The plain language consent form on the IRB’s website includes language asking you to clarify whether the study team is able to take information or samples out of the study after the study has started, e.g. if the subject decides to end participation early. If the consent form you’re using doesn’t include this language, the IRB may ask you to revise it to address this issue. Here are some pointers about how to handle the data of a subject who drops out early: If the study is an FDA-regulated clinical, data cannot be removed, and the consent form must not give the subject the option of having data removed. For non-FDA-regulated research, the consent form should address whether or not you will remove data if the subject drops out early. While the IRB does not require you to give subjects the option of having data removed, it will require the issue to be addressed in the consent process and accurately documented in the consent form. Also take care to make sure your submission is consistent throughout regarding removing data. For example, don’t tell subjects that their data will be stored completely without identifiers and then tell them you can remove it later.