Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW

Version Date: July 21, 2011

UW-Madison has a Five Year Replacement/Renewal policy for studies that have been open for 5 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 5 years.

What studies will be affected? The HS-IRBs office will begin asking study teams to submit replacement applications for studies that have been open for more than five years AND continue to enroll subjects or collect data/specimens/images.

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 in one of 2 ways:
  • At their next continuing review, study teams who need to submit a replacement study will see a note in the approval letter for the continuing review that the study will need to be submitted as a replacement study if it is not closed or open only for data analysis by the time of the next continuing review; OR
  • For studies that fall under the 5 year rule and have particularly complex IRB files, the HS-IRBs office will contact the study team to discuss when the replacement study should be submitted.
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.

Should the original study being replaced be closed? Yes, the original study for which a replacement study is being submitted should be closed. 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 study teams required to submit a legacy application before submitting a replacement study?  No.  Study teams may submit a replacement study for studies falling under the Five Year Renewal Policy prior to submitting the legacy application for that study in ARROW.  Study teams interested in taking this approach should first contact the HS-IRBs Office to discuss the submission process.

See Also:

Keywords:5 year, 5-year, replacement, renewal, replace, yr, replacement protocol, replacement study, 5 year rule renewals   Doc ID:18868
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-06-16 18:00 CSTUpdated:2016-12-12 10:46 CST
Sites:Health Sciences IRBs
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