What to do with your data after you finish your study? And when do I tell the IRB of my plans?
All studies eventually end. Do you know what you’ll do with your research data once your study’s over?
In fact, you’ll be asked to start thinking about what you plan to do with your data long term as you complete your new submission form in CLARA. The Risks section includes several questions about data storage, starting with asking for a description of how you will maintain your data during the study, through when and how your study data will be destroyed.
If you are planning to use your identifiable study data only for the current study, you can destroy the identifiers once you have finished your analysis. You’ll want to hang on to your deidentified dataset though. Current UAMS policy is that it be retained for seven years after publication. We recommend that you address this requirement in your protocol by using language such as, “The deidentified data will be stored in accordance with institutional policy and destroyed at the end of this period” in your protocol and new submission form.
The possibility of future use of previously collected data raises additional issues. Please keep in mind that if you want to keep data for use in future studies, you must let subjects know about this planned future use during the consent process and, in most cases, let them opt in or out of this future use. In these cases, IRB Policy 15.1 requires the protocol and consent to address: How the data will be stored (including a description of whether the data stored long term will include any identifying information; the types of future research that are anticipated; how long the data will be stored; and an indication of whether subjects can request later to have their data withdrawn and, if so, how.