Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW
UW-Madison has a Five Year Replacement/Renewal policy for studies that have been open for five years or longer. If a study does not meet the criteria for exception to this policy, it must be submitted as a new IRB application after the study has been open for five years.
Version Date: November 2017
What studies will be affected?
Generally, the only studies affected by this policy are those still enrolling subjects after the study has been open for five years. Please see the policy for a detailed list of what studies require a replacement study and which are excepted from this requirement.
How will study teams know whether to submit a replacement study?
The HS-IRBs office will be letting study teams know if they need to submit a replacement study via the following methods:
- At their next continuing review, study teams who may need to submit a replacement study will see a note in the approval letter for the continuing review that the study may need to be submitted as a replacement study if it does not meet one of the exceptions by that time. Study teams also will receive a Five Year Renewal email notification via ARROW if the IRB determines at continuing review that a five year replacement study may be needed.
- As part of its continuous quality improvement program, the HS IRBs office also will reach out individually to study teams who have studies that received a five year renewal notification in advance of the deadline for submitting the replacement study to help ascertain whether the study may qualify for an exception.
Can a study be closed rather than submitting a replacement study?
Yes, if a study meets the criteria for studies which can be closed, study teams should close a study rather than replace it. Please see the HS-IRBs Protocol Closure Guidance for more information about when studies can be closed.
Will IRB fees apply to replacement studies?
Marc Drezner, Associate Dean for Clinical & Translational Research, has determined that SMPH researchers required to replace a protocol that is subject to IRB fees will be charged as continuing reviews rather than initial reviews. After the replacement study is approved, it will continue to be subject to IRB fees, if applicable, as with any other new study. The continuing review rate is half that of the initial review. For guidance on what types of studies are subject to IRB fees, please see IRB Fee Policy.
Will replacement studies undergo IRB review?
Yes. Replacement studies will be reviewed by either the full IRB or, if eligible, under expedited procedures by an experienced IRB member. The review will be similar to that for an initial review application.
When do replacement studies need to be submitted?
Study teams are advised to submit replacement applications no later than 90 days prior to the expiration of IRB approval for the protocol being replaced. The HS-IRBs Office will prioritize the review of replacement applications to help ensure the new application is approved before the IRB approval for the current protocol expires. NOTE: Replacement studies for VA protocols should be submitted further in advance to accommodate the additional time needed to secure VA review and approval.
Should the original study being replaced be closed?
Yes, the original study for which a replacement study is being submitted should be closed after the replacement study is approved. Do NOT close the original study until the replacement study is approved. IRB approval for the original study is valid until the expiration date and closing the study prematurely will require the study team to cease all activities for that study until the replacement study is approved. Study teams are encouraged to contact the IRB office if they have questions about when to close a study being replaced.
Can the replacement study include changes to the study originally approved by the IRB?
Yes, the replacement study can include changes to the original study and does not need to match the existing, IRB-approved study. Please note that the existing study must continue as currently approved by the IRB. If changes are needed to the existing study before the replacement study is approved, these must be submitted separately as changes of protocol.
Are replacement studies needed for studies that qualify for an exception to ongoing continuing review?
No, replacement studies are not required for studies that do not require ongoing continuing review. Instead, study teams may complete a short “Request Renewal” activity in ARROW to extend the approval period for another five years.