How can we investigate the effects of caffeine on performance of a balance task in children? Are there any considerations, ethical problems or health risks for caffeine usage in children?
In PubMed, I was quickly able to find 19 clinical trial studies that used caffeine consumption by children. (I know that there are more out there.) I would interpret this to indicate that the researchers and their institutional review boards did not consider the risks of caffeine consumption to be more than minimal. I am assuming that for these studies, the period of caffeine consumption was brief.
Regarding the health aspects of the study, it all depends to whether caffeine is considered hazardous to children or not. I know that a recent position paper from the American Academy of Pediatrics said that high caffeine loads are not appropriate for children.
How prolonged will the intake of caffeine be? What is the dosage? From your description, I can guess that this will be an one/two time intake. These would be some answers that the IRB would want to get here in the US to grant permission for the study.
I believe it sends the wrong message for kids to use any type of substance in an attempt to boost performance. If I were on an IRB I would strongly question the purpose of such a study.
Dear Saeed: what is the purpose of the study? Children are a vulnerable population in research, and ethics principles state that carrying a research in children should consider: 1) the aim of the research should be to address a children's problem, and to give answers that could improve their health. 2) if the research can be done in adult population, should it be that way, in first place. 3) no risk or minimal risk to the research subjects is the golden standard. Being a member of a Bioethics Committee at a Pediatrics' setting I would like to know these answers first, in order to consider the protocol.
Cheers. Susie.
This is a complex question. Dose may be relevant. Many children are exposed to caffeine in low doses on a regular basis, through tea, soda, chocolate, etc. Some would argue that this is not good for their health but low-dose exposure is not generally considered an excessive risk. If the risk is small and there are potential benefits, it may be justifiable. Children with specific risk factors, such as certain arrhythmias should be screened out.
This is a question to be answered by your IRB after reviewing the full protocol and considering risks and benefits of the study.