CIP Protocol Review & Approval Process 5

Question 1

A protocol is submitted for IRB review mid-year with a funding expiration deadline in 3 months. Which aspect of the timeline is the IRB obligated to consider when scheduling review?

Accepted Answer

The IRB should schedule review in a timely manner but is not obligated to alter its review process or standards based on funding deadlines

Answer

While IRBs should conduct reviews in a timely manner, funding deadlines do not change the applicable review standards or obligate the IRB to compromise its process.

Question 2

What is the significance of 'assent' in the context of IRB-approved research involving children?

Accepted Answer

Assent is the child's affirmative agreement to participate, which is required in addition to parental permission when the child is capable of providing it

Answer

Assent reflects respect for the developing autonomy of children; the IRB must determine when assent is required and whether any child's dissent should be respected even if parents consent.

Question 3

An IRB is reviewing a protocol involving prisoners. Which Subpart of 45 CFR 46 provides additional protections for this population?

Accepted Answer

Subpart C

Answer

Subpart C of 45 CFR 46 (46.301–46.306) provides additional protections for prisoners as research subjects, including requirements for the composition of the IRB and permissible categories of research.

Question 4

Which of the following best describes a 'protocol deviation' versus a 'protocol violation' in IRB oversight?

Accepted Answer

Deviations are unplanned departures that do not affect subject safety; violations are departures that affect subject rights, safety, or data integrity

Answer

While terminology varies by institution, deviations typically refer to minor unplanned departures without safety impact, while violations involve departures that may compromise participant safety, rights, or data integrity.

Question 5

An investigator wants to conduct a study entirely within a single classroom using an educational intervention on normal school curriculum. Under 45 CFR 46, which exemption category is most applicable?

Accepted Answer

Category 1 — research conducted in established educational settings involving normal educational practices

Answer

Category 1 exemption applies to research involving normal educational practices in established educational settings, such as comparing instructional methods or curricula.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Protocol Review & Approval Process 5