Assessing Participant Understanding

It is the consenting researcher’s responsibility to ensure that potential participants understand the extent of their role in the research project. Read through the consent document with them and discuss participation prior to signing the informed consent document. During these discussions you should ask probing questions to determine comprehension and answer any questions that are posed.

A few of the questions you may want to ask the participant:

• In your own words, what is the purpose of the study?
• Do you understand where the treatment will take place?
• Do you understand the risks and benefits of participation? Do you have any concerns?
• Do you understand what your alternatives are?
• What more would you like to know?

It is especially important to ascertain that the potential subject understands what they are being asked to do. However, the idea is not to quiz the participant. Foster an open exchange of information and encourage them to ask questions. Remind them to continue to ask questions as they arise during their participation.