IRBManager FAQ

How do I find a protocol?
Click on the Home tab at the top of the screen. This will list all protocols for which you are listed as either a principal investigator or a co-investigator.

How do I change my password?
From any screen in IRBManager:

Click the link My Settings
Click the link Change My Password
You will then be prompted to enter your old password, followed by your new password and confirmation of your new password.

How do I change my contact information (Name, phone number, or email address)?
To change your name, phone number, or email address:

From any screen in IRBManager:

Click the My Settings link
Click the link for User Settings
This will take you to the screen where you will make the necessary changes.

To change your address:

From any screen in IRBManager:

Click the My Settings link
Click the link for Address Information.
This will take you to the screen where you will make any necessary changes.

How do I start a new protocol?
From the Home screen:

Click the link xForms, under My Documents & Forms.
Click Start Form under the Actions section.
In the pop-up window, click the New Protocol Application link.

From within a protocol:

Click Start xForm link under Actions.
In the pop-up window, click the New Protocol Application link.

How do I start a continuing review form?

In the appropriate protocol (see How do I find a protocol?), in the sixth section, (Events) click on the link Continuing Review.
Click Start xForm link under Actions.
In pop-up window, click Project Update (Continuing Review) Form link.

How do I start a project closure form?

In the appropriate protocol (see How do I start a new protocol?), click Start xForm link under Actions.
In the pop-up window, click the Project Closure Form link.

How do I start a revision to a previously approved protocol form?

In the appropriate protocol (see How do I find a protocol?), click Start xForm link under Actions.
In the pop-up window, click the Revision to a Previously Approved Protocol link.

How do I start an adverse event form?

In the appropriate protocol (see How do I find a protocol?), click Start xForm link under Actions.
In the pop-up window, click the Adverse Event Form link.

What do I do if I have multiple informed consent (recruitment, letters of cooperation, etc.) documents?

For documents of three pages or more, combine the files into one document and attach.

What are the requirements for waiver of documentation of informed consent?

This waiver is requested when all of the elements of informed consent will be explained to participants but the letter of informed consent is not signed by the participant, such as in an anonymous survey. The IRB may waive the requirement for the investigator to obtain signed informed consent if one or both of the following conditions are met:

The only record linking the participant to the research would be the signed document of informed consent AND the principal risk associated with participation in the research would be the potential harm that might result from a breach of confidentiality. According to the Federal Regulations, research participants must be asked if they want documentation linking them with the research. Participants who prefer to sign an informed consent document must be given this opportunity.
The research presents no more than minimal risk of harm to research participants and involves no procedures for which written consent is normally required outside of the research context.

If you are requesting a waiver of documentation of informed consent, please complete the appropriate section asking for the justification for requesting a waiver. You will then need to upload a letter of informed consent in the attachment section at the end of the new protocol application. This would typically be a cover letter explaining the research but would not have a signature line. A sample letter can be obtained by contacting either Cory Clasemann at (317) 788-2063 or cclasemann@uindy.edu, or Gavyn Ryan at (317) 781-5774 or gryan@uindy.edu.

What are the requirements for waiver of informed consent?
To obtain a waiver of informed consent, all of the following conditions must be met:

The research involves no more than minimal risk to the participants
The waiver or alteration will not adversely affect the rights and welfare of the participants
The research could not practicably be carried out without the waiver or alteration
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If the protocol satisfies all of these requirements and you are requesting a waiver, please enter the justification in the appropriate section.

How do I check the status of a submission using IRBManager?

Go to the protocol for which you are checking the status (see How do I find a protocol?)
In the sixth section of the protocol screen, (Events) you will find all actions that have occurred for the protocol. Click on the appropriate link for which you would like to check the status (i.e. continuing review)
In the fourth section of the Event Details screen, you will see the Step section. This is the area where you will see what items have been completed for your protocol.

I submitted a protocol using IRBManager but I can’t see it when I go to the Home tab. Why is it not there?

A new protocol that has been submitted will not appear on the Home tab until it has been accepted into IRBManager by the IRB and assigned a protocol number. To do this, a protocol must be approved by the submitting investigator, the PI, and the department chair, and then accepted into the system by the IRB.

How do I know when my protocol/revision is approved?

Click on the link for 'New Protocol' under the Events section in the applicable protocol. (This will take you into the event steps of the protocol). On the fourth line from the bottom, 'Protocol is Approved' you will see the status of the approval.

I haven’t received the IRB review results for the protocol I submitted. Why?

Find the applicable protocol and click on the link for 'New Protocol' under the Events section. (This will take you into the event steps of the protocol). If there are any steps that have 'no' next to them, please send that information to Cory or Gavyn. If you are sure you sent all information with your original submission, please contact either Cory Clasemann at (317) 788-2063 or cclasemann@uindy.edu, or Gavyn Ryan at (317) 781-5774 or gryan@uindy.edu.