» Deadlines and Approvals

Research projects that include the involvement of human subjects are required to be reviewed and approved by the Intitutional Review Board (IRB) prior to the project's commencement. To initiate the review process, investigators must submit the appropriate documents and consider the IRB process.

  • Deadlines and Full Board Meetings
  • Review Process at a Glance
  • Approval Conditions
  • The first step to Institutional Review Board (IRB) review is to determine which review category applies to your research.  Your research will qualify for one of the following three categories:  Exempt Review, Expedited Review, or Full Board Review.

    See the FAQs page for definitions of each review category.  Once the appropriate category is determined, you can begin and complete an IRB submission in Cayuse IRB.  If you are still not sure which category applies to your research, contact the IRB office.

    NOTE: IRB submission review times vary, as they are based on the review categories and submission completeness.  Follow the below submission times and deadlines 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 before your study's proposed start date.
    Expedited Reviews Submit 3-4 weeks before your study's proposed start date.
    Full Board Reviews Submit 2-3 weeks before the meeting date during which you wish to have your submission reviewed.
    Renewals Submit 45-60 days before your study's expiration date.

     

    The Full IRB 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

    June 25, 2018
    July 9, 2018
    July 30, 2018
    August 13, 2018
    August 27, 2018
    September 10, 2018
    September 24, 2018
    October 8, 2018
    October 29, 2018
    November 12, 2018
    November 26, 2018
    December 10, 2018
    December 31, 2018
    January 14, 2019
    January 28, 2019
    February 11, 2019
    February 25, 2019
    March 11, 2019
    March 25, 2019
    April 8, 2019
    April 29, 2019
    May 13, 2019
    May 27, 2019
    June 10, 2019
    June 24, 2019
    July 8, 2019
    July 29, 2019
    August 12, 2019


    *To ensure submission completeness prior to IRB review, the IRB office may request revisions and 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.

  • 1.  Appropriate CITI training is completed
    2.  Complete IRB application is submitted

    3.  If Exempt Review:

    1.  Review cycle by Administrator
    2.  Notice sent: research can begin

    3.  If Expedited Review:

    1.  Review cycle by Adminstrator and office designee(s)
    2.  Review/approval by IRB Chair or Adminstrator
    3.  Approval Letter sent: research can begin

    3.  If Full Review:

    1.  Review cycle by Adminstrator, office designee(s), and IRB Chair
    2.  Review at IRB Full Board Meeting
      1.  Deferred Approval
        1.  Revisions submitted by investigator
      2.  Contingent Approval
        1.  Contingencies addressed by Investigator
      3.  Approval Letter sent: research can begin
  • 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.

    Closure Report

    A closure report should be filed with the Chapman University IRB when the research concludes.