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Human Subjects

Process Overview

Submitting your study to the IRB can sometimes seem like you’re sending it off into a black hole. Here’s what goes on behind the scenes.

Step 1 - Submission: Once the investigator takes the Submit for Review action, an automatic notification from KC IRB is sent to the Human Subjects Office (HSO) to begin the process.

Step 2 - Intake: During intake, HSO staff inputs submission information into our internal tracking system and reviews your submission to make sure it’s complete (all investigator requirements have been met, etc.). Once the submission is complete, the item is assigned to one of our professional staff (called a screener) for pre-review.

Step 3 – Pre-Review: The screener performs pre-review on the study by reviewing all the information you have submitted and making sure the submission is complete and that you have submitted all the documents that you need to for your study. 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. Taking this action will automatically send you (and any Co-PI and aggregator listed on the KC Protocol) an email with instructions on how to access and respond to the pre-review. Click HERE to review the steps for responding to pre-review.

HSO strives to have pre-review completed on all submissions within two weeks of the date they are submitted to our office. If you have not heard anything from us within two weeks, please contact our office to check on the status.

Once pre-review comments have been returned to you, processing of your submission will be held until the HSO receives a response from you. If we do not receive a response within two weeks, your submission may be administratively withdrawn.

Step 4: Depending on the level of review required for your submission, the next steps take a varying amount of time.

Full Board: Full Board submissions must be available for review by the IRB at least one week before the meeting date. Therefore, if you have a Full Board submission, expect at least a week after pre-review is completed before your submission will be reviewed by the Board. Your screener will let you know the scheduled meeting date when your submission will be reviewed by the Board.

From time to time, a Principal Investigator may be asked to attend an IRB meeting at which his/her study is being reviewed. This is typically requested by the Board when a study is tabled, to provide the PI an opportunity to answer the Board’s questions in person. However, if a PI anticipates questions with a study (prior to a tabling), he/she can prospectively offer to attend the meeting in person or over the phone. The PI will have an opportunity to address the Board and answer any questions, but will not be able to be in the room while the study is discussed and voted upon.

Expedited: Expedited submissions are reviewed by specific Expedited reviewers. Reviewers are given one week to review new studies and return their determinations back to the HSO. Other submissions, such as amendments or expedited renewals, may be reviewed much more quickly.

Exempt: Exempt submissions are reviewed by qualified HSO staff members to ensure that these submissions are appropriately categorized and meet the regulatory requirements for exempt studies.

Step 5: You will receive a notification of the determinations made by the Board or the reviewer with regard to your submission via an automatic notification from KC IRB. The notification will instruct you to log in to KC IRB to retrieve your approved documents or, if your study was provisionally approved, tabled, or disapproved, a summary of the Board's discussion and any requests can be found in the Protocol Action tab under “Manage Review Attachments.”

Note: If your study is disapproved by the IU IRB, major changes are required (and will be outlined in the minutes of the IRB meeting) in order to resubmit. Studies that have been disapproved by the IU IRB cannot be submitted to an external IRB for review regardless of whether changes are made.

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