(iRIS) Modification Form

The modification form starts with a section explaining the form. Please reach out to the IRB office at irb@gcu.edu if you are unsure if this is the appropriate form for you.

This section contains information on the principal investigator (you) populated from your IRB application.

NOTE If you select Other as the University Affiliation, you will need to specify your affiliation. Keep in mind that other affiliations may require prior approval before submitting the modification form.

In section 1.3, you will select the checkboxes for the type of modifications that you would like to make to your study. If you select an option from the list, you will be prompted to answer questions related to your modification in the sections below.

Sections 1.4 through 1.12 are conditional, you will only be able to edit a section if you have checked the box for that section in 1.3 Type of Modification.

1.4 New Data Collection Procedure(s)

In this section, you are able to add new research collection procedures. Please follow the format listed in the description. If revised recruitment scripts and revised consent forms are required, they must be uploaded in the Documents section of the form.

1.5 Study Title Change

If you need to update the title of your study, please do so in this section.

1.6 Change in Study Personnel

This section will allow you to add or remove key personnel from the study. If you are modifying the Supervisor (Chair) for your study, please add them in section B.

When adding a user, click the + Add option. On the next page, you will be able to search for a user by first and last name. Click Find to locate the user and click on the checkmark under Select User to add them.

1.7 Change of Site

If you need to make changes to your site, please do so here.

1.8 Change in Enrollment

Please make any necessary changes to enrollment here. If you need to upload additional material, please do so in the Documents section at the end of the form.

1.9 Consent Change

If you need to make changes to consent forms, you can do so by revising existing forms or adding new consent forms. Please explain the changes you have made in the text section.

To revise an existing consent form, click Select or Revise Existing.

Find the consent form that you would like to change and click the icon under Create Revision.

The version number for the document will be automatically updated. Make any necessary changes to the title, date, and language, then select Check-out Document.

You will receive some brief instructions about how to download and open the file. Follow the instructions and click Complete Checkout.

The revision window should now indicate that you have checked out the document. If you need to make changes and return to the modification form later, you can click Save Consent.

To return to the page and check the document back in, navigate back to section 1.9 and you will see the document you have checked out. Click Select or Revise Existing once again.

Select the pencil and pad icon for the document you have started revisions on.

This will return you to the Content Revision page where you can select Check-in Document.

Select Choose File and upload the file you edited. When you are finished, select Save selected file.

The document will be checked back into the system, and you can click Save Consent.

The revised document will now be visible in section 1.9.

1.10 Recruitment Materials

If you need to update your recruitment materials, please do so here. Please be sure to upload any additional revised materials in the Documents section at the end of the form.

1.11 Instruments (surveys, questionnaires, interviews, etc.)

If you need to update any instruments used, please do so here. Please be sure to upload any additional revised materials in the Documents section at the end of the form.

1.12 Other Changes

Any other changes that need to be made can be detailed here. Please be sure to upload any additional revised materials in the Documents section at the end of the form.

If additional documents are required for your study, please be sure to add them here in the Documents section when you reach the end of the form. You may also revise existing forms here.

When you add a University Affiliation you will be asked if you changed your Chair. If you select yes, please email irb@gcu.edu with the name of your new chair and wait for some correspondence before submitting the modification form.

If you need to add your supervisor to the application, select Add Selected User. If your supervisor is not listed in the directory, ask them to log into iRIS to activate their account.