CRP Regulatory Compliance & Guidelines 3 — Questions and Answers
Question 1: A researcher wants to conduct a retrospective chart review using de-identified patient records at a hospital. Which of the following is most accurate regarding IRB oversight?
- Full IRB review is always required for any access to medical records
- The research may qualify for exemption if data cannot be linked back to individuals (Correct answer)
- HIPAA authorization is sufficient; no IRB review is needed
- Retrospective studies are automatically exempt from all federal regulations
Correct answer: The research may qualify for exemption if data cannot be linked back to individuals
Retrospective chart reviews using truly de-identified data may qualify for IRB exemption because de-identified data does not meet the definition of human subjects research under 45 CFR 46.
Question 2: Which of the following best describes a 'minimal risk' study under the Common Rule (45 CFR 46)?
- A study in which no participant has ever been harmed in any prior similar research
- The probability and magnitude of harm are not greater than those encountered in daily life or routine physical/psychological examinations (Correct answer)
- A study that involves no more than one interview session with participants
- Any study approved for expedited review by the IRB
Correct answer: The probability and magnitude of harm are not greater than those encountered in daily life or routine physical/psychological examinations
The Common Rule defines minimal risk as research where the probability and magnitude of harm are not greater than those ordinarily encountered in daily life or routine examinations.
Question 3: Under HIPAA, which of the following is NOT one of the 18 identifiers that must be removed to create a de-identified dataset under the Safe Harbor method?
- Full ZIP codes (all 5 digits)
- Dates (other than year) directly related to an individual
- Participant's research ID number assigned by the study team (Correct answer)
- Geographic subdivisions smaller than a state
Correct answer: Participant's research ID number assigned by the study team
Research ID numbers assigned by the study team are not PHI identifiers under HIPAA's Safe Harbor method; the 18 identifiers include account numbers, SSNs, and medical record numbers but not arbitrary study codes.
Question 4: A clinical trial sponsored by a pharmaceutical company is underway. The FDA inspects the site and finds that the investigator failed to follow the protocol. Under 21 CFR Part 312, what action can FDA take?
- Only issue a warning letter with no further authority
- Disqualify the investigator from receiving investigational drugs (Correct answer)
- Require the IRB to revoke the investigator's approval immediately
- Impose criminal penalties on all site staff
Correct answer: Disqualify the investigator from receiving investigational drugs
Under 21 CFR Part 312.70, FDA can disqualify a clinical investigator who has repeatedly or deliberately failed to comply with regulatory requirements.
Question 5: Which element of informed consent is required under 45 CFR 46.116 but is often misunderstood as optional?
- A statement that participation is voluntary and refusal involves no penalty (Correct answer)
- The name of the IRB chairperson to contact with complaints
- The participant's social security number for identification
- A promise that the study will benefit the participant personally
Correct answer: A statement that participation is voluntary and refusal involves no penalty
45 CFR 46.116 explicitly requires that consent documents state participation is voluntary and that refusal or withdrawal will involve no penalty or loss of benefits.
Question 6: What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- To ensure that all data is entered into the database within 24 hours of collection
- To independently monitor accumulating data and recommend stopping or modifying the trial if safety concerns arise (Correct answer)
- To audit financial expenditures and ensure the sponsor stays within budget
- To certify that electronic data capture systems comply with 21 CFR Part 11
Correct answer: To independently monitor accumulating data and recommend stopping or modifying the trial if safety concerns arise
A DSMB independently reviews accumulating trial data to protect participant safety and may recommend halting or modifying a study if risk-benefit balance shifts unfavorably.
Question 7: Under the FDA's regulations for Institutional Review Boards (21 CFR Part 56), how often must an IRB conduct continuing review of approved research?
- At least once every 6 months for all studies
- At least once per year, or more frequently if specified by the IRB (Correct answer)
- Every 2 years for minimal-risk studies; annually for greater-than-minimal-risk studies
- Only when a protocol amendment is submitted
Correct answer: At least once per year, or more frequently if specified by the IRB
21 CFR Part 56 requires IRBs to conduct continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year.
CRP Regulatory Compliance & Guidelines 3
A researcher wants to conduct a retrospective chart review using de-identified patient records at a hospital.
Which of the following is most accurate regarding IRB oversight?