This form is intended for use as a tool for your reference when preparing your consent form. Federal regulations for the protection of human subjects require that the items listed below are included on all informed consent forms. Please remember to adapt the language on your consent form to the readers for which it is intended. Also remember that it is important to keep the consent form as clear and uncomplicated as possible. Describe the purpose of the activity.
Procedures Describe the procedures involved, including the nature of questionnaires or interviews.
Include the commitment of time for each, the total amount of time involved, and how long the study will last. State that subjects may refuse to answer any question in any test, inventory, questionnaire, or interview and may withdraw themselves or their data without penalty at any time. When applicable, specify the size of samples to be taken and names and doses of substances to be given. When applicable, indicate that the research includes the use of medical, academic, or other records, photographs, audio or visual recordings. If investigational drugs are used, state that any information developed during the study that might affect subjects' willingness to participate will be provided to them.