Research Access

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

The applicant should upload a Biographical Sketch and Research Plan to the NEI Data Commons BRICS system through the request a new account option (https://brics.nei.nih.gov/portal/publicAccounts/createAction!create.action).

The eyeGENE^® Coordinating Center will forward the application packet to the eGRASC for review. Review is usually conducted within two weeks of receipt to the Coordinating Center. The eGRASC Chair will communicate approval or denial to each requestor and the eyeGENE^® Coordinating Center. 

To apply for access to eyeGENE, please provide the following documents when requesting an account:

• Biographical Sketch (short version is encouraged), Curriculum Vitae, or Resume
• Research Proposal including:
  • Descriptive title
  • Types of information being sought
  • Detailed description of proposed project including timeline
• Data Management and Sharing Plan
• IRB Determination, if applicable
• Data Management and Sharing
  • What data will you collect or create? What documentation and metadata will accompany the data?
  • What tools, software, and/or code are required to access or manipulate the data?
  • What standards will be applied to the data and metadata?
  • How will you share the data? Are any restrictions on data sharing required?
  • Who will be responsible for data management? What resources will you require?

If approved, the applicant will complete a Data Use Agreement (DUA). 

1. Requests for access to only BRICS
2. Requests for access to both BRICS and DNA samples
3. Requests to contact interested participants for independent research and/or treatment studies

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

Note: Data is defined as family history data, clinical data, and genotype data. Biomaterials are defined as blood and DNA from donors who have chosen to participate in the eyeGENE^® Stage 1 protocol. The term “Investigator” in the following discussion refers to the individual/researcher submitting the request for access to eyeGENE^® database information and/or biomaterials.

a. Requests for access to the database:  The eyeGENE^® Coordinating Center will work with the Investigator to provide login information and a brief tutorial of the NEI Data Commons BRICS tool.

b. Requests for access to data and biomaterials: Using the NEI BRICS tool, the Investigator will create a list of specimens (using GUID or eyeGENE ID) that are desired to support the Research Plan and return it to the eyeGENE^® Coordinating Center. Up to 5µg of DNA may be requested per sample. The de-identified biomaterial will be aliquoted and shipped from the eyeGENE^® Lab (CLIA Certified) to the Investigator. The Investigator is responsible for shipping charges.

c. Requests to contact interested participants for independent research and/or treatment studies: 

For Investigators who would like to contact eyeGENE^® Participants) for an independent research study involving minimal risk, the eyeGENE^® Coordinating Center will send an IRB approved template letter to the participant providing the title of the independent study and the contact information of the Principal Investigator. The eyeGENE^® Coordinating Center will mail the letter to qualified eyeGENE^® participants selected by the Investigator at the address maintained by the Coordinating Center. 

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 NIH CNS IRB as a protocol amendment. If the IRB grants approval the Coordinating Center will mail the letter to participants as described above.

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^® Data Usage Agreement.

The NEI expects approved Investigators to share both raw and analyzed information generated from use of the data and samples from the eyeGENE^® Network with the eyeGENE^® Coordinating Center and the vision community through the NEI Data Commons. If data sharing will not be possible, the Investigator must provide an appropriate explanation. The ability to share, and the richness 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.

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 Data Usage Agreement, access to the eyeGENE^® database will be revoked and all eyeGENE^® Data and Materials must be destroyed. A written statement of destruction of eyeGENE^® materials will be countersigned by your Signatory Official and submitted to the eGRASC.