Steps for Initial Submission

IRB Basic Steps

The steps below are for a new study submission. A job aid is available for creating a new study, modification, continuing review, closure, or reportable new information. The job aids provide more in-depth step details for submissions. The job aids can be found in the IRB library in the electronic IRB system or in the job aids.

Note: Only a principal investigator (PI) or PI proxy (staff member that can submit on behalf of the PI) can submit to the IRB. The PI proxy has to be listed as staff in the IRB submission. Alert the IRB coordinator if you want to make a staff member a PI proxy for the study.

Step 1: Is it Human Subjects Research?

Refer to the Do I need to submit to the IRB? page. Contact the IRB Administrator.

Step 2: Requirements

Be familiar with the HRP-103-GENERAL-ORSIRB Principal Investigator Manual found in the IRB library within the electronic IRB system. The HRP-103-GENERAL-ORSIRB Principal Investigator Manual provides the information needed for the researcher to successfully apply the requirements, policies and procedures of the Institution’s Human Subjects Protection Program.

Before submitting your study in the electronic IRB system, prepare your documents. The required documents can be found in the IRB library. A list of required templates can be found on the Forms and Templates page.

Training will be required for the principal investigator and any study staff. Refer to the Education and Resources page.

Step 3: Using the electronic IRB system

Click on the “Create New Study” button. Enter the information in the Smartform and attach all required and relevant documents for your study. Relevant documents can be consent forms, recruitment forms, surveys, interview questions, etc.

If the wrong template version is used, it will be returned to you to complete the most current version before IRB review begins.

Documentation of human subjects training for the principal investigator must be completed before an initial review of the study by the IRB. Documentation of human subjects training for all key study staff must be completed before a study will be approved.

When complete, submit your study to the IRB. Saving your submission does not mean it has been submitted.

On the study workspace, click on the “Submit” button.

Step 4: After submitting to IRB

Your study has been submitted to the IRB for review. Refer to the IRB process for a general estimate of how long the IRB may take to review your study.

Clarification Request

The IRB may request clarifications or revisions during the pre-review or review of a submission. Such requests will come in the form of a "Clarification Request" action found under the "History" tab of the submission.

Saving your changes does not mean it has been submitted. You must click “Submit Response” button to reply to the IRB. The Clarification Request function is the official communication from the IRB. The study team must respond to requests for clarification within the electronic IRB within 30 days. If a response or request for additional time is not received in 30 days, the submission will be discarded permanently.

The IRB will not make a determination until all study team members have completed the required training in CITI.

Step 5: After Determination

The IRB will provide you with a written decision indicating the determination of IRB review.

While a study is active, make sure that training stays up-to-date for all staff.

If there are any changes to the study, a modification has to be submitted to the IRB.

A continuing review or annual review will be needed until your study is completed.

When a study is completed, a closure must be submitted to the IRB.

Any reportable event must be reported to the IRB immediately

Refer to the How to Submit to the IRB page for more information.