Question

A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?
a, Seek permission from one of the child's parent instead.
b, Request the child reconsider assenting to the study.
c, Honor the child's decision.
d, Consent both of the child's parents instead.

Answer 1

The answer is: Honor the child's decision.

Studies that conducted by the researchers could potentially caused unwanted physical and psychological damage to the subjects. This is why IRB often required the subjects' consent to make sure that the subjects are completely comfortable in being involved in the studies.

Several reasons might cause the child to refuse the offers to be involved in that study. (that child might find the idea of giving his/her urine to be disturbing).The investigator need to honor the child's decision in such situation in order to prevent any form of  psychological trauma to happen.