Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed 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, if applicable:

Other Attachments

?Study Protocol (required) - a detailed study protocol must be included.

The filename "StudyProtocol.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers.

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, quality assurance and analytical procedures; 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.

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, disease-impacted tissue) and, if applicable, plans for repeated or longitudinal biospecimen collection to support scientific hypotheses
• How study biospecimens will be collected, processed, analyzed, managed and 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 "Biospecimen Plan 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. 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, with the following additional instructions:

Specific? Aims:

This section should include the public health relevance of the study with regard to the ability to move vision science forward.

Research Strategy:

Provide applicable details pertaining to the clinical activities, statistical considerations, and project monitoring.

Provide a description of the study administration including, but not limited to:

• Leadership's past track record and/or future performance potential in clinical research (NEI-sponsored or otherwise);
• Plans for carrying out the leadership's roles and responsibilities on a day-to-day basis;
• Plans for identifying and engaging qualified investigators to participate in the study;
• Plans for assuring study integrity, protocol fidelity and completion; and
• Plans for manuscript preparation and results dissemination.

Letters of Support: Letters of support from institutions with a key role in the study must be provided.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When involving NIH-defined human subjects research, clinical research, and/or 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

2.4 Inclusion of Women, Minorities, and Children 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 (e.g., pilot 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).

All instructions in the SF424 (R&R) Application Guide must be followed. 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. 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 there a strong scientific premise for the project? 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? 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 the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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? 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? 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.

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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.

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.

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

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.

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.

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.

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. 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.

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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees 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 study results. The design, methods, and procedures of the epidemiologic study will be detailed in an awardee-prepared and maintained, study-adopted Manual(s) of Procedures and the awardees will have the responsibility for following the protocol

Retaining custody of and have primary rights to the data developed under these awards, subject to Government rights of access, consistent with current DHHS, PHS, and NIH policies. 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 DMOC receives study progress and quality reports as requested.

Ensuring that the DMOC receives a copy of the study’s primary manuscripts for review and approval in advance of journal submission.

Implementing DMOC recommendations -Timely implementation of substantive DMOC recommendations is expected. If the study leadership and/or NEI do not concur with the DMOC recommendation, it will be the responsibility of the NEI Director or designee, study leadership, and DMOC Chair to reach a mutually acceptable decision.

Reporting details of the oversight monitoring process in the grant’s annual non-competing renewal (also called RPPR). Specifically, the renewal must note: 1) actual dates for all DMOC meetings; 2) verification that monitoring minutes have been reviewed and approved by a quorum of DMOC and, 3) an update on the status of monitoring and general 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://nei.nih.gov/funding/datastudies

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:

• 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)
• Date of ClinicalTrials.gov registration, as encouraged;
• 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
• Date of initiation of data sharing

Reporting on compliance with NIH policies related to the study. Specifically, for epidemiologic studies, the RPPR must note the status of or compliance with 1) Relevant NIH trainings (e.g. 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 epidemiologic study. 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.

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.

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:

Nominate members of an independent Data Monitoring and Oversight Committee (DMOC). The DMOC membership will be based on recommendations from the Study Leadership and NEI program staff.

Assist the Study PD/PI, Coordinating Center Director, and, when appropriate, the Executive Committee, in assuring that patient information handbooks, recruitment information, press releases, and publicity exhibits are properly prepared, approved and disseminated.

Assist the Study PD/PI and Coordinating Center Director in the identification of additional participating clinics, if necessary, to enhance patient recruitment.

Assist the Study Leadership Committee in site visits and 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 or study core centers. The NEI Program Director will attend and participate in study meetings as appropriate.

Assist the Editorial/Writing Committee in the preparation and review of study results for publication.

Assist the DMOC as an expert resource in their evaluation of quality and progress on an ongoing basis, as applicable. Serving as a steward of federal funds, the NEI Program Official will assist but not direct deliberations and decisions of the Committee, e.g., proceeding from one phase of the study to the next; implementing protocol changes, evaluating study progress and quality including patient recruitment, overall clinical and resource center performance; monitoring study timeliness and progress toward meeting milestones, approving ancillary studies, planning data analysis; releasing unmasked data; announcing study findings; determining the timing of release of any interim or final reports; and, reviewing primary outcome manuscript(s) prior to journal submission.

The NEI reserves the right to curtail, withhold, or terminate support for the study, for an individual award, or support for a participating consortium, in situations involving: inadequate progress toward meeting study milestones including those related to: patient recruitment, follow-up, data reporting, or quality control; a major breach of the study protocol or NEI/NIH policy; a substantive change in the agreed-upon 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 receive recommendations from the DMOC. Additionally, the NEI Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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.

Key responsibilities of the DMOC include but are not limited to:

• Determine the adequacy and appropriateness of the proposed study protocol and procedures.
• Recommend and review proposed protocol changes.
• Recommend/evaluate proposed ancillary or pilot/feasibility studies.
• Evaluate patient safety.
• Evaluate the informed consent document and procedures.
• Monitor performance, including recruitment, retention, overall study progress, and adherence to study protocol.
• Assess data quality and quality control procedures.
• Evaluate the data analytic plan.
• Evaluate the publication plan, including topics and preparation schedule.
• Review performance of individual centers, and if necessary, recommend actions to improve performance or terminate participation of specific centers.
• Review and provide recommendations prior to submission of primary manuscripts and oral presentations that address the specific aims of the study.
• Review overall scientific direction of the study.
• Review plans for Data Sharing

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 individual awardee. This special dispute resolution procedure does not alter the awardee's 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

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]

Maryann Redford, DDS, MPH
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected] Anne Schaffner, PhD (NEI)
National Eye Institute
Telephone: 301-451-2020
Email:[email protected] Karen Robinson-Smith
National Eye Institute (NEI)
Telephone 301-451-2020
Email: [email protected] 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.