Federal regulations mandate that ongoing research must be reviewed by the IRB at least once a year (except in the case of exempt research). Most protocols are approved for one year, although the review interval may be less if the IRB determines that it is necessary to review the protocol on a shorter review cycle, for example, because of uncertainty of the level of risk to participants or a need to monitor the consent process.
The investigator is responsible for submitting ongoing research for review before approval lapses. To assist the investigator in securing timely renewal of IRB approval of on-going research, approximately 60 days before the end of the review interval, the investigator will receive a notification through the electronic protocol tracking system that the IRB approval is about to expire. The investigator should submit an appropriate application and a copy of the most current consent form. If the IRB approval lapses before the continuing review application is approved, the investigator must suspend any research activities involving human participants and any additional participant recruitment.
For SBS IRB and ED IRB protocols, UW-Madison’s Five Year Renewal Policy requires that, if a project continues for more than five years, the investigator must submit a complete application after every fifth year just as though the protocol had never been reviewed. The new protocol submission will incorporate all intervening changes to the research made during the preceding five years. This policy provides the investigator with the opportunity to comply with all changes that have been made in the protocol application form and in the human research protection policies and guidelines since the original submission and makes it easier for reviewers to track protocol changes over time for long-term projects.
A five year renewal policy may also apply to some HS IRB and MR IRB protocols.
Investigators must also notify the IRB when a research project is complete.
For protocols approved by the HS IRB or MR IRB, the investigator submits a Protocol Closure Report form. See, Protocol Closure Guidance.
For protocols approved by the SBS IRB or ED IRB, the investigator should send the IRB Office an email that the project is complete.