StATS: Special issues for research involving children (created 2006-09-15)

Research is difficult enough, but it becomes more difficult when the research involves children. The issues that you need to consider are physiologic, ethical, and statistical.

The physiologic issues can be summarized in the well known saying "children are not little adults." You cannot scale things down because children have physiologic issues that adults do not have to deal with. These issues are not always at play, but you should always think about these things when planning a research study.

There are legal constraints on what you can do to a child in a research setting, and it is impossible to summarize this as the legal requirements from state to state and from country to country.

The ethical issues for research involving children are quite complex. They can be broadly summarized into three categories: consent, financial incentives, and risk.

Consent: Children under a certain age (the age varies depending on the context and the locality of the research) are unable to consent by themselves for medical procedures, much less medical procedures in the context of a research study. Generally, you need to get permission from one parent (or sometimes both parents). When the child is able to understand what is going on, you also need to get assent from the child.

Financial incentives: This is a troublesome area. Some ethicists argue that any financial incentives are inappropriate.

Risk: There is a level of risk that you or I as adults would be willing to shoulder in an altruistic effort to help others who may have the same disease. In general, we do not allow children to shoulder the same degree of risk.

Statistical issues can be divided into two areas: subgroup analysis and sample size issues.

[[To be continued...]]

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Ethics in research.