Human Research Protection Program

Protocol Review Process

Ready to submit your initial protocol? Below is an outline of the review process your protocol will undergo.

  1. Once your protocol is received, you will be emailed a confirmation of receipt.

  2. Your protocol will undergo an administrative review, and you may be sent suggestions for improving your protocol.

  3. If you do receive suggestions, make the appropriate changes and submit the revised protocol.

  4. Once the office has received your revisions, your protocol will be assigned a category of review:

    • Exempt: The protocol is reviewed on a rolling basis by a member of the Institutional Review Board or a qualified member of the HRPP staff.

    • Expedited: The protocol is reviewed on a rolling basis by designated reviewers assigned by the IRB chair.

    • Full Committee: The protocol requires review by the fully convened IRB at a monthly meeting.

  5. If you submitted an exempt protocol and it is determined that your protocol does qualify for exempt status and requires no further revisions, you will be notified that you may proceed with your planned research immediately.

  6. If you submitted an exempt protocol and it is determined that your protocol does not qualify for exempt status, you will be notified that a revised protocol is required, and the review process will begin again.

  7. If it is determined that your protocol qualifies for expedited review, the IRB chair will designate one or more IRB members to review your protocol. Possible outcomes of this review are:

    • Approval: Your protocol is approved and no changes are required or recommended.

    • Requires revisions: Your protocol cannot be approved without revisions, clarifications or additional documents. Once these are submitted, the review process will recommence.

    • Does not qualify for expedited review: Your protocol does not qualify for expedited review and the full committee review process is observed.

  8. If your protocol does not qualify for exempt status or expedited review, it will be reviewed at a convened meeting of the committee (full committee review). Possible outcomes of this review are:

    • Approval: Your protocol is approved and no changes are required or recommended.

    • Requires revisions: Your protocol cannot be approved without revisions, clarifications or additional documents. Once these are submitted, the review process will recommence. (At this point, a subset of the committee may be designated to review your revisions on a rolling basis.)

    • Disapproval: Your protocol cannot be approved due to issues the committee believes are non-revisable and inherent in the research.

  9. Once this review is complete, you will be notified of the determination and next steps.

  10. When you receive your determination notification, be sure to keep a copy with your protocol for your own records.

  11. You should carefully note the following requirements in your IRB determination:

    • Start date: The date upon which you may begin your research.

    • End date: The final date upon which you may collect or analyze data. If the research is exempt or expedited, there is no end date except in special circumstances.
    • Responsibilities:
      • Note that there is no "retroactive" IRB approval; no research may begin before the start date. If your research is begun before your protocol is approved, you will be out of compliance.

      • If your research will continue beyond the end date, you must submit a continuation request 30 days prior to the end date. 

      • If your research is continued beyond the end date and before a continuation request is approved, you will be out of compliance.

      • Mark the 30-day-prior date on your calendar and set a reminder one week in advance so that you don't forget!

      • When your research is complete — even for exempt research — you must submit a termination report.