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) 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 
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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