Guidelines for Developing a Proper Assent Form for Minors

The consenting process refers to both the content and procedure for conveying information about your study and securing an agreement to participate. If participants in your study will be minors, you will need to develop an assent form for the minors to complete in addition to an informed consent form for parents/guardians to sign. An assent form is different from an informed consent form, and is specifically designed to simply indicate that the minor is willing to participate in the study and understands what he or she will be expected to do as part of the study.

Process questions include:

• Will you obtain signed assent or request a waiver?

• Will you seek assent with a written form and/or an oral briefing? For children younger than age 7, it may not be possible for them to read and comprehend a written document that asks them to assent to participate in a study.

Content questions include:

• Is all of the information in the assent form or oral script consistent with information in the research protocol?

• Is your form or oral script written in an easy-to-read format that uses language and vocabulary appropriate to the age of the participants? A good guideline is that the assent form should be written at a 2nd or 3rd grade reading level.

• Are all of the following included?

  1. Introduction of researcher

  2. Simple explanation of purpose of study

  3. Basic description of all research activities required of participants

  4. Brief explanation of how long the project will last and what kind of time commitment is required of participants

  5. Description of any potential risks and/or benefits of the study, and information about compensation (if any) for participation.

  6. Statement that participation is completely voluntary; that the refusal to participate in any part of the research will involve no penalty; that potential participants may withdraw at any time without penalty.

  7. A final assent statement and place for date and signature OR if waived, for indication of assent.

Determining What Type of Consenting Process to Use

One of the most important ethical rules governing research on humans is that participants must give their informed consent before taking part in a study. According to the U.S. Office for Human Research Protections (OHRP), the Code of Federal Regulations (45 CFR 46) requires that certain information be provided to research subjects before they participate in a study. This information is outlined in the IRB Informed Consent Guidelines.

Review the informed consent processes to determine what aspects of the informed consent process are appropriate for the assent process in your study. Note that unless a waiver of signed consent is justified by the PI and approved by the IRB, informed consent shall be documented by the use of a written consent form approved by the IRB, and signed by the participant’s legally authorized representative. A copy shall be given to the person signing the form.