HEALTH COMMUNICATION RESEARCH: IMPROVED STRATEGIES RELEASE DATE: October 28, 2002 RFA: DC-03-001 National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) LETTER OF INTENT RECEIPT DATE: January 14, 2003; January 13, 2004 APPLICATION RECEIPT DATE: February 14, 2003, February 13, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA This Request for Applications (RFA) emphasizes the ongoing commitment of the National Institute on Deafness and Other Communication Disorders (NIDCD) to support research activities focusing on the development and dissemination of health communication information across the disciplines of communication sciences and disorders. The purpose of this RFA is to encourage the submission of research grant applications that investigate the creation, development, and evaluation of health information in one or more mission areas of the NIDCD: hearing, balance, smell, taste, voice, speech or language. Projects should be based on current health communication theory and directed to address issues in disease prevention and health promotion. The goal is improved public information, based upon scientific discovery. Applications should be from interdisciplinary teams that include both health communication experts and scientists knowledgeable about normal and disordered processes of human communication. RESEARCH OBJECTIVES The purpose of this RFA is to encourage the submission of research grant applications that investigate the creation, development, and evaluation of health information in one or more mission areas of the NIDCD: hearing, balance, smell, taste, voice, speech or language. The NIDCD seeks research applications that investigate methods to inform the public and to be used by public health and professional audiences in disseminating information. These applications should be based on current health communication theory and focus on disease prevention and/or the promotion of healthy behaviors. Topic areas should be based on contemporary scientific knowledge and current research findings in any of the seven mission areas of the NIDCD. Of particular interest are projects that explore new and innovative approaches to health communication. Examples of appropriate projects include, but are not limited to, early identification of hearing, voice, speech, or language disorders to ensure intervention and rehabilitation, prevention of diseases or disorders (e.g. prevention of noise-induced hearing loss), and making complex disease issues more understandable to the public (e.g. materials to accompany genetic counseling in areas of inherited disorders or diseases of human communication). It is expected that applications in response to this RFA will be from interdisciplinary teams of health communication experts knowledgeable about strategies, tactics, development, dissemination and evaluation of health information and scientists knowledgeable about normal and disordered processes of human communication. Applications must demonstrate that a functioning partnership will exist between communication experts and scientific experts, with a clear description of the contribution and nature of each partner's role. Proposed projects should be targeted to any (or several) of a variety of audiences including patients, families, health care professionals, educators, industry, or the general public. Investigators should demonstrate thorough knowledge of the scientific principles of health communication, as well as the current state-of-the-science within the field chosen. Projects that explore innovative approaches to education/health communication are encouraged. NIDCD will support only projects that include the creation or development of new materials as well as a well-defined evaluation plan. Investigators should provide evaluation plans for development and dissemination of all materials generated. The project plan should include evidence of consideration of the appropriateness of materials for women, men, underrepresented minority groups, and/or children. Also, attention should be given to key ethnic or cultural groups for whom the specific health information is directly relevant. Projects should also demonstrate plans for inclusion of key groups in planning materials on culturally sensitive topics or in dissemination efforts that involve diverse cultural groups. Teams should demonstrate knowledge of existing materials within the subject area to ensure non- duplication of effort. The dissemination strategy must incorporate a plan for publicizing the availability of materials to appropriate groups, organizations, communities, or health professionals. The R25 Grant is not intended to be used to conduct workshops or training sessions, unless they are part of the materials development under investigation. Applicants are encouraged to consider all appropriate information delivery systems, including the World Wide Web. Materials developed under this mechanism must be submitted to the Office of Health Communication and Public Liaison at the NIDCD for consideration and possible inclusion in the Combined Health Information Database (CHID), an annotated resource for finding health materials produced with Federal money. MECHANISM OF SUPPORT This RFA will use the NIH R25 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award dates are December 1, 2003, and December 1, 2004. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE It is anticipated that NIDCD will have approximately $750,000 total costs available for this initiative in Fiscal Years 2004 and 2005 and that up to three (3) awards will be made for each of the two submission rounds. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDCD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Principal investigators should have expertise in either health communication theory or normal and disordered processes of human communication. Applications should be from interdisciplinary teams that include both health communication experts and scientists knowledgeable about normal and disordered processes of human communication. NIDCD will support only projects that have a well-defined evaluation plan. Applications must demonstrate knowledge of existing materials to ensure non-duplication of effort. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Amy M. Donahue, Ph.D. Scientific Programs Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: 301-402-3458 Fax: 301-402-6251 Email: amy_donahue@nih.gov o Direct your questions about peer review issues to: Craig Jordan, Ph.D. Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: 301-496-8683 Fax: 301-402-6250 Email: jordanc@nih.gov o Direct your questions about financial or grants management matters to: Sara Stone Grants Management Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B, MSC-7180 Bethesda, MD 20892-7180 Telephone: 301-402-0909 Fax: 301-402-1758 Email: stones@nidcd.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NIDCD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Amy M. Donahue, Ph.D. Scientific Programs Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: 301-402-3458 Fax: 301-402-6251 Email: amy_donahue@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SUBMITTING AN APPLICATION: Submit a signed, typewritten original of the application, including the Checklist, and three 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, two additional copies of the application and all copies of the appendix materials must be sent to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd, Room 400-C, MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20851 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the NCDC 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? Does your application demonstrate knowledge of existing materials to ensure non-duplication of effort? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project in the areas of health communication as well as the scientific field chosen? Do you acknowledge potential problem areas and consider alternative tactics? Does your project have a well-defined evaluation plan for development and dissemination of all materials generated? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR(S): Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? Is your application from an interdisciplinary team that includes both health communication experts and scientists knowledgeable about normal and disordered processes of human communication? Does your application provide a clear description of the contribution and nature of each partner's role? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: 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. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 14, 2003 January 13, 2004 Application Receipt Date: February 14, 2003 February 13, 2004 Peer Review Date: June 2003 June 2004 Council Review: September 2003 September 2004 Earliest Anticipated Start Date: December 1, 2003 December 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA 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. HP2010 includes chapter 28 on "Vision and Hearing" that addresses specific areas of disease prevention and health promotion related to early identification of infant hearing impairment, otitis media and prevention of noise-induced hearing loss and chapter 11 related to "Health Communication", in which there are specific objectives related disease prevention and health promotion. These chapters may be obtained at: http://www.health.gov/healthypeople/Document/HTML/Volume2/28Vision.htm http://www.health.gov/healthypeople/document/HTML/Volume1/11HealthCom.htm AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.173, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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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