Continuing Review Instructions

In accordance with Federal Regulations, all current projects must undergo 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).

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:

a.         Indicate the number of subjects accrued during this reporting period and, for ongoing studies, the total number accrued.

b.         Report all changes in personnel involved with the study.

c.         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.

d.         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.