Writing an assent form for minors to sign
This may require a professional’s touch
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IRBs will need to have an assent form to provide minors who will be involved in clinical research involving products regulated by the U.S. Food and Drug Administration (FDA), and the same form could be used for other clinical research as well. But how can the IRB make certain the assent form is written simply and clearly enough to be capable of fulfilling its purpose? "Don’t forget that kids of a given age vary widely in their reading fluency, grasp of scientific concepts, degree of magical thinking, altruistic sense, and a bazillion other things that have impact on consent or assent," says Dale E. Hammerschmidt, MD, FACP, associate professor of medicine and director of Education in Human Subjects’ Protection at the University of Minnesota Medical School in Minneapolis. "Having a good form is one thing, but having a good assent discussion may be an entirely different thing and may require tailoring the product to the child," Hammerschmidt says.
Consider these suggestions
Nonetheless, here are some of Hammerschmidt’s suggestions for how to write an assent form directed at children:
• Ask a trained professional to write the form. Don’t assume that you can write well for children unless you’ve had formal training in doing so, Hammerschmidt says. Child psychologists, therapists, educators, or pediatricians are possible candidates for learning how to write such a form.
• Use reading level scores as rough guides. Consent/assent language is likely to be different from the language used in computer programs that determine a child’s reading level, so these test scores should not be considered entirely representative, Hammerschmidt says.
• Find a consultant. "If there is a writing-for-children program at your university, don’t hesitate to get a formal consultation," Hammerschmidt says.
Get help from the pros
• Ask children to help with the form. "Sit down with a kid of the target age group and talk about the study until you think the kid understands it pretty well," Hammerschmidt suggests. "Then have the kid help you write the assent form." Once that form is written, it can be given to a second child of the target age group. "Then ask the second child to explain the study after reading the form," Hammerschmidt says. "Sometimes the results are gratifying, and sometimes they’re startling."
• Have a nonthreatening adult give the child the assent form to sign. "Don’t forget that children may be more easily intimidated by and/or more easily resentful of an authority figure," Hammerschmidt says. "A person with a neutral image may be able to do a better job than a doc in a white coat."
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