Submitting a Study for Review

After entering all required information into the SmartForm and attaching files, the Principal Investigator must submit the study for IRB review.

TIPS
  • Make sure you attach all applicable information to the study, as identified in Checklist of Information to Attach.
  • Check for missing information before attempting to submit the study, as described in Checking the Study for Errors. Any errors or omissions not corrected are shown when attempting to submit the study and must be corrected before you can submit it for review.

To submit the study for IRB review:

Important! Only the Principal Investigator(PI) can complete the following steps for an initial application.  Once a study is approved, the PI can assign a proxy to submit modifications or continuing reviews on his/her behalf.  See Managing Principal Investigator (PI) Proxy.

1. Log in to irb.harvard.edu

2. Make sure you are in My Inbox. If you do not see My Inbox, click the My Inbox link (in the top navigation menu)

3. Click the name of the submission to open it. It should be in the Pre-Submission state
Image of the inbox with the name of submission highlighted

If the study does not appear on this list, perhaps it was already submitted, or it does not include you as a study team member. To find the study, try clicking IRB in the top left navigation area. If you do not see it in that list, see Accessing a Submission for more ideas.

4. Click the red Submit button from the Next Steps list on the left.
Image of the submit activity

5. The system will conduct an ‘error check’ to identify if any required questions were missed. If any errors or warnings are shown, click the link in the Jump To column to go to the form containing the problem. For more information, see Checking the Study for Errors. When all errors are corrected, try submitting the study by clicking Submit again.

6. Click OK to agree to the PI assurance statement presented on the screen.  If you would like to separately refer to the PI assurance statement
> Before completing the activity, click on the Submit activity, but choose cancel to close the window after reading.
> Once the Submit activity is completed, click on the name of the activity on the History details of the workspace to read elements of the activity form.

When an initial study, modification/update or continuing review is submitted to the IRB office; the PI, PI Proxy and Primary Contact receive a notice confirming that the activity is completed. This notice includes the PI assurance statement.

Submitting information to the IRB initiates a series of activities that may include:

  • Review within your department
  • Pre-review by an IRB staff member
  • Review by the IRB committee or a designated reviewer
  • Communication of the IRB decision to the investigator

Any of these may lead to a request for the study team to take further action, such as providing clarifications or modifying the study. Whenever the study team needs to act, the PI receives an e-mail notification, and the study appears in My Inbox for all study team members when they log in to the IRB system.

Important! Make sure the appropriate person is listed as the primary contact to receive e-mail and see the study in My Inbox (along with the PI and any PI proxies, who also receive these). By default, the person who created the study is the primary contact. See Changing the Study Primary Contact.