The additional information below serves as a guide to preparing your consent form. Federal regulations for protecting human subjects require that all informed consent forms include the items listed below.
The overall goal of the consent process is to give your subjects enough information for them to decide whether they wish to participate in your study. That includes (at a minimum) telling them what will happen, what the risks are, and what compensation or benefits they will receive.
Because it can be challenging to write a consent form, the best place to start is with one of our consent form templates:
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. The form should be written in a language and style that is understandable to your subjects. For example, if you are working with people who are more comfortable speaking Farsi, the consent form should be in Farsi (with a translation available for the IRB to review).
If your study may produce intense emotions in your subjects, or remind them of experiences of trauma, you should include a list of resources available to your subjects to help them manage those feelings.
When you are constructing your consent form, you should include each of the following points, unless it is irrelevant to your study (e.g., you don’t need to address drug side effects if you are only conducting a survey), or would be unduly confusing to your subjects. Note that the IRB carefully reads and evaluates your consent forms.
- Identify the Institution you are affiliated with (Middlebury College/Middlebury Institute/Bread Loaf/etc.)
- Study Title
- Investigator Name
- Consent to Participate in Research
- Brief explanation of the purpose of the consent form
- Summary of the Research
- In a few sentences, describe the key information that someone would want to know in order to decide whether or not to participate in your study.
- 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. Note that benefits do not include inducements or compensation for participating in the study. Compensation is described below. It is common for a study to offer no benefits to a participant.
- 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, unless that isn’t true. Note that this is almost always true, and if your study has a different framework, you should explain fully to the IRB why subjects are not allowed to skip questions or withdraw themselves from the study.
- 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.
- Risk, 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 (email@example.com) in case there are questions about the subjects’ rights.
- State whether data will be anonymous (no way to link a specific person to their data) or confidential (it is possible to link a specific person to their data).
- 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.
- Describe alternative procedures and standard care that are available, if applicable.
- If necessary, provide a 24-hour emergency telephone number and/or support resources available during or after their participation in the study.
- 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.
- Subject Statement
- Provide a standard statement, e.g., “I have read and understood this consent form. I understand that I will be given a copy of this form. I am over 18 years old and agree to participate in this study.”
- Include a line for the subject to sign, print their 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 their name, and enter the date. The minor or person not competent to make their own decisions should be asked to provide oral assent to the procedure.