Once You Have Submitted Your Application for Review...

Your submission will be assigned to an IRB Administrator who will communicate with you via ESTR. You will receive an email notice from ESTR if your attention or action is required.

• If your proposal will require Convened IRB Review at a monthly meeting, the IRB Administrator will:
  • Assign it to the next possible meeting
  • Notifiy you of the meeting date, deadlines and requirements prior to the IRB meeting.
  • Work with you to whip your proposal into the best possible shape for the meeting. (See below.)
     
• If your proposal will NOT require Convened IRB Review (i.e., it falls under the Exempt or Expedited review category), you will work with the reviewer on any revisions/requirements until the proposal may be approved. (See below.)
   

What to Expect While the Review is In Progress
 

Ancillary Review
 

Many studies must undergo additional review by another office at Harvard. This additional review happens through the Ancillary Review process in ESTR. The reviewer assigned to your study triggers this additional review through ESTR and this typically does not require any additional action by the research team. If there are questions, either the reviewer assigned to your study or a representative from the Ancillary Review office will contact you.

• Faculty Sponsor
  • If you were required to list a Faculty Sponsor (see PI eligibility requirements), the IRB reviewer will trigger an action via ESTR for that person to provide assurances that they have reviewed and are in support of your study. The Faculty Sponsor will be notified via email that their action is required. Once this is in place, the review will begin.
  • If you were NOT required to list a Faculty Sponsor, the review will begin.
• Provostial Review
  • Some studies require additional review by the Office of the Vice Provost of Research. See criteria for Provost Review here.
• HUIT Data Security Review
  • Studies that include data that have been determined to be “sensitive” by the IRB require additional review by HUIT.
• COMS
  • The Committee on Microbiological Safety (COMS) registration is needed for all research involving recombinant DNA as well as work involving biohazards e.g., Recombinant DNA; Synthetic Nucleic Acids; Infectious Agents; Select Agents; Biological Toxins; Human Blood and Tissues; Non-Human Primate Blood and Tissues; Prions; Dual Use Agents; Clinical Gene Transfer; Clinical Xenotransplantation; Clinical Trials that use potentially biohazards materials (i.e., vector, viable micro-organisms as vaccines.

• Radiation Safety Committee

  • Radiation Safety Committee (RSC) approval is required for all research involving radioactive materials, lasers, x-rays, etc.

• General Data Protection Regulation (GDPR)

  • If data is being collected from individuals who reside in the European Economic Area, and it is considered sensitive according to the GDPR, a separate GDPR review will occur.

• Harvard Undergraduates

  • If Harvard Undergraduates are a focus population in your study, a separate review by the Harvard Office of Undergraduate Education is required.

Clarifications or Revisions Requested
 

• In most cases, clarifications and/or revisions to your study materials will be requested. How simple or complex these are often depend on how complete your application is upon submission. Sometimes much back-and-forth communication between you and your study's reviewer is needed.
• You will be guided and advised on how to adhere to best practices and institutional and regulatory regulations.
• A phone call or in-person meeting may be requested by you or your study's reviewer if ESTR communication is not clear.
• Any study team member can make revisions and respond to requests for clarification.
• Use the ESTR Study Submission Guide for guidance on most questions, like, how do I...
   
  • check the status of the review
  • leave a question or comment for the study's reviewer
  • get detailed instructions for responding to a request for clarifications
  • edit a submission
  • change document on a submission