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eyeGENE® Researchers

Sample Diagnoses

Information on applying/terms/requirements

All researchers interested in gaining access to clinical data, genetic analysis data, and DNA samples from eyeGENE® must submit a proposal for approval from the eyeGENE® Resource Access Subcommittee (eGRASC).

Application and Approval

Access requests may be completed through electronic submission or through hard copy mail and includes the following:

  1. An eyeGENE® Access Application (SF 424 R&R, Biographical Sketch and Research Plan) The application documents should include a descriptive title for the proposed project and a description of the types of information sought. The proposal must state how samples will be used, detailed description of the proposed project including a project time-line, and description of secondary distribution (if any). The Biographical Sketch should be no longer than 4 pages and the Research Plan must not exceed 3 pages.
  2. eyeGENE® Material Transfer Agreement for Access to Biomaterials and/or Data. This document outlines the terms and conditions for use of eyeGENE® Data and Materials. It must be completed and a final copy filed at the NEI’s Technology Transfer Office before eyeGENE® Data and/or Materials will be distributed. Please refer to separate instructions for completion of the MTA.

Proposals should be accompanied by proof of Institutional Review Board (IRB) approval or exemption. The eGRASC may review an application and provide provisional access for the materials contingent on IRB approval or exemption.

The eyeGENE® Coordinating Center will forward the application packet to the eGRASC for quarterly review according to the following schedule. The eGRASC Chair will communicate approval or denial to each requestor and the eyeGENE® Coordinating Center.

Application received by eGRASC Review Date
Feb. 25th April 25th
May 25th July 25th
Aug. 25th Oct. 25th
Nov. 25th Jan. 25th

MTA and Instructions PDF*

Types of Access

After approval from the eGRASC, the following procedures will be followed based on the type of access requested.

a. Requests for access to only the database: The eyeGENE® Coordinating Center will work with the Investigator to provide login information and a brief tutorial of the eyeGENE® database. Access will be limited to the specific types of information requested in the Research Plan and approved by the eGRASC.

b. Requests for access to both data and DNA samples: The eyeGENE® Coordinating Center will work with the Investigator to provide login information and a brief tutorial of the eyeGENE® database. The Investigator will create a list of specimens that are desired and provide it to the eyeGENE® Coordinating Center. Up to 5 µg of DNA may be requested per participant. The de-identified biomaterial will be aliquoted and shipped from the CLIA-certified eyeGENE® Laboratory to the Investigator. The Investigator is responsible for providing shipping arrangements.

c. Requests to contact interested participants for independent research and/or treatment studies:
For Investigators who would like to contact eyeGENE® participants (individuals for which a sample was submitted) for an independent research study involving minimal risk, the eyeGENE® Coordinating Center will mail an NIH IRB-approved template letter to the eyeGENE® participants who meet the criteria described and selected by the Investigator in the study proposal, providing the title of the independent study and the contact information of the Principal Investigator.

Investigators who are interested in contacting participants for independent research involving above minimal risk must submit a draft of a letter intended for participants, explaining the study and providing contact information. The letter will be submitted to the NEI IRB as a protocol amendment. If the NIH IRB grants approval, the Coordinating Center will mail the letter to participants as described above. The Coordinating Center will also mail the participants’ referring health care providers to inform them that their patients may be eligible for a research study.

In each case, the participant will be responsible for contacting the Investigator of the proposed research or treatment study directly to enroll in the independent study. The Principal Investigator of the independent study and his/her institution are responsible for ensuring that all uses of the data are consistent with federal, state, and local laws and regulations and any relevant institutional policies, and agree to provide a list of the eyeGENE® participants who choose to participate as described in the eyeGENE® Material Transfer Agreement. Note: Participants who enrolled in eyeGENE® as minors and who are now adults must be re-consented before the Coordinating Center can contact them about an independent study.

Data Sharing

To continue to offer high quality information, especially when dealing with the rare disease populations within the eyeGENE® biorepository, data resulting from research analyses of eyeGENE® resources is required to be returned to the eyeGENE® Coordinating Center. The NEI expects approved Investigators to share information generated with the eyeGENE® Coordinating Center and the vision community. If data sharing is not possible, the Investigator must provide an appropriate explanation. The ability to share, and the quality of the data resulting from a study, may be considered by the eyeGENE® Resource Access Subcommittee as part of the approval decision. Please include details of a data sharing plan in the Research Plan. Data pending publication will be released at a later date.

Reporting Requirements

The Principal Investigator will be required to submit an annual progress report to the eGRASC which is countersigned by the Signatory Official. The eGRASC will review annual progress reports and may terminate the Agreement immediately if sufficient progress is not made.

Upon termination of the Material Transfer Agreement, access to the eyeGENE® database will be terminated and all eyeGENE® Materials in the Principal Investigator’s possession must be destroyed. A written statement of destruction of eyeGENE® materials will be countersigned by the Signatory Official and submitted to the eGRASC.

How are eyeGENE Samples processed?