Institutional Review Board (IRB)
Assent To Participate In Research
Download: Assent To Participate In Research Sample Consent Template [Microsoft Word format]
If you have problems using the Word document listed above, provide us with the information below:
[Insert lay language study title here.]
- My name is [identify yourself to the child by name].
- We are asking you to take part in a research study because we are trying to learn more about [outline what the study is about in language that is both appropriate to the child’s maturity and age]
- If you agree to be in this study, [describe what will take place from the child’s point of view in language that is both appropriate to the child’s maturity and age]
- [Describe any risks to the child that may result from participation in the research]
- [Describe any benefits to the child from participation in the research]
- Please talk this over with your parents before you decide whether or not to participate. We will also ask your parents to give their permission for you to take part in this study. But even if your parents say “yes” you can still decide not to do this.
- If you do not want to be in this study, you do not have to participate. Remember, being in this study is up to you and no one will be upset if you do not want to participate or even if you change your mind later and want to stop.
- You can ask any questions that you have about the study. If you have a question later that you did not think of now, you can call me [insert your telephone number] or ask me next time. [If applicable: You may call me at any time to ask questions about your disease or treatment.]
- Note to the Researcher: The State of California mandates that investigators and their staff report a reasonable suspicion or known abuse or neglect of a child (CA Penal Code Section 11160-11163.5). When research is likely to reveal possible child abuse, such as interviews about personal behavior, practices, discipline, relationships, etc. or when research is conducted in the subject’s home, medical facility, or a doctor’s office, the consent should clearly indicate that the investigator is required to report a reasonable suspicion or known abuse or neglect of a child. The following sample is meant to guide investigators in constructing fair and honest assent form:
We know your answers to questions are personal and we are very careful with any information you give us. We will not tell anyone what you tell us without your permission unless there is something that could be dangerous to you or to someone else. If you tell us that someone is or has been hurting you, we will have to let people who are responsible for protecting children know, so they can make sure that you are safe. - Signing your name at the bottom means that you agree to be in this study. [If the study is related to treatment insert the following: Your doctors will continue to treat you whether or not you participate in this study.]
- You and your parents will be given a copy of this form after you have signed it. Nobody will be mad at you if you say no. Even if you say yes now and change your mind after you start doing this study, you can stop and no one will be mad.
- Be sure to ask Dr. (insert name) to tell you more about anything that you don’t understand.
- Yes, I will be in this research study.
- No, I don’t want to do this.
Signature/Date should be provided
Print name
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