Sticklers for neatness that we are (as anyone who has ever stopped by IRB Blog Headquarters can attest — heh), we have added a query to CLARA’s “modification” and “site addition” forms. These forms now have a free-text box labeled “Notes for the IRB reviewer(s).” Please use this area to add any information the IRB should know as it reviews your modification. This text box should make it unnecessary for you to upload any separate “letters to the IRB” from the study team describing any background information. Thoughtful use of this text box will also likely reduce the number of contingencies we send back.
Items you could address in this response include things such exactly what has changed in revised documents, any special instructions from an industry sponsor, whether anything will change for currently enrolled subjects, etc.
Here’s an example. In a modification form submitting an amended consent form, you’ll indicate, in response to the “please describe the requested change” that the consent form has been revised. In the “Notes for the IRB reviewers” text box, you’ll describe any plans to reconsent subjects using the revised form, or the rationale for not reconsenting subjects.
Ditto for the site addition modification form, which applies to multisite studies for which we are the reviewing IRB. Use this text box to let us know any specifics about the site you’re adding, to describe the documents you’ll upload with this modification, or any other information that will help the IRB review the form.