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.
The list below includes some common modifications that the UAB IRB reviews:
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.
The outgoing investigator submits the Project Revision/Amendment Form. In addition, the following written and signed notifications must be submitted:
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:
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:
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.
Please direct any questions about modifications to the protocol, informed consent process, or informed consent document to the OIRB (934-3789, firstname.lastname@example.org).