The IRB will look to see if there is undue inducement. Many of the ethical and safety issues related to research in children will be addressed in a report due out this month from the Office for Human Research Protections, says Koski. The document will even suggest how researchers should handle situations in which parents of a critically ill child consent to research but the child opposes the experimental treatment. In the meantime, parents should take their time before entering a child in a research program, experts say. The informed consent document should be written in clear, understandable language.
Many hospitals offer forms in English and Spanish.
The decision to enter a trial can be more complicated if a child is seriously ill, says Goad. In that case, you may need a second opinion. When a child is ill, research typically involves a choice between the standard therapy and the drug under investigation, experts say. A solicitation to enter a clinical trial should never be high-pressure, says Angst. It is voluntary.