Information for researchers regarding IRBNet submission and IRB protocols in general.
What is the difference between a project, a package, and a protocol?
What are the basic steps to submit a project in IRBNet?
The Department Rep’s form has suggested revisions. Do I make those now or after IRB review?
What does it mean when I get an email that says my package has been unlocked?
How do I re-lock my package/project?
What does it mean when I get an email that says board action has occurred?
What does it mean when I get an email that says a board document has been published?
How do I see my outcome letter (board document)?
How do I submit my revisions to my protocol to secure approval?
How do I link my CITI training to my User Profile?
How do I link my CITI training to my project?
How do I link my co-investigators’ CITI training?
Can I submit additional requests to my protocol if a package is currently pending review?
How do I navigate between packages in an existing project?
What are the basic steps to submit a continuation request for a project previously approved in IRBNet?
What are the basic steps to submit a modification request for a project previously approved in IRBNet?
What are the basic steps to submit a continuation request for a project not previously approved in IRBNet?
What is the difference between waiver of informed consent and a waiver of the documentation of informed consent?
How do I request a waiver of informed consent documentation for my survey questionnaire?
If I do not receive a waiver of documentation of informed consent, do I need to provide the subject a copy of the consent form?
Do I have to destroy my data?
Who conducts reviews of my protocol?
Your project is your initial submission to the IRB. 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 consent documents, appendices, instruments, etc. Your protocol must be followed by all members of the research team.
That is up to you. If you don’t make them prior to submission, we will include them in the IRB review. In order to expedite the review process we suggest that the DR and the PI discuss possible revisions and that the revisions are addressed before the DR finalizes their form.
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 having been “submitted” instead of as a “work in progress.” To view step by step instructions and screen shots, click here.
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.
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.
Waiver of informed consent means that the IRB may approve a consent procedures that either doesn't include, or which alters, some of all of the elements of informed consent. 45CFR46.116.
Waiver of the documentation of informed consent means that the consent process is still required, but a signed consent form might not be. An example might be an online survey where the participant signifies consent by clicking a button to proceed to the survey.
The Code of Federal Regulations (45 CFR 46.117) allow only two scenarios under which the IRB can waive the requirement of a signed consent form. In Section B.2.b.ii of your protocol, choose the statement below that is the most appropriate for your protocol:
“I am requesting a waiver of documentation of informed consent since the signed consent form will be the only record linking the subject and the research and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.”
“I am requesting a waiver of documentation of informed consent since the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.”
Yes. 45CFR46.117(a) states that unless a waiver has been granted, “a copy shall be given to the person signing the form.” It is not sufficient to just state that the participant can ask for a copy.
There are no requirements that data must be destroyed. You just have to state what your plans are for the data both in the protocol and in the consent process. Keep in mind that if you are retaining the data, you must do so in accordance with the approved protocol.
The IRB Chair or the Vice Chair conducts the final review of protocols. For exempt protocols, the IRB Vice Chair conducts the reviews. For expedited protocols, the protocols are reviewed by a member of the IRB executive committee and the IRB chair. For full board protocols, the protocol is reviewed by 2 primary members of the IRB executive committee and then reviewed by the full IRB executive committee. REC staff does not conduct the reviews of protocols.