When completing modification forms in CLARA, please help speed IRB review and approval by using the “Notes for IRB reviewer(s)” open text response to:
–Specifically address whether any currently enrolled subjects will be affected by the proposed change and if so, how you will inform them of the change. For example, will they be asked to undergo a new consent process/sign a new consent form? Will you let them know of the change at the next study visit and document this discussion in the research record? If you will use any written materials to advise subjects of the change, please include a copy with your modification form.
–Spell out any staff changes, including the names of who is being added, who is being removed, and whose responsibilities may have changed. This information allows the IRB to easily describe staffing changes on the approval letter.
Including this information will reduce contingencies and speed approval time.