Basic Consent Presentation and Documentation

As mentioned previously, the consent process is more than just handing a participant a form and making sure that their signature is on it.  The consent process may include multiple steps:

Initial meeting

You will meet with the participant, provide a copy of the consent form to them, and go over the items on the form.  In addition, take more time to explain the “What you will do” section in the study so that the participant knows exactly what is involved.

Time to digest

Give the participant some time to think about their participation in a non-pressured environment.  This may be as simple as leaving the room for a moment so that they can go over the document in private.  For studies that involve greater risk to the subject, it may be appropriate for a participant to take the consent document home to think about it and perhaps talk it over with family and friends before agreeing to participate.

Question/ answer period

Before a participant signs the consent form, give them a chance to ask questions about the study and ask for clarification.  Sometimes participants may be intimidated to ask questions so take time to assess their understanding and make sure that they know what they are consenting to.  For studies that involve greater risk, it may be appropriate to provide them with a questionnaire about the study or ask them to explain the study back to you to assess their readiness to participate.

Consent documentation

The participant agrees to participate and documents their agreement by signing the consent form. 

Ongoing consent

The participant has the right to refuse participation at any time, regardless of whether he or she has already signed the consent form.  The researcher should continually ensure that the participant is freely and voluntarily consenting to all study tasks.  This may require observation for signs of hesitation or distress and asking permission to continue before beginning study tasks that may be challenging or aversive.  At these times, the participant should be told, “Remember, you have the right to stop the study at any time or to skip portions of the study if you would prefer not to do them.”