Researcher Resources

Written Consent

Prospective participants, their legally authorized representative, or the parents of children who are participants are presented with a consent document on which they sign their name to document that they agree to participate in the study.  A copy is given to the participant.  The document includes the elements of informed consent required by HHS and FDA.  This form may be read to the participant or the participant's legally authorized representative; but in any event, the investigator shall give either the participant or the representative adequate opportunity to read it before it is signed.