Institutional Review Board for Health Sciences Research (IRB-HSR)

Managing Protocol After Initial Approval

Background Information

Modifications (Amendments/Revisions) to Currently Approved Research

The terminology used to describe a change to a protocol may vary, including terms such as modification, amendment or revision. Typically outside sponsors may call any change to the protocol an amendment. For purposes of this document the term modification will be used to designate a change.

All modifications to currently approved research are required to have IRB review and approval prior to implementation except when necessary to eliminate apparent immediate hazards to the subject.

The modification application should include any required changes to the protocol, IRB protocol or application (regardless of study study status) and consent(s)/assent(s) (if open to enrollment) and/or other study documentation. The modification reviewer has access to the same documentation as the initial or continuing reviewer and is expected to conduct the review with the same diligence as an original or continuing review regardless of whether or not the review is expedited or full board review.

Regulations permit the use of expedited procedures for review of minor changes to previously approved research during the period for which the approval is authorized. Modifications that alter the risk/benefit ratio are assigned to a primary reviewer and presented to the full board at a convened meeting.

The essence of the study should be summarized by the reviewer for IRB members and the reviewer should state what the proposed modification is and how it will affect the conduct of the study, the risk/benefit ratio, and whether or not the modification should be approved as written. If the modification requires a change in the informed consent document, then the reviewer must review that change and recommend appropriate board action. Modifications submitted to the IRB, along with supporting correspondence, are entered into the IRB database, and placed in the study file.

Investigators are notified in writing of the decision of the IRB and of any changes required. Modification approval is not granted until all required changes have been made and submitted for review and approval. Once approved, the investigator is sent a modification approval form. The IRB may only approve modifications through the current approval expiration period, unless considered at the time of continuation review. Upon receipt of the approval for the modification, the investigator may initiate the modification.

If approved research is changed to eliminate an apparent immediate hazard(s) to the subject, the investigator is required to notify the IRB of the change(s) promptly (within five (5) business days). The IRB will review at the next convened meeting to determine if the change(s) instituted were consistent with the subject's continued welfare.

DEFINITIONS AND EXAMPLES: MINOR VS MAJOR MODIFICATIONS

The following definitions may be helpful to determine the level of approval to pursue; investigators are encouraged to contact the IRB-HSR office with any questions prior to submitting the request if uncertain about the review type required.

Minor Changes

Level of Approval: Expedited
Definition: Minor changes have no substantive effect upon an approved protocol or reduce the risk to the subject

Examples of minor changes are:

Major Changes

Level of Approval: Full Board
Definition: Major changes are changes that may increase the research population's risk or are of questionable risk.

Examples of major changes that are considered to increase the risk to the subject

Submission of Materials and Feedback Time Frame

Approval of a modification does not extend or otherwise change the project's expiration date.

Deadlines for submissions only apply to full board reviews. Refer to the Meeting Dates schedule on the IRB website. Full board reviews must be submitted by a deadline that is usually 7 days prior to the convened meeting.

Expedited modifications can be reviewed at anytime and will be, typically, reviewed within 3-5 business days after which the researcher will receive feedback from the review.

Protocol Modifications for IRB-HSR

For additional information see: Modifications Process

For Submission Deadlines see: Calendars & Deadlines

Last Modified: Monday, 19-Jun-2017 09:13:51 EDT