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:

  • Changes implemented prior to IRB approval: Changes in approved research initiated without prior IRB review and approval to eliminate apparent hazards to a participant must be reported to the IRB within 14 days of implementation, at which time an amendment to the protocol, and if needed, to the informed consent document must be submitted to the IRB. Use the Reportable Event Form in ARROW to report these potential unanticipated problems to the IRB. The report will be reviewed by the IRB to determine that the action taken by the investigator was necessary to eliminate an apparent immediate hazard to the participant(s) and the change of protocol is consistent with ensuring the particpants' continued welfare. Other changes implemented prior to IRB may constitute noncompliance and should be reported to the IRB as such.
  • Changes are a result of new information: Changes that are the result of new information that identifies new risks or other findings that may affect a subject's willingness to take part in the study (e.g., action letter, revised IDB, memo from the study sponsor) should be submitted within the following time frames:
  • If the study team receives the new information document (e.g., action letter, revised IDB) at the same time they receive the revised study documents, then submit all the documents to the IRB as a change of protocol within 60 days of receipt.
  • If the study team receives the new information document prior to receiving the revised study document, then the study team should proceed as follows:
  • If the study team will receive the revised study documents within 14 days of receipt of the new information, then submit all documents as a change of protocol within 60 days of receipt of the new information document.
  • If the study team either does not when they will receive the revised study documents OR knows they will NOT receive the revised study documents within in 14 days of receipt of the new information, then the study team should submit a new information report within 14 days of receipt of the new information. The revised study documents should then be submitted as a change of protocol within 60 days of receipt of the revised study documents.
  • Other Changes: When a change of protocol is planned it should be submitted to the IRB for review as soon as possible, especially if the changes include revisions that (1) affect the risk/benefit ratio of the study (e.g., result in a change to the protocol); (2) affect alternatives to study participation for subjects; (3) represent new information that should be provided to subjects; or (4) affect the local conduct of the study. In the case of sponsored studies that involve amendments that are externally generated, changes of protocol should be submitted to the IRB within a maximum of 60 days of their receipt by the local study team. This timeframe should allow the research team sufficient time to prepare the change of protocol application materials and obtain approval by a scientific review committee, when required, prior to review by the IRB. In the case of oncology changes with a 90 day deadline, the study team needs to account for time for both PRMC and IRB reviews and must submit those changes to the IRB within 45 days of receipt.

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




Keywords:change   Doc ID:25193
Owner:Faye L.Group:Health Sciences IRBs
Created:2012-07-17 12:45 CSTUpdated:2016-12-22 12:53 CST
Sites:Health Sciences IRBs
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