Many research studies involve multiple visits, with specific procedures to be carried out at each visit. Consent forms often describe this kind of research in visit-by-visit lists that include each procedure at every visit. This format can lead to a long consent form that includes a lot of repetition, if procedures will be repeated.
We encourage you to consider alternative ways of presenting this information, if you have the flexibility to do so. While an industry sponsor may not allow major changes to the consent form, you may be able to provide supplementary material to prospective subjects that simplifies the description of procedures. And you will of course have more leeway to describe the schedule in an investigator-initiated study.
One alternative is a single list describing the various procedures to be done, and then, either next to each item, or in a separate calendar-type chart, indicate when each activity will occur. (Hint: If you go the chart route, don’t just cut and paste the one from the protocol; please create a simpler one that doesn’t use protocol-esque language and tiny footnotes).
One source we’ve seen suggests just listing the procedures and then including language along the lines of “your study doctor will give you more information about when these procedures will be done.” This language may work for a relatively short, simple study. However, the IRB may feel that it is not informative enough for a longer study. What do you think?
Adapted from How to Simplify Your Consent Form by Quorum Review IRB.