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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. (See
Monitoring the Safety of Clinical Trials.)
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.
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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.
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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 principial
investigators and leading the study), nurses, social workers and other health
care professionsals. 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.
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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.
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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.
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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. |
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