Assessing Comprehension

Abstract

Nor is it enough to simply provide information to prospective subjects. In addition to that, there must also be a determined and good faith effort on the part of researchers to ascertain whether or not the prospective subject has heard and adequately understood what you have told him or her.¹ The basic underlying intent of the requirement for informed consent, after all, is for researchers to insure that prospective subjects understand the purposes, procedures, risks, etc. of the research, i.e., that they have in their minds the full measure of information necessary for making an informed and free choice. Simply reading information, facts or data to a prospective subject does not satisfy the intent of the principle of informed consent, particularly when “the potential for misunderstanding is considerable,” as it will be with AIDS vaccine trials.² The intent of the principle is to insure that each prospective subject fully understands what they might be getting themselves into, so they can make a good decision based on adequate and true information.