DEVELOPMENT OF INNOVATIVE APPROACHES TO ENHANCE VISION HEALTH COMMUNICATION RELEASE DATE: November 25, 2002 RFA: EY-03-002 National Eye Institute (NEI) (http://www.nei.nih.gov) APPLICATION RECEIPT DATE: November 12, 2003 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 Where to Send Inquiries 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 The purpose of this RFA is to encourage the submission of research grant applications that create, develop, and evaluate health communication strategies aimed at translating vision research advances into improved health. Projects should be based on current health communication theory and directed towards disease prevention and health promotion. The NEI seeks investigator-initiated applications using novel methods that reach out to public, public health, or professional audiences. The research should focus on improving utilization of current scientific knowledge in visual disease prevention and treatment in any of the six scientific mission areas of the NEI. 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, as well as vision scientists knowledgeable about the visual system. RESEARCH OBJECTIVES Background This Request for Applications (RFA) emphasizes the ongoing commitment of the National Eye Institute (NEI) to support research activities aimed at translating advances in the prevention and treatment of visual disorders into practice. The development and dissemination of health information is integral to the mission of the NEI. Although NEI-supported research has done much to enhance vision, the promise of research advances can only be realized when translated into practice. Thus, the NEI has long been involved with health information dissemination activities, such as public, patient, and health professional education programs. An important focus of these ongoing programs has been the encouragement of regular eye examinations and an increased awareness of services and devices that are available for people with low vision. NEI successes in the area of health education include traveling exhibits, which have been viewed by more than 3.8 million people nationwide; a school curriculum on vision for grades 4-8; and the establishment of the National Eye Health Education Program (NEHEP). NEHEP is a partnership of 70 professional, civic, and voluntary organizations and government agencies concerned with eye health. NEHEP currently is involved with three major ongoing education/outreach programs: the Diabetic Eye Disease Education Program, The Glaucoma Education Program, and the Low Vision Education Program. Detailed information regarding NEHEP is available at the NEI website, http://www.nei.nih.gov Objectives Applications responding to this RFA should provide well-defined dissemination and evaluation plans. Proposed projects can target patients, families, health care professionals, educators, and/or the general public. Evaluation outcomes should include some form of change in behavior, health status, health care delivery, or health care utilization. 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 disease incidence, prevalence, or disparities in care. 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 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. Further, all materials produced under this effort must include consideration of accessibility for individuals who are disabled. Proposed projects should have the potential to narrow the gap between the development of scientific/technologic discoveries and their application to improve eye health, rehabilitate individuals with disabilities resulting from low vision and blindness, or reduce health disparities. In devising health communication strategies in response to this RFA, care must be taken not to over simplify or over generalize research results. Where applicable, investigators must demonstrate a clear understanding of the complexities involved in the interpretation of research results and devise messages appropriately. In general, the efficacy of the proposed health communication strategies should have been demonstrated for other health conditions before the proposed adaptation or extension to vision. Investigators should provide evidence that the research team has the experience and expertise to conduct the research study. Since a multidisciplinary approach will be required for these projects, investigators should demonstrate that a functioning partnership will exist between communication experts and vision scientists with a clear description of the contribution and nature of cooperation among partners. Scope Investigators should identify an important discovery in the vision sciences that should be transferred into practice. The list below provides examples of NEI-supported clinical research advancements and opportunities that may lend themselves to health communication research initiatives. This listing is neither inclusive nor limiting: o The Amblyopia Treatment Study found that the use of atropine eye drops given once a day to treat amblyopia, the most common cause of visual impairment in children, works as well as the standard treatment of patching one eye. o The Age-Related Eye Disease Study found that individuals older than 55 should have dilated eye exams and, if found to be at high risk of developing advanced stages of Age-Related Macular Degeneration, should consider taking high doses of antioxidants and zinc. o The Early Treatment of Diabetic Retinopathy Study found that laser surgery/photocoagulation is a safe and effective means of treating diabetic retinopathy. This potentially blinding disease affects between 40-45 percent of the approximately 10.5 million Americans who have been diagnosed with diabetes. o The Vitamin A Supplementation for Retinitis Pigmentosa(RP)Study suggested that most adults with the common forms of RP should consider taking a supplement of Vitamin A while under the supervision of an ophthalmologist. o The NEI Strategic Plan on Reducing Health Disparities has identified several significant health disparities related to vision that may also serve as the bases for health communication research initiatives. There is a substantially higher prevalence and severity of primary open-angle glaucoma in African-Americans than in Whites. Diabetic retinopathy occurs more often and is more severe in Hispanic Americans and African Americans than in Whites. Myopia has a significantly higher prevalence in Asian-Americans, Alaskan Eskimos, and some Native American groups. In glaucoma and diabetic retinopathy, early detection and treatment are proven to help prevent vision loss, but only a fraction of those who would benefit are receiving treatment. These facts strongly argue for improvements in the quantity and quality of eye care services offered to and utilized by different segments of the American population. o The utilization of rehabilitative services among individuals with disabilities resulting from low vision and blindness is an area that might benefit from health communication research. MECHANISM OF SUPPORT This RFA will use NIH R01 Research Project Grant award mechanism(s). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2004. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://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 The NEI intends to commit approximately $2 million in FY 2004 to fund four to eight new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NEI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) 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 or foreign 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. 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: Staff Contact Name Maryann Redford, D.D.S, M.P.H. Division of Extramural Research National Eye Institute Building EPS, Room 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: 301-402-0528 Email: maryann.redford@nei.nih.gov o Direct your questions about peer review issues to: Samuel C. Rawlings, Ph.D. Chief, Scientific Review Branch Division of Extramural Research National Eye Institute Building EPS, Room 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: 301-402-0528 Email: rawlings@nei.nih.gov o Direct your questions about financial or grants management matters to: William W. Darby Grants Management Officer National Eye Institute Building EPS, Room 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: 301-496-9997 Email: wwd@nei.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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 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 http://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 http://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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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: Samuel C. Rawlings, Ph.D. Chief, Scientific Review Branch Division of Extramural Research National Eye Institute Building EPS, Room 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Rockville, MD 20852 (for express/courier service) Telephone: (301) 451-2020 FAX: 301-402-0528 Email: rawlings@nei.nih.gov 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 (IC). Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 (IC) 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 applications will be discussed and assigned a priority score o Receive a second level review by the National Advisory Eye 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 that can be answered by effective communication and dissemination strategies and materials? If the aims of your 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 your project? Do you acknowledge potential problem areas and consider alternative tactics? If the health message that's being communicated is based upon clinical trials results, is it consistent with a careful interpretation of study findings and targeted to the appropriate population group? (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: 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)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed studies 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 DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: o The adequacy of the proposed evaluation and dissemination plans. o The adequacy of plans for a functional partnership between communication experts and vision scientists. RECEIPT AND REVIEW SCHEDULE Application Receipt Date: November 12, 2003 Peer Review Date: February/March, 2004 Council Review: May, 2004 Earliest Anticipated Start Date: July 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 REQUIRED FEDERAL CITATIONS 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://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. 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 http://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 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 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.867, 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 284) and administered under NIH grants policies described at http://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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