CIP Protocol Review & Approval Process 3 — Questions and Answers
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?
- Deception studies are prohibited under the Common Rule
- The IRB must determine that debriefing will be provided and that deception is necessary to the study's validity (Correct answer)
- Waiver of consent is automatically granted for all deception studies
- The study must qualify as exempt to use any deceptive elements
Correct 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.
Question 2: Under 21 CFR Part 56, which entity has the authority to inspect an IRB's records and operations?
- The Office for Human Research Protections (OHRP) exclusively
- The Food and Drug Administration (FDA)
- Both OHRP and FDA, each within their respective jurisdictions (Correct answer)
- The National Institutes of Health (NIH)
Correct 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.
Question 3: When reviewing a protocol for a vulnerable population (e.g., children), what additional criterion must the IRB satisfy before approval?
- The study must offer direct benefit to each child enrolled
- The research must meet the applicable subpart requirements, such as Subpart D categories for allowable risk levels (Correct answer)
- Children may only participate in research already approved at another institution
- Parental permission always eliminates the need for assent from the child
Correct 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.
Question 4: What is the purpose of a 'Certificate of Confidentiality' in the context of IRB-reviewed research?
- It certifies that the IRB has maintained confidential records of its meetings
- It protects researchers from being compelled to disclose identifiable research data in legal proceedings (Correct answer)
- It exempts the study from HIPAA requirements
- It certifies that participants have been informed of all confidentiality limits
Correct 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.
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?
- A Memorandum of Understanding (MOU)
- A single IRB (sIRB) reliance agreement or authorization agreement (Correct answer)
- An Investigational New Drug (IND) application covering all sites
- A HIPAA Business Associate Agreement
Correct 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.
Question 6: Which of the following best describes the 'minimal risk' standard as defined under 45 CFR 46?
- Risk that is no greater than what subjects would encounter in their normal daily lives or during routine physical exams (Correct answer)
- Risk that is acceptable given the anticipated benefits of the research
- Risk that has been deemed tolerable by the IRB based on study population characteristics
- Risk that is present in fewer than 10% of study participants
Correct 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.
Question 7: 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?
- Tabled decision
- Deferred approval
- Approval contingent on minor modifications (verified by chair or designee) (Correct answer)
- Provisional disapproval
Correct 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.
CIP Protocol Review & Approval Process 3
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?