Thoughts?

It's common knowledge to those in the clinical research industry that when a new ICF is issued, subjects actively participating in a trial should be reconsented to inform them of changes to the study so that they can decide whether or not they would like to continue participating.  Generally the guidance as to whether the subject should be reconsented or not comes from the IRB, although the sponsor will supercede that decision (even though they shouldn't, in my opinion, but that's another story).  This reconsenting process should mirror the initial consent discussion done prior to study entry, and 90% of the time subjects agree to continue their study participation...but what happens if the subject actually refuses to continue and won't sign the new consent?

When considering this, it seems there are three options: 

1) Document the situation and let the patient leave without any early termination assessments because the subject is not a part of the new consent and hasn't agreed to any further study procedures

2) Document the situation, but proceed with early termination assessments if required by the protocol

3) Proceed with the new consent under the provision that the subject will sign consent, then immediately withdraw from the study.

After thinking about this for some time, I believe that option 2 is the best choice.  Here's why:  Some would argue that by declining to sign the revised ICF, the subject is withdrawing consent to participate in the trial, which is true.  Also because there was a new ICF issued, the old consent is no longer valid and the subject is technically not participating under any ICF by the time they are presented with a new consent form.  Thus any procedures done prior to the new consent would be done without the consent of the subject, and a big no-no.  The previous two sentences are where my opinion differs.

By signing the original consent at the start of the study, the subject is agreeing to take part and follow all study procedures, including the early termination assessment.  If a new consent is administered, the subject is still participating under the old consent and no further procedures may be carried out until the new consent is signed.  However an early termination assessment is likely something that was required under the old protocol, and in almost every case, is a critical safety assessment to ensure the subject's health was not compromised over the course of study participation.  For this reason, I would argue that it is acceptable to perform early termination assessments if a subject refuses to sign the new consent (as long as the subject agrees to those assessments) and once that is finished, the subject can be formally considered withdrawn from a trial.  The one caveat to this situation is if the early termination assessment is a procedure that was changed from the start of the study....in that case I would say the sponsor should be contacted to see if the old ET procedure would suffice because the new assessment would contain procedures that the subject did NOT agree to have done (and doing these would be a big no-no). 

As for the other options: choice 1 could be okay, but would likely require additional documentation to show why an ET visit was not done.  Choice 3 would be the worst choice because a consent signature means the subject agrees to participate/complete a study and I feel that having a subject sign the form with the direct intention of discontinuing immediately afterwards violates the meaning of the consent signature itself.  You may disagree with my opinion, and if so, I'd love to hear your reasoning, so shoot me and email or leave me a comment!

Oh, and by the way, the MOST important thing to remember if this situation arises, is to document the whole thing to death.  I cannot overstate the importance of a clear explanation of this type of situation in the event of an audit.