If a Human Subjects Office screener provides you with feedback on required changes to your submitted protocol, you will use IU’s KC IRB system to respond.
The following sections provide information on how you can respond to screener comments using the KC IRB system.
From KC IRB, under By Protocol Number — enter Protocol Number, followed by *, enter Protocol Number + * in the search field and click the “search” button.
When your search results return, click edit under the Actions column for your study/submission (NOTE: the study/submission should display a Protocol Status of Return to PI. When responding to a pre-review to post an approval submission, you should locate the appropriate submission.
a. For amendments, search for an A00X suffix added to the protocol number (e.g. 1234567890A001)
b. For renewals, search for an R00X suffix added to the protocol number (e.g. 1234567890R001)
c. For FYIs, search for an F00X suffix added to the protocol number (e.g. 1234567890F001)
d. For initial applications, there will be no suffix (e.g. 1234567890)
Once you have accessed your KC protocol in edit mode, navigate to the Protocol Actions tab and follow these steps for reviewing and addressing HSO screener comments:
Click show on the Summary and History panel
Click show on the Submission Details section
Click show on the Review Comments section
Any general comments or comments related to parts of the KC IRB protocol can be found here.
Click show on the Review Attachments section.
a. Click view in the Action column associated with any protocol documents (e.g. ICS)
i. Once the document is opened, review the HSO screener comments and/or revisions and address or revise, as appropriate.
ii. Save the revised document for future upload into KC IRB.
b. Click view in the Action column associated with the KC Questionnaire PDF document.
i. Ensure you are opening the PDF in a full version of Adobe Acrobat, i.e. not a Reader version.
ii. Click on Comments to display the HSO screener comments; OR
iii. Position your mouse over the yellow highlighted text, right click, and Open Pop-up Note to view the HSO screener comments.
If you need to replace any existing documents in response to your pre-review, access your KC protocol in edit mode, navigate to the Notes & Attachments tab, and follow these steps for replacing documents that were revised as part of your response to the HSO screener comments:
Click show on the Protocol Attachments panel
Click show on line associated with the document you need to replace
Click replace and upload revised document
Click save at the bottom of the page
Repeat above steps for all protocol documents that need to be replaced
If you need to add any existing documents in response to your pre-review, access your KC protocol in edit mode, navigate to the Notes & Attachments tab, and follow these steps for uploading new documents that are required in response to the HSO screener comments:
Under Add Protocol Attachment, upload the new document(s) as follows:
Select attachment type
Enter Description of document
File Name = choose file
Click add
If you need to revise any existing documents in response to your pre-review, access your KC protocol in edit mode, navigate to the Questionnaire tab, and follow these steps for revising responses to questions in the KC IRB Questionnaire(s):
Click show to expand the Questionnaire that you need to revise
Navigate to specific question ID(s) and make necessary revisions to your response
Click update at bottom of page when complete
Click update at bottom of each questionnaire when finished
Note: If you receive a message when trying to navigate away from the Questionnaire page stating that a newer version of a questionnaire has been published, scroll to that questionnaire and choose the option to…copy answers from old version to new version…and answer any additional/revised questions that may appear.
Once you have addressed all comments from your HSO screener, navigate to the Protocol Actions tab and follow these steps for resubmitting your response to your HSO screener:
Click show on Request an Action panel
Click show for the Submit for Review action
As applicable, identify the appropriate Submission Type, Submission Review Type, and Expedited Category
Click submit
You are done! Your HSO screener will receive notification that you have resubmitted your protocol and will review your response. If you do not hear from the HSO or receive notification from KC IRB regarding the status of your submission within a week, or if you have questions about your pre-review, please contact your HSO screener at the contact information provided in the notification or at 812-274-8289 or via email at irb@iu.edu.
