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Learn About Clinical Trials

  • Reviewed: 05/26/2005

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The Assent Process

Federal regulations entrust each research institution's Institutional Review Board (IRB) with determining what the assent process should involve and how the child's assent (or dissent) should be documented. IRBs are panels of medical specialists, nurses, social workers, medical ethicists, and patient advocates who review clinical trial protocols at institutions that conduct medical research.

The Institutional Review Board Guidebook published by the Department of Health and Human Services (DHHS) Office for Human Research Protections suggests that "[t]he child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if he or she agrees to participate.

Tip for Parents and Guardians -- Children's Expectations:

Many parents feel the desire to protect their child from learning about the possible discomforts and inconveniences of the trial, and only tell them about the good that may come of it. However, it's essential they be given a complete picture of what the trial involves and have access to as much information as they want. This is likely to help them understand what is expected of them, and how they may feel, as they participate in research.

Like the informed consent process, the assent process is intended to be an ongoing, interactive conversation between the research team and the child or young adult. The research team may include doctors (who are often principal investigators and leading the study), nurses, social workers and other health care professionals. The process is not about getting the young person "to sign on the dotted line"; rather, it is about making sure they understand the trial and what it means to participate. By engaging young people in understanding the research project, health care providers and young patients may become "partners" in the project. Children are likely to feel more in control and more involved in the trial as a result.

Although the assent process varies from institution to institution, certain elements remain constant. Before the process can begin, parents or guardians must give permission for their children to participate. Then, the child or teenager may be provided with a form that explains, in concrete and age-appropriate terms, the purpose of the research, what they will be asked to do, and what procedures they will undergo. For older adolescents (ages 16 or older), this might look very much like the adult informed consent document. For younger children, the terms and explanations will be greatly simplified into words they can understand.

Usually, the principal investigator in charge of the study, or a nurse or other health professional working with the investigator, explains the information and gives the child a chance to ask questions. The process typically takes place apart from parents or the key researchers on the study, so that the young person does not feel undue pressure. In some cases, though, especially when teenagers are involved, the assent process may turn into a discussion that includes parents, the potential participant, and researchers.

Whatever form it takes, the process should always make clear that the young person has the right to leave the trial, at any time and for any reason, without penalty or consequences, and that any information gathered will be kept confidential.

The research team may use other approaches in addition to written forms, conversations, and question-and-answer sessions. These might include videotapes, diagrams, pictures, or drawings. Researchers also may provide a chance for the young person to speak with other children or teens who have been in similar trials and are willing to talk about their experiences.

Tip for Parents and Guardians -- Learning Styles:

If your child seems to be struggling with the information the research team presents, ask about other strategies that might be tried. For instance, if your child learns better through seeing or hearing information, rather than just reading it, ask about videotapes or other visual aids.

It may take several sessions before the research team feels that the young person has developed a clear understanding of the what the trial involves. At that point, he or she is asked to indicate assent or dissent either by signing the form or checking off a box that says "yes" or "no" (again, it will depend on age and capabilities). A "no" answer, or dissent to participation, should be considered binding. Occasionally, as discussed elsewhere in this guide, situations exist where a young person's assent is not required.

Tip for Parents and Guardians -- Watch for Gaps:

Although a child or adolescent may say that he or she understands that a choice exists, they may not be able to identify all the possible options and consequences. If there seem to be gaps in your child's understanding, it may help to go back over the information.