IRB Information and Tips: April 2nd, 2007
Continuing Review Notes
All non-exempt protocols, including HDE's, approved by the IRB are subject to continuing review by the Board to ensure the rights and welfare of human subjects are protected and to review the progress of the study.
Generally, protocols are reviewed every 12 months. Based on subject risk, study interventions, vulnerability of the study population, etc.; the IRB has the discretion to require more frequent review.
Review reminder notices are mailed to the study PI 90 days and 45 days before the study expiration date. If the study expires, you cannot receive funding, enroll new subjects, perform study interventions (except those therapeutic procedures that if stopped would place the subject at risk) or collect and use data while the study is expired.
If the study expires, you have 30 days from the expiration date to submit the continuing review/study closure report. If this report is not submitted within 30 days, the study will automatically be moved to expired/nonrenewable status. You will then have to re-submit your study as a new study to proceed with the research or to receive additional funding.
The IRB meets the first and third Wednesday of each month. It is recommended that continuing review/study closure report be submitted 2 meetings prior to the study expiration date.
Tip
Given that the submission deadline for the IRB meetings is 23 days before each meeting, the continuing review/study closure report should be submitted a minimum of 37 days prior to the study expiration date. Although Darlene and Butch work to track the status of your studies, it is imperative that you inform them when you receive the continuing review reminder notices to allow time for the preparation of the report.
