Question

An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study?
Assent is not required, however, both parents must give permission for the inclusion of the adolescent child.
Assent of the child only is required.
Assent is not required, however, one parent must give permission for the inclusion of the adolescent in this study.
Assent of the child and permission of both parents are required.

Answer 1

The correct answer is D. Assent of the child and permission of both parents are required.

Explanation:

In any research study, it is required to ask for the assent of the participants, no matter if the risk is low, which is established by the Institutional Review Board or IRB that regulates ethics in research. This implies in the case presented, the assent of the child is necessary, especially because a medical procedure (additional bone marrow aspirates) will be performed, and this is related to risks.

Besides this, if the participant is a minor the permission of both parents or the legal is needed as the child might not have the maturity to decide whether to participate in the research study. Thus, the requirements are " Assent of the child and permission of both parents are required".