Prospective participants, their legally authorized representative, or the parents of children who are potential 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.
Situations when it is used
Because obtaining a signature is the standard, written consent is used with any face-to-face research activity regardless of the study's overall risk determination in both Biomedical and Social Behavioral research.
If you plan to use or share protected health information (PHI), you must conduct your study in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). In addition to obtaining written informed consent for participation in the research study, you must obtain written HIPAA authorization from prospective participants for the use or disclosure of their PHI. To meet this requirement, the IRB Office requires the use of its consent form template which includes HIPAA authorization language.
*Note that the HHS and FDA regulations do not require the participant's copy to be a signed copy, although a photocopy with signature(s) is preferred. However, HIPAA does require that the participant receive a copy of the signed HIPAA authorization form. If your consent form also includes HIPAA language, you will need to give the participant a copy of the signed consent/HIPAA authorization form.