Informed Consent Overview - Module 2m Sec 1


Module 2 Objectives

Selecting Participants
Describing Research
Discussing Participation
Ensuring Readability
Assessing Understanding


Federal code states that "[a]ny research project utilizing
human subjects requires the informed consent of those subjects." The
first step in the process is detailing the specifics of your study that
are important to communicate to participants and to the IRB.
IRB Approval: Issues to Consider

Remember that obtaining participant consent is a process.

participants must understand the nature of the study and the
risks and benefits involved if they are to make an informed decision about
their participation. The details should be presented in simple language
by someone who is knowledgeable about both the study and informed

This process requires a "consent document" that explains the
nature of the research and any risks and benefits to the participant. A
copy of the consent document is reviewed by the IRB before it is presented
to prospective participants.

Because informed consent is an ongoing process, it starts before any forms
are signed, and it continues through the completion of the subject's
involvement in the study. The consent document is only a confirmation of
the consent process.