KC IRB Responding to Pre-Review

Quick Guide: Responding to Human Subjects Pre-Review

Applies to:  All research studies

Once a submission has been assigned to an HRPP 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 If you do not re-submit within two weeks, your submission may be administratively withdrawn.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.

From the Kuali Financial & Research Services (KFS) dashboard:

  1. Click KC IRB from the left-hand navigation bar.  A list of activities you can perform is displayed.
  2. Click Search Protocols from the list of KC IRB Activities. The Protocol Lookup window will open.  You can search for the protocol using a variety of search fields. Partially populate any field, and add an asterisk *, to return a list.

    • To search by Protocol number: Enter protocol number, followed by “*” in the Protocol # search field (e.g. 1701123456*).  Click search.
    • To search by Investigator, i.e., PI: Enter the Last Name of the PI followed by “*” in the Investigator search field (i.e. Smith*).  Click search.
  3. Select edit under the actions column, next to the protocol for which you want to respond to. (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.

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

  1. Click ►show on the Summary and History panel.
  2. Click ►show on the Submission Details section.
  3. Click ►show on the Review Comments section.
    1. Any general comments or comments related to parts of the KC IRB Protocol can be found here.
  4. Click ►show on the Review Attachments section.
    1. Click view in the Action column associated with any protocol documents, e.g. ICS.
      1. Once the document has been opened, review the HSO screener comments and/or revisions and address or revise, as appropriate.
      2. Save the revised document for future upload into KC IRB.
    2. Click view in the Action column associated with the KC Questionnaire PDF document.
      1. Ensure you are opening the PDF in a full version of Adobe Acrobat, e.g. not a Reader version.
      2. Click on Comments to display the HSO screener comments; OR
      3. Position your mouse over the yellow highlighted text, right click, and Open Pop-up Note to view the HSO screener comments.

Replace Existing Document(s) in KC IRB with Revised Documents

  1. Click ►show on the Protocol Attachments panel.
  2. Click ►show on line associated with the document you need to replace.
  3. Click replace and upload revised document.
  4. Click save at the bottom of the page.
  5. Repeat above steps for all protocol documents that need to be replaced.

Adding New Document(s) into KC IRB in response to pre-review

  1. Under Add Protocol Attachment, upload the new document(s) as follows:
    1. Select attachment type.
    2. Enter Description of document.
    3. File Name = choose file.
    4. Click add.

Revise the KC IRB Questionnaire(s) in KC IRB

If you need to REVISE any existing documents in response to your pre-review, follow these steps for revising responses to questions in the KC IRB Questionnaire(s):

  1. Click ►show to expand the Questionnaire that you need to revise.
  2. Navigate to specific question ID(s) and make necessary revisions to your response.
  3. Click update at bottom of page when complete.
  4. Click update at bottom of each questionnaire when done.
  5. 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 to the HRPP

Once you have addressed all comments from your HRPP screener, follow these steps for resubmitting your response to your HRPP screener:

  1. Click ►show on Request an Action panel.
    1. Click ►show for the Submit for Review action.
  2. As applicable, identify the appropriate Submission Type, Submission Review Type, and Expedited Category.
  3. Click submit.

You are done! Your HRPP screener will receive notification that you have re-submitted your protocol and will review your response. If you do not hear from the HRPP 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 HRPP screener at the contact information provided in the notification or at (317) 274-8289 or via email at irb@iu.edu.

e IU Human Research Protection Program

Human Subjects Research Questions:

Email: irb@iu.edu

Phone: (317) 274-8289

QIO – Human Subjects Research Auditing Questions:

Email: researchcompliance@iu.edu

Phone: (317) 278-3458

KC IRB Help:

Email: kcirb@iu.edu

Phone: (812) 845-4242