» IRB Deadlines and Approvals

Research projects that include the participation of human subjects are required to gain IRB approval prior to commencement. To initiate the review process, investigators must submit the appropriate documentation and await the allotted review period.

  • Deadlines/ Full Committee Meetings
  • Review Process at a Glance
  • Approval Conditions
  • The first step to complete an IRB submission is to determine under which category your research falls.  Your research will fall under the following three categories:  Exempt Review, Expedited Review, or Full Committee Review.

    For definitions of each category, see the IRB-FAQs page.  If you are unsure which category under which your research falls, contact the IRB office.  Once the appropriate category is determined, you can begin and complete an IRB submission through Cayuse IRB

    NOTE: Review times of IRB submissions vary, as they are based on the categories and the completeness of submissions.  Follow the submission times and deadlines below when completing and certifying IRB submissions. All researchers and organizational approvers must certify submissions by the submission deadlines to be reviewed accordingly.

    • Exempt Reviews
      • Submit 2-3 weeks prior to proposed start date
        • Renewals:  Submit 45-60 days prior to expiration date 
    • Expedited Reviews
      • Submit 3-4 weeks prior to proposed start date
        • Renewals:  Submit 45-60 days prior to expiration date
    • Full Committee Reviews
      • Submit 2 weeks prior to the meeting during which you wish to have your submission reviewed
        • Renewals:  Submit 45-60 days prior to expiration date
    The IRB Full Committee meets once a month and reviews submissions that were received at least two weeks prior to a meeting.  Submissions that require full committee review must be submitted by the deadline that corresponds with the meeting to be reviewed during that meeting.  See the submission deadlines and corresponding meeting dates below to allow sufficient time for full committee review prior to study implementation.

    Submission Deadlines:

    Meeting Dates:

    • November 15, 2017
    • December 15, 2017
    • January 29, 2018
    • February 26, 2018
    • March 26, 2018
    • April 30, 2018
    • May 28, 2018
    • June 25, 2018
    • July 30, 2018
    • December 11, 2017
    • January 8, 2018
    • February 12, 2018
    • March 12, 2018
    • April 9, 2018
    • May 14, 2018
    • June 11, 2018
    • July 9, 2018
    • August 13, 2018


    *To ensure completeness of submissions prior to IRB review, the IRB office may request revisions and/or supplemental materials.  Supplemental materials include but are not limited to consent/assent forms, surveys/questionnaires, interview questions, recruitment advertisements, HIPAA authorization or waivers of authorization, certification of human subjects protection training, etc.

  • IRB Review Process Flowchart. If you are unable to see, please reach out to irb@chapman.edu.
  • Approval Conditions for all Chapman University Human Research Protocols

    The Principal Investigator of the study is ultimately responsible for assuring all study team members adhere to applicable policies for the conduct of human-subjects research. 

    Principal Investigators are responsible for the retention of protocol–related records. 

    Protocol Expiration

    The Chapman University IRB approval letter references the protocol expiration date under the IRB Chair’s signature authorization. A courtesy email will be sent approximately 60 to 90 days prior to expiration reminding the Principal Investigator to apply for continuing review. For studies granted Extended IRB Approval, a courtesy e-mail will be sent annually to verify eligibility for the continuation of extended approval. It is the Principal Investigator’s responsibility to apply for continuing review and in order to ensure continuing approval throughout the conduct of the study. Lapses in approval must be avoided to protect the safety and welfare of enrolled subjects. 

    Modifications & Amendments

    No changes are permissible to the approved protocol or the approved, stamped consent form without the prior review and approval of the Chapman University IRB. All changes (e.g., a change in procedure, number of subjects, personnel, study locations, new recruitment materials, study instruments, etc.) must be prospectively reviewed and approved by the IRB before they are implemented. APPROVED VERSIONS OF CONSENT DOCUMENTS, INCLUDING STUDY INFORMATION

    Sheets 

    Unless a waiver of informed consent is granted by the IRB, the consent documents (consent form; study information sheet) with the Chapman University IRB approval stamp must be used for consenting all human subjects enrolled in this study. Only the current approved version of the consent documents may be used to consent subjects. Approved consent documents are not to be used beyond the expiration date provided on the IRB approval letter. ADVERSE EVENT &

    Unanticipated Problems Report

    All unanticipated problem involving risk to subjects or others or serious adverse events must be reported to the Chapman University IRB in accordance with Federal regulations and Chapman University policy.

    Changes in Financial Interest

    Any changes in the financial relationship between the study sponsor and any of the investigators on the study and/or any new potential conflicts of interest must be reported immediately to the Chapman University Financial Conflict of Interest Oversight Committee (FCOI). If these changes affect the conduct of the study or result in a change in the text of the currently-approved informed consent document, these changes must also be reported to the Chapman University IRB via a modification request. Research subject to FCOI oversight is not eligible for Extended IRB Approval.CLOSING REPORT: 
    A closing report should be filed with the Chapman University IRB when the research concludes.