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. What procedure describes the action to be taken by the investigator?

Answer 1

The researcher must adhere to the informed consent (IC). It is generally used in medicine. Is the formal medical procedure, an ethical requirement, and a right recognized by the legislations of all countries, whose objective is to apply the principle of patient autonomy. It implies the obligation to respect patients as individuals and honor their preferences. It is the authorization that a person with full physical and mental faculties makes so that the health professionals can carry out a diagnostic or therapeutic procedure after having understood the information provided about them.