In this section you will provide the long term plan for the data, including how the data will be reported, stored, and potentially shared with others.
Properly storing data can be as critical as carefully collecting it; it the data are sensitive, you will need to have an appropriate data security plan in place. Data security is a UVA policy, not just an IRB-SBS recommendation. For more information, see IRB-SBS Data Security. The UVA Library has an excellent site on research data management. In addition, UVA’s ITServices site outlines the policies regarding data security, particularly security for highly sensitive data. In this question, you will need to demonstrate that you have a plan that is compliant with UVA policy and meets the standards necessary for the data’s level of security. Studies that are considered “highly sensitive” will be reviewed by an information security professional as part of your IRB-SBS review process.
Understanding how the data will be reported is an important component in assessing how well a participant’s confidentiality will be protected. Confidentiality doesn’t necessarily need to be guaranteed; rather, a participant needs to understand how their data will be used and that information needs to be included in the consent form. The Board will compare your answers in this section (and others in the protocol) to what you’ve provided in the consent form to make sure that the participant is receiving the complete picture when they are provided the opportunity to consent.
Not every study will be able to guarantee that data can be withdrawn from a study if a participant decides to withdraw; however, if it’s possible, the option should be presented to the participant in the consent form. Essentially whatever process you have for withdrawing the participant should be described here and it will need to match what is described in the consent form. If you can’t withdraw a participant’s data, they need to understand that fact before they provide consent.
Increasingly more researchers are publishing raw data and making it accessible for other researchers. In some ways, this reduces the burden on participants as researchers can reuse data rather than duplicate efforts by gathering their own data and putting other participants at risk. However, if you plan to publish your raw data or even if you think it is a possibility, this fact needs to be communicated in the consent form. It is much easier to inform participants of the possibility (even if it doesn’t happen) than try to inform participants about the additional use of their data after the fact.
If the answer to this question is yes, please include this information in the consent form so that participants understand how their data will be used.