Protocol amendments often entail changes to consent forms. However, sometimes a revised protocol is ready for submission before the revised consent form is. When is it acceptable to submit a protocol change before the new consent form is ready?
This practice should be avoided when possible, according to a recent blog post by WCG IRB. The post raises some good points about how consent forms are supposed to include accurate descriptions of protocol activities, which may not be the case when revisions are submitted separately. WCG IRB states “the IRB cannot approve these changes until the consent form accurately reflects these updates.”
But sometimes we don’t have a lot of choice in the matter, and sponsors want their protocol amendments approved before the consent form is finalized. In those cases, it’s important to include appropriate justification for submitting the protocol modification early. You can use the “note for IRB reviewer(s)” section on the modification form for this justification. Please also include a plan of how you will inform new and existing subjects about the protocol changes in the interim. And as always, when you submit the revised consent form, please let us know whether there are any subjects currently on study, and if so, whether and how you plan to reconsent them to give them new information.