EXPLORATORY RESEARCH: FEASIBILITY PILOT STUDIES Release Date: May 31, 2001 PA NUMBER: PAR-01-103 National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov) Application Receipt Date: August 10, 2001 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. (http://grants.nih.gov/grants/funding/modular/modular.htm) PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for exploratory, initial feasibility pilot studies focused on hearing, balance, smell, taste, voice, speech, and language, the scientific mission areas of the NIDCD. This Program Announcement (PA) supersedes a previous NIDCD PA: High Impact Research: Feasibility Studies, PAR-00-075 (NIH Guide, March 6, 2000). The current PA places more emphasis on exploratory, initial feasibility pilot studies into new areas of research within the communication sciences and less emphasis on the potential for high impact. Exploratory research involves initial feasibility pilot studies in which the technological, methodological, or theoretical approach to a problem lacks sufficient preliminary/baseline data and a body of peer-reviewed publications, but whose successful outcome would make a significant contribution to a scientific area or field. It is anticipated that most applications will be submitted by investigators with ongoing research programs who wish to change the focus of their current research effort or move into a new area of research within the communication sciences but need additional funds to complete initial pilot studies. The NIDCD encourages applications from investigators conducting research outside the communication sciences who possess expertise with methodological or technological approaches which have not been typically applied to but which would greatly promote scientific progress within the communication sciences. The NIDCD R21 funding mechanism is not intended for the advanced postdoctoral fellow starting to plan an independent research career or for the new investigator at the early stages of independence. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting focus areas. This PA is related to one or more of the focus areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. 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 or local governments, and eligible agencies of the Federal government. Applications from minority individuals, women, and individuals with disabilities are encouraged. Foreign organizations or organizations in foreign countries are not eligible, subcontracts to foreign organizations are allowable, with sufficient justification. Submission of an application under this PA precludes concurrent submission of any other application to the NIH containing substantially the same research proposal. In addition, awards made in response to this initiative may not be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of projects under review by the Department of Health and Human Services. MECHANISM OF SUPPORT Support for this program will be provided through the National Institutes of Health (NIH) Exploratory/Developmental Grants (R21) mechanism. This mechanism provides nonrenewable awards for up to two years of support and up to $50,000 in direct costs per year to support exploratory research where sufficient pilot data to support a regular research grant application is lacking. Areas of science with sufficient existing preliminary data to support the submission of a regular research grant application do not qualify under this PA. Specific application instructions have been modified to reflect "MODULAR GRANT" streamlining efforts established by the NIH. 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. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. Complete and detailed instructions and information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. RESEARCH OBJECTIVES The purpose of this PA is to encourage established investigators working within and outside the communication sciences to submit exploratory, initial feasibility pilot studies within the scientific mission areas of the NIDCD: hearing, balance, smell, taste, voice, speech, and language. The proposed research should have the potential for leading to a technological, methodological, or conceptual contribution in the basic or clinical biomedical or behavioral sciences investigating one or more of the aforementioned areas. This research should involve preliminary exploration of novel scientific experimental hypotheses and/or the development of new methodologies or technologies that represent a different research focus or new research direction for the laboratory. The NIDCD R21 grant mechanism provides an opportunity to propose research that has an uncertain outcome because sufficient experimental data are unavailable. It is intended that the additional pilot data generated by these exploratory grants, if promising, will serve as a basis for a more extensive follow-up investigation, commonly pursued through the submission of an investigator-initiated R01 grant application. This mechanism does not support research that is essentially the logical progression of an ongoing research program. The NIDCD R21 grant mechanism is designed primarily for investigators with ongoing research programs who wish to introduce a change in research focus or a new research direction into the laboratory but need additional research funds to complete initial feasibility pilot studies. A change in research focus or new research direction may involve a different methodological approach, the adoption of a newer technology, the use of another animal model, the exploration of a gap area of research, or entry into an area of the communication sciences that is not typically associated with the research of the laboratory. Investigators without an ongoing research program and who have had a history of research support and productivity are not precluded from applying. In these special cases, the application must demonstrate a need for research funds to conduct pilot studies that represent a change in research focus or a new research direction. Although the amount of pilot data that typically accompanies an R01 application is not required as a part of this NIDCD R21 funding mechanism, the applicant has the responsibility to provide sufficient pilot data to demonstrate the soundness of the research plan. Moreover, since the goal of the NIDCD R21 grant mechanism is to encourage a change in research from that of an ongoing research program, the appropriate expertise of key personnel and collaborators to pursue such novel research must be evident. A new investigator at the beginning of an independent research career is not eligible to submit a NIDCD R21 grant application in response to this PA. A new investigator is defined as an individual (including an advanced postdoctoral fellow) who is in the planning- or early-stages of pursuing an independent research career and has not received Federally-funded research support, with the exception of National Research Service Award (NRSA) fellowships and trainee-ships or mentored career development awards. It is recommended that such individuals use the NIDCD Small Grant (R03) mechanism to pursue new research ideas. The NIDCD R03 grant mechanism is designed specifically to support the transition of scientists who are in the early stages of pursuing an independent research career (including advanced postdoctoral fellows) but who are not yet ready to submit a R01 application. 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 sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research (http://grants.nih.gov/grants/guide/notice-files/not94-100.html). 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 the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. 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. There are also new requirements for education in the protection of human research participants (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html). Investigators may obtain copies from these sources or from the program staff person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The PHS 398 (rev 4/98) is the form to be used to apply for this program. The form may be downloaded from the NIH Home Page at http://grants.nih.gov/grants/forms.htm. It is also available at most institutional offices of sponsored research, or it may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892-7910, telephone: 301/710-0267, email: GrantsInfo@nih.gov. The instructions in the PHS 398 application kit must be adhered to, except where they have been modified by the following Supplemental Instructions. RESEARCH PLAN Do not exceed a total of 10 pages for the research plan, Sections a-d. This limitation includes the introductory justification paragraph described below, tables and figures, but not Sections e-i. Do not use the appendix to circumvent the 10-page limit by including tables or figures in the appendix that should appear in the research plan. Avoid the use of color photographs in the research plan to demonstrate critical pilot data, experimental approaches, and unique equipment because the applications are reproduced using black-and-white photocopying. A larger color version of any black-and-white photograph in the research plan may be included in the appendix. Justification as Exploratory Research Amply justify the designation of the application as an initial feasibility pilot study in an introductory paragraph at the beginning of the research plan. Explain how this project represents a change in research focus or a new research direction for your laboratory, justify why the project would not be appropriate for submission as a regular research grant at this time, and how this project, if fruitful, would enable you to craft a research program appropriate for submission as a full-scale research grant application. Label this paragraph, Justification as Exploratory Research. Applications that lack the introductory justification will not be reviewed and will be returned to the applicant. Some applications submitted in response to this PA may be design-driven (e.g., development of new technologies) or data-driven (e.g., database management, mining or distribution) rather than problem-driven (e.g., testing of scientific hypotheses). In the cases of design-driven or data-driven applications, the Specific Aims should state the technique/technology development needs or the data acquisition needs driving the research rather than the experimental hypotheses to be tested. BUDGET INSTRUCTIONS 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: Item 7a should indicate Direct Costs (in $25,000 increments up to a maximum of $50,000). Item 7b should indicate 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 - Use 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. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. o For consortium/contractual costs, provide an estimate of total costs (direct costs plus Facilities and Administrative costs) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom the contractual arrangements have been made, the per cent effort of all personnel and their role on the project. Indicate whether the contracting organization is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested direct cost amount for the application. Provide an additional budget justification narrative for any variation in the number of modules or direct cost amount requested across a two-year grant period. 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 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. It is important to identify all exclusions that were used 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. SUBMISSION INSTRUCTIONS The title, EXPLORATORY RESEARCH: FEASIBILITY PILOT STUDIES, and the number of this PA, PAR-01-103, must be typed on line 2 of the face page of the application form and the YES box must be marked. The completed original application and three copies (without appendices) must be submitted 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) Send two additional copies of the application and five sets of appendices to: CHIEF, SCIENTIFIC REVIEW BRANCH DIVISION OF EXTRAMURAL RESEARCH NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS 6120 EXECUTIVE BOULEVARD, ROOM 400-C, MSC 7180 BETHESDA, MD 20892-7180 ROCKVILLE, MD 20852 (for express/courier service) The submission, review, and award schedule is: Application Receipt Dates: August 10, 2001 NIDCD Committee Review: October/November, 2001 Council Review: January, 2002 Earliest Funding: April, 2002 REVIEW CONSIDERATIONS All applications will be examined for completeness by NIDCD staff. Incomplete applications or applications failing to comply with NIH grant format guidelines (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-012.html) will be returned. Complete and complying applications will be reviewed for scientific and technical merit in accordance with the standard NIH procedures by a review group convened by the NIDCD Scientific Review Branch. As part of the initial review, all applications will receive a written critique. Those applications deemed to have the highest merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level of review by the NDCD Advisory 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. 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. (1) Significance: Does this pilot study address an important problem and have the potential to impact the scientific enterprise significantly. If the aims of the application are achieved, how will scientific knowledge be advanced? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the application contain a sound research plan that is designed to adequately assess the feasibility of the pilot project? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator, key personnel and other collaborators (if any)? (5) Environment: Does the scientific environment in which the work will be conducted contribute to the probability of success? Is there evidence of sufficient institutional support for the research? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? (6) Evaluate the adequacy of plans to include children, 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 also be evaluated. (7) Evaluate the reasonableness of the proposed budget and the project’s duration in relation to the proposed research. (8) Evaluate the adequacy of the measures proposed for protection of humans, animals and/or the environment, to the extent they may be adversely affected by the research proposed in the application. SPECIAL REVIEW CRITERIA In addition to the above criteria, all applications will also be reviewed with respect to the following: 1. Does the proposed research represent a change in research focus or a new research direction for the laboratory that requires feasibility pilot studies, or is the proposed research the logical continuation of ongoing research efforts? 2. In the case of research that is hypothesis-driven, will the successful outcome of the proposed studies likely generate sufficient data to pursue follow-up studies and lead to a full-scale research grant application? 3. In the case of proposed research that is either technology-driven or design-driven, will the project generate a body of data, a technological advance or product that will be useful to the communication sciences community? 4. How will the successful completion of the proposed studies impact the concepts, methods, or technologies that drive the field? AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. Funding decisions will be based on the quality of the proposed project as determined by peer review, program priorities, and availability of funds. INQUIRIES NIDCD staff welcome the opportunity to clarify any issues or questions about this initiative and strongly encourage potential applicants to contact the appropriate program officer prior to the start of formulating a grant proposal. Direct inquiries regarding programmatic issues, including eligibility and responsiveness, to: Hearing: Dr. Amy Donahue Telephone: (301) 402-3458 Email: amy_donahue@nih.gov Dr. Nancy Freeman Telephone: (301) 402-3458 Email: nancy_freeman@nih.gov Dr. Thomas Johnson Telephone: (301) 402-3461 Email: thomas_johnson@nih.gov Dr. Lynn Luethke Telephone: (301) 402-3458 Email: lynn_luethke@nih.gov Balance: Dr. Daniel Sklare Telephone: (301) 496-1804 Email: daniel_sklare@nih.gov Taste and Smell: Dr. Barry Davis Telephone: (301) 402-3464 Email: barry_davis@nih.gov Language: Dr. Judith Cooper Telephone: (301) 496-5061 Email: judith_cooper@nih.gov Voice and Speech: Dr. Lana Shekim Telephone: (301) 496-5061 Email: Lana_Shekim@nih.gov The address and FAX number for all of the above named persons are: Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC-7180 Rockville, MD 20892-7180 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Castilla McNamara, M.S. Grants Management Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B, MSC 7180 Rockville, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: CM249E@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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and 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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