Involves the analysis factor, observational factor and avoid the confinement of animals in a laboratory. 2-HOW ARE STUDIES INVOLVING MINORS REGULATED IN YOUR COUNTRY? parental consent is required, a family interview before the research to define boundaries and decide whether or not to participate. 3-WHY ARE THE ETHICAL REGULATIONS NECCESARY? They are necessary because they ensure that the research does not cause harm to the study subject.