COLLABORATIVE RESEARCH ON THERAPY FOR VISUAL DISORDERS

Release Date:  November 29, 2000

PAR NUMBER:  PAR-01-022 (This PA has been reissued, see PAR-05-110)

National Eye Institute

This Program Announcement expires on December 1, 2003, unless reissued.

PURPOSE

The National Eye Institute (NEI) announces a program to support collaborative 
multidisciplinary research focused on the development of novel therapies to 
restore or prevent the loss of function due to visual diseases and disorders.  
Many visual system diseases are complex, and the rapid and efficient 
translation of research findings into clinical application will require a 
comprehensive and highly integrated approach.  Such a collaborative approach 
would be particularly appropriate for therapeutic research that involves a 
biological intervention, such as gene therapy or pharmacological approaches.  
The intention of this program is to make resources available to scientists 
from several disciplines to form research teams to address scientific and 
technical questions that would be beyond the capabilities of any one research 
group.

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 Program Announcement (PAR), 
COLLABORATIVE RESEARCH ON THERAPY FOR VISUAL DISORDERS, is related to priority 
areas 28-3 to 28-10.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic or foreign, for-profit and non-
profit organizations, public and private, such as universities; colleges; 
hospitals; laboratories; units of State, Tribal, and local governments; and 
eligible Federal government agencies.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.

MECHANISM OF SUPPORT

This PAR will support resource-related research projects under either the R24 
or U10 funding mechanisms.  The R24 Resource-Related Research Project grant 
mechanism should be used for studies which require resources from various 
disciplines in order to gain further understanding of the basic biology of a 
therapeutic approach.  The U10 Cooperative Clinical Research cooperative 
agreement mechanism should be employed when the project expects to carry out 
clinical studies or a clinical trial to test a therapy in human subjects.  
Investigators who have questions regarding the choice of mechanism are urged 
to contact one of the officials listed under INQUIRIES.

Responsibility for the planning, direction, and execution of the proposed 
project will be that of the applicant.  The total project period for an 
application submitted in response to this PAR may not exceed five years.  The 
award may be competitively renewed for a second period, up to five years, 
based on peer review of a renewal application and the availability of funds.  
The NEI does not envision more than one renewal period.

The total costs to be awarded in any year may not exceed $2 million per grant.  
The number of awards and level of support will depend upon receipt of a 
sufficient number of applications of high scientific merit and upon the 
availability of funds.

PART A  R24 RESOURCE-RELATED RESEARCH PROJECTS

Investigators proposing collaborative pre-clinical or basic science research 
which does not involve a clinical study or a clinical trial component should 
use the National Institutes of Health (NIH) R24 Resource-Related Research 
Project mechanism.  PIs should follow the research objectives and application 
procedures described below when developing an application.


PART B  U10 COOPERATIVE CLINICAL RESEARCH--COOPERATIVE AGREEMENTS

Investigators proposing clinical studies or clinical trials using human 
subjects will be supported by the National Institutes of Health (NIH) U10 
Cooperative Clinical Research--Cooperative Agreements funding mechanism.  PIs 
should follow the RESEARCH OBJECTIVES and APPLICATION PROCEDURES described 
below when developing their application.

Under the cooperative agreement, there will be substantial NEI scientific 
and/or programmatic involvement with the awardee.  The NEI purpose is to 
assist, support, and/or stimulate the recipient's activity by facilitating 
performance of the effort as a partner.  The NEI will not assume direction, 
prime responsibility, or a dominant role in the activity.  Details of the 
responsibilities, relationships and governance of the study to be funded under 
cooperative agreement(s) are discussed below:

Terms and Conditions of a Cooperative Agreement Award

These special Terms and Conditions of Award are in addition to and not in lieu 
of otherwise applicable Office of Management and Budget administrative 
guidelines, Department of Health and Human Services (DHHS) grant 
administration regulations at CFR Parts 74 and 92, as applicable, and other 
DHHS, PHS, and NIH Grant Administration policy statements.

1. Awardee Rights and Responsibilities

o Awardees have primary authorities and responsibilities to define objectives 
and approaches, and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of their studies.  The design, methods, and 
procedures of the clinical trial will be detailed in an awardee-prepared and 
maintained, study-adopted Manual of Procedures (MOP).  The awardees will have 
the responsibility of following the protocol.

o Awardees will retain custody of and have primary rights to the data 
developed under these awards, subject to Government rights of access 
consistent with DHHS, PHS, and NIH policies.

o The Principal Investigator (PI) is responsible for the overall conduct of 
the clinical trial and for providing scientific, technical, and administrative 
leadership to the study.  The PI will have lead responsibility for planning 
and directing all phases of the study and for using the study's resources.  In 
carrying out these responsibilities, the PI will actively seek advice from all 
of the study's components, including the representative of the NEI.

o Resource core centers (e.g., Data Coordinating Center) may be involved in 
performing specified support functions such as training and certification of 
clinical center staff, designing and maintaining quality assurance programs, 
managing data, analyzing data, and preparing publications.  The director of 
each resource core center is responsible for all aspects of the operations of 
his/her resource center and for the local implementation of the study 
protocol.

o  The director of any participating clinical center has the primary 
responsibility of identifying and recruiting eligible patients at that center.  
The director will be responsible for the follow up, as specified in the study 
protocol, of each patient enrolled in the clinical trial and for submitting 
required data to the resource center(s).  The director is also responsible for 
ensuring that clinic personnel are trained and certified to carry out study 
procedures.

o  The PI agrees to the governance of the study through a Steering Committee 
when appropriate.  Steering Committee voting membership shall consist of the 
PI, directors of any resource core centers or participating clinical centers, 
and the NEI Program Director.

2. NEI Staff Responsibilities

The appropriate NEI extramural program director from the Division of 
Extramural Research whose name appears on the Notice of Grant Award will 
participate with and assist, but not direct:

o the PI in the nomination and selection of an independent Safety Monitoring 
Committee;

o the PI and the Steering Committee, in assuring that patient information 
handbooks, recruitment information, press releases, and publicity exhibits are 
properly prepared and disseminated;

o the PI in identifying additional participating clinics, when needed to 
enhance patient recruitment;

o  the Steering Committee in routine performance monitoring of the entire 
study including matters of quality control within and among various 
components, and in the determination of inadequate patient recruitment or 
failure to comply with the protocol on the part of individual clinics;

o  an Editorial Committee in the preparation and review of study results for 
publication;

o  the Safety Monitoring Committee as an ex officio member and will 
participate in all decisions of the Committee, such as to proceed from one 
phase of the study to the next, implement protocol changes, evaluate patient 
recruitment issues, t approve any ancillary studies, plan data analysis, 
announce study findings, and determine the timing of release of any reports.

The NEI reserves the right to curtail, withhold, or terminate support for the 
study, for an individual award, or for support of a participating consortium, 
in situations involving:  inadequate patient recruitment, follow up, data 
reporting or quality control; a major breach of the study protocol; a 
substantive change in the set protocol to which the NEI does not agree; 
statistical evidence that the major study endpoint has been reached ahead of 
schedule; or human subject ethical issues that dictate a premature 
termination.  Prior to taking such actions, NEI will consult with and received 
recommendations from the Safety Monitoring Committee.

3. Collaborative Responsibilities

Safety Monitoring Committee:  A group composed of individuals not directly 
involved in patient care or data collection in the trial, who are responsible 
for periodically reviewing accumulated data for evidence of adverse or 
beneficial treatment effects; for initiating recommendations for modification 
of the study protocol, including termination of the treatment when 
appropriate; and for assessing data quality and clinic performance.

Steering Committee:  A group composed of the PI, who serves as Chair; 
directors of any resource core centers; the NEI representative; and a small 
group of clinical center directors who are elected for a set term by the full 
group of clinical center directors.  This committee acts as the administrative 
and executive arm of the trial.  It makes decisions on day-to-day operational 
issues; considers and adopts changes in study procedures as necessary; reviews 
and implements recommendations from the Safety Monitoring Committee; reviews 
progress of the trial in achieving its main goal and takes steps required to 
enhance likelihood of success; and reviews data collection practices and 
procedures as summarized in performance monitoring reports for clinical 
centers to identify and correct remediable deficiencies.

Editorial Committee:  A group composed of the PI, Coordinating Center 
director, the NEI representative, and several clinical center directors 
elected by the full group of participating clinical center directors.

4.  Outside Participation

Support or other involvement of industry or any other third party in the 
study--e.g., participation by the third party; involvement of study resources 
or city the name of the study or NEI support; or special access to study 
results, data, findings, or resources--may be advantageous and appropriate.  
However, except for licensing of patents or copyrights, support or involvement 
of any third party will occur only following notification of and concurrence 
by NEI.

5.  Arbitration

Any disagreement that may arise on scientific/technical matters within the 
scope of the award between award recipients and the NEI may be brought to 
arbitration.  An arbitration panel will be composed of three members, one 
member selected by the Study Chairperson, a second member selected by the NEI, 
and a third member selected by the two prior selected members.  This special 
arbitration procedure in no way affects the awardee's rights to appeal an 
adverse action that is otherwise appealable in accordance with PHS regulations 
at 42 CFR Part 50, subpart D, and DHHS regulations at 45 CFR Part 16.

RESEARCH OBJECTIVES

Background

The development of new therapies for the treatment of visual diseases or 
disorders is too complex to be solved by a single research group; 
collaborators are needed in several disciplines in order to translate the 
results of research from the laboratory into the clinic.  For example, 
progress in the treatment of retinal degenerations using gene replacement 
therapy could require collaborations among geneticists who have identified and 
cloned a defect-specific gene, molecular biologists who can produce 
appropriate vectors, cell biologists with animal model systems in which to 
test products, and clinical trialists who can perform Phase I and/or II human 
safety and/or efficacy trials.  Similarly, pharmacologic treatments to 
preserve function, reverse degenerative processes, or facilitate 
transplantation strategies with neuroprotective agents, growth factors, or 
other biologics could require collaborations among pharmacologists who can 
isolate and purify factors, chemists who can synthesize drug delivery systems, 
cell biologists, toxicologists, and clinical trialists.  The creativity of 
such interdisciplinary teams is expected to result in the development of 
innovative clinical applications.

Objective and Scope

The objective of this program announcement is to encourage collaborative 
translational research that rapidly and efficiently brings the results of 
laboratory and animal studies into clinical practice.  Applicants should 
consult "Vision Research, a National Plan:  1999-2003", which articulates 
NEI's current research needs, opportunities, and priorities.  It is available 
at http://www.nei.nih.gov 

The scope of this program is broad and it is intended to cover all visual 
system diseases and disorders which are relevant to the mission of the NEI.  
The following topics are presented as general examples, and are not intended 
to be exclusive or to limit creativity and innovation:

Gene transfer has the potential for novel medical applications.  Considerable 
progress has been made in vector design and therapeutic strategies are 
emerging.  Gene therapy is most likely to reach clinical importance in 
monogenic disease where the replacement of one mutated single gene may be 
curative (such as juvenile glaucoma, macular corneal dystrophy, retinitis 
pigmentosa, pseudoxanthoma elasticum, juvenile cataract) or in pathological 
conditions which require a temporary expression of a transferred gene (such as 
a growth factor or ribozyme) to achieve a beneficial clinical effect.  
Successful gene therapy requires research teams able to contribute such 
resources such as therapeutic genes, vectors capable of appropriate tissue 
expression, animal models for toxicology and efficacy testing, and clinical 
study expertise.

Characterization of pathways leading to ganglion cell death could provide 
target points for therapeutic intervention in diseases such as glaucoma.  
Conversely, the identification of factors that enhance ganglion cell survival 
may protect against cell degeneration.  Such development of neuroprotection 
strategies to halt the degeneration of visual function or stimulate the 
regeneration of damaged tissue would benefit from a multidisciplinary research 
collaboration.  Different scientific disciplines would be necessary to devise 
delivery systems for agents such as neurotrophic factors or neuroprotective 
drugs, test the efficacy and safety of such agents in animal models, and 
design clinical trials for human testing.

Organizational Structure

The proposed study must have an organizational structure which clearly defines 
the role of collaborators and the relationships among the various components.

Applicants should bring together the necessary expertise to focus on a 
significant disease or disorder that is within the mission of the NEI.  The 
collaborators may be at the same institution, or may come from different 
institutions.  The proposals can vary in size and exhibit diverse forms of 
organization, participation, and operation.  The administrative structure will 
depend upon the size and scope of the proposed research.  The PI is 
responsible for management, staffing, and resource allocation and for 
administering the award in accordance with NIH policies.  The PI has the 
responsibility to use funds in the most productive way to achieve the goals 
proposed in the application.  For example, in the early stages of a gene 
therapy study there may be intense involvement of a collaborator preparing 
vectors and little role for a clinical collaborator.  But these roles might be 
reversed in the later stages of the study.

Summary

The development of a successful treatment for an ocular disease will be 
expedited through the focused involvement of multiple basic research and 
clinical disciplines.  Such success relies on the quality of the underlying 
science, the care with which clinical protocols are designed, and the merging 
of different disciplines and strategies into a cohesive approach.  In 
addition, it is of critical importance as the field moves from the bench into 
the clinical arena that the safety of human subjects be assessed and monitored 
in a rigorous manner.  It is expected that applications for this initiative 
will thoroughly address the safety and appropriateness of proposed 
interventions in human subjects.

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 subpopulations 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 officials 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

DATA AND SAFETY MONITORING IN CLINICAL TRIALS

Applicants are directed to the full text of the NIH Policies regarding Data 
and Safety Monitoring and Reporting of Adverse Events that are found in the 
NIH Guide for Grants and Contracts Announcements at the following web sites:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

All applicants receiving an award under this PAR must comply with the NIH 
policy cited in these NIH Announcements and any other data safety and 
monitoring requirements found elsewhere in this PAR.

The following is a brief summary of the Data and Safety Monitoring and Adverse 
Event Reporting Requirements:

Data and Safety Monitoring is required for every clinical trial.  
Monitoring must be performed on a regular basis and the conclusions of 
the monitoring reported to the Program Director.

The type of data safety and monitoring required will vary based on the 
type of clinical trial and the potential risks, complexity and nature of 
the trial.  A plan for data and safety monitoring is required for all 
clinical trials.  Phase III clinical trials generally require the 
establishment of a Data Safety Monitoring Board (DSMB).  The 
establishment of a DSMB is optional for Phase I and Phase II clinical 
trials.

The DSMB/Plan is established at the time the protocol is developed and 
must be approved by both the Institutional Review Board (IRB) and the 
Government and in place before the trial begins.  If the protocol will 
be developed during the research funded under this PAR, a general 
description of the data and safety monitoring plan must be submitted as 
part of the proposal and will be reviewed by the initial review group.  
If the protocol is developed and is included as part of the submitted 
proposal, a complete and specific data and safety monitoring plan must 
be submitted as part of the proposal.

Monitoring Plans, at a minimum, must include the prompt reporting of 
adverse events to the IRB, FDA and NIH.  The frequency of reporting of 
the conclusions of the monitoring activities should also be described in 
the plan.  The overall elements of each plan may vary depending on the 
size and complexity of the trial.  Examples of monitoring activities to 
be considered are described in the NIH Policy for Data and Safety 
Monitoring at 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.

For multi-site Phase I and Phase II trials, a central reporting entity 
that will be responsible for preparing timely summary reports of adverse 
events for distribution among sites and IRBs should be considered.

Organizations with a large number of clinical trials may develop 
standard monitoring plans for Phase I and Phase II trials.  In this 
case, such organizations may include the IRB-approved monitoring plan as 
part of the proposal submission.

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.

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 for 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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit.  Application kits are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected].

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact NEI 
program staff before submitting the application, i.e., as plans for the study 
are being developed.  Furthermore, the application must obtain agreement from 
the NEI staff that the NEI will accept the application for consideration for 
award.  Finally, the applicant must identify, in a cover letter sent with the 
application, the NEI staff member who agreed to accept assignment of the 
application.  This policy requires an applicant to obtain agreement for 
acceptance of both any such application and any such subsequent amendment.  
Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

Applicants should follow the PHS 398 instructions for "Preparing Your 
Application" with modifications and additions as described in the sections 
below:

Page Limits:  For applications in response to this PAR, the page limitations 
are increased from the normal 25 page limit to a maximum of 40 pages for 
Sections A-D of the "Research Plan".

Title and Description:  Identify the institution leading the multidisciplinary 
collaboration and any other participating institutions.  The description 
should clearly present the visual disease or disorder that will be the focus 
of research, the planned multidisciplinary approach, the specific milestones 
to be achieved, and timelines for achievement for the first year and 
additional years of the grant.

Organizational Structure:  An organization chart must be included in the 
application within the 40 page limit.  The chart should clearly define the 
collaborators and the relationships among the various proposed components.  A 
program plan should accompany the organization chart and list major tasks with 
a timeline of expected milestones for the entire project period.  The 
organization chart and program plan must not exceed one page each.

Budget Items:  Include a separate budget for each collaborator/partner.  When 
appropriate for clarity, present a separate budget for each partner within the 
grantee institution.  Include a summary budget for all participants, with 
partners at non-grantee institutions shown as consultants, sub-contractors, or 
consortium arrangements.  The annual total cost may not exceed $2 million.

Personnel:  The PI should devote approximately 20% effort to this grant.  The 
per cent effort requested for other personnel should be limited to time 
devoted exclusively to the collaborations for this grant.  Information 
documenting these levels of effort should be included in the application.  The 
need for all requested personnel costs should be thoroughly justified.  
Administrative support is permitted only for matters directly pertaining to 
this grant.

Travel:  Applicants may request travel funds.  These could be used to promote 
collaboration among partners at different institutions or at a distant site, 
be used for travel of external advisors to the grantee institution, and/or be 
used for partners to attend scientific meetings essential to the progress of 
the grant and for which other funds are not available.

Other Expenses:  This category may include costs necessary for the 
administration and fiscal management of the grant, including relevant costs 
for reprints, graphics, and publications.

Outside Funding:  Some collaborative initiatives may anticipate or receive 
commitments for significant funding from non-NIH sources, such as a 
collaborating company or research foundation.  When this is the case, 
applications should describe the source, annual amount, and use of outside 
funding.

Other Support:  Provide a complete listing of current and pending support for 
the PI and key personnel.

Resources:  Describe the equipment and facilities available on Form Page 
Eight.  If the application requires an institutional commitment of resources 
across boundaries in the institution or anticipates the provision of 
institutional resources, include letters from the relevant senior level 
individuals describing those commitments.  Where appropriate, describe the 
shared facilities to be established.  Describe plans for maintaining and 
operating the facilities, including staffing and plans for ensuring access.  
Distinguish between existing facilities and those to be developed.

Research Plan:  

A.  Specific Aims.  In one page, describe the specific aims and the goals for 
the first year and for the long term.  Describe the expected applications of 
the collaborative research that will improve human health.

B.  Background and Significance.  Briefly describe the research that is the 
focus of the application.  Critically evaluate existing knowledge and 
approaches that have been or are being directed in the area, and specifically 
describe how the proposed activities will advance the field.  Clearly indicate 
current activities, why this award is necessary, and what unique opportunities 
will be provided by the proposed collaboration.  State concisely the 
importance and visual health relevance of the proposed research to the 
Specific Aims.

C.  Preliminary Studies and Rationale.  Describe preliminary results, the 
rationale, and the scientific basis for the proposal.

D.  Research Design and Methods.  Describe an overall research plan that 
justifies a collaborative organization and is flexible enough to permit change 
as the research proceeds.  Explain the integrative approach and why it is 
essential to the proposed research.  If any proposed activities are closely 
related to ongoing research, explain how the proposed study will complement 
but not overlap with existing research.  Describe the resources to be provided 
by each collaborator/partner and how these will be integrated and organized to 
accomplish the specific aims of the project.  Provide a tentative sequence or 
timetable for the proposed milestones of the project.  Include how data will 
be collected, analyzed, and interpreted.

Appendix:  Appendix material may include up to 20 publications or manuscripts 
accepted for publication, abstracts, or patents directly relevant to this 
project; an MOP, data collection instruments, and/or clinical protocols; 
and/or original glossy photographs or color images of photocopies included 
within the 40 page limit of items A-D of the Research Plan.

The title and number of this PAR must be typed on line two of the face page of 
the application form and the YES box must be checked.  Submit a signed, 
typewritten original of the application, including the Checklist, and five 
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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened by the NEI in accordance 
with the standard NIH peer review procedures.  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 applications under review, will be discussed, 
assigned a priority score.  All applications will 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 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.  Note that 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.  For example, an 
investigator 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 this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that drive 
this field?

(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?  Are the milestones and evaluation procedures 
appropriate?  Is the proposed Organization Chart appropriate?

(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 technologies?

(4) Investigator:  Is the PI capable of leading, coordinating, and managing 
the proposed collaboration?  Are the investigators appropriately trained in 
their disciplines and well suited to carry out this work?  Is the integrative 
collaborative plan effective?  Does the application document appropriate 
commitments from the proposed collaborators?  Do the advantages of any 
collaborations at distant sites outweigh the disadvantages?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

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.

o  The adequacy of the required education of key personnel in the protection 
of human research participants.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Peter A. Dudley, Ph.D.
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
Bethesda, MD  20892-7164
Telephone:  (301) 496-0484
FAX:  (301) 402-0528
Email:  [email protected]

Direct inquiries regarding review issues to:  

Andrew P. Mariani, Ph.D.
Chief, Scientific Review Branch
National Eye Institute
Executive Plaza South, Suite 350
Bethesda, MD  20892-7164
Telephone:  (301) 496-5561
FAX:  (301) 402-0528
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

William W. Darby
Grants Management Officer
National Eye Institute
Executive Plaza South, Suite 350
Bethesda, MD  20892-7164
Telephone:  (301) 496-5884
FAX:  (301) 496-9997
Email:  [email protected]

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.684.  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 and contract 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, and 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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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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