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) No more than minimal risk to the child
(b) Honor the Childs decision
(c) Assent of the child and permission of both parents are required.
(d) None of the above

Answer 1

Answer: 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.

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.

The best procedure that describes the action to be taken by the investigator is:

• Honor the Childs decision .

Explanation:    

The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. It promotes fully informed and voluntary participation by prospective subjects capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy), and seeks to maximize the safety of subjects.

The capacity admits degrees. The same patient may be able to decide certain things and not others. So, the more transcendent or delicate a decision is, the higher the level of capacity required must be. When the patient is not capable, it is up to his relatives to make the decisions.