The review process involves a back and forth between the study team and the IRB Reviewer. When submitting the application, give yourself enough time to thoroughly address requested clarifications from the IRB Reviewer and any applicable ancillary reviews. Be sure to answer all questions in the ESTR SmartForm and IRB Template Protocol that pertain to your research. More complete answers can avoid back and forth between you and the IRB Reviewer.

Tip: Please see First Time Submitters page for more information on Tools and Timing

You must list your Faculty Sponsor on the Study Team Member's page in ESTR if you are not eligible to serve as a Principal Investigator. Obtaining your Faculty Sponsor's assurance is the first step in the review process. Not listing your Faculty Sponsor can hold up review of your application.

When the Faculty Sponsor ancillary review has been triggered, they will get an email with a link to the application. The IRB Reviewer will also post step-by-step instructions in ESTR for how to complete the ancillary review. You may want to notify your faculty sponsor that this request is forthcoming.

Tip: Learn more about Faculty Sponsors here

One of the main reasons submissions are sent back to the researcher is missing documentation.

Our ESTR SmartForm pages clearly outline which documents should be uploaded into which SmartForm section. ESTR decides which document receives an “IRB Approved” stamp based on where it is uploaded. This is especially important with informed consent forms.

If a document is uploaded to the wrong section of the SmartForm, your IRB Reviewer will send the submission back for clarifications to request that the document be placed in the correct section.

Here is a guide to help you upload your documents in the correct SmartForm section in ESTR:

   Tip: Several pages in ESTR have a list of Suggested Attachments. Take a quick look at these lists as you are completing the SmartForm to see if there is anything else you should upload

The Contacts Tab shows if a study team member's ethics training is complete.

Missing or Expired Certificates:

• Ask the team members to complete the correct CITI course.  For instruction on which course to take and how to access it, please see the Required Ethics Training Page. 
• Upload Harvard affiliated study team members' certification from other institutions (within the last 3 years) to the main study page in ESTR using the "Add Comment" feature.
• Question 2 of the Study Team Members page is reserved for HRP-220 and ethics training certificates of non-Harvard University Area affiliates.

Tip: If you do not see your Faculty Sponsor listed on this page, go back and add them to the Study Team Members page - in the role of Faculty Sponsor

The PI must click the red “Submit” arrow in the menu on the left side of the screen to send the application to us. If the status of the application says “Pre-Submission” you have not yet submitted it. If it says “Pre-Review” it has been submitted and is in line to be reviewed (note that the application stays in this state during the review process, aside from when it is in “Clarifications Requested”).

Tip: The "Submit" button is only viewable for the PI in the initial submission. The PI Proxy will see the "Submit" button in subsequent submissions

The “Add Comment” feature can be used to communicate with your IRB Reviewer about anything you want them to be aware of. Please use this feature for questions about timelines, funding, CITI training, ancillary reviews, and any other questions.

            Select “IRB Coordinator” in item 3 to make sure the comment is sent to your reviewer.

Tip: Did you forget to include something? It's an easy fix to make changes to an already submitted application;  just withdraw it. The submission will revert to an editable state. Once you have finished making your changes, Save; Exit; and Submit the application