IRB Continuing Review Instructions

In accordance with Federal Regulations, all Full Board and some expedited projects (determined by the IRB) must undergo a continuing review.  Investigators must submit a protocol summary, a status report on the progress of the research, and current/new consent forms.  Although investigators will receive a request from the IRB Office for review information, it is their responsibility to submit review information in sufficient time to allow for IRB review (at least three weeks prior to the approval expiration).

Where continuing review is not required, the IRB requires submission of a progress report at periodic intervals. At the time of initial approval, the IRB will specify the interval for submission in the approval notice. The IRB may set the interval for reporting at one, two, or three years. Future reporting requirements will be assessed during each review and may be changed at any time. The IRB office will send the PI a reminder for when the progress report is due.

Regardless of the requirement set by the IRB for reporting study progress (continuing review or progress report), investigators still must inform the IRB of any changes to the protocol and inform the IRB of reportable events.

Please respond to the following questions:  (Please type your responses on a separate sheet of paper.)

  1.  Include a brief protocol summary.  (This should be no more than one or two pages.)
  2.  Status Report Includes:
    1.  Indicate the number of subjects accrued during this reporting period and, for ongoing studies, the total number accrued.
    2.  Report all changes in personnel involved with the study.
    3.  Include a description of any:  adverse events or unanticipated problems involving risks to subjects or others, withdrawal of subjects from the research, or complaints about the research.
    4. Include a summary of any recent literature, findings obtained thus far, amendments or modifications to the research since the last review, and any other relevant information, especially information about risks associated with the research.
  3. Attach a copy of the current, IRB-approved informed consent document (stamped copy).  Also include a “clean” copy for approval and stamping.