IRB Notes: Analyst notes on consent forms

Did you know that obtaining a signature on a consent form does not complete the consent process? Maintaining informed consent requires that subjects be provided with any new information that arises during the course of a study (such as changes to the research plan, change in risk/benefit profile, the results of related research, etc.) that may affect a subject’s decision whether or not to continue participation in the study.

When such information arises, the investigator must submit a modification request to revise the consent form that includes a clear description of what changes have been made since subjects last provided informed consent. The type of revisions will determine the level of review received by the Institutional Review Board (IRB) – whether it may be reviewed administratively or will require full board review. In either instance, the IRB approval memo will make it clear whether or not re-consent of subjects is required, when it is required (i.e., the next study visit), and whether or not an unscheduled visit is needed so that subjects receive the information in a timely manner. If the consent revision is minor, the memo will state that re-consent is not  required, i.e., addition/deletion of study personnel.

Please contact your managing analyst after your modification has been approved if it is not clear whether or not subjects must be re-consented.