[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.
- Some children have limited or no language skills. Keep in mind that certain medical conditions are associated with developmental delays, including language skills.
- Children are growing, so anything that retards growth will have serious consequences in children.
- Children have different nutritional requirements than adults.
- The liver of a child changes as the child grows, and the ability to perform biotransformations can be quite different than adults and quite different among younger and older children.
- Adolescents who are learning to become independent, to make their own choices, and to live their own lives, will often rebel by failing to adhere to medical treatments.
- Very young children will have more difficulty swallowing pills than adults.
- The dietary habits of children are different than most adults.
- The environmental exposures of children are different than most adults.
- Children will never or almost never have certain chronic conditions that plague us adults, such as narrowing of the arteries, dementia, or arthritis.
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.
research](../category/EthicsInResearch.html). for pages similar to this one at [Category: Ethics in with general help resources. You can also browse Children’s Mercy Hospital website. Need more information? I have a page reproducing it here as a service, as it is no longer available on the Hospital. Although I do not hold the copyright for this material, I am This page was written by Steve Simon while working at Children’s Mercy