Timeframe for Submission of Changes of Protocol to the IRB

Version date: January 1, 2013

The UW-Madison's Changes in Research Activities: Submission and Review describes the policies and procedures that UW-Madison IRBs and researchers are expected to follow related to the submission and review of changes of protocol. Federal regulations require researchers to obtain IRB approval of changes prior to their implementation unless to eliminate apparent immediate hazards to subjects. In addition, the federal regulations require IRBs to have written procedures to ensure prompt reporting to the IRB of proposed changes in a research activity.

Since December 2009, campus policy has defined the following timeframes to ensure prompt reporting of changes of protocol to the IRB as follows:

In addition to these policy requirements, the Health Sciences IRBs has further clarified timelines for reporting to help ensure prompt review and reporting of new information to subjects and compliance with external sponsor requirements (e.g., NCI deadlines for IRB approvals of changes of protocol).

Summary of Reporting Timeframes and Mechanisms

Type of change

How to Report to the IRB

Timing of Report to the IRB

Changes implemented prior to IRB approval to eliminate an apparent immediate hazard to subjects

Reportable Event Form – Unanticipated Problem

14 business days from the implementation of the change

Change of Protocol Form

As soon as possible, but no later than 60 days from implementation of the change

Changes as a result of new information

Change of Protocol Form*

 

60 business days from the study team’s receipt of the new information document*

*See above guidance on when to submit the new information document associated with this change. Also see New Information Reporting Guidance

Changes issued by study sponsors/external entities

Change of Protocol Form

As soon as possible, but no later than 60 days from the study team’s receipt of the changes

“90-Day” Changes for Oncology Protocols

Change of Protocol Form – the study team must flag in submission notes to the IRB that the change is a “90-day change” and provide the date by which IRB approval is needed

As soon as possible, but no later than 45 days from the study team receiving the change

Related Policies and Guidance:

HRPP: Noncompliance

HRPP: Unanticipated Problems

HRPP: Changes in Research Activities: Submission and Review

Changes to Eliminate Immediate Hazards to Subjects Guidance

Cancer Center: Submitting Changes with a 90-Day Review Deadline