Assessing Ability to Comply

Sometimes this is a subjective call on the part of the RTM, but usually there will be specific evidence in the dialogue if compliance is going to be an issue. Qualified commitments "I'll do this, unless, of course, something comes up" or pre-emptive excuses "sure I'll do this, but sometimes I can't make appointments. I mean, I'll do what I can, but if I can't make it, well that's just how it will have to be" suggest that this issue needs in-depth exploration. More commonly, the consenting RTM may get the impression that although claiming comprehension, the prospective participant "just doesn't quite get it". Does the participant understand enough to really volunteer? Can he or she safely complete the protocol, even if all that is required is to faithfully note and report side-effects? These requirements are protocol specific and require judgment on the part of the RTM. Often the safest course is to exclude the prospective participants about whom one has doubts.