NIDCD INVESTIGATOR-INITIATED CLINICAL TRIALS Release Date: June 22, 2000 PA Number: PA-00-107 (superceded by PA-02-157) National Institute on Deafness and Other Communication Disorders PURPOSE This document announces the willingness of the National Institute on Deafness and Other Communication Disorders (NIDCD) to accept applications for the conduct of clinical trials related to disorders of hearing, balance, smell, taste, voice, speech and language. It lists the requirements placed on the receipt, review, and funding of these applications. NIDCD policy and procedures for investigator-initiated clinical trials can be found at http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp. 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 priority areas. This PA, NIDCD Investigator-Initiated Clinical Trials, is related to one or more of the priority 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 (including consortia of institutions), 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 All responses to this program announcement must be submitted as applications using the R01 mechanism. For those applications that are to be awarded $500,000 or more in direct costs in any year or support for a multi-center clinical trial, the R01 will be converted to the U01 mechanism (a cooperative agreement), indicating substantial NIDCD staff involvement and the Terms and Conditions of Grant Award will reflect that arrangement. See http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp for further information. Regardless of the mechanism of support, NIDCD staff will closely monitor progress during the award period. This monitoring may include regular communication with the principal investigator and staff, as well as, in the case of the cooperative agreement, participation in the steering committee, data and safety monitoring committee, and related committee meetings. The level of NIDCD staff participation will be specified in the Terms and Conditions of Award. As it is anticipated that applications responsive to this program announcement (NIDCD Investigator-Initiated Clinical Trials) will request funds exceeding $250,000 direct costs per annum, modular grant instructions do not apply. RESEARCH OBJECTIVES The objective of this PA is to encourage the submission of investigator- initiated clinical trial applications assessing the treatment or prevention of diseases and disorders of hearing, balance, smell, taste, voice, speech and language. Progress in basic research, with expanding knowledge of biological and other factors influencing disease initiation, progression, and response to treatment affords an unparalleled opportunity to translate these advances into interventions that can improve the health of the American people. This initiative is designed to encourage the development and implementation of protocols examining the efficacy of interventions aiming to treat or prevent disorders of human communication. NIDCD does not accept, review, or fund pilot studies. A pilot study is one whose major purpose is to demonstrate the feasibility of further studies. The NIDCD will accept, review, and fund clinical trial planning grants, in response to the NIDCD Clinical Trials Planning Grant Program Announcement. A planning grant is intended to support the development of a Manual of Procedures amongst other activities necessary to develop a complete clinical trial application package. For further information regarding the NIDCD Clinical Trial Planning Grant, see http://grants.nih.gov/grants/guide/pa-files/PAR-00-007.html. 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 are 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 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 may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information regarding the policy. LETTER OF INTENT Prospective applicants are asked to submit 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 other key personnel and participating institutions, and the number and title of the PA 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the Director, Clinical Trials Program, at the address indicated under INQUIRIES. Applicants planning to submit an investigator-initiated application (or a group of applications for a multi-site clinical trial) requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. Regardless of anticipated application cost level, applicants are encouraged to consult with program staff listed under INQUIRIES below. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit, through special arrangement, by the Clinical Trials Review Committee of the National Heart Lung and Blood Institute, in accordance with the standard NIH peer review procedures. 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 of review by an appropriate National 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. 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: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (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? (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 and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to additional criteria, listed in the document NIDCD INVESTIGATOR INITIATED CLINICAL TRIALS at the following URL: http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp. The original and THREE copies of the completed application must be mailed to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040-MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) In addition to the copies submitted to the Center for Scientific Review, two copies should be sent, under separate cover to: Craig A. Jordan, Ph.D. Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C, MSC 7180 6120 Executive Boulevard Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) Submission of separate copies to the Chief, Scientific Review Branch, will allow more time to study the application and plan for its review. INQUIRIES Inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: A. Julianna Gulya, MD Director, Clinical Trials Program National Institute on Deafness and Other Communication Disorders Executive Plaza South, 400D-7, MSC 7180 6120 Executive Blvd Bethesda, Maryland 20892-7180 Telephone: 301-435-4085 Fax: 301-402-6251 E-mail: julie_gulya@nih.gov Direct inquiries regarding scientific review issues to: Craig A. Jordan, Ph.D. Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, 400-C, MSC-7180 6120 Executive Boulevard Bethesda, Maryland 20892-7180 Telephone: 301-496-8693 FAX: 301-402-6250 E-mail: cj34b@nih.gov Direct inquiries regarding fiscal issues to: Ms. Sharon Hunt Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders EPS, 400-B, MSC-7180 6120 Executive Boulevard Bethesda, Maryland 20892-7180 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 will be made under the authority 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 part 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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