Zusammenfassung

After discussion of a research protocol, our institutional review board (IRB) sometimes spends a great deal of time editing the consent form. While the edits are sometimes necessary to fix inconsistencies with the protocol, the changes suggested by members are often more editorial; reformatting the way a list of risks is presented, changing the grammar of sentences, removing medical terms (even when they are defined) and replacing them with lay language. Some members have started to complain about the amount of time spent “wordsmithing” the consent document, while others insist that the changes are necessary to make the consent document understandable to the potential participants. How do we find middle ground? Sincerely, Finding Understandability Necessary