RFA-DC-02-001: PROMOTION AND DISEASE PREVENTION: HEALTH COMMUNICATION, DEVELOPMENT, AND DISSEMINATION

Department of Health
and Human Services (HHS)

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PROMOTION AND DISEASE PREVENTION: HEALTH COMMUNICATION, DEVELOPMENT, AND DISSEMINATION Release Date: July 24, 2001 RFA: RFA-DC-02-001 National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov) Letter of Intent Receipt Date: September 15, 2001 Application Receipt Date: October 10, 2001 PURPOSE 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. Health communication and research information dissemination are integral components of the NIDCD mission. The NIDCD seeks applications using methods that reach out to public health and professional audiences focusing on disease prevention or the promotion of healthy behaviors, based on contemporary scientific knowledge in any of the seven mission areas of the NIDCD. Of particular interest are projects that explore new and innovative approaches to health communication, including health literacy and strategic dissemination in areas of public health emerging from research in hearing, balance, smell, taste, voice, speech or language. Examples include projects focusing on early identification of hearing, voice, speech or language disorders to ensure intervention and rehabilitation, prevention of disease or disorder (e.g. prevention noise- induced hearing loss), and materials that make 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 based upon scientific discovery and scientists knowledgeable about normal and disordered processes of human communication. 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 "Health Promotion and Disease Prevention: Health Communication, Development, and Dissemination" 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/. Further, HP2010 includes a new chapter on vision and hearing [#28] 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. There are specific objectives related to public understanding of disease prevention and health promotion. A copy of this chapter may be obtained at: http://www.health.gov/healthypeople/Document/HTML/Volume2/28Vision.htm. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Education Project Grant (R25) 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 RFA may not exceed three years. This RFA is a one-time solicitation. The anticipated award date for this RFA is July 1, 2002. FUNDS AVAILABLE It is anticipated that NIDCD will have approximately $600,000 total costs available for this initiative in Fiscal Year 2002 and that up to three (3) awards will be made. 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. RESEARCH OBJECTIVES The purpose of this RFA is to encourage the submission of research grant applications that create, develop, and evaluate the way health information is communicated in one or more mission areas of the NIDCD. Projects should be based on current health communication theory and directed to address important problems of disease prevention, health promotion, and improved understanding of the basis for human communication disorders through public information. In responding to this RFA, investigators should have identified an important public health issue in human communication research and selected the best research-driven strategies and tactics to reach appropriate targeted audiences. Investigators should provide plans for dissemination and evaluation of all materials generated in this plan. In addition, research and communication teams must demonstrate that a functioning partnership will exist between communication experts and scientific experts, with a clear description of the contribution and nature of cooperation from each partner. 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 must 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 have a well-defined evaluation plan. 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 due to incidence or prevalence. 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 must demonstrate knowledge of existing materials within the subject area, selected to ensure non-duplication of effort. Dissemination strategy must incorporate a plan for publicizing the availability of materials to appropriate groups, organizations, communities, or health professionals. Further, all materials produced under this effort must include consideration of all accessibility issues for individuals who are disabled (e.g., filmed or taped materials must be captioned and those costs must be included within the budget, as well as accommodations such as large print materials for visually-impaired audiences.) In general, applications to support media documentaries will not be accepted, except in special circumstances. Exceptions may include cases in which there is compelling evidence that the proposed program will have sound educational value for a broad segment of the population, will include timely and accurate scientific information, and that the dissemination has been established through an identified, appropriate media outlet partner. It is essential that applications that relate to controversial or differing treatments address the full range of views on issues addressed. 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 and modern 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. 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 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://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: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA (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. 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 RFA 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 by September 15, 2001. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.pdf is to be used in applying for these grants. This version of PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applications submitted in response to this RFA must have a complete budget and should not be submitted in the modular format. 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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 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 Applications must be received by October 10, 2001. If an application is received after that date, it will be returned to the applicant without review. Appendices should not be sent to the Center for Scientific Review and should 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 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. REVIEW CONSIDERATIONS 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 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 the applications under review, will be discussed, assigned a priority score, and receive a second level 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 project address an important problem that can be answered by effective communication strategies and materials? If the aims of the application are achieved, how will disease prevention and health promotion 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? (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 strategies? (4) Investigator: Are the project team members appropriately trained and well-suited to carry out this work? Has the research team committed the appropriate time to accomplish project goals? (5) Environment: Do the scientific and communication environments in which the work will be conducted contribute to the probability of success? Are the resources necessary to complete the project available? 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. Schedule Letter of Intent Receipt Date: September 15, 2001 Application Receipt Date: October 10, 2001 Peer Review Date: February 2002 Council Review: May 2002 Earliest Anticipated Start Date: July 1, 2002 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. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is encouraged. Direct inquiries regarding programmatic issues, including eligibility and responsiveness, 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 Direct inquiries regarding scientific 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: craig_jordan@nih.gov Direct inquiries regarding fiscal 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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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 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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