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?

Answer 1

When a 10-year-old child declines to participate in a research study requiring assent, the investigator must respect the child's decision and cannot include the child in the study.

Step-by-step explanation:

If a 10-year-old child firmly declines to participate in a federally funded research study that requires assent for involvement, the investigator must respect the child's decision not to participate. In research involving minors, assent is the agreement of someone not of the age of majority and is distinct from consent, which is legally recognized and typically provided by the parent or guardian. The investigator must honor the assent process just as they would with informed consent, ensuring that participation is voluntary and that the child's choice is respected without penalty or negative consequences.

Answer 2

The researcher should respect and honour the child's decision

Step-by-step explanation:

According to the National Research Act of 1974, the consent of a research subject is necessary for a research to go on. if a test subject refuses to give consent to his or her inclusion in a study, his or her decision should be honoured by the researcher.