Are there any guidelines for obtaining assent from children?
The federal regulations repeatedly refer to “adequate provisions…for the assent of the children.” However, the regulations leave it up to IRBs to determine what constitutes adequate provisions, and IRBs vary greatly in how they address the issue. However, there does seem to be broad agreement on two matters. First, investigators have a moral obligation to take a child’s refusal to become a research subject very seriously. Second, the age at which the child should have an opportunity to accept or refuse participation varies with a) the child’s maturity / intelligence / understanding of the situation (rather than an arbitrary age) and b) the circumstances of the research. Children younger than eight years usually cannot meaningfully reason about the benefits and consequences of participation in research. However, they may well understand concrete aspects of what an investigator will ask of them, such as cooperation with procedures. Also, chronically ill children often have an appreciatio
Related Questions
- Are the new China Center of Adoption Affairs (CCAA) guidelines any different for the China Waiting Children Program than for the traditional China Program?
- Do parental permission and child assent for research involving children have to occur at the same time or in any particular order?
- Can you suggest a reliable source of information about sound nutritional guidelines for young children?
