Instructions for responding to human subjects pre-review
Once a submission has been assigned to an HSO professional staff member (called a “screener”), (s)he will review all the information you submitted, including attached documents; this is known as “pre-review.” If the screener has any questions or concerns with, or requires revisions to your submission, (s)he will take the Return to PI action in KC IRB. You (and any Co-PI and aggregator listed on the KC Protocol) will be notified via email that action is required on your part. Your submission will not be processed further until you have addressed the comments and re-submitted back to the IRB. If you do not re-submit within two weeks, your submission may be administratively withdrawn.
To ensure your study is processed in a timely manner, please follow the instructions below for responding to pre-review.
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 a post approval submission, you should locate the appropriate submission.
For amendments, search for an A00X suffix added to the protocol number, e.g. 1234567890A001.
For renewals, search for an R00X suffix added to the protocol number, e.g. 1234567890R001.
For FYIs, search for an F00X suffix added to the protocol number, e.g. 1234567890F001.
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.
Click view in the Action column associated with any protocol documents, e.g. ICS.
Once the document has been opened, review the HSO screener comments and/or revisions and address or revise, as appropriate.
Save the revised document for future upload into KC IRB.
Click view in the Action column associated with the KC Questionnaire PDF document.
Ensure you are opening the PDF in a full version of Adobe Acrobat, e.g. not a Reader version.
Click on Comments to display the HSO screener comments; OR
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.
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 done.
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.
You are done! Your HSO screener will receive notification that you have re-submitted 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 (317) 274-8289 or via email at email@example.com.