Quick Guide: Responding to Human Subjects Pre-Review
Applies to: All research studies
Once a submission has been assigned to a Human Subjects Office (HSO) professional staff member (called a “screener”), (s)he will review all the information 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 If you do not re-submit within two weeks, your submission may be administratively withdrawn.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.
The KC IRB Protocol is setup using a system of tabs. Within each tab are "folders", which contain bits of information about the research protocol. Expand the sections below to see tab specific instructions.
Access & Address Screener Comments & Attachments
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 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 screener comments; OR
Position your mouse over the yellow highlighted text, right click, and Open Pop-up Note to view the screener comments.
Replace Existing Document(s) in KC IRB with Revised Documents
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.
If applicable, revise the Description field
Click save at the bottom of the page.
Repeat above steps for all protocol documents that need to be replaced.
Add New Document(s) into KC IRB in response to pre-review
Under Add Protocol Attachment section, upload the new document(s) as follows:
Select attachment type.
Enter Description of document.
File Name = choose file.
Revise the KC IRB Questionnaire(s) in KC IRB
If you need to REVISE any existing Questionnaire responses, 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 each questionnaire when done.
Click save at bottom of page when complete.
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.
Resubmit Your Protocol
Once you have addressed all comments from your pre-review, follow these steps for resubmitting your response back to the IRB:
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 firstname.lastname@example.org.
The Indiana University Human Research Protection Program (HRPP) supports all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.