The informed consent process begins during initial contact with a potential subject and continues for the duration of the subject’s study participation. The Informed Consent Form (ICF) provides a summary of the study (including its purpose, the duration, the procedures and schedule, potential risks and benefits, alternatives to participation, etc.), explains the subject’s rights as a participant, and documents the subject’s willingness to be in the study. Federal regulations outline the required elements of informed consent, specifically 21 CFR 50 and 45 CFR 46.
The ICF and all materials given to subjects (including advertisements, contact letters, questionnaires, telephone scripts, and study summary sheets) should be written in “lay language” at an 8th grade reading level or lower, and should limit the use of technical and medical terminology or jargon.
Templates for Covered Entities (HIPAA applies)
Combined consent and HIPAA research authorization template for an adult to consent to participate in research.