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.
Potential 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 consent.
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.