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![]() Introduction ![]() 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.
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.
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