peer review, availability of funds, and program priority will be considered in making funding decisions. INQUIRIES Inquiries are strongly encouraged early in the development of the application. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. A. Julianna Gulya Chief, Clinical Trials Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, 400D-7, MSC-7180 6120 Executive Boulevard Bethesda, MD 20892-7180 Rockville, MD 20852 (for courier/express service) Telephone: 301-435-4085 Fax: 301-402-6251 E-mail: julie_gulya@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sharon Hunt Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, 400-C, MSC-7180 6120 Executive Boulevard Bethesda, MD 20892-7180 Rockville, MD 20852 (for courier/express service) Telephone: 301-402-0909 Fax: 301-402-1758 E-mail: sh79f@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. 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, 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.

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