Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Eye Institute (NEI)
UG1 Clinical Research Cooperative Agreements - Single Project
The National Eye Institute (NEI) supports investigator-initiated, complex, multi-center and other high resource risk epidemiologic studies under the cooperative agreement mechanism, UG1 activity code. Specifically, the purpose of this Funding Opportunity Announcement (FOA) is to support new and innovative ocular epidemiology research.
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 25, 2021 * | September 25, 2021 * | January 07, 2022 * | March 2022 | May 2022 | July 2022 |
| January 25, 2022 * | January 25, 2022 * | May 07, 2022 * | July 2022 | October 2022 | December 2022 |
| May 25, 2022 * | May 25, 2022 * | September 07, 2022 * | November 2022 | January 2023 | April 2023 |
| September 25, 2022 * | September 25, 2022 * | January 07, 2023 * | March 2023 | May 2023 | July 2023 |
| January 25, 2023 * | January 25, 2023 * | May 07, 2023 * | July 2023 | October 2023 | December 2023 |
| May 25, 2023 * | May 25, 2023 * | September 07, 2023 * | November 2023 | January 2024 | April 2024 |
| September 25, 2023 * | September 25, 2023 * | January 07, 2024 * | March 2024 | May 2024 | July 2024 |
| January 25, 2024 * | January 25, 2024 * | May 07, 2024 * | July 2024 | October 2024 | December 2024 |
| May 25, 2024 * | May 25, 2024 * | September 07, 2024 * | November 2024 | January 2025 | April 2025 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose:
The purpose of this Funding Opportunity Announcement (FOA) is to support epidemiologic studies that utilize creative and innovative approaches to studying vision diseases and disorders with high public impact and whose findings will inform prevention and treatment strategies as well as basic sciences research.
Background:
Clinical vision research projects, including epidemiologic studies, are part of NEI’s core strategy for improving visual health and decreasing visual impairment in populations through research on the burden of disease, its causes, diagnosis, prevention, treatment and rehabilitation.
Projects should focus on NEI’s mission to protect and improve visual health including, but not limited to:
The NEI encourages applications to support ocular epidemiologic research. These projects are supported under the cooperative agreement mechanism.
Applicants are strongly encouraged to contact Scientific/Research staff as plans for an application are being developed (see Section VII, Agency Contacts), preferably no later than 12 weeks prior to the anticipated application submission date.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
New
Renewal of PAR-10-207,PAR-14-096,PAR-14-097,PAR-14-098,PAR-14-099, PAR-14-100, PAR 18-864 and this FOA
Resubmission of PAR 18-864 and this FOA
Revision of PAR-14-096,PAR-14-097,PAR-14-098,PAR-14-099, PAR-14-100, PAR 18-864 and this FOA
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The scope of the proposed project should determine the project period. The maximum period is five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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 support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
The following must be included as an attachment, as applicable:
Other Attachments
1. Study Protocol (required)
The filename "StudyProtocol.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers.
2. Manual of Procedures (MOP) (required)
Basic elements in the MOP may include, but are not limited to: visit schedule; examination and testing procedures; study organization, publication policies, draft Informed consent forms (ICFs) and, if applicable, assent form(s); sample data collection forms; data capture, management and quality assurance; project management including administrative support of the Data Monitoring and Oversight Committee; and applicable clinical center and resource center information.
The filename "MOP.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers. A detailed study protocol must be included.
3. Study Design (required)
The filename "Study Design.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers. A description of the study design/methodology must be included.
4. Statistical Analysis Plan (required)
The SAP must describe study measures and include estimates. The plan should justify the proposed sample size based on appropriate study assumptions, expected loss to follow-up, and power calculations. The plan should also include a description of the methods to be used; plans for methods of bias control; and methods for handling missing data (as applicable).
The filename "Statistical Analysis Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers.
5. Biospecimen Plan (must be provided if applicable to the study proposed)
Provide details for each of the bullets below:
Description of which biospecimens will be collected (e.g., blood, urine, tissue) and, if applicable, plans for repeated or longitudinal biospecimen collection to support scientific hypotheses
How study biospecimens will be collected, processed, analyzed, managed, tracked, and stored
Plans for adherence to Good Laboratory Practices (GLP) and use of current best practices for biospecimen management and quality control
The filename "BiospecimenPlan.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims:
This section should include discussion of the study's public health relevance and its ability to move vision science forward.
Research Strategy:
Provide details for clinical activities, statistical considerations, and project monitoring.
Provide a description of the study administration including, but not limited to:
Letter of Support: Letters of support from institutions with a key role in the study must be provided.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
with the following additional instructions:
Section 2 - Study Population Characteristics
2.3a Inclusion of Individuals Across the Lifespan has the following additional instruction:
Justify the anticipated or projected sample size for the overall study and for any relevant subgroups (i.e., is the sample size sufficiently powered to address the study's aims?)
2.4 Inclusion of Women and , Minorities has the following additional instruction:
Justify the anticipated or projected sample size for the overall study and for any relevant subgroups (i.e., is the sample size sufficiently powered to address the study's aims?)
2.5 Recruitment and Retention Plan has the following additional instructions:
Demonstrate that each recruitment site has access to sufficient numbers of potential participants to attain its target enrollment
Provide estimates or other data to demonstrate the feasibility of meeting proposed recruitment goals, broken down by enrollment site as applicable
Describe contingency plans to manage potential delays or barriers with participant recruitment in the overall study as well as in key subgroups
2.7 Study Timeline has the following additional instructions:
Milestone Plan - Applicants are required to provide detailed project performance and timeline objectives. The proposed milestones must include achievable goals for the project as follows:
Completion of start-up activities as applicable (finalization of protocol, completion of IRB approvals, contracting of sites, etc.)
Establishment of study infrastructure, such as committees, biospecimen storage, and study sites
Finalized standard operating procedures (SOPs), data collection protocols, and informed consent/assent document(s)
Start of recruitment and enrollment of 25%, 50%, 75% and 100% of the projected recruitment
Completion of data collection
Completion of data analyses
Publication of primary outcome manuscripts
Preparation of final dataset for public use
The title "Milestone Plan" should be used for easy access to reviewers.
Section 3 - Protection and Monitoring Plans
3.1 Protection of Human Subjects has the following additional instruction:
When discussing potential benefits and risks to participants, include a description of whether any research data or findings might be returned to participants, and if so which type(s) of results would be returned (e.g., medically actionable genomic variation, clinically significant or incidental exam findings).
3.5 Overall Structure of Study Team is required for this FOA, and has the following additional instructions:
The Overall Structure of the Study Team attachment is required. In addition to describing the various study sites (e.g., administrative sites, data coordinating sites, enrollment/participating sites, laboratory or testing centers), applicants must also describe any committees, sub-committees, and/or working groups that will be used to coordinate and oversee study activities (e.g., steering committee, publications, community engagement).
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
In order to expedite review, applicants are requested to notify the NEI Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
How well does the experience of the PD(s)/PI(s) qualify him/her to lead a large epidemiology study and its related activities (e.g., recruiting participants, establishing study infrastructure, data cleaning and quality control, overseeing multiple study sites if proposed)?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are innovative approaches to streamline or facilitate data collection and management being proposed? If so, will they be able to translate into study efficiencies?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
How well will the epidemiologic study be able to address multiple scientific hypotheses? How feasible are the short, intermediate, and long-term goals of the study?
How feasible are the recruitment goals? How realistically will the contingency plans manage potential delays or barriers with participant recruitment in the overall study as well as in key subgroups? How achievable are the study's timeline and milestones? How well will the participant assessment support: (a) the study's multiple research hypotheses? (b) the investigation of endpoints of clinical significance and other health outcomes of interest? and (c) follow-up of participants over time, if applicable?
Is the study design/methodology well described and appropriate? Does the research plan include plans to control or account for potential biases and deficiencies (e.g., missing, inconsistent or implausible data; misclassification and information bias; selection bias; potential cofounding)?
If applicable, what are the strengths and weaknesses of the applicant's plan for collecting, processing, analyzing, managing, tracking, and storing study biospecimens? How rigorous are the applicant's plans for managing study data? If applicable, are the plans for active and/or passive participant follow-up robust?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
How will the facilities and other resources available to the applicant(s) enable the effective implementation of this study and, if applicable, the efficient operation of a multi-site study? What are the strengths and weaknesses of the study team's overall structure? How effectively will the proposed study sites, committees, sub-committees, and/or working groups be able to coordinate and oversee study activities?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the study?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
As part of the scientific peer review, all applications will receive a written critique.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Eye Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
NEI Involvement Statement:
Applicants must provide a statement acknowledging and agreeing to NEI staff post-award involvement in conducting the aforementioned types of clinical research studies and should describe plans to accommodate this involvement.
Cooperative Agreement Terms and Conditions of Award:
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below
Project Director/Principal Investigator (PD/PI) Rights and Responsibilities:
The PD/PI will have the primary responsibility for:
Defining objectives and approaches, and planning, conducting, analyzing, interpreting, drawing conclusions from and publishing trial results. The design, methods, and procedures of the clinical trial will be detailed in a recipient-prepared and maintained, study-adopted Manual(s) of Procedures and the recipients will have the responsibility for following the protocol.
Ensuring that study progress and quality reports are prepared and distributed as requested by the Data Monitoring and Oversight Committee (DMOC). Ensuring that there is formal documentation of all DMOC deliberations, as applicable. This documentation will clearly list all recommendations and explicit action items and will be reviewed and approved by a quorum of DMOC members as applicable. It is the responsibility of the PD/PI to ensure that their responses to oversight monitoring recommendations or action items are formally reviewed and approved by a quorum of the DMOC. The PD/PI is responsible for ensuring that there is proper administrative management of the Committee. The PD/PI must give all DMOC members the name and contact information of the responsible NEI program director and advise them to contact the NEI program director directly with any concerns about the adequacy of study implementation. In addition, the study PD/PI must officially notify the NEI program director within 24 hours whenever the DMOC makes a recommendation to substantively modify or stop the study.
Ensuring that the NEI and the medical monitor or DMOC receives study progress and safety reports as requested.
Ensuring that the DMOC receives a copy of the study’s primary manuscript(s) for review and approval in advance of journal submission.
Implementing DMOC recommendations -Timely implementation of substantive DMOC recommendations is expected.
Reporting details of the study monitoring process in the grant’s annual non-competing renewal (also called RPPR). Specifically, the renewal must note: 1) actual dates for all medical monitor or DMOC meetings, as applicable; 2) verification that monitoring minutes have been reviewed and approved by the medical monitor or quorum of DMOC as applicable and 3) an update on the status of monitoring and general medical monitor or DMOC action items.Note: status reports must not contain any confidential study data or patient information.
The NEI Guidelines for Data Monitoring and Oversight of Observational Studies is available at:https://www.nei.nih.gov/grants-and-training/policies-and-procedures
Documenting progress toward the stated study timeline and milestones as specified in the in the grant application and/or as modified during pre- or post-award negotiations. Specifically, the annual non-competing renewal must include but not be limited to:
Reporting on compliance with NIH policies related to the study. Specifically, for clinical trials, the RPPR must note the status of or compliance with: 1) Relevant NIH trainings (e.g. GCP, human protection etc.) for applicable study personnel; 2) data sharing; and 3) public access.
The PD/PI is responsible for the overall conduct of the epidemiologic study and for providing scientific, technical, and administrative leadership to the study. He/She 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 Study PD/PI will actively seek advice from all the study's components, including the representative of the NEI. The PD/PI is usually the individual who developed the idea for the epidemiologic study and is the leader in preparing the Manual of Procedures and organizing the study components.
The principal investigator of each resource core center (e.g., data coordinating center, image reading center, laboratory center) will play an important role in the design, implementation, and execution of the clinical trial. Each PD/PI is responsible for all aspects of the operations of his/her resource center and for the local implementation of the study protocol. The resource core centers are involved in performing specified support functions such as training and certification of clinical center staff, designing and maintaining quality assurance programs, data management, data analysis, and preparing publications.
The principal investigator of each participating clinical center has the primary responsibility of identifying and recruiting eligible patients at his/her center. He/She will be responsible for the follow-up, as specified in the study protocol, of each patient enrolled in the clinical study and for submitting required data to the resource center(s). The PD/PI is also responsible for ensuring that his/her clinic personnel are trained and certified to carry out study procedures.
PD/PI are expected to publish and publicly disseminate results, data and other products of the study, concordant with governance policies and protocols and according to NIH Policies (https://grants.nih.gov/grants/policy/data_sharing/).
Publications and oral presentations of work performed under this agreement will require appropriate acknowledgement of support by the NEI/NIH. The requirements for acknowledging NIH-supported Research can be accessed at https://grants.nih.gov/policy/federal-funding.htm
Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. Participation by the third party; involvement of study resources, citing the name of the study or NEI support, or special access to study results, data, findings or resources requires notification and concurrence by the NEI. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NEI.
The grantee institution will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
The grantee must comply with Public Health Service (PHS) policy relating to distribution of unique research resources produced with PHS funding (NIH Grants Policy Statement Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources, as well as the grantee’s data release plan included in the application. For further information see: NIH Data Sharing Policy: http://grants.nih.gov/grants/policy/data_sharing/index.htm
For Genomic Data Sharing: https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/
To advance science and improve human health, NIH makes the peer-reviewed articles it funds publicly available onPubMed Central. The NIH public access policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central immediately upon acceptance for publication.
https://publicaccess.nih.gov/include-pmcid-citations.htm
NIH Responsibilities:
An NIH Program Director, serving as Project Coordinator, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The appropriate NEI extramural Program Director from the Division of Extramural Science Programs whose name appears on the Notice of Grant Award (NoA) will:
Areas of Joint Responsibility Include:
Data Monitoring and Oversight Committee (DMOC)
The DMOC is an independent group composed of individuals not directly involved in patient care or data collection for the study who are responsible for safeguarding the interests of all study participants, and for monitoring the overall conduct of the study. The DMOC receives and reviews the accruing data from the study and provides recommendations about stopping or continuing the study. The DMOC may also formulate recommendations to enhance the study’s scientific integrity and timeliness including recommendations relating to the selection/ recruitment/ retention of participants, their management, improving adherence to protocol-specified treatments, and procedures for data management and quality control. The DMOC operates under the guidance of an approved Charter.
Key responsibilities of the DMOC include but are not limited to:
Study Leadership Committee:
Comprised of the Study PD/PI, PD/PIs of the Coordinating Center (s) and Resource Center(s) as applicable and the NEI representative. This committee acts as the administrative and executive arm of the study. It makes decisions on operational issues; schedules study meetings and conference calls; considers and adopts changes in study procedures as necessary; reviews and implements recommendations from the DMOC; reviews progress of the study 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 individual resource centers and clinical centers to identify and correct remediable deficiencies.
Editorial Committee/Writing Committee:
This committee has the responsibility for reviewing all study presentations, publications and for assisting in the interpretation and preparation of the main study results. Its members are the study PD/PI, coordinating center director, the NEI representative, and several clinical center investigators, as applicable.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the recipients. This special dispute resolution procedure does not alter the recipients' right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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Sangeeta Bhargava, PhD,
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Donald Everett, MA
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Jimmy Le, ScD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email:[email protected]
Brian Hoshaw, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Karen Robinson-Smith
National Eye Institute (NEI)
Telephone 301-451-2020
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.