XeIRB (eirb.med.cornell.edu) is the new electronic submission system that researchers at WCMC must use to submit research proposals involving human subjects to the IRB Office. eIRB replaces the JIRA ticketing/submission system (JIRA will still be accessible to retrieve documents for at least 1.5 years) and it is the only way you can submit to the IRB Office. eIRB incorporated the following Word forms into an electronic question format (i.e. the following forms will no longer be used): IRB Expedited Review Protocol Application, IRB Protocol Application, Cooperative Agreement Form, CIRB Facilitated Review Form, Request for Exemption, IRB Continuing Review Application Form, IRB Amendment Form, Human Tissue Request Form, Pharmacy Section, Protocol Exception Request, Immediate Reporting Form. These forms will no longer be used by the IRB Office.

In addition, requests for emergency use of non-FDA approved drugs or devices must now be submitted through eIRB.

XeIRB is accessible to WCMC and NYP researchers. To log into eIRB, go to eirb.med.cornell.edu and log in using your CWID and password (same as email). Only the PI can actually submit a submission, but anyone who has access to a study (see below on how to obtain access) can create a submission on the PIs behalf. After reviewing the submission for completeness, the PI will have to click the "Submit for Review" button which takes place of their physical signature.

XeIRB is accessible via the following intranet site: eirb.med.cornell.edu. If you are outside of the secure network, you will have to use webVPN or the VPN client offered by ITS to access it. For more information regarding remote access, please visit the following ITS site: http://weill.cornell.edu/its/network/remote/.

XeIRB will give researchers access to all of their active studies and allow them to submit the following submission types:

a) New Protocol - Full Board, Expedited and Exempt have been combined into one application
b) New Protocol - Cooperative
c) New Protocol - CIRB
d) Emergency Use Request
e) Response to Questions (RTQ) - Response to a Deferral, Modifications Required, or Tabled letter
f) Amendment
g) Continuing Review
h) Continuing Review + Amendment
i) Study Closure
j) Immediate Report (Adverse Event, Protocol Deviation, etc.)
k) Protocol Exception Request
l) Acknowledgment

XIf you are a PI/Co-Investigator, the first time you log into eirb.med.cornell.edu and go to "My IRB Protocols," a list of all the protocols that you are a PI or Co-Investigator on will appear under the tabs listed based on the status of the protocol. The research coordinator for a PI will see all studies that they have access to (either view only rights or editing rights).

XFor someone other than the PI to have access to a protocol, the PI must give the person view only or editing rights. To do this, the PI must go to "Access Permissions" under Protocol Options and grant access to those who need it. Once a person has access and editing rights, they can add other people to this list.

If someone other than the PI creates a new protocol on behalf of the PI, they will automatically have editing rights to the protocol.

XIf you do not see your PIs protocols under "My IRB Protocols" then you do not have access to them. Either the PI can grant you access by adding you under "Access Permissions," or you can contact the IRB Office at 646-962-8200 so we can give you access.

X a) Create New Protocol - This tab allows you to start creating a new protocol for IRB review. The application is the same regardless of whether you are submitting a Full Board, expedited, or exempt protocol application.

b) Action Required: The submissions listed here are in two categories: 1) "Pending" or "Renewal/Amendment in Progress," which means the submission has not been submitted for IRB review; or 2) "Modifications Required," "Deferred" or "Tabled," which means the IRB reviewed the submission and there were issues that need to be addressed by the PI. The protocol at this time is editable. Co-Investigators who need to certify a study will be able to certify under this tab.

c) In-Progress Submissions: Studies under this tab are not editable because they are in routing and on their way to the IRB Office. To see exactly where the study is and who is meant to review and approve it, select the protocol and select "Where is My Protocol?" under "Protocol Options."

d) All Active Protocols - These are all the active, IRB approved research studies for which there is nothing pending. You can only submit a renewal, amendment, immediate report, or acknowledgment to active studies.

e) Inactive Protocols - All closed studies can be found here.

XAll Investigators on a study must "certify" the protocol before it can be submitted to the IRB for review. By "certifying" a protocol, the Investigator answers the potential conflicts question and agrees to be a part of the study. All investigators must answer the conflicts question. Depending on their response, a SSR may be required. SSRs must be submitted in the following ways for the following category of investigator:

a. WCMC employee (including voluntary faculty) - If there is NO conflict to report, a SSR is NOT required. To be able to certify the study, they must have completed their most recent annual survey (the survey can be accessed at conflicts.med.cornell.edu). If there is a conflict, they must complete both the SSR within the online Conflicts Management System and the most recent annual survey. They do not need to attach the SSR in eIRB.

b. NYP employee - If there is NO conflict to report, a SSR is NOT required. If there is a conflict, they will have to attach an external SSR indicating the conflict. Before being able to certify the protocol, the investigator themselves will have to attach the external SSR in the indicated area on the certify screen.

c. Completely external - An external SSR is required for every external co-investigator. Since they are not able to log into the system, the external SSR will take place of them certifying the protocol within eIRB. Either the PI or the research coordinator will have to attach the SSR on their behalf in the PI/Co-Investigator section. The external Co-Investigator must send the external SSR to the PI or coordinator to upload into eIRB on their behalf.

XPlease call the IRB Office so that we can add them to our database. This can be done very quickly.

X a. First, you must locate the protocol under "My IRB Protocols" and "Action Required."

b. Select the protocol. Review the issues letter that was sent to you via JIRA. Each section and form in eIRB must be answered based on what was written in the first application submitted to the IRB Office, making sure that it incorporates the changes requested by the IRB in the issues letter. PLEASE NOTE THAT IF THE ISSUES LETTER REFERENCES QUESTION NUMBERS UNDER PROTOCOL REVIEW, THEY WILL NOT COINCIDE WITH eIRB.

c. If changes were requested to the Consent, HIPAA, or advertisements, the highlighted and clean copies must be attached in the "Attachment" section. Highlighted and clean copies of the protocol application do not need to be submitted.

d. A response memo addressing each issue must also be in the "Attachments" section.

e. Once you are done with the response, then you must go to "Submission Options" and select "Submit for Review." PLEASE NOTE THAT THE PROTOCOL WILL BE ROUTED TO THE DEPARTMENT CHAIRMAN AND ANY OTHER INSTITUTIONAL APPROVERS THAT ARE REQUIRED BASED ON YOUR RESPONSE TO THE QUESTIONS. THIS WILL BE DONE EVEN IF THEY HAVE ALREADY APPROVED THE STUDY.

XOnce you have answered all of the questions in a section/form, a checkmark will appear to the left of the section. As long as you are selecting "Save and Proceed" after each question, you can close the protocol and return at a different time to finish answering the forms that don't have checkmarks next to them. Once all of the sections that are required have checkmarks and all investigators have certified the protocol, the PI can submit the new protocol into routing. If there is something missing from the submission, you will be directed to the sections that are incomplete when you try to submit.

XYes, you have to obtain approval from the Department Chairman and any other Institutional Approvers (IA) whose services you are using. HOWEVER, similar to the Electronic Routing Form (ERF), your protocol will be automatically routed to them once the PI hits the submit button. The IA will have the option to "approve" or "return" the submission. "Approving" the submission moves it along in routing. "Returning" a submission returns the protocol to the research team for editing based on the indicated comments from the IA.

XAll letters (approval and issues) can be found under "Protocol Options" in "View History." "View History" is where you can see the history of the protocol separated by submission type. To find a letter, expand the submission type and click the PDF icon next to the approval. Only letters generated after 6/25 will be available here. To get previous letters, please look to JIRA.

To find IRB stamped documents like consent and HIPAA forms, look in "Attachments." The IRB Office will label the document as "Stamped".

X No, all of the study information will not be in eIRB once it goes live on 6/25. The first time you have to submit a Continuing Review or Amendment to the IRB you will be required to go through each form and enter the correct information. Some information may have been entered by the IRB Office but we strongly recommend you go through each form and confirm the information is correct. THE FIRST TIME YOU HAVE TO SUBMIT A CR OR AMENDMENT TO AN ALREADY APPROVED PROTOCOL, MAKE SURE YOU GIVE YOURSELF EXTRA TIME TO ENTER THE MISSING INFORMATION.

X No, you do not have to enter any missing information to submit an Immediate Report. Simply find your study under "All Active Protocols," then go to "Submission Options" and submit the Immediate Report.

XOnce approved, the following "Protocol Options" exist (to get to Protocol Options, you must select the protocol under "All Active Protocols"):

a) Submission options - This is where you can submit Other Submissions like Acknowledgments, Exceptions and Immediate Reports (Adverse Events, Protocol Deviations, Etc.).

b) Comments - This is where you can ask the IRB Office questions regarding this specific study.

c) Amendments/Renewals History - A brief description of each amendment and renewal can be found here.

d) View History - This is where you can see the history of the protocol separated by submission type. This is also where you find any letters from the IRB office (approval, issues, etc.). To find a letter, expand the submission type and click the PDF icon next to the approval.

e) New Amendment - To make a change to any sections of the protocol, you must submit an amendment. The first screen that will come up is "Amendment summary." This should be a brief description of the amendment (Amendment 2.0, adding a co-investigator, etc.). This should NOT include the rationale for the amendment (that will be asked later). The description you add here will show up in the approval letter. Below this box you should select each section of the protocol that you want to make an edit to. If you do not select a section, it will not open up for editing. The second section you will have to fill out is the "Amendment Information" under Additional Forms. This should include the detailed amendment description. If you are making any changes to attachments (like a consent form or HIPAA Authorization) then you must attach the highlighted/clean copies for review. Once you are done with the form, then you must go to "Submission Options" and select "Submit for Review."

Please note, if the protocol will be expiring within 2 months from when you are submitting the amendment, a pop-up box will appear suggesting that you submit a continuing review with an amendment. Please remember, only one amendment or continuing review can be submitted at a time.

f) Continuing Review (with Amendment option) - The first screen that will come up is "Renewal Summary." This should be a brief description of the renewal (e.g. 2012 Renewal) and the amendment (if you are submitting an amendment). The description you add here will show up in the approval letter. If you are submitting an amendment at this time, below the Renewal Summary box you should select each section of the protocol that you want to edit as a result of the amendment. If you are not requesting an amendment, you should not select any checkboxes for editing. If you do not select a section, it will not open up for editing. The second section you will have to fill out is the "Continuing Review Information" under the Additional Forms. Also under Additional Forms, all the sections that you selected to amend will be open for editing. Once you have completed the forms, then you must go to "Submission Options" and select "Submit for Review."

g) Access Permissions - This is where the PI or creator of the protocol can give view-only or editing rights to anyone.

h) Print Summary - From here you can print the entire protocol or just sections of the protocol.

X Yes, the HIPAA complete and partial waivers are built into eIRB. The only HIPAA form you may have to attach under "Attachments" is the written HIPAA Authorization form. The HIPAA Preparatory to Research Form (Form 8) is not submitted through eIRB, but should be sent as a PDF to irb@med.cornell.edu.

X No, you cannot add charts and figures in response to questions. You must add them as PDF documents in the "Attachments" section with a reference to the chart/figure (e.g. see Chart 1 in Attachments) in the answer to the question.

X "Administrative Contact" should indicate the one person who is administratively responsible for this study (if it is the PI, then this section can be left blank). "Access Permissions" gives a person other than the PI and Co-Investigators access to the study. There are two types of "Access Permissions:" View-Only and Allow Editing. The PI and the person who created the new protocol automatically have editing rights to the study.

XThis tab is only for Departmental Approvers like Chairmen, Pathology, Pharmacy and Radiology. If you do not have this role within eIRB, nothing will show up here.

X Yes, the HRBAF will have to be attached to the study in the "Attachments" section. It is not required to submit to the IRB but will be required before the IRB can release any approval documents.

X Each submission can be printed by selecting "Print Summary" under Protocol Options. After selecting "Print Summary" you will have the option to print the entire submission, or just a particular section. To print an Acknowledgment, Immediate Report or Exception submission, you must first complete the submission, and at the bottom of the completed form you will have the option to "Print" the form before you submit it for review. If you want to print the information after you have submitted it for review, find the submission under "In-Progress Submissions", select the submission information under "Forms" and select "Print" from the bottom of the screen.

X Please call the IRB Office at 646-962-8200.

X Yes, the IRB Office recommends using Firefox (Windows: version 3.x; Mac version 12.0) when using eIRB.