Use this page as a guide to prepare your consent form. Federal regulations for protecting human subjects require that all informed consent forms include the items listed below. Keep your consent form as clear and uncomplicated as possible and adapt the language on the form to the readers for which it is intended.
If you're planning to use a survey, you still must obtain consent, but you can do so by incorporating this statement into the survey itself.
- Middlebury College
- A title for this project
- Consent Form
- Purpose and Benefits
- State that this is a research activity.
- Describe the purpose of the activity.
- Describe any expected benefits to individual subjects and/or society, not including inducements or compensation.
- Describe the procedures involved, including the nature of questionnaires or interviews.
- Include the time commitment for each procedure, the total amount of time involved for each subject, 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 physiological 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, or audio or video recordings.
- Risks, Stress, or Discomfort
- State whether any procedure entails potential risks, including side effects (either psychological or physical), stress, discomfort, or invasion of privacy.
- If you intend to use investigational drugs, state that any information developed during the study that might affect subjects' willingness to participate will be provided to them.
- If side effects are possible, state how they will be handled.
- Other Information
- Provide all investigators' names, titles, departments/divisions, and telephone numbers.
- Provide 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 to identifiers) or confidential (linked to identifiers).
- If data will be confidential, indicate who will have access to identifiable data.
- Describe how you will use the data , how long you will retain them, and where.
- State whether or not you will give subjects inducements (such as money, service, course credit) for participation.
- Indicate any costs subjects may immediately or ultimately have to bear.
- Include a line on which to print your name and to sign and date the statement.
- If your study will examine a drug or medical device regulated by the U.S. Food and Drug Administration, include this wording: "The U.S. Food and Drug Administration (FDA) reserves the right to review study data which that may contain identifying information."
- Describe alternative procedures and standard care that are available, if applicable.
- If necessary, provide a 24-hour emergency telephone number.
- If your study procedures involve potential physical risk, include this wording: "If physical injury occurs 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.
- Provide a standard statement, e.g., "I have read and understood this consent form. I understand that I can request a copy of this form."
- Include a line for the subject to sign, print his or her name, and enter the date.
- If you intend to work with subjects who are minors or incompetent to provide informed consent, include a line for the Parent/guardian/legally authorized representative signature to sign, print his or her name, and enter the date.