Confusion reigns about how to complete the new submission forms asking what your study’s enrollment goal is, and how many people you’ll need to consent to reach that goal. Here is a guide for how to handle these queries for various study types:
For studies with consented subjects: The first question the submission form asks what your enrollment goal is. This refers to the number of subjects you would like to have complete your study. Let’s say for example you need 100 evaluable completed subjects, this is where you would enter “100”. The second number on the submission form is how many subjects you anticipate consenting to meet this goal- this number should be HIGHER than the number you intend to complete, to account for attrition. Let’s say you expect to lose 20 subjects to dropouts and screen failures- add those 20 consented participants to the 100 you will complete, and you get 120. Enter this number in the second text box. Under this scenario the IRB counts accrual by the number of consented subjects, whether or not they complete study procedures- therefore, this 120 number is significant as this is your upper accrual limit before you need to submit a modification to add subjects.
For studies involving data, tissues, or actual humans who will not be consented (i.e. you’re granted a waiver of the consent process): The first question about the enrollment goal is answered the same way – how many completed subjects’ data do you plan to include in your dataset? A “subject” for data or tissue studies is the person who provided the data or sample you are analyzing. For studies that interact with subjects but do so under a waiver of consent, the subjects count the same as if you were getting a signed consent.
However, you’ll handle the second “how many subjects do you anticipate consenting to meet this goal” query differently. The wording in the CLARA help text is confusing, as it states “for studies without subjects.” This language is intended to refer to studies that do not involve a consent process at all, i.e. the entire consent process has been waived. (Note that if only the documentation of consent has been waived, you’ll still be doing a consent process.) Many studies involving chart reviews or analysis of existing biospecimens qualify for waivers of the entire consent process, and occasionally a study involving interaction with living human subjects does as well. If there are no subjects consented, you will put the SAME NUMBER in this field as you put in the answer to the first question- this is because CLARA pulls the “approved study accrual goal” from this field. If you put zero, this is what shows up as the number of subjects you are approved to have in your study (a problem at continuing review, for sure…).
We know some conflicting information about this issue has been floating around for a while, and we apologize for the confusion. We hope the above information helps.