CIP Protocol Review & Approval Process 3

Question 1

A researcher proposes to use deception in a study by telling participants they are testing a product when they are actually observing social behavior. What IRB requirement most directly applies?

Accepted Answer

The IRB must determine that debriefing will be provided and that deception is necessary to the study's validity

Answer

When deception is used, the IRB must ensure that participants will be debriefed as soon as possible and that the deception is scientifically necessary.

Question 2

Under 21 CFR Part 56, which entity has the authority to inspect an IRB's records and operations?

Accepted Answer

Both OHRP and FDA, each within their respective jurisdictions

Answer

OHRP oversees compliance with the Common Rule (45 CFR 46) for HHS-funded research, while FDA regulates IRBs reviewing FDA-regulated products under 21 CFR 56.

Question 3

When reviewing a protocol for a vulnerable population (e.g., children), what additional criterion must the IRB satisfy before approval?

Accepted Answer

The research must meet the applicable subpart requirements, such as Subpart D categories for allowable risk levels

Answer

Research involving children must satisfy one of the risk-benefit categories in 45 CFR 46 Subpart D (46.404–407) in addition to the standard approval criteria.

Question 4

What is the purpose of a 'Certificate of Confidentiality' in the context of IRB-reviewed research?

Accepted Answer

It protects researchers from being compelled to disclose identifiable research data in legal proceedings

Answer

A Certificate of Confidentiality, issued under 42 USC 241(d), prohibits compelled disclosure of identifiable research information in any federal, state, or local civil, criminal, or administrative proceedings.

Question 5

An IRB is reviewing a multi-site clinical trial coordinated by a lead institution. What mechanism allows one IRB to serve as the IRB of record for all participating sites?

Accepted Answer

A single IRB (sIRB) reliance agreement or authorization agreement

Answer

Reliance agreements (authorization agreements) allow one reviewing IRB to serve as the IRB of record for multiple sites, which is now mandated for most federally funded multi-site research under the revised Common Rule.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Protocol Review & Approval Process 3