SOCRA Institutional Review Board (IRB) 3

Question 1

For research involving children that poses greater than minimal risk and offers no direct benefit, which regulatory criterion must be met?

Accepted Answer

The risk must represent only a minor increase over minimal risk and yield generalizable knowledge about the disorder

Answer

Under 45 CFR 46.406, research with children involving more than minimal risk and no direct benefit must present only a minor increase over minimal risk and offer generalizable knowledge about the subjects' disorder or condition.

Question 2

What is the key distinction between 'assent' and 'consent' in pediatric research?

Accepted Answer

Assent is the child's affirmative agreement; consent is the legally valid permission from parents or guardians

Answer

Assent refers to a child's affirmative agreement to participate, while parental or guardian consent provides the legally authorized permission.

Question 3

Which federal subpart specifically provides additional protections for prisoners as research subjects?

Accepted Answer

45 CFR 46 Subpart C

Answer

45 CFR 46 Subpart C specifically addresses additional protections for prisoners involved as research subjects.

Question 4

Which of the following is a required safeguard when prisoners are enrolled in research?

Accepted Answer

At least one IRB member must be a prisoner or prisoner representative

Answer

45 CFR 46 Subpart C requires that a majority of the IRB members involved in reviewing prisoner research have no association with the prison, and at least one member must be a prisoner or prisoner representative.

Question 5

When may an IRB waive the requirement to obtain parental permission for research involving children?

Accepted Answer

When the research involves no more than minimal risk and the waiver would not adversely affect subjects' rights

Answer

The IRB may waive parental permission when the research involves no more than minimal risk and the waiver would not adversely affect the rights and welfare of subjects.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Institutional Review Board (IRB) 3