Why Continuing Review 
eResearch Central, http://eresearch.umn.edu/erc/ is a University Web initiative providing a
central electronic location for University research forms, tools, and resources.
Researchers need to complete their IRB continuing reviews online, through eResearch Central.
Regulations state that the IRB must conduct Continuing Review of an approved study at intervals appropriate to the degree of risk, but not less than once per year.
The purpose of this process is to review an entire study and determine that the anticipated risks and benefits are reflected in the actual experience of subjects and that the safeguards in place at the time of original approval are, in fact, adequate to ensure the safety of subjects.
How the Process Works
- An email notice for "renewal" is sent to the principal investigator, co-investigators and coordinators prior to the annual review date.
- The notice contains a link to eResearch Central to access the online form.
- The continuing review form must be completed before the expiration date for processing and review.
- A copy of any consent and/or assents forms currently in use must be included with the continuing review form and can be uploaded electronically or sent via regular mail.
It is the principal investigator's responsibility to complete the continuing review form in a timely manner or the study may be inactivated.
Projects involving high risk may require more frequent review. The IRB may require frequent review or reports on a specific number of cases. The terms of the review and the written documentation required for that special review are delineated at the time the original approval is granted.
For more about Continuing Review, see chapter 6. Continuing Review in the Protecting Human Subjects Guide. |
