When you revise an informed consent form, the IRB will consider whether you need, or plan, to addressing the following items in your modification form will allow the IRB to review and approve your revised form more quickly:
–Does the change affect any subjects currently on study? The IRB needs to know whether current subjects might be affected by the new consent form information. Some examples: You’re changing some aspect of the first study visit, so it would only apply to new subjects, and not to your current subjects, who have already completed the first study visit. Or your sponsor has identified a new risk related to your study drug. Does it apply only to people currently on the drug? Or can the risk emerge well after active dosing is completed? The answer would help the IRB determine if any subjects in long-term follow-up only need to be reconsented.
–What is your current study enrollment, and what is the status of any enrolled subjects? This information may spare you a contingency. Knowing that you have no enrollment, or everybody who is enrolled was a screen failure or has already completed all study interventions, or that you still have several subjects active on the study, will guide the IRB’s decision regarding whether reconsent is needed. The IRB will need to send you a contingency if this information is adequately addressed in your modification form.