Frequently asked questions related to Vertebrate Animal Research at Illinois State University.
Your project is your initial submission to the IACUC. You will have a separate project covering each protocol. The project includes not only your protocol submission form and related documents, but also includes information on your co-PIs, submission history, and other general information related to the project. You will only create a new project once for each protocol. Upon initial submission, the project is assigned a six digit project number followed by a hyphen and another number, such as 877632-1. The number after the hyphen is the package number (explained below).
A package is a subcomponent of your project. The initial submission is the first package of the project. After that, you will create a “New package” for all subsequent submissions. Packages can contain revisions to secure approval, continuation requests, or modification requests. Each request should be submitted as a separate package. While the six digit project number remains the same, the package number will increase sequentially for each package submitted. For example, if your initial package had a number of 877632-1, the second package would be numbered 877632-2 and so forth.
Your protocol is the actual document(s) that describes your plan for conducting your research and how to carry it out. The protocol includes the protocol submission form and all related appendices, permits, etc. Your protocol must be followed by all members of the research team.
We send this notification prior to the review of your submission when we have determined that we cannot proceed with the review because documents or other items are missing. The notification tells you what is missing in order for the review to begin. It also provides instructions on how to mark the revisions complete in order to relock and resubmit the package (see next FAQ as well). Instructions contained in the notification may also be viewed by clicking on the “View History” link next to the red “Unlocked-Revisions Pending” words on the “Designer” tab within your package. Once you have resubmitted with all missing items included, we will forward your package for review. Please note that this is not the notification you receive when revisions are required after review.
Once the requested items have been completed you will need to go to your project (for initial submission) or package (for subsequent submissions). Then go to the “Designer” tab. Towards the top of this screen, click on the blue words “Mark Revisions Complete.” This will “re-lock” and resubmit the project/package. If you do not re-lock the project/package we will not know that you are ready for your project to be reviewed.
This notification is alerting you that an action has been taken on your submission, such as an approval or that approval has been withheld pending modifications. There is no action required from you for this notification, but watch for another notification shortly after this indicating that a board document has been published that may require action on your part.
This means the review of your protocol documents has been completed and you should log in to IRBNet to view the review outcome letter.
Log in to IRBNet and enter the correct project (and package if there is more than one). Then go to the “Reviews” tab to the left. View the published board document by clicking on the piece of paper icon to the right of the document. The document will include instructions for further action if required.
The initial submission of the project creates the first package of the project. Each revision/modification/continuation after the original submission requires a new package for the project. To create a new package to submit your revisions, select “Project History” from within the project and click “Add new package” to create a new package. (You will see that the number after the hyphen has increased by one.) From the new package, select the “Designer” tab to add or revise documents, link your CITI training to the package, sign the new package, and then submit the new package. Select “Revisions” as the submission type. Please make sure that the package status shows as "submitted" instead of "work in progress."
In your User Profile, scroll down to “External Accounts.” Click “add an external account.” Then enter your CITI Member ID number, not your completion report ID number. Then click “Continue” to finish. Once you add your CITI account to your IRBNet profile, you will be sent an email at the address or record to verify your ownership of the external account. To do this, you will open the verification e-mail and click on the activation link. Training will show as unverified until you click on the activation link in the email. Once you verify the account, CITI importation will take approximately 24 hours to complete. IRBNet will now pull your information directly from CITI and your CITI reports will be available in the Designer tab after the importation has occurred.
Please note that linking your training to your user profile does not link it to each project.
This can only be completed if you have already linked your training to your User Profile (see previous question). Once that has been done, go to the Designer tab in the project. Click on the link/unlink blue link at the bottom of the page. This will take you to a new screen where your CITI training information should appear. Put a check by the CITI training information you want to link to your project. Then hit save. You will be taken back to the Designer tab and it should now show “1 Training & Credentials record” linked.
To link your co-investigators’ CITI training or other research staff you must first share your project with them. To share your project with them, they must have an IRBNet User Profile created. Once in your project, select the “Share this Package” tab to the left. The select the blue “Share.” Enter “Illinois State University” and then click “Select Organization.” There is a search box towards the bottom of the screen. In this location, enter the researcher you wish to share your project with and assign them an access level. Once the researcher’s name appears, you then need to click “save.” You can now go to the “Designer” tab and follow the instructions for “How do I link my CITI training to my submission?” provided above. If the co-PI’s CITI training does not appear as an option to link it to your submission, this means that the researcher has not linked their CITI training to their User Profile. They will have to do so before you can link it to your submission.
Yes, you do not have to wait for a submission within your project to be reviewed before submitting an additional package. Just make sure you track the review outcome of each submission.