Consent Form

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.

Heading

• Middlebury College
• A title for this project
• Consent Form

Investigator's Statement

• Purpose and Benefits
  • State that this is a research activity.
  • Describe the purpose of the activity.
  • When applicable, describe the expected benefits to individual subjects and/or society, not including inducements or compensation.
• 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.
• Risks, Stress, Or Discomfort
  • State whether or not there are risks, including side effects (either psychological or physical), stress, discomforts, or the invasion of privacy which might result from each procedure.
  • 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.
  • When applicable, state how side effects will be handled.
• Other Information
  • Investigators' names, titles, departments/divisions, telephone numbers.
  • Contact information for the chair of the Institutional Review Board in case there are questions about the subjects' rights.
  • State whether data will be anonymous (no links) or confidential (linked to identifiers) and, if the latter, state who will have access to the data.
  • Indicate who will have access to identifiable data.
  • Describe how the data will be used and how long they will be retained.
  • State whether or not subjects may expect to receive inducements (including money, service, course credit) for participation.
  • Indicate any costs subjects may immediately or ultimately have to bear.
  • Investigator's signature, printed name, and date lines.
  • For drug and medical device studies regulated by the U.S. Food and Drug Administration, add: "The U.S. Food and Drug Administration (FDA) reserves the right to review study data which may contain identifying information".
  • When applicable include descriptions of alternative procedures and standard care that are available.
  • When applicable provide a 24-hour emergency telephone number.
  • When applicable, state: "If there is a physical injury as a direct result of study procedures, subjects will be (cared for by a member of the investigating team OR referred for appropriate treatment)." State who will be responsible for the cost of such treatment.

Subject's Statement

• Standard statement, e.g., "I have read and understood the above. I understand that I can request a copy of this form."
• Subject's signature, printed name, and date lines.
• Parent/guardian/legally authorized representative signature and date line when subject is a minor or incompetent to provide informed consent.

Sample Consent form

View an Informed Consent Checklist