somewhat mixed directions on the question of a minimum age for seeking affirmative assent. As long as investigators and IRB members recognize that the assent process for young children should be age appropriate and quite simple, it is not unreasonable for investigators to be asked to seek assent for children as young as age 7 years. (Such an age-defined policy may be useful for practical reasons, but investigators should also be encouraged to provide simple explanations for children younger than that age who seem to be capable of understanding basic information.)

For younger children (to age 9 or 10), assent information and procedures can be limited and can focus on a subset of the information required for adults. For example, the discussion and, if appropriate, written material or assent form for younger children should explain in simple language

  • what the study is about and whether it might help (e.g., “We want to see whether a new medicine will or won’t help children like you who have earaches.” or “We want to understand your illness better.”);

  • what will happen and when (e.g., “You will have to come to the clinic once a week for 8 weeks to have a shot, you will not be allowed to eat for 12 hours, and then the following things will happen: …”);

  • what discomfort there might be and what will be done to minimize it (e.g., “Your head may hurt after the test and you may need to stay in bed for a day.” “You will get a cream on your skin that will keep you from feeling the shot.” or “You will have someone to whom you can talk about your feelings.”);

  • who will answer the child’s questions during the study; and

  • whether an option to say “no” exists (e.g., “You do not have to be in this study and no one will be mad at you.” or “If you say “yes” and then change your mind, that is okay.”).

With the increasing age of the child, assent information should become correspondingly more substantive and specific and should use language appropriate to the cognitive and emotional maturity of the child or adolescent. The nearer an adolescent is to the age of majority, the more the assent process should resemble a well-designed informed-consent process for adults. Most research suggests that by age 14 or 15 years adolescents are similar to adults in their ability to comprehend the meaning of participation in research, although they may still be maturing in other areas of understanding and decision making. If consent forms for adults are written to be easily read by those with reading skills at less than a high school level, they may be appropriate to use as the assent form for middle to older adolescents. As for adults, in designing assent processes and written information for children and adolescents, investigators should take into account the



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