Amendments and Revision

Amendments and Revision

No protocol, informed consent process, or informed consent document may be modified without prior approval from the IRB unless it is necessary to eliminate an apparent and immediate hazard to one or more of the participants.

Modification means any change. It encompasses two commonly used terms: A revision is a change in something that exists, such as increasing the number of participants. An amendment adds something new, such as a person who will obtain informed consent.

Commonly Reviewed Modifications

The list below includes some common modifications that the UAB IRB reviews:

  • A change in the procedures of the protocol, such as
    • when the inclusion/exclusion criteria change
    • when a genetic or sample-storage component is added or changed
    • when the protocol is no longer open for enrollment of new participants
    • when a sponsor temporarily suspends enrollment
    • when the protocol ends
  • A change in the procedures used to recruit or enroll participants, such as
    • New or newly revised advertisements
    • New or newly revised script or questionnaire for screening
    • A change in the circumstances under which informed consent is discussed or obtained
    • A change in the wording or format of the informed consent document
  • Changes in study personnel, such as
    • Adding or removing an investigator
    • Adding or removing key personnel
    • Adding or removing persons who are involved in the informed consent process
    • Changing the Principal Investigator.

Application Procedures

Any planned modification must be submitted to the IRB for review and approval before being implemented or used with participants. In the rare cases where a change is necessary to eliminate a hazard, the investigator has 5 working days in which to report the modification to the IRB.

Investigators submit the Project Revision/Amendment Form for review of any change in the protocol—including changes undertaken as necessary to eliminate a hazard. Some modifications require that the investigator include materials in addition to the Project Revision/Amendment Form. For example, sponsors often initiate modifications in procedures or documents used with participants. In these cases, the investigator also provides the IRB with a copy of all investigator-sponsor correspondence and other documents related to the change.

Change in Principal Investigator

The outgoing investigator submits the Project Revision/Amendment Form. In addition, the following written and signed notifications must be submitted:

  1. The current Principal Investigator notifies the IRB that he or she has relinquished the responsibilities of Principal Investigator to the person named, or will do so on a specified date.
  2. The newly named Principal Investigator notifies the IRB that he or she has read the protocol and agrees to accept the responsibilities of Principal Investigator.

Changes in the Informed Consent Document

When a modification makes it necessary to change the informed consent document, regardless of whether any participants are enrolled, include two copies of the revised consent form:

  1. One “mark-up” copy showing all changes from the previous version (e.g., highlighting all additions and striking-through all the deletions). You may use the “track changes” function available in most word processing software.
  2. One “clean” copy for the IRB-approval stamp, without highlighting or outdated text.

Addendum Informed Consent Documents

If participants have already signed a consent document and it becomes necessary to inform them of modifications or new information, an addendum informed consent document may be necessary when:

  1. The protocol is open for recruitment and enrollment
  2. Some participants are already enrolled and
  3. The change might be related to the participants’ willingness to continue their participation in the study;
OR
  1. The protocol is closed to enrollment and
  2. The change might be related to the participants’ willingness to allow the continued use of data from their participation.

The FDA does not require re-consenting of participants who have completed their active participation in the study, or who are still actively participating when the change will not affect their participation, for example when the change will be implemented only for subsequently enrolled participants.

Further Information

Please direct any questions about modifications to the protocol, informed consent process, or informed consent document to the OIRB (934-3789, irb@uab.edu).

Page updated: May 8, 2013