## Consent/Opt-Out Template: Parental Consent/Combined Parental Consent and Student Assent/Parental Opt-Out

To provide the necessary information to enable parents/guardians to decide whether to allow their children to participate in research, a comprehensive consent form is needed. For your convenience, a parental consent/opt-out template is provided on the next page.

- • the children/minors you hope to have participate in your study will be under 15 years • the children/minors you hope to have participate in your study will be under 15 years of age, this template should be used to gain the consent of parents/guardian, and a separate child assent form will need to be created and used to gain the assent of the children/minors.
- • the minors you hope to have participate in your study will be 15 to 17 years of age, this • the minors you hope to have participate in your study will be 15 to 17 years of age, this template can be used to gain the consent of parents/guardians and the assent of the minors (i.e., Both parties will sign the same document.).
- • your study will involve minimal risk to participants; circumstances that would make • your study will involve minimal risk to participants; circumstances that would make obtaining signed consent from parents impracticable, like the implementation of a teaching intervention involving entire classes or grades; and the appropriate district or school official grants permission, you may provide consent information to parents but only require it to be signed and returned if they prefer that their students not participate (i.e., opt-out). Related options are provided within the template.

### To reduce the potential for IRB revision requests and delayed study approval, please use our template.

The contents of the consent template have been organized to facilitate comprehension. Consent documents should be written in plain language, excluding technical terms, and generally at 8th-grade an reading level. For more information on plain language, go to http://www.plainlanguage.gov/.

Please note the following:

- 1. Text in [brackets] represents information about your study that you must add.
- 2. A forward slash (/) indicates that you must select an option specific to your study (e.g., “will/will not” or “I/we”) and remove the remaining option(s).
- 3. Additional instructions or sample text are provided in
- boxes.
- 4. Before you submit your consent document to the IRB, delete this cover page(s), all brackets, and the boxes. You’ll also need to remove any extra spaces created when the boxes were removed.
- 5. Please follow the instructions in blue below, revising or providing the information in red. You will need to remove the instructions as you go, including these instructions. The font color of your completed document should be black.
- 6. The finished document should reflect what you will give to prospective participants.
- 7. If your study involves multiple types of participants who will complete different procedures (e.g., students who will be interviewed and take part in a focus group and students who will complete a survey), you will need to create different consent forms for each participant group.