Protocol Review & Approval Process Flashcards
7 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Protocol Review & Approval Process flashcards as text
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?
Answer: The IRB must determine that debriefing will be provided and that deception is necessary to the study's validity
When deception is used, the IRB must ensure that participants will be debriefed as soon as possible and that the deception is scientifically necessary.
Under 21 CFR Part 56, which entity has the authority to inspect an IRB's records and operations?
Answer: Both OHRP and FDA, each within their respective jurisdictions
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.
When reviewing a protocol for a vulnerable population (e.g., children), what additional criterion must the IRB satisfy before approval?
Answer: The research must meet the applicable subpart requirements, such as Subpart D categories for allowable risk levels
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.
What is the purpose of a 'Certificate of Confidentiality' in the context of IRB-reviewed research?
Answer: It protects researchers from being compelled to disclose identifiable research data in legal proceedings
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.
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?
Answer: A single IRB (sIRB) reliance agreement or authorization agreement
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.
Which of the following best describes the 'minimal risk' standard as defined under 45 CFR 46?
Answer: Risk that is no greater than what subjects would encounter in their normal daily lives or during routine physical exams
45 CFR 46.102(j) defines minimal risk as risks not greater in probability and magnitude than those ordinarily encountered in daily life or during routine physical or psychological examinations.
Which approval action is appropriate when the IRB determines that a protocol requires modifications before it can be approved, but the changes are minor enough to be verified by the chair rather than returned to the full board?
Answer: Approval contingent on minor modifications (verified by chair or designee)
Many IRBs use a 'conditional approval' or 'approval pending minor modifications' action where the chair verifies that required changes were made without reconvening the full board.