Informed consent is an ongoing process to assure that prospective participants will understand the research they are asked to participate in, so they can knowledgeably and voluntarily decide whether or not to participate.
Federal guidelines require investigators to obtain the legally effective informed consent of human participants or the participant's legally authorized representative before conducting research.
The consent form should be written in second person and at a 7th grade reading level or lower. The consent form should still be written in second person if a parent or guardian is signing the consent form for a minor. For example "You agree to allow your child to participate in the study...".
If minors will be research participants, a separate consent form must be written for their consent. This form is called an Assent Form. It must be written in the second person and at a level the minors will understand. Both the parent/guardians and the minor must consent to be included in the research study.
If any form of video/audio recordings will be made during the research study, the participants must sign a separate consent form to allow the video/audio recordings to be used. This form is called a Videotape/Audiotape Consent Form.
Click here for a sample informed consent form
Click here for a sample assent form
Click here for a video tape/audio tape consent form