Typos in consent forms — do they need fixing?

It’s tempting to review written consent forms closely and note all the little typos and grammar errors that could use correction. However, keep in mind that, when reviewing informed consent in research, the IRB’s role is to assure that informed consent will be¬†appropriately sought and, if written consent is required, documented using an approved consent form. So keep those approval criteria — and their limits — in mind when reviewing consent forms. See IRB Policy 7.1 and 45 CFR 46.116 and 46.117 for more information and specifics.

If you notice typos and minor grammatical errors in a consent form, ask yourself if they are significant enough to significantly impact the informed consent process or document. If so, the errors would merit a contingency. If not, suggested corrections could be conveyed to the study team in a note, recommending the changes the next time the consent form is amended.