Simplify your consent form, part 4 (and maybe prevent yourself some hassle too)
The requirement to list the planned number of study subjects in a consent form is nothing new. It’s described in 45 CFR 46.116(b)(6) (applicable to all human subject research done at UAMS), 21 CFR 50.25(b)(6) (applicable to FDA-regulated studies), and UAMS IRB Policy 15.1.
Even though this is not the most complicated consent form element, is there a way to state it that simplifies consent form language? Quorum Review IRB, in its publication titled How to Simplify Your Consent Form, has an idea for doing so. When the estimated number of subjects is not a nice, easy-to-grasp round number, consider including an estimate of total enrollment rather than the specific number. For example, instead of saying, “There will be 142 people in the study,” your form could state, “There will be approximately 150 people in the study.”
This rounding upward offers several advantages. First, it meets the requirements of the above-listed regulations and policy, all of which require the approximate number of subjects. It also is easier for subjects to grasp and remember than a specific number. Lastly, it gives study teams the flexibility to go over the expected number of subjects without exceeding their stated accrual goal (assuming they also don’t exceed the protocol’s accrual goal). That could save researchers the need to amend consent forms as enrollments change, and/or if the accrual goal is revised slightly upward as the study progresses.