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
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
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
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.
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
(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.
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 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
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.